Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
  • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
  • A61F2/02—Prostheses implantable into the body
  • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
  • A61F2/06—Blood vessels
  • A61F2/07—Stent-grafts
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
  • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
  • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
  • A61F2/954—Instruments specially adapted for placement or removal of stents or stent-grafts for placing stents or stent-grafts in a bifurcation
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
  • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
  • A61F2/02—Prostheses implantable into the body
  • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
  • A61F2/06—Blood vessels
  • A61F2002/065—Y-shaped blood vessels
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
  • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
  • A61F2/02—Prostheses implantable into the body
  • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
  • A61F2/06—Blood vessels
  • A61F2/07—Stent-grafts
  • A61F2002/072—Encapsulated stents, e.g. wire or whole stent embedded in lining
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
  • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
  • A61F2/02—Prostheses implantable into the body
  • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
  • A61F2/06—Blood vessels
  • A61F2/07—Stent-grafts
  • A61F2002/075—Stent-grafts the stent being loosely attached to the graft material, e.g. by stitching
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
  • A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
  • A61F2210/0014—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof using shape memory or superelastic materials, e.g. nitinol
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
  • A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
  • A61F2220/0008—Fixation appliances for connecting prostheses to the body
  • A61F2220/0016—Fixation appliances for connecting prostheses to the body with sharp anchoring protrusions, e.g. barbs, pins, spikes
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
  • A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
  • A61F2220/0025—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
  • A61F2220/0075—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
  • A61F2240/00—Manufacturing or designing of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
  • A61F2240/001—Designing or manufacturing processes
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
  • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
  • A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
  • A61F2250/006—Additional features; Implant or prostheses properties not otherwise provided for modular
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
  • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
  • A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
  • A61F2250/0081—Prosthesis for animals

Definitions

• the invention relates to a multi-lumen implant for use in human and animal
• Vascular systems comprising a substantially tubular member which is divided into a proximal and a distal portion and at least one fixing member for fixing the proximal portion in a target vessel, wherein the tubular member in the distal portion branches into two or more lumens, said Fixing element is a clamping ring, which is on the outside of the proximal portion of the tubular
• Element is arranged, wherein the free end of the proximal portion of the tubular member is guided around the clamping ring and encloses the clamping ring pocket-shaped.
• Aneurysms are bulges of the vessel wall.
• the specific causes can be very different, but one can say in general that the affected part of the vessel wall is initially weakened and spreads by the constantly resting on him blood pressure more and more.
• Aneurysms can in principle arise in all parts of the body and at all points in the vessel. However, there are certain sites in the human body that are predestined for the formation of aneurysms solely because of their vascular anatomy. These include, for example, all vascular fissures, so-called bifurcations.
• aneurysm itself can cause problems, for example, if it presses on other vessels or organs. This can cause pain and / or undersupply of other parts of the body and organs. For example, if the brain is affected, more or less severe neurological deficits are the result. On the other hand, it can lead to a rupture of the aneurysm, that is, aneurysms can also tear. This is especially dangerous to the patient if the aneurysm is in the brain or on a large vessel that carries a lot of blood.
• an aneurysm ruptures on a large vessel in the body of the patient, it can lead to a fatal loss of blood within a very short time, for example, in ruptures of abdominal arterial aneurysms or even thoracic aneurysms.
• a stent-graft consists of a stent framework and a coating, which in combination leads to a clever implant.
• a stent graft bridges the area of the aneurysm by connecting the stent graft to the healthy areas of the vessel and allowing the blood to flow through the stent graft in the region of the aneurysm. This not only ruptures the aneurysm, but also eliminates the pressure exerted by the aneurysm on other structures, as it eliminates the flow of blood through the aneurysm.
• the problem is the insertion of such a stent-graft in the form of a simple tube, especially if depart in the region of the aneurysm side branches of the affected vessel.
• the lateral branches located in the area are then cut off from the blood supply by the implantation of a stent-graft. Accordingly, the areas and / or organs to be supplied by the side branches are cut off from the blood supply.
• EP 2 749 251 B1 discloses an expandable stent-graft graft consisting of body and rings, which in some way can be modularly adapted to the particular vascular anatomy.
• EP 2 081 515 B1 discloses special window arrangement in stent-grafts in order to be able to bind side branches to the implant as universally as possible.
• WO 2014/197743 A1 claims a variable stent-graft system which, due to its modular structure, allows the side branches of the implant to be adapted to the vascular anatomy of the patient in predetermined longitudinal paths.
