Abstract
Multilumen implant for application in human and animal vascular systems/bodies, with a substantially tubular element (1) divided into a proximal (2) and a distal section (3), and a fixation element (8) for the fixation of the proximal section (2) in a target vessel, wherein the tubular element (1) branches into two or more lumens (4, 5) in the distal section (3), with the fixation element (8) being at least one clamping ring (8) arranged on the outside of the proximal section (2) of the tubular element (1), and wherein the free end of the proximal section of the tubular element (1) is folded around the clamping ring (8) and embraces the clamping ring (8) in a pocket-like manner.
Claims
1. Multilumen implant for application in human and animal vascular systems/bodies, with a substantially tubular element (1) divided into a proximal (2) and a distal section (3), and a fixation element (8) for the fixation of the proximal section (2) in a target vessel, wherein the tubular element (1) branches into two or more lumens (4, 5) in the distal section (3), characterized in that the fixation element (8) has at least one clamping ring arranged on the outside of the proximal section (2) of the tubular element (1), and wherein the free end of the proximal section of the tubular element (1) is folded around the at least one clamping ring (8) and embraces the clamping ring (8) in a pocket-like manner.
2. Multilumen implant according to claim 1, characterized in that the clamping ring or rings (8) are of undulating shape.
3. Multilumen implant according to claim 1, characterized in that the tubular element (1) branches in the distal section (3) into a main lumen (4) and several secondary lumens (5).
4. Multilumen implant according to claim 3, characterized in that the secondary lumens (5) have a smaller caliber than the main lumen (4).
5. Multilumen implant according to claim 1, characterized in that the lumens (4, 5) of the distal section (3) of the tubular element (1) taper in distal direction (d) (12).
6. Multilumen implant according to claim 1, characterized in that the branches (6, 7) have distally in particular annular reinforcements (10, 11).
7. Multilumen implant according to claim 1, characterized in that the tubular element (1) is secured to the clamping ring or rings (8) in particular by means of clamping, bonding/gluing, sewing or welding.
8. Multilumen implant according to claim 1, characterized in that the tubular element (1) consists of ePTFE.
9. Multilumen implant according to claim 8, characterized in that the tubular element (1) made of ePTFE is produced by electrospinning.
10. Multilumen implant according to claim 1, characterized in that the clamping ring or rings (8) consist of a self-expanding material.
11. Multilumen implant according to claim 1, characterized in that the clamping ring or rings (8) consist of a balloon-expanding material.
12. Multilumen implant according to claim 1, characterized by two clamping rings (8).
13. Multilumen implant according to claim 12, characterized in that the second clamping ring (8) is arranged on the inner side of the tubular element (1) at the level of the first clamping ring (8).
14. Multilumen implant according to claim 12, characterized in that the first and second clamping ring (8) are connected to each other through the tubular element (1).
15. Multilumen implant according to claim 1, characterized in that it comprises fastening elements for securing at least the proximal section (2) of the tubular element (1) to the vessel wall.
16. Multilumen implant according to claim 15, characterized in that the fastening elements are hooks and/or screws that extend into the vessel wall.
17. Kit comprising an implant according to claim 1 and a catheter for its implantation.
18. Kit according to claim 17, further comprising two or more stent grafts, for connecting the distal ends (6, 7) of the lumens (4, 5) to vessels.
Description
[0065] Elucidation of the invention is provided by the following figures where
[0066] FIG. 1 shows a schematic representation of the tubular element;
[0067] FIG. 2 is a schematic representation of a first embodiment of the implant proposed by the invention;
[0068] FIG. 3a-b illustrate a schematic representation of the folding of the proximal onto the distal section for a better understanding of a second embodiment of the inventive implant;
[0069] FIG. 4 illustrates a usable clamping ring proposed by the invention;
[0070] FIG. 5 is a schematic representation of a second embodiment of the implant proposed by the invention;
[0071] FIG. 6a-b show a transverse a) and a longitudinal section b) through a second embodiment of the implant according to the invention;
[0072] FIG. 7a-d show a schematic representation of possible distribution options of the distal lumina;
[0073] FIG. 8a-d show possible configurations of the distal ends of the branches for better fixation of the conveying stents; and
[0074] FIG. 9 shows another embodiment.
[0075] FIG. 1 is a schematic representation of the tubular element 1 of an implant in accordance with the invention, said implant being divided into a proximal section 2 and a distal section 3. The proximal (p) single-lumen tubular element 1 branches distally (d) into at least two lumens 4, 5, with a preferred embodiment comprising one main lumen 4 and four secondary lumens 5, or correspondingly one large branch 6 and four smaller branches 7.
