Endoluminal device

Abstract

An endoluminal device includes a composite yarn with a polymer yarn and an alloy wire. The polymer yarn includes a biodegradable polymer, and the alloy wire includes a biocompatible alloy. An endoluminal device can include a plurality of polymer yarns and at least one alloy wire, in which the polymer yarns include a biodegradable polymer, and the least one alloy wire includes a biocompatible alloy. A surgical system or kit includes an endoluminal device and a delivery instrument.

Claims

1. An endoluminal device comprising at least one composite yarn, wherein the at least one composite yarn comprises at least one polymer yarn and at least one alloy wire, wherein the at least one polymer yarn comprises a biodegradable polymer selected from the group consisting of polylactide, polyglycolide, poly(3-hydroxybutyrate), poly(4-hydroxybutyrate), polycaprolactone, poly(trimethylene carbonate), copolymer comprising repeating monomer units selected from the group consisting of lactide units, glycolide units, 6-hydroxyhexanoic acid units, 3-hydroxybutyrate units, 4-hydroxybutyrate units, trimethylencarbonate units and a combination of at least two of said monomer units, and a blend of at least two of said polymers, and the at least one alloy wire comprises magnesium alloy, zinc alloy, iron alloy, cobalt-chromium alloy or combinations thereof, wherein the at least one composite yarn is a wrapped yarn, and wherein the at least one polymer yarn is spirally wrapped by the at least one alloy wire, wherein the endoluminal device additionally comprises at least one non-composite yarn consisting of polymer, wherein the at least one non-composite yarn and the at least one composite yarn are connected to each other by means of a textile technique to form a tubular device.

2. The endoluminal device according to claim 1, wherein the at least one polymer yarn comprises polylactide and/or a copolymer comprising lactide units.

3. The endoluminal device according to claim 1, wherein the at least one alloy wire comprises a magnesium alloy.

4. The endoluminal device according to claim 1, wherein the at least one non-composite yarn consists of the same polymer as the at least one polymer yarn of the at least one composite yarn.

5. The endoluminal device according to claim 1, wherein the at least one composite yarn and the at least one non-composite yarn extend in oppositely directed spirals along a longitudinal direction of the endoluminal device.

6. The endoluminal device according to claim 5, wherein the spirals are connected to each other.

7. The endoluminal device according to claim 1, wherein the at least one composite yarn and/or the at least one non-composite yarn extend in unidirectional spirals along a longitudinal direction of the endoluminal device.

8. The endoluminal device according to claim 1, wherein the at least one composite yarn comprises a plurality of composite yarns.

9. The endoluminal device according to claim 1, wherein the endoluminal device comprises a plurality of the composite yarns, wherein a number of the plurality of the composite yarns extend along a longitudinal direction of the endoluminal device and a remaining number of the plurality of the composite yarns is arranged in a circumferential direction of the endoluminal device or surrounds the endoluminal device along its circumference.

10. The endoluminal device according to claim 1, wherein the endoluminal device further comprises a coating.

11. The endoluminal device according to claim 1, wherein the endoluminal device is a stent.

12. The endoluminal device according to claim 1, wherein the textile technique is selected from the group consisting of weaving, knitting, braiding and a combination of at least two of said textile techniques.

13. The endoluminal device according to claim 1, wherein the endoluminal device comprises additional composite yarns in the form of enlacements each being arranged perpendicularly to the longitudinal axis of the endoluminal device.

14. An endoluminal device comprising of at least one composite yarn, wherein the at least one composite yarn comprises at least one polymer yarn and at least one alloy wire, wherein the at least one polymer yarn comprises a biodegradable polymer selected from the group consisting of polylactide, polyglycolide, poly(3-hydroxybutyrate), poly(4-hydroxybutyrate), polycaprolactone, poly(trimethylene carbonate), copolymer comprising repeating monomer units selected from the group consisting of lactide units, glycolide units, 6-hydroxyhexanoic acid units, 3-hydroxybutyrate units, 4-hydroxybutyrate units, trimethylencarbonate units and a combination of at least two of said monomer units, and a blend of at least two of said polymers, and the at least one alloy wire comprises magnesium alloy, zinc alloy, iron alloy, cobalt-chromium alloy or combinations thereof, wherein the at least one composite yarn is a wrapped yarn, and wherein the at least one polymer yarn is spirally wrapped by the at least one alloy wire, wherein the endoluminal device additionally comprises at least one non-composite yarn consisting of polymer, wherein the at least one non-composite yarn and the at least one composite yarn are connected to each other by means of a textile technique to form a tubular device and wherein the endoluminal device additionally comprises a non-textile coating, wherein the non-textile coating covers the at least one composite yarn and/or the at least one non-composite yarn.

