Abstract:
A stentless support structure capable of being at least partly assembled in situ. The support structure comprises a braided tube that is very flexible and, when elongated, becomes very long and very small in diameter, thereby being capable of placement within a small diameter catheter. The support structure is preferably constructed of one or more thin strands of a super-elastic or shape memory material such as Nitinol. When released from the catheter, the support structure folds itself into a longitudinally compact configuration. The support structure thus gains significant strength as the number of folds increase. This radial strength obviates the need for a support stent. The support structure may include attachment points for a prosthetic valve.

Description:
CROSS-REFERENCE TO RELATED DOCUMENTS  
       [0001]     This application is related to and claims priority benefit of U.S. Provisional Patent Application Ser. No. 60/685,349, filed May 27, 2005, entitled Stentless Support Structure, by Wilson et al. and U.S. Provisional Patent Application Ser. No. 60/709,595, filed Aug. 18, 2005, entitled Stentless Support Structure by Wilson et al. These applications are also hereby incorporated by reference herein. This application also incorporates by reference U.S. patent application Ser. No. ______ entitled Intravascular Cuff filed by Applicant on even date herewith and U.S. Provisional Patent Application Ser. No. 60/685,433, filed May 27, 2005, entitled Intravascular Cuff 
     
    
     BACKGROUND OF THE INVENTION  
       [0002]     There has been a significant movement toward developing and performing cardiovascular surgeries using a percutaneous approach. Through the use of one or more catheters that are introduced through, for example, the femoral artery, tools and devices can be delivered to a desired area in the cardiovascular system to perform many number of complicated procedures that normally otherwise require an invasive surgical procedure. Such approaches greatly reduce the trauma endured by the patient and can significantly reduce recovery periods. The percutaneous approach is particularly attractive as an alternative to performing open-heart surgery.  
         [0003]     Valve replacement surgery provides one example of an area where percutaneous solutions are being developed. A number of diseases result in a thickening, and subsequent immobility or reduced mobility, of heart valve leaflets. Such immobility also may lead to a narrowing, or stenosis, of the passageway through the valve. The increased resistance to blood flow that a stenosed valve presents can eventually lead to heart failure and ultimately death.  
         [0004]     Treating valve stenosis or regurgitation has heretofore involved complete removal of the existing native valve through an open-heart procedure followed by the implantation of a prosthetic valve. Naturally, this is a heavily invasive procedure and inflicts great trauma on the body leading usually to great discomfort and considerable recovery time. It is also a sophisticated procedure that requires great expertise and talent to perform.  
         [0005]     Historically, such valve replacement surgery has been performed using traditional open-heart surgery where the chest is opened, the heart stopped, the patient placed on cardiopulmonary bypass, the native valve excised and the replacement valve attached. A proposed percutaneous valve replacement alternative method on the other hand, is disclosed in U.S. Pat. No. 6,168,614 (the entire contents of which are hereby incorporated by reference) issued to Andersen et al. In this patent, the prosthetic valve is mounted on a stent that is collapsed to a size that fits within a catheter. The catheter is then inserted into the patient&#39;s vasculature and moved so as to position the collapsed stent at the location of the native valve. A deployment mechanism is activated that expands the stent containing the replacement valve against the valve cusps. The expanded structure includes a stent configured to have a valve shape with valve leaflet supports begins to take on the function of the native valve. As a result, a full valve replacement has been achieved but at a significantly reduced physical impact to the patient.  
         [0006]     However, this approach has decided shortcomings. One particular drawback with the percutaneous approach disclosed in the Andersen &#39;614 patent is the difficulty in preventing leakage around the perimeter of the new valve after implantation. Since the tissue of the native valve remains within the lumen, there is a strong likelihood that the commissural junctions and fusion points of the valve tissue (as pushed apart and fixed by the stent) will make sealing around the prosthetic valve difficult. In practice, this has often led to severe leakage of blood around the stent apparatus.  
