JP2005192933A - Prosthesis carrier system, prosthesis carrier system assembling method and kit for prosthesis carrier system - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide an improved prosthesis carrier system for installation in the lumen (blood vessel). <P>SOLUTION: This prosthesis carrier system is provided with a cylindrical frame part comprising a plurality of unit members expandable radially; and the frame part is provided with a longitudinal part in the long axial direction, a distal end and a proximal end. This system is further provided with a catheter having an inflatable balloon which has an approximately same length to the longitudinal part of the cylindrical frame part before the inflation and having a cylindrical swelling part. The cylindrical frame part is mounted on the swelling part of the inflatable balloon, the both ends of the cylindrical swelling part of the balloon are restricted to extend approximately 1 mm at most from the respective adjoining longitudinal both ends in the long axial direction of the frame part. The smoothing processing is performed on inner surfaces of the respective prosthesis portions having the longitudinal part in the long axial direction and the plurality of inflatable unit members in the radial direction, and inserted into the body lumen. <P>COPYRIGHT: (C)2005,JPO&NCIPI

Description

  The present invention generally relates to the construction of a radially prosthetic luminal prosthesis, such as a stent or graft. In particular, the present invention relates to providing a movable coupling structure for constructing flexible and pseudo-flexible prostheses and providing an end face structure for constructing an atraumatic transportable prosthesis. ing.

  Lumen prostheses serve a variety of medical purposes. For example, luminal stents can be placed in a variety of body lumens such as blood vessels, ureters, urethra, biliary tracts, and gastrointestinal tracts to maintain patency. Luminal stents are particularly useful for placement at pre-expanded atherosclerotic sites within blood vessels. The luminal graft can be placed in a blood vessel to support a diseased region such as an abdominal aorta or other aneurysm sites.

  Both stent prostheses and graft prostheses need to meet certain mechanical criteria in order to function well. In particular, such a prosthesis is at least partially flexible in the length direction or has a movable coupling part (such as a rigid part that is movably coupled to each other), such as the coronary vascular lumen. The interior of the tortuous body lumen can be advanced. Furthermore, these prostheses preferably maintain their original length or minimize the degree of contraction when the prosthesis has an expanded shape. In addition, such prostheses have sufficient mechanical strength, in particular, sufficient hoop strength to mechanically increase lumen wall strength and thus maintain lumen patency. The ability to meet these requirements is severely limited in the case of a cylindrical endoluminal prosthesis that is delivered in a radially constrained shape, ie, a deflated shape. Such a prosthesis must be expanded radially at the target site within the body lumen, so whatever the intent is to increase flexibility, the ability to expand in the radial direction and the strength after expansion Must not interfere with the ability to maintain

  Prior art luminal prostheses are wounded when delivered through the lumen to a target site within the patient's body lumen (ie, following the path) and / or released at the target site. Often the structure is such that there is a danger of attaching. In particular, many vascular stents are composed of a number of longitudinal members that are circumferentially connected and spaced apart from one another, and these longitudinal members deform circumferentially when the stent expands radially. To do. The Palmaz stent described in US Pat. Nos. 5,102,417 and 4,776,337 is a typical example of such a stent. These conventional prostheses tend to cause a phenomenon known as “scraping off the scales” when the prosthesis is bent or bitten in the middle of transport or following the course, and this phenomenon is prone to the length of the prosthesis. This occurs when members distributed along the length project outward from the surface of the prosthesis. Such a stent exhibits only poor “track following characteristics”, but “track tracking” here is defined as the ability to smoothly pass through a tortuous path. A member that protrudes along the length of the prosthesis will not only cause the prosthesis to dig into or engage with the wall of the body lumen during delivery, but the prosthesis or prosthetic delivery system will advance to the lesion area (ie, target site). The possibility of even stopping it increases. In addition, the longitudinal members at the distal or proximal end of the prosthesis are bent outwardly, resulting in bending forces applied to the longitudinal member as it passes through a tortuous body passage. When it comes to take on the shape of a crown, a lesser known phenomenon called “flaring” occurs. Flaring causes a dangerous effect similar to the phenomenon of scratching the scales described above, and when the prosthesis is transported or followed in the course of the blood vessel, it may damage the blood vessel or cause trauma.

  Another challenge in stent construction and deployment relates to the ability to detect stents with fluoroscopy during the deployment procedure. The most common stent material, stainless steel, is generally radiolucent, i.e., hardly visible by X-ray irradiation, allowing X-ray fluoroscopy with the stent attached. Advantageously, such a stent does not interfere with subsequent fluoroscopic examination of the treatment area of the body lumen, such as a 6 month follow-up. However, because of its radiolucency, stents are much more difficult to position accurately within the lumen. To make it radiopaque, the prosthesis can be made from a radiopaque material such as tantalum, platinum, or nickel titanium (NiTi). As an alternative, the entire prosthesis may be plated or coated with a uniform layer of radiopaque material to improve the visibility of the prosthesis. As disclosed in co-pending US Patent Application Serial No. 08 / 691,661, filed on the same day, the entire disclosure of that patent application is incorporated herein by reference. I am doing. While such methods address the problem of radiopacity, a uniform layer of radiopaque material, or a prosthesis made entirely of radiopaque material, can see the tissue inside the prosthesis. It is customary to improve the radiopacity while compensating to reduce the radiation.

  For these reasons, it would be desirable to provide improved stents and other luminal prostheses. In particular, it would be desirable to provide an improved luminal prosthesis and method for intraluminal installation, in which case the prosthesis would not bite to traumatically impact the body lumen wall. , It must be transported or tracked to a target site within the body lumen. The prosthesis is preferably composed of a member that minimizes the “scale-off” action associated with the risk of damage or retention within the body lumen. Such a prosthesis is also provided with an end face ring that minimizes trauma, both while the prosthesis is being transported within the body lumen and both ends of the prosthesis are expanding radially. It is intended to reduce the risk of damaging the lumen. Optionally, rigid members may be incorporated at both ends of the prosthesis, making it less likely that the prosthesis will stick out or expand into a trumpet when following a path in a tortuous body lumen. . Furthermore, the prosthesis is preferably radially expandable at the target location, and it is preferable to maintain a cylindrical shape after expansion and maintain the ability to be plastically or movablely coupled. Such a prosthesis further has sufficient hoop strength to function effectively as a stent maintaining luminal patency and / or as a graft with improved lumen strength, and Should have other mechanical properties. In order to increase the accuracy of the orientation of the force supported by the scaffold at the lesion site, the prosthesis may have a special expanded shape. Furthermore, not only is the prosthesis visible during both the course follow-up and deployment, but also the radiation insufficiency that allows the tissue in the lumen to be seen during the subsequent follow-up of angiogenesis after deployment. It would be desirable to provide an improved prosthesis with permeable properties. The present invention provides at least some of the desirable improvements.

