AN IMPLANT FOR REPAIR OF BONE DEFECTS

Abstract

An implant for repairing a segmental defect in a subject's bone at a segmental defect site, the implant comprising a scaffold for implantation at the segmental defect site and the implant optionally comprising: a plate for internal fixation, the plate being attachable to or integral with the scaffold, and the plate having means for securing it to bone outside of the segmental defect site; a hollow cavity within the scaffold; a plurality of longitudinal channels within the scaffold; and or a membrane received around the scaffold.

Claims

1. An implant for repairing a segmental defect in a subject's bone at a segmental defect site, the implant comprising: a scaffold for implantation at the segmental defect site, the scaffold comprising a body, the body having a first end and a second end, the first and second ends being first and second open ends respectively, the scaffold further comprising a cavity extending between said first and second open ends.

2. An implant according to claim 1, wherein said first and second ends of the scaffold are opposing ends.

3. An implant according to claim 1, wherein each of said first and second open ends of the scaffold is configured to engage bone at the segmental defect site when implanted.

4. An implant according to claim 1, wherein each of said first and second open ends of the scaffold is configured to abut bone at the segmental defect site when implanted.

5. An implant according to claim 1, wherein the length of the scaffold between its first and second ends is selected such that the first end of the scaffold abuts bone at one side of the segmental defect site and the second end of the scaffold abuts bone at the other side of the segmental defect site when implanted.

6. An implant according to claim 1, wherein the implant is configured for implantation at a segmental defect site in a subject's long bone.

7. An implant according to claim 6, wherein the cavity in the scaffold has a longitudinal axis, the implant being configured such that the longitudinal axis of the cavity substantially aligns with a longitudinal axis of the subject's long bone at the defect site when implanted in said long bone.

8. An implant according to claim 6, wherein the cavity is configured to align with the medullary cavity of said long bone when implanted.

9. An implant according to claim 6, wherein the cross-sectional size of the cavity is selected to substantially correspond with the cross-sectional size of the medullary cavity of said long bone when implanted.

10. An implant according to claim 6, wherein the cross-sectional size of the scaffold is selected to substantially correspond with the cross-sectional size of said long bone.

11.-17. (canceled)

18. An implant according to claim 1, wherein the scaffold further comprises a plurality of channels within its body, the plurality of channels being substantially aligned with a longitudinal axis of the scaffold.

19. (canceled)

20. An implant according to claim 18, wherein the scaffold is porous and the plurality of channels are formed by interconnected pores in the porous structure.

21.-25. (canceled)

26. An implant according to claim 1, wherein the scaffold is configured such that it has a first Young's modulus value in a direction of its longitudinal axis and a second Young's modulus value in a direction transverse to the longitudinal axis, the first and second Young's modulus values being different.

27. (canceled)

28. An implant according to claim 32, the membrane comprising: collagen and a resorbable polymer selected from: poly lactic acid (PLA); poly glycolic acid (PGA); poly lactic-co-glycolide (PLGA); polycaprolactone (PCL); and chitosan.

29. An implant according to claim 28, wherein the membrane has a first side for facing the scaffold when assembled and a second side for facing away from the scaffold when assembled, wherein the first side of the membrane is seeded with cells, preferably bone-forming cells selected from the group consisting of osteocytes, osteoblasts, osteoblast progenitor cells and stem cells.

30. An implant according to claim 28, wherein the membrane has a first side for facing the scaffold when assembled and a second side for facing away from the scaffold when assembled, wherein the second side of the membrane is seeded with cells.

31. An implant according to claim 28, wherein the membrane incorporates antibiotics and/or bactericidal compounds.

32. An implant according to claim 1, the implant further comprising a resorbable membrane received around the scaffold of the implant.

