reference is now made to fig1 a and 1b , which are schematic , pictorial views of an exemplary implantable device 100 , in a constricted state and an expanded state , respectively , in accordance with an embodiment of the present invention . device 100 is adapted for use particularly in restricting blood flow through the coronary sinus , as described in the above - mentioned pct publication wo 01 / 72239 and u . s . patent application ser . no . 09 / 534 , 968 . alternatively , devices in accordance with the principles of the present invention may be implanted elsewhere in the vascular system , as well as in other body passages . for the sake of simplicity and clarity , however , and not limitation , embodiments of the present invention are described hereinbelow with reference to implantation of flow - constricting devices in blood vessels of varying diameter , such as the coronary sinus . device 100 is of general tubular construction with two expandable ends 110 and a central section 120 . further alternatively or additionally , device 100 may comprise a mesh or coil , as is known in the art . device 100 comprises a deformable material , such as a suitable metal or plastic , as is known in the art of implantable devices , which is sufficiently flexible to be expanded by inflation of a balloon ( shown in fig2 ), but strong enough to hold its shape when it is deployed and expanded within a body passage , in the manner of stents known in the art . furthermore , the shape of device 100 , combined with its flexibility , enables the device to be deployed in compact form , as shown in fig1 a , and subsequently expanded , as shown in fig1 b , either partially or completely , within the coronary sinus . a non - expandable constricting element 125 may attached around a central section 120 of device 100 , in order to ensure that the central section remains constricted , as shown in fig1 b . a flexible sleeve ( not shown ) may be fixed around or within device 100 , in order to prevent blood from flowing through the openings in the sides of the device when it is implanted , so that substantially all the blood flows through central section 120 . typically , the sleeve comprises a biocompatible fabric such as gore - tex or dacron , which is stitched or otherwise fastened to device 100 . alternatively , other sleeve materials may be used , such as thin plastic or rubber materials . constricting element 125 is fitted around the sleeve , over central section 120 . as can be seen in fig1 b , the effect of the constricting element is to maintain a predetermined reduced diameter of device 100 in the region of central section 120 , defining a lumen with a constricted central section diameter . constricting element 125 may comprise a closed ring , made of metal or plastic , or it may alternatively comprise a thread . reference is now made to fig2 , which is a schematic pictorial view of an exemplary high pressure stent balloon 200 , used to expand device 100 , in accordance with an embodiment of the present invention . balloon 200 has a generally conical shape , having a blunt , narrowed distal end 210 and a widened proximal end 220 . the balloon terminates in a taper 225 , which forms a continuation of the channel portion of a catheter ( shown in fig4 ), through which the balloon is inflated and deflated . balloon 200 typically comprises a high - pressure , non - elastic material , as is known in the art , which is designed to apply an outward radial force when inflated , as described in the above - mentioned article from medical device & amp ; diagnostic industry magazine . generally , device 100 is deployed into a body passage with deflated balloon 200 contained concentrically within it . the shape of balloon 200 is adapted so that when balloon inflates , it expands device 100 and positions it within a preselected varying - diameter body passage , as is discussed hereinbelow . balloon 200 is typically fabricated from materials such as polyethlylene tererphthalate ( pet ) or nylon . some considerations for fabricating balloon 200 using these materials include : high tensile strength , allowing high operating pressures ; thin balloon wall formation , allowing precise balloon shape and low profile ; and low elongation ( otherwise known as “ low compliance ”). the latter consideration ensures that balloon 200 , when fully pressurized , exhibits relatively unchanging dimensions , ensuring that device 100 is not uncontrollably over - expanded in a body passage . low elongation also means that balloon 200 will not over - expand at either end of device 100 and that the expansion force of the balloon is directed generally radially to expand device 100 substantially against the walls of the body passage . reference is now made to fig3 , which is a schematic view of vascular paths to a human heart 300 having a coronary sinus 302 . coronary sinus 302 comprises a junction of three major cardiac veins ( not shown ), and becomes progressively wider as it empties into a right atrium 306 . the diameter of coronary sinus 302 increases as it opens out into right atrium 306 . to implant device 100 , the device is passed through the vascular system to a preselected position in coronary sinus 302 , using a suitable percutaneous catheter ( shown in fig4 ). suitable methods of catheterization for this purpose are known in the art . during the insertion procedure , device 100 is maintained in the non - expanded configuration shown in fig1 a , so that its outer diameter is substantially smaller than the blood vessels through which it must pass , allowing the physician operating the catheter to pass the device through the blood vessels . typically , the physician inserts the catheter through a jugular vein 310 or a subclavian vein 312 , and then guides the catheter into a right atrium 306 via a superior vena cava 308 . another insertion point is through a femoral vein 322 , and the catheter is then guided to an inferior vena cava 324 and into right atrium 306 . once in right atrium 306 , the physician steers the catheter through a sharp bend in order to guide device 100 into coronary sinus 302 . reference is now made to fig4 , which is a detailed schematic view of coronary sinus 302 following expansion of device 100 by balloon 200 , in accordance with an embodiment of the present invention . a catheter 410 is used , as described hereinabove , to position the device and balloon in coronary sinus 302 via right atrium 306 . balloon 200 is then inflated , via catheter 410 , and assumes a general shape as shown in the figure . the physician may choose the shape of balloon 200 in advance , so as to optimally match the given dimensions of the coronary sinus of the patient in question . these dimensions may be determined , for example , by taking fluoroscopic images while injecting a contrast agent into the coronary sinus , as is known in the art . when balloon 200 is inflated , it applies a radial force to plastically expand device 100 against the walls of coronary sinus 302 . as shown in the figure , due to the varying diameter of balloon 200 , the distal end of device 100 is only partially expanded , whereas the proximal end of device 100 is more completely expanded , reflecting the varying diameter of coronary sinus 302 . as previously noted , balloon 200 does not over - expand at either end of device 100 . distal end 210 of balloon may protrude slightly from the distal end of device 100 . in a similar fashion , widened proximal end 220 and the taper 225 of balloon 200 may protrude from the proximal end of device 100 . because the shape of device 100 is fit to the natural shape of the coronary sinus , both the distal and proximal ends of the device press outward against the wall of the coronary sinus with approximately equal force . thus , device 100 is securely anchored in place , without exerting excessive pressure against the wall of the coronary sinus at any point . central section 120 , however , remains constricted due to the presence of constricting element 125 or other means provided for this purpose . once device 100 is satisfactorily positioned and expanded , balloon 200 is deflated and withdrawn from device 100 . catheter 410 and balloon 200 are then withdrawn from the body . device 100 remains in place to restrict the flow of blood through coronary sinus 302 . as noted above , this flow restriction increases the blood pressure in the coronary veins , thereby fostering angiogenesis . device 100 may be left in place indefinitely , in substantially the form shown in fig4 . alternatively , it may be desirable in some cases to eliminate the flow restriction caused by the device . in such cases , a catheter with a suitable cutting tool may be inserted percutaneously to the location of the device , and the cutting tool may then be used to cut constricting element 125 or central section 120 . a balloon , such as balloon 200 , may then be reinserted via catheter into device 100 and the balloon may then be inflated in order to open section 120 . although in the embodiments described above , device 100 and balloon 200 are shown to have certain particular shapes , alternative shapes and forms of these elements , which will be apparent to those skilled in the art , are considered to be within the scope of the present invention . similarly , balloons of the general type described above may be used to deliver not only device 100 , but also other implantable devices for implantation in other body passages of variable diameter , as are otherwise known in the art . furthermore , although the catheter shown here provides a convenient means for delivering implantable devices in accordance with the present invention , balloons in accordance with the present invention may also be used in conjunction with other means for implant deployment , including both minimally invasive ( typically percutaneous ) and invasive ( i . e ., surgical ) types . for example , fig5 and 6 are schematic , pictorial views of balloons 500 and 600 , which may be used in place of balloon 200 , in accordance with alternative embodiments of the present invention . instead of the generally conical profile of balloon 200 , these alternative balloons comprise a broad proximal segment 510 and a narrow distal segment 520 . the proximal and distal segments are generally cylindrical , and have different , respective diameters . alternatively , the proximal and distal segments may have trapezoidal profiles . for stent implantation in the coronary sinus , these balloons are typically about 30 mm long , and have diameters of about 10 mm in the broad segment and 7 mm in the narrow segment . alternatively , larger or smaller dimensions may be used , depending on application requirements and physiological characteristics of the patient . in balloon 600 , narrow segment 520 terminates distally in a bulb 610 , which is broader than the narrow segment . for example , if narrow segment 520 is 7 mm in diameter , bulb 610 may have a diameter of about 8 mm . the bulb helps to open the upstream end 110 of the stent in order to anchor the stent more securely in the coronary sinus ( or other body passage ). additionally or alternatively , broad segment 510 may terminate proximally in a similar sort of a bulb . fig7 a - 7d are schematic , pictorial views of balloons 700 , 720 , 730 and 740 , in accordance with further embodiments of the present invention . each of these balloons comprises a narrow neck 710 between segments 510 and 520 . typically , the neck is about 3 mm in diameter , although smaller or larger dimensions may also be used . neck 710 fits inside central section 120 of stent 100 during inflation of the stent . it thus prevents the balloon