Patent Abstract:
A method of reducing the risk of clinical sequelae to catheter induced vascular injuries may include introducing a guide wire into a vascular sheath residing in a blood vessel, proximally retracting the vascular sheath while leaving the wire in place, and observing indicia of the presence or absence of a vascular injury caused to the blood vessel by the vascular sheath or a procedural catheter previously advanced through the vascular sheath. If indicia of a vascular injury are observed, the method may further involve proximally retracting the guide wire to position the inflatable balloon adjacent the injury and inflating the balloon to reduce blood flow past the injury, while leaving the guide wire in place to provide subsequent access to the injury. The inflatable balloon can be inflated and deflated through a valve positioned at the proximal end of the guide wire.

Full Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    This application is a continuation-in-part of U.S. patent application Ser. No. 13/531,227, entitled “Method And Devices For Flow Occlusion During Device Exchanges,” filed on Jun. 22, 2012, which claims priority to U.S. Provisional Patent Application Ser. Nos. 61/501,125, entitled “Methods, Devices, and Systems for Flow Occlusion During Device Exchanges,” filed on Jun. 24, 2011; and 61/540,994, entitled “Method and Devices for Flow Occlusion During Device Exchanges,” filed on Sep. 29, 2011. This application is related to U.S. patent application Ser. No. 11/112,877, entitled “Apparatus and Methods for Sealing a Puncture in Tissue,” filed on Apr. 22, 2005, and now issued as U.S. Pat. No. 8,002,742. The full disclosures of these references are hereby incorporated by reference. 
     
    
     FIELD 
       [0002]    The field of the present application pertains to medical devices, and more particularly, to methods and systems for maintaining vascular access and/or minimizing bleeding, for example, during and after catheter-based interventions, for example, in the settings of device exchanges, vascular access closure, and the management of vascular complications. 
       BACKGROUND 
       [0003]    Catheter-based medical procedures using large diameter (or “large bore”) vascular access sheaths are becoming increasingly more common. Two examples of such large bore catheterization procedures that are gaining rapid popularity are Transcatheter Aortic Valve Implantation (“TAVI”) and EndoVascular abdominal Aortic aneurysm Repair (“EVAR”). Although these procedures may often be effective at treating the condition addressed, they often cause injury to the blood vessel in which the large bore vascular access catheter is inserted to gain access for performing the procedure. In fact, vascular injury requiring treatment occurs in as many as 30-40% of large bore vascular procedures, according to some sources. Injury to the blood vessel may include perforation, rupture and/or dissection, which causes blood to flow out of the artery (“extravascular bleeding”), often requiring emergency surgery to repair the damaged blood vessel wall. If not properly treated, such a vascular injury may lead to anemia, hypotension or even death. 
         [0004]    Vascular injury during large bore intravascular procedures is typically caused by the vascular access sheath itself and/or one or more instruments passed through the sheath to perform the procedure. Larger diameter vascular access sheaths are required in a number of catheter-based procedures, such as those mentioned above, where relatively large catheters/instruments must be passed through the sheath. Several other factors may increase the risk of vascular injury, including occlusive disease of the access vessel(s) and tortuosity/angulation of the access vessel(s). Another vascular injury caused by large bore intravascular procedures that can be challenging is the access site itself. Typically, large bore catheterizations create a significantly large arteriotomy, due to a disproportionately large ratio of the diameter of the vascular access catheter to the diameter of the artery in which it is placed. Large arteriotomies may require special management and multiple steps during closure. This may lead to significant blood loss while access closure is attempted. 
         [0005]    Several techniques have been attempted to reduce the incidence of vascular injury in large bore vascular access procedures. For example, preoperative imaging of the blood vessel to be accessed, in the form of CT and MR angiography, may provide the physician with an idea of the anatomy of the vessel. If a particular vessel appears on imaging studies to be relatively tortuous or small, possible adjunctive maneuvers to prevent arterial dissection include pre-dilatation angioplasty of the iliofemoral vessels prior to large bore sheath placement, utilization of smaller access sheaths when possible, stiffer wires to aid in sheath placement and/or use of hydrophobic sheaths. In another attempt at preventing vessel injury, sheath placement may be performed under fluoroscopic guidance, and advancement may be halted when resistance is encountered. Despite the availability of these techniques, vascular injury requiring treatment still occurs in a large percentage of large bore vascular procedures. 
         [0006]    Vascular injuries caused by intravascular procedures are generally quite difficult to diagnose and treat. When an arterial dissection occurs, it often remains undetected until the catheterization procedure is completed and the vascular access sheath is removed. For example, upon removal of the access sheath, large segments of the dissected vessel wall may be released within the vessel. The dissected vessel wall may lead to a breach in the artery wall, a flow-limiting stenosis, or distal embolization. Perforation or rupture of the iliofemoral artery segment may occur from persistent attempts to place large access sheaths in iliac arteries that are too small, too diseased, and/or too tortuous. Here too, a perforation may be likely to remain silent until sheath withdrawal. 
         [0007]    Generally, vascular perforations and dissections caused by large bore vascular procedures allow very little time for the interventionalist to react. Frequently, these vascular injuries are associated with serious clinical sequelae, such as massive internal (retroperitoneal) bleeding, abrupt vessel closure, vital organ injuries, and emergency surgeries. In some cases, an interventionalist may first attempt to repair a vascular injury using an endovascular approach. First, the injury site may be controlled/stabilized with a balloon catheter, in an attempt to seal off the breached vessel wall and/or regain hemodynamic stability in the presence of appropriate resuscitation and transfusion of the patient by the anesthesiologist. Subsequently, endovascular treatment solutions may be attempted, for example if wire access is maintained through the true lumen. This may involve placement of one or more balloons, stents, or covered stents across the dissection/perforation. If the hemorrhage is controlled with these maneuvers and the patient is hemodynamically stabilized, significant reduction in morbidity and mortality may be realized. If attempts at endovascular repair of the vessel fail, emergency surgery is typically performed. 
         [0008]    Presently, vascular injuries and complications occurring during and after large bore intravascular procedures are managed using a contralateral balloon occlusion technique (“CBOT”). CBOT involves accessing the contralateral femoral artery (the femoral artery opposite the one in which the large bore vascular access sheath is placed) with a separate access sheath, and then advancing and maneuvering a series of different guidewires, sheaths and catheters into the injured (ipsilateral) femoral or iliofemoral artery to treat the injury. Eventually, a (pre-sized) standard balloon catheter is advanced into the injured artery, and the balloon is inflated to reduce blood flow into the area of injury, thus stabilizing the injury until a repair procedure can be performed. Typically, CBOT involves at least the following steps: (1) Place a catheter within the contralateral ilofemoral artery (this catheter may already be in place for use in injecting contrast during the intravascular procedure); (2) Advance a thin, hydrophilic guidewire through the catheter and into the vascular access sheath located in the ipsilateral iliofemoral artery; (3) Remove the first catheter from the contralateral iliofemoral artery; (4) Advance a second, longer catheter over the guidewire and into the vascular access sheath; (5) Remove the thin, hydrophilic guidewire; (6) Advance a second, stiffer guidewire through the catheter into the vascular access sheath; (7) In some cases, an addition step at this point may involve increasing the size of the arteriotomy on the contralateral side to accommodate one or more balloon catheter and/or treatment devices for treating arterial trauma on the ipsilateral side; (8) Advance a balloon catheter over the stiffer guidewire into the damaged artery; (9) Inflate the balloon on the catheter to occlude the artery; (10) Advance one or more treatment devices, such as a stent delivery device, to the site of injury and repair the injury. 
         [0009]    As this description suggests, the current CBOT technique requires many steps and exchanges of guidewire and catheters, most of which need to be carefully guided into a vascular access catheter in the opposite (ipsilateral) iliofemoral artery. Thus, the procedure is quite challenging and cumbersome. Although considered the standard of care in the management of vascular complications, the CBOT technique may not provide immediate stabilization of an injured segment, may lack ipsilateral device control, and/or may not provide ready access for additional therapeutics such as stents, other balloons and the like. 
         [0010]    Therefore, in the management of vascular injuries and complications stemming from large bore intravascular procedures, it would be useful to provide a solution for minimizing blood loss and bridging the time to treatment (for example, an endovascular or surgical procedure) while maintaining an access pathway for delivering one or more treatment devices (balloon catheters, stents, etc.) to the injury site. It would also be desirable to provide blood flow occlusion during vascular closure after femoral artery catheterization. Ideally, a device for blood flow occlusion would be compatible with commonly available blood vessel closure devices and techniques, to facilitate blood flow occlusion during closure and occlusion device removal after closure. At least some of these objectives will be met by the embodiments described herein. 
       SUMMARY 
       [0011]    Example embodiments described herein have several features, no single one of which is indispensable or solely responsible for their desirable attributes. Without limiting the scope of the claims, some of the advantageous features of some embodiments will now be summarized. 
         [0012]    The present application is directed generally to medical devices, and more particularly, to methods and devices for maintaining vascular access and/or minimizing bleeding during percutaneous interventions. 
         [0013]    For example, the methods and devices described herein may allow for simultaneous blood flow occlusion and device exchanges in the iliofemoral segment. In addition or alternatively, the methods and devices may maintain percutaneous vascular access while allowing for simultaneous flow occlusion and device exchanges. Optionally, the methods and devices may be utilized through the same (ipsilateral) interventional access site. The methods and devices may also be compatible with commonly available balloon/stent, and/or vascular closure systems. 
         [0014]    In one aspect, a method of reducing the risk of clinical sequelae to catheter induced vascular injuries may involve: introducing a guide wire into a vascular sheath residing in a blood vessel, the guide wire having a distal end and an inflatable balloon at least 5 cm proximal of the distal end; proximally retracting the vascular sheath while leaving the wire in place; and observing indicia of the presence or absence of a vascular injury caused to the blood vessel by the vascular sheath or a procedural catheter previously advanced through the vascular sheath. If indicia of a vascular injury are observed, the method may further include proximally retracting the guide wire to position the inflatable balloon adjacent the injury and inflating the balloon to reduce blood flow past the injury, while leaving the guide wire in place to provide subsequent access to the injury. 
         [0015]    In some embodiments, prior to the introducing step, the vascular sheath may be used for performing an intravascular procedure, such as but not limited to implantation of an aortic valve (TAVI/TAVR) and abdominal aortic aneurysm repair (EVAR). In some embodiments, observing indicia may involve observing contrast injected into the blood vessel using a radiographic imaging device. In some embodiments, the vascular sheath may have an external diameter at least about 80 percent as large as an internal diameter of the blood vessel. In some embodiments, the vascular sheath may be disposed in a femoral artery, the inflatable balloon may be at least 15 cm proximal of the distal end, and introducing the guide wire may involve advancing a tip of the wire into an aorta. 
         [0016]    In some embodiments, inflating the balloon may involve inflating at a location of the vascular injury. Alternatively, inflating the balloon may involve inflating at a location upstream of the vascular injury. In some embodiments, the method may further include: removing the vascular sheath from the blood vessel; forming at least a partial seal at a puncture site in the blood vessel through which the vascular sheath was removed from the blood vessel; deflating the inflatable balloon of the guide wire; and removing the guide wire from the blood vessel through the seal at the puncture site, where the seal closes around a small hole left in the seal when the guide wire is removed. In some embodiment, the method may further involve introducing a vascular repair device over the guide wire and repairing the vascular injury using the vascular repair device. In some embodiments, the vascular repair device may include a stent deployment catheter, and repairing the vascular injury comprises placing a stent in the blood vessel. 
         [0017]    In another aspect, a method of treating a patient may include: advancing a guide wire into a vascular sheath following an intravascular procedure, the guide wire comprising a distal end and a radially expandable structure spaced at least 5 cm proximally of the distal end; proximally withdrawing the sheath; evaluating the presence of a vascular injury caused by the sheath or a device introduced through the sheath; and if a vascular injury is observed, repositioning the guide wire and expanding the radially expandable structure to stabilize the injury. In some embodiments, the vascular sheath may be located in an iliofemoral artery, and advancing the guide wire may involve advancing the wire through into the vascular sheath from outside the body. 
         [0018]    In one embodiment, the intravascular procedure includes implantation of an aortic valve. In another embodiment, the intravascular procedure includes an abdominal aortic aneurysm repair. In some embodiments, expanding the radially expandable structure may involve inflating a balloon. In some embodiments, expanding the radially expandable structure to stabilize the injury may involve reducing blood flow in an area around the vascular injury. 
         [0019]    In another aspect, a method of treating a patient may involve introducing a guide wire into a blood vessel, the guide wire comprising a distal end and an inflatable balloon spaced at least 5 cm proximally of the balloon, introducing an index procedure catheter over the wire, and conducting an index procedure proximally of the balloon. In some embodiments, the index procedure may include implantation of an aortic valve. In some embodiments, the index procedure may include an abdominal aortic aneurysm repair. 
         [0020]    In another aspect, a method of reducing the risk of clinical sequelae to catheter induced vascular injuries may include introducing a guide wire into a vessel, the guide wire having a distal end and a radially enlargeable structure at least 5 cm proximal of the distal end, advancing a procedure catheter along the wire, and performing a procedure with the procedure catheter, such that if the procedure catheter or an access sheath used introduce the procedure catheter produces a vascular injury, the guide wire can be advanced or retracted to position the radially enlargeable structure adjacent the injury, and the structure can be radially enlarged to control the injury while leaving the guide wire in place to provide subsequent access to the injury. In one embodiment, the procedure catheter may be an over the wire catheter. In one embodiment, the procedure catheter may be a rapid exchange catheter. In one embodiment, the procedure may be a heart valve repair. In one embodiment, the procedure may be a heart valve replacement. In one embodiment, the procedure may be implantation of an abdominal aortic aneurysm graft. 
         [0021]    In some embodiments, if a vascular injury is not observed, the guide wire may be advanced or retracted without radially enlarging the radially enlargeable structure. In some embodiments, the radially enlargeable structure may be an inflatable balloon. Some embodiments may further include the step of evaluating the presence of a vascular perforation using Doppler ultrasound. Some embodiments may further include the step of evaluating the presence of a vascular perforation using contrast injection. In some embodiments, a vascular perforation is observed, the radially enlargeable structure is enlarged to control the injury, and a repair catheter is advanced along the guide wire. In some embodiments, the repair catheter may include a stent delivery catheter. In some embodiments, the repair catheter may include a graft delivery catheter. In some embodiments, a vascular injury is observed, the radially enlargeable structure is enlarged to control the injury, and the injury is thereafter surgically repaired. 
