Vascular prosthesis delivery system

Abstract

To provide a system for delivery of an endoluminal prosthesis into a body lumen, especially into a blood vessel, of a patient to restore patency of the blood vessel.SOLUTION: A system 1 comprises a delivery catheter 20 and a prosthesis 10 to be delivered, and further comprises a preloaded wire 40 preloaded to extend through at least a portion of a main lumen of the prosthesis. The preloaded wire extends in a distal direction to a position in proximity to a distal opening 114 of the prosthesis, and extends in a proximal direction from a proximal opening 113 of the prosthesis along a catheter shaft 22 up to a handle 30, where the handle comprises at least one spool 50 to receive a proximal end of the preloaded wire with a proximal portion of the preloaded wire being coiled onto the spool.SELECTED DRAWING: Figure 1

Description

Technical Field

[0001] The present invention relates to a system for delivering an endoluminal prosthesis into a patient's body cavity, particularly into a blood vessel, to restore the patency of the blood vessel.

Background Art

[0002] The present invention relates to a system for delivering an endoluminal prosthesis into a body cavity, the system including a delivery catheter and a prosthesis to be delivered, the delivery catheter including a catheter tip, a catheter shaft, and a handle for disposing the prosthesis, the prosthesis including a hollow cylindrical body and a preloaded wire preloaded to extend through at least a part of the main lumen of the prosthesis.

[0003] Generally, endoluminal prostheses include vascular prostheses. Vascular prostheses, also called vascular implants, are placed to treat aneurysms, occlusions, lesions, and other injuries to arteries. Such endoluminal prostheses include stents, stent grafts, or combinations thereof. Vascular prostheses are introduced into the blood vessel by an endoluminal technique using an appropriate delivery device to restore the patency of the blood vessel obstructed by the lesion.

[0004] Furthermore, a delivery system including a preloaded wire is usually used when another access is required at a predetermined position of the prosthesis in the next stage of the treatment process of the damaged artery after the prosthesis has been delivered to the target site of the blood vessel. Thus, examples include a system for treating lesions or occlusions in branch blood vessels and a system for treating aneurysms in the thoracic and abdominal arteries. In such treatments, an additional access to another blood vessel or a collateral branch is required to ensure the blood flow direction to the collateral blood vessel. Such access to the collateral branch during the prosthesis implantation surgery is often difficult and time-consuming, but by preloading an additional wire, so-called preloaded wire, into the prosthesis, for example, an exit to the collateral branch of the artery can be secured through the fenestration of the prosthesis.

[0005] For example, EP2517671A1 discloses a system for positioning an intraluminal prosthesis having branches and fenestrations in the side walls of a tubular graft body, and further having pre-loaded wire segments that extend through the lumens of the fenestrations and branches. This system is used to treat aneurysms and lesions of the thoracoabdominal aorta. In such treatments, it is necessary to establish connections between the main aortic vessel and arteries branching from the aorta, such as the renal arteries, in order to ensure blood flow. Positioning such branches requires the insertion of guidewires and delivery devices, but this operation is considered to be very time-consuming and difficult because cannulation of the multiple fenestrations of the grafts and their corresponding branch vessels is extremely complex when positioning multiple small branch grafts. Using the pre-loaded wire described above allows for rapid access to the side branches by avoiding the time-consuming fenestration search. However, in some surgeries, the pre-loaded wire needs to be very long because it passes through the body and loads multiple guide catheters required for the surgery, which is a major drawback of the systems disclosed in the art. When using such long wires, additional personnel are needed to maintain their function and sterility during the surgery. Furthermore, when using the system disclosed in EP2517671A1, a pivot-type fenestration is required for half of the multiple side branches, as the bridging stent must be inserted against the blood flow within the prosthesis body and in the direction of the blood flow of the branch. Alternatively, an additional self-sealing fenestration is required on the side wall of the main body to allow the physician to insert all side branches in the direction of blood flow. However, both requirements increase the risk of surgical failure. [Overview of the project] [Problems that the invention aims to solve]

[0006] Therefore, the object of the present invention is to provide an intraluminal prosthesis delivery system that can effectively, safely, and relatively quickly place an intraluminal prosthesis and provide lumen access from the prosthesis to a side vessel or branch vessel. Furthermore, if intraluminal prosthesis can be effectively, safely, and relatively quickly placed, it will also lead to a reduction in patient radiation exposure, a reduction in the use of contrast agents, and a reduction in traumatic interventions. [Means for solving the problem]

[0007] This objective is achieved by the present invention through the system for delivering an intraluminal prosthesis into a patient's body cavity as described in claim 1.

[0008] Accordingly, the present invention relates to a delivery system for an intraluminal prosthesis. The system includes a delivery catheter and a prosthesis to be delivered, the delivery catheter including a catheter tip, a catheter shaft, and a handle for positioning the prosthesis, the prosthesis including a hollow cylindrical body having side walls, a proximal opening and a distal opening, and a main lumen extending between the two openings, the system including a preloaded wire that extends through at least a portion of the main lumen of the prosthesis, the preloaded wire extending distally to a position close to the distal opening of the prosthesis, and proximal to the proximal opening of the prosthesis, along the catheter shaft to a handle, the handle comprising at least one spool for housing the proximal end of the preloaded wire, the proximal portion of the preloaded wire wound around the spool.