15. The endoluminal device according to claim 14, wherein the non-textile coating covers the at least one alloy wire of the at least one composite yarn.

16. The endoluminal device according to claim 14, wherein the non-textile coating covers the at least one polymer yarn of the at least one composite yarn.

17. The endoluminal device according to claim 14, wherein the non-textile coating covers the at least one composite yarn only partially.

18. The endoluminal device according to claim 14, wherein the non-textile coating covers the at least one composite yarn completely.

19. The endoluminal device according to claim 14, wherein the non-textile coating comprises at least one agent.

Description

BRIEF DESCRIPTION OF THE DRAWING FIGURES

(1) In the FIGS. 1 to 11, different embodiments of an endoluminal device according to the present invention are schematically displayed which will be described in more detail in the following.

(2) FIG. 1 schematically displays an embodiment of an endoluminal device according to one embodiment;

(3) FIG. 2 schematically displays a further embodiment of an endoluminal device;

(4) FIG. 3 schematically displays a further embodiment of an endoluminal device;

(5) FIG. 4 schematically displays a further embodiment of an endoluminal device;

(6) FIG. 5 schematically displays a further embodiment of an endoluminal device;

(7) FIG. 6 schematically displays a further embodiment of an endoluminal device;

(8) FIG. 7 schematically displays a further embodiment of an endoluminal device;

(9) FIG. 8 schematically displays a further embodiment of an endoluminal device;

(10) FIG. 9 schematically displays a further embodiment of an endoluminal device;

(11) FIG. 10 schematically displays a further embodiment of an endoluminal device; and

(12) FIG. 11 schematically displays a further embodiment of an endoluminal device.

DETAILED DESCRIPTION

(13) FIG. 1 schematically displays an embodiment of an endoluminal device 10 according to the present invention.

(14) The endoluminal device 10 comprises a plurality of polymer yarns 12 and one composite yarn 14. The composite yarn 14 comprises at least one polymer yarn and at least one alloy wire. Preferably, the composite yarn 14 is a wrapped yarn. Preferably, the at least one polymer yarn is wrapped, in particular helically wrapped, by the at least one alloy wire.

(15) The polymer yarns 12 and the composite yarn 14 extend in unidirectional helices along a longitudinal direction of the endoluminal device 10. The longitudinal direction of the endoluminal device 10 is shown as a solid arrow.

(16) The polymer yarns 12 and the composite yarn 14 and/or the helices may be connected to each other, in particular by means of a textile technique such as weaving, knitting or braiding and/or by means of a material bonding engagement such as gluing, welding or melting.

(17) The polymer yarns and the at least one polymer yarn of the composite yarn 14 may comprise or consist of poly(L-lactide).

(18) The at least one alloy wire of the composite yarn may comprise or consist of a magnesium alloy.

(19) Preferably, the endoluminal device 10 is in a thermoset condition.

(20) Further it is preferred that the endoluminal device 10 is embodied as a stent, preferably as an endoarterial stent.

(21) FIG. 2 schematically displays a further embodiment of an endoluminal device 10 according to the present invention.

(22) The endoluminal device 10 comprises a plurality of polymer yarns 12 and a plurality of composite yarns 14. Each composite yarn 14 comprises at least one polymer yarn and at least one alloy wire. Preferably, each composite yarn 14 is a wrapped yarn. Preferably, the at least one polymer yarn is wrapped, in particular helically wrapped, by the at least one alloy wire.

(23) The polymer yarns 12 and the composite yarns 14 extend in unidirectional helices along a longitudinal direction of the endoluminal device 10. The longitudinal direction of the endoluminal device 10 is shown as a solid arrow.

(24) The polymer yarns 12 and the at least one polymer yarn of the composite yarns 14 may comprise or consist of poly(L-lactide).

(25) The at least one alloy wire of the composite yarns 14 may comprise or consist of a magnesium alloy.

(26) The polymer yarns 12 and the composite yarns 14 and/or the helices may be connected to each other, in particular by means of a textile technique such as weaving, knitting or braiding and/or by means of a material bonding engagement such as gluing, welding or melting.

