Delivery catheters, systems, and stent grafts

Abstract

The present application discloses a stent graft and a method for navigating the stent graft to a branch vessel, the stent graft comprising a main body and at least one lateral side branch connected to the main body, a stent graft system and a method for implanting the stent graft, including interconnecting the stent grafts.

Description

[0001] This application is a divisional application of the PCT international invention patent application with application number 201780042162.3, application date May 26, 2017, and invention name “Vascular Medical Devices and Systems”. Technical Field

[0002] The present disclosure relates generally to the field of medical devices. More specifically, the present disclosure relates to vascular medical devices, which are stent grafts, stent implants, or endoprostheses for fluid communication with one or more side branch vessels, and systems of such devices, for example, multiple stent grafts, for assembly with one another and for placement at a target site in a patient. In addition, a medical procedure for placement of such devices and systems is disclosed. The target site of the patient includes, for example, at least a portion of the patient's aorta. More specifically, a method of treating at least a portion of the patient's aorta by implanting such a device or system during a medical procedure is disclosed. The medical procedure is preferably a minimally invasive vascular repair. Background Art

[0003] Modular stent grafts or stent implants are known for treating or repairing vascular diseases, such as aneurysms. WO2005 / 027784 discloses a modular stent graft system for implantation in a diseased vessel, wherein the stent graft has an orifice along its midsection. The orifice is used to align with a branch vessel of the main vessel, allowing for the attachment of an additional stent graft at the orifice from the main vessel stent graft. The orifice needs to be precisely aligned with the orifice of the side vessel. From the main vessel stent graft, another stent graft then protrudes from each orifice into the branch vessel.

[0004] In WO2004 / 019823, an intraluminal stent implant system is disclosed for implanting a limb of a branched stent implant into a blind vessel. The branched stent implant has a body and a limb extending from the body. The branched stent implant is mounted on an expansion device having a separate deflecting guidewire extending into the limb. A method for implanting a branched stent implant into a blind vessel in a human or animal body comprises releasing the limb from the branching device, extending a guidewire from the limb into the blind vessel, manipulating the implant by slightly withdrawing the device so that the limb enters the blind vessel with the aid of the guidewire, and releasing the stent implant from the expansion device.

[0005] One undesirable problem with this known device is that it can be difficult for the operator to properly implant the stent graft into the main vessel in alignment with the branch vessel. The orifices or branches from the main vessel stent graft must be correctly positioned in the main vessel relative to the location of the branch vessel. The branch vessel is in fluid communication with the main vessel, i.e., via a branch vessel stent graft with arms or a portion of a larger stent graft unit.

[0006] The main vessel stent-graft is expanded and then implanted in the main vessel. Once expanded and implanted, the main vessel stent-graft cannot be repositioned. Misaligned orifices or branch stent-grafts that are misaligned with the branch vessel may, for example, cause kinking of the branch vessel stent-graft. This kinking may result in an undesirable reduction in blood flow to the branch vessel. Due to pulsatile flow, the durability and lifespan of the stent-graft may also be compromised during implantation. It may also cause the side-branch stent-graft unit to leak or loosen from the main vessel modular stent-graft.

[0007] Furthermore, when the operator attempts to find a branch vessel with the modular stent graft, particularly in the presence of some misalignment, there is a certain risk of damaging the vessel. Prior art modular stent grafts with orifices have a further risk of causing damage to the vessel wall during operation, as they are more or less open circular orifices facing the sides of the modular stent graft. When the operator subsequently attempts to navigate such a side branch vessel into position, as described above, the open orifices may tear or otherwise damage the delicate vessel wall while moving inside the vessel, causing the vessel wall to rupture leading to internal bleeding. This situation should be avoided, and an improved stent graft or (modular) stent graft system or implantation procedure for the latter would be advantageous.

[0008] The aforementioned alignment challenges result in very long operating times for previously known devices and medical procedures. These extended operating times increase patient risk and potential problems associated with such procedures. These problems include, for example, an increased risk of clots developing during the procedure. Furthermore, extended operating times mean extended X-ray use, exposing both the operator and the patient to these rays. Furthermore, large amounts of contrast agents are used.

[0009] Therefore, it is also desirable to reduce the X-ray dose to the patient and the operator. Shorter scan times or fewer scan positions are required as well as the use of contrast agents that need to be injected into the patient's blood. Therefore, it is necessary to reduce the time required for this implantation process, which reduces both the patient's radiation exposure to primary radiation and the operator's secondary radiation (scattered radiation). Providing a covered stent, a covered stent system or a procedure is beneficial for reducing scan times. The embodiments of the present invention described below will provide such advantages as described below.

[0010] Another undesirable problem with the known art is that implantation of a stent graft, particularly a longer endoprosthesis system of such a stent graft covering multiple side branch vessels, is a complex procedure.

[0011] In known endoprostheses, the stent grafts need to be assembled in a single placement of the stent graft system. For example, if the side branch vessel opening of the main stent graft is mispositioned relative to the side vessel when deployed, repositioning the main (vessel) stent is very difficult or impossible. Prior art systems do not allow for flexibility or very small tolerances during placement for mispositioning of the main stent relative to the side vessel. Flexibility of the side vessels with such stents is desirable.

[0012] Advantageously, the repositioning of the other parts of the stent graft system relative to the side vessel should be provided, and the implantation process should be facilitated. Therefore, a novel stent graft, stent graft system or implantation operation is needed to allow single positioning of one or more side vessel stent grafts. The embodiments of the present invention described below provide this advantage as described in more detail below.

[0013] Minimally invasive implantation of the endoprosthesis requires what has heretofore been continuous fluoroscopic scanning by X-ray, allowing the operator to see where and how the different stent graft modules are positioned in the patient's vascular system to assemble the endoprosthesis in the patient.

[0014] The scanning angle of the X-ray modality needs to be frequently changed to enable the operator to find the branch vessels in three dimensions and the relationship of the stent graft to the orifice of the stent graft module in the main vessel. The scanning technology used for this only allows the operator to see the scanned object in only one plane at a time, that is, in two dimensions, one layer at a time.

[0015] Three-dimensional visualization of the branch vessel position and orifice relative to the stent graft's orifice requires repeated movement of the fluoroscopic scanner arm from one plane to another and back again. This ensures three-dimensional alignment between the stent graft in the primary vessel and the side branch vessel. This is crucial for proper placement of the components at the patient's implant site.

[0016] This task is particularly complicated by the multiple orifices and side branch vessel connections aligned to a single stent graft in the main vessel.

[0017] There is therefore a need to make the assembly less complex. The disclosure of the following embodiments of the present invention advantageously provides a less complex stent graft assembly. Reduced X-ray time and associated radiation dose are beneficial to both the patient and clinical staff.

[0018] Therefore, there is a need for a safer medical device and / or system or medical procedure that avoids the above-mentioned disadvantages of known systems and procedures. Preferably, a device and / or system or method is desired that results in a shorter operating time. It is desired that the operator can perform the procedure more easily. A simplified implantation process is desired. It is desired to reduce the incidence of complications. It is desired to have new medical procedures that reduce patient risks. There is a need for simpler implants. It is desired to perform medical procedures that can be avoided despite the fact that these procedures can be avoided when the patient is currently assessed for risk. For example, known stent systems imply an excessively high risk of complications, and open-chest surgery is not an option for many patients, particularly elderly patients, and there is a need for such simplified implants or devices that facilitate simplified implants. It is also desired that less X-ray doses are required during the operation. Therefore, it is desired to be able to provide novel medical procedures that mean reduced patient risks. Summary of the Invention

[0019] Therefore, embodiments of the present disclosure preferably seek to mitigate, alleviate or eliminate one or more deficiencies, shortcomings or problems in the art by providing medical devices, systems and methods according to the present invention, for example, by providing medical devices, systems and methods according to the accompanying independent claims, alone or in any combination.

[0020] The novel stent graft system of the present invention specifically allows for the separate delivery of side vessel stent branches. This significantly reduces overall procedure time. Furthermore, patient safety is improved as the time required to deploy a stent in one side vessel is reduced and / or the other side vessels remain perfused.

[0021] The novel system requires a novel medical procedure that represents an excessively high risk for the patient. Due to the simpler implant, medical procedures that are avoided in current patient risk assessments can be performed. For example, known stent systems carry an excessively high risk of complications, and open-chest surgery is unacceptable for many patients, particularly the elderly.

[0022] The embodiments of the present invention described below facilitate reducing the time of some or all of the procedure. Compared to prior art systems, implantation time is shortened, thereby, for example, facilitating a reduction in total dose. The angle of the X-ray modality is altered less than with prior art systems. Less contrast agent is required. All of the following disclosures are intended to reduce potential side effects for the patient. Furthermore, the cost of the procedure is reduced.

[0023] The stent grafts discussed herein are self-expanding in one embodiment or, in another embodiment, expandable by another device, such as an inflatable balloon.

[0024] According to a first embodiment, a medical device is provided. The device is a stent graft having a main body and at least one lateral side branch connected to the main body. The side branch is flexible and expandable.

[0025] According to one aspect of the present disclosure, a system is provided.

[0026] The devices and / or systems may be used in the medical procedures and methods described herein.

[0027] The solutions of the present disclosure include but are not limited to the following.

[0028] -In a first embodiment, a coated stent is provided, which has a body and at least one branch, the branch including one, two or three branches connected to the body. The coated stent also includes at least one bendable and / or flexible guiding element, which is permanently or releasably connected to the interior of at least one of the branches at a connection point, preferably at the distal orifice of the branch. The guiding element is arranged proximally inside the body, passes through and along the proximal portion of the body, and extends proximally along the proximal opening of the body. In this way, a catheter can be guided on the guiding element through the body toward the distal orifice of the branch.

[0029] -In a second embodiment, a delivery catheter is provided for delivering a second stent graft to be connected to the first stent graft. The catheter has a delivery lumen with a distal orifice for delivering and deploying the second stent graft at a target site of the catheter of the first stent graft. The catheter also has a guide fitting for receiving a guide element whose distal end is attached to a connection point at a branch. In this way, the catheter can be slid along the guide element on the guide fitting to the orifice of the branch, and the second stent graft is delivered and deployed through the delivery lumen of the catheter. The guide fitting for receiving the guide element preferably has a distal end that is positioned at a certain distance from the distal orifice of the delivery lumen so that when the distal end of the guide fitting engages the connection point, the delivery lumen extends beyond the connection point.

[0030] - A modular system of the stent graft according to the first embodiment and the delivery catheter according to the second embodiment, wherein a guide element passes through the guide fitting for delivering the second stent graft to the target site of the branch via the delivery catheter. The second stent graft is preferably an extended stent graft.

[0031] - A modular stent graft system comprising a plurality of stent grafts, wherein at least one stent graft is preferably a stent graft of the first embodiment of the present disclosure. The plurality of stent grafts are configured to be interconnected with each other. The plurality of stent grafts include a first main vessel stent graft having a first single distal upstream inlet branching into at least two proximal downstream outlet branches, and at least two stent grafts having at least one lateral side branch orifice. Each of the at least two stent grafts can be distally interconnected to one of the downstream outlet branches of the first main vessel stent graft and can be laterally connected to a side flow vessel of the main vessel. The at least two stent grafts can be sequentially interconnected to one of the downstream outlet branches for providing a blood conduit arranged in parallel by at least two stent grafts. The modular system includes a second main vessel stent graft having at least two distal upstream inlet branches collected in a single proximal downstream outlet, each distal inlet branch interconnected to the proximal outlet of one of the at least two stent grafts.

[0032] -A method for navigating a stent graft to a target site in a blood vessel, comprising providing the stent graft of the first embodiment of the present disclosure. In addition, the method comprises delivering the stent graft to the target site in the blood vessel and guiding the branch of the stent graft into or towards the branch vessel. The method comprises providing a catheter according to the second embodiment of the present disclosure, and arranging a guide element attached to the stent graft through a guide fitting of the catheter, advancing the catheter along the guide fitting until its attachment point stops further advancement. The method comprises delivering a second stent implant or its guide wire through the lumen of the delivery catheter to the target site of the branch of the stent graft, the second stent graft preferably being an extended stent implant. The method optionally comprises securing the extended stent implant proximally to the branch and distally in the branch vessel.

