Patent Publication Number: US-7594926-B2

Title: Methods, systems and devices for delivering stents

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This patent application claims priority to U.S. Provisional Patent Application Ser. No. 60/344,661, filed Nov. 9, 2001, U.S. Provisional Patent Application Ser. No. 60/345,333, filed Nov. 9, 2001, U.S. Provisional Patent Application Ser. No. 60/347,500, filed Jan. 11, 2002, and U.S. Provisional Patent Application Ser. No. 60/341,092, filed Dec. 12, 2001, the disclosures of which are herein incorporated by this reference. 
    
    
     BACKGROUND OF THE INVENTION 
     1. The Field of the Invention 
     The invention generally relates to the field of interventional cardiology. More specifically, the invention relates to interventional cardiology procedures that require the placing of a stent in a body lumen, such as a body lumen of a patient or animal. The present invention further relates to systems for providing embolic protection during placing of a stent in a body lumen. 
     2. The Relevant Technology 
     Human blood vessels often become occluded or blocked by plaque, thrombi, other deposits, or material that reduce the blood carrying capacity of the vessel. Should the blockage occur at a critical place in the circulatory system, serious and permanent injury, and even death, can occur. To prevent this, some form of medical intervention is usually performed when significant occlusion is detected. 
     Several procedures are now used to open these stenosed or occluded blood vessels in a patient caused by the deposit of plaque or other material on the walls of the blood vessel. Angioplasty, for example, is a widely known procedure wherein an inflatable balloon is introduced into the occluded region. The balloon is inflated, dilating the occlusion, and thereby increasing the intra-luminal diameter. 
     Another procedure is atherectomy. During atherectomy, a catheter is inserted into a narrowed artery to remove the matter occluding or narrowing the artery, i.e., fatty material. The catheter includes a rotating blade or cutter disposed in the top thereof. Also located at the tip are an aperture and a balloon disposed on the opposite side of the catheter tip from the aperture. As the tip is placed in close proximity to the fatty material, the balloon is inflated to force the aperture into contact with the fatty material. When the blade is rotated, portions of the fatty material are shaved off and retained with the interior lumen of the catheter. This process is repeated until a sufficient amount of fatty material is removed and substantially normal blood flow is resumed. 
     In another procedure, introducing a stent into the stenosed region to open the lumen of the vessel treats stenosis within the artery or other blood vessel. The stent typically includes a substantially cylindrical tube or mesh sleeve made from such material as stainless steel or Nitinol. The design of the material permits the diameter of the stent to be radially expanded, while still providing sufficient rigidity such that the stent maintains its shape once it has been enlarged to a desired size. 
     To place a stent, many medical devices are typically used. Once access to the inside of the arterial system is established, usually through the femoral artery, a guide catheter is inserted into the artery and the tip thereof is guided to a position just proximal to the stenosed region to be treated. This guide catheter serves the purpose of allowing other devices to rapidly be delivered to that position without each being carefully guided from the point of access, through the tortuous anatomy of the arterial system to the point of intervention. 
     Typically, a small diameter guidewire is then inserted through the guide catheter and guided to the point distal to the stenosed region. When guidewire access to the lesion is established, and if there is sufficient cross sectional area in the narrowed part of the lesion, a stent, mounted on a delivery device, is installed over the guidewire. When correctly placed within the stenosed region, the stent will then be deployed, propping open the vessel at that point. 
     Various types of stents are used in these cases, but a common one requires that the stent be deployed from, or expanded from, a compressed state by a balloon upon which it is mounted. The balloon is inflated from the proximal end of the delivery device to a high pressure, which both opens the stenosis and embeds the stent into the inner lumen of the vessel at that point. 
     Once the guidewire is placed, the guidewire is used as a guide for all of the other devices that are used in the procedure. These devices have an inner lumen through which the proximal end of the guidewire, which is outside of the body of the patient, is inserted. The device is then slid along the guidewire into the body, allowing the guidewire to guide the device to the required position in the vascular system. The process of sliding another device over the guidewire is commonly known as an exchange. 
     Two basic types of devices facilitate exchanging of stent systems and dilation balloons. The first type of device encloses a guidewire within an inner lumen of the device for the entire length of the device. The second type of device only encloses the guidewire for a small distal segment of the device, with the remainder of the guidewire exiting from the inner lumen of the device through a side hole to allow the device and the guidewire to be side by side. In both cases, control of the guidewire is paramount during the exchange as the correct positioning of the device is reliant upon maintaining the position of the guidewire; this being difficult as at least a section of the guidewire is inaccessible due to it being enclosed in the inner lumen of the device being exchanged. 
     Providing a stent delivery device that reduces the complexity of an interventional procedure would advance the art of stent delivery. Furthermore, reducing the number of devices used to perform a stent implanting procedure would advance the art of stent delivery. 
     In addition, when these interventional procedures are performed, embolic particles may break off, flow down-stream, and cause potential adverse events. Devices are emerging that are designed to catch or filter these particles to prevent their down-stream flow, to occlude the vessel during the intervention, and then allowing the particles to be aspirated out before they may flow downstream. 
     Current technology for embolic protection devices requires that they be delivered in a sheath distal to the point of intervention. This requires crossing the lesion with a large-diameter, relatively stiff device that is itself a potential embolic event that may occur before the embolic protection device is in place. The sheath must then be removed allowing the filter to be deployed in the vessel. After the device is deployed, balloons, stents, or other therapies of choice may be exchanged over the device to treat the area of interest. When the procedure is completed, the embolic protection device is captured by another catheter that is exchanged over the embolic protection device capturing any potential embolic material within it. This relatively complicated procedure adds complexity to providing stenting and other procedures. 
     The device and methods described herein are meant to overcome deficiencies of the current devices allowing quicker, safer and easier protection and stenting procedures to be undertaken. 
     BRIEF SUMMARY OF THE INVENTION 
     Embodiments of the present invention can provide systems, methods, and devices that combine the functionality of a guidewire, a stent delivery device, a dilation balloon, and an embolic protection device, or subset grouping thereof, into a single device insertable into a body lumen. In this manner, embodiments of the present invention reduce the number of devices needed to perform a procedure, decrease the time needed to perform the procedure, reduce the difficulty and complexity of the procedure, thereby creating the potential for safer procedures and increased effectiveness to the patient. 
     In one embodiment, a delivery device includes a guide member having a distal end and a proximal end. The guide member functions as a guide catheter, a guidewire, and a stent delivery device. A dilation assembly is disposed at the distal end of the guide member with a stent preloaded upon the dilation assembly. The distal end of the guide member is configured to apply a restraining force upon the dilation assembly to selectively maintain the dilation assembly and stent within a lumen of the delivery device. Associated with the distal end of the guide member is a restraining member or mechanism that can be operated to release the restraining force applied to the dilation assembly and stent, thereby allowing the dilation assembly and stent to be deployed from within the lumen. The restraining mechanism cooperates with an actuating assembly to deploy the dilation assembly and stent. 
     In one embodiment, the actuating assembly cooperates with a proximal end of the guide member and includes an actuating member that extends from the restraining mechanism or member at a distal end of the delivery device to an actuating element disposed at the proximal end of the guide member. Thus, operation of the actuating element translates movement to the actuating member to release the restraining mechanism or member and release the restraining force applied by the restraining mechanism or member, whether alone or in combination with the distal end of the guide member, upon the dilation assembly and/or the stent. 
     In operation, the delivery device is placed in position within a body lumen of a patient, with the dilation assembly and stent in a restrained position. Operation of the actuating assembly releases the dilation assembly and the stent from within the guide member. The guide member may be pulled proximally to allow the dilation assembly and stent to be entirely free of the guide member. Alternatively, a dilation tube and/or a positioning member connected to the dilation assembly may be advanced distally to deploy the dilation assembly and the stent. The stent may then be placed in the vasculature by inflating the dilation balloon associated with the dilation assembly, for example, through the dilation tube. After the stent is implanted, the dilation assembly is deflated and the delivery device can be removed from the patient. 
     According to another aspect of the present invention, the delivery device can include an embolic protection device that is adapted to collect embolic particles released during the procedure. As the stent is implanted, the embolic protection device can filter the blood flowing past the lesion and prevent embolic particles or matter flowing downstream. In one configuration, the embolic protection device is mounted to a distal end of a guidewire associated with the delivery device. The embolic protection device can be a filter assembly that includes a filter and a filter basket. The filter basket includes a plurality of struts that restrain the filter during insertion of the delivery device into the body lumen, while supporting and deploying the filter upon releasing a restraining force applied to the plurality of struts to maintain the filter assembly in a closed position during insertion of the delivery device. The structures used to apply the restraining force to the plurality of struts can be similar to the structures applying the restraining force to the dilation assembly and/or stent. 
     According to another aspect of one embodiment of the present invention, the delivery device may cooperate with a capture mechanism or device for retrieving the filter assembly without removing the delivery device from the body. 
     Thus, the delivery devices of the present invention allow protected interventions to be accomplished with a single device insertion, without requiring exchanges, while still allowing guidewire access distal to the treatment region throughout the entire procedure. 
