FI88111B - SJAELVFOERSTAERKANDE SURGICAL MATERIAL OCH MEDEL - Google Patents

Description

1 88111

Self-reinforced surgical materials and instruments

The invention relates to self-reinforced, absorbable surgical implants as further defined in the preamble of claim 1.

It is known in surgery to use implants made of at least partially absorbable polymer and / or polymer composite containing reinforcing elements 10, or parts or components thereof, for the fixation of fractures, osteotomies or arthrodesis, joint damage, tendon and ligament damage, and the like. Such tools include, for example, rods, screws, plates, core nails, and staples, which have been extensively described in the literature.

U.S. Pat. Pat. Well. 3,620,218, E. Schmitt and R. Polistina, "Cylindrical Prosthetic Devices of Polyglyco-20 lie Acid" and U.S. Pat. Pat. Well. 3,739,773, E. Schmitt and R.

As the polyst "Polyglycolic Acid Prosthetic Devices", absorbable implants made of polyglycolic acid such as rods, screws, plates or cylinders are disclosed.

2-5 In U.S. Pat. Pat. Well. 4,052,988 to N. Doddi, C.

Versfelt and D. Wasserman, "Synthetic Absorbable Surgical Devices of Poly-dioxanone," disclose absorbable sutures and other surgical instruments made of polydioxanone.

3 O .:

In U.S. Pat. Pat. Well. No. 4,279,249 to M. Vert, F. Chabot, J. Leray, and P. Christel, "New Prosthesis Parts, Their Preparation, and Their Application," discloses osteosynthesis devices made of polylactide or a copolymer rich in 35 lactide units that has been reinforced. reinforcing elements made of polyglycolide or a copolymer containing mainly glycolic acid units.

2 88111

In DE 29 47 985, S. Belych, A. Davydov, G. Chromov, A. Moscenskij, I. Movsovic, G. Rojtberg, G. Voskresenskij, G. Persin and V. Moskvitin "Biodestruct-Ver Stoff fiir Verbindungselemente ftir Knochengewebe "shows at least partially degradable composites consisting of, for example, a copolymer of methyl methacrylate and N-vinylpyrrolidone reinforced with polyamide fibers or oxycellulose fibers.

10 In U.S. Pat. Pat. Well. 4,243,775, M. Rosensaft and R.

Webb "Synthetic Polyester Surgical Articles" discloses absorbable surgical products made from a copolymer of glycolic acid and trimethylene carbonate.

15 In U.S. Pat. Pat. Well. 4,329,743, H. Alexander, R.

Parsons, I. Strauchler and A. Weiss "Bioabsorbable composite tissue scaffold" is a composite of a bioabsorbable polymer and carbon fibers suitable for making surgical articles.

20

In U.S. Pat. Pat. Well. No. 4,343,931 to T. Barrows, "Synthetic Absorbable Surgical Devices of Poly (esteramides)," discloses an absorbable polyester amide suitable for making implants.

25

EPO 0 146 398, R. Dunn and R. Casper, "Method of Producing Biodegradable Prosthesis and Products Therefrom", discloses a process for making biodegradable prostheses from a biodegradable polymer-30 'matrix and the bioabsorbable fibers reinforced therein.

WO 86/00533, J. Leenslag, A. Pennings, R. Veth and H. Jansen "Bone Implant" discloses an implant material for reconstructive surgery of bone material consisting of biodegradable or biostable fibers and a porous matrix of biodegradable polymeric material. .

3 88111

D. Tunc, "A High Strength Absorbable Polymer for Internal Bone Fixation," 9th Annual Meeting of the Society for Biomaterials, Birmingham, Alabama, April 27 - May 1, 1983, p. 17, discloses a high strength 5 absorbable polyactide having an initial strength n .50-60 MPa and which retains a significant proportion of its adulthood after 8-12 weeks of implantation. This gives legitimacy after the material is implanted. This justifies the further evaluation of the material as a base material for total internal bone fixation devices absorbed by the body.

In D. Tunc, M. Rohovsky, W. Lehman, A. Strong-water, and F. Kummer, “Evaluation of Body Absorbable Bone 15 Fixation Devices,” 31st Annual ORS, Las Vegas, Nevada,

Jan. 21, 22, 23, 24, 1985, p. 165, high-density, totally absorbable polylactide (initial strength 57.1 MPa) was used as plates and screws for the fixation of radial osteotomies in dogs.

