MXPA98003109A - Catheter and method for an endoprote supply system - Google Patents

Abstract

The present invention relates to a catheter, characterized in that it comprises: an arrow having an outer surface, a central axis, a proximal end and a distal end, a substantially tubular sheath, of a length substantially equal to the arrow and slidably disposed on the arrow, and a removable close cube, without seams, respectably attached to the proximal end of the arrow to retain the liner therein, where the proximal end of the arrow engages the hub through a perforation distant from the hub.

Description

.CATÉTER AND METHOD FOR ON SYSTEM OF SUPPLY OF ENDOPROTESIS 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 catheter having a removable proximal hub, which allows a stent delivery liner to be loaded and discharged from the catheter, without requiring removal of the catheter from the patient. Description of the Related Art Stents in general are cylindrically shaped devices that function to keep a segment of a blood vessel or other lumen or body opening open and sometimes expanding. Stents are particularly suited to support and maintain open or maintain a liner that may otherwise occlude the passageway for fluid. Stents are also useful for maintaining the opening of a body lumen, such as a coronary artery, after a percutaneous transluminal coronary angioplasty (PTCA) or an atherectomy procedure is performed to open an area with stenosis. of the artery. Several intervention treatment modalities are currently used for heart disease, including balloon and laser angioplasty, atherectomy and bypass surgery. In typical balloon angioplasty procedures, a guiding 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 tip The distal guidewire catheter sits in the ostium of a desired coronary artery. A guide wire is placed inside an inner lumen of a dilatation catheter and then both the catheter and the guidewire are advanced through the guide catheter to the distal end of the guide catheter. The guidewire is advanced out of the distal end of the guiding catheter into the coronary vasculature until the distal end of the guidewire crosses the dilating lesion. Then, the dilatation catheter having an inflatable balloon in its distant position is advanced to the 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 inelastic materials is inflated with liquid to a predetermined size at relatively high pressure (e.g. greater than 4.05 bars (4 atmospheres) twice to compress the plate atherosclerosis of the lesion against the inside of the arterial wall and to otherwise expand the inner lumen of the artery.The dilatation balloon is then deflated in such a way that the blood flow can be resumed through the dilated artery and the catheter Dilatation can be removed Additional details of dilatation catheters, guidewires and associated devices for angioplasty procedures can be found in U.S. Patent No. 4,323,071 (Simpson-Robert), U.S. Patent No. 4,439,185 (Lindquist); U.S. Patent No. 4,516,972 (Samson); U.S. Patent No. 4,538,622 (Samson et al.); U.S. Patent No. 4,55 4,929 (Samson et al.); U.S. Patent No. 4,616,652 (Simpson); U.S. Patent No. 4,638,805 (Powell); and US patent. No. 4,748,982 (Horzewski et al.). A concomitant procedure of balloon angioplasty may be the formation of innermost flaps that collapse and occlude the artery when the balloon is deflated at the end of the angioplasty procedure. Another feature of a balloon angioplasty procedure may be restenosis of 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 dissected lining, after the balloon dilatation is deflated, the patient may require immediate medical attention, particularly when occlusion occurs in an artery. coronary A focus of work recently developed in the treatment of heart disease has been directed to 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 prevent restenosis or to attach an innermost 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 frequently described method for delivering a stent to a desired intraluminal location includes mounting the expandable stent on an expandable member, such as a balloon, which has been provided at the distal end of an intravascular catheter, advancing the catheter to the desired location within of the body lumen, inflate the balloon into the catheter to expand the stent in a permanent expanded condition and then deflate the balloon and remove the patient's 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 stent deployment is involved in a balloon angioplasty procedure or when multiple endoprostheses are deployed in the body lumen Therefore, it may be important to improve existing endoprosthesis delivery systems, to provide rapid delivery of stent while at the same time allowing a cardiologist 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, without requiring removal of the catheter from the body lumen before deployment of the stent. The invention generally comprises a catheter for stent deployment having an arrow with a removable proximal hub removably attached to a proximal end of the shaft. In a preferred embodiment the catheter shaft has an expandable member at the distal end of the shaft. The next removable hub may include a control device for controlling expansion of the expandable member. The catheter may also include a clamping device that prevents rotation of the proximal hub releasable relative to the arrow shaft. This fastening device may include one or more projections extending from the next releasable hub that is configured to be received in one or more openings in the catheter shaft. In a preferred embodiment, the endoprosthesis deployment catheter may comprise a portion of a system for stent deployment. The endoprosthesis deployment system generally comprises the aforementioned catheter with an arrow and a removable proximal hub, a substantially tubular liner configured to move slidably over the catheter shaft and a substantially tubular endoprosthesis positioned on a distal portion of 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 an expandable member, flexible, extending from the inner surface of the liner to the outer surface of the liner. The proximal portion of the liner is resistant to compression forces. The preferred catheter includes at its distal end an expandable device such as a dilating device or a balloon. The substantially tubular stent is preferably a radially expandable stent having a delivery configuration and deployment configuration. The stent is placed in the target body lumen, while