DE102008042401A1 - Intervertebral disk implant for use between vertebras of spinal column of humans and vertebrate animals, has support component comprising flexible core and biocompatible matrix layer, which is formed with tissue cells - Google Patents

Abstract

The disk implant has a support component (3) comprising a flexible core (1) and a complete or partial biocompatible matrix layer (2), which is arranged around the core. The matrix layer is porous and is formed with tissue cells such as chondrocytes. The support component is made of nitinol or titanium, and comprises an alkylamine plasma-chemical coating. The flexible core is made of silicone and the matrix layer is made of polystyrene. Shape of the support component corresponds to shape of the disk implant. An independent claim is also included for a method for producing an intervertebral disk implant.

Description

The The invention relates to an artificial disc implant and a method of manufacturing such according to first or eleventh claim.

Band washers are cartilage-like fasteners that intervene any vertebra of a spine of a human or a human Vertebrate arranged and fused with these. They persist from an outer fiber ring (Anulus Fibrosus) and an inner nucleus (nucleus pulposus). Intervertebral discs are in contrast to the vertebrae elastic and thus cause the mobility of the Spine. They take over next to the recording body weight also the function of bending elements.

at A so-called herniated disc usually occurs as a result of overloading damage or destruction of an intervertebral disc, in particular the outer fiber ring. Is the disc After that it is not repairable anymore, it is, if you have an artificial one to avoid local stiffening, through an intervertebral disc implant to replace.

Known Disc implants are bending elements that replace the discs be inserted between two vertebrae and firmly connected with these become.

The example discloses DE 103 11 477 A1 an artificial implant for insertion between vertebral bodies of the spine instead of a distant disc. The height of the implant is mechanically adjustable. The vortex-side bearing surfaces consist of disc-shaped components with openings that can grow together with the vertebrae. A similar construction reveals the DE 10 2006 030 124 A1 , where the bearing surfaces as well as in the DE 101 16 412 C1 are fixed to the vertebrae with bone screws.

The However, the aforementioned disc implants are not only expensive and complex in their construction, but also often require anchoring significant interference with adjacent tissue areas or bones.

alternative Disc implants are known that consist of a biocompatible or bioresorbable material consisting of a matrix for Form the new growth of intervertebral fibrocytes and after formation they regress.

For example disclosed DE 691 26 971 T2 an intervertebral disc prosthesis made of a bioabsorbable matrix structure for the ingrowth of fibrocytes, which penetrate the implants after a certain time and increasingly assume their role as an intervertebral disc.

absorbable Carrier materials are characterized by a simple Handling during implantation, but often have only an insufficient mechanical stability and are therefore prone to prolonged or recurrent loading to plastic deformation.

From that Based on the object of the invention is an intervertebral disc implant to propose that by a mechanical long-term stability and uncomplicated handling. Further lies the task also therein, a method for producing the disc implant propose.

The Task is with an intervertebral disc implant and a procedure with the features of claim 1 or 12 solved. under claims give advantageous embodiments again.

The Disc implant essentially comprises two components, a carrier component and a core, in whole or in part coated with a matrix layer. The carrier component preferably has a perforation or openings or is made of a netting. This is her cell culture good penetrable and well integrable in their volume. It surrounds preferably completely or partially the core and the matrix layer and has a preferably the shape of a natural Intervertebral disc.

Of the Core serves the elastic deformability of the disc implant and preferably consists of an elastic molded body. He takes as a power bridge between each two adjacent Whirl up the forces between two vertebrae. Preferably, the core consists of a solid or hollow body made of an elastic biocompatible material such. B. silicone rubber.

If the core is formed as a hollow body, it has one or more cavities filled with one or more fluids. Preferably, the fluids are non-toxic and bioabsorbable, so that they can cause damage to the core with leakage of the fluids from the cavities as possible damage and biodegrades in the body. Gaseous fluids are compressible and cause an adjustment of the elastic properties, but cause special problems in the event of damage with the escape of gas into the body. Liquid or pasty fluids (eg gels or saline solutions) do not cause these problems. Although they limit compression of the intervertebral disc prosthesis, overall, but allow advantageously greater adjustments of the prosthesis between two vertebrae during insertion and relative movements, in particular tilting. A prosthesis is thus implantable without major individual shaping. Locally occurring stress sinks and tips can be compensated by local compliances due to the fluid movement.

The Carrier component is used in particular the additional radial stiffening and shape stabilization of the core against a Dodging the nucleus from the gap between the two adjacent vertebrae. It consists of a biocompatible and non-absorbable material with a pronounced elastic compliance, preferably a metal such as titanium or an alloy such as a shape memory alloy, z. Nitinol. The carrier component is as required Stiffness preferably as a comparatively resilient elastic Wire mesh or a comparatively stiff metal ring with openings or open porosity. A plasmachemical Coating of the carrier component with simple organic Molecules like allylamine (thin, plastic-like Layer) advantageously promotes rapid and stable connection of the cell cultures and thus a particularly robust integration the carrier component in the cell culture.

