MXPA99001801A - Stent delivery system having stent securement apparatus - Google Patents

Abstract

A system/assembly for delivery and deployment of an inflation expandable stent within a vessel, comprising a catheter having proximal and distal ends;a stent, inflation expandable from a delivery diameter to a deployment diameter, such that the delivery diameter is reduced from the deployment diameter for conforming the stent to the catheter, such that the stent, in its delivery diameter, is coaxially mounted on the catheter near the catheter distal end;an expandable inflation means coaxially mounted on the catheter axially within the stent, for expansion of the stent from the delivery diameter to the deployment diameter upon application of fluid deployment pressure to the inflation means;and a securement component coaxially mountedon the catheter, axially within the expandable inflation means, the securement component designed and adapted to provide a securement pressure to the stent in the delivery diameter to maintain the stent in position on the catheter during delivery to the deployment site.

Description

STENT SUPPLY SYSTEM THAT HAS A STENT SAFETY DEVICE DESCRIPTION OF THE INVENTION The present application is a continuation in part of the application based on Serial No. 0,8 / 807, 791 North American filed on February 28, 1997. Serial No. 08 / 702,150, presented on August 23, 1996, Serial No. 08 / 697,453, presented on August 23, 1996, and Serial No. 08 / 701,979, presented on August 23. of 1997, all of which are incorporated for reference in their entirety. This invention relates to an assembly and method for delivering and deploying a stent that can expand from inflammation, particularly within the lumen of a body vessel. More specifically, this invention relates to stent safety devices markedly placed between the balloon and the internal arrow of the catheter. Stent and stent delivery assemblies are used in a number of medical procedures and situations, and as such their structure and function are well known. A stent is a cylindrical general prosthesis introduced through a catheter into the lumen of a vessel of a body, in a configuration having a generally reduced diameter and then expanding toward the vessel diameter. In its expanded configuration, the stent supports and reinforces the walls of the vessel, while maintaining the vessel in an open, unobstructed condition. Both self-expanding stents and those that can be expanded through inflation are well known and widely available. Self-expanding stents must be maintained under positive external pressure in order to maintain their reduced diameter configuration during delivery of the stent to its deployment site. Stents that expand by inflation (also known as stents that expand with balloons), are clamped from their reduced diameter around the delivery catheter, placed at the deployment site, and then expand into the vessel through the diameter by Inflation with balloon fluid placed between the stent and the delivery catheter. The present invention particularly relates to improved stent safety and a more secure stent loading in the delivery and deployment of balloon-expanding stent. In an angioplasty procedure, restenosis of the artery may occur, which either requires another angioplasty procedure, a surgical bypass procedure, or some method to repair or reinforce the area. To prevent restenosis and reinforce the area, the doctor can implant an intravascular prosthesis to maintain vascular opening, that is, a stent, inside the artery in the lesion. The stent is expanded to a larger diameter to be placed in the vasculature, usually through the catheter balloon portion. Stents delivered to a restricted coronary artery, expanded a larger diameter through a balloon catheter, and left in place in the artery at the site of the dilated lesion are shown in U.S. Patent No. 4,740,207 Kreamer; U.S. Patent No. 5,007,926 of Derbyshire; U.S. Patent No. 4,733,665 to Palmaz; U.S. Patent No. 5,026,377 to Burton et al .; United States Patent 'No. 5,158,548 to Lau et al .; U.S. Patent No. 5,242,399 to Lau et al .; U.S. Patent No. 5,344,426 to Lau et al. U.S. Patent No. 5,415,664 to Pinchuck; U.S. Patent No. 5,453,090 to Martinez et al .; United States Patent No. 4,950,227 of Savin; U.S. Patent No. 5,403,341 to Solar; U.S. Patent No. 5,108,416 to Ryan et al .; and European Patent Application No. 707837A1 to Scheiban, all of which are incorporated herein by reference. A particularly preferred stent for use with this invention is described in the PCT application NO. 96/03092-A1, published on February 8, 1996, the 'content of which is incorporated herein for reference. By advancing a stent that expands with a balloon through the vessel of a body to the deployment site, there are a number of important considerations. The stent must be able to maintain its axial position securely on the delivery catheter. The stent, particularly its distant and nearby ends, is sometimes protected to prevent stent deformation and minimize trauma to vessel walls. Balloon expandable stent delivery and deployment assemblies are known and utilize restriction means that cover the stent during delivery. U.S. Patent No. 4,950,227 to Savin et al., Refers to a balloon delivery stent delivery system wherein a cuff covers the distant or near margin (or both) of the stent during delivery. During stent inflation at the deployment site. the margins of the stent are released from the sleeve or protective sleeves and the sleeves are then crushed to the delivery catheter for removal. A number of balloon-expanding stent delivery and deployment assemblies and deployment assemblies do not utilize overlapping restricting members, such as Savin's sleeves, to place the stent for delivery. European Patent Application No. EP. 055 3960A1 by Lau et al., Uses a separate elastic sheath between the balloon and the stent. The sheath is said to act as a barrier to protect the balloon from the stent, allow a uniform expansion of the stent, reduce the deflation time of the balloon, prevent undesirable flattening of the balloon after deflation, and provide a friction substrate for the stent. The Lau sheath can be placed on the inside or outside of the balloon. U.S. Patent No. 5,409,495 to Osborne similarly uses an elastic sleeve or sheath surrounding and in contact with the balloon to control radial expansion of the balloon. In addition, it is said that Osborne uses restriction bands or a pair of balloons to obtain the controllable stent expansion characteristics. U.S. Patent No. 5,403,341 to Solar, refers to a stent delivery and deployment assembly, which utilizes a retention sheath positioned around the opposite ends of the compressed state. The solar retention sheaths are adapted to rupture under pressure as the stent is radially expanded, thereby releasing the stent from engagement with the sheaths. U.S. Patent No. 5,108,416 to Ryan et al., Discloses a stent delivery system, which utilizes one or two flexible end caps and an annular receptacle surrounding the balloon to place the stent during the introduction to the site. deployment. The content of all these patents is incorporated here * for reference. When placing a stent that expands with a balloon over the delivery catheter in the balloon that expands with fluid, the stent should be moderately and evenly clamped to conform closely to the entire profile of the catheter and the unexpanded balloon. It has been observed that, due to the physical properties of the material used to manufacture the stent (usually a configured memory metal, such as stainless steel or Nitinol ™) there is a certain amount of "recoil" of the stent despite the very careful and firm hold . That is, the stent tends to open slightly from the fully clamped position and once the clamping force has been released. For example, in the typical stent delivery and delivery assembly, if the stent has been fully clamped to a diameter of approximately 0.0087 cm, (.0035 inches) it has been observed that the stent is opened or delayed by approximately 0.0093 cm. (.0037 inches). This phenomenon has been characterized as "backward clamping". Due to the recoil grip to this slightly enlarged diameter, it can be understood that the stent tends to present a certain amount of looseness from its desired narrow adherence towards the entire profile of the catheter and underlying balloons. That is, the stent tends to have a relatively perceptible loose fixation in its mounted and clamped position. During delivery, the stent thus tends to slide and dislocate from its desired position on the catheter or even become detached from the catheter, requiring further intervention by the physician.

According to the present invention, a safety device is secured on the inner catheter below the balloon to compensate for unwanted looseness or looseness that due to the recoil hold and to help secure the stent to the balloon, as well as to protect the balloon. Balloon material sandwiched between the stent and any metal or article that comes out, which can be mounted on the internal arrow / lumen of guide wire, to supply the stent. The safety devices secure the stent during tracing and delivery and provide a good friction fit to the stent and ensure good contact between the stent and the underlying balloon and catheter, rather than merely holding the stent over the balloon and the stent. underlying catheter and. leave the volume of the flaccid balloon that is supported by the stent. The technique named and / or described above is not intended to constitute an admission that any patent, publication or other information referred to herein is the "prior art" with respect to this invention. In addition, this section should not be constructed to mean that an investigation has been made or that no other relevant information exists as defined in 37 C.F.R. & 1.56 (a). This invention relates to a catheter apparatus suitable for performing angioplasty and for delivering stent to body cavities. In general, stents are prosthetic devices that can be placed within the cavity of a body, for example, a blood vessel or some other hard-to-reach place in the body of a living human or animal. The stent prosthesis is formed of a generally tubular body, the diameter of which can be reduced or increased. Stents are particularly useful for permanently widening a vessel, which is either in a narrow state, or internally supporting a vessel damaged by an aneurysm. Such stents are typically introduced into the body cavity through the use of a catheter. The catheter is usually of the balloon catheter type, where the balloon is used to expand the stent, which is placed over the balloon for delivery, to be placed in a selected location in the body cavity. The present invention is particularly directed to improved arrangements for releasably attaching and securing the stent to the catheter to facilitate its delivery specifically by having a safety device within the balloon. The embodiments identified below, all describe improved means for securing the stent to the catheter during the delivery procedure. In certain embodiments, the stent is held in place on the catheter through an enlarged mounting body, carried within the balloon through the arrow of the catheter to which the stent and balloon are attached. The stent is fixed on the balloon, through clamping. According to the invention in some embodiments, the enlarged body is axially movable on the internal arrow of the catheter so that it can be retracted from the mounting area of the stent to provide. a small profile to perform the angioplasty. The catheter can then be removed. The enlarged body can be moved towards the mounting area of the stent; the stent can be mounted and the catheter can be inserted again to implant the stent. In other modalities, the enlarged body can be arranged to be able to be reduced and enlarged in size instead of being mobile. Alternatively, the movable mounting body can be carried out of the balloon. A catheter of this type makes possible a method in which, before loading the stent with the associated mounting body arranged to provide a reduced diameter in the region of the balloon, the catheter can be used to dilate a region or the like. The catheter can be removed and the mounting body can then be selectively manipulated to provide an enlarged diameter in the stent mounting region and a stent can be loaded onto the catheter. The catheter can be re-inserted to implant the stent. The catheter can be removed or left in situ and the mounting body can be manipulated to provide a reduced diameter again, and the catheter can be used for any desired post-dilatation. Also, the catheter can be used many times in the stent dilation and implantation procedure. Another embodiment of the present invention is also an assembly for delivering and deploying a stent that can be expanded with inflation within a vessel. The assembly comprises a catheter, an expandable tube component mounted on the catheter, an expandable balloon mounted on the catheter and encompassing the tube component and a stent mounted on the balloon. The catheter has both near and far ends. The stent can be expanded with inflation from a supply diameter to a deployment diameter. The delivery diameter is reduced from the deployment diameter to conform the stent to the catheter. The stent, in its delivery diameter, is coaxially mounted on the catheter near the distal end of the catheter. The expandable balloon is coaxially mounted on the catheter axially within the stent. The balloon is designed and adapted for the expansion of the stent from the delivery diameter to the deployment diameter after the application of fluid deployment pressure to the balloon. The expandable tube component is coaxially mounted on the catheter, axially within the expandable balloon. The tube components are designed and adapted for fluid expansion to provide a safety pressure to the stent at the delivery diameter to hold the stent in place on the catheter during delivery to the deployment site. The expandable tube component is dimensioned and constructed that can be expandable with fluid to no more than the supply diameter. The tube component is essentially equal in length to the stent and the stent is placed on the assembly essentially coextensive with the tube component. In another embodiment, this invention is a method of delivering and deploying a stent using an assembly as described. A catheter is provided having a proximal and distant end. An expandable balloon is coaxially mounted on the catheter. An expandable tube component is coaxially mounted on the catheter, axially within the expandable balloon. The balloon and the tube component each are in an unexpanded condition. A stent is provided, which can be expanded from a delivery diameter to a deployment diameter. The stent, in a diameter greater than the supply diameter, is mounted on the balloon. The stent is crushed toward the delivery diameter to conform to a total profile of the catheter, the tube component and the balloon. The tube component is inflated to provide the stent with a safety pressure to hold the stent over the assembly at the delivery diameter. The assembly is supplied to a deployment site. The balloon is inflated to expand the stent to its deployment diameter. An alternative embodiment of the present invention is also an assembly for supplying and deploying inflation expandable stent within a vessel. The assembly comprises a catheter, an expandable balloon mounted on the catheter, a corrugated pipe mounted on the catheter below or inside the balloon, and a stent mounted on the balloon. The catheter has both near and far ends. The stent can be expanded with inflation from a supply diameter to a deployment diameter. The delivery diameter is reduced from the deployment diameter to conform the stent to the catheter. The stent, in this delivery diameter, is coaxially mounted on the catheter near the distal end of the catheter. The expandable balloon is coaxially mounted on the catheter axially within the stent. The balloon is designed and adapted for the expansion of the stent from the supply diameter to the deployment diameter after the application of fluid deployment to the balloon. The corrugated tubing is mounted and adhered coaxially on the catheter and is located between the balloon and the catheter itself. When the stent is attached and loaded to the balloon, the balloon is located, therefore, between the stent and the corrugated tubing. The pipe preferably is essentially equal to the length of the stent and the stent is placed in the assembly essentially coextensive with the tube component. The tubing over the catheter effectively holds the stent in place, takes the slack due to recoil, and protects the balloon material from being damaged during clamping. Yet another embodiment of the present invention comprises an assembly for delivering and deploying a stent that expands for inflation. The assembly comprises a catheter which has distant proximal ends. An annular collar or the like is coaxially located on the distal end of the catheter. A balloon that expands with the fluid is coaxially mounted on the collar at the distal end of the catheter. The balloon can expand from a contracted state to an expanded state. A stent is mounted coaxially on the balloon. The stent can be expanded by inflation from a reduced to an enlarged condition, the reduced condition forming the stent to the balloon, collar and catheter in the preferred embodiment. The stent has at least one end portion covering the balloon. At least one cup is coaxially mounted on the distal end of the catheter. The cup has a first end portion, which can cover the end portion of the stent. The cup and collar are cooperatively constructed and arranged to retain the end portion of the stent over the catheter in the reduced stent condition, when the balloon is in the contracted state. The balloon and the catheter are cooperatively constructed and arranged to cause expansion of the balloon from the contracted state to the expanded state to cause enlargement of the stent, including the stent end portion, from the reduced to the enlarged condition, and thus release the stent end portion of the cup end portion. The cup can be axially separated from the collar, but preferably they are relatively close. The second end portion of the cup may be attached to the catheter. The cup can cover at least a portion of the collar. The collar can be configured as an individual member with the catheter, which is integral with it or the collar can be a separate body mounted axially and mounted on the catheter. The collar may be a mounting ring or a cylinder axially positioned between the end portions of the stent under the stent and the balloon. The collar may be a sheath under the stent and balloon. An additional embodiment is also directed to improved arrangements for releasably attaching the stent to the catheter for ease of delivery. The stent is held in place on the catheter through an enlarged body carried by the arrow of the catheter within the balloon to which the stent and balloon are fixed, by clamping in combination with one or more cuffs releasably covering the end portion or portions of a stent or balloon.