[0009] Throughout this specification, the term “proximal” generally means that a location, orientation, or part or end of a component of the system is close to the handle of the device or the physician treating the patient. Conversely, the term “distal” means that a location, orientation, or part or end of a component of the system is far from or away from the handle of the device or the physician treating the patient, or is the furthest away.

[0010] Prosthesis:

[0011] The intraluminal prosthesis delivered is a stent, graft, stent graft, valve, or any combination thereof. In one embodiment, the intraluminal prosthesis is a vascular prosthesis, also known as a vascular implant.

[0012] The stent portion of the prosthesis can be made of any suitable material, such as metal, metal alloy, or polymer material. Exemplary materials include stainless steel, nitinol, cobalt-chromium alloy, ceramics, composite materials, bioabsorbable polymers, biostable polymers, and thermotropic liquid crystal polymers. The stent of the prosthesis can be fabricated by any of the many methods known in the art. For example, a stent can be fabricated from a hollow tube or formed tube machined using laser, electrical discharge milling, chemical etching, or other known techniques. The stent can also be fabricated from a tubular member made by rolling a sheet, or from a toroidal ring, wire, or filament structure, as is known in the art. In a preferred embodiment of the present invention, the medical device includes a metal stent. The stent can also be made from a biodegradable or non-biodegradable polymer. Generally, the stent may be balloon-expandable or self-expanding. In a preferred embodiment, the stent is a self-expanding stent made of a shape memory alloy, such as nitinol.

[0013] In a further preferred embodiment, the prosthesis is a stent graft, which is preferably a metal stent covered with a graft material. Suitable graft materials include PTFE, stretched PTFE (ePTFE), or PTFE produced by electrospinning, such as Bioweb® from Zeus Industrial Products. In a further embodiment, the membrane of the stent graft may be made of polyester, polyurethane, polystyrene, polytetrafluoroethylene, ultra-high molecular weight polyethylene (UHMPE), or a mixture thereof. The membrane or cover or graft material of the stent graft may cover the entire stent or only a portion thereof. Furthermore, the graft material may cover the entire outside or the entire inside (also called the luminal side) of the stent, or both the outside and inside of the stent, or only a portion thereof. Numerous methods for fixing graft material to a stent are well known in the art, including, for example, methods of suturing or adhering a membrane to the stent, methods of directly spinning the graft material on the stent, and methods of fixing the graft material between stent supports configured to function as clamps.

[0014] In one embodiment, the intraluminal prosthesis includes at least one opening in the side wall of its hollow cylindrical body. In this specification, the term "opening" means an opening in the side wall of the prosthesis that penetrates from the inside to the outside of the prosthesis. The shape of the opening may vary, including circular, semicircular, elliptical, or oblong shapes.

[0015] In another embodiment, the intraluminal prosthesis includes at least one lateral branch, the lateral branch including a hollow cylindrical lateral branch body having a lateral wall, a proximal opening and a distal opening, and a lateral branch lumen extending between the two openings, the lateral branch lumen being in fluid communication with the main lumen.

[0016] In one embodiment, the at least one lateral branch of the intraluminal prosthesis extends from at least one opening in the side wall of the hollow cylindrical body of the prosthesis, the lateral branch having a first lateral branch opening and a second lateral branch opening, and a lateral branch lumen extending between the first lateral branch opening and the second lateral branch opening, the first lateral branch opening being firmly connected to the periphery of the opening in the side wall of the prosthesis and on the prosthesis material.

[0017] In another embodiment of the present invention, the at least one lateral branch of the intraluminal prosthesis is integrally formed with the hollow cylindrical body of the prosthesis. The side walls of the hollow cylindrical body of the prosthesis and the side walls of the lateral branches are made from a single piece of material. In this case, the opening in the side wall of the hollow cylindrical body of the prosthesis is not a window created by cutting the side wall, but an opening due to the bifurcated shape of the prosthesis. An example of such a bifurcated prosthesis is described in EP3920845A1.

[0018] In one embodiment of the present invention, the side branches extend in the direction of blood flow from an opening or window in the side wall of the hollow cylindrical body of the prosthesis along the outside of the main lumen of the prosthesis.

[0019] In another embodiment of the present invention, the lateral branch enters the main lumen of the prosthesis through an opening in the side wall of the hollow cylindrical body of the prosthesis and extends in the direction of blood flow within the main lumen. In another embodiment, if the hollow cylindrical body of the prosthesis and the side wall of the lateral branch are made from a single piece of material, the lateral branch enters the main lumen of the prosthesis through an opening in the side wall of the hollow cylindrical body of the prosthesis and extends in the direction of blood flow within the main lumen. In other words, the lateral branch is folded into the main lumen inside the prosthesis body.

[0020] In this design, where the side branches enter the main lumen of the prosthesis through a window or opening in the side wall of the hollow cylindrical body of the prosthesis and extend in the direction of blood flow within the main lumen, there is an advantage that the openings of the side branches are within the cross-sectional plane of the main lumen, i.e., the plane transverse to the direction of blood flow. Therefore, the bridging stent can be easily positioned within the lumen of the side branch of the prosthesis and further reach the outward branch of the vessel from the prosthesis. Furthermore, this concept ensures that the amount of blood distributed to the side branch vessels is adequately maintained by appropriately selecting the cross-section of the side branch.

