Tubular medical device

Abstract

To provide an apparatus that implants a tubular device to reduce a risk of an adverse event due to manipulation of devices through a lumen of a natural vessel to enable access for subsequent procedures via a dilated lumen.SOLUTION: An apparatus for progressively dilating a lumen of a narrow natural vessel such as an iliac artery and implanting a tubular device (240) enabling access through the dilated lumen to conduct subsequent procedures via the dilated lumen, includes an inflatable integrated balloon (245) locatable at least partially within the tubular device, the tubular device (240) having a length L1 providing a self-expanding tubular body having at least a portion (250) including stents (244), so that when the integrated balloon (245) is removed, the dilated lumen of the natural vessel remains dilated and is supported by the tubular device (240).SELECTED DRAWING: Figure 24

Description

[Technical field]

[0001] The present disclosure relates to medical devices, particularly those used in treating defective natural segments of the vascular system. The present disclosure relates to grafts and delivery systems for such grafts for use in The present invention relates to methods, delivery systems, and devices useful in the narrow lumens of native blood vessels. ,There exists a significant and heretofore unmet need for such techniques and apparatus. Without limitation, it will be described with reference to the vascular system. [Background technology]

[0002] Arteries can be affected by stenosis, which is when the lumen within the artery becomes abnormally narrowed over time. Such stenosis can lead to adverse effects, including blockage of arteries, restriction of blood supply to tissues, and increased blood pressure. In particular, the iliac artery is difficult to access due to its tortuous nature and narrow lumen. In elderly patients, these arteries are more susceptible to disease caused by atherosclerosis or calcification. Iliac artery occlusion can lead to reduced mobility, fatigue, and leg pain. It can lead to leg problems such as cramps and, if left untreated, can be fatal in people with diabetes. In some cases, this can lead to tumor and tissue necrosis. Although surgical intervention is sometimes possible, endovascular treatment, which is a minimally invasive technique, is often not available to patients. This provides a more effective treatment approach with fewer risks.

[0003] A typical endovascular treatment is endovascular aneurysm repair (EVAR). Typically, the procedure involves: The endograft on the delivery system is inserted into the femoral artery via a groin incision. By inserting the catheter along the guidewire, the catheter can be inserted into the major blood vessels of the vascular system. However, the delivery method includes the step of accessing the aneurysm site at one of the aneurysm sites. If any part of the vascular pathway used is occluded, excessively tortuous, or In cases where patency is limited, such as in the case of arterial stenosis, such an approach may be hindered. may be prevented or prevented.

[0004] In endovascular procedures, a manufactured medical device containing a tubular component is inserted into a diseased portion of a natural blood vessel. as a replacement graft for diseased or weakened parts of natural blood vessels, or to replace diseased or weakened parts of natural blood vessels As a prosthetic support for the natural or native blood vessels that form part of the vasculature Insert. Summary of the Invention [Problem to be solved by the invention]

[0005] The present disclosure relates to intravascular devices that may be useful in treating patients suffering from defects and weaknesses in the vascular system. In particular, the present invention relates to the treatment of stenosis in the native iliac vessels, including the common iliac artery, the internal iliac artery, and the external iliac artery. The device is intended for patients who need treatment for vascular stenosis.

[0006] The iliac arteries typically have a small luminal diameter, limiting access to the vessels and making intravascular Treatment requires low-profile instruments. Such treatments are often used as an introduction to The introducer sheath is used to insert the catheter, introducer, Or, an access guidewire is guided to deliver instruments to a target site within the vascular system. The purpose of endovascular treatment is to insert a tubular device to bridge diseased or weakened sections of an artery. By providing a replacement lumen between the remaining healthy parts of the artery, However, the iliac artery is susceptible to injury, such as sheath-induced laceration. It has been observed that removal of the introducer sheath may cause iliac artery occlusion. Unintentionally rupturing a vein or exposing a weak spot that can be ruptured by abrasion. Therefore, it is not known whether the iliac vessels can be used to deliver the drug to a target site in the vasculature. Access to deliver instruments to the fossa is difficult.

[0007] Such tubular devices typically comprise a physiologically acceptable tubular support formed in a tubular sleeve. The tubular sleeve is constructed from a woven fabric. The tubular sleeve is configured in a folded or folded configuration within the delivery system. The device is delivered in a compact configuration and can be expanded using a balloon device or an attached elastic stent. The expandable balloon device or attached elastic stent may be inserted into the tubular strut and expanded at the target site. Supporting the septum and maintaining its lumen open to permit fluid flow through the tubular sleeve. It can be made possible.

[0008] Limited access to and through the native iliac vessels As this is expected, a preliminary approach with imaging and preparation for transplantation of an appropriate graft is required. Assessment indicates that appropriate treatment requires access through and beyond the target vessel. It may be shown that successive expansion steps are necessary to improve performance. The successive dilation steps aim to gradually enlarge the target vessel with each step. The expansion can be accomplished using an inflatable balloon device. However, inserting such a balloon device into a vessel of the vascular system requires multiple introductions. A inducer sheath / catheter must be used, which must also be inserted and removed sequentially. These actions can damage the wall of the vessel that has been penetrated. Even when expanded, the expansion achievable may be inconsistent with the intended graft and its associated delivery system. In some cases, the surgical incision may be insufficient to allow access to the stem. Due to these issues, it may still be necessary to intentionally disrupt the target vessel. It would be beneficial if at least some of this could be mitigated or alleviated. [Means for solving the problem]

[0009] The present disclosure relates to a method for expanding the lumen of a native blood vessel to provide access through the expanded lumen of the native blood vessel. The present invention provides a method for treating a vascular graft, comprising the steps of: implanting a tubular device in a vascular graft; Reduces risk of adverse events and allows access for subsequent procedures through an expanded lumen This invention relates to an apparatus for

[0010] Devices for expanding the lumen of native blood vessels include removable expansion devices such as inflatable balloons. and a self-expanding device having at least a portion into which a stent is inserted. and a support component, such as an expandable tubular body, that supports the expanded lumen. This allows the remaining luminal support component to remain when the expansion component is removed. The dilated lumen of the native blood vessel thus remains dilated.

[0011] Native vessels are parts of the vascular system, particularly narrow or tortuous natural vessels such as the iliac arteries. Thus, the present disclosure provides an improved intravascular dilation device that is in tubular form, A delivery system for an internal dilatation tubular device and a method for treating a natural blood vessel having a narrow and tortuous lumen of the vascular system The present invention also relates to an approach for addressing problems associated with the use of an implantable intravascular dilation device having a tubular configuration. It expands from its initial compact configuration within a removable sheath for subsequent endovascular intervention. Therapeutic (e.g., instruments, devices, and materials) beyond the implanted tubular intravascular dilation device. Provides access for the patient to advance to another treatment site.