BRIEF DESCRIPTION OF THE DRAWINGS Figure 1 is an isometric view, a portion of which is enlarged in longitudinal section, of a balloon catheter having a mounting body in a retracted position; Figure 2 is an even more enlarged view in longitudinal cross-section of the distal end portion of the catheter of Figure 1; Figure 3 is similar to Figure 2, but showing the advanced mounting body for receiving a stent mounted on the balloon; Figure 4 is an enlarged cross-sectional view of the distal end portion of the catheter of the Figure 1, similar to agüella of the enlarged view of Figure 3, but showing the balloon in an expanded condition together with the expanded stent; Figure 5 is a schematic view showing a preferred mounting body carried by the catheter shaft within the balloon, the body being spirally cut to improve flexibility; Figure 6 is a schematic view showing a cross-section of another preferred embodiment of the invention with a mounting body mounted to receive a stent but with a stent not yet mounted; Figure 7 is a schematic view showing another embodiment of the invention; Figure 8 is a schematic view showing means for conveniently holding the stent about the embodiment shown in Figure 5; Figure 9 is a schematic view showing still another embodiment of the invention; Figure 10 shows another embodiment of a mounting body according to the invention; Figure 11 is a schematic view of an enlargable mounting body, which is not axially movable; Figure 12 is a static view of an alternate enlarging mounting arrangement, which is not axially movable; Figures 13 and 14 are schematic views showing one more embodiment wherein the axially movable mounting body is carried out of the balloon; Figures 15 and 16 are schematic views showing a further embodiment of the invention; Figures 17 and 18 are modified versions of the embodiment shown in Figure 11; Figures 19-21 are modified versions of the security means of the present invention; Figure 22 is a side profile section showing a stent delivery and deployment assembly that is balloon-expanded, with the stent attached to the delivery diameter over the balloon, the underlying inflation component and the catheter, and with the delivery component. Inflation tube inflated to safety pressure. Figure 23 is a side profile section, similar to Figure 22, with the balloon and the stent fully inflated to the deployment diameter; Figure 24 is a side profile section showing an alternative embodiment of a stent delivery and deployment assembly that is balloon expanded, having a tube component formed in several sections; Figures 25, 26 and 27 are cross-sectional views taken along lines 4 -4, 5-5 and 6-6 of Figure 24, respectively; Figure 28 is a side profile section showing a stent delivery and deployment assembly ballooning, with the stent attached to the delivery diameter over the balloon, the underlying tube component and the catheter; Figure 29 is a side profile section, similar to Figure 28, with the balloon and the stent fully inflated to the deployment diameter; Figure 30 is a perspective view of the corrugated pipe of the present invention; Figures 31-33 are side profile sections showing alternative embodiments of balloon delivery and deployment stent assembly assemblies, with the pipe component formed in a plurality of sections; Figures 34-35 are latitudinal profile sections showing alternative embodiments of balloon expandable delivery and delivery assemblies, the tube component is inflated to safety pressure; Figure 36 is a side profile section showing a stent delivery and deployment assembly that is balloon-expanded, with the stent attached to the delivery diameter over the balloon, the underlying tube component and the catheter, and also having airway sleeves. containment covering the ends of the stent; Figure 37 is a side profile section showing a stent delivery and deployment assembly that is balloon-expanded, the stent attached to the supply diameter over the balloon, the underlying tube component and the catheter, and also having a cable traction attached to the tube component; Figure 38 is a longitudinal cross-sectional view of a stent delivery and deployment assembly of this invention showing a catheter with a collar mounted at the distal end of the catheter, an uninflated balloon mounted over the catheter in the collar, a stent not expanded, mounted on the balloon, bumping into the collar and a cup covering the proximal end portion of the stent. Figure 39 is a longitudinal cross section of another stent delivery and delivery assembly of this invention showing the catheter with a collar mounted as a mounting ring on the distal end of the catheter, an uninflated balloon mounted on the catheter over the ring of assembly, a non-expanded stent mounted on the balloon covering the mounting ring and a cup covering the proximal end portion of the stent; Note that the collar is placed closer to the cup than in Figure 38; Figure 40 is a longitudinal profile of a partial cross section of an agglomeration assembly of Figure 38, with a protuberance formed above the uninflated balloon at the distal end of the catheter; Figure 41 is a longitudinal cross-sectional profile of the assembly shown in Figure 38, with the balloon inflated and the stent expanded, showing the inclined cup end portion to release the stent; Figure 42 is a longitudinal profile, similar to Figure 41, showing the end portion of the roll tightly wound to release the stent; Figure 43 is a longitudinal profile of another delivery and deployment assembly of the stent of this invention, with the balloon mounted on the catheter, having a collar formed as an enlarged individual tapering piece over the catheter, an unexpanded stent, mounted on the unexpanded balloon bumping into the collar and a cylindrical sleeve covering the proximal end portion of the stent. Figure 44 is a longitudinal profile of the assembly of Figure 43 with the balloon inflated and the stent expanded, showing the cuff moved in a close manner to release the stent; Figure 45 is a side profile of yet another stent delivery and deployment assembly of this invention with the non-inflated balloon mounted on the catheter, having two collars integrally formed with the catheter, a. non-expanded stent, mounted on the balloon abutting the collar and a cylindrical cup covering the proximal end portion of the stent and the underlying collar; Figure 46 is a longitudinal profile of another stent delivery and deployment assembly of this invention with the non-inflated balloon mounted on the catheter, an unexpanded stent, mounted on the balloon, mounting a cylinder on the catheter and a pair of cups covering the ends of the stent; Figure 47 is an isometric view, a portion of which is enlarged and in. longitudinal section of a balloon catheter having a stent attached to the catheter over the balloon; Figure 48 is an even more enlarged view in longitudinal section of the distal end portion of the catheter of Figure 47; Figure 49 is a schematic view showing a form of retraction of the releasable sleeve after expansion of the balloon; Figure 50 is a schematic view showing another form of retraction of the releasable sleeve after expansion of the balloon; Figure 51 is still another form of retraction of the releasable sleeve after balloon extraction; Figure 52 is a schematic view showing another form of retraction of the releasable cuff after expansion of the balloon; Figure 53 is a schematic view showing a modified form for the releasable sleeve; Figure 54 is a schematic view showing in cross section another embodiment of the invention with non-mounted stent; Figure 55 is a schematic view showing another embodiment of the invention; and Figure 56 is a schematic view showing another embodiment of the invention. The present invention relates to stent safety devices, most notably placed between the balloon and the internal arrow of the catheter. The individual elements of the embodiments described below are generally interchangeable if desired. Referring to Figures 1-4, an angioplasty and stent delivery catheter system, generally indicated at 10, includes a balloon catheter 12 having a balloon 14 on the distal end portion generally indicated at 16. Figure 1 shows a proximal portion of the catheter at 12a and a distal portion 12b in an enlarged view. Figures 2 and 3 show the far end portion 16 in an even more enlarged view. The illustrative catheter 12 is of the type known as an individual or rapid exchange operator catheter. However, other types of catheters can be used, such as cable and fixed cable types. The balloon 14 is fixed to the catheter * 12 through standard means. The balloon is shown in a contracted state. A stent 18 is fixed around the globe holding it thereto. The stent has a larger expanded diameter, which is obtained when the balloon is expanded in a known manner. In Figures 1 and 2 the catheter is shown ready to perform angioplasty and in Figure 3 it is prepared for stent implantation.

In Figures 1 and 2, an axially movable mounting body 30 is shown in a position close to the end portion 16 of the catheter, where a stent can be mounted., the catheter includes at its near end a manifold, generally designated 13 as is known in the art. The manifold includes an inflation port 15 as is known in the art. A cable 31 is attached to the body 30 to allow remote base and retraction (of the near catheter end) thereof, axially on the internal lumen 26 on which it slides. In the retracted position shown in Figures 1 and 2, the catheter has a low profile to perform the angioplasty. This position is a retracted position and is selected by the operation of an extraction cable 31. The retracted position of the mounting body may vary. In order to maximize the low profile of the distal end 16 of the catheter, the retracted position may be within the external member 24. After such a procedure, the balloon is deflated, the catheter is withdrawn and the mounting body is advanced through the cable 31 towards the mounting position of the stent shown in Figure 3. A stent 18 can then be fixed around the deflated balloon by holding it thereto. The stent has a larger expanded diameter, which is obtained when the balloon is again expanded in a known manner. That is, the stent is released from the catheter after balloon expansion as shown in Figure 4 which will be placed in a vessel at the desired location. When the balloon is again deflated, removal of the balloon and catheter can be accomplished, leaving the stent in place. The illustrative dimensions of the inner part 26 is a diameter of * _ • mm and for the body 30 a diameter of% mm. As is known in the art, the balloon can be both attached at its ends through the adhesive 20 and 22, respectively, to the outer member 24 of the catheter, and to the internal member 26 of the catheter in a manner as shown, or is made of one piece with the outer member as known in the art. The catheter balloon can be inflated through fluid (gas or liquid) from an inflation port extending from a lumen 28 (seen in Figures 2 and 3) contained in the catheter shaft and opening towards the balloon as shown in FIG. shows, or through other known arrangements, depending on the design of the catheter. The details and mechanics of balloon inflation and its specific total catheter construction will vary according to the particular design involved in any given case, and are known in the art per se. Such details are only shown esguemáticamente aguí. All variations are acceptable for use with this invention.

