RU2792286C2 - Multi-lumen implant - Google Patents

Abstract

FIELD: medical equipment.

SUBSTANCE: multi-lumen implant for use in human and animal vascular systems/bodies, as well as a kit for placing a multi-lumen implant in human vascular systems/bodies, can be used to treat aneurysms. The multi-lumen implant includes a substantially tubular element (1), which is divided into a proximal (2) and a distal (3) section, and a fixing element (8) for fixing the proximal section (2) in the target vessel. The tubular element (1) branches in the distal section (3) into two or more lumens (4, 5). The fixing element (8) has a clamping ring, which is located on the outer side of the proximal section (2) of the tubular element (1), and the free end of the proximal section of the tubular element (1) is encircled around the clamping ring (8) and encloses the clamping ring (8) in the form of a pocket, wherein the clamping ring (8) is a closed wire ring having a wavy or zigzagged shape. A multi-lumen implant placement kit includes the above-described implant and a catheter for implantation thereof. Due to its versatile possibilities of use and ability of connection without pre-invasive assembly or individualization, this invention is suitable for the treatment of a variety of patients and clinical presentations, for emergency cases, and can be stocked by default in hospitals; has the smallest possible diameter when folded, can be inserted through a port with a small diameter, so that in addition to the femoral (from the side of the thigh) accesses from the side of arm are also possible, in particular by default; compatible with common accessories; has the simplest design and the most easily implantable system; suitable for the sanitation of known systems in the event of a defect, providing a seal that is completely independent of the original system and an own anchorage, so that already existing parts of the prosthesis, such as the endosteum, may remain in the body.

EFFECT: use in human and animal vascular systems/bodies with versatile possibilities and ability of connection without pre-invasive assembly or individualization.

17 cl, 9 dwg

Description

The invention relates to a multi-lumen implant for use in human and animal vascular systems, comprising a substantially tubular element that is divided into a proximal and a distal section, and at least one fixing element for fixing the proximal section in the target vessel, the tubular element branching into distal section into two or more gaps, and the locking element is a clamping ring, which is located on the outside of the proximal section of the tubular element, and the free end of the proximal section of the tubular element is circled around the clamping ring and encloses the clamping ring in the form of a pocket. The invention also relates to a corresponding kit comprising said implant and a catheter for its implantation.

One of the most common pathologies of the human vascular system is formed by aneurysms. Speaking of aneurysms, we are talking about protrusions of the vessel wall. The specific causes may be very different, but in general it can be said that the corresponding part of the vessel wall is initially weakened and expands more and more due to the constantly acting blood pressure on it.

Aneurysms can in principle occur in all parts of the body and in all places in the vessel. Nevertheless, there are certain places in the human body that, due to their vascular anatomy, are predetermined for the formation of aneurysms. These include, for example, all ramifications of blood vessels, the so-called bifurcations.

The danger that comes from an aneurysm for the patient's health has two sides. On the one hand, the aneurysm itself can lead to problems if, for example, it puts pressure on other vessels or organs. This can lead to pain and/or insufficient supply of other parts of the body or organs. If, for example, the brain is affected, more or less serious neurological complications are the result.

On the other hand, an aneurysm may rupture, i.e. aneurysms may also rupture. This is dangerous for the patient, in particular, if the aneurysm is in the brain or in the main vessel, which carries a lot of blood. In the brain, ruptured aneurysms lead to cerebral hemorrhages, which, depending on the size of the vessel and the severity of bleeding, can lead to neurological damage from mild to severe. In the worst case, such a cerebral hemorrhage leads to the death of the patient.

If an aneurysm ruptures in a great vessel in the patient's body, it can lead to fatal blood loss within a very short time, for example, when ruptured aneurysms of the abdominal artery or thoracic aneurysms.

Until a few years ago, many aneurysms had to be treated with open surgery. Currently, there is a fairly wide range of alternative treatments and medical products for the minimally invasive and intravascular treatment of aneurysms.

