Non-absorbable tissue reconstruction device, in particular for tissues such as ligaments

Abstract

There is described a device (1) of the reversible type for the connection and reconstruction of a ligament, comprising a central reconstruction portion (9) and two connecting portions (10a, 10b) at the two ends of said central portion (9), characterized in that said connection device is made of silicone, said central portion covers said two connecting portions (10a, 10b), said two connecting portions (10a, 10b) being generally grid-shaped for receiving fixing means adapted to fix said device (1) to said ligament, said device (1) further comprising an outer carbon coating (14).

Claims

1. A device for the connection and reconstruction of a ligament of the reversible type comprising a central portion for reconstruction and two connecting portions to the two ends of said central portion, said device further comprising an outer carbon coating, characterized in that said central portion of said connection device is made of silicone, said central portion covers said two connecting portions, said two connecting portions being generally shaped as a grid for receiving fixing means adapted to fix said device to said ligament, and in that said central portion is made with a plurality of superimposed silicone layers.

2. A device according to claim 1, wherein said connecting portions are made of polyethylene terephthalate.

3. A device according to claim 1, wherein said connecting portions are fixed to said central portion between two silicone layers.

4. A device according to claim 1, wherein said central portion is a circular-base prism.

5. A device according to claim 1, wherein said central portion is a hollow cylinder.

6. A device according to claim 1, wherein said central portion has a diameter in the range from 1 to 15 mm.

7. A device according to claim 1, wherein said central portion has a length in the range from 5 to 45 mm.

8. A device according to claim 1, wherein said connecting portions are fixed to said central portion, respectively, and wherein each of said connecting portions overlaps said central portion by at least 1.5 cm.

Description

LIST OF FIGURES

(1) The technical features of the present invention as well as advantages thereof will become apparent from the following description to be considered in conjunction with the accompanying drawings, in which:

(2) FIG. 1 shows a top view of a tissue reconstruction device according to the present invention;

(3) FIG. 2 shows a sectional view of a second embodiment of a tissue device according to the present invention;

(4) FIG. 3 shows a first embodiment of a tissue reconstruction device according to the present invention.

DETAILED DESCRIPTION

(5) The following description and the accompanying drawings are intended for illustrative purposes and therefore they do not limit the present invention, which may be implemented according to other and different embodiments; moreover, it is worth noting that these figures are diagrammatic and simplified.

(6) With reference to FIG. 1, there is shown a device of the reversible type for the connection and reconstruction of ligaments according to the present invention. The term reversible means a device to be installed at a damaged ligament to allow the physiological tissue reconstruction thereof. Such a device is removed once the reconstruction has been completed, after a predetermined period of time. Such a device can be applied to a single ligament (e.g. the anterior cruciate ligament of the knee joint) or to a group of ligaments (e.g. the rotator cuff of the shoulder). Device 1 comprises a central reconstruction portion 9 and two connecting portions 10a, 10b at the two ends of the central portion 9. According to the present invention, the central reconstruction portion 9 is made of silicone and the connecting portions 10a, 10b are generally grid-shaped to receive fixing means adapted to fix said device to said ligaments. The central portion covers the connecting portions 10a and 10b. The device (i.e. the central portion 9 and the portions 10a and 10b) has an outer carbon coating 14.

(7) It is worth noting that the connecting portions 10a and 10b have a general stiffness in order to receive the fixing means. Thereby, the two opposite end stretches of device 1 are configured to receive said fixing means, known per se, which comprise either absorbable or non-absorbable staples, anchors or synthesis screws.

(8) The central portion 9 is a part of device 1 on which the tissue reconstruction for which the device 1 itself is intended takes place.

(9) In use, the device is placed in a predetermined reconstruction position according to anatomical constraints and to the extent of the ligament portion to be reconstructed. It is therefore essential, for a successful reconstruction of the ligament, that the device remains in such a position for the entire duration of the reconstruction process. To this end, the two connecting portions 10a, 10b are configured to receive the fixing means stably after the operations aimed to place it in its reconstruction position. In this first condition, the device has such a structure as to favor the tissue regrowth.

(10) Thereafter, the physiological reconstruction process absorbs the fixing means; the ligament (or ligaments, in the case of a bundle of ligaments for which a device according to the present invention is to be used) under reconstruction has its tissue regrowth on the central portion 9 of the device. In this second condition, the device has such a structure as to support the tissue regrowth, and in particular up to its complete reconstruction.

(11) The ends 10a and 10b are not reabsorbed with the fixing means, they remain segregated from the central portion 9. Thereby, once the reconstruction has been completed, device 1 can be easily removed.

(12) In particular, in the second condition, and in particular once the ligament reconstruction has been completed, the central portion 9 is completely or almost completely covered by fibers that make up the ligament. At this point, device 1 may be removed. According to an embodiment, the central portion 9 and the ends 10a and 10b are made of silicone and polyethylene terephthalate (e.g. using Dacron), respectively. The central portion 9 covers the ends 10 and 10b and further comprises a carbon coating 14. The fibers that make up the ligament will advantageously reconstruct around the central portion 9 without settling thereon. Such a feature is achieved due to the carbon coating 14 which covers device 1. Therefore, the removal of the central portion 9 can take place with ease and especially without causing damage to the reconstructed ligament.

(13) According to a preferred embodiment, the connecting portions 10a, 10b are made of polyethylene terephthalate.

(14) As seen in FIG. 2, according to a preferred embodiment, the central portion 9 is made with a plurality of superimposed silicone layers 11, 12.

(15) The connecting portions 10a, 10b are made integral with the central portion 9 by fixing them between the two layers 11 and 12 (or between two layers of three or more layers which make up the central portion 9) of the central portion 9.

(16) This device configuration is particularly sturdy and can be used for groups of ligaments which are larger than an average ligament, such as the rotator cuff.

(17) The outer carbon coating 14 advantageously provides a high degree of biocompatibility with the tissues which it contacts.

(18) Preferably, the central portion 9 of a device according to the present invention is a circular-base prism. Of course, different shapes are suitable to implement the section of the central portion 9, they may be evaluated from time to time in the light of the structural constraints to be met.

(19) As seen in FIG. 4, according to an embodiment, the central portion 9 is a hollow cylinder. However, according to an alternative embodiment, the central portion 9 is a solid cylinder.

(20) The dimensions of the central portion 9 are devised to fit any size of ligaments for which the device is intended. Such a portion has a diameter from 1 to 15 mm; a length from 5 to 45 mm.

(21) Moreover, the connecting portions 10a, 10b are fixed to the central portion, respectively, overlapping by at least 1.5 cm said central portion 9.