MXPA98003110A - Lining and method of use for an endoprote supply system - Google Patents

Abstract

The present invention relates to a system for deployment of stents, to place one or more stents within a body lumen, the system is characterized in that it comprises: a catheter having an arrow with an outer surface, a proximal end and a distant end which includes an expandable member, a substantially tubular liner having an end and a distal end, a proximal rigid portion located in proximity to only a less rigid remote portion, an exterior surface and a through lumen defining an interior surface, the lining is configured for slidable movement on the catheter shaft, and a substantially tubular stent having a delivery configuration and deployment configuration, the stent is removably connected in the delivery configuration on the distal portion of the liner and alternately disposed superimposed on the expandable member proximal to the expandable member; a handle arranged in the prix portion

Description

LINING AND METHOD OF USE FOR AN ENDOPROTESIS SUPPLY SYSTEM BACKGROUND OF THE INVENTION Field of the Invention The invention relates to endoprosthesis delivery systems, which are used to implant an endoprosthesis in a patient's body lumen, to maintain its opening. More particularly, the present invention relates to a liner or sleeve for stent delivery that is mounted on a catheter to deploy a stent in a body lumen. Description of the Related Art Stents in general are cylindrically shaped devices that function to keep a segment of a blood vessel or other body lumen open and sometimes expand. These devices are particularly suitable for use in supporting and holding a dissected arterial lining that can occlude the passageway for fluid. Stents are also used to maintain the opening of a body lumen, such as a coronary artery, after a percutaneous transluminal coronary angioplasty procedure.

(PTCA = Percutaneous Transluminal Coronary Angioplasty) or an atherectomy procedure to open an area with stenosis of the artery. Currently, several intervention treatment modalities for heart disease are used, including laser and balloon angioplasty, atherectomy, and bypass surgery. In typical balloon angioplasty procedures, a guide catheter having a preformed distal tip is introduced percutaneously through the femoral artery into a patient's cardiovascular system in a conventional Seldinger technique and advanced into the cardiovascular system until the Distant tip of the guide catheter sits in the ostium of a desired coronary artery. A guidewire is placed inside an inner lumen of a dilatation catheter and then both are advanced through the guiding catheter to its distant end. The guide wire is advanced away from the distal end of the guide catheter to the coronary vasculature of the patient until the distal end of the guide wire crosses a lesion to be dilated. Then, the dilatation catheter having an inflatable balloon in its distant position is advanced to the patient's coronary anatomy on the previously introduced guidewire, until the balloon of the dilatation catheter is properly placed through the lesion. Once in position through the injury, the balloon that is typically made of relatively non-extensible materials is inflated to a predetermined size with relatively high pressure liquid (for example greater than 1013 x 105 Pa (4 atmospheres)) to compress the atherosclerotic plaque of the lesion against the inside of the artery wall and to otherwise dispense the inner lumen of the artery. The balloon dilatation is then deflated in such a way that blood flow can be resumed through the dilated artery and the dilatation catheter can be removed. Additional details of dilatation catheters, guidewires and associated devices for angioplasty procedures can be found in U.S. Pat. No. 4,323,071 (Simpson-Robert); U.S. Patent No. 4,439,185 (Lindquist), patent of the U.S.A. No. 4,516,972 (Samson); U.S. Patent No. 4,538,622 (Samson et al.); U.S. Patent No. 4,554,929 (Samson et al.); U.S. Patent No. 4,616,652 (Simpson); U.S. Patent No. 4,638,805 (Powell); U.S. Patent No. 4,748,982 (Horzewski et al.); U.S. Patent No. 5,180,368 (Garrison), U.S. Pat. No. 5,458,613 (Gharibadeh et al.); and US patent. No. 5,496,346 (Horzewski et al.). A major problem that can occur during balloon angioplasty procedures is the formation of intimal fins that can crush and occlude the artery when the balloon is deflated at the end of the angioplasty procedure. Another major problem characteristic of balloon angioplasty procedures is the large number of patients who are subject to restenosis in the treated artery. In the case of restenosis, the treated artery may again undergo balloon angioplasty or other treatments such as bypass surgery, if additional balloon angioplasty procedures are not guaranteed. However, in the case of a partial or total occlusion of an artery resulting from the crushing of the lining of a dissected artery, after the balloon dilation is deflated, the patient may require immediate medical attention, particularly when the occlusion occurs in a coronary artery. A major focus of recent development work in the treatment of heart disease is aimed at devices called endoprostheses. Stents are generally cylindrical intravascular devices that are placed inside a damaged artery to keep it open. These devices can be used to reduce the development of restenosis or to adhere an intimal flap to maintain the opening of the blood vessel immediately after intravascular treatments such as PTCA. Various means for supplying and implanting stents have been described. A method frequently described for delivering a stent at a desired intraluminal site includes mounting the expandable stent on an expandable member, such as a balloon, which is provided at the distal end of an intravascular catheter, advancing the catheter to the desired site within the lumen. patient's body, inflate the balloon into the catheter to expand the stent in a permanent expanded condition and then deflate the balloon and remove the catheter. However, the rapid and efficient delivery of a stent to the desired site within the vasculature of a patient is difficult and time-consuming, particularly when the deployment of stents is accompanied by a balloon angioplasty procedure or when multiple stents are deployed at the body lumen Therefore, it may be important to improve existing stent delivery systems, to provide rapid stent delivery while at the same time allowing a surgeon to choose a desired stent-and-catheter combination. The