33. (canceled)

34. An implant according to claim 1, wherein the scaffold is porous.

35. An implant according to claim 1, wherein the scaffold is made of titanium mesh.

36.-41. (canceled)

Description

DESCRIPTION OF THE DRAWINGS

[0057] A preferred embodiment of the present invention will now be more particularly described by way of example only with reference to the accompanying drawings, wherein:

[0058] FIG. 1A is a diagrammatic view of an implant according to an embodiment of the invention, the implant shown implanted in a long bone, the implant including an internal fixation plate attached to a scaffold;

[0059] FIG. 1B is a diagrammatic view of an implant according to a further embodiment, the implant shown implanted in a long bone, the implant including an internal fixation plate integral with the scaffold;

[0060] FIG. 2 is a diagrammatic view of a scaffold according to an embodiment the invention;

[0061] FIG. 3 is a diagrammatic close-up view of part of a membrane and scaffold according to an embodiment of the invention;

[0062] FIG. 4 is a perspective view of a further embodiment of an implant according to the invention, the implant shown implanted in a long bone;

[0063] FIG. 5 is a perspective view of the implant of FIG. 4.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0064] The present embodiments represent currently the best ways known to the applicant of putting the invention into practice. But they are not the only ways in which this can be achieved. They are illustrated, and they will now be described, by way of example only.

[0065] Referring to FIGS. 1A and 1B, two schematic diagrams of implants according to the invention for repairing a segmental defect in a subject's bone at a segmental defect site are shown. In each of the embodiments shown in FIGS. 1A and 1B, the implant 10, 110 comprises a scaffold 20, 120 for implantation into bone at a segmental defect site 11 and a plate 30, 130 for internal fixation. In the embodiment of FIG. 1A, the plate 30 is attachable to the scaffold 20 and to the bone 12 outside of the segmental defect site 11. In the embodiment of FIG. 1B, the plate 130 is integral with the scaffold 120. In the embodiments shown in FIGS. 1A and 1B, the bone 12 is a long bone and the scaffold 20, 120 is a spacer to be received in a bone defect between first and second long bone elements, but implants according to the invention could be employed to repair defects in other types of bone other than long bones.

[0066] In the embodiments of FIGS. 1A and 1B the scaffold 20, 120 is a selective laser sintered 3D titanium mesh but other types of scaffold can be used as will be described later. The scaffold 20, 120 stabilises the segmental defect 11 and the plate 30, 130 attaches to the subject's bone surface proximally and distally to the defect 11. The plate 30, 130 stabilises the implant via internal fixation (i.e. the plate 30, 130 is implanted internally rather than external of the body).

[0067] Referring to FIG. 1A, in this embodiment the plate has through holes 31 for receiving screws 32 to attach the plate to bone and through holes 33 for receiving screws 34 to attach the plate to the scaffold 20. Screws 32 and 34 may be the same type of screws, or different screws for attachment to bone and to the scaffold may be employed. The plate 30 may be of the type known as a LISS plate (Less Invasive Stabilization System) wherein at least the through holes 31 for receiving screws for attachment to bone, and optionally also the through holes 33, are internally threaded for receiving locking screws that have externally threaded heads. The plate 30 is preferably secured such that it is spaced away from the surface of the bone 12 such that it does not contact the bone 12 when implanted. The through holes 33 for receiving screws 34 for attaching the plate 30 to the scaffold 20 are in a scaffold portion 35 of the plate which overlies the scaffold 20 when implanted. The screws 34 for attaching the plate to the scaffold may be locking screws or other types of screws. FIGS. 1A and 1B are diagrammatic and the implant may have more or fewer screw holes than shown in the diagram.

[0068] The scaffold 20 preferably includes a solid or less porous region at the or each location where a screw 34 is to be received by the scaffold 20, the solid or less porous region including an internally threaded bore to receive the screw 34. This provides a stable site for the screw 34 to secure to.

[0069] Alternatively, instead of attaching the plate 30 to the scaffold 20 using screws, some other attachment means may be used. For example, the plate 30 may be attached to the scaffold 20 using at least one tape or strap that is received around plate 30 and scaffold 20 to hold them together.

