Abstract:
A catheter assembly has an engaged state and an unengaged state comprising a proximal member having a longitudinal axis and a distal member having a longitudinal axis. A distal end of the proximal member is removably engageable to the distal member. The distal member has a first distal portion and a second distal portion, and the first distal portion is retractable from the second distal portion. In the engaged state the distal member is substantially freely rotatable about its longitudinal axis and in relation to the proximal member. In the engaged state the proximal member is constructed and arranged to be moved in a direction along the longitudinal axis such that proximal movement of the proximal member retracts at least the first distal portion of the distal member from at least the second distal portion.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS  
       [0001]     Not Applicable  
       STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH  
       [0002]     Not Applicable  
       BACKGROUND OF THE INVENTION  
       [0003]     1. Field of the Invention  
         [0004]     At least one embodiment of the present invention is directed to the field stent delivery systems used to treat stenoses, and more particularly to stenoses at a bifurcation of a passage.  
         [0005]     2. Description of the Related Art  
         [0006]     Stent systems are widely used in the treatment of stenoses. Intravascular stents are used in coronary, renal, and carotid arteries, for example, to maintain an open passage through the artery. In patients whose coronary heart disease consists of focal lesions, stents have proven effective. For example, where only a single coronary artery is clogged or where there are short blockages in more than a single artery, stents have been used with a great amount of success. An intravascular stent may be positioned in a clogged artery by a catheter assembly and is often set in place by inflating a balloon upon which the stent is mounted. This expands the diameter of the stent and opens the previously clogged artery. The balloon is then deflated and removed from the patient while the stent retains an open passage through the artery.  
         [0007]     It is recognized, however, that a stent can be deployed in manners other than inflating and deflating a balloon. For example, self-expanding stents have been developed in which a cover is removed from over a stent, thereby allowing the stent to deploy or spring into place. It is also contemplated that other deployment mechanisms or means may be used or developed to advantageously deliver and deploy a stent in position.  
         [0008]     Nevertheless, a need still exists for properly delivering and locating a stent at a bifurcation. Although efforts have been made to use a stent at bifurcations, these sites have previously been inadequately treated by a stent. For example, U.S. Pat. No. 5,749,825, the entire contents of which being incorporated herein by reference, is representative of a catheter assembly system that treats stenoses at an arterial bifurcation.  
         [0009]     A stent having different diameters has been proposed to allow placement in both a main passage, such as an artery, and a side branch passage, such as a continuation branch artery. Additionally, these stents generally have an opening which allows for unimpeded blood flow into the side branch artery. However, problems are still encountered in orienting the stent relative to the side branch at the bifurcation of the main and branch passages.  
         [0010]     Many current devices rely on either passive torque (e.g., pushing the stent forward and allowing the stent that is fixed on the guide wire/balloon to passively rotate itself into place) or creating torque from outside of the patient to properly orient the stent delivery system in the passage. These devices and methods of achieving proper angular orientation have not been shown to be effective in properly placing and positioning the stent. As will be appreciated and understood by those skilled in the art, improper placement of the stent with respect to its rotational or circumferential orientation, or its longitudinal placement, could lead to obstruction of the side branch passage. It is important to properly position or center an opening formed in the bifurcated stent with the side branch passage to maximize flow therethrough.  
         [0011]     Thus, a need exists for effectively treating stenosed passage bifurcations. This need includes more precise and exact longitudinal placement and rotational/circumferential orientation of the stent.  
         [0012]     Commercially available devices do not maintain side branch access at the time of stent deployment. This results in the potential for plaque shift and occlusion of the side branch passage.  
         [0013]     It would also be advantageous if stents could be placed across the side branch while wire position is maintained thereby helping to protect and secure further access to the side branch.  
         [0014]     All US patents and applications and all other published documents mentioned anywhere in this application are incorporated herein by reference in their entirety.  
         [0015]     Without limiting the scope of the invention a brief summary of some of the claimed embodiments of the invention is set forth below. Additional details of the summarized embodiments of the invention and/or additional embodiments of the invention may be found in the Detailed Description of the Invention below.  
