Fracture fixation systems

• US 9,730,740 B2
• Filed: 10/22/2015
• Issued: 08/15/2017
• Est. Priority Date: 07/25/2008
• Status: Active Grant

• Current Assignee: Smith & Nephew Incorporated (Smith & Nephew PLC)
• Original Assignee: Smith & Nephew Incorporated (Smith & Nephew PLC)
• Inventors: Rains, James K.
• Primary Examiner(s): Philogene, Pedro
• Application Number:
  US14/920,561
• Publication Number:
  US 20160106482A1
• Time in Patent Office: 663 Days
• Field of Search: 606 63- 68, 606 92- 94, 606191, 606192, 604 21, 604508
• CPC Class Codes: A61B 17/64 Devices extending alongside the bones to be positioned
• CPC Class Codes: A61B 17/68 Internal fixation devices , including fasteners and spinal fixators, even if a part thereof projects from the skin bone staples A61B17/0642
• CPC Class Codes: A61B 17/72 Intramedullary pins, nails or other devices A61B17/744 takes precedence
• CPC Class Codes: A61B 17/7258 with laterally expanding parts, e.g. for gripping the bone
• 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 17/82 for bone cerclage apparatus for manipulating wires or straps A61B17/8861; wires, bands or straps other than cerclage A61B17/842
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61F 2/2846 Support means for bone substitute or for bone graft implants, e.g. membranes or plates for covering bone defects nets or sleeves applied to surface of endoprostheses A61F2/30907; bone plates A61B17/80; bone regeneration in dental surgery A61C8/0006
• CPC Class Codes: A61F 2/30965 Reinforcing the prosthesis by embedding particles or fibres during moulding or dipping
• CPC Class Codes: A61F 2002/30062 (bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive
• CPC Class Codes: A61F 2210/0004 bioabsorbable
• CPC Class Codes: A61F 2210/0066 shrinkable
• CPC Class Codes: A61F 2210/0085 hardenable in situ, e.g. epoxy resins
• CPC Class Codes: A61F 2240/001 Designing or manufacturing processes
• CPC Class Codes: A61F 2250/001 for adjusting a diameter
• CPC Class Codes: A61F 2310/00179 Ceramics or ceramic-like structures
• CPC Class Codes: A61L 24/0084 containing fillers of phosphorus-containing inorganic compounds, e.g. apatite
• CPC Class Codes: A61L 2400/06 Flowable or injectable implant compositions
• CPC Class Codes: A61L 27/46 with phosphorus-containing inorganic fillers
• CPC Class Codes: A61L 27/56 Porous materials, e.g. foams or sponges
• CPC Class Codes: A61L 27/58 : Materials at least partially resorbable by the body
• CPC Class Codes: C08L 75/04 : Polyurethanes

Abstract

Systems for bone fracture repair are disclosed. One system includes a biocompatible putty that may be packed about a bone fracture to provide full loadbearing capabilities within days. The disclosed putties create an osteoconductive scaffold for bone regeneration and degrade over time to harmless resorbable byproducts. Fixation devices for contacting an endosteal wall of an intramedullary (IM) canal of a fractured bone are also disclosed. One such fixation device includes a woven elongated structure fabricated from resorbable polymer filaments. The woven elongated structure has resilient properties that allow the woven structure to be radially compressed and delivered to the IM canal using an insertion tube. When the insertion tube is removed, the woven structure expands towards its relaxed cross-sectional width to engage the endosteal wall. The woven elongated structure is impregnated with a resorbable polymer resin that cures in situ, or in the IM canal.

Claims

1. An assembly for placing a fixation device in contact with an endosteal wall of an intramedullary (IM) canal of a fractured bone, the assembly comprising:

an insertion tube having a flared proximal end and a narrow distal end;

a woven elongated structure having a closed distal end, the woven elongated structure having a relaxed cross-sectional width and a compressed cross-sectional width, wherein the relaxed cross-sectional width is at least about 50% larger than the compressed cross-sectional width; and

an injection tube having a proximal end in communication with a supply of uncured injectable resin and a distal end that is disposed axially within the woven elongated structure;

wherein the compressed cross-sectional width of the woven elongated structure is smaller than an inner diameter of the insertion tube, and wherein the relaxed cross-sectional width of the woven elongated structure is greater than an outer diameter of the insertion tube and is configured to engage the endosteal wall of the IM canal.

2. The assembly of claim 1 further comprising a retention element that surrounds the woven elongated structure for retaining resin, the retention element being selected from the group consisting of a balloon, bag and sleeve.

3. The assembly of claim 2 wherein the retention element is fabricated from a resorbable polymer.

4. The assembly of claim 1 wherein the woven elongated structure is selected from the group consisting of a braided elongated structure, a triaxial braided elongated structure, a pair of braided elongated structures with one smaller inner braided elongated structure disposed axially within a larger outer braided elongated structure, a bundle of braided elongated structures, a bundle of braided elongated structures disposed axially within an outer braided elongated structure, a braided elongated structure with a plurality of cavities extending along a length of the braided elongated structure, and an elongated structure fabricated from the spacer fabric.

