Abstract:
An apparatus for relining a blood vessel, including a tubular liner of biocompatible material and an anchoring device connected to a distal end thereof. The proximal end of the tubular liner is configured for attachment to a blood vessel following delivery of the apparatus to the blood vessel. The apparatus can include a delivery system, preferably having a removable hub that is initially attached to the tubular liner and a hollow tip that is positioned over the anchoring device.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS  
       [0001]    This application is a continuation of application Ser. No. 09/678,505, filed Oct. 2, 2000, the entirety of which is expressly incorporated by reference as if fully set forth herein. 
     
    
     
       STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT  
         [0002]    Not applicable.  
         REFERENCE TO A COMPACT DISK APPENDIX  
         [0003]    Not applicable.  
         BACKGROUND OF THE INVENTION  
         [0004]    The present invention relates generally to the field of medical devices, and more particularly, to a graft to re-line a debulked vessel.  
           [0005]    Arterial stenosis is a disease of the artery wherein a portion of the vessel becomes occluded, primarily with plaque (atheroma) containing cholesterol, lipid material, macrophages and proliferating smooth muscle cells, consequently restricting blood flow and causing further complications. Traditionally, arterial stenosis has been treated by surgical construction of a bypass channel to connect healthy parts of the vessel around the atheroma. While the bypass method may produce good results, a major disadvantage is the invasiveness of the surgery because the procedure requires general anesthesia and a substantial post-surgical healing period.  
           [0006]    Another, less invasive method of treatment includes balloon catheter angioplasty, where a balloon catheter is inserted into the diseased portion of the vessel and inflated, pushing the atheroma outward and opening the vessel. While balloon catheter angioplasty is much less invasive than bypass surgery, it does not enjoy similar success rates due to frequent restenosis of the vessel. To overcome this problem, stents and other similar endoluminal devices may be inserted to keep the vessel open following angioplasty. Cellular infiltration through the stents&#39; mesh-like structure makes the use of bare stents less than optimal, particularly in longer (&gt;5 cm) legions. Consequently, the stent may be covered with a biocompatible material such as polytetrafluoroethylene (PTFE) to prevent cellular infiltration.  
           [0007]    Endarterectomy is a method for treating occluded portions of a vessel where the atheroma is surgically removed, along with the inner two layers (intima and media) of the three-layered artery. Following the endarterectomy, only the adventitia layer remains, thus the vessel can be prone to cellular accumulation and thrombosis.  
           [0008]    Artherectomy is a method for treating occluded blood vessels where a mechanical device is inserted into the vessel, removing atheroma by cutting or grinding the plaque and creating an open channel. Similar to endarterectomy, this procedure can trigger a cellular response that leads to thrombosis and/or restenosis of the vessel.  
           [0009]    Another term for endarterectomy and artherectomy is “debulking.” Debulking is simply the removal of atheroma, plaque and other tissue to restore blood flow in a vessel. To prevent the cellular response that leads to thrombosis and/or restenosis following a debulking procedure, the vessel can be re-lined with PTFE or other biocompatible materials.  
           [0010]    Many delivery systems have been used for introducing stents, grafts, and other endoluminal devices into bodily vessels with minimum invasiveness. One problem with a number of these systems, however, is that they require multiple components and procedural steps to deliver and deploy the device against the vessel wall. In addition, grafts and other endoluminal devices used to currently re-line vessels are not optimal due to problems with effectively anchoring the device within the vessel.  
           [0011]    The present invention overcomes these stated drawbacks by providing a simple delivery system and device to re-line a vessel following debulking.  
         BRIEF SUMMARY OF THE INVENTION  
         [0012]    The present invention is directed to a delivery system and device for re-lining blood vessels. In particular, following debulking procedures, a graft containing a stent or other fixation device is deployed slightly distal to the debulked section of the vessel. A small balloon on the shaft of the delivery catheter is inflated to ensure good opposition of the graft to the vessel wall. Next, the delivery system is removed through the newly implanted graft, which is sutured proximally to the debulked vessel.  