from exerting pressure against non - expandable constricting element 125 , and is also useful in facilitating removal of the balloon from the stent after completion of the stent implantation procedure . the walls of segments 510 and 520 may be parallel to the axis of the balloon , as shown in fig7 a , or they may be sloped relative to the axis in order to better fit the shape of the coronary sinus . as shown in fig7 b , 7c and 7 d , either one or both of segments 510 and 520 may be sloped in this manner . fig8 is a schematic , pictorial illustration showing the use of a tubular accessory 820 in removing balloon 200 from the body , in accordance with an embodiment of the present invention . in this embodiment , an operator , typically a physician , has inserted a guide wire 800 through a patient &# 39 ; s vascular system into the coronary sinus , using techniques known in the art . stent 100 and balloon 200 have been passed over wire 800 into the coronary sinus , and balloon 200 has been inflated in order to expand the stent to the proper dimensions . the balloon has an annular cross - section , in order to fit over wire 800 , and is inflated and deflated via an annular tube 810 . at the stage of the procedure pictured in fig8 , balloon 200 has been deflated ( likewise via tube 810 ), and is now to be withdrawn over wire 800 from the patient &# 39 ; s body by pulling tube 810 in the proximal direction , out of the body . the inventors have found that under these circumstances , it is sometimes difficult to extract balloon 200 from stent 100 and through the vascular system . therefore , to facilitate extraction of the balloon , the operator inserts accessory 820 over wire 800 to a position just proximal of balloon 200 , and then draws the balloon in the proximal direction into the accessory . once the balloon is held inside accessory 820 , the accessory containing the balloon can be withdrawn easily from the body . similar sorts of accessories and methods may be used for inserting and extracting a balloon over other sorts of guides , such as a “ monorail ” guide , as is known in the art . for these purposes , accessory 820 typically comprises a tube of small diameter , for example , about 2 . 8 mm , with a length of about 500 mm . the tube should be flexible enough to pass through the vascular system , but stiff enough so as not to deform significantly when balloon 200 is pulled inside it . accessory 820 may comprise , for example , polyurethane or another biocompatible plastic material , with a wall thickness of about 0 . 4 mm . an additional catheter or other insertion tube ( not shown in the figures ) may be attached to the proximal end of accessory 820 , for use in advancing the accessory into place adjacent to balloon 200 , and then pulling the accessory and balloon out of the body . similar techniques and accessories may be used in inserting and removing balloons of other shapes , such as those shown in fig5 - 7 . fig9 a and 9b schematically show details of the distal end of accessory 820 and its use in capturing balloon 200 , in accordance with an embodiment of the present invention . in this embodiment , the distal end of accessory 820 is scored or perforated along score lines 900 . the score lines are designed to rip open under sufficient outward radial force . a stiffening ring 910 limits the extent of the rip to a predetermined length from the distal end of the accessory , typically about 3 . 5 mm . ring 910 may comprise metal or another radiopaque material , so that the location of accessory 820 is visible under x - ray imaging . in operation , accessory 820 is advanced in the distal direction , as shown by an arrow 915 in fig9 a , until the scored , distal end of the accessory slides inside the expanded proximal end of stent 100 . if balloon 200 is sufficiently flaccid at this point , it will be possible to draw the balloon into accessory 820 simply by pulling tube 810 in the proximal direction , as indicated by an arrow 930 in fig9 b . if there is residual pressure in the balloon , however , or inherent stiffness of the balloon material , the balloon may tear score lines 900 , causing the distal end of accessory 820 to widen by opening into multiple flaps 920 . these flaps widen out to create a funnel structure at the distal end of the accessory . this structure may be supported radially by stent 100 , as shown in the figure . the funnel aids in compressing the balloon gradually as it is pulled in the direction of arrow 930 , so that the balloon slides smoothly into accessory 820 . other means for widening the distal end of accessory 820 may alternatively be provided , as will be apparent to those skilled in the art . it will be appreciated that the embodiments described above are cited by way of example , and that the present invention is not limited to what has been particularly shown and described hereinabove . rather , the scope of the present invention includes both combinations and subcombinations of the various features described hereinabove , as well as variations and modifications thereof which would occur to persons skilled in the art upon reading the foregoing description and which are not disclosed in the prior art .
a method for deploying an expandable implant in a body passage of varying diameter includes selecting a balloon having a radial dimension that varies , when the balloon is inflated , in accordance with the varying diameter of the body passage . the balloon is inserted , in a deflated state , into the body passage , with the expandable implant fitted radially around the balloon . the balloon is inflated so as to cause the implant to open , responsively to the varying radial dimension of the balloon , into an expanded shape that approximately matches the varying diameter of the body passage , thus anchoring the implant in the body passage .