A multi-part vascular stent joined by an axial hinge structure is disclosed in US Pat. Nos. 5,195,984, 5,104,404, 5,102,417, and European Patent Publication EP 540,290. It is described in. Other stent structures are described in US Pat. No. 5,282,824, European Patent Publication EP 481,365, and Canadian Patent Publication No. 2,079,944. U.S. Pat. No. 4,776,337 discloses a Polmaz stent, which is constructed by joining a number of longitudinal box-like members together with short circumferentially oriented tabs. US Pat. No. 5,195,984, a single short beam joins at least two longitudinal box-like portions in the longitudinal direction.
US Pat. No. 5,102,417 U.S. Pat. No. 4,776,337 US Patent Application Serial No. 08 / 691,661 US Pat. No. 5,195,984 US Pat. No. 5,104,404 European Patent Publication EP540,290 US Pat. No. 5,282,824 European Patent Publication EP 481,365 Canadian Patent Publication No. 2,079,944 US Pat. No. 5,599,306 US Patent Application Serial No. 08 / 704,801

  The present invention provides an improved prosthesis and method for intraluminal installation, particularly intravascular installation. Such a prosthesis may be in the form of a stent, intended to maintain lumen patency, or intended to protect the lumen wall or increase the strength of the lumen wall. And may take the form of an implant. The prosthesis of the present invention applies a force from the inside to expand the (typically malleable) prosthetic structure with minimal elasticity, or the radial direction by the elastic prosthetic structure (self-expanding) It is possible to expand in the radial direction by either releasing the constraint or by either method.

  In the first aspect of the present invention, the prosthesis is composed of a plurality of unit members that can be expanded in the radial direction, such as a ring portion, and a plurality of extensible members that will be described later as expansion joint members. A plurality of beam members that connect points separated from each other in the axial direction on adjacent unit members are provided, and the latter is an extended joining member that connects adjacent points in the axial direction on adjacent unit members. . The beam members are typically aligned with each other in the axial direction and maintain a constant distance between the points isolated from each other at any time, including when the prosthesis is radially expanded. Compared to this, the expansion joint member allows relative movement of points close to each other while the prosthesis is bent, while the prosthesis is expanded, or while other deformations are applied to the prosthesis. To. The extended joining member may have a convenient geometric shape such as an S-shape, a Z-shape, a meandering shape pattern, or a zigzag pattern. Therefore, the expansion joint member is connected to the points close to each other on the plurality of unit members with extensibility and flexibility, so that the prosthesis can be deployed in the winding path or at the target site where the prosthesis is curved. (Expansion) Reduces or prevents the proximity point from protruding or suffering from a “scale scraping” action.

  In order to provide the desired path following characteristic and expansion characteristic for the prosthesis, the beam member and the expansion joint member are installed in a specific pattern between the unit members. For example, the unit members adjacent to each other of the prosthesis need only be connected by an expansion joining member and a beam member, but are preferably joined by only one beam member and several expansion members. By using only one beam member, the advantages of length correction and prosthesis flexibility are balanced. The prosthetic beam members are preferably installed in a “ladder step-like shape”, with continuous longitudinal beam members arranged in a staggered pattern in the circumferential and longitudinal directions, typically non-expanded Sometimes there is a predetermined amount of major axis overlap between the beam members. The amount of overlap is approximately one third of the length of each beam member, and preferably is one half of the length of the beam member. In some embodiments, the beam may be weaker at the center and narrower than the rest of the region, and may be weakened to increase the transverse flexibility of the prosthesis. The expansion joint may also be weakened for the purpose of maximizing flexibility and minimizing interference with the path following ability of the prosthesis. As a typical example, the weakened expansion joint member is narrower than the longitudinal strut of the unit member and lacks depth.

  In the second aspect of the present invention, the prosthesis includes a member for increasing the rigidity in the radial direction both in the non-expanded state and in the expanded state. As such a member, for example, the end surface member is a central region of the prosthesis. The expansion force in the radial direction is required to be stronger than the other member. As an example, the end face member may be a meandering ring member having a longitudinal column shorter than the longitudinal column of each member in the central region of the cylindrical frame portion. In an alternative, the end face ring member has increased stiffness and therefore employs a hinge member with an increased width or depth between the longitudinal portions of the struts, which was established in August 1996. As disclosed in co-pending U.S. Patent Application Serial No. 08 / 691,661, filed on the 2nd, the complete disclosure of that patent application is already incorporated by reference in the prior part of this specification. ing. Increasing radial stiffness at both ends of the prosthesis, such as a concave strut member with a short length or a box-like structure member with an unequal strut length, while following the path to the prosthesis in a tortuous path This tends to reduce the overhanging of both ends and expansion to the trumpet type. Another improvement to reduce the prosthesis from overhanging or expanding into a trumpet type utilizes a radial end-face member that is hinged to an adjacent member by a long beam member. The members are movably coupled with one beam member, and the load imposed on the column of the end surface member is reduced. Furthermore, the prosthesis at the time of expansion may be formed into a non-cylindrical shape, and the prosthesis may be attached to an expansion member such as a balloon. For example, the prosthesis may taper when expanded to better fit a conical body lumen and provide a better scaffold. The ability of inflatable members, such as non-cylindrical balloons, to expand the prosthesis to a shape that more closely matches the geometry of the lumen is a unit member whose stiffness changes in the radial direction by providing different stiffness gradients for each part. Or by providing a unit member with non-uniform rigidity along the length of the prosthesis.

  In a third aspect, a system according to the present invention comprises a cylindrical frame part forming a prosthesis, the frame part comprising a plurality of unit members that are radially expandable, a longitudinal longitudinal member, A proximal end and a proximal end. The frame portion is preferably mounted over an expandable cylindrical portion of an inflatable member such as a balloon. In this third aspect, the expandable cylindrical portion has the same length as the longitudinal member of the cylindrical frame. This expands the balloon beyond the prosthetic ends, minimizing the possibility of tearing damage, especially at the distal location of the body lumen in which the system was delivered. Is advantageous. It is preferable that the inflated portion of the balloon is not more than about 1 mm from the end of the generally cylindrical frame portion, and more preferably approximately the same length as the cylindrical frame portion. The present invention also provides a kit with instructions describing how to install a prosthesis over a balloon of a length consistent with the attachment device.

  In a fourth aspect, a prosthesis according to the present invention has a coating of a radiopaque material such as gold that covers at least the entire outer surface of the prosthesis. The coating preferably comprises a first region having a first desired thickness and another region having a second desired thickness. In one embodiment, both ends of the prosthesis have a 15.24 μm gold coating and the remaining portion of the prosthesis, usually the central region, but this portion has a 7.62 μm coating. In another embodiment, the prosthesis may be made using the method of the present invention with both ends having a 15.24 μm gold coating, but no center coating at all. Good. The prosthesis has a radiopaque prosthesis with different thicknesses of radiopaque material added to facilitate accurate placement of the prosthesis in the lumen, while continuing to expand the prosthesis. It would be advantageous to be able to examine the tissue during follow-up.

  In another aspect, in the present invention, when reinforcing the wall of the body lumen, the points where the plurality of unit members are adjacent to each other are constrained by the expansion joint member, and the unit members adjacent to each other are isolated from each other. Method for realizing a prosthesis joined by a beam member (preferably one beam member) being introduced into a target site inside a body lumen and expanding the prosthesis in a radial direction after reaching the target site I will provide a. The prosthesis may be expanded by applying each tension, such as the force provided by the balloon catheter, or alternatively, the prosthesis may be released from radial constraints at the target site. It may be. As an alternative, the method of the present invention can be used to convey or follow a path in a tortuous body path by delivering and expanding a prosthesis that is constrained in the radial direction or that is restricted in the radial direction. It is involved in reducing the possibility of the prosthesis overhanging or spreading into a trumpet shape.