(27) Preferably, the endoluminal device 10 is in a thermoset condition.

(28) Further it is preferred that the endoluminal device 10 is embodied as a stent, preferably as an endoarterial stent.

(29) FIG. 3 schematically displays a further embodiment of an endoluminal device 10 according to the present invention.

(30) The endoluminal device 10 comprises a plurality of polymer yarns 12 and one composite yarn 14. The composite yarn 14 comprises at least one polymer yarn and at least one alloy wire. Preferably, the composite yarn 14 is a wrapped yarn. Preferably, the at least one polymer yarn is wrapped, in particular helically wrapped, by the at least one alloy wire.

(31) The polymer yarns 12 and the composite yarn 14 extend in oppositely directed helices along a longitudinal direction of the endoluminal device 10. The longitudinal direction of the endoluminal device 10 is shown as a solid arrow.

(32) The polymer yarns 12 and the composite yarn 14 and/or the helices may be connected to each other, in particular by means of a textile technique such as weaving, knitting or braiding and/or by means of material bonding engagement such as gluing, welding or melting.

(33) More preferably, at crossing points 15, the oppositely directed helices are connected to each other, in particular by means of a material bonding engagement such as gluing, welding or melting, or by means of a textile technique such as weaving, knitting or braiding. Thus, the radial stiffness of the device 10 can be additionally increased.

(34) The polymer yarns 12 and the at least one polymer yarn of the composite yarn 14 may comprise or consist of poly(L-lactide).

(35) The at least one alloy wire of the composite yarn 14 may comprise or consist of a magnesium alloy.

(36) Preferably, the endoluminal device 10 is in a thermoset condition.

(37) Further it is preferred that the endoluminal device 10 is embodied as a stent, preferably as an endoarterial stent.

(38) FIG. 4 schematically displays a further embodiment of an endoluminal device 10 according to the present invention.

(39) The endoluminal device 10 comprises a plurality of polymer yarns 12 and a plurality of composite yarns 14. Each composite yarn 14 comprises at least one polymer yarn and at least one alloy wire. Preferably, each composite yarn 14 is a wrapped yarn. Preferably, the at least one polymer yarn is wrapped, in particular helically wrapped, by the at least one alloy wire.

(40) The polymer yarns 12 and the composite yarns 14 extend in oppositely directed helices along a longitudinal direction of the endoluminal device 10. The longitudinal direction of the endoluminal device 10 is shown as a solid arrow.

(41) The polymer yarns 12 and the composite yarns 14 and/or the helices may be connected to each other, in particular by means of a textile technique such as weaving, knitting or braiding and/or by means of a material bonding engagement such as gluing, welding or melting.

(42) More preferably, at crossing points 15, the oppositely directed helices are connected to each other, in particular by means of a material bonding engagement such as gluing, welding or melting, or by means of a textile technique such as weaving, knitting or braiding. Thus, the radial stiffness of the device 10 can be additionally increased.

(43) The polymer yarns 12 and the at least one polymer yarn of the composite yarns 14 may comprise or consist of poly(L-lactide).

(44) The at least one alloy wire of the composite yarns 14 may comprise or consist of a magnesium alloy.

(45) Preferably, the endoluminal device 10 is in a thermoset condition.

(46) Further it is preferred that the endoluminal device 10 is embodied as a stent, preferably as an endoarterial stent.

(47) FIG. 5 schematically displays a further embodiment of an endoluminal device 10 according to the present invention.

(48) Against the endoluminal device 10 as shown in FIG. 4, the endoluminal device of FIG. 5 additionally comprises enlacements (loops) 16 which are arranged in a circumferential direction of the endoluminal device 10. The circumferential direction of the endoluminal device 10 is indicated as a dashed arrow. Thus, the radial stiffness and/or the suspension of the device 10 can be significantly enhanced.

(49) Each enlacement 16 is preferably made of a composite yarn, wherein the composite yarn preferably comprises at least one polymer yarn and at least one alloy wire. Preferably, the at least one polymer yarn may comprise or consist of the same polymer as the at least one polymer yarn of the composite yarns 14 described in FIG. 4 and/or the at least one alloy wire may comprise or consist of the same alloy as the at least one alloy wire of the composite yarns 14 described in FIG. 4.

(50) Regarding further features and advantages of the endoluminal device 10, reference is made to the description of FIG. 4.