[0070] The plates 30, 130 may be shaped and sized to suit the geometry of the bone they are to be attached to. For example a plate for attachment to a long bone will be elongate, having a proximal extension portion to extend proximal of the scaffold and a distal extension portion to extend distal of the scaffold, the proximal extension and distal extension portions of the plate being attachable to the bone. The plate may be bent or otherwise shaped to suit the shape of the underlying bone.

[0071] Referring to FIG. 1B, in this embodiment the plate 130 and scaffold 120 are integrally formed. The plate 130 therefore has no through holes for receiving screws for attachment of the plate to the scaffold 120. Instead, the scaffold 120 and plate 130 are portions of a one-piece, unitary construction wherein the scaffold portion 120 is monolithic with the plate portion 130. The plate 130 has through holes 131 for receiving screws 132 to attach the plate to bone. Like the implant 10 of FIG. 1A, the screws 131 may be locking screws having externally threaded heads for engagement with internally threaded through holes in the plate 130. Preferably the plate 130 closely faces the bone or contacts the bone outside of the segmental defect site 11 when implanted.

[0072] The scaffold 20, 120 will now be further described. The scaffold 20, 120 may be a porous metallic scaffold or it may be a polymeric scaffold, such as a scaffold made of a resorbable polymer. In preferred embodiments the scaffold is a selective laser sintered 3D titanium mesh. The scaffold may be a hybrid scaffold produced using both titanium and other materials such polymers. The mesh scaffold is preferably coated with hydroxyapatite. Coating with hydroxyapatite may be via an electrochemical process. Such a coating promotes osteoconduction after the scaffold has been implanted. The scaffold is preferably shaped and sized to be received at the segmental defect site 11 and to engage the native bone around the defect site. The scaffold can be custom made to suit the particular subject's defect site. If the implant includes a plate for internal fixation, the plate may be custom made for the particular subject or may be a standard piece. For an implant for repairing a bone defect in a long bone, the scaffold may preferably be substantially cylindrical in shape.

[0073] The Scaffold may optionally have a hollow void within its body surrounded by a porous or non-porous body of the scaffold. FIG. 2 shows a diagrammatic representation of a scaffold 220 that may be used with the plates shown in FIGS. 1A and 1B or in implant embodiments without internal fixation plates. For scaffolds 220 that have an internal void, preferably the scaffold 220 has first and second open ends 221, 222 and a hollow cavity 223 extending between. The scaffold 220 is sized such that first and second open ends 221 and 222 engage the bone 12 distally and proximally to the defect site. The cavity 223 may be substantially empty when it is implanted or alternatively allograft/autograft material (not shown in the diagram of FIG. 2) can be packed into the hollow cavity 223 in the scaffold 220 before it is implanted in the subject. A scaffold 220 with an engineered cavity 223 like that shown in FIG. 2 allows the invasion of bone marrow 13 into the graft from the subject's bone 12 (represented by arrows A in FIG. 2). The cavity 223 also aids bone ingrowth into the scaffold 220 from the inside of the cavity.

[0074] The scaffold 220 has a longitudinal axis running between first and second ends 221, 222 (whether these be open ends, as in a scaffold with a hollow cavity as shown in FIG. 2 or a non-hollow scaffold). The scaffold 220 may have a plurality of channels or tubes within its body, the plurality of channels being substantially aligned with the longitudinal axis of the scaffold. The channels are indicated diagrammatically in FIG. 2 by arrows B. The channels are microtubes, preferably each having a diameter of up to around 1000 micrometres, preferably around 150 to 400 micrometres, more preferably around 200 to 350 micrometres. The channels may be formed by interconnecting pores in a porous scaffold. For example the pores forming the channels may be elongated along the longitudinal axis of the scaffold. Each or some of the channels may extend fully between the first and second ends 221, 222 of the scaffold or only part way between the first and second ends 221, 222.

