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Engineered scaffolds for intervertebral disc repair and regeneration and for articulating joint repair and regeneration

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Engineered scaffolds for intervertebral disc repair and regeneration and for articulating joint repair and regeneration


Methods for the engineering and preparation of intervertebral disc repair scaffolds and articulating joint repair scaffolds are disclosed. The methodology utilizes either magnetic resonance images or combined magnetic resonance and computed tomography images as a template for creating either the intervertebral scaffold or the joint repair scaffold (e.g., osteochondral scaffold) with fixation to the underlying bone. The disc scaffold design may include an outer annulus that may contain desired structures and a central nucleus pulposus region that could either contain a designed microstructure or a contained hydrogel. The osteochondral scaffold may include a bone compartment interface with a cartilage compartment. The bone compartment may interface with a cutout portion of the bone through fixation components. Different microstructure designs may be created for the bone and cartilage compartment to represent desired mechanical and mass transport properties. The microstructure controls elastic and permeability property distribution within the scaffold.
Related Terms: Articulating Joint Intervertebral Disc Nucleus Pulposus

Inventors: Chia-Ying Lin, Frank LaMarca, Stephen E. Feinberg, William L. Murphy, James R. Adox, Scott J. Hollister
USPTO Applicaton #: #20120330423 - Class: 623 1716 (USPTO) - 12/27/12 - Class 623 
Prosthesis (i.e., Artificial Body Members), Parts Thereof, Or Aids And Accessories Therefor > Implantable Prosthesis >Bone >Spine Bone >Including Spinal Disc Spacer Between Adjacent Spine Bones

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The Patent Description & Claims data below is from USPTO Patent Application 20120330423, Engineered scaffolds for intervertebral disc repair and regeneration and for articulating joint repair and regeneration.

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CROSS-REFERENCES TO RELATED APPLICATIONS

This application is a divisional application of U.S. patent application Ser. No. 11/927,281 filed Oct. 29, 2007, which claims priority from U.S. Provisional Patent Application No. 60/855,234 filed Oct. 30, 2006.

STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH

This invention was made with government support under grant number RO1 DE 13608 and grant number AR 052893 awarded by the National Institutes of Health. The government has certain rights in the invention.

BACKGROUND OF THE INVENTION

1. Field of the Invention

This invention relates to biomaterial scaffolds, and more particularly to biomaterial scaffolds for intervertebral disc repair and/or regeneration and biomaterial scaffolds for articulating joint repair and/or regeneration.

2. Description of the Related Art

It is reported in U.S. Patent Application Publication No. 2003/0069718 and corresponding U.S. Pat. No. 7,174,282 that biomaterial scaffolds for tissue engineering perform three primary functions. The first is to provide a temporary function (stiffness, strength, diffusion, and permeability) in tissue defects. The second is to provide a sufficient connected porosity to enhance biofactor delivery, cell migration and regeneration of connected tissue. The third requirement is to guide tissue regeneration into an anatomic shape. It is further noted that the first two functions present conflicting design requirements. Specifically, increasing connected porosity to enhance cell migration and tissue regeneration decreases mechanical stiffness and strength, whereas decreasing porosity increases mechanical stiffness and strength but impedes cell migration and tissue regeneration.

U.S. 2003/0069718 provides a design methodology for creating biomaterial scaffolds with internal porous architectures that meet the need for mechanical stiffness and strength and the need for connected porosity for cell migration and tissue regeneration. The design methods of U.S. 2003/0069718 combine image-based design of pore structures with homogenization theory to compute effective physical property dependence on material microstructure. Optimization techniques are then used to compute the optimal pore geometry. The final optimized scaffold geometry voxel topology is then combined with a voxel data set describing the three dimensional anatomic scaffold shape which may be obtained by magnetic resonance (MR) images or combined MR and computed tomography (CT) images. Density variations within the anatomic scaffold voxel database are used as a map to guide where different optimized scaffold voxel topologies are substituted. The final voxel representation of the anatomically shaped scaffold with optimized interior architecture is then converted automatically by software into either a surface representation or wire frame representation for fabrication of the scaffold by way of solid free form fabrication or casting.

While the advances of U.S. 2003/0069718 have significantly improved the design of biomaterial scaffolds for tissue engineering, there is still a need for further advances in this technology to provide for even more optimized biomaterial scaffolding and tissue generation systems.

SUMMARY

OF THE INVENTION

The present invention provides methods for the engineering and preparation of scaffolding and tissue generation systems for the repair of bone/cartilage composites, including, but not limited to, osteochondral scaffolds/tissue repair systems for the tibial plateau, proximal femoral head, acetabulum, humeral head, and intervertebral spinal disc repair and regeneration. The methodology utilizes either magnetic resonance images or combined magnetic resonance and computed tomography images as a template for creating either the intervertebral scaffold as well as the fixation for the scaffolding into adjacent vertebral bodies or the osteochondral scaffold with fixation to the underlying bone.