[0012] The presently disclosed delivery system for a tubular device, such as an intravascular tubular device, includes a delivery shaft. The balloon also provides a compact form within the tubular device. and can be delivered within an intravascular dilation device in a compact form within a removable sheath. In one embodiment of a typical use of the system and tubular device, an expandable tubular device Both the balloon and the integrated balloon are used to initiate the initial dilation of the native vessel. They are delivered simultaneously on the same delivery shaft in a compact form within a removable sheath. The device includes a self-expanding tubular body having at least a portion thereof with a stent inserted therein. Therefore, when the removable sheath is removed, the tubular device expands immediately and the integral balloon The only limit is the extent to which the natural blood vessels are expanded by the expansion of the tube. During use, expansion of the lumen of the native vessel is initiated by the integrated balloon. Once the tube is removed, it is retained by the tubular device.

[0013] The intravascular tubular device comprises a fabric sleeve and a tubular support member extending along at least a length of the fabric sleeve. and a plurality of ring stents attached to the thickness portion.

[0014] The expansion of the luminal dimension of a native vessel using a dilation device involves successive steps; The loon is expanded and then the integral balloon on its delivery shaft is removed to release the expansion capacity inserting at least one further delivery shaft carrying a higher balloon; In the narrow, thin, and possibly tortuous lumen of natural blood vessels, the desired degree of freedom from It will be appreciated that care must be taken during expansion to avoid adverse events. A careful approach using multiple balloons to increase expansion capacity in successive steps , the risks associated with the necessary complex procedures can be minimized.

[0015] The apparatus for accomplishing this sequential expansion procedure comprises an expandable tubular device and an integral balloon. A delivery system including a delivery shaft with a catheter and an integrated balloon is used to deliver the catheter. a plurality of expanding catheters each of which is deliverable on a delivery shaft after the expansion of the catheter; and an expandable balloon. Native blood vessels with a lumen are suitable for any endovascular treatment (EVAR, TEVER, TAVR and others). Acceptable delivery systems suitable for delivery of the device on delivery systems such as those required for the The catheter may be expanded in successive steps until the desired lumen size is reached. Even when it is necessary to split open natural blood vessels with tortuous and narrow lumens, tubular instruments Through the dilation procedure, it acts as a substitute for the torn part of the natural blood vessel and remains in place after the dilation procedure. The device is then inserted into the graft and the open portion of the expanded native blood vessel is bridged, allowing the device to be delivered and the procedure to be completed. Thus, the present disclosure provides a method for performing a procedure that would otherwise require open surgery. It provides access through natural lumens that are difficult to use without extensive surgical intervention, e.g. For example, in the case of a site of a natural blood vessel having a twisted and narrow lumen, a surgical intervention by laparotomy is required. To reinforce or replace a tortuous, narrow lumen with the aim of performing endovascular treatment without It will be understood that.

[0016] In an embodiment, the present invention provides a method for supporting a dilated native blood vessel and maintaining the patency of the dilated native blood vessel. The tubular device used to hold the patient in place is, for example, a self-expanding stent made of a shape-memory material. The stent may be a complete intraluminal tubular body incorporating a stent including:

[0017] In some alternative embodiments, a dilated natural blood vessel is supported, and the dilated natural blood vessel is Tubular devices used to maintain the patency of natural blood vessels are used to dilate natural blood vessels. The catheter may be a fully endoluminal tubular body that is passively expanded under the control of a balloon that is .

[0018] In an embodiment, the present invention provides a method for supporting a dilated native blood vessel and maintaining the patency of the dilated native blood vessel. The tubular device used to hold the device in place is preferably made of a material such as a shape memory material, with only the length of the tubular device being made of a material such as a shape memory material. The present invention relates to a hybrid stent, which is an intraluminal tubular body incorporating a stent including a self-expanding stent. It may be a lid device.

[0019] In an embodiment, the device in kit form suitable for intravascular use comprises a removable seal. a tubular body configured for insertion into a lumen of a natural vessel of the vascular system in a compact form within the sac; In combination with an intravascular dilation device, a delivery shaft, and a removable identical sheath. The integrated device is configured to be inserted into the lumen of a natural vessel of the vascular system in a compact form within the catheter. A delivery system including a balloon, the balloon defining a maximum potential expansion size of the tubular body. a delivery system that is smaller than the conventional method; and a different method for continuous use in expanding the tubular body. a plurality of expandable balloons having an expanded size of: A compact catheter on a delivery shaft for use in gradually expanding the lumen of a native vessel in the vasculature. and a balloon that is in turn insertable into the lumen in a flexible configuration. a shaft, a flexible delivery shaft, and optionally a guidewire or catheter. It's fine.

[0020] A tubular body that expands simultaneously with the integral balloon or any subsequent balloons is used to It expands the lumen of the blood vessel, preventing the collapse of the natural blood vessel after the balloon is removed, and Alternatively, the integrated balloon may be used to maintain the patency of the dilated lumen of the natural vessel. The combination acts through the tubular body as an intravascular dilation device in the intraluminal dilation device. You can think that it works.

[0021] In an embodiment, the tubular body is adapted to be delivered with an integral balloon on a delivery shaft. The tubular body may be fully compressed within the removable sheath, as shown in FIG. The tubular body may be configured to be completely placed in place by treatment. , completely self-expanding when the delivery system and any lumen-expanding balloon are removed. In order to achieve this, the stent can be fully stented with a sufficient number of self-expanding stents over its entire length. do.

[0022] The tubular devices suitable for use as intravascular dilation devices disclosed herein include removable The catheter is configured for insertion into the lumen of a native vessel of the vascular system in a compact form within a suitable sheath. The tubular body has a length L, and at least one tubular length portion L 1 teeth , which are initially covered but then can expand within the lumen of the native vessels of the vascular system, and one further tubular length L 2 The present invention allows the use of an elastic support for the placement of the tubular body. , on the elastic support. This allows the tubular length L 1 A, natural blood vessels and releasing it from the removable sheath into the lumen of a native vessel of the vascular system. A release aperture can be provided.

[0023] The elastic support may be an elongated catheter, an elongated flexible shaft, or an elongated guidewire. The resilient support may include a malleable material forming a metal rod; Alternatively, metal rods co-extruded with a flexible polymer resin or flexible composite resin coating. A rod or coil may be used to form the delivery shaft. The delivery shaft may be formed from a natural blood vessel. To aid in locating or accessing a portion of tissue adjacent to a duct or native blood vessel; It can be shaped by the user during the procedure. The malleable material can be stainless steel or may be a metallic material such as a shape memory alloy.

[0024] In an embodiment, the tubular length L 2 forms part of a delivery system for a tubular device or a related elongated catheter, elongated flexible shaft, or elongated guide The tubular length L has an internal valve that provides a fluid-tight seal around the wire. 2 Is, heaven A surgical procedure aimed at repairing deteriorated parts of natural blood vessels, e.g. blood vessels in the vascular system It provides an access route for the delivery system, which is required for the intravascular step.