One of the preferred minimally invasive, intravascular aneurysm treatments is the use of stent grafts. The stent graft consists of a stent scaffold and a sheath, which in combination results in a tubular shaped implant. To treat an aneurysm, the area of the aneurysm is covered with such a stent graft due to the fact that the stent graft connects the healthy areas of the vessel, and the blood flows accordingly in the area of the aneurysm through the stent graft. As a result, on the one hand, the rupture of the aneurysm is prevented, on the other hand, the pressure that the aneurysm exerted on other structures is eliminated to the maximum extent, since the blood no longer flows through the aneurysm.

The introduction of such a stent graft in the form of a simple tube becomes problematic, first of all, if collaterals extend from the affected vessel in the area of the aneurysm. Just like the aneurysm itself, in this case also the collaterals located in the area are cut off from the blood supply by implantation of the stent graft. Accordingly, the areas and/or organs supplied with collaterals are cut off from the blood supply.

In order for the collaterals not to be cut off from the blood supply, it is necessary to supply them through the branches of the stent graft. Many technologies are known in the art that provide solutions for this. To date, first of all, custom-made or modular implants have proven themselves, which are produced according to the needs of each individual patient. Such individual designs as well as modular systems are expensive. In particular, individual executions take time, as they must be produced individually in most cases by hand. On the contrary, modular systems are often assembled during surgery by the surgeon himself in the patient.

EP 2 749 251 B1 (Cook Medical Technologies LLC) discloses, for example, an expandable stent-graft consisting of a main body and rings that can be modularly adapted to the respective vascular anatomy in a certain way. EP 2 081 515 B1 (Cook Medical Technologies LLC) discloses a particular arrangement of windows in the stent graft in order to enable the most universal connection of the collaterals to the implant. Finally, WO 2014/197743 A1 (Aortic Innovations Surena LLC) claims a variable stent graft system that, due to its modular design, allows the waste of implant collaterals in predefined longitudinal paths to be adapted to the patient's vascular anatomy.

All of these systems have disadvantages. Implantation generally requires an experienced surgeon, in many cases even system-specific training, in order for modular implants to be properly assembled during surgery in the patient's body.

The fixation of the main lumen with stents also has the disadvantage that the implant requires a lot of space in the unexpanded state, which makes it difficult to place it by means of a catheter, in particular due to increased friction. As a rule, large caliber catheters are required to place such implants.

Similarly, the implantation of systems that are custom-made presents the surgeon with great problems. The anatomically accurate adaptation of the implant to the main branch and collateral passages requires the surgeon to very accurately fit the implant to the patient's anatomy. What seems simple on a fixed model is a highly complex and risky task in practice, since the vessels are not exactly fixed and can change their position relative to each other.

The consequences of using such complex systems, whether now entirely custom-made or modular systems, are - along with an increased likelihood of device failures - sometimes long and thus tiring for the patient and the operating team, the duration of the surgical intervention.

In addition, the known systems generally have to be completely implanted within a single surgical procedure. Staged implantation, whether planned or as a response to the patient's condition, is usually not possible or at least unsafe, since only a fully implanted system leads to the desired result. Thus, the surgeon practically cannot react to the deteriorating, for example, condition of the patient during the surgical intervention by the fact that partial steps are postponed to later dates. Likewise, it is generally not possible to plan surgery from the outset in stages over several days.

Also, the accessibility of known systems is often limited due to their design. As a rule, these systems, due to their complexity, even when folded, have rather large diameters and can only be inserted through correspondingly large ports. This makes hand access generally impossible. Similarly, retrograde access, for example, to connect collaterals, in most cases, due to structural conditions, is impossible with known systems.

The disadvantage of the known systems is also that, due to migration (displacement of the prosthesis), damage to the texture or progression of the disease in the upper and lower segment of the seal, they can develop leaks, the so-called endo-leakage. Sanitation can be extremely difficult and can usually only be done with open surgery.

A decisive disadvantage of the known systems is the further necessary individualisation. Known systems, even if they are made partially modular, must nevertheless be produced in most cases for a specific case by hand. This takes by default from several days to several weeks and in exceptional cases even several months. Emergency medical care with such implants is therefore generally not possible, which can lead to preventable death of the patient during the waiting time for the respective implant.

Accordingly, the object of the invention is to provide a multi-lumen implant which, thanks to its universal possibilities of use and connection without pre-invasive assembly or customization, is suitable for the treatment of a variety of patients and clinical presentations. Such a system is also suitable for emergencies and can be stocked by default in hospitals.

