Abstract:
A catheter system with a proximal end and a distal end means at the proximal end to actuate a device at the distal end of the system, and an actuator element ( 32 ) that runs the length of the system, from the actuator means to the device and actuates the device by transmitting a physical force from the proximal end to the distal end and characterized by a pre-tensioner ( 40 ) near the distal end of the system, that can be set in a pre-tensioning disposition prior to actuation of the device, the pre-tensioner thereby reducing the magnitude of the said physical force that must be transmitted from the proximal end when acutation of the device is required.

Description:
TECHNICAL FIELD 
       [0001]    This invention relates to a transluminal catheter-type system to deliver a bodily implant such as a self-expanding stent, the system having a proximal end with an implant release means and a distal end that carries the implant radially confined within a sheath which, to release the implant, is pulled proximally from the proximal end of the system by the release means to translate the sheath proximally relative to the implant to release the implant from its radial confinement, progressively, starting at the distal end of the implant. The delivery may be via a vascular lumen but could be via a bodily lumen not part of the vascular system. The implant need not be a stent but could be something else, such as a valve or a filter for placement in the bodily lumen. 
       TECHNICAL BACKGROUND 
       [0002]    The archetypal catheter-type system to release a self-expanding stent into a bodily lumen takes the form of a catheter shaft extending between a proximal end of the system that remains outside the body and a distal end of the system that carries the stent. The proximal end is manipulated, to release the stent. This manipulation involves pulling on one component of the system, at the proximal end, in order to pull back proximally a sheath that radially confines the stent. 
         [0003]    Since the stent is exerting radially outward force on the sheath, up to the time that the stent is released from the sheath, the stent will tend to be carried with the sheath, whenever the sheath is pulled proximally, relative to the shaft of the catheter system. Thus, that shaft needs to engage with a surface portion of the stent and restrain the stent as the sheath retracts proximally, relative to the stent. This restraining of the stent naturally imposes on the catheter shaft an endwise compressive stress, as that shaft “pushes” on the stent during proximal withdrawal of the sheath. 
         [0004]    Thus, the shaft of the catheter system inherently includes components that are sliding over each other, throughout the length of the system, which length can be rather large, typically between 100 cm and 150 cm. 
         [0005]    As experience grows, self-expanding stents can be delivered to ever more demanding locations in the body, with the delivery system advancing along ever more tortuous and confined lumens. Today, there is vigorous demand for delivery systems that can keep to an overall diameter of 6F or smaller (6F equals 2 mm, with the unit of “1 French” corresponding to ⅓ mm). As the diameter is continually brought down, so the pressure on the system designer increases, to minimise the forces of friction that arise with sliding contact along the shaft length. 
         [0006]    Further, with greater radial force, greater axial length, and with ever more sophisticated coverings on the stent strut matrix the “drag” of the stent on the proximally-moving sheath gets bigger. This, in turn, raises the tension required in the stent release means. It can well be imagined that a need therefore exists to hold down the absolute values of endwise tensile stress, to values that the system can tolerate without kinking or buckling and without failure of any one of the very long, very thin components involved. 
       SUMMARY OF THE INVENTION 
       [0007]    The invention is defined in claim  1  and the claims dependent on that independent claim recite further technical features that are optional, and embodiments that are preferred. 
         [0008]    The system provides a pre-tensioner, conveniently a tube, which is actuable, prior to actuation of the implant release means, to set the pre-tensioner in a tensioning disposition in which it imposes on at least a portion of the sheath a tension which pulls the portion in a proximal direction, thereby to reduce the force which the release means must impose on the proximal end of the sheath to initiate the set proximal translation of the sheath to begin said release of said implant. 
         [0009]    Thus, it will be appreciated by the reader that the essence of the invention is to provide a “pre-tensioner” at the distal end of the system which somehow “helps” the system components that must pull the stent sheath proximally, from the proximal end of the system. If the pre-tensioner can impose on the sheath a significant force urging the sheath proximally, before the medical practitioner at the proximal end of the system begins to actuate the implant release means, then the burden of stress that must be carried the length of catheter shaft by the implant release means will be reduced by an amount corresponding to the “help” being given to the release means by the pre-tensioner at the distal end of the system. 