[0025] Optionally, use an external tool to cut the length part L 2 Clamp the lid, for example, to the heavens being treated. The placement, deployment, or manipulation of an instrument within or through a tubular body within a natural blood vessel. As a hemostatic or water stop valve to minimize blood loss at any stage of the procedure, It can provide control,

[0026] Tubular length L 2 does not require any internal support, such as a stent, along its entire length. No, but corrugated or pleated fabrics that are fluid impermeable or negligibly permeable The sleeve may include a

[0027] Unstented tubular length L 2 The casing has externally attached tabs for easy handling. Or it may have a ribbon loop.

[0028] In the embodiment, the length portion L 2 is the tubular length L that can be placed within the lumen of a native blood vessel. 1 twist may also be significantly shorter.

[0029] When properly compressed within the sheath of the delivery system or delivery device, the lumen of the native blood vessel The outer width dimension that fits within the tubular may range from 3 mm to 6 mm. device, and maintaining the tubular device in a compact configuration for delivery into the lumen of the native blood vessel. The sheaths used can range from about 6 to 18 French.

[0030] The removable sheath is made of a physiologically compatible material such as polytetrafluoroethylene (PTFE). Can be made from benign low-friction or slippery polymeric materials; alternatively, removable The sheath may be made of polyethylene terephthalate (PET). The materials used are biocompatible and easily pass through natural or artificial blood vessels without adhesion. The removable sheath shall be surface treated. For example, the substrate may be provided with a hydrophilic coating to impart or enhance hydrophilic properties. It's fine.

[0031] Suitable polymeric flexible materials for the removable sheath include nylon, polyurethane, and polyester. Polytetrafluoroethylene (PE), Polytetrafluoroethylene (PTFE), Expanded polytetrafluoroethylene Polyethylene (ePTFE), Fluorinated Ethylene Propylene, Polyether Block Amide (P EBA), polyimide, polyether ether ketone, and polybutylene terephthalate The polymer may be selected from thermoplastic polymers, elastomers, and copolymers such as tungsten.

[0032] The sheath may be attached to the device using a handle, draw wire, or strap. It can be removed by pulling it with a

[0033] The sheath tears (ruptures) in a predictable and controllable manner under the application of an appropriately applied force. Such forces can be achieved by designing a slit that can be built into the delivery system. Such a force is applied using a pulling tool. The tubular body can be broken apart along its length to release the tubular body.

[0034] In an embodiment, the splittable sheath is adapted to be stented after placement within the native vessel. to a hub including a splitter mechanism that facilitates removal of the retracted sheath from the tubular portion; It is storable.

[0035] In an embodiment, the splitter mechanism includes a slitter blade extending in a proximal-distal axial direction of the tubular body. It includes one or more passive (static) slitter elements arranged to present an edge. The sheath may be arranged to cover these slitter blade elements of the passive slitter element. It is split by retreating against the edge.

[0036] In an embodiment, the splitter mechanism may be provided on or within the hub. It may include a pair of slitter elements.

[0037] The splitter mechanism separates the splittable sheath at one or more locations and separates at least one The sheath may be formed in one piece or in several pieces, e.g., in a longitudinal direction, by forming two longitudinal slits. It is possible to split it in half.

[0038] The slitter elements are made of a plastic material such as polyamide (e.g., nylon). It's fine.

[0039] In an alternative embodiment, the splittable sheath may include tear lines, perforations, pre-cuts, etc. By incorporating segments or introducing sutures that facilitate separation in a controlled manner The adhesive may be designed to be pulled apart, peeled away or otherwise separated.

[0040] An option for such an embodiment is a retractable, splittable sheath through which the catheter passes and the splittable sheath passes. A thin pull strand is attached to the distal end of the splittable sheath, for example by suturing. The pull strand returns to the proximal end over a splittable sheath. The splittable sheath is thin enough to split the splittable sheath when it is drawn over the splittable sheath. The user pulls the pull strand outward from the proximal end of the pull strand. The distal end of the strand lifts, initiating splitting of the splittable sheath by the pull strand. As the user continues to pull the pull strand externally, the splittable sheath splits from the distal end to the proximal end. The proximal end of the splittable sheath is pulled apart for retrieval of the split sheath. It may be attached to a wire or pull strap.

[0041] the tubular body, when released into the target native blood vessel, forms a restored lumen for blood flow; Facilitates passage of instruments through native blood vessels.

[0042] Length of tubular body L 1 is permanently inserted to maintain the expanded dimensions after the expansion step. The catheter may be formed of a readily expandable material.

[0043] In the embodiment, the length L of the tubular body 1 Expanded polytetrafluoroethylene (eP It may be made of TFE or polyester fabric.

[0044] Any physiologically inert or benign material, such as polyester, can be used to wick air. The tubular body may be formed to be substantially impermeable to fluids and body fluids, including:

[0045] The prosthetic grafts commonly used for such replacements are typically woven or knitted. It is made of polyester fabric obtained by mixing with gelatin or collagen. It may be sealed with a sealant.

[0046] The tubular body is made of ePTFE, PTFE or polyester, polyethylene or polypropylene. They may be made of soft fabric (usually knitted or woven) and have properties that reduce friction. Optionally, the drug may be coated to prevent clotting and deliver the drug. The fabric generally has at least Both surfaces will be porous.

[0047] When the balloon device is used to expand the lumen of the native blood vessel, the length of the tubular body L 1 but The balloon device can be expanded. 5571(A2) and European Patent Application Publication No. 2676639(A1). A balloon device representative of a suitable device is known in the art. Typically, the delivery shaft or catheter is a tubular catheter. A balloon is used to expand a device, such as a balloon expandable graft as will be presented above. The Loon has a collapsible tubular shape with tapered ends. , the tubular shape is a straight tubular profile section with a distal end and a proximal end with a truncated cone. A tapered section of the tubular element can be presented, the tapered section being on or fixed to the tubular element, and usually includes a delivery wire into such tubular element. Accepts the passage of ears, shafts or catheters. Straight tubular profile section The graft may be expanded into a hollow cylindrical shape. Such devices are attached to the exterior surface of a straight tubular section. In conjunction with the deployment of the tubular body, a clear passageway is provided for accessing the stenotic portion of the native blood vessel. The present invention is useful for expanding the lumen of a natural blood vessel, providing a passageway therethrough.

[0048] Length of tubular body L 1 is designed to receive a balloon associated with the delivery system. The balloon may be removed along with the delivery system. Devices such as tubular body grafts with balloon expandable components, delivery systems for such devices The stem and balloon are attached together as an assembly by a release wire. The balloon may be an integral part of the delivery system for insertion into the patient. The stem and balloon are removed following delivery, placement and release of the device.

[0049] Length of tubular body L 1 The expanded profile is supported by one or more stent elements. The balloon may be supported by a file, thereby allowing the enlarged lumen to remain open even after the balloon is removed. The width dimension is maintained. Length section L 1 The present invention relates to a method for producing a tubular body that can be inserted into the lumen of a natural blood vessel. Because it is a part of the internal section, it may be referred to below as the "internal section."