[0033] A medical procedure includes accessing a target site, which is a patient's blood vessel, and delivering a first stent graft to the interior of the blood vessel at the target site via a delivery catheter. The target site has a side branch vessel, and the method includes delivering a second stent graft to the first stent graft and connecting the first stent graft to the second stent graft to provide blood flow to the side branch vessel. Delivery of the second stent graft includes sliding a catheter along a guide element to a position within the lumen of the side branch of the first stent graft. The method may include expanding the second stent graft to connect to the first stent graft.

[0034] A medical procedure includes accessing a target site, which is a patient's blood vessel, and delivering a first stent graft to the interior of the target site's blood vessel via a delivery catheter. The target site has a side branch vessel, and the method includes dilating the side branch and delivering a second stent graft to the first stent graft and through the side branch to the side vessel. The method includes connecting the first stent graft to the second stent graft to provide blood flow to the side branch vessel.

[0035] -A medical procedure for aortic revascularization includes delivering stent graft modules in a specific sequence. The method may begin with implanting a three-legged stent graft in the ascending aortic arch. The method includes delivering two parallel stent grafts in the aortic arch in a downstream direction of the aorta, each stent graft having a side branch, and sequentially connecting the parallel stent grafts to the legs of the three-legged stent graft and the branch vessels of the aortic arch. The method includes delivering a stent graft downstream of the aorta that collects the parallel stent grafts. For example, the collection includes providing two distal legs that are incorporated into a single lumen having a proximal orifice, connecting the two distal legs to the proximal end of each of the two parallel stents. Thus, a different number of parallel stent grafts exceeding two changes the number of legs. An intermediate collection number of legs can be provided by the device, system and method.

[0036] Further embodiments of the disclosure are defined in the dependent claims, wherein the features of the second and subsequent aspects of the disclosure are the same as for the first aspect, applicable mutatis mutandis.

[0037] Some embodiments of the present disclosure provide for improved navigation and assembly of a stent graft or multiple stent grafts, each in a side branch vessel from a main vessel.

[0038] Using the innovative system, device and / or method, the operation of positioning a covered stent with side branch connections, particularly for multiple side vessels (up to four side branches) with, for example, three or four side branches, the time required for implantation is expected to be significantly reduced, several hours less than the conventional time required. Using traditional prefabricated stent implants, such a process would require a considerable amount of time, approximately 10 hours of operating time or longer. Although the surgical time for positioning the covered stent device / system is greatly reduced, the surgical safety is not lost. On the contrary, safety can be improved. The delivery of the innovative device and system is very reliable. The implantation time is significantly reduced by the implantation procedure made possible by the novel modular system and / or its components and / or system features. This will be described in detail below.

[0039] A covered stent is a stent that has a lining, shell, or is surrounded by a fabric or material that is impermeable to liquids. A covered stent may be partially or completely covered. A covered stent may also be called a stent implant or an endoprosthesis.

[0040] The side branches 3 may be laterally extendable and / or foldable, i.e., expandable in the direction of the longitudinal axis of the side branches 3, which direction is preferably substantially perpendicular to the longitudinal axis of the main body 2 of the stent graft 1. Alternatively, the side branches 3 may expand in a transverse direction, i.e., expandable perpendicular to the axis of the side branches 3. The side branches 3 may include a stent graft, and in some embodiments may be a stent graft.

[0041] In an embodiment, the side branches 3 may extend laterally by about 1 cm to 1.5 cm.

[0042] The side branch 3 is integral with the main body 2 in an embodiment, either by the main body 2 stent graft and the side branch 3 stent graft being integral, or by the main body 2 cover and the side branch 3 cover being integral. In one embodiment, the main body 2 cover and stent graft are integral with the side branch 3 stent graft cover and stent graft. When the side branch stent 3 includes a stent graft, it is stiffer and can withstand more handling, such as placement and / or re-placement of any further covered extension stent grafts. This also allows the side branch 3 to form a tighter connection with any additional covered extension stent grafts from the side branch 3.

[0043] It should be emphasized that when used in this specification, the term "include / comprises" is used to specify the presence of stated features, integers, steps or components, but does not preclude the presence or addition of one or more other features, integers, steps, components or groups. BRIEF DESCRIPTION OF THE DRAWINGS

[0044] These and other aspects, features and advantages of the embodiments of the present disclosure will be apparent from and elucidated from the following description of the embodiments of the present disclosure with reference to the accompanying drawings, in which

[0045] Figure 1 is a schematic diagram of a system showing different stent graft modules for implantation into a patient's aortic arch and thoracic aorta;

[0046] Figure 2 It means Figure 1 Schematic diagram of the system when implanted in the patient's aorta;

[0047] Figure 3 is a schematic diagram of a stent graft having three legs, and navigation elements and sutures for easy navigation to all three legs;

[0048] Figure 4 is a schematic diagram of a stent graft with side branches;

[0049] Figure 5a -b is a schematic diagram of two embodiments of a stent graft with more than one side branch;

[0050] Figure 6 is a bottom-up schematic diagram of one embodiment of a side branch that is self-expandable from a contracted shape to an expanded shape;

[0051] Figure 7 is a schematic diagram of a stent graft with folded or folded side branches for positioning a branch vessel;

[0052] Figure 8is a schematic diagram of a stent graft with side branches and a catheter with a guide fitting.

[0053] The guide fitting is used to guide a catheter to facilitate side branch navigation;

[0054] Figure 9a -c is a schematic diagram of a constraining member and a stent graft that self-expands from a contracted shape to an expanded shape by removing the constraining member;

[0055] Figure 10 is a schematic diagram of a sheath for holding a stent graft in a collapsed or folded manner and controllably releasing the stent graft partially or completely;

[0056] Figure 11 is a schematic diagram of the stent graft before and after full deployment of the stent graft;

[0057] Figure 12 is a flow chart of one embodiment of a medical procedure;

[0058] Figure 13 is a flow chart of an embodiment of a method for navigating a stent graft to a branch vessel;

[0059] Figure 14A -D is a perspective view, a top view, a side view, and a front view of an embodiment of a modular stent graft 300 having a single lateral side branch;

[0060] Figure 15A are perspective and cross-sectional views of modular stent graft 300 (upper portion of the figure) with a perspective view of lateral side branches in a delivery configuration (lower portion of the figure);

[0061] Figure 15B and 15C It is expanded before releasing the subject Figure 15A Schematic diagram of a lateral side branch of a modular covered stent 300;

[0062] Figure 16 is a cross-sectional view of a double-lumen delivery catheter;

[0063] Figure 17A are perspective and cross-sectional views of modular stent graft 300 having lateral side branches in another delivery configuration;

[0064] Figure 17B Schematic diagram of the release of the main body and lateral side branches of the modular stent graft 300;

[0065] Figure 18 is a schematic diagram of a catheter tool for releasing a navigation unit from an extension of a lateral side branch; and

[0066] Figure 19A, B, and 20 are schematic diagrams of different stent patterns for lateral side branches. DETAILED DESCRIPTION

[0067] Specific embodiments of the present disclosure will now be described with reference to the accompanying drawings. However, the present disclosure can be implemented in many different forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided to make this disclosure thorough and complete and to fully convey the scope of this disclosure to those skilled in the art. The terms used in the detailed description of the embodiments shown in the accompanying drawings are not intended to limit the present disclosure. In the accompanying drawings, like numbers represent like elements.

[0068] The following description focuses on embodiments of the present disclosure that can be applied to medical devices, and specifically relates to medical devices that facilitate navigation and assembly of a covered stent or multiple covered stents that are at least in communication with side branch vessels. The implant can be used to treat and / or repair vascular diseases, such as aneurysms. This embodiment is illustrated by placement in the aorta. Blood vessels like the aorta can be structurally damaged for various reasons and require repair along at least a portion of the aorta 500. Sometimes an extensive endoprosthesis is required for aortic repair, partially or completely descending from the ascending aorta 501 through the aortic arch 502 to the aorta 503 and along the abdominal aorta 504 past the renal arteries 505.

[0069] Embodiments of such endoprostheses, including modular embodiments and assemblies, are described in Figure 1 and 2 and the corresponding text of this article. When implanted, the entire system can provide total aortic reconstruction or repair, such as Figure 2 As shown. Only selected submodules of the system can be implanted to provide partial aortic reconstruction or repair. However, other anatomical structures can be provided for treatment using the devices and / or systems of the present disclosure, including abdominal stent grafts, peripheral stent implants, endoluminal prostheses, and including, for example, laparoscopic stents. This includes, but is not limited to, peripheral veins, leg arteries, spinal cord, neural structures, lymphatic system, and the like.

[0070] Figure 1 and Figure 2 A system of various stent-graft modules 200, 300, 310, 320, 400, 410, 420, 430, 600 is shown for implantation within the aortic arch 502 and abdominal aorta 504 of a patient. Figure 2 Shown Figure 1 The system 100 is implanted in the patient's aorta 500 and the modules are connected to each other. Figure 1 The additional extended stent graft 600 not shown is connected and shown in Figure 2The prosthesis provides reliable blood flow in the main vessel, here the aorta 500, and into the branch vessels, here the neck vessels, the renal arteries 505, etc. In the embodiment shown, the aortic wall has weakening / aneurysms in the descending aortic arch and the abdominal aorta, requiring the treatment provided by the exemplary stent graft system 100 for aortic replacement / repair.

[0071] In the illustrated embodiment, a plurality of stent grafts 1 (reference numerals "1" referred to together in this specification may be considered a placeholder for "stent graft" or "stent grafts," such as the types disclosed herein, e.g., stent grafts 200, 300, 310, 320, 400, 410, 420, 430, 600, etc.) are assembled and interconnected to fit an entire portion or the entire aorta of a patient to form system 100 or its modular subsystems. The stent grafts 1 discussed herein may also be implanted in other target sites of the body for repairing and / or reconstructing vascular conduits for fluid communication through the blood vessels.

[0072] Figure 1 Shown are different types of modular stent grafts 1 that may be used in an exemplary assembly of a system 100 of modular stent grafts 1 that fit within and around a vessel of a patient's aortic arch 502. System 100 may be assembled in vivo or in vitro.

[0073] Alternatively, the system can include more or fewer stent graft modules. For example, only the aortic arch could be covered with stent graft modules 200, 300, 310, 320, 400, 410, etc.—all depending on the treatment site and treatment needs. Other examples of stent graft module combinations include: a) 200, 2x300 + 2x600, 400, and optionally 600 in 201; b) 420, 310 + optionally 2x600, 320 + optionally 2x600 and 430; c) intermediate 410 + embodiments a) and b); and so on.

[0074] Some stent grafts 1 have side branches 3 that are configured to extend blood communication through the system and preferably extend into branch vessels. Examples of such stent grafts are modular stent grafts 300 , 310 , 320 .

[0075] Some stent grafts 1 have legs, ie, the body 2 of the stent graft 1 is divided into two or more tubular portions. Examples of such stent grafts are modular stent grafts 200, 400, 420, 430.

[0076] Alternatively or additionally, although not shown in the figures, the stent graft 1 may have two side branches 3 and legs. Stent graft 200 may be considered an embodiment having two legs 202, 203 and side branches 201. In this document, both legs and side branches may be considered branches. Other stent grafts not discussed or shown herein but currently in common use may also be used in system 100.

[0077] Modular stent graft system 100 includes a plurality of stent grafts 1, wherein at least one stent graft is stent graft 1. The plurality of stent grafts 1 are configured to be connectable to each other.

[0078] Alternatively or additionally, the system further comprises an elongated navigation element 20 that allows the operator to navigate the stent graft and / or the side branches 3 of the stent graft 1 and to align the side branches 3 with the branch vessels. The elongated navigation element 20 is preferably a guide wire, e.g. Figure 1 As shown in .