     These and other objects and features of the present invention will become more fully apparent from the following description and appended claims, or may be learned by the practice of the invention as set forth hereinafter. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       To further clarify the above and other advantages and features of the present invention, a more particular description of the invention will be rendered by reference to specific embodiments thereof that are illustrated in the appended drawings. It is appreciated that these drawings depict only typical embodiments of the invention and are therefore not to be considered limiting of its scope. The invention will be described and explained with additional specificity and detail through the use of the accompanying drawings in which: 
         FIG. 1  illustrates a perspective view of an exemplary stent delivery device in accordance with one aspect of the present invention; 
         FIG. 2  illustrates a sectional side view of a distal end of the device of  FIG. 1 ; 
         FIG. 3  illustrates a sectional side view of the distal end of the device of  FIG. 1  with a distal end in an unrestrained configuration; 
         FIGS. 4   a  and  4   b  illustrate a sectional side view of the distal end of the device of  FIG. 1  with a deployed dilation assembly; 
         FIG. 5  illustrates a sectional side view of the distal end of the device of  FIG. 1  with associated inflated dilation balloon and implanted stent; 
         FIG. 6  illustrates a sectional side view of an exemplary proximal end of the device of  FIG. 1  in accordance with another aspect of the present invention; 
         FIG. 7  illustrates a plan view of a distal end of another embodiment of the stent delivery device in accordance with another aspect of the present invention; 
         FIG. 8  illustrates a side view of the distal end of the stent delivery device of  FIG. 7  in accordance with one aspect of the present invention; 
         FIG. 9  illustrates a perspective view of a distal end of another embodiment of a stent delivery device in accordance with one aspect of the present invention; 
         FIG. 10  illustrates a perspective view of the distal end of the stent delivery device of  FIG. 9  with deployed dilation assembly in accordance with one aspect of the present invention; 
         FIG. 11  illustrates a perspective view of another embodiment of a stent delivery device of the present invention; 
         FIG. 12  illustrates another perspective view of the distal end of the delivery device of  FIG. 11  before a restraining member is coupled to the delivery device; 
         FIG. 13  illustrates a perspective view of the distal end of the delivery device of  FIG. 11 , illustrating the restraining member partially coupled to the delivery device; 
         FIG. 14  illustrates a side view of another restraining mechanism usable with the delivery device of  FIG. 11  in accordance with one aspect of the present invention; 
         FIG. 15  illustrates a perspective view of another embodiment of the stent delivery device in accordance with one aspect of the present invention; 
         FIG. 16  illustrates a perspective view of the distal end of the delivery device of  FIG. 15  before a restraining mechanism is coupled to the delivery device; 
         FIG. 17  illustrates a side view of the delivery device of  FIG. 15  illustrating the restraining member partially coupled to the delivery device; 
         FIG. 18  illustrates a side view of the delivery device of  FIG. 15  illustrating the restraining member partially coupled to the delivery device; 
         FIG. 19  illustrates a side view of the delivery device of  FIG. 15  illustrating the restraining member partially coupled to the delivery device; 
         FIG. 20  illustrates a perspective view of another embodiment of a stent delivery device in accordance with another aspect of the present invention; 
         FIG. 21  illustrates a perspective view of another embodiment of a stent delivery device in accordance with another aspect of the present invention; 
         FIG. 22  illustrates a side view of the delivery device of  FIG. 21  before the restraining mechanism is coupled to the delivery device; 
         FIG. 23  illustrates a side view of the delivery device of  FIG. 21  illustrating the restraining member partially coupled to the delivery device; 
         FIG. 24  illustrates a perspective view of the delivery device of  FIG. 21  having the restraining mechanism coupled to a distal end thereof; 
         FIG. 25  illustrates a perspective view of a proximal end of another embodiment of a stent delivery device in accordance with another aspect of the present invention; 
         FIG. 26  illustrates a perspective view of a proximal end of yet another embodiment of a stent delivery device in accordance with another aspect of the present invention; 
         FIG. 27  illustrates a perspective view of a proximal end of yet another embodiment of a stent delivery device in accordance with another aspect of the present invention; 
         FIG. 28  illustrates another embodiment of the proximal end of another embodiment of a stent delivery device in accordance with another aspect of the present invention; 
         FIG. 29  illustrates a sectional side view of another embodiment of a stent delivery device of the present invention in accordance with another aspect of the present invention; 
         FIG. 30  illustrates a sectional side view of the distal end of the stent delivery device of  FIG. 30  in accordance with another aspect of the present invention; 
         FIG. 31  illustrate sectional side views of another embodiment of a stent delivery device in accordance with another aspect of the present invention; 
         FIG. 32  illustrates a sectional side view of another embodiment of a stent delivery device in accordance with another aspect of the present invention; 
         FIG. 33  illustrates a sectional side view of another embodiment of a stent delivery device in accordance with another aspect of the present invention; 
         FIG. 34  illustrates a sectional side view of yet another embodiment of a stent delivery device in accordance with another aspect of the present invention; 
         FIG. 35  illustrates a sectional side view of still another embodiment of a stent delivery device in accordance with another aspect of the present invention; 
         FIG. 36  illustrates a sectional side view of another embodiment of a stent delivery device in accordance with another aspect of the present invention; 
         FIG. 37  illustrates a sectional side view of an embodiment of a stent delivery device that includes an embolic protection device in accordance with another aspect of the present invention; 
         FIG. 38  illustrates a sectional side view of a distal end of the delivery device of  FIG. 37 ; 
         FIG. 39  illustrates a sectional side view of a portion of the delivery device of  FIG. 37  with a filter assembly deployed in accordance with another aspect of the present invention; 
         FIG. 40  illustrates a sectional side view of a portion of the delivery device of  FIG. 37  with the filter assembly and the stent deployed in accordance with another aspect of the present invention; 
         FIG. 41  illustrates a perspective view of a restraining mechanism for a filter assembly usable with the delivery device of  FIG. 37  in accordance with another aspect of the present invention; 
         FIG. 42  illustrates a perspective view of a filter assembly usable with the delivery device of  FIG. 37  in accordance with another aspect of the present invention; 
         FIG. 43  illustrates a perspective view of the embodiment of the filter assembly of  FIG. 42  in accordance with another aspect of the present invention; 
         FIG. 44  illustrates a perspective partial sectional view of a distal end of another embodiment of a delivery device in accordance with another aspect of the present invention; 
         FIG. 45  illustrates a perspective view of an embodiment of a capture mechanism according to one aspect of the present invention; and 
         FIG. 46  illustrates a perspective view of another embodiment of a capture mechanism according to one aspect of the present invention. 
     
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS 
     The present invention provides systems, methods, and devices that combine the functionality of a guide catheter, a guidewire, a stent delivery device, a dilation balloon, and/or an embolic protection device, or a subset group of such devices, into a single device that is insertable into a body lumen. In this manner, the present invention reduces the number of devices needed to deliver and position a stent, providing the possibility of decreasing the time needed to perform procedures and reducing the difficulty and complexity associated with performing a procedure. Further, embodiments of the present invention aid with decreasing the possibility of patient complications during and subsequent to the procedure. 
     Referring now to  FIG. 1 , depicted is an exemplary embodiment of a delivery device of the present invention, designated by reference number  10 . As illustrated, delivery device  10  includes a guide member  12  having a distal end  14  and a proximal end  16 . The term “guide member” can refer to any structure that is capable of functioning as a guidewire that can be steered through the tortuous anatomy of a patient. It will be appreciated that guide member  12  can be hollow or partially hollow depending upon design considerations. 
     Extending between distal end  14  and proximal end  16  of guide member  12  is a lumen  18  within which is disposed a dilation assembly  40  and a stent  42  (see  FIG. 2 ). Distal end  14  of guide member  12  includes a tip  15  that is configured for percutaneous insertion into a body lumen, while proximal end  16  either includes or is adapted to cooperate with an actuating assembly  20  that is adapted to deploy dilation assembly  40  and/or stent  42 . 
     Illustratively, guide member  12  can have an outside diameter of between about 0.010 inches to about 0.650 inches and an inside diameter or diameter of lumen  18  from about 0.004 inches to about 0.55 inches. Additionally, guide member  12  can be fabricated from a variety of different materials. For example, guide member  12  can be fabricated from Nitinol, steel, metals, metal alloys, composites, plastic, polymers, synthetic materials, such as, but not limited to, PEEK, Rydel, or combinations thereof. Additionally, guide member  12  can have the configuration of a braid-reinforced polymer tube or a rigid polymer tube. Furthermore, guide member  12  can be covered with one or more coatings. For instance, and not by way of limitation, guide member  12  can include one or more coatings that improve lubricity, reduce platelet aggregation, or have anti-thrombogenic properties. In addition to the above, guide member  12  can include one or more hydrophilic coatings, heparinized coatings, Polytetrafluoroethylene (PTFE) coatings, silicone coatings, combinations thereof, or other coatings that may aid with positioning guide member  12  and/or preventing damage to the body lumen. 
     Optionally, guide member  12  may include one or more cuts, slits, grooves, or other structures, illustratively identified by numeral  17 , that provide flexibility to all or a portion of guide member  12 . Although reference is made to use of cuts, slits, or grooves to provide flexibility, it can be appreciated by one skilled in the art that guide member  12  or other portion of device  10  may have a lattice structure, i.e., portions of guide member  12  or device  10  removed therefrom, which provides flexibility to a portion of guide member  12  and/or other portion of device  10 . 
     The cuts, slits, or grooves can be located at any location of guide member  12  and may have various pitches to allow or provide for different flexibilities. These one or more grooves, cuts or slits can partially or completely extend through portions of guide member  12 . Additionally, these grooves, cuts, or slits can have a variety of different configurations, such as but not limited to, straight, helical, geometric, combinations thereof, or various other configurations known to those skilled in the art, so long as those same provide flexibility to guide member  12 . Further, any number of grooves, cuts, or slits can be included in guide member  12  and optionally portions of dilation assembly  40 . For example, the more grooves, cuts, or slits included in guide member  12  or a portion of dilation assembly  40 , the greater the flexibility of guide member  12 , and hence delivery device  10 . Similarly, the depth of each groove, cut, or slit can vary depending upon the desired flexibility. For instance, the deeper the groove, cut, or slit, the greater the flexibility of guide member  12 , and hence delivery device  10 . Furthermore, differences in the configuration of each groove, cut, or slit can affect the flexibility of guide member  12  and therefore delivery device  10 . For instance, the steeper the sides of a particular groove, cut, or slit, the less flexibility provided to guide member  12  and/or delivery device  10 . 
       FIG. 1  depicts dilation assembly  40  and stent  42  ( FIG. 2 ) disposed at tip  15  of guide member  12 . Dilation assembly  40  terminates in an atraumatic tip  48 . Dilation assembly  40  and stent  42  are retained at tip  15  of guide member  12  by a restraining mechanism or restraining member  25 . In the embodiment of  FIG. 1 , an actuating member  28  operates restraining member  25  and extends to an actuating assembly  20  disposed at a proximal end of device  10 . Actuating member  28  extends to the proximal end of device  10  and is exposed to allow the restraint applied by restraining member  25  to be released as a clinician moves actuating member  28  in a proximal direction. Alternatively, actuating member  28  can optionally extend outside guide member  12  to proximal end  16  of device  10 . 
     Dilation assembly  40  is connected to a dilation tube  44  that extends along the length of guide member  12 . Dilation tube  44  is used to fill a dilation balloon  46  with a fluid. The fluid may be introduced through a luer lock fitting  45  located at proximal end  16  of guide member  12 . Dilation tube  44  may also be used, in some embodiments, as a positioning member for deploying dilation assembly  40  and stent  42 . Additionally, dilation assembly  40  of device  10  is coupled by dilation tube  44  to actuating element  21 . By sliding actuating element  21  with respect to proximal end  16  of guide member  12 , dilation assembly  40  is moved with respect to guide member  12  and can be deployed from tip  15  of guide member  12 . These and other features of the present invention will now be described in further detail. 
     With reference now to  FIG. 2 , distal end  14  of guide member  12  includes one or more struts  24  that are adapted to retain dilation assembly  40  and stent  42  within lumen  18  until the same are to be deployed. Each strut  24  can be biased to extend outwardly to release dilation assembly  40  and stent  42 . Although reference is made to each strut  24  being biased to extend outwardly, it can be understood by one skilled in the art that each strut  24  need not be biased to extend outwardly. 
     The one or more struts  24  can be formed using a variety of different processes. For instance, the processes can include, but not limited to, machining processes performed using a laser or conventional machining process, including, but not limited to, hydro-machining, grinding, end milling, slitting saws, abrasive saws, electrical discharge machines, combinations thereof, or other machining processes capable of creating slots or slits sufficient to form one or more struts  24 . In the embodiment of  FIG. 2 , each strut  24  can be formed integrally with guide member  12 . In other embodiments, one or more of struts  24  are formed as part of a discrete strut assembly that is attached to guide member  12 . 
     Surrounding struts  24  is restraining member  25 . In the embodiment of  FIG. 2 , restraining member  25  is a sleeve  26 . Sleeve  26  is adapted to retain or maintain struts  24  in a restrained or closed configuration so that the combination of sleeve  26  and struts  24  maintain dilation assembly  40  and stent  42  within lumen  18 . Sleeve  26  is adapted to cooperate with the exterior of guide member  12  so that sleeve  26  can be displaced in a proximal direction to release struts  24 . Since struts  24 , in this exemplary configuration, are biased to extend outwardly, upon moving sleeve  26  in a proximal direction, struts  24  extend outwardly to release dilation assembly  40  and stent  42 . 
     Sleeve  26  can be fabricated from various types of materials so long as sleeve  26  is capable of securely retaining struts  24 . For instance, sleeve  26  can be fabricated from heat shrink synthetic material, including but not limited to, low-density polyethylene (LDPE), polyethylene terphthalate (PET), Polytetrafluoroethylene (PTFE), fluorinated ethylene propylene (FEP), polyethylene (PE), polyurethane (PU), silicone tubing, and other suitable polymers or synthetic materials. 
     Actuating member  28  extends from sleeve  26 , travels along an exterior of guide member  12 , and passes through an aperture  30  in guide member  12 . Actuating member  28  continues to travel within lumen  18  of guide member  12  until it reaches proximal end  16  of guide member  12 . It will be appreciated that in other embodiments, actuating member  28  may remain external to lumen  18  of guide member  12 . 
     Actuating member  28  can be fabricated from various materials and have various configurations so long as it is capable of performing the function of displacing sleeve  26 . For example, actuating member  28  can be fabricated from plastics, polymers, metals, composites, alloys, synthetic materials, and combinations thereof. 