20

In D. Tunc, M. Rohovsky, J. Zadwadsky, J. Spieker, and E. Strauss, "Evaluation of Body Absorbable Screw in Avulsion Type Fractures," The 12th Annual Meeting of the Society for Biomaterials, Minneapolis -25 St. Paul, Minnesota , USA, May 29 to June 1, 1986, p.

168, discloses the use of a screw made of high-strength polylactide to fix avulsion-type fractures (fixation of canine calcaneus osteotomy). Pat. Well. 4,776,329, R. Treharne "Resorbable Compressing Screw and Method" discloses a compression screw apparatus having non-resorbable compression members and a screw. At least the screw head is formed of a material that resorbs upon contact with tissue fluids.

Significantly higher strengths than for unreinforced absorbable fixation means, it is possible to provide 4,811,111 for self-reinforced absorbable fixation means. In U.S. Pat. Pat. Well. 4,743,257 to P. Törmälä, P. Rokkanen, J. Laiho, M. Tamminmäki and S. Vainionpää "Material for Osteosynthesis Devices" shows a self-reinforced surgical composite material consisting of an absorbable polymer reinforced with absorbable reinforcing elements, having the same chemical elemental composition as the matrix.

.0 In FI Pat. Hak. Well. 87 Olli, P. Törmälä, P.

Rokkanen, S. Vainionpää, J. Laiho, V.-P. Heponen and T. Pohjonen "Surgical Materials and Instruments" disclose self-reinforced surgical devices for the treatment of bone fractures made of at least partially fibril-l15 absorbable polymeric materials.

For self-reinforced (SR) absorbable surgical materials, T. Pohjonen, P. Törmälä, J. Mikkola, J. Laiho, P. Helevirta, H. Lähde, 20 S. Vainionpää and P. Rokkanen "Studies on Mechanical

Properties of Totally Biodegradable Polymeric Rods for Fixation of Bone Fractures "Vlth International Conference PIMS, Leeuwenhorst Congress Center, The Netherlands, 12-14 April 1989, pp. 34 / 1-34 / 6, according to excellent strength value-25 and, e.g., SR- polyglycolide has a flexural strength of 415 MPa and ... SR polylactide has a flexural strength of 300 MPa Also D. Tunc and J. Jadhav, "Development of Absorbable Ultra High Strength Polylactide", Am. Chem. Soc., 196th ACS Meeting, Abstracts of Papers, LA , Califor-30 nia, Sept. 25-30, 1988, pp. 383-387, has a good tensile strength (300 MPa) reported for SR polylactide.

In E. Partio, 0. Böstman, S. Vainionpää, H. Pätiälä, E. Hirvensalo, K. Vihtonen, P. Törmälä and P. 35 Rokkanen "The Treatment of Cancellous Bone Fractures with Biodegradable Screws", Acta Orthop. Scand., 59 (5), 1988, p. 18, discloses the fixation of pumice fractures with a self-contained, absorbable screw, the base 5 88111 of which is shaped (flat) so that the screw can be screwed into place in the bone channel with a screwdriver with a full tip. , where the screw head at least partially fits.

5

Although known self-reinforced absorbable surgical materials have certain good mechanical strength properties, they lack the strong anisotropy of mechanical strength properties. Since the known self-reinforced absorbable composites prepared e.g. by sintering or fibrillation technology are so-called parallel-reinforced (parallel jitus = reinforcement elements such as fibers or fiber bundles form parallel structures to the matrix) the bonds between the reinforcement elements are determined by the strengths of the matrix and the matrix reinforcement element interface.

Typically, the strengths of the reinforcement elements are in the order of hundreds of 20 or thousands of MPa, but the internal strength of the matrix and the strength of the matrix-reinforcement element interface are in the order of tens of hundreds of MPa. As a result, the fracture of self-reinforced absorbable composites occurs relatively easily as a dela-.25 minination between parallel reinforcement element layers or parallel reinforcement elements when external forces act in a direction where the reinforcement elements are unable to support. external forces. Delamination refers to the rupture of a reinforced composite composite material along a matrix material along an interface between reinforcement elements and / or between a matrix and reinforcement elements.