(51) FIG. 6 schematically displays a further embodiment of an endoluminal device 10 according to the present invention.

(52) The endoluminal device 10 comprises a plurality of polymer yarns 12 and composite yarns 14a; 14b. Each composite yarn 14a; 14b comprises at least one polymer yarn and at least one alloy wire. Preferably, each composite yarn 14a; 14b is a wrapped yarn. Preferably, the at least one polymer yarn is wrapped, in particular helically wrapped, by the at least one alloy wire.

(53) The composite yarns 14a; 14b are differently embodied in terms of diameter of the at least one alloy wire. For example, the endoluminal device 10 may have a composite yarn 14a comprising at least one alloy wire having a diameter of 30 μm and a composite yarn 14b comprising at least one alloy wire having a diameter of 50 μm

(54) The polymer yarns 12 and the composite yarns 14a; 14b extend in oppositely directed helices along a longitudinal direction of the endoluminal device 10. The longitudinal direction of the endoluminal device 10 is shown as a solid arrow.

(55) The polymer yarns 12 and the composite yarn 14a; 14b and/or the helices may be connected to each other, in particular by means of a textile technique such as weaving, knitting or braiding and/or by means of a material bonding engagement such as gluing, welding or melting.

(56) More preferably, at crossing points 15, the oppositely directed helices are connected to each other, in particular by means of a material bonding engagement such as gluing, welding or melting, or by means of a textile technique such as weaving, knitting or braiding. Thus, the radial stiffness of the device 10 can be additionally increased.

(57) The polymer yarns 12 and the at least one polymer yarn of the composite yarns 14a; 14b may comprise or consist of poly(L-lactide).

(58) The at least one alloy wire of the composite yarns 14a; 14b may comprise or consist of a magnesium alloy.

(59) Preferably, the endoluminal device 10 is in a thermoset condition.

(60) Further it is preferred that the endoluminal device 10 is embodied as a stent, preferably as an endoarterial stent.

(61) FIG. 7 schematically displays a further embodiment of an endoluminal device 10 according to the present invention.

(62) The endoluminal device 10 comprises a plurality of polymer yarns 12 and a plurality of composite yarns 14, wherein each composite yarn is embodied as an enlacement (loop) 16 which is arranged in a circumferential direction of the endoluminal device 10. The circumferential direction of the device 10 is indicated as a dashed arrow. By means of the enlacements, the radial stiffness and/or suspension of the endoluminal device 10 can be significantly increased.

(63) Each composite yarn 14 comprises at least one polymer yarn and at least one alloy wire. Preferably, each composite yarn 14 is a wrapped yarn. Preferably, the at least one polymer yarn is wrapped, in particular helically wrapped, by the at least one alloy wire.

(64) The polymer yarns 12 extend in oppositely directed helices along a longitudinal direction of the endoluminal device 10. The longitudinal direction of the endoluminal device 10 is shown as a solid arrow.

(65) The polymer yarns 12 and/or the helices may be connected to each other, in particular by means of a textile technique such as weaving, knitting or braiding and/or by means of a material bonding engagement such as gluing, welding or melting.

(66) The composite yarns 14 and enlacements, respectively may be connected to the polymer yarns 12 and/or helices, in particular by means of a textile technique such as weaving, knitting or braiding or by means of material bonding engagement such as gluing, welding or melting.

(67) The polymer yarns 12 and the at least one polymer yarn of the composite yarns 14 may comprise or consist of poly(L-lactide).

(68) The at least one alloy wire of the composite yarns 14 may comprise or consist of a magnesium alloy.

(69) Preferably, the endoluminal device 10 is in a thermoset condition.

(70) Further it is preferred that the endoluminal device 10 is embodied as a stent, preferably as an endoarterial stent.

(71) FIG. 8 schematically displays a further embodiment of an endoluminal device 10 according to the present invention.

(72) The endoluminal device 10 comprises a plurality of polymer yarns 12 and one alloy wire 14.

(73) The polymer yarns 12 and the alloy wire 14 extend in unidirectional helices along a longitudinal direction of the endoluminal device 10. The longitudinal direction of the endoluminal device 10 is shown as a solid arrow.

(74) The polymer yarns 12 and the alloy wire 14 and/or the helices may be connected to each other, in particular by means of a textile technique such as weaving, knitting or braiding and/or by means of a material bonding engagement such as gluing, welding or melting.