         [0007]     Other drawbacks of the Andersen &#39;614 approach pertain to its reliance on stents as support scaffolding for the prosthetic valve. First, stents can create emboli when they expand. Second, stents are typically not effective at trapping the emboli they dislodge, either during or after deployment. Third, stents do not typically conform to the features of the native lumen in which they are placed, making a prosthetic valve housed within a stent subject to paravalvular leakage. Fourth, stents are subject to a tradeoff between strength and compressibility. Fifth, stents cannot be retrieved once deployed. Sixth, the inclusion of the valve within the stent necessarily increases the collapsed diameter of the stent-valve complex and increases the caliber of the material that must be delivered into the vasculature.  
         [0008]     As to the first drawback, stents usually fall into one of two categories: self-expanding stents and expandable stents. Self-expanding stents are compressed when loaded into a catheter and expand to their original, non-compressed size when released from the catheter. These are typically made of Nitinol. Balloon expandable stents are loaded into a catheter in a compressed but relaxed state. These are typically made from stainless steel or other malleable metals. A balloon is placed within the stent. Upon deployment, the catheter is retracted and the balloon inflated, thereby expanding the stent to a desired size. Both of these stent types exhibit significant force upon expansion. The force is usually strong enough to crack or pop thrombosis, thereby causing pieces of atherosclerotic plaque to dislodge and become emboli. If the stent is being implanted to treat a stenosed vessel, a certain degree of such expansion is desirable. However, if the stent is merely being implanted to displace native valves, less force may be desirable to reduce the chance of creating emboli.  
         [0009]     As to the second drawback, if emboli are created, expanded stents usually have members that are too spaced apart to be effective to trap any dislodged material. Often, secondary precautions must be taken including the use of nets and irrigation ports.  
         [0010]     The third drawback is due to the relative inflexibility of stents. Stents typically rely on the elastic nature of the native vessel to conform around the stent. Stents used to open a restricted vessel do not require a seal between the vessel and the stent. However, when using a stent to displace native valves and house a prosthetic valve, a seal between the stent and the vessel is necessary to prevent paravalvular leakage. Due to the non-conforming nature of stents, this seal is hard to achieve, especially when displacing stenosed valve leaflets.  
         [0011]     The fourth drawback is the tradeoff between compressibility and strength. Stents are made stronger or larger by manufacturing them with thicker members. Stronger stents are thus not as compressible as weaker stents. Most stents suitable for use in a valve are not compressible enough to be placed in a small diameter catheter, such as a 20 Fr, 16 Fr or even 14 Fr catheter. Larger delivery catheters are more difficult to maneuver to a target area and also result in more trauma to the patient.  
         [0012]     The fifth drawback of stents is that they are not easily retrievable. Once deployed, a stent may not be recompressed and drawn back into the catheter for repositioning due to the non-elastic deformation (stainless steel) or the radial force required to maintain the stent in place (Nitinol). Thus, if a physician is unsatisfied with the deployed location or orientation of a stent, there is little he or she can do to correct the problem.  
         [0013]     The sixth drawback listed above is that the combination of the valve within the stent greatly increases the size of the system required to deliver the prosthetic device. As a result, the size of the entry hole into the vasculature is large and often precludes therapy, particularly in children, smaller adults or patients with pre-existing vascular disease.  
         [0014]     It is thus an object of the present invention to address these drawbacks. Specifically, it is an object of the invention to provide a support structure that expands gently, with gradual force, thereby minimizing the generation of emboli.  
         [0015]     It is further an object of the invention to provide a support structure that traps any emboli generated, thereby preventing the emboli from causing damage downstream.  
         [0016]     It is yet another object of the invention to provide a support structure that conforms to the features of the lumen in which it is being deployed, thereby preventing paravalvular leakage.  
         [0017]     It is still another object of the invention to provide a strong support structure capable of being deployed from a very small diameter catheter.  