         [0016]     A brief abstract of the technical disclosure in the specification is provided as well only for the purposes of complying with 37 C.F.R. 1.72. The abstract is not intended to be used for interpreting the scope of the claims.  
       BRIEF SUMMARY OF THE INVENTION  
       [0017]     In at least one embodiment the catheter assembly has a longitudinal axis and has an engaged state and an unengaged state. In at least one embodiment the catheter assembly comprises a proximal member and a distal member. In at least one embodiment the distal member has a first distal portion and a second distal portion and the first distal portion may be constructed and arranged to be retractable from the second distal portion. In at least one embodiment the distal member and the proximal member are substantially moveable independent of one another in the unengaged state. In at least one embodiment while in the engaged state, a distal end of the proximal member may be engaged to at least a portion of the distal member and the distal member may be substantially freely rotatable about the longitudinal axis and in relation to the proximal member. In at least one embodiment while in the engaged state, the proximal member may be constructed and arranged to be moved in a direction along the longitudinal axis such that proximal movement of the proximal member in the engaged state retracts at least the first distal portion of the distal member from at least the second distal portion.  
         [0018]     In at least one embodiment the distal member comprises a retractable sheath. In at least one embodiment the first distal portion comprises the sheath.  
         [0019]     In at least one embodiment the sheath defines a slit, and the sheath has edges along the length of the slit.  
         [0020]     In at least one embodiment the slit extends distally from a position on the sheath distal to the proximal most portion of the sheath.  
         [0021]     In at least one embodiment the slit may be substantially parallel to the longitudinal axis.  
         [0022]     In at least one embodiment the slit may be in the form of a wave. In at least one embodiment the slit may be in the form of a spiral.  
         [0023]     In at least one embodiment the slit has an open configuration and a closed configuration. In at least one embodiment in the closed configuration, the edges of the sheath are retained together with a holding member. In at least one embodiment in the open configuration the holding member may be removed from the edges to open the slit.  
         [0024]     In at least one embodiment the slit in the open configuration allows for retraction of the sheath along a first guidewire in a primary body lumen without removing a second guidewire in a secondary body lumen at the bifurcation site.  
         [0025]     In some embodiments the holding member may be a wire or thread used in lacing up the slip. In some embodiments the holding member may be not removed, rather one portion of the holding member on one side of the slit may be separated from another portion of the holding member on another side of the slit. In some embodiments the member may be compatible with hook and loop material wherein the sheath and/or the holding member may include hook and loop material. Snaps, buttons, screws, adhesives, and/or magnetic material may be used as the holding member in at least some embodiment. In at least one embodiment the sheath comprises a distal sheath and a proximal sheath. In at least one embodiment in the engaged state the distal sheath may be retracted proximally and the proximal sheath may be retracted distally when the proximal member may be moved in the proximal direction.  
         [0026]     In at least one embodiment the stent has an unexpanded configuration and an expanded configuration. In at least one embodiment in the unexpanded configuration the stent may be disposed about at least a portion of the second distal portion of the distal member.  
         [0027]     In at least one embodiment the stent may be expanded from the unexpanded configuration to the expanded configuration when the first distal portion of the distal member may be retracted from the second distal portion of the distal member.  
         [0028]     In at least one embodiment the stent may be selected from at least one member of the group consisting of self-expanding stents, inflation expandable stent, hybrid expandable stents and any combination thereof.  
         [0029]     In at least one embodiment the stent may be a bifurcated stent.  
         [0030]     In at least one embodiment the bifurcated stent has a pant configuration.  
         [0031]     In at least one embodiment at least a portion of the first distal portion of the distal member defines a clutch housing and at least a portion of the proximal member defines a clutch extension. In at least one embodiment in the engaged state the clutch extension may be engaged to the clutch housing.  
         [0032]     In at least one embodiment the clutch extension comprises a balloon portion having an unexpanded state and an expanded state. In at least one embodiment in the unengaged state the balloon may be in the unexpanded state such that the balloon portion may pass through the clutch housing. In at least one embodiment in the engaged state the balloon may be expandable to the expanded state such that the balloon portion may be retainingly engaged by the clutch housing.  