It has surprisingly been found in the present invention that in self-reinforced absorbable surgical materials and implants made therefrom, parts and / or components thereof, in which the reinforcing elements rotate at least partially about a perpendicular axis of the implant substantially substantially perpendicular to said axis. in the cross-sectional area, fracture by delamination is almost completely eliminated or at least considerably made more difficult when comparing their fracture behavior with the fracture behavior of known self-reinforced absorbable material and implants.

The present invention then provides self-reinforced, absorbable surgical materials and / or implants and / or parts and / or components thereof for implantation in or on living tissue, e.g., for repairing tissue damage, joining tissues, or parts thereof, or expanding tissue. , or to separate tissues or parts thereof from each other and / or from their environment and / or to conduct material between and / or outside or outside the tissues or parts thereof, in which the self-reinforcing materials and / or implants or their parts and / or components are reinforced elements rotate at least partially about the perpendicular axis of an implant.

The reinforcing elements may typically be oriented molecular chains, groups of molecular chains or parts thereof, directed crystal lamellae, spherulites, fibrils or parts thereof, or morphological structural elements of a similar type. They may also be fibers, filaments, film fibers, yarns, braids, non-woven structures, nets, knits or woven structures or the like.

Since the reinforcement elements in the materials of the invention do not form uniform straight planar structures, the delamination planes in the materials of the invention are at least partially curved and / or partially or completely eliminated depending on the way the reinforcement elements are oriented to rotate about one axis of the implant 7,881. As a result, the materials according to the invention have known isotropic strength properties of known self-reinforced absorbable materials and implants made therefrom, their parts or components, which in turn gives the implants more reliability and diversifies their applicability.

According to a particularly preferred embodiment, the self-reinforced implants according to the invention, their parts or components comprise at least one hole, cavity or cavity around which the reinforcing elements at least partially rotate. Such implants have several advantages over those known. When the implant 15 has a hole, cavity or cavity, the amount of material in the implant is smaller than in the closed implant. This preferably means less contaminant for the patient. A hole, cavity, or cavity can also be used to increase the surface area of the implant and accelerate its hydrolysis in tissue. The hole inside the implant can also be used to guide the implant into the tissue, e.g. by means of a suitable guide device, and a metal rod, wire, etc. inserted into the hole, cavity or cavity can act as an X-ray positive probe. An elongate hole or cavity in the center of the implant can also be used to rotate the self-reinforced absorbable screws of the invention into the bone to distribute torque to the screw shaft 30 over a wider range than known absorbent screws where torque is concentrated on the screw head. As a result, the screws according to the invention withstand a much stronger torque than the known absorbable self-reinforcing screws.

3 5

In the following description, the invention will be illustrated by reference to the accompanying drawings. In the drawings β 88111, Fig. 1 shows typical cross-sectional forms of a core nail application of the invention, Fig. 2 shows typical cross-sectional forms of a core nail application of the invention having a groove, crack or holes in the wall, Fig. 3 shows perspective views (3a to 3d) of some a cross-section of a mounted core nail fixed to the bone by a screw (3e), Fig. 4 schematically shows the manufacturing technique of the implant according to Example 1, Fig. 5 schematically shows the manufacturing technique of the implants according to Examples 4 and 5, Fig. 6 shows the manufacturing technique of the implant according to Example 7, schematic shows a perspective partial view of the implant of Example 8, Figures 8 'and 9' schematically show the experimental arrangement of Example 9, and Figure 10 shows a perspective view of the blank of Example 10 schematically.

3 0

According to a preferred embodiment, the implant according to the invention is a core nail which is at least partially hollow and in which the reinforcing elements at least partially rotate the longitudinal axis of the core nail. Such a core nail in cross section 35 may be a circle, ellipse, triangle, rectangle or polygon, quadrilateral, kidney-like, etc. Figure 1 shows some typical shapes of the core nail cross section. It is clear that cross-sectional shapes other than those shown in Figure 1 are also possible.

According to a preferred embodiment, the core nail wall 5 has at least one elongate groove or recess formed when the core nail wall is bent inward or at least partially split or perforated to provide flexibility to the core nail to the extent that the core nail does not easily split the bone when it 10 is hammered into a tight drill channel inside the bone. Figure 2 shows typical cross-sections of core nails with a groove, crack or holes in the wall to increase flexibility.

