Abstract:
A sheathed catheter system is described where the sheath comprises a distal portion and a proximal portion that are moveable axially relative to each other, and relative to a tube carrying a medical device thereon. The distal and proximal sheath portions can be brought together in order to enclose therewithin the medical device. The distal sheath has a proximal section that is configured to bias radially inwardly to minimize an otherwise exposed annular surface catching on protruding surfaces that may exist on the catheter or other medical tool in use at the time, or to minimize scraping the inner native lumen of the patient upon retrieval.

Description:
BACKGROUND OF THE INVENTION 
     1. Field of the Invention 
     The present invention relates generally to an apparatus and method for deploying a medical device from a minimally invasive delivery system, such as a delivery catheter, and deploying the device within a patient. 
     2. Description of the Related Art 
     Percutaneous aortic valve replacement (PAVR) technology is emerging that provides an extremely effective and safe alternative to therapies for aortic stenosis specifically, and aortic disease generally. Historically, aortic valve replacement necessitated open heart surgery with its attendant risks and costs. The replacement of a deficient cardiac valve performed surgically requires first placing the patient under full anesthesia, opening the thorax, placing the patient under extracorporeal circulation or peripheral aorto-venous heart assistance, temporarily stopping the heart, exposing and excising the deficient valve, and then implanting a prosthetic valve in its place. This procedure has the disadvantage of requiring prolonged patient hospitalization, as well as extensive and often painful recovery. Although safe and effective, surgical aortic valve replacement (SAVR) presents advanced complexities and significant costs. For some patients, however, surgery is not an option for one or many possible reasons. As such, a large percentage of patients suffering from aortic disease go untreated. 
     To address the risks associated with open-heart implantation, devices and methods for replacing a cardiac valve by less invasive means have been developed. For example, CoreValve, Inc. of Irvine, Calif. has developed a prosthetic valve fixed to a collapsible and expandable support frame that can be loaded into a delivery catheter. Such a bioprosthesis may be deployed in-situ minimally invasively through the vasculature at significantly less patient risk and trauma. A description of the CoreValve bioprosthesis and various embodiments appears in U.S. Pat. Nos. 7,018,406 and 7,329,278, and published Application Nos. 2004/0210304 and 2007/0043435. By using a minimally invasive replacement cardiac valve, patient recovery is greatly accelerated over surgical techniques. In the case of the CoreValve device, the support frame is made from shape memory material such as Nitinol. Other catheter-delivery valve replacement systems use stainless steel, or do not rely upon a rigid frame. 
     As demonstrated successfully to date, using a transcatheter procedure, percutaneous aortic valve replacement proceeds by delivering a prosthetic valve to the diseased valve site for deployment, either using a balloon to expand the valve support against the native lumen or exposing a self-expanding support in situ and allowing it to expand into place. With the latter, the self-expanding frame remains sheathed during delivery until the target site is reached. Advantageously, the frame may be secured to the catheter to avoid premature deployment as the sheath is withdrawn. In the CoreValve valve prosthesis, a hub is employed with two lateral buttons or ears around each of which a loop or alternatively a frame zig may reside during delivery. The internal radial force of the sheath keeps the frame compressed against the catheter, including the frame zigs in place around the lateral buttons. The catheter generally comprises at least two tubes, an inner tube that carries the prosthesis and a central tube that carries the sheath, permitting the sheath to move relative to the prosthesis. 
     As with traditional cardiovascular interventional therapies, transcatheter device deployment may proceed retrograde against normal blood flow, or antegrade, with blood flow. For percutaneous aortic valve replacement, entry through the femoral arteries proceeds in a retrograde format up through the iliac, the descending aorta, over the arch and to the native annulus. In some cases, entry has been made closer to the arch; for example through the left subclavian artery. Antegrade procedures have been performed where delivery takes place through the venous system transeptally to the native aortic annulus. More recently, transapical procedures have been performed whereby a cardiac surgeon delivers a catheter through the patient&#39;s chest wall, then through the exposed left ventricle apex and then to the target site. 