[0079] In one embodiment, the stent grafts have substantially the same diameter at the interconnection between the two stent grafts to provide a fluid-tight interconnection.

[0080] In one embodiment, having the same diameter at the interconnection means that the outer diameter of the interconnection of one stent graft is substantially the same as the inner diameter of the interconnection of the other stent graft, at least along a portion of the stent graft. If overlapping, the same diameter is maintained at least along the overlapping portion of the two stent grafts. Thus, two stent grafts can be connected, for example, by overlapping each other to deliver fluid and one tube within the other connecting tube.

[0081] The stent structure of a stent graft is the portion of the stent graft. It may have a pattern, such as a wavy pattern. This pattern can be created by braiding, weaving, laser-cutting a tube, or the like. This structure is the scaffold, providing external support and providing a generally tubular structure to ensure undisturbed blood flow through the tube during implantation. It is covered with a suitable liquid-tight cap.

[0082] The undulations or patterns may be denser at the overlapping connection area than in other areas of the stent graft - for a reliable fluid-tight connection of the two stent grafts and through improved mechanical strength.

[0083] Figure 19A , B and 20 are schematic diagrams of some exemplary stent patterns / waves of lateral side branches.

[0084] Figure 19A The pattern in FIG shows a wavy (nitinol) wire or laser cut structure that is easy to reduce its outer diameter and fold it into the delivery configuration next to the prosthesis body. When the constraining member is released or removed from the catheter, it will expand longitudinally elastically, as shown in FIG. Figure 19Band Figure 20 Designed like that.

[0085] Figure 19A The pattern in FIG. 3B has an area without a support frame in region 3b, with which the extension prosthesis 600 will overlap. The frame pattern has an asymmetrical design. The dotted line 3c in the figure indicates the area that will cause the stent to collapse. This design requires less closing force and less space to store it for delivery in the outer sheath. The portion with a longer support frame (on the left side of the figure) will ensure that the side branch prosthesis is expanded to a sufficient length that it will remain in the side branch or be directed radially outward from the main body.

[0086] Figure 20 The pattern in shows two halves of a frame pattern that will advantageously close together in the middle. In addition, this design requires less closing force and requires less space to store it for transport in an outer sheath.

[0087] The contraction of the side branch 3 for delivery through a catheter can be achieved in a variety of ways. It can be closed back, slid laterally along the catheter lumen, or compressed along its longitudinal axis. If a cover is provided (Figure 9, etc.), the side branch and the stent graft are closed and retained within the cover / constraint member 8. The constraint member 8 can be a material with low friction, such as PTFE. The constraint member 8 allows the pull / push release of the stent graft contained in the constraint member 8 until deployment during delivery. Alternatively or in addition, the interior of the catheter can be provided with a material with good sliding properties to facilitate the movement of the stent graft along the lumen to the target site, wherein the constraint member optionally covers the stent graft during delivery until it is finally implanted.

[0088] In another embodiment of having the same diameter, it is meant that the two stent grafts to be connected have substantially the same inner diameter at the point of mutual connection and are connected in a non-overlapping manner, e.g., end-to-end. An additional liner may be provided at the connection site of the two stent grafts, preferably downstream from the upstream positioned stent graft into the interior of the downstream oriented stent graft.

[0089] In one embodiment, the two stent grafts to be interconnected have substantially the same inner diameter and substantially the same outer diameter at the interconnection, and the stent grafts are connected by overlapping them when one of the stent grafts is in a partially closed or closed state.

[0090] Covering stents with the same or substantially the same diameter makes it easy for the operator to connect various stent grafts because the diameters of the corresponding stent graft components of system 100 are similar and the operator does not need to worry about any specific connection method, stent shape, connection location, etc. This means that the operator only needs to consider whether the previous stent graft is a single stent, a double stent, a triple stent, or a legged stent. This also makes the manufacture of the stent graft easier because the diameters of the connections of the various stent grafts are the same. One embodiment is the diameter of the legs 202, 203, the stent graft body 300, and the upstream directional legs of the stent graft 400.

[0091] The overlapping area allows the length of the modular system to be adapted. For example, the modular stent grafts 400, 410, 420 can be provided as a single integral unit. However, a straight intermediate stent graft 410 is provided that is separate from the branched end member stent grafts 400, 420 to allow adjustment for specific patient anatomy (in this embodiment, the length of the abdominal aorta is different). The overlap of the intermediate stent graft can be changed accordingly. The length adjustment of the modular stent graft system is provided by the overlapping portion at the opening of the stent graft, allowing the overlap to be changed and determining the total length of the assembled modular system when implanted. This is suitable for side vascular dilation stent graft 600 connections, etc.

[0092] In the prior art, the system of stent graft modules is provided with stent grafts having different diameters, such as cones. They are connected by inserting a first, closed cone-shaped stent graft into a second, expanded cone-shaped stent graft. When the first stent graft expands, the two stent grafts form a connection. In addition to tracking all stent graft modules, such a system also creates unnecessary additional tasks, not only to track the correct order and correct direction before and during the entire operation, but also to track where and how the two cones fit together. In contrast, the embodiments of the present disclosure provide a simpler, safer and faster implantation process.

[0093] Providing stent grafts 1 with substantially the same diameter offers the advantage that the operator can implant each stent graft 1 as described above, or in any embodiment of the orientation he or she deems best. This will significantly reduce the time required to assemble system 100 and therefore the operating time.

[0094] In one embodiment, when the stent graft 1 has substantially the same diameter as described above and is expanded, or when the side branches 3 or legs of the stent graft 1 are expanded, the flow through the stent graft 1 will more or less not pass through it. Meaning that fluid (e.g., blood) entering one side (e.g., body 2) will pass through the stent graft 1 and out through, e.g., the two legs on the other side and due to the expansion of the connection at the stent graft 1 and the same diameter, the inlet and outlet areas are substantially the same. This allows the operator to focus on connecting one stent graft 1 or a portion of a stent graft 1, such as a leg. The operator does not have to worry about the stent graft 1 interfering with the flow or flux in the stent graft 1 or the blood vessel.

[0095] Furthermore, this allows a stent graft or multiple stent grafts to be used in the system and assembled at the target implantation site, i.e., not pre-manufactured for a specific patient. This is an advantage over known systems, which have so far included pre-built patient-specific endoprostheses. Typically, an imaging modality is used to scan the vascular system, including the target site, such as a weakened aorta, at an early stage. The endoprosthesis is then manufactured based on the imaging data and delivered to the surgeon for implantation. The manufacture of such patient-specific endoprostheses typically takes days to weeks, which is undesirable. During this waiting time, the anatomical structure of the blood vessels may change. The result may be that the manufactured endoprosthesis no longer fits the patient. Moreover, this waiting time is undesirable because the patient often urgently needs an endoprosthesis, for example, to avoid rupture of an aortic aneurysm. However, if necessary, specific embodiments of the stent graft disclosed herein can also be customized to the patient. However, standard devices of different sizes that can be easily used for implantation are preferred because this avoids waiting times due to manufacturing.

[0096] The modular stent graft system 100 may further include a guide element 10, such as a suture or thread. Along the guide element 10, a delivery catheter may be threaded proximally to the distal end of the guide element 10. The guide element 10 is distally fixed to the stent graft, for example, the suture may be fixed by a knot, staple, weld, adhesive or the like. Thus, the guide element 10 is fixed to the stent graft. Preferably, the attachment point where the guide element 10 is distally fixed to the stent graft is located internally, for example at the location of the lateral side branches of the stent graft. The guide element 10 is preferably preloaded in the delivery catheter of the stent graft. The guide element acts as a manipulator for the guide fitting 9 of the catheter in use. The guide element 10 is preferably bendable and / or flexible.

[0097] In an embodiment, the guiding element 10 is therefore permanently or releasably attached distally to the interior of a branch, such as a lateral side branch, at a connection point, preferably at the distal orifice of the branch 3 .

[0098] The guide element 10 is arranged proximally inside, passes through and along another portion or another branch 3 of the body 2, and extends proximally through the proximal opening of the body 2 (see, for example Figure 3 or 8). Thus, in use, the guiding element is used to guide a catheter over the guiding element 10 through the body 3 towards the distal orifice of the lateral side branch 3.

[0099] See also Figure 3 or 8 and the corresponding text below for a more detailed description of embodiments of the guide element 10 and its corresponding use and application in a modular stent graft system.

[0100] Alternatively or additionally, introducer element 10 may be distally attached to the patient's aorta at a desired target location.

[0101] Alternatively or additionally, the attachment of the introducer element at its distal end may be releasable, preferably releasable externally from the body upon activation, to allow removal of the introducer element as required during the implantation process. A knot may be releasable, and a thermal detachment device may be provided for controlled detachment of the introducer element at the point of attachment. Alternatively or additionally, the introducer element may be configured to be cut away after use. A suitable tool may be used for severing, such as a sheath with an internal fixed cutter that slides over and along the introducer element towards the point of attachment, wherein the cutter is activated and the introducer element is severed. The introducer element may then be reliably retracted outside the body, such as within a sheath with a cutter, or simply pulled proximally out of the vasculature through the puncture site / introducer.

[0102] However, the guide element 10 is preferably left in place at the end of the implantation procedure. The guide element 10 can be left in place after use (to guide the delivery and deployment of, for example, an extended stent implant). It can be made of a biodegradable material or a bioabsorbable material. In any case, the guide element 10 is made of a biocompatible material, including absorbable agents such as polyglycolic acid, polylactic acid, monocrystalline and polydioxanone, and non-absorbable nylon, polyester, PVDF and polypropylene, PTFE or Dacron. The guide element 10 can be made of a metallic material, such as nitinol or stainless steel, or a suitable metal alloy, which may be beneficial for durability during implantation. This is advantageous when the guide element is left in place after the implantation process of the modular covered stent system is completed. Since the guide element does not need to be disassembled or cut at or near the connection point, the process can be shortened. It can be cut only at the proximal end, or not cut at all.

[0103] Along the guide element 10, the delivery catheter 30 can be moved toward the distal end of the guide element 10, for example, by a guide fitting 9 on the catheter, as described below ( Figure 8). Another element, device or unit can then be delivered through the delivery catheter to the desired location at the distal end of the guide element 10. This can help reduce or omit X-ray guidance, detection, navigation attempts, etc.

[0104] In this way, the catheter can be moved along the guide element to or towards its distal end without fluoroscopic guidance. In this way, reliability and delivery speed are improved while radiation exposure can be reduced.

[0105] Such a delivery catheter 30 is provided for delivering the extended stent graft 600. The catheter 30 has a delivery lumen with a distal opening for delivering and deploying the extended stent graft 600 at a target site of the lateral side branch 3 of the stent graft 1.

[0106] The catheter 30 also has a guide fitting 9 for receiving a guide element 10 distally attached to a connection point at the branch 3. Thus, the catheter 30 is configured to slide over the guide fitting 9 along the guide element 10 to the orifice of the branch for deploying an element, such as an extended stent graft 600, through the delivery lumen of the catheter.

[0107] The guide fitting 9 for receiving the guide element has a distal end that is positioned at a distance from the distal orifice of the delivery lumen. In this way, when the distal end of the guide fitting 9 engages the connection point, the delivery lumen extends beyond the connection point.

[0108] For example, Figure 8 As shown, the distal end of the delivery catheter 30 can be pre-bent to facilitate access to the side vessels from the branch orifice. In this way, the operation time is reduced, the fluoroscopic examination burden on the patient and clinical staff is reduced, and the implantation can be more secure and reliable.

[0109] A modular stent graft system is provided, comprising a stent graft 1 and a delivery catheter 30 having a guide element 10 that is positionable or deployable via a guide fitting 9. In this manner, a unit such as an extended stent graft 600 can advantageously be delivered to a target site at a branch 3 via the delivery catheter 30.