It is also an object of the present invention to provide a multi-lumen implant with the smallest possible diameter when folded, which can be inserted respectively through a port with a small diameter, so that in addition to the femoral (from the side of the thigh) accesses from the hand are also possible, in particular by default.

It is further an object of the present invention to provide a multi-lumen implant which is compatible with conventional accessories. In particular, it should be possible to use as many known coated stents and stent grafts as possible to connect the implant to the downstream vascular system. Equally, the conditions for staged surgical interventions should also be created.

A further object of the invention is to provide the simplest possible design and the most easily implantable system. As a result, both the cost and error rate of the system, as well as the duration and risks of surgical intervention, can be minimized.

It is also an object of the invention to provide an implant that is suitable for the repair of known systems in the event of a defect, providing a seal that is completely independent of the original system and its own anchorage, so that parts of the prosthesis already present, for example, the endostent, can remain in the body.

The implant according to the invention uses an approach to solve the problem that is conceptually very different from the known implant. Known implants try to reproduce the anatomy of the damaged area of the vessel, so to speak, to veneer the area being sanitized. These implants must accordingly, as stated above, be individually made and implanted in the most precise manner. The implant according to the invention, on the other hand, is in principle a kind of distribution insert, the lumens of which can be individually connected to the supplied vessels via covered stents.

This problem is solved using a multi-lumen implant with the features of paragraph 1 of the claims. Preferred embodiments are the subject of the dependent claims, respectively. It should be pointed out that the features mentioned individually in the claims can also be combined in an arbitrary and technologically expedient way with each other and thus show further embodiments of the invention.

The implant according to the invention can be used in particular in the thoracoabdominal region and also in the iliac region as a docking system (locking device).

In a first embodiment according to the invention, the implant consists of a substantially tubular element and a clamping ring for fixing the tubular element in the vessel.

The tubular element is divided into a proximal and a distal section, with the distal section branching into at least two gaps. In this application, "distal" means always the part of the structure that points in the direction of blood flow, respectively, "proximal" means the part that points against the direction of blood flow.

The tubular element can be thought of as a glove. The proximal section of the tubular element corresponds, in this comparison, to the part of the glove predominantly surrounding the palm, and the distal section of the tubular element essentially corresponds to the fingers of the glove, the distal ramifications of the implant corresponding to the fingers having open ends or can open at their ends.

In a preferred embodiment, the proximal lumen branches distally into five lumen, one main lumen and four additional lumen, however, other distributions are also possible and can be realized without problems. The implant according to the invention is in no way limited to embodiments that resemble the proportions, dimensions or other properties of a glove.

The tubular element is fixed with one or more clamping rings on the inner or outer side of the proximal section of the tubular element upstream of the aneurysm in the target vessel. The tubular element can be secured by further measures on the clamping ring or clamping rings, for example by clamping, welding, gluing, stitching or other known measures. Preferably a clamp connection as disclosed in WO 2012/084202 A2. Most preferably, at least one clamping ring is sewn into the fold formed by the tubular element.

The clamping ring or clamping rings are located in the proximal region of the tubular element. In this case, at least one clamping ring is located on the outer side, facing the vessel wall side, of the tubular element and is enclosed in the form of a pocket by a free end wrapped outwards. The clamping ring can then be sewn into this pocket. This version has the advantage that the pressure of the clamping ring on the vessel wall is “softened”.

The clamping ring itself has a wavy shape, where “wavy” should be understood as meandering or zigzag. This allows a significant contraction of the clamping ring for transporting the implant in the catheter and an expansion adapted to the caliber of the vessel during placement. Self-expanding clamping rings are preferred according to the invention.

The clamping ring has the advantage of a greater radial force compared to a stent. For a stent that is used to secure a graft, the radial force is distributed over the entire surface, while the clamping ring concentrates the force on the contact ring with the vessel wall. The wavy design of the clamping ring also makes it possible, by selecting the correct diameter, to purposefully carry out expansion in the vessel in such a way that the maximum possible radial force is transmitted.