         [0022]    In another aspect, a method of treating a catheter induced vascular injury may involve: advancing an inflatable balloon of a guide wire through a vascular sheath disposed in an iliofemoral artery, where the vascular sheath was used to perform a catheter based intravascular procedure; retracting the vascular sheath proximally; assessing the artery for injury; repositioning the guide wire within the artery; inflating the balloon to occlude the artery; removing an inflation device from the guide wire, wherein the balloon remains inflated after the inflation device is removed; advancing a vascular repair device over a proximal end of the guide wire; performing a repair procedure on the artery, using the repair device; removing the repair device over the guide wire; deflating the balloon using the inflation device; and removing the guide wire from the artery. 
         [0023]    In some embodiments, prior to the advancing step, the vascular sheath is used for performing an intravascular procedure, such as but not limited to implantation of an aortic valve or abdominal aortic aneurysm repair. In some embodiments, observing indicia involves observing contrast injected into the artery using a radiographic imaging device. In some embodiments, the vascular sheath may be disposed in a femoral artery, the inflatable balloon may be at least 15 cm proximal of a distal end of the guide wire, and advancing the guide wire may involve advancing a tip of the wire into an aorta. In some embodiments, inflating the balloon may involve inflating at a location of the vascular injury. In some embodiments, inflating the balloon may involve inflating at a location upstream of the vascular injury. 
         [0024]    In another aspect, a vascular guide wire may include: an elongate tubular body having a proximal end, a distal end and a lumen extending longitudinally through at least part of the body, which may include a proximal portion, a flexible distal tip that is at least about 15 cm long and is more flexible than the proximal portion, and a transition portion between the proximal and distal portions. The guide wire may further include an inflatable balloon disposed on the transition portion and in communication with the lumen and a valve on the proximal portion of the elongate body configured to couple with an inflation device to allow for inflation and deflation of the balloon. 
         [0025]    In some embodiments, the valve may include an axially movable occluder, positioned within the lumen, and the valve may be configured to lock inflation fluid inside the lumen when in a closed position, to allow the inflation device to be removed, thus leaving a hubless proximal end over which one or more devices may be advanced. In some embodiments, the occluder may be movable between a proximal position and a distal position, and the valve may be closed when the occluder is in the distal position. In some embodiments, the distal tip may include a proximal section having a first flexibility and a J-tip at the distal end of the elongate body having a second flexibility that is greater than the first flexibility. In some embodiments, the proximal section may have a length of at least about 15 cm, and the J-tip may have a length of at least about 5 cm. In some embodiments, the distal tip may have a length of at least about 20 cm. In some embodiments, the distal tip may have a length approximately equal to an average length of an iliofemoral artery. 
         [0026]    In some embodiments, the proximal portion may include a tube with a spiral cut along a portion of its length nearer its distal end, and the spiral cut may have decreasing spacing toward the distal end. In some embodiments, the distal tip may include a core wire wrapped in a coil, and the core wire may extend through the transition portion and into the proximal portion. Optionally, some embodiments may further include a coating over the spiral cut to prevent fluid from passing out of the lumen through the cut. 
         [0027]    In another aspect, a vascular guide wire may include an elongate tubular body having a proximal end, a distal end, and a lumen extending longitudinally through at least part of the body. The elongate body may include a proximal section having a first average stiffness, a transition section having a second average stiffness that is less than the first stiffness, and a distal tip having a length of at least about 15 cm and a third average stiffness that is less than the second stiffness. The guide wire may further include an expandable member disposed on the transition section, wherein the expandable member is expandable via fluid advanced through the central lumen of the elongate body. 
         [0028]    In some embodiments, the distal tip may have approximately the same stiffness as the transition section immediately adjacent a distal end of the transition section and may become significantly more flexible toward the distal end of the elongate body. In some embodiments, the guide wire may also include a valve within the tubular body. In some embodiments, the valve may include a locking feature for locking in an inflated configuration to maintain the expandable member in an expanded configuration even after an inflation device is removed from the wire. In some embodiments, the distal tip may include a preformed J-tip such that a curved sidewall of the J-tip rather than the distal end of the elongate body is the leading structure during normal transvascular advance. 
         [0029]    Optionally, the guide wire may also include at least one radiopaque marker for indicating a position of the expandable member. In some embodiments, the expandable member may be an inflatable balloon. In some embodiments, the distal tip may have a length of at least about 20 cm. In some embodiments, the distal tip may have a length approximately equal to an average length of an iliofemoral artery. In some embodiments, the proximal end of the elongate body may be hubless, such that at least one additional device may be passed over the proximal end while the guide wire device is in the patient with the expandable member in an expanded configuration. 
         [0030]    In another aspect, a vascular guide wire system may include a guide wire device and an inflation device. The guide wire device may include an elongate tubular body having a proximal portion, a flexible distal tip that is at least about 15 cm long and is more flexible than the proximal portion, a transition portion between the proximal and distal portions, and a lumen extending longitudinally through at least part of the body. The guide wire device may also include an inflatable balloon disposed on the transition portion and in communication with the lumen and a valve on the proximal portion of the elongate body. The inflation device may be configured to couple with the elongate body to open and close the valve and allow for inflation of the inflatable balloon. 
         [0031]    In some embodiments, the valve may include an axially movable occluder, positioned within the lumen, and the valve may be configured to lock inflation fluid inside the lumen when in a closed position, to allow the inflation device to be removed, thus leaving a hubless proximal end of the elongate body, over which one or more devices may be advanced. Optionally, some embodiments of the system may further include an inflation medium injection device, such as but not limited to a pump. In some embodiment, the distal tip of the guide wire device may be a J-tip and may have a length of at least about 20 cm. In some embodiments, the proximal end of the elongate body may be hubless. In some embodiments, the distal tip of the guide wire device may include a core wire wrapped in a coil, and the core wire may extend through the transition portion and into the proximal portion. 
         [0032]    In another embodiment, the valve provided to lock inflation fluid inside the lumen when in a closed position, can comprise a microvalve assembly. The microvalve assembly can be provided such that it allows the inflatable balloon to be inflated while the valve is in the open position, and upon closing the valve it locks the inflation fluid inside the lumen. The microvalve can be provided with a profile small enough such that the vascular guide wire or elongate body can continue to function as a guide wire. To deflate the balloon, the valve can be re-opened. 
         [0033]    In yet another embodiment, the valve can comprise a micro O-ring that can be constrained on each end by a pair of small sleeves. A movable wire, or piston element, can be integrated with a frictional element and handle that when shifted into the lumen of the guide wire in a distal direction can act as a sealing mechanism. The O-ring can be stationary and the action of the piston shifting into the inner diameter of the O-ring sealing member can cause it to seal and provide a closed state. Shifting the handle of the piston in a proximal direction, partially withdrawing the piston from the lumen of the guide wire can open the valve by removing the piston from the O-ring inner diameter. Alternatively, the O-ring can be attached at the end of the piston and movable together with the piston to block the inflation port or fill ports. 
         [0034]    These and other aspects and embodiments of the invention will be described below in further detail, in relation to the attached drawings. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0035]      FIGS. 1A-1E  are diagrammatic illustrations of a femoral artery, iliofemoral segment and aorta portion, showing an exemplary method for controlling blood flow during vascular access closure, according to one embodiment; 
           [0036]      FIGS. 2A-2I  are diagrammatic illustrations of a femoral artery, iliofemoral segment and aorta portion, showing an exemplary method for stabilizing vascular injuries and managing blood flow during interventions to treat vascular injuries, according to one embodiment; 
           [0037]      FIG. 3  is a side view of an exemplary guide wire balloon device, along with close-up, cross-sectional views of a distal tip, balloon section and valve section of the device, according to one embodiment; 
           [0038]      FIGS. 4A and 4B  are cross-sectional side views of an alternative embodiment of a valve section (fluid regulator/valve), shown in a valve-closed configuration ( FIG. 4A ) and a valve-open configuration ( FIG. 4B ), which may be included in a guide wire device, such as the guide wire device shown in  FIG. 3 ; 
           [0039]      FIGS. 5A and 5B  are cross-sectional side views of another alternative embodiment of a valve section (fluid regulator/valve), shown in a valve-closed configuration ( FIG. 5A ) and a valve-open configuration ( FIG. 5B ), which may be included in a guide wire device, such as the guide wire device shown in  FIG. 3 ; 
           [0040]      FIGS. 6A and 6B  are cross-sectional side views of an alternative embodiment of a valve section (fluid regulator/valve), shown in a valve-open configuration ( FIG. 6A ) and a valve-closed configuration ( FIG. 6B ), which may be included in a guide wire device, such as the guide wire device shown in  FIG. 3 ; 
           [0041]      FIGS. 7A and 7B  are cross-sectional side views of an alternative embodiment of a valve section (fluid regulator/valve), shown in a valve-open configuration ( FIG. 7A ) and a valve-closed configuration ( FIG. 7B ), which may be included in a guide wire device, such as the guide wire device shown in  FIG. 3 ; 
           [0042]      FIG. 8  is a side view of a guide wire balloon device, along with close-up, cross-sectional views of a distal tip, balloon section and valve section of the device, according to an alternative embodiment; 
           [0043]      FIGS. 9A-9L  illustrate alternative stiffness characteristics of the individual segments of a guide wire device, according to various alternative embodiments; 
           [0044]      FIG. 10  is a diagrammatic illustration of a femoral artery, iliofemoral segment and aorta portion, illustrating the relative length of a portion of a guide wire device, with the device in position across an iliofemoral segment, according to one embodiment; 
           [0045]      FIG. 11  is a diagrammatic illustration of a femoral artery access site and a side view of a portion of a guide wire device passed through an access site in the artery, where the guide wire device has a flexible distal end, extending across a nonlinear path at the vascular access site, according to one embodiment; 
           [0046]      FIG. 12  is a chart illustrating experimental results comparing the stiffness characteristics of a guide wire device according to one embodiment with existing products; 
           [0047]      FIG. 13  shows an angiogram of a guide wire device according to one embodiment, illustrating the device&#39;s ability to occlude blood flow in a blood vessel; 
           [0048]      FIGS. 14A and 14B  show angiographic images of the guide wire device of  FIG. 13  extending from an iliofemoral segment to an aorta; 
           [0049]      FIG. 15  is a perspective view of a guide wire balloon system, including close-up views of an inflation device, a balloon section of a guide wire device, and a core wire and distal tip of the guide wire device, according to one embodiment; 
           [0050]      FIG. 16  is a perspective view of the system of  FIG. 15  partially packaged in a kit with other components, according to one embodiment; 
           [0051]      FIG. 17A  is a side view of a guide wire device such as that shown in  FIG. 15 ; 
           [0052]      FIG. 17B  is a side, cross-sectional view of the distal tip of the guide wire device of  FIG. 17A ; 
           [0053]      FIGS. 17C and 17D  are side, cross-sectional views of the valve section of the guide wire device of  FIG. 17A , shown in a valve-closed configuration ( FIG. 17C ) and a valve-open configuration ( FIG. 17D ); 
           [0054]      FIGS. 18-25  are side, cross-sectional views of balloon sections of guide wire devices, according to various alternative embodiments; 
           [0055]      FIG. 26A  is a perspective view of an inflation device for use with a guide wire balloon device, according to one embodiment; 
           [0056]      FIG. 26B  is an exploded view of the inflation device of  FIG. 26A ; 
           [0057]      FIGS. 26C-26F  are top, perspective, side and end-on views, respectively, of the inflation device of  FIG. 26A ; 
           [0058]      FIGS. 27A and 27B  are top views of an inflation device and the hands of a user, illustrating a method for using the inflation device, according to one embodiment; 
           [0059]      FIG. 28  is a side view of an exemplary guide wire balloon device, along with close-up, cross-sectional views of a distal tip, balloon section and valve section of the device, according to one embodiment; 
           [0060]      FIGS. 29A and 29B  are cross-sectional side views of an alternative embodiment of a valve section (fluid regulator/valve), shown in a valve-closed configuration ( FIG. 29A ) and a valve-open configuration ( FIG. 29B ), which may be included in a guide wire device, such as the guide wire device shown in  FIG. 28 ; 
           [0061]      FIG. 30  is a cross-sectional side view of a piston assembly inserted at the proximal end of a guide wire device, such as the guide wire device shown in  FIG. 28 ; 
           [0062]      FIG. 31A  is a side view of a piston assembly with a split tube attached to a piston of the piston assembly, prior to forming the split tube into a frictional element; 
           [0063]      FIG. 31B  is a side view of the piston assembly of  FIG. 31A , where the split tube has been formed into the frictional element; and 
           [0064]      FIGS. 32A and 32B  are cross-sectional side views of another alternative embodiment of a valve section (fluid regulator/valve), shown in a valve-closed configuration ( FIG. 32A ) and a valve-open configuration ( FIG. 32B ), which may be included in a guide wire device. 
       
    
    
     DETAILED DESCRIPTION 
       [0065]    Although certain embodiments and examples are disclosed below, inventive subject matter extends beyond the specifically disclosed embodiments to other alternative embodiments and/or uses, and to modifications and equivalents thereof. Thus, the scope of the claims appended hereto is not limited by any of the particular embodiments described below. For example, in any method or process disclosed herein, the acts or operations of the method or process may be performed in any suitable sequence and are not necessarily limited to any particular disclosed sequence. Various operations may be described as multiple discrete operations in turn, in a manner that may be helpful in understanding certain embodiments; however, the order of description should not be construed to imply that these operations are order dependent. Additionally, the structures, systems, and/or devices described herein may be embodied as integrated components or as separate components. 
         [0066]    For purposes of comparing various embodiments, certain aspects and advantages of these embodiments are described. Not necessarily all such aspects or advantages are achieved by any particular embodiment. Thus, for example, various embodiments may be carried out in a manner that achieves or optimizes one advantage or group of advantages as taught herein without necessarily achieving other aspects or advantages as may also be taught or suggested herein. 