[0021] In a further embodiment, the intraluminal prosthesis includes a plurality of fenestrations, particularly two, three, four, five, or six fenestrations, in the side wall of the main lumen.

[0022] In further embodiments, the intraluminal prosthesis may have side branches that branch off at an opening or window of the main body, either inside or outside the main body lumen. Any combination of an opening without branching, side branches branching at an opening or window and located inside the main body lumen, and side branches branching at an opening or window and located outside the main body lumen is included in the present invention.

[0023] In a particular embodiment of the present invention, the intraluminal prosthesis is a prosthesis for treating a thoracoabdominal artery aneurysm having four fenestrations, four side branches, or four sets of fenestrations and side branches.

[0024] In another specific embodiment of the present invention, the intraluminal prosthesis is a prosthesis for treating a thoracoabdominal artery aneurysm having five fenestrations, five side branches, or five sets of fenestrations and side branches.

[0025] In a further specified embodiment of the present invention, the intraluminal prosthesis is preferably a self-expanding vascular prosthesis or stent graft including a hollow cylindrical body having a longitudinal axis, a proximal opening, and a distal opening, and a main lumen extending between the proximal opening and the distal opening. The body has a proximal end portion including a first opening, a distal end portion including a second opening, and an intermediate portion located between the proximal end portion and the distal end portion. The vascular prosthesis or the stent graft includes at least four side branches, each side branch entering the main lumen from a fenestration or opening of the prosthesis material, extending distally within the main lumen, and each side branch having a first side branch opening, a second side branch opening, and a side branch lumen extending between the first side branch opening and the second side branch opening, the side branch lumen being in fluid communication with the main lumen.

[0026] In a further embodiment, the side branches are disposed in a central portion of the intraluminal prosthesis, and the diameter of the central portion is smaller than or equal to the diameter of both end portions of the prosthesis.

[0027] In another embodiment of the present invention, the intraluminal prosthesis is a prosthesis for treating a lesion of the aortic arch, and is an intraluminal prosthesis having one, two or three fenestrations or side branches, or three sets of fenestrations and side branches.

[0028] In yet another embodiment of the present invention, the intraluminal prosthesis is a prosthesis for treating a lesion of the iliac artery, and is an intraluminal prosthesis having one fenestration or side branch.

[0029] In a preferred embodiment, the prosthesis is preferably a stent graft comprising a stent ring made of a self-expanding material, preferably a shape memory material such as nitinol, and a membrane attached thereto, the membrane preferably comprising or being made of a material selected from polyester, polyurethane, polystyrene, polytetrafluoroethylene, ultra-high molecular weight polyethylene (UHMPE) or mixtures thereof. More detailed information regarding such a prosthesis is described, for example, in US10952840B2, the entire disclosure of which is incorporated herein by reference, except for definitions, disclaimers, denials and inconsistencies.

[0030] Preload wire:

[0031] The preload wire may be arranged in any manner suitable for the intended use along the prosthesis. In one embodiment, the preload wire extends from a spool provided on a handle at the proximal end of the catheter, through the proximal and distal openings of the prosthesis body, to a position adjacent to the distal opening of the prosthesis.

[0032] In a first preferred embodiment, the preload wire extends from a spool provided on a handle at the proximal end of the catheter to a position outside the main lumen in the proximal region of the prosthesis, enters the lumen of the prosthesis through a fenestration in the side wall of the hollow cylindrical body of the prosthesis, and extends through the lumen to a position adjacent to the distal opening of the prosthesis.

[0033] In a second preferred embodiment, the preload wire extends from a spool provided on a handle at the proximal end of the catheter to a position outside the main lumen in the proximal region of the prosthesis, enters the main lumen of the prosthesis through a fenestration and a side branch lumen in the side wall of the hollow cylindrical body of the prosthesis, and extends through the main lumen to a position adjacent to or distal to the distal end of the prosthesis.

[0034] Note that if the intraluminal prosthesis has multiple fenestrations or side branches, preload wires may or may not be provided at each fenestration or side branch.

[0035] In a more preferred embodiment of the present invention, the intraluminal prosthesis has at least two openings. At least one preload wire extends from a spool provided on the handle at the proximal end of the catheter to a position outside the main lumen in the proximal region of the prosthesis, through a first opening in the side wall of the hollow cylindrical body of the prosthesis, through the lumen of the prosthesis body to a second opening in the side wall of the body, and through the second opening, along the outside of the lumen of the prosthesis body, to a position proximal to the proximal end of the prosthesis and adjacent to the handle.

[0036] Those skilled in the art will readily understand that in a further embodiment of the intraluminal prosthesis, one or more of the openings may have side branches located either inside or outside the main lumen of the prosthesis, and the prosthesis may have side branches formed integrally with the main body. In these embodiments, the preload wire passes through the lumen of the side branch.