     With retrograde deployment, it is generally desired that the catheter be advanced within the vasculature so that the device is positioned where desired at the annulus site. With some embodiments under development, the desired site is the annulus itself With the CoreValve device, the desired site extends from the annulus to the ascending aorta, given its relative length. In the transfemoral approach, when the CoreValve device is positioned at the desired site, the sheath is withdrawn to the point where the inflow end of the device (preferably positioned at the native annulus) expands to engage and push radially outwardly the native valve leaflets. The sheath continues to be withdrawn proximally as the prosthesis continues to expand as it is exposed until the sheath covers just the outflow portion of the prosthesis still secured to the hub ears. Any readjustment of the axial position of the device in situ can be made during this process based upon electronic visual feedback during the procedure. Once well positioned, the sheath is fully withdrawn, the device fully expands in place, and the catheter is withdrawn through the center of the device and out through the vasculature. While it would be possible to deploy the prosthetic device such that the sheath could be withdrawn distally so that the outflow end of the prosthesis deploys first, such an arrangement would require advancing distally the central tube of the catheter connected to the sheath distally. In the case of transfemoral retrograde delivery, that would cause the central tube to project well into the left ventricle, which is not desirable. In a antegrade approach, for example transapical delivery, the reverse situation exists. There it is more desirable to advance the sheath distally to expose the inflow end of the prosthesis at the native annulus first. The native anatomy can accommodate this distal deployment because the central tube carrying the sheath is advanced up the ascending aorta towards the arch. Like the retrograde approach, once the valve prosthesis is fully deployed, the catheter may be withdrawn through the center of the prosthesis and removed through the apex of the heart. 
     Regardless of the direction of approach, with self-expanding frame technology, it is sometimes observed that even well-placed prosthetic valves inadvertently shift from the intended target site a small distance during the final delivery stage. The valve may still function effectively, but it is not optimized when, for example, the valve is placed so that it projects more than desired into the left ventricle. If the frame is implanted too low into the left ventricle, there is a risk of paravalvular leak where a portion of the blood ejected from the ventricle returns through the frame below the annulus. 
     In doing so, the catheter may sometimes inadvertently advance into the left ventricle for one of several possible reasons. One theory is that conical expansion of the zigs of the frame may influence positioning by following the path of least resistance until the inflow section is completely deployed in both the annulus and the ascending aorta may cause the prosthesis to shift. Another is the friction between the catheter sheath and the vessel wall, which may limit retraction of sheath even though the operator is pulling on it through the handle button. Consequently, the valve is pushed distally through the forward action of the plunger rather than the valve remaining stationary relative to the target site by the retraction of the sheath in the proximal direction. If the valve is not fully deployed (i.e., the sheath is not fully retracted) so that the valve frame is still secured to the catheter, axial adjustment is still possible. This is known as dynamic catheter positioning. In some cases, however, it is not determined until after full deployment that the frame is deployed amiss. In that circumstance, a repositioning procedure might need to be taken to correct placement. While possible in one of several different ways, it adds a level of complexity to the medical procedure that would be preferably avoided if possible. The problem is exacerbated because with transcatheter delivery, unlike surgical implantation, the clinician is unable to directly see the target site and must rely upon videographic technology to assess appropriate placement of the prosthesis. 
     One solution is to split the sheath into two discrete sections; a proximal section and a distal section. Doing so permits a controlled deployment that is central to the device, rather than at the distal or proximal end as with a single sheath. In U.S. Pat. No. 7,238,197, Seguin et al. have suggested such an arrangement, without any specificity or demonstration. See col. 14:36-42. No mention is made of the benefits or advantages of doing so, nor the particular configuration. Another example is shown in U.S. Pat. No. 7,022,133 to Yee et al. However, the distal and proximal portions are overlapping. Moreover, that disclosure does not address the issue regarding minimizing inaccurate deployment once the prosthesis is positioned at the target site. With an ill-configured split sheath arrangement, it has been observed that withdrawal of the catheter post-deployment may cause the proximal portion of the distal sheath to cause trauma to the native lumen where the vasculature is arcuate, such as the aortic arch. The problem may be encountered regardless of whether delivery proceeds antegrade or retrograde. 
