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1. WO2020109081 - PROCESS FOR MACHINE REPOSITIONING OF A PRE-CRIMPED DRUG-COATED STENT

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[ EN ]

Claims

1. A process for repositioning a drug-coated stent (2) that is pre-crimped on a balloon (30) of a balloon catheter (3) extending in an axial direction (z), so that an inner surface (2a) of the stent (2) lies against an outer surface (30b) of the balloon (30), the process having the following steps:

- Moving the stent (2), by means of at least one contact element (40, 41 , 42), in the axial direction (z) with respect to the balloon (30) of the balloon catheter (3), to reposition the stent (2) with respect to the balloon (30), and, to reposition the stent (2), the at least one contact element (40, 41, 42) gripping the stent (2) with a protection device (60, 61, 62; 70) between them, to prevent contact between the stent (2) and the at least one contact element (40, 41, 42).

2. A process according to claim 1, wherein the at least one contact element (40, 41, 42) is moved out of a first position toward the balloon catheter (3) into a second position, so that at least one contact element (40, 41, 42) reaches behind a face (2c) of the stent (2) with the protection device (60, 61, 62; 70) between them, or that, to grip the stent (2), this contact element presses against the stent (2) with the protection device (60, 61, 62; 70) between them.

3. A process according to claim 1 or 2, wherein the at least one contact element (40, 41, 42) has, to reach behind the stent (2), a tapering end section (40a, 41a).

4. A process according to claim 2 or 3, wherein to reposition the stent (2), the at least one contact element (40, 41, 42) located in the second position is moved in the axial direction (z) along the balloon catheter (3), carrying the stent (2) along, the balloon catheter (3) being fixed with respect to the axial direction (z).

5. A process according to any one of the preceding claims, wherein, to reposition the stent (2), it is moved in the axial direction (z) until the distance (A) in the axial direction (z) from one end (2d) of the stent (2) to an X-ray marker (31) arranged on the balloon catheter (3) corresponds to a predefined distance.

6. A process according to any one of the preceding claims, wherein the protection device has at least one film (60, 61, 62), the at least one contact element (40, 41, 42) gripping the stent (2) with the at least one film (60, 61, 62) between them, to prevent contact between the stent (2) and the at least one contact element (40, 41, 42).

7. A process according to claim 6, wherein after the at least one film (60, 61 , 62) makes contact with the stent (2), it is moved so that a stent that is subsequently to be repositioned makes contact with a section of the at least one film (60, 61, 62), this section not yet previously having been in contact with the stent.

8. A process according to claim 7, wherein the film (60, 61, 62) is moved in the axial direction (z) of the balloon catheter (3), or the film (60, 61, 62) is moved in a direction orthogonal to the axial direction (z).

9. A process according to claim 7 or 8, wherein the at least one film (60, 61, 62) is moved by unwinding the at least one film (60, 61, 62) from a feed roller (600) and winding it up onto a take-up roller (601).

10. A process according to any one of the preceding claims, wherein to reposition the stent (2) with respect to the balloon (30), the stent (2) is moved, by means of multiple contact elements (40, 41, 42), in the axial direction (z) with respect to the balloon (30) of the balloon catheter (3), and, to reposition the stent (2), each of the contact elements (40, 41, 42) grip it with a film (60, 61, 62) between the contact element and the stent, to prevent contact between the stent (2) and the contact elements (40, 41,

42), in particular the respective contact element (40, 41, 42) being moved out of a first position toward the balloon catheter (3) into a second position, so that the respective contact element (40, 41, 42) reaches behind a face (2c) of the stent (2) with a film (60, 61, 62) between them, or that, to grip the stent (2), this contact element presses against the stent (2) with a film (60, 61, 62) between them, in particular, to reposition the stent (2) the respective contact element (40, 41, 42) located in the second position being moved along the balloon catheter (3), carrying the stent (2) along with it.

11. A process according to claim 5 or to any one of claims 6 through 9, to the extent that it refers back to claim 5, wherein the distance is monitored with a camera (4) or with a capacitive sensor (4) or with an inductive sensor (4).

12. A process according to any one of claims 1 through 5, wherein the protection device is formed by a protective sheath (70) arranged on the stent (2) and surrounding the stent (2), the at least one contact element (40, 41, 42) gripping the stent (2) with the protective sheath (70) between them, to prevent contact between the stent (2) and the at least one contact element (40, 41, 42).

13. A process according to claim 12, wherein to reposition the stent (2) with respect to the balloon (30), the stent (2) is moved, by means of multiple contact elements (40, 41, 42), in the axial direction (z) with respect to the balloon (30) of the balloon catheter (3), and, to reposition the stent (2), the contact elements (40, 41, 42) grip it with the protective sheath (70) between the contact element and the stent, to prevent contact between the stent (2) and the contact elements (40, 41, 42), in particular the respective contact element (40, 41, 42) being moved out of a first position toward the balloon catheter (3) into a second position, so that the respective contact element (40, 41, 42) reaches behind a face (2c) of the stent (2) with the protective sheath (70) between them, or, to grip the stent (2), this contact element presses against the stent (2) with the protective sheath (70) between them, in particular, to reposition the stent (2) the respective contact element (40, 41, 42) located in the second position being moved along the balloon catheter (3), carrying the protective sheath (70) und the stent (2) along with it.

14. A process according to claim 5 and claim 12 or 13, wherein the distance (A) is determined by means of a capacitive or inductive sensor (5).

15. A process according to claim 14, wherein before the stent (2) is moved in the axial direction (z), the balloon catheter (3) is moved in the axial direction (z) with respect to the sensor (5) until the sensor (5) detects the aforementioned X-ray marker (31) and the aforementioned end (2d) of the stent (2).