SYSTEM COMPRISING AN APPLICATOR AND A STENT FOR A EUSTACHIAN TUBE

Abstract

A system includes a stent Including a first end for arrangement on a tubal ostium, a second end for arrangement on a bony isthmus of smaller diameter than a diameter of the first end, and adjacent to the second end a length portion of decreasing diameter. The system further includes an applicator for placement of the stent in a Eustachian tube. The applicator has a proximal end for handling the applicator and a distal end for receiving the stent. The distal end includes an inner part which has at least one area that is plastically deformable by manual force, for adaptation to a patient-dependent access angle of the Eustachian tube, and an outer tube which surrounds the inner part at a radial distance and which delimits an annular gap for receiving the stent, with the stent in the annular gap made of nitinol and being self-expanding.

Claims

1.-14. (canceled)

15. A system, comprising: a stent including a first end designed for arrangement on a tubal ostium and having a diameter of 4.5 to 5.5 mm, a second end designed for arrangement on a bony isthmus and having a diameter which is smaller than a diameter of the first end and ranging from 2.5 mm to 3.5 mm, and adjacent to the second end a length portion which decreases in diameter and extends over 20% to 40% of a length of the stent; and an applicator for placing the stent in a Eustachian tube, said applicator having a proximal end for handling the applicator and a distal end for receiving the stent, said distal end including an inner part which has at least one area that is plastically deformable by manual force, for adaptation to a patient-dependent access angle of the Eustachian tube, and an outer tube which surrounds the inner part at a radial distance and which delimits an annular gap for receiving the stent, with the stent in the annular gap made of nitinol and being self-expanding.

16. The system of claim 15, wherein the inner part has a length of 20 to 40 mm.

17. The system of claim 15, wherein the distal end of the inner part has an orientation which deviates from a longitudinal axis of the applicator by up to 70°.

18. The system of claim 15, wherein the outer tube is made of a plastically deformable material at least in a region of the inner part.

19. The system of claim 15, wherein the applicator includes a rounded tip with a diameter of 1.9 to 2.6 mm.

20. The system of claim 15, wherein the applicator includes a shaft made of high-quality steel.

21. The system of claim 20, wherein the shaft has a diameter of 1.8 to 2.3 mm.

22. The system of claim 15, wherein the applicator includes a working channel with a diameter of smaller than or equal to 0.8 mm.

23. The system of claim 15, wherein the applicator includes a movable optical fiber arranged in the inner part for position control before releasing the stent.

24. The system of claim 15, wherein the stent has an adjustable crimping diameter of 1 to 2.5 mm.

25. The system of claim 15, wherein the stent has a wall thickness in a range from 0.09 to 0.15 mm.

26. The system of claim 15, wherein the stent has a closed-cell design and is guidable about a curved path.

27. The system of claim 15, wherein the length portion of the stent is conical.

28. The system of claim 15, wherein the applicator has a length) of 8 to 40 mm.

Description

[0027] The invention is explained hereinafter with reference to exemplary embodiments that are shown purely schematically in the drawings. It is shown in:

[0028] FIG. 1 a schematic illustration of an applicator;

[0029] FIG. 2 a second illustration of an applicator with a curved tip;

[0030] FIG. 3 a side view of a stent for use with the applicator according to the invention; and

[0031] FIG. 4 an end view of the stent of FIG. 3.

[0032] FIG. 1 shows the greatly simplified applicator 1 for placing a stent 2 in a Eustachian tube, not shown in greater detail. At its proximal end 3, the applicator 1 has a widened stop 4 for a handle 5 which is attached to an outer tube 6 of the applicator 1. The handle 5 can be moved to the stop 4 in the direction of the arrow P1. As a result, the stent 2, which is held inside the outer tube 6, can be released at the distal end 7 of the applicator. The stent is made of nitinol. It is self-expanding. The released stent is shown purely symbolically in its expanded form with reference number 2′.

[0033] The applicator 1 has a long, slender shaft 8, which is shown in shortened form. It can have a longitudinal channel extending over the entire length. In the area of the distal end 7, there is a region on the shaft 8 with a reduced diameter. This involves an inner part 9 that is located in the outer tube 6 which is displaceable in longitudinal direction. The diameter in the inner part 9 is reduced to such an extent that the stent 2 can be placed in an annular space 10 prior to its release. The annular space 10 can also be referred to as a sluice. The inner part 9 and the outer tube 6 can be deformed by manual force.

[0034] The exemplary embodiment in FIG. 2 shows such an applicator 1 with a malleable inner part 9. The reference signs introduced for FIG. 1 are also retained for FIG. 2 for the designation of components that are essentially functionally the same. As in the exemplary embodiment in FIG. 1, the shaft 8 is surrounded by the outer tube 6, which in turn can be displaced in the direction of the longitudinal axis LA of the shaft 8. The stent can be arranged in the annular space 10. The distal end 7 has a rounded tip 11.

[0035] This applicator 1 is provided with a longitudinal channel which extends through the applicator 1 over the entire length. A light guide is arranged within the longitudinal channel. The light guide is connected to a light source. As a result, a light beam 12 can exit at the tip 11. The deformable area of the applicator can be bent by up to 70° in relation to the longitudinal axis LA in the non-bent length area of the applicator 1.

[0036] The forward region of the applicator, i.e. the inner part 9 and the region of the outer tube 6 there, are curved in an arc. The bend has been implemented using manual force. In addition, it can be seen that the outer tube 6 follows the bend of the inner part 9 essentially coaxially, so that the annular space 10 has an essentially constant cross section.

[0037] An exemplary embodiment of a stent 2, which is preferably used with such an applicator 1, is shown in FIG. 3. It has a length L1. A cylindrical length portion with the length L2 extends over two-thirds of the length L1 of the stent 2. It is followed by a length portion 15 that becomes smaller in diameter with a length L3, which extends over a third of the length L1 of the stent 2. The diameter D1 on the left in the image plane, i.e. at the first end 13, is therefore greater than at the opposite second end 14. The larger diameter D1 is e.g. 5 mm and the smaller diameter D2 3 mm. The total length L1 of the stent 2 is 12 mm in this exemplary embodiment. FIG. 4 shows an end view of the stent 2 of FIG. 3 onto the second end 14 with a reduced diameter.

REFERENCE SIGN

[0038] 1—applicator [0039] 2—stent [0040] 2′—expanded stent [0041] 3—proximal end of 1 [0042] 4—stop [0043] 5—handle on 6 [0044] 6—outer tube of 1 [0045] 7—distal end of 1 [0046] 8—shaft of 1 [0047] 9—Inner part of 1 [0048] 10—annular space of 1 [0049] 11—tip of 1 [0050] 12—light beam [0051] 13—first end of 2 [0052] 14—second end of 2 [0053] 15—the region of 2 reduced in diameter [0054] D1—diameter of 13 [0055] D2—diameter of 14 [0056] LA—longitudinal axis of 1 [0057] L1—length of 2 [0058] L2—length [0059] L3—length of 15