(75) The polymer yarns may comprise or consist of poly(L-lactide), while the alloy wire preferably comprises or consists of a magnesium alloy.

(76) Preferably, the endoluminal device 10 is in a thermoset condition.

(77) Further it is preferred that the endoluminal device 10 is embodied as a stent, preferably as an endoarterial stent.

(78) FIG. 9 schematically displays a further embodiment of an endoluminal device 10 according to the present invention.

(79) The endoluminal device 10 comprises a plurality of polymer yarns 12 and a plurality of alloy wires 14.

(80) The polymer yarns 12 and the alloy wires 14 extend in unidirectional helices along a longitudinal direction of the endoluminal device 10. The longitudinal direction of the endoluminal device 10 is shown as a solid arrow.

(81) The polymer yarns 12 and the alloy wires 14 and/or the helices may be connected to each other, in particular by means of a textile technique such as weaving, knitting or braiding and/or by means of a material bonding engagement such as gluing, welding or melting.

(82) The polymer yarns may comprise or consist of poly(L-lactide), while the alloy wires preferably comprise or consist of a magnesium alloy.

(83) Preferably, the endoluminal device 10 is in a thermo-fixed condition.

(84) Further it is preferred that the endoluminal device 10 is a stent, preferably an endoarterial stent.

(85) FIG. 10 schematically displays a further embodiment of an endoluminal device 10 according to the present invention.

(86) The endoluminal device 10 comprises a plurality of polymer yarns 12 and one alloy wire 14.

(87) The polymer yarns 12 and the alloy wire 14 extend in oppositely directed helices along a longitudinal direction of the endoluminal device 10. The longitudinal direction of the endoluminal device 10 is shown as a solid arrow.

(88) The polymer yarns 12 and the alloy wire 14 and/or the helices may be connected to each other, in particular by means of a textile technique such as weaving, knitting or braiding and/or by means of a material bonding engagement such as gluing, welding or melting.

(89) More preferably, at crossing points 15, the oppositely directed helices are connected to each other, in particular by means of a material bonding engagement such as gluing, welding or melting, or by means of a textile technique such as weaving, knitting or braiding. Thus, the radial stiffness of the device 10 can be additionally increased.

(90) The polymer yarns 12 may comprise or consist of poly(L-lactide), while the alloy wire 14 preferably comprises or consists of a magnesium alloy.

(91) Preferably, the endoluminal device 10 is in a thermoset condition.

(92) Further it is preferred that the endoluminal device 10 is embodied as a stent, preferably as an endoarterial stent.

(93) FIG. 11 schematically displays a further embodiment of an endoluminal device 10 according to the present invention.

(94) The endoluminal device 10 comprises a plurality of polymer yarns 12 and a plurality of alloy wires 14.

(95) The polymer yarns 12 and the alloy wires 14 extend in oppositely directed helices along a longitudinal direction of the endoluminal device 10. The longitudinal direction of the endoluminal device 10 is shown as an arrow.

(96) The polymer yarns 12 and the alloy wires 14 and/or the helices may be connected to each other, in particular by means of a textile technique such as weaving, knitting or braiding and/or by means of material bonding engagement such as gluing, welding or melting.

(97) More preferably, at crossing points 15, the oppositely directed helices a connected to each other, in particular by means of material bonding engagement such as gluing, welding or melting, or by means of textile technique such as weaving, knitting or braiding. Thus, the radial stiffness of the device 10 can be additionally increased.

(98) The polymer yarns 12 may comprise or consist of poly(L-lactide), while the alloy wires 14 preferably comprise or consist of a magnesium alloy.

(99) Preferably, the endoluminal device 10 is in a thermoset condition.

(100) Further it is preferred that the endoluminal device 10 is a stent, preferably an endoarterial stent.

(101) As regards further features and advantages of the endoluminal device 10 as depicted in the FIGS. 1 to 11, reference is made in its entirety to the general description which does apply accordingly. It goes without saying that the devices as shown in FIGS. 1 to 11, in particular the yarn(s) and/or wire(s) thereof, may also comprise or consist of alternative materials (polymers and alloys, respectively) as described in the general description.