[0076] The relative proportions shown in this schematic representation have been selected purely with a view to making the individual parts to be easily recognizable. Accordingly, the ratio of proximal section 2 to the distal section 3 as well as the ratios of the individual distal lumens 4 and 5 or the lengths of the branches 6 and 7 may differ from what is shown in the figure.
[0077] FIG. 2 illustrates the tubular element 1 shown in FIG. 1, with a clamping ring 8 being arranged for securing or fixation of the tubular element 1 in a vessel within the proximal section 2. In this embodiment, the clamping ring 8 is located in proximal section 2. If considered expedient, the proximal end of the tubular element 1 can project beyond the clamping ring 8 and be folded inwards over the proximal end of the clamping ring into the lumen of the proximal section 2. Clamping ring 8 has an undulated shape.
[0078] FIGS. 3a and 3b indicate in general the arrangement of the proximal section 2 of the tubular element 1 in a first preferred embodiment. In this case, the proximal section 2 is folded over onto the distal section 3, so that the distal section 3 is finally at least partially encased by the proximal section 2. FIG. 3b shows the clamping ring 8 inserted into the space 9 of the folding of the proximal section, said ring having a zigzag configuration and being shown as a dashed line.
[0079] FIG. 4 shows a clamping ring 8 that can be used according to the invention in top view (a) and in perspective (b). In general, clamping ring 8 is a construct the coils of which are pressed together during the compression process, such as a wire ring or a tube cutout produced in a known manner with the help of a laser.
[0080] FIG. 5 depicts a preferred embodiment which is based on the folded over proximal section 2 as shown in FIGS. 3a and 3b. The proximal section 2 is folded over distally (d) up to the end of the branches 6, 7. Clamping ring 8 is arranged inside the folding 9 thus created. The lengths of the clamping ring 8, the proximal 2 and the distal section 3 are approximately the same in this illustration; the clamping ring 8 is completely arranged within the folding 9.
[0081] FIG. 6 shows a cross section 6a and a longitudinal section 6b through the preferred embodiment of the implant illustrated in FIG. 5. The dotted line indicates the clamping ring 8, the broken line the distal section 3 and the continuous line the proximal section 2 of the tubular element 1. As can be seen in both figures, the proximal section 2 is folded over to distal (d) and folded over inwardly to proximal around the clamping ring 8 located in the folding 9, so that clamping ring 8 is covered on all sides by the proximal section 2.
[0082] FIG. 7 is a schematic representation of cross sections through the implant, with different distributions and arrangements of the distal lumens 4, 5 being shown. The main lumen 4 can be arranged centrally (a, b) or eccentrically (c, d). The secondary lumens 5 can be arranged around the main lumen 4 (a, b) or on one side of it (c, d). In the cross sectional view, the main lumen 4 can be of round shape (a, c) or oval (b, d). Conceivable as well are embodiments in which the secondary lumens 5 also have an oval shape. A preferred embodiment is illustrated in FIG. 7c.
[0083] FIG. 8 shows various design options for the distal ends d of the distal branches 6, 7 for better fixation of the stents, which connect the distal branches 6, 7 with the respective vessels to be perfused. For this purpose and in a preferred embodiment, the distal branches may be tapered conically towards their end 12 entirely (a) or at the distal tip (d), at the tip they may have annular stabilizations 10 or a distally entirely reinforced structure 11 (c).
[0084] In FIG. 9 a version of the inventive implant is shown, in which two clamping rings 8 ensure that expansion takes place. The tubular element is divided into five lumina, one main lumen 6 and four secondary lumina 7. The proximal section 2 of the tubular element is folded over and forms a pocket/envelope 9, in which an outer clamping ring 8 (broken line) is arranged. A second clamping ring 8′ is placed against it on the inside of the tubular element so that the radial forces exerted by the two clamping rings are combined. The inner and outer clamping ring 8 have a staggered arrangement, i.e. the wave peaks of the inner clamping ring 8′ are located in the wave troughs of the outer clamping ring 8. Both clamping rings 8 can be connected to each other through the tubular element, for example by sewing.
LIST OF REFERENCE NUMERALS
[0085] 1 Tubular element [0086] 2 Proximal section [0087] 3 Distal section [0088] 4 Main lumen [0089] 4 Secondary lumen [0090] 5 Main branch [0091] 6 Secondary branch [0092] 7 Clamping ring [0093] 9 Folding [0094] 10 Annular stabilization [0095] 11 Annular reinforcement [0096] 12 Taper [0097] p Proximal [0098] d Distal