in the delivery configuration on the distal portion of the liner. In a preferred embodiment, the catheter is a dilatation catheter with an expandable member at the distal end of the catheter shaft. The catheter can be introduced into the body lumen, such that the expandable member is at the desired treatment site and then the expandable member can expand to dilate the coproral lumen. In a preferred method of operation, after the body lumen has been dilated by the dilating device, the removable proximal hub can be peeled off, and the liner can slide longitudinally in and over the liner, until the distant position of the liner contains 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 expansion device expands. This expansion of the dilatation device and distant 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 regain its unexpanded shape. The endoprosthesis, however, retains its expanded expanded form and remains in the body lumen. In another preferred method of operation, the removable proximal hub is peeled off and the liner slides longitudinally in and on the liner, before dilation of the body lumen. The distal portion of the liner containing the stent is positioned just proximal to the expandable member. Because the stent is close to the expandable member, expansion of the expandable member to dilate the body lumen will not cause the stent to deploy. After dilation is performed, the liner is advanced such that the distal portion of liner containing the stent is placed on the expandable member. The expandable member then expands again, thereby expanding and deploying the stent at the treatment site. In another modality, dilation of the body lumen and deployment of the endoprosthesis occurs as a single stage. In this embodiment, the removable proximal hub is removed and the liner slides longitudinally in and on the liner until the distal liner position containing the stent is placed on the expandable member. The expandable member then expands, thereby causing the stent to expand and acquire its deployed configuration. The expansion of the endoprosthesis and the expandable member also dilates the body lumen, such that the deployment of endografts and dilation of the body lumen occur as a single stage. After the stent is deployed, the proximal hub can be removed again to allow the liner to slide off the catheter shaft. A new liner containing one or more additional stents, can then slide over the catheter shaft and thus enter the body lumen at a selected site. The proximal hub can then be reconnected, and the new endoprosthesis (s) deployed to desired sites. These steps can be repeated for several linings and additional stents, without requiring the catheter to be removed from the body lumen, until the deployment of all stents is complete. The invention is applicable to various catheter designs, including so-called over-the-wire catheters (OTW) and fast-exchange catheters. Examples of fast exchange catheters are illustrated and described in U.S. Pat. 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.). 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 FIG. 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 2A is a perspective view of an alternate embodiment of a liner according to the present invention. Figure 3A 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 the liner and stent structure according to an alternate embodiment of 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 delivery catheter, according to the invention. Figure 7 is a perspective view of the delivery catheter, with the dilatation balloon expanding to dilate a body lumen. Figure 8 is a perspective view of the catheter of Figure 7 with the liner and stent structure and with the proximal hub removed from the catheter according to a preferred embodiment of the present invention. Figure 9 is a perspective view illustrating the delivery catheter of Figure 6 with a liner and stent structure, with the stent positioned for deployment in the body lumen. Figure 10 is a perspective view illustrating the supply catheter, liner and stent structure of Figure 9, with the balloon expanded to deploy the stent in the body lumen. Figure HA is a perspective view showing a structure of delivery catheter, liner and stent, with the balloon expanding to deploy a stent test in a body lumen. Figure 11B is a perspective view illustrating a delivery catheter, liner and stent structure of Figure 11A, with the balloon expanding to deploy a second stent in the body lumen. Figure 12 is an exploded perspective view of the proximal portion of a delivery catheter according to a preferred embodiment of the present invention. Figure 13A is an exploded cross-sectional view of a proximal portion of a delivery catheter according to an embodiment of the invention. Figure 13B is a cross-sectional view of a proximal portion of the delivery catheter of Figure 13A. Figure 14 is a cross-sectional view of a proximal portion of a delivery catheter according to an embodiment of the invention. Figure 15A is a cross-sectional view of a proximal portion of a delivery catheter according to the invention. Figure 15B is a cross-sectional view of a proximal portion of a delivery catheter according to still another embodiment of the invention. Figure 15C is a cross-sectional view of a proximal portion of a delivery catheter according to a further embodiment of the invention. Figure 16A is a cross-sectional view of a proximal portion of a coaxial delivery catheter according to the invention.

Figure 16B is a cross-sectional view of a proximal portion of a dual lumen delivery catheter according to a further embodiment of the invention. Figure 17 is a cross-sectional view of a proximal portion of a delivery catheter according to the invention. Figure 18A is a perspective view of a proximal portion of a delivery and liner catheter used to deploy a stent in a patient. Figure 18B is a perspective view of a supply and liner catheter of Figure 18A. Figure 19 is a perspective view of a delivery catheter having an extended section according to the invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS The present invention is illustrated in Figures 1 to 19, for use in various body lumens and procedures, including for use in deploying stents in dilated arteries during balloon angioplasty. However, the present invention is not limited to use in blood vessels or angioplasty procedures, but may also be employed in other body lumens and methods for deploying stents, endovascular grafts and similar devices.