[0037] In one embodiment of these further embodiments, when the side branch is located within the main lumen of the prosthesis, the preload wire extends from a spool provided on the handle at the proximal end of the catheter to a position outside the main lumen in the proximal region of the prosthesis, enters the main lumen of the prosthesis through a first window or opening in the side wall of the hollow cylindrical body of the prosthesis and the lumen of the first side branch, reaches the position of the opening of the second side branch within the main lumen, extends along the lumen of the second side branch to a second window or opening in the side wall of the hollow cylindrical body of the prosthesis, and then extends through the second window or opening along the outside of the lumen of the prosthesis body to a position proximal to the prosthesis and adjacent to the handle.

[0038] In another embodiment of the present invention, the prosthesis includes at least one fenestration or side branch and an auxiliary fenestration in the side wall of its hollow cylindrical body. The auxiliary fenestration is not intended to allow access to a side branch artery, but is a small opening for extending a preload wire from a spool provided on the handle at the proximal end of the catheter to a position within the main lumen in the proximal region of the prosthesis. The preload wire passes through this auxiliary fenestration in the side wall of the hollow cylindrical body of the main lumen of the prosthesis, extends along the outside of the lumen of the hollow cylindrical body of the prosthesis to a fenestration or side branch in the side wall of the prosthesis body, enters the main lumen of the hollow cylindrical body of the prosthesis through the fenestration or side branch, and extends to a position adjacent to or distal to the distal end of the prosthesis.

[0039] In a preferred embodiment of the present invention, the prosthesis includes two, three, four, five or more side branches extending from two, three, four, five or more windows or openings in the side wall of its hollow cylindrical body, each side branch housing a preload wire. Preferably, each preload wire extends from a spool at the proximal end of the catheter to a position outside the main lumen in the proximal region of the prosthesis, enters a side branch lumen, and further enters the main lumen of the prosthesis, extending through the main lumen to a position distal to the distal end of the prosthesis.

[0040] The preload wire is a highly elastic and flexible wire that does not undergo plastic deformation, is biocompatible, and is resistant to breakage. The preload wire can be tightly wound onto a spool, but returns to a straight shape when unwound from the spool. Suitable wires include those made of highly elastic materials, and wires made of materials containing nitinol are preferred. Suitable wires for use as preload wires also include guide wires available on the market. The preload wire may be a solid wire, a solid core wire in which the core wire is covered with one or more metal spring coils, a ribbon wire in which both the core wire and ribbon wire are covered with spring coils, or any combination thereof.

[0041] To prevent the preloaded wire from damaging the target blood vessel, the distal end of the wire is required to be non-traumatic and flexible. In a preferred embodiment, the distal end of the preloaded wire is a conical tip with a rounded distal end, achieved by polishing.

[0042] In one preferred embodiment, at least the distal tip of the preloaded wire is visible under X-ray irradiation. In one embodiment, the tip of the nitinol preloaded wire is covered with a wire made of a radiopaque material such as tungsten. In one preferred embodiment, the preloaded wire is a solid nitinol wire having a distal tip that is polished and covered with a tungsten coil.

[0043] In various situations, depending on the medical surgery being performed, it may be necessary for the preloaded wire to be used as a retrograde wire, and for the distal end of the preloaded wire to be captured by a lasso device or snare device. Therefore, the distal end of the preloaded wire should be designed to be easily captured and not deformed even when captured.

[0044] Characteristics of the catheter:

[0045] As described above, the intraluminal prosthesis delivery system according to the present invention includes a delivery catheter, which includes a catheter tip, a catheter shaft, and a handle for positioning the prosthesis. The prosthesis is loaded onto the catheter shaft, in the proximal portion immediately from the distal end of the catheter. The distal end of the preload wire extends distally to a position close to the distal opening of the prosthesis.

[0046] In one preferred embodiment of the present invention, the preload wire is removably captured within the catheter tip at the distal end of the catheter. In another preferred embodiment, the distal end of the preload wire is located adjacent to the distal end within the main lumen of the prosthesis and is captured beneath the prosthesis configured to be delivered.

[0047] During the procedure, as the prosthesis expands, the distal end of the preload wire becomes loosely suspended within the lumen of the prosthesis body, the lumen of the side branches, or within a body cavity distal to the distal end of the prosthesis, and is captured by a lasso device or snare device introduced into the lumen from the distal or proximal part of the prosthesis. The preload wire is then withdrawn, and as its distal end is pulled distally from the body, the preload wire functions as a guide for introducing a guide catheter through the fenestration or side branch of the prosthesis, enabling connection between the side branch of the prosthesis and the side branch of the branching artery.

[0048] The delivery catheter may further include a guidewire lumen for housing a guidewire. The guidewire lumen is either an "over-the-wire" type extending from the proximal end to the distal end of the catheter, or a "rapid-exchange" type extending from a position proximal to the catheter but distal to the proximal end of the catheter to the distal end of the catheter, both of which are well known in the art.

[0049] The proximal end of the catheter is fitted with a handle that has a spool for the preloaded wire.

[0050] Handle / Spool Features:

[0051] The handle features a spool that houses the proximal end of the preload wire. The proximal portion of the preload wire is wound onto the spool. The preload wire extends from the spool at the proximal end of the catheter, through the handle, and along the catheter shaft to the prosthesis. The handle is equipped with a suitable seal to seal the entry point into the catheter system through which the preload wire passes.