Figure 3 shows examples of perspective views of core nails according to the invention. For the sake of clarity, lines illustrating the orientation of the helical reinforcement are drawn on the surface of the core nail of Fig. 3a.

The core nails may also include holes through which they can be attached to the bone, e.g. by means of screws, as shown in cross-sectional view 3e.

The fixative devices of the invention can be made from absorbable (biodegradable 1. resorbable) polymers, copolymers, polymer blends, or composites disclosed in many publications, such as the following inventions: U.S. Pat. Pat. 3,297,033, U.S. Pat. Pat. 3,636,956 to U.S. Pat. Pat. 4,052,988 to U.S. Pat. Pat. ~ G 4,343,931, U.S. Pat. Pat. 3,960,152 to U.S. Pat. Pat. 4,243,775, FI Pat.hak. 85 5079, FI Pat.hak. 86 0366, FI Pat.hak.

86 0440 and FI Pat. hak. 88 5164.

Table 1 shows a number of known biodegradable polymers which or mixtures thereof can be used as raw materials for the devices according to the invention both as matrix (or binder polymers) and / or as reinforcing elements.

10 88 1 1 1

Table 1. Biodegradable polymers I. Polyglycolide (PGA)

Glycolide copolymers 5 2. Glycolide / lactide copolymers (PGA / PLA) 3. Glycolide / trimethylene carbonate copolymers (PGA / TMC)

Polylactides (PLA) 10 Stereoisomers and copolymers of PLA 4. Poly-L-lactide (PLLA) 5. Poly-D-lactide (PDLA) 6. Poly-DL-lactide (PDLLA) 15 7. L-lactide / DL-lactide copolymers L-lactide / D-lactide copolymers PLA copolymers 8. Lactide / tetramethylene glycolide copolymers 20 9. Lactide / trimethylene carbonate copolymers 10. Lactide / β-valerolactone copolymers II. Lactide / t-caprolactone copolymers 12. Polydepsipeptides / glycine-DL-lactide copolymer) 13. PLA / ethylene oxide copolymers (PLA / PEO) 25 14. Asymmetrically 3,6-substituted poly-1,4-dioxane-2,5-diones 15 Poly-B-hydroxybutyrate (PHBA) 30 16. ΡΗΒΑ / β-hydroxyvalerate copolymers (PHBA / PHVA) 17. Poly-B-hydroxypropionate (PHPA) 18. Poly-B-dioxanone (PDS) 19. Poly-6-valerolactone 15 20. Poly-t-caprolactone 21. Methyl methacrylate-N-vinylpyrrolidone copolymers 22. Polyesteramides 23. Polyesters of oxalic acid 40 24. Polydihydropyrans 25. Polyalkyl-2-cyanoacrylates 26. Polyurethanes (PU) 27. Polyvinyl alcohol (PVA) 28. Polypeptide 29. Poly-B-maleic acid (PMLA) 30. Poly-B-alkanoic acids 31. Polyethylene oxide (PEO) 32. Chitin polymers 50 Reference; S. Vainionpää, P. Rokkanen and P. Törmälä, Proqr.

Knees. Sci. , in print.

It is clear that biodegradable polymers other than those mentioned in Table 1 can be used as raw materials for the implants, devices or parts thereof according to the invention.

For example, the biodegradable (absorbable) polymers disclosed in the following publications can be used in the above.

purposes: U.S. Pat. Well. 4,700,704, U.S. Pat. Pat. Well.

4,653,497 to U.S. Pat. Pat. Well. 4,649,921 to U.S. Pat. Pat. Well. 4,559,945 to U.S. Pat. Pat. Well. 4,532,928, U.S. Pat. Pat. Well. 4,605,730, U.S. Pat. Pat. Well. 4,441,496 to U.S. Pat. Pat. Well. 4,435,590 to U.S. Pat. 10 Pat. Well. 4,559,945.

The devices according to the invention can be made of the above polymers using a single polymer or a polymer mixture. In addition to self-reinforcing, the devices can also be reinforced by using fibers made of a resorbable polymer or polymer blend, or resorbable glass fibers such as β-tricalcium phosphate fibers or CaAl fibers (see EP-A-146) and / or biofiber carbon or polymer fibers.

The devices according to the invention may also contain layered parts comprising e.g. flexible, toughness. . a healing and / or hydrolysis barrier surface layer and a rigid inner layer.