With reference to Figure 1, in a preferred embodiment, the structure 10 for deploying stent 12 comprises a balloon catheter 14. The balloon catheter 14 comprises a removable proximal hub 16 having various controls 18 there located, which is subject to a proximal end 19 of a catheter shaft 15. The catheter shaft 15 has a distal end 20 having a dilatation device, which in the illustrated embodiment is a dilatation balloon 22. In the embodiment shown, the catheter shaft 15 it has an inner lumen 24 which allows a guide wire 26 to traverse it. The structure 10 further comprises a liner 28 having a distal end 30 and a proximal end 32. The liner 28 which is illustrated in greater detail in Figure 2, comprises two portions - a distal portion 34 and a proximal portion 36. Distant portion 34, preferably comprises an expandable elastic material, which can be expanded by pressure outwardly from inside the liner 28. The proximal portion 36 is preferably formed of a material that enhances the pushing ability of liner 28, however It is flexible enough to navigate the vascular system. The length of the proximal portion 40 is typically several times the length of the distal portion 42. The liner 28 illustrated in Figure 2 has an interior lumen 44 that passes through the length of liner 28. The lining has an interior surface 46 defined by the inner lumen 44 and an outer surface 48. The inner lumen 44 is dimensioned for sliding movement on the arrow of the catheter 15 of the balloon catheter 14. The liner 28 of Figure 2 has an outer diameter 50 sized to pass within of a body lumen. The liner 28 preferably has a length 52 which allows the distal end of liner 30 to be placed at a desired treatment site in a body lumen, while the proximal end of liner 32 is placed outside the body lumen and exterior to the patient, such that a user can manipulate the liner 28 by clamping and maneuvering the next end of liner 32. The exact value of the liner length 52 will be determined by the particular application. The liner 28 may include a slot 47 extending from the proximal end of liner 32 to the distal end of liner 30. The slot 47 allows the liner to peel off to facilitate insertion or removal of various devices such as a catheter or wire guide, on the lining side. Figure 2A illustrates an alternate embodiment of a supply liner 28 having a distal portion 34 configured to receive a stent, but wherein the majority of the proximal portion 36 is replaced by a mandrel 49. The mandrel 49 performs as much as the portion next 36 described above with respect to Figure 2. The mandrel 49 is preferably formed of a material such as a polymer, stainless steel, titanium, nickel-titanium alloy, fiber reinforced polymer, woven polymer or reinforced-woven polymer that improves the pushing ability of liner 28 however is flexible enough to navigate the vascular system. The length of the mandrel 51 is typically several times the length 42 of the distal portion 34. While the proximal portion of the liner 36 illustrated in Figure 2 is configured to slide slidably over a catheter, the mandrel 49 of Figure 11 is configured to pass along and rest near a catheter. The mandrel 49 may include a handle 53 by which a user can hold the device. This embodiment can be used with so-called rapid exchange catheters and particularly as a rapid exchange catheter having a removable proximal hub, according to the present invention. Figures 3A and 3B illustrate an illustrate an expandable stent 12, for use with the balloon catheter 14 and liner 28 of the present invention. The stent has an inner lumen 54 that defines an inner surface 56 and an outer surface 58 that defines a first outer diameter 60a. Figure 3A shows the stent 12 in its delivery configuration, wherein the first outer diameter 60a is small enough to pass within a body lumen. Figure 3B shows the stent 12 in its deployed configuration, wherein the second 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 typically is in the range of 5 to 50 mm, and preferably about 10 to 20 mm, but stent of almost any length can be employed with the invention, depending on the particular application. Figures 3A and 3B illustrate an endoprosthesis 12 having an open network configuration, similar to the stent disclosed in US Pat. No. 5,569,295 (Lam). 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 totally expanded with a dilatation device such as a balloon catheter. Figure 4 shows a stent-and-liner structure 64 for use in accordance with the present invention, wherein the liner 28 is similar to that previously described with respect to Figure 2. Stent 12 is placed in its delivery configuration in the distal portion of the liner 34, with the inner surface of stent 56 contacting the outer lining surface 48. In the embodiment shown, the length of the distal portion of the liner 42 is greater than the length of the stent 62, so such that the endoprosthesis 12 can be fully assembled in the distant portion of liner 34, without contacting the proximal portion of the liner 36. Figure 4A shows an alternate embodiment of a stent and liner structure 64a, wherein the liner 28 comprises a portion 34 and a mandrel 49 as shown and described previously with respect to Figure 2A. The liner and stent structure are described in greater detail in the U.S. patent application. Serial No. 08 / 840,487 entitled "SHEATH AND METHOD FOR A STENT DELIVERY SYSTEM" (LINER AND METHOD FOR AN ENDOPROTESIS SUPPLY SYSTEM), with Jefferey Bleam and Andrew Mackenzie as inventors, presented on April 21, 1997. The Figure 5 shows the structure of catheter, liner and endoprosthesis in use, in a balloon angioplasty procedure for deploying a stent 12 in a coronary artery in a patient 68. The structure has been percutaneously introduced through the femoral artery 70 into the cardiovascular system of patient 68 with the dilatation balloon 22 placed at the site where the treatment will be provided. Both the proximal catheter hub 16, which includes the catheter controls 18, and the proximal end of liner 32 are placed outside the patient 68, such that a user can easily hold and manipulate the catheter 14 and liner 28. The user can also remove the proximal hub of catheter 16 of the catheter proximal end 19 of the catheter shaft 15, without having to remove the catheter shaft 15 from patient 68. FIG. 6 shows a balloon catheter 14 in accordance with the present invention. The balloon catheter 14 includes a removable proximal hub 16 having various controls 18 located there. The proximal hub 16 can be removably attached to a proximal end 19 of a catheter shaft 15. In a preferred embodiment, the catheter shaft 15 has a distal end that has a dilatation device, which in the embodiment shown is a balloon dilatation. 