         [0067]    Referring now to  FIGS. 1A-1E , one embodiment of a method for controlling bleeding during vascular closure, for example after femoral artery catheterization, is illustrated.  FIG. 1A  shows a segment of an arterial pathway, including the iliofemoral artery  100 , the femoral artery  102 , and the aorta  101 . (This and other anatomical drawings are not drawn to scale and are not necessarily anatomically correct but are provided for descriptive, exemplary purposes.) Many of the descriptions herein discuss accessing and treating an iliofemoral artery (or “iliofemoral segement”), which is a length of an artery extending from a portion of a femoral artery to a portion of an iliac artery. These descriptions are for exemplary purposes only, and in various embodiments, other blood vessels may be accessed and/or treated, such as but not limited to femoral arteries, iliac arteries, aortas and the like. For example, using various devices and methods described below, a guide wire balloon catheter device may be advanced into a femoral artery, a distal tip of the device may be passed into the aorta, and the device may then be used to occlude flow within, and provide access to, an iliofemoral artery. Thus, the descriptions below should not be interpreted to limit the scope of the invention to a particular blood vessel. 
         [0068]      FIG. 1B  shows a vascular access sheath  110  inserted through a vascular access site in the femoral artery  102  and extending through the iliofemoral segment  100  for conducting any suitable diagnostic and/or therapeutic catheterization procedure. The sheath  110  may have a diameter of 14F, 16F, 18F or the like in some embodiments, or may be smaller or larger in alternative embodiments. Generally, the sheath  110  may be any suitable sheath for performing an intravascular procedure and is placed in the iliofemoral artery  100  to perform the procedure (i.e., prior to the introduction and use of the guide wire device described herein.) The sheath  110  may be introduced in a retrograde orientation, as shown, or alternatively, in some procedures, the sheath  110  and/or other devices herein may be introduced antegrade relative to the patient&#39;s blood flow, as appropriate for a given application. 
         [0069]    Referring now to  FIG. 1C , upon completion of the catheter-based procedure, and before sheath withdrawal, a guide wire balloon device  120  or system (for example, any of the embodiments described elsewhere herein or in the applications incorporated by reference herein) may be inserted into the sheath  110  such that a tip  121  of the guide wire device  120 , for example, a floppy “J tip,” is positioned past the distal tip  111  of the sheath  110  inside the aorta  101 . The guide wire balloon device  120  may be described herein as an “guide wire,” “guide wire balloon catheter,” “guide wire device” or the like. As described further elsewhere herein, the guide wire device  120  may have a cross-sectional size that allows the sheath  110  to be inserted, withdrawn and/or exchanged over the guide wire shaft (and/or allow secondary devices to be advanced over the device  120 ). Thus, the sheath  110  may be withdrawn (partially or completely) proximally and/or advanced distally over the guide wire device  120  to adjust positioning of the sheath  110  relative to the device  120 . 
         [0070]    As illustrated in  FIG. 1D , in a next step, the sheath  110  may be retracted/withdrawn relative to the guide wire device  120 , while maintaining the device  120  in position, to expose a balloon  122  or other expandable member on the guide wire device  120 . The balloon  122  may be positioned and inflated at a desired occlusion site before, during, or after complete withdrawal of the sheath, as shown in  FIG. 1D . 
         [0071]    With continuing reference to  FIG. 1D , after the sheath  110  has been removed from the femoral artery, the vascular access site may be closed, for example, with a suture/sealant combination  130 , advanced about or otherwise in cooperation with the guide wire device  120  at the site of arteriotomy. Exemplary closure devices and methods that may be delivered over or otherwise in conjunction with the guide wire device  120  (or any of the embodiments herein) are disclosed in U.S. Pat. Nos. 7,316,704, 7,331,979, 7,335,220 and 7,806,856, and U.S. Patent Application Publication Nos. 2007/0231366, 2008/0082122, 2009/0088793, 2009/0254110, 2010/0168789, 2010/0274280 and 2010/0280546. The entire disclosures of these references are expressly incorporated by reference herein. 
         [0072]    As shown in  FIG. 1E , next the balloon  122  may be deflated, and the guide wire device  120  may be withdrawn through the closed arteriotomy. In these embodiments, the sealant  130  may be capable of closing the hole left by the guide wire device  120  after withdrawal. 
         [0073]    Referring now to  FIGS. 2A-2I , another method is provided for managing vascular complications and/or controlling bleeding during or after trans-femoral catheterization.  FIG. 2A  again illustrates the femoral artery  102 , iliofemoral artery  100  (or “iliofemoral segment”) and a small portion of the aorta  101 . As shown in  FIG. 2B , the method may initially include inserting a vascular access sheath  110  (or “procedure sheath”) into the femoral artery  102  and advancing its distal end  111  into the iliofemoral segment  100  for conducting a catheterization procedure, similar to the previous embodiment. In most embodiments, the vascular access sheath  110  will be used for performing one or more intravascular or transvascular procedures, such as but not limited to EVAR or TAVI (also called transvascular aortic valve replacement, or “TAVR”). Next, as illustrated in  FIG. 2C , upon completion of the procedure, and before withdrawing the vascular access sheath  110 , a guide wire balloon device  120  (for example, any of the embodiments described elsewhere herein or in the applications incorporated by reference herein) may be inserted into the procedure sheath  110 , such that a tip  121  of the guide wire device  120  is positioned past the sheath tip  111  inside the aorta  101  (or other body lumen). 
         [0074]    Referring to  FIGS. 2D and 2E , the sheath  110  may then be withdrawn, for example, under angiographic guidance, while maintaining the position of the guide wire device  120  in the iliofemoral artery  100 . If sheath withdrawal uncovers a vascular injury, such as dissections  132  (shown in  FIG. 2D ) or perforations  134  (shown in  FIG. 2E ), expedient catheter management of the injury is possible by the guide wire device  120 , which is positioned in the true lumen of the vessel  100 . As shown in  FIG. 2F , as a first step, the balloon  122  may be positioned at the location of the vascular injury  132  and inflated, in an effort to stabilize the vessel wall at the site of injury, and/or to bridge the complication for further treatment options. 
         [0075]    With reference to  FIG. 2G , the guide wire device  120  may provide a path for ipsilateral insertion of a treatment device, such as a catheter  134  with a balloon  136  and possibly a stent mounted on the balloon  136 , for treating the vascular injury  132 . In most or all embodiments, the guide wire device  120  may be “hubless,” meaning that once an inflation device (not shown) is removed from the device  120 , one or more instruments may be passed over the proximal end of the guide wire device  120  without having to remove or navigate over a proximal hub. This hubless feature provides a significant advantage in ease of use for passing one or more additional devices to the area of the vascular injury. In other embodiments, alternative or additional treatment devices may be advanced over guide wire device  120 , such as but not limited to any suitable catheter device, such as balloon expandable devices, stent delivery devices, graft delivery devices, radiofrequency or other energy delivery devices or the like. Under such scenarios, the device(s)  134  may be inserted into the target vessel over the guide wire device  120  while the injury is stabilized and bleeding is minimized by the expanded balloon  122 , as shown in  FIG. 2G . 
         [0076]    Referring now to  FIG. 2H , to facilitate positioning of a treatment device  134 , the balloon  122  of the guide wire device  120  may be deflated and moved as desired within the vessel, for example, to an upstream location, as shown. Optionally, the tip  121  may be positioned past the iliofemoral segment  100  in the aorta  101  at anytime during the procedure, for example, in order to prevent tip-related injury. In such procedures, the floppy tip  121 , which may include the entire length distal to the balloon  122 , may be sufficiently long to extend into the aorta when the balloon  122  is positioned in the iliofemoral segment  100 . For example, in various embodiments, the tip  121  may be at least longer than the average length of the iliofemoral segment  100 , such as at least about 15 cm, more preferably at least about 20 cm, and even more preferably between about 20 cm and about 25 cm. 
         [0077]    In the embodiments described above, the guide wire device  120  and therapeutic device(s)  134  are advanced to the injury site through vasculature on the same side of the patient&#39;s body that the procedural vascular access sheath  110  was placed. For the purposes of this application, this side of the patient is referred to as the ipsilateral side of a patient. In other words, in this application, “ipsilateral” refers to the side of the patient&#39;s body on which the main access was achieved for performing a given endovascular procedure. For example, the “ipsilateral femoral artery” or “ipsilateral iliofemoral artery” will generally be the artery in which a vascular access sheath  110  (or any other access device) is placed for advancing instruments to perform the intravascular procedure (TAVI, EVAR, etc.). “Contralateral” refers to the opposite side of the patient, relative to the procedure access side. In this regard, “ipsilateral” and “contralateral” relate to the side on which access is gained to perform the main procedure and do not relate to where the physician stands to perform the procedure. In any case, various embodiments of the methods and devices described herein may be used exclusively via an ipsilateral approach, exclusively via a contralateral approach, or interchangeably via an ipsilateral or contralateral approach. 
         [0078]    The method just described in relation to  FIGS. 2A-2I  may have a number of advantages over the prior art contralateral balloon occlusion technique (CBOT). One advantage, for example, is that the guide wire balloon device  120  will typically be located very close to the vascular injury  132 ,  134  when the vascular sheath  110  is withdrawn. Thus, the balloon  122  may be inflated quickly within the iliofemoral artery  100 , aorta  101  or femoral after  102 , perhaps after minor positional adjustments, to quickly occlude the vessel and stabilize the injury  132 ,  134  while treatment options are being assessed and prepared. Another potential advantage of the method described above is that only one combined guide wire balloon device  120  is needed to stop blood flow/stabilize the injury  132 ,  134  and to provide a path along which treatment device(s)  134  may be advanced into the vessel. In other words, the method does not require multiple different guidewires, guide catheters, introducer sheaths and the like, nor does it require difficult threading of a guidewire into a contralaterally placed sheath. In general, therefore, the described method may be easier and quicker to perform, thus facilitating a quicker and more effective vascular repair. 
         [0079]      FIG. 3  illustrates one embodiment of a guide wire device  300  for performing the various procedures described herein, such as occluding an artery to stop blood flow past a vascular injury and to provide a path for delivering one or more treatment devices to the injury site. Generally, the guide wire device  300  may include a hollow guide wire body having a central lumen  320 , an occlusion balloon  302  (or other expandable member) attached to or otherwise carried on a distal end of the guide wire  300  adjacent a distal tip of the guide wire  300 , and a hubless extracorporeal or proximal end  303  including a valve with an inflation port  306  in communication with the lumen  320  and a balloon inflation port  305 . 
         [0080]    The guide wire device  300  may have dimensions and/or characteristics similar to conventional guide wires. For example, the guide wire device  300  may allow for introduction of other devices, such as catheters or other tubular devices carrying therapeutic and/or diagnostic elements (for example stents, covered stents, stent-grafts, balloons, etc.) In certain embodiments, the guide wire device  300  (including the balloon  302  in a collapsed state) may be sized to be received in and/or to occlude an arterial or other body lumen, for example, sized between about 3 mm and about 15 mm in some embodiments and in other embodiments as large as about 30-40 mm. The guide wire device  300  may also have a sufficient working length to allow introduction of other devices over the guide wire shaft. 
         [0081]    The entire length or the distal end of the guide wire device may be made of compliant material that provides a flexible shape and/or accommodates the distal end conforming to the target lumen geometry. Alternatively, the proximal end  303  may be rigid, semi-rigid, or simply stiffer than the distal end to facilitate advancement of the guide wire device  300  from the proximal end  303 . 
         [0082]    In some embodiments, the central lumen  320  of the guide wire  300  may communicate with the external surface or environment of the device through a series of valves (or other flow regulators) for example, within or on the proximal end  303  of the guide wire device  300 . 
         [0083]    In some embodiments, the deflated balloon  302  may have an overall low profile substantially similar to the guide wire shaft dimension, for example, such that at least the distal end has a substantially uniform diameter and/or the entire length of the guide wire device  300  has a substantially uniform diameter. 
         [0084]    In certain embodiments, the proximal end  303  of the guide wire shaft may be attached to a detachable inflation unit for balloon  302  inflation/deflation. The inflation unit may be sealingly attached around or otherwise to the balloon shaft to provide inflation. 
         [0085]    Some embodiments may include a fluid regulation system, for example, within the proximal end  303  of the guide wire shaft, that maintains inflation/deflation state during operation, for example, when the inflation unit has been utilized to inflate or deflate the balloon  302  and then removed. The fluid regulation system may include a plurality of fluid regulators that are serially installed in order to maintain the balloon  302  in an inflation state, for example, in case of failure of an individual fluid regulator (for example, as a result of balloon catheter manipulation). In one embodiment, the fluid regulator system may include an internal fluid regulator and an external fluid regulator, which are operatively coupled such that opening the internal fluid regulator may cause the external fluid regulator to open as well. The fluid regulation system may also include one or more mechanisms designed to automatically lock at least one fluid regulator. In certain embodiments, the fluid regulator system may also include one or more protective features to prevent or minimize accidental manipulation, kinking etc., which may adversely affect inflation or deflation status. For example, one or more protective sleeves, caps, segments of enhanced stiffness, locking mechanisms, etc. (not shown) may be provided. 
         [0086]    In one embodiment, the guide wire shaft may be configured to accept parts that enable extension of the guide wire shaft. For example, a shaft extension mechanism may be connected to the fluid regulator system in an effort to simplify overall design. 
         [0087]    In certain embodiments, the guide wire device  300  may be compatible with vascular closure devices, for example, utilizing sutures, clips, and other implants, etc. The guide wire device  300  may also include one or more radiographic markers, for example, on the distal end adjacent to the balloon  302 , to aid radiographic positioning. 
         [0088]      FIG. 3  shows an exemplary embodiment of a guide wire balloon device or system  300  that includes a guide wire shaft or other outer tubular member including a proximal end  303 , a distal end terminating in a substantially non traumatic distal tip  301 , and a balloon or other expandable member  302  carried on the distal end. The balloon  302  may be formed from a soft membrane  304 , for example, to provide a compliant balloon. The balloon  302  communicates with an internal guide wire lumen  320  of the guide wire shaft, for example, via one or more inflation ports  305  in a side wall of the tubular member. Optionally, an internal wire may be provided within the guide wire shaft, for example, within the lumen  320 , to stiffen, straighten, or otherwise support the distal end or the entire length of the guide wire shaft. The internal wire may be smaller than the lumen  320 , as shown, for example, to accommodate fluid delivery through the lumen  320  around the internal wire. Optionally, the distal tip  301  may include a “J” tip and/or other features (not shown) beyond the balloon  302 , similar to conventional guide wires, if desired. 