         [0018]     It is further an object of the invention to provide a support structure that is capable of being retracted back into a delivery catheter and redeployed therefrom.  
         [0019]     It is another object of the invention to provide a device that is delivered with the valve distinctly separated from the inside diameter of the final configuration of the support structure in order to reduce the amount of space required to deliver the device within the vasculature of the patient.  
       BRIEF SUMMARY OF THE INVENTION  
       [0020]     The present invention accomplishes the aforementioned objects by providing a tubular mesh support structure for a native lumen that is capable of being delivered via a very small diameter delivery catheter. The tubular mesh is formed one or more fine strands braided together into an elongate tube. The strands may be fibrous, non-fibrous, multifilament, or monofilament. The strands exhibit shape memory such that the elongate tube may be formed into a desired folded shape, then stretched out into a very small diameter, elongated configuration. The small diameter, elongated configuration makes a very small diameter delivery catheter possible.  
         [0021]     Upon deployment, the elongated tube is slowly pushed out of the delivery catheter, where it gradually regains its folded, constructed configuration. The tube conforms to the internal geometries of the target vessel. In addition, the braid effectively traps all emboli that may be released from the vessel walls.  
         [0022]     As the tube continues to be pushed from the delivery catheter, it begins to fold in upon itself as it regains its constructed configuration. As it folds in upon itself, the forces exerted by each layer add together, making the structure incrementally stronger. Thus, varying levels of strength may be achieved without changing the elongated diameter of the device.  
         [0023]     Using this folded tube, the valve can be attached such that the valve or other structure (such as a filter) in its elongated configuration within the delivery catheter does not reside within the elongated tube, but on deployment can be positioned in, above or below the tube. 
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0024]      FIG. 1  is a perspective view of a preferred embodiment of the present invention in an elongate configuration;  
         [0025]      FIG. 2  is a side view of a preferred embodiment of the present invention;  
         [0026]      FIGS. 3-12  are a sequence of perspective views of a preferred embodiment of the present invention being deployed from a delivery catheter;  
         [0027]      FIG. 13  is a perspective view of a preferred embodiment of the present invention;  
         [0028]      FIG. 14  is a first end view of the preferred embodiment of  FIG. 13 ;  
         [0029]      FIG. 15  is a second end view of the preferred embodiment of  FIG. 13 ;  
         [0030]      FIG. 16  is a side view of a preferred embodiment of the present invention;  
         [0031]      FIG. 17  is a second end view of the preferred embodiment of  FIG. 16 ;  
         [0032]      FIG. 18  is a first end view of the preferred embodiment of  FIG. 16 ;  
         [0033]      FIG. 19  is a side view of a preferred embodiment of the present invention;  
         [0034]      FIG. 20  is a first end view of the preferred embodiment of  FIG. 19 ;  
         [0035]      FIG. 21  is a second end view of the preferred embodiment of  FIG. 19 ;  
         [0036]      FIG. 22  is a partial perspective view of a preferred embodiment of the present invention;  
         [0037]      FIG. 23  is a partial perspective view of a preferred embodiment of the present invention;  
         [0038]      FIG. 24  is a perspective view of a preferred embodiment of the present invention;  
         [0039]      FIG. 25  is a side elevation of the embodiment of  FIG. 24 ;  
         [0040]      FIG. 26  is a second end view of the embodiment of  FIG. 24 ;  
         [0041]      FIGS. 27-36  are a sequence of perspective views of a preferred embodiment of the present invention being deployed from a delivery catheter against a clear plastic tube representing a native valve;  
         [0042]      FIG. 37  is a side elevation of a preferred embodiment of the present invention;  
         [0043]      FIG. 38  is an end view of a downstream side of the embodiment of  FIG. 37 ;  
         [0044]      FIG. 39  is an end view of an upstream side of the embodiment of  FIG. 37 .  