22. In the embodiment shown in Figure 6, the balloon catheter shaft 15 has an inner lumen 24 which allows a guide wire 26 to traverse it. Now with reference to Figure 7, the catheter is shown with the balloon 22 placed within a body lumen 72 at a desired treatment site 74, and the proximal, removable hub 16 is placed outside the patient's body. The desired treatment location 74 may comprise a block 76, such as a stenosis caused by plaque deposits, which partially occlude the body lumen 72. With the dilatation balloon 22 placed in the desired treatment site 74, the dilatation balloon 22 it expands, thereby dilating the block 76 and the body lumen 72. When the dilation is complete, the balloon can be deflated 22. Figure 7 shows that dilation occurs without a liner present in the catheter shaft, as it would be. the case when the dilatation catheter has been initially introduced into the body lumen without a liner. However to reduce the stages and time between dilation of body lumen and stent deployment, the liner can be placed on the catheter shaft during a dilation procedure, but with the distal lining portion (36) containing the stent ( 12) that remains close to the balloon dilatation. Furthermore, the dilatation catheter shaft can be introduced initially into the body lumen with or without the lining. If the dilatation catheter shaft is initially introduced into the body lumen without the liner, the liner can subsequently be introduced over the catheter shaft by removing the removable proximal hub (16) and advancing the liner over the catheter shaft (15) then, the removable proximal hub can be reconnected to the catheter shaft (15) in this manner, the liner can be inserted into the body lumen after the catheter shaft has been inserted, and even after a first dilatation procedure has been achieved. . In Figure 8, block 76 has been dilated and balloon 22 has been deflated. The removable proximal hub 16 has been detached from the catheter shaft 15 to allow a liner 28, containing a select stent 12, to slide in and distally advance over the proximal end of catheter 19 of the catheter shaft 15. Now with reference to Figure 9, when the proximal end of liner 32 ee distant from (in front of) the proximal end of catheter shaft 19, the removable proximal hub 16 can be reconnected to the balloon catheter shaft 15. Liner 28 slides forward over the balloon 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, when he or it holds the proximal end of liner 32 and then pushes the liner 28 distally (forward) on the catheter shaft 15. Because the proximal portion of liner 36 preferably consists of a material generally more rigid than the material of the distal portion of the liner 34, i.e., a material that is generally resistant to longitudinal compressive forces, the push by the user at the proximal end of liner 32 causes the liner 28 to slide over the catheter shaft 15, such that the distal portion of the liner 34, including the stent 12, advances on the balloon Dilatation 22. After the removable proximal hub 16 has been reconnected to the catheter shaft 15 and the stent 12 is placed on the expandable balloon 22, as illustrated in Figure 10, the dilatation balloon is expanded. 22 The outward pressure of the dilatation balloon 22 causes the distal portion of the liner 34 to expand outwardly, which in turn forces the stent 12 to expand outwardly, until the stent acquires its expanded outer diameter 60b. In the unfolded diameter, the outer surface of stent 58 contacts and exerts some pressure outwardly against the walls 82 of body lumen 72, thereby preventing walls 82 that have been weakened by the dilatation procedure or by the locking 76 , squeeze inward and cause a renewed blockage of the body lumen 72. After the endoprosthesis 12 is deployed, the removable proximal hub 16 can be detached from the proximal end 19 of the catheter shaft 15 as illustrated in Figure 8. liner 28 can then be slidably withdrawn proximally from the catheter shaft 15 by the user holding and pulling the proximal end of liner 32, such that liner 28 passes over the proximal end of catheter shaft 19 while the arrow of catheter 15 remains in place in the patient. Next, a new liner with one or more new stents can be loaded onto the catheter shaft, the removable proximal hub can be reconnected, the liner can slide distally or forward until the stent is, or the stents are on the dilatation balloon , and the dilatation balloon can be expanded to deploy the endoprosthesis (s). (Alternatively, new stents may be loaded onto the original liner and the original "overfilled" liner may then be reintroduced onto the catheter shaft 15 and the patient.These stages may be repeated to deploy multiple, multi-lining stents, without requiring the removal of the endoprosthesis. the catheter shaft 15 until all deployment procedures are completed Figures 1, 4 and 8-10 show a single endoprosthesis 12 mounted on the liner 28. However, as described in the US patent application concurrently presented Serial No. 08 / 840,487 under the title SHEATH AND METHOD FOR A STENT DELIVERY SYSTEM (LINER AND METHOD FOR ENDOPROTESIS SUPPLY SYSTEM) another embodiment of a liner compatible with the present invention involves multiple stents mounted on a single liner. Thus, a single liner can be used to deploy multiple stents in a body lumen during a single procedure, without the need so that the liner is removed from the body lumen until a plurality of stents have been deployed. Figures 11A-11B show the balloon catheter 14 used to deploy multiple endoprostheses 12 in a body lumen during a single procedure, unnecessarily because the arrow of the catheter 15 is removed from the lumen of the body until the procedure is completed. In one method, the locations 74a, 74b to be treated can all be dilated by the balloon 22 before deployment of any of the stent 12a, 12b. After all the locations to be treated have been dilated, the deflated balloon 22 is placed at site 74a, where the first stent 12a is to be deployed. The first liner 28a is slidably advanced over the catheter shaft 15 until the first stent 12a is placed over the deflated balloon 22., the dilatation balloon expands, thereby deploying the first stent 12a as illustrated in Figure HA. The balloon 22 then deflates. The removable proximal hub 16 is detached from the catheter shaft 15 and the first liner 28a is removed from the catheter shaft 15. The dilatation balloon is relocated to site 74b where a second stent 12b is to be deployed. A new liner 28b including the new stent 12b is slidably advanced over the catheter shaft 15 until the proximal end of the liner 32a is distant from the proximal end of the catheter shaft 19. The removable proximal hub 16 is reconnected to the shaft. of catheter 15, and second liner 28b is advanced distally over the catheter shaft 15 until the second stent 12b is placed over the deflated balloon 22. The balloon dilates to deploy the second stent 12b as illustrated in FIG. Figure 11B. This procedure may be repeated as necessary to deploy additional stents in the patient. In another method, the dilation of selected treatment locations 74a, 74b may occur just prior to deployment of each stent, such that the first location 74a is dilated before deployment of the first stent 12a, followed by removal of the first liner. 