present invention satisfies these needs. SUMMARY OF THE INVENTION The present invention is directed to an apparatus and method for deploying one or more endoprostheses within a body lumen. The invention generally comprises a substantially tubular liner, configured for slidable movement on a catheter shaft, with the liner configured to have a substantially tubular stent positioned on a distal portion of the liner. The liner may comprise a portion of a stent deployment system including a substantially tubular stent positioned on a distal portion of the liner and a catheter slidably received within the liner. The substantially tubular liner preferably has proximal and distal ends, proximal and distal portions, an outer surface and a through lumen defining an interior surface. The liner is configured for sliding movement on the catheter shaft. The distal portion of the liner comprises a flexible, expandable material that extends from the inner surface of the liner to the outer surface of the liner. The proximal portion of the liner is resistant to compressive forces. The catheter is preferably a dilatation catheter or a balloon catheter having an expandable member such as a balloon at its distal end. The substantially tubular stent is preferably a radially expandable stent, having a delivery configuration and a deployed configuration. The stent is placed in the delivery configuration on the distal portion of the liner. When the apparatus is inserted into the body lumen, the liner is placed on the arrow of the catheter, such that the distal portion of the liner supporting the stent is close to the expandable member. Agree with this, the expandable member can expand freely in the body lumen, as necessary to dilate a selected portion of the body lumen, without radially expanding and thus deploying the stent. Once the body lumen has dilated by the expandable member, the liner can be advanced longitudinally until the distal portion of the liner containing the stent is placed on the expandable member. The expandable member can then be expanded. Because the distal portion of the liner is formed of an elastomeric material, the distal portion of the liner expands as the expandable member expands. This expansion of the expandable member and the distal portion of liner also expands and deploys the stent at the desired site. The expandable member can then deflate, thereby causing the distant lining portion to acquire the unexpanded form again. The stent retains the expanded, expanded form and remains in the body lumen as the catheter and liner are removed. In an alternate embodiment, all or part of the proximal portion of the tubular liner is replaced by a rigid mandrel, dimensioned and configured to be placed on the side of the catheter shaft. The mandrel may already be of a solid or hollow configuration. This embodiment can be used with so-called rapid exchange catheters, such as the catheters shown and described in the US patent. No. 5,180,368 (Garrison), U.S. Pat. No. 5,458,613 (Gharibadeh et al.) And U.S. Pat. No. 5,496,346 (Horzewski et al.). In one embodiment, the proximal portions of the catheter and liner have positioning signals, such as visible marks or surface interruptions in their proximal portions, which can be seen by a user during a procedure. The positioning signals can be used to indicate the relative location of the stent with respect to the expandable member. By aligning the positioning signals of the liner and catheter, the user can determine when the stent is placed on the expandable member. The proximal portion of the liner may also contain signals that describe characteristics of the apparatus, such as the length of the liner and the number and type of stents attached to the liner. The proximal portion of tubular liner preferably has a length of at least 50 cm, depending on the particular application and body lumen to be treated. The length of the proximal portion should be sufficient to allow the proximal end of the liner to be outside the patient while the distal portion supporting the stent is at the desired deployment site within the body lumen. The proximal potion of tubular liner is preferably resistant to compression forces, such that a user can advance the liner over the catheter by holding the proximal end of the liner and distantly pushing the liner.

The invention can be used with various catheters, using so-called over-the-wire catheters and rapid-exchange catheters. The liner may contain one or more stents. When two or more stents are mounted in the liner, the apparatus can be used to deploy multiple stents in the body lumen without requiring the catheter or liner to be removed from the body lumen until the deployment of all stents is complete. The distal portion of the liner protects the expandable member, such as a balloon dilatation against mechanical damage that could otherwise be caused by the stent or by the characteristics of the lesion itself. The distal portion also helps in deflating and re-folding the balloon after deployment of the stent, as well as offering some protection to the body lumen against balloon rupture damage. The delivery liner of the invention is of particular use with a catheter having a removable proximal hub, such as that described in the U.S. patent application. copendent serial number 08 / 840,495 for CATHETER AND METHOD FOR A STENT DELIVERY SYSTEM (CATHETER AND METHOD FOR A SYSTEM OF SUPPLY OF ENDOPHROTESIS) with Andrew James Mackenzie as the inventor, presented on April 21, 1997.

Other features and advantages of the present invention will become more apparent from the following detailed description of the invention, when taken in conjunction with the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS Figure 1 is a perspective view, partially in section, illustrating a delivery catheter, liner and stent structure according to the present invention. Figure 2 is a perspective view of a liner according to the present invention. Figure 3 is a perspective view of a stent in a delivery configuration. Figure 3b is a perspective view of the stent of Figure 3a in a deployed configuration. Figure 4 is a perspective view of a liner and stent structure according to the present invention. Figure 4a is a perspective view of an alternate embodiment of a liner and stent structure according to the present invention. Figure 5 is a perspective view, partially in section, of a supply and liner catheter structure used to deploy a stent in a human patient in accordance with the present invention.