• Implantation usually requires an experienced surgeon, and in many cases even system-related training is required to correctly construct the modular implants during the intervention in the patient's body.
• fixation of the main lumen via stents also has the disadvantage that the implant has a high space requirement in the non-expanded state, which complicates the placement by a catheter, in particular and due to increased friction.
• large catheter calibers are needed to place such implants.
• a gradual implantation, whether planned or in response to the condition of the patient, is usually not or at least not safely possible, since only a fully implanted system provides the required result.
• the surgeon can hardly respond to an example deteriorating condition of the patient during the intervention that sub-steps are postponed to later appointments.
• it is usually not possible to plan the intervention gradually over several days from the beginning.
• a disadvantage of the known systems is also that they can develop a leak, a so-called endoleakage, by migration (displacement of the prosthesis), damage to the texture or progression of the disease in the upper and lower sealing segments.
• the renovation can be extremely complex and usually only open surgical.
• a crucial disadvantage of the known systems is also the necessary individualization.
• the known systems even if they are executed partially modular, must still be made in most cases for the individual case dog. By default, this takes days to weeks and, in exceptional cases, several months. An emergency care with such implants is thus regularly not possible, which can lead to the avoidable death of a patient within the waiting time for a corresponding implant. It is therefore an object of the invention to provide a multi-lumen implant that, due to its universal use and connection options - without pre-interventional packaging or individualization - is suitable for the treatment of a large number of patients and clinical pictures. Such a system is also suitable for emergencies and can be stored by default in hospitals.
• An object of the present invention is also the provision of a multi-lumen implant with the smallest possible diameter in the folded state, which can be introduced via a lock with a small diameter, so that in addition to femoral in particular arm side accesses are possible by default. It is a further object of the present invention to provide a multi-lumen implant which is compatible with common accessories. In particular, the use of as many of the known covered stents and stent grafts should be possible for the connection of the implant to the secondary vascular system. Likewise, intermittent interventions should be made possible.
• a further object of the invention is to provide a system which is constructed as simply as possible and which is as simple as possible to implant. This can minimize both the cost and error rates of the system, as well as the intervention time and intervention risks.
• the implant according to the invention pursues an approach which differs conceptually from the known implants in order to solve the stated tasks.
• Known implants try to replicate the anatomy of the damaged vascular region, as it were to line the area to be rehabilitated. Accordingly, these implants, as described above, must be made individually and accurately implanted.
• an implant according to the invention in principle, represents a type of distributor insert whose lumen can be individually connected to the vessels to be supplied via covered stents. This object is achieved by a multi-lumen implant having the features of claim 1.
• Advantageous embodiments are the subject matter of the dependent claims. It should be noted that the features listed individually in the claims can also be combined with one another in any desired and technologically sensible manner and thus show further embodiments of the invention.
• the implant according to the invention can be used in particular in the thoracoabdominal as well as in the iliac area as a docking system (interlocking device).
• the implant consists of a substantially tubular element and a clamping ring for fixing the tubular element in a vessel.
• the tubular element is divided into a proximal and a distal portion, wherein the distal portion branches into at least two lumens.
• distal refers always to the part of a structure pointing in the direction of the blood flow, corresponding proximally to the part facing the direction of the blood flow.
• the tubular element can be thought of finger-glove-like.
• the proximal portion of the tubular member substantially corresponds to the portion of the glove surrounding the palm and the distal portion of the tubular member substantially to the fingers of the glove, with the distal branches of the implant corresponding to the fingers open-ended or openable at their ends ,
• the proximal lumen branches out distally into five lumens, one main lumen and four secondary lumens, but other divisions are also conceivable and feasible without any problem.
• the implant according to the invention is in no way limited to embodiments which resemble the relations, dimensions or other properties of a finger glove.
• the tubular element is fixed by means of one or more clamping rings on the inside or outside of the proximal portion of the tubular member upstream of the aneurysm in the target vessel.
• the tubular element can by further measures be attached to the one or more clamping rings, for example by clamping, welding, gluing, sewing or by other known measures.
• Preference is given to a clamp-type compound as disclosed in WO 2012/084202 A2.
• Particularly preferred is the sewing at least one clamping ring in the envelope formed by the tubular element.
• the one or more clamping rings are arranged in the proximal region of the tubular element.
• the clamping ring can be sewn into this bag. This design has the advantage that the pressure of the clamping ring is "padded" on the vessel wall.