           [0013]    It is an object of this invention to provide an endoluminal vascular graft device to re-line a debulked vessel as a less invasive alternative to traditional surgical bypass.  
           [0014]    It is another object of this invention to provide an endoluminal vascular graft device that has a minimal profile when loaded into an insertion system, can be seen with fluoroscopic imaging and can be deployed quickly and easily.  
           [0015]    It is yet another object of this invention to provide a delivery system to introduce the endoluminal vascular graft device quickly, easily and effectively within the debulked vessel.  
           [0016]    These and additional objects are accomplished by delivering a graft with an attached stent or other support structure to a debulked vessel. The replacement lining is delivered to the desired site by using a delivery system, including a tip to house the stent, a sliding hub attached to the graft lining material, and an inner shaft connected to the tip.  
           [0017]    To prepare the replacement lining for delivery, the distal stent is bonded, attached or encapsulated to the graft material. The graft material can either be supported, unsupported, or a combination of the two to resist compression. The distal portion is compressed into the atraumatic tip for delivery to the desired site within the treated vessel. Ideally, a self-expanding stent is used for this purpose so that the deployment of the stent occurs quickly, as soon as it is released from the atraumatic tip, thus ensuring that the stent can be deployed at the pre-selected location without migration in either direction within the vessel.  
           [0018]    The atraumatic tip is connected to an inner shaft that extends through the compressed stent and graft material to the proximal end of the delivery device. The connection between the tip and the shaft allows the device to be maneuvered as it is being inserted into the vessel. Optionally coupled to the shaft, proximal to the loaded stent, is a balloon that is positioned to be inside of the stent after the stent is removed from the atraumatic tip. Once the stent is removed from the atraumatic tip and expands to come into contact with the vessel wall, the balloon can be inflated to ensure a good fit to the vessel wall. A sliding hub is attached to the proximal end of the graft lining material so that the distal stent can be pulled out of the atraumatic tip. After the delivery system is removed from the vessel and the graft lining material is pulled taut, the sliding hub is cut off of the graft lining material and the lining material is sutured to the treated vessel.  
           [0019]    A more complete understanding of the endoluminally placed vascular graft and delivery system will be afforded to those skilled in the art, as well as a realization of additional advantages and objects thereof, by a consideration of the following detailed description of the preferred embodiment. Reference will be made to the appended sheets of drawings, which will first be described briefly. 
       
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0020]    [0020]FIG. 1 is a perspective view of a distal end of the vascular graft device after it has been deployed from the catheter.  
         [0021]    [0021]FIG. 2 is a cross-sectional view of a preferred embodiment of the vascular graft device and delivery system of the present invention.  
         [0022]    [0022]FIG. 3A is a cross-sectional view of the present invention being delivered in vivo.  
         [0023]    [0023]FIG. 3B is cross-sectional view of the present invention after the stent has been deployed from the atraumatic tip.  
         [0024]    [0024]FIG. 3C is a cross-sectional view of the present invention as the stent is tightly fit to the vessel wall.  
         [0025]    [0025]FIG. 3D is a cross-sectional view of the present invention as the delivery system is being removed from inside the replacement lining.  
         [0026]    [0026]FIG. 4 is a cross-sectional view of an alternate embodiment of the present invention. 
     
    
     DETAILED DESCRIPTION OF THE INVENTION  
       [0027]    The following detailed description should be read with reference to the drawings, in which like elements in different drawings are identically numbered. The drawings, which are not necessarily to scale, depict selected preferred embodiments and are not intended to limit the scope of the invention. The detailed description illustrates by way of example, not by way of limitation, the principles of the invention. This description will clearly enable one skilled in the art to make and use the invention, and describes several embodiments, adaptations, variations, alternatives and uses of the invention, including what is presently believed to be the best mode of carrying out the invention.  
