US20030150821A1 - Emboli filtration system and methods of use - Google Patents

Abstract

An emboli filtration apparatus is provided comprising a guide wire having a filter element captured thereon, so that the guide wire is free to rotate and translate while the filter element remains stationary. The apparatus allows for movement and rotation of the guide wire as devices are advanced over it to treat occlusive disease, substantially without dislodging the filter element. In a preferred embodiment, the guide wire comprises a proximal stop configured to reposition the filter element during a medical procedure without having to remove or insert additional interventional devices.

Description

REFERENCE TO RELATED APPLICATIONS
• The present application is a continuation-in-part of U.S. patent application Ser. No. 09/774,197, filed Jan. 29, 2001, which is a continuation-in-part of U.S. patent application Ser. No. 09/354,897, filed Jul. 16, 1999, now U.S. Pat. No. 6,179,859.[0001]
FIELD OF THE INVENTION
• The present invention relates to apparatus and methods for removing emboli from the blood stream that are generated during treatment of vascular disease, such as angioplasty, atherectomy or stenting. More particularly, an emboli filtration device and methods are provided having a captured filter that enables movement of a guide wire associated with the filter without displacing the filter.[0002]
BACKGROUND OF THE INVENTION
• Atherosclerosis and other vascular occlusive diseases are becoming prevalent today in many developed countries. In such diseases, the flow areas of blood vessels become narrowed or occluded by the buildup of plaque on the walls of the vessels, leading to ischemia, and depending upon the location of the vessel, damage to the organ or limb. A number of surgical and percutaneous procedures have been developed for treating stenosis in the coronary arteries and carotid arteries, including endarterectomy, angioplasty, atherectomy and stenting.[0003]
• One problem frequently encountered during such procedures is that pieces of plaque (“emboli”) often are dislodged from the stenosis or the vessel wall. Such emboli may travel into smaller diameter regions of the vasculature, blocking blood vessels and causing ischemic injury. This problem is especially severe where the emboli are permitted to travel into the coronary arteries and carotid arteries, and can result in infarction, stroke and even death.[0004]
• Emboli filtration devices are known in which filter elements are deployed against the walls of a vessel distal of a stenosis. Such filters typically comprise a polymer or wire sac mounted on a distal region of a guide wire or angioplasty catheter, and permit blood to flow through the filter while trapping emboli. Once treatment of the stenosis is completed, the filter containing the captured emboli is contracted and withdrawn from the vessel.[0005]
• For example, U.S. Pat. No. 5,814,064 to Daniel et al. (Daniel) describes an emboli capturing system having a radially expandable mesh filter disposed on the distal end of a guide wire. The filter is deployed distal of a region of stenosis, and any interventional devices, such as an angioplasty balloon or stent delivery system are advanced along the guide wire. The filter is designed to capture emboli generated during treatment of the stenosis while permitting blood to flow through the filter.[0006]
• U.S. Pat. No. 4,723,549 to Wholey et al. (Wholey) describes an angioplasty catheter having a filter element disposed on its distal end. The filter is supported on a plurality of circumferential struts, and is expanded against an interior wall of a vessel, distal of a stenosis, by an inflation balloon. An angioplasty balloon is disposed on the catheter proximal of the filter for dilating the stenosis. The filter captures emboli dislodged during the dilatation procedure, and then is contracted and removed from the vessel with the angioplasty catheter.[0007]
• A key disadvantage of previously known emboli filtration systems, such as described in the foregoing patents, is that the filters in those devices are fixedly attached to the guide wire or angioplasty catheter, respectively. If the catheter or guide wire is rotated, bumped or moved after the filter has been deployed, there is a substantial risk that the filter will become temporarily dislodged or skewed, thereby permitting emboli to escape past the filter. Such motion is especially likely to occur when other devices such as an angioplasty balloon catheter are deployed along the guide wire after the filter is deployed, as in the Daniel patent.[0008]
• U.S. Pat. No. 6,336,934 to Gilson et al. (Gilson) describes an embolic protection device having a collapsible filter element that is mounted on a tubular sleeve, wherein the tubular sleeve is slidable and rotatable on a guide wire between proximal and distal stops. The filter element on the tubular sleeve is delivered in a collapsed state within a catheter and self-deploys when the catheter is retracted. In the deployed state, the tubular sleeve facilitates some manipulation of the guide wire while potentially reducing disruption of the filter element.[0009]
• One drawback associated with the device described in the Gilson patent is that the guide wire is delivered into the patient's vessel with the filter element disposed in a collapsed state between the proximal and distal stops near the distal end of the guide wire. The placement of the filter element near the distal end of the guide wire during delivery may make it difficult for the guide wire to negotiate tortuous anatomy during delivery. It would be advantageous to deliver the guide wire in an unencumbered manner to the site of the occlusion, then subsequently deliver other interventional devices including the filter element.[0010]
• In view of these drawbacks of previously known devices, it would be desirable to provide emboli filtration apparatus and methods having a filter element that remains stationary once deployed.[0011]
• It also would be desirable to provide emboli filtration apparatus and methods having a filter that may be deployed along a guide wire, but is configured so that subsequent displacements or rotation of the guide wire will not dislodge the filter.[0012]
• It further would be desirable to provide emboli filtration apparatus and methods that reduce the risk of emboli escaping from a filter element.[0013]