According to the invention, the clamping ring is preferably a closed wire ring which is zigzag or wavy. This allows compression in the catheter to a small diameter and subsequent expansion after removal from the catheter. The expansion takes place preferably by self-expansion of a shape memory material, such as a nickel-titanium alloy, but a balloon-expandable material, such as a spring steel alloy, may also be used. With balloon-expandable materials, it is important that the clamping ring has a permanent expansion capability in the vessel that secures the multilumen implant in the vessel.

A laser-cut ring from a pipe can also be used for the clamping ring. The same criteria as described above apply.

The clamping ring has, for example, a diameter of 0.15 to 0.80 mm, in particular 0.40 to 0.60 mm. This is true for both the wire-made clamping ring and the laser-cut clamping ring.

Therefore, the clamping ring is sized such that it has sufficient clamping force to secure the implant to the vessel wall. In addition, there must be a margin in order to take into account the expansion of the surrounding vessel, due, for example, to aging.

According to an embodiment of the invention, the multi-lumen implant has one clamping ring, which is located externally in the inversion of the tubular element. Preferably this clamping ring is sewn in. This embodiment has the advantage that the clamping ring has some freedom of movement in the torsion, which improves movement in the catheter and placement in the vessel.

According to another embodiment of the invention, the multi-lumen implant has two clamping rings, of which the outer one is located outside in the torsion of the tubular element, and the inner one is seated opposite on the inner side of the tubular element in the proximal area. The two clamping rings are expediently connected to each other via a tubular element, for example sewn together. Expediently, the waves of both clamping rings are located on the gaps, as a result of which there is a better fixation of the proximal part of the tubular element between the clamping rings and the multi-lumen implant on the vessel wall.

It should be understood that two or more clamping rings can also be arranged in another way in the implant, for example next to each other in the torsion or alternately in the torsion and on the inside of the tubular element.

In order to fix the implant according to the invention in the vessel, fastening elements, for example hooks and/or screws, which engage in the vessel wall, can be further provided. Such anchors are known per se and are clinically used (Heli-FX EndoAnchor ^TM ). These fasteners can be hooks connected to the clamping ring, which, when expanded, engage with the vessel wall, or screw elements, which in the proximal region of the tubular element fix it with the clamping ring on the vessel wall.

The distal portion of the tubular element branches into at least two lumens, the number of lumens being arbitrary, and the number of branches may depend, for example, on the number of vessels to be supplied. However, embodiments with two or five branches are preferred.

In particular, embodiments with one main lumen with a larger diameter and with four additional lumens with a smaller diameter are preferred. However, the diameters are fundamentally arbitrary and can be selected according to the intended use of the implant. Thus, when using the implant in the thoracic and abdominal region, proximal diameters between 5 and 45 mm, preferably between 20 and 42 mm are possible, for the main lumen, diameters between 3 and 30 mm, preferably between 12 and 25 mm, are possible, and for the secondary lumen, diameters between 2 and 12 mm, preferably between 4 and 10 mm. When using the implant in the cerebral region, proximal diameters between 2 and 15 mm, preferably between 2 and 8 mm are possible, diameters between 1 and 5 mm, preferably between 2 and 4 mm are possible for the main lumen, and diameters between 1 and 4 mm are possible for the secondary lumen. 4 mm, preferably between 2 and 3 mm. When using the implant in the coronal region, proximal diameters between 2 and 8 mm, preferably between 4 and 6 mm are possible, diameters between 2 and 6 mm are possible for the main lumen, preferably between 3 and 5 mm, and diameters between 2 and 2 mm are possible for the secondary lumen. 5 mm, preferably between 2 and 3 mm.

In addition to the above, embodiments are also possible that have a total of more or less than five lumens, furthermore, embodiments are also possible that have more than one main lumen and more or less than four additional lumens.

If one imagines a cross section of the implant area after the ramification, embodiments with an eccentric lumen distribution are preferred, with the ram with the largest lumen on one side and one or more ramifications with smaller lumen on the other side in cross section. However, the distribution of ramifications in the distal portion of the tubular is not rigidly defined, and embodiments are also possible in which, for example, one ramification is located in the central region, and further ramifications are evenly or unevenly distributed around the central lumen.

In a preferred embodiment, the individual branches are of the same length. However, embodiments are also possible in which the branches have different lengths. In general, it is preferred that the ramifications terminate distally approximately at the implant fixation stent. However, it is possible that the ramifications also protrude distally from the stent or protrude distally from the stent framework.