Any balloon expandable stent can be used with this invention. Many are known in the art, including plastic and metal stent. Some are much better known, such as stainless steel stent shown in U.S. Patent 4,735,665; the stent of cable shown in U.S. Patent 4,950,227; another metal stent shown in European Patent Application EPO 707 837 A1 and that shown in U.S. Patent 5,445,646 or U.S. Patent 5,242,451. All these patents are incorporated for reference. 'Also, configured metal memory stent can be used. As already indicated, the stent of the PCT application 960 3092 Al is particularly preferred. The stent is typically, for example, a length of about 16 mm, although the balloon may be a length of 20 mm for example. These dimensions, however, are merely representative only for illustrative purposes and are not intended to limit. The stent is placed on the balloon portion of the dilatation catheter and moderately held on the balloon either by hand or with a tool such as forceps or the like, to be assembled for delivery as shown in Figure 3. Fasteners can easily be achieved by the doctor during the procedure.

In accordance with this invention, the mounting body 30, best seen in Figures 2 and 3, is included within the balloon 14 to provide a cushion and / or substrate of enlarged diameter relative to the stent to support and maintain the stent and secure it during the clamping and the supply procedure. The mounting body can be axially movable close to or distantly from the position shown in Figure 3, a near shape being preferred. In the first embodiment shown in Figures 1-3, the mounting body 30 has a cylindrical shape and takes the form of an axial sleeve and slidably carried over the internal lumen 26, providing an enlarged area or portion for receiving the balloon and the stent when the latter is attached to the balloon. A marking band 34 may also be included on the inner part 26, as shown. Any radio-opaque material such as gold is useful for this purpose. A stop member 36 of generally conical shape or any other shape may also be included on the marking band 34 as shown, to provide additional resistance to movement of the stent during delivery and to protect the leading edge of the stent during delivery. The polyethylene or similar material is suitable for the stop member. Other marking arrangements and stop arrangements may also be used.