The disc scaffold design may include an outer annulus that may contain desired porous structures and a central nucleus pulposus region that could either contain a designed porous microstructure or a contained hydrogel or other bioactive agent(s). Instrumentation for surgical placement is also included. The scaffolding has designed microstructure that controls elastic and permeability property distribution within the intervertebral zone.

The osteochondral scaffold may include a bone compartment interface with a cartilage compartment. The bone compartment may interface with a cutout portion of the bone through fixation components such as pegs and screws and the like.

Different microstructure designs may be created for the bone and cartilage compartment to represent desired mechanical and mass transport properties.

Advantages of the method of the invention include the ability to create designed microstructures that can mimic intervertebral load carrying capability, to provide directed nutrients to seeded/migrated cells in the disc, and the capability of creating disc structures that can regrow natural tissue. This provides a potential advantage over artificial discs, which as synthetic materials are subject to wear and fatigue failure. Regrowth of a new disc would provide a natural tissue that could remodel in response to applied loads and would be subject to the wear and fatigue problems of synthetic materials. In addition, the capability of creating designed scaffolding would provide the necessary load bearing capability via designed elasticity and permeability for tissue engineering an intervertebral disc that non-designed scaffolds could not provide. In addition, if the designed scaffolding is used for fusion, it could provide load bearing capability that would eliminate the need for some or all of the hardware needed for current interbody fusion techniques.

For the osteochondral scaffold, advantages include the ability to design a separate bone/cartilage interface, and more importantly, the ability to design these bone and cartilage compartments to have desired effective mechanical and mass transport properties. In addition, the osteochondral scaffolds could have virtually any interface with surrounding tissue or for surgical fixation.

For the total joint interface, advantages again include the ability to have control over the designed microstructure interface, giving it desired interface elasticity properties and the ability to control geometric thickness.

In one aspect of the invention, there is provided a method for designing a tissue scaffold for generating tissue in a patient. In the method, a first set of databases is created representing a plurality of porous microstructure designs for the scaffold in image based format. A second database is created representing scaffold exterior geometry desired to replace the native tissue in the patient in image based format. A third database is created representing scaffold external fixation structure. Then, the first set of databases representing the desired microstructure designs and the second database and the third database are merged into an image-based design of the scaffold. The image-based design may then be converted to a fabrication geometry such as surface representation or wireframe representation.

In one form, the scaffold external fixation structure is designed to be porous, and is designed to include at least one projection extending away from the scaffold. Example projections are a peg or a spike or a plate. The projection can be designed to include fastening means selected from threads and/or throughholes. In one embodiment, the scaffold is designed for intervertebral disc repair. In another embodiment, the scaffold is designed for articulating joint repair. In yet another embodiment, the scaffold is designed for total joint replacement.

The scaffold external fixation structure can be designed to include at least one projection extending away from the scaffold, and at least one marking including a tracer that provides enhanced visibility via a medical imaging device can be placed on the at least one projection. The scaffold external fixation structure can be designed to include at least one projection extending away from the scaffold, and at least one radiopaque marking that provides enhanced visibility via a fluoroscope can be placed on the at least one projection. The scaffold can be designed to include a region of no material or radiolucent material such that the region forms an imaging window for enhanced visibility through the imaging window via a medical imaging device. The scaffold external fixation structure can be designed to include at least one projection extending away from the scaffold, and at least one marking for alignment during implantation can be placed on the at least one projection.

In another aspect of the invention, there is provided a method for designing an intervertebral disc scaffold. In the method, a first set of databases is created representing a plurality of porous microstructure designs for the scaffold in image based format. A second database is created representing scaffold exterior geometry desired to replace the native disc in the patient in image based format. Then, the first set of databases representing the desired microstructure designs are merged with the second database into an image-based design of the scaffold. The image-based design can be converted to a fabrication geometry. The second database can represent an intervertebral space to be occupied by the scaffold.

In one form, the image-based design of the scaffold can be designed to include an outer annulus having a first designed porous microstructure, and the image-based design of the scaffold can be designed to include a central region having a second designed microstructure. In another form, the image-based design of the scaffold can be designed to include an outer annulus having a first designed porous microstructure, and the image-based design of the scaffold can be designed to include a central region designed for containing a biocompatible material. At least one of the microstructure designs can be a wavy fiber design. In one form, the image-based design of the scaffold is designed to include spherical or elliptical pores.