The ramifications of the implant are connected by covered stents, the so-called stent grafts, to the vessels distal to the implant, as a result of which the aneurysm area is closed, blood flow into the aneurysm is prevented, and the aneurysm is unloaded. At the same time, the distal vessels are supplied with blood in a targeted manner via the stents.

For a better fixation of the stents which connect the distal ramifications of the tubular element to the vessels supplied in each case, the distal ramifications can in a preferred embodiment taper conically towards their end over their entire length or in a specific area.

Further measures for fixing the stents in the distal ramifications are possible in the form of annular or other reinforcements or reinforcements, in particular in the distal regions. As a result, on the one hand, a rigid fit of the stent graft is ensured, on the other hand, due to this reinforcement, the risk of rupture of the distal branches during implantation of the stent grafts is also reduced.

The ramifications in the distal region preferably extend freely from each other, however, embodiments are also possible in which all or some of them are connected to each other, optionally also in groups. The ramifications can also be attached - additionally or alternatively - to the stent serving for fixing the implant or to the wrapped proximal section of the tubular element.

As materials for the tubular element, all physiologically acceptable materials known in the prior art are taken into account, in particular ePTFE (polytetrafluoroethylene), which can also be processed by electrospinning (electrospinning).

For the clamping ring, all materials known in the prior art are taken into account, which provide a permanent fixation of the tubular element and are non-absorbable.

As a rule, the implant according to the invention is inserted at the proximal end of the aneurysm into a still healthy part of the vessel there. The implant here performs the function of a distributing disk, which allows blood to flow only through the gaps of the distal branches. The distal ramifications of the tubular element are connected by covered stents to the vessels lying distally relative to the implant. Thus, the area of the aneurysm overlaps.

Thanks to this technique, surgical intervention can also be performed in stages, since the insertion of the implant does not initially block the blood flow to the vessels distal to the implant. For example, in the first surgical intervention, the implant itself may be inserted, and in one or more further surgical interventions, vessels are attached.

A retrograde approach, which can only be realized with known implants only with difficulty or not at all, is also possible in order to connect the vessels and the ramifications of the implant to each other.

The multi-lumen implant according to the invention, thanks to its universal adaptability, also makes it possible to repair already located systems, which, due to migration (displacement of the prosthesis), damage to the texture or progression of the disease in the upper and lower segment of the seal, have developed leaks, the so-called endo-leakage. Already placed parts of the prosthesis can remain in the body, since the multi-lumen implant provides a completely independent seal and its own anchorage.

However, the advantages offered by the implant according to the invention are much more varied. They also refer to the cost of manufacture and thus to the costs of the healthcare system, patient safety, planning, availability, product safety, and surgical safety.

The implant can, due to its universal applicability, be produced in large quantities by uniformity over preferably five distal lumens at a correspondingly lower unit cost and is thus significantly more advantageous than individualized implants.

Since the implant can be used universally due to its flexible attachment options, it can be stocked in the clinic and thus used even in acute emergencies. Individual production with partly long waiting times is not required.

The implant can be implanted in a simple manner, it does not have to be pre-assembled or mounted in the patient's vascular system. In principle, implantation is carried out similarly to the introduction of a conventional stent. Also, the connection of vessels to the ramifications does not require special knowledge, it corresponds to the daily use of stent grafts.

The simplicity of the implant also makes it less prone to "device failures" than prior art implants, the foundations for which may have been laid during surgery or prior fabrication and assembly.

Thus, it should be assumed, not least, also from the increased safety of the actual surgical intervention, since due to the simplicity of the surgical intervention, the complex connection of vessels and the installation of the implant in the patient are eliminated, the time of the surgical intervention and thus automatically also the risk of complications accompanying the operation will decrease.

The above problem is also solved using a set with the features of paragraph 16 of the claims. A kit for placing a multi-lumen implant in human and animal vascular systems/bodies includes said implant and a catheter for its implantation. Additionally, the kit may include two or more stent grafts to connect the distal ends of the lumen to the vessels.

The invention as well as the technical environment will be explained in more detail in the following on the basis of the drawing. It should be pointed out that the drawing shows the most preferred embodiment of the invention. However, the invention is not limited to the embodiment shown. In particular, the invention covers, if technically feasible, any combination of technical features that are given in the claims and described in the description and related images as essential to the invention.

