ABSORBABLE DEVICE FOR BONE REGENERATION

Abstract

A device for bone regeneration includes a fill element adapted to be inserted, during use, in a cavity present in a bone of a patient; the fill element being made of PGA fibers.

Claims

1. A device for bone regeneration comprising a fill element adapted to be inserted, during use, in a cavity present in a bone of a patient; said fill element being made of PGA fibers and being counter-shapeable or counter-shaped with respect to the bone cavity in which the fill element is insertable.

2. The device according to claim 1, wherein the fill element is made of PGA fiber fabric.

3. Device The device according to claim 2, wherein the fabric is a knitted fabric.

4. The device according to claim 1, wherein the fill element can be counter shaped is counter-shapeable with respect to the bone cavity in which the fill element is insertable.

5. The device according to claim 1, wherein the fill element is counter-shaped with respect to the bone cavity in which the fill element is insertable.

6. The device according to claim 5, wherein said fill element is cylinder-shaped, parallelepiped-shaped, pyramid-shaped or cone-shaped.

7. The device according to claim 2, wherein said fabric is a warp knitted fabric.

8. The device according to claim 1, wherein the fabric has a net configuration wherein the weft is such that its interstitial space is less than 200 μm, corresponding to an average area of holes equal to approximately 0.02 mm.sup.2.

9. The device according to claim 1, wherein the fabric has a net configuration wherein the weft is such that its interstitial space is less than 160 μm, corresponding to an average area of holes equal to approximately 0.02 mm.sup.2.

10. The device according to claim 2, wherein the fabric has a net configuration wherein the weft is such that its interstitial space is less than 200 μm, corresponding to an average area of holes equal to approximately 0.02 mm.sup.2.

11. The device according to claim 2, wherein the fabric has a net configuration wherein the weft is such that its interstitial space is less than 160 μm, corresponding to an average area of holes equal to approximately 0.02 mm.sup.2.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0016] Further characteristics and advantages of the present invention will be clearer from the exemplifying and therefore non-limiting description of a preferred but not exclusive embodiment of a bone regeneration device, as illustrated in the enclosed drawings, in which:

[0017] FIG. 1 is a schematic view of the bone regeneration device in accordance with the present invention.

[0018] With reference to the enclosed drawing, reference number overall indicates a bone regeneration device in accordance with the present invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0019] The device 1 comprises a fill element 2 which, during use, is inserted in a cavity “C” present on a bone “O” of a patient.

[0020] In particular, the cavity “C” can be situated at a reassembled fracture line “L” of the bone “O” itself.

[0021] The fill element 2 is made of a solid resorbable material.

[0022] More precisely, the fill element 2 is made of PGA fibers (polyglycolide or polyglycolic acid), preferably homopolymer. PGA is a highly biocompatible and resorbable polymer.

[0023] The average resorption time of the PGA fibers is approximately one month.

[0024] Advantageously, during the resorption of the fill element 2, there is the formation of bone tissue, which progressively takes the place of the dissolving PGA fibers.

[0025] The bone tissue being formed simultaneously with the dissolution of the fill element 2 completely fills the cavity “C” and has the same nature as the bone tissue of the patient's bone.

[0026] Consequently, the newly-formed bone tissue possesses the same mechanical characteristics as the original bone tissue.

[0027] In such a manner, the cavity is filled with naturally compatible tissue and does not alter the mechanical and physiological characteristics of the repaired bone.

[0028] Advantageously, the fill element 2 is made of PGA fiber fabric.

[0029] In such a manner, once the fill element 2 is inserted in the cavity “C”, the fabric is impregnated with blood and in particular with plasma, which facilitates the bone regeneration.

[0030] The fabric 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.

[0031] Preferably, the fabric is a knitted fabric, still more preferably a warp knitted fabric.

[0032] In such cases, the fabric has a rougher surface capable of assuming a net configuration with sufficiently small meshes.

[0033] In detail, its weft is such that its interstitial space is less than 200 μm, preferably around 160 μm, corresponding to an average area of the holes equal to approximately 0.02 mm.sup.2.

[0034] Furthermore, the fabric is preferably textured so as to give it even greater surface roughness and greater rigidity.

[0035] In a first embodiment, the fill element 2 can be shaped in a manner such that it is substantially counter-shaped with respect to the shape of the cavity to be filled. The fabric with which the fill element 2 is obtained is sufficiently flexible to allow the operator to bend it, so as to counter-shape the fill element 2 at the time of implant.

[0036] In a second embodiment, the fill element 2 is already shaped. In particular, the fill element 2 is already counter-shaped with respect to the cavity “C” to be filled.

[0037] In particular, the fill element 2 can have a cylindrical, parallelepiped, pyramid or cone shape, or it can have another shape.

[0038] For the obtainment of the fill elements 2, three-dimensional weaving techniques can also be used that allow the obtainment non-hollow solids made of PGA fiber.

[0039] In particular, such techniques provide for the weaving and subsequent superimposition of fabric layers of suitable shapes, which are then connected to each other by means of suture points made of the same material as the fabric, i.e. in this case PGA.

[0040] During obtainment, fill elements 2 can be created of any shape and size that are completely solid, i.e. without any cavity therein.

[0041] The use of the PGA fiber allows obtaining solids provided with a softness sufficient to be slightly compressed, in order to better adapt the fill element 2 to the shape and/or size of the cavity “C” to be filled.

[0042] In addition, the fill elements 2 can be easily cut, with scissors or scalpels, by the operator in the operating room in order to adapt the shape and/or size thereof to the cavity “C” to be filled.

[0043] The invention attains the preset object.

[0044] Indeed, due to the implant of the absorbable fill element made of PGA, there is a bone regeneration process that fills the bone cavity in which it is inserted.

[0045] As already stated, given that the regenerated bone tissue is equivalent to that of the bone on which the device is implanted, there is no lessening of the mechanical characteristics of the reassembled and healed bone.

[0046] The healing process is therefore more complete and does not leave any significant consequences.