28a. The second site 74b is dilated after deployment of the first endoprosthesis 12a and removed from the first liner 28a, but before the introduction of the second liner 28b and deployment of the second endoprosthesis 12b, etc. Various embodiments of attaching the removable proximal hub 16 to the catheter shaft 15 are applicable to the invention. For example, in the embodiment shown in Figure 12, a catheter 14 has a removable proximal hub 16 including several projections 86 extending distally from the distal end 84 of the proximal hub. The proximal end 19 of the catheter shaft 15 includes corresponding openings 88 that are dimensioned and configured to slidably receive the proximal hub projections 86. The openings 88 may be formed by various methods such as insert molding. When the removable proximal hub 16 is removably attached to the proximal end of the arrow 19, the projections 86 are located within the openings 88, thereby preventing axial rotation of the next releasable hub 16 relative to the catheter shaft 15. In another embodiment, projections can be located at the proximal end of the arrow, with corresponding openings located in the removable proximal hub. Another mode of the catheter is illustrated in Figure 13a wherein the removable proximal hub 16 has a base element 90 with a threaded element 92 at its distal end 84. The proximal hub 16 also includes a cap 94 configured to threadably receive the threaded member 92 and a compression fitting 96 positioned between the threaded member 92 and cap 94. Cap 94 and compression fitting 96 each have a central through bore 98 with an inner diameter 100 that is sized to receive outer diameter 102 of the proximal end of catheter shaft 19 as shown in FIG. illustrated in Figure 13B. When the cap 94 is screwed onto the threaded element 92, the compression fitting 96 presses inward against the catheter shaft 15. The compression fitting 96 can be formed of a compressible material, such as urethane, rubber or any plastic material that it recovers after deformation, which also serves to create a seal with respect to the proximal end of the catheter shaft 19 when compressed. Figure 14 illustrates another embodiment of the invention, wherein the catheter has an inner member 104 and an outer member 106, as is typical of over-the-wire catheters. The removable proximal hub 16 has an inner piercing 98, with a piercing distal diameter 100a configured to receive the outer catheter member 106 with a diameter 102, and a proximal piercing diameter 100b configured to receive the inner catheter member 104 with a diameter 102b. In the embodiment of Figure 14, the base member 90 has a first threaded member 92a configured to threadably receive a first cap 94a, with a first compression fitting 96a positioned between the first threaded member 92a and the first cap 94a. The base member 90 also has a second threaded member 92b, configured to threadably receive a second cap 94b with a second compression fitting 96b positioned between the second threaded member 92b and the second cap 94b. In the embodiment of Figure 14, the first threaded member 92a is located at the distal end 108 of the proximal hub base member 90 and the second threaded member 92b is located at the proximal end 110 of the proximal hub base member 90. The member catheter interior 104 extends proximal to the catheter outer member 106. With the inner catheter member 104 positioned within the second compression fitting 96b, the second coping 94b is screwed onto the second threaded member 92b, thereby compressing the second compression fitting 96b inwardly against inner member 104. In this manner, second compression fitting 96b holds inner member 104 while also providing a seal with respect to inner member 104. Similarly, outer catheter shaft member 106 is placed within the first compression fitting 96a, the first cap 94a is screwed onto the first thread element 92a and the first compression fitting 96a is pressed inwardly against the outer member 106. Figure 15a illustrates a further embodiment of the invention, wherein the removable proximal hub 16 is attached to the catheter shaft 15 by projections or directed spikes. inward 112. The base member 90 of the proximal hub 16 has a central bore 98 configured to receive the proximal end 19 of the catheter shaft 15. The inwardly directed projections 112 are located within the central bore 98. The proximal end 19 of the catheter shaft 15 may have corresponding openings 114, sized to receive the inwardly directed projections 112. When the proximal end of the catheter shaft 19 slides within the central bore of the base member 98, the projections directed inwardly 112 coupling against the outer surface 116 of the arrow of the catheter 15. When openings are present respondents 114 on the catheter shaft 15, the inwardly directed projections 112 are placed in the openings 114, thereby holding the removable proximal hub 16 to the catheter shaft 15. The projections 112 may comprise one or more separate projections. Alternatively, the projections 112 may comprise a continuous single annular ring with respect to the central perforation 98. The projections 112 may comprise a deformable material which compresses against the catheter shaft 15. Depending on the shape and configuration of the projections 112, the Projections can serve to seal the seam between the catheter shaft. 15 and the removable proximal hub 16. As illustrated in Figure 15B, the catheter 14 may also include a collar 118 that reinforces the connection and seals between the proximal hub 16 and the catheter shaft 15. The collar 118 may be located in the base element 90 and when advancing slidably or rotatably in position, it compresses central perforation 98 which may include projections 112 on the catheter shaft 15. Alternatively, collar 118 may be located on the shaft of catheter 15, such as when the catheter shaft 15 fits around the distant end of the removable proximal hub 16. Various alternate configurations of projections and / or openings can be employed to attach the removable proximal hub 16 to the catheter shaft 15. For example, the catheter shaft 15 can be equipped with outwardly directed projections 120, as illustrated in Figure 15C. These projections can align with and engage against inwardly directed projections 112 and / or cut openings 122 in the central bore 98 of the removable proximal hub 16. Figure 16A shows an alternate configuration of the invention, wherein the catheter has an inner member 104 and an outer member 106, as is typical of wire-over catheters. The removable proximal hub 16 has an inner piercing 98, with a distal inner piercing diameter 100a configured to receive the outer catheter member 106 with a diameter 102a, and an inner piercing proximal diameter 100b configured to receive the inner catheter member 104 with a diameter 102b. The central perforation 98 has a first set of projections 112a configured to engage the outer catheter