     It is therefore desired to provide a transluminal catheter that enables prosthesis implantation accurately at the target location without the need for dynamic catheter positioning upon sheath retrieval. It is expected that, with such a solution, the prosthesis implantation procedure would become easier to manage with the desirable result that final positioning becomes more consistent. 
     SUMMARY OF THE INVENTION 
     The invention described and claimed herein comprises embodiments for minimally invasively delivering a medical device to a patient. The apparatus comprises a sheathed catheter system comprising an inner tube and a central tube, wherein the central tube has an outside surface suitable for accepting a medical device collapsed thereon in a stationary fashion. The sheath comprises a distal portion and a proximal portion that are moveable axially relative to each other, and with respect to the central tube, and can be brought together to abut in order to enclose therewithin a bioprosthesis such as a self-expanding frame supporting a tissue valve. In one embodiment, the distal sheath has a proximal section that is configured to bias radially inwardly to minimize a larger exposed annular surface that may catch on protruding surfaces or may scrape the native lumen surface of the patient upon retrieval. In another embodiment, a retaining hub for retaining a portion of the medical device being delivered comprises an extended portion that is generally cylindrical, or may have a non-tapered surface, such that it is configured to maintain low profile engagement with the distal sheath portion. Such an arrangement can also, when the distal sheath is retrieved, minimize vascular trauma or avoid being impeded by irregular surfaces. As contemplated, there are several different embodiments that can be made to employ the invention claimed herein. These and other features, aspects and advantages of embodiments of the present invention are described in greater detail below in connection with drawings of the apparatus and method, which is intended to illustrate, but not to limit, the embodiments of the present invention. 
     Thus one embodiment of the invention provides an apparatus for minimally invasively delivering a medical device to a target site within a patient, the apparatus comprising a first tube having an outside surface suitable for accepting a medical device collapsed thereon in a stationary position; and a sheath comprising first and second portions that may be moved axially relative to each other and with respect to the first tube, the sheath portions configured so as to enclose a medical device collapsed onto the first tube when brought together, and configured to expose the medical device when directed away from each other, the first sheath portion comprising a section that is normally biased radially inwardly so as to maintain a low profile. 
     Another embodiment of the invention provides an apparatus for delivering a medical device to a target site within a patient via a body lumen, the apparatus comprising: an inner tube; a distal sheath portion attached to the inner tube; an intermediate tube, moveable over the inner tube and at least partially into the distal sheath portion; an outer tube, moveable over the intermediate tube; a proximal sheath portion attached to the outer tube, so that, in use, the proximal sheath portion and the distal sheath portion can be moved together to substantially cover a medical device mounted on the intermediate tube and moved apart to deploy the medical device; the distal sheath portion having a proximal end portion configured to extend away from the walls of the body lumen when, in use, the sheath portions are apart and the distal sheath portion is moved proximately. 
     Another embodiment of the invention provides an apparatus for minimally invasively delivering a medical device to a target site within a patient, the apparatus comprising: a first tube having an outside surface suitable for accepting a medical device collapsed thereon in a stationary position, the first tube comprising a hub for retaining at least a portion of a medical device on the first tube, wherein the hub comprises a generally extended non-tapered portion; and a sheath comprising first and second portions that may be moved axially relative to each other and with respect to the first tube, the sheath portions configured so as to enclose a medical device collapsed onto the first tube when brought together, and configured to expose the medical device when directed away from each other; wherein, during operation, the first sheath portion may be moved in a direction sufficient to expose the medical device while said first sheath portion still covers at least a part of the extended non-tapered portion of the hub. 