[0052] To prevent blood leakage from the system or blood vessels during the placement of the intraluminal prosthesis, the handle includes at least one seal that liquid-tightly seals the exit from the system to the spool through which the preload wire passes. In one preferred embodiment of the present invention, the seal is a seal ring or seal disc that seals the outer circumference of the preload wire. In another embodiment of the present invention, the seal is a lip seal or a duckbill seal. In one more preferred embodiment, the handle includes two seals arranged in series. The first seal is the ring seal described above, which seals the exit from the handle and / or the system through which the preload wire passes. The second seal is a lip seal or a duckbill seal. This second seal, located inside the handle, seals the system when the preload wire is completely withdrawn from the system. The combination of the ring seal and the lip seal ensures liquid-tight closure of the system at all stages of the intraluminal prosthesis placement surgery. Such double seals are provided at each exit from the system or handle through which the preload wire passes.

[0053] In one preferred embodiment, the proximal end of the preload wire is removably fixed to the spool with the preload wire fitted into a recess in the spool. However, it will be readily apparent to those skilled in the art that the proximal end of the preload wire may be fixed to the spool by any suitable method, such as adhesive, welding, or friction fitting.

[0054] The spool is connected to the handle. In one embodiment, the spool is attached to the handle via a retainer. In a preferred embodiment, the spool is detachably attached to the handle. In a further preferred embodiment, the spool is attached to the handle by a detachable connector. In another embodiment, the spool is attached to the handle by a detachable connector via a retainer attached to the handle.

[0055] The spool and / or retainer are detachably secured to the handle, allowing the spool to be removed from the handle. Such detachable fastening can be implemented by any suitable method known in the art, such as, but not limited to, a bayonet lock, a click closure, or a locking button.

[0056] This is advantageous in that it simplifies the handling of the delivery device. Specifically, the spool containing the preloaded wire can be removed when the preloaded wire is withdrawn from the system or is no longer needed during surgery. This makes the entire system less bulky and easier to handle. Additionally, removing the spool allows two doctors to work on the spool and handle simultaneously.

[0057] The spool may be constructed in any suitable manner, as long as it can wind up the preload wire. In a preferred embodiment, the spool includes a removable lid to allow for proper winding of the preload wire. Winding the preload wire on the spool facilitates handling of the preload wire. The distal end of the preload wire, released from the distal tip of the catheter, is pulled out of the spool and pulled further distal to the distal end of the catheter to be captured by a snare device, allowing the guide catheter to be guided from the distal end portion of the preload wire to a position adjacent to the desired treatment site of the intraluminal prosthesis. Alternatively, the preload wire can be wound onto the spool and retracted from the desired treatment site, or it can be completely wound onto the spool and completely withdrawn from the blood vessel.

[0058] In a system including a prosthesis with two, three, four, five, or more fenestrations or side branches, each fenestration or side branch may be provided with a preload wire. Each preload wire extends from a position close to the distal opening of the prosthesis to a spool attached to the handle at the proximal end of the catheter. In one embodiment, each spool is separately secured to the handle via a retaining device or via a retaining device and a removable spool connector.

[0059] In another embodiment, two, three, four, five or more spools are arranged in parallel, all of which are attached to the handle via a single fixed retainer or via a retainer and a removable spool connector. When multiple spools are used in parallel, each spool moves independently. In a preferred embodiment of the present invention, adjacent spools operate in opposite winding directions, and the preload wires are positioned on the handle at a sufficient distance from each other, so that each spool can be operated individually easily and conveniently.

[0060] In a preferred embodiment, the intraluminal prosthesis is a prosthesis for repairing a thoracoabdominal aortic aneurysm and includes four side branches extending into the lumen of the body through four openings in the side wall of the hollow cylindrical body. Each side branch houses a preload wire. The delivery device handle comprises four spools, each spool housing one preload wire. Each preload wire extends from the spool around which its proximal portion is wound, through the handle, along the catheter shaft, and further along the outside of the main lumen of the intraluminal prosthesis to one opening or window in the side wall of the prosthesis body, through the opening, through the lumen of the side branch, and to a position close to the distal opening of the main lumen of the prosthesis.

[0061] In a more preferred embodiment, two sets of two spools are each connected to a handle via a single retainer, and each of the two sets of two spools can be operated independently. In an even more preferred embodiment, the two spools connected to the handle via a single retainer operate in opposite winding directions. [Brief explanation of the drawing]

[0062] Exemplary embodiments of the present invention are shown in the drawings and will be described in more detail below with reference to them.

[0063] [Figure 1] This is a diagram illustrating the system according to the present invention.

[0064] [Figure 2] This figure shows an intraluminal prosthesis equipped with a preload wire according to the present invention.

[0065] [Figure 3] This is a schematic diagram of a portion of the handle of a delivery device according to the present invention, including a spool for winding a preloaded wire.