EXAMPLES

1. Manufacture of Endoluminal Devices

(102) 1.1 Eight poly(L-lactide) yarns (100f15) were braided onto a mandrel. Additionally, wrapped yarns made of Eight poly(L-lactide) yarns (100f15) and one magnesium alloy wire were arranged as enlacements (loops) in the circumferential direction of the mandrel. The poly(L-lactide) yarns and the magnesium alloy wire had a diameter of 30 μm. Subsequently, the braided device was thermoset onto the mandrel at 100° C. during 30 minutes. The thermoset device was removed from the mandrel and tailored to a defined length. The ends of the device were humidified with LDL7030-29/5 5% ethyl acetate solution in order to avoid a fanning out of the ends of the endoluminal device. 1.2 Six poly(L-lactide) yarns (100f15) and two wrapped yarns made of six poly(L-lactide) yarns (100f15) and a magnesium alloy wire were braided onto a mandrel. Both the poly(L-lactide) yarns and the magnesium alloy wire had a diameter of 30 μm. Subsequently, the braided device was thermoset onto the mandrel at 100° C. during 30 minutes. The thermoset device was removed from the mandrel and tailored to a defined length. The ends of the device were humidified with LDL7030-29/5% ethyl acetate solution in order to avoid a fanning out of the ends of the endoluminal device. 1.3 six poly(L-lactide) yarns (100f15) and two wrapped yarns made of 6 poly(L-lactide) yarns (100f15) and a magnesium alloy wire were braided onto a mandrel. Both the poly(L-lactide) yarns and the magnesium alloy wire had a diameter of 30 m. Additionally, wrapped yarns made of six poly(L-lactide) yarns (100f15) and a magnesium alloy wire were arranged as enlacements (loops) in the circumferential direction of the braided device. Subsequently, the device was thermoset onto the mandrel at 100° C. during 30 minutes. The thermoset device was removed from the mandrel and tailored to a defined length. The ends of the device were humidified with LDL7030-29/5% ethyl acetate solution in order to avoid a fanning out of the ends of the endoluminal device. 1.4 Four poly(L-lactide) yarns (100f15), two wrapped yarns made of four poly(L-lactide) yarns (100f15) and a magnesium alloy wire having a diameter of 30 μm and two wrapped yarns made of four poly(L-lactide) yarns (100f15) and a magnesium alloy wire having a diameter of 50 μm were braided onto a mandrel. Subsequently, the braided device was thermoset onto the mandrel at 100° C. during 30 minutes. The thermoset device was removed from the mandrel and tailored to a defined length. The ends of the device were humidified with LDL7030-29/5% ethyl acetate solution in order to avoid a fanning out of the ends of the endoluminal device. 1.5 Six poly(L-lactide) yarns (100f15) and two wrapped yarns made of six poly(L-lactide) yarns (100f15) and a magnesium alloy wire were braided onto a mandrel. The poly(L-lactide) yarns had a diameter of 30 μm. The magnesium alloy wire had a diameter of 50 μm. Subsequently, the braided device was thermoset onto the mandrel at 100° C. during 30 minutes. The thermoset device was removed from the mandrel and tailored to a defined length. The ends of the device were humidified with LDL7030-29/5% ethyl acetate solution in order to avoid fanning out of the ends of the endoluminal device. 1.6 Seven poly(L-lactide) yarns (100f15) and one wrapped yarn made of seven poly(L-lactide) yarns (100f15) and one magnesium alloy wire were braided onto a mandrel. The poly(L-lactide) yarns had a diameter of 30 μm. The magnesium alloy wire had a diameter of 50 μm. Subsequently, the braided device was thermoset onto the mandrel at 100° C. during 30 minutes. The thermoset device was removed from the mandrel and tailored to a defined length. The ends of the device were humidified with LDL7030-29/5% ethyl acetate solution in order to avoid a fanning out of the ends of the endoluminal device. 1.7 Six poly(L-lactide) yarns (100f15) and two magnesium alloy wires were braided onto a mandrel. The poly(L-lactide) yarns had a diameter of 30 μm, while the magnesium alloy wires had a diameter of 50 μm. The braided device was thermoset onto the mandrel at 100° C. during 30 minutes. The thermoset device was removed from the mandrel and tailored to a defined length. The ends of the device were humidified with LDL7030-29/5% ethyl acetate solution in order to avoid a fanning out of the ends of the endoluminal device. 1.8 Four poly(L-lactide) yarns (100f15) and four magnesium alloy wires were braided onto a mandrel. The poly(L-lactide) yarns had a diameter of 30 μm while the magnesium alloy wires had a diameter of 50 μm. The braided device was thermoset onto the mandrel at 100° C. during 30 minutes. The thermoset device was removed from the mandrel and tailored to a defined length. The ends of the device were humidified with LDL7030-29/5% ethyl acetate solution in order to avoid a fanning out of the ends of the endoluminal device.