     As shown in  FIG. 2 , dilation assembly  40  includes a dilation balloon  46  mounted to a dilation tube  44 . Dilation tube  44  extends from distal end  14  of guide member  12  toward proximal end  16  of guide member  12 . Dilation tube  44  can include a plurality of holes  50 . Each hole  50  and/or plurality of holes  50  in combination provide a fluid path to an interior  52  of dilation balloon  46 . In this way, fluid may pass along a lumen  54  of dilation tube  44  to flow into dilation balloon  46 . To restrict the flow of such fluid, atraumatic tip  48  seals the distal end of dilation tube  44 . In addition to providing a fluid path to inflate dilation balloon  46 , holes  50  provide a fluid path to deflate dilation balloon  46  or remove the fluid to deflate dilation balloon  46 . Each hole  50  can have various configurations so long as each hole  50  is capable of allowing fluid to pass therethrough. 
     Dilation tube  44 , in one configuration, is an internal support for dilation balloon  46  and stent  42 . Dilation tube  44  can be fabricated from Nitinol, steel, metals, metal alloys, composites, plastic, and combinations thereof. Further, dilation tube  44  can be covered with a variety of different coatings, such as, but not limited to, one or more coatings to improve lubricity, anti-thrombogenic properties, and reduce platelet aggregation. Other coatings can include, but not limited to, hydrophilic coatings, heparinized coatings, Polytetrafluoroethylene (PTFE) coating, silicone coating, or combinations of the coatings described herein. 
     Dilation tube  44  may have a variety of different configurations and embodiments. In another embodiment, dilation tube  44  includes a proximal end where provision is made for connecting dilation tube  44  to an inflation device with an annular clamping device, such as a touhy-borst adaptor. Alternatively, as shown in  FIG. 1 , a proximal end of dilation tube  44  has the form of a luer fitting, whether the male or female part of the luer fitting. 
     Mounted to a distal end of dilation tube  44  is an atraumatic tip  48 . Atraumatic tip  48  is disposed within lumen  54  of dilation tube  44  and seals dilation tube  44 , prevents fluid from escaping therefrom during inflation and deflation of dilation balloon  46 , and provides a flexible tip that aids in positioning and steering of delivery device  10  through the tortuous anatomy of the patient. In the illustrative embodiment, dilation tube  44  extends to a distal end of dilation balloon  46  and atraumatic tip  48  is disposed therein. Alternatively, dilation tube  44  can extend to a position proximal to the distal end of dilation balloon  46  and a portion of atraumatic tip  48  then extends from a distal end of dilation tube  44  to a position distal to the distal end of dilation balloon  46 . Furthermore, in another alternate embodiment, dilation tube  44  terminates within a lumen formed in atraumatic tip  48 . 
     Atraumatic tip  48  includes a core  56  that is surrounded by a flexible coil  58 . As shown, flexible coil  58  terminates at a distal end of tip  48  with an atraumatic portion, such as a solder ball or other mechanism for forming an atraumatic distal end of tip  48 . More generally, atraumatic tip  48  can have a variety of other configurations so long as atraumatic tip is flexible and optionally shapeable. Furthermore, atraumatic tip  48  may be radiopaque to allow steerable positioning of delivery device  10  while allowing a physician or clinician to observe the location of tip  48  using appropriate devices, such as a fluoroscopic device or X-ray device. Materials that facilitate or provide radiopacity may include, but not limited to, platinum, alloys of platinum, gold, or combinations thereof, metals, alloys, plastic, polymer, synthetic material, combinations thereof, or other materials that provide an appropriate radiopaque signature, while capable of being shaped by a physician or clinician. Alternatively, tip  48  can be a polymer that is dipped or coated with an appropriate radiopaque material, such as, but not limited to, barium sulphate, bismuth subcarbonate, titanium dioxide, or combinations thereof. 
     Referring now to  FIG. 3 , depicted is distal end  14  of delivery device  10  upon disposition of sleeve  26  in a proximal direction. In this illustrative configuration, because struts  24  are biased to extend outwardly, dilation assembly  40  and stent  42  can be deployed from within lumen  18 . Deploying of dilation assembly  40  and stent  42  can occur as guide member  12  is displaced in a proximal direction, dilation tube  44  is displaced in a distal direction, or a combination of proximal and distal movements of guide member  12  and dilation tube  44  respectively. 
     Referring now to  FIG. 4   a , schematically depicted is delivery device  10  in a deployed configuration where dilation assembly  40  and stent  42  have been deployed at a lesion  70  of a body lumen  72 . Deployment of dilation assembly  40  and stent  42  can be achieved through manipulating actuating assembly  20  ( FIGS. 1 and 2 ). Upon positioning dilation balloon  46  and stent  42  to the desired position, such as adjacent to lesion  70 , fluid can be introduced through lumen  54  of dilation tube  44  to expand dilation balloon  46  and therefore deploy or force stent  42  into body lumen  72  and surrounding lesion  70 , as is illustrated in  FIG. 5 . 
     Various configurations of stent  42  are known to those skilled in the art. For example, an expandable stent may be used that automatically opens under the pressure of dilation balloon  46 . In another configuration, a self-expanding stent can be used, as illustrated in  FIG. 4   b  with dotted lines. The self-expanding stent automatically opens as the restraining force applied by struts  24  and/or restraining member  25  is removed and guide member  12  is moved proximal to the stent. In this case, the self-expanding stent surrounds dilation balloon  46 , as illustrated in  FIG. 4   b , or alternatively, the stent can surround dilation tube  44  with dilation balloon  46  being located proximal to the stent and still mounted to dilation tube  44 , as illustrated by dotted lines referenced by numeral  46   b . Various stents may be used with the present invention, so long as the stent can be reduced in size to surround the dilation balloon and be disposed within guide member  12  of delivery device  10 . 
     Referring now to  FIG. 6 , depicted is an exemplary embodiment of actuating assembly  20  that can be used to deploy dilation balloon  46  and stent  42 . Operating actuating assembly  20  releases dilation assembly  40  and stent  42  from a restrained configuration at distal end  14  of guide member  12 . More specifically, dilation balloon  46  forming part of dilation assembly  40  can be deployed with stent  42  being disposed substantially around dilation balloon  46 . 
     As illustrated, actuating assembly  20  includes an actuating element  21  coupled to a proximal end of dilation tube  44 . Actuating element  21  includes a distal end  74  configured to be mounted to and cooperate with proximal end  16  of guide member  12 . A proximal end  76  of actuating element  21  is attached to a proximal end of dilation tube  44 , while a proximal end of actuating member  28  passes through a sealed aperture  47  of actuating element  21 . In this exemplary embodiment, the proximal end of dilation tube  44  includes a luer fitting  45  that allows various complementary luer fittings to be attached thereto. For instance, a syringe (not shown) can be attached to luer fitting  45  for introducing fluid to and removing fluid from dilation balloon  46  ( FIG. 5 ) during inflation and deflation of dilation balloon  46 . Although reference is made to use of luer fitting  45 , it can be understood by one skilled in the art that various other configurations of fitting can be attached to or formed at the proximal end of dilation tube  44 . 
     Actuating element  21  is adapted to be displaced in a distal direction to deploy dilation assembly  40  and stent  42 . To aid with positioning actuating element  21 , distal end  74  can have a step configuration and include protrusions  78  that mate with complementary indentations  80  formed in proximal end  16  of guide member  12 . The protrusions  78  and indentations  80  provide an indication of the relative position of dilation assembly  40  and stent  42  relative to distal end  14  of guide member  12 . Therefore, actuating element  21  and/or guide member  12  can include one or more protrusions and indentations. As actuating element  21  is displaced in a distal direction, protrusions  78  mate with indentations  80 . To seal lumen  18  of guide member  12 , one or more seals  84  surround protrusions  78 . Additionally, one or more seals (not shown) can surround dilation tube  44  and/or actuating member  28 . Illustratively, each seal can be one or more O-rings in one or more grooves, one or more O-rings, a gasket, or a viscous fluid seal. 
     When actuating element  21  is displaced in the distal direction, distal end  74  contacts a wall or stop  82  formed in guide member  12  that prevents further displacement of actuating element  21  in the distal direction. Through this configuration, actuating element  21  is prevented from excessive longitudinal displacement in the distal direction. This stopping of the longitudinal displacement of actuating element  21  indicates that dilation balloon  46  and stent  42  are deployed from within lumen  18  of guide member  12  to the desired position for expanding or implanting stent  42 . 
     Although reference is made to one manner of indicating the particular location of stent  42 , one skilled in the art can identify a variety of different embodiments. For instance, a plurality of indentations and/or protrusions can be included within actuating element  21  and guide member  12  to control the distance which actuating element  21  and, consequently, stent  42  is displaced. In another configuration, a wall or stop formed in actuating element  21  can mate with the distal end of guide member  12  to prevent excessive longitudinal displacement in the distal direction. In still another configuration, a combination of one or more walls or stops in actuating element  21  and guide member  12  can be used. In still another configuration, distal end  74  of actuating element  21  can be tapered and cooperate with a taper formed in proximal end  16  of guide member  12 . The complementary tapers control the longitudinal displacement of actuating element  21  relative to proximal end  16  of guide member  12 . In still other configurations, a combination of indentations, protrusions, walls, stops, threads, or tapers can be used. Various other manners are known to control the distance traveled by actuating element  21  while indicating the position of stent  42 . 
     In addition to the above, it can be appreciated that actuating element  21  can include one or more elements, such that wall or stop  82  and indentations  80  are formed in separate elements or members that are attached or coupled to proximal end  16  of guide member  12 . By so doing, actuating element  21  can be fabricated separately from guide member  12 , thereby reducing costs and expenses associated with fabricating proximal end  16  of guide member  12  in the desired configuration. 
       FIGS. 7 through 24  illustrate alternative embodiments for restraining mechanism  25 . It will be appreciated that many features of the delivery devices depicted in  FIGS. 7 through 24  are substantially similar in structure and function as for delivery device  10 . Consequently, features and functions of one embodiment of the present invention are applicable to other embodiments of the present invention. 
     Referring now to  FIGS. 7 and 8 , another illustrative embodiment of a delivery device  100  of the present invention is depicted. As shown, a guide member  112 , which can be similar to the other guide members described herein, has a distal end  114 , a proximal end (not shown), and a lumen  118  extending from distal end  114  to the proximal end. A tip  115  of guide member  112  includes a plurality of struts  124 , such as two or more struts. Each strut  124  can be optionally biased so that a distal end of each strut  124  moves outwardly from a longitudinal axis of guide member  112  when each strut  124  is released by a restraining member  125 . Although reference is made to each strut  124  being biased, one skilled in the art can appreciate that one or more of struts  124  can be biased. 
     As shown in  FIG. 8 , at least one strut, designated by reference numeral  124   a , is biased toward the longitudinal axis of guide member  112 . Disposed upon strut  124   a , as more clearly seen in  FIG. 7 , is an atraumatic tip  148 . This atraumatic tip  148 , either alone or in combination with strut  124   a , may be shapeable by a physician or clinician before insertion into a body lumen. In this manner, the physician or clinician is able to configure tip  148  with an appropriate shape, such as, but not limited to a “J” shape, which enables guide member  112  to be guided through the tortuous anatomy of a patient. All or a portion of atraumatic tip  148  can be fabricated from platinum, platinum alloys, radiopaque materials, materials doped or coated with a radiopaque material, metals, alloys, plastic, polymer, synthetic material, combinations thereof, or other materials that provide an appropriate radiopaque signature, while are capable of being shaped, whether alone or in combination with strut  124   a , by a physician or clinician. In this configuration, a guidewire with an associated dilation assembly can be disposed within lumen  118 , with a distal end of the guidewire optionally including a flexible atraumatic tip, since atraumatic tip  148  can function as the atraumatic tip for delivery device  100 . 