         [0033]     In at least one embodiment the clutch extension comprises an expansion portion with fingers having an unexpanded state and an expanded state. In at least one embodiment in the unengaged state the fingers are in the unexpanded state such that the expansion portion may be constructed and arranged to allow the fingers to pass through the clutch housing. In at least one embodiment in the engaged state the fingers are expandable to the expanded state such that the expansion portion may be retainingly engaged by the clutch housing.  
         [0034]     In at least one embodiment the fingers are constructed of a self-expanding material.  
         [0035]     In at least one embodiment the fingers are constructed of nitinol.  
         [0036]     In at least one embodiment at least a portion of the first distal portion of the distal member comprises a first magnetic portion on its proximal portion and the proximal member comprises a second magnetic portion on its distal portion. In at least one embodiment in the engaged state the first magnetic portion may be magnetically engaged to the second magnetic portion.  
         [0037]     In at least one embodiment the catheter assembly comprises a barrier member having a first position and a second position. In at least one embodiment the barrier member may be constructed and arranged to substantially interfere with magnetic attraction between the first magnetic portion and the second magnetic portion. In at least one embodiment in the first position the barrier member may be between the first magnetic portion and the second magnetic portion. In at least one embodiment, in the second position the barrier member may be removed. In at least one embodiment in the unengaged state the barrier member may be in the first position. In at least one embodiment in the engaged state the barrier member may be in the second position.  
         [0038]     In at least one embodiment the first magnetic portion and the second magnetic portion are magnetically engaged by an electromagnetic current.  
         [0039]     In at least one embodiment the clutch extension comprises a grappling base having distally extending extensions. In at least one embodiment the grappling base has a forward position and a back position. In at least one embodiment in the forward position the grappling base is constructed and arranged such that the extensions engage the clutch housing of the distal member, and in the back position the grappling base is constructed and arranged such that the extensions extend to a position proximal to the clutch housing of the distal member. In at least one embodiment in the engaged state the grappling base may be in the forward position, and in the unengaged state the grappling base may be in the back position.  
         [0040]     In at least one embodiment the grappling base is rotatable within the proximal member.  
         [0041]     In at least one embodiment the clutch housing comprises a connecting portion selected from the group consisting of a looped wire ring, a looped polymer ring, a locking wire ring, a locking polymer ring, and any combination thereof.  
         [0042]     In at least one embodiment the clutch housing comprises a rotating portion constructed and arranged to rotate independently of the sheath.  
         [0043]     In at least one embodiment at least a portion of the distal end of the proximal member defines a clutch housing and at least a portion of the first distal portion of the distal member defines a clutch extension. In at least one embodiment the clutch extension comprises proximally extending extensions which have a proximally extending position and a relaxed position. In at least one embodiment in the proximally extending position the extensions are constructed and arranged such that the extensions engage the clutch housing of the proximal member, and in the relaxed position the extensions do not engage the clutch housing. In at least one embodiment in the engaged state the extensions are in the proximally extending position, and in the unengaged state the extensions are in the relaxed position.  
         [0044]     In at least one embodiment the extensions are constructed and arranged with materials selected from the group consisting of magnetically attracted materials, shape memory materials, and any combination thereof.  
         [0045]     In at least one embodiment the extensions are constructed and arranged such that a pull back member can pull the extensions proximally back to engage the proximal member.  
         [0046]     In at least one embodiment the proximal member comprises on its distal portion a clutch housing which is constructed and arranged to rotate substantially about the longitudinal axis.  
         [0047]     In at least one embodiment the clutch extension rotates substantially about the longitudinal axis and substantially independent of other portions of the distal member.  
         [0048]     In at least one embodiment the distal member comprises a balloon.  
         [0049]     In at least one embodiment the balloon comprises the first distal portion and is substantially freely rotatable about the longitudinal axis.  
         [0050]     In at least one embodiment the proximal member comprises inflatable protuberances positioned substantially at the distal end of the balloon and positioned substantially at the proximal end of the balloon. In at least one embodiment the protuberances have an inflated state and an uninflated state. In at least one embodiment in the inflated state the protuberance forms a seal with the balloon such that in the unengaged state all the protuberances are in the uninflated state and such that in the engaged state one or more inflatable protuberances are in the inflated state.  