         [0089]    The proximal (extra-corporeal) end  303  of the guide wire device  120  may be connected to an inflation device (not shown) for balloon inflation and deflation. In addition, the proximal end  303  may have an integrated flow regulator (valve) system designed to maintain balloon  302  inflation/deflation state, for example, when inflation device is disconnected, such as the embodiments described elsewhere herein and/or in the applications incorporated by reference herein. 
         [0090]    Turning to  FIGS. 4A and 4B , an exemplary embodiment of a fluid regulator (valve) system is shown that includes an internal piston  309  that may be directed to sealingly engage and disengage an internal valve  307  within the proximal end  303  of the guide wire shaft, for example, when piston shaft  308  is moved axially relative to the guide wire shaft. For example, as shown in  FIG. 4A , the piston shaft  308  may be advanced distally until the piston  309  engages the valve  307  in a distal position. Thus, in the distal position, the lumen  320  of the guide wire shaft may be substantially sealed, for example, after delivering sufficient fluid into the lumen  320  to inflate the balloon  302 . Conversely, as shown in  FIG. 4B , the piston shaft  308  may be retracted proximally until the piston  309  reaches a proximal position proximal to an outlet or side port  306  in a side wall of the proximal end  303  of the tubular member. The internal lumen  320  may communicate with the external environment adjacent the proximal end  303  through the outlet  306  when the piston shaft  308  is retracted to the proximal position such that fluid may be delivered into or evacuated from the lumen  320 , for example, to inflate or deflate the balloon  302  (not shown). Optionally, a low profile plunger (not shown) may be provided on the proximal end of the piston shaft  308  outside the proximal end of the guide wire shaft to facilitate actuation of the valve system. Alternatively, a cap (not shown) similar to other embodiments herein may be provided on the proximal end of the guide wire shaft that is coupled to the piston shaft  308 . The cap may have a profile small enough to accommodate advancing supplementary devices (not shown) over the cap onto the guide wire shaft. For example, the proximal end of the guide wire shaft may be smaller than the adjacent length of the guide wire shaft such that the cap provides a substantially uniform outer diameter (“O.D.”) on the guide wire device. 
         [0091]    Turning to  FIGS. 5A and 5B  another embodiment of a fluid regulator (valve) system is shown that may be provided on the proximal end  303  of a guide wire device, such as device  300  described above. In this embodiment, the internal piston  308  is driven by a spring  310 , for example, a tension spring, which, in a substantially relaxed or relatively lower energy position ( FIG. 5A ) maintains a substantially sealed and/or closed fluid regulator (valve) system. As shown in  FIG. 5B , when the piston  308  is moved distally relative to the guide wire shaft, the internal valve  307  may be opened to allow communication between the internal lumen  320  and the external environment of the guide wire device through outlet or side port  306 . When the piston shaft is advanced distally to open the valve  307 , the spring  310  may be subjected to increased tension such that, when the piston shaft is released, the piston shaft may resiliently retract proximally to engage the piston  308  with the valve  307  to automatically seal the lumen  320 , for example, after inflating or deflating the balloon (not shown), similar to the previous embodiments. 
         [0092]      FIGS. 6A and 6B  show yet another embodiment of a fluid regulator (valve) system that may be provided on a guide wire device, such as any of the embodiments herein, whereby an external cap  312  covers the outlet or side port  306  that communicates between the guide wire internal lumen  320  and the external environment of the guide wire device  300 . The cap  312  may be moved relative to the outlet  306 , for example, between a proximal position (shown in  FIG. 6A ) and a distal position (shown in  FIG. 6B ) to open and substantially seal the outlet  306 , for example, to allow fluid to be delivered into and evacuated from the lumen  320 , similar to the previous embodiments. 
         [0093]    Turning to  FIGS. 7A and 7B , still another embodiment of a fluid regulator (valve) system is shown that may be provided on a balloon guide wire device. Unlike the previous embodiments, the system includes an internal valve element  307  and an external valve element  306 , which are operatively (serially) connected such that a single actuation step may open both valves (as shown in  FIG. 7A ) or close them (as shown in  FIG. 7B ). Such a combination of valves may assure that flow within wire&#39;s internal lumen  320  is controlled to maintain a desired balloon inflation state. 
         [0094]    In certain embodiments, devices and methods described herein may be compatible with existing devices and work-flow, for example, such that the guide wire device may be the last device to be removed from the target artery. Therapeutic device exchanges may be possible while vascular complications are stabilized endovascularly with a balloon. This may be especially significant, for example, if bleeding occurs at vascular segments that are inaccessible for manual compression (for example, the iliac artery, the proximal femoral artery, specific patient anatomy, etc.). 
         [0095]    In certain clinical scenarios, there might be a need for the guide wire device to be introduced before or during sheath advancement, i.e. through devices with true wire lumens. Therefore, in some embodiments, the guide wire device may have a uniform diameter over the entire length including the inflatable segment and the distal tip. 
         [0096]    The devices and methods described herein may also ensure that access to the true lumen of the target vessel is maintained, when vascular complications are anticipated, but before they are encountered. 
         [0097]    In some embodiments, the devices and methods described herein may facilitate an ipsilateral approach, for example, for better device control and improved blood loss management. 
         [0098]    In certain clinical scenarios, it may be necessary to obtain angiographic guidance during insertion/withdrawal/maneuver of the guide wire device. Therefore, the guide wire device could incorporate mechanisms allowing for contrast injection at or close to the distal tip of the device. Such mechanisms may include channels, valves, and orifices for contrast injection. Alternatively, a custom sheath could be used in conjunction with the guide wire device. Such a custom sheath may be sufficiently dimensioned for housing the guide wire device and allowing for simultaneous contrast flow. The custom sheath may be equipped with a contrast injection port and an extracorporeal valve that prevents contrast back-flow during injection. 
         [0099]    In special clinical scenarios, it may also be useful to assess intravascular pressure, flow, temperature, general morphology, or other properties of the anatomy encountered, for example, to interrogate a special condition beyond angiography. In one embodiment, the guide wire device or system may include elements providing physiological or image data during operation. These elements may include one or more pressure, flow and/or temperature sensors, and/or ultrasound, light, infrared, or other imaging elements. Additionally, one or more features may be provided for assessing intravascular dimensions, including balloon inflation dimension and/or pressure, for example, for estimating vessel sizes, and/or for targeting a specific inflation threshold. 
         [0100]    The devices and systems herein may also have characteristics that allow it to be integrated into a robotic vascular surgery environment, such as the DaVinci system, the Zeus System, the Sensei system, etc. 
         [0101]    In special scenarios, additional treatment to a body lumen or other target segment may be needed beyond balloon inflation. In one embodiment, the system may provide capabilities of local drug or agent or energy delivery through the guide wire system, for example, more desirably through the balloon. 
         [0102]    In special scenarios, it may also be useful to provide a source of therapeutic and/or diagnostic agents, for example, including one or more devices for injection of agents about the target treatment area. For example, the system may include a syringe, pump, or other source for intravascular injection of agents. Such guide wire devices may include an extracorporeal injection port in the proximal end, an injection channel or other lumen, and/or a distal agent release port located in proximity to the balloon. 
         [0103]    In certain clinical scenarios, the best therapy option is endovascular stent implantation. The guide wire device may, thus, incorporate a stent delivery system that is readily available for treatment or in anticipation of vascular injuries. 
         [0104]    The guide wire device may integrate additional lumens for introduction of therapeutic/diagnostic agents/devices. Alternatively, the guide wire system may be provided with a larger sheath that can be introduced over the wire, thereby forming a channel around the external surface of the wire. 
         [0105]    In cases where prolonged flow occlusion is desired, it may be useful to provide simultaneous occlusion of a target region, and perfusion of distal regions. Therefore, the guide wire device or system may include tissue perfusion across the balloon occlusion area. Such features may include perfusion channels in the shaft or balloon, for example, with appropriate ports, valves, and/or flow drivers. 
         [0106]    In special clinical scenarios, it may be useful to isolate a specified segment of a body lumen for diagnostic or treatment purposes. In one embodiment, the guide wire system can be combined with a standard balloon catheter to create a double-balloon catheter system that is capable of isolating a targeted vessel or other bodily passages. 
         [0107]    In certain embodiments, the balloon may provide an anchoring mechanism for the guide wire device, for example, such that over-the-wire device insertion is facilitated. 
         [0108]    In certain embodiments, the occlusion balloon may be conforming to the lumen shape, and may grow axially/longitudinally during inflation. The balloon could exhibit varying wall thicknesses to provide preferential inflation shape. For example, thinner sections inflate first followed by thicker sections as the thin walled portions contact the vessel wall. The balloon could be corrugated by thicker wall sections or Kevlar inflation restrictions to mitigate pressure on the vessel wall. 
         [0109]    In some scenarios, balloon occlusion/inflation is required over long vascular segments. One embodiment could incorporate a device shaft with multiple balloon units that collectively cover a longer vascular segment. The balloon units could be collectively or individually connected to the same/multiple inflation system(s). 
         [0110]    In certain clinical scenarios, balloon dilatation might be required. The guide wire balloon device could incorporate a balloon that fulfills occlusion and dilatation function. 
         [0111]    In one embodiment, the guide wire device could be a closed system with balloon inflation agent stored inside a sealed tubing system. Collapse (or expansion) of the internal lumen of the tubing system would move the fluid into (or away) from the balloon thereby causing balloon inflation (or deflation). This embodiment foresees a tubing system that is not in communication with the external surface and has a pre-installed balloon inflation agent. 
         [0112]    In special clinical scenarios, it may be desirable to have a system for facilitating device insertion through tortuous vascular segments. For example, it might be desirable to have a guide wire device or system that includes a flexible tip designed for retrograde insertion and a stiffer shaft proximal to the tip designed for facilitating over-the-wire device insertion through tortuous segments. 
         [0113]    In certain clinical scenarios, vessel tortuosity may require straightening in order to ease device (sheath) insertion/retraction. The guide wire device could have a stiff shaft capable of non-traumatic straightening originally tortuous vessel. The stiffness could vary along the length. The distal section should be flexible and atraumatic. 
         [0114]    In certain clinical scenarios, vessel tortuosity may require intravascular shape change of the distal tip. The proposed system may integrate steerability mechanisms that allow for temporary shape change of individual segments of the device. 
         [0115]    Referring now to  FIG. 8 , in certain clinical scenarios, the target treatment segment may be rigid and/or tortuous and may not respond to straightening attempts. Therefore, it would desirable for the balloon to adapt to vessel tortuosity. In one embodiment, the inflatable segment (i.e., the portion of the device  300  along which the balloon  302  is mounted) may include a more flexible, distal segment  340  (or joint), which allows for the inflatable segment to bend and provide flexibility, and a less flexible, proximal segment  330 . The flexible segment  340  will not impact the balloon inflation functionality. 
         [0116]    Referring now to  FIGS. 9A-9L , in certain clinical scenarios, insertion or advancement of the guide wire device requires a minimum of catheter shaft back-bone support (stiffness). This guide wire characteristic is required for segments of the guide wire device such as the device shaft and the proximal part of the distal tip.  FIGS. 9A-9L  illustrate the stiffness characteristics of the balloon segment  212   a - 212   l  relative to the stiffness proximal and distal to the balloon segment  212   a - 212   l , according to various alternative embodiments of the guide wire device. The stiffness/flexibility along each embodiment is designated, from a proximal end  205   a - 205   l  to a distal end  219   a - 219   l . In the graphs, the upward direction designates more stiffness (i.e., less flexibility), and the lower direction designates less stiffness (i.e., more flexibility). In all the embodiments shown, the balloon segment  212   a - 212   l  may be described as a transition zone or transition segment between a proximal portion and a distal portion. Also, in all embodiments, there is a drop-off in stiffness (increased flexibility) in the balloon segment  212   a - 212   l  relative to the proximal portion. In some embodiments, such as those shown in  FIGS. 9A-9D  and  9 G- 9 J, flexibility is greater in the balloon segments  212   a - 212   d ,  212   g - 212   j  of the guide wire devices than in the areas of the devices immediately proximal and distal to the balloon segments  212   a - 212   d ,  212   g - 212   j . In alternative embodiments, such as those shown in  FIGS. 9E ,  9 F,  9 K and  9 L, flexibility is greater in the balloon segments  212   e ,  212   f ,  212   k ,  212   l  of the guide wire devices than in the areas of the devices immediately proximal to the balloon segments  212   e ,  212   f ,  212   k ,  212   l , but the portions of the devices immediately distal to the balloon segments  212   e ,  212   f ,  212   k ,  212   l  are either as flexible as, or more flexible than, the balloon segments  212   e ,  212   f ,  212   k ,  212   l . In other alternative embodiments, other flexibility profiles may be possible. In general, however, it may be advantageous to have a balloon segment  212   a - 212   l  of a guide wire device that is positioned between a relatively proximal portion and a relatively stiff distal section, where the balloon segment  212   a - 212   l  is more flexible than at least the proximal portion. 
         [0117]    In some embodiments, the removable inflation handle may integrate a torque system that provides torqueing of the guide wire device during operation if desired. 
         [0118]    Referring now to  FIG. 10 , in certain clinical scenarios, it is necessary to provide occlusion at the level of the femoral arteriotomy  900 , for example with an inflatable occlusion balloon  302  of a guide wire balloon device  300 , while maintaining position of the distal tip  301  of the device  300  in the aorta  101 . It is therefore desirable for the distal end  311  of the device  300  to be of sufficient length to extend through the iliofemoral  100  segment and be safely positioned (during femoral occlusion) in the aorta  101 , as shown in  FIG. 10 . In one embodiment of the guide wire device  300 , the outer diameter of the device  300  may be between about 0.014 and about 0.038 inches. In one embodiment, the length of the distal tip  311  of the device  300  may be between about 20 cm and about 50 cm. Optionally, the distal tip  311  may include a J-tip  301 , as shown, and/or other features (not shown) beyond the balloon  302 , similar to conventional guide wires, if desired. 