         [0010]    As will be seen below, the pre-tensioner can perform other functions, besides pre-tensioning. A pre-tensioner in the form of a tube can provide a passage, sealed from the bodily lumen, for transporting a fluid, such as flushing liquid, lengthwise along the catheter. If it takes the place of a pre-existing tubular component for fluid flow, it can simplify the construction of the delivery system even while it improves its performance. 
         [0011]    Furthermore, if the pre-tensioner is provided in the form of a tube, that surrounds a core tube of the system that is in endwise compressional stress during release of the stent, then an annulus is provided between the core tube and the pre-tensioner tube that can accommodate a pull wire of the implant release means, within the annulus. In this way, the pre-tensioner tube shields bodily tissue from any contact with the pull wire. The pull wire typically having a very small diameter, it would otherwise have the potential to cause lesions on bodily tissue on the walls of the lumen in which the system has been deployed. Yet further, in a tortuous lumen, when the pull wire is under high endwise tensional stress, there exists the possibility that the tension in the pull wire can cause the core tube to bow outwardly, away from the tensioned pull wire. With a pre-tensioner tube fitting relative snugly around the core tube, and with only a narrow annulus to accommodate the pull wire, the pre-tensioner tube will be very effective in keeping the pull wire close to the core tube and preventing any significant bowing of the core tube away from the tension wire. 
         [0012]    In one preferred embodiment, the pre-tensioner tube is of a polymer material that can be pre-tensioned to result in a significant increase of its length, by elastic deformation. Thus, with a polyurethane material PUR it might be possible, for example, to pre-tension it to four or five times its original length in the relaxed disposition, to impose on the stent sheath a substantial proximal pull, before any actuation of the implant release means of the system. In some embodiments, the pull from such a pre-tensioner tube is not enough itself to cause translation of the stent sheath but it is enough to ease the task of the implant release means, when actuated. In other embodiments, the pull from the pre-tensioner is more than enough, in which case there would need to be a component that pushes on the stent sheath, distally, until the time when the stent is to be released. This component could be a push ring bonded to the luminal surface of the stent sheath at its proximal end, or the distal end of the pre-tensioner, and connected to the proximal end of the system by a push rod that can carry an endwise compressional stress until the stent is to be released. 
         [0013]    As the stent sheath moves proximally, the strain in the pre-tensioner tube is relieved but, as the deformation is elastic, the pre-tensioner tube simply reverts to a more relaxed disposition, without any significant concertina effect that might otherwise add to the bulk and wall thickness of the tube. This is important because, as noted above, great efforts are being made currently to reduce even further the overall diameter of the shaft of such catheters. Any simplification of shaft structure is interesting for its potential to get overall shaft diameters down even lower. 
         [0014]    Polymer deformation is usually time-dependent. Thus, the elastic deformation of a tube pre-tensioner might decay with time, if the tension is imposed in the factory, during manufacture of the system, and prior to transport and lengthy storage of the system prior to use. This invention, therefore envisages embodiments in which the pre-tensioner is of a polymer material that is allowed to remain in its relaxed form until shortly before use of the system, whereupon a manipulation of the proximal end of the system will impose endwise tension on the pre-tensioner and for the first time deliver to the stent sheath a significant proximal pull from the pre-tensioner that will later assist in release of the stent. 
         [0015]    The PUR material mentioned above is available from Lubrizol Corporation, Engineered Polymers Division, under the trademark TECOFLEX. 
         [0016]    One convenient way of imposing the endwise stress on the pre-tensioner is to couple a proximal end of the pre-tensioner to a tube of the delivery system that extends to the proximal end of the system and offers there a proximal end of the tube that can be pulled proximally (such as just before any part of the stent delivery system comes into contact with the body of the patient) to impose the said axial strain on the pre-tensioner. A bonus effect of this “cocking” process is that it will slightly reduce the wall thickness and diameter of the pre-tensioner tube, as the tube is stretched, all of which can be useful if the distal end of the delivery system is to be advanced along a particularly tortuous or narrow bodily lumen. As explained above, this pre-tension might not be enough to begin the translation of the sheath relative to the stent, but is enough to be of significant help to the stent release means, when the time comes to pull on the sheath to translate it proximally to release the stent into the lumen. Alternatively, the pre-tension might in other embodiments be more than enough so that one has to push on the stent sheath until the implant is to be deployed, to prevent premature deployment. One envisages a combination of a pre-tensioner and an implant release means that can carry both a tensile and a compressive end-to-end stress. Until the implant is released any stress is compressive. When the implant release process begins, however, any end-to-end stress in the implant release means is tensile. 