[0110] In addition, the distal end of the guide element 10 is arranged at a marker 21, for example. Alternatively or additionally, the guide element 10 can itself be provided with a marker. A marker refers to a reference mark that is visualized by a suitable imaging device and is used by the surgeon performing the implantation procedure. The marker 21 is preferably arranged at the leg 4 of the coated stent for guiding another coated stent toward and / or through the distal orifice of such a leg 4 (for example, as described below) to a side branch vessel of the main vessel. The marker can be elongated and extend along at least a portion of the length of the guide element 10, for example as a radiopaque multi-strand thread / suture / line, and / or one or more marking bands.

[0111] To facilitate positioning of the other stent graft relative to the legs of the first, markers 21 are placed on, for example, the legs of the first stent graft. Similarly, markers 21 can be placed on side branches 3 of stent graft 1, making it easier to align stent graft 1 relative to the branch vessel. X-rays can then be used for position confirmation, which reduces the dose compared to full X-ray-assisted navigation using contrast agents.

[0112] The illustrated modular stent-graft system 100 includes a first main vessel stent-graft 200, 420 having a first upstream inlet that branches into at least two downstream outlet branches.

[0113] In addition, it includes a covered stent type 300, 310, 320 having a main body and at least one lateral side branch connected to the main body. The lateral side branch is preferably flexible and expandable. The covered stent can be interconnected with one of the downstream outlet branches and can be laterally connected to the side flow vessel of the main vessel through its lateral side branch. Therefore, at least two covered stents 300, 310, 320 can be interconnected sequentially to one of the downstream outlets of the main vessel covered stent 200. In this way, the blood conduit is arranged in parallel by at least two covered stents, and is assembled one at a time by the operator. The parallel blood conduits can each be provided with one or more side branches. Alternatively or in addition, a blood conduit in the form of a covered stent can be provided, which does not have a lateral side branch, which then provides a straight blood flow path parallel to the covered stent, for example, with one or more lateral side branches.

[0114] The parallel arrangement of stent grafts offers several advantages. Repositioning one of multiple parallel stent grafts is easier than repositioning a single stent graft covering an entire vessel with multiple side branches. It is easier to sequentially implant multiple parallel stent grafts with one or a few branches than a single large stent graft with many branches. Neither the proximal nor the distal ends of stent grafts 300, 310, 320 are inserted into the vessel tissue wall. Consequently, mechanical stability and adhesion are better controlled relative to the anatomy, particularly if it is weakened, such as in an aneurysm. This is advantageous because parallel stent grafts 300, 310, 320 can better adapt to vessel movement. With reduced contact, there is less risk of damaging the tissue vessels, which positively impacts the long-term implant stability of the modular system. Because the rotational and longitudinal positions are adjustable during surgery, surgeons can easily adapt to the anatomy during implantation. This eliminates the need for aortic clamping, avoids cardiac arrest, reduces patient side effects, and allows for faster procedures with lower patient risk. Because the diameter of each parallel stent graft 300, 301, 320 is smaller than the diameter of the vessel in which they are implanted, the distance of the side branches to the main lumen of the stent graft can be provided. This in turn allows the stent graft to navigate space relative to the orifice of the side branch vessel. Therefore, the positioning of the side branches of the stent graft relative to the orifice is not as important as in known systems. When a side vessel is implanted from the main vessel, the distance between the side branches of the stent graft and the orifice of the side vessel orifice can be compensated for, for example, by bending the side branches and / or by bending and extending the stent graft 600 without kinking one or both of the latter mentioned.

[0115] The modular stent graft system also includes a second type of main vessel stent graft 400, 430, wherein at least two upstream inlet branches are collected in a downstream outlet. The inlet branch can be interconnected with the distal outlet of one of the two stent grafts, for example Figure 1 and 2 Stent graft types 300, 310, 320 are shown.

[0116] From Figure 1-2 Starting at the top of the illustrated system 100, a first stent graft 200 having three legs is shown. This module is first implanted over a guidewire 20.

[0117] It should be noted that the stent graft modules are delivered in a specific sequence, starting with the three-legged stent graft 200 in the ascending aortic arch. Additional stent graft modules are then delivered to the target site until the entire system is implanted. This is accomplished in a very efficient and advantageous manner.

[0118] For example, when the three-legged stent graft 200 is deployed and implanted first in the ascending aortic arch in all modules, this can be done over the guidewire 20, such as in a femoral access approach. The other components can then be connected to the legs 201, 202, and / or 203.

[0119] For example, the stent graft 600 may be delivered to the first leg 201 by a delivery catheter that slides along the guide element 10 to or toward the connection point 11, for example, as shown in FIG. Figure 8 The stent graft 600 can then extend blood flow into the first cervical vessel, as Figure 2 As shown, stent graft 600 is a stent graft without an orifice for a side vessel. Extended stent graft 600 is configured to fit proximally at the orifice of first leg 201 and connect to the distal portion in a fluid-tight manner. The connection can be made in an appropriate manner and overlapping manner using suitable methods known in the art for connecting stent grafts to each other to provide a communication path for fluid passing through the target vessel.

[0120] Thus, delivery can be provided in two steps. First, the side branch 3 is expanded. Then, the side branch stent graft 600 is deployed through the expanded side branch 3. The side branch stent graft 600 is then secured. The entire prosthesis is flexible until the side branch is finally cannulated, i.e., the side branch stent graft 60 is expanded and thus "locked" in place.

[0121] During delivery of stent graft 600, the two remaining legs 202, 203 are not blocked and blood flow through the aortic arch is ensured during the implantation procedure, which is an important advantage.

[0122] Introducing element 10 also extends inside third leg 203. This means that stent graft 300 with side branches is deliverable on the same introducing element 10 and delivery catheter to which stent graft 600 is delivered.

[0123] The initial guidewire 20 used to deliver the three-legged stent graft 200 to its target site is used to deliver and connect the stent graft 300 to the second leg 202 .

[0124] The position of the three-legged stent graft 200 is preferably marked with fiducial markers 21, which can be seen during imaging by, for example, MRI, CT or X-ray. Thus, a shortened radiation time and dose can be provided.

[0125] When the guide element 10 is extended from the first leg 201, all three legs can be positioned and interconnected at the orifices of the three legs of the modular stent graft, so that the surgeon does not need to perform additional navigation, searching or probing, thus reducing radiation time and dose.

[0126] Guide elements 10 are used to guide a subsequent stent graft along them so that the subsequent stent graft can be connected to the previously implanted covered stent.

[0127] Additionally, or alternatively, navigation element 20 (eg, a guidewire) is used instead of or in conjunction with one or more guide elements 10 in system 100 to guide all or substantially all of the stent grafts of system 100 to their target sites.

[0128] Next, the system 100 includes two stent grafts 300 each having a side branch in the proximal direction, downstream of the aorta, which are positioned in the aortic arch 502 when implanted. The two stent grafts 300 are guided by a guide element 10 and a guide wire 20, respectively. These modular stent grafts 300 will be described in more detail below, for example, with reference to Figure 5a 、 6 , 7, 8, 10, 11, 14, 15, 17, 19 and 20. The distal end of each stent graft 300 is connected to the legs 202, 203 of the three-leg stent graft 200. The side branch outlet is preferably expandable and is in fluid communication with the neck vessels when expanded. Another stent graft 600 is also connected to its proximal end, extending into the remaining two neck vessels (see Figure 2 Delivery of these additional stent grafts 600 may be guided by fiducial markers over a guidewire and contrast agent feedback (not shown), and / or the guide element 10 may be connected to the branch (see Figure 8 ) to facilitate delivery of another coated stent 600 to the corresponding neck blood vessel through the orifice of the side branch of the coated stent 300.

[0129] Each stent graft 300 is delivered and extended sequentially. During delivery of the first of the two units 300, the other leg of the tripod 200 remains unimpeded, ensuring blood flow through the aorta. Furthermore, while the extended portion is delivered into the neck vessels, blood flow downstream in the aorta and in the neck vessels remains uninterrupted during the procedure.

[0130] When two stent grafts 300 are connected to each other and delivered, parallel flow through the aorta provides the required sufficient blood flow due to the high ratio of lumen diameter to (healthy) aorta diameter.

[0131] Due to the parallel arrangement of multiple stent grafts 300, the ostium of the side branch can be located at a certain distance from the ostium of the target vessel, and the exact position relative to each other (ostium / ostium) is not as important as with known stent grafts. Flexibility without the risk of kinking is provided with or without extending stent graft 600.

[0132] Then, downstream of the aorta, there is a stent graft 400 at the proximal end, which has two distal legs that are incorporated into a single lumen with a proximal orifice. The first leg of the stent graft 400 is transported along the guide element 10 for interconnection with the proximal orifice of the stent graft 300, which in turn is distally interconnected with the distal and upstream third leg 203 of the stent graft 300 previously set in the aorta and previously implanted. The other distal leg of the stent graft 400 is transported along the guide wire 20. It is distally interconnected with the proximal orifice of another stent graft 300, which was previously distally interconnected with the distal and upstream second leg 202 of the aorta. Thus, the parallel stent grafts 300 are collected together in a single lumen.

[0133] Another stent graft 410 without side branches or legs is distally interconnected to the proximal orifice of stent graft 400. Additional stent graft 410 is delivered over a guide element 10 and a guidewire 20, both of which extend within the interior of stent graft 410 through one of the distal legs of stent graft 400. Where stent graft 300 includes one or more guide elements 10 that were previously used to insert an extension stent graft into a neck vessel, these one or more guide elements 10 will also pass through the lumen of stent graft 410.

[0134] The overlap of stent grafts 400, 410, 420 may be adjusted during implantation to accommodate the patient's aortic anatomy.

[0135] Next, a dual-leg stent graft 420 is implanted / deployed downstream of the aorta, branching blood flow into two proximal legs from a distal common lumen and orifice, which can be connected to the proximal orifice of the previously implanted distal stent graft 410. A guide element 10 extends within the interior of the first leg. A guidewire 20 extends inside the other leg. The dual-leg stent is delivered via a delivery catheter, which can be the same delivery catheter used to deliver the previously distally delivered module.

[0136] Finally, at the bottom of the figure, two stent grafts 310, 320 are shown, each with two side branches 3. Figure 5a and 5b The two stent grafts 310, 320 are described in more detail.

[0137] The first stent graft 310 is delivered via the guide element 10 (the catheter slides over the guide element 8 to the legs of the stent graft 420). Additional delivery catheters may also be used for this purpose, such as those described in Figure 8As described, the difference is that the guide element extends all the way through the first stent graft 310. One or more additional guide elements 10 can be attached to one or more side branches of the first stent graft 310 for delivering the extended stent graft 600 extending into the side vessel when implanted. Figure 2 .

[0138] Second stent graft 320 is delivered over guidewire 20. A delivery catheter is again used for this purpose, as described above. Another guide element may be connected to one or more side branches of second stent graft 320 for delivering extended stent graft 600 extending into the side vessels, when implanted. Figure 2 .

[0139] The proximal ends of the two stent grafts 310 and 320 are interconnected to the two distal legs of the double-leg stent graft 430, thereby providing a fluid path. Guidewire 20 and introducing element 10 are passed through stent graft 430 accordingly.

[0140] As described above, the system 100 is thus Figure 2 Positioning shown.

[0141] In one embodiment, a method of interconnecting a plurality of stent grafts is provided, which can be performed in vivo and / or in vitro.

[0142] In one embodiment, before and / or during assembly, the stent grafts of system 100 are sorted and placed in the correct order for assembly. In one embodiment, and if assembled during implantation, multiple catheters 30 can be used as described and required. The components of the system can be provided as kits with appropriate numbers to facilitate implantation by the surgeon. Before the implantation procedure, the kit components and compositions can be computer applications. Software can be provided to support the surgeon and / or clinical staff in performing the process. The surgeon can plan the procedure in advance. The order of the components can then be suggested by the software during the implantation process, preferably with the numbers and program steps in the kit components. Quality assurance can be provided by inputting software feedback of the components used and the steps performed. X-ray images and timestamps and other medical device measurements or input data can also be saved. Therefore, the process can be effectively executed and recorded at the same time.