The surgical instruments of the invention can be made from soluble polymers and possible soluble and / or biostable reinforcing fibers by various methods used in plastic engineering such as injection molding, extrusion and associated fibrillation and shaping (see e.g. Ol Pat. A. 87). where the pieces are formed from raw materials by heat and / or pressure -35.

The devices according to the invention can also be made from the above-mentioned raw materials. using solvent techniques in which at least a portion of the polymer is dissolved in a suitable solvent or softened as a solvent and the material or material mixture is compressed into a piece by pressure and possible gentle heat, the dissolved or softened polymer gluing the material into a macroscopic piece from which the solvent is removed.

It will be appreciated that the devices of the invention may further comprise various additives or excipients to facilitate the processability of the material (e.g. stabilizers, antioxidants or plasticizers) or to modify its properties (e.g. plasticizers or powdered ceramic materials or biostable fibers such as polyaramide or carbon fibers). ) or to facilitate its handling (eg dyes).

In a preferred embodiment, the devices of the invention contain a bioactive agent or 3.0 agents such as antibiotics, chemotherapeutic agents, wound healing agents, growth hormone, contraceptive agent, anticoagulant (such as heparin), etc. Such bioactive agents are particularly preferred in clinical use. in addition to the mechanical effect, they have biochemical, medicinal, etc. effects in various tissues.

Because the materials of the invention have good mechanical properties, they can be mechanically processed into a variety of shapes. For example, sheet blanks can be rolled, pressed, stamped, punched, bent, etc., either cooled below room temperature, at room temperature, or at an elevated temperature. They can also be machined by drilling, grinding, milling, etc. mechanical machining methods, as well as other methods such as laser machining or water jet cutting and ultrasonic cutting. The rods and tubes according to the invention can be processed by the corresponding 88111 methods. For example, a screw thread can be rolled onto the surface of a rod or tube by rolling the rod or tube between rotating (possibly heated) rollers (usually 3 rollers) which are suitably grooved. Such screw rolling is commonly used in the metal industry, but has not previously been applied to the processing of self-reinforced materials. The rod can also be pushed into the base, they can be twisted into a spiral, bent into hooks, etc.

10

The invention and its functionality are illustrated by the following examples.

i4 881 1 1

Example 1.

A parallel yarn bundle was assembled from polyglycolide wound sutures (Dexon®; size 2 USP) and the yarn bundle 5 was twisted about its longitudinal axis so that the yarns twisted at an angle of about 45 ° to the longitudinal axis direction of the yarn bundle (Figure 4). The twisted wire bundle was inserted into a pressurized cylindrical mold (length 70 mm, diameter 3.2 mm) and sintered (T = 218 °, time = 10 5 min., Pressure = 2000 bar) into a self-reinforced rod according to the invention (spiral reinforced rod) with reinforcing elements (fibers). ) revolved around the longitudinal axis of the rod. As a reference material, a corresponding rod was prepared by sintering a parallel wire bundle.

The torsional load bearing capacity of the helically reinforced rod was determined by attaching the ends of the rod to a torsion measuring device and rotating the other end of the rod in the same direction as the spiral reinforcement had rotated in the rod. 20 The tensile load-bearing capacity of a parallel fiber rod was determined as a reference value. For the spiral-reinforced rod, a max. for a force of 18 N and for a parallel reinforced 10 N.

25 Example 2.

Fibers were prepared by melt spinning and (hot) drawing from the following absorbable polymers: poly-L-lactide (Mw 260,000), L-lactide / D-lactide copolymer: c (molar ratio 90/10), glycolide / lactide copolymer (molar ratio 90/10), glycolide / lactide copolymer (molar ratio 90/10) and poly-e-hydroxybutyrate (Mw ca.

700.000).

'') Prepared according to Example 1 from the above fibers by sintering spirally reinforced and parallel reinforced absorbable (self-reinforced) rods. The torsional load bearing capacity was determined according to Example 1 is 88111 for each rod. The values of the helically oriented rods were 1.3-2 times the values of the parallel-reinforced rods.