Although the material of the mounting body may be hard, it preferably is of any deformable thermoplastic material, preferably an elastomer material and more preferably a relatively elastic elastomer material, for example, lower durometer silicone. A preferred deformable thermoplastic material is high density polyethylene (HDPE). A preferred lower durometer silicone is in the form of a pipe. The deformation of the elastic material of the mounting body when the stent / balloon is attached to it, causes an external radial force on the stent / balloon increasing the pressure between them in spite of any retraction of the stent. During the delivery of the stent, the balloon catheter is advanced through, and placed in a vasculature of a patient, so that the stent is adjacent to the portion of the vessel in which the treatment is presented. The balloon is inflated to expand the stent to an enlarged diameter. When the stent has reached the desired diameter, the balloon is deflated so that the catheter can be removed leaving the stent in place. Another embodiment of the invention is shown in Figure 5. In this embodiment, the mounting body 30 is a spiral cutting elastomer or other suitable material, such as a rigid or flexible plastic, to provide clearance for flexibility in this portion of the catheter, allowing easier movement or tracking around the push-ups. The spiral cut may be only partially through the mounting body or may be all the way as shown in Figure 5. Also, although the stop member 36 is shown at the distal end portion of the catheter in this embodiment, No cap member can be used. Another similar version is shown in Figure 6, which includes a cylindrical mounting body 30 made of a plurality of spaced adjacent rings 30a held together through cable 31, which extends therethrough as shown with the stops 29 to secure the rings together. The rings 30a may be individual bodies carried on the sheaths or cut bodies of a cylinder to separate them partially or completely. Proper arrangements can also be made for the cable 31 at each end of the body 30 to hold the rings together, as shown. The embodiment shown in Figure 7 includes another aspect based on the geometry of the mounting body to additionally secure the stent after clamping. This feature is referred to herein as "interblogging". That is, the stent can be interlocked to the assembly so that the stent can not slide near or distant over the balloon, unless it is deformed, such as through expansion. This can be seen by observing the structure shown in Figure 7, which includes the internal part 26 which has a two-piece mounting body made of separate mounting bodies 30a and 30b. These bodies are connected to one another via connecting means 33, which may also be of a separate or integral cylindrical body of smaller diameter or may be one or more relatively rigid cable members, as shown. The spacing between the bodies 30a and 30b allows the portions of the stent 18 and the balloon 14 to be compressed or inserted between the bodies after the stent is clamped, thus forming an interlocking against stent sliding axially or longitudinally before the stent be free. The interlocking or clamping formation is easily accomplished through any suitable means such as a two piece die 40, shown in Figure 8, or the like. Figure 9 shows that more than one two-piece mounting body arrangement can be used if desired. In this embodiment, the mounting body is composed of three separate interconnected bodies 30a, 30b and 30c on the internal part 26. Preferably, in the embodiments of Figures 7 and 9, the mounting bodies will have a shape similar to a ring or a cylindrical shape although * other configurations will be readily apparent to those skilled in the art. Referring now to Figure 10, another embodiment of a movable mounting body 30 is shown in the form of a rigid coil of plastic, metal or the like having a control cable 31, preferably integral therewith. When in the metal form, the spiral can be coated with a polymer such as polyethylene or PTFE or encased in a polymeric sheath of similar material. The spiral can be received slidably on the internal part 26 similar in disposition to that shown in the preceding Figures. As already mentioned, an alternative arrangement can be used wherein the mounting body, instead of being mobile, is designed to be elongated and reduced or crushed, while remaining in a fixed position in the mounting area of the catheter stent. Figures 11 and 12 are directed to such an arrangement. In Figure 11, an inner balloon 50 of smaller diameter than the outer balloon 14 is mounted on the inner part 26. The balloon 50 may have a separate inflation conduit 52 on the inside 26, preferably including a valve arrangement 54. Valve 54 may be a one-way valve that allows inflation of balloon 50 only if desired. However, the inner part 26 can serve as the inflation conduit, too. In addition to completely inflating the balloon, the inner balloon 50 may also be partially inflated. Figure 19 shows a modification of Figure 11 where two internal balloons 50a and 50b are included. Figure 20 shows a modification where two inflation valves 54a and 54b are included. Figure 21 shows a total arrangement of the inner balloon 50, wherein a syringe 120 is inserted at the distal end of the liner 26 of the catheter. The syringe has at its ends blocks 122 and 124 to allow local pressurization of the inner part 26 to inflate the balloon 50. Figures 17 and 18 show an inner balloon 50 similar to the arrangement of Figure 11, but the balloon 50 in Figure 17 has a narrow central portion and broad ends to provide a mounting shape similar to agüella of Figure 7. In Figure 17, the balloon 50 is inflated and the balloon 14 is partially inflated. In Figure 18, balloon 50 is inflated and balloon 14 is deflated ready for stent loading. The balloon material is preferably a polyethylene or urethane elastomer such as Tecoflex or Tecothane from Thermedics. With reference to Figure 12, an alternative embodiment is shown in which the near portion of the inner part 26 is axially movable, while the distal portion 26b is fixed with respect to the catheter. Between the portion 26a and the portion 26b is a helical spring 60 within a flexible sheath 62 of PTFE or the like. The portion 26 of the internal part is attached to the balloon 14 at the very distant end portion of the catheter. The portion 26a moves axially within the outer part 22. In this way, if the portion 26a is pushed in the distal direction and maintained to compress the spiral 60, the spiral will enlarge in diameter to provide an enlarged mounting area for a stent Twisting the inner part to twist the spiral will improve the enlargement. Alternatively, the coil spring 60 can be replaced by a braided element. . Also, the proportion of a different step on the length of the spiral can be made to enlarge some regions more than others. For example, if the windings of the spiral are closer in the central portions than in the end portions, when the spiral undergoes compression, the two end portions will enlarge in diameter more than the central portion to provide an assembly similar to that of the Figure 7. Referring now to Figures 13 and 14, another modality is shown which is alternative to the modalities already described, which are found within the catheter balloon. In this embodiment, a sheath 80 is carried on the external part of the catheter. Sheath 80 is elastomeric and is axially movable from a stent mounting position as shown in Figure 14 to a remote position, from the stent mounting position, such as the retracted position shown in Figure 13. In the position shown in Figure 13, the balloon 14 can be inflated and deflated. In the position shown in Figure 14, balloon 14 will be deflated for the low profile. The sheath 80 when on the balloon as shown in Figure 14, acts to increase the profile of the catheter to facilitate the attachment of the stent to the same during the deployment of the stent. Pod 80 will expand with balloon 14 to facilitate inflation and during disinflation, the elastomer sheath will return to its original dimension. An elastomer material, which is currently preferred, is Tecothane, a trademark for a thermoplastic polyurethane available from Thermedics, Inc., of Oburn, Massachusetts. This may have a thickness of about 0.0076 cm (0.003 inches) for example. With respect to Figures 15 and 16, a further embodiment of the invention is shown, wherein the inner part 26 carries a mounting body 30, the distal end 100 of which is secured or fixedly attached to the inner part 26, as through any adhesive material. The rest of the body 30 can be slid over the inner part 26 through the compression application in the distant direction at the near end 102. This can be achieved through a push cable 104, which extends towards the near end of the catheter for remote manipulation as is known in the art. The mounting body 30 is bent as an accordion with widely spaced folds at the end portions 106 that at the center portion 108. Thus, as can be seen in Figure 15, a relatively low profile is provided without compression for normal use. of angioplasty. When a stent is to be mounted (not shown), compression through the push cable 104 will result in an enlarged diameter configuration of the body 30 as shown in Figure 16 to provide an assembly similar to that of Figure 7 in a general configuration. If the spring is uniform on the body, it remains uniformly large, similar to the inner balloon of Figure 11. The figures are shaped in a schematic view, but the concept can be easily appreciated. As an alternative to a bent construction, the body can be braided construction to obtain the same operation. Also, this shape of the body 30 can be inserted into an internal part of two pieces 26 similar to the arrangement shown in Figure 12. In all these arrangements, the body material bent as an accordion can be of any suitable polymer, such as polyethylene . For example, a pipe can be used having a wall thickness of about 0.00508 cm. (.002 inches). Folds or accordion folds can easily be formed in such a pipe through a pressure mold containing separate blades placed in a hot chamber. Figures 22-27 show embodiments, wherein the internal security device comprises an internal balloon below the external catheter balloon, similar to the interior. Figures 22 and 23 illustrate a side profile section, showing a stent delivery and deployment assembly that is expanded by the inflation generally designated 110. The assembly 110 includes a catheter composed of internal arrows 112 and 113 and an external arrow 115 of the coaxial type, a balloon that expands with inflation 114, an inflation tube component 116 such as an internal balloon and a stent that expands by inflation 118. Any conventional type of catheter may be used, such as a catheter type generally used for PTA or PTCA angioplasty procedures for prostate therapy and TTS endoscopic catheters for gastrointestinal use. However, coaxial types are more preferred, as shown. The particular catheter 112 shown is formed of a compatible biocompatible and hydrophilic material, such as a lubricating polyimide or polyethylene. Other materials suitable for catheter 112 include nylon, urethanes and polypropylene materials compatible with coating such as silicone and / or hydrophilic coatings. In addition to compatible hydrophilic materials, any biocompatible material may be used. For example, polyethylene or polypropylene can be coated with a hydrophilic material to make it hydrophilic compatible. Catheters suitable for use in accordance with the present invention include a number of catheters available from SciMed Life Systems, Inc., Maple Grove, Minnesota, the assignee of the present invention, such as the BANDITMR, COBRAMR, VIVAMR and VIVA PRIM0MR catheters. The inflatable tube component 116 is fixed at its distal end and close to the inner arrow 112 and at its end near the inner arrow 113 in a position that will be encompassed within the distant and near ends of the outer balloon 114 In accordance with the recognized convention of the technique, the length LB of the balloon 114 is defined as the length of the body portion of the balloon 114, excluding the terminal cone sections 120. As seen in Figure 23, the body portion of the balloon 114 is generally cylindrical when in contact with the balloon. your unfolded or inflated condition. The tube component 116 is illustrated as having terminal sections 122, which are relatively more vertical than the cone sections 120 illustrated for the balloon 114. However, it should be understood, in accordance with the present invention, any of the terminal sections 120, 122 may have a relatively cone shape, may be relatively vertical, or may have any other configuration known to those skilled in the art. A preferred length LT of the tube component 116 is illustrated in Figures 22 and 23 as substantially equal to the length LB of the balloon 114 and substantially equal to the length LS of the stent 112. However, according to the present invention, the stent 112 must be supported by the underlying tube component 116 for a length sufficient to allow achievement of the stated purpose of the tube component 116 when inflated, to provide the safety pressure for the stent 112 to hold the stent 112 in place with the assembly 110 during delivery. It is also within the invention that the tube component 116 is slightly shorter than the stent 112, for example, the distal end 119 of the stent 112 may extend distally beyond the distal end 121 of the tube component 116 (not shown), so that the distal end 119 of the stent 121 can be clamped on the distal end 121 of the tube component 116 to prevent the distal end 119 of the stent 112 from being trapped and tending to open further as it is maneuvered into the cup of a stent. body. As already explained above, the tube component 116 is designed and constructed to be inflated to no more than what is necessary to compensate the restraint for the stent 112 and to adapt closely (or even slightly overcompress) the supply diameter of the stent 112. stent 112, taking into account the thickness of the uninflated intervention balloon 114. The tube component 116 is inflated through the opening or openings 117 of the internal arrow 112. Normally, the component 116 will have a wall thickness of approximately 0.00049 - 0.00177 cm (.0002 - .0007 inches) and may be inflated to no more than approximately 0.088-0.1143 cm (.035-.045 inches). The inflation tube component 116 can be formed of either condescending or non-condescending balloon materials. Condensing materials include relatively soft or flexible, low pressure polymeric materials, such as thermoplastic polymers, thermoplastic elastomers, polyethylenes (high density, low density, intermediate density, low linear density), various copolymers and polyethylene blends, ionomers, polyesters, polyurethanes, polycarbonates, polyamides, polyvinyl chloride, acrylonitrile-butadiene-styrene copolymers, polyether-polyester copolymers and polyether polyamide copolymers. Suitable materials include a copolymer polyolefin material available from E.I. DuPont de Nemours and Co. (ilmington, Del.), Under the tradename of Surlyn ™ Ionomer and a polyether block amide available under the trade name of PEBAX ™. Non-condescending materials include relatively rigid high pressure polymeric materials, such as thermoplastic polymers and thermofixing polymer materials, polyethylene terephthalate (commonly referred to as PET), polyimide, thermoplastic polyimide, polyamides, polyesters, polycarbonates, polyphenylene sulfides, polypropylene and rigid polyurethanes. A balloon 114 for use in accordance with the present invention can be any conventional balloon for catheter delivery, such as a balloon of the general type used for PTA and PTCA procedures. Normally, the balloon 114 is fixed at its distal end to the internal arrow 112 near the distal end of the catheter and at its end near the outer arrow 115. The balloon 114 is larger in diameter than the tube component 116, since the balloon 114 must be capable of expanding to a larger diameter than the tube component 116. The balloon 114 can be inflated through an inflation conduit 123, i.e. the space between the coaxial inner arrow 113 and the outer arrow 115 of the catheter. The distal and near ends of the balloon 114 are shown in Figures 22 and 23 placed outside the far and near ends of the tube component 116, respectively, and of a length LB generally equal to the length LT of the tube component 116. To be compatible to be compatible with the tube component 116 illustrated in Figures 22 and 23 and described above, the balloon 114 may be inflated in deployment around the diameter of the vessel in which the stent 118 goes. to be deployed. The balloon 114 may be formed of a condescending or non-condescending material, of the condescending material types described above, such as polyethylene or any standard balloon material. The balloon 114 typically has a wall thickness of about 0.00177-0.01016 cm, (.0007-0.004 inches) for example. A stent for use in accordance with the present invention can be any conventional type of balloon-expanding stent, including stents of the type used for PTA and PTCA angioplasty procedures for prostate therapy and TTS endoscopic catheters for gastrointestinal use. The proper stent material is biocompatible stainless steel in the form of a metal foil, tube component cable or Nitinol. A preferred stent is disclosed in PCT application No. 960 3072 Al, published on February 8, 1996, the content of which is incorporated by reference. All of these stents are well known in the art in general, and additional examples are described in U.S. Patent No. 5,507,768 to Lau et al.; in U.S. Patent No. 5,458,615 to Klemm et al; in U.S. Patent No. 5,226,889 to Sheiban; in U.S. Patent No. 4,875,480 to Imbert, in U.S. Patent No. 4,848,343 to Wallsten et al .; and in the United States Patent No. 4,733,665 of Palmaz. The stent 18 as shown in Figures 22 and 23 is positioned on the balloon 114, the underlying inflatable tube component 116 and the distal end of the catheter. The length LS of the stent 118 is shown to be essentially the same or slightly smaller than the length LT of the tube component 116 and is placed on the assembly 110 to be coextensive with the tube component 116. In this position, the stent 118 is shown in Figure 22 attached to its supply diameter DI, which is approximately 0.088-0.1143 cm (.0035 -.045 inches), for example. As discussed above, despite the very careful and firm attachment of the stent 118 to conform closely to the total profile of the unexpanded balloon of catheter 114 and the underlying inflatable tube component 116, there is a certain amount of "recoil" of the stent 118 or a stent 118 trend open slightly from a desired hypothetical minimum clamped diameter. The actual minimum diameter that can be obtained for the stent 118 fully clamped on the assembly 110 is referred to as the delivery diameter Di of the stent 118. This tendency of the stent 118 to slightly open or retract when it is clamped on the assembly 10 has been characterized as "recoil hold". In Figure 22, the inflatable tube component 116 is shown inflated to a diameter that is generally sufficient to compensate for any looseness or looseness between the attached stent 118 and the total profile of the catheter, the unexpanded balloon 114 and the inflatable tube component. underlying 116, due to the recoil hold. Figure 23 illustrates a side profile section showing a stent delivery and deployment assembly 110 of this invention with balloon fluid 114 inflated to its fully expanded position. As a result of balloon fluid inflation 114, stent 118 has also been fully expanded to its deployment diameter D2 where it can be deployed against the walls of a body vessel where it is located. The tube component 116 may have a shape different from the cylindrical shape described and illustrated with respect to the embodiment shown in Figures 22 and 23. In addition, the tube component may be composed of more than one separate inflatable cavity. For example, as illustrated with respect to Figure 24, the tube component of an alternative stent delivery and deployment assembly and generally designated 130 may be composed of three separate inflatable cavities 136, 138, 140 *. The cavities 136, 138, 140 each can be inflated separately through their respective inflation passages 137, 139, 141, and each of the cavities 136, 138, 140 can be inflated to a different degree. The ducts are formed in the wall of the arrow 132 as can be seen in Figures 25-27. The stent delivery and deployment assembly 130 of Figure 24 is also comprised of a catheter having an internal arrow 132 and an outer arrow 135, a balloon 134, with its balloon inflation passage 139 and the terminal cone sections of balloon 144, and a stent 142. As already explained above with reference to Figures 22 and 23, the stent 142 is clamped to closely conform to the total profile of the non-expanded balloon catheter 134 and the underlying inflatable cavities 136, 138, 140 Even with the most careful and firm hold, there is a certain amount of "recoil" of the stent 142 or a tendency of the stent 142 to open slightly from a desired hypothetical minimum diameter. In Figure 24, the first cavity 136 and the third cavity 140 are inflated to a slightly larger size than the second cavity 138. As discussed above, the inflation of the cavities 136, 138, 140 to this configuration is generally sufficient to compensate for any looseness or looseness between the attached stent 142 and the total profile of the catheter, the unexpanded balloon 134 and the underlying inflatable cavities 136, 138, 140 due to the recoil hold. Once the cavities 136, 138, 140 have been inflated to the configuration shown in Figure 24, the stent 142 is firmly secured against axial movement with respect to the assembly 130. The distant 146 and near ends 148 of the stent 142 are protected of any possible unwanted contact of the vessel walls during maneuver, which helps to protect the arm walls by abrasion and also helps to protect the ends 146, 148 of the stent 142 from deformation. In addition, the stent 142 may be a length so that it is fixed on the cavity 140 and the cavity 136, as well as the cavity 138. The method for using the delivery and deployment assembly of the stent 110 of this invention, as shown in FIG. Figures 22 and 23 are described below. The assembly 110 is constructed as described above. The stent 118 is compressed or clamped on the balloon 114, the inflatable tube component 116 and the catheter at a DI delivery diameter. This clamping can be done manually or with the help of tool specially designed for this purpose, either by the doctor or the manufacturer. In the clamped position, the stent conforms closely to the total profile of balloon 114, inflatable tube component 116 and the catheter, except for the looseness or light release due to the recoil clamp. The tube component 116 is inflated with fluid to the degree necessary to compensate for this looseness or looseness due to the recoil grip. The pressure of the force required to inflate the tube component 116 to this degree is also mentioned as a safety pressure, that is, the force or pressure necessary to secure the stent 112 in place. It should be noted that since the tube component 116 is designed and constructed to be capable of fully expanding to no more than the size needed to compensate for the recoil grip, there is no possibility that the stent 112 will expand or begin to open. to a larger diameter. In this way, there is no danger of the stent 112 moving out of its position on the catheter during delivery or being separated from the catheter within a body vessel. The distal end of the catheter is delivered through normal techniques to the deployment site within the body interest vessel. At this point, the stent 112 is positioned as regulated by the physician and the balloon 114 is inflated with fluid through a standard technique to expand the stent 121 to its deployment diameter D2. During this expansion, the stent 112 is expanded to fill the body vessel. After deployment of the stent 112, the balloon 114 and optionally the tube 116 are deflated from the assembly 110 which is closely retracted and removed from the body. If it is regulated by the procedure, the entrance site of the body is appropriately closed. The method for using the stent delivery and delivery assembly 130 of this invention, as shown in Figure 24, is similarly described. The assembly 130 is constructed as described above. The stent 142 is compressed or clamped to closely conform to the overall profile of the balloon 134, inflatable cavities 136, 138, 140 and the catheter, except for slight looseness or looseness due to the recoil hold. The cavities 136, 138, 140 are each inflated with fluid to the profile shown in Figure 24 through separate fluid inflation conduits (not shown) to secure the pressure to compensate for this looseness and loosening and secure the stent 142 in its place. The total configuration of the cavities 136, 138 and 140 further serves to place the stent 142 against axial dislocation during delivery. The catheter is delivered through standard techniques to the deployment site within the vessel of interest to the body. In this point, the stent 142 is placed as required by the physician and the balloon 134 is inflated with fluid through standard techniques to expand and deploy the stent 142. After deploying the stent 142, the balloon 134 and optionally the cavities 136, 138 and 140 are deflated and the assembly 130 is retracted closely and removed from the body. If required by the procedure, the entrance site to the body is appropriately closed. The inflation tube component provided by this invention maximizes the safety force of the stent by optimizing the frictional force between the inflation tube component, the balloon wall and the internal diameter of the stent at its reduced clamped delivery diameter. The inflation tube component is more flexible than a solid sheath under the expandable balloon, and thus the entire assembly has greater flexibility. This invention has particular advantages for assemblies wherein the stent is provided for use as pre-attached to the balloon and covering the catheter, increasing the service life of the pre-clamped assembly. The aspects and principles described for this invention are suitable for use with fixed, cable, and individual cable operator exchange assemblies. Figures 28-37 describe further embodiments of the security device. Figures 28 and 29 illustrate a side profile section showing an inflation expandable stent delivery and deployment assembly, generally designated at 210. The assembly 210 includes a catheter composed of an internal arrow 212 and an external arrow 213 of the coaxial type and an optional retractable delivery arrow 211 (commonly referred to as a guide catheter), shown retracted in Figure 29, a balloon expandable by inflation 214, a corrugated / ribbed stent 216 safety device, optional marker bands 217, and an expandable stent by inflation 218. Any type of conventional catheter may be used, such as a catheter of the type generally used for PTA or PTCA angioplasty procedure, for prostate therapy and TTS endoscopic catheters for gastrointestinal use. However, coaxial types are very preferred as shown. The particular catheters 212 and 213 shown are formed of a biocompatible and hydrophilic compatible material such as a lubricating polyimide or polyethylene. Other materials suitable for catheters 212 and 213 include nylon, urethanes and polypropylene materials compatible with coatings such as silicone and / or hydrophilic coatings. In addition to compatible hydrophilic materials, any biocompatible material may be used. For example, polyethylene or polypropylene can be coated with a hydrophilic material to make it hydrophilic compatible. Catheters suitable for use in accordance with the present invention include a number of catheters available from SciMed Life Systems, Inc., Maple, Grove, Minnesota, the assignee of the present invention, such as the BANDIT, COBRA, VIVA, VIVA PRIMO1 catheters.