         [0028]    The present invention satisfies the need for a replacement lining for a vessel and a method of delivering the lining to a desired location. This is accomplished by bonding, attaching or encapsulating a stent at one end of a biocompatible plastic lining material and loading the stent and lining into a delivery system including an atraumatic tip, a sliding hub and an inner shaft with a balloon.  
         [0029]    Referring now to the drawings, in which like reference numbers represent similar or identical structures throughout, FIG. 1 illustrates a preferred embodiment of the replacement lining of the present invention. A distal end of a replacement lining  20  is shown with a shadow view of a stent  22  attached thereto. The stent  22  may be attached to the lining  20  at its distal end in any number of ways including, but not limited to, direct bonding, bonding with the use of an adhesive material, and encapsulation with the use of an additional tubular portion of ePTFE. The stent  22  can be attached to the luminal or abluminal surface of the lining, or in the case of encapsulation, the stent can have the lining as its luminal or abluminal surface. The lining is a biocompatible graft material, which in the preferred embodiment is expanded polytetrafluoroethylene (ePTFE). The preferred ePTFE is one optimized for bond strength as described in U.S. Pat. No. 5,749,880, incorporated by reference herein. In FIG. 1, the stent  22  is self-expanding, thus not requiring any external force to conform to the sides of the vessel wall in which it is placed. However, many other stent configurations are possible, including various self-expanding and balloon-expandable stents.  
         [0030]    [0030]FIG. 1 shows encapsulation of the stent  22  as the attachment method to the lining  20 . The stent  22  is encapsulated between two layers of ePTFE  24  and  26  by utilizing a mandrel assembly. Once the appropriate ePTFE coverings are placed onto the luminal and abluminal surfaces, the stent  22  is encapsulated within the replacement lining  20  at the lining&#39;s distal end by connecting or bonding the luminal covering  26  to the abluminal covering  24 . The replacement lining  20  represents the continuation of the ePTFE covering whether it be a continuation of the abluminal covering  24  from the stent to the proximal end of the device  10  (see FIG. 2), the luminal covering  26 , or both luminal and abluminal coverings  24  and  26 . Encapsulation can be accomplished by a number of methods as is well-known in the art.  
         [0031]    [0031]FIG. 2 illustrates a cross-section of the delivery system  10  containing the replacement lining  20  before introduction into the vessel of a patient. The delivery system  10  contains an atraumatic tip  32  that encloses the stent  22  in a small-diameter state, after it has been reduced in size by any of the known loading methods, including the method disclosed in U.S. Pat. No. 6,096,027, which is incorporated by reference herein. Attached to the atraumatic tip  32 , extending the length of the delivery system  10 , is a shaft  30  that connects the tip  32  to a stopper  36 . Built into the stopper  36  is a hub  38  for the inflation of an optional balloon  34  located proximally a short distance from the loaded stent  22  along the shaft  30 . The optional balloon  34  has radiopaque markers  35  situated at both ends to reveal the proximal and distal ends of the balloon  34  to assist in the positioning of the balloon  34  with respect to the stent  22 . The stent  22  is attached to the biocompatible replacement lining  20  at the distal end thereof. At the proximal end of the replacement lining  20 , a sliding hub  28  is attached to the lining  20  to pull back the replacement lining  20  from the atraumatic tip  32  and deploy the stent  22  and replacement lining  20  within a vessel.  
         [0032]    [0032]FIGS. 3A through 3D illustrate the replacement lining  20  as it is deployed within a vessel  40 . In FIG. 3A, the delivery system  10  is introduced into the vessel  40  through a single entry point (not shown), distal to the end of the endarterectomy or atherectomy, in which the replacement lining  20  is to be implanted. The delivery system  10  can be manipulated through the vessel  40  by the stopper  36  due to the rigidity of the shaft  30 , which is connected proximally to the stopper  36  and distally to the atraumatic tip  32  (shown in FIG. 2). In order to monitor the device  10  as it is guided through the treated vessel  40 , markers can be placed on or encapsulated within the replacement liner  20 , on the stent  22 , and/or on the optional balloon  34  (as shown in FIGS.  2 - 4 ) when included as a part of the device  10 . Once the device  10  has reached the desired location within the vessel  40 , the stent  22  is removed from the atraumatic tip  32  and deployed within the vessel  40  as shown in FIG. 3B.  