• It still further would be desirable to provide emboli filtration apparatus and methods that reduce the risk of trauma to vessel endothelium resulting from movement transferred to the emboli filtration apparatus.[0014]
• It still further would be desirable to provide emboli filtration apparatus and methods that enable a filter element to be repositioned during a medical procedure without having to remove or insert additional interventional devices.[0015]
SUMMARY OF THE INVENTION
• In view of the foregoing, it is an object of the present invention to provide emboli filtration apparatus and methods having a filter element that remains stationary once deployed.[0016]
• It is another object of the present invention to provide emboli filtration apparatus and methods having a filter that may be deployed along a guide wire, but is configured so that subsequent displacements or rotation of the guide wire will not dislodge the filter.[0017]
• It is also an object of this invention to provide emboli filtration apparatus and methods that reduce the risk of emboli escaping from a filter element.[0018]
• It is a further object of the present invention to provide emboli filtration apparatus and methods that reduce the risk of trauma to vessel endothelium resulting from movement transferred to the emboli filtration apparatus.[0019]
• It is still a further object of the present invention to provide emboli filtration apparatus and methods that enable a filter element to be repositioned during a medical procedure without having to remove or insert additional interventional devices.[0020]
• These and other objects of the present invention are accomplished by providing emboli filtration apparatus comprising a guide wire having a filter element captured thereon, so that the guide wire is free to rotate and translate while the filter element remains stationary. The apparatus thus allows for movement and rotation of the guide wire as devices are advanced over it to treat a stenosis, substantially without dislodging the filter element. Accordingly, the risk of permitting emboli to escape during temporary displacement or skewing of the filter element is reduced, as well as movement-induced trauma of the vessel endothelium.[0021]
• In a preferred embodiment, the apparatus comprises a guide wire having a filter element captured for rotation and translation on a distal end thereof. The filter element preferably comprises a wire or polymer sac affixed to a plurality of self-expanding struts. The filter element has a contracted state, suitable for transluminal insertion disposed inside a retractable sheath, and a deployed state, wherein an outer perimeter of the filter element engages the walls of a vessel when the sheath is retracted proximally.[0022]
• The filter element includes a proximal capture ring having a diameter that is larger than the diameter of the guide wire, but smaller than the diameter of the distal tip of the guide wire. The capture ring allows the guide wire to move freely relative to the filter element over a limited range, so that movement or rotation of the guide wire does not cause the filter to move or to scrape against the walls of the vessel. When it is desired to retract the filter element, the guide wire is pulled proximally so that the distal tip of the guide wire engages the capture ring and pulls the filter element back into a sheath to its contracted state.[0023]
• Optionally, the filter element may include a cylindrical sleeve that ensures that the filter forms an adequate seal against the walls of the vessel in the deployed state, thus preventing bypass flow around the filter. The sleeve also assists in orienting the axis of the filter element parallel to the axis of the vessel.[0024]
• In a further alternative embodiment of the present invention, the guide wire further comprises a proximal stop disposed proximal of the distal tip. The proximal stop is configured so that a filter element having an elastomeric capture ring may be advanced distally over the proximal stop during delivery of the filter element and locked distal of the proximal stop. As a further alternative, the proximal stop may be configured to permit the capture ring to pass distally over it, but prevent proximal passage.[0025]
• During a medical procedure, the filter element is advanced to a central position between the proximal stop and distal tip. Advantageously, if it becomes necessary to advance the filter element distally during the medical procedure, the guide wire may be advanced distally to cause the proximal stop to abut the capture ring and urge the filter element distally. Using the proximal stop of the guide wire, it is not necessary to remove interventional devices or insert a push tube over the guide wire to reposition the filter element.[0026]
• Methods of using the apparatus of the present invention to remove emboli during a surgical or percutaneous transluminal procedure also are provided.[0027]
BRIEF DESCRIPTION OF THE DRAWINGS
• Further features of the invention, its nature and various advantages will be apparent from the accompanying drawings and the following detailed description of the preferred embodiments, in which:[0028]
• FIG. 1 is a side view of the components of a first embodiment of apparatus constructed in accordance with the principles of the present invention;[0029]
• FIGS.[0030]2A-2B are, respectively, a perspective view and end view of the filter element of FIG. 1;
• FIGS.[0031]3A-3E are side sectional views showing deployment, use and removal of the apparatus of FIG. 1 in accordance with the methods of the present invention;
• FIGS.[0032]4A-4B are, respectively, side sectional views of an alternative embodiment of the apparatus of the present invention in deployed and contracted states;
• FIGS.[0033]5A-5B are side sectional views depicting use of an alternative embodiment of the present invention having a proximal stop disposed on a guide wire;
• FIGS.[0034]6A-6C are, respectively, a side view of an alternative embodiment of the proximal stop of FIGS.5A-5B, and enlarged views of the proximal stop in relaxed and contracted states; and
• FIGS.[0035]7A-7B are side views of a further alternative embodiment of a proximal stop provided in accordance with principles of the present invention.