     To maintain struts  124  in a restrained position, i.e., not extending outwardly from guide member  112 , restraining member  125  surrounds struts  124 . The restraining member  125  and other restraining members or mechanisms described herein are examples of means for applying a restraining force upon one or more struts or means for applying a restraining force upon a distal end of a guide member. In this embodiment, restraining member  125  can extend completely or partially from the distal end to the proximal end of guide member  112 . For example, restraining member  125  can surround substantially only struts  124  or can have a configuration similar to those depicted in  FIGS. 9-24 . 
     In the configuration depicted in  FIGS. 7 and 8 , restraining member  125  or means for applying a restraining force is a catheter  127  that applies a force against struts  124  to prevent struts  124  from extending outwardly or applies a force against struts  124  to maintain a dilation assembly  140  and a stent  142  in lumen  118 . Through displacing guide member  112  with respect to catheter  127 , or vice versa, the force applied to struts  124  is released and, in one configuration, the distal ends of struts  124  are allowed to move outwardly to allow dilation assembly  140  and stent  142  to be deployed. 
     As mentioned above, catheter  127  can extend completely or partially the length of the guide member. In another configuration, catheter  127  can be replaced with a sleeve or other structure that completely or partially extends toward the proximal end of guide member  112  from the distal end. These alternate configurations are also means for applying a restraining force, as described herein. These restraining members or mechanisms can be radiopaque or include one or more radiopaque markers that aid with positioning the device. Furthermore, these restraining members or mechanisms can be slidable relative to the guide member using an actuating member and/or an actuating assembly disposed on an exterior of the guide member, within a lumen of the guide member, or partially within the lumen and partially on the exterior of the guide member. The actuating assembly may be similar in structure and function to actuating assembly  20  described in  FIG. 6  or any other actuating assembly described herein. Therefore, systems, methods, and devices of the present invention can optionally use catheters, sleeves, bands, or other structures described herein interchangeably to perform the desired function of restraining one or more struts or a distal end of the guide member. 
       FIGS. 9 and 10  depict another embodiment of a delivery device  200  of the present invention. As illustrated, delivery device  200  includes a guide member  212  with a plurality of struts  224  disposed at a distal end  214  thereof. Struts  224  are maintained in a restrained position using a restraining member  225 . In this embodiment, restraining member  225  is a sleeve  226  surrounding struts  224 . Sleeve  226  acts as a restraining member or mechanism that applies a force against the struts to prevent the struts from extending outwardly or to maintain the dilation balloon and/or stent within the lumen. 
     Struts  224 , when in a restrained position, maintain dilation assembly  240  and stent  242  within lumen  218  of guide member  212 . Disposed within sleeve  226  or between sleeve  226  and guide member  212  are one or more actuating members  228 . Actuating members  228 , optionally forming part of the restraining mechanism or member, are attached to guide member  212  at a location proximal to the proximal end of each strut  224 , identified by letter A. Actuating members  228  extend distally to the distal end of sleeve  226  and subsequently extend proximally on the outside of sleeve  226  to terminate at the proximal end (not shown) of device  200 . Since one end of each actuating member  228  is located at the proximal end of sleeve  226 , whether forming part of sleeve  226 , attached to sleeve  226 , attached to guide member  212 , or combinations thereof, displacing actuating member  228  in the proximal direction causes actuating member  228  to preferentially separate sleeve  226  into one or more portions  232 , illustrated in dotted lines. By so doing, struts  224  are released, as illustrated in  FIG. 10 . 
     To operate actuating members  228 , a proximal end (not shown) of actuating member  228  extends to a proximal end (not shown) of guide member  212 , either within or without lumen  218  of guide member  212 . Actuating members  228  can extend to an actuating element (not shown) of an actuating assembly, such as, but not limited to, the actuating assembly of  FIG. 6  and other actuating assemblies described herein and understood by one skilled in the art in light of the teachings contained herein. The actuating member  228  can be displaced in the proximal direction relative to guide member  212 . By so doing, the restraining force applied by sleeve  226  is released, struts  224  extend outwardly, and dilation assembly  240  and/or stent  242  are deployed. 
     Sleeve  226  can be formed from a variety of different materials, so long as the material is sufficiently strong to secure struts  224 , while being configured to preferentially separate under the action of actuating members  228 . For example, sleeve  226  can be fabricated from heat shrink synthetic material, including but not limited to, low-density polyethylene (LDPE), polyethylene terphthalate (PET), Polytetrafluoroethylene (PTFE), fluorinated ethylene propylene (FEP), polyethylene (PE), polyurethane (PU), or silicone tubing. 
     The one or more actuating members  228  can be formed from a variety of different materials, so long as the material used is sufficiently strong to allow an actuating assembly, such as, but not limited to, those actuating assemblies disclosed herein, to displace actuating member  228  proximally without breaking the same. For example, actuating members  228  can be fabricated from plastics, polymers, metals, composites, alloys, synthetic materials, and combinations thereof. 
     Instead of using actuating members  228 , embodiments of the present invention can employ various other means to preferentially separate sleeve  226 . For example, sleeve  226  can have dissolvable chemical bonds which dissolve due to a chemical reaction with the fluid in the body lumen within which the delivery device is disposed, bonds that are broken through applying resistive heating, ultrasonic, or radio frequency energy to actuating members  228  and/or region of the body lumen containing device  200 , preferential tear or cut regions or zones where the material has a weaker strength than other regions or zones of the sleeve, or combinations thereof. 
     Referring now to  FIGS. 11 through 14 , depicted is an embodiment of a delivery device  300  having another embodiment of a restraining member or mechanism  325 . In this embodiment, restraining member  325  is in the form of a sleeve  326  which is adapted to surround one or more struts  324  of a guide member  312  and apply a restraining force against struts  324  to maintain struts  324  in a restrained configuration. Sleeve  326  includes a first side  364  and a second side  366  with first and second sides  364 ,  366  being separated by an intermediate portion  368 . Intermediate portion  368  surrounds guide member  312  in such a manner that portions of intermediate portion  368  contact, are juxtaposed to, are contiguous with, or are adjacent to one another. An actuating member  328  passes through such portions of intermediate portion  368  to secure sleeve  326  upon guide member  312 . To further aid with applying a restraining force against struts  324 , first side  364  and second side  366  are folded to attach to respective portions of outside surface of sleeve  326 . 
     The process of forming the restraining member or mechanism of  FIG. 11  is illustrated in  FIGS. 12 and 13 . With reference first to  FIG. 12 , which depicts sleeve  326  in an open position before actuating member  328  is coupled thereto, sleeve  326  can be directly formed on guide member  312  or can be formed on a separate tubular member and subsequently attached or coupled to guide member  312 . Sleeve  326  is illustrated as having a generally polygonal configuration, however, one skilled in the art can appreciate that sleeve  326  can have various other configurations so long as it is capable of performing the functions described herein. In this exemplary configuration, sleeve  326  is coupled directly to guide member  312 . First side  364  and second side  366  of sleeve  326  are wrapped around at least a portion of guide member  326 , until a portion of intermediate portion  368  is in close proximity with another portion of intermediate portion  368 , as illustrated in  FIG. 13 . Alternatively, a first side  364  can contact second side  366  or be juxtaposed, contiguous, or adjacent to second side  366 . 
     When the portions of intermediate portion  368  are in close proximity, actuating member  328 , or alternatively some other actuating member, is stitched through both portions of sleeve  326  to couple the portions of intermediate portion  368 , as shown in  FIG. 13 . Once actuating member  328  is drawn substantially straight or otherwise positioned through sleeve  326 , first end  364  and second end  366  are respectively folded to attach to respective outside surfaces of sleeve  326 , as shown in  FIG. 11 . 
     As illustrated in  FIG. 14 , in an alternate configuration, sleeve  326  can include a plurality of apertures  360  on portions of intermediate portion  368  that receive actuating member  328 . In this manner, actuating member  328  can pass through apertures  360  rather being stitched through sleeve  326 . In another embodiment, first end  364  of sleeve  326  can be coupled to second end  364  of sleeve  326  without attaching first end  364  or second end  366  to the outside surface of sleeve  326 . In still another configuration, a portion of first end  364  can overlap a portion of second end  366 , or vice versa. Alternatively, first end  364  and second end  366  contact each other but do not overlap. Similarly, first end  364  and second end  366  can be adjacent to one another, adjoining one another, contiguous to one another, or juxtaposed to one another. 
     To operate the restraining member or mechanism described in reference to  FIGS. 11-14 , a proximal end of actuating member  328  extends to a proximal end of guide member  312 , either within or without a lumen of the guide member  312 . Upon displacing actuating member  328  in a proximal direction relative to guide member  312 , vice versa, or combination thereof, actuating member  328  is released from being disposed through at least a portion of sleeve  326 . By so doing, the restraining force applied by sleeve  326  is released, struts  324  extend outwardly, and the dilation assembly and/or stent are deployed. A clinician or physician can initiate the longitudinal motion of actuating member  328 , either directly or through using of an actuating mechanism or device. 
     Sleeve  326  can be formed from a variety of different materials, so long as the material is sufficiently strong to restrain one or more struts  324 . For example, sleeve  326  can be fabricated from various types of polymer or silicone films, such as but not limited to, heat shrink plastic, polymer, low-density polyethylene (LDPE), polyethylene terphthalate (PET), Polytetrafluoroethylene (PTFE), fluorinated ethylene propylene (FEP), polyethylene (PE), polyurethane (PU), or silicone tubing. 
     Actuating member  328  can be formed from a variety of different materials, so long as the material used is sufficiently strong to allow the actuating assemblies disclosed herein to displace actuating member  328  proximally without breaking actuating member  328 . For example, actuating member  328  can be fabricated from plastics, polymers, metals, composites, alloys, synthetic materials, combinations thereof, or other material that is capable of performing the function of being disposed through sleeve  326  and capable of being withdrawn therefrom. 
     Referring now to  FIGS. 15-19 , illustrated is another embodiment of a delivery device  400  having an alternate configuration of a restraining member or mechanism. This particular embodiment utilizes a restraining member or mechanism  425  having a hinged configuration with an actuating member  438 , optionally forming part of restraining member or mechanism  425 , acting as the pin to maintain the hinged portions of the restraining member in a configuration that retains or restrains a portion of the guide member. 
     As shown in  FIG. 15 , restraining member  425  is a sleeve  426  having a plurality of channels  464   a - 464   f  that are adapted to receive actuating member  428 . Both a first side  466  and a second side  468  of sleeve  426  are formed with some of channels  464   a - 464   f , i.e., channels  464   a ,  464   c , and  464   e  on first side  466  and channels  464   b ,  464   d , and  464   f  on second side  468 . By passing actuating member  428  through channels  464   a - 464   f  in sequential order, so that actuating member  428  passes through a channel on first side  466  and subsequently a channel on second side  468 , first side  466  is coupled to second side  468  and sleeve  426  applies a restraining force against struts  424  of guide member  412 . 
     An exemplary process of forming the restraining member or mechanism of  FIG. 15  is illustrated in  FIGS. 16-19 . With reference first to  FIG. 16 , which depicts sleeve  426  in an open position before actuating member  428  is coupled thereto, sleeve  426  includes a number of extensions or tongues  460   a - 460   f . These extensions  460   a - 460   f  are configured to form channels  464   a - 464   f  and surround a tubular member or tube, such as, but not limited to, a guide member  412  within which actuating member  428  is located. 
     To attach sleeve  426  to guide member  412 , sleeve  426  is positioned over the desired portion of guide member  426 . Actuating member  428  is placed in close proximity to guide member  412 , as shown in  FIGS. 17-19 . The ends of the extensions  460   a - 460   f  are inserted between guide member  412  and actuating member  428 , as shown in  FIG. 18 . Alternatively, extensions  460   a - 460   f  can be partially wrapped around guide member  412  and actuating member  428  placed into contact with these partially wrapped extensions  460   a - 460   f.    