     
    
     DETAILED DESCRIPTION OF THE INVENTION  
       [0045]     Referring now to the Figures and first to  FIG. 1 , there is shown a stentless support structure  10  of the present invention in an extended configuration. The valve support  10  includes a first end  12 , a second end  14  and an elongate tubular body  16  extending between the first end  12  and the second end  14 .  
         [0046]     The elongate tubular body  16  is preferably formed from one or a plurality of braided strands  18 . The braided strands  18  are strands of a super-elastic or shape memory material such as Nitinol. The strands are braided to form a tube having a central lumen  20  passing therethrough.  
         [0047]     In one embodiment, the tubular body  16  is folded in half upon itself such that the second end  14  becomes a folded end and the first end  12  includes a plurality of unbraided strands. The tubular body  16  is thus two-ply. The unbraided strands of the first end  12  are gathered and joined together to form a plurality of gathered ends  22 . The gathered ends  22  may be used as commissural points for attaching a prosthetic valve to the support structure  10 . (See, e.g.  FIG. 2 ). Alternatively, as shown in  FIG. 1 , the gathered ends  22  may be used as attachment points for a wireform  24  defining a plurality of commissural points  26 .  
         [0048]     Notably, the commissural points  26  are positioned such that, when a valve is attached to the support structure in the extended configuration, the valve is longitudinally juxtaposed with the support structure rather than being located within the support structure. This juxtaposition allows the support structure  10  and valve to be packed into a very small catheter without damaging the delicate valve. This longitudinal juxtaposition may be maintained when the support structure assumes a folded or constructed configuration (see  FIG. 19  for example), or the valve may become folded within the support structure.  
         [0049]      FIGS. 3-6  show the second end  14  emerging from the catheter  28  to expose a first layer  30 . In  FIG. 7 , the first layer  30  is completely exposed and has assumed its constructed configuration. Notably, the first layer  30  contracts longitudinally when fully deployed. Also shown in  FIG. 7  is a second layer  32  beginning to emerge from the catheter  28 . As the second layer exits the catheter, the pre-set super-elastic fold inverts the mesh, such that a second, inner layer is formed within the first outer layer. Alternatively, the first layer can be deployed against the wall of the vascular structure (such as an artery, vein, valve or heart muscle). As the second layer exits the catheter, the physician can aid inversion of the mesh my advancing the deployment system. In another embodiment, the mesh support structure can be advanced in the vasculature such that it is deployed in a reverse direction (such as deployment through the apex of the heart ventricle or from the venous system), where the mesh inversion occurs as a result of pulling or retracting the deployment system.  
         [0050]     In  FIG. 10 , the second layer  32  is fully deployed and the third layer  34  is fully exposed, but has not yet been inverted. Retracting the catheter  28 , relative to the device  10 , while advancing the catheter  28  slightly, relative to the target site, causes the third layer  34  to “pop” inwardly, thereby inverting itself against an inside surface of the second layer  32 , as seen in  FIG. 11 .  
         [0051]     In  FIG. 12 , additional material has been ejected from the catheter  28  such that the third layer  34  is fully expanded against the second layer. One skilled in the art will realize that numerous additional layers can be achieved in this manner, and that each layer adds additional radial strength to the resulting support structure  10 .  
         [0052]     Throughout the deployment process, the stentless support structure  10  emerges from the delivery catheter  28  gradually. This characteristic also allows the structure  10  to be pulled back into the delivery catheter  28 , in the event that it is desired to relocate the support structure  10 . Doing so causes the support structure  10  to reacquire its extended configuration.  
         [0053]     Having described the mechanics of building a support structure in situ, attention can now be turned to various embodiments made possible by the present invention.  FIGS. 13-15  show a support structure  10  having many layers  38  and a first end  12  with numerous gathered ends  22  formed from unbraided strands. Some of the gathered ends  22  are attached to a wireform  24  having three commissural points  26 . A prosthetic valve  36 , either harvested or manufactured, is attached to the wireform  24 .  FIG. 15  shows the internal lumen  20  of the support structure  10 .  