         [0017]    An anchoring means may be provided for anchoring the outer tube of the delivery system that extends to the proximal end of the system and that is coupled to the proximal end of the pre-tensioner to hold the tube in a “cocked” position following the “cocking” process. The anchoring means may involve the outer tube being anchored to the core tube. This may be achieved by providing holes on the outer and core tubes that align upon “cocking” so that a pin can be placed therethrough preventing relative axial movement of the outer tube and core tube. 
         [0018]    The description above is of one way to impose a pre-tension on the stent sheath. Other ways will occur to readers. For example, a pre-tensioner component in the form of a helical spring of, say, stainless steel might be thought attractive. Advantageously, such a spring is covered by a film, so that the pre-tensioner can serve as a liquid conduit as explained above. It might be advantageous to use any such film as a pre-tensioner to act with the spring to deliver an aggregate pre-tensioning force. Here, the different stress strain properties of the metal and the polymer could deliver interesting aggregate effects. Other combinations of materials can be used, or composite materials, to deliver the elastic deformation performance required of the pre-tensioner in any given product. 
         [0019]    The present invention can be applied to delivery systems in which an implant is radially constrained by a sheath of two co-axial layers. The pre-tensioner pulls the outer of the two sheaths, whereupon the inner of the two sheaths can release the implant. 
         [0020]    One such two layer sheath is a so-called rolling membrane, which is a sheath doubled back on itself at its distal end, at the distal end of the implant. 
         [0021]    Another such two layer sheath is formed by an inner sheath that has two long edges held together by stitches, that run the full axial length of the implant. Alternatively, the long edges may be held together by stitches that run along a portion of the full axial length of the implant. See WO2010/063795, which is incorporated herein by reference in its entirety. The pre-tensioner provides an outer sheath that covers the inner sheath and the stitches. It is bonded to the inner sheath, or contiguous with the inner sheath around the circumference at the distal end of the inner sheath. It is in endwise tension but the inner sheath is not. On pulling back the thread, the thread releases the stitches one by one, to allow the inner sheath long edges to move away from each other on the circumference of the implant. This release of the stitches enables the pre-tensioner for the first time to pull the distal end of the inner sheath proximally, out of the way of the radially expanding implant, beginning at the distal end and progressing proximally, to the proximal end of the implant. 
         [0022]    Other configurations will occur to those skilled in the art. As explained above, an advantage of the invention is that it is no longer necessary to expose the full length of the catheter delivery system to the full endwise force needed to pull the sheath proximally off the stent. With a pre-tensioner near the distal end of the system, some of the high forces needed can be contained in a circuit within the distal end portion of the delivery system, so that less than the full amount of the necessary stress need be delivered to the sheath at the distal end of the system, all the way from where it originates, at the proximal end of the system. The shaft of the system can thus be made less stiff and bulky than might otherwise be the case. 
         [0023]    In the case where the pre-tensioner takes the form of a tube located proximal of the sheath, the forces can be contained in the circuit within the distal end portion of the delivery system by employing the aforementioned anchoring means. 
         [0024]    Besides, in a rapid exchange catheter system, the absence of telescoping tubes in the catheter shaft proximal of the implant could allow the proximal guidewire lumen exit port to be brought somewhat closer to the distal end of the catheter than might be possible with a telescoping system of tubes. The avoidance of a telescopic arrangement could help to get down to an even lower value the aggregate wall thickness of the catheter system near its distal end, with consequential reduction in outside diameter of the catheter shaft. It is a challenging engineering problem, to achieve near 100% reliability of telescopic sliding, when the telescopic elements have minimal wall thickness. Elimination of telescopic tubes in the catheter shaft, therefore, can reduce the number of challenges facing the designers of systems such as these. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0025]    For a better understanding of the invention, and to show more clearly how the same may be carried into effect, reference will now be made, by way of example, to the accompanying drawings, in which 
           [0026]      FIGS. 1 to 7  each show a lengthwise section through the longitudinal axis of a stent delivery system.  FIGS. 2 to 7  are in accordance with the present invention. Only a distal end zone of the system is shown. Experienced readers will be familiar with the construction and operation of the proximal end of such systems. 
