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 Device and methods for in vivo culturing of diverse tissue cells

Details
Inventors: Brekke, John H.;
Assignee: Kensey Nash Corporation (Exton, PA)
Primary Examiner: Milano; Michael J.
Assistant Examiner:
Attorney, Agent or Firm: Kamrath; Alan D. Rider Bennett Egan & Arundel LLP

An anatomically specific, bioresorbable, implant device for facilitating the healing of voids in bone, cartilage and soft tissue is disclosed. A preferred embodiment of using the implant device for facilitating the healing of a human joint lesion includes a cartilage region invested with an alginate microstructure joined with a subchondral bone region invested with a hyaluronan microstructure. The alginate selectively dispersed in the cartilage region enhances the environment for chondrocytes to grow articular cartilage. The hyaluronan selectively dispersed in the subchondral bone region enhances the environment for mesenchymal cells which migrate into that region's macrostructure and which differentiate into osteoblasts. The microstructures can be invested at varying concentrations in the regions. A hydrophobic barrier, strategically positioned within the subchondral bone region macrostructure, shields the chondrocytes from the oxygenated blood in subchondral cancellous bone. In the preferred form, the cartilage region includes a tangential zone including a network of intercommunicating void spaces having a horizontal orientation and in communication with synovial fluid and includes a radial zone including multiple void spaces oriented in both horizontal and vertical planes and providing intercommunication between the tangential zone and the subchondral bone region.

DETAILED DESCRIPTION The anatomically specific device is a living prosthesis or implant for transport and for in viva culturing of tissue cells in a diverse tissue lesion.
The entire macrostructure of this device is composed of a bioresorbable polymer.
The anatomically specific device integrates a macrostructure, microstructure, free precursor cells cultured in vitro or from tissue, and biologically active agents, such as associated growth factors, morphogens, drugs and therapeutic agents.
The anatomically specific device in the embodiment designed for treating a cartilage and bone lesion has two main regions: a cartilage region and a subchondral bone region.
The cartilage region has a macrostructure composed of two distinct zones.
The tangential zone of the cartilage region has intimate contact with synovial fluid.
The radial zone located between the tangential zone and the subchondral bone region and comprising about 70% to 90% of the cartilage region is distinguished by vertically oriented plates which are fenestrated by multiple voids.
The radial zone of the cartilage region is intimately bound to the macrostructure of the subchondral region at an interface surface.
The microstructure material of the cartilage region in the most preferred form is alginate or hyaluronan.
Alginate, also known as alginic acid, is used for the transport of both in vitro and in vivo cultured cells and the establishment of an in vivo cell culture system within the device.
Alginic acid, though having no chemotactic properties, is especially suitable for use in a device for treating articular cartilage defects because it facilitates the culturing and transport of chondrocytes.
The structure and the strategic location of the alginate microstructure inside the macrostructure provides the opportunity to segregate microstructure material from the subchondral bone region.
The alginate microstructure has a primary function of delivering chondrocytes only to the cartilage region of the device by sequestering the chondrocyte cell population with the in vitro cell culture medium in its alginate gel



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