DETAILED DESCRIPTION OF THE INVENTION
• The present invention is directed to an emboli filtration system and methods that filter out emboli generated during surgical or percutaneous interventional procedures. In accordance with the principles of the present invention, a filter element is captured on a guide wire so that the guide wire is capable of rotation and translation, without disturbing the placement of the filter element. Because the filter element is captured on the guide wire, however, the filter element is readily removed by retracting the guide wire into a sheath.[0036]
• Referring to FIG. 1,[0037]apparatus10 of a first embodiment of the present invention comprisesguide wire11,delivery sheath20 andfilter element30. In accordance with the principles of the present invention,guide wire11 includes enlarged diameterdistal region12.Guide wire11 may be constructed of material commonly used in guide wire construction, such as stainless steel or a high strength polymer.Distal region12, which acts as a distal stop to limit travel offilter element30 in the distal direction, comprises a soft metal or metal alloy coil or may be formed from a flexible polymer, such as polyethylene or nylon, molded onto the distal region of the guide wire. Alternatively,guide wire11 anddistal region12 may comprise a mechanism, such as are known in the art, for steeringdistal region12 through a patient's vasculature. Illustratively,guide wire11 may have a diameter of about 0.018 inches (0.46 mm) and the diameter ofdistal region12 may be about 0.022 inches (0.56 mm).
• [0038]Delivery sheath20 comprisesflexible catheter21 havingproximal end22,distal end23, andinterior lumen24. Pushtube25 is disposed withinlumen24, and includesproximal end26,distal end27 andguide wire lumen28, to permitcatheter21 and pushtube25 to be advanced alongguide wire11.Proximal end26 ofpush tube25 extends throughproximal end22 ofcatheter21, so thatpush tube25 may be translated in the distal and proximal directions relative tocatheter21.Catheter21 and pushtube25 preferably comprise flexible materials such as are commonly used in catheter construction, for example, polyethylene, polyurethane or nylon.Delivery sheath20 preferably has an outer diameter of about 4 Fr.
• Referring now to FIGS. 2A and 2B,[0039]filter element30 comprises funnel-shapedfilter sac31 coupled to plurality of self-expandingstruts32 atproximal end33 and softelastomeric cone34 atdistal end35.Struts32 are affixed to capturering36, and self-expand from a contracted state, when filter element is disposed inlumen24 ofcatheter21, and a deployed state, when filter element is ejected fromdelivery sheath20. In the deployed state, struts32 extend outward to urge the perimeter ofsac31 into engagement with the walls of a vessel.
• [0040]Struts32 may comprise a resilient metal or metal alloy, such as stainless steel or nickel-titanium, or a resilient polymer. It is expected that at least threestruts32 spaced equidistant apart around the perimeter ofsac31 should be employed to provide adequate expansion and control of the sac, although a greater number may be used. Alternatively, struts31 may comprise flexible strands, and expansion ofsac31 may be accomplished by adding a flexible and resilient self-expanding nickel-titanium hoop alongperimeter38 of the sac.
• Particulate matter, such as emboli, pass through struts[0041]32 and are trapped againstsac31, which permits blood to pass freely through. The size of emboli trapped bysac31 is determined by the pore size of the sac, and preferably is about 0.0012 inches (30 microns).Sac31 may comprise a polymer sleeve affixed to struts32 or a self-expanding wire mesh constructed from a resilient metal alloy, for example, nickel-titanium.