           [0027]      FIG. 1  included for the sake of clarity, shows the system without any pre-tensioner. 
           [0028]      FIG. 2  shows the system of  FIG. 1  but with a pre-tensioner tube added, and in its relaxed disposition. 
           [0029]      FIG. 3  shows the system of  FIG. 2 , and with the pre-tensioner tube in its tensioned disposition. 
           [0030]      FIG. 4  shows the system of  FIG. 2 , with the implant part released into the bodily lumen. 
           [0031]      FIGS. 5 to 7  show a second embodiment of implant deliver system in accordance with the invention, in which  FIG. 5  shows a storage disposition,  FIG. 6  a pre-tensioned disposition and  FIG. 7  an implant release disposition. 
       
    
    
     DETAILED DESCRIPTION 
       [0032]    Although the present invention is embodied in an implant delivery system, which does not require the presence of an implant, nevertheless, we show a stent implant  10  in the drawings, in the interests of clarity and so that the reader can better grasp how the system works. 
         [0033]    In  FIG. 1 , the stent  10  is surrounded by a sheath  12  that confines the self-expanding stent radially until the moment of its release into a bodily lumen. In this embodiment, the sheath  12  has a distal end  14  that exhibits an inward taper  16  to provide the leading end of the system with an atraumatic profile. The tip tapers to a core tube  18  of the system which serves as a lumen  20  for a guidewire. On the abluminal surface  22  of the core tube  18  is mounted a stent pusher element  24  which, here, is in the form of a ring, that will restrain the stent  10  from moving proximally during the time when the sheath  12  is being pulled proximally, to release the stent. Other forms of pusher element are known, that are not in the form of a ring, and then can be used in the present invention too. It will be appreciated that the pusher element  24  and the core tube  18  will therefore hold the stent  10  at an axial position in the bodily lumen, exactly where the medical practitioner desires to release the stent  10  into the lumen. 
         [0034]    At the proximal end  26  of the sheath  12 , on the luminal surface  28  of the sheath, there is provided a pull ring  30  by means of which the sheath  12  can be pulled proximally to release the stent. Attached to the pull ring  30  is the distal end of a pull wire  32  that runs all the way to the proximal end of the system, where it can be put into tension. The tension runs the length of the pull wire  32  and through the pull ring  30  to the sheath  12 , to pull the sheath proximally, when required. 
         [0035]    Thus, the fundamentals of the illustrated embodiment include a core tube  18  that runs all the way to the proximal end of the system and is in endwise compressive stress during release of the stent, and a pull wire  32 , that runs (at least in a distal portion of the system) outside the lumen of the core tube  18  and is in tensional stress when the stent is being released. 
         [0036]    Readers will, however, be aware of delivery systems for self-expanding stents in which the stent sheath is connected to the proximal end of the system by a pull tube with a lumen that contains a push rod connected to a component analogous to the pusher ring  24 . The present invention is applicable also to such “pull tube” systems. 
         [0037]    As mentioned above, other embodiments have a pre-tensioner with more than enough force to pull the implant sheath proximally. In such embodiments one needs a pusher, to push on the pre-tensioner or the stent sheath until the implant is to be released. Then, with a relaxing of this push, the pre-tensioner becomes free to pull the sheath proximally, to release the implant. 
         [0038]    In  FIG. 1 , we show schematically an outer tube  34  that surrounds the core tube  18  and the pull wire  32  and also runs all the way to the proximal end of the system. One can appreciate that there is an axial gap G 1  between the distal end  36  of the outer tube  34  and the pull ring  30 . In this gap G 1 , the core tube  18  and pull wire  32  lie side by side. It can be imagined that, when G is big enough and when the tension in pull wire  32  is high enough, there might be some tendency for the core tube  18  to bow outwardly and away from the pull wire  32  in tension. The present Applicant has indeed proposed (see WO2010/115925, which is incorporated herein by reference in its entirety) the use of a plurality of belts at spaced intervals along the length of the gap G 1 , to prevent any such bowing. 