         [0119]    As shown in  FIG. 11 , in certain embodiments, a distal portion and/or balloon portion  123  of the guide wire device  120  may be capable of bending at sites of procedural bends such as the site of percutaneous catheter insertion. The embodiment shown in  FIG. 11  may have a similar “flexibility profile” to those shown in  FIGS. 9A-9E , where the portion of the device  120  between the proximal and distal ends of the balloon  122  is more flexible than the shaft of the device  120  immediately proximal and immediately distal to the balloon. 
         [0120]    Referring now to  FIG. 11 , several catheter characteristics such as pushability, trackability, and adaptability to vessel tortuosities are directly related to stiffness patterns of the catheter along its shaft. To determine the appropriate stiffness patterns for the guide wire device described herein, the following experiment was performed. The device disclosed herein was compared to the Guardwire balloon system (Medtronic PercuSurge, 0.014″) and the Guideright guide wire (St. Jude, 0.038″). Each device was inserted into a catheter fixture, and the region of interest was aligned with the fixture. After the Instron was calibrated with regard to push force, deflection, and position, the Instron was advanced to cause a 5 mm deflection at the region of interest. Deflection force (LbF, N) and position of deflection (distance from inflatable segment) were recorded. The procedure was then repeated for each additional region of interest. The experimental results are illustrated in  FIG. 12 , where the solid line  910  represents the flexibility profile of the exemplary embodiment of the device  120  described herein, the dashed line  912  represents the profile of the Guardwire device, and the dashed line  914  represents the profile of the Guideright device. 
         [0121]    Two catheters, the guide wire device disclosed herein and Guardwire, showed comparable stiffness profiles at the distal tip. The guide wire device, however, showed a different stiffness profile marked by the segmental decrease in stiffness at the balloon segment (position 0) relative to the proximal catheter shaft and the distal tip. This functionality lends a special flexibility feature to the balloon and allows for balloon occlusion at sites of significant tortuosity (where complications are expected), and/or at sites of procedure induced bends (such as transitions from tissue tract into arteriotomy). 
         [0122]    Referring now to  FIGS. 13 ,  14 A and  14 B, the utility of the guide wire device was successfully tested in the sheep and showed that the intended design of decreased stiffness at the balloon segment allowed for balloon occlusion at sites of significant tortuosity (where complications are expected), and/or at sites of procedure induced bends (such as transitions from tissue tract into arteriotomy).  FIG. 13  shows an angiogram of the sheep femoral artery at the site of 18Fr arteriotomy, showing the guide wire device&#39;s ability to occlude blood (contrast) flow at the site of percutaneous catheter insertion (arteriotomy).  FIG. 14B  is an angiographic image showing a clinical scenario where an occlusion at the femoral arteriotomy is required. In this scenario, as shown in  FIG. 14A , it would be desirable for the J-tip of the distal tip to be of sufficient length to extend through the iliofemoral segment and be safely positioned (during femoral occlusion) in the aorta. 
         [0123]    Referring now to  FIG. 15 , in another embodiment, a guide wire balloon system  200  (or “guide wire system”) for providing blood vessel occlusion, blood vessel injury stabilization and/or a device along which one or more treatment devices may be introduced during or after a large bore or other intravascular procedure may include a guide wire device  202  (or “guide wire balloon device”) and an inflation device  222 . Optionally, the system  200  may also include an inflation medium container/injection device (not shown), such as but not limited to a syringe, a pump or the like. The guide wire device  202  extends from a hubless proximal end  205  to a distal end  219  and includes an expandable member such as an inflatable balloon  220  closer to the distal end  219  than the proximal end  205 . The guide wire device  202  may be described as having a valve portion  204  (or “proximal portion”), a middle portion  210 , a balloon portion  212  (or “transition portion”, “transition section” or “transition zone”) and a flexible tip  216  (or “J-tip,” “distal tip” or “distal portion”). These designations of the various portions of the guide wire device  202  are made for descriptive purposes only and do not necessarily connote specific demarcations or mechanical differences between the various portions, although in some embodiments, the various portions may have one or more unique characteristics. 
         [0124]    The guide wire device  202  may further include a shaft  206  that extends from the valve portion  204  of the guide wire device  202  to at least a proximal end of the balloon  220 . In one embodiment, the shaft  206  may be a hypotube, made of Nitinol, stainless steel, or some other metal, and may include a spiral cut  211  along part of its length to increase flexibility, as will be described in greater detail below. Inside the shaft  206 , within the valve portion  204 , there may reside an inflation hypotube  207  (or “inner tube”) with an inflation port  209 , through which inflation fluid may be introduced. A valve cap  203  may be slidably disposed over the proximal end of the inflation hypotube  207 , such that it may be moved proximally and distally to close and open, respectively, the inflation port  209 . As best seen in the bottom magnified view of  FIG. 15 , a core wire  208  may be disposed within the shaft  206  along at least part of the middle portion  210  and may extend through the balloon portion  212  and in some embodiments through at least part of the distal tip portion  216 . A coil  214  may be wrapped around part of the core wire  208  and may also extend beyond the core wire  208  to the extreme distal end  219 . Various aspects and features of the shaft  206 , inflation hypotube  207 , core wire  208 , coil  214 , etc. will be described in further detail below. 
         [0125]    The inflation device  222 , which is also described in more detail below, may generally include a handle  224 , a wire lumen  226  for inserting the guide wire device  202 , and a locking inflation port  228 . The handle  224  may be movable from a first position in which the guide wire device  202  may be inserted into the lumen  226  to a second position in which the handle  224  locks onto the shaft  206  and the valve cap  203 . The handle may also be moveable from a valve-open position, in which inflation fluid may be passed into the inflation port  209  of the guide wire device  202 , to a valve-closed position, in which the inflation fluid is trapped inside the balloon  220  and guide wire device  202 . These positions and other aspects of a method for using the inflation device  222  will be described further below. 
         [0126]    In one embodiment, the guide wire device  202  may have varying amounts of stiffness along its length, typically being stiffest at the proximal end  205  and most flexible at the distal end  219 . The proximal/valve portion  204  and a proximal portion of the middle portion  210  of the guide wire device  202  are typically the stiffest portions of the device and will have sufficient stiffness to allow the device  202  to be advanced through a sheath and into a blood vessel, typically against the direction of blood flow (i.e., retrograde advancement). Along the middle portion  210 , the device  202  may be relatively stiff at a most proximal end and quite flexible at a distal end (within, or adjacent the proximal end of, the balloon  220 ). This change in stiffness/flexibility may be achieved using any of a number of suitable mechanical means. In the embodiment shown, for example, the shaft  206  includes a spiral cut  211  along its length, where the spacing between the cuts becomes gradually less along the middle portion  210  from proximal to distal. In other words, the “threads” of the spiral cut are closer together distally. In alternative embodiments, increasing flexibility of the shaft  206  from proximal to distal may be achieved by other means, such gradually thinning the wall thickness of the shaft, using different materials along the length of the shaft or the like. 
         [0127]    In the embodiment of  FIG. 15 , the spiral cut  211  may be configured such that the shaft  206  has a relatively constant stiffness along a the valve portion  204  and a proximal part of the middle portion  210 . As the shaft  206  approaches the proximal end of the balloon  220 , the stiffness may fall off abruptly. In other words, the stiff shaft  206  has a significant drop-off in stiffness immediately proximal to the balloon  220 . This type of stiffness/flexibility profile is in direct contrast to the typical prior art balloon catheter, which simply becomes more flexible at a gradual, consistent rate over its length. The unique stiffness profile of the guide wire device  202  may be advantageous, because maintaining significant stiffness along most of a proximal length of the device  202  provides for enhanced pushability against blood flow, while a significantly more flexible portion immediately proximal to, within, and distal to the balloon  220  will help to prevent injury to the vessel through which the device  202  is being advanced. A stiffer proximal portion  204  and middle portion  210  may also help temporarily straighten out a tortuous blood vessel, which may facilitate stabilizing and/or treating an injury in the vessel. 
         [0128]    The top portion of  FIG. 15  is a close up of the balloon section  212  of the guide wire device  202 , with the balloon  220  removed. In this embodiment, the shaft  206  extends into a portion of the balloon section  212 , with the spiral cut getting tighter, and then ends, leaving a small portion of the core wire  208  exposed. Inflation fluid exits from the distal end of the shaft  206  to inflate the balloon  220 . The shaft  206  thus forms an inflation lumen (not visible in  FIG. 15 ), and in the embodiment with the spiral cut  211 , a coating or sleeve may be used to seal the shaft  206  to prevent inflation fluid from escaping the shaft  206  through the spiral cut  211 . For example, a polymeric coating may be used, such as a shrink wrap coating, sprayed-on coating, dip coating, or the like. In alternative embodiments, the shaft  206  may end at the proximal end of the balloon  206  or may continue through the entire length of the balloon  220  and include one or more inflation ports in its sidewall. A distal portion of the core wire  208  is wrapped by the core wire  214 . In these or other alternative embodiments, core wire  214  may stop at a distal end of the balloon  220  or alternatively extend all the way through the balloon  220 . A number of various embodiments of the balloon section  212  will be described below in greater detail. 
         [0129]    Referring now to the bottom close-up of  FIG. 15 , the core wire  208  may, in some embodiments, have a varying diameter at one or more points along its length. In alternative embodiments, it may have a continuous diameter. In the embodiment shown, for example, the core wire  208  has a relatively small diameter proximally, widens to a wider diameter, widens again to a widest diameter, and contracts gradually to a smallest diameter the flexible, J-tip portion  216 . As will be described in greater detail below, the proximal end of the core wire  208  (not visible in  FIG. 15 ) may also be widened, flattened or otherwise shaped to facilitate attaching the proximal end to an inner wall of the shaft  206  via gluing, welding, soldering or the like. The widest diameter section of the core wire  208 , in this embodiment, is located where the distal end of the balloon  220  is mounted onto the core wire  208 . This widest portion thus helps provide strength at an area of stress of the device  202 . In some embodiments, the proximal end of the core wire  208  is attached to an inner surface of the shaft  206  by any suitable means, such as by welding, soldering, gluing or the like. In some embodiments, the attachment point of the core wire  208  to the shaft  206  is proximal to the area along the shaft  206  where the spiral cut  211  begins. Alternatively, the core wire  208  may be attached at any other suitable location. 
         [0130]    As illustrated in the bottom close-up of  FIG. 15 , in one embodiment, the diameter of the core wire  208  gets smaller and smaller distally along the length of the flexible J-tip portion  216 , thus forming the most flexible, J-curved, distal portion of the guide wire device  202 . In alternative embodiments, the core wire  208  may end proximal to the extreme distal end  219  of the guide wire device  202 , and the coil  214  may continue to the distal end  219 . In other alternative embodiments, the distal tip  216  may be straight, may include two core wires  208 , may include more than two core wires  208 , may be straightenable and/or the like. In the embodiment shown, the core wire includes a flat portion through the curve of the J-shape of the tip  216  and is attached to the coil  214  at the distal end  219  via a weld (or “weld ball”). The distal, curved portion of the J-tip is designed to be atraumatic to blood vessels through which it is advanced, due to its flexibility and shape. 
         [0131]    The distal J-tip  216  of the guide wire device  202  may include special properties and/or features allowing for retrograde (against blood flow) insertion, maneuvering, and/or placement. For example, the “J-tip” shape of the distal tip  216  allows it to be advanced against blood flow without accidentally advancing into and damaging an arterial wall. Additionally, the distal tip  216  has a proximal portion through which the core wire  208  extends and a distal portion that is more flexible and includes only the coil  214 . This provides for a slightly stiffer (though still relatively flexible) proximal portion of distal tip  216  and a more flexible (or “floppy”) distal portion of distal tip  216 , thus providing sufficient pushability while remaining atraumatic. The extreme distal end  219  may also have a blunt, atraumatic configuration, as shown. In various embodiments, the distal tip  216  may also include a tip configuration, flexibility, radiopacity, rail support, core material, coating, and/or extension characteristics that enhance its function. Alternatively or in addition, device length considerations and/or overall shaft stiffness may be modified accordingly. 
         [0132]    The core wire  208 , the shaft  206  and the coil  214  may be made of any of a number of suitable materials, including but not limited to stainless steel, Nitinol, other metals and/or polymers. Each of these components may also have any suitable size and dimensions. For example, in one embodiment, the shaft  206  has an outer diameter of approximately 0.035 inches (approximately 0.9 mm). The guide wire device  202  may also have any suitable overall length as well as lengths of its various parts. Generally, the distal tip  216  will have a length that allows it to extend into an aorta when the balloon is inflated anywhere within an iliofemoral artery. In other words, the distal tip  216  may be at least approximately as long as the average iliofemoral artery. In various embodiments, for example, the distal tip  216  (measured from the distal end  219  of the device  202  to a distal end of the balloon  220 ) may be at least about 15 cm long, and more preferably at least about 20 cm long, and even more preferably between about 20 cm and about 25 cm long, or in one embodiment about 23 cm long. In various embodiments, the balloon section  212  of the device  202  may have a length of between about 10 mm and about 15 mm, or in one embodiment about 12 mm. In various embodiment, the middle section  210  of the device  202  may have a length of between about 70 cm and about 90 cm, and more preferably between about 75 cm and about 85 cm, or in one embodiment about 80 cm. And finally, in some embodiments, the valve section  204  may have a length of between about 10 cm and about 3 mm, or in one embodiment about 5 cm. Therefore, in some embodiments, the overall length of the device  202  might be between about 85 cm and about 125 cm, and more preferably between about 95 and about 115 cm, and even more preferably between about 105 cm and about 110 cm. Of course, other lengths for the various sections and for the device  202  overall are possible. For example, in some embodiments, the distal tip  216  may be longer than 25 cm, and in various embodiments, the overall length of the guide wire device  202  may range from may be longer than 115 cm. It may be advantageous, however, for ease of use and handling, to give the guide wire device  202  an overall length that is shorter than most currently available catheter devices. For an ipsilateral approach, the device  202  should generally have a length such that it is possible for the proximal portion  204  to extend at least partially out of the patient with the balloon  220  positioned within the iliofemoral artery and the distal end  219  residing in the aorta. 