[0143] Although not in Figure 1, but as explained, additional navigation elements 20 and / or guide elements 10 may be provided for navigating and aligning the side branches 3 with the branch vessels. To make it easier to see which navigation element 20 or guide element 10 reaches a particular stent graft, leg, or side branch, each navigation element and guide element is labeled in one embodiment.

[0144] The modular stent grafts as described in system 100 will now be described in greater detail. As described above, the modular stent grafts can be arranged differently in systems other than the one shown in the figures. Depending on the target site, treatment needs, and / or patient history, some modular stent grafts can be provided separately to be connected to a known unit, or provided separately.

[0145] Figure 3 A stent graft 200 is shown having three legs 201, 202, 203, and a navigation element 20 and guide element 10 entering from the suture line to facilitate navigation to all three legs. Figure 3 and Figure 8 An embodiment of how one or more (one is shown) introducing elements 10 (eg, sutures) may be passed through a stent graft during implantation of the stent graft system 100 is shown.

[0146] Three legs 201, 202, 203 are provided for connecting to three aortic arch side vessels: one to the carotid artery and two through channels with side branch vessel connections (when assembled). The three legs 201, 202, 203 can have different lumen diameters and lengths. The overlapping stent grafts 300, 600 can be selected during the implantation procedure based on the patient's anatomy.

[0147] A pre-attached guide element 10 extending into one leg (203) and the other leg (201) allows direct cannulation of the side vessels. All side branches enter directly into the prosthesis, and there is no difficulty in positioning the side branches with the open leg of such an implant. Due to the length of the delivery catheter, the operator generally has no sense of aiming at the side vessels, making navigation difficult to achieve so far. In addition, pulsatile blood flow during surgery and other procedural difficulties of cannulation of side branches are less associated with known covered stents. By avoiding 3D to 2D visualization difficulties, less X-ray dose is required, the time of the procedure is significantly reduced, and the patient risk is reduced.

[0148] The guide element 10 is used to guide the additional stent graft to a connection position so that the stent grafts can be connected together into the stent graft system 100. Figure 8 More information is available on the GitHub repository.

[0149] In such Figure 3In the embodiment shown, navigation element 20, here a guidewire, is positioned within and through a three-legged stent graft 200 via legs 202. During implantation of system 100, navigation element 20 is inserted far enough into the vessel that any stent graft can follow navigation element 20 to the desired target location.

[0150] In one embodiment, the stent grafts are guided to their respective positions by sliding them along a navigation element 20 within a delivery catheter. After the distal catheter tip is released, the stent graft is expanded to the appropriate position and implanted at the target site. A restraining member 8 may be provided.

[0151] Figure 3 Also shown are one or more guide elements 10, such as sutures, that may be attached to stent graft 200. In this figure, suture 10 is attached within second leg 4 and extends through third leg 4. As described above, guide element 10 has a purpose similar to that of navigation element 20, namely, to guide a delivery catheter for delivering the stent graft so that they can be connected to form a system of stent graft 100.

[0152] The operator can easily position both legs and guide a further stent graft to either of the two legs. The operator can navigate the first further stent graft 600 to leg 201, to which the guiding element 10 is attached, by means of the guiding element 10. When the first further stent graft 600 is correctly positioned and connected to the three-legged stent graft 200, the operator can guide the second further stent graft to leg 203, by means of the same guiding element 10, with the sutures exiting proximally from the three-legged stent graft 200. The navigation element 20 ensures that the operator can also position the third leg, as Figure 3 as shown, and deliver the unit in this manner as required.

[0153] Generally, one advantage of using a guide element 10 is that the suture or wire is flexible and can be bent and manipulated as needed without breaking, such as in place of or in addition to the navigation element 20, such as a guidewire. The navigation element 20 is typically stiffer when used as a guidewire, allowing it to exert distal force from the operator, such as pushing along the blood vessel from the puncture site. The catheter is then passed over and along the guidewire. The guidewire can then be removed from the catheter to allow the catheter to be delivered to the unit.

[0154] The flexible nature of the guide element 10 allows, for example, the stent graft to be placed and / or navigated around corners within the stent graft and / or within the vessel and / or side branch 3. In some embodiments, the guide element 10 runs outside the lumen of the delivery catheter through which the unit is delivered. Alternatively or additionally, the guide element can pass through the same lumen as that used to deliver the unit.

[0155] Preferably, the distal end of the catheter 30 has a design such that the distal orifice extends beyond the attachment point of the distal end of the guide element 10. This can be provided, for example, by a longitudinal recess (not shown) in the catheter lumen wall, into which the guide element 10 fits. The distal end of the catheter 30 has its delivery orifice which can then protrude beyond the attachment point 11, wherein the proximal end of the groove will be positioned when the delivery catheter 30 is pushed forward distally. The groove can be a longitudinal cut. The groove can have at least a V-shaped portion to allow the guide element 10 to be more easily captured or introduced into the groove. The catheter 30 can be swung and / or rotated slightly to allow the guide element 10 to enter the groove.

[0156] As previously explained with respect to guide element 10, location 11 is preferably marked, where the distal end of guide element 10 is permanently or releasably connected to the stent graft so that it can be easily seen during a scan, such as an MRI, CT, or X-ray. Connection point 11 serves as a stop for guide element 10 to prevent the surgeon from experiencing physical resistance and further distal advancement of catheter 30 during the delivery process.

[0157] Figure 4 A stent graft 1 with side branches is shown, and is an embodiment of a stent graft 300 with side branches 3 of the exemplary system 100 ( Figure 1 and Figure 2 ).

[0158] The stent graft 1 has a main body 2, which is the stent graft, and lateral side branches 3 connected to the main body 2. The side branches 3 protrude from the main body 2 and are flexible and expandable. One advantage of the flexibility and expandability of the side branches 3 is that the side branches 3 can be easily moved in at least one dimension independent of the movement of the main body 2, making it easier to find the branch vessels and to align them during implantation for access.

[0159] Figure 14A -D are perspective, top, side and front views of an embodiment of a modular stent graft 300 having a single lateral side branch. Alternatively or additionally, the stent graft 1 may have more than one side branch 3, such as Figure 5a and 5b The stent grafts 310, 320 are shown in FIG. The connecting portion 3a provides a degree of mobility to the branches 3. This improves long-term stability and can help prevent clot formation.

[0160] Alternatively or additionally, the stent graft 1 has a plurality of legs, and at least one of the legs includes a side branch 3. Thus, in one embodiment (not shown), the stent graft 1 has a plurality of legs, and each leg includes a side branch 3. In one embodiment, the side branches 3 are deflated, contracted, or closed and may appear to be Figure 3 3. The constriction may include radial and / or longitudinal constriction, allowing for a reduced cross-section for delivery.

[0161] In one embodiment, the side branches 3 may be dome-shaped or substantially hemispherical in shape when closed. Figure 7 This makes the stent graft 1 safer during manipulation and / or navigation to the branch vessels than currently known devices because the side branches 3 do not have any sharp edges that could tear, rip or penetrate the branch vessels as with currently known devices. However, the branch vessels 3 are preferably only longitudinally expandable from the smallest body 2 and may be cylindrical, e.g., as Figure 1 、 2 , 4, 5a, 5b, 6, 8, 10, 11, 14, 15B, C, 20.

[0162] The side branch 3 is configured so that its shape can be changed to fit the branch vessel and to allow further extension from the main body of the stent graft into a branch vessel with, for example, another stent graft or stent grafts. This expanded state particularly includes a longitudinally expanded shape of the branch 3, e.g. Figure 4 、 5a , 5b, 9 and 10, 11, 14, 15, 17, 19, 20 are schematically shown. Figure 6 As shown, the transition from the longitudinally contracted state to the expanded state can be accomplished by unfolding, stretching, spring effect, or other similar operation of the branches 3.

[0163] Figure 5a -b shows two embodiments of stent grafts with more than one side branch in the expanded state. Figure 5a The stent graft 310 shown in FIG. 3 has two lateral side branches 3 protruding from the same side. Figure 5b The stent graft 320 in FIG. 3 also has two side branches 3 , but they protrude from opposite sides.

[0164] For anatomical reasons, side branches of other structures are provided as needed at the target site. In one embodiment, the side branches 3 are distributed at any desired location on the main body 2. In one embodiment, the location is based on the layout of the blood vessel in which the coated stent 1 is to be placed and its side vessels. Although not shown, the coated stent 1 can also have more than two side branches 3. The side branches can have an angle inclined toward the side branch, that is, an angle other than 90 degrees to the longitudinal axis of the main body, for example between about 30 or 45 degrees and less than 90 degrees.

[0165] As will be further explained below, the lateral side branches 3 can expand from a first protruding length or size to a second protruding length or size. This expansion can be independent of the expansion of the main body 2, and vice versa, the expansion of the main body 2 can be independent of the expansion of the side branches 3. This means that when the coated stent 1 with side branches 3 is contracted or closed, in one embodiment, the side branches 3 can expand or expand without the main body 2 of the coated stent 1 expanding or expanding. In another embodiment, the main body 2 of the coated stent 1 can expand or expand without the side branches 3 expanding or expanding.

[0166] Because the side branch portion 3 of the stent graft 1 is flexible when extended in some embodiments, alignment with the side branch vessel may not be as critical as with conventional stent grafts. Due to this flexibility, navigation toward and / or into the side branch vessel is facilitated during implantation and by the flexible nature of the side branch 3, e.g. Figure 7 and 11 Some misalignment of the orifice of the side branch 3 at the body of the stent graft 1 relative to the orifice of the branch vessel can be corrected by the path of the flexible, laterally extending side branch 3. The blood communication path of the side branch 3 can be extended by matingly engaging another stent graft or stent graft that interconnects at the distal end of the side branch 3 and extends into the side branch vessel.

[0167] Figure 6 A bottom illustration of an embodiment of a side branch is shown that is self-expandable from a collapsed shape to an expanded shape. Figure 6 One embodiment of a stent graft 1 is shown. The stent grafts discussed herein are self-expanding in one embodiment or, in another embodiment, expandable by another device, such as an inflatable balloon, a pusher unit, or the like. Figure 6 Three different side branches 3 are shown at different expanded lengths.

[0168] The stent graft 1 has a main body 2, which is a stent graft, and side branches 3 connected to the main body 2. The side branches 3 protrude from the main body 2 and are expandable and optionally flexible, or are inclined at a certain angle relative to the longitudinal axis of the main body and / or are arranged at such an angle when protruding from the main body 2. One advantage of the flexibility and expandability of the side branches 3 is that the side branches 3 can be easily moved in at least one dimension regardless of the movement of the main body 2, thereby making it possible to find branch vessels and more easily align to access the side branches 3 during implantation.

[0169] In one embodiment, the stent graft 1 may have more than one side branch 3. In one embodiment, the stent graft 1 has multiple legs, and at least one of the legs includes a side branch 3. Thus, in one embodiment, the stent graft 1 has multiple legs and each leg includes a side branch 3. In one embodiment, the side branches 3 are deflated, contracted, or closed and in one embodiment may look like Figure 7 3. Contraction may include radial and / or longitudinal contraction states.

[0170] In one embodiment, the side branches 3 are dome-shaped or substantially hemispherical in shape when closed. Figure 7 The above allows the stent graft 1 to be safer during manipulation and / or navigation to the branch vessel than currently known devices because the side branch 3 does not have any sharp edges that can tear, lacerate or penetrate the branch vessel as with currently known devices.

[0171] The side branch 3 is configured so that its shape can be changed to fit the branch vessel and to allow further extension from the main body of the stent graft into a branch vessel with, for example, another stent graft or stent grafts. This expanded state particularly includes a longitudinally expanded shape of the branch 3, e.g. Figure 4 、 5a , 5b, 6, 8, 9 and 10, 11, 14, 15, 17, 19, 20. Figure 10 As shown, the longitudinal contraction state to the expanded state can be achieved by expansion, stretching, spring effect or other similar operations of the branch 3.

