Abstract:
A thin-walled guide wire tube is fixedly and sealably attached to both a proximal section and a distal section of a balloon angioplasty catheter. A stent is co-axially mounted onto the inflatable balloon of the balloon angioplasty catheter. Because the guide wire tube forms an inner liner for the balloon angioplasty catheter, the fluid inflation lumen of the catheter is sealed so the inflation liquid that pressurizes the balloon will not leak as it would be if there were no “inner liner” and the balloon angioplasty catheter were attached to the guide wire itself. By not having a traditional inner shaft through which a conventional guide wire slides, the deflated balloon on which the stent is mounted can have a reduced diameter.

Description:
FIELD OF USE 
     This invention is in the field of devices for percutaneous insertion into a vessel of the human body to place a stent at the site of an obstruction. 
     BACKGROUND OF THE INVENTION 
     Stents are well known devices for placement in vessels of the human body to obtain and maintain patency of that vessel. The greatest use for stents has been for placement within a stenosis in a coronary artery. When a stent is used for treating a coronary artery stenosis, it has always been necessary to first place a guide wire through the stenosis. The next step in the stenting procedure is typically to pre-dilate the stenosis with a balloon angioplasty catheter that is advanced over that guide wire. The balloon angioplasty catheter is then removed and a stent delivery system that includes the stent is advanced over the guide wire and the stent is then deployed at the site of the dilated stenosis. 
     Recent improvements in the design of stent delivery systems have made it possible to eliminate the step of pre-dilatation for the treatment of many classes of stenoses. The delivery of a stent to the site of a stenosis without pre-dilatation has been given the name “direct stenting”. However, even with direct stenting, a guide wire is still required as a precursor to advancing the stent delivery system over that guide wire to place the stent at the site of a stenosis. Placing the guide wire requires additional procedure time and additional cost for the procedure. 
     In U.S. Pat. No. 6,375,660, Fischell et al. describe a stent delivery system with a fixed guide wire that is not steerable. This fixed, not steerable, guide wire system will not be as capable for rapid delivery of the stent through the tortuous coronary arteries as stent delivery systems that are advanced over a steerable guide wire. 
     SUMMARY OF THE INVENTION 
     The present invention is a stent delivery system that uses a steerable guide wire that is coaxially enclosed for most of its length in a guide wire tube. A thin-walled guide wire tube is fixedly and sealably attached to both a proximal section and a distal section of a balloon angioplasty catheter. A stent is co-axially mounted onto the inflatable balloon of the balloon angioplasty catheter. Because the guide wire tube forms an inner liner for the balloon angioplasty catheter, the fluid inflation lumen of the catheter is sealed so the inflation liquid that pressurizes the balloon will not leak as it would be if there were no “inner liner” and the balloon angioplasty catheter were attached to the guide wire itself. By not having a traditional inner shaft through which a conventional guide wire slides, the deflated balloon on which the stent is mounted can have a reduced diameter. Therefore, the outside diameter of the pre-deployed stent mounted onto that balloon is also minimized. This provides a minimum profile, i.e., a minimum outside diameter, for the stent. 
     A minimum profile at the distal section of the stent delivery system is highly advantageous for improving the percentage of cases that can be treated by means of direct stenting; i.e., without requiring pre-dilation of, a stenosis. 
     Another advantage of the present invention is that a separate guide wire is eliminated thus saving the cost of such a guide wire. Additionally, the time to perform a stent delivery procedure is reduced because a separate guide wire does not have to be placed prior to using the stent delivery system to place the stent at the site of a stenosis. 
     The present invention uses a steerable guide wire that extends for the entire length of the stent delivery system. A distal portion of the steerable guide wire can have its shaped changed after it is placed in the patient&#39;s vascular system by manipulation of the proximal portion of the steerable guide wire. Thus the shape of the guide wire&#39;s distal portion can be straight or highly curved or any curvature in between. This is a great advantage for getting the distal end of the steerable guide wire into the vessel that is to be stented more efficiently as compared to the use of a conventional guide wire. 