Figure 6 is a perspective view of a distal portion of a delivery catheter, liner and stent structure with the balloon expanded to dilate a body lumen. Figure 6a is a perspective view of a distal portion of an alternate embodiment of a delivery catheter, liner and stent structure, with the balloon expanding to dilate a body lumen. Figure 7 is a perspective view illustrating the distal portion of the delivery catheter, liner and stent structure of Figure 6, with the stent positioned for deployment in the body lumen. Figure 8 is a perspective view illustrating the distal portion of the delivery catheter, liner and stent structure of Figure 6, with the balloon expanding to deploy the stent in the body lumen. Figure 9 is a perspective view illustrating an alternate embodiment of the liner. Figure 10 is a perspective view of the liner of Figure 9 removed from a catheter. Figure 11 is a perspective view of an alternate embodiment of a liner and stent structure according to the present invention.

Figure 12 is a perspective view of the liner and stent structure of Figure 11 associated with a fast exchange delivery catheter. Figure 12a is a cross-sectional view of the fast exchange and liner supply catheter of Figure 12. Figure 13 is a view of perspective of the liner and stent structure having multiple stents according to the present invention. Figure 14 is a perspective view of a section of a distant liner portion material that supports multiple stents. Figure 15a is a perspective view of a proximal portion of a supply liner and catheter structure having signals to indicate the position of the distal portion of the liner relative to the expandable member. Figure 15b is a perspective view of a proximal portion of a supply liner and catheter structure according to an alternate embodiment of the invention, wherein the delivery catheter and liner have signals to indicate the position of the distal portion of the liner relative to the expandable member. Figure 15c is a perspective view of a proximal portion of a supply liner and catheter structure in accordance with an alternate embodiment of the invention, wherein the delivery and liner catheter have signals to indicate the position of the distant portion. of the liner with respect to the expandable member. DETAILED DESCRIPTION OF THE PREFERRED MODALITIES Particular embodiments of the present invention are illustrated in Figures 1 to 15 for use in various body lumens and procedures, including use in deploying stents in dilated arteries during balloon angioplasty. However, the present invention is not limited to use in blood vessels or angioplasties, but can be used in other body lumens and procedures for deploying stents, endovascular grafts and similar devices. With reference to Figure 1, in a preferred embodiment, the structure 10 for deploying the stent 12 includes a balloon catheter 14. The balloon catheter 14 has a catheter shaft 15, a proximal end 16 with various controls 18 therein located, and a distal end 20 having a dilatation device, which in the embodiment illustrated is a balloon 22. Although it is preferred that balloon 22 be a balloon dilatation, the device is thus not limited, and may include any expandable member. able to expand a stent. In the illustrated embodiment, balloon catheter 14 has an inner lumen 24 which allows a guidewire 26 to pass.

The structure 10 further includes a liner 28 having a distal end 30 and a proximal end 32. The liner 28 that is illustrated in greater detail in Figure 2, comprises two portions - a distal portion 34 and a proximal portion 36. Distal potion 34, preferably comprises an expandable, elastic material that can be expanded by pressure outwardly from inside the liner 28. Materials such as elastomeric and urethane polymers, rubber, latex and a material sold under the TEC0FLEXMR trademark, by Thermedics , Inc. can be employed to form the distal portion 34. The proximal portion 36 is preferably formed of a material such as that commonly referred to as PEEK (polyether ether ketone), a rigid plastic such as ABS (acrylonitrile-butadiene-styrene) or PVC (polyvinyl chloride), a tube of flexible material formed from stainless steel or nitinol alloys (nickel titanium or "NiTi") or a reinforced woven or fiber tube from any combination of these materials, all of which improve the pushing ability of the liner 28 and each of which is flexible enough to allow navigation of the vascular system. The length 40 of the proximal portion is typically several times greater than the length 42 of the distal portion. The liner 28 illustrated in Figure 2 has an inner lumen 44 that passes over the length of the liner 28. The lining has an inner surface 46, defined by the inner lumen 44 and an outer surface 48. The inner lumen 44 is sized to sliding movement on the dilatation balloon catheter 14 and particularly on the arrow of the catheter 15. The liner 28 of Figure 2 has an outer diameter 50 that is sized to be able to pass inside a body lumen. The liner 28 preferably has a length 52 which allows the distant end 30 of the liner to be placed in a desired treatment site in a body lumen while the proximal end 32 of the liner is placed outside the body lumen and the patient, such that a user can manipulate the liner 28 by holding and maneuvering its proximal end 32. By maneuvering the proximal end 32 of the liner 28 relative axial movement is provided between the distal end of liner 30 and the dilatation balloon 22, such that the endoprosthesis 12 in this way is placed in the desired treatment site. The proximal portion 36 of the liner may include a handle 53 or a similar manipulation device by which a wearer can hold and move the liner 28 axially over the arrow of the catheter 15. Different liners may have various lengths, custom-fitted to the particular application. For example, in a balloon angioplasty procedure, where a liner is used to deploy a stent in a coronary artery (as illustrated for example in Figure 5), the length of liner 52 is generally at least 50 cm long , and preferably will be in the order of 100 cm to 140 cm in length. The precise optimum length of the liner will be determined by the application. Figures 3a and 3b illustrate an expandable stent 12, for use with balloon catheter 14 and liner 28 of the invention. The stent has an inner lumen 54 that defines an inner surface 56 and an outer surface 58 that defines an outer diameter 60a. Figure 3a illustrates the stent 12 in its delivery configuration, wherein the pre-deployment outer diameter 60a is