[0066] [Figure 4]This is a schematic diagram of a portion of the handle of a delivery device according to another embodiment of the present invention, including a spool for winding a preload wire. [Modes for carrying out the invention]

[0067] Figure 1 shows an exemplary embodiment of the system (1) of the present invention. The intraluminal prosthesis delivery system (1) includes a delivery catheter (20) and a prosthesis (10) to be delivered. The delivery catheter (20) includes a catheter tip (21), a catheter shaft (22), and a handle (30) for positioning the prosthesis. Optionally, the catheter may further include a guidewire lumen (23) for housing a guidewire (not shown). The prosthesis, positioned proximal to the catheter tip (21) and loaded in the distal region of the catheter shaft (22), includes a hollow cylindrical body (11) having side walls (112), a proximal opening (113), and a distal opening (114), and a main lumen (115) extending between the two openings. The system (1) further includes a preloaded wire (40) that extends through at least a portion of the main lumen (115) of the prosthesis (10), the preloaded wire extending distally to a position close to the distal opening (114) of the prosthesis (10), and proximal to the proximal opening (113) of the prosthesis, along the catheter shaft (22) to a handle (30). The handle (30) comprises at least one spool (50) that accommodates the proximal end (441) of the preloaded wire. The proximal portion of the preloaded wire (40) is wound on the spool (50).

[0068] In Figure 1, the distal end of the preload wire (40) is located adjacent to the distal opening (114) of the prosthesis (10). In another embodiment, the distal end of the preload wire (40) may be detachably captured within the catheter tip (21).

[0069] As described above, the prosthesis may be a bare stent, a graft, a stent graft, or any combination thereof. The prosthesis (10) shown in Figure 1 includes a single fenestration (60) in the side wall (112) of its hollow cylindrical body (11). As shown in Figure 1, the preload wire (40) extends from the spool (50) at the proximal end of the catheter (28) to a position outside the main lumen (115) in the proximal region of the prosthesis, enters the lumen (115) of the prosthesis through the fenestration (60) in the side wall (112) of the hollow cylindrical body (11) of the prosthesis, and extends through the lumen (115) to a position adjacent to the distal end of the prosthesis (114).

[0070] Generally, the prosthesis does not need to include a fenestration. However, it is preferable that the prosthesis includes at least one fenestration. Alternatively, the prosthesis may further include a lateral branch (70) extending from a fenestration (60) in the side wall (112) of its hollow cylindrical body (11), the lateral branch (70) having a first lateral branch opening (771), a second lateral branch opening (772), and a lateral branch lumen (773) extending between the first lateral branch opening (771) and the second lateral branch opening (772), wherein the first lateral branch opening (771) is firmly connected on the prosthesis material to the periphery (60) of the fenestration (60) in the side wall (112) of the hollow cylindrical body (11) of the prosthesis. Such a side branch (70) may enter the main lumen (115) through an opening (60) in the side wall of the hollow cylindrical body (11) of the prosthesis and extend distally within the main lumen. In the latter case, the preload wire (40) extends from the spool (50) at the proximal end of the catheter (28) to a position outside the main lumen (115) in the proximal region of the prosthesis (10), enters the main lumen (115) of the prosthesis through the opening (60) and side branch lumen (773) in the side wall of the hollow cylindrical body (11) of the prosthesis, and extends distal to a position distal to the distal end of the prosthesis (114) through the lumen (115) of the prosthesis body (11).

[0071] In another embodiment, the prosthesis includes four side branches (70a, b, c, d) extending from four openings (60a, b, c, d) in the side wall (112) of its hollow cylindrical body (11), each side branch housing a preload wire (40a, b, c, d).

[0072] Figure 2 shows a schematic diagram of one embodiment of the intraluminal prosthesis (10) used in the present invention. Generally, it will be understood that a prosthesis has a compressed form for delivery when loaded into a catheter, and an expanded form after being placed in the body. Figure 2 shows the prosthesis in its expanded form.

[0073] This prosthesis is designed for the repair of thoracoabdominal aortic aneurysms. The body (11) of the prosthesis has three parts: a proximal part (P), a distal part (D), and an intermediate part (M) between them, the diameter of which is smaller than the diameters of the distal part (D) and the proximal part (P). The prosthesis (10) includes four side branches (70a, b, c, d) that extend into the lumen (115) of the body from four openings (60a, b, c, d) in the central part (M) of the side wall (112) of the hollow cylindrical body (11). Each side branch (70a, b, c, d) accommodates a preloaded wire (40a, b, c, d). The handle (30) of the delivery device (not shown) comprises four spools (50a, b, c, d) (not shown), each spool housing one preload wire (40). Each preload wire (40a, b, c, d) extends from the spool (50) around which the proximal portion of the preload wire (40) is wound, through the handle (30), along the catheter shaft (22), and further along the outside of the main lumen (115) of the intraluminal prosthesis (10) to one of the windows (60a, b, c, d) in the side wall (112) of the hollow cylindrical body of the prosthesis, enters through the windows (60a, b, c, d), passes through the lumens (773a, b, c, d) of the side branches, and extends within the main lumen (115) of the prosthesis (10) to a position adjacent to the distal opening (114) of the main lumen (115).

