Expandable implant for partial disc replacement and reinforcement of a disc partially removed in a discectomy and for reduction and maintenance of alignment of cancellous bone fractures and methods and apparatuses for same

• US 20040024463A1
• Filed: 04/18/2003
• Published: 02/05/2004
• Est. Priority Date: 08/27/2001
• Status: Abandoned Application

• Current Assignee: James C. Thomas Jr
• Original Assignee: James C. Thomas Jr
• Inventors: Forster, David C. Jr., Mast, Gregory M., Rowe, Travis, Thomas, James C. Jr.
• Application Number:
  US10/418,480
• Publication Number:
  US 20040024463A1
• Time in Patent Office: Days
• US Class Current: 623/17.16
• CPC Class Codes: A61B 17/70 Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
• CPC Class Codes: A61B 17/7095 the filler comprising unlinked macroscopic particles
• CPC Class Codes: A61B 17/7266 with fingers moving radially outwardly
• 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 2/4601 for introducing bone substitute, for implanting bone graft implants or for compacting them in the bone cavity
• 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 2002/30166 H-shaped or I-shaped
• CPC Class Codes: A61F 2002/30233 Stepped cylinders, i.e. having discrete diameter changes
• CPC Class Codes: A61F 2002/30235 tubular, e.g. sleeves
• CPC Class Codes: A61F 2002/30242 spherical
• CPC Class Codes: A61F 2002/30289 helically-coiled
• CPC Class Codes: A61F 2002/30299 umbrella-shaped or mushroom-shaped
• CPC Class Codes: A61F 2002/30566 Helical springs
• CPC Class Codes: A61F 2002/30576 with extending fixation tabs
• CPC Class Codes: A61F 2002/30579 with mechanically expandable devices, e.g. fixation devices
• CPC Class Codes: A61F 2002/30581 having a pocket filled with fluid, e.g. liquid
• CPC Class Codes: A61F 2002/30588 filled with solid particles
• CPC Class Codes: A61F 2002/30593 : hollow
• CPC Class Codes: A61F 2002/30841 : Sharp anchoring protrusions for impaction into the bone, e.g. sharp pins, spikes
• CPC Class Codes: A61F 2002/3093 : for promoting ingrowth of bone tissue
• CPC Class Codes: A61F 2002/4435 : Support means or repair of the natural disc wall, i.e. annulus, e.g. using plates, membranes or meshes
• CPC Class Codes: A61F 2002/444 : for replacing the nucleus pulposus
• CPC Class Codes: A61F 2002/4495 : having a fabric structure, e.g. made from wires or fibres
• CPC Class Codes: A61F 2002/4622 : having the shape of a forceps or a clamp
• 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 2002/4628 : with linear motion along or rotating motion about an axis transverse to the instrument axis or to the implantation direction, e.g. clamping
• CPC Class Codes: A61F 2002/4658 : for measuring dimensions, e.g. length
• 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 2230/0028 : Shapes in the form of latin or greek characters
• CPC Class Codes: A61F 2230/0069 : cylindrical
• CPC Class Codes: A61F 2230/0071 : spherical
• CPC Class Codes: A61F 2230/0091 : helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section
• CPC Class Codes: A61F 2230/0093 : Umbrella-shaped, e.g. mushroom-shaped
• CPC Class Codes: A61F 2310/00023 : Titanium or titanium-based alloys, e.g. Ti-Ni alloys
• CPC Class Codes: A61F 2310/00616 : Coating made of titanium oxide or hydroxides
• CPC Class Codes: A61F 2310/00982 : Coating made of collagen

Abstract

Expandable implants for repair of a defect in an intervertebral disc or in a cancellous bone fracture, and methods and apparatuses for delivering the same into the defect. The implants [generally comprise a compressed form having a size adapted for insertion into the defect, and a composition that allows the implant to expand from the compressed form into an expanded form after the implant is inserted into the defect. The expanded form of the implant has a configuration that fills the defect. The composition used to make the implant can include a shape memory alloy (SMA), Elasthane™ polyetherurethane, or any other suitable material. Further, multiple implants can be used to repair a single defect. The implants can be inserted into the defect by various types of insertion devices, including a needle that provides for percutaneous delivery.