     After the extensions  460   a - 460   f  are pulled tightly around guide member  412  and actuating member  428 , an end of each extension  460   a - 460   f  is folded over actuating member  428  to attach to the outer surface of sleeve  426 , as shown in  FIGS. 15 and 19 . In this manner, channels  464   a - 464   f  are formed and sleeve  426  is configured with actuating member  428  to releasably restrain struts  424  of guide member  412 . 
     Releasing the restraining force applied by sleeve  426 , alone or in combination with actuating member  428 , is achieved through displacing actuating member  428  longitudinally with respect to guide member  412 , vice versa, or combination thereof. Actuating member  428  is released from channels  464   a - 464   f  to allow the biasing force of struts  424  to extend the struts outwardly to deploy dilation assembly and/or stent. A clinician or physician can initiate the longitudinal motion of actuating member  428 , either directly or through using of an actuating mechanism or device. 
     Referring now to  FIG. 20 , depicted is another delivery device  500  having another embodiment of a restraining member or mechanism  525  of the present invention. The restraining member  525  includes a cord  529  forming a number of hoops  564   a - 564   n . One or more of hoops  564   a - 564   n  are adapted to receive an actuating member  528 , which is optionally part of restraining member or mechanism  525 . The actuating member  528  is disposed within hoops  564   a - 564   n  so that cord  529  applies a restraining force against struts  524  of guide member  512 . Actuating member  528  can be removed from hoops  564   a - 564   n  to thereby allow struts  524  to extend outwardly to deploy the dilation assembly and/or stent. Cord  529  may be made from metallic wires, polymer actuating members, or other materials that can be manipulated to form hoops through which an actuating or securing member. Optionally, cord  529  is adapted to expand outwardly either under the influence of one or more struts or due to a biasing force applied or incorporated within cord  520  by the configuration and/or material of the cord, the hoops, and/or the restraining member. 
     Cord  529  can be attached to guide member  512  and/or one or more of the struts associated therewith through various attachment mechanisms. For instance, cord  529  can be attached to guide member and/or one or more of the struts through adhesives, mechanical fasteners, securing loops, or other manner that securely attaches cord  529  to guide member  512  and/or one or more of struts  524 . Alternatively, cord  529  may be attached to actuating member  528  and be removed when actuating member  528  is moved in a proximal direction. A clinician or physician can initiate the longitudinal motion of actuating member  528 , either directly or through using of an actuating mechanism or device. 
     Referring now to  FIGS. 21-24 , depicted is another delivery device  600  having another embodiment of a restraining member or mechanism  625  of the present invention. As illustrated, a guide member  612  includes a plurality of struts  624  that are adapted to extend outwardly to enable deployment of the stent and dilation balloon disposed within a lumen  618  of guide member  612 . A restraining member  625  restrains struts  624 . This restraining member  625 , in one configuration, is a flexible member  627  configured with flaps  660  and  662 . The flaps  660  and  662  extend between a gap  664  between the two adjacent struts  624   a  and  624   b  and are adapted to be pulled around struts  624  to compress stent (not shown) and dilation balloon (not shown) within lumen  618 , as illustrated in  FIG. 23 . These flaps  660  and  662  can be two separate members that are bonded or otherwise connected to struts  624   a  and  624   b  or a single member that is coupled to struts  624   a  and  624   b  while forming flaps  660  and  662 . 
     When flaps  660  and  662  have been positioned to securely retain struts  624 , they are then stitched together at a location  666 , identified in  FIG. 23 , with an actuating member  628 . This actuating member  628 , optionally forming part of the restraining member or mechanism, extends the length of delivery device  600  toward an actuating assembly, such as, but not limited to, the actuating assembly described in  FIG. 6  and other actuating assemblies known to those skilled in the art in light of the teachings contained herein. A clinician or physician can initiate longitudinal motion of actuating member  628  to release restraining member or mechanism  625 , either directly or through using of an actuating mechanism or device as known to those skilled in the art. 
     Following coupling of flaps  660  and  662  using actuating member  628 , flaps  660  and  662  are folded back around struts  624  and the remainder of flaps  660  and  662 , and then attached to struts  624 , or other portion of guide member  612 , as illustrated in  FIG. 24 . When actuating member  628  is displaced in a proximal direction, flaps  660  and  662  are released and stent (not shown) and dilation balloon (not shown) are deployed as struts  624  extend outwardly. 
     Referring now to  FIG. 25 , depicted is an illustrative embodiment of a proximal end of a delivery device  700   a . The features and structures discussed with other embodiments of the delivery device of the present invention apply to delivery device  700   a.    
     As shown, a proximal end  716  of a guide member  712  terminates in a guide member housing  722 . This guide member housing  722  can be integrally formed with guide member  712  or alternatively be a separate member coupled, connected, or attached to a proximal end of guide member  712 . Proximal end  716  of guide member  712  is coupled to an actuating element  721  of an actuating assembly  720 . This actuating element  721  slidably engages with guide member housing  722 . Manipulation of actuating element  721  effects the movement of dilation tube  744  upon which is mounted the dilation balloon (not shown). Actuating member  728  extends through an aperture  786  in actuating element  721  that is adapted with a seal (not shown) through which actuating member  728  can slide. In this manner, aperture  786  and the seal (not shown) allow access for the operator to release or displace the restraining member (not shown) that restrains the one or more struts (not shown) disposed at distal end  714  of delivery device  700   a . The seal can include a polymer gasket, such as, but not limited to, polyurethane, silicone rubber, or other materials that are capable of making a seal around actuating member  728  and allow the actuating member  728  to slide therethrough while a fluid seal is maintained. 
     A dilation tube  744 , optionally having a similar configuration to dilation tube  44  of  FIG. 1 , extends from a distal end  714  of guide member  712  through guide member housing  722  to terminate and be attached to proximal end  776  of actuating element  721 . As depicted, proximal end  776  of actuating element  721  includes a luer fitting  745 , which is adapted to cooperate with a complementary luer fitting for inflating and deflating a dilation balloon (not shown) disposed at distal end  714  of guide member  712 . 
     In this illustrative embodiment, an additional luer fitting  790  is formed in or coupled to actuating element  721 . Luer fitting  790  is provided to infuse fluid through a lumen  718  of guide member  712 , thereby allowing introduction of a contrast media in the blood flow around the vicinity of the device as it is advance in the vasculature. 
     Referring now to  FIG. 26 , an alternate configuration of delivery device  700   a  is depicted as illustrated delivery device  700   b . In this configuration, the engagement between actuating element  721  and guide member housing  722  can be achieved through complementary threads  792  formed in actuating element  721  and guide member housing  722 . These complementary threads  792  can be configured to allow longitudinal movement of actuating element  721  relative to guide member housing  722  through rotational motion of actuating element  721  or motion parallel to the longitudinal axis of guide member  712 . By using threads  792 , very precise control of the longitudinal movement of the dilation balloon (not shown) and stent (not shown) disposed at distal end  714  of guide member  712  can occur. 
     Although reference is made to using complementary threads, it can be understood by one skilled in the art in light of the teaching contained herein that various other structures can be used to provide controllable longitudinal movement of actuating element  721  relative to guide member housing  722 . For instance, actuating element  721  can include a key that mates with a key way formed in guide member housing  722 , or vice versa. Further, although reference is made to rotational motion and motion parallel to the longitudinal movement of the dilation balloon and stent, one skilled in the art can identify various other directions of motion that can enable or facilitate deployment of the dilation balloon and/or stent. For instance, the motion of actuating element can be at any angular orientation relative to the longitudinal axis of the guide member, whether or not such motion includes one or more revolutions of the actuating element relative to the guide member. 
     As depicted in  FIG. 27 , another embodiment of delivery device  700   c  is illustrated. To aid with moving actuating element  721  relative to guide member housing  722 , actuating element  721  and guide member housing  722  and/or guide member  712  can include optional handles  796  and  798  respectively. These handles  796  and  798  can optionally include gripping regions that are adapted to cooperate with one or more appendages of a user of the device. In another configuration, each handle  796  and  798  can have a substantially constant cross-section along their lengths. In still other configurations, each handle  796  and  798  can have variable cross-sections along their lengths. Additionally, although a single luer fitting  745  is depicted in  FIG. 27 , it can be understood by one skilled in the art that delivery device  700   c  can include one or more fittings to facilitate introduction of one or more fluids to an interior of delivery device or to a dilation balloon. 
       FIG. 28  shows yet another embodiment of delivery device  700   d  in which actuating element  721  includes a housing  760  that contains a rotatable gear  762  adapted to cooperate with complementary features or structures  770  formed in a proximal end of guide member  712 . The gear  762 , with associated one or more teeth, features or structures  768 , can be manipulated or rotated by an actuator  764  as a clinician or other individual selects an actuator member  766  and rotates actuator  764  to rotate gear  762 . Optionally, actuator  764  has one or more teeth, features or structures that can cooperate with gear  762 , such that rotational motion of actuator  764  is translated to movement of gear  762 . 
     As actuator  764  and hence gear  762  are rotated, the complementary features  770  of guide member  712  mate with the teeth, features or structures  768  of gear  762  to move guide member  712  in a proximal and/or distal direction, dependent upon the rotational direction of actuator  764 . By so doing, the dilation assembly and the stent can be deployed from a distal end (not shown) of device  700   d.    
     In addition to moving or positioning guide member  712 , actuating member  728  may also be operated through using a sliding switch  762  associated with housing  760  and actuating element  721 . The actuating member  728  is coupled to a leg  762  that is attached to switch  762 , while sliding switch  762  is slidably coupled to housing  760 . The sliding translation of switch  762  moves actuating member  728  in the respective direction to release a restraining force applied by the restraining member or mechanism (not shown) of device  700   c . One skilled in the art can identify various other configurations of actuating element  721  in light of the teaching contained herein. 
     Referring now to  FIGS. 29-37 , depicted are various configurations of alternative embodiments of a delivery device in accordance with the present invention. The features and functions of other described delivery devices apply to the discussion of delivery devices  800   a  through  800   g . Furthermore, it will be appreciated that the majority of features and functions described with respect to delivery device  800   a  also apply to delivery devices  800   b  through  800   g  described further below. The delivery devices of  FIGS. 29-37  illustrate various embodiments wherein a delivery device is adapted to be used with a guidewire. For ease of explanation, the embodiments of  FIGS. 29-37  do not include a restraining member or mechanism that restrains the dilation assembly and stent inside the guide member. However, it will be appreciated that any restraining member or mechanism with any actuating assembly, as disclosed herein or understood by those of skill in the art, may be employed with devices  800   a - 800   g.    
     As shown in  FIG. 29 , delivery device  800   a  includes a guide member  812  having a proximal end  816  and a distal end  814 , with a lumen  818  extending from distal end  814  toward proximal end  816 . The distal end  814  can have a similar configuration to the other guide member distal ends described herein. For instance, a restraining member (not shown) may be disposed at distal end  814  to cooperate with structures adapted to restrain a dilation assembly  840  and/or a stent  842 . Disposed at proximal end  816  is a guide member housing  822  that cooperates with an actuating element  821  of an actuating assembly  820 , in a similar manner to that described with respect to  FIG. 6 . 
     Extending from an aperture  834  in a proximal end of actuating element  821  toward distal end  814  of guide member  812  is a guidewire  832 . As shown best in  FIG. 30 , guidewire  832  cooperates with a dilation assembly  840  disposed at a distal end of guide member  812 . In this illustrative configuration, dilation assembly  840  includes a tubular member  836  that cooperates with a dilation balloon  846  coupled or attached thereto. The tubular member  836  can function as a positioning member that facilitates deployment of dilation assembly  840  and stent  842 . The guidewire  832  extends through tubular member  836  that allows dilation balloon  846 , and a stent  842  coupled to dilation balloon  846 , to be moved along guidewire  832  when necessary. The internal diameter of a lumen of tubular member  836  is complementary to the exterior diameter of guidewire  832 . 
     Guidewire  832  terminates at a distal end with an atraumatic tip  848  that can include a core wire  856  wrapped with a coiled spring  858 . The core wire  856  may be an extension of the remainder of guidewire  832  or alternatively may be a separate member coupled or attached to the distal end of guidewire  832 . In either case, core wire  856  can be made from the same or a different material than guidewire  832  and may optionally be a solid member or a tubular member. 