         [0133]    The balloon  220  of the guide wire balloon device  202  is generally a compliant balloon made of any suitable polymeric material, such as polyethylene terephthalate (PET), nylon, polytetrafluoroethylene (PTFE) or the like. The balloon  220  may be inflatable to any suitable diameter outside and inside the body. In one embodiment, for example, the balloon  220  may be inflatable within a blood vessel to a diameter of between about 6 mm and about 12 mm. In alternative embodiments, the balloon  220  may be semi-compliant or noncompliant. In some embodiments, the balloon  220  and/or portions of the device  202  immediately proximal and distal to the balloon  220  may include one or more radiopaque markers, to facilitate visualization of the balloon outside a patient&#39;s body using radiographic imaging techniques and thus facilitate placement of the balloon  220  in a desired location. The balloon  220  may be inflated, according to various embodiments, by any suitable inflation fluid, such as but not limited to saline, contrast solution, water and air. 
         [0134]    With reference now to  FIG. 16 , the guide wire balloon system  200  is shown in kit form, with one embodiment of a packaging component. The guide wire device  202  and inflation device  222  are shown, along with a guide wire balloon packaging card  230 , a syringe  232  (for example 10 mL syringe with clips) for inflating the balloon  220 , and a guide wire balloon sheath valve introducer  234 . The sheath valve introducer  234  is generally a funnel-shaped device for facilitating introduction of the J-tip  216  into a vascular sheath through which the device  202  is to be introduced. In various embodiments, the system  200  or kit may include fewer or more components. 
         [0135]    Referring now to  FIGS. 17A-17D , further details of the guide wire device  202  are shown.  FIG. 17A  shows the entire length of the guide wire device  202 , though it may not be drawn to scale.  FIG. 17B  shows a close-up view of the J-tip portion  216 , including the core wire  208 , coil  214  and distal end  219 . For simplicity, the core wire  208  is shown as transitioning from a larger diameter proximally to a smaller, constant diameter distally. Alternatively, however, the core wire  208  may transition to a gradually smaller and smaller diameter distally. 
         [0136]      FIGS. 17C and 17D  show the inner workings of one embodiment of the valve portion  204 . As mentioned previously, in at least some embodiments, the proximal end  205  and valve/proximal portion  204  of the guide wire device  202  are hubless, meaning that no hub or other obstruction is located on these portions to interfere with the advancement of one or more additional devices over the proximal end  205 . The inflation device  222  is, of course, attached to inflate or deflate the balloon  220 , but once the balloon  220  is inflated, the inflation device  222  may be removed, leaving the balloon  220  inflated and the proximal end  205  (located outside the patient&#39;s body) free for advancement of one or more additional devices. 
         [0137]    In the embodiment shown, the valve portion  204  includes a proximal portion of the shaft  206 , which forms an inflation lumen  213 , and the valve cap  203 , which is slidably disposed over the inflation hypotube  207  and abuts the proximal end of the shaft  206 . In this embodiment, the valve cap  203  has a different wall thickness than that of the shaft  206 . The valve cap  203  may be made of the same material as the shaft  206  or, in alternative embodiments, a different material, such as but not limited to Nitinol, stainless steel, other metals or polymers. The inflation hypotube  207 , which is fixedly attached to an inner surface of the proximal end of the shaft  206 , may also be made of Nitinol, stainless steel or any other suitable material, and may be the same material as the shaft  206  and the valve cap  203  in one embodiment. The inflation hypotube  207  also includes the inflation port  209 , as described previously. In one embodiment, a silicone ring  241  (or “coating”) may be positioned on an inner surface of the valve cap  203  at or near its distal end. The silicone ring  241  may form a seal between the valve cap  203  and the inflation hypotube  207 , thus preventing the escape of inflation fluid between the two. 
         [0138]    The valve portion  204  may also include a proximal end cover  246  attached to the proximal end  205  of the valve cap  203 . A post  242  (or “wire”) may be attached to the proximal end cover  246 , and a flow regulator  240  may be attached to the post  242 . Finally, the valve portion  204  may also include a stop member  244  on an inside surface of the inflation hypotube  207  at or near its proximal end. The stop member  244  may stop the flow regulator  240  from being drawn too far proximally and thus being pulled out of the inflation hypotube  207 . 
         [0139]    These components of the valve portion  204  effectively form a two-part valve, where inflation fluid is blocked from escaping externally by the valve cap  203  and is blocked internally by the flow regulator  240 . The valve portion  204  may work as follows. Referring to  FIG. 17C , to close the valve, the valve cap  203  is advanced distally to cover the inflation port  209  and abut the proximal end of the shaft  206 . In this valve-closed configuration, the flow regulator  240  is positioned distal to the inflation port  209 , thus blocking inflation fluid from entering the inflation hypotube  207  from the inflation lumen  213 . Thus, again, inflation fluid is prevented from entering or exiting the inflation lumen  213  by the flow regulator  240  and the valve cap  203 . 
         [0140]    Referring now to  FIG. 17D , to open the valve, the valve cap  203  may be moved proximally to expose the inflation port  209  and to move the flow regulator  240  proximal to the inflation port  209 . At this point, with the valve portion  204  in the valve-open position, the inflation device  222  may be used to pass contrast solution, saline solution, air, water or other inflation medium through the inflation port  209  and into the inflation lumen  213  of the shaft  206  to inflate the balloon  220 . When the balloon  220  is inflated, the valve cap  203  may be once again advanced distally to the valve-closed position, thus covering the inflation port  209  and blocking the inflation hypotube  207  with the flow regulator  240 . If desired, the inflation device  222  may then be removed from the guide wire device  202 , and one or more therapeutic devices may be passed over the hubless proximal end  205  of the device  202 . In one embodiment, the inflation device  222  may be used to advance and retract the valve cap  203 , as will be described further below. 
         [0141]    Referring to  FIGS. 18-25 , balloon segments of various alternative embodiments of guide wire balloon devices are shown. In general, in all the embodiments described in  FIGS. 18-25 , various structural configurations are included to provide a desired flexibility/stiffness profile immediately proximal to the balloon, between the two ends of the balloon, and immediately distal to the balloon. In the embodiment shown in  FIG. 18 , for example, the balloon segment  212  includes a balloon  220 , an shaft  206  proximal to the balloon  220 , an extension  227  extending distally from the shaft  206  and on which the balloon  220  is mounted, a core wire  208  extending through the extension  227  and attached to the shaft  206  via an attachment member  242 , and a coil  214  wrapped around the core wire  208  and a portion of the extension  227 . The extension  227  fits within the distal end of the shaft  206 . The balloon  220  may be mounted to the extension  227  via one or more threads  224  and epoxy  246  or other form of adhesive. The extension  227  includes a spiral cut  211 , which increases its flexibility. The core wire  208  may have a varying diameter along its length, for example a widened section to close off the inner lumen of the extension  227  to prevent air or other inflation fluid from escaping distally out of the balloon  220 . The proximal end of the core wire  208  may be attached to the shaft  206  by any suitable attachment member  242  or attachment means. For example, attachment member  242  may be a weld, glue, other adhesive, anchor or the like. 
         [0142]    With reference to  FIG. 19 , in an alternative embodiment, a balloon segment  412  of a guide wire balloon device may include a balloon  420 , a shaft  406 , a core wire  408  with a thinner balloon section  408 ′ and a coil  414  around at least part of the core wire  408 . The shaft  406  may, for example, be a hypotube. A flattened proximal end of the core wire  408  may be attached to the shaft  406  by any suitable means, such as welding, gluing, soldering or the like. Coil  414  provides extra support to the balloon segment  412 . 
         [0143]    In another alternative embodiment, and with reference now to  FIG. 20 , a balloon segment  442  of a guide wire balloon device may include a balloon  440 , a shaft  446 , a core wire  448  with a thinner balloon section  448 ′ and a coil  444  around at least part of the core wire  448 . In this embodiment, the thinner balloon section  448 ′ may include a bend  450  (or fold), which may help provide stress relief when the balloon segment  442  is bent during use. A flattened proximal end of the core wire  448  may be attached to the shaft  446  by any suitable means, such as welding, gluing, soldering or the like. Coil  444  provides extra support to the balloon segment  442 . 
         [0144]    Referring to  FIG. 21 , in another alternative embodiment, a balloon segment  462  of a guide wire balloon device may include a balloon  460 , a shaft  466 , a core wire  468  with a thinner balloon section  468 ′ and a coil  464  around at least part of the core wire  468 . In this embodiment, a proximal end of the core wire  468 , which may be part of the thinner balloon section  468 ′, may include (or be attached to) a ball-shaped member  470 . Shaft  466  may include an inward facing stop member  472 . Together, the ball-shaped member  470  and the stop member  472  act as a joint, allowing the balloon segment to flex at the joint and thus accommodate bending during use. Coil  464  provides extra support to the balloon segment  462 . 
         [0145]    Referring to  FIG. 22 , in another alternative embodiment, a balloon segment  482  of a guide wire balloon device may include a balloon  480 , a shaft  486 , a core wire  488  with a thinner balloon section  488 ′ and a coil  484  around at least part of the core wire  488 . In this embodiment, a proximal end of the core wire  488 ″ may be flattened to facilitate attachment to shaft  486  via welding, gluing, soldering or the like. The thinner balloon section  488 ′ may continue up to the proximal end  488 ″. Coil  484  provides extra support to the balloon segment  482 . 
         [0146]    Referring to  FIG. 23 , in another alternative embodiment, a balloon segment  502  of a guide wire balloon device may include a balloon  500 , a shaft  506 , a core wire  508  with a thinner balloon section  508 ′ and a coil  504  around at least part of the core wire  508 . In this embodiment, as in the previously described embodiment, a proximal end of the core wire  508 ″ may be flattened to facilitate attachment to shaft  506  via welding, gluing, soldering or the like. The thinner balloon section  508 ′ may continue up to the proximal end  508 ″. Unlike the previous embodiment, in this embodiment, the thinner balloon section  508 ′ is not covered with the coil  504 . This will make the thinner balloon section  508 ′ more flexible than in the previously described embodiment. 
         [0147]    With reference now to  FIG. 24 , in yet another alternative embodiment, the balloon segment  522  may include a balloon  520 , a shaft  526  having a spiral cut  527  along at least a portion of its length proximal to a proximal end of the balloon  520 , a core wire  528  extending from the distal tip  536  and through the extension balloon segment  522  and attached to the shaft  526  proximally, and a coil  524  disposed over at least a portion of the core wire  528  distal to the balloon  520 . The core wire  528  may include a thinner balloon section  528 ′ underlying the balloon  520  and a flattened proximal end  528 ″, which may facilitate attachment to the shaft  526  via welding, gluing, soldering or the like. As in most or all embodiments, the shaft  526  forms an inflation lumen  530  for inflating the balloon  520 . Due to the spiral cut  527 , the shaft  526  will typically be coated or covered with a sheath, such as a polymeric coating or sheath, to prevent inflation fluid (air, saline, etc.) from leaking through spiral cut  527 . The balloon  520  may be mounted to the shaft  526  proximally and to the core wire  528  distally via threads  534  and epoxy  532  or other form of adhesive. 
         [0148]    Referring now to  FIG. 25 , in another alternative embodiment, the balloon segment  542  may include a balloon  540 , a shaft  546  proximal to the balloon  540 , an extension tube  556  extending distally from the shaft  206  and on which the balloon  540  is mounted, a core wire  548  extending through the extension  556  and attached to the shaft  546  via welding, gluing, soldering or the like of a flattened proximal end  548 ″ to the shaft  546 , and a coil  544  wrapped around a portion of the core wire  548  distal to the balloon  540 . The extension tube  556  attaches to the proximal end of the shaft  546  by fitting around its outer surface. In one embodiment, the extension tube  556  may be made of polyamide or other flexible plastic. The balloon  540  may be mounted to the extension tube  556  via one or more threads  554  and epoxy  552  or other form of adhesive. The core wire  548  may have a varying diameter along its length, such as a thinner balloon section  548 ′ and a wider proximal end  548 ″. The wider proximal end  548 ″ may be attached to the shaft  546  by any suitable attachment means. 
         [0149]    The foregoing examples of balloon sections of various embodiments of a guide wire balloon device are provided for exemplary purposes only and should not be considered as an exhaustive list or as limiting the scope of the claims of this application. Various features and elements described above may be interchanged or eliminated and/or other features may be added in alternative embodiments. 
         [0150]    Referring now to  FIGS. 26A-26F , further detail of the inflation device  222  is shown. As shown in  FIG. 26A , the inflation device  222  may include one or more markings  223 , for example to show which direction the parts of the device  222  may be moved to release or secure the guide wire device, to open or close the valve, etc. As shown in  FIG. 26B , the inflation device  22  may suitably include a high pressure luer  250   a ,  250   b , extension tubing  252 , O-ring seal  254 , a handle body main portion  256 , a handle body cap  258 , a flared hypotube  260 , a one-way stopcock/luer  262 , a handle outer shell slider  264 , a handle outer shell main portion  266 , an outer shell pin  268 , a handle luer cap  270 , and a non-vented luer cap  272 . In various alternative embodiments, one or more of these components may be changed, replaced with another like component, repositioned, etc., without departing from the scope of an inflation device as described in the claims. In various embodiments, the components of the inflation device  222  may be made of one or more polymers, metals or combinations thereof. Some or all of the various components will be described in further detail below, in relation to an exemplary method for using the device  222 . 
         [0151]      FIGS. 26C-26F  are top, perspective, side and end-on views of the inflation device  222 , respectively, according to one embodiment. The inflation device  22  may have any of a number of suitable configurations and dimensions. For example, it may be advantageous to have an inflation device  222  that can be easily held in one hand, so a user may use his/her other hand for holding a syringe or other inflation medium carrying/injecting device coupled with the inflation device  222 . The inflation device  222  may also have a size selected such that a user may grip the outer shell slider  264  with one hand and the outer shell main portion  266  with the other hand, to move the two portions  264 ,  266  away from and towards one another to open and close the valve of the guide wire balloon device. In some embodiments, for example, an outer diameter of the outer shell slider  264  may be between about 20 mm and about 30 mm, or more preferably between about 24 mm and about 25 mm. In some embodiments, the inflation device  222  may have an overall length from one end of the luer cap  270  to an opposite end of the non-vented luer cap  272  of between about 120 mm and about 150 mm, or more preferably between about 130 mm and about 140 mm. These and other dimensions may be different in alternative embodiments and are thus provided here for exemplary purposes only. 