         [0051]     In at least one embodiment during and after rotation the inflated protuberances form a seal with the balloon.  
         [0052]     In at least one embodiment the proximal member is a wire.  
         [0053]     In at least one embodiment the catheter assembly is in the engaged state prior to entry into a lumen.  
         [0054]     In at least one embodiment the method of preassembling the catheter may be done such that the proximal member is engaged to the distal member such that the assembly is in the engaged state before entry into the lumen.  
         [0055]     In at least one embodiment the method of preassembling the catheter may be done such that the distal member and the proximal member are engaged such that the assembly is permanently in the engaged state.  
         [0056]     These and other embodiments which characterize the invention are pointed out with particularity in the claims annexed hereto and forming a part hereof. However, for a better understanding of the invention, its advantages and objectives obtained by its use, reference should be made to the drawings which form a further part hereof and the accompanying descriptive matter, in which there is illustrated and described embodiments of the invention. 
     
    
     BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING(S)  
       [0057]     A detailed description of the invention is hereafter described with specific reference being made to the drawings.  
         [0058]      FIG. 1  is a side view of an embodiment of the invention wherein a catheter assembly having a slit sheath configuration is illustrated.  
         [0059]      FIG. 2  is a partial top down view of the catheter assembly shown in  FIG. 1  wherein an embodiment of the sheath is illustrated.  
         [0060]      FIG. 3  is a partial top down view of the catheter assembly shown in  FIG. 1  wherein an embodiment of the sheath is illustrated.  
         [0061]      FIG. 4  is a partial top down view of the catheter assembly shown in  FIG. 1  wherein an embodiment of the sheath is illustrated.  
         [0062]      FIG. 5  is a partial top down view of the catheter assembly shown in  FIG. 1  wherein an embodiment of the sheath is illustrated.  
         [0063]      FIG. 6  is a side view of an embodiment of the invention wherein the catheter assembly is configured for delivery of a pant style bifurcated stent.  
         [0064]      FIG. 7  is a side view of the embodiment of the invention wherein the catheter assembly comprises a proximal sheath and a distal sheath.  
         [0065]      FIG. 8  is a perspective view of an embodiment of the invention wherein the proximal member and the distal member are separated.  
         [0066]      FIG. 9  is a side view of the embodiment shown in  FIG. 8  in the engaged state.  
         [0067]      FIG. 10  is a side view of the embodiment shown in  FIG. 8  in the unengaged state with a barrier member.  
         [0068]      FIGS. 11 and 12  are side views of an embodiment of the invention wherein the sheath engagement mechanism and pull back mechanism are shown.  
         [0069]      FIG. 13  is a side view of the embodiment of  FIGS. 11 and 12  wherein the catheter assembly is shown in the engaged state.  
         [0070]      FIG. 14  is a perspective view of the distal member with clutch housing shown.  
         [0071]      FIG. 15  is a side view of an embodiment shown in  FIG. 14  unengaged to the proximal member.  
         [0072]      FIG. 16  is a side view of an embodiment shown in  FIG. 14  engaged to the proximal member.  
         [0073]      FIG. 17  is a perspective view of the distal member with clutch housing and through hole shown.  
         [0074]      FIG. 18  is a side view of an embodiment shown in  FIG. 17  unengaged to the proximal member.  
         [0075]      FIG. 19  is a side view of an embodiment shown in  FIG. 17  engaged to the proximal member.  
         [0076]      FIG. 20  is a side view of an embodiment of the invention in the engaged state.  
         [0077]      FIG. 21  is a side view of an embodiment of the invention in the engaged state.  
         [0078]      FIG. 22  is a side view of an embodiment of the invention in the unengaged state.  
         [0079]      FIG. 23  is a side view of an embodiment of the invention in the engaged state. 
     
    
     DETAILED DESCRIPTION OF THE INVENTION  
       [0080]     While this invention may be embodied in many different forms, there are described in detail herein specific preferred embodiments of the invention. This description is an exemplification of the principles of the invention and is not intended to limit the invention to the particular embodiments illustrated.  
         [0081]     For the purposes of this disclosure, like reference numerals in the figures shall refer to like features unless otherwise indicated.  