5 Example 3.

Absorbent, self-reinforcing screws were prepared from DexonR wire (size USP 1) with the following dimensions: length 120 mm, screw core diameter 6 mm, thread 10 length 20 mm at screw tip, maximum thread diameter 8 mm, base max. diameter 9 mm, by sintering DexonR wire rods in a screw-shaped, hydraulically sealing mold into a self-reinforcing structure (T = 215 - 225 ° C, pressing time 10 min, pressure 2000 bar).

15

Two types of screws were made: A) Screws according to the invention were made by winding Dexon wire (thickness UPS 1) around a rotating polished 20 metal (steel) mandrel (length 140 mm, max. Thickness 3 mm from the thicker end and 2 mm from the thinner end, square cross section) " filament win-ding "technique by varying the value of the winding angle from -60 ° to 0 ° to + 60 °, where 0 ° was the direction perpendicular to the direction of the longitudinal axis of the mandrel and ± 60 ° varied the winding angle on both sides of this direction. maximum and minimum values. The wound blank was cut to a length of 125 mm and sintered into an unsupported screw blank with a thread of 20 mm at a distance of 30 so that the metal mandrel was inside the screw blank. The base was pushed into the base end of the screw blank by hot pressing so that the metal mandrel became visible at a distance of 5 mm. The metal mandrel was removed from inside the screw, forming a square cross-sectional hole through the screw that penetrated 15 screws.

ie 88111 B) Screws were made from a DexonR parallel wire bundle in which the reinforcing elements (DexonR wires) were oriented in the direction of the longitudinal axis of the screw.

The torsional load bearing capacity of the spiral-oriented screw according to the invention was measured by inserting a long screwdriver bit into the hole and attaching the screwdriver head and the screw thread to the torsional strength device and twisting the screw tip about 10 longitudinal axes of the screw.

A corresponding measurement was made on the parallel reinforced screw by attaching its base and tip to the torsion device and twisting the screwdriver around the longitudinal axis of the screw until it began to break. The maximum torque value was defined as the load-bearing capacity of the Tor-15 shear load.

The torsional load-bearing capacity of the screw according to the invention was 1.6 times that of a parallel reinforced screw.

20 Example 4.

Glycolide / lactide was prepared from wound sutures (Vic-rylR, size 1 USP) from plain weave fabric using Vicryl wound sutures as both warp and weft yarns. The fabric was wound on a roll into a roll about 8 mm thick and 40 mm long, which was flattened into a flat roll about 5 mm thick and inserted into an open 5 x 15 x 40 mm mold on one side. A suitable rectangular plate 30 was pressed onto the fabric roll in a mold, the mold was evacuated and the fabric material was sintered at about 180 ° C (time = 10 min, pressure 2000 bar) into a self-reinforced 5 x 5 x 40 mm rod. A corresponding layered rod was made by filling the mold with VicrylR fabric strips and sintering them together. Figure 5a schematically shows a rod according to the invention, in which the helical orientation of the fabric plane is depicted by a thick line (at the end of the rod) and the passage of the warp and weft yarn on the surface of the rod is depicted by thin lines. Figure 5b shows a corresponding layered rod (fabric layers upright); the compression direction of the rod was horizontal).

5 The rods were sawn into 5 mm long sections which were cast in half in epoxy plastic (EP) according to side figures 5c and 5d. It was determined in the vertical direction of the material (5c) in accordance with the invention shear strength and the layered material (5d) of the shear strength of the layers by loading the plane 10 in the direction in epoxy molded articles direction indicated by the arrow (~ >>).

A value of 80 MPa was obtained for the shear strength of the material according to the invention (Fig. 5c) and 45 MPa for the layered material in the direction of the layers (Fig. 5d).

Spiral-reinforced rods as well as layered rods were split by sawing in their longitudinal direction to obtain rods according to Figure 5e (spiral reinforcement) and (layer reinforcement) according to Figure 5e (rod in Figure 5f is rotated 90 ° about its longitudinal axis after splitting against rod 5b). The rods were hydrolyzed for 3 weeks in distilled water (T = 37 ° C) and their flexural strengths were determined by three-point bending by supporting 25 rods at their ends and loading them in the middle (arrows in Figures 5e and 5f). A bending strength of 40 MPa was obtained for the bars according to the invention and 25 MPa for the layered bars.

: 30; Example 5.

Prepared by compression molding from poly-L-lactide (Mw ca.