• [0042]Capture ring36 has bore37 with an inner diameter greater than the diameter ofguide wire11, but smaller than the diameter ofdistal region12. This allowsguide wire11 to be rotated or translated distally relative to filterelement30, without imposing a force on the filter element that might temporarily dislodge the filter element. Accordingly, various devices, such as angioplasty catheters, atherectomy devices or stent delivery systems may be exchanged onguide wire11 without disturbingfilter element30 or causing it to scrape against the walls of the vessel. As will of course be understood,capture ring36 need not be a tubular member, but may have any suitable shape that allowsguide wire11 to pass freely through it.
• [0043]Elastomeric cone34 is coupled to the distal end ofsac31 and includes a tapered central lumen that permitsguide wire11 to freely pass throughcone34 with minimal clearance.Elastomeric cone34 preferably comprises a non-stick or slick surface, such as polytetrafluoroethylene, and is designed so that emboli trapped insac31 are prevented from passing out of the filter element through the space betweenguide wire11 and the lumen ofelastomeric cone34.Cone34 is sufficiently soft and flexible so that its lumen can expand to permitdistal region12 ofguide wire11 to be pulled proximally through the cone, and then the lumen will seal itself to prevent emboli from escaping through the lumen, as described hereinafter.
• Referring now to FIGS.[0044]3, preferred methods of using the apparatus of FIG. 1 are described. In FIG. 3A,guide wire11 first is percutaneously and transluminally inserted into vessel V, such as a coronary artery or common carotid artery, so thatdistal region12 is disposed distal of stenosis S in the direction of blood flow (indicated by arrow F).
• In FIG. 3B,[0045]delivery sheath20 withfilter element30 loaded inlumen24 in the contracted state is advanced alongguide wire11 until the filter element is disposed at a desired location distal of the stenosis, as determined, for example, by fluoroscopy.Proximal end26 ofpush tube25 is then held stationary whilecatheter21 is retracted in the proximal direction.
• As[0046]catheter21 is retracted, struts32 offilter element30 expand outward to urge the perimeter ofsac31 into engagement with the walls of vessel V, as depicted in FIG. 3C.Delivery sheath20 then is withdrawn proximally and removed fromguide wire11.Guide wire11 then may be advanced a short distal distally, so that any incidental movement of the guide wire associated with exchanging interventional instruments alongguide wire11 will not causedistal region12 to contactfilter element30.
• In FIG. 3D,[0047]angioplasty catheter40 is illustratively advanced alongguide wire11 untilballoon41 is disposed across the stenosis.Balloon41 then is inflated and deflated for one or several cycles, as in conventional, to dilate and disrupt the plaque comprising stenosis S and increase the diameter of vessel V. During this dilatation procedure, particles of plaque or emboli E are generated. These emboli are carried by blood flow in direction F intosac31 offilter element30, where they become trapped.
• Insertion and advancement of[0048]angioplasty catheter40 alongguide wire11 may cause the guide wire to be translated over a short range or rotated. Becausefilter element30 is not affixed to guidewire11, however, such motion of the guide wire is not transferred to the filter element. Instead, filterelement30 remains stationary even though the guide wire rotates or translates relative to the filter element.
• Once[0049]balloon41 has dilated stenosis S,angioplasty catheter40 is withdrawn alongguide wire11 while leaving the guide wire in place. If desired, a stent delivery system (not shown) may be advanced alongguide wire11 and one or more stents deployed across the dilated stenosis to retain the patency of the dilated vessel.
• When treatment of the stenosis is completed, delivery sheath[0050]20 (withpush tube25 removed) may again be advanced alongguide wire11 to a position just proximal offilter element30.Guide wire11 then is pulled proximally so thatdistal region12 passes throughelastomeric cone34 and bears againstcapture ring36. The lumen incone34 seals itself afterdistal region12 passes through it so that emboli trapped insac31 do not escape through the lumen ofcone34.
• When[0051]guide wire11 is pulled further in the proximal direction, withcatheter21 held stationary, struts32 are forced radially inward by the distal edge of the catheter. This in turn causessac31 to disengage the vessel walls. As the guide wire continues to be pulled proximally, struts32cause sac31 to collapse inward to its contracted position and the filter element is retracted intolumen24 ofcatheter21. Emboli E are trapped and retained infilter element30 throughout treatment of the stenosis, and are withdrawn from the vessel when the filter element is retracted withincatheter21.Catheter21 then is removed from the vessel.
• Referring now to FIGS. 4A and 4B, an alternative embodiment of the filter element and guide wire of the present invention is described.[0052]Guide wire50 is similar in construction to guidewire11 described with respect to FIG. 1, except that it includesflange51 on enlarged diameterdistal region52 ofguide wire50, and enlargeddistal region52 has length L₁that is longer than the length of thefilter element60 in the contracted state.