small enough to pass within a body lumen. Figure 3b shows the stent 12 in its deployed configuration, wherein the outer diameter 60b is dimensioned such that the outer surface of the stent 58 contacts the walls of the body lumen. The length 62 of the stent 12 is typically in the range of 5 to 50 mm, and preferably approximately 15 to 20 mm, but with the invention, stent grafts of almost any length can be used., depending on the particular application. Figures 3a and 3b illustrate an endoprosthesis 12 of an open network configuration, similar to the stent described in US Pat. No. 5,569,295 (Laü, et al.). However, other types and configurations of stents are well known in the art and are also compatible for use in accordance with the invention, provided that the endoprosthesis defines an inner lumen and can be partially or completely expanded with a device such as a catheter. balloon. Figure 4 shows a stent and liner structure 64 according to a preferred embodiment of the present invention. The endoprosthesis 12 is placed in its delivery configuration in the distal portion 34 of the liner 28, with the inner surface of the stent 56 contacting the outer lining surface 48. In the preferred embodiment illustrated, the length of the distal portion of the liner 42 is greater than the length of the stent 62, such that the stent 12 can be fully assembled in the distal portion of liner 34, without contacting the proximal portion of the liner 36. In one embodiment of the invention, one or more stent 12 is pre-load in the distant portion of liner 34 at the point of manufacture. Accordingly, the user does not have to manually load the stent into the distant portion of liner 34, and instead choose a distant portion of liner 34 having a desired stent 12 or stent 12 there pre-loaded. In an alternate embodiment, the stent 12 is not preloaded on the distant portion of liner 34 at the point of manufacture. Instead, the user chooses a desired stent 12 or stent 12, and loads the same in the distant portion of liner 34. In the embodiment illustrated in Figures 2 and 4, the distal portion of liner 34 and the proximal portion liner 36 have the same outer diameter 50. However, in other embodiments, the outside diameter of the distal portion 34 and the proximal portion 36 may vary. For example, as illustrated in Figure 4a, the distal portion of liner 34 may have a diameter 50a slightly smaller than the diameter 50b of the proximal portion of liner 36. The reduced diameter 50a of the distal portion of liner 34 allows space extra radial for a stent 12 to be placed in the liner 28, such that the outer diameter 60a of the stent 12, when mounted to the distant portion of liner 34 in the delivery configuration, can easily pass within a lumen bodily. In one embodiment, such as that illustrated in Figure 4a, the outer diameter 60 of the stent 12 is equal to or less than the diameter 50b of the proximal portion of liner 36. In Figure 5, the catheter, liner and stent structure it is illustrated as in a balloon angioplasty procedure to deploy a stent 12 in a coronary artery 66 of a patient 68. The structure has been introduced percutaneously through a guiding catheter 69 into a femoral artery 70 within the vascular system of the patient 68 , with the dilatation balloon 22 placed, for example, in the coronary artery to be treated. Both the proximal end of the catheter shaft 16, which includes the catheter controls 18 and the proximal end of the liner 32, including the liner handle 53, are placed outside the patient 68, such that a user can easily hold and manipulate the catheter 14 and the liner 28. Now with reference to Figure 6, the catheter / liner / stent structure is illustrated with the dilatation balloon 22 placed within a body lumen 72 at a desired treatment site 74. The site The desired treatment 74 may comprise a block 76 such as a stenosis caused by plaque deposits, which has partially occluded the body lumen 72. The liner 28 is positioned such that the endoprosthesis 12 which is mounted on the distal portion of the liner 34, is right next to the balloon of expansion 22. Accordingly, as the balloon 22 expands against the block 76, expansion of the balloon 22 does not cause the stent 12 to acquire its expanded diameter. In the embodiment illustrated in Figure 6, the distal end of liner 30 is placed just proximal to the balloon 22, such that expansion of balloon dilation 22 causes no expansion of any portion of the distal portion of liner 34. However, in another embodiment, as illustrated in Figure 6a, the liner 28 may have a distant portion of liner 34 significantly longer in length than the stent 12, with the distant portion of liner 34 extending distal to the stent 12. and on the balloon of expansion 22. In this embodiment, the expansion of the balloon 22 to dilate the block 76 will expand a forward section 78 of the distant portion of liner 34, except the back section 80 of the distant portion of liner 34 over which stent 12 is mounted, does not expand significantly, such that expansion of balloon dilatation 22 to treat block 76, does not cause stent 12 to give your expanded diameter. In Figure 7, block 76 has been dilated and balloon 22 has deflated. The liner 28 has been slidably (remotely) advanced over the catheter 14 by maneuvering the proximal end of liner 32 until the stent 12 is placed over the dilatation balloon 22. The sliding advance of the liner 28 can be achieved by the user, such as a cardiologist, by grasping the proximal end of the liner 32, shown in Figure 5, and pushing the liner 28 forward (distally) over the catheter 14. Because the proximal liner portion 36 is preferably constituted by a Generally more rigid material that is resistant to longitudinal compressive forces, the user pushing the proximal end of the liner 32 causes the liner 28 to slide over the catheter 14, such that the distal portion of the liner 34, including the stent 12 proceeds over the expansion balloon 22. In Figure 8, the expansion balloon 22 expands. The external pressure from the balloon 22 causes the proximal portion of liner 36 to expand outward, which in turn forces the stent 12 to expand outwardly until the stent acquires its deployed outer diameter 60b. In the deployed diameter, the outer surface of stent 58 contacts and exerts some pressure outwardly against walls 82 of body lumen 72, thereby preventing walls 82, which can be weakened by the dilation or locking procedure 76 they bulge inward and cause renewed blockage of the body lumen 72. Figure 9 shows another