• the clamping ring itself has a wave-shaped course, whereby “undulating” means meandering or zigzag-shaped. This allows for extensive compression of the tension ring for transporting the implant in a catheter and for expansion adapted to vessel caliber placement. Self-expanding clamping rings are preferred according to the invention.
• a clamping ring has the advantage of greater radial force over a stent.
• the radial force spreads over the entire surface while a tension ring concentrates the force on the contact ring with the vessel wall.
• the wave-shaped design of the clamping ring also makes it possible, when selecting the correct diameter, to perform the expansion in the vessel so targeted that the greatest possible radial force is transmitted.
• a clamping ring is preferably a closed wire ring, which is designed zigzag or wavy. This allows compression in a catheter to a small diameter and subsequent expansion after deployment from the catheter. Expansion is preferably by self-expansion of a shape memory material, such as a nickel-titanium alloy, but a balloon-expandable material may also be used, such as a spring steel alloy. For self-expanding materials, it is important that the clamping ring in the vessel has a residual expansion capacity, which ensures the fixation of the multi-lumen implant in the vessel. For the clamping ring, a cut from a tube using a laser ring can be used. The same criteria apply as described above.
• the clamping ring has, for example, a diameter of 0.15 to 0.80 mm, in particular 0.40 to 0.60 mm. This applies both to wire-made clamping rings as well as laser cut.
• the multi-lumen implant has a clamping ring, which is arranged externally in an envelope of the tubular element.
• this clamping ring is sewn. This embodiment has the advantage that the clamping ring in the envelope has some freedom of movement, which improves the displacement in the catheter and the placement in the vessel.
• the multi-lumen implant has two clamping rings, one outer of which is disposed on the outside of the envelope of the tubular member and an inner one on the inside of the tubular member in the proximal portion.
• the two clamping rings are suitably connected to each other through the tubular element, for example, sewn.
• the waves of the two clamping rings are arranged on a gap, resulting in a better fixation of the proximal part of the tubular element between the clamping rings and the multi-lumen implant on the vessel wall.
• two or more clamping rings can also be arranged in another way in the implant, for example next to each other in the envelope, or alternately in the envelope and on the inside of the tubular element.
• fasteners may be provided, for example, hooks or screws that extend into the vessel wall.
• fasteners are known per se and become clinically used (Heli-FX EndoAnchor TM).
• These fastening means may be hooks connected to the clamping ring, which engage in the expansion in the vessel wall, or screw elements which fix the latter in the proximal region of the tubular element with the clamping ring on the vessel wall.
• the distal portion of the tubular element branches into at least two lumens, wherein the number of lumens is arbitrary and the number of branches can depend, for example, on the number of vessels to be supplied. However, embodiments with two or five branches are preferred.
• the diameters are basically arbitrary and can be selected according to the intended use of the implant.
• the diameter of the proximal section between 5 and 45 mm, preferably between 20 and 42 mm is possible, for the main lumen between 3 and 30 mm, preferably between 12 and 25 mm, and for the secondary lumina between 2 and 12 mm, preferably between 4 and 10 mm possible.
• diameters of the proximal section between 2 and 15 mm, preferably between 2 and 8 mm are possible, for the main lumen between 1 and 5 mm, preferably between 2 and 4 mm, and for the secondary lumens between 1 and 4 mm, preferably between 2 and 3 mm possible.
• diameter of the proximal portion between 2 and 8 mm preferably between 4 and 6 mm possible for the main lumen between 2 and 6 mm, preferably between 3 and 5 mm possible, and for the secondary lumens between 2 and 5 mm, preferably between 2 and 3 mm possible.
• embodiments are also conceivable which have a total of more or less than five lumens; furthermore, embodiments are also conceivable which have more than one main lumen and more or less than four secondary lumens.
• embodiments with an eccentric distribution of the lumens are preferred in which the branch with the largest lumen on one side and one or more branches with smaller lumens on the other side in FIG Cross section are located.
• the distribution of the branches in the distal portion of the tubular element is not fixed and embodiments are also conceivable in which, for example, a branching is located in the central region and further branchings are arranged uniformly or unevenly distributed around the central lumen.
• the individual branches are the same length. However, embodiments are also conceivable in which the branches are of different lengths. Overall, it is preferred that the branches terminate distally approximately with the stent for fixation of the implant. However, it is conceivable that the branches are also projected distally of the stent or protrude distally from the stent framework.