MAXXUMTnM1 ™ R, MAXXUM ENERGY / M18 * R and RANGERMR. The security device 216 is fixed at its ends distant and / or close to the inner arrow 212 in a position that will be encompassed within the distant and near ends of the outer balloon 214. According to the recognized technique convention, the length LB of the balloon 214 is defined as the length of the portion of the balloon body 214, excluding the terminal cone sections 220. As seen in Figure 29, the balloon body portion 214 generally cylindrical when in its deployed or inflated condition . The safety device / tube component 16 is illustrated as having terminal sections 221, 222. It will be understood that, in accordance with the present invention, any of the terminal sections 220, 222 may have a relatively cone-shaped, relatively vertical, relatively flat or any other configuration known to those skilled in the art. A preferred length LT of the pipe 216 is illustrated in Figures 28 and 29 substantially equal to the length LB of the balloon 214, and substantially equal to the length LS of the stent 218. However, according to the present invention, the stent 218 must be supported by the underlying tube component 216 for a sufficient length to allow achievement of the stated purpose of the tube component 216 to provide superior safety and a protective surface for the stent 218 to hold the stent 218 in place with the assembly 210 and protect the balloon material during loading / securing. It is also within the present invention that the tube component 216 is slightly shorter than the stent 218, for example, the distal end 219 of the stent 218 may extend distally beyond the distal end 21 of the tube component 216 (not shown) so that the distal end 19 of the stent 18 can be clamped on the distal end 221 of the tube component 216 to prevent the distal end 221 of the stent 218 from catching and tending to move or even more open as the vessel is maneuvered. As already explained above, the tube component 216 is designed and constructed to have sufficient flexibility and to have sufficient volume no more than necessary to compensate for the retraction support of the stent 218 and to adapt closely (or even slightly over tension) to the supply diameter of the stent 218, taking into account the thickness of the uninflated intervention balloon 214. Typically, the tube component 216 will have a consistent frequency of ribs, but will also vary by having intermittent groups of ribs along the pipe.

The globe and the stent lightly fastened make up the corrugations of the tube component for greater assurance, but this configuration is not illustrated. The tube component 216 can be formed from a thermoplastic material, preferably a low modulus polymer, such as Suryln ™ Pebax and urethane. The device such as polypropylene, low density polyethylene (LDPE), high density polyethylene (HDPE), ethylene vinyl acetate (EVA), nylon, polyester and polyethylene terephthalate ("PET") can be prepared through free blowing in a mold or in a spiral. The pipe is extruded with relatively thin walls and then blown free in a mold, spiral or other accessory to form the ribs / corrugation. A balloon 214 for use in accordance with the present invention can be any conventional balloon for catheter delivery, such as a balloon of the type generally used for PTA and PTCA procedures. Typically, balloon 214 is fixed at its distal end to internal arrow 212 near the distal end of the catheter and at its near end to internal arrow 212 near the distal end of outer arrow 213. Balloon 214 can be inflated through of an inflation duct 223, that is, the space between the coaxial internal arrow and the external arrow 213 of the catheter. The distant-and-near ends of the balloon 214 are shown in Figures 28 and 29 placed outside "the far and near ends of the tube component 216., respectively, and of a length LB generally equal to the length LT of the tube component 216. To be compatible with the tube component 216 illustrated in Figures 28 and 29, and described above, the balloon 214 can be inflated in the deployment around the diameter of the vessel in which the stent 218 is to be deployed. The balloon 214 can be formed of a condescending or non-condescending material, such as polyethylene or any standard balloon material. Condescending materials include relatively low pressure, flexible or soft polymeric materials, such as thermoplastic polymers, thermoplastic elastomers, polyethylene (high density, low density, intermediate density, low linear density), various copolymers and polyethylene blends. , ionomers, polyesters, polyurethanes, polycarbonates, polyamides, polyvinyl chloride, acrylonitrile-butadiene-styrene copolymers, polyether-polyester copolymers, and polyether polyamide copolymers. Suitable materials include a copolymer polyolefin material available from E.I. DuPont de Nemours and Co. (Wilmington, Delaware), under the trademark Surlyn ™ Ionomer and a polyether block amide available under the tradename PEBAX ™. Non-condescending materials include relatively rigid, high-pressure polymeric materials, such as thermoplastic polymers and polymeric heat-setting materials, (polyethylene terephthalate), (commonly referred to as PET), polyimide, thermoplastic polyimide, polyamides, polyesters, polycarbonates, sulfides of polyphenylene, polypropylene and rigid polyurethanes, or combinations thereof. Balloon 214 typically has a wall thickness of about 0.00177 - 0.01016 cm (.0007 - 0.004 inches), for example. A stent for use in accordance with the present invention can be of any conventional balloon-expanding stent type, including stents of the type used for PTA and PTCA angioplasty procedures for prostate therapy and TTS endoscopic catheters for gastrointestinal use. The appropriate stent material is biocompatible stainless steel in the form of a metal foil, tube component cable or Nitinol. A preferred stent is disclosed in PCT application No. 960 3072 Al, published February 8, 1996, the content of which is incorporated herein by reference. All of these stents are well known in the art in general, and additional examples are described in U.S. Patent No. 5,507,768 to Lau et al.; in U.S. Patent No. 5,458,615 to Klemm et al; in U.S. Patent No. 5,226,899 to Sheiban; in U.S. Patent No. 4,875,480 to I bert, in U.S. Patent No. 4,848,343 to allsten et al .; and in the United States Patent No. 4,733,665 of Palmaz. The stent 218 as shown in Figures 28 and 29 is positioned on the balloon 214, the underlying inflatable tube component 216 at the distal end of the catheter. The length LS of the stent 218 is shown to be essentially the same or slightly more sticky than the length LT of the tube component 216 and is placed on the assembly 210 to be coextensive with the tube component 216. In this position, the stent 218 is shown in Figure 28 attached to its DI supply diameter, which is approximately 0.088-0.1143 cm (0.088 -0.1143 inches), for example. As discussed above, despite the very careful and firm attachment of the stent 218 to closely conform to the total profile of the unexpanded balloon of catheter 214 and the underlying inflatable tube component 216, there is a certain amount of "recoil" of the stent 218 or a tendency of stent 218 open slightly from a desired hypothetical minimum fastened diameter. The actual minimum diameter that can be obtained for the stent 218 fully clamped on the assembly 210 is referred to as the supply diameter DI of the stent 218. This tendency of the stent 218 to slightly open or retract when it is clamped on the assembly 210 has been characterized as "recoil hold". In Figure 28, the tube component 216 is shown inflated to a diameter which is generally sufficient to compensate for any looseness or looseness between the clamped stent 218 and the total catheter profile, the unexpanded balloon 214 and the underlying tube component 216 , due to the recoil hold. Figure 29 illustrates a side profile section showing a stent delivery and deployment assembly 210 of this invention with balloon fluid 214 inflated to its fully expanded position. As a result of balloon fluid inflation 214, stent 218 has also been fully expanded to its deployment diameter D2 where it can be deployed against the walls of a body vessel where it is located. Figure 30 illustrates the preferred configuration of the tube component 216. The tube component has a plurality of ribs 230 and is configured in a corrugated or accordion shape. The ends of the tube component 216, 222 and 221 are substantially free of ribs in order to provide a flat surface for receiving an adhesive and thus be joined to the inner arrow 212. Preferred adhesives include cyanoacrylates such as Loctite 4061/4011 or urethanes such as HB Fuller 3507/3506. The tube component can also be heat bonded to the inner shaft. The ribs can vary in frequency and separation. Tube component 216 may have different configurations in other embodiments, as shown in Figures 31-33. The pipe component 216 may be composed of more than one piece of corrugated pipe (Figure 31), a single piece more glued (Figure 32) or a single piece of pipe sectioned into a plurality of sections with rib, where the pipe is attached to the inner arrow 212 is more than two locations (Figure 33). Figure 31 shows two component parts of • pipe 216a, 216b. Both pieces adhere to the inner arrow 212 at points of adhesion 232. Figure 32 describes a mode comprising a smaller piece of the tube component 216, which is adhered to the internal arrow 212 at the bonding points 232. The Figure 33 discloses an embodiment comprising a tube component 216, which has interrupted rib sections 234 adhered to the inner arrow 212. The Figures 34 and 35 illustrate an alternative embodiment, wherein the pipe component can be inflated to increase the safety pressure on the inside of the balloon 214 when the stent is held in the balloon in order to negate an additional recoil. The complete expansion of the tube component 216 should only be slightly greater than the diameter of the interior of the balloon 214 when the stent 218 is completely attached to the balloon 214. In Figure 34, the inflation fluid comes through the cable lumen of the balloon. guide 212 under pressure from the near end or the distal end of the guide wire lumen 212, preferably through a syringe, and fill the pipe component 216 through a one way valve 247 (preferably supporting up to about 4 atm ) in the inner catheter 212. In Figure 35, the tubing component 216 is inflated through an additional lumen 242, which extends from the proximal end of the catheter along the guide wire lumen 240, much like to any built-in inflation lumen to inflate a balloon. In an alternative embodiment, as shown in Figure 36, sleeves or sleeves 251 can be incorporated to stretch over the ends of the stent to prevent obstruction and secure the stent over the balloon. Such sleeves are presented in U.S. Patent Application No. 08 / 702,149, filed August 23, 1996, and 08 / 701,979, filed August 23, 1996, which are hereby incorporated by reference in their entirety. . In yet another embodiment, as shown in Figure 37, the pipe component 216 is axially slidable along the internal arrow 212 and is connected to a retraction wire 250 so that the pipe component can be retracted towards the internal arrow 213 after the balloon has been inflated to reduce the profile of the balloon 214 when the catheter is removed. The pipe component, since it is not adhered to the inner arrow 212 in this mode, must fit tightly enough over the inner arrow to remain in place, but not tightly so that it can be retracted by pulling it over the cable. retraction 250. The method for using the stent delivery and delivery assembly 210 of this invention, as shown in Figures 1, and 2, is described below. The assembly 210 is constructed as described above. The stent 218 is compressed or clamped on the balloon 214, the tube component 215 and the catheter at a supply diameter DI. This clamping can be done manually with the help of a tool specifically designed for the purpose of the doctor or manufacturer. In the clamped position, stent 218 closely conforms to the total profile of balloon 214, inflatable tube component 216 and catheter, except for the looseness or light release due to the recoil clamp. The tube component 216 is sufficiently flexible to crush slightly during clamping and reattachment to the degree necessary to compensate for looseness or looseness due to back clamping, thus securing the stent. As a result, the stent does not move out of position on the catheter during delivery or is separated from the catheter within a body vessel. The distal end of the catheter is delivered through standard techniques to the deployment site within the vessel of interest to the body. At this point, stent 218 is placed as regulated by the physician and balloon 214 is inflated with fluid through standard techniques to expand stent 218 to its deployment diameter D2. During this expansion, the stent 218 can be expanded to fill the body vessel. After deployment of the stent 218, the balloon 214 is deflated and the assembly retracted in shape, close and withdrawn from the neck. If it is controlled by the procedure, the entrance site of the body is appropriately closed. The tube component provided by this invention increases the safety force of the stent by increasing the frictional force between the tube component, the balloon wall and the internal diameter of the stent at its reduced clamped delivery diameter. The tube component is more flexible than a solid sheath under the expandable balloon, and in this way, the entire assembly has greater flexibility. This invention has particular advantages for assemblies wherein the stent is provided to be used as a pre-clamped to the balloon and underlying catheter, increasing the life of the pre-clamped assembly. The tube component also protects the balloon material during clamping by acting as a cushion between the balloon material and anything that can be mounted on the inner arrow, such as the marker bands 217. The aspects and principles described in this invention are suitable for use with a fixed cable operator, cable and individual exchange assembly. Figures 38-46 describe alternative embodiments of the security device. Figure 38 shows a stent delivery and delivery assembly generally designated 310. A catheter 312 has a collar 314 coaxially mounted to the distal outer portion of catheter 316. A deflated balloon 318 is coaxially mounted over catheter 312 over collar 314 An unexpanded stent 320 is coaxially mounted on the balloon 318 supporting, but not covering the collar 314. A cup 322 coaxially covers the proximal end portion 324 of the stent. The cup 322 may be elastomeric or rigid, preferably elastomeric. The cup 322 is over-expanded on the stent 320, so that the recoil of the cup 322 is sufficient to secure the stent 320 in place and prevent it from being pulled out of the assembly 310 remotely or in a close-to-measure manner The assembly 310 is supplied to a deployment site in the body vessel. The cup 322 also protects the proximal end of the stent 324 from being inadvertently trapped on anatomical structures or other things during maneuvering within the body or during loading and other handling. The ends of the stent can exit and must be protected during stent 320 maneuver to keep the stent 20 over the assembly 310 in its contracted configuration and to maintain the structural integrity of the stent 320 '. The collar 314 abuts the distant end of the stent 326 without covering the stent 320. The position of the icop 322 covering the stent 320 and containing the stent 320 against the collar 314 increases the safety force, keeping the stent 320 in its axial position and radial over the catheter 12. Figure 40 is similar to Figure 38, showing a protrusion 28 below the uninflated balloon 318 at the distal end of catheter 316. Any of the various known types of stents can be used in systems of delivery of this invention, even the self-expanding stents, which in part can be expanded with the balloon, can be used, the balloon initiates the release of the stent and / or finally settling the stent after self-expansion. However, balloon expandable stents are preferred and observed in the above.

