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P&P artificial ligament

上市日期: 2015-11-15

Ligamentous injuries are common in sports or our daily life. Currently, there are three kinds of materials to choose when ligament reconstruction is necessary for curing ligamentous injuries; they are autologous ligament, allogeneic ligament, and artificial ligament. P&P artificial ligaments are biological ligaments with the function of tissue remodeling. The ligament consists of nano-level fibers similar to extracellular matrix, which are made of degradable polymer material and biological materials by using the electro-spinning technology. It is a non-crosslinked tissue repair material with 3-D net-like framework.  

Product description

Classes of ligaments

There are three classes of ligaments for clinical applications, which are autologous ligament, allogeneic ligament, and artificial ligament.

1) Autologous ligament: during operation, the surgeon takes a piece of tendon, hamstring tendon, or patellar tendon from the patient’s own shanks or other parts according to the length of the ligament to be reconstructed, uses the tendon as the ligament for reconstruction, then ties it well, and fix it to the position of ACL with absorbable screws. The advantage of the surgery is that there is no rejection for the tendon is taken from the patient himself (herself). The disadvantages are as follows: the source of the ligaments is often limited; the parts, where the ligaments are taken, are injured; the rehabilitative period is long.

2) Allogeneic ligament: the needed ligament is taken from individuals belonging to the same species (such as dead bodies) to avoid injuring the patient’s own health. The disadvantages are as follows: the source is very limited, and the market is in short supply; there are risks of transmitting prion (BSE) and causing immunoreaction.

3) Artificial ligament: it can be subdivided into synthetic artificial ligament and biological artificial ligament. There is only one kind of synthetic artificial ligament in Chinese market, i.e. the LARS ligament from France, which is made from polyester material and has good histocompatibility. Regenerated tissue can grow in the spaces between the fibers. Using artificial ligaments for ligament reconstruction has many advantages as follows: the source of ligaments is unlimited; it overcomes the limitation on the supply of tendon taken from autologous tissue as well as the defect of immunoreaction caused by allogeneic tissue; it avoids the donor-site complications caused by taking tendon from autologous tissue; it simplifies the operative process, realizes early postoperative stability, and requires no postoperative immobilization; there is always room for improvements with the applications of new materials.

Development history of artificial ligaments

The development of artificial ligament technology has experienced three stages: the stage of carbon fiber ligament, the stage of polyester material ligament, and the stage of stent-type ligament. Most of artificial ligaments on the markets are polyester material ligaments, and stent-type ligaments represent the future of artificial ligaments.  

1) At the early stage: carbon fiber ligament:

Carbon fiber ligaments had been used for ACL reconstruction since 1975. The main weakness of several kinds of artificial ligaments developed in 1970s-1980s was their poor performance in resisting torsion, creep, and wear. Clinical observation showed significant early clinical results, but poor mid-long-term clinical results. The poor performance was mainly reflected in relaxation and fracture of ligaments and serious synovitis, which would always lead to revision of ligaments. The main reason for this result is the lack in synthetic materials. This kind of products has been eliminated from clinical applications.

2) Polyester material ligament (represented by LARS ligament):

Biological polyester materials began to be used for making artificial ligaments in 1990s, and LARS ligament is a typical example of them. The fibers of polyester ligaments are aligned in parallel in a joint, but in a crisscross pattern within the tunnel. This structure not only accords with the physiological structure of ACL, but also significantly improving the anti-torsion performance. The tensile strength of polyester fiber is much higher than that of the previous materials, reaching up to 2000-4000 N, and the maximum tensile strength of normal ACL is only 1700-1800N.

The artificial ligaments made from polyester fiber have good histocompatibility, and regenerated tissue can grow in the spaces between the fibers. Trieb et al ever carried out the biopsy and histological analysis to patients who received LARS ligament transplantation 6 month before, and found that cells and fibrous tissue grew into the entire ligaments. In addition, the in vitro experiment, in which fibroblasts and osteoblasts were transplanted on LARS ligament for cultivation, showed that the two kinds of cells generated a cell web and wrapped up the fibers of LARS ligament. Thus, the good histocompatibility of LARS ligament has been confirmed by the above two studies.

3) Stent-type ligament: the future of artificial ligaments

At the early stage of artificial ligament reconstruction, the artificial ligament can function as good as the original ligament. However, only when the body tissue and artificial ligament grow into a whole, can the stability of the ligament be guaranteed. The new-generation artificial ligament can induce the body tissue to grow into the ligament, then gradually evolve into ligamentous tissue, and finally replace the artificial ligament. P&P artificial ligament is a kind of stent-type ligament.

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