  In the present invention, the inner surface of each part of the prosthesis to be inserted into the body lumen having a longitudinal portion in the major axis direction and a plurality of unit members expandable in the radial direction is subjected to a smoothing process. Yes. The inner surface of each part of the prosthesis mentioned here is a “wetted part” inside the expanded prosthesis, that is, blood as a representative example. Conventionally, it has been known that an outer surface part such as a vascular endothelial cell that directly contacts a living cell is damaged, and the outer surface part has been smoothed. However, the roughness of the inner surface of the prosthesis changes the fluid, such as blood, to a more “turbulent” state, thereby causing fluid stagnation conditions and partial stimulation conditions in the prosthetic strut region segment. This inclines complications and restenosis of the prosthetic placement site in the direction of promotion. Therefore, by processing the inner surface of each part of the prosthesis by a specific processing method such as electrolytic polishing or chemical etching, nano-level smoothing can be realized even under photographing confirmation such as an electron microscope. The optimum smoothing degree is processing of a metal reduction rate of 12.8 to 36.5 wt% in the biocompatible metal material. From an appropriate clinical medical standpoint, the effect of using this technique with a prosthesis added confirms a significant difference in the restenosis rate in the chronic phase around 6 months after placement. Another effect is as follows. When a prosthesis is attached to a catheter having an expandable inflatable member provided with a cylindrical inflatable portion, the inner surface of the prosthetic support column, that is, the contact surface to the inflatable member is changed from a rough surface to a mirror smooth surface. This necessarily increases the contact area significantly. This greatly contributes to avoiding the fatal danger of dropping off during prosthetic conveyance or detachment of the prosthesis in an incompletely expanded state. A further understanding of the nature and advantages of the present invention may be realized with reference to the remaining portions of the specification and the attached drawings.

I. Introduction The present invention provides devices and methods for placing a prosthesis intraluminally, particularly within the vasculature, for the treatment of cardiovascular diseases such as vascular stenosis, vascular transection and aneurysms. However, such a device and method can also be installed in a body lumen other than the vascular system, such as the ureter, urethra, biliary tract, gastrointestinal tract, etc. to place a reinforcing or protective structure in the body lumen. It is also useful for the purpose of treating various symptoms other than the above that may be beneficial by introduction. The prosthesis is placed in the lumen. As used herein, the term “intraluminally” shall mean placement through a body opening or percutaneous or incision procedure, In some cases, the prosthesis is advanced through the body lumen through a body lumen from a remote location to a target site within the lumen. In a vascular procedure, the prosthesis is typically introduced “into the blood vessel” using a catheter through a guidewire with fluoroscopic guidance. The catheter and guidewire can be introduced through conventional access sites to the vasculature such as the femoral artery, brachial artery, subclavian artery, or radial artery for access to the coronary artery.

  A luminal prosthesis according to the present invention is usually composed of a plurality of generally cylindrical body members or units that are expandable in at least two radial directions. The term “radially expandable” means that this member is normally radially expanded, from a small diameter shape (used for endoluminal placement), achieved when the prosthesis is implanted at the desired target site. It means to be converted into a cylindrical shape. The prosthesis minimizes elasticity, that is, has malleability, so that it is necessary to apply an internal force to expand the target site and install it at the target site. Typically, the expansion force is provided by a balloon, such as an angioplasty catheter balloon for a vascular procedure. As will be described later, in the present invention, a non-traumatic connecting portion is provided between successive unit members, and this means that "scaling off the scale" at the position of the prosthesis that is not protected by the sheath member during the transportation. It is particularly useful for preventing action. As an alternative, the prosthesis may be self-expanding. Such a self-expanding structure is formed by using an elastic material such as a tempered stainless steel or a superelastic alloy such as a NiTi alloy to form a main body member. When released from the radial direction restraining force, it is provided by taking an expanded diameter in a desired radial direction. In order to remain anchored within the body lumen, the prosthesis remains partially constrained by the lumen. The self-expanding type prosthesis is, for example, made to follow the path while keeping the shape constrained in the radial direction by installing the prosthesis inside the delivery sheath member or the delivery tube and removing the sheath member at the target site, Be transported.

  The dimensions of the luminal prosthesis depend on the intended use. Typically, the prosthesis is in the range of about 5 mm to 100 mm in length, but for vascular applications, it is usually in the range of about 8 mm to 50 mm. The small diameter (radially contracted diameter) of a cylindrical prosthesis is usually in the range of about 1 mm to 10 mm, but more often in the range of 1.5 mm to 6 mm when applied to blood vessels. . The expanded diameter is usually in the range of about 2 mm to 50 mm, but for vascular applications, it is preferably in the range of about 2.5 mm to 30 mm.

  The body or unit is formed from conventional materials used for stents and grafts for body lumens, but is usually a malleable metal such as 300 series stainless steel, or NiTi alloy, spring steel Formed from an elastic metal such as a shape memory alloy. The body member may be formed from a combination of metals as described above, or a combination of the above types of metals and other non-metallic materials. Other constructions of the body member or unit member of the present invention are illustrated in U.S. Pat. Nos. 5,195,417, 5,102,417, and 4,776,337. The full disclosure is incorporated herein by reference.

  The present invention provides an improved example superior to a conventional stent by using a beam member and an extensible member as components in the design of a prosthesis. However, the extensible member projects in a non-radial direction. It includes a joining member that expands, and aims to minimize the contracting action in the long axis direction when expanding in the radial direction and to maintain the outer surface of the prosthesis approximately smoothly during transport. Both the beam member and the expansion joint member connect a plurality of unit members such as a ring member having a meandering structure and / or a box-like structure, and isolate these unit members at a substantially constant distance from each other. And hold. The expansion joint member is preferably connected between the projecting elements of the unit members, and prevents the projection from engaging the wall of the body lumen when the prosthesis is traversed within the body lumen. The expansion joint is designed to accommodate the bending of the prosthesis that occurs when the device is tracked in a tortuous path in the body.

  The present invention may further include a unit member such as a radial ring portion having increased rigidity in the radial direction at the distal end and the proximal end of the prosthesis. By reducing the length of the longitudinal strut member of the ring portion, not only the compression rigidity but also the radial expansion can be increased. The unit member shortened in the long axis direction may take the form of a ring having a box-like structure or a meandering shape structure, but is more resistant to radial expansion than a ring part having a longer support member. strong. As an alternative, the rigidity of the unit member may be increased by adjusting a hinge member that connects a plurality of support members together. Whether such a member having increased rigidity is directly connected to adjacent unit members or a single long beam member, such a structure can be used to project both ends of the prosthesis outwardly, or a trumpet type. Minimize expansion to. The cause of prosthetic overhang or trumpet expansion of the prosthesis is the transverse stiffness of the prosthesis itself that resists bending and bending of the prosthesis attached to the delivery catheter during path tracking in a tortuous path. Overhang or trumpet expansion is undesirable because it can cause the prosthesis to engage the body lumen wall and cause trauma to the wall or deter delivery of the prosthesis to the target site. Because there is. In addition, the prosthesis is attached to an expandable inflation member, such as a balloon, having a generally cylindrical inflation portion that is approximately the same length as the catheter, and is ruptured by balloon expansion, particularly at a distal location. Damage can be reduced. The prosthesis can also be attached to an expandable inflation member having a shaped expansion shape, such as a single taper or multiple tapers, to match the prosthesis to the contour of the body lumen, or to the body lumen The expansion force of the prosthesis may be directed at a target site such as a cavity opening.