     Yet another embodiment of the invention provides an apparatus for delivering a medical device to a target site within a patient via a body lumen, the apparatus comprising: an inner tube; a distal sheath portion attached to the inner tube; an intermediate tube, moveable over the inner tube and at least partially into the distal sheath portion, the intermediate tube having a hub at its distal end and having a region on the intermediate tube proximal of the hub for mounting the medical device; an outer tube, moveable over the intermediate tube; a proximal sheath portion attached to the outer tube, so that, in use, the proximal sheath portion and the distal sheath portion can be moved together to substantially cover a medical device mounted on the intermediate tube and moved apart to deploy the medical device; the hub having an axial length sufficient to permit the medical device to be deployed while the distal sheath portion covers at least part of the hub. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIGS. 1A and 1B  show schematic views of a catheter having a sheath with distal and proximal portions. 
         FIGS. 2A and 2B  show schematic views of the catheter of  FIGS. 1A and 1B  inserted within the vasculature. 
         FIGS. 3A-E  show cross-sectional views of one embodiment of a device delivery system showing sequential axial movement of proximal and distal sheath portions. 
         FIGS. 3F and 3G  show schematic views of the delivery system of  FIGS. 3A-E . 
         FIGS. 4A-D  show cross-sectional and schematic views of a second embodiment of a device delivery system showing sequential axial movement of distal sheath relative to an internal tube. 
     
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT 
     Referring to  FIGS. 1A and 1B , an example of a split sheath delivery system embodiment  10  for delivering a medical device  12  comprises a catheter  14  having a proximal end  16  and a distal end  18 . In the figures shown, and by way of example, the medical device  12  is a self-expanding frame. 
     The split sheath catheter  14  of  FIGS. 1A and 1B  comprises a first inner tube  22  and a central tube  24 , all of which may be controlled by the clinician. At the distal end of the central tube  24  is a hub or cap  26  affixed to the central tube  24 . The hub  26  is preferably tapered distally and configured to have a smooth rounded surface at its distal-most end. The hub is further configured to comprise at least one but preferably two or more buttons  28  for assisting in retaining the medical device  12  until full deployment. Depending upon the configuration and arrangement, as well as semantics, the buttons may be described as projecting ears, tabs, or hooks. It is important to note that a hub is not required for the invention described herein. 
     The catheter  14  further comprises a sheath  30  preferably made of resilient pliable material, such as those used in the industry. The sheath may comprise in whole or in part a braided, woven, or stitched structure, a polymer, or may comprise an inflatable balloon. The sheath  30  comprises a distal portion  32  and a proximal portion  34  that when pulled together to form joint  36  fully enclose the medical device  12  within. A first end  38  of distal sheath portion  32  is affixed to the central surface of inner tube  22  proximal its distal end  18 . The proximal sheath portion  34  is affixed at its proximal end  40  to an exterior tube  44  that extends in the proximal direction and covers both the proximal portions of central tube  24  and inner tube  22  in a preferably concentric configuration. 
     As shown in  FIG. 1A , when the distal and proximal portions  32 ,  34  of sheath  30  are adjoined at joint  36 , the medical device  12  is covered, thus permitting delivery of the medical device  12  to the desired target site. As shown in  FIG. 1B , when the distal and proximal portions  32 ,  34  of sheath  30  are directed away from each other, the medical device  12  is exposed and permitted to expand. Referring to  FIGS. 2A and 2B , one limitation with a split sheath arrangement may be appreciated.  FIG. 2A  shows a split sheath catheter embodiment similar to the one illustrated in  FIGS. 1A-B  and inserted within a patient&#39;s vasculature; in particular, the aortic arch  50  (with peripheral vessels not shown). When the distal and proximal sheath portions  32 ,  34  are directed apart, the central tube  24  carrying the medical device (not shown) is exposed so that the medical device may be released. Upon retrieval of the distal sheath  32 , however, given the curvilinear nature of the native vasculature, the proximal end  48  of distal sheath  32  is pressed tightly up against the endothelial lining of the native lumen. Movement of the proximal end  48  in a proximal direction may cause trauma to the vasculature. Moreover, in a split sheath catheter embodiment where a hub  26  is employed or where the hub has buttons  28  that extend radially outward, the proximal end  48  of distal sheath  32  may also catch on the buttons  28  as the distal sheath is moved proximally. 