         [0054]      FIGS. 16-18  show a support structure  10  having fewer layers  38  and a wireform  24  with a prosthetic valve  36  attached thereto. The first end  12  (hidden), to which the wireform  24  is attached, has been preformed to fold inwardly upon deployment. Thus, the wireform  24  and prosthetic valve  36 , is located in the inner lumen  20  of the support structure  10  when the support structure  10  is in a constructed configuration.  
         [0055]      FIGS. 19-21  show a support structure  10  with several layers  38  and a first end  12  preformed to have a smaller diameter than the rest of the layers and the second end  14 , which is folded. The terminal ends of the braided strands at the first end  12  have not been formed into gathered ends. Rather, the wireform  24  is attached to the braids. The prosthetic valve  36  is attached to the wireform  24  and has skirting tissue  40 , which is placed around the outside of the end  12 . The skirting tissue  40  may be adhered to the first end  12 .  
         [0056]      FIG. 22  shows a stentless support structure  10  with a folded end  14 , which has been folded back on itself, and a material  42  trapped between the two layers of the fold. The material  42  is provided to further improve the paravalvular leak prevention and embolic trapping characteristics of the stentless support structure  10 . The material  42  could consist of a non-woven material, woven or braided fabric, a polymer or other material.  
         [0057]      FIG. 23  shows a stentless support structure  10  that includes a fiber  44  that is larger than the rest of the strands comprising the support structure  10 . Thus,  FIG. 23  demonstrates that strands of different sizes may be used in the braided support structure  10  without significantly affecting the minimum delivery size of the device. Different sized strands may be used in order to improve strength, provide stiffness, create valve attachment points, provide radiopaque markers, and the like.  
         [0058]      FIGS. 24-26  show a stentless support structure  10  that has a first end  12  that has had the unbraided strands trimmed such that they do not extend past the first end  12  of the folded structure  10 . This embodiment may be used to create, preserve or enlarge a lumen. A prosthetic valve may or may not be attached to this embodiment.  
         [0059]     Turning now to  FIGS. 27-36 , a deployment sequence of a preferred embodiment of the stentless support structure  10  is shown whereby a clear piece of tubing  46  is used to demonstrate a targeted location of a native vessel, such as a native valve. In  FIG. 27 , the delivery catheter  28  is advanced beyond the targeted valve  46  and the stentless support  10  is starting to be ejected from the catheter  28 .  
         [0060]     In  FIG. 28 , enough of the stentless support  10  has been ejected that the second, folded end  14  has begun to curl back on itself slightly, forming a cuff  48 . In  FIG. 29 , the cuff  48  is more visible and has assumed its full, deployed shape. The cuff  48  acts as a catch that a physician can use to visually or tactilely locate the targeted valve  46  and seat the stentless support  10  thereagainst. The cuff also acts to ensure the entire native lumen through the targeted valve  46  is now being filtered by the support  10 . Unlike balloon expandable stents, blood flow is not significantly inhibited by the deployment of the stentless support structure  10 . Also shown in  FIG. 29  is that the first layer  30  has been fully ejected from the catheter  28 , as has much of the second layer  32 . The first layer  30 , being very flexible prior to reinforcement by subsequent layers, is able to conform to any shape of the targeted vessel. The second layer  32  has not yet inverted itself into the first layer  30 .  
         [0061]     In  FIG. 30 , the first layer  30  is deployed, the cuff  48  is acting against the valve  46 , and the second layer  32  has been inverted. In  FIG. 31 , material forming the third layer  34  is ejected from the catheter  28  but the third layer  34  has not yet inverted.  
         [0062]     In  FIGS. 32-33 , the catheter  28  is being advanced to allow the third layer  34  to invert into the second layer  32 . The angle of  FIG. 32  shows the relatively low profile created by the first and second layers  30  and  32 , and how little resistance to blood flow is presented by the support structure  10 .  