  Furthermore, the present invention can be an improvement over conventional prostheses by providing a film of radiopaque material that coats at least some of the surface of the prosthesis with a selective thickness. This allows the radiopacity of the prosthesis to be changed individually, for example by providing a more radiolucent central part to increase the visualization of the tissue under treatment inside the prosthesis and radiopaque Providing an end portion with higher properties is advantageous in that it makes it easier to place the prosthesis in the body lumen and to make it easier to place a plurality of prostheses side by side or overlap. Such a coating of radiopaque material can be applied by selective electroplating or other processes such as dipping or sputtering.

  The prosthesis of the present invention preferably includes the beam member / expanded joint member as described above, a plurality of members that increase rigidity in the radial direction, and a selective radiopaque marking mechanism. It can be seen that it may be employed independently or in combination to provide an improved prosthesis.

II. Prosthetic Embodiments Referring now to FIG. 1, a radially expandable luminal prosthesis 10 is generally comprised of a frame portion 20 formed from a plurality of radially expandable unit members 22. . The final shape of the prosthesis 10 is generally cylindrical, but it is possible to allow the prosthesis to fit into a lumen having a non-cylindrical cross section and to fit in a transversely curved lumen. It should be evaluated correctly what can be done. In the first specific embodiment of FIG. 2, the frame portion 20 is formed of a plurality of unit members 22 that are connected to each other by a plurality of beam members 24 and expansion joint members 26 and that are adjacent to each other in the longitudinal direction. ing. The frame part 20 is usually defined to have a central part 27, in which the unit member 22 does not come to positions at both ends in the longitudinal direction of the frame part.

A. Unit Member The unit member 22 that can be expanded in the radial direction is a basic unit that forms the frame portion 20. The unit member 22 is preferably in the form of a single elongate member that is patterned into a serpentine or "wavy" shape. However, as long as the final unit member 22 is capable of producing the desired radial expansion of the luminal prosthesis 10, members such as the box 30 and the zigzag 32 illustrated in FIGS. 2, 3A, and 3B are incorporated. It should be noted that various structures may be used. The box mold 30 typically has a plurality of sets of longitudinal support members 31 and 33 having non-uniform lengths. After the unit member 22 is radially expanded, it is typically maintained in a “zigzag”, diamond, or other pattern to properly support the vessel wall between successive unit portions, or And further suppress local tissue hyperplasia. Conventionally, the entire prosthesis 10 including a unit member, a beam member, and an expansion joint member can be formed by applying laser cutting, electric discharge machining, photochemical etching, or the like to a thin-walled tubular (ie, cylindrical) material. Such techniques are actively described in technical literature and patent literature.

  Typically, the radially expandable unit member 22 is characterized by having a plurality of proximity points 34 and remote points 36. In this case, the proximity point 35 is defined as a position on a cutting surface of a certain unit member 22 that is closest to another unit member 22 adjacent in the long axis direction in the axial direction. These proximity points 34 are typically positions where there is the highest possibility of meshing with the wall of the body lumen when following the course of the prosthesis, that is, when the prosthesis is being conveyed. In the present case, the remote point 36 has the broadest definition of all points spaced from the adjacent point 34 on the same member for a unit member 22. The remote point 36 on the unit member 22 adjacent to the reference unit member 22 in the major axis direction is generally the most distal position facing each other. The proximity point 34 and the remote point 36 are illustrated in FIG. 2 to FIG. 3B with respect to various shapes of the unit member 22 such as a meandering shape, a zigzag shape, and a box shape.

B. Beam Member and Expansion Joining Member Referring now to FIGS. 1-2, the beam member 24 and the expansion joining member 26 used to connect a plurality of unit members 22 together will be described below. As illustrated in FIG. 1, the beam member 24 is typically a straight, elongated member aligned axially with the major axis of the prosthesis 10. The beam member 24 may have various profiles or various contours as long as they do not interfere with the function of the prosthesis 10. For example, the beam member 24 depicted in FIGS. 1 and 4 is provided with a central portion 25 having a narrow width (the way of narrowing is exaggerated for illustration), and the beam member is provided in each central portion. It can be bent in the vicinity. This improves the flexibility in the longitudinal direction, prevents interference between the beam member 24 and the column member of the unit member adjacent thereto, and at the same time, the prosthesis moves to the target site in the lumen. It is bent while being conveyed or following the path. The beam members 24 are typically axially aligned between the unit members 22 and continue to the remote point 36, and the remote points are always separated by a fixed distance while the prosthesis 10 is expanding radially. To maintain.

  The expansion joining member 26 interconnects the proximity points 34 between the unit members 22, but maintains the outer surface of the cylindrical frame portion 20 substantially smoothly while the prosthesis 10 has a curved shape. This is used to prevent the scraping action of scales. Scale scraping is markedly displayed by the prior art prosthesis illustrated in FIG. 3C, where a prior art prosthetic protruding member (Global Therapeutics, Bloomfield, Colorado, USA) is shown. Inc.) can be purchased under the trade name Freedom Stent), while the prosthesis is being retracted or advanced as indicated by arrow 27, the progression in the lumen is blocked or the body lumen May damage it. The expansion joint member 26 of the present invention minimizes the harmful effects of such protrusions. As illustrated in FIG. 3D, the expansion joint member 26 is designed to connect the proximal points 34 together to maintain the smooth outer surface of the prosthesis 10, while at the same time relative to the unit members 22. Designed to minimize interference with axial positioning. Due to the flexibility of the prosthesis 10, it is preferred that the prosthesis can be maintained in a curved shape without a tendency to become linear, and if there is a tendency to become linear, the curved body The lumen is excessively distorted, causing unnecessary trauma to the lumen at both ends of the prosthesis.

  With reference to FIGS. 1 to 4, the expansion joining member 26 is formed as an S-shaped member. The S-shaped shape allows for axial linear expansion and compression as illustrated in FIGS. 4A-4C. As illustrated in FIG. 3D, during such linear expansion and linear compression, the outer surface remains substantially smooth while the expansion joint member 26 is expanding or compressing. When the prosthesis 10 has a curved shape, some of the expansion joint members 26 are in a compressed state, the remaining joint members are in an expanded state, and the outer surface of the frame 20 on both the expansion and contraction sides of the prosthesis Keep it smooth. As illustrated in FIGS. 1 and 2, not all proximity points 36 are necessarily connected by the expansion joining member 26.