• the branches of the implant are connected via covered stents, so-called stent grafts, with the vessels lying distally to the implant, whereby the area of the aneurysm bridges, the blood flow into the aneurysm is prevented and the aneurysm is relieved.
• the distal vessels are specifically supplied with blood via the stents.
• the distal branches may taper conically towards their end or in a specific section.
• the branches in the distal section preferably extend freely from one another, but embodiments are also conceivable in which all or some of them are connected to one another, if appropriate also in groups.
• the branches can also - additionally or alternatively - be attached to the stent used to fix the implant or to the folded proximal portion of the tubular element.
• Suitable materials for the tubular element are all known in the art physiologically acceptable materials in question, especially ePTFE, which may also be processed by electrospinning.
• the implant according to the invention is inserted at the proximal end of the aneurysm into the still intact vessel section.
• the implant fulfills the function of a distributor disc, which allows the blood to flow only through the lumens of the distal branches.
• the distal branches of the tubular element are connected via covered stents with the vessels located distally of the implant. This bridges the area of the aneurysm.
• This technique makes it possible to perform the intervention step by step, since the use of the implant initially does not prevent the blood supply to the vessels located distally of the implant.
• the implant in a first intervention the implant can be used on itself and in one or more further interventions the vessels are connected.
• the multi-lumen implant according to the invention also makes it possible to repair already lying systems which have developed leakage (so-called endoleakage) due to migration (displacement of the prosthesis), damage to the texture or progression of the disease in the upper and lower sealing segments.
• the existing prosthetic components can remain in the body as the multi-lumen implant offers a completely independent seal and anchorage.
• the implant Due to its universal applicability, the implant can be produced in larger numbers at relatively lower unit costs by standardizing on preferably five distal lumens and is therefore significantly cheaper than individualized implants.
• the implant can be universally used due to its flexible connection options, it can be stored in the clinic and thus also be used in acute emergencies. An individual preparation with partly long waiting times is not necessary.
• the implant is easy to implant, it does not need to be pre-assembled or mounted in the patient's vasculature.
• the implantation is analogous to the insertion of an ordinary stent.
• the connection of the vessels to the branches requires no special knowledge, it corresponds to the routine use of stent grafts.
• the simplicity of the implant also makes it less susceptible to device failures than known implants, which may be due to intervention or prior fabrication and packaging.
• FIGS. show a particularly preferred embodiment of the invention.
• the invention is not limited to the embodiment shown.
• the invention includes, as far as is technically feasible, any combination of the technical features that are listed in the claims and described in the description and the accompanying drawings as being relevant to the invention. Show it:
• Fig. 1 is a schematic representation of the tubular element
• Fig. 2 is a schematic representation of a first
• 3a-b is a schematic representation of the folding of the proximal to the distal portion for a better understanding of a second embodiment of the implant according to the invention
• FIG. 4 shows a clamping ring which can be used according to the invention
• Fig. 5 is a schematic representation of a second
• 6a-b show a) transverse and b) longitudinal section through a second embodiment of the implant according to the invention
• Fig. 7a-d is a schematic representation of possible
• Fig. 9 shows another embodiment.
• FIG. 1 schematically shows the tubular element 1 of an implant according to the invention, which is divided into a proximal section 2 and a distal section 3.
• the proximal p-lumen tubular element 1 branches distally d into at least two lumens 4, 5, wherein in a preferred embodiment there is a main lumen 4 and four secondary lumens 5, or a corresponding large branch 6 and four smaller branches 7.
• the relative size ratios of this schematic representation are purely based on a good visibility of the individual parts. Thus, both the ratio of proximal 2 to distal portion 3 and the ratios of the individual distal lumens 4 and 5 or the lengths of the branches 6 and 7 may be different than shown here.
• FIG. 2 shows the tubular element 1 from FIG. 1, with a clamping ring 8 for fixing or fixing the tubular element 1 in a vessel inside the proximal section 2.
• the clamping ring 8 is located in the proximal section 2.
• the proximal end of the tubular element 1 may optionally project beyond the stent 8 and be folded over inwardly into the lumen of the proximal section 2 via the proximal end of the stent.
• the clamping ring 8 is formed wave-shaped.
• Figures 3a and 3b generally illustrate the arrangement of the proximal portion 2 of the tubular member 1 in a first preferred embodiment.