700,000) 5 mm thick billets rolled at elevated temperature (rolling temperature> 90 ° C) into 0.4 mm thick films. The 30 mm wide film was wound into a hot roll as shown in Figure 5a and the roll was sintered into a 5 x 5 x 30 mm spiral oriented rod in the mold of Example 4 at 175 ° C.

18 381 1 1

A layered rod according to Figure 5b was made by stacking 5 x 30 mm sheets cut from a tensile rolled sheet into a mold and sintering them into a 5 x 5 x 30 mm rod.

5 The shear strengths of the helically oriented and parallel oriented rod were determined by the experimental arrangements of Figures 5c (spiral oriented) and 5d (parallel oriented). A shear strength of 120 MPa was obtained for the helically oriented material according to the invention and 40 MPa for the parallel-oriented material.

Example 6.

Prepared by extrusion (single screw machine, model Axon) 15 blanks with a diameter of 4 mm made of polylactide (Mw 260,000). The extruded preform was drawn through a conical nozzle (cone angle 25 °, length 20 mm) (hole diameter on the outlet side 2.6 mm) at a temperature (T) Tm> T> Tg, where Tm = melting point of the material and Tg = glass transition temperature of the material. The drawing was repeated on the once drawn blank using a 1.2 mm diameter nozzle. The thickness of the self-reinforced (parallel reinforcement) rod was 1.15 mm. The rod was cut into 20 mm pieces. Some of the rods were converted to helical reinforcements by rotating the ends of the rods in opposite directions at 90 ° C so that the direction of the reinforcing fibrils was finally 45 ° deviating from the direction of the longitudinal axis of the rod. The torsional load resistances of helically reinforced and parallel reinforced rods at room temperature were determined. The spiral-reinforced bar had a torsional load resistance of 1.4 times that of the parallel-reinforced bar when rotated in the direction of rotation of the reinforcement.

35 Example 7.

A. Manufactured in a cylindrical mold 60 mm long and 4.8 mm outside diameter self-reinforced i9 88 1 1 1

(parallel reinforcement) polylactide rods by sintering poly-L-lactide fibers (PLLA) (Mw approx. 700,000, melting point of the fibers approx. 180 ° C) and L-lactide / DL-lactide (PLDLA) copolymer fibers (molar ratio L-lactide / D, L-lactide = 5 90/10) (melting point of the fibers approx. 155 ° C) together 175 ° C

at a temperature such that the PLDLA fibers melted and wetted the PLLA fibers (PLDLA formed a binder matrix around the PLLA fibers).

B. Polylactide preforms were prepared by a winding technique by winding PLLA fibers and PLDLA fibers (1: 1 by weight) around a cylindrical mandrel (diameter 3.8 mm) and sintering in a cylindrical mold (T = 175 ° C) preforms with an outer diameter of 4.8 mm cylinders. The mandrel was removed from the inside of the tube and replaced by another mandrel with a longitudinal groove about 1 mm deep and wide. A cross-sectional view 6a shows a tube and a mandrel with a longitudinal groove. The tube was pressed in a hot state (T 20 about 110 ° C) with a hot tool into the groove on the outside of the mandrel (cross-sectional view 6b), the tube was cooled and the mandrel was removed from the inside to obtain core nails of cross-section as shown in Figure 6c.

25 '20 rabbit femurs were taken and drilled into them with a 4.5 mm drill along the longitudinal axis of the femur from the proximal end. Ten bones (drill channel) were tapped with the nuclear nails of section A. The other ten bones (borehole) were tapped with hollow, grooved core nails according to item 30 B (according to the invention). Of the closed nuclei (according to A), two split the bone longitudinally. The nailing of all the hollow, grooved core nails (point B nails) according to the invention went smoothly.

36 20 881 1 1

Example 8.

Braided from DexonR yarns (size 1 USP) from a three-dimensional, cylindrical elongated braid of the so-called 3-D 5 technique (schematic diagram of the placement of DexonR yarns in the braid structure: Fig. 7) with a thickness of about 6 mm. Self-reinforcing screws according to the invention were sintered from the braid in a cylindrical screw mold (screw length 40 mm, max. Base diameter approx. 8 mm, thread 10 along the entire screw distance, nominal thread diameter 4.5 mm and minimum thread diameter 3.2 mm) . The sintering conditions were T = 208-215 ° C, time approx. 10 min, pressure approx. 2000 bar.