  Referring again to FIGS. 4A-4C, the expansion joint members are generally more fragile than the adjacent strut members to facilitate each plastic deformation. In the illustrated example, the expansion joint is weakened by reducing the width. The joining member 26 may also be weakened by increasing the length of the joining member (the length when fully expanded) or by reducing the depth of the joining member. As illustrated in FIGS. 5 to 7, the expansion joining member 26 may take various shapes other than those described above, for example, a U-shaped joining member, an O-shaped joining member, or a zigzag joining. In this case, it is assumed that the joining member recognizes that the outer surface of the prosthesis 10 is maintained substantially smoothly when the prosthesis 10 is conveyed. The expansion joint member 26 is devised to obtain axial compression / expansion and transverse bending, and as indicated by arrows 42, 44, 46, the desired linear freedom and desired bending freedom. It is preferred to provide a degree. The joining member 26 preferably has a stretchable and malleable structure. Although not limited to such an embodiment, it is desirable that the beam member is a major longitudinal structure and that the joining member 26, at best, undergo minimal suppression.

C. Apart from the bending characteristics inherent to the pattern beam member and the joining member, the path following characteristic and the expansion characteristic of the prosthesis 10 are usually determined by the positions of the beam member 24 and the expansion joining member 26 between the unit members 22. Yes (Figures 1 and 2). For example, when the expansion joint member 26 is used, the prosthesis 10 is generally improved in track following ability, because the proximal end is constrained to each of them, and the risk of scraping the scale is reduced. Because. Similarly, when the beam member 24 is used, by joining the unit members 22 adjacent to each other, one long flexible (extensive) beam can be engaged between the unit members when following the path of the prosthesis. By substantially improving, the course following characteristic of the prosthesis 10 is improved. Another important advantage of the beam member 24 relates to improved radial expansion characteristics, because the shortening of the prosthesis is substantially compensated by the beam member and unit member geometry. However, if the number of the beam members 24 and the joining members 26 is too large, or if the number of the joining members is too small, another quality deterioration such as reducing the flexibility characteristic in the transverse direction of the prosthesis is caused. May occur. For this reason, there exists a performance compromise that should be considered in terms of the number and positioning of the beam members 24 and the joining members 26 used in the prosthesis 10.

  Referring to FIGS. 1 and 2, the beam member 24 and the expansion joint member 26 are installed in a variety of patterns between the unit members 22 between the prosthesis and the flexibility and other competing performance characteristics. It should be understood that the balance may be maintained. In the embodiment illustrated in FIG. 1, the beam members 24 and the expansion joint members 26 may be alternately arranged in a straight line to connect a plurality of adjacent unit members 22. Unit units adjacent to each other are connected to each other by only one beam member and one or more expansion joint members 26.

  FIG. 2 illustrates the first specific prosthesis 10 embodiment taking the “as-deployed” shape. As shown, the adjacent unit members 22 of FIG. 2 are connected together using both a beam member 24 and an expansion joint member 26. As illustrated in FIG. 2, the beam member 24 and the expansion joint member 26 are not necessarily aligned in the long axis direction. In this embodiment, only one beam member 24 is used per connection between adjacent unit members 22. This maximizes flexibility in the long axis direction and at the same time corrects the shortening effect in the long axis direction. Further, the beam member 24 is “ladder stepped” in shape, where adjacent beam members are long axis as illustrated in FIG. 2 and the second specific embodiment of FIG. A predetermined amount of overlap is provided in the direction, and they are arranged in a staggered pattern in the horizontal direction (expressed as the circumferential direction) and the long axis direction. This overlap is preferably at least one third of the length of the beam member 24 and more preferably about one half while the prosthesis is in the contracted shape. If the prosthesis is recognized as its typical cylindrical shape, it is advantageous to have a helical connection pattern as a result of placing the beam member 24 in a ladder step shape. Such a connection pattern improves the transverse flexibility of the prosthesis by distributing a plurality of beam members independently around the periphery of the device.

  The correction of the length of the prosthesis in the axial direction is performed by the above-described interconnection pattern between the beam member 24 and the unit member 22 when the prosthesis is radially expanded from the contracted state to the expanded shape or the deployed shape. Is conveniently achieved. The geometrical relationship is best recognized in FIGS. 8A and 8B, where the three adjacent unit members 22 are depicted in both a contracted shape and a radially expanded shape. . The length M2 of the axial strut member in the expanded configuration is shorter than the length M1 of the axial strut member in the contracted configuration, which is a serious concern in many prior art designs. It was. However, in the pattern of the present invention, the total length of the prosthesis is actually large because the major axis distance L2 from the base of the first beam member 24a to the base of the adjacent beam member 24b is contracted. This is because it is longer than the distance L1 of the time shape. Furthermore, if the unit member 22 is of the box type as illustrated in FIGS. 1 and 2, due to the difference in length N1 and N2 as illustrated in FIGS. 8C and 8D. The length in the major axis direction of each box-shaped portion related to the base portion of the first beam member 24 is shortened. The prosthetic expansion and contraction described in connection with FIGS. 8A / B and 8C / D, respectively, may be used to achieve optimal length correction when the prosthesis is expanded or deployed. It is advantageous.

III. Axial Selective Radial Stiffness Referring now to FIGS. 9 and 10, a prosthesis having an axial radial selective stiffness has a geometric characteristic that, by devise, produces undesirable track following performance. Can be controlled. One factor that determines radial stiffness is the type of material used to manufacture the prosthesis. This material is a material such as 316L stainless steel, and is strong and malleable in the annealed state. Therefore, it is preferable to keep the recoil to a minimum in the expanded shape. Of course, the higher the strength of the material, the lower the extent to which the prosthesis will expand. Another factor of the radial rigidity is the length of the support member 102 used in the unit member 22. The shorter the strut member 102, the more the strut member has to deform the hinge member with a smaller leverage, i.e. with a lower mechanical advantage. Therefore, in order to extend the hinge member between the two support members, the shorter support member requires a larger force than the longer support member. Another factor is the design of the hinge member 104 that complains of the strut members 102 adjacent to each other. As indicated by arrows 106, 107, and 108, the hinge member 104 becomes weaker as the hinge member 104 is longer, narrower, and thinner. As the hinge member 104 is shorter, wider and thicker, the hinge member becomes more rigid.

  Referring to FIGS. 10A and 10B, a prosthesis 10 having an expanded radial stiffness selective in the axial direction is described. As illustrated in FIG. 10A, a conventional luminal prosthesis tends to overhang near the distal end 110 and the proximal end 112 and follows a path in a tortuous anatomy. This tendency is particularly remarkable during the interval, but the same can be said when the balloon is expanded radially. This creates an hourglass shape or a trumpet shape at both ends, which can cause trauma to the body lumen wall while following the path of the prosthesis to the target site, or even prevent the catheter attached to the prosthesis from progressing. is there. Such a shape can also cause excessive edge deformation when expanded, and thus can potentially be a source of a more severe restenosis effect. As a cause of the occurrence of overhang or trumpet shaping, it is preferable to follow the path in the path where the prosthesis is tortuous and it is preferable that the strut members at both ends of the prosthesis are deformed (as illustrated in FIG. 10A) ), Instead of resisting excessive bending and remaining in the desired cylindrical shape along the entire length of the prosthesis, it has shown the shape of a double-ended trumpet. Such a situation occurs in the prior art, in particular, the central unit member of the prosthesis 10 is connected to the adjacent unit member, or is constrained by the adjacent unit member, and the unit members at both ends. However, this is because the prosthesis is given transverse rigidity while acting like a cantilever with only one side constrained. For this reason, the end portion is more easily deformed when following the course. Since such prostheses are usually made from malleable materials, they will remain deformed even if the delivery catheter returns to a linear shape.