The scaffold can be designed to include at least one projection, such as a plate, peg or spike, extending away from the scaffold, and at least one marking including a tracer that provides enhanced visibility via a medical imaging device can be placed on the at least one projection. The scaffold can be designed to include at least one projection extending away from the scaffold, and at least one radiopaque marking that provides enhanced visibility via a fluoroscope can be placed on the at least one projection. The scaffold can be designed to include at least one projection extending away from the scaffold, and at least one marking for alignment during implantation can be placed on the at least one projection. The scaffold can be designed to include a region of no material or radiolucent material such that the region forms an imaging window for enhanced visibility through the imaging window via a medical imaging device.

In yet another aspect of the invention, there is provided a method for designing an osteochondral scaffold for replacing native tissue in a patient. In the method, a first set of databases is created representing a plurality of porous microstructure designs for the scaffold in image based format. A second database is created representing scaffold exterior geometry desired to replace the native tissue in the patient in image based format. The first set of databases representing the desired microstructure designs are merged with the second database into an image-based design of the scaffold that includes a bone region designed to have a first physical or biochemical property and a cartilage region designed to have a second physical or biochemical property. At least one of the microstructure designs can be a wavy fiber design. The bone region can be designed to have a pore structure different from a pore structure of the cartilage region. The cartilage region can be designed to include spherical or elliptical pores. The bone region can be designed to allow greater mass transport than the cartilage region.

The first physical or biochemical property can be a mechanical property (such as elasticity), and the second physical or biochemical property can be a mechanical property (such as elasticity). The first physical or biochemical property can be a mass transport property (such as permeability), and the second physical or biochemical property can be a mass transport property (such as permeability). The first physical or biochemical property can be a biochemical property (such as bioactive agent delivery control), and the second physical or biochemical property can be a biochemical property (such as bioactive agent delivery control).

In one embodiment, the first physical or biochemical property can be achieved by coating at least a portion of the bone region with an osteoconductive mineral. In another embodiment, the first physical or biochemical property can be achieved by coating at least a portion of the bone region with an osteoconductive mineral comprising a calcium compound. In yet another embodiment, the first physical or biochemical property can be achieved by coating at least a portion of the bone region with an osteoconductive mineral comprising a material selected from hydroxyapatite, calcium-deficient carbonate-containing hydroxyapatite, tricalcium phosphate, octacalcium phosphate, dicalcium phosphate, calcium phosphate, and mixtures thereof. In still another embodiment, the first physical or biochemical property can be achieved by coating at least a portion of the bone region with an osteoconductive mineral comprising a plurality of discrete mineral islands. In yet another embodiment, the first physical or biochemical property can be achieved by coating at least a portion of the bone region with an osteoconductive mineral comprising a substantially homogeneous mineral coating. In still another embodiment, the first physical or biochemical property can be achieved by coating at least a portion of the bone region with an osteoconductive mineral and associating a bioactive agent with the mineral coating. The bioactive agent can be selected from bone morphogenetic proteins.

In yet another aspect of the invention, there is provided a method for designing a joint replacement for a patient. In the method, a first set of databases is created representing a plurality of porous microstructure designs for the joint replacement in image based format. A second database is created representing joint replacement exterior geometry in image based format. The first set of databases representing the desired microstructure designs are merged with the second database into an image-based design of the joint replacement that includes a bone region designed to have a first physical or biochemical property and a surface region designed to have a second physical or biochemical property. At least one of the microstructure designs can be a wavy fiber design. The bone region can be designed to have a pore structure different from a pore structure of the surface region. The surface region can be designed to include spherical or elliptical pores. The bone region can be designed to allow greater mass transport than the cartilage region.

The first physical or biochemical property can be a mechanical property (such as elasticity), and the second physical or biochemical property can be a mechanical property (such as elasticity). The first physical or biochemical property can be a mass transport property (such as permeability), and the second physical or biochemical property can be a mass transport property (such as permeability). The first physical or biochemical property can be a biochemical property (such as bioactive agent delivery control), and the second physical or biochemical property can be a biochemical property (such as bioactive agent delivery control).

In one embodiment, the first physical or biochemical property can be achieved by coating at least a portion of the bone region with an osteoconductive mineral. In another embodiment, the first physical or biochemical property can be achieved by coating at least a portion of the bone region with an osteoconductive mineral comprising a calcium compound. In yet another embodiment, the first physical or biochemical property can be achieved by coating at least a portion of the bone region with an osteoconductive mineral comprising a material selected from hydroxyapatite, calcium-deficient carbonate-containing hydroxyapatite, tricalcium phosphate, octacalcium phosphate, dicalcium phosphate, calcium phosphate, and mixtures thereof. In still another embodiment, the first physical or biochemical property can be achieved by coating at least a portion of the bone region with an osteoconductive mineral comprising a plurality of discrete mineral islands. In yet another embodiment, the first physical or biochemical property can be achieved by coating at least a portion of the bone region with an osteoconductive mineral comprising a substantially homogeneous mineral coating. In still another embodiment, the first physical or biochemical property can be achieved by coating at least a portion of the bone region with an osteoconductive mineral and associating a bioactive agent with the mineral coating. The bioactive agent can be selected from bone morphogenetic proteins.