Claims

1. An expandable shape memory alloy implant adapted for insertion into an intervertebral disc comprising means for restoring elasticity in a nucleus, an annulus, or nucleus and annulus wherein support and structure are provided to the nucleus or the annulus without use of a fusion device.

2. The expandable implant of claim 1 wherein the means for restoring elasticity comprises a configuration that prevents the expandable implant from exiting the nucleus or the annulus after insertion therein.

3. The expandable implant of claim 2 wherein the configuration comprises a compressed form having a size adapted for insertion into the nucleus or the annulus, and an expanded form that is larger than the compressed form after the expandable implant is inserted into the nucleus or the annulus.

4. The expandable implant of claim 3 adapted for positioning within a tube, needle, cannula, syringe, or other similar device, such that the expandable implant can be injected into the nucleus or the annulus percutaneously.

5. The expandable implant of claim 3 wherein the shape memory alloy is nitinol, and the expanded form is a helical sphere configuration.

6. The expandable implant of claim 5 wherein the expandable implant is encapsulated by polyetherurethane.

7. A method of repairing a defect in an intervertebral disc or in a cancellous bone fracture comprising:

loading a plurality of implant devices into a delivery device adapted for insertion into the defect, wherein the implant devices are in a compressed form;

inserting the delivery device into the defect; and

releasing the implant devices from the delivery device, wherein the implant devices transform from the compressed form to an expanded form.

8. The method of claim 7 wherein the delivery device comprises a needle having a gauge between 10-gauge and 27-gauge.

9. The method of claim 7 further comprising inserting the delivery device into the defect percutaneously.

10. The method of claim 7 wherein the implant devices comprise helical spheres formed of nitinol.

11. The method of claim 7 wherein the implant devices comprise spherical beads formed of polyetherurethane.

12. The method of claim 7 further comprising inserting a pliable pouch into the defect before inserting the implant devices, and then inserting the delivery device into a valve in the pliable pouch, and then releasing the implant devices into the pliable pouch, such that the implant devices are contained within the pliable pouch.

13. The method of claim 12 wherein the pliable pouch has a composition comprising polyetherurethane.

14. The method of claim 9 wherein the defect is in a nucleus or an annulus of the intervertebral disc, and the implant devices restore elasticity and provide support and structure without use of a fusion device.

15. The method of claim 7 wherein the cancellous bone fractures comprises distal radius fractures, tibial plateau fractures, calcaneous fractures, and vertebral compression fractures.

16. An implant for repair of a defect in an intervertebral disc or in a bone fracture or in a cartilaginous joint, wherein a plurality of the implant are used to repair the defect, and each implant comprises:

a pre-insertion shape adapted for insertion into the defect;

a composition that allows the pre-insertion shape to be transformed to a post-insertion shape after the implant is inserted into the defect; and

the post-insertion shape defines a larger volume than the pre-insertion shape.

17. The implant of claim 16, wherein the plurality of the implant provide support to the defect when each implant device is in its post-insertion shape.

18. The implant of claim 16 wherein the defect is in a nucleus or an annulus of the intervertebral disc.

19. The implant of claim 16 wherein the bone fracture comprises distal radius fractures, tibial plateau fractures, calcaneous fractures, and vertebral compression fractures.

20. The implant of claim 16 wherein the implant is adapted for insertion into a needle of a delivery device having a gauge between 10-gauge and 27-gauge, such that the implant can be inserted into the defect percutaneously.

21. An implant for repair of a defect in an intervertebral disc or in a bone fracture, the implant comprising a hollow body adapted to receive and contain multiple implant devices.

22. The implant of claim 21 wherein the implant is a pliable pouch adapted for insertion into the defect and comprises a valve that allows the implant devices to be inserted into the pliable pouch after the pliable pouch is positioned within the defect.

23. The implant of claim 22 wherein the defect is in a cartilaginous joint.