  In a preferred embodiment of the prosthesis 10, the unit members near the distal end 111 and the proximal end 113 are more rigid in the radial direction than the unit members near the center of the prosthesis 10 or at the central portion 27. Although the prosthesis is not limited to this mode, it is confirmed that the outward projecting action can be minimized by increasing the radial rigidity. Radial stiffness can be increased in a variety of ways, for example, using a short unit member in the major axis direction or changing the geometry, i.e., the width and length of the outermost component of the unit member This is possible by changing the thickness. Thus, the amount of force required to expand the prosthesis may vary throughout the length of the prosthesis.

  In one embodiment, as illustrated in FIG. 10B, the ring portions 120 and 121 at both ends forming the distal and proximal ends of the prosthesis 10 include a plurality of substantially longitudinal portions, ie, strut members 122. Although incorporated, these strut members are shorter in length than the longitudinal portion 130 characterizing the unit member 22 in the central portion of the prosthesis. The longitudinal portion 122 may take a variety of lengths, but this portion is typically half the length of the longitudinal portion 130 of the unit member 22. It is preferable that the ring portions 120 and 121 at both ends, which are provided with long portions having high strength because they are short, protrude very slightly outward during follow-up and expansion of the prosthesis. The ring portions 120 and 121 at both ends, which increase in rigidity in the radial direction, are preferably provided in the embodiment of the prosthesis 10 as illustrated in FIGS. 1 and 2. The ring portions 120 and 121 at the end may have a meandering shape, a zigzag shape, or a similar shape other than these.

  In the embodiment of FIG. 11, it is illustrated that the ring portions 120 and 121 in which the support member 122 is shortened are connected to the adjacent unit members by the combination of one beam member 24 and the expansion joint member 26. Yes. One ring part, 120 or 121, may be directly connected to the unit member 22 to form a structure that is movably joined to the unit member. The ring part 120 or 121 is connected to the unit member 22 by the expansion joining member 26, and can prevent the scraping action of scales without suppressing the flexibility in the transverse direction.

  In an alternative embodiment, a serpentine shaped ring incorporates other members to increase radial stiffness. For example, in FIG. 13, the distal and proximal ends of the prosthesis 10 may be covered by annular sheath members 130 and 131 made from an expandable material that radiates at both ends. Constrained in a direction and with minimal overhang, it is typically implanted into a body lumen with a prosthesis. For other suitable devices and methods for constraining the expansion of unit members 120, 121, and 22, see U.S. Patent Application Serial Number for which an expansion limiting hinge member and the like were filed on August 2, 1996. No. 08 / 691,661, the complete disclosure of which was already incorporated earlier in the specification.

IV. Intraluminal Delivery and Expansion As illustrated in FIG. 13, in a preferred embodiment, the prosthesis 10 is placed on an expandable expansion member 80 in a contracted state with a typically cylindrical expansion portion 82. Although preferably contracted, such an inflation member is typically placed at the distal end of the catheter 100 (FIG. 14). However, the prosthesis 10 is a U.S. Pat. No. 5,599,306 assigned to the same assignee as the present case, or a co-pending application filed on August 26, 1996 and assigned to the same assignee as the present case. It is understood that it may be coupled to the expansion member 80 by other methods known in the art, such as a stent delivery sheath member as described in US application Ser. No. 08 / 704,801. It should be noted that the complete disclosures of the above patents and patent applications are hereby incorporated by reference. In a preferred embodiment, the prosthesis 10 as mounted on an expandable inflation member 80, such as a non-extensible elastomeric balloon, is routed within a curved and tortuous body lumen as illustrated in FIG. It is designed to follow and reach the target site T. As shown in the figure, the expansion joint member 26 prevents the prosthesis 10 from engaging the lumen wall when the prosthesis 10 has a curved shape. Furthermore, it is preferable that the prosthesis is provided with an end portion that expands in the radial direction with increased rigidity to reduce the deformation of the prosthesis into a trumpet shape. Such characteristics improve the path following function of the prosthesis 10 in the lumen. When the prosthesis and balloon reach the desired target site T, the expansion member 80 is expanded to deploy the prosthesis 10 as illustrated in FIGS. 15A-15D. After deployment of the prosthesis 10 is completed, the balloon or expandable member 80 is deflated and removed from the body lumen along with the catheter. The prosthesis 10 remains in the body lumen and maintains the patency of the lumen.

  In a preferred embodiment of the present invention, the prosthesis 10 is mounted on a “matching” length of the inflatable member 80 to minimize balloon expansion due to the tearing characteristic of known catheter / stent assemblies. I am doing so. The term “match” is defined as the inflated portion 82 (cylindrical, tapered, or other shape) of the expansion member 80 being substantially the same length as the length of the prosthesis 10. As can be seen in FIGS. 16A-16C, even if both ends of the prosthesis are straightened, while the balloon is attempting to expand the prosthesis, and after subsequent full expansion, The outer end diameters exceed the outer diameter of the prosthesis. Excessive radial expansion of the balloon is caused by inflating the portion of the balloon that is not constrained by the prosthesis. By fully expanding the prosthesis within the lumen by high pressure inflation (in the range of 10 to 20 atmospheres), particularly at the distal end, the unconstrained portion or valve 84 as described above is damaged to the body lumen. May be reached, i.e., sufficient to cut through the body lumen. In order to eliminate such a valve 84, the system 200 according to the present invention illustrated in FIGS. An expandable expansion member 80 having a major axis length substantially the same as the directional length is employed. The term “inflatable part” can be defined as an inflated region of the inflatable member 80 that can expand beyond the outer diameter of the prosthesis 10 under high pressure inflated conditions, usually under unconstrained conditions. Although not limited to this embodiment, the distal and proximal ends of the expansion member 80, i.e. both tips, are typically provided by molding and do not expand beyond the diameter of the expansion member. Cylindrical inflatable portion 82 is at most only about 1.0 mm longer than the prosthesis at either end, preferably about 0.5 mm long, and most preferably the same length as the prosthesis. As illustrated in FIGS. 17A to 17C, by matching the length of the balloon portion to be expanded to the length of the prosthesis, the balloon shape 84 becomes an undesirable shape when the prosthesis 10 is fully expanded in place. Is significantly reduced. Once expanded, it should be recognized that the inflatable portion 82 can assume a variety of shapes.

  In a preferred embodiment, the system 200 in which the prosthesis 10 and the expandable member 80 have the same length is configured with the prosthesis 10 coupled to the expandable member 80. Alternatively, the prosthesis 10 may be implemented as a separate entity that is substantially mounted on a suitable expandable expansion member 80. Referring to FIGS. 18A to 18C, as a method of attaching the prosthesis 10 to a suitable expansion member 80, an expandable member including an expansion portion 82 having a length in the major axis direction substantially the same as the length of the prosthesis 10 is selected ( There is a way) as already mentioned. An expandable inflation member 80 is placed in the longitudinal lumen of the prosthesis 10 prior to clinical intervention. The position of the longitudinal portion of the prosthesis 10 is aligned with the longitudinal portion of the expansion portion 82 of the expansion member 80. The prosthesis 10 is then attached onto the expansion member 80 by either crimping by hand or preferably using a crimping instrument (not shown). As shown, the inflation member 80 is preferably attached to the catheter 100. However, it should be understood that the prosthesis may be pre-loaded in a delivery device such as a balloon catheter or sheath catheter at the factory.