         [0082]     In  FIG. 1 a  side view of an embodiment of a distal member  8  of the invention is shown. Here the sheath  10  covers a stent  12  having a first guidewire  14  and a second guidewire  16  passing through it. Such a stent  12  can be used in a vessel bifurcation. In some embodiments the distal member  8  is advanced along two guide wires  14  and  16 . The first guidewire  14  is positioned in the primary passage or branch vessel and the second guidewire  16  diverges from the first guidewire  14  upon passage into the secondary branch in the region of the bifurcation. As the distal member  8  approaches the bifurcation, the sheath  10  may then rotate so as to be aligned with the side wall passage at the bifurcation.  
         [0083]     The sheath  10  has a slit  18  which allows the sheath  10  to be retracted without first removing second guidewire  16 . The sheath  10  is engaged to stent sheath clutch housing  15 . The different embodiments of the mechanism  15  are shown in detail in later figures. In at least one embodiment the sheath  10  is retracted before the stent  12  is deployed. In  FIG. 2 a  partial top down view of the catheter assembly  8  shown in  FIG. 1  is illustrated. Here the stent  12  has a special cell  20  that provides structure through which another medical device may pass. In at least one embodiment, the special cell  20  may extend at an oblique angle into the bifurcation.  
         [0084]     Due to the loads on the slit  18  in the sheath  10 , in some embodiments it may be desirable to provide the slit with a variety of configurations. For example, in the embodiment shown in  FIG. 3 , the slit  18  has a substantially s-shaped configuration. Such a substantially s-shaped slit may prevent the stent  12  from trying to force itself into a non-round position beneath the sheath  10 . The substantially s-shaped slit  18  may comprise a variety of different shapes, lengths, and configurations. For example, in the embodiment shown the slit  18  comprises two peaks  22  and valleys  24 . The magnitude of the peaks and valleys may be substantially similar. However, in some embodiments a far greater number of peaks  22  and valleys  24  may be beneficial. Additionally, in some embodiments a far wider array of magnitudes for both the peaks and/or valleys may be beneficial.  
         [0085]     In some embodiments the slit  18  may be held together with a holding member  26 . In some embodiments it may be beneficial to provide the slit  18  with a variety of holding members. In some such embodiments hook and loop material, snaps, buttons, screws, adhesives, and/or magnetic material, etc may be used as the holding member  26 . For example, in the embodiment shown in  FIG. 4 , the holding member  26  is a thread which can lace the edges of the slit together and can be unraveled prior to the pulling of the sheath  10  or as the sheath  10  is being retracted.  
         [0086]     In other embodiments the slit  18  of the sheath  10  may have spiraled configurations. One such embodiment is shown in  FIG. 5 . In order to retract the sheath  10  it may be useful to employ a “smart” manifold and a small clutch to rotate the sheath  10  off at the same pitch of spiral as that of the spiral slit  18 . It may be beneficial in some embodiments to combine the substantially s-shaped slit or the spiral slit of with the lacing of  FIG. 4 .  
         [0087]     In some embodiments the slit  18  may be unnecessary. For example, in the embodiment shown in  FIG. 6  the stent may be of the sort illustrated having a pant leg design. The stent  12  has two longitudinal portions wherein the first longitudinal portion  12   a  is disposed about first guidewire  14  along the length of first longitudinal portion  12   a  and second longitudinal portion  12   b  is disposed about second guidewire  16  along the length of second longitudinal portion  12   b . In this embodiment the stent may have a self expanding pant design. Here, there is a single sheath  10  covering the stent  12  and longitudinal portions  12   a  and  12   b . The second longitudinal portion  12   b  of the stent  12  is disposed about second guidewire  16  while the first longitudinal portion  12   a  of the stent  12  is disposed about first guidewire  14  passing through the tip of the stent end of the delivery system  28 .  
         [0088]     In some embodiments the sheath  10  is split into a proximal sheath portion  10   a  and a distal sheath portion  10   b  as illustrated in  FIG. 7 . The distal sheath portion  10   b  may be moved distally while the proximal sheath portion  10   a  may be moved proximally, thus allowing the stent  12  to expand from the center of the stent  12  to the ends of the stent  12  rather than from one end of the stent  12  to another (e.g. from the distal end to the proximal end).  