[0050] The stent elements may include ring stents, at least some of which may include a septum. Suitable stents are described in WO 2012 / 164292 (A1 ) issue.

[0051] Length of tubular body L 1 is a normal natural blood vessel, i.e., not constricted, diseased, weakened or The catheter is expandable to a width dimension that exceeds the size of the lumen of a native blood vessel not affected by the stenosis. The length L of the tubular body may be 1 can be used to dilate the iliac vessels and A reinforced graft can be provided in the iliac vessels. which provides protection against fragile blood vessels and also allows for further expansion of the delivery system Provides an opportunity for subsequent passage of components such as balloons or articles such as grafts. Provide.

[0052] In the embodiment, the length L of the tubular body 1 expands to dimensions within the range of 6mm to 14mm It may be possible.

[0053] In use, the length of the tubular body L 1 is the portion of the tubular instrument distal to the user.

[0054] Length L 2 The open lumen of the vessel is that of a normal native vessel, i.e., unconstricted and disease-free. , a size at least substantially equal to the lumen of a natural, unweakened or unstenosed blood vessel. The size of the delivery system components or compact devices can be The length part L can be set so that 2 The opening lumen is 6mm to 14mm. It may have a width dimension within a range.

[0055] In use, the length of the tubular body L 2 is the portion of the tubular instrument proximal to the user

[0056] The tubular body may include a delivery system connector that extends through the lumen of the tubular body, such as in a typical EVAR procedure. The material must be resistant to friction or physical contact resulting from repeated passage of components. The material may be a material for inserting and withdrawing the delivery system through the lumen of the tubular body. Tolerate at least 3, 4, 5, or 6 or more consecutive treatments It can be designed.

[0057] Suitable materials include expanded polytetrafluoroethylene (ePTFE) or polyester. Fabric included.

[0058] Physiologically inert or benign materials such as polyester can be used.

[0059] The prosthetic grafts commonly used for such replacements are typically woven or knitted. It is made of polyester fabric that can be used for making collagen such as gelatin. The container may be sealed with a liner.

[0060] The tubular body is made of ePTFE, PTFE or polyester, polyethylene or polypropylene. They may be made of soft fabric (usually woven or knitted) and have properties that reduce friction. Optionally, the drug may be coated to prevent clotting and deliver the drug. The fabric may be provided with at least one The surface may be porous.

[0061] In an embodiment, the material is a polyester fabric which may be woven or knitted. and may be sealed with a sealant such as gelatin or collagen. stomach.

[0062] At least a portion of the material forming the tubular body may be pleated or corrugated. A pleated fabric sleeve may be used to secure at least one portion of the tubular body. When the portion is formed, the length can be adjusted, and the tubular body can be stretched in the longitudinal direction to the desired length as needed. It can be bent in any desired direction.

[0063] As used in this disclosure, the term "pleated" refers to a generally zigzag pattern when viewed from the side. having a contoured or sinusoidal profile, a circumferential wave or helical profile; The outer surface repeats from a maximum dimension to a minimum dimension over a substantial length of the crimped portion of the tubular body. The fabric is wavy. With such a pleated profile, the vertical By stretching in the axial direction, it is possible to obtain additional length in the pleated portion of the tubular body. Alternatively, shorter lengths can be obtained by compressing the material in the longitudinal direction. In addition, the pleated surface can accommodate bending of the pleated portion, and the tubular body can be easily connected to the natural blood vessel and and from linear to curved profiles required to accommodate patient vascular variations. In addition, the corrugated surface also accommodates bending of the corrugated area. This allows for a linear to curved profile that may be required for connection to the native vessel. This is to accommodate changes in the direction of the tubular body and to take into account fluctuations in the patient's blood vessels.

[0064] In an embodiment, a portion of the tubular body has a length that includes a series of sections, each section having a The tubular body has a tab that can be gripped to facilitate trimming the length of that portion of the tubular body. do.

[0065] In an embodiment, each section has a retention loop instead of a tab to prevent the release of bodily fluids. Due to the slippery conditions of the surgical procedure, the tubular body can be grasped and trimmed. Improves ability to acquire and retain

[0066] The tabs or loops may be made of a biocompatible material that may be the same or different from the material used for the tubular body. It is possible.

[0067] In an embodiment, the tubular body includes a delivery system component or device passing therethrough. The interior is lined or coated with a low-friction or slip-promoting material to facilitate the passage of For this purpose, a PTFE liner, coating or layer may be used. may be appropriate.

[0068] The thickness of the material forming the tubular body may be in the range of 0.05 mm to 1.0 mm. , preferably 0.7mm±0.2mm.

[0069] The tubular body is supported at least in part by a resilient support, which may be a stent or a series of stent elements. A suitable stent type may be a ring stent. The availability of spiral, Z-shaped or zigzag, and tubular mesh types, as well as ring stents. Any combination of these types, with or without, may also be suitable.

[0070] In an embodiment, the tubular body has a length L, and at least one length portion L 2 Is At least one further length L that is not supported by the tent 1 Stent Thus, it may be externally or internally supported. The stent may be a self-expanding stent. The stent may be made of a shape memory material.

[0071] In an embodiment, the tubular body has a length L, and at least one length portion L 1 Few At least one further length L 2 is shorter than.

[0072] In an embodiment, the tubular body has a length L, and at least one length portion L 1 Few At least one further length L 2 Longer than.

[0073] In an embodiment, the tubular body has a length L, and at least one length portion L 1 Few At least one further length L 2 is almost the same length.

[0074] In an embodiment, at least a portion of the tubular body is tapered.

[0075] In an embodiment, at least one further length portion L 2 The width of the blood vessel is approximately the same as that of the natural blood vessel. It is tapered to match.

[0076] In an embodiment, the tubular body has at least one length L 1 And at least one The length portion L 2 and a curved portion, optionally sewn to hold the required curvature. At least one of the at least one grooves is configured to introduce a pleated fabric material. Length of part L 3 In an embodiment, at least one length portion has a length L including Minute L 3 has at least one length part L 1 and at least one length portion L 2 Between In an embodiment, at least one length portion L 3 At least one length Minute L 1 And, L 1 and at least one further length of the type.

[0077] In an embodiment, the tubular body has a length L at each end of the length L. 2 Including the length of the type, The total length L is defined by at least one length portion L therebetween. 1 It is made up of; Alternatively, the tubular body has a length L at each end thereof. 2 The total length L includes the length of the type. At least one length segment L 1 and at least one length segment L 3 and are alternately configured in succession. Therefore, the total length L includes at least one expandable portion and at least one curve. Contains.

[0078] The tubular body may have perfusion branches extending laterally therefrom.

