Resorbable device for the reconstruction of cartilage

Abstract

A resorbable device for the reconstruction of cartilage includes a piece of fabric made of PGA, which can be impregnated with patient blood and fixable to a bone at an articulation, the piece preferably being impregnated with collagen.

Claims

1. A resorbable device for the reconstruction of cartilage consisting of: a resorbable piece of fabric textured and made of PGA fixable to a bone at an articulation, said piece of fabric being impregnated with blood and collagen, wherein the resorbable device is configured for the PGA to dissolve giving way to the constructed cartilage in approximately one month, and wherein the fabric of said piece is woven fabric made of monofilament, wherein the fabric of said piece is of warp knitted type, wherein the thickness of the fabric of said piece is between 0.1 mm and 2 mm, and optionally constraining means for fixing said piece to said bone.

2. The device according to claim 1, wherein the fabric of said piece is obtained with a thread having a density between 50 and 200 denier.

3. The device according to claim 1, wherein the constraining means for fixing said piece to said bone is present.

4. The device according to claim 3, wherein said constraining means is fibrin glue.

5. The device according to claim 3, wherein said constraining means is at least one member selected from the group consisting of screws, anchors, staples, and pins.

6. A resorbable device for the reconstruction of cartilage consisting of: a resorbable piece of fabric textured and made of PGA fixable to a bone at an articulation, said piece of fabric being impregnated with blood and collagen, wherein the resorbable device is configured for the PGA to dissolve giving way to the constructed cartilage in approximately one month, and wherein the fabric of said piece is woven fabric made of monofilament, wherein the fabric of said piece is of warp knitted type, wherein the thickness of the fabric of said piece is between 0.1 mm and 2 mm, and optionally constraining means for fixing said piece to said bone, wherein said piece is impregnated with patient blood before being fixed to the bone.

7. The device according to claim 1, wherein the thickness of the fabric of said piece is between 0.3 mm and 0.6 mm.

8. The device according to claim 1, wherein the thickness of the fabric of said piece is between 0.4 mm and 0.53 mm.

9. The device according to claim 1, wherein said piece of fabric is impregnated with patient blood and porcine collagen, and wherein said constraining means is present and consists of fibrin glue for fixing said piece of fabric to said bone.

10. The device according to claim 3, wherein said constraining means is at least one resorbable member selected from the group consisting of resorbable screws, anchors, staples, and pins.

11. The device according to claim 1, wherein said piece of the fabric being impregnated with collagen is a sheet of said fabric, wherein the fabric is warp knitted fabric having a weft providing interstitial space less than 200 m, wherein the fabric is obtained with a thread having a density between 50 and 200 denier, and wherein the fabric is between 0.3 and 0.6 mm thick.

12. The device according to claim 11, wherein the constraining means for fixing said piece to said bone is present and selected from fibrin glue and at least one resorbable member made of PGA selected from the group consisting of screws, anchors, staples and pins.

13. The device according to claim 1, wherein the constraining means for fixing said piece to said bone is present and selected from at least one member selected from the group consisting of fibrin glue, screws, anchors, staples, and pins.

14. The device according to claim 1, wherein the constraining means for fixing said piece to said bone is present and selected from fibrin glue and at least one member selected from the group consisting of screws, anchors, staples and pins.

15. The device according to claim 6, wherein said piece of the fabric being impregnated with collagen is a sheet of said fabric, wherein the fabric is warp knitted fabric having a weft providing interstitial space less than 200 m, wherein the fabric is obtained with a thread having a density between 50 and 200 denier and wherein the fabric is between 0.3 and 0.6 mm thick.

16. The device according to claim 6, wherein the constraining means for fixing said piece to said bone is present and selected from at least one member selected from the group consisting of fibrin glue, screws, anchors, staples, and pins.

17. The device according to claim 1, wherein the entire said single piece of fabric is woven, wherein the single piece of woven fabric has first and second opposed exposed surfaces, wherein the first exposed surface is for contacting a first bone of the articulation and the second exposed surface facing away from the first bone for contacting a second said device.

18. The device according to claim 16, wherein the constraining means for fixing said piece to said bone is present and is fibrin glue.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

(1) Further characteristics and advantages of the present invention will be clearer from the exemplifying and hence non-limiting description of a preferred but not exclusive embodiment of a resorbable device for the reconstruction of cartilage, as illustrated in the set of drawings in which:

(2) FIG. 1 is schematic perspective view of a resorbable device for the reconstruction of cartilage in accordance with the present invention;

(3) FIG. 2 is a schematic view of the device of FIG. 1 installed in an articulation of a patient; and

(4) FIG. 3 is an enlarged view of FIG. 2.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

(5) With reference to the enclosed drawings, reference number 1 overall indicates a resorbable device for the reconstruction of cartilage in accordance with the present invention.