     The dilation balloon  846  of dilation assembly  840  is inflated through a dilation tube  844  that extends from dilation balloon  846  to terminate at the proximal end of actuating element  821  with a luer fitting  845 . An additional luer fitting  890  may be provided attached to actuating element  821 . It will be appreciated that luer fitting  890  can perform substantially the same function as luer fitting  790 . 
     The distal end of dilation tube  844  cooperates with an interior of dilation balloon  846 . The distal end of dilation tube  84  can be connected to tubular member  836 , dilation balloon  846 , or to both tubular member  836  and dilation balloon  846 . The dilation tube  844  can be used to position dilation balloon  846  and/or stent  842  during a procedure. Consequently, dilation tube  844  can have sufficient strength to enable distal movement of dilation tube  844  to translate to distal movement of the remainder of dilation assembly  840 . Similarly, dilation tube  844  can have sufficient strength to enable proximal movement of dilation tube  844  to translate to proximal movement of the remainder of dilation assembly  840 . 
     Delivery device  800   a  is configured so that guidewire  832  can be positioned in a body lumen, and delivery device  800   a  can be removed from within the body lumen while retaining guidewire  832  at the desired position. As such, other conventional, interventional devices may then be used to complete the procedure. A device may be connected to the distal end of the guidewire such as, for example, a filter assembly for collecting embolic particles that are dislodged in the body vessel during a stenting operation, as will be discussed in greater detail hereinafter. Other devices may be exchanged over guidewire  832  as will be understood by those of skill in the art. 
     Depicted in  FIG. 31  is another embodiment of a device  800   b . The device  800   b  includes a dilation assembly  840   b  that is adapted to cooperate with a guidewire  832 . As shown, dilation assembly  840   b  includes a tubular member  836  that cooperates with an expandable dilation balloon  846 . Disposed at a proximal end of tubular member  836  is a positioning member  838 . The positioning member  838  is coupled to a proximal end of tubular member  836  to facilitate transfer of forces applied to positioning member  838  to tubular member  836  to position dilation assembly  840 . The positioning member  838  can be coupled or attached to tubular member  836 , dilation balloon  846 , or both tubular member  836  and dilation balloon  846 , whether such coupling or attachment occurs at a proximal end, distal end, or other portion of tubular member  836  and/or dilation balloon  846  between the respective proximal ends and distal ends thereof. Similarly, the coupling or attaching of positioning member  838  to one or both of tubular member  836  and dilation balloon  846  can be to or upon internal and/or external surfaces of tubular member  836  and dilation balloon  846 . By so doing, positioning member  838  can be manipulated by a physician or clinician to position dilation assembly  840   b  in the desired location to dilate a stent (not shown) and/or lesion. For instance, positioning member  838  can be used to slide dilation balloon  846  along guidewire  832 . 
     As shown, positioning member  838  is separate from dilation tube  844 . Although reference is made to positioning member  838  being separate from dilation tube  844 , it can be ,appreciated that positioning member  838  can be removably disposed within dilation tube  844 , while being capable of positioning dilation balloon  846  in the desired location within the body lumen or vessel. For instance, as illustrated in dotted lines in  FIG. 31 , extending from tubular member  836  or formed in tubular member  836  is a stop  837  that can cooperate with a distal end of a positioning member  838  disposed within a lumen of dilation tube  844 . By moving the positioning member in the distal direction, the distal end of the positioning member cooperates with stop  837  to move dilation assembly  840   b  in the distal direction. To move tubular member  836  in the proximal direction, a clinician or physician can move dilation tube  844  in a proximal direction. In another configuration, stop  837  can include a recess (not shown) that friction fits or otherwise cooperates with the distal end of the positioning member, such that the positioning member is retained in the recess with sufficient force that the positioning member can move the tubular member  836  in both proximal and distal directions. 
     The proximal end of guide member housing  822  as illustrated in  FIG. 31 , cooperates with an actuating assembly  821   b , while a distal end  814  of guide member  812  cooperates with a restraining member or mechanism (not shown) and is adapted to aid in applying a restraining force to dilation assembly  840   b  and/or stent  842 . Actuating element  821   b  is adapted to enable a clinician to operate delivery device  800   b  to deliver stent  842 , such as in a similar manner to the device described in  FIG. 29 . For instance, positioning member  838  can be coupled to actuating element  821   b  such that distal movement of actuating element  821   b  moves dilation assembly  840   b.    
     In addition, the proximal end of actuating element  821   b  includes an annular clamping mechanism  862 , such as, but not limited to, touhy-borst adaptor, compressible polymer or silicone rubber gasket, or other clamping mechanisms  862  known to those skilled in the art in light of the teaching contained herein. The annular clamping mechanism  862  receives guidewire  832  and creates a mechanical connection and a fluid seal between actuating element  821   b  and guidewire  832 . This seal prevents fluid escaping from within lumen  818 , while providing a mechanism for releasing delivery device  800   b  from guidewire  832  in the event that other conventional, interventional devices are to be used without loosing the vascular access that is gained by the device as a whole. For example, by rotating annular clamping mechanism  862 , the seal is broken and delivery device  800   b  can be removed from guidewire  832 . A similar clamp or other seal can cooperate with positioning member  838  to prevent fluid escaping from within device  800   b.    
       FIG. 32  depicts another embodiment of delivery device  800   c . In this embodiment, tubular member  836  extends substantially between distal end  814  and proximal end  816  of guide member  812 . Tubular member  836  is adapted to receive guidewire  832  therethrough. Thus, tubular member  836  extends from a distal end of dilation balloon  846  to a proximal end of guide member  812 , such that the proximal end of tubular member  836  terminates at a point proximal to a proximal end of dilation tube  844 . Additionally, the proximal end of tubular member  836  cooperates with a proximal end of guide member  812  and/or an actuating element  821   c  disposed at the proximal end of guide member  812 . 
     Actuating element  821   c  includes a fixed portion  829  and a movable portion  831  slidably disposed with portion  829 . The portion  829  can be integrally formed with a proximal end of guide member  812  or a separate member that is coupled or attached to the proximal end of guide member  812 , where such coupling or attaching can be achieved by complementary threads, key and keyway configuration, chemical bonding, thermal bonding, or adhesives. 
     The portion  831  cooperates with portion  829  in sealing manner so that a fluid entering an interior space defined by the interiors of portion  829  and a portion of portion  831  is prevented from exiting therefrom. This seal can be created by one or more sealing members  833  and/or between the tolerances associated with portion  829  and portion  831 . Illustratively, sealing member  833  can be one or more O-rings in one or more grooves, one or more O-rings, gasket, or viscous fluid seal. 
     The portion  831  contains a support structure  823  extending across a distal end thereof. The proximal end of tubular member  836  is fixedly attached to support structure  823 . Support structure  823  also includes an aperture  825  through which extends guidewire  832 . Preferably, a seal  827  is disposed between and/or within aperture  825  and guidewire  832  to retain fluid inside guide member  812 . Consequently, upon depressing portion  831  in the direction of arrows A, dilation balloon  846  is deployed from within lumen  818  of guide member  812 . Similarly, upon moving portion  831  of actuating element  821   c  in the direction of arrows B, dilation balloon  846  is retracted into lumen  818  of guide member  812 . 
     As depicted in  FIG. 33 , another embodiment of delivery device  800   d  is illustrated. In this embodiment, dilation balloon  846  is coupled or attached directly to guidewire  832 . Consequently, positioning member  838  is connected to guidewire  832  and/or optionally dilation balloon  846  instead of tubular member  836 . Positioning member  838  is manipulatable by a physician, clinician, or the like to position dilation assembly  840  in the desired location to dilate the stent and lesion. Consequently, by moving positioning member  838 , dilation balloon  846  can be placed in the position to optionally pre-dilate the lesion and/or dilate the lesion during implanting of stent  842 . 
       FIG. 34  illustrates another embodiment of delivery device  800   e . In this embodiment, positioning member  838  is connected to dilation balloon  846 . Positioning member  838  is manipulatable by a physician, clinician, or other individual to position dilation assembly  840  in the desired location to dilate the stent and lesion. Consequently, by moving positioning member  838 , dilation balloon  846  can be placed in the position to optionally pre-dilate the lesion and/or dilate the lesion during implanting of a stent (not shown). 
     Guidewire  832  passes between dilation balloon  846  and stent  842 . Although not depicted for ease of explanation, guidewire  832  may have an atraumatic tip attached or formed at a distal end thereof. The dilation balloon  846  includes an integrally formed dilation tube  844  that extends from a distal end of dilation balloon  846 . The dilation balloon  846 , as with other dilation balloons described herein, can have various configurations, such that dilation balloon  846  can having substantially constant cross-section along its length or alternatively have a variable cross-section along its length. Furthermore, the dilation balloons of the present invention can be formed from one or more separate dilation balloons, with associated one or more dilation tubes, which collectively provide the functionality of a single dilation balloon. 
     In addition,  FIG. 34  depicts a tip  864  disposed at distal end of guidewire  832 . Tip  864  provides a transition between guidewire  832  and guide member  812  to limit the potential of damaging the body lumen or vessel of the patient during insertion and removal of delivery device  800   e  during a procedure. Various types of tips are known to those skilled in the art, such as, but not limited to, those discussed herein and others known to one skilled in the art in light of the teaching contained herein. For instance, tip  864  can have various configurations so long as the configuration provides a transition between guidewire  832  and guide member  812  to aid in preventing damage to the body lumen or vessel during insertion and removal of delivery device  800   e . Further, tip  864  can be coupled or attached to guidewire  832  through various manners, such as, but not limited to, adhesives, mechanical bonds, thermally created bonds, being integrally formed therewith, or combinations thereof. 
     As depicted in  FIG. 35 , illustrated is another embodiment of delivery device  800   f . In this embodiment, guidewire  832  passes between guide member  812  and dilation assembly  840  to terminate distally of a distal end of guide member  812 . Although not depicted for ease of explanation, guidewire  832  may have an atraumatic tip attached or formed at a distal end thereof. Connected to dilation balloon  846  is a positioning member  838 , similar to those described herein. Positioning member  838  is manipulatable by a physician, clinician, or other individual to position delivery device  800   f  in the desired location to dilate the stent and lesion. Consequently, by moving positioning member  838 , dilation balloon  846  can be placed in the position to optionally pre-dilate the lesion and/or dilate the lesion during implanting of stent  842 . Delivery device  800   f  also includes a tip  864 , similar in structure and function to the tip  864  shown and discussed with respect to  FIG. 34 . 
       FIG. 36  illustrates yet another embodiment of a delivery device of the present invention. As shown, a delivery device  800   g  includes a dilation assembly  840   g , which may be similar to other dilation assemblies described herein, which is disposed past a distal end  814  of guide member  812 . Guide member  812  acts as a positioning member to position dilation assembly  840   g  in the desired location to dilate the stent and lesion. Consequently, by moving guide member  812 , dilation balloon  846  can be placed in the position to pre-dilate the lesion and/or dilate the lesion during implanting of a stent. Although not depicted for ease of explanation, guidewire  832  may have an atraumatic tip attached or formed at a distal end thereof. 
       FIGS. 37 through 44  depict another aspect of the present invention. During a procedure to dilate a lesion and/or implant a stent at a lesion, often emboli becomes dislodged and is carried downstream in the body vessel. To prevent the emboli from blocking even smaller body vessels further downstream, one or more embodiments of the present invention can include means for providing embolic protection. The means for providing embolic protection can be included in a delivery device having a unitary configuration where the delivery device and the means for provide embolic protection, such as a filter device, can be inserted into a body lumen substantially simultaneously. 