2. Test of Compression Behaviour

(103) Four different designs of an endoluminal device were manufactured.

(104) The first design, in the following denoted as EKU 01, had a spiral configuration made of eight fibres of poly(L-lactide) together with one magnesium alloy wire. Both the fibres of poly(L-lactide) and the magnesium alloy wire had a diameter of 30 μm.

(105) The second design, in the following denoted as EUF 01, had a braided configuration made of eight fibres of poly(L-lactide) only.

(106) The third design, in the following denoted as EUF 03, had a braided configuration made of eight fibres of poly(L-lactide) with composite yarns made of eight filaments of poly(L-lactide) together with one magnesium alloy wire, wherein the composite yarns were arranged as enlacements (loops) in the circumferential direction of the endoluminal device. While the fibres of poly(L-lactide) had a diameter of 30 μm, the magnesium alloy wire had a diameter of 50 μm.

(107) The fourth design, in the following denoted as EUF 06, had a braided configuration made of eight fibres of poly(L-lactide) and one magnesium alloy wire. While the fibres of poly(L-lactide) had a diameter of 30 μm, the magnesium alloy wire had a diameter of 50 μm.

(108) The aim of the investigation was to study the behaviour of the above designs under compression in comparison to a drug eluting stent of the last generation of Coroflex ISAR Neo.

(109) The designs were tested before and after drug coating. The coating was the same coating as used in Coroflex ISAR DES. The aim was to see possible changes in stability after coating.

(110) In order to see the deformation during compression, a new test method was developed to measure the radial resistance with parallel plates according to ISO 25539-2:2012 (point 8.6.2.4, crush resistance with parallel plates). It was the determination of the load required to cause clinically relevant buckling or a deflection reduction of at least 50% of the original distance between the plates or of the expanded stent diameter.

(111) The developed scaffolds exhibited self-memory properties. Therefore, two compression cycles were planned to analyze the self-memory properties of uncoated pieces.

(112) The test results without coating are shown in the below table 1.

(113) The lowest compression value was measured with the coil design EKU 01 of 0.01 N and the highest compression was measured with the radially mounted enlacements in the scaffold type EUF 03 of 0.046 N. The second compression of the designs showed the same compression forces (values in table 1 with the identification “measurement 2”) and similar correlation in force versus displacement behaviours compared to the first measurements.

(114) TABLE-US-00001 TABLE 1 Measurements of the maximal compression forces of the designs without coating at a 50% inner diameter reduction and the measurements of the second compression cycle are indicated with “measurement 2”. Probe labelling F.sub.max [N] EUF 01 0.17 EUF 01 “measurement 2” 0.17 EUF 03 0.46 EUF 03 “measurement 2” 0.47 EUF 06 0.16 EUF 06 “measurement 2” 0.16 EKU 01 0.02 EKU 01 “measurement 2” 0.02

(115) After design coating the compression forces were measured in order to study the mechanical effect of the coating. The maximal compression forces are indicated in the below table 2.

(116) TABLE-US-00002 TABLE 2 Measurements of the maximal compression forces of coating designs at a 50% inner diameter reduction in comparison to the latest generation drug eluting stent design Coroflex ISAR Neo. Probe labelling F.sub.max [N] Cx ISAR Neo 4.0 × 38 mm 2.75 EKU 01 0.13 EUF 01 0.44 EUF 03 1.02 EUF 06 — EUF 06 0.45

(117) Evaluation:

(118) The designs had an important influence on the reaction during compression. The radial filament arrangements the scaffold design increased the reaction force about 2.7 times. Due to the coating, the compression force of design “EUF 03” increased about two times compared to the scaffold without coating.

(119) The compression force of a drug eluting stent of the latest generation was about 2.7 N. The achieved compression force of the coated design “EUF 03” was about 1.02 N. This is a relation of less than one third of a drug eluting stent. The increase of wall thickness was about 100 μm in those locations where free fiber layers overlapped. The wall thickness in the locations where only two fiber layers overlapped was about 60 μm.

(120) The arrangement of the 30 μm fibres of magnesium and poly(L-lactide) and the coating had an influence on the compression force of the designs.