  Referring to FIG. 19, the prosthesis 10 according to the present invention can be packaged together with instructions for use (IFU) into a kit as illustrated in FIG. The conventional packing material may be the pouch 202 or any other suitable packing material such as a tray, box, tube, etc., which is used to enclose the prosthesis 10 and the IFU 204. Thus, here, the IFU may be printed on a separate sheet and / or printed on the package. The kit may include an instrument 206 for attachment, and in particular, includes a crimping device and / or an expandable expansion member 80 that can be permanently or removably coupled to the prosthesis 10. May be. Typically, the expansion member 80 is attached to the catheter 100. The instructions clearly indicate any of the above-described aspects of the method of the present invention, such as the method for attaching the prosthesis 10.

  Another embodiment of the prosthesis 10 of the present invention has an expanded shape designed to address the need for special interventional measures. For example, the prosthetic shape at the time of expansion may be designed so as to match the shape of the lumen defined in the target site of the prosthesis. It has been proposed that most body lumens have irregular shapes, with more than 40% of all blood vessels in the body being tapered. In order to match the shape of such a body lumen, the prosthesis of the present invention is mounted on an expandable balloon 90 formed into the expanded shape of the prosthesis as illustrated in FIGS. 20A to 20D, respectively. Preferably it is done. Available from Banka Tapered Balloon, available from CR Bard, Inc., Billerica, Mass., USA, and CardioVascular Dynamics, Inc., Irvine, CA, USA A balloon 90, such as a possible CAT balloon, can be tapered or otherwise expanded to a desired shape. The prosthesis of the present invention attached to such a balloon 90 has a matched expanded shape.

  Matching the shape of the prosthesis 10 to the shape of the body lumen reduces stress concentrations that can occur when the body lumen is excessively expanded by the expanded prosthesis that remains inconsistent (usually cylindrical). It is advantageous. Molded prosthesis can provide effective scaffolding support for tapered shaped lesions, providing more effective support to the anastomotic lesion, and more accurate dimensioning of stoma lesions It becomes possible to set and give support by the scaffold. Compared to conventional transport-type prostheses, prosthetics molded by special transport means concentrate more of the support force more directly on the lesion site, which has the potential to expand potentially potentially damaging. Harm can be prevented from affecting the surrounding lumen wall. It should be appreciated that an infinite number of results and shapes can be created by changing the radial stiffness along the length of the prosthesis and the shape of the delivery system.

  Furthermore, as can be seen from FIG. 20A to FIG. 20F, the length of the support member can be varied to optimize the expansion force and the support force of the molded prosthesis. By changing the length of the support member, it is possible to provide a radial rigidity gradient between the unit members and further improve the support by the scaffold in the lumen. In the prosthesis, the support member 212 can be shortened and the support member 214 can be lengthened to form a tapered expanded shape (FIG. 20A). In other tapered shapes at the time of expansion, the short strut member S and the long strut member L are used together (FIG. 20B), the entire strut member L is made long (FIG. 20C), or the short strut member and Gradually longer strut members L / L + / L ++ can be used together (FIG. 20D). In the cylindrical shape, the prosthesis 10 uses a short strut member S and a long strut member L together (FIG. 20E), or uses a short strut member S, a long strut member L, and an intermediate strut member M together. (FIG. 20F). As shown, desired prosthetic properties can be optimized using a combination of lengths of strut members.

V. Radiopaque marking mechanism Proper placement of the prosthesis within the body lumen may be important to obtain the optimal therapeutic effect from the device. For example, treating a long lesion may require juxtaposition of several prostheses within the same body lumen. This may require pressing the end of one prosthesis against the end of another prosthesis, or slightly overlapping each end. In order to visualize the position of each of these prostheses while being delivered within the body lumen, the surgeon uses radioscopy or angiography to irradiate the device within the body lumen. The prosthesis preferably has some radiopaque marking properties, or if it is made from a radiopaque material that can be detected by radioscopy or similar visualization devices. Good.

  A method for plating a conventional prosthesis made from stainless steel with a radiopaque material such as gold, platinum, platinum iridium, tungsten, and tantalum will be described below with reference to FIGS. 22A to 22E. The method of the present invention creates a prosthesis provided with a radiopaque coating having a selective thickness in the axial direction. However, this method is not limited to the variation of the thickness in the axial direction, and can be used to provide an unlimited number of thickness shapes. The prosthesis is completely covered with a layer of radiopaque material, while near the ends, the radiopaque material or other material is increased in volume and the remainder of the device, typically the central part It is preferable that the volume is reduced above the thickness. When the coating material is gold, the thickness near both ends 111 and 113 is preferably between 7.62 μm and 22.86 μm, more preferably between 10.16 μm and 17.78 μm. The thickness above the remaining portion of the prosthesis may be in the range of 5.08 μm to 10.16 μm. The increased volume near the ends of the prosthesis increases the radiopacity at both ends, thus producing a more robust image and facilitating placement of the prosthesis at the desired location. Also, the extent of the coating in the central region 304 is such that the lumen inside the prosthesis is examined by fluoroscopy so as to be more radiopaque than the uncoated member under fluoroscopy. It is preferable to allow sufficient radiation transparency. As an alternative, the central region 304 may be left uncoated and only the ends of the prosthesis remain coated to achieve an optimal axial radiopaque distribution. This visualization of the interior of the central region 304 can be important for observing future stenosis or hyperplasia inside the prosthesis. The process of coating the entire prosthesis with a uniform thickness using the optimum thickness applied to both ends can obscure such visualization. By selectively applying a coating in the axial direction, the prosthetic features are changed for each desired problem. It should be understood that various thickness materials can be added to the prosthesis using the method of the present invention.

  One embodiment of the present invention utilizes an electroplating process to add a radiopaque material to the prosthesis. However, it is to be understood that other processes known in the art can be adapted in accordance with the present invention. This method involves infiltrating the completed prosthesis (ie, cut and polished) into the electrolyte, electroplating the entire prosthesis, and forming a layer 300 of radiopaque material such as gold. This includes a step of providing a preferable thickness of 62 μm (FIG. 21A). The prosthesis is shown in cross-section, and the plating process is illustrated with an inappropriate thickness for clarity. Next, the portion of the prosthesis 10 (in this example, both ends) where it is desirable to increase the thickness is covered with a resist material 302 to protect the coating material from the plating removal process or the plating addition process (FIG. 21B). Such resist material 302 may be, for example, a microposit.RTM.FSC.RTM. Surface coating manufactured by Shipley Company of Marlborough, Massachusetts. An electroplating process is then performed in reverse order to remove the radiopaque material not coated with the resist material. In the embodiment of FIG. 21C, the radiopaque material has been completely removed. The resist material is then removed and the remaining prosthesis 10 is coated with a selected region of the layer 300 of radiopaque material while the remaining region 304 remains exposed (FIG. 21D). Next, the entire prosthesis 10 is coated with another layer 306 of radiopaque material, such as gold, to a thickness of 7.62 μm (FIG. 21E). Thus, the resulting prosthetic embodiment is coated with 15.24 μm thick gold at both ends and the remainder of the prosthesis is coated with 7.62 μm gold. If a radiopaque coating is desired only at both ends of the prosthesis, the initial coating thickness as illustrated in FIG. 21A is increased to, for example, a 15.24 μm gold coating, omitting the final coating process of FIG. 21E. May be. As a result, the prosthesis has a 15.24 μm gold coating at both ends, but the central region remains uncoated.