[0079] The perfusion branch is formed of fabric attached to a tubular body and is generally The perfusion branch may be formed from the material used to form the tubular body, forming a bifurcated "Y" configuration. The perfusion branches can be made of the same materials as the natural blood vessels used in the surgical procedure. It can be anastomosed.

[0080] During use, the tubular body acts as a permanent reinforcement for the typically fragile natural blood vessels. requires dilation or expansion, or removal of an obstruction or luminal restriction, for access In this way, the catheter is retained within the target native blood vessel. Subsequent access is facilitated and the risk of damage to accessible target native vasculature is reduced can be.

[0081] For example, subsequent blood flow to treat diseased or dysfunctional segments of the aorta. Endoluminal aneurysm repair (EVAR) is a procedure in which a vascular graft is repaired through a native aneurysm in which the native aneurysm is located. This can be done with reduced risk of damaging the blood vessels.

[0082] It should be noted that the aforementioned tubular body, once placed in the target native blood vessel, has good expansion capability. Using a different balloon dilation device with a higher diameter, the natural vessels are expanded in successive steps. In an embodiment, the tubular body has a self-expanding stent, Once the delivery shaft is removed, the vessel is only constrained by the extent of the natural blood vessels. When the balloon expansion device expands the natural blood vessel, the tubular body expands from the self-expanding stent. The support maintains the expanded dimension.

[0083] Thus, a dilation procedure using a balloon within an expandable tubular body to enlarge a native blood vessel is desired. This can be repeated multiple times to achieve the desired lumen size. A delivery system with a balloon is used to provide initial expansion to the dimensions of the native vessel and support The tubular body is positioned and deployed to maintain the initial dilation of the native blood vessel. If the desired EVAR treatment is not available, the delivery system with integrated balloon can be used and then a second balloon with a higher expansion capacity is introduced onto the delivery system and inflated to induce natural This step is repeated to achieve the desired lumen dimension. In some circumstances, severely damaged or occluded native blood vessels, such as the iliac vessels, may be restored. 4. Split the tubular body and sufficiently expand it to the desired lumen dimension to accept the EVAR delivery system. It may be desirable or even necessary to expand the tubular body. Alternatively, it may remain within the disrupted native vessel, replacing the damaged area and maintaining luminal patency.

[0084] The handheld delivery system for tubular instruments of the present disclosure is capable of supporting and delivering the tubular instrument thereon. and an elongated, malleable, "delivery" shaft (or catheter or wire) capable of or functional equivalent thereof). The delivery shaft may include a non-stented section ( Tubular length L 2 ) into the lumen of the tubular instrument. , through the introducer dry seal / valve to prevent leakage of body fluids and ingress of air It is possible.

[0085] An elongated, malleable delivery shaft has an integral balloon mounted thereon. This is also fine.

[0086] In use, the tubular body used as an intravascular dilation device is fitted over an elongated, malleable delivery shaft. and the instrument and the balloon are attached to the instrument and the balloon. The application of a removable sheath allows for constraining to a low profile, compact, deliverable configuration .

[0087] The delivery system includes a user-operated actuator attached to one end of the delivery shaft distal to the distal tip. The control handle further allows a user to control the delivery system and the tubular instrument deployed therefrom. to be able to move, manipulate, and control the position of

[0088] The handle includes a slot configured to fit over and around the elongated delivery shaft. The device may include a housing with a removable sheath on which the device is mounted. The slotted housing may be constrained in a compact configuration within the delivery shaft. When deployed, it covers at least a portion of the tubular device.

[0089] The removable sheath may be configured, for example, with a slit in the distal end to split the sheath longitudinally upon removal. It can be split along a fixed tear line, which allows the removable sheath to When pulled through, it is punctured by contact with the slitter elements or cutter blades. The sheet may be cut, slit, or otherwise removed.

[0090] One embodiment of the delivery system splits the sheath longitudinally to provide access to the intravascular section of the tubular device. and at least one constrained stented tubular portion of the device for expanding to a deployed configuration. and a slitter element connected to the sheath to allow removal of the sheath. and a sheath removal element, such as a pull strap, cord, tape, wire, etc. The pull strap may include a release mechanism for releasing the sheath from the slitter element. Upon contact, the sheath may be slit.

[0091] The slitter element may allow for linear even division of the sheath.

[0092] The slitter element comprises a hub removably attached to an elongated, malleable delivery shaft. The bearing may be fixed to the bearing or disposed within the hub.

[0093] The hub fits around the elongate delivery shaft (and guidewire, if used); Clipped or otherwise removably fastened together; 2 The cylindrical component may include two partial cylindrical components.

[0094] In an embodiment, the hub splits the sheath during retraction of the sheath to allow the inner vascular prosthesis device to be removed. A slit edge is provided to provide a slitter element that allows for deployment of the stented tubular section. The protrusion may be configured to

[0095] The hub has pull straps attached to either side of the tail of the sheath for removing the sheath. It has a pair of slits through which a pull handle can be passed for use by a user. This is also fine.

[0096] In the following description, further details of the embodiments are set forth by way of illustrative examples with reference to the accompanying drawings, in which: Reveal. [Brief description of the drawings]