In still another aspect of the invention, there is provided an intervertebral disc repair and/or regeneration scaffold. The scaffold includes a central core shaped to approximate the nucleus pulposus of a natural intervertebral disc wherein the central core has a first porous microstructure. The scaffold further includes an outer annulus shaped to approximate the annulus fibrosus of a natural intervertebral disc wherein the outer annulus is connected to and surrounds the central core and wherein the outer annulus has a second porous microstructure. In one embodiment, the central core and the outer annulus have different elasticity. In another embodiment, the central core and the outer annulus have different permeability. In yet another embodiment, the central core and the outer annulus have different bioactive agent release properties.

In one form, the central core includes a biocompatible material. In another form, the central core includes a hydrogel. In yet another form, the central core includes a bioactive agent. In one embodiment, the bioactive agent is selected from undifferentiated chondrocyte precursor cells from periosteum, mesenchymal stem cells from bone marrow, chondrocytes, sclerosing agents, angiogenesis activators, angiogenesis inhibitors, and mixtures thereof. The central core can comprise wavy fibers.

The scaffold can be formed from biodegradable polymers, biodegradable ceramics, non-biodegradable metals, non-biodegradable metal alloys, or mixtures thereof. The scaffold can include at least one marking including a tracer that provides enhanced visibility via a medical imaging device. The scaffold can include at least one radiopaque marking that provides enhanced visibility via a fluoroscope. The scaffold can include a region of no material or radiolucent material such that the region forms an imaging window for enhanced visibility through the imaging window via a medical imaging device. The scaffold can include at least one marking for alignment during implantation.

In one embodiment, an osteoconductive mineral coating is disposed on at least a portion of the scaffold. The osteoconductive mineral coating can include a plurality of discrete mineral islands. Alternatively, the osteoconductive mineral coating can include a substantially homogeneous mineral coating. The osteoconductive mineral coating can include a calcium compound. For example, the osteoconductive mineral coating can include hydroxyapatite, calcium-deficient carbonate-containing hydroxyapatite, tricalcium phosphate, octacalcium phosphate, dicalcium phosphate, calcium phosphate, and mixtures thereof. A bioactive agent can be associated with the mineral coating. Example bioactive agent are bone morphogenetic proteins.

These and other features, aspects, and advantages of the present invention will become better understood upon consideration of the following detailed description, drawings and appended claims.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows a slice from an external shape design dataset for an intervertebral disc. The internal rings represent the different density regions for mapping heterogeneous microstructure.

FIG. 2A shows an example of a designed microstructure for scaffolding with interconnected cylindrical pores.

FIG. 2B shows an example of a designed microstructure for scaffolding with topology optimized microstructure.

FIG. 2C shows an example of a designed microstructure for scaffolding with wavy fibered microstructure.

FIG. 3 shows a slice of a designed intervertebral scaffolding with wavy fibered microstructure in the correct anatomic shape. The central region approximates the shape of the nucleus pulposus in a natural intervertebral disc.

FIG. 4 shows an example of an integrated anterior plate fixation on a disc regeneration scaffold. This integrated plating can be used for either disc regeneration or spinal fusion.

FIG. 5A shows an example of a spiked vertebrae interface on the top of an intervertebral disc scaffold.

FIG. 5B shows an example of a spiked vertebrae interface on the bottom of the intervertebral disc scaffold of FIG. 5A.

FIG. 6 shows a density map for a tibial plateau.

FIG. 7 shows an example final osteochondral scaffold with desired shape and microstructure.

FIG. 8 shows the fit of a designed osteochondral scaffold into the whole tibia.

FIG. 9 shows a stem simulating a hip stem with a designed microstructure as an interface for fixation of the stem to surrounding bone.

FIG. 10 shows the steps in engineering a mandibular condyle scaffold from image to fabricated scaffold.

FIG. 11 shows an example of a cervical disc regeneration scaffold with designed anterior fixation plate and wavy fiber microstructure fabricated from polycaprolactone (PCL).



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stats Patent Info
Application #
US 20120330423 A1
Publish Date
12/27/2012
Document #
13595333
File Date
08/27/2012
USPTO Class
623 1716
Other USPTO Classes
424400, 424 937
International Class
/
Drawings
11


Articulating Joint
Intervertebral Disc
Nucleus Pulposus


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