         [0089]     In  FIG. 8  an embodiment of the invention is shown wherein the sheath  10  is disposed over the distal member  8  of the catheter assembly. Though many geometrical shapes may be used, in at least one embodiment the stent sheath clutch housing  15  is oval shaped and has a magnetically attracted surface. The clutch housing  15  may be able to rotate about the catheter assembly. The distal end of the proximal member  32  comprises a magnetic configuration  34  which may be able to rotate. In this embodiment when an electric current is applied to the configuration  34  substantial magnetic properties may be produced and the distal end of the proximal member  32  engages stent sheath clutch housing  15  of the distal member  8  such that the stent sheath  10  may be retracted by retracting the proximal member  32 . Proximal member  32  and the distal member  8  are shown engaged in  FIG. 9 . The magnetic attraction between stent sheath clutch housing  15  and magnetic configuration  34  substantially disappears when current is no longer flowing to the configuration  34 .  
         [0090]     In some embodiments, the configuration  34  may also be a permanent magnet. In at least one embodiment the proximal member  32  and stent sheath clutch housing  15  may be advanced with a barrier member  36  between them. When the barrier member  36  is removed the attractive forces between the clutch housing  15  and the configuration  34  on proximal member  32  may be capable of retracting stent sheath  10  upon moving the proximal member  32  in a proximal direction.  
         [0091]     In at least one embodiment the distal member  8  may have a clutch housing  15  of a looped wire (metallic or polymer) ring and/or a metallic or polymer locking ring which may consist of a band disposed inside or outside distal member  8 . At least one embodiment is shown in  FIG. 11  where a looped wire ring may be included. The hooks  38  of  FIG. 12  may be attached to grappling base  39  which can be pushed forward by distal movement of push/pull wire  40 . The hooks  38  may be extended distally beyond the distal most portion of proximal member  32  and engage the clutch housing  15  of distal member  8 . Once engaged as illustrated in  FIG. 13 , proximal movement of the proximal member  32  or proximal movement of push/pull wire  40  may retract sheath  10 .  
         [0092]     In at least one embodiment, as shown in  FIG. 14 , the clutch housing  15  may have hooks  42  which can be restrained from extending proximally with an intervening device or barrier member  36  as in  FIG. 10 . The clutch housing  15  having hooks  42  may be of a shape memory material that returns to an original extended shape upon heating. For example, when the hooks  42  are heated by the warmth of the body lumen or by electrical resistance they may extend proximally from clutch housing  15 . The clutch housing  15  in at least one embodiment may have hooks  42  which are magnetically attracted to extend proximally towards the proximal member  32 . This may comprise an electrically induced magnetic attraction. A pullwire may also be used to pull the hooks  42  proximally from the clutch housing  15 . In all instances above, the hooks  42  are intended to engage the proximal member  32  through proximal member engagement mechanism  44  arranged about the opening of the proximal member  32 . The mechanism  44  in some embodiments may be wire loop rings arranged about the distal opening of the proximal member  32  or a lock ring arranged about the distal opening of the proximal member  32  as shown in  FIGS. 15 and 16 .  
         [0093]     In at least one embodiment a distal member  8  has a through hole  46 . For example, the distal member  8  of  FIG. 17  illustrates at least one embodiment. Proximal member  32  may be positioned such that inner clutch extension  48  extends into through hole  46 . For example, at least one embodiment is shown in  FIG. 18 . Inner clutch extension  48  may have expanding fingers  50  on its distal end. The distal member  8  may rotate around the expanding fingers  50  much like bearings. As shown in  FIG. 19 , upon the inner clutch extension  48  being advanced distally, the fingers  50  may expand such that proximal retraction of the inner clutch extension  48  may retract the sheath  10  as well.  
         [0094]     As illustrated in  FIG. 20 , the clutch extension  48  may comprise an inflation lumen  52  for inflating balloon  54 . Before insertion into the through hole  46  the balloon  54  may be partially inflated or the balloon may be deflated in order for the clutch extension  48  to pass through through hole  46 . Upon insertion, the balloon  54  may be inflated thereby inhibiting the proximal motion of clutch extension  48  in relation to through hole  46 . Thus, proximal motion of the clutch extension  48  may result in the sheath  10  being retracted.  