15 Similar screws were made from DexonR wires by filling the mold with parallel wires and sintering them into screws. The torsional strengths of the screws were determined. A value of 1.4 NM was obtained for the 3-D braided screws according to the invention. A value of 0.8 NM was obtained for the parallel reinforced 20 screws.

Example 9.

According to Example 8, 3-D braided blanks of about 4 to 25 mm thick were prepared from PLLA fibers and PLDLA fibers (1: 1 weight ratio). The blanks were sintered in a cylindrical mold into rods 120 mm long and 2.6 mm thick (T = 175 ° C). A screw thread (max. Thread diameter 3.2 mm) was rolled to the other end of the rods for a distance of 20 mm by passing heated (T approx. 100 ° C) between the rollers.

Figure 8 shows a schematic cross-section of the experimental arrangement. The rods were cut to a length of about 30 mm, and a flat base (max. Diameter of the base about 6 mm) was inserted into the base end in a hot (T about 100 ° C) mold.

A vertical osteotomy was performed on the distal femur of the rabbit femur. The osteotomy was secured with the two screws prepared above as shown in Figure 9. After one year of follow-up, the osteotomy was found to be well ossified.

Example 10.

5

Made by braiding DexonR yarns (size USP1) into a tubular blank with a max. the thickness was 3 mm and the wall thickness was 1 mm. Figure 10 schematically shows a blank. Some of the DexonR yarns are drawn at the 10 ends of the blank.

A 40 mm long piece of braided blank was placed in an injection mold with a screw-shaped cavity (length 40 mm, max. Thread diameter 4.5 mm, thread 15 min. Diameter 3.2 mm, flat base max. Diameter approx. 8 mm). A polyglycolide distillate was filled into the mold by injection molding (injection molding machine: model Battenfeldt), which filled the mold and the core channel in the Dexon wire blank and covered the braided Dexon wire blank. 20 The mold was cooled rapidly. In the same mold, screws were made of polyglycolide melt without Dexon wire braid. Spiral-reinforced screws (containing Dexon wire braid) had a shear strength of 120 MPa and unreinforced screws had a shear strength of 75 MPa.

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Claims (8)

A self-reinforcing, absorbent surgical implant comprising reinforcing elements in a xenatrix, the reinforcing elements and the matrix having the saronic keroic eleroentar aroma composition and which are intended to be implanted into a living tissue or surface thereof e.g. for remedying tissue damage, for joining or propagating tissues or portions of desaroma, or for separating tissues or portions of desaroma from each other and / or from the environment and / or for conducting materials between tissues and portions thereof / or out-of-the-tissue aroma or external to tissues, characterized in that in the self-reinforcing implants, the reinforcing elements circulate at least partially around any of the shafts that pass through the implant substantially in the region of the transverse section perpendicular to the entire said axis. Implant according to claim 1, characterized in that the reinforcing elements are aligned molecular chains, molecular chain groups or parts thereof, aligned crystal lamellae, spherulites, fibrils or parts of the same or morphological structural elements of such type. Implant according to claim 1 or 2, characterized in that the reinforcing elements are fibers, filaments, film fibers, yarns, twists, non-woven structures, nets, knitwear or woven structures or the like. Implants according to any one of claims 1-3, characterized in that they comprise at least one h & l, an opening or a depression, around which the reinforcing elements circulate at least partially. An implant according to claim 1, characterized in that the implant is formed as a core nail and that it is at least partially hollow and its wall is provided with at least one elongated latch or heel which is deformed by bending the wall of the implant. in mesh or by cleaving or perforating the substance of the implant at least partially. Method for manufacturing implants according to any one of claims 1-5, characterized in that the reinforcing elements are brought into helical shape with at least one axis, that the reinforcing elements are placed in a matrix, and that in the matrix the melt of the matrix polymer and / or the reinforcing elements are brought into such a physical state by means of heat and / or pressure, in which they are at least partially attached to each other. 15 Process according to claim 6, characterized in that said self-reinforced, helical reinforcing elements containing the material are mechanically processed by rolling, pressing, punching, pulling, cutting or bending or by combining various machining processes. Method according to claim 6 or 7, characterized in that the implant is formed as a rod, a nail, a bolt, a core nail, a screw, a hook, a tube, a plate or a rivet.