5. The assembly of claim 1 wherein the woven elongated structure comprises filaments selected from the group consisting of polyurethanes, poly-alpha-hydroxy acids, polylactides, polyglycolides, poly-(D,L-lactide-co-glycolide), polyglycolide-co-trimethylenecarbonate, poly-(L-lactide), poly-(L-CO-D,L-lactide), poly-(D,L-lactide), polyglactin acid, a combination, poly-(D-lactide), combinations thereof and copolymers thereof.

6. The assembly of claim 1 wherein the woven elongated structure accommodates a plurality of loose resorbable fibers for mixing with resin injected into the woven elongated structure.

7. The assembly of claim 1 wherein the woven elongated structure accommodates an elongated structural reinforcing element.

8. The assembly of claim 1 wherein the woven elongated structure is fabricated from spacer fabric comprising a top panel, a bottom panel, and vertical fibers connecting the top and bottom panels.

9. The assembly of claim 8 wherein the vertical fibers are arranged in spaced apart groups of vertical fibers.

10. The assembly of claim 8 wherein the top and bottom panels comprise longitudinally extending fibers and transversely extending fibers, the longitudinally extending fibers being thicker than the transversely extending fibers.

11. The assembly of claim 8 wherein the vertical fibers are thicker than the transversely extending fibers.

12. The assembly of claim 8 wherein the top and bottom panels comprise longitudinally extending fibers and transversely extending fibers, the longitudinally extending fibers and the vertical fibers being thicker than the transversely extending fibers.

13. The assembly of claim 1 wherein the woven elongated structure is pre-wetted with the uncured injectable resin.

14. The assembly of claim 1 further comprising a light emitting device axially positioned within the woven elongated structure, the light emitting device being configured to cure the uncured injectable resin in situ after it is placed in the IM canal.

15. An assembly for placing a fixation device in contact with an endosteal wall of an intramedullary (IM) canal of a fractured bone, the assembly comprising:

an insertion tube having a flared proximal end and a narrow distal end;

a woven elongated structure having a closed distal end, the woven elongated structure having a relaxed cross-sectional width and a compressed cross-sectional width, wherein the relaxed cross-sectional width is at least about 50% larger than the compressed cross-sectional width;

a retention element surrounding the woven elongated structure, the retention element being fabricated from a resorbable polymer;

an injection tube having a proximal end in communication with a supply of uncured injectable resin and a distal end that is disposed axially within the woven elongated structure; and

a light emitting device axially positioned within the woven elongated structure, the light emitting device being configured to cure the uncured injectable resin in situ after it is placed in the IM canal.

16. The assembly of claim 15 wherein the compressed cross-sectional width of the woven elongated structure is smaller than an inner diameter of the insertion tube;

and

wherein the relaxed cross-sectional width of the woven elongated structure is greater than an outer diameter of the insertion tube and is configured to engage the endosteal wall of the IM canal.

17. The assembly of claim 15 wherein the woven elongated structure is selected from the group consisting of a braided elongated structure, a triaxial braided elongated structure, a pair of braided elongated structures with one smaller inner braided elongated structure disposed axially within a larger outer braided elongated structure, a bundle of braided elongated structures, a bundle of braided elongated structures disposed axially within an outer braided elongated structure, a braided elongated structure with a plurality of cavities extending along a length of the braided elongated structure, and an elongated structure fabricated from the spacer fabric.

18. The assembly of claim 15 wherein the woven elongated structure comprises filaments selected from the group consisting of polyurethanes, poly-alpha-hydroxy acids, polylactides, polyglycolides, poly-(D,L-lactide-co-glycolide), polyglycolide-co-trimethylenecarbonate, poly-(L-lactide), poly-(L-CO-D,L-lactide), poly-(D,L-lactide), polyglactin acid, a combination, poly-(D-lactide), combinations thereof and copolymers thereof.

19. An assembly for placing a fixation device in contact with an endosteal wall of an intramedullary (IM) canal of a fractured bone, the assembly comprising:

an insertion tube having a flared proximal end and a narrow distal end;

a braided elongated structure having a closed distal end, the braided elongated structure being fabricated from a spacer fabric comprising a top panel, a bottom panel, and vertical fibers connecting the top and bottom panels;

a retention element surrounding the braided elongated structure, the retention element being selected from the group consisting of a balloon, bag and sleeve; and

an injection tube having a proximal end in communication with a supply of uncured injectable resin and a distal end that is disposed axially within the braided elongated structure;

wherein the braided elongated structure has a compressed cross-sectional width and a relaxed cross-sectional width that is at least about 50% larger than the compressed cross-sectional width, the relaxed cross-sectional width being configured to engage the endosteal wall of the IM canal, and wherein the compressed cross-sectional width is smaller than an inner diameter of the insertion tube, and wherein the relaxed cross-sectional width is greater than an outer diameter of the insertion tube.

20. The assembly of claim 19 wherein the braided elongated structure is pre-wetted with the uncured injectable resin.