Absorbable biomedical polymeric material and ligature clip

Claims

1. An absorbable biomedical polymer material consisting of a first polymer and a second polymer, characterized in that, based on 100% of the total mass composition, the mass fraction of the first polymer is from 2.5 to 80 wt.%, and the mass fraction of the second polymer is from 20 to 97.5 wt.%; wherein the first polymer consists of poly-L-lactide in an amount of from 50 to 100 wt.% and polyglycolide in an amount of from 0 to 50 wt.%, and the second polymer is poly(p-dioxanone).

2. An absorbable biomedical polymer material according to claim 1, characterized in that the mass fraction of the first polymer is from 2.5 to 70 wt.%, and the mass fraction of the second polymer is from 30 to 97.5 wt.%.

3. An absorbable biomedical polymer material according to claim 2, characterized in that the mass fraction of the first polymer is from 2.5 to 60 wt.%, and the mass fraction of the second polymer is from 40 to 97.5 wt.%.

4. An absorbable biomedical polymer material according to claim 3, characterized in that the mass fraction of the first polymer is from 2.5 to 50 wt.%, and the mass fraction of the second polymer is from 50 to 97.5 wt.%.

5. An absorbable biomedical polymer material according to claim 4, characterized in that the mass fraction of the first polymer is from 2.5 to 40 wt.%, and the mass fraction of the second polymer is from 60 to 97.5 wt.%.

6. An absorbable biomedical polymer material according to claim 5, characterized in that the mass fraction of the first polymer is from 2.5 to 35 wt.%, and the mass fraction of the second polymer is from 65 to 97.5 wt.%.

7. An absorbable biomedical polymer material according to claim 1, characterized in that the first polymer consists of poly-L-lactide in an amount of 70 to 100 wt.% and polyglycolide in an amount of 0 to 30 wt.%.

8. An absorbable biomedical polymer material according to claim 1, characterized in that the first polymer consists of poly-L-lactide in an amount of 50 to 90% by weight and polyglycolide in an amount of 10 to 50% by weight.

9. An absorbable biomedical polymer material according to claim 1, characterized in that the first polymer consists of poly-L-lactide in an amount of 75 to 90% by weight and polyglycolide in an amount of 10 to 25% by weight.

10. A ligature clip made from an absorbable biomedical polymeric material according to any one of paragraphs 1-9, characterized in that it comprises a ligature clip body; wherein the ligature clip body includes a clip body and a locking device intended to hold the clip body in a closed state; wherein the clip body consists of a first clamping element and a second clamping element connected in a V-shape, wherein the first and second clamping elements are designed in the form of a co-directionally curved arc-shaped structure, or both clamping elements have a rectilinear structure; the locking device includes a hook-shaped portion located on the distal end of the first clamping element, and a mating portion located on the distal end of the second clamping element and configured to engage with the hook-shaped portion, wherein the hook-shaped portion is provided with a cutting structure with an acute angle or a cutting structure of a rectilinear type with a sharp edge;and two limiting blocks mounted opposite each other at the distal end of the second clamping element; wherein the hook-shaped part engages with the two limiting blocks and is held between them.

11. A ligature clip according to claim 10, characterized in that the first and second clamping elements are made in the form of a co-directionally curved arc-shaped structure; a through groove is made at the junction of the first and second clamping elements; and a stiffening rib is additionally made on the inner side of the hook-shaped part.

12. A ligature clip according to claim 10, characterized in that a locking device is installed on the clip body; the locking device includes a first locking projection located on the left and right sides of the distal end of the first clamping element along the width direction of the clip body; or the locking device comprises a first locking projection located on the left and right sides of the distal end of the first clamping element along the width direction of the clip body; and a second locking projection located on the left and right sides of the distal end of the second clamping element along the width direction of the clip body.

13. A ligature clip according to claim 10, characterized in that a positioning device is additionally located on the clip body; the positioning device comprises a first positioning groove formed on the inner side of the distal end of the first clamping element, and a first positioning projection formed on the inner side of the second clamping element and corresponding to the first positioning groove; and / or a second positioning projection formed on the outer side of the distal end of the second clamping element, and a second positioning groove formed on the outer side of the first clamping element and corresponding to the second positioning projection.