[0172] In one embodiment, expansion can be achieved by the spring effect of the stent graft 1 and / or the side branches 3, such as Figure 10 In one embodiment, the expansion can achieve an equilibrium position within the blood vessel.

[0173] The lateral side branches 3 are preferably formed integrally with the main body. In some embodiments, the side branches are provided with springs that elastically expand the side branches 3 in the longitudinal direction without radial expansion. The springs may be coil springs, such as Figure 15B, C. A spring-like structure may preferably be provided to assist in the expansion of the side branches from the prosthesis body, for example perpendicular to the prosthesis body, or alternatively, at an angle other than 90 degrees to the longitudinal axis of the body.

[0174] The stent graft 1 or side branch 3 may comprise a wire suitably arranged as the stent / support frame portion of the stent graft. In one embodiment, the wire may have a U-shape in the longitudinal direction of the stent graft. In another embodiment, the wire may be helically wound, such as Figure 10 In other embodiments, they may be arranged in a suitable pattern, such as a zigzag pattern, etc.

[0175] In one embodiment, the wire can be interwoven with the covering. The wire can be formed into a mesh, such as a knitted pattern or a braid. The wire can also be laser cut to form the elastic pattern of the stent portion.

[0176] Alternatively or additionally, the wire or other expandable component of the device can be made of a shape memory material. The shape memory effect of such a wire can provide a change in shape, such as contraction to an expanded shape, by a known trigger such as temperature. Suitable materials include Nitinol, CrMo alloys, shape memory polymers, etc. The shape of the components of the embodiments made of such materials can be provided by heat treatment. The components of the embodiments of these materials can rely solely on elastic or superelastic properties (e.g., Nitinol) to change the shape from a contracted or compressed structure to an expanded, released structure.

[0177] When the stent graft 1 is made into an elastic structure, it will elastically extend from the main body of the stent graft when leaving the delivery catheter, for example, as shown below. Figure 10 As stated.

[0178] Figure 7 This figure illustrates how a stent graft with a closed or retracted side branch can be used to locate a branch vessel. The volcano-shaped side branch 3 described above is merely one example. A guidewire 20 is fed through the side branch, and a catheter is passed over the guidewire. A delivery channel is then provided through the side branch.

[0179] The guidewire 20 may be previously guided through the guide element 10 through the catheter 30 to the target site, for example at the side branch 3. The catheter 30 may be retracted and a different catheter may be passed over the guidewire and thereby placed in place by the guiding catheter 30.

[0180] Figure 8 A stent graft 300 having a side branch 3 is shown, along with a catheter having a guide fitting 9 for guiding the catheter 30 to facilitate navigation of the side branch.

[0181] In one embodiment, Figure 8As shown, the catheter 30 includes a guide fitting 9 that is configured to be advanced over the guide element 10 and / or navigation element 20 when guided to the side branch 3 by the guide / navigation element.

[0182] In this embodiment, the guide fitting 9 is a section of tubing connected to the catheter 30. Alternatively, the guide fitting 9 is formed integrally with the catheter, for example by suitable extrusion of a tubular member of the catheter. The guide fitting can be formed as a lumen, and / or integral with the catheter wall. The guide fitting 9 can be integral with the catheter, or alternatively, a separate element suitably attached to the guide element 10, for example by bonding, welding or other mechanical attachment means. The catheter 30 can be a multi-lumen catheter having at least one lumen. Preferably, it is a double-lumen catheter. Figure 16 An embodiment is schematically illustrated in FIG. A first lumen 30a is provided for transporting a unit deployable through the distal orifice of the first lumen. A second lumen, serving as a guide fitting 9, is provided for passage over the proximal end of the guide element 10 toward its distal end and its attachment point, as described above. The second lumen preferably has an orifice proximal to the distal orifice of the first catheter lumen. In this manner, the distal orifice of the first lumen can be positioned distally beyond the attachment point of the guide element 10.

[0183] Alternatively or additionally, the guide fitting 9 comprises a ring, an eyelet, a snarl or a loop for passing the guide element 10. The inner diameter of the guide fitting 9 is matched to receive the outer diameter of the guide element 10, with a certain tolerance to avoid excessive friction between the two elements, thereby sliding along each other.

[0184] The guide fitting 9 is a unit for cooperatively receiving a guide element 10 therethrough for slidably moving along the guide fitting 9 to and from the distal end of the guide fitting, at which the guide fitting is preferably attached to the stent graft. The guide element 10 is configured to pass through the guide fitting 9 so as to be slidably movable along the guide fitting 9. Suitably, a guide element 10, such as a multifilament thread such as a suture, thread, filament or thread, which is, for example, braided together, is passed outside the patient's body at the proximal end of the guide fitting.

[0185] Alternatively or additionally, guide fitting 9 may be a lumen of a double (or multi-) lumen catheter or any other suitable element configured to allow sliding over guide element 10 and preferably without damaging the vessel or lumen in which it is used.

[0186] Guide fitting 9 preferably has a distal end or opening that is disposed at a suitable length, i.e., proximal, of the distal end of catheter 30. In this manner, when in the distal position of guide element 10 and / or navigation element 20, the distal end or opening of catheter 30 can be advanced further than guide fitting 9, e.g., at a fixation point, such as a knot in a suture, where guide element 10 and / or navigation element 20 is distally fixed to the stent graft, e.g., at an orifice or opening as described and illustrated herein.

[0187] Therefore, the guide fitting 9 has a distal end or opening which is preferably arranged proximal (at a distance) to the distal end or distal opening of the catheter 30 .

[0188] In this manner, it is ensured that the distal end of catheter 30 can be positioned distal to connection point 11, for example, by delivery through the lumen of the catheter into a side branch, such as a stent graft into the side vessel and assembly and interconnection with the main vessel stent graft, where the fixation point is located. In this manner, the side vessel stent graft can be delivered to the correct location of the main vessel stent graft, i.e., the branch opening, with minimal X-ray dose, because the operator does not need 3D visualization.

[0189] In one embodiment, also with Figure 8 Relatedly, a guide element 10 is attached to the side branch 3. This allows any other implanted element, preferably a stent graft, to be easily delivered through the catheter 30 with the guide fitting 9, e.g. connected to the side branch 3 or output from the side branch 3 with minimal effort and improved reliability and patient safety.

[0190] like Figure 8 As shown, in some embodiments, guide fitting 9 is placed at a distance from the distal end of catheter 30. One advantage of having guide fitting 9 at a distance from the distal end of catheter 30 is that catheter 30 can then be reached at a location further away than attachment location 11 of guide element 10. For example, if guide element 10 is attached at side branch 3, the catheter can be extended further outward through side branch 3. This allows for easy access to position and connect, for example, extension stent graft 600 at side branch 3.

[0191] The distal portion of the catheter 30, preferably distal to the distal end of the guide fitting 9, may additionally or alternatively be curved, see Figure 8 This allows the orifice of the delivery catheter 30 at its distal end to be at a desired exit angle, such as substantially perpendicular relative to the longitudinal axis of the body 300 .

[0192] However, in some embodiments, the distal portion or tip of the guide fitting 9 may reach all the way to the distal end of the catheter 30. In any case, an improved, advantageous, minimally invasive delivery of the element through the side branch is ensured.

[0193] In one embodiment, Figure 9a As shown in a, b, c, 10 and 11, 15 and 17, the stent graft 1 is provided with a restraining member 8, which can prevent the stent graft 1 from expanding before the restraining member is released to controllably expand the stent graft 1.

[0194] In one embodiment, the restraining member 8 is made of PTFE or The constraining member 8 can be configured as a flat plate, fabric, or nonwoven material that is releasably arranged around the stent graft for delivery. Alternatively, any other suitable biocompatible material can be selected for the constraining member, which can be inserted into the body and easily manipulated, and protects any blood vessels or lumens from the stent graft 1 during deployment.

[0195] Figure 9a -c shows an embodiment of a constraining member. For example, a self-expandable stent graft 200 may be provided with such a constraining member 8. By removing the constraining member, the stent graft can be controllably transformed from a contracted state to an expanded shape.

[0196] In one embodiment, removal of the constraining member 8 is accomplished by simply pulling on the wire, which then releases the seam that holds together the sheet of constraining member 8 arranged around the stent graft. Pulling the release wire deploys the constraining member along the seam, depending on how far the wire is pulled. The constraining member is thereby partially or fully deployed, e.g. Figure 9a In one embodiment, more than one thread / seam is used to select the location where the constraining member 8 is removed to constrain the stent graft and / or side branches 3 .

[0197] Alternatively or additionally, the constraining member 8 is configured to be partially removable so that the stent graft 1 and / or the side branches 3 can be individually selected for expansion. Figure 9a , where the stent graft is completely constrained by the constraining member 8. Figure 9b In FIG, constraining member 8 is shown as partially opened, thereby allowing the stent graft to partially expand. If necessary, the partially expanded stent can still be repositioned.

[0198] Figure 9c The illustrated embodiment shows more than one restraining member 8 for restraining a portion of the stent graft. Thus, each restraining member is arranged to restrain a different portion of the stent graft, in this embodiment a three-legged stent graft 200. In this way, the three legs are easily expanded individually, one at a time, or simultaneously. In the same manner, a stent graft 1 having side branches 3 can be partially or fully expanded by releasing it from, for example, a restraining member around the main body 2 and another restraining member 8 around the side branches 3. Figure 18 An embodiment is described.

[0199] The contraction unit ( Figure 9a ) is introduced into the target site, and the delivery catheter has a guide fitting 9 as described above that can slide along the guide element 10. The assembly shown in Figure 9 (and similar other assemblies) can include one or more guide fittings 10 themselves, such as Figure 3 The latter guide element 10 is guided outward from the interior of the constraining member 8 from the stent graft (here 200) and further proximally toward the proximal end of the catheter outside the patient. Thus, as described herein, other elements can be advantageously delivered through the stent graft when implanted.

[0200] In one embodiment, more than one wire is used to select the location where constraining member 8 is removed from stent graft 1 and / or side branch 3 .

[0201] Alternatively or additionally, when attached to the stent graft 200, the suture line of the constraining member is one of the guide elements 10. The guide element 10 is then attached distally to the stent graft, e.g. Figure 3 , extending proximally from the orifice of the stent graft 200. It is then folded back to extend inside the protective unit 8. Turning back proximally again, it provides a releasable seam. When pulled out and removed from the seam, i.e. the restraining member is released, it is pulled back further, leaving the guide element 10 acting as a catheter guide. The advantage of this coordinated guide element 10 and the seam of the protective unit / restraining member 8 is that it reduces the number of parts that need to be pulled outside the patient's body, among other advantages. The restraining member 8 is configured to be partially removable so that the stent graft 1 and / or the side branches 3 can be selected to be expanded individually. This is in Figure 9a , where the stent graft 200 is completely constrained by the constraining member 8. Figure 9b In the embodiment of the present invention, the constraining member 8 is partially opened, thereby allowing the coated stent 200 to partially expand along its length.

[0202] Another embodiment is Figure 9c , wherein more than one constraining member 8 is used to constrain different portions of a three-legged stent graft. In this manner, for example, one or more of the three legs of stent graft 200 can be easily expanded individually, one at a time, or simultaneously. In the same manner, a stent graft 1 having side branches 3 can be partially or fully expanded by releasing, for example, a constraining member around the main body 2 and another constraining member 8 (not shown) surrounding the side branches 3.

[0203] Figure 10 It shows how a sheath can be used to hold the stent graft in a collapsed or collapsed manner and can provide partial or complete controllable release of the stent graft.