         [0095]     It should be noted that most of the clutch mechanisms described in this application may be preassembled such that the proximal member  32  and the distal member  8  are in the engaged state. The distal member  8  may rotate about the clutch extension  48  with pullback means being necessary without the need for a corresponding push means. This is illustrated in  FIG. 21  wherein pullback apparatus  56  may not pass through through hole  46  after assembly. It should be recognized that  FIG. 21  illustrates only a generic pullback apparatus  56 . All of the embodiments in this application may be of the type where substantial movement of the proximal member  32  in relation to clutch housing  15  is inhibited.  
         [0096]     This invention includes the use of balloon expandable stents. Though the use of a sheath has application with balloon expandable stents, in at least one embodiment a sheath is not necessary. As illustrated in  FIG. 22  the stent  12  may be disposed about balloon  58  without a sheath. The balloon  58  may be free to rotate about clutch extension  48  in order to better place and deploy the stent. Use at bifurcations is at least one application of this invention. The balloon  58  may be sealingly engaged to the clutch extension  48  at the distal and/or the proximal portions of the balloon  58 . In  FIG. 22  proximal expandable seal  60  and distal expandable seal  62  are at least partially uninflated.  
         [0097]     Upon positioning the stent  12  the balloon  58  and clutch extension  48  may be moved together proximally by inflating the proximal expandable seal  60  and/or the distal expandable seal  62 . The inflated state is shown in  FIG. 23 . It should be noted that the balloon  58  may rotate in this inflated state.  
         [0098]     In some embodiments, as in  FIGS. 22 and 23 , the clutch extension  48  does not have the proximal member  32  disposed about it at the distal portion of the proximal member  32 . In some embodiments the proximal member  32  may be disposed about clutch extension  48  and may extend distally to the proximal end of balloon  58  and in some embodiments be disposed about balloon  58  and stent  12 .  
         [0099]     In some embodiments, as in  FIGS. 22 and 23 , the clutch extension  48  has diameters which are unequal at the proximal contacting balloon section  64  and the distal contacting balloon section  66 . In some embodiments, clutch extension  48  may be of the substantially same diameter at all locations on the member  48  and longitudinally aligned along all portions of the member  48 . In some embodiments, the proximal contacting balloon section  64  and the distal contacting balloon section  66  may have substantially similar diameters. In some embodiments different lumens may be used in inflating the balloon  58 , the proximal expandable seal  60 , and/or the distal expandable seal  62 . In some embodiments the balloon  58 , the proximal expandable seal  60 , and the distal expandable seal  62  may also share one or more inflation lumens.  
         [0100]     The above disclosure is intended to be illustrative and not exhaustive. This description will suggest many variations and alternatives to one of ordinary skill in this art. All these alternatives and variations are intended to be included within the scope of the claims where the term “comprising” means “including, but not limited to”. Those familiar with the art may recognize other equivalents to the specific embodiments described herein which equivalents are also intended to be encompassed by the claims.  
         [0101]     Further, the particular features presented in the dependent claims can be combined with each other in other manners within the scope of the invention such that the invention should be recognized as also specifically directed to other embodiments having any other possible combination of the features of the dependent claims. For instance, for purposes of claim publication, any dependent claim which follows should be taken as alternatively written in a multiple dependent form from all prior claims which possess all antecedents referenced in such dependent claim if such multiple dependent format is an accepted format within the jurisdiction (e.g. each claim depending directly from claim  1  should be alternatively taken as depending from all previous claims). In jurisdictions where multiple dependent claim formats are restricted, the following dependent claims should each be also taken as alternatively written in each singly dependent claim format which creates a dependency from a prior antecedent-possessing claim other than the specific claim listed in such dependent claim below.  
         [0102]     This completes the description of the preferred and alternate embodiments of the invention. Those skilled in the art may recognize other equivalents to the specific embodiment described herein which equivalents are intended to be encompassed by the claims attached hereto.