The drawing shows:

fig. 1 is a schematic representation of a tubular element;

fig. 2 is a schematic representation of a first embodiment of an implant according to the invention;

fig. 3a-b are schematic representations of the fold-over of the proximal portion to the distal portion for a better understanding of the second embodiment of the implant according to the invention;

fig. 4 shows the clamping ring used according to the invention;

fig. 5 is a schematic representation of a second embodiment of an implant according to the invention;

fig. 6a-b show a) transverse and b) longitudinal section of a second embodiment of an implant according to the invention;

fig. 7a-d is a schematic representation of possible options for the distribution of distal lumens;

fig. 8a-d - possible versions of the distal ends of the ramifications for better fixation of the stents leading further; And

fig. 9 shows a further embodiment.

Fig. 1 schematically shows a tubular element 1 of an implant according to the invention, which is divided into a proximal section 2 and a distal section 3. The tubular element 1, which is single-lumen on the proximal side p, branches on the distal side d into at least two lumens 4, 5, with the preferred embodiment having one main lumen 4 and four additional lumen 5 or, respectively, one large ramification 6 and four small ramifications 7.

The relative size ratios of this schematic representation are based solely on the good visibility of the individual parts. So the ratio of the proximal section 2 to the distal section 3, and the ratio of the individual distal gaps 4 and 5 or the lengths of the branches 6 and 7 may differ from those shown here.

Fig. 2 shows the tubular element 1 of FIG. 1, the clamping ring 8 for fixing or fixing the tubular element 1 in the vessel is now located inside the proximal section 2. The clamping ring 8 is located in this embodiment in the proximal section 2. The proximal end of the tubular element 1 can, if necessary, protrude beyond the stent 8 and wrap around the proximal end of the stent inward into the lumen of the proximal section 2. The clamping ring 8 is made wavy.

Fig. 3a and 3b show in general the location of the proximal portion 2 of the tubular element 1 in the first preferred embodiment. Here the proximal section 2 wraps over the distal section 3 so that the distal section 3 is ultimately at least partially covered by the proximal section 2. FIG. 3b shows a clamping ring 8 inserted into the intermediate space 9 of the inversion of the proximal section with a zigzag run in the form of a dotted line.

Fig. 4 shows the clamping ring 8 used according to the invention in plan view (a) and in perspective view (b). In principle, with regard to the clamping ring 8, we are talking about a structure whose coils are compressed when compressed, for example, a wire ring or a ring cut from a pipe, which was created in a known way using a laser.

Fig. 5 shows a preferred embodiment which is based on wrapping the proximal portion 2 as shown in FIG. 3a and 3b. The proximal section 2 folds in the distal direction d until the end of the ramifications 6, 7. In the resulting fold 9 there is a clamping ring 8. The lengths of the clamping ring 8, the proximal 2 and the distal 3 sections are approximately equal in this image, so that the clamping ring 8 is completely located inside the fold 9.

Fig. 6 shows a cross section 6a and a longitudinal section 6b of the FIG. 5 of the preferred embodiment of the implant. The dotted line indicates the clamping ring 8, the dotted line the distal section 3 and the solid line the proximal section 2 of the tubular element 1. As can be seen in both figures, the proximal section 2 wraps in the distal direction d and then wraps in the proximal direction inward around the clamping clamp 9 in the twist rings 8, so that the clamping ring 8 is covered in all places by the proximal section 2.

Fig. 7 shows purely schematically in cross-sectional view of the implant the various distributions and arrangements of the distal lumen 4, 5. The main lumen 4 can be centrally located a, b or eccentrically c, d. Additional gaps 5 can be located respectively around a, b of the main gap 4 or on the side c, d. The main lumen 4 may be round in cross section a, c or oval b, d. Similarly, embodiments are possible in which also the additional gaps 5 are oval. The preferred embodiment is shown in FIG. 7c.

Fig. 8 shows various possibilities for the execution of the distal ends d of the distal ramifications 6, 7 for better fixation of the stents that connect the distal ramifications 6, 7 to the vessels supplied in each case. To this end, the distal ramifications may in the preferred embodiment taper towards their end over the entire length a or at the distal apex d, 12, or they may have annular reinforcements 10 at the apex or a completely distally reinforced structure c, 11.