shaft member 106 and a second set of projections 112b configured to engage the inner catheter shaft member 104. FIG. 16A shows a catheter shaft that it has two coaxial members, i.e. an inner member and an outer member. However, as illustrated in the Figure 16B, the catheter shaft may comprise two adjacent members 122, 124 and a side-by-side configuration. In the embodiment of Figure 16B, the first catheter member 122 is an inflation lumen, and the second catheter member 124 is a guide wire lumen. The removable proximal hub 16 has two bores 126, 128. The first bore 126 is sized to receive the first catheter member 122 and the second bore 128 is sized to receive the second catheter member 124. Figure 17A illustrates a removable proximal hub 16 having a distal end 108 that is sized to be received within an inner lumen 130 of the catheter shaft 15. The distal end 108 of the removable proximal hub 16 may have one or more projections or barbs directed outward 132. The projection 132 may comprise a continuous single annular ring relative to the distal end of the removable proximal hub 108. When the remote end of the removable proximal hub 108 is inserted into the inner catheter shaft lumen 130, the projection 132 engages the outer surface 134 of the shaft. of catheter 15, thereby holding the proximal hub 16 to the catheter shaft 15. The projection 132 can also serve go to seal the seam between the catheter shaft 15 and the removable proximal hub 16. The strength of the connection and seal can be improved by having inwardly directed openings or cuts 136 and / or projections 138 disposed on the inner catheter surface 134 When the inner catheter surface 134 has inwardly directed projections 138, corresponding cuts or openings 140 in the distal end 108 of the removable proximal hub 16 may be employed to improve the connection and seal. Various techniques may be employed to maintain the catheter shaft 15 in position in the body lumen, while a liner 28 slides over the proximal end of catheter 19 and over the catheter shaft 15. For example, the catheter shaft 15 may have sufficient total length such that, with the dilatation device properly positioned at the deployment site in the body lumen, the catheter shaft portion extending away from the patient 68 is of sufficient length to completely contain the liner 28 as shown in FIG. illustrated in Figure 18A. Accordingly, as a liner 28 is advanced or withdrawn over the proximal end of the catheter shaft 19, a user can secure the catheter shaft 15 in position by a grasping section 142 of the catheter shaft that is remote from the catheter shaft. liner 28 but still outside the patient 68. As the liner 28 is advanced to the body lumen and over the attachment section 142 as illustrated in Figure 18B, the user can secure the catheter shaft 15 in position by the proximal end of the liner. catheter arrow 19. Accordingly, the catheter shaft 15 is clamped at all times, either in the clamping section 142 just outside the body lumen or by the proximal end of the catheter shaft 19, thereby preventing movement accidentally releasing the balloon 22 from the location for deployment of the desired endoprosthesis. When the catheter embodiment of Figures 18A and 18B is employed with a liner embodiment such as that illustrated in Figure 4, the catheter shaft 15 is preferably two or more times as long as the length of the liner 28. This allows liner 28 to be completely removed from the patient 68 without any portion of the liner 28 passing over the proximal end of catheter 19. For the lining mode illustrated in Figure 4, the catheter shaft does not need to be as long as that which is preferred for the embodiment of Figures 18A and 18B . In contrast, in the embodiment illustrated in Figure 4A, only a catheter arrow section with only moderate length is required to extend outside the patient, due to the short length of the front "tubular" section of the liner 28. Unlike of the proximal portion 36 of the liner illustrated in Figure 4, the mandrel 49 of the illustrated embodiment of Figure 4A does not encircle the catheter shaft 15, but instead lies along the catheter shaft 15. According to With this, a user can easily hold a section of the catheter shaft 15, even as the mandrel 49 advances along that section.

Another embodiment is shown in Figure 19, whereby the catheter 14 includes a removable paver section 144 that has a length 146 similar to or greater than the length of liner 52. The distal end 147 of the removable paver section 144 is attached to the catheter 14. proximal end 19 of the main catheter shaft 15. The resulting structure of the catheter shaft 15 and the paver section 144 can be held in place by a user by the proximal end 148 of the removable paver section and then a liner 28 can slide from the paver section 144 on the main catheter shaft 15 and the position suitable for deploying a stent 12 at a desired location in the body lumen. After stent deployment, an "exhausted" liner (ie, without stent) can slide from the main catheter shaft 15 onto the paver section 144. The paver section 144, which contains the spent liner, can then be removed from the shaft. of main catheter 15 and either discarded or recharged with a liner containing a stent. During the removal and replacement of the spreader section 144, the catheter shaft 15 can be held in position by a proximal portion such as the proximal end 19 of the main catheter shaft 15. The spreader section 144 can include controls that regulate various aspects of the catheter shaft. catheter, such as controlling the inflation of the balloon dilatation. The controls 18 can be located in a proximal hub 16, at the proximal end 148 of the paver section 144. The proximal hub 16 can be removably attached to the paver section 144. A paver section can be provided with a pre-loaded stent and liner structure, Such that a user can choose a paver section having a desired liner and stent structure, hold the paver section to the proximal end of the catheter shaft, advance the liner over the catheter shaft until the stent is located in the position desired in the body lumen and deploy the endoprosthesis. The liner can then slide off the main arrow and back into the paver section. The spreader section can then be replaced with another preloaded spreader section containing a liner with a stent. The process can be repeated to deploy several stents in the patient without removing the main catheter shaft from the patient until after the entire deployment procedure is completed. The embodiments described illustrate the structure of liner-and-stents used with a catheter having an inflatable balloon to deploy the stent. However, the invention is not limited to catheters with 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 (42)

1. CLAIMS 1. A catheter, characterized in that it comprises an arrow having an outer surface, a central axis, a proximal end and a distal end; and a removable proximal hub, detachably attached to the proximal end of the arrow.