         [0063]     In  FIG. 34 , the first end  12  has emerged from the catheter  12 , and the gathered ends  22  are showing. A wireform  24  is attached to some of the gathered ends  22  and is nearly completely deployed from the delivery catheter  28 . In  FIGS. 35-36 , the support structure  10  has been completely released from the catheter  28 .  FIG. 36  shows the size of the lumen  20  of the support structure  10 .  
         [0064]      FIGS. 37-39  show a preferred embodiment  100  of the present invention including a mesh support structure  102 , a wireform  104  and a valve  106 . The support structure  102  differs slightly from support structure  10 , described previously, as it is constructed from a two individual wires  108 . Upon completion of the braiding process, the two free ends of the wire are spliced together. As such, there are no free wire ends and the structure can be loaded into a delivery catheter in a single-ply state (not shown). In the deployed state shown in the Figures, the support structure  102  is folded once to form a two-ply device.  
         [0065]     The support structure  102  is preferably formed of a memory alloy such as Nitinol. The single-wire construction allows the device to be compressed into an extremely small catheter, such as one sized 16 Fr or smaller. Though the support structure gains rigidity by the two-ply deployed configuration, radial strength is a function of a several factors and can thus be varied widely.  
         [0066]     First, as with the other embodiments, radial strength may be increased by incorporating more folds or layers into the deployed configuration of the support structure  102 . The three-ply configuration shown in  FIGS. 37-39  is the most preferred configuration because it only has to be folded in on itself twice, making deployment less complicated.  
         [0067]     Second, strength may be increased by using a heavier wire. Because the support structure  102  is made from a single-wire, and can thus be loaded into a catheter in a single-ply configuration, a larger diameter wire may be used while maintaining a small diameter elongated profile. Support structures  102  have been constructed according to the present invention using single wires having diameters between 0.005 and 0.010 inches in diameter. Preferably, the diameter of the wire is between 0.007 and 0.008 inches.  
         [0068]     Third, strength may be increased by increasing the braid density. A tighter braid will result in a stronger support.  
         [0069]     Fourth, the strength may be increased by altering the heat setting parameters. Super-elastic and shape memory alloys, such as Nitinol, attain their deployed shape within the vasculature by being heat set. The wires are held in a desired configuration and heated to a predetermined temperature for a predetermined period of time. After the wires cool, they become set to the new configuration. If the wires are later disfigured, they will return to the set configuration upon heating or simply releasing the wires. The force with which a super-elastic or shape memory alloy returns to a set configuration can be increased by modifying the temperature at which the configuration is set, or by modifying the period of time the alloy is maintained at the elevated setting temperature. For example, good results have been attained setting a Nitinol support structure of the present invention at 530° C. for 7 minutes. Stiffer support structures can be made using the same Nitinol wire by setting the structure at a temperature other than 530° C. or by setting the structure at 530° C. for a time other than 7 minutes, or both.  
         [0070]     The device  100  includes a wireform  104 , to which a valve  106  is attached. The wireform  104  form commissural points  109  separated by arcuate portions  110 . The arcuate portions  110  are attached to an inside surface of the support structure  102 . The commissural points  109  facilitate natural and efficient opening and closing of the valve  106 . Alternatively, the valve commissural points can be attached to an outer surface of the support structure (not shown).  
         [0071]     The valve  106  may be any form of prosthetic or harvested biological valve. Preferably, as shown in the Figures, the valve  106  is a valve having three leaflets. The valve  106  is sutured or otherwise attached to the wireform  104 . Preferably, the valve  106  is cut or constructed to include a skirt portion  112  which continues along the length of the support structure  102  in its deployed configuration.  
         [0072]     Although the invention has been described in terms of particular embodiments and applications, one of ordinary skill in the art, in light of this teaching, can generate additional embodiments and modifications without departing from the spirit of or exceeding the scope of the claimed invention. Accordingly, it is to be understood that the drawings and descriptions herein are proffered by way of example to facilitate comprehension of the invention and should not be construed to limit the scope thereof.