embodiment of a liner 28 according to the present invention. The liner 28 is similar to that shown in Figure 2, and comprises a distal end 30, a proximal end 32, a distal portion 34 and a proximal portion 36. However, the embodiment shown in Figure 9a further includes a slot 84. which extends from the proximal end of liner 32 to the distal end of liner 30. The slot 84 preferably passes completely through the outer liner wall, i.e. from the outer liner surface to the inner liner surface 48, v allows the liner to be detached, to allow introduction or removal of various devices, such as a guidewire or catheter, on the liner side. Due to an opening in the side of the expandable remote portion 34 may complicate expansion and contraction of the distal portion 34, the slot 84 preferably ends close to the expandable distant portion of liner 34. In the illustrated embodiment, the slot 84 terminates approximately 10 cm proximate to the distal portion 84 of the liner 28. In the embodiment shown in Figure 9, the liner 28 has a handle 53, by which a user can hold and manipulate the liner. The handle 53 includes a channel 86 dimensioned to receive a catheter shaft, so that a catheter shaft and / or guide wire can pass completely. The slot 84 and channel 86 facilitate removal of the liner 28 from a catheter 14, by allowing the liner to detach from the catheter, as the liner is removed from the patient. As illustrated In Figure 10, as the liner 28 is removed, the wearer can peel the liner 28 from the catheter 14, the peel begins at the site of the proximal end 32. In this way, a wearer can peel liner 28 from the catheter 14 while securely holding the end proximal to catheter 16. When liner 28 has been completely removed from the patient, the only portions of liner 28 that still remain in catheter 14 are the distal portion of liner 34 and the "non-slotted" portion. of the next portion of liner 36 (such as the last 10 cm illustrated in Figures 9 and 10). Removal of liner 28 can be completed by grooving the sides of the lining portion 34 and the non-slotted portion (previously) of the next liner portion 36. Alternately, the lining portion 34 and the remaining non-grooved portion. of the proximal end of liner 36 can slide out of the proximal end of catheter 16, especially when the proximal end of catheter 16 has a diameter small enough to pass through the distal portion of liner 34 or when catheter 14 is equipped with a proximal hub removable, such as that described in the US patent application No. 08 / 840,495, entitled CATHETER AND METHOD FOR A STENT DELIVERY SYSTEM (CATHETER AND METHOD FOR AN ENDOPROTESIS SUPPLY SYSTEM) filed on April 21, 1997. FIG. 11 shows an alternative embodiment of a supply liner 28 which it has a distal portion 34 to which a stent 12 is attached, but where the majority of the proximal portion 32 of the liner is replaced by a mandrel 88. The mandrel 88 performs the same as the proximal portion 36 described above with respect to the Figure 2. The mandrel 88 is preferably formed of a material such as a semi-rigid polymer, stainless steel, titanium, nickel-titanium or similar material, which improves the pushing ability of the liner 28 however it is flexible enough to navigate the system vascular. The mandrel 88 may have a selected cross section of various configurations, such as solid, hollow, tubular, etc. The length of the mandrel 90 is typically several times larger than the length 42 of the distant portion 34 of the liner. While the proximal portion of the liner 36 illustrated in Figure 2 is configured to slide slidably over a catheter, the mandrel 88 of Figure 11 is configured to pass over and be placed over a catheter. The mandrel 88 could include a handle 53 by which a user can hold the device. A short section of the pushable liner 92 of material and features similar to the proximal portion 36 of the embodiment illustrated in Figure 2, may be provided to facilitate the transition between the rigid mandrel 88 and the distal expandable liner portion 34. This short pushable section 92 assists the pushing ability and tracking ability of the liner 28 and avoids the tearing that can result if the mandrel 88 were held directly to the distal expandable liner portion 34. The supply liner 28 of Figure 11 is particularly suitable for used with rapid exchange catheters, such as the rapid exchange catheter 94 with the dilatation balloon 95 illustrated in Figure 12. Examples of so-called rapid exchange catheters are illustrated and described in US Pat. No. 5,180,368 (Garrison), in the US patent. No. 5,458,613 (Gharibadeh et al.) And in the US patent. No. 5, 496, 346 (Horzewski et al.). When used with a rapid exchange catheter 94, the delivery liner 28 can be easily removed from and inserted into the patient without removal of the catheter 94 being necessary. An additional advantage of the supply liner 28 with the mandrel 88 is that the user can hold the holder in a proximal portion of catheter 96, while removing or inserting the supply liner 28. The mandrel can specifically be configured to present a surface that can rest uniformly against the catheter. For example, Figure 12a shows a mandrel 88 having a curved inner surface 89, configured to be placed or to rest evenly against a substantially tubular catheter 94. The supply liner 28 can be placed around the catheter 94 before introducing the catheter 94 to the patient, and catheter 94 and liner 28 are introduced to the patient in a single step. Alternatively, the supply liner 28 can be slidably inserted over the catheter 94 after the catheter 94 is in place in the patient. This introduction of the delivery liner onto the catheter can be facilitated by having a catheter whose proximal portion 96 has a diameter small enough to pass through a distant portion of liner 34 and characterized by a short pushable section 92 or with a catheter having a removable next cube. During introduction of the supply liner 28 over the quick exchange catheter 94, such as that illustrated in FIG. 12, the distant portion of liner 34 and the short pushable section 92 slide over the quick exchange catheter 94 and the guide wire 26. with the mandrel 88 spaced some distance away from the proximal portion of the catheter 96, such that the mandrel 88 does not interfere with the fastening of a user in the proximal portion of the catheter 96. During removal of the supply liner 28, the portion Distant liner 34 of the short pushable section 92 slides over the quick exchange catheter 94 and the guide wire 26. Towards