Implantable Composite Apparatus and Method

• US 20080269750A1
• Filed: 02/07/2008
• Published: 10/30/2008
• Est. Priority Date: 04/24/2007
• Status: Active Grant

• Current Assignee: FlexFix, LLC
• Original Assignee: OsteoLign, Inc.
• Inventors: Justin, Daniel F.
• Granted Patent: US 8,167,881 B2
• Time in Patent Office: Days
• US Class Current: 606/63
• CPC Class Codes: A61B 17/7044 also having plates, staples or washers bearing on the vertebrae
• CPC Class Codes: A61B 17/7059 Cortical plates A61B17/7007, A61B17/7058 take precedence
• CPC Class Codes: A61B 17/7064 Devices acting on, attached to, or simulating the effect of, vertebral facets; Tools therefor
• CPC Class Codes: A61B 17/7071 Implants for expanding or repairing the vertebral arch or wedged between laminae or pedicles; Tools therefor
• CPC Class Codes: A61B 17/72 Intramedullary pins, nails or other devices A61B17/744 takes precedence
• CPC Class Codes: A61B 17/7208 Flexible pins, e.g. ENDER pins
• CPC Class Codes: A61B 17/7233 with special means of locking the nail to the bone
• CPC Class Codes: A61B 17/7275 with expanding cylindrical parts
• CPC Class Codes: A61B 17/80 Cortical plates , i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates
• CPC Class Codes: A61B 17/864 hollow, e.g. with socket or cannulated
• CPC Class Codes: A61B 17/866 Material or manufacture
• CPC Class Codes: A61B 2017/00004 (bio)absorbable, (bio)resorbable, resorptive for implantable prostheses A61F2210/0004
• CPC Class Codes: A61F 2/0077 Special surfaces of prostheses, e.g. for improving ingrowth A61F2/30767 takes precedence
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61F 2/91 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
• CPC Class Codes: A61F 2/915 with bands having a meander structure, adjacent bands being connected to each other
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2250/0052 differing in bone ingrowth capacity
• CPC Class Codes: A61L 2400/06 Flowable or injectable implant compositions
• CPC Class Codes: A61L 2400/16 Materials with shape-memory or superelastic properties
• CPC Class Codes: A61L 2430/02 : for reconstruction of bones; weight-bearing implants
• CPC Class Codes: A61L 27/18 : obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61L 27/50 : Materials characterised by their function or physical properties , e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
• CPC Class Codes: A61M 29/02 : Dilators made of swellable material balloon catheters for angioplasty A61M25/104

Abstract

The present invention provides a bone fixation device for implantation into the intramedullary canal of a bone. The bone fixation device may have a composite portion including a support structure and a thermo-chemically activated matrix, and may have a non-composite portion. The support structure may be radially expandable and contractible, and sufficiently flexible to be inserted into the intramedullary canal through an opening not parallel to the intramedullary canal. The matrix may attain a first thermo-chemical state via the addition of energy, and a second thermo-chemical state via the dissipation of energy. While in the first thermo-chemical state, the matrix is substantially deformable and can conform to a shape matching the contours of the intramedullary canal of the bone. As the matrix attains the second thermo-chemical state, it may crystallize and becomes substantially hardened. An implant deformation apparatus may be used to expand the device within the intramedullary canal.

Claims

1. A device configured to be implanted in a mammal, the device comprising:

a first composite portion comprising;

a thermo-chemically activated thermoplastic matrix material configured to be substantially deformable at a first thermo-chemical state and substantially hardened at a second thermo-chemical state; and

a second non-composite portion permanently joined to the first composite portion to form an elongated shape in combination with the first composite portion.

2. The implantable device of claim 1, wherein the implantable device is configured to be implanted in the intramedullary canal of a bone to provide intramedullary bone fixation.

3. The implantable device of claim 1, wherein the second non-composite portion comprises a biocompatible material chosen from the group consisting of:

metals, metal alloys, ceramics, and polymers.

4. The implantable device of claim 1, wherein the first composite portion has an elongated shape and is configured to be radially expandable.

5. The implantable device of claim 1, wherein the first composite portion further comprises a support structure.

6. The implantable device of claim 1, further comprising a third non-composite portion permanently joined to the first composite portion.

7. The implantable device of claim 6, wherein the third non-composite portion comprises the thermo-chemically activated thermoplastic matrix material configured to be substantially deformable at a first thermo-chemical state and substantially hardened at a second thermo-chemical state.

8. The implantable device of claim 6, wherein the first composite portion, the second non-composite portion and the third non-composite portion are positioned in a substantially linear sequence along a length of the implantable device, wherein the first composite portion is positioned adjacent to the second non-composite portion and to the third non-composite portion.

9. A device configured to be implantable contiguous to a bone in a mammal, the implantable device comprising:

a first portion; and

a second portion permanently joined to the first portion to form an elongated shape in combination with the first portion;

wherein the first portion is radially expandable to a first diameter and the second portion is radially expandable to a second diameter, wherein the first diameter is greater than the second diameter.

10. The implantable device of claim 9, wherein the first portion comprises a composite formed of at least two non-identical biocompatible materials, and the second portion comprises a single biocompatible material, wherein the biocompatible materials are selected from the group consisting of:

metals, metal alloys, polymers, and ceramics.