[0074] The system for repairing thoracoabdominal aortic aneurysms according to the present invention has several advantages compared to the prior art. Firstly, the prosthesis of the present invention, preferably self-expanding, is a vascular prosthesis system that can successfully bridge a thoracoabdominal aortic aneurysm while ensuring reliable blood delivery to branched side vessels. This is achieved by connecting an additional connecting stent / connecting stent graft positioned inside the main lumen of the vascular prosthesis. The inward branching of the side vessels ensures sufficient space for the vascular prosthesis within the vessel when the vascular prosthesis is opened, while simultaneously maintaining the function of the branch vessels. The inward branching of the side vessels has the advantage of a longer overlap zone with the connecting stent / connecting stent graft for the branched side vessels. Furthermore, because this system has high flexibility due to its specific configuration in which the side vessels branch inward toward the main lumen, it does not require the fabrication of a special prosthesis for each patient being treated, taking into account the specific arrangement and dimensions of the side vessels, and can be fabricated in advance for many patients.

[0075] Furthermore, preloaded wires allow for relatively easy and rapid access to branched or diverging side vessels. Each side vessel has its own preloaded wire, avoiding the time-consuming process of searching for a fenestration, thus enabling rapid access to the side vessels. Additionally, because access to the branches is in the direction of blood flow in each side vessel, bridging stents can be placed smoothly, reducing the risk of failure when restoring blood flow to the branch vessels.

[0076] Figures 3 and 4 show two exemplary embodiments of a portion of a handle (30) and a spool structure (57) attached to the handle (30) via a retainer (51). The spool structure (57) may be a single spool (50) or may include two spools (50a, 50b) arranged in parallel, as shown in Figure 3. The spools (50) and / or the retainer (51) are fixed to the handle. In Figure 3, the spools (50) and / or the retainer (51) are firmly fixed to a gadget (552) in the handle (30) for housing the spool retainer (51). The retainer can be fixed to the handle by any known suitable means, e.g., adhesive, or by any mechanical connection means, e.g., snap fasteners or screws. The handle (30) shown in Figure 3 is designed to accommodate two sets of two spools arranged in parallel. Figure 3 shows two spools (50a, 50b) connected to a handle (30) via a single retainer (51), but the handle (30) in the figure is further provided with a second gadget (552) for housing a third spool or a pair of two spools. As shown in Figure 3, the two spools (50a, 50b) are connected to the handle (30) via a single retainer (51), and each spool (50a, 50b) can be operated separately. The handle (30) is shown to be able to house four spools, but it will be apparent to those skilled in the art that the handle (30) can be easily designed to hold one single spool, two single spools, one double spool (i.e., a pair of two spools) and one single spool, or two double spools.

[0077] In another embodiment (not shown), each holder can hold two, three, four, five or more spools arranged in parallel, and each spool can be operated independently.

[0078] In a more preferred embodiment of the present invention, a plurality of spools held via a single holder are arranged in parallel but operate in opposite directions. That is, the first spool winds the first preload wire in a first winding direction, and the adjacent second spool winds the second preload wire in a second winding direction opposite to the first winding direction. Because the winding directions are opposite in this way, the two preload wires are positioned opposite each other, allowing each preload wire to be handled easily and conveniently.

[0079] Each spool (50) houses one preload wire (40). The proximal end (441) of the preload wire may be detachably fixed to the spool with the preload wire fitted into a recess (not shown) of the spool. The proximal portion of the preload wire (40) is wound on the spool (50). As can be seen in the figure, the preload wires (40a, 40b) enter a handle (30) with a seal (80) and extend along the catheter to a prosthesis (not shown).

[0080] The spool (50) is covered with a removable lid (55) to keep the preloaded wire (40) wound around the spool (50). During the procedure, the preloaded wire (40) can be wound onto or withdrawn from the spool (50) as needed for the distal end of the preloaded wire (40). Having the preloaded wire (40) wound around the spool (50) makes the entire system very compact and easy to handle. It also eliminates the need to handle long wires during the implantation procedure and helps maintain sterility. The spool can also be removed from the handle (30), allowing the catheter and preloaded wire (40) to be operated separately. Furthermore, when the preloaded wire (40) is no longer needed, the preloaded wire can be fully retracted (wound), and the spool with the preloaded wire wound around it can be removed from the handle.

[0081] Figure 4 shows a part of the handle (30) and a spool structure (57) attached to the handle (30) via a retainer (51), similar to the embodiment shown in Figure 3. However, the spool structure (57) shown in Figure 4 is attached to the handle via a retainer and a removable spool connector (52). Similar to the embodiment in Figure 3, the spool structure (57) may be a single spool (50), or it may include two spools (50a, 50b) arranged in parallel, as in Figure 3. As described above, the spool structure may include three, four, five or more spools arranged in parallel.

[0082] As can be seen from the figure, since the winding directions of the two spools (50a, 50b) shown in Figure 4 are opposite, the preload guide wires (40a, 40b) pass through both sides of the retainer, making it easy to handle, wind, or withdraw only one of the preload wires during the endovascular prosthesis placement process.

[0083] In the embodiment shown in Figure 4, the removable spool connector (52) is configured to allow the spool assembly (57) to be removed from the handle via a click closure including a spring button (58). In another embodiment, the removable connector is embodied in a suitable manner known in the art, such as a bayonet lock or a click closure, but is not limited to the following.

[0084] While this specification describes the disclosed subject matter with reference to specific embodiments, those skilled in the art will understand that various modifications and improvements can be made to the disclosed subject matter without departing from its scope. Furthermore, while individual features of one embodiment of the disclosed subject matter may be described in that embodiment (and not in other embodiments) or shown in the drawings corresponding to that embodiment, it will be apparent that these individual features can be combined with one or more features of another embodiment or one or more features of other embodiments.