     Referring to  FIG. 37 , an exemplary delivery device  900  is depicted having many of the same features and functionality of the delivery devices heretofore described. Consequently, the descriptions of the various other delivery devices described herein apply to delivery device  900 . As illustrated, delivery device  900  includes a guide member  912  having a dilation assembly  940  and stent  942  disposed therein. It will be appreciated that in the embodiment of  FIG. 37  and subsequent embodiments hereafter, a restraining member or mechanism, illustrated in dotted lines, may be disposed at distal end  914  of guide member  912  to restrain dilation assembly  940  and stent  942  adjacent or near distal end  914  of guide member  912  until deployment of same is desired. It will be appreciated that any restraining member or mechanism may be employed as disclosed herein or understood by those of skill in the art. Furthermore, appropriate structures may be employed for deploying dilation assembly  940  and stent  942  as described herein or understood by those skilled in the art. 
     With continued reference to  FIG. 37 , delivery device  900  has a filter assembly  931  disposed distally of guide member  912 . Consistent with teachings of the present invention, delivery device  900  has a guidewire  932  disposed through dilation assembly  940  and optionally through filter assembly  931 . In the illustrated configuration, guidewire  932  terminates at filter assembly  931 , with the filter assembly  931  being coupled to a distal end of guidewire  932  and includes an atraumatic tip, as will be described in more detail below. 
     Filter assembly  931  is adapted to provide embolic protection during use of device  900 . As depicted in  FIGS. 37 and 38 , filter assembly  931  has a low profile to facilitate insertion of the same with a body lumen. A transition member  936  is disposed between filter assembly  931  and dilation assembly  940 . The transition member  936  is adapted to provide a transition between guide member  912  and filter assembly  931 . This transition prevents damage to the body lumen within which device  900  is disposed and prevents catching upon a wall or junction of one or more body lumens as device  900  is steered through the tortuous anatomy of a patient. As illustrated, transition member  936  includes a passageway  938  disposed therethrough for receiving guidewire  932 . Passageway  938  can be adapted to securely retain guidewire  932  therein or optionally removably receive guidewire  932 . Alternatively, transition member  936  can include a hole through which guidewire  932  passes or is received. In still another configuration, transition member  936  includes a hole adapted to receive a distal end of guidewire  932 , while a distal end of transition member  936  is formed or cooperates with filter assembly  931 . 
       FIGS. 37 and 38  illustrate filter assembly  931  being restrained in preparation for deploying filter assembly  931 , while  FIGS. 39-41  depict filter assembly  931  being deployed or activated. As shown in  FIG. 41 , filter assembly  931  includes a filter basket  934  and a filter  933 . Before deployment, filter  933  can be disposed inside filter basket  934 , surround filter basket  934 , or a combination thereof. The filter  933  is adapted to capture embolic particles or material that may become dislodged during a procedure associated with delivery device  900  or optionally other procedures when delivery device  900  is optionally slidably removed from guidewire  932  and associated filter assembly  931 . Consequently, filter  933  can optionally float within a body lumen upon being deployed, with a distal end of filter  933  floating in the body lumen and the proximal end of filter  933  being coupled to filter basket  934 . In another configuration, a distal end of filter  933  can be coupled to a portion of filter basket  934 . 
     The filter  933  can be fabricated from a variety of different materials, such as, but not limited to, a woven or braided plastic or metallic mesh, a perforated polymer film, a Nitinol mesh, combinations thereof, or other material that is capable of capturing material within flowing blood, while allowing the blood to flow through the pores or apertures thereof. Generally, filter  933  can be fabricated from a variety of materials so long as filter  932  is capable of being packed within filter basket  934 , and optionally float in the blood flow or stream passing through the body lumen within which it is inserted, and is bio-compatible. 
     Filter  933  can have a variety of differently sized pores ranging from about 50 microns to about 200 microns, from about 60 microns to about 180 microns, or from about 75 microns to about 150 microns. For instance, the pores can have a variety of different configurations, such as but not limited to circular, oval, polygonal, combinations thereof or other configurations known to one skilled in the art in light of the teaching contained herein. In one configuration, therefore, filter  933  can include pores that are differently sized and configured. Consequently, a major or minor axis of each pore can have a variety of different sizes ranging from about 50 microns to about 200 microns, from about 60 microns to about 180 microns, or from about 75 microns to about 150 microns. Generally, the pore size can vary as needed, so long as the pores are sized so that the pores do not compromise blood flow through the filter, i.e., prevent blood flowing through the filter, and collect material that could potentially occlude smaller downstream vessels, potentially blocking blood flow to tissue or result in stroke or infarction. 
     In addition to the above, filter  933  can be coated with a hydrophilic coating, a heparinized coating, a Polytetrafluoroethylene (PTFE) coating, a silicone coating, combinations thereof, or various other coatings as know or desired by one skilled in the art in light of the teaching contained herein. 
     The filter basket  934  supports filter  933  following deployment of filter  933 . The filter basket  934  includes a plurality of struts  960  that extend from a body  962 . Struts  960  of filter basket  934  are adapted to extend outwardly to position filter  933  within the body lumen. A strut  960   a  of struts  960  can include an atraumatic tip  948 , with struts  960   a  forming at least a portion of the core wire of atraumatic tip  948 . This strut may also be covered with a flexible coil  958 . The body  962  of filter basket  934  includes a hole  967  that is adapted to receive guidewire  932 . Alternatively, body  962  can include a passageway that is adapted to receive a distal end of guidewire  932 . 
     The filter  933  can be attached to struts  960  of filter basket  934  in a variety of ways. For instance, filter  933  can be attached through adhesives, solvent bonding, thermal bonding, mechanical connections, or combinations thereof. Further, the distal end of two or more struts  960  can include a hole through which strands of filter media  932  can be passed and attached to struts  960 . Alternatively, the strands can be tied in a knot, folded back upon filter  933 , and affixed to filter  933 . Various other manners exist of coupling or connecting filter  933  to filter basket  934 . 
     Optionally, filter assembly  931  includes a number of radiopaque bands and/or markers affixed to a variety of positions on filter assembly  931 . For instance, bands, markers or other means for radiopacity can be included upon filter  933 , filter basket  934  and/or struts  960 . In other configurations, the delivery device generally includes means for radiopacity at one or more locations or positions thereof to aid with viewing the position of the delivery device and the various elements and components thereof. 
     As illustrated, a restraining member or mechanism  925  restrains struts  960 , while another retraining member, shown in dotted lines, restrains a distal end of guide member  912 . Optionally, restraining member or mechanism  925  restrains both the distal end of guide member  912  and struts  960 .  FIGS. 37 and 38  depict restraining member or mechanism  925  restraining struts  960 , while  FIGS. 39-41  depict struts  960  being released from restraining member or mechanism  925 . In the exemplary configuration of  FIG. 41 , restraining member or mechanism  925  has a similar configuration to restraining member or mechanism  525 . Therefore, restraining member or mechanism  925  includes a cord  929  forming a number of hoops, with one or more of the hoops being adapted to receive an actuating member  928 , which is optionally part of restraining member or mechanism  925 . The actuating member  928  is disposed within the hoops so that cord  929  applies a restraining force against struts  960 . Actuating member  928  can be removed from the hoops to thereby allow struts  960  to extend outwardly to deploy filter  933 . Cord  929  may be made from metallic wires, polymer actuating members, or other materials that can be manipulated to form hoops through which an actuating or securing member. Optionally, cord  929  is adapted to expand outwardly either under the influence of one or more struts or due to a biasing force applied or incorporated within cord  929  by the configuration and/or material of the cord, the hoops, and/or the restraining member. 
     Cord  929  can be attached to one or more struts  960  of filter assembly  931  through various attachment mechanisms. For instance, cord  929  can be attached to guide member and/or one or more of the struts through adhesives, mechanical fasteners, securing loops, or other manner that securely attaches cord  929  to one or more of struts  960 . Alternatively, cord  929  may be attached to actuating member  928  and be removed when actuating member  928  is moved in a proximal direction. A clinician or physician can initiate the longitudinal motion of actuating member  928 , either directly or through using of an actuating mechanism or device. Although reference is made to one particular embodiment of restraining member or mechanism  925 , one skilled in the art can appreciate that other restraining members or mechanism described herein can be used to restrain struts  960 . 
     As shown, filter basket  934  includes one or more holes  970  that are adapted to receive at least a portion of restraining member or mechanism  925 . The holes  970  can be disposed at various locations of filter assembly  931 . For instance, and not by way of limitation, body  962  and each strut  960  can include one or more holes  970 . The restraining member or mechanism  925  can be at least partially disposed through one or more of holes  970 , with cord  929  or other portion of restraining member or mechanism  925  being optionally releasably coupled to one of struts  960  or body  962  of filter basket  934 . Moving actuating member  928  of restraining member or mechanism  925  in a proximal direction causes struts  960  to move outwardly to release filter  933 . 
     A proximal end (not shown) of restraining member or mechanism  925  or actuating member  928  can be accessible by a clinician or physician to allow the same to operate restraining member or mechanism  925  to release the restraining force applied to struts  960 . Optionally, the proximal end of restraining member or mechanism  925  can cooperate with an actuating assembly that can be operated to move restraining member or mechanism  925  as needed to release the restraining force applied by restraining member or mechanism  925 . 
     In the illustrative configuration of  FIGS. 37-41 , actuating member  928  of restraining member or mechanism  925  can be moved in a proximal direction with sufficient movement and force to be removed from engagement with the hoops of cord  929 . By breaking the coupling or engagement between actuating member  928  and cord  929 , struts  960  are allowed to expand or move outwardly to deploy filter  933 . Following deploying filter  933 , an actuating assembly (not shown) can be manipulated to deploy dilation assembly  940  and stent  942  from guide member  912 , in a similar manner to that described herein, and as illustrated in  FIG. 40 . Therefore, two actuating assemblies can be used, one to release restraining member or mechanism  925  and one to release dilation assembly  940  and stent  942 . 
     It will be appreciated that restraining member or mechanism  925  is but one means for restraining struts  960  of filter basket  934 . Other configurations may be employed, such as, but not limited to, the restraining configurations or means for restraining described in  FIGS. 2-24 . For instance, struts  960  of filter basket  934  can be restrained in the same manner as the strut associated with the guide member of the present invention. 
     Turning to  FIG. 40 , depicted is delivery device  900  with filter assembly  931  deployed and dilation assembly  940  and stent  942  deployed from guide member  912 . Deploying of dilation assembly  940  and stent  942  can be achieved in a similar manner to that described with respect to other dilation assemblies and stents discussed herein. Similarly, manipulating restraining member or mechanism  925  to release struts  960  and deploy filter  933  can deploy filter assembly  931 . Through moving guide member  912  relative to guidewire  932 , vice versa, or combinations thereof, dilation assembly  940  and stent  942  can be released from within guide member  912 . 
       FIGS. 42 and 43  illustrate another embodiment of a filter assembly  1031 . Filter assembly  1031  has another embodiment of a mechanism for restraining struts  1060 . This particular configuration of struts  1060  illustrates that struts  1060  can be coupled to or attached to a distal end of a guidewire  932  or transition member  936  ( FIG. 37 ). The length of struts  1060  can vary based upon the particular configuration of guide member  1012 . 
     A restraining mechanism  1064  maintains struts  1060  in a restrained position as shown in  FIG. 43 . In this embodiment, restraining mechanism  1064  includes a tubular member  1062  attached to each strut  1060  and a restraining or actuating member  1025  disposed therein. Although reference is made to tubular member  1062  being attached to each strut  1060 , it can be understood that one or more tubular members  1062  can be attached to each strut  1060  and/or fewer than each strut  1060  includes tubular member  1062 . 
     Each tubular member  1062  is adapted to receive restraining or actuating member  1025 . As shown in  FIG. 43 , when struts  1060  are restrained, tubular members  1062  are aligned to receive restraining or actuating member  1025 . That is, each tubular member  1062  is staggered on adjacent struts  1060  with respect to other tubular members  1062 , such that tubular members  1062  line up from the proximal end to the distal end of filter assembly  1031 . Restraining or actuating member  1025  is then disposed through the series of tubular members  1062  to restrain struts  1060  and prevents them from extending outwardly, as illustrated in  FIG. 43 . 