the proximal portion of the catheter 96, the mandrel 88 can be laterally detached from the catheter 9'4, thereby allowing the user maintains a firm hold on the proximal portion of the catheter 96. When the liner 28 is completely removed from the patient's interior, the removal of the portion of the liner component 34 and short pushable section 92 of the catheter can be completed by grooving the sides of the distal portion of liner 34 and short pushable section 92. Alternately, the distal liner portion 34 and short pushable section 92 can slide detaching from the proximal portion of catheter 96, especially when the proximal portion of catheter 96 has a diameter small enough to pass through the distal portion of liner 34 and short pushable section 92 or when the catheter is equipped with a removable proximal hub . Figures 1 and 6 to 12 show a preferred embodiment whereby a single stent 12 is mounted on the liner 28. However, as illustrated in Figure 13, another embodiment involves multiple stents 12a-c mounted on the liner 28. In this manner, a single liner 28 can be used to deploy multiple stents 12a-c in a body lumen during a simple procedure, without need either because the liner 28 or the catheter 14 is removed from the body lumen until the procedure is completed. In one method, the sites 74a, 74b, 74c to be treated can all be dilated by the balloon 22 before deployment of any of the stent 12. After all sites have been dilated, the balloon dilated deflate 22 it is placed at site 74a, where the first stent 12a is to be deployed. The liner 28 is slidably advanced over the catheter until the first stent 12a is placed over the deflated balloon 22. Then, the dilatation balloon is expanded., in this way deploying the first endoprosthesis 12a. The balloon dilatation is then deflated and relocated to site 74b, where the second stent 12b is to be deployed. The liner is again slidably advanced over the catheter until the second stent 12b is placed over the deflated balloon 22. The balloon dilates again to deploy the second stent 12b and the procedure is repeated for any additional stent grafts. can be transported in the catheter and are intended to be deployed. In another method, the dilation of the selected treatment sites 74a-c may occur just before each stent is deployed, such that the first site 74a is dilated before the first stent 12a is deployed, the second site 74b is dilated after deploying the first endoprosthesis 12a, but before deploying the second endoprosthesis 12b, etc. The stents 12 are preferably spaced a distance that allows the balloon 22 to expand any stent 12 without accidentally causing complete or partial expansion of adjacent stents 12. In Figure 13, the liner is illustrated with three stents 12. However, any amount of prosthesis 12 may be employed, with the length 42 of the distant portion of liner 34, selected to allow for the size and number of particular stents. The invention can also be employed in methods wherein dilation of the body lumen and deployment of stents should comprise a single step. In this procedure, the body lumen does not expand before stent deployment. In contrast, outward expansion of the stent during deployment dilates the body lumen. The distal portion 34 and the proximal portion 36 of the liner 28 can be preformed at the point of manufacture. However, the distal portion of liner 34 may be a separate structure that is connected to the proximal portion 36 by the user, such as a physician, just before or during a procedure. In this way, a doctor or other user can select from a variety of stents and distant liner portions, with the selection of stents and distant liner portions dependent on the particular application. The user can also tailor the length of the distant portion of liner 34 as well as the number of stents 12 therein located. For example, a user may be provided with a distant portion of liner 34, material 98, which contains multiple stents 12, as illustrated in Figure 14. The user may then select the length of the distant portion of liner and the number of stents that are desired for a particular procedure, and consequently cutting from the length of material 98, a distant liner portion of the desired length and containing the number of selected stents. For example, if the user wants three stents, the user can cut a distant portion of liner 34 that contains stents 12a-12c. The user can then fasten the distant portion of "custom" liner 34 to a proximal portion of liner 36 to form a complete liner 28. Stent 12 is conveniently spaced a minimum distance in the range of about 4 mm to 10 mm, This spacing allows a user to cut the liner into sections containing separate and distinct prostheses. This spacing also allows the user to deploy a stent, without accidentally deploying stents that may be adjacent, with the tapered portion of the expandable balloon. Figure 15a shows another aspect of a preferred embodiment of the invention, whereby the proximal end 32 of the liner 28 and the proximal end 16 of the arrow of the catheter 14 have signals 100, 102 to indicate the position of the liner 28 relative to the catheter 14 and / or the position of the stent or stents with respect to the dilatation balloon 22. In the embodiment shown, the catheter 14 has several signals 102 including numbers and lines, and the lining signals 100 merely consist of the proximal end of liner 32. The alignment of the proximal end of liner 32 with the catheter signals 102 shows the position of the endoprosthesis with respect to to the dilatation balloon 22. For example, in the embodiment of Figure 15a the alignment of the proximal end of liner 32 with the number "-15" in the catheter, indicates that the longitudinal (ie near-distant) center of the endoprosthesis is 15 mm proximal to the longitudinal center of the dilatation balloon 22. In additional embodiments, the lining signals 100 may comprise more than simply the proximal end of liner 32. For example, in the embodiment shown in Figure 15b, a section next, such as a handle portion 53 of the liner 28 may have a channel 86 (or may have peepholes or be substantially transparent) and have signals 100, such as lines or other markings which can be aligned with corresponding signals 102 in the catheter 14. In this embodiment, the channel 86 (or peepholes or transparent portion) of the handle 53 allows the catheter signals 102 to be visualized through a liner 28. In a further embodiment shown in Figure 15c, the catheter signals 102 may comprise an interruption 104 on the