2. 2. The catheter in accordance with the claim 1, characterized in that the distal end of the arrow includes an expandable member.
3. 3. The catheter in accordance with the claim 2, characterized in that the removable proximal hub includes a control device for controlling expansion of the expandable member.
4. The catheter according to claim 1, characterized in that the proximal end of the arrow has a diameter and the removable proximal hub has a diameter greater than the diameter of the proximal end of the arrow.
5. The catheter according to claim 1, characterized in that the removable proximal hub comprises a base element having a first threaded element; a first coping having a threaded element and a central bore dimensioned to receive the catheter shaft, the first coil threaded member is configured to be threadably attached to the first threaded element of the base element; and a first compression fitting adjacent to the base member and first coping.
6. 6. The catheter in accordance with the claim 5, characterized in that the first compression fitting is formed of a substantially compressible material.
7. 7. The catheter in accordance with the claim 6, characterized in that the first compression fitting contains a substantially annular element having a central bore dimensioned to receive the catheter shaft.
8. The catheter according to claim 5, characterized in that the catheter is a rapid exchange catheter.
9. The catheter according to claim 5, characterized in that the catheter shaft comprises an inner member and an outer member.
10. The catheter according to claim 9, characterized in that the base element of the removable proximal hub further includes a second threaded element, the central bore of the first coping is dimensioned to receive the outer catheter shaft member and the catheter further comprises: a second cap having a threaded element, the second cap threaded element is configured to be threadably attached to the second threaded element of the base element; and a second compression fitting adjacent to the base member and the second cap.
11. The catheter according to claim 9, characterized in that the first threaded element of the base element of the removable proximal hub is located at a distal end of the proximal hub, and the second threaded element of the removable proximal hub base member is located at a proximal end of the removable next hub.
12. 12. The catheter according to claim 10, characterized in that the catheter is an over-the-wire catheter.
13. 13. The catheter according to claim 1, characterized in that it further comprises a first set of one or more projections in the removable proximal hub; and a first set of one or more openings in the catheter shaft, the first set of shaft openings are sized and configured to receive the first set of removable proximal hub projections.
14. The catheter according to claim 13, characterized in that the first set of arrow openings each comprises an annular groove.
15. The catheter according to claim 13, characterized in that the removable proximal hub includes a central bore dimensioned to receive the catheter shaft, the first set of removable proximal hub projections is located within the central bore and the first set of Arrow openings are located on an outer surface of the arrow.
16. 16. The catheter according to claim 13, characterized in that the catheter shaft includes an inner surface defining a central lumen dimensioned and configured to slidably receive a distal portion of the proximal proximal hub, the first set of removable proximal hub projections are located in the distal portion of the proximal, removable hub, and the first set of arrow openings are located on the inner surface of the catheter shaft.
17. The catheter according to claim 13, characterized in that the catheter shaft comprises a first element and a second element, and the first set of catheter shaft openings is located in the first catheter shaft element, wherein the Catheter further comprises: a second set of one or more projections in the next removable hub; and a second set of one or more openings in the catheter shaft, the second set of shaft openings is located in the second catheter shaft element and sized and configured to receive the second set of removable proximal hub projections.
18. 18. The catheter in accordance with the claim 17, characterized in that the first catheter arrow element and the second catheter arrow element comprise coaxial arrows.
19. 19. The catheter in accordance with the claim 1, characterized in that it further comprises: a first set of one or more projections extending from the arrow of the catheter; and a first set of one or more openings in the removable proximal hub, the first set of removable proximal hub openings is sized and configured to receive the first set of catheter arrow projections.
20. The catheter according to claim 19, characterized in that the catheter shaft includes an inner surface defining a central lumen sized and configured to slidably receive a distal portion of the proximal, removable hub, the first set of removable proximal hub openings being locates in the distant portion of the removable proximal hub, and the first set of catheter arrow projections is located on the inner surface of the catheter shaft.
21. 21. A system for deployment of stents, for deploying one or more stents within a body lumen, the system is characterized in that it comprises: a substantially tubular sheath having a proximal end and a distal end, a proximal portion and a distal portion , an outer surface and a through lumen defining an interior surface; 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; and a catheter having: an arrow with an outer surface, a central axis, a proximal end and a distal end, the arrow is configured to be slidably received within the lumen of the tubular liner; and a removable proximal hub having a distal end, the removable proximal hub is removably attached at its distal end to the proximal end of the arrow.
22. 22. The system in accordance with the claim 21, characterized in that the catheter shaft includes an expandable member at the distal end of the shaft.
23. 23. The system in accordance with the claim 22, characterized in that the removable proximal hub includes a control device for controlling expansion of the expandable member.
24. 24. The system in accordance with the claim 21, characterized in that it further comprises: a clamping device that prevents rotation of the proximal cube removable with respect to the arrow shaft when the removable next hub is attached to the arrow.