[0204] Figure 10It shows how the stent graft 1 is first released from the restraining member 8 from one side (right side), as shown in FIG. Figure 10 As shown in the top (a). Figure 10 As shown in the middle and bottom (b and c), the portion of the stent graft 1 including the side branches 3 is then released. Figure 11 , wherein the stent graft 300 is partially released from the restraining member 8 to allow the side branch 3 to easily adapt to the branch vessel. When the portion of the stent graft 300 including the side branch 3 is released from the restraining member 8, the side branch 3 is aligned with the branch vessel and then expanded into the branch vessel. The stent graft 300 is then fully released from the restraining member 8, as shown in FIG. Figure 11 The stent graft 600 further extended into the side vessel is shown as delivered and deployed as described herein.

[0205] Figure 11 An embodiment of a stent graft 1 is shown, which can be used in a simple method for finding branch vessels. The stent graft 300 is completely pushed out of a delivery device 30, such as a catheter, and the body 2 of the stent graft 1 is expanded.

[0206] The side branches 3 are expanded in embodiments by being pushed outwards and / or configured to expand themselves, as disclosed above and in e.g. Figure 6 、 7 and as shown in 9.

[0207] Another pushing element (not shown) can be used to push the flexible side branch 3 outward in a desired direction to expand it from a closed or contracted state. This is suitable for situations where the side branch 3 is not self-expandable.

[0208] In the case of a self-expandable side branch 3, once released from the delivery catheter (30), it will expand radially outward from the body and / or remove the constraining unit 8.

[0209] In order to make it easier to align with the branch blood vessel, the side branch 3 of the stent graft can be provided with a marker 21, such as Figure 3 As shown. When the side branch 3 is flush or aligned with the branch vessel, the marker 21 will be visible to the operator. By having only one marker at the side branch 3, it will be easier for the operator to align the coated stent 1 to its desired position by using an imaging device such as an X-ray, rather than existing coated stents with multiple markers that require alignment under fluoroscopy. If an imaging device such as MRI, X-ray, ultrasound, etc. is used for medical care or coated stent placement, the marker 21 is, in an embodiment, any reference marker that is visible under ordinary types. The coated stent structure is generally difficult to see, for example, under fluoroscopy. The marker can be made of gold or a similar material, for example, to allow good visibility in such imaging.

[0210] In one embodiment, the side branch 3 is folded or closed and constrained by a guide element 10, such as a suture 10. The guide element 10 is, for example, wrapped around the side branch 3 and releasably connected to the inside of the side branch 3 or otherwise attached to the side branch 3, allowing it to be releasably closed or closed. Pulling the guide element proximally then releases the side branch 3 from the contracted state to the expanded state. The guide element 10 remains in place to serve as a catheter guide.

[0211] In one embodiment, the stent graft 1 is aligned with the branch vessel by moving the body 2 of the stent graft 1, as shown in Figures 9-11. In one embodiment, this is achieved by the stent graft 1 being only partially pushed out of the catheter 30 and / or partially released from the restriction device 8 as described above, so that the stent graft 1 can be moved by moving the catheter 30, or by, for example, a pusher wire, or in other ways, as shown in Figures 9 and 10. Preferably, the side branch 3 is self-expandable.

[0212] In one embodiment, stent graft 1 is moved upward until marking 21 on side branch 3 is aligned with the branch vessel. Stent graft 1 is then rotated until side branch 3 enters the branch vessel. Once side branch 3 enters the branch vessel, guiding element (e.g., suture 10) is released, allowing side branch 3 to expand into the branch vessel, either by itself or by being pushed outward.

[0213] In another alternative embodiment, the stent graft 1 is aligned with the branch vessel by navigating the main body 2 of the stent graft 1 and by navigating the side branches 3 of the stent graft 1 .

[0214] Figure 15A are perspective and cross-sectional views of modular stent graft 300 having lateral side branches in a delivery configuration. Figure 15B and 15C Before releasing the subject Figure 15A Schematic diagram of the lateral side branch deployment of the modular covered stent 300. There are two layers of external restraining members / sheaths covering the prosthesis / covered stent. The side branch external restraining member 8a only restrains the side branch prosthesis. It is wrapped around the outside of the first external restraining member 8. It is only a portion, for example 1 / 3 of the entire prosthesis length. The first external restraining member 8 covers the entire body of the prosthesis and a shape is cut out of it to allow the side branch prosthesis to pop out. The side branch external restraining member 8a is first opened to release the side branch guidewire and the side branch prosthesis. Once the side branch vessel is positioned, the first external restraining member 8a can be opened to fully expose the prosthesis body, as shown in FIG. Figure 15B and 15CAs shown. The prosthesis delivery system is inserted and aligned with the side branch tip, close to or pointing towards the side branch vessel. If necessary, the position of the prosthesis can be adjusted, for example with the aid of a reference marker, and optionally, a guide wire can be used to find the side branch entrance. The side branch outer sheath 8a is opened. The side branch outer sheath 8a can be fully opened to release the side branch prosthesis. The side branch prosthesis is fully expanded. The prosthesis body outer sheath 8 is then opened to release the entire prosthesis. The double lumen catheter 30 can be brought onto the guide element 10 to introduce another guide wire into the side branch for connection to the prosthesis delivery system. One of the lumens 9 will pass over the side branch guide element 10 to enter the side branch vessel. Once the two lumen catheter 30 is in place, another guide wire will be introduced into the side branch through the lumen 30a, which can be freely moved upward for deeper entry, as described in more detail below with reference to the following methods and procedures.

[0215] Figure 17A are perspective and cross-sectional views of modular stent graft 300 having lateral side branches in another delivery configuration. Figure 17B Schematic diagram of the release of the main body and lateral side branches of the modular covered stent 300. Figure 18 is a schematic diagram of a catheter tool used to release a navigation unit from an extension of a lateral side branch.

[0216] The single-layer outer sheath 8 covers the entire prosthesis / stent graft. Prosthesis exposure can be divided into three stages:

[0217] Phase 1: The distal portion of the outer sheath 8 opens, releasing approximately 1 / 3 of the prosthesis body. The outer sheath 8 slowly opens to release the first portion of the prosthesis body. The position of the prosthesis can be adjusted.

[0218] ·Second stage: The outer sheath 8 continues to open until the side branch prosthesis 3 is fully exposed. Once the correct position is found, the middle part of the outer sheath 8 opens to release the side branch 3. The side branch 3 expands. The outer sheath 8 opens further until the side branch 3 prosthesis is fully exposed and its position is adjusted if necessary. In order to open the tip of the side branch prosthesis, the provided ring is released from the rod that holds it. Once the ring is released from the locking mechanism, the coated stent will expand elastically and / or by shape memory effect. The outer sheath 8 continues to open until the main body 2 is exposed. The surgeon can now deliver the expanded coated stent 600 to the side branch vessel. Expanding a portion of the prosthesis main body 2 before activating the side branch may help the surgeon to place the guide wire in the side branch vessel.

[0219] Final stage: until the side branch prosthesis is located in the side vessel and the sheath 8 is fully opened.

[0220] Figure 18Schematic diagram of a catheter tool for releasing a navigation unit from an extension of a lateral side branch. The distal end of the catheter 30 lumen may include a distal unit for releasably attaching the branch 3. The branch 3 may include, for example, an attachment device such as a ring 35. The attachment device may be connected to the distal end of the prosthetic side branch 3 such as one or more wires or wire loops 35 and may be releasably fixed to a locking portion 38. The locking portion 38 may be movable upward or downward relative to the stop unit, such as Figure 18 The flange at the distal end is shown. The locking portion may include one or more rods or struts that are longitudinally movable and engageable with the ring 35. The locking portion 38, if it includes a rod or strut, can be releasably locked to the connection device in the same way as the ring 35, for example when moved upwardly to a stop flange, as shown. The release of the locking unit from the attachment device can be achieved by reversing the above-mentioned rod in the opposite direction, thereby releasing the branch 3 and allowing the catheter to be withdrawn proximally. A central space 39 is provided for passing a guide wire or coated stent therethrough. In this way, when connected to the branch, the branch 39 can be moved by moving the catheter end with the locking unit. Preferably, it is moved away from the main body towards the branch vessel, but if necessary, it can also be arranged to withdraw the branch 3 towards the main body to adapt to the anatomical situation. As described above, the catheter can be guided by a guiding element 10.

[0221] An embodiment of the side branch prosthesis 300 is implemented as follows:

[0222] The length of the prosthetic side branch 3 is about 15 mm

[0223] Some other exemplary but non-limiting measures are given in Figure 14

[0224] Features of the preload guide element 10:

[0225] o is secured through the side branch, preferably in a position that facilitates manipulating the orientation of the catheter to snugly engage the guide element 10. The connection point is, for example, on the inner side of the branch 3 toward the distal end, so that the guide catheter 30 can be advantageously navigated through the lumen of the branch 3 toward the side vessel ostium or lumen.

[0226] o Preload guide element 10 serves as a guide for catheter 30, e.g. Figure 16 Double-lumen catheter shown reaching the side vessels.

[0227] o The preload guide element 10 is preferably configured to be easily unlocked from the prosthesis.

[0228] Examples of visceral side branches 310 are as follows:

[0229] The prosthetic side branches 3 can be arranged at a certain angle relative to the longitudinal axis of the body 2 , such as approximately 30 degrees or 45 degrees, to help the surgeon access the lateral vessels with the catheter 30 .

[0230] The inner diameter of the side branches can be in the range of about 7 mm,

[0231] • The side branch prosthesis 3 is provided to allow a degree of movement to allow adjustment of various connection angles towards the side vessels.

[0232] Figure 12 Flowcharts showing two embodiments of medical procedures.

[0233] Method 700 includes the following steps: 710 accessing a target site that is a patient's blood vessel; 720 delivering a first stent graft to the interior of the blood vessel at the target site via a delivery catheter, wherein the target site has a side branch vessel; 730 delivering a second stent graft to the first stent graft; 740 connecting the first stent graft to the second stent graft for providing blood flow to the side branch vessel. Delivery of the second stent graft includes sliding a catheter 30 along a guide element 10 to a position within the lumen of the side branch of the first stent graft; and expanding the second stent graft to connect to the first stent graft. The catheter 30 with the guide fitting 9 can be used to deliver a guide wire. Once the guide wire is in place in the side branch and extends sufficiently long into the side vessel at the side branch, the catheter 30 can be retracted. The extended stent graft 600 can then be delivered to the side vessel via the guide wire.

[0234] Alternatively or additionally, method 800 is provided. The second stent-graft may have a side branch 3. The method includes delivering the second stent-graft to a side vessel through the side branch 3 of the first stent-graft. Method 800 includes the following steps: 810 accessing a target site that is a patient's blood vessel; 820 delivering the first stent-graft to the interior of the blood vessel at the target site through a delivery catheter, wherein the target site has a side branch vessel; 830 dilating the side branch 3, 840 delivering the second stent-graft to the first stent-graft and delivering it to the side vessel through the side branch 3; 850 connecting the first stent-graft to the second stent-graft for providing blood flow to the side branch vessel. As described above, a catheter 30 having a guide element 10 may be used between steps 830-840.

[0235] In certain embodiments, the method includes delivering and assembling the system 100 as described above, and having Figure 1 and Figure 2 The final layout is shown in .

[0236] The method begins in an embodiment by inserting a soft guidewire into a patient's blood vessel. Using a flexible guidewire ensures that no portion of the blood vessel is damaged during insertion. Furthermore, the soft guidewire can be bent to allow navigation through the patient's vascular system to the target site, in this embodiment the ascending aorta. As mentioned above, other target sites in the body may also be selected as alternatives.

[0237] Then, the first catheter is inserted into the patient's blood vessel on the soft guide wire and navigated until it reaches the target site. Under the guidance of the first catheter, the harder navigation element 20 is then inserted into the catheter and thereby into the patient's blood vessel.

[0238] The target site in this embodiment is the ascending aorta, where the three-legged stent graft 200 is subsequently positioned via a delivery catheter in the aortic arch. Figure 2 Shown in.

[0239] The three-legged stent graft 200 is then collapsed or folded to fit within the first catheter 30 and pushed along it, and the navigation element / guidewire 20 can extend within the main portion of the stent graft and out through one of the legs 201.