     An important feature of the present invention is a thin-walled, guide wire tube that extends for essentially the entire length of the balloon angioplasty catheter. The guide wire tube is fixedly and sealably attached at its proximal end and its distal end to the balloon angioplasty catheter. Specifically, the guide wire tube forms a liquid tight seal at its proximal end with the proximal fitting of the balloon angioplasty catheter and also a liquid tight seal at its distal end with the balloon onto which the stent is mounted. 
     Another important aspect of the present invention is the distal seal that is attached to the cylindrical distal end of the balloon and also the distal end of the guide wire tube. This seal is lubricity coated and also has a taper at a small angle in the distal direction that acts like a wedge to open a tight stenosis (sometimes called “Dottering”) in an artery. The outer diameter of the distal seal and the cylindrical distal section of the balloon are optimally equal to or slightly larger than the outer diameter of the stent as it is crimped onto the balloon prior to deployment of the stent. This diameter of the cylindrical distal section of the balloon and the distal seal, and the lubricity coating of the conical front surface of the distal seal, together provide the least resistance for pushing through a tight stenosis. Also, the pushability of the combined steerable guide wire and balloon angioplasty catheter work together to get the stent to be pushed through a tight stenosis. 
     It is envisioned that the guide wire tube would be fixedly attached to the guide wire at one or more locations. The attachment could be by either the use of an adhesive and/or by shrinking the guide wire tube down onto the outer surface of the guide wire to minimize the diameter of the stent delivery system. 
     It is also envisioned that instead of using a thin-walled guide wire tube to form a sealed inner liner for the inflation lumen of the balloon angioplasty catheter, the guide wire itself could be coated with a polymer to form a water tight seal. The polymer coating would then be sealed to the balloon angioplasty catheter at its proximal and distal ends. This embodiment while more difficult to produce would have a potentially smaller diameter than the embodiment using a separate tube shrunk down onto the guide wire&#39;s outer surface. 
     Thus, the present invention provides a means for placing a stent within a vessel of the human body without requiring a separate guide wire, thus saving the cost of the guide wire and also saving the time required to place a separate guide wire through an obstruction such as an arterial stenosis. 
     The invention reduces the outside diameter (i.e., the profile) of the distal section of the stent delivery system so as to optimize the capability of the stent delivery system for direct stenting. 
     This invention provides a steerable guide wire such that the shape of its distal portion can be altered by a means at the guide wire&#39;s proximal portion, the changing shape providing better access to a particular coronary artery into which the stent is to be guided. The steerable guide wire and the balloon angioplasty catheter combine in such a manner as to enhance the pushability of the entire stent delivery system. Further, a highly tapered, lubricity coated, distal seal that attaches to the distal end of the balloon of the balloon angioplasty catheter, which tapered distal seal is designed to open a tight stenosis to provide easier passage for the stent mounted onto the balloon. Finally, the outer diameter of the cylindrical distal section of the balloon and the distal seal to be equal to or slightly larger than the diameter of the stent as crimped onto the balloon so as to provide easier passage for the stent through a tight stenosis. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWING 
         FIG. 1  is a longitudinal cross section of a distal portion of the stent delivery system having a balloon angioplasty catheter mounted co-axially over a steerable guide wire. 
         FIG. 2  is a longitudinal cross section of the proximal portion of the stent delivery system that is shown in  FIG. 1  utilizing a proximal seal. 
         FIG. 3  is a longitudinal cross section of the proximal portion of the stent delivery system that is shown in  FIG. 1  utilizing a Luer fitting onto which a hemostasis valve can be placed to seal pressurized fluid for inflating the balloon of the balloon angioplasty catheter. 
     
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       FIGS. 1 ,  2  and  3  illustrate a stent delivery system  10  having a fixed but steerable guide wire  16  that is placed within a guide wire tube  17 . The distal end and proximal end of the guide wire tube  17  can be joined by a small amount of adhesive to fixedly attach the guide wire tube  17  to the steerable guide wire  16  to prevent the guide wire from moving longitudinally within the stent delivery system  10 . The guide wire  16  would typically have a diameter that lies between 0.010 and 0.038 inches. The optimum diameter for use in coronary arteries will be approximately 0.014 inches. 