25. 25. The system according to claim 21, characterized in that the proximal end of the arrow has a diameter and the liner is configured for slidable movement on the proximal end of the arrow.
26. 26. The system in accordance with the claim 25, characterized in that the removable proximal hub has a diameter greater than the diameter of the proximal arrow end.
27. 27. The system according to claim 21, characterized in that the catheter is an over-the-wire catheter.
28. 28. The system according to claim 21, characterized in that the catheter is a rapid exchange catheter.
29. 29. The system according to claim 21, characterized in that the expandable member is a balloon of expansion.
30. 30. The system according to claim 21, characterized in that the lining has a length of at least 50 cm.
31. 31. A method for deploying one or more endoprostheses in a body lumen, the method is characterized in that it comprises the steps of: (a) inserting a catheter shaft into a body lumen; (b) placing a first stent relative to a distal portion of a first tubular sheath, the first stent is disposed in a delivery configuration; (c) slidably passing the first tubular liner over a proximal end of the catheter shaft, thereby introducing the first tubular liner into the body lumen; (d) placing the first stent at a desired first site within the body lumen; (e) attaching a removable proximal hub to the proximal end of the catheter shaft; and (f) deploying the first stent in the first desired location, wherein the first stent acquires a deployed configuration.
32. 32. The method according to claim 31, characterized in that it includes before step (c) but before step (a), the additional step of: (g) removing a removable next hub from a proximal end of the arrow of catheter.
33. 33. The method according to claim 31, characterized in that the catheter includes an expandable member at the distal end of the catheter shaft and wherein step (a) comprises the additional step of: (h) placing the expandable member in the first desired position within the body lumen.
34. 34. The method of compliance with the claim 33, characterized in that step (d) comprises the step of: (i) sliding the first tubular sheath over the catheter shaft until the first stent is placed on an expandable member, and wherein step (f) includes the step additional to: (j) expanding the expandable member to deploy the first stent.
35. 35. The method according to claim 34, characterized in that the step of expanding the expandable member to deploy the first stent simultaneously dilates the body lumen.
36. 36. The method according to claim 33, characterized in that it further comprises the step of: (k) dilating the body lumen with the expandable member.
37. 37. The method according to the claim 31, characterized in that it comprises, after step (f), the additional steps of: (1) removing the removable proximal hub from the catheter shaft; (m) slidably removing the first tubular liner from the catheter shaft; (n) placing a second stent relative to a distal end portion of a second tubular sheath, the second stent is disposed in a delivery configuration; (o) slidably passing the second tubular liner over the proximal end of the catheter shaft, thereby introducing the second tubular liner into the body lumen; (p) placing the second stent in a second desired location within the body lumen; (q) attaching the removable proximal hub to the proximal end of the catheter shaft; and (r) deploying the second stent in the second desired location, wherein the second stent acquires a deployed configuration.
38. 38. The method according to claim 37, characterized in that steps (1) to (r) are repeated for additional linings and stents.
39. 39. A system for deploying stent to deploy one or more stent within a body lumen, the system is characterized in that it comprises: a substantially tubular sheath having a proximal end and a distal end, a proximal portion and a distal portion, a outer surface, a through lumen defining an interior surface and a length; and a substantially tubular stent having a delivery configuration and deployed configuration, the stent is removably connected in the delivery configuration on the distal portion of the liner; and a catheter having: an arrow with an outer surface, a central axis, a proximal end and a distal end, the arrow is configured to be slidably received within the lumen of the tubular liner; and a catheter shaft spreader section, the spreader section is removably attached at its distal end to the proximal end of the catheter shaft, the spreader section being configured to slidably receive within the lumen of the tubular sheath.
40. 40. The system according to claim 39, characterized in that the spreader section has a length that is greater than the length of the tubular sheath.
41. 41. The system in accordance with the claim 40, characterized in that the catheter has an expandable member at the distal end of the catheter and the paver section includes a control device for regulating the expansion of the expandable member.
42. 42. A system for deploying stent to deploy one or more stent within a body lumen, the system is characterized in that it comprises: a substantially tubular sheath having a proximal end and a distal end, a proximal portion and a distal portion, a outer surface, a through lumen defining an interior surface and a length; and a substantially tubular stent having a delivery configuration and deployed configuration, the stent is removably connected in the delivery configuration on the distal portion of the liner; and a catheter having: an arrow with an outer surface, a central axis, a proximal end and a distal end, the arrow is configured to be slidably received within the lumen of the tubular liner and the arrow has a length at least twice that of the length of the lining. SUMMARY OF THE INVENTION The present invention relates to an apparatus and method for deploying one or more endoprostheses within a body lumen, comprising a catheter such as a dilatation catheter, having a removable proximal portion. Dislodging the removable proximal portion of the catheter shaft allows a substantially tubular liner to be slidably received over the proximal end of the catheter shaft. The tubular liner has one or more substantially tubular stents placed in a delivery configuration on a distal portion of the liner. The liner preferably has a proximal portion that is resistant to compressive forces, such that a wearer can advance the liner over the catheter by pushing the proximal end of the liner, thereby placing the stent (s) in a deployment location. desired within the body lumen. With the stents in place, the proximal end of the catheter can be connected to the catheter shaft and the stents can be deployed in the desired position. After the stents have been deployed, the removable proximal hub can be removed, the first liner slid off the catheter shaft, a second liner (containing additional stents) slidably inserted over the catheter shaft, the removable proximal hub can reconnected and can be deployed. additional stents In this way, multiple stents can be deployed without requiring removal of the catheter shaft, until the procedure is completed.