         [0039]    However, with the present invention, as shown in  FIGS. 2 ,  3  and  4  a pre-tensioner tube  40  bridges the gap G, thereby eliminating the need for any of the above-mentioned belts. Nevertheless, we can envisage retaining such belts, inside the pre-tensioner tube. 
         [0040]    Comparing  FIGS. 1 and 2 , it can be seen that the outer tube  34  extends distally in  FIG. 2  further than in  FIG. 1 . Indeed, it will be noted that in  FIG. 2  the length of the gap G 2  is significantly less than the length of the stent to be deployed. It would appear that the gap G 2  is not big enough to allow the sheath to be retracted far enough to release the full length of the stent. However, comparing  FIGS. 2 and 3 , we see that the outer tube has been pulled back proximally in preparation for use of the delivery system, so that gap G 3  is now a multiple of the length of the gap G 2  in  FIG. 2 . The proximal withdrawal of the distal end of the outer tube  34  has imposed considerable elastic deformation on the pre-tensioner tube  40 , but that tension has not, of itself, moved the pull ring  30  at all in the proximal direction. Nevertheless, the pull ring  30  is experiencing a proximal pull from the tensioned pre-tensioner tube  40 , that will allow the sheath to be translated proximally, relative to the push ring  24 , at rather lower levels of endwise tension in the pull wire  32  than would be the case in the absence of the pre-tensioner tube  40 . 
         [0041]    When the time comes to release the stent, the release process is accomplished in the  FIG. 3  system just as in the  FIG. 1  system, but is accomplished at a lower level of stress in the pull wire  32  than would be needed in the  FIG. 1  embodiment. Furthermore, it can be seen that the abluminal cylindrical surface of the delivery system in the distal end zone is more streamlined in the case of the embodiment in accordance with the present invention, because that abluminal surface lacks any shoulder at the pull ring  30  and the distal end  36  of the outer tube  34 . Instead, the pre-tensioner tube eliminates both of these shoulders exposed to the walls of the bodily lumen. 
         [0042]    Furthermore, it will be appreciated that the addition of the pre-tensioner tube  40  does not increase at all the number of surfaces in the delivery system that during stent release must slide over each other. On the contrary, by eliminating a telescopic or concertina arrangement, the pre-tensioner tube can reduce the aggregate wall thickness of a distal portion of the delivery system to less than what it would otherwise have been. Although the magnitude of frictional forces that arises, with surfaces sliding over each other, can be managed down to remarkably low levels, nevertheless they remain above zero, so that minimisation of mutually sliding surfaces is a design objective of great interest to high performance catheter type stent delivery systems. Any tendency that telescopically sliding surfaces have to bind against each other and stick, during sliding, is eliminated when the telescopic elements are eliminated from the system. 
         [0043]    Although the illustrated embodiment shows a pull wire  32 , a pull tube co-axial with core tube  18  can be used. 
         [0044]    Although the above description is of a sheath with only one layer, the present invention is applicable to sheaths that are in the form of a two layer membrane, doubled back on itself at its distal end to function during release of the implant as a so-called “rolling membrane”. One example is the embodiment of  FIGS. 5 to 7 . 
         [0045]    Turning to the embodiment of  FIGS. 5 ,  6  and  7 ,  FIG. 5  shows the delivery system  100  for a self-expanding stent  102  carried on a catheter shaft tube  104  and confined radially by a rolling membrane sheath  106  that comprises an inner membrane  108  and an outer membrane  110 , connected together at the respective distal end  112 . The proximal end of the inner membrane  108  is fixed to the shaft  104  at a fixation zone  114 . The proximal end of the outer membrane  110  has a pull ring  116  to which is fixed the distal end of a pull wire  118  that runs all the way back to the proximal end of the delivery system. The distal end of the stent  102  is just proximal of an atraumatic tip  120  on the shaft tube  104 , with the usual distal guidewire exit port  122  on the axis of the tip  120 . The proximal end of the stent  102  butts up against a stop ring  124  also fixed to the shaft  104 . 