Figure 39 shows another stent delivery and delivery assembly generally designated 330. A catheter 332 has a collar coaxially mounted as a mounting ring 334 in the catheter. An uninflated balloon 338 is coaxially mounted over the catheter 332 in the mounting ring 334. An unexpanded stent 340 is coaxially mounted on the balloon 338 covering the mounting ring 34. A cup 342 covers the proximal end portion of the stent 344 for securing the stent 340 in place, and preventing it from being pulled out of the assembly 330 in a distant or near manner, as the assembly 330 is delivered to a deployment site in the body vessel. The cup 342 also protects the near end of the stent 40 from being inadvertently trapped on the anatomical structures during maneuvering within the body. The position of the cup 342 covering the stent 340 together with the closest placement of the mounting ring 334 as compared in Figure 38 increases the safety force by keeping the stent 340 in its axial and radial position on the catheter 342. The more close the mounting ring 334 to the cup 342, more securely is the stent held in place and locked between this cup and the ring. When used in conjunction with the mounting ring 334, the cup 342 will also prevent the proximal stent segment 344 from opening, i.e., increasing its diameter, and will keep the stent 340 locked on the mounting ring 334. This will prevent the Stent 340 moves on the catheter in a distant as well as close manner. This cup does not have to be an elastomer, but may be of a sufficiently rigid material to prevent the stent 340 from expanding. The cups 322, 342 of Figures 38-40 release the stents 320, 340 when the balloons 318, 338 are inflated during deployment. The cups 322, 342 can, for example, be radially outwardly enlarged as illustrated with reference to Figure 41, axially wound from the stents 320, 340 as illustrated with reference to Figure 42, or axially slid away from the stents. 320, 340 as illustrated with reference to Figures 42, or slide axially away from the stents 320, 340 as illustrated with reference to Figures 43 and 44. Also, the cups can be formed with weak axial areas separating the balloon inflation, as described in Savin's aforementioned patent. Figure 41 shows an assembly generally designated 310 as shown in Figures 38 and 36 with inflated balloon 318 and expanded stent 320, showing end portion 322 of the flared cup to release stent 320. As noted above, the cup 322 may be elastomeric or rigid. The dimension L is short enough and the material of the cup 322 is sufficiently elastic so that the cup 3 * 22 widens and is no longer in contact with the stent 320 when the balloon 318 is inflated and the stent 320 expanded for the deployment . Figure 42 shows an assembly generally designated 310, as shown in Figures 38 and 36, with the balloon. 318 'inflated and the stent 320 expanded, showing the end portion of the cup 322 coiled close to release the stent 320. As noted above, the cup 322 may be elastomeric to facilitate coiling. The cup can also have an accordion shape or buckle on itself to release the stent. Figures 43 and 44 show another stent delivery and deployment assembly designated 350. The catheter 352 has a coaxial collar 354 formed integrally with the catheter 352 at the distal end of the catheter 356. A balloon 358 is coaxially mounted over the catheter 352 and covering the collar 354. In Figure 43, the balloon 358 is coaxially mounted on the catheter 352, covering the collar 354. In Figure 43, the balloon 358 is shown deflated, with an unexpanded stent 360 mounted on the balloon 358. bumping on the collar 354 and a cylindrical cup in the form of a sleeve 362, covering the near end portion of stent 364. Figure 44 shows assembly 350 of Figure 43 with balloon 358 inflated and stent 360 released and expanded. The sleeve 362 is designed, constructed and adapted so that, as the balloon 358 and the stent 260 are enlarged, the sleeve portion 366 gathers or moves closely to release the stent 360. Increasing the angle of the balloon 358 (the tapered end sections of the balloon 358) during inflation push the sleeve 362 axially from the stent 360. This can be done by configuring the sleeve 362 with preformed accordion folds 368. The sleeve 362 can also be formed such that the portion that stops (ie, abut or cover) the stent 360 is of a material thicker or more rigid than the sleeve portion 362 axially distant from the stent 360. The materials that can be used to provide the above functions are silicones, urethanes and the like, as well as other elastomers, for example. A rigid sleeve worn over the catheter for sliding movement can also be used. The cuffs can be included in the near and distant end of the stent. Figure 45 shows yet another stent delivery and delivery assembly generally designated 370. A catheter 372 has two collars 374 integrally formed with catheter 372 and spaced apart from one another on the distal end portion of the catheter. A balloon 378 is coaxially mounted on the catheter 372, covering the collars 374. The balloon 378 is shown not inflated with an unexpanded stent 380 mounted on the balloon 378 abutting both collars 374. It can be seen that the distance between collars 374 can be selected to closely match the stent 380 in its fully contracted position around the balloon 378 and underlying catheter 372. A cup 382 covers the near end portion of the stent 384 and the underlying near collar 374. The cup 382 will deploy during inflation on the balloon 378 in the manner described above with reference to Figures 41-44. Figure 46 shows another stent delivery and deployment assembly generally designated 390. The deflated balloon 398 is shown coaxially mounted on a catheter 392 on the distal outer portion of the catheter. A non-expanded stent 400 is coaxially mounted on balloon 398. A pair of cups 402 cover the ends of the ends of stent 400. A mounting cylinder 404 is carried by catheter shaft 392. The figure also shows cups at both ends of the stent, a provision that can be used in all the previous modalities. The cups or sleeves used in the various embodiments of the invention may be of an elastomeric or rigid material to contain one or both ends of the stent. In preferred embodiments of this invention, the cups are used together with one or more stent collars placed below the balloon. The collar can be formed as a ring, to abut the end of the stent, to fall under the stent and the intervention balloon, or as a cylinder, to lie below essentially the entire length of the stent and the intervention balloon . Stent arrest in accordance with the present invention offers increased stent assurance, particularly in pre-assembled delivery systems. The cups and sleeves illustrated in the various embodiments of this invention can be secured to the catheter, through adhesive or thermal bonding, or they can be sliding cups or sleeves. When the cups slide freely over the catheter, they should always be used directly on a collar, so that there is a friction fit between the cup and the stent. A method for delivering and deploying a stent using an assembly according to the present invention is described below: A catheter is provided as described above with reference to any of the Figures 38-40, 43 and 45. At least one collar is 'coaxially mounted on the distant end of the catheter. As discussed above, the collar may be a separate element fixed to the catheter or collar and the catheter may be formed together as an individual element. The collar may be placed abutting one end of the stent. The collar can be a mounting ring, and can be placed under the stent or covering the balloon. The collar can be a cylinder essentially coextensive in length with the stent and covering the balloon. A balloon expandable with fluid is coaxially mounted on the collar at the distal end of the catheter. A stent is provided, which is expandable by inflation from a reduced to an enlarged condition. The stent, in its reduced condition, is coaxially mounted on the balloon, so that at least one end portion of the stent covers the balloon. A cup is provided, which has first and second end portions. The cup is in an expanded form and also has a retracted shape. The expanded cup is coaxially mounted on the catheter at the distal end portion, so that the first end portion of the cup stops the end portion of the stent. The first end portion of the cup stops the end portion of the stent by covering the end portion of the stent, or by tightly adapting the stent against the uncovered collar at the end portion of the stent. The cup is then contracted around the catheter and the end portion of the stent to attach the stent to the catheter. The cup and collar cooperate to retain the stent on the catheter in its reduced condition. The assembly is then maneuvered by the physician through the body vessel through methods known per se to search for a pre-selected deployment site. The surgeon can determine when the assembly has reached the deployment site through means that are known per se. For example, the assembly can be provided with radio-opaque marker bands at either end of the stent, or the cups or collars or both can be made of radio-opaque material. Once the surgeon determines that the stent has been placed correctly in the desired location, the balloon is inflated to expand the stent to its enlarged condition. Inflation of the balloon expands to the stent and the stent is released from the cup or cups. As discussed above, the cups can be deployed to release the stent in a number of ways, depending on the construction and materials of the cup or cups. The cup can be widened or enlarged radially following the angle of increase of the cones of the balloon. The cup can be rolled axially away from the stent. The portion of the axially distant cup of the stent may take the form of an accordion. The cup can slide axially. The cup can be like accordion or loop. If the cup is not fixed to the catheter, but is freely slidable over the catheter, the cup can slide axially away from the stent. After deployment of the stent, the balloon, in accordance with previously known procedures, is deflated and the assembly is removed in close proximity to the body vessel. Any incision made to allow access from the assembly is properly closed. Figures 47-56 illustrate alternative modes of security devices. Referring to FIGS. 47 and 48, a stent delivery system generally indicated at 410 includes a balloon catheter 412 having a balloon 414 on the distal end portion generally indicated at 416. FIG. 47 shows a proximal portion of the catheter in FIG. 412a and a distal portion 412b in an enlarged view. Figure 48 shows the far end portion 416 in an even more enlarged view. Illustrative catheter 412 is of the type known as one in the cable catheter. However, other types of catheters can be used, such as the fast exchange / individual operator exchange and fixed cable types. The balloon 414 is fixed to the catheter 412 through standard means. The balloon is shown in its contracted state in Figures 47 and 48. A stent 418 is fixed around the balloon holding it thereto. The stent has a larger expanded diameter which is obtained when a balloon is expanded in a known manner. That is to say, the stent is released from the catheter after balloon expansion when placed in a vessel. When the balloon is then deflated, removal of the balloon and catheter can be accomplished while leaving the stent in place. As is in the art, the balloon is either attached at its ends through adhesive 420 and 422, respectively to the external member 424 of the catheter and to the internal member 426 of the catheter in a known manner, or is made as one piece with the external member as is known in the art. The catheter balloon can be inflated through fluid (gas or liquid) from an inflation port extending from a lumen 428 contained in the catheter shaft and opening to the balloon as shown, or through other known arrangements, depending on the design of the catheter. The details and mechanics of balloon inflation and specific total catheter construction will vary according to the particular design involved in any given case, and are known in the art per se. All variations are acceptable for use with this invention. Any balloon expandable stent can be used with this invention. Many are known in the art, including plastic or metal stent. Some are more known, such as the stainless steel stent shown in U.S. Patent No. 4,735,665; the cable stent shown in U.S. Patent No. 4,950,227; another metal stent shown in European Patent Application No. EPO 707 837 A1 and shown in U.S. Patent No. 5,445,646. All these patents are incorporated for reference. Also, configured metal memory stents can be used. As already indicated, the stent of PCT Application 960 3092 Al is particularly preferred. The stent typically has a length of about 16 mm, while the balloon may have a length of 20 mm. However, these dimensions are merely representative for illustrative purposes only and are not limiting. The stent is placed on the portion of the balloon of the dilatation catheter and moderately held on the balloon either by hand or with a tool such as forceps or the like to be assembled for delivery, as shown in Figures 47 and 48. Fastening can be achieved either by the manufacturer or the doctor. In accordance with one embodiment of this invention, mounting bodies 430, seen in Figures 47 and 48 are included within balloon 414 to provide a cushion and / or substrate of enlarged diameter relative to the arrow to support and maintain the stent and Secure it during fastening and the supply procedure. The mounting bodies are preferably located in the portion of the balloon body.