11. The implantable device of claim 9, wherein the first portion comprises a composite formed of a thermo-chemically activated thermoplastic matrix material and a biocompatible material non-identical to the thermo-chemically activated thermoplastic matrix material.

12. The implantable device of claim 9, wherein the implantable device is a bone fixation device configured to be implanted in the intramedullary canal of a bone.

13. A bone fixation device comprising:

a first composite portion having a first end and a second end; and

a second non-composite portion having a first end and a second end, wherein the second end of the second non-composite portion is permanently joined to the first end of the first composite portion to form an elongated shape configured to be implanted in the intramedullary canal of a bone.

14. The bone fixation device of claim 13, wherein the first composite portion comprises a composite formed of at least two non-identical biocompatible materials, and the second non-composite portion comprises a single biocompatible material, wherein the biocompatible materials are selected from the group consisting of:

metals, metal alloys, polymers, and ceramics.

15. The bone fixation device of claim 13, wherein the first composite portion has an elongated shape and is configured to be radially expandable.

16. The bone fixation device of claim 13, further comprising a third non-composite portion having a first end and a second end, wherein the first end of the third non-composite portion is permanently joined to the second end of the first composite portion.

17. A method for implanting an implantable device in a mammal, the implantable device having an elongated shape and comprising a first thermo-chemically activated composite portion which is deformable at a first thermo-chemical state and hard at a second thermo-chemical state, and a second non-composite portion permanently joined to the first thermo-chemically activated composite portion, the method comprising:

transforming the first thermo-chemically activated composite portion from the second thermo-chemical state to the first thermo-chemical state;

inserting the implantable device into the mammal; and

transforming the first thermo-chemically activated composite portion from the first thermo-chemical state to the second thermo-chemical state to harden the first thermo-chemically activated composite portion.

18. The method of claim 17, further comprising:

increasing a temperature of the first thermo-chemically activated composite portion to transform the first thermo-chemically activated composite portion from the second thermo-chemical state to the first thermo-chemical state;

inserting the implantable device into the intramedullary canal of a bone in the mammal; and

deforming the first thermo-chemically activated composite portion within the intramedullary canal.

19. The method of claim 18, wherein increasing the temperature of the first thermo-chemically activated composite portion comprises increasing the temperature to a maximum of about 65°

C.

20. The method of claim 18, wherein deforming the first thermo-chemically activated composite portion within the intramedullary canal comprises radially expanding the first thermo-chemically activated composite portion.

21. The method of claim 17, wherein transforming the first thermo-chemically activated composite portion from the first thermo-chemical state to the second thermo-chemical state further comprises decreasing a temperature of the first thermo-chemically activated composite portion.

22. The method of claim 21, wherein decreasing the temperature of the first thermo-chemically activated composite portion comprises decreasing the temperature to a minimum of about 15°

C.

23. The method of claim 17, wherein the implantable device further comprises a third non-composite portion permanently joined to the first composite portion such that the first composite portion, the second non-composite portion and the third non-composite portion are positioned in a substantially linear sequence along a length of the implantable device, wherein the first composite portion is positioned adjacent to the second non-composite portion, and the first composite portion is positioned adjacent to the third non-composite portion

24. The method of claim 23, further comprising inserting the implantable device in the intramedullary canal of a bone in the mammal such that the third non-composite portion enters the intramedullary canal first, followed by the first composite portion, followed by the second non-composite portion.

25. A method for stabilizing a fractured bone, comprising:

inserting an implantable device contiguous to the bone, the implantable device comprising a first portion and a second portion permanently joined to the first portion to form an elongated shape;

radially expanding the first portion to a first diameter; and

radially expanding the second portion to a second diameter;

wherein the first diameter is greater than the second diameter.

26. The method of claim 25, wherein the first portion comprises a composite formed of a thermo-chemically activated matrix material and a biocompatible material non-identical to the thermo-chemically activated matrix material.

27. The method of claim 26, wherein radially expanding the first portion further comprises:

increasing the temperature of the thermo-chemically activated matrix material; and

deforming the first portion.

28. The method of claim 25, wherein the second portion comprises a thermo-chemically activated matrix material.

29. The method of claim 28, wherein radially expanding the second portion further comprises:

increasing the temperature of the thermo-chemically activated matrix material; and

deforming the second portion.

30. The method of claim 25, further comprising inserting the implantable device into the intramedullary canal of the bone.

31. A method for stabilizing a fractured bone, the method comprising:

providing a bone fixation device comprising a first composite portion joined to a second non-composite portion to form an elongated shape; and

inserting the bone fixation device in the intramedullary canal of the fractured bone to stabilize the fractured bone.

32. The method of claim 31, wherein the first composite portion comprises at least two non-identical biocompatible materials, and the second non-composite portion comprises a single biocompatible material, wherein the biocompatible materials are selected from the group consisting of:

metals, metal alloys, polymers, and ceramics.

33. The method of claim 31, further comprising radially expanding the first composite portion within the intramedullary canal of the bone.

34. The method of claim 31, wherein the bone fixation device further comprises a third non-composite portion joined to the first composite portion to form the elongated shape.