     In an effort to avoid these issues, another embodiment of split sheath catheter, shown in  FIGS. 3A through 3G , comprises a distal sheath having an inwardly biased proximal section. Specifically, alternative split sheath delivery embodiment  110  for delivering a medical device  112  comprises a catheter  114  that comprises an inner tube  122  (with an optional internal lumen for passing a guide wire therethrough) where the inner tube  122  is concentrically positioned within a central tube  124 . In the embodiment illustrated, the medical device  112  can be a self-expanding frame supporting a valve such as CoreValve&#39;s aortic valve prosthesis. 
     At the distal tip of the central tube  124  is a hub  126  having a generally tapered distal configuration and at least one but preferably two or more buttons  128  ( FIG. 3D ) for retaining the medical device  112  during travel. Enclosing the central tube  124 , hub  126  and medical device  112  is split sheath  130  comprising a distal sheath portion  132  and proximal sheath portion  134  that are configured to abut together at joint  136  to fully enclose the medical device  112  therewithin. The distal sheath portion  132  comprises a tapered section  138  affixed to the distal end of inner tube  122 . The proximal sheath portion  134  comprises a proximally tapered section  140  that forms external tube  144  controllable by the clinician. It should be noted that the relative size of the distal sheath  132  to the proximal sheath  134  is not critical, so it may be a ratio of 50/50 or a ratio where one is larger than the other. 
     When it is desired to expose the medical device  112 , the distal sheath portion  132  is directed in the distal direction  160  while the proximal sheath portion  134  is directed in the proximal direction  170 . In preferably stepped deployment fashion, the distal and proximal sheath portions  132 ,  134  are directed moved away from each other to the point that each portion still retains the respective distal end  112 A and proximal end  112 B of the medical device  112 . The sequence of movement is not critical; i.e., it is not critical whether the proximal sheath is directed proximally before or after the distal sheath is directed distally. The distal sheath portion  132  is moved distally by directing the inner tube  122  distally  160 , while the proximal sheath portion  134  may be moved proximally by pulling the external tube  144  in the proximal direction  170 . By stepped deployment, more accurate placement of the medical device at the target site may be permitted. When the mid-portion of the medical device  112  expands to engage the luminal surface of the vasculature, the clinician can assess whether it is placed in situ at the desired location. If not, the catheter system  114  may be moved into either distally or proximally as needed. 
     When it is determined that the medical device  112  is properly positioned, the proximal sheath portion  134  may be further moved proximally to expose the proximal end  112 B of the medical device and permit expansion thereof, as shown in  FIG. 3C . With the medical device  112  more firmly positioned in the vasculature, the distal sheath portion  132  may be advanced further distally to release the distal end  112 A of the medical device. The medical device is now fully deployed, as shown in  FIG. 3D . Preferably, the distal sheath portion  132  has a proximal section  148  that is configured to radially bias inwardly when unconstrained. By continuing to advance the distal sheath portion  132  in the distal direction  160  beyond the axial position of the hub  126 , the proximal section  148  of the distal sheath portion  132  collapses inwardly toward the inner tube  122 . This reduces the profile of the distal sheath portion  132 . The proximal section  148  of distal sheath  132  may be made of a membrane (e.g., polyurethane, silicon, etc.) elastically expandable up to a given diameter to host the prosthesis, or a generally cylindrical layer that can fold back along predetermined pleats to a smaller profile (e.g., ePTFE, Dacron™, etc.) so that its natural state is to be collapsed. Preformed polymeric material, encapsulated spring material or the like, are contemplated. Alternatively, it could be made with longitudinal splits inside a conventional sheath that tend to fold back towards the inner side when a given radial force (of the folded prosthesis) is removed; or it could be made by expansion of elastic material. Other materials and/or other modes of preparing the sheath  130  for effective function are also contemplated to achieve the functions described herein. 