[0075] The scaffold 220 may be made of oriented mesh such that it directs bone in a longitudinal fashion. This is particularly useful in implants for repair of bone defects in long bones. An oriented mesh allows for the mesh to have a different Young's modulus in different directions depending on the mesh orientation. The scaffold is therefore anisotropic. The overall Young's modulus of the scaffold could be engineered to enhance osteocoductivity by controlling the strut thickness in the porous scaffold structure, thereby reducing the modulus of the implant appropriately for bone formation. For example, the scaffold may have a first Young's modulus value in a direction of its longitudinal axis and a second Young's modulus value in a direction transverse to the longitudinal axis, the first Young's modulus value preferably being greater than the second Young's modulus value.

[0076] Referring to FIGS. 1A and 1B, implants according to any of the embodiments described herein may optionally have a membrane 40 received around the scaffold before it is implanted. The membrane comprises collagen in combination with a biodegradable polymer selected from poly lactic acid (PLA); poly glycolic acid (PGA); poly lactic-co-glycolide (PLGA); polycaprolactone (PCL); and chitosan. Preferably the biodegradable polymer is provided as a porous mesh sheet onto which collagen coated. The collagen may be coated on both sides of the porous mesh sheet or on one side. The collagen fibres may intersperse through the porous mesh sheet. The membrane is preferably resorbable. The membrane is capable of being sutured. Preferably the membrane comprises collagen and poly lactic acid (PLA).

[0077] Antibiotics may be incorporated into the membrane, for which the collagen would act as a carrier, whereby the antibiotics may leach from the collagen as it is resorbed. The collagen may be cross-linked to control the rate of resorption. Additionally or alternatively the porous mesh sheet, such as a PLA sheet, can be made by 3D printing, by casting a thin film or electro spinning. The porous mesh sheet may contain a bactericidal agent such as silver or an antibiotic. The membrane is preferably porous, allowing blood vessel ingrowth to the scaffold.

[0078] The membrane 40 has a first side for facing the scaffold when assembled and a second side for facing away from the scaffold when assembled. One or both sides of the membrane 40 may be preferably seeded with cells. One or both sides may be seeded with bone forming cells such as stem cells or stem cells that have been differentiated into osteoblasts progenitor cells prior to seeding. Preferably only one side of the membrane is seeded with bone forming cells. Preferably the first side, facing the scaffold is seeded with bone forming cells prior to placement of the scaffold within the membrane. FIG. 3 shows diagrammatically a cross-section through part of a porous scaffold 220 with membrane. Stem cells or osteoprogenitor cells 42 are shown seeded on the first side 41 of the membrane. Blood vessels 14 are shown passing through the resorbable porous membrane 40. The membrane 40 is shown as comprising a porous mesh sheet 44 onto both sides of which is incorporated collagen fibres 43, which intersperse through the pores in the porous mesh sheet 44.

[0079] In addition to the seeding of bone forming cells shown in FIG. 3 onto the first side of the membrane 40, there may be cells seeded onto the second side of the membrane 40, which may also be bone forming cells or may be other cells such as fibroblasts or endothelial progenitor cells (EPCs).

[0080] In operation, in order to make and implant an implant according to the invention, firstly a scaffold is custom manufactured or selected from a standard set of pre-manufactured scaffolds. The scaffold may be packed with allograft or autograft. A membrane is formed as described above and optionally seeded with cells as described above. The membrane is wrapped around the scaffold. The membrane may be secured to the scaffold in some way, for example using sutures or using a tie or strap that wraps around outside of the membrane to hold it around the scaffold. The sutures/tie or strap may be resorbable. The scaffold is implanted into the defect site. A plate may optionally be installed for internal fixation as described above.

[0081] Referring to FIGS. 4 and 5, a further embodiment of an implant 310 according to the invention is shown. The implant has a titanium mesh scaffold 320 for implantation between proximal and distal parts of a long bone 12 with a bone defect 11 therebetween. The implant 310 has a plate 330 for attachment to the scaffold 320 and to the bone 12 using screws. The plate 330 is shaped to suit the geometry of the bone around the defect site 11. One end of the plate has an additional plate 350 affixed to it for fixing to the bone via screws for extra fixation.

[0082] It will be understood that various modifications, additions and alterations may be made to the invention by one skilled in the art without departing from the spirit and scope of the invention as defined in the appended claims.