[0097] [Figure 1] FIG. 2 is a side view of an implantable tubular body including a stented section connected to an unstented section. [Diagram 2] 2 is a side view of the implantable tubular body shown in FIG. 1 after expansion of the stented section using a balloon expander. [Diagram 3] FIG. 13 is a top side view of another embodiment of an implantable tubular body. [Figure 4] FIG. 4 is a side view of the implantable tubular body of FIG. 3. [Diagram 5] FIG. 4 is a top view of the implantable tubular body of FIG. 3. [Figure 6] 4 is an end view of the implantable tubular body of FIG. 3, viewed longitudinally from the left in FIG. 3. [Figure 7] FIG. 13 is a schematic diagram showing the first step of the surgical procedure to locate native blood vessels, e.g., blood vessels relative to the ilium, with reference to the inguinal ligament, which runs from the anterior superior iliac spine to the pubic tubercle. [Figure 8] FIG. 13 is a schematic showing subsequent steps in the surgical procedure in which the initial surgical incision site is retracted to the side of all surgeons and native vessels, such as those relating to the iliac bone, are exposed, tied off (by ligation), and transected to provide access points. [Figure 9]FIG. 13 is a schematic showing the introduction of a guidewire (Seldinger wire technique) to prepare for the introduction of the delivery system. [Figure 10] 13A-13C are schematic diagrams illustrating, inter alia, the application of a hemostatic clamp to a perfusion branch of a tubular instrument carried by a delivery system, and the advancement of the delivery system through an incision access point into a native blood vessel. [Figure 11] FIG. 13 shows a schematic of anastomosis of a perfusion branch to a native vessel. [Figure 12] FIG. 13 is a schematic diagram showing the procedural steps of evacuating air from the delivery system via an internal valve associated with the tubular portion of the tubular device, and deploying the indwelling portion of the tubular device into the native vessel during expansion of an integrated balloon carried by the delivery system in which the tubular device is positioned. [Figure 13] FIG. 13 is a schematic diagram showing the expansion of a deployed tubular device by inflating an integrated balloon (which can later be deflated for removal) from an external fluid supply device (syringe shown). [Figure 14] 13A-13C are schematic diagrams illustrating removal of a delivery system with an integrated balloon via a valve disposed within a tubular portion of a tubular device. [Figure 15] 13A-13C are schematic diagrams illustrating the inflation of a larger balloon inserted through a valve disposed within a tubular device, and the deflation thereof after the tubular device has been expanded to a larger luminal dimension. [Figure 16] FIG. 13A is a schematic showing removal of the deflated larger balloon. [Figure 17] FIG. 13 is a schematic showing threading of the EVAR system onto a guidewire (Seldinger guidewire technique) for subsequent introduction through the valve, through the tubular device, and through the vasculature to the site requiring endograft deployment. [Figure 18] FIG. 1 shows a schematic of a deployed bifurcated graft introduced by an EVAR system, the system being retracted (retracted). [Figure 19]FIG. 13 shows a schematic diagram illustrating removal of the guidewire to allow cutting of excess length of the valve and tubular device, and suturing closure of the portion of the tubular body through which the delivery system passed to access the vasculature. [Figure 20] FIG. 13 is a schematic showing final tubular instrument placement within the retracted incision site. [Figure 21] FIG. 13 shows a schematic of the final surgical step of suturing the incision. [Figure 22] FIG. 1 illustrates a handle portion of one embodiment of a delivery system. [Figure 23] FIG. 1 illustrates one embodiment of a delivery system that includes a tubular instrument in a low-profile, compact form within a removable sheath. [Figure 24] FIG. 13 is a partial cross-sectional view of one embodiment of a delivery system that includes a tubular device and an integral balloon in a low-profile, compact form within a removable sheath. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0098] In the embodiment shown in FIGS. 1 and 2, the implantable graft is secured, for example, by sutures 12. The blood supply includes two tubular sections secured together by a pair of wires to form a blood-tight seal. The tubular section has a tubular length L 1 and a further tubular length L 2 Includes linear dimensions The hollow tubular body 1 has a tubular length L. 1 10. Intravascular Section The stents 11 are formed in a compact shape. and has a tubular length L in the expanded (inflated) configuration. 1 Can be expanded to support The use of a removable sheath allows the device to be maintained in a compact configuration for delivery. can.

[0099] The implantable graft is made of fabric in the form of a collapsible sleeve, At least a portion of the tubular length may be pleated or fluted. Part L 1 and a further tubular length L 2 stands for ePTFE, PTFE or Physiologically acceptable materials such as knitted or woven polyester, polyethylene or polypropylene fabrics. The same or different fluid impermeable fabrics are selected from acceptable or benign materials. The dough may be made of a brick. The dough may be made of a sealer, for example gelatin or collagen. The container may be sealed with a sealant.

[0100] The stent 11 is made up of separate deformable limbs individually attached to a fabric sleeve. At least some, and optionally all, of these stents 11 are The ring may be made of a shape-memory metal or plastic material so as to be self-expanding. Each of the stents 11 is made of a resilient material such as stainless steel or Nitinol (nickel titanium). shape memory metal alloys such as PTFE (polyether ether ketone) or high-temperature It may be made of a continuous loop of a modulus polymer and may be attached by a suture, adhesive, or other suitable material. Each ring stent may be attached to the intravascular section 10 by thermal bonding. 11 is formed from a shape memory material that can be heat set against the exterior surface of the intravascular section 10. In the illustrated example, the contours of each ring stent 11 may be configured to vary during use. Two peaks and two valleys are inserted to form a "saddle-shaped" ring stent. The shape memory material is compressible to easily form the 22. The use of a continuous loop of winding is advantageous for this purpose.

[0101] Delivery systems suitable for the implantable grafts described herein include, among others, Assist in the expansion of the endovascular section 10 without any obstruction and at least initiate the expansion of the native blood vessel. The balloon 15 in one example includes a tapered end. The tubular shape is collapsible. The tubular shape is formed by a straight tubular profile 18 on the distal and proximal ends. Each of the tapered sections 16 and 17 has a truncated cone shape. 16, 17 are secured to tubular element 19 to define an expansion volume therebetween. is the initial native volume of the corresponding length of the narrow lumen target native vessel at its maximal expansion. may exceed.

[0102] The narrow lumen target native vessels are parts of the naturally narrow and tortuous vascular system, such as the iliac arteries, and The lumen of a natural blood vessel is constricted by stenosis, stricture, or calcification. It could be.

[0103] In the use of this embodiment, the balloon 15 is at least partially expanded. During inflation of the balloon, the implantable graft is adapted to provide support to the lumen of the implanted native blood vessel. Packaged to be expandable and for delivery within a removable sheath Thus, in particular, the intravascular section 10 is designed for delivery into the narrow natural vessels of a target in the vascular system. and at least the intravascular section 10 is positioned at a predetermined position within the target native blood vessel. The implantable graft includes an integral balloon 15 so that the graft is uncovered when in position. After removal of the sheath, the balloon 15 covers the native blood vessel to at least a first extent. 3. The endovascular section 10 is expanded to a diameter of 1 mm. .

[0104] For example, if additional expansion is required to accommodate an EVAR system, the delivery system and The integrated balloon expander is removed and another balloon with a larger expansion capacity is inserted for further delivery. The balloon is then inflated to further expand the native blood vessel and form an intravascular section. 10 after deflation of the balloon, and then further expansion of the delivery system and The procedure is continued until the native vessel is fully expanded or until the native vessel is fully expanded. The vessel ruptures while the fully expanded endovascular section has the desired luminal patency. This can be repeated with further balloon replacements until the implantable graft functions. Cut.

[0105] In one embodiment shown in FIGS. 3-6, referring first to FIG. 3, the implantable graft is A tubular length portion L having a branched (Y) configuration 1 and a further tubular length L 2 Includes linear dimensions The tubular body 31 has a tubular length L. 1 forms an intravascular section 30, The stent 41 is compressible into a compact configuration. and in the expanded (inflated) configuration, the tubular length L 1 It can be expanded to support In use, the endovascular section 30 is adapted to be inserted into a target native blood vessel of the vasculature for delivery into the target's native blood vessel. Subverted.

[0106] One of the branched limbs is an irrigation vessel that is anastomosed to a native blood vessel 60 (FIG. 11) during the surgical procedure. It functions as a flow branch 36 .

[0107] The other branched limb is a catheter for the introduction or removal of the delivery system components. It also serves as an access branch 34 for performing EVAR surgery.

[0108] At least a portion of the access branch 34 is trimmable and includes a series of sections 37. Each section has a length that can be trimmed by trimming the length of its branch limb of the tubular body 31. It has a tab or loop 38 that can be grasped for ease.