In the embodiment shown, the mounting bodies 430 have a ring-like shape and are mounted on the inner lumen 426, providing an enlarged area or portion for receiving the balloon and the stent when the latter is held. Marker bands 432 and 434 may also be included on the inner portion 426 as shown. Any radio-opaque material such as gold, is useful for this purpose. Although, the material of the mounting bodies can be hard it is preferably of any thermoplastic elastomer having elastic or deformable properties, more preferably of a relatively elastic elastomer material, eg, silicone, preferably of a lower durometer silicone, or a polyurethane, such as Techothane 1055D. A deformable thermoplastic material such as high density polyethylene (HDPE) can be used. Any deformation of the elastic material of the mounting body when the stent / balloon is attached to it causes an extreme radial force on the stent / balloon increasing the fraction between them despite stent recoil. The stent is also fixed in place through two underlying retaining sleeves 436 and 438. The sleeves 436 and 438 are formed of polyurethane, preferably Tecothane 1055D, and are axially fixed on the catheter 412 through adhesive seals 440 and 442. of urethane adhesive. The adhesive seals can be tapered toward the catheter as shown to facilitate movement of the catheter in a vessel. The sleeve overlaps the marginal end portions of the stent 418, as shown. A lubrication solution such as a silicone fluid can be used between the balloon 414 and the sleeves 436 and 438 and thereon to facilitate the release of the stent 418 from the sleeves. During delivery, the balloon catheter is advanced through, and placed in a vasculature of a patient so that the stent is adjacent to the portion of the vessel where the treatment is to occur. The balloon is inflated to expand the stent to an enlarged diameter. At this time, the expansion of the balloon causes the end margin of the sleeves to slide axially over the stent thereby releasing the stent ends of the catheter. Various forms of sleeve retraction 436 and 438 are shown in Figures 49-52. These figures illustrate the configuration of the sleeves 436 and 438 in their retracted state after the balloon 414 has been fully expanded. Only the distant sleeve 438 is shown. Figure 49 illustrates the preferred retraction configuration. To promote easier retraction, the sleeves are coated with silicone. The sleeves are preferably adhered to the outer shaft 424 and the inner shaft 426 at point 440, 442, but may be adhered to the waste 441 of the balloon. The retraction settings can be controlled either by pre-flexing the sleeves or by adhering the sleeve to a point above the waist of the balloon. The sleeves tend to flex in a pre-bent fold or at the point of adhesion. The preferred cone angle of 45 ° for the balloon is shown in Figure 52, which shows an expanded balloon 414 and retracted sleeves 436, 438. When the stent has reached the desired diameter, the balloon is deflated so that the catheter can be be removed leaving the stent in place. A modified sleeve configuration 439 is shown in Figure 53 in a stepped manner 43 having a large diameter at 444 in a section 446 and a small diameter 445 in a second section 450. Figures 54-56 show alternative embodiments of the invention. Specifically, the alternative placement and the number of mounting bodies 430. These figures show an unexpanded balloon having the assembled bodies 430 inside the balloon. These figures illustrate essentially the same structure shown in Figure 448, differing only in the numbers and placement of the assembled bodies 430. In the embodiment shown in Figure 54, the ring type mounting body 430 is unique. Another similar version is shown in Figure 55, which includes three ring-type mounting bodies 430. The embodiment shown in Figure 56 includes four ring-type mounting bodies 430. It should be understood that the various elements and materials of all modalities can be used in each "i ..- of you.; > ? -. L, .I3 modalities, if injured. The above examples and the description are intended to be illustrative and not exhaustive. These examples and description will suggest many variations and alternatives to one skilled in the art. All these alternatives and variations are intended to be included within the scope of the attached 1 civindicacior.es. Those familiar with the technique can recognize others equivalent to the specific modalities described here. Such equivalents are also intended to be encompassed by the appended claims.

Claims (70)