     By either withdrawing the inner tube  122  with distal sheath portion  132  proximally, or by advancing the central tube  124  and hub  126  distally (as shown in  FIGS. 3E and 3F ), the distal sheath portion  132  may enclose the hub  126 . The resilient nature of the proximal section  148  permits it to be expanded so as to permit the hub  126  to advance within the distal sheath portion  132 . With this arrangement, a smoother and lower profile is created for withdrawing the catheter through the medical device  112  in the proximal direction  170 , as shown in  FIG. 3F . 
     Referring to  FIGS. 4A-4D , an alternative embodiment catheter  214  comprises similar components as described above, including a central tube  224  with hub  226  at a distal end thereof. The catheter system  214  further comprises a distal sheath portion  232  having a proximal section  248  enclosing the distal end  212 A of medical device  212 . When being delivered to the target site, the distal sheath portion  232  encloses the hub  226 . After proper placement of the medical device  212  in situ, the medical device may be fully deployed, as shown in  FIG. 4B , by advancing the distal sheath portion  232  distally to expose the distal end  212 A of the medical device. In this embodiment, it is contemplated that the hub  226  have an elongate configuration with an extended cylindrical portion  260  that results in a hub  226  longer than the hubs  26  and  126  of other embodiments described herein. With this configuration, the distally-advanced distal sheath portion  232  need not advance beyond the distal end of hub  226  (see  FIGS. 4B and 4C ). The distal sheath portion  232  may maintain a low profile by remaining biased against the hub  226  for retrieval through the deployed medical device  212 . This may also be advantageous where it is preferred not to advance any portion of the catheter too far past the target site, for example, circuitous vasculature like the aortic arch. As shown in  FIG. 4D , the catheter  214  may be withdrawn proximally through the deployed medical device  212 . 
     It should be understood that the terms distal and proximal as used herein are with reference to the clinician and that other inventive embodiments contemplated may orient the catheters  14 ,  114  and  214  differently with respect to the vasculature, depending upon the entry point and the target site. It is also contemplated that either the distal sheath portion or proximal sheath portion, or both, could be configured so as to invert outwardly or inwardly, as described further in co-pending and co-owned application Ser. No. 12/212,620 filed on Sep. 17, 2008. By way of example, instead of the distal sheath portion  132  of  FIG. 3C  being moved distally with the inner tube  122  to expose the distal end  112 A of medical device  112 , the distal sheath portion could be inverted at a distal position and drawn into the interior of inner tube  122 . 
     In operation, the catheters described are particularly suited for delivery of a heart valve, where precise placement is important. Other critical and less-critical target sites are also contemplated. In the case of a self-expanding aortic valve replacement, the catheter may be delivered transfemorally, transeptally, transapically or through the sub-clavian, among other possible entry ways. In one procedure, the catheter is deployed so that the valved frame is positioned entirely aligned with the target site; e.g., aortic annulus up to ascending aorta. The frame may then be exposed from one end to the other, depending upon the direction of delivery, by either advancing the inner tube relative to the central tube or vice versa, or retraction of the central shaft. As the frame is exposed, it expands outwardly to engage the native intimal lining so placement accuracy is maximized. When the sheath is fully removed and the frame fully expanded, the catheter may then be withdrawn though the functioning prosthetic valve and removed from the patient. 
     Although embodiments of this invention have been disclosed in the context of certain preferred embodiments and examples, it will be understood by those skilled in the art that the embodiments of the present invention extend beyond the specifically disclosed embodiments to other alternative embodiments and/or uses of the invention and obvious modifications and equivalents thereof. In particular, while the present loading system and method has been described in the context of particularly preferred embodiments, the skilled artisan will appreciate, in view of the disclosure, that certain advantages, features, and aspects of the system may be realized in a variety of other applications, many of which have been noted above. Additionally, it is contemplated that various aspects and features of the invention described can be practiced separately, combined together, or substituted for one another, and that a variety of combination and subcombinations of the features and aspects can be made and still fall within the scope of the invention. Thus, it is intended that the scope of the present invention herein disclosed should not be limited by the particular disclosed embodiments described above, but should be determined only by a fair reading of the claims.