[0109] The implantable graft is made of fabric in the form of a collapsible sleeve. Shape length part L 1 and a further tubular length L 2 are ePTFE, PTFE or The fabric may be a physiologically acceptable material, such as knitted or woven polyester, polyethylene or polypropylene. The same or different fluid impermeable films are selected from commercially acceptable or benign materials. The dough may be made of a fabric. The dough may be made of a seed material such as gelatin or collagen. The container may be sealed with a sealant.

[0110] The endovascular section 30 includes a stent 41 which is a separate ring stent. 41 is individually attached to the fabric sleeve, Peak 42 and Valley 4 The three-section "saddle" stent supports an expanded fabric sleeve. It is designed for end uses that require

[0111] Each of the ring stents 41 is made of a resilient material such as stainless steel or Nitinol (Ni Shape memory metal alloys such as Kelvin (Ti alloy) or polyether ether ketone (PEEK) The catheter may be made of a continuous loop of a high modulus polymer such as a suture, adhesive, or other suitable material. The fabric sleeve may be attached by thermal bonding as required.

[0112] Each ring stent 41 can be heat set against the outer surface of the endovascular section 30. In the illustrated example (FIG. 3), each ring stent 41 The contoured profile of the stent allows the two pins to come together to form a "saddle-shaped" ring stent during use. The shape memory material includes a compressible shape memory material that easily forms a peak 42 and two valleys 43. The use of a continuous loop of multiple windings of Nitinol wire is advantageous for this purpose.

[0113] Thus, the stented endovascular section is self-expanding and does not obstruct the target native vessel. After being fully expanded by the loons, a fully open luminal dimension can be achieved.

[0114] In use, with reference to FIGS. 7-21, a surgical procedure using the embodiment of FIGS. The surgical procedure may be performed as follows.

[0115] After preparing the surgical field according to current recommended medical practice, the anterior superior iliac spine to the pubic tubercle was Identify the location of native blood vessels, for example the iliac vessels, with reference to the inguinal ligament, which extends to the

[0116] Next, appropriate incisions are made and retracted to expose the targeted iliac vessels, which are then ligated (by ligation). a branched intravascular tubular device including a branch suitable for use in dissecting and perfusing the iliac vessels; Provides an access point for inserting

[0117] A guidewire was introduced into the iliac vessels (Seldinger wire technique), and an intravascular tubular device was inserted. The indwelling section of the endovascular tubular device is positioned over the guidewire. The catheter is passed through and guided into the iliac vessels.

[0118] A hemostatic clamp suitable for the instrument, including the irrigation branch of the tubular instrument carried by the delivery system. The catheter is then applied to present a perfusion branch to the iliac vessels at a point distal to the initial insertion incision point. The delivery system is then inserted through the incision access point into the iliac vessels until sufficient Move forward.

[0119] The perfusion branch is then anastomosed to the iliac vessels to establish a perfusion bypass pathway through the intravascular tubular device. Complete.

[0120] At this stage of the procedure, the delivery system is opened via an internal valve associated with the tubular portion of the tubular instrument. The stented portion of the tubular device can be evacuated from the stem. The system uses an integrated balloon on which the tubular device is placed. The catheter is deployed within a native blood vessel that is at least partially dilated by the catheter.

[0121] The expansion of the deployed tubular device may be accomplished by the application of an external fluid supply device (e.g., a syringe as shown in FIG. 13). The procedure proceeds with the inflation of the integral balloon from the catheter, which then retracts for removal. It can be shortened.

[0122] Leaving the expanded stented intravascular portion of the tubular device supporting the dilated portion of the iliac vessel; A delivery system incorporating a balloon is inserted through a valve disposed within the tubular portion of the tubular device. Pull out the meter.

[0123] For example, the dilated portion of the iliac vessels may be further expanded to allow passage of an EVAR system. If further expansion is required, a larger balloon from a separate delivery system is inserted into the tubular device. The device is inserted through a valve located in the tubular device and then inflated to remove the tubular device from the stem. The intravascular portion with the catheter can then be further inflated. The second balloon is then deflated. The delivery system was then withdrawn, and the stented portion of the tubular device was further expanded. By leaving the catheter in this state, the already dilated iliac vessels can be expanded to a larger luminal dimension. Further balloon use with increasing inflation volume in the above repeated steps continues. The native vessel is fully expanded or the native vessel ruptures while the intravascular stent is inserted. Tubular body part L 1 until it can be properly expanded and EVAR systems can be accessed. The tubular device replaces a potentially ruptured iliac vessel and The luminal dimension is sufficient to access the vascular system beyond the tubular graft graft in the bone vessel. The graft is left implanted as a permanent tubular graft.

[0124] Assuming that the iliac vessels were sufficiently dilated by continued use of the balloon, the permanent dilation The tubular device is inserted through the EVAR system via a guidewire (Seldinger guidewire). The Ya method involves the placement of an endograft through a tubular device and through the vascular system to the site requiring placement. Maintain sufficient patency for subsequent introduction.

[0125] The delivery system can then be removed and the surgical procedure completed according to normal good practice. Cut.

[0126] Referring to FIG. 22, the delivery system includes an operating system for operating and controlling the system. The handle 220 is made up of parts and is a delivery tube. The length is designed to overlap at least a portion of the device, such as a wire, catheter, or The shaft has a longitudinal through hole through which a flexible or malleable shaft can pass. The handle assembly receives a pull handle strap that is threaded through a removable sheath. A first handle portion 221, a hub 222, and a slotted tapered guide for receiving the A sheath slitter tool 224 is provided in the handle and optionally on the hub. 2, but the distal surface of the slotted tapered grip 223 is It is convenient to place it in front of the 20.

[0127] FIG. 23 illustrates a tubular catheter 200 housed in a removable sheath 230 in a low-profile, compact configuration. An embodiment of the delivery system is shown loaded with an instrument 231. U-shaped pull hand The handle 232 is removable via the operator handle 220 by a strap 233. In use, the operator holds the operator handle 220 Operate the delivery system using the catheter to advance the delivery system relative to the inserted guidewire. or retract (Seldinger technique) to place the tubular device 231 into the native iliac vessels. Once the tubular instrument 231 is properly positioned, it can be pulled using the U-shaped pull handle 232. The sheath 230 can then be retracted to deploy the tubular device 231 within the native iliac vessels. After the appropriate balloon inflation step, the operator handle 220 is used to insert the tubular instrument into the The stent was deflated via a dry seal / valve (Figure 14) installed in the unstented limb of The insertion portion of the delivery system, including the integral balloon, can be retracted.

[0128] FIG. 24 illustrates a tubular catheter configured in a low profile, compact form within a removable sheath 241. FIG. 1 shows an embodiment of an apparatus including a delivery system loaded with an instrument 240 and an integral balloon 245. 1 shows a partial cross-sectional view of the configuration.