Fig. 9 shows an embodiment of an implant according to the invention, in which two clamping rings 8 provide expansion. The tubular element is divided into five gaps, namely one main gap 6 and four additional gaps 7. The proximal section 2 of the tubular element is wrapped and forms a pocket 9, in which the outer clamping ring 8 is located (shown in dotted line). The second clamping ring 8 is seated opposite it on the inner side of the tubular element, so that the radial forces of the two clamping rings are added. In this case, the inner and outer clamping rings 8 are seated at gaps, i.e. the crests of the waves of the inner clamping ring 8 correspond to the troughs of the waves of the outer clamping ring 8. Both clamping rings 8 can be connected to each other via a tubular element, for example by stitching.

LIST OF REFERENCES

1 tubular element

2 proximal section

3 distal site

4 main lumen

5 additional clearance

6 main branch

7 additional ramification

8 clamping ring

9 inversion

10 ring hardening

11 ring reinforcement

12 constriction

p proximal side

d distal side

Claims (19)

1. Multi-lumen implant for use in human and animal vascular systems/bodies, comprising essentially a tubular element (1), which is divided into a proximal (2) and distal (3) section, and a fixing element (8) for fixing the proximal section (2) in the target vessel, wherein the tubular element (1) branches in the distal portion (3) into two or more lumens (4, 5), characterized in that the fixing element (8) has a clamping ring, which is located on the outer side of the proximal section (2) of the tubular element (1), and the free end of the proximal section of the tubular element (1) is encircled around the clamping ring (8) and surrounds the clamping ring (8) in in the form of a pocket, and moreover, the clamping ring (8) is a closed wire ring having a wavy or zigzag shape. 2. Multi-lumen implant according to claim. 1, characterized in that the tubular element (1) branches in the distal section (3) into one main lumen (4) and four additional lumens (5). 3. Multi-lumen implant according to claim 2, characterized in that the additional lumens (5) have a smaller diameter than the main lumen (4). 4. Multilumen implant according to any one of paragraphs. 1-3, characterized in that the gaps (4, 5) of the distal section (3) of the tubular element (1) narrow (12) in the distal direction (d). 5. Multilumen implant according to any one of paragraphs. 1-4, characterized in that the gaps (4, 5) of the distal section (3) of the tubular element (1) have distal annular reinforcements (10, 11). 6. Multilumen implant according to any one of paragraphs. 1-5, characterized in that the tubular element (1) is fixed on the clamping ring (8), in particular by clamping, gluing, stitching or welding. 7. Multilumen implant according to any one of paragraphs. 1-6, characterized in that the tubular element (1) consists of polytetrafluoroethylene ePTFE. 8. Multi-lumen implant according to claim 7, characterized in that the tubular element (1) is obtained from ePTFE by electrospinning. 9. Multilumen implant according to any one of paragraphs. 1-8, characterized in that the clamping ring (8) consists of a self-expanding material. 10. Multilumen implant according to any one of paragraphs. 1-8, characterized in that the clamping ring (8) consists of a balloon expandable material. 11. Multilumen implant according to any one of paragraphs. 1-10, characterized in that a second clamping ring (8) is additionally provided. 12. Multi-lumen implant according to claim 11, characterized in that the second clamping ring (8) is located on the inner side of the tubular element (1) at the height of the first clamping ring (8). 13. Multi-lumen implant according to claim 11 or 12, characterized in that the first and second clamping rings (8) are connected to each other via a tubular element (1). 14. Multilumen implant according to any one of paragraphs. 1-13, characterized in that it has fasteners for fixing at least the proximal section (2) of the tubular element (1) on the vessel wall. 15. A multi-lumen implant according to claim 14, characterized in that the fasteners are hooks and/or screws that enter the vessel wall. 16. A set for placing a multi-lumen implant in the vascular systems/bodies of a human and an animal, including an implant according to any one of paragraphs. 1-15 and a catheter for its implantation. 17. The kit according to claim 16, which also includes two or more stent grafts for connecting the distal ends (6, 7) of the lumens (4, 5) with the vessels.

Images