surface of the catheter 14, and the liner signals 100 may comprise a corresponding interruption 106 on the surface of the liner 28. The alignment of the liner interruption 106 and the interruption of catheter 104, cause physical contact between them. This physical contact may be sufficient for a user whose hand to slide the liner senses by touch the contact between liner interruption 106 and catheter 104 interruption. Physical contact may also be sufficient to resist and / or prevent further longitudinal movement of the liner. lining over the catheter. The liner signals 100 may further comprise signals describing characteristics of the subject stent or liner, such as the type and number of stents, etc. The embodiments described have illustrated the liner and stent structure employed with a catheter having an inflatable balloon to deploy the balloon. stent However, the invention is not limited to the use of expandable balloons. Other expandable devices for lumen dilatation and stent deployment are also compatible with the invention. Although preferred and alternative embodiments of the invention have been described and illustrated, the invention is susceptible to modifications and adaptations within the capacity of those skilled in the art and without the exercise of inventive ability or ability. Thus, it will be understood that various changes in form, detail and use of the present invention can be made without departing from the scope of the invention. Accordingly, the invention is not intended to be limited, except by the appended claims.

Claims (36)

1. CLAIMS 1. A system for deployment of stents, for placing one or more stents within a body lumen, the system is characterized in that it comprises: a catheter having an arrow, an outer surface, a proximal end and a distal end; a substantially tubular liner having a proximal end and a distal end, a proximal portion and a distal portion, an exterior surface and a through lumen defining an interior surface, the liner is configured for slidable movement on the catheter shaft; and a substantially tubular stent having a delivery configuration and deployment configuration, the stent is removably connected in the delivery configuration over the distal portion of the liner.
2. 2. The system in accordance with the claim 1, characterized in that the catheter includes an expandable member at the distal end of the catheter.
3. 3. The system in accordance with the claim 2, characterized in that the distal portion of the liner is formed of a flexible, expandable polymeric material.
4. 4. The system in accordance with the claim 3, characterized in that the proximal portion of the liner is formed from a polymer material that provides sufficient rigidity to the liner to allow relative axial movement of the distal portion of the liner over the catheter in response to axial movement of the proximal end of the liner over the catheter .
5. 5. The system according to claim 4, characterized perqué further comprises a substantially longitudinal groove in the proximal portion of the liner.
6. The system according to claim 1, characterized in that the catheter has catheter placement signals and the liner has lining placement signals, the catheter placement signals and the lining placement signals, are placed in such a manner that the alignment of the lining placement signals with the catheter placement signals locates the endoprosthesis in a desired longitudinal position adjacent to the distal end of the catheter.
7. The system according to claim 6, characterized in that the catheter placement signals include a marker visible on the catheter, and the lining placement signals include the proximal end of the liner.
8. The system according to claim 6, characterized in that the catheter placement signals comprise a physical interruption on the outer surface of the catheter, and the lining placement signals comprise a physical break in the inner surface of the liner, wherein the alignment of the catheter placement signals with the lining placement signals results in physical contact between the catheter placement signals and the lining placement signals, the contact resists sliding movement at least in one direction between the catheter and the cover.
9. 9. The system according to claim 1, characterized in that the lining has a length of at least 50 cm 10.
10. An apparatus for delivering a stent to a desired position within a body lumen, the apparatus is characterized in that it comprises: a substantially tubular liner having a proximal end and a distal end, a proximal portion and a distal portion, an outer surface and an interior lumen through which defines an interior surface that passes the length of the liner, the interior lumen is configured so that a catheter shaft moves slidably there, and at least one substantially tubular stent having a delivery configuration and a configuration of In the deployment, the stent is removably connected in the delivery configuration over the distal portion of the liner.
11. The apparatus according to claim 10, characterized in that the proximal portion of the liner is formed from a polymeric material that provides sufficient rigidity to the liner to allow relative axial movement of the distal portion of the liner over the catheter, in response to axial movement of the proximal end of the liner on the catheter.
12. 12. The apparatus according to claim 11, characterized in that the inner lumen is configured for a catheter shaft having an expandable member to move slidably there, and the distal portion of the liner is formed of a flexible expandable polymer material.
13. The apparatus according to claim 11, characterized in that it further comprises a substantially longitudinal groove in the proximal portion of the liner.
14. The apparatus according to claim 10, characterized in that the liner includes two or more of the substantially tubular stents, the stents are placed in the distal portion of the liner.
15. 15. The apparatus according to claim 10, characterized in that the proximal end of the liner includes a handle by which a user can hold the liner.
16. 16. The apparatus according to claim 15, characterized in that the handle includes a channel, the channel is configured to receive a catheter shaft.
17. The apparatus according to claim 10, characterized in that the proximal portion of the liner includes signals describing characteristics of the apparatus.
18. 18. The apparatus according to claim 10, characterized in that the tubular lining has a length of at least 50 cm.