         [0046]    Thus far, the arrangement described is that of a “conventional” rolling membrane release system for a self-expanding stent. By pulling on the pull wire  118 , the membrane is caused to roll back proximally on itself, gradually to release the self-expanding stent, distal end first. However, the embodiment of  FIG. 5  reveals a variant, in that the inner membrane  108  is of the form described in Applicant&#39;s earlier WO2010/063795 mentioned above, with two long edges held together by stitches. The stitches are shown schematically in  FIG. 5  as short branches  130  on a thread  132  that runs all the way to the proximal end of the catheter delivery system. Upon pulling the thread  132  proximally, the stitches  130  are released, one at a time, commencing at the distal end of the inner sheath  108 , that is to say, that the distal end of the self-expanding stent  102 . It will be appreciated that, with the stitches  130  all intact, the stent  102  is confined radially by the inner membrane  108  and outer membrane  110  of the rolling membrane  106 . 
         [0047]    Turning now to  FIG. 6 , attention is directed to the pull ring  116  on the outer membrane  110 . The pull wire  118  has been used to pull the pull ring  116  to a position well proximal of its location in the  FIG. 5  storage disposition. However, the distal end of the outer membrane  110  has not moved proximally. The elastic deformation of the outer membrane  110  generates a pull on the distal end of the inner membrane  108  which is not sufficient, for as long as the stitches  130  remain intact, to permit the distal end of the inner membrane  108  to invert on itself and roll proximally down the abluminal surface of more proximal parts of the inner membrane  108 . 
         [0048]    However, looking at  FIG. 7 , as soon as the thread  132  through the stitches  130  is pulled proximally, the stitches will open, one by one, commencing at the distal end of the system next to the tip  120 . This opening of the distal stitches releases the hoop stress around the circumference of the inner membrane  108  at its distal end, and this has the further consequence of allowing the tensioned outer sheath  110  to invert the distal end of the inner membrane  108  and pull it back proximally, outside that proximal portion of the length of the inner membrane  108  where the stitches are still in tact. It will be appreciated that the tension in the outer membrane  118  helps to pull the rolling membrane, both inner membrane  108  and outer membrane  110 , proximally clear of the radially expanding stent  102 , with most or all of the rolling membrane, at the end of the stent release process, pulled to a position proximal of the fixation zone  114  at the proximal end of the inner membrane  108 . An advantage of this proximal movement is a reduced likelihood of any part of the rolling membrane ending up being squeezed between the radially expanded stent  102  and the stenosed bodily lumen in which the stent has been placed. This proximal pulling of the rolling membrane, away from the stenting site, is a routine feature of a rolling membrane release system, but not of a delivery system in which stent release is effected simply by release of a line of stitches along the length of a sheath confining a self-expanding stent. The combination of a line of stitches, a rolling membrane, and a pre-tensioning facility opens up possibilities for the designer of catheters for delivery of implants into a bodily lumen that are unavailable in other system architectures. 
         [0049]    Although the illustrated embodiment shows an “over the wire” system, readers will be able to adapt the inventive concept to rapid exchange systems which exhibit a guidewire lumen confined to a distal portion of the length of the catheter of the system. As mentioned above, the pre-tensioner tube can open up possibilities to get the proximal guidewire exit port closer to the distal end of the delivery system. 
         [0050]    Devices manufactured for use later have a “shelf life” over which they can be stored and, afterwards, still used safely. While it is assumed above that the pre-tensioning will be done after the storage period and before use, it is also imagined that pre-tensioning might be feasible as part of the manufacturing process, even before the storage period on the “shelf” even starts. 
         [0051]    The catheter system of the present invention may be incorporated with a device for catheter sheath retraction, such as that disclosed in WO 2009/007432 A1, which is incorporated herein by reference in its entirety. Such a device may incorporate a housing connectable to the proximal end of the catheter system and a mover associated with the housing for actuating the catheter system via the actuating means of the catheter system. 
         [0052]    Thus, the storage disposition, where the pre-tensioner takes the form of a tube located proximal of the sheath, may take the form depicted in either of  FIG. 2  or  3 . Where the pre-tensioner takes the form of an outer sheath, the storage disposition may take the form depicted in either of  FIG. 5  or  6 . 
         [0053]    The present invention may have application to catheters other than those for delivery of an implant. The pre-tensioner can be useful whenever a load is to be transmitted from an accessible proximal end of the catheter outside the body to the distal end of the catheter, in the body, inaccessible and perhaps separated from the proximal end by a bodily lumen that is long and/or tortuous. A pre-tensioner near the distal end can reduce the load and this alone can open up design possibilities that would otherwise be precluded.