         [0152]    Referring now to  FIGS. 27A and 27B , a method for using the inflation device  222 , according to one embodiment, will be described. First, the proximal end of a guide wire balloon device (not shown in these figures) may be passed into the inflation device via the wire lumen  226  on the handle luer cap  270  (inflation port  226  visible in  FIG. 15 ). In one embodiment, the proximal end of the guide wire device may be advanced into the inflation device  222  until it contacts a stop. To lock the inflation device  222  onto the guide wire device, the two slide members  250   a ,  250   b  that make up the high pressure luer  250   a ,  250   b  may be moved towards one another within the outer shell slider  264  and the outer shell main portion  266 , as designated by the words “SECURE” and the accompanying arrows marked on the outer shell slider  264  and the outer shell main portion  266 . Next, as in  FIG. 27A , the outer shell slider  264  and outer shell main portion  266  may be moved apart from one another to open the valve of the guide wire balloon device (i.e., to expose the inflation port  209  shown in  FIGS. 15 ,  17 C and  17 D). This may optionally be designated, for example, by markings  223 , such as the “VALVE OPEN” marking and arrows shown in  FIG. 26A . At this point (or, alternatively, at any time before this point), an inflation medium carrying and injection device, such as but not limited to a syringe, pump or the like, may be attached to the stopcock/luer  262 , and inflation medium may be introduced into the guide wire to inflate the balloon. In some embodiments, for example, approximately 2-3 mL of diluted contrast solution (e.g., about 50% contrast and about 50% saline) may be used to inflate the balloon. In other embodiments, more or less fluid and/or some other fluid may be used, such as saline, undiluted contrast, water, air or the like. 
         [0153]    Next, as illustrated in  FIG. 27B , once the balloon of the guide wire device (or other expandable member) is inflated, the outer shell slider  264  and outer shell main portion  266  may be moved toward one another to close the valve of the guide wire balloon device, thus locking the inflation medium inside the balloon so that it maintains its inflated configuration. The slide members  250   a ,  250   b  of the high pressure luer  250   a ,  250   b  may next be moved away from one another to unlock the inflation device  222  from the guide wire device, and the inflation device  222  may then be removed from the guide wire device. At this point, the guide wire device has its balloon (or other expandable member) locked in the expanded/inflated configuration and has a hubless proximal end, over which one or more additional devices (such as vessel treatment devices) may be passed. 
         [0154]    Once a vascular repair procedure is complete, or whenever the user wants to deflate the balloon of the guide wire device, the user may reattach the inflation device  222  to the guide wire device and repeat the steps outlined above, except that the inflation fluid is withdrawn instead of injected. This process may be repeated as many times as desired, for example to reposition the balloon of a guide wire balloon device within an iliofemoral artery, aorta and/or femoral artery one or more times. Alternatively, the user can reopen the valve positioned at the proximal end of the guide wire, which allows the inflation fluid to release through the valve opening resulting in the deflation of the balloon. 
         [0155]    Turning to  FIGS. 28 ,  29 A and  29 B, another exemplary embodiment of a fluid regulator (valve) system is shown that includes an internal piston  609  that may be directed to engage and disengage in a fluid-tight manner an internal sealing member  607  within the proximal end  303  of the guide wire shaft, for example, when piston  609  is moved axially relative to the guide wire shaft. For example, as shown in  FIGS. 28 and 29A , the piston  609  may be advanced distally until the piston  609  engages the sealing member  607  in a distal position by passing through the sealing member  607  and effectively blocking the inner diameter of the sealing member, preventing flow out of the catheter and through the sealing member  607 . Thus, in the distal position, the lumen  320  of the guide wire shaft may be substantially sealed or closed, for example, after delivering sufficient fluid into the lumen  320  to inflate the balloon  302 , providing the valve in a closed position. Conversely, as shown in  FIG. 29B , the piston  609  may be retracted proximally until the piston  609  reaches a position proximal to an outlet or side port  306  in a side wall of the proximal end  303  of the tubular member. The internal lumen  320  may communicate with the external environment adjacent the proximal end  303  through the outlet  306  when the piston  609  is retracted to the proximal position such that fluid may be delivered into or evacuated from the lumen  320 , for example, to inflate or deflate the balloon  302  (not shown), where the valve is in an open position. 
         [0156]    In one aspect, the sealing member  607  can comprise an O-ring that is held stationary in the lumen of the guide wire. The O-ring can be constrained between a pair of small collars or sleeves inside of the lumen  320 , or in another aspect, the O-ring can be constrained by providing an indentation or crimp in the guide wire on one or both sides of the O-ring to hold it in place. In yet another aspect, the collar can comprise a pair of hypotubes  630 A and  630 B, or stainless steel tubes, as shown in  FIG. 30 . The collars or hypotubes can restrain movement of the O-ring inside of the lumen of the guide wire. In another embodiment, the O-ring can be constrained in a groove machined in the internal lumen  320 . In yet another embodiment, the O-ring can be constrained by crimps or swaged features both proximally and distally of the O-ring formed in the body of the guide wire shaft  303 . As mentioned above, the sealing member  607  is opened and closed by sliding the piston  609  in and out of the inner diameter of the sealing member  607 , such as an O-ring. The O-ring can be kept static within the inner lumen  320  of the guide wire while the piston moves in and out of the inner diameter of the O-ring to close and open the valve, respectively. The inner diameter of the O-ring sealing member  607  should be less than the outer diameter of the guide wire shaft at that position in the guide wire, i.e., at the proximal end  303 . Thus, the inner diameter of the sealing member  607  should be smaller than the outer diameter of the guide wire, which in some embodiments can be about 0.035 inches. For example, the inner diameter of the sealing member  607  can have a range from about 0.004 inches to about 0.040 inches, or in another embodiment, can have a range from about 0.004 inches to about 0.035 inches, or in yet another instance, the inner diameter of the sealing member  607  can be about 0.010 inches. The O-ring used for the valve can comprise any material that is known in the art for use with a guide wire or catheter and, in particular, can comprise EPDM (ethylene propylene diene monomer) or, in another aspect, can comprise silicone, rubber, Viton, nitrile, polyurethane, PVC, or thermoplastic elastomers, such as styrene-ethylene/butylene-styrene (SEBS), styrene-butadiene-styrene (SBS), styrene-ethylene/propylene-styrene (SEPS), thermoplastic polyolefins (TPO), among others. 
         [0157]    The O-ring sealing member can be loaded into the lumen  320  of the guide wire utilizing a loading process that can include an O-ring loading tool. The first hypotube, or the distally-positioned hypotube  630 B, can be placed on the tool, which looks like a wire that can fit inside of the guide wire lumen, followed next by the O-ring, and another hypotube, or the proximally-positioned hypotube  630 A. The hypotubes  630 A and  630 B and the O-ring  607  can then be inserted into the lumen  320  of the guide wire by advancing the loading tool into the lumen  320 . The loading tool can be advanced distally into the lumen  320  until it abuts a distal crimp in the lumen  320 . A distal crimp  608  formed in the guide wire can act as a positive stop against the distal hypotube  630 B. 
         [0158]    The adjacent hypotubes  630 A and  630 B can have a slightly larger inner diameter than the O-ring  607  in order to hold the O-ring  607  in place, thus, essentially having an inner diameter sized to maintain the O-ring within the lumen  320  of the guide wire. In one aspect, the hypotubes  630 A and  630 B can have an inner diameter in the range of about 0.005 inches to about 0.035 inches and, in another aspect, can have a range from about 0.005 inches to about 0.034 inches, and in yet another aspect can have an inner diameter of approximately 0.017 inches. The outer diameter of the hypotubes  630 A and  630 B should be slightly less than the inner diameter of the guide wire shaft  320  at the position of the hypotubes  630 A and  630 B and can be in the range of about 0.006 inches to about 0.035 inches or, in another aspect, can have an outer diameter of about 0.025 inches. The hypotubes  630 A and  630 B can have a length between about 0.004 inches and about 1 inch and, in one aspect, a length of about 0.100 inches. It is preferred that both hypotubes have the same length, but is not necessary. The hypotubes can be any material that is appropriate for its use adjacent the O-ring and, in one aspect, can be a stainless steel tube. It is preferred that the hypotubes  630 A and  630 B are made out of a rigid or semi-rigid material in order to properly restrain movement of the O-ring and, in one aspect, can be any metal, ceramic or plastic material. In one embodiment, the hypotubes can be of polyimide, polyether ether ketone, polyether block amide, or other polymers that have a high durometer and rigid stiffness. 
         [0159]    The hypotubes  630 A and  630 B can be kept in place by any method known in the art, such as by swaging, providing an adhesive to adhere the hypotubes in place, laser welding, providing a crimp, or any other appropriate process. In one aspect, the hypotubes  630 A and  630 B can be held in place by providing indentations or crimps in the guide wire. A middle crimp, or a second indentation  606 , and a distal crimp  608 , or a first indentation, can be provided on either end of the hypotubes  630 A and  630 B, as shown in  FIG. 30 . The second crimp  606  can be placed proximal to the proximally-positioned hypotube  630 A and helps to hold the hypotubes in place, while the distal crimp  608  can be placed distal to the distally-positioned hypotube  630 B and can also hold the hypotubes in place but it can also be used to aid in positioning the O-ring  607  between the two hypotubes. A crimp can be used to either restrict the inner diameter of the proximal end of the shaft  320  or to hold something in place, like the hypotubes, or both. The crimping of the wire can reduce the diameter of the wire. In one aspect, the inner diameter of the lumen  320  containing the crimp can range from about 0.006 inches to about 0.035 inches and, in another aspect can range from about 0.006 inches to about 0.034 inches, and in still another aspect can range from about 0.0225 inches to about 0.0275 inches. In yet another aspect, each end of the hypotube can have a different diameter crimp. In one preferred embodiment, the middle crimp  606  proximal to hypotube  630 A can have a diameter of about 0.0215 inches while the distal crimp  608 , distal to hypotube  630 B, can have a diameter of about 0.0165 inches. However, the middle and distal crimps  606  and  608  can have different values than those indicated or can have values that are identical to one another. In adding the crimp marks to the wire, they can either be added manually using a crimp tool or by an automated process, using standard procedures known in the art. The crimp marks can comprise two crimp marks or indentations in the wire, with a middle section therebetween which is not indented. In the case of the distal crimp  608 , it is preferred to have the center section C of the distal crimp  608  at a set distance from the proximal end  603  of the wire, as shown in  FIG. 30 . This ensures that the placement of the O-ring sealing member  607  will be positioned properly. In one aspect, the center C of the distal crimp  608  can be positioned at about 0.95 inches to about 0.97 inches from the proximal end  603  of the wire, as shown by distance Y in  FIG. 30 . Thus, if the distal crimp  608  is placed too far distal along the wire, then the O-ring  607  may not be positioned properly within the lumen of the guidewire. 
         [0160]    The proximal end  303  of the guide wire can be provided with a valve handle assembly, or piston assembly  600 , which can be used to slide the piston  609  back and forth axially in and out of the lumen of the guide wire and in and out of the inner diameter of the sealing member  607 . The piston assembly  600 , can include a handle  610  with an integrated piston portion or piston  609  of smaller diameter. The distal end of the piston  609  can be provided with a rounded tip or edge for easier insertion through the inner diameter of the O-ring when closing the valve. When the piston assembly  600  is moved in the proximal position, as shown in  FIG. 29B , the one or more side ports  306  in the body of the guide wire are exposed such that they are no longer covered up or blocked by the piston  609 ; this is the valve open position. When the piston assembly  600  is in its closed position, as shown in  FIG. 29A , the sealing member  607  is engaged by the piston to prevent fluid from escaping from the lumen  320  to the one or more side ports  306  and the valve is closed by the inner piston  609 . In one aspect, there is at least one side port  306  and, in another aspect, there can be any number of side ports as are necessary for fluid flow. In yet another aspect, there can be up to 8 side ports positioned in the proximal end of the guide wire. The one or more side ports  306  can be provided in the body of the guide wire at a proximal end and if there are more than one, the ports can be equidistantly spaced from one another or they can be placed in any position that is most appropriate for fluid flow through and into the inner lumen  320  of the guide wire and into the open valve. In one aspect, the side ports can be laser cut holes into the guide wire such that the laser cut holes provide low restriction to fluid flow therethrough for inflation and deflation of the balloon, and it can be further electropolished such that the holes are burn-free allowing the O-ring to be loaded into the lumen of the guide wire without getting cut or damaged. The diameter of these side port holes can be any diameter that is appropriate for proper fluid flow therethrough and can range from about 0.0005 inches to about 0.03 inches, and in another aspect, can be from about 0.0005 inches to about 0.0265 inches, and in still another aspect, can be about 0.007 inches in diameter. 
         [0161]    In order for the piston assembly  600  to be movable within the lumen  320  of the guide wire, it can be provided with a frictional element, such as a spring element  640 , that collapses when placed into the lumen  320  of the guide wire and acts to push against the inner diameter of the guide wire to provide a certain level of friction. The amount of friction can be adjusted by the bend angle on the frictional element, by the thickness of the spring members, and/or by the modulus of the material chosen for the frictional element. The spring element  640  can be made by splitting the wire of the piston, such as creating a “w” shaped wire, or from a separate piece of material, such as a split tube, for example, that is welded onto the wire of the piston  609 , such that it acts as a spring to create friction between the spring element and the guide wire lumen to prevent the valve from being inadvertently opened or closed. A “w” shaped wire can be formed in the wire of the piston, such that the straight piston is bent at a section of the wire to make several bends resembling the peaks and valleys of the letter w. Fewer or additional bends may be added to decrease or increase the amount of friction. Alternatively, other materials or elements can be used as a friction element such as elastomeric materials, another O-ring, or multiple O-rings, for example. 