[0129] Tubular device 240 is an implantable graft similar to tubular devices 31, 231 described above. The tubular devices 240 are secured together, for example by sutures 242, to form a blood-tight system. The two tubular sections forming the hole include a tubular length L1 and a further The hollow tubular body 243 has a length dimension L including a tubular length L2. Length L1 forms an intravascular section 250 and includes a plurality of stents 244. The plurality of stents 244 are compressible into a compact configuration and are expandable (expandable) in configuration. The removable sleeve can be expanded to support a tubular length L1. The use of a graft allows the implant to remain in a compact form for delivery. The sheath is used to cover the intravascular section 250 when the section 250 is not covered by the sheath. The balloon 245 includes a tapered, expandable, integral balloon 245. The tubular shape has a collapsible tubular shape with an end portion. The tubular shape is distal to the straight contour portion 248. on the distal and proximal ends, respectively, The tapered sections 246, 247 are secured to a tubular element 249 and extend therebetween. The expansion volume is defined as the volume that exceeds the native volume of the corresponding length of the target native vessel. Intravascular section 250 includes stent 244, which is a separate ring stent. The stents 244 are individually attached to the fabric sleeve and have peaks 246 and 248. The expanded fascia is a “saddle” shaped stent with a 52 and 253 valley section. It is configured for end use, supporting the brick sleeve.

[0130] The delivery system is of the type described with reference to FIG. 23 and is The handle 260 is made up of the following parts: and having a length designed to overlap at least a portion of the tubular device to be delivered. , a length through which a wire, catheter or flexible or malleable shaft can be passed The handle part has a through hole in the hand direction. The handle part has a plug that is inserted into a removable sheath. A first handle portion 261 for receiving a handle strap, a hub 262, and and a slotted tapered grip 263. The sheath slitter tool 264 is The slotted tapered grease can be installed in the hub as desired. It is convenient to provide the distal surface of tip 263 on the front surface of handle 260 .

[0131] The embodiment of FIG. 24 may be used similarly to that described for the embodiment of FIGS. 7-21 and used in surgical procedures as described above.

Claims

1. A vascular graft (60) in a compact form within a removable sheath (230, 241). A tubular body including a self-expanding tubular body (1, 31, 243) configured for insertion into a lumen. a lumen expansion device; and a delivery system configured to expand the lumen of the native blood vessel (60). and a delivery system including a delivery shaft (249) and at least a portion of a front an integral balloon (15, 245) that is positionable within the tubular body (1, 31, 243); The integral balloon (15, 245) also includes the removable sheath (23 0,241)。 In a compact form (60) for insertion into the lumen of the natural blood vessel (60). The device being used.

2. The integrated balloon (15, 245) is a potential The device of claim 1 , which is small relative to its maximum expanded dimension.

3. The tubular body (1, 31, 243) is expandable, and the tubular body (1, 31, 243) providing a lumen having a width dimension greater than that of the lumen of the target natural blood vessel (60) into which it is to be inserted; 2. The apparatus of claim 1.

4. The tubular body (1, 31, 243) has a length L, and at least one of the tubular bodies has an intravascular Part L １ The catheter can be expanded by removing the sheath (230, 241) and can be inserted into the vascular system. The lumen of the natural blood vessel is expanded, and the tubular length L １ Multiple a ring stent (11, 41, 244), and at least one further member of said tubular body Tubular length L ２ The device of claim 1 , wherein the distal end of the catheter is stent-free.

5. The tubular body (31, 243) has the further tubular length L ２ But without two stents 2. The apparatus of claim 1, bifurcated to include branches (34, 36).

6. A perfusion branch, one of the unstented branches being anastomosed to the native blood vessel (60). (36), and the other ( 34) is configured to provide access for a delivery system. The apparatus described.

7. The further tubular length L ２ The invention relates to a valve for controlling the flow of fluid. The device according to any one of claims 4 to 6.

8. The valve allows fluid to pass through the tubular body of a delivery system component without harmful leakage.

8. The device of claim 7 including an introducer seal to allow insertion of a

9. The delivery system components include a delivery shaft (249) and an expandable balloon.

9. The apparatus of claim 8, further comprising: (245).

10. The tubular length L ２ The apparatus of any one of claims 1 to 9, wherein the fabric comprises a crimped fabric.

11. The tubular length L ２ At least a portion of the outer surface of the The device according to any one of claims 1 to 10, comprising a bonnet loop.

12. the intravascular tube being expandable to maintain expansion of the lumen of the native blood vessel of the vascular system; Shape length part L １ includes a saddle-shaped ring stent (244), each of which has a peak (2 The device according to any one of claims 1 to 11, having a rib portion (52) and a valley portion (253). Place.

13. The intravascular tubular length L １ is lined with a low friction or slip promoting material, Item 13. The device according to any one of items 1 to 12.

14. The method according to any one of claims 1 to 13, wherein at least a portion of the tubular body is tapered. The equipment.

15. As a reinforcing graft for the portion of the vasculature required for passage of any intravascular delivery system Use of a device according to any one of claims 1 to 14.

16. A delivery system for use in a device according to any one of claims 1 to 14, comprising: a malleable or flexible delivery shaft and a a slotted housing configured to fit around said malleable or flexible an integrated balloon attached to a flexible shaft; and an intravascular tube covering the integrated balloon. A removable sheath for containing the shaped body, a sheath removal mechanism, and the removable and a pull strap attached to the removable sheath.

17. 17. The method of claim 16, wherein the sheath detachment mechanism includes at least one sheath splitter. Delivery system.

18. Each time the pull strap is pulled to bring the sheath into contact with the slitter element, The removable sheath includes at least one slitter element for splitting the removable sheath in the longitudinal direction.

17. The delivery system of claim 16.

19. The at least one slitter element is removably mounted on an elongated malleable delivery shaft.

17. The delivery system of claim 16, disposed on or within an attached hub. 。

20. At least one pair of slitter elements is provided on or within the hub.

17. The delivery system according to claim 16.

21. The device is adapted to extend the natural blood vessels of the vascular system in a compact form within a removable sheath (230, 241). A self-expanding tubular body (1, 31, 243) configured to be inserted into a lumen. an intravascular dilation device and a delivery system configured to dilate the lumen of the native blood vessel and wherein the delivery system comprises a delivery shaft and at least partially the tubular body (1 and an integral balloon (15, 245) that is positionable within the balloon (31, 243), The integral balloon (15, 245) also fits into a compact configuration within the removable sheath. and configured to be inserted into a lumen of a natural blood vessel of the vascular system in a balloon-like configuration, (15, 245) relative to the maximum potential expansion dimension of the tubular body (1, 31, 243) small; different for successive use in expanding said tubular body (1, 31, 243) a plurality of expandable balloons of expanded sizes, each of the expandable balloons being connected to the tubular body (1, A compact catheter on a delivery shaft for use in incrementally expanding the catheter (31, 243). The device in kit form, in a configuration which can be inserted into the lumen of said native blood vessel in sequence.

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