[0085] Furthermore, the disclosed subject matter is not limited to the various embodiments described in the drawings and claims, but also relates to other embodiments having any other possible combinations of the dependent features described in the claims below and the features disclosed above. Thus, it will be understood that the disclosed subject matter also relates to other embodiments having any other possible combinations, since the individual features described in the dependent claims and disclosed above can be combined with each other in other ways within the scope of the disclosed subject matter. Accordingly, the above descriptions relating to specific embodiments of the disclosed subject matter are presented for illustrative and explanatory purposes only. The above descriptions are not intended to be exhaustive or to limit the disclosed subject matter to the disclosed embodiments.

[0086] It will be apparent to those skilled in the art that many modifications, variations, and equivalents exist for the particular embodiments described above. The scope of this disclosed subject matter is defined not only by the following claims but also by the modifications, variations, and equivalents that will be apparent to practitioners familiar with the art. Thus, the disclosed subject matter includes the modifications and variations of the appended claims and their equivalents. [Explanation of Symbols]

[0087] System (1) Intraluminal prosthesis (10) Delivery catheter (20) Catheter tip (21) Catheter shaft (22) Proximal end of the catheter (28) Handle (30) Hollow cylindrical body (11) Hollow cylindrical body side wall (112) Proximal opening (113) Distal opening (114) Main lumen(115) Preload wire (40) Spool (50) Spool structure (57) Proximal end (441) of the preload wire (40) Fenestration(60) Side branches (70) First lateral branch opening (771) Second lateral branch opening (772) Side branch lumen (773) Lumen for guidewire (23) Spool holder (51) Removable spool connector (52) Removable lid (55) Spring button (58) Spool receiving gadget (552) Seal (80)

Claims

1. A delivery system for intraluminal prostheses (1), The delivery system (1) includes a delivery catheter (20) and a prosthesis (10) to be delivered. The delivery catheter (20) includes a catheter tip (21), a catheter shaft (22), and a handle (30) for positioning the prosthesis (10). The prosthesis (10) comprises a hollow cylindrical body (11) having side walls (112), a proximal opening (113), and a distal opening (114), and a main lumen (115) extending between the two openings. The prosthesis (10) includes at least one lateral branch (70), the lateral branch (70) includes a hollow cylindrical lateral branch body having a lateral wall, a proximal opening and a distal opening, and a lateral branch lumen (773) extending between the two openings, the lateral branch lumen (773) being in fluid communication with the main lumen (115), The delivery system (1) further includes a preloaded wire (40;441) that extends through at least a portion of the main lumen (115) of the prosthesis (10), the preloaded wire (40) extending distally to a position close to the distal opening (114) of the prosthesis (10), and proximal to the proximal opening (113) of the prosthesis (10) along the catheter shaft (22) to the handle (30), The handle (30) comprises two spools (50a, 50b) that house the proximal ends of the preload wire (441), the proximal portions of the preload wire (40) are wound around the two spools (50a, 50b), the two spools (50a, 50b) are attached to the handle (30) via a holder (51), the two spools (50a, 50b) are arranged in parallel, but the winding directions of the two spools (50a, 50b) are opposite, so that the two preload wires (40a, 40b) are in opposing positions, and the two spools (50a, 50b) operate in opposite directions to each other. system.

2. The system according to claim 1, wherein the prosthesis (10) is a stent, a graft, a stent graft, or a combination thereof.

3. The system according to claim 1, wherein the prosthesis (10) includes at least one opening (60) in the side wall (112) of its hollow cylindrical body (11).

4. The system according to claim 3, wherein the preload wire (40) extends from two spools (50a, 50b) at the proximal end of the catheter to a position outside the main lumen (115) in the proximal region of the prosthesis (10), enters the lumen of the prosthesis through an opening (60) in the side wall of the hollow cylindrical body (115) of the prosthesis, and extends through the lumen to a position close to the distal end of the prosthesis.

5. The system according to claim 1, wherein the preload wire (40) extends from two spools (50a, 50b) at the proximal end of the catheter to a position outside the main lumen (115) in the proximal region of the prosthesis (10), enters a side branch lumen (773), passes through the side branch lumen and enters the main lumen (115) of the prosthesis, and extends to a position close to the distal end of the prosthesis.

6. The system according to any one of claims 1, 2, 3, 4, or 5, wherein the prosthesis includes four lateral branches (70a, b, c, d), each lateral branch having a lateral branch lumen, each lateral branch lumen being in fluid communication with the main lumen (115), and each lateral branch lumen accommodating a preload wire (40).

7. The system according to any one of claims 1, 2, 3, 4, or 5, wherein the delivery catheter (20) further includes a guidewire lumen (23) for housing a guidewire.

8. The system according to any one of claims 1, 2, 3, 4, or 5, wherein the two spools (50a, 50b) are removable from the handle (30).

9. The system according to claim 8, wherein the two spools (50a, 50b) are attached to the retainer (51) by a removable connector (52).

10. The system according to any one of claims 1, 2, 3, 4, or 5, wherein the handle (30) includes at least one seal (80) for each preload wire housed in the system.

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