(6) The device 1 comprises a piece of fabric 2. For example, the device 1 is a single layer of the piece of fabric 2, as shown in FIGS. 1-3. As will be clearer hereinbelow, the piece 2 is intended to be fixed on a bone O of a patient articulation.

(7) In particular, the fabric is made of PGA (polyglycolide or poylglycolic acid), preferably homopolymer. Still more in particular, the fabric is made with an ultralight monofilament or thread deriving from PGA fibers.

(8) PGA is a highly biocompatible and resorbable polymer. In detail, the resorption time of PGA is approximately one month.

(9) The fabric of the piece 2 can be obtained by weaving the PGA thread in various ways, giving rise to a knitted fabric, a woven fabric or a non-woven fabric.

(10) Preferably, the fabric is a knitted fabric, still more preferably a warp knitted fabric.

(11) In such case, the fabric has a rougher surface capable of assuming a net configuration with sufficiently small meshes.

(12) In detail, its weft is such that its interstitial space is less than 200 m, preferably around 160 m, corresponding to an average area of the holes equal to approximately 0.02 mm.sup.2. This ensures good protection of the tissues covered by the piece 2.

(13) Furthermore, the fabric is preferably textured so as to give it even greater surface roughness and greater rigidity and impermeability.

(14) In addition, the fabric is preferably obtained with a thread having a density comprised between 50 and 200 denier.

(15) Merely by way of example, the fabric has a thickness substantially comprised between 0.3 mm and 0.6 mm, more preferably comprised between 0.4 mm and 0.53 mm, and still more preferably is substantially 0.45 mm.

(16) According to the preferred embodiment, the piece 2 has square form. Preferably, the side of the piece 2 substantially measures 10 cm.

(17) During use, the user can cut a portion of the piece according to a shape and size that are suitable for the zone to be treated.

(18) Preferably, the piece 2 is impregnated with collagen. Still more preferably, the piece 2 is impregnated with purified porcine collagen.

(19) The device 1 also comprises constraining means 3 necessary for fixing the piece 2 to the bone.

(20) Preferably, the constraining means 3 comprise fibrin glue which is affixed in specific points between the piece 2 and the bone O in a manner so as to obtain the fixing.

(21) In addition, the constraining means 3 also comprise screws and/or anchors and/or staples and/or pins. In FIG. 3, two staples 4 and one pin 5 are illustrated.

(22) The screws and/or anchors and/or staples 4 and/or pins 5 are made of resorbable material. Preferably, the screws and/or anchors and/or staples 4 and/or pins 5 are made of PGA/PLA.

(23) According to a method for applying device 1 according to the present invention, the piece 2 is first immersed in the blood of the patient himself.

(24) The blood necessary for this phase can be drawn during the operation by means of syringe.

(25) In case of bleeding of the operating field, the blood deriving from such bleeding can be advantageously used.

(26) Before proceeding with the implant of the device 1, the zone of the articulation with the damaged cartilage is cleaned. In other words, fragments of cartilage and damaged strips thereof still fixed to the bone are removed.

(27) Also before implantation, preferably, one or more holes can be made in the bone O in the zone intended to be covered by the piece 2. The maximum depth of such holes F is 3 cm.

(28) The depth of the holes F is such to allow the flow of cells and proteins from within the bone O itself towards the piece 2 in order to facilitate the reconstruction of the new cartilage.

(29) This completed, the piece is fixed on the bone O at the zone to be reconstructed.

(30) For such purpose, the fibrin glue is arranged on the bone O in a finite number of points and then the piece 2 is applied.

(31) Subsequently and preferably, further constraining means 3 are applied, such as the abovementioned screws and/or anchors and/or staples and/or pins.

(32) The application of these further constraining means 3 depends on the extension of the piece 2 and on the position and on the form of the zone of the bone O to be covered.

(33) Such operation of application of the device 1 can occur during arthroscopy or arthrotomy depending on the articulation involved or other factors evaluated in each instance by the doctor.

(34) At the same time as the reconstruction of the cartilage tissue, the dissolution process of the piece 2 proceeds over the course of approximately one month. In other words, the piece 2as it dissolvesgives way to the constructed cartilage.

(35) The invention thus described attains the pre-established objects.

(36) Indeed, the described use of the resorbable device for the reconstruction of cartilage allows avoiding the culture which, being quite extensive, is an extremely long, costly and complex operation.

(37) It is also possible to prevent the periodic patient visits for the subsequent intra-articular injections.

(38) The reconstruction of the cartilage is indeed ensured by the blood with which the piece is impregnated and by the proteins coming directly from the perforated bone.