• the proximal portion 2 is turned over to the distal portion 3, so that the distal portion 3 is finally at least partially encased by the proximal portion 2.
• Figure 3b shows the introduced into the space 9 of the envelope of the proximal portion clamping ring 8 with zigzag-shaped course as a dashed line.
• FIG. 4 shows a clamping ring 8 which can be used according to the invention in plan view (a) and in perspective (b).
• the clamping ring 8 is a construct whose turns are compressed during compression, such as a wire ring or a pipe cut, which was produced by means of a truck in a known manner.
• Figure 5 shows a preferred embodiment based on the turnover of the proximal portion 2 as shown in Figures 3a and 3b.
• the proximal portion 2 is deflected distally d to the end of the branches 6, 7.
• the clamping ring 8 In the resulting envelope 9 is the clamping ring 8.
• the lengths of the clamping ring 8, the proximal 2 and the distal portion 3 are approximately equal in this illustration; the clamping ring 8 is completely within the envelope.
• FIG. 6 shows a cross section 6a and a longitudinal section 6b through the preferred embodiment of the implant shown in FIG.
• the dotted line indicates the tension ring 8, the dotted line the distal portion 3 and the solid line the proximal portion 2 of the tubular element 1.
• the proximal portion 2 is folded distally d and turned inside out around the inside of the envelope 9 clamping ring 8 to the proximal end, so that the clamping ring 8 on all sides of the proximal Section 2 is covered.
• FIG. 7 shows purely schematically as cross-sections through the implant various divisions and arrangements of the distal lumina 4, 5.
• the main lumen 4 can be arranged centrally a, b or eccentrically c, d.
• the secondary lumens 5 can be arranged correspondingly around the main lumen 4 around a, b or on a side c, d.
• the main lumen 4 may be round a, c or oval b, d in cross section.
• embodiments are conceivable in which the secondary lumens 5 are oval.
• a preferred embodiment is shown in Figure 7c.
• FIG. 8 shows various possible embodiments of the distal ends d of the distal branches 6, 7 for better fixing of the stents which connect the distal branches 6, 7 with the vessels to be supplied in each case.
• the distal branches may taper conically towards the end a, or taper conically at the distal tip d, 12, at the tip there may be annular 10 solidifications or distally reinforced structure c, 11, respectively.
• FIG. 9 shows an embodiment of the implant according to the invention in which two clamping rings 8 ensure expansion.
• the tubular element is divided into five lumens, one main lumen 6 and four secondary lumens 7.
• the proximal portion 2 of the tubular element is folded over and forms a pocket 9, in which an outer clamping ring 8 (shown in phantom) is arranged.
• an outer clamping ring 8 (shown in phantom) is arranged.
• a second clamping ring 8 is placed on the inside of the tubular element, so that the radial forces of both clamping rings unite.
• the inner and outer clamping ring 8 are set to gap, ie the wave crests of the inner clamping ring 8 correspond to the troughs of the outer clamping ring 8.
• Both clamping rings 8 can be interconnected by the hose member, for example by sewing.

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• Health & Medical Sciences (AREA)
• Engineering & Computer Science (AREA)
• Biomedical Technology (AREA)
• Heart & Thoracic Surgery (AREA)
• Oral & Maxillofacial Surgery (AREA)
• Transplantation (AREA)
• Cardiology (AREA)
• Vascular Medicine (AREA)
• Life Sciences & Earth Sciences (AREA)
• Animal Behavior & Ethology (AREA)
• General Health & Medical Sciences (AREA)
• Public Health (AREA)
• Veterinary Medicine (AREA)
• Pulmonology (AREA)
• Gastroenterology & Hepatology (AREA)
• Prostheses (AREA)

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• 2018
  • 2018-05-15 DE DE102018111614.4A patent/DE102018111614A1/de active Pending
• 2019
  • 2019-05-15 BR BR112020023192-4A patent/BR112020023192A2/pt unknown
  • 2019-05-15 US US17/054,967 patent/US11931240B2/en active Active
  • 2019-05-15 IL IL278704A patent/IL278704B1/en unknown
  • 2019-05-15 EP EP19729616.3A patent/EP3793477A1/de active Pending
  • 2019-05-15 CN CN201980047178.2A patent/CN112423705A/zh active Pending
  • 2019-05-15 JP JP2021514477A patent/JP2021524797A/ja active Pending
  • 2019-05-15 WO PCT/EP2019/062431 patent/WO2019219728A1/de unknown

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