1. CLAIMS 1. A system / assembly for supplying and deploying a stent expandable by inflation in a vessel, characterized in that it comprises: a catheter having proximal and distant ends and an internal arrow; a stent, which has a length and which is being expanded by inflation from a delivery diameter to a deployment diameter, such that the delivery diameter is reduced from the deployment diameter to conform the stent to the catheter, such that the stent, in its delivery diameter, is coaxially mounted on the catheter near the distal end of the catheter; an expandable inflation means coaxially mounted on the catheter axially within the stent, for expansion of the stent from the delivery diameter to the deployment diameter in the application of fluid deployment pressure to the inflation means; and A securing component coaxially mounted on the catheter, axially within the expandable inflation means, the securing component designated and adapted to provide a pressure secured to the stent at the delivery diameter to hold the stent in position over the catheter during the delivery to the deployment sites by increasing the profile of the internal arrow at a position within the balloon, wherein the securing component is substantially the same length as or longer than the stent. The system according to claim 1, characterized in that the expandable inflatable means comprises a balloon, the balloon being associated with the arrow in a distant part of the arrow, the insured components including means that mount and hold to receive the stent on the balloon for radial expansion of the stent, the mounting and retaining means being constructed and arranged to selectively provide a body mounted lengthwise to receive the stent, the body mounted being within the balloon and being substantially the same length as the stent 3. The system in accordance with the claim 2, characterized in that the mounted body is at least as large as the stent. The system according to claim 2, characterized in that the mounted body is transported by the catheter and is axially movable between the mounted position of the stent associated with the balloon and a position at least partially removed from the mounted position of the stent and which includes means for moving the assembled body. 5. The supply system according to claim 2, characterized in that the mounted body is a tube mounted on the inner arrow. 6. The stent delivery system according to claims 2 and 4, characterized in that the mounted body is made of a material which elastically deforms under radial pressure. 7. The stent delivery system according to claim 5, characterized in that the configuration of the assembled body includes at least one separation whereby the flexibility of the body and the catheter is increased. 8. The stent delivery system according to claim 7, characterized in that the separation is in the form of a spiral cut. 9. The stent delivery system according to claim 5, characterized in that the assembled body is positionable to receive a stent and hold the means that mount and retain on the balloon for delivery. 10. The stent delivery system according to claim 2, characterized in that the mounted body is a rigid coil in the arrow. 11. The stent delivery system according to any of the preceding claims, characterized in that it includes a retainer positioned at the distal end of the catheter and transported by the arrow that enters the inflatable means. The stent delivery system according to claim 2, characterized in that the mounted body is in a fixed position and is adapted and arranged to enlarge in diameter to receive a stent. 13. The stent delivery system according to claim 12, characterized in that the mounting body is made of a material that elastically deforms under radial pressure. The stent delivery system according to claim 12, characterized in that the mounting body is a structure similar to a coil adapted and arranged to be crushed and the proximal portion of the incoming arrow is connected thereto to crush the structure to enlarge its diameter. 15. The stent delivery system according to claim 14, characterized in that the structure similar to a coil is a braided element. The system according to any of the preceding claims characterized in that the catheter further comprises a receptacle having a first end and a second end, the first end being secured to the catheter and the second end extending over at least a portion of the stent . 17. The stent delivery system according to any of the preceding claims, characterized in that the catheter further comprises a second receptacle having a first end and a second end, the first end being connected to the catheter and the second end being connected to the catheter. extends over at least a portion of the stent. 18. The stent delivery system according to claim 16, characterized in that the first end of the sleeve is adhered to the catheter. 19. The stent delivery system according to claim 17, characterized in that the first ends of the sleeves adhere to the catheter. 20. The stent delivery system according to claim 14, characterized in that the coil is covered with a polymer. 21. The stent delivery system according to claim 14, characterized in that the coil is waxed in a polymeric sheath. 22. The stent delivery system according to claim 1, characterized in that the securing component is a transportable slidable coil, the coil being slidable within the internal axis and can be slid into the place inside the balloon thereby increasing the profile of the arrow inside the balloon. 23. A system / assembly for delivery and deployment of a stent expandable by inflation within a vessel, characterized in that it comprises a catheter having proximal and distant ends; a stent, expandable by inflation, from a delivery diameter to a deployment diameter, such that the delivery diameter is reduced from the deployment diameter to conform the stent to the catheter, such that the stent, in its supply diameter, is coaxially mounted on the catheter near the distal end of the catheter; an inflation means expandable coaxially mounted on the catheter axially within the stent, for the expansion of the stent from the supply diameter to the deployment diameter in the application of fluid deployment pressure to the inflation means, the inflation means being a balloon; and a securing component coaxially mounted on the catheter, the securing component designated and adapted to provide a secure pressure to the stent at the delivery diameter to hold the stent in position over the catheter during delivery to the deployment site, the component securing being a sheath carried over the balloon, the sheath being constructed and arranged for a movement and axial position between a stent mounting position on the balloon and a position removed from the stent mounting position. 24. The stent delivery system according to claim 23, characterized in that the sheath is elastomeric. 25. A method for changing the profile of a balloon catheter to improve the mounting of a stent therein and providing a catheter for multiple uses, characterized in that it comprises the steps of: providing a balloon catheter of a relatively low profile adapted and redisposed for use in an angioplasty procedure; sliding a stent mounting body from a position associated with the balloon to a position for receiving a stent and enlarging the profile of the catheter in this position, the mounting body being substantially the same length as or larger than the stent, and mount a stent on the balloon and mount the mounting body in this position. 26. The method according to claim 25, characterized in that the enlarged mounting body is slid to a position within the balloon to receive the stent. 27. The method according to claim 26, characterized in that there is more than one enlarged body. 28. A method for changing the profile of a balloon catheter to improve the mounting of a stent therein and providing a catheter for multiple uses, characterized in that it comprises the steps of: providing a balloon catheter of a relatively low profile adapted and redisposed for use in an angiplasty procedure; providing an enlarged stent mounting body within the balloon to a position for receiving a stent and enlarging the catheter profile in that position, wherein the enlarged body is provided by crushing a body from before in the position to enlarge its diameter to receive a stent, and mount a stent on the balloon and the mounting body in that position. 29. A system / assembly for delivery and deployment of a stent expandable by inflation within a vessel, characterized in that it comprises: a catheter having proximal and distant ends; a stent, expandable by inflation, from a delivery diameter to a deployment diameter, such that the delivery diameter is reduced from the deployment diameter to -conform the stent to the catheter, such that the stent, in its supply diameter is coaxially mounted on the catheter near the distal end of the catheter; a balloon mounted coaxially on the catheter axially within the stent, for expansion of the stent from the delivery diameter to the deployment diameter in the application of fluid deployment pressure to the inflation means, the inflatable means comprises an expandable balloon; and a first coaxially annular collar located at the far end portion. of the catheter, the expandable balloon coaxially mounted on the first collar at the distal end portion of the catheter, the balloon being expandable from a contraction to an expanded state, the stent coaxially mounted on the balloon, the reduced condition conforms the stent to the balloon and catheter, the stent having at least one end portion covering the balloon, the system further comprises a first cup (receptacle) coaxially mounted on the distal end portion, the first cup having a first end portion that holds the end portion of the stent and the first cup and the first collar cooperatively constructed and arranged to retain the end portion of the stent over the catheter in the reduced condition of the stent when the balloon is in the contracted state, the balloon and the catheter constructed and arranged cooperatively for cause the expansion of the balloon from the contracted state to the expanded one and to free the extreme portion of the the stent from the first end portion cup. 30. The assembly according to claim 29, characterized in that the first cup is axially separated from the first collar. 31. The assembly according to claim 29, characterized in that the first cup has a second end portion fixed to the catheter, the first collar abuts the stent as a retainer. 32. The assembly according to claim 29, characterized in that the first cup of the first end portion covers the stent end portion. 33. The assembly according to claim 29, characterized in that the first cup is elastomeric. 34. The assembly according to claim 29, characterized in that the first cup is rigid. 35. The assembly according to claim 29, characterized in that the first collar is formed as a single member with the catheter. 36. The assembly according to claim 29, characterized in that the end portion of the stent is a distal end portion and wherein the first cup and the first collar cooperate to retain the stent at the distal end portion of the stent. 37. The assembly according to claim 29, characterized in that the first collar is positioned axially and axially separated from the stent at an end portion of the stent opposite the end portion of the stent retained by the first cup. 38. The assembly according to claim 37, characterized in that the first collar is formed as a single member with the catheter. 39. The assembly according to claim 29, characterized in that the first collar is a mounting ring positioned axially between the end portions of the stent. 40. The assembly according to claim 39, characterized in that the mounting ring is formed as a single member with the catheter. 41. The assembly according to claim 39, characterized in that at least a portion of the mounting ring is contained by the first cup. 42. The assembly according to claim 29, characterized in that the first collar is a cylinder under the stent. 43. The assembly according to claim 42, characterized in that the cylinder is longer than the stent. 44. The assembly according to claim 42, characterized in that the cylinder is shorter than the stent. 45. The assembly according to claim 29, characterized in that a second collar is a mounting ring positioned axially between the end portions of the stent. 46. The assembly according to claim 29, characterized in that a second collar is positioned axially, and immediately axially separated from the stent at an end portion of the stent opposite the end portion of the stent retained by the first cup. 47. The assembly according to claim 29, characterized in that the first cup has a second end portion with regions running axially with looseness. 48. The assembly according to claims 29-47, and further characterized in that it includes a second cup mounted coaxially on the catheter at the distal end of the catheter, the second cup has a first end portion covering a second end portion of the stent; the cups and the collar constructed and arranged cooperatively to retain the end portion of the respective stent over the catheter in the reduced condition of the stent when the balloon is in its contracted state, the balloon and the catheter constructed and arranged cooperatively to cause balloon expansion from the contracted to the expanded state to cause the release of the end portions of the stent from the. extreme portions of the glass. 49. The assembly according to claim 48, characterized in that the collar is positioned axially and immediately spaced axially from the stent at an end portion of the stent opposite the end portion of the stent retained by the cup. 50. A method for the delivery and deployment of a stent, characterized in that it comprises: providing a catheter having proximal and distant ends, with a collar mounted coaxially at the distal end of the catheter, and a fluid expandable balloon mounted coaxially on the collar at the distal end of the catheter, providing a stent that is expandable from a reduced to an enlarged condition; mounting the stent in the reduced condition coaxially in the balloon, so that an end portion of the stent covers the balloon; providing a cup having first and second end portions, the cup being in an expanded form and also having a retracted shape; mounting the cup expanded coaxially over the distal end of the catheter, so that the first end portion of the cup covers the end portion of the stent; contracting the cup towards the catheter and the end portion of the stent for attaching the stent to the catheter, the cup and the collar cooperating to retain the stent in the reduced condition, delivering the assembly to a deployment site; inflate the balloon to release the stent from the cup. 51. The method for the delivery and deployment of a stent according to claim 50, further characterized in that it comprises: providing a second cup having first and second end portions, the second cup being in an expanded form and also having a shape retracted; mounting the expanded cups coaxially at the distal end of the catheter so that the first end portions of the cup cover the end portions of the stent; contracting the cups towards the catheter and the end portions of the stent to fix the stent to the catheter, the cups cooperate to retain the stent in the reduced condition; supply the assembly to a deployment site; Inflate the balloon to expand the stent to its enlarged condition so the stent is released from the cups. 52. A system / assembly for delivery and deployment of a stent expandable by inflation within a vessel, characterized in that it comprises a catheter having proximal and distant ends, the catheter has an arrow; a stent, expandable by inflation, from a delivery diameter to a deployment diameter, such that the delivery diameter is reduced from the deployment diameter to conform the stent to the catheter, such that the stent, in its supply diameter, is coaxially mounted on the catheter near the distal end of the catheter; an inflation means expandable coaxially mounted on the catheter axially within the stent, for the expansion of the stent from the supply diameter to the deployment diameter in the application of fluid deployment pressure to the inflation means, the inflatable / expandable means being associated with the distant part of the arrow; and an assurance component coaxially mounted on the catheter, axially within the expandable inflation means, the securing components designated and adapted to provide a pressure secured to the stent at the delivery diameter to hold the stent in position over the catheter during supply to the deployment site, the securing component comprises mounting and retaining means for receiving the stent on the expandable means for radial expansion of the expanding stent of the expandable means, the mounting and retaining means including at least two bodies of assembly, each being shorter than the stent, carried on the arrow within the inflatible means, whereby the diameter of the arrow and the expandable means is increased in the distal part to facilitate the assembly and retention of the stent. 53. The stent delivery system according to claim 52, characterized in that the mounting bodies are made of a material that elastically deforms under radial pressure. 54. The stent delivery system according to claim 53, characterized in that the material is elastomeric. 55. The stent delivery system according to claim 53, characterized in that the material comprises polyurethane. 56. The stent delivery system according to claim 52, characterized in that the stent is attached to the mounting and retaining means for delivery, the stent being interlocked with the mounting and retaining means. 57. The stent delivery system according to claim 52, characterized in that the expandable means comprise a balloon. 58. The stent delivery system according to claim 52, characterized in that the stent is generally tubular in shape and the mounting bodies are generally ring-shaped. 59. The stent delivery system according to claim 52, characterized in that at least three separate mounting bodies are included. 60. The stent delivery system according to claim 52, characterized by at least four spaced mounting bodies are included. 61. The stent delivery system according to claim 52, characterized in that the separate mounting bodies are interconnected. 62. The stent delivery system according to claim 61, characterized in that the separate mounting bodies move axially along the arrow. 63. The stent delivery system according to claim 59, characterized in that the separate mounting bodies are interconnected. 64. The stent delivery system according to claim 63, characterized in that the separate mounting bodies move axially along the arrow. 65. The stent delivery system according to claims 52-64, fur characterized in that it includes a sleeve at the distal portion of the catheter, having a first end fixed to the catheter and a second end covering an end portion of the stent, the sleeve slides axially to release the expanding stent from the expandable means. 66. The stent delivery system according to claim 65, characterized in that the system fur comprises a second sleeve in the distal portion of the catheter positioned around the catheter, having a first end fixed to the catheter and a second end covering the catheter. second end portion, the first and second cuffs are fixed separately to the stent prior to expansion thereof and expanding the expandable means and the stent, releasing the stent by sliding axially from the opening of the stent. 67. A system / assembly for delivery and deployment of a stent expandable by inflation within a vessel, characterized in that it comprises a catheter having proximal and distant ends, the catheter has an arrow; a stent, expandable by inflation, from a delivery diameter to a deployment diameter, such that the delivery diameter is reduced from the deployment diameter to conform the stent to the catheter, such that the stent, in its supply diameter, is coaxially mounted on the catheter near the distal end of the catheter; an expandable inflation means coaxially mounted on the catheter axially within the stent, for the expansion of the stent from the delivery diameter to the deployment diameter in the application of fluid deployment pressure to the inflation means, the inflatable / expandable means being associated with the distant part of the arrow; and an assurance component coaxially mounted on the catheter, axially within the expandable inflation means, the securing components designated and adapted to provide a pressure secured to the stent at the delivery diameter to hold the stent in position over the catheter during supply to the deployment site, the securing component comprises mounting and retaining means for receiving the stent on the expandable means for radial expansion of the expanding stent of the expandable means, the mounting and retaining means including at least one body of assembly, at least one mounting body being shorter than the stent, carried on the arrow within the inflatable means, whereby the diameter of the arrow and the expandable means increases in the distal part to facilitate the storing and retention of the stent, and also includes a cuff in the distal portion of the catheter, which has a first end fixed to the catheter and a second end covering an end portion of the stent, the sleeve sliding axially to release the expanding stent from the expandable means. 68. The stent delivery system according to claim 67, characterized in that the system further comprises a second sleeve in the distal portion of the catheter positioned around the catheter, having a first end fixed to the catheter and a second end covering the catheter. second end portion of the stent, the first and second sleeves that separately secure the stent before expansion and expansion of the expandable means and the stent, • release the stent by axial slip starting to open the stent. 69. A method for changing the profile of a balloon catheter to improve the mounting of a stent therein and providing a catheter for multiple uses, characterized in that it comprises the steps of: providing a balloon catheter of a relatively low profile adapted and redisposed for use in an angioplasty procedure. sliding at least one stent mounting body in a position associated with the balloon to a position for receiving a stent and enlarging the catheter profile in that position, the mounting body being shorter in length than the stent, and mounting a stent over the globe and the mounting body in that position. 70. The method according to claim 69, characterized in that there is more than one assembly body.