14. A ligature clip according to claim 10, characterized in that a piercing device is also located on the fixing device, intended for a joint action to cut tissue when the closing of the clip body begins; the piercing device contains a pointed cutting head formed on the outer end of the hook-shaped part; when the closing of the clip body begins, the pointed cutting head interacts with an inclined surface on the counterpart to cut tissue.

15. A ligature clip according to any one of paragraphs 10-14, characterized in that an antibacterial layer is applied to the surface of the body of the ligature clip, wherein the composition of the antibacterial layer includes an antibacterial substance, the mass of which is from 0.1 to 3% by weight of the total mass of the body of the ligature clip; or an antibacterial substance uniformly distributed in the body of the ligature clip, wherein the mass of the antibacterial substance is from 0.1 to 10% by weight of the total mass of the body of the ligature clip.

16. The ligature clip of claim 15, wherein the antibacterial agent used is one or more of the following: halogenated hydroxy ethers, acyloxy diphenyl ethers, vanillin or ethyl vanillin compounds, acylanilides, imidazoles, thiazoles, isothiazolone derivatives, quaternary ammonium salts, biguanides, and phenols; or the antibacterial agent may be nanoparticles containing any of the metal ions silver, cerium, zinc, or a combination thereof; or one or more of the following components are used as the antibacterial substance: tetracycline hydrochloride, neomycin sulfate, chloramphenicol, streptomycin sulfate, penicillin potassium salt, oxytetracycline hydrochloride, gentamicin sulfate, cephalothin sodium salt, furanone, rifamycin, benzalkonium chloride, oxacillin sodium salt, dihydrostreptomycin sulfate, carbenicillin disodium salt and sodium nitrofurantoin; or 2,4,4'-trichloro-2'-hydroxydiphenyl ether is used as an antibacterial substance.

17. A ligature clip made from an absorbable biomedical polymeric material according to any one of claims 1-9, characterized in that it includes a ligature clip body, wherein the clip body contains an inner clamp and a U-shaped outer clamp; and the content of the first polymer in the outer clamp is higher than the content of the first polymer in the inner clamp.

18. A ligature clip according to claim 17, characterized in that the outer wall of the inner clamp has a groove running along its length, and the inner wall of the U-shaped region of the outer clamp is equipped with a protruding rib that interacts with the groove; when the protruding rib snaps into the groove and slides along it, the inner clamp is deformed, positioned inside the outer clamp, gradually completing the clamp.

19. A ligature clip according to claim 17 or 18, characterized in that an antibacterial layer is applied to the surface of the ligature clip body, wherein the composition of the antibacterial layer includes an antibacterial substance, the mass of which is from 0.1 to 3% by weight of the total mass of the ligature clip body; or an antibacterial substance uniformly distributed in the ligature clip body, wherein the mass of the antibacterial substance is from 0.1 to 10% by weight of the total mass of the ligature clip body.

20. The ligature clip of claim 19, wherein the antibacterial agent used is one or more of the following: halogenated hydroxy ethers, acyloxy diphenyl ethers, vanillin or ethyl vanillin compounds, acylanilides, imidazoles, thiazoles, isothiazolone derivatives, quaternary ammonium salts, biguanides, and phenols; or the antibacterial agent may be nanoparticles containing any of the metal ions silver, cerium, zinc, or a combination thereof; or one or more of the following components are used as the antibacterial substance: tetracycline hydrochloride, neomycin sulfate, chloramphenicol, streptomycin sulfate, penicillin potassium salt, oxytetracycline hydrochloride, gentamicin sulfate, cephalothin sodium salt, furanone, rifamycin, benzalkonium chloride, oxacillin sodium salt, dihydrostreptomycin sulfate, carbenicillin disodium salt and sodium nitrofurantoin; or 2,4,4'-trichloro-2'-hydroxydiphenyl ether is used as an antibacterial substance.