19. 19. An apparatus for supplying a stent to a desired position within a body lumen, the apparatus is characterized in that it comprises: a substantially tubular sheath having a proximal end and a distal end, an outer surface and a through lumen defining an inner surface As the length of the liner passes, the inner lumen is configured so that a catheter shaft moves slidably there; and a mandrel having a proximal end and a distal end, the distal end of the mandrel is connected to the liner.
20. 20. The apparatus in accordance with the claim 19, characterized in that in addition it comprises at least one substantially tubular stent having a delivery configuration and a deployed configuration, the stent is at least removably connected in the delivery configuration on the liner.
21. 21. The apparatus in accordance with the claim 20, characterized in that the mandrel is formed of a polymeric material that provides sufficient rigidity to the mandrel to allow relative axial movement of the distal end of the mandrel along the catheter, in response to movement of the end proximal to the mandrel.
22. 22. The apparatus in accordance with the claim 21, characterized in that the inner lumen of the liner is configured for a catheter shaft having an expandable member to move slidably there, and a distal portion of the liner is formed of an expandable flexible polymer material.
23. The apparatus according to claim 22, characterized in that the mandrel is secured to a proximal portion of the liner and the proximal portion of the liner is formed of a polymeric material that provides sufficient rigidity to the liner to allow relative axial movement of the liner on the liner. catheter in response to movement of the proximal end of the mandrel.
24. 24. An apparatus for delivering a stent to a desired position within a body lumen, the apparatus is characterized in that it comprises: a substantially tubular sheath having a proximal end and a distal end, an outer surface and a through lumen defining a inner surface passing the length of the liner, the inner lumen is configured so that a catheter shaft moves slidably there; and a plurality of substantially tubular stents, each stent having a delivery configuration and a deployment configuration, the stents are removably connected in the delivery configuration on the liner.
25. 25. The apparatus according to claim 24, characterized in that the liner is formed of an expandable flexible material.
26. 26. A method for deploying one or more endoprostheses in a body lumen, the method is characterized in that it comprises the steps of: a) placing a first stent relative to a distal portion of a tubular liner, the first stent being in a delivery configuration, - b) slidably moving the tubular liner over a catheter shaft; c) insert the catheter shaft into the body lumen; d) introducing the tubular lining to the body lumen; e) placing the first stent in the first desired site within the body lumen; and f) deploying the first stent in the first desired location, wherein the first stent acquires a deployed configuration.
27. 27. The method according to claim 26, characterized in that step (a) is carried out before step (b).
28. 28. The method according to claim 26, characterized in that steps (c) and (d) are performed as a single step.
29. 29. The method according to claim 26, characterized in that the catheter includes an expandable member, and wherein step (c) comprises the additional step of: (g) placing the expandable member in the first desired position within the body lumen .
30. 30. The method according to claim 29, characterized in that the liner has a distal end portion formed from an expandable, flexible material, and wherein step (e) occurs after step (g) and wherein step (e) comprises the additional step of: (h) sliding the liner over the catheter shaft until the first stent is placed on the expandable member
31. 31. The method according to claim 30, characterized in that it comprises, before step (h) the additional step of: (i) dilating the body lumen with the expandable member
32. 32. The method according to claim 1. 26, characterized in that step (a) comprises the additional step of: (j) placing one or more additional stents relative to a distal end portion of the tubular liner, each additional stent being in a delivery configuration.
33. 33. The method of compliance with the claim 32, characterized in that it comprises the additional steps of: (k) placing the additional stents at one or more additional desired locations within the body lumen, and (1) deploying the additional stents at the additional desired sites, wherein each additional stent acquires a deployed configuration.
34. 34. The method of compliance with the claim 33, characterized in that it comprises after it is performed. steps (k) and (1), the additional steps of: (m) removing the tubular lining from the body lumen; and (n) removing the catheter from the body lumen.
35. 35. The method according to claim 34, characterized in that the tubular liner includes a channel in the proximal lining portion and the step (m) includes the step of detaching the lining of the catheter.
36. 36. The method according to claim 26, characterized in that the positioning step (e) includes signals on the catheter shaft and signals on the tubular liner, the method further comprising moving the tubular liner relative to the catheter shaft and aligning the signals on the tubular liner with the signals on the catheter shaft, thereby placing the stent on an expandable member near the distal end of the catheter shaft. SUMMARY OF THE INVENTION An apparatus and method for deploying one or more endoprostheses within a body lumen, comprising a substantially tubular liner configured for sliding movement on a catheter shaft and configured to receive a stent and on a flexible, expandable remote portion of the body. cover. The liner may comprise a portion of a stent deployment system that includes a dilatation catheter (such as a balloon catheter) and one or more substantially tubular stents, placed in their delivery configurations on the expandable, distant portion of the liner. The preferred liner has a proximal portion, which is configured in such a way that a user can advance the lining over the catheter by maneuvering the proximal end of the liner. The substantially tubular stent is preferably a radially expandable stent having a delivery configuration and an unfolded configuration. When the apparatus is inserted into a body lumen, the liner is placed on the catheter shaft, such that the distal lining portion containing the stent (12) is proximate the expandable catheter member (e.g., balloon). In this manner, the expandable catheter member can be used to dilate the body lumen without deploying the stent. After completing the dilation, the liner is advanced until the stent is placed around the expandable member which then expands, thereby expanding radially and deploying the stent or stents.