The Matrix layer on the core serves to connect tissue cells to the core. For a good connection, preferably biocompatible elastomeric matrix layer has a preferably open porosity on, before inserting the disc prosthesis in the context of a in vitro cell culture with tissue cells, preferably cartilage cells filled and closed. In cell cultivation Not only the growth of the matrix layer occurs, but also ingrowth of the carrier component with the tissue cells, wherein the carrier component the implant an additional Lends supporting effect.

The The invention further includes a method of manufacturing an intervertebral disc implant of the aforementioned type. The method comprises the aforementioned cell cultivation, starting from an intervertebral disc implant with core, matrix layer and carrier component. A cartilage tissue is preferably cultivated preferably starting from the body's own cells for the implantation provided patients. The method comprises an inoculation preferably of the matrix layer with cells, preferably autologous cartilage cells, which subsequently formed the basis for represent a cell culture. As part of the cell cultivation takes place preferably filling the porosity of the matrix layer starting from this also as cell layers on the matrix layer.

While the formation of the cartilage cell layer is an adequate supply (Nutrition) with nutrient medium. in the Within the scope of the invention, this is done by a recurring and relief of the disc implant, whereby an alternating Compressing and expanding the porosity of the matrix and cell layer is realized. As a result, it comes to a Mass transfer to the forming cartilage cells in the porosity, d. H. the nutrient medium becomes (similar to a sponge, So-called sponge principle) in the unloaded state in a magnifying Porosity sucked it to a subsequent compression of the Expel porosity again.

trained Cartilage tissue, on the other hand, requires no further nutrient medium supply and therefore no vessels for cell supply.

To the formation of cartilage cells, the disc implant is ready placed and applied in the patient. The from the body's own Accelerated cells of the patient grown cartilage cell layer an integration of the implant in the patient's body and reduces the risk of body rejection.

Possible Embodiments of the invention will be described with reference to the following Figures explained in more detail. Show it

1 a first lenticular embodiment as well

2a to c further, a natural disc shape modeled embodiment.

All disc implants shown in the figures have a core 1 z. B. of silicone rubber with matrix layer 2 and carrier component 3 on. Starting from the matrix layer, the formation of the aforementioned cell cultures takes place, the cartilage cell layer 4 the carrier component 3 and grows after implantation of the disc prosthesis with the adjacent vertebrae.

In 1 such as 2a and c, the matrix layer extends 2 and thus also the cell layer 4 over the entire core surface while 2 B shows an embodiment in which the matrix layer and the cartilage cell layer extends only over the outer region of the disc implant and binds there only to the vertebrae.

2c shows an example of an intervertebral disc implant with a core as a hollow body with cavity 12 in the aforementioned manner.

1

core

2

matrix layer

3

support component

4

cell layer

12

cavity

QUOTES INCLUDE IN THE DESCRIPTION

This list The documents listed by the applicant have been automated generated and is solely for better information recorded by the reader. The list is not part of the German Patent or utility model application. The DPMA takes over no liability for any errors or omissions.

Cited patent literature

• - DE 10311477 A1 [0005]
• - DE 102006030124 A1 [0005]
• - DE 10116412 C1 [0005]
• - DE 69126971 T2 [0008]

Claims (11)

An intervertebral disc implant comprising a carrier component with an elastic core and a wholly or partially around this arranged biocompatible matrix layer, which cultured with tissue cells is. An intervertebral disc implant according to claim 1, wherein said Tissue cells are cartilage cells. An intervertebral disc implant according to claim 1 or 2, wherein the carrier component a perforation or breakthroughs has or is formed from a mesh. Disc implant according to one of the aforementioned Claims, wherein the shape of the carrier component the shape of the disc implant corresponds. Disc implant according to one of the aforementioned Claims wherein the carrier component is nitinol or titanium. An intervertebral disc implant according to claim 5, wherein said Carrier component of a plasmachemic coating Allylamine has. Disc implant according to one of the aforementioned Claims, wherein the elastic core is made of silicone. Disc implant according to one of the aforementioned Claims, wherein the matrix layer and / or the core is a biocompatible coating. Disc implant according to one of the aforementioned Claims, wherein the matrix layer consists of polystyrene. Disc implant according to one of the aforementioned Claims, wherein the matrix layer has an open porosity having. Method for producing an intervertebral disc implant, comprising the following method steps a) Provision a perforated carrier component with an elastic Core and arranged around this biocompatible elastomeric Matrix layer with an open porosity, b) inoculation Matrix layer with autologous cartilage cells, c) cultivating the Cartilage cells, which fill the open porosity and seal, by repeated loading and unloading the matrix layer in a nutrient medium.