     Restraining or actuating member  1025  extends from filter assembly  1031  into a lumen of guidewire  1032  to terminate at a proximal end of guide member  1012  and optionally extend beyond the proximal end of guide member  1012 . Alternatively, restraining or actuating member  1025  can extend proximally from filter assembly  1031  to exit through an aperture  1069 , depicted in dotted lines, before terminating at the proximal end of guide member  1012  and optionally extend beyond the proximal end of guide member  1012 . In this latter configuration, restraining or actuating member  1025  can be disposed externally to guide member  1012  or partially externally to guide member  1012  as it extends to the proximal end of guide member  1012  and optionally extend beyond the proximal end of guide member  1012 . It will be appreciated that a clinician or physician can manipulate restraining member or mechanism  1064  to release the restraining force applied by restraining member or mechanism  1064 . Alternatively, restraining member or mechanism  1064  can be optionally operated by an actuating assembly similar to that described herein, such as, but not limited to, the actuating assembly described with respect to  FIG. 6 , or any other actuating assembly known by those of skill in the art. 
     Each tubular member  1062  coupled to struts  1060  can be fabricated from a metal, a plastic, polymer, a polymer, a synthetic materials, whether or not the material is the same as that forming guide member  1012 . In one embodiment, each tubular member  1062  is a polymer tube, such as a polyimide or polyurethane tube that is fixed to respective struts  1060  with adhesive. In another configuration, each tubular member  1062  is a metallic cut tube that may be attached to respective struts  1060  with and adhesive or solder. In still another configuration, each strut  1060  includes an aperture through which actuating member  1025  passes to restrain struts  1060  and prevents the same from extending outwardly. 
     Referring now to  FIG. 44  is an exemplary configuration of another filter assembly according to another aspect of the present invention. The features of functions of filter assembly  1131  are applicable to other filter assemblies of the present invention, and vice versa. Furthermore, the discussion related to the one or more other struts of filter assembly  1131  is applicable also to the struts associated with the guide members of the delivery devices of the present invention. 
     As depicted in  FIG. 44 , filter assembly  1131  includes a body  1162  and one or more struts  1160 . Coupled to one or more struts  1160  is a filter  1133 . Extending from body  1162  through filter  1133  is an atraumatic tip  1148 , with associated coil  1158 . For ease of explanation, the restraining member or mechanism associated with filter assembly  1131  is not shown, however, it will be understood that any of the restraining members or mechanisms described herein can be used to apply a restraining force to one or more struts of filter assembly  1131 . 
     Struts  1160  extend from a body  1162  of filter assembly  1131 . Although reference is made herein to struts  1160  being integrally formed with body  1162 , it can be appreciated that struts  1160  can be separate members coupled to body  1162 . Further, struts  1160  can be integrally formed with guidewire  1132  or separate members coupled to guidewire  1132 . 
     Each strut  1160  includes a distal portion  1162 , a proximal portion  1166 , and an intermediate portion  1164  disposed between distal portion  1162  and proximal portion  1166 . Struts  1160  may attach to filter  1133  on the exterior of filter  1133 , on the interior of filter  1133 , along the edge of filter  1133 , through filter  1133 , or combinations of one or more of the proceeding. To provide additional surface area to connect each strut  1160  to filter  1133 , each strut  1160  can be configured so that distal portion  1162  has a cross-sectional dimension larger than intermediate portion  1164 . Stated another way, distal portion  1162  can have a larger surface area than intermediate portion  1164 . The large cross-sectional area provided by the cross-sectional dimension of distal portion  1162  provides large area for bonding each strut  1160  to filter  1133 . In this configuration, a strong bond is created between each strut  1160  and filter  1133 . 
     Similarly, each strut  1160  can be configured so that proximal portion  1166  has a cross-sectional dimension larger than intermediate portion  1164 , while optionally having a similar, larger, or smaller cross-sectional dimension than distal portion  1162 . By having a large cross-sectional dimension and hence large surface area, each strut  1160  can apply a greater biasing force to extend strut  1160  outwardly to deploy filter  1133 . 
     By varying the cross-sectional dimensions of distal portion  1162 , intermediate portion  1164 , and/or proximal portion  1166 , the degree of bias exerted by each strut  1160  to move distal portion  1162  toward the wall of a blood vessel can be varied. The biasing force can also be changed through optionally varying the length of each strut  1160  and/or changing the curvature of each strut  1160 . 
     Although reference is made herein to each strut  1160  having the above-referenced configurations, one skilled in the art can appreciate that one or more of struts  1160  can be configured as described above. Further, each strut  1160  can optionally be configured differently so that each strut  1160  can have similar or dissimilar biasing forces compared to others struts  1160  of the same delivery device. Through varying the biasing forces, the delivery device can be used for a variety of different procedures or blood vessel configurations. 
     Struts  1160  can be formed from Nitinol, stainless steel, metals, alloys, composites, plastics, polymers, synthetic materials, or combinations thereof. Each strut  1160  can have a generally straight distal portion  1162 , proximal portion  1166 , and/or intermediate portion  1164 . Alternatively, each strut  1160  can have a generally curved distal portion  1162 , proximal portion  1166 , and/or intermediate portion  1164 . In still another configuration, each strut  1160  can have a combination of one or more straight and/or one or more curved portions. 
     Coupled to body  1162 , such as within a lumen or hole  1137 , is an atraumatic tip  1148 . The atraumatic tip  1148  can include a core wire  1156  and a flexible coil  1158  disposed thereon. Core wire  156  passes through an aperture  1170  in a distal end of filter  1133 . Alternatively, core wire  1156  passes through one or more pores formed in filter  1133 . To secure filter  1133  to atraumatic tip  1148 , a securing coil  1186  surrounds a portion of coil  1158  and the distal end of filter  1133 . Although this is one manner to connect filter  1133  to atraumatic tip  1148 , one skilled in the art can identify various other manners to connect filter  1133  to atraumatic tip  1148 . For instance, the distal end of filter  1133  can be bonded to atraumatic tip  1148  using adhesives, mechanical fasteners, crimping, seals, friction fit, press fit, or other manners to connect filter  1133  to atraumatic tip  1148 . In another configuration, filter  1133  is not connected to atraumatic tip  1148  but can slide along a portion of atraumatic tip  1148 . 
     Turning now to  FIGS. 45 and 46 , two exemplary embodiments of capturing device or mechanism capable of being used to capture the filter of the filter assembly are depicted. After the filter is deployed, it is desirable to capture the filter after the stenting operation has taken place. More specifically, it is desirable to capture the embolic particles that may have been captured by the filter and remove the same. 
       FIG. 45  illustrates a capture device  1200  according to one aspect of the present invention. Capture device  1200  includes a capture catheter  1202 . As shown, capture catheter  1202  includes a capturing portion  1204  and a positioning member  1206  connected or attached to capturing portion  1204 . Capturing portion  1204  has a distal end  1208  and a proximal end  1210 . Capturing portion  1204  includes a lumen  1212  extending from distal end  1208  to terminate at an aperture  1214  at proximal end  1210  thereof. The distal end  1208  optionally includes one or more radiopaque markers or bands  1216 , only one being shown. Similarly, a proximal end of positioning member  1206  can include one or more radiopaque marker or bands  1216 . More generally, capture device and any of the delivery devices and guidewires of the present invention can include one or more radiopaque indicators, whether such indicators are marker, bands, studs, or other radiopaque display elements. 
     Lumen  1212  is configured to receive a guidewire with attached filter assembly (not shown) of a delivery device. In one embodiment, lumen  1212  can include a stop member  1218 , depicted in dotted lines, with a hole  1220  there through. A guidewire, as represented by dotted lines identified by reference numeral  1232 , passes through hole  1220  of stop member  1218 . The guidewire  1232  can have various configurations, such as, but not limited to those described herein and others known to those skilled in the art. 
     Stop member  1218  prevents a filter assembly disposed at a distal end of guidewire  1232  to pass through hole  1220  once capture catheter  1202  has received within lumen  1212  the filter assembly associated with guidewire  1232  sufficiently that the filter of the filter assembly is at least closed to prevent escape of embolic material. In one configuration, the filter assembly and associated filter are completely enclosed by capture portion  1204  of capture device  1200 . In other configurations, the filter assembly and/or filter are partially enclosed by capture portion  1204  of capture device  1200 . One skilled in the art can identify various other configurations of stop member  1218 , so long as stop facilitates completely or partially capturing the filter assembly and/or the filter associated with guidewire  1232 . 
     Positioning member  1206  is attached to capture catheter  1202  and can be used to move capture catheter  1202  along guidewire  1232 , whether such movement is caused by moving catheter  1202  relative to guidewire  1232 , guidewire  1232  relative to catheter  1202 , or combination thereof. Positioning member  1206  has sufficient stiffness that application of a force at a proximal end  1224  can be transferred to longitudinal motion of capturing portion  1204  of capture catheter  1202 . In one configuration, positioning member  1206  is a solid member, while in another configuration positioning member  1206  is partially or completely hollow. Positioning member  1206  can be fabricated from a polymer, a plastic, polymer, a synthetic material, a metal, an alloy, combinations thereof, or other material that can be used for medical devices and has the needed stiffness. 
     As illustrated in  FIG. 46 , an alternate embodiment of a capture device  1300  is illustrated. As shown, capture device  1300  has a form of a tubular member, whether such tubular member is completely hollow or partially hollow along its length. The capture device  1300  includes a capturing portion  1304  disposed at a distal end  1308 . A lumen  1312  extends between distal end  1308  and a location proximal of distal end  1308  to terminate at an aperture  1326 . In one embodiment, the location of aperture  1326  and the proximal end of lumen  1312  coincide; such that lumen  1312  extends from proximal end  1310  to distal end  1308  of capture device  1300 . Aperture  1326  is adapted to receive a guidewire  1332 , in a similar manner to aperture  1214  of  FIG. 45 . Lumen  1312  is configured to receive a filter assembly of a delivery device (not shown). More generally, lumen  1312  completely or partially receives a filter assembly and/or filter associated with guidewire  1322 . 
     Capturing portion  1304  is configured to prevent passage of filter assembly of the delivery device. In this exemplary configuration, the length of lumen  1312  is optionally configured to prevent capturing portion  1304  from being advanced further over the filter assembly and/or the filter thereof than is required. In other configurations, lumen  1312  can be advanced over the filter assembly and/or the filter more than is required to capture the same. In another configuration, lumen  1312  can include a stop member similar to stop member  1218  discussed herein. Furthermore, capturing portion  1304  can optionally include one or more radiopaque markers similar to markers  1216  disposed at and/or between a distal end and a proximal end thereof. 
     Generally, therefore, embodiments of the present invention can provide systems, methods, and devices that combine the functionality of a guidewire, a stent delivery device, a dilation balloon, an embolic protection device, or subset grouping thereof, into a single device insertable into a body lumen. In this manner, embodiments of the present invention reduce the number of devices needed to perform a procedure, decrease the time needed to perform the procedure, reduce the difficulty and complexity of the procedure, thereby creating the potential for safer procedures and increased effectiveness to the patient. 
     Portions of the various delivery devices and associated dilation assemblies, stents, guide members, actuator assemblies, guidewires, filter assemblies, and other elements of the present invention can be used interchangeably one with another. Therefore, descriptions of one delivery device and associated components and/or elements is also applicable to other delivery devices described herein and such other devices as known by one skilled in the art in light of the disclosure herein. 
     The present invention may be embodied in other specific forms without departing all from its spirit or essential characteristics. The described embodiments are to be considered in respects only as illustrative and not restrictive. The scope of the invention is, therefore, indicated by the appended claims rather than by the foregoing description. All changes which come within the meaning and range of equivalency of the claims are to be embraced within their scope.