         [0033]    Referring again to FIG. 2, the deployment of the stent  22  is preferably accomplished by holding the stopper  36  steady while pulling the sliding hub  28 , attached to lining  20 , toward the stopper  36 . This action pulls the stent  22  attached to a distal end of the lining  20  out of the atraumatic tip  32 , allowing the stent  22  to self-expand to its pre-loaded diameter to bring it and the attached lining  20  in close proximity to the vessel wall  42 . Alternatively, the stopper  36  can be pushed toward the sliding hub  28  while the hub is held steady, thereby pushing the atraumatic tip  32  off of the stent  22 . The optional balloon  34 , when present, is positioned proximal to the stent  22  so that removal of the stent  22  from the atraumatic tip  32  places the expanding stent  22  over the top of the balloon  34  as shown in FIG. 3B. The balloon  34 , which is then within the lumen created by the stent  22  as the stent  22  expands close to the vessel wall  42 , can be inflated to come into contact with the stent  22  as shown in FIG. 3C, thus ensuring a tight fit to the vessel wall  42 .  
         [0034]    Referring to FIG. 3D, once the replacement lining  20  has been implanted within the vessel  40 , the delivery system  10  is withdrawn from the vessel  40  through the replacement lining  20 . The stopper  36 , with atraumatic tip  32  in tow, is pulled through the lining  20  and out of the single incision site (not shown). Prior to removing the delivery system  10 , the sliding hub  28  is detached from the lining  20  by cutting the lining material near the hub  28 . The remaining lining material is then surgically attached to the vessel  40  wall through suturing or other accepted medical procedures, thus completing the proximal anastomosis.  
         [0035]    [0035]FIG. 4 illustrates an alternate embodiment of the vascular graft device and delivery system of the present invention. In this embodiment, a delivery system  100  contains many of the same features as those of the delivery system  10  shown in FIG. 2, including the atraumatic tip  32 , the shaft  30  that connects the atraumatic tip  32  to the stopper  36 , and the balloon  34 . In this embodiment, however, in addition to the stent  22  that is initially constrained within the atraumatic tip  32 , there are several small balloon-expandable stents  42 ,  52 , and  62  located at axially spaced apart intervals along the replacement lining  20 . These stents can be expanded by the balloon  34  as it is withdrawn in a proximal direction. Only those areas requiring such support need to have a stent expanded in the corresponding location in the replacement lining  20 . Thus, any vessel irregularity can be tailored according to stents that are expanded. It should be appreciated that any number of stents can be placed along the replacement lining  20 . By having numerous stents placed at spaced apart intervals, the physician is permitted great flexibility in tailoring the present invention to each individual procedure.  
         [0036]    Having thus described a preferred embodiment of the endoluminally placed vascular graft, it will be apparent by those skilled in the art how certain advantages of the present invention have been achieved. It should also be appreciated that various modifications, adaptations, and alternative embodiments thereof may be made. For example, while replacement linings with ePTFE have been illustrated, it should be apparent that the inventive concepts described herein would be equally applicable to other types of biocompatible covering materials. Moreover, the words used in this specification to describe the invention and its various embodiments are to be understood not only in the sense of their commonly defined meanings, but to include by special definition in this specification structure, material or acts beyond the scope of the commonly defined meanings. The definitions of the words or elements of the following claims are, therefore, defined in this specification to include not only the combination of elements which are literally set forth, but all equivalent structure, material or acts for performing substantially the same function in substantially the same way to obtain substantially the same result. The described embodiments are to be considered illustrative rather than restrictive. The invention is further defined by the following claims.