       FIG. 1  is a longitudinal cross section of a proximal portion of the stent delivery system  10  showing an inflated balloon  11  onto which the stent  30  is mounted, the balloon having a cylindrical distal section  12  that is fixedly attached to the distal seal  14  and the balloon  11  also having a cylindrical proximal section  13  that is fixedly attached to the distal end of the distal shaft  15 . The distal seal  14  is sealed to the distal end of the guide wire tube  17  that surrounds the guide wire  16 . The proximal radiopaque marker band  21  and the distal radiopaque marker band  22  are used in a conventional manner to indicate to the operator by fluoroscopy the location of the proximal end and distal end of the stent  30 . These marker bands  21  and  22  assist the operator in accurately placing the stent  30  at a proper site within a stenosis of a coronary artery. 
     The distal seal  14  is fixedly and sealably attached to both the distal cylindrical section  12  of the balloon  11  and the distal end of the guide wire tube  17 . In this manner, pressurized liquid for inflating the balloon  11  (and thereby deploying the stent  30 ) is sealed within the stent delivery system  10 . The distal seal  14  also has other design features to assist in placement of the stent  30  into a tight stenosis of a coronary (or other) artery. Specifically, the tapered front conical surfaces of the distal seal  14  and the guide wire tube  17  are both lubricity coated to assist in having the system pushed through a tight stenosis. Also the taper angle is typically less than 30 degrees and optimally less than 15 degrees. Another feature of this invention is that the outer diameter “D” of the cylindrical distal section  12  of the balloon  11  and the distal seal  14  are optimally designed to be approximately equal to or slightly greater in diameter as compared to the outer diameter of the stent  11  as it is crimped or heat nested onto the balloon  11  in its pre-deployed state. For example, if the outer diameter of the stent  11  as crimped onto the balloon  11  before it is inflated is (let us say) 0.7 mm, then the diameter “D” should be approximately 0.7 mm±0.2 mm. Another concept is that the diameter “D” would be optimally between 0.7 and 0.9 mm; i.e., the diameter “D” should be the same dimension as the outer diameter of the crimped stent  30  and possibly the diameter “D” should be as much as 0.2 mm larger than the outer diameter of the crimped stent  30 . This inventive concept of having a lubricity coated distal seal  14  with a small cone angle that is attached to the cylindrical distal section  12  of the balloon  11  and having a diameter at least as large as the diameter of the pre-deployed stent  30  can enhance the ability of the stent delivery system  10  to have the pre-deployed stent  30  pushed through even a tight arterial stenosis. 
     It should be understood that the length of the steerable guide wire  16  that extends beyond the distal end of the distal seal  14  should optimally be less than 5 cm. It should also be understood that the wall thickness for the guide wire tube  17  is less than 0.002 inches and optimally approximately 0.0005 inches. 
       FIG. 2  is a longitudinal cross section of a proximal portion of the stent delivery system  10  which shows the distal shaft  15  being sealably and fixedly joined to a proximal shaft  23 .  FIG. 2  also shows the proximal shaft  23  being joined to a Luer fitting  19  that is used to connect a source of a liquid for inflating and deflating the balloon  11  of the stent delivery system  10 . The liquid used with such a stent delivery system  10  is typically contrast medium diluted with normal saline solution. Also shown in  FIG. 2  is a proximal seal  20  that is fixedly and sealably attached to the Luer fitting  19  and the guide wire tube  17  that is placed around the steerable guide wire  16 . The length of the distal shaft  15  would be between approximately 1 cm and 20 cm. The length of the proximal shaft  23  would be typically more than 100 cm. The reason for having the smaller diameter distal shaft  15  is to improve the flexibility of the stent delivery system  10  near its distal end. The reason why the proximal shaft  23  has a larger diameter is to improve liquid flow for inflating and deflating the balloon  11  for deployment of the stent  30 . It should be understood that a shaft of a single diameter could be used for this invention. 