  As an alternative, another method of providing a selective coating of radiopaque material may employ a combination of electrolytic deposition, electroless dipping, and sputtering processes (FIGS. 22A to 22C). For example, both ends of the prosthesis are continuously immersed in a radiopaque material so that the prosthesis is provided with an exposed central region 310 and coated ends 312. Next, the prosthesis is completely re-filmed using a sputtering process in the vacuum chamber 314 (FIG. 22B). As a result, the prosthesis is completely covered with the radiopaque material, but at both ends, the thickness is increased and the radiopacity is higher than the other parts (FIG. 22C). The process using electroplating and resist material is more flexible with respect to the shape and position of the area where the film thickness is increased, but it can be completely made of a radiopaque material using an immersion process and / or sputtering process. A prosthesis in which the thickness of the coating on both ends is increased may be provided. The steps of the above method can be performed in a variety of different orders, for example, by first coating the entire prosthesis and then coating both ends to provide the desired radiopaque coating distribution. Also good. Approximately the same thickness as that for gold can be used for other widely used radiopaque materials, but may be used, for example, for platinum or platinum iridium alloys.

  Although the invention has been described in some detail by way of illustration and example for clarity of understanding, it will be appreciated that certain changes and modifications may be practiced within the scope of the appended claims. It is clear. For example, the prosthesis can be sized appropriately for use in a variety of body lumens, such as the aorta or other blood vessels in the body.

1 is a longitudinal side view of a prosthesis according to the present invention. 1 is a “deployment” view of a first specific embodiment of the prosthesis of the present invention. FIG. A is a side view in the long axis direction of each part of the prosthesis using the box-type structure, B is a side view in the long axis direction of each part of the prosthesis using the zigzag structure, and C is a curved shape of the prior art. It is the figure which illustrated that the prosthesis showed the "scale scraping off" effect | action, and D is a figure which illustrates the prosthesis of FIG. 1 of curved shape. A to C are side views of the expansion joint member according to the present invention. FIG. 6 is a side view of an alternative embodiment of the expansion joint member of the present invention. FIG. 6 is a side view of an alternative embodiment of the expansion joint member of the present invention. FIG. 6 is a side view of an alternative embodiment of the expansion joint member of the present invention. A to D are views illustrating the length correction effect of the beam member and the box structure used in the present invention. It is a perspective view of a part of a meandering ring part. A is a drawing depicting a prior art stent that has both ends projecting out due to a path following operation, and B is a prosthesis according to the present invention in which ring portions at both ends having increased rigidity in the radial direction are provided. FIG. FIG. 4 is a “deployment” view of a second specific embodiment of the prosthesis of the present invention. FIG. 6 illustrates an alternative embodiment of a device that seeks to minimize overhang of the prosthesis. It is a figure which illustrates that the prosthesis of this invention is attached to the balloon of the catheter. FIG. 7 illustrates the catheter / prosthesis assembly of FIG. 6 being transported within a blood vessel at a target site within a body lumen, ie, following the path of the blood vessel. FIGS. 15A-D illustrate the catheter / prosthesis system of FIGS. 13 and 14 being transported, expanded, and secured within a body lumen. FIGS. 3A to 3C are cross-sectional views illustrating balloon and prosthetic expansion resulting in valve-shaped ends resulting from tearing. FIGS. 13A to 14C are cross-sectional views illustrating the expansion of the balloon and the prosthesis in FIGS. 13 and 14 having the same length. FIGS. 9A to 9C are diagrams illustrating a method of mounting a prosthesis on an expandable expansion member. FIGS. It is the figure which illustrated the kit by this invention. A to F are views illustrating examples of prosthetic devices having various unit member shapes. A through E are cross-sectional views illustrating the prosthesis being coated with a layer of radiopaque material having a selective thickness in accordance with the present invention. A to C are cross-sectional views illustrating the prosthesis being coated by a method of volumetric layers of radiopaque material having a selective thickness in accordance with the present invention.

Explanation of symbols

10 Prosthesis 20 Frame

Claims (8)

Prosthetic delivery system
A cylindrical frame portion composed of a plurality of radially expandable unit members, the frame portion having a longitudinal longitudinal portion, a distal end and a proximal end;
The prosthetic delivery system further includes a catheter having an expandable balloon with a cylindrical inflatable portion having a length substantially the same as the longitudinal portion of the cylindrical frame portion prior to expansion. The cylindrical frame portion is mounted on the inflatable portion of the expandable balloon, and both ends of the cylindrical inflatable portion of the balloon are respectively adjacent to both ends of the longitudinal portion of the cylindrical frame portion in the longitudinal direction. At most, it only extends about 1mm,
A prosthetic delivery system in which a smoothing process is performed on an inner surface of each part of the prosthesis to be inserted into a body lumen having a longitudinal portion in a long axis direction and a plurality of unit members that are expandable in a radial direction.   Each of both ends of the cylindrical inflating portion of the balloon extends at most about 0.5 mm from each adjacent both ends of the longitudinal portion of the cylindrical frame portion. Item 2. The prosthetic delivery system according to Item 1. The method of assembling the prosthetic delivery system is
Providing a radially expandable prosthesis and a catheter having an expandable inflation member with a cylindrical inflation portion;
Mounting the prosthesis on the inflatable member, and before expansion, each end of the cylindrical inflatable portion of the inflatable member extends no more than about 1 mm from each adjacent end of the prosthesis. ,
Prosthetic delivery system assembly in which the inner surface of each part of the prosthesis to be inserted into a body lumen having a longitudinal portion in the long axis direction and a plurality of unit members expandable in the radial direction is subjected to a smoothing process. Method. Prosthetic delivery system kit
A prosthesis for insertion into a body lumen having a longitudinal portion in the longitudinal direction and a plurality of radially expandable unit members;
Instructions for use specified in the method of claim 3;
A kit for a prosthetic delivery system, comprising a packing material containing a prosthesis and instructions for use.   The kit for a prosthetic delivery system according to claim 4, further comprising a catheter having an inflation member.   The prosthetic delivery system kit according to claim 4, further comprising a crimping instrument. The method of assembling the prosthetic delivery system is
Selecting a prosthesis whose inner surface has been smoothed;
Selecting a catheter comprising an expandable inflation member provided with a cylindrical inflation portion having a longitudinal portion generally the same as the length of the prosthesis;
Installing an expandable expansion member in the longitudinal lumen of the prosthesis;
The position of the longitudinal portion of the prosthesis in the longitudinal direction is aligned with the longitudinal portion of the cylindrical expansion portion of the expandable expansion member, and before expansion, both ends of the prosthesis are longitudinal in the longitudinal direction of the cylindrical expansion portion. A process of extending at most about 1 mm from each adjacent end of the part;
Mounting the prosthesis on the expansion member.   The prosthetic delivery system assembly method according to claim 7, wherein the mounting step includes a step of crimping the prosthesis on the expansion member.

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