• [0053]Distal region52 may be formed from a malleable material, a coil spring, or a pliable thermoplastic material molded ontoguide wire50, and preferably is covered with a smooth hydrophilic coating to facilitate movement offilter element60 as described hereinafter. Alternatively,guide wire50 anddistal region52 may comprise a mechanism, such as are known in the art, for steeringdistal region52 through a patient's vasculature.Distal region52 also may comprise a radiopaque material or may include a radiopaque band (not shown) to assist in visualization and placement of the guide wire.
• [0054]Filter element60 comprises self-expandingstruts61 coupled to capturering62 andtubular sleeve63.Sleeve63 is affixed at its distal end to funnel-shapedfilter sac64, which in turn is coupled todistal ring65.Capture ring62 has bore66 with an inner diameter larger than the diameter ofguide wire50, but smaller than the diameter ofdistal region52. Accordingly,guide wire50 may freely translate and rotate throughbore66 ofcapture ring62 while the filter element remains stationary.
• [0055]Distal ring65 has bore67 with a diameter slightly larger than the diameter ofdistal region52. This enablesdistal ring65 to slide or rotate freely overdistal region52, but with minimal clearance for emboli to escape fromsac64 through the annulus betweendistal ring65 anddistal region52.Distal region52 includesflange51, which has a diameter that is larger than the diameter ofbore66 ofcapture ring62. Thus,filter element60 is captured onguide wire50 proximally bydistal ring65 abutting againstflange51, and distally bycapture ring62 abutting againstflange51.
• [0056]Sleeve63 andsac64 filter blood passing through the vessel, and preferably have a pore size selected to filter out particles having a diameter greater than 0.0012 inches (30 microns).Sleeve63 andsac64 preferably comprise a flexible woven metal alloy, polymer tube, or perforated fabric, and are expanded to the deployed state, as shown in FIG. 4A, by struts61. Advantageously,sleeve63 is designed so that its perimeter conforms to the inner diameter of the vessel to seal against bypass flow, even in curved vessels. In addition,sleeve63 tends to prevent skewing of the filter element and ensures that the filter is properly oriented parallel to the axis of the vessel when the filter element is deployed.
• [0057]Filter element60 is suitable for delivery percutaneously and transluminally to a desired location in a vessel usingdelivery sheath20 of FIG. 1. In particular, struts61 may be radially compressed to collapsesleeve63 andsac64, as shown in FIG. 4B, thereby permitting the filter element to be loaded intolumen24 ofcatheter21 so thatcapture ring62 abuts againstdistal end27 ofpush tube25.
• Deployment of[0058]filter element60 is similar to the method described with respect to FIGS. 3B and 3C. Specifically,delivery sheath20 is advanced through a vessel withdistal region52 extending beyonddistal end23 ofcatheter21. Oncedistal region52 has crossed the stenosis, as confirmed by fluoroscopy, pushtube25 is held place andcatheter21 is retracted proximally. Alternatively, pushtube25 may be omitted and guidewire50 may be held stationary withfilter element60 held in position byflange51. Retraction ofcatheter21 uncoversfilter element60, allowingstruts61 to expand outward and urge the perimeter ofsleeve63 andsac64 into engagement with the walls of the vessel.
• [0059]Delivery sheath20 then is removed, and one or more interventional devices may be serially employed onguide wire50. Like the embodiment of FIG. 1, motion imparted to guidewire50 during exchange of instruments along the guide wire causes the guide wire to slide throughfilter element60 without causing skewing or displacement of the filter element. Advantageously, this prevents emboli from escapingsac64 or damage to the endothelium caused by scraping of the filter element.
• Once treatment of the stenosis is completed, the treatment device (e.g., angioplasty catheter, etc.) is removed, and[0060]delivery sheath20 is again advanced alongguide wire50. Whendistal end23 ofcatheter21 is disposed adjacent to capturering62,guide wire50 is pulled proximally. As a result of this motion,distal region52 passes throughfilter element60 untilflange51 abuts againstcapture ring62. Further proximal movement ofguide wire50 causes struts61 to be urged inward, collapsingsleeve63 andsac64 so that they can be drawn intolumen24 ofcatheter21.
• Unlike the embodiment of FIG. 1, where the distal region passes through[0061]cone34, length L₁is sufficiently long so thatdistal ring65 is still disposed over the enlarged diameter ofdistal region52 when the filter element is in the contracted state. Accordingly, whenfilter element60 is contracted for removal, emboli cannot escape through bore67 ofdistal ring65, since the bore continues to be substantially