       FIG. 3  (like  FIG. 2 ) shows the distal portion of a stent delivery system  40  with the distal shaft and the proximal shaft formed as a single shaft  35  which is joined to the Luer fitting  33 . The shaft  35  is formed from a single plastic tube with most of its length being of a larger diameter and its distal extent of 1 cm to 20 cm in length being of a smaller diameter.  FIG. 3  differs from  FIG. 2  in that there are two Luer fittings  36  and  38 . The Luer fitting  36  is used to inject and remove the balloon inflation liquid. The Luer fitting  38  is designed to have a hemostasis valve (not shown) attached to seal the inflation liquid within the balloon angioplasty catheter. Such a hemostasis valve could be tightened down onto the guide wire tube  17  to form a liquid-tight seal prior to inflating the balloon  11 . 
     The guide wire tube  17  could be solvent swelled for placement over the outer surface of the steerable guide wire  16 . As the solvent leaves the plastic of the guide wire tube  17 , the final inside diameter of the guide wire tube  17  would be essentially the same diameter as the outer diameter of the guide wire  16 . Another method for attaching the guide wire tube  17  to the guide wire  16  would be by shrink fitting the guide wire tube  17  onto the outer surface of the steerable guide wire  16 . For the guide wire  16  to be steerable, the outer coil of that guide wire  16  cannot be forced against the inner core of the guide wire  16  but it should exert a gentle pressure so that the steerable guide wire  16  cannot slide easily within the guide wire tube  17 . Thus, in its pre-deployed state, with no liquid pressure within the stent delivery system  10 , the inner surface of the guide wire tube  17  can gently press against the outer surface of the steerable guide wire  16  but it cannot exert a large force against the outer surface of the guide wire  16 . Therefore, in its pre-deployed state, the stent delivery system  10  can steer the steerable guide wire  16  into the artery where the stent  30  is to be placed. When the pre-deployed stent  30  is in place within an arterial stenosis, it can be deployed under a high liquid pressure (typically 8 to 20 atms.) and during that time, the steerable guide wire  16  will not be steerable because of the high force of guide wire tube  17  against the outer coil of the steerable guide wire  16 . Such a high pressure would create a high frictional force between the outer coil and the core wire of the steerable guide wire  16 . Since no steering is necessary at that time, this is not a detriment to the operation of the stent delivery system  10 . 
     It is also envisioned that instead of using a thin-walled guide wire tube  17  to form a sealed inner liner for the inflation lumen of the balloon angioplasty catheter, the guide wire  16  could be coated with a polymer to form a water tight seal. The polymer coating would then be sealed to the balloon angioplasty catheter  10  at its proximal and distal ends. This embodiment, while more difficult to produce, would have a potentially smaller diameter than the embodiment using a separate guide wire tube  17  shrunk down onto the guide wire  16 . 
     An important goal of this invention is to have an outer diameter of the pre-deployed stent  30  to be no greater than 0.8 mm. As such, it would present one of the lowest profiles for any stent that is used to treat an arterial stenosis. The diameter of the deployed stent  30  could be in the range from as small as 1.5 mm to as large as 6 mm. The larger diameter stents  30  would have a larger pre-deployed diameter because of the increased thickness of the pre-deployed balloon  11 . A wall thickness of the stent would optimally be between 0.0015 and 0.004 inches. Furthermore, the optimal type of stent  30  would be a drug eluting stent with a drug such as sirolimus or paclitaxel or any other drug that decreases neointimal hyperplasia subsequent to balloon deployment. The optimum stent would be formed from a high density (i.e. radiopaque) metal such as tantalum or a cobalt-chromium alloy such as L605. 
     Various other modifications, adaptations, and alternative designs are of course possible in light of the above teachings. Therefore, it should be understood at this time that within the scope of the appended claims, the invention might be practiced otherwise than as specifically described herein.