[0240] As described above, three-legged stent graft 200 is provided with guide element 10 attached within one of the other legs. In one embodiment, a location near or to the left of the aortic arch is preferred.

[0241] Each guide element 10 and navigation element 20 may be marked proximally at the distal end for easy identification. The proximally marked distal end is configured to be external to the patient during implantation.

[0242] Then, when in the correct position at the target site, stent graft 200 is pushed out of catheter 30 and allowed to fully or partially expand or deploy, as described above. It is rotated until the legs align with the main vessels and the aortic neck branches. As described above, this alignment can be performed in a variety of ways.

[0243] Next, when the three-legged stent graft 200 is in place, the system 100 can be easily constructed with other modules. As described above, this can be done in several ways, and in this embodiment, two stent grafts 1 with side branches 3 and stent grafts 600 for extending into branch vessels are in the same manner as described above. Figure 1 and 2 The tripod stent graft 200 is then deployed.

[0244] exist Figure 1 and Figure 2 In the embodiment shown, extension stent graft 600 is navigated via guide element 10, which is attached within one leg of three-legged stent graft 200 and is navigated through the three-legged stent graft 200 and positioned so that it can extend into the leg. Here, stent graft 200 is expanded and connected to the legs in an overlapping manner.

[0245] Next, first stent graft 300 having side branch 3 is slid into position along guide element 10 and connected to third leg 203. After or before deployment along guide element 10, second stent graft 300 is slid along guide wire 20 and connected to second leg 202.

[0246] It is necessary not to use an aortic clamp to block blood flow in the aorta or cardioplegia.Due to the parallel arrangement of stent graft 300, blood flow through the aorta and side vessels is not interrupted during the procedure.

[0247] When the stent graft is delivered, the side branch 3 is simultaneously navigated into position with the stent graft and expanded at least toward the branch vessel.Next, any additional extension stent grafts may be inserted based on the desired need for further extension into the branch vessel.

[0248] Next, a stent graft 400 having two legs is moved in a contracted state along guidewire 20 and guide element 10 within first catheter 30. Stent graft 400 is oriented so that the legs are positioned toward an already connected stent graft 300. Each leg is guided along one of guide element 10 and guidewire 20 so that each leg can be guided to one of the previous stent grafts 300 having side branches 3. Once in place, stent graft 1 is released from catheter 30 and can be expanded.

[0249] Alternatively, collection stent graft 400 may be connected to the proximal end of branch stent graft 300 prior to connecting the side branch and / or delivery extension stent graft 600 .

[0250] Next, a tubular stent graft 410 without legs or side branches is advanced into position via catheter 30 and navigated and connected to the previous stent graft 400 in a similar manner, but now with both guide element 10 and guidewire 20 running internally. In interconnecting these stents, the length of the assembled prosthesis can be adjusted by the variable overlap of the stent grafts selected by the surgeon during implantation.

[0251] Then, in the same manner, a double-legged stent graft 420 is connected to the tubular stent graft 1. This double-legged stent graft 420 is oriented so that the legs are distally connected to the stent graft upstream of the aorta. These legs extend along the guide element 10 and the guidewire 20, respectively. When these stents are interconnected, the length of the assembled prosthesis can be adjusted by the variable overlap of the stent grafts selected by the surgeon during implantation.

[0252] After connecting the double-leg stent graft 420, the stent graft 310 with two side branches 3 is guided through the delivery catheter along the guide element 10 in a manner similar to the previously delivered stent graft 300. When the main body of the stent graft is in the approximately correct position, further navigation of the side branches 3 is performed to correctly orient them rotationally toward the side vessels. Thus, the side branches 3 are aligned with the branch vessels and expanded into the branch vessels. At the distal end, the stent graft 310 is connected to one leg of the double-leg stent graft 420.

[0253] Then, stent graft 320 having two side branches 3 and an additional guide 10 or navigation element 20 is guided via catheter 30 , aligned with the branch vessels and connected to the second leg of double-leg stent graft 420 .

[0254] Finally, the final double-legged stent graft 430 is positioned and the two legs are connected to the two stent grafts 310, 320 with two side branches 3 in a similar manner as described above using a delivery catheter 30 and connected along a guide element 10 and a guide wire 20, respectively.

[0255] When the system 100 is connected and completed, all remaining navigation element 20 and catheter 30 are removed from the patient. The introducing element 10 may be cut distally and the remaining length left in place, preferably for subsequent biodegradation.

[0256] In one embodiment, Figure 2 , the complete system 100 is shown assembled and implanted in the aortic arch of a patient. It can be seen that different stent grafts 1 have been connected to each other, and the side branches 3 have been extended into the branch vessels and further extended with stent grafts 1.

[0257] An additional proximal stent graft module (not shown), such as for iliac artery reconstruction or repair, may be provided and implanted, such as connected to the proximal end of stent graft 430 .

[0258] Figure 13 A method for navigating a stent graft 1 to a branch vessel is shown. Method 900 includes the following steps: 910 providing a stent graft 1 as described above, and 920 navigating a lateral side branch 3 into a branch vessel by moving the lateral side branch 3 .

[0259] In one embodiment, this is performed using the elongated navigation element 20, as described above. In one embodiment, this is performed using the guide element 10 and the catheter 30 having the guide fitting 9, as described above. Figure 8 described.

[0260] The method may further include the step of expanding the lateral side branch 3 from a contracted state into the branch vessel when the lateral side branch 3 is navigated to a desired position in the branch vessel. As described, for example, in Figures 9-11 , this may be accomplished by navigating the stent graft 1 to align the side branch 3 with the branch vessel, then expanding the side branch 3 into the branch vessel, and finally expanding the remainder of the stent graft 1.

[0261] In one embodiment, the method further comprises the step of interconnecting an expansion element at the lateral side branch 3 into the branch vessel to further extend into the branch vessel. The expansion element may be a stent graft 1 .

[0262] Further examples of methods and processes are given below:

[0263] A method for navigating a stent graft into a branch vessel is provided. The method includes providing a stent graft 200, 300, 310, 320 and guiding or navigating the lateral side branch into the branch vessel by moving the lateral side branch using a guide element 10. The method may include expanding the stent graft delivered through the lateral side branch 3 from a contracted state into the branch vessel while navigating the branch vessel. The method may include interconnecting an expansion element 600 at the lateral side branch into the branch vessel to further extend the stent graft into the branch vessel, wherein the expansion element is preferably a stent graft.

[0264] A method for interconnecting multiple stent grafts is provided. The method includes providing a stent graft having a flexible guide element that is connected at the exit of a side branch. The method may include interconnecting multiple such stent grafts, including sliding a catheter along the guide element to the exit of the side branch with the aid of a guide fitting 9, and passing another stent graft through the catheter along the flexible guide element for interconnecting the stent grafts. The stent grafts preferably have the same size at the interconnection.

[0265] A medical procedure is provided, comprising 710 accessing a target site as a patient's blood vessel; 720 delivering a first stent-graft to the interior of the blood vessel at the target site via a delivery catheter, wherein the target site has a side branch vessel; 730 delivering a second stent-graft to the first stent-graft; 740 connecting the first stent-graft to the second stent-graft for providing blood flow to the side branch vessel, wherein the delivery of the second stent-graft comprises sliding the catheter along a guide element 10 to a position within the lumen of the side branch of the first stent-graft; and expanding the second stent-graft to connect to the first stent-graft.

[0266] A medical procedure is provided, including 810 accessing a target site as a patient's blood vessel; 820 delivering a first covered stent to the interior of the blood vessel at the target site through a delivery catheter, wherein the target site has a side branch vessel; 830 dilating side branch 3; 840 delivering a second covered stent to the first covered stent and to the side vessel through side branch 3; 850 connecting the first covered stent to the second covered stent so as to provide blood flow to the side branch vessel.

[0267] Another embodiment of the delivery procedure is as follows:

[0268] 1. Insert the delivery system into the patient through the introducer sheath.

[0269] 2. Open the outer sheath 9 and remove it from the proximal end of the prosthesis towards the side branch prosthesis. Keep it open until the side branch prosthesis is loosened and fully deployed.

[0270] 3. Stop opening until the side branch prosthesis is fully exposed.

[0271] 4. Adjust the position of the prosthesis for initial fit.

[0272] 5. Insert the double lumen catheter 30 over the preloaded introducing element 10 and allow it to advance to the side branch prosthesis until it hits the end at the connection point 11 .

[0273] 6. An additional guidewire is inserted through the double lumen catheter 30 and protrudes from the side branch 3 .

[0274] 7. Optionally further adjust the position of the prosthesis.

[0275] 8. Once the location of the collateral vessels is identified and confirmed, advance the additional guidewire to secure the position.

[0276] 9. Once the additional guidewire is securely located in the side vessel, remove the double lumen catheter and deliver the connection prosthesis 600 using the additional guidewire.

[0277] 10. Once the connection prosthesis 600 is in the side vessel and fully expanded, remove the remainder of the outer sheath 9 of the previous prosthesis, completely releasing it.

[0278] 11. Unlock the introducing element 10 from the side branch prosthesis and remove all guidewires and delivery systems from the patient.

[0279] The present disclosure has been described above with reference to specific embodiments. However, other embodiments than those described above are also possible within the scope of the present disclosure. Method steps different from those described above can be provided within the scope of the present disclosure, and the method can be performed by hardware or software. The various features and steps of the present disclosure can be combined in other combinations than those described. The scope of the present disclosure is limited only by the appended patent claims.

Claims

1. A modular stent graft system comprising: - a plurality of stent grafts (1), wherein: At least one of the plurality of stent grafts is a stent graft comprising a main body (2), - at least one side branch (3) connected to the main body (2), comprising one or more side branches, and characterized in that - one or more guide elements (10) permanently or releasably connected to the interior of each of the one or more side branches (3) at a connection point at the distal orifice of the one or more side branches (3), defining one or more connected guide elements (10), said guide elements (10) being bendable and / or flexible; The guide element (10) is arranged proximally from the one or more side branches (3) in the interior, passes through and along the proximal portion of the main body (2), and extends proximally through the proximal opening of the main body (2), or passes through the legs of the stent graft (1); wherein the one or more connected guide elements (10) allow one or more of the plurality of stent grafts to be advanced into the one or more side branches for deployment therein.

2. The modular stent graft system according to claim 1, wherein: The plurality of stent grafts are configured to be interconnected, and wherein the plurality of stent grafts include a first main vessel stent graft (200, 420) having a first single distal upstream inlet branching into at least two proximal downstream outlet branches.

3. The system according to claim 2 further includes at least two coated stents (300) with at least one lateral side branch orifice, each of the at least two coated stents (300) being remotely interconnected to one of the proximal downstream outlet branches of the first main vessel coated stent (200) and being laterally connected to a side flow vessel of the main vessel.

4. The system according to claim 3, wherein: The at least two stent grafts are configured to be sequentially interconnected to one of the proximal downstream outlet branches and to provide a blood conduit arranged in parallel by the at least two stent grafts (300).

5. The system according to claim 3 or 4 further includes a second main vessel covered stent (400, 430) having at least two distal upstream inlet branches collected in a single proximal downstream outlet, each of the distal upstream inlet branches being configured to be interconnected to the proximal outlet of one of the at least two covered stents (300). The system of claim 1 , further comprising a delivery catheter.

7. The system according to claim 2, wherein: The first main vessel covered stent (200) includes a first leg (201).

8. The system according to claim 7, comprising: a first guide element, the proximal end of which is arranged to enter the first of the proximal downstream outlet branches and the distal end of which is fixed to the inner wall of the first leg (201); a second guiding element, a proximal end of which is arranged to enter the proximal outlet of the first stent graft of the two stent grafts, and a distal end of which is fixed to the inner wall of the side branch of the first stent graft; and a third guiding element, a proximal end of which is arranged to enter the proximal outlet of the second stent graft of the two stent grafts, and a distal end of which is fixed to the inner wall of the side branch of the second stent graft, and A guide wire (20) is included.

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