         [0162]    In one embodiment, the frictional element  640  can be formed by adding a separate element, or split tube, welded onto the piston  609 , which can then be bent after it is attached to the piston  609  to provide the frictional element  640 . Alternatively, a separate tube can first be bent into shape and then attached to the piston. The frictional element may also be bonded or crimped onto the piston. Where a split tube  614  is welded onto the piston  609  of the piston assembly  600  prior to shaping it in the bent configuration, it can be welded at a location on the piston assembly  600  that is on the piston near the distal end  611  of the piston  609 , as seen in  FIG. 31A . In one aspect, the split tube  614  can be welded by laser beam welding. The split tube  614  can be welded at a distal end  615  of the split tube  614  positioned a certain distance from the distal end  611  of the piston  609  such that the split end  616  of the tube is positioned a certain distance from the handle  610 . The split end  616 , in one embodiment, can be formed by splitting a tube in half such that two leaves or wings  612  are created. In another aspect, the split tube  614  can be attached at a position that is about 0.250 inches proximal to the distal end  611  of the piston  609 . In yet another aspect, the split tube  614  can be welded at a position that is between about 0.010 inches to about 6 inches from the distal end  611 . The diameter of the split tube  614  can be slightly larger than that of the piston and, in one aspect, the diameter of the split tube can be about 0.017 inches. The split tube  614  outer diameter, not including the formed frictional portion, can be slightly smaller than the inner diameter or lumen of the guide wire to allow it to slide freely in and out of the lumen without interference. The wings  612  of the frictional element, once formed or shaped, are larger than the inner diameter of the guide wire so that it can cause friction upon axially shifting the piston in the lumen. 
         [0163]    In one embodiment, the diameter of the piston  609  can be about 0.015 inches and the diameter of the handle  610  can be about 0.0320 inches. In another embodiment, the diameter of the piston can range between about 0.005 inches to about 0.035 inches, or in another aspect from 0.005 inches to about 0.034 inches. The diameter of the handle  610  can range between about 0.005 inches to about 0.04 inches, and in another aspect can range from about 0.005 inches to about 0.038 inches. The piston  609  can be provided integrated with the handle  610  such that there is a reduction in diameter from the handle to the piston and, in one aspect, this reduction can be about 50%. The piston can also be electropolished to aid in minimizing wear upon the O-ring each time the piston is inserted into the inner diameter of the O-ring. The distal end of the piston, i.e., the end being inserted into the inner diameter of the O-ring, can be provided as a fully rounded end. The piston can also be electropolished, ground smooth, lapped or chemically polished to provide a smooth surface, e.g., a burn-free surface, to slide smoothly without cutting the O-ring each time it is opened and closed. The length of the piston assembly  600 , can have a length that is long enough to be inserted into the lumen  320  of the guide wire and advance distally through the lumen  320  and through the inner diameter of the O-ring an appropriate distance to provide a closed state of the valve. In one aspect, the length of the piston assembly  600  can be about 1.355 inches, where the handle  610  can be about 0.50 inches in length and the piston  609  can be about 0.855 inches in length. In a preferred embodiment, the length of the piston  609  can be greater than the length of the handle  610 , where these two lengths can range from about 0.010 inches to about 6 inches. Alternatively, the handle  610  can be longer than the piston  609 . In another preferred embodiment, the diameter of the piston can be less than the diameter of the handle. Alternatively, the handle can have a smaller diameter than the piston. In one aspect, the piston  609  can comprise at least 50% of the length of the piston assembly and, in a preferred aspect, at least 60% of the piston assembly, and still more preferred, at least 63% of the piston assembly. In one embodiment, the handle  610  can comprise 37% of the piston assembly  600  while the piston  609  can comprise about 63% of the piston assembly. The handle and piston can be formed as one unit and can be formed out of stainless steel, however, other materials of construction appropriate for use with the guide wire can be provided. It is preferred that the diameter of the handle provides a similar profile as the guide wire shaft or lumen, e.g., has a similar diameter, or still more preferred that the diameter of the handle is slightly smaller than the diameter of the lumen so as not to catch on catheters or other devices sliding over it, in order to prevent the valve from being inadvertently opened or closed. It is preferred that the diameter of the piston is compatible with the O-ring inner diameter, and is still more preferred that the diameter of the piston is slightly larger than the inner diameter of the O-ring, for example, by at least 0.0005 inches, in order to form a seal, yet not too large where it could tear the O-ring. In one aspect, the O-ring inner diameter is 0.010 inches and the piston outer diameter is about 0.015 inches. 
         [0164]    The length of the split tube  614  can be shorter than the overall length of the piston  609  extending distal from the handle  610 . In one aspect, the length of the split tube can be about 0.35 inches, with the leaves or wings  612  having a length of about 0.25 inches. In another aspect, the length of the split tube can vary between about 0.030 inches to about 6 inches and the length of the wings can vary between about 0.020 inches to about 6 inches, or in another aspect the length of the wings can vary between about 0.020 inches to about 5.950 inches. Any length of the wings is appropriate that can be made into the frictional element. In one aspect, the length of the wings can comprise at least about 10% of the overall length of the split tube, in another aspect, at least about 60% of the overall length of the split tube, and in yet another aspect, can comprise at least about 70% of the overall length of the split tube, and in still another aspect, at least about 71% of the overall length of the split tube. 
         [0165]    One method of forming the frictional element includes attaching the split tube, which can comprise two leaves or wings, and placing the split tube and piston on a bending tool between two pins. The leaves or wings of the split tube can then be spread such that the wings can catch on the two pins and can be spread apart and away from the piston to stick outward in a V-shape. The piston is then shifted in a manner that further separates the wings of the split tube and brings them in contact with a second set of pins. The second set of pins can bring the outward ends of the wings together while at the same time bending the mid-section of the wings around the first set of pins to result in a diamond-shape orientation of the wings. This diamond-shape orientation can result in the frictional element of the piston, as shown in  FIG. 31B . Alternatively, other methods for forming bends in a wire or tube may be employed. 
         [0166]    Another method of forming a frictional element is to machine, stamp, etch or laser cut a flat or curved piece of metal, and form it into a spring. This formed sheet metal component can then be attached to the piston and pushed onto the inner diameter of the guide wire shaft to provide friction. In one embodiment, a frictional element can be formed from a flat sheet of sheet metal. The sheet metal can have a hole cut in the middle of it and bend along bend lines, where the hole remains as a centerpoint. When bent, the sheet metal can look like a backwards ‘C.’ This bent sheet metal can then be attached to the piston, by inserting the piston through the hole of the bent sheet metal. In other embodiments, a plurality of sheet metal parts can be bent and formed without cutting a hole in the middle and can be attached to the piston. 
         [0167]    One benefit of utilizing the frictional element-split tube design is that the bends in the split tube are located symmetrical to one another such that upon inserting the piston into the lumen  320  of the guide wire the frictional element provides for a centering of the piston in the lumen  320 . If a w-wire is used, it may sometimes provide an off-center positioning of the piston due to its w-orientation of the bends, i.e., non-symmetrical bends on either side of the wire. 
         [0168]    The spring element  640  in a relaxed, uncollapsed state can be seen in  FIG. 31B , prior to it being introduced into the lumen  320 . When the piston and piston assembly  600  are placed inside of the lumen  320  of the guide wire, the spring element  640  can collapse inside of the lumen  320 , as seen in  FIG. 30 . 
         [0169]    At the proximal end  602  of the guide wire, can be provided another crimp or third indentation  604 . This crimp, or proximal crimp  604 , can provide a positive stop on opening the sealing member  307 , i.e., proximally withdrawing the piston  609  from the lumen  320 , which interacts with the frictional element  640  such that it catches on the proximal end of the frictional element  640  and prevents the frictional element  640  and handle from being pulled out of the lumen  320  upon withdrawing the piston  609  in a proximal direction. This proximal crimp  604  can provide a narrowed or smaller diameter than that of the guide wire and, in one aspect, can provide a reduced diameter of about 0.006 inches to about 0.035 inches, or in another aspect from about 0.006 inches to about 0.034 inches. In yet another aspect, the reduced diameter can be about 0.0275 inches or less. In still another aspect, the proximal crimp  604  can have a diameter of about 0.0225 inches. The piston  609  becomes visible upon opening valve because the diameter of the piston  609  is less than the diameter of the piston assembly  600  such that a difference in thickness between the two becomes visible. Upon closing the valve, i.e., moving the piston  609  in a distal direction further into the lumen  320  and into the inner diameter of the O-ring, the handle  610  and, in particular, the larger diameter of the handle in comparison to the piston, can provide a positive stop against the guide wire shaft upon closing the valve due to a stepped portion on the handle (not shown in Figures). When the diameter of the handle is similar to the diameter of the guide wire shaft, this can allow for a smooth transition between the two in the closed position to allow devices to pass over the proximal end of the guide wire. As previously mentioned, the difference in the diameter of the handle and the piston (e.g., for instance, where the handle diameter is greater than the piston diameter) can provide a visual feedback that the valve is in an open state. When the piston shaft is no longer visible, then the valve is in a closed state. In another aspect, the piston can be marked, plated, covered in colored heat shrink, or painted a different color to improve contrast to show that it is in an open state. 
         [0170]    Turning to  FIGS. 32A and 32B , another embodiment of a fluid regulator (valve) system is shown that includes the sealing member (e.g., O-ring)  607  attached to the piston  609 , and reciprocating distally past the fill port(s)  306  to seal it in the closed position, i.e., covering/blocking the fill ports  306  with the piston  609  to prevent any fluid from escaping or entering, and shifted proximally of the fill port(s)  306  to allow fluid flow. In this embodiment, the O-ring can move with the piston and can also act as a friction element. 
         [0171]    Some benefits of having the piston assembly at the proximal-most end of the guide wire is that the there is a visual indication whether the valve is in a closed or open position based upon the position of the piston assembly. For instance, when the valve is in an opened position, the piston assembly is pulled proximally away from the guide wire such that it exposes the piston and exposes one or more side ports  306 . When the piston assembly is in this extended position, as shown in  FIG. 29B  or  32 B, a certain distance of the piston  609  is exposed. In one aspect, at least about 4 millimeters of the piston tube  609  are visible. When in the closed position, the piston is not visible outside of the lumen such that the user understands that the valve is closed. Another benefit of a valve system with a frictional element, is that the friction element of the piston assembly requires a certain force be exerted upon the proximal end to slide the handle proximal to the valve and thus, accidental opening or closing of the valve is prevented. The piston assembly allows for the user to easily open and close the valve manually and to do so multiple times, as necessary. 
         [0172]    In addition, the sealing member  607  can have a small profile such that the outer diameter of the sealing member is smaller than the guide wire outer diameter. The small diameter and the way in which the O-ring is constrained on either end by a small hypotube sleeve allows for the profile of the O-ring as the sealing element to remain small. The integrated piston and design of the friction element allows for a small profile where the piston has an end integrated into a handle that substantially matches the outer diameter of the guide wire. Moreover, the piston  607  provided in the guide wire can be robust enough such that it allows other devices, such as introducers, to be passed over the valve. As the piston is integrated with the handle as a single unit, i.e., as the piston assembly, it can all be ground from stainless steel or other high strength metal or alloy to improve its robustness. The proximal end of the handle can be provided with a smooth rounded tip and the distal end of the handle can further provide a smooth transition to the main body of the guide wire when in the closed position, hence minimizing any sharp edges when passing other devices over the proximal end of the handle and guide wire assembly. Furthermore, the integrated frictional element can help to center the piston into the O-ring and to center the handle to the guide wire body to help maintain them coaxial to one another. 
         [0173]    Other benefits are that when the valve is in the open position, there are minimal flow restrictions to any fluid that is introduced to allow for adequate inflation and deflation of the balloon. Multiple ports in the guide wire can help to reduce flow restrictions into the lumen of the guide wire. Additionally, there is provided a visual feedback to the user to determine if the valve is in an opened state or a closed state. This can be provided by a stepped transition from the piston to the handle, which can be visible when the valve is in the open position, providing the necessary visual feedback when the valve is in the open position. Another benefit is in having the frictional element along the piston can prevent accidental opening and/or closing of the valve provided by a spring force to increase friction to keep the valve from accidentally opening or closing. 
         [0174]    Further benefits include the ability to open and close the valve manually by a user, even a user that is wearing gloves or a covering on the hands. Special tools are not required to open and close the valve. The amount of friction provided by the frictional element can be adjusted to allow for ease of opening and closing, yet to prevent an accidental opening or closing. Additionally, providing a stationary O-ring valve allows for multiple actuation of the valve with minimal wear upon the valve. Providing the valve in an open position where the piston is not engaged with the O-ring can minimize the effects of compression on the O-ring during storage. Alternatively, a non-stationary O-ring valve can also be provided upon the end of a piston, which can also provide for multiple actuation of the valve with minimal wear upon the valve. 
         [0175]    The method of inflating the balloon provided herein also applies to the alternative valve embodiment provided above and in  FIGS. 28-31B . In order to inflate the balloon, the sealing member  607  can first be opened by sliding or withdrawing the piston assembly  600  in a proximal direction to expose the piston  609  as well as exposing the holes  306  and opening the sealing member  607 , as shown in  FIG. 29B . The balloon can then be inflated as already provided herein and in order to maintain the inflation of the balloon, the valve should be closed, as shown in  FIG. 29A . To close the valve, the piston assembly  600  can be advanced in a distal direction until the piston  609  is no longer visible. This ensures that the distal end of the piston  609  has passed through the inner diameter of the sealing member, e.g., O-ring, closing off the valve, as well as blocking off the holes  306  and preventing any fluid from exiting therethrough. The piston assembly  600  can remain in this position until it is necessary to deflate the balloon, then the piston assembly can be withdrawn once more in the proximal direction to expose the piston at the proximal end of the guide wire and to slide the piston proximally out of the O-ring inner diameter to open the valve allowing the fluid to escape through the holes and O-ring and thus deflating the balloon. The side ports or holes  306  do not need to be completely exposed in order to allow for fluid to escape therethrough. There can be enough of a gap provide between the piston and, in particular, between the piston and the frictional element that even if the piston is not withdrawn completely to expose the holes, the gap between the piston and the holes is adequate to provide for fluid to escape therethrough. Similarly, the balloon can be inflated in a like manner in the embodiments of  FIGS. 32A and 32B , only the method of closing and opening the valve varies. 
         [0176]    Elements or components shown with any embodiment herein are exemplary for the specific embodiment and may be used on or in combination with other embodiments disclosed herein. 
         [0177]    While the invention is susceptible to various modifications, and alternative forms, specific examples thereof have been shown in the drawings and are herein described in detail. It should be understood, however, that the invention is not to be limited to the particular forms or methods disclosed, but to the contrary, the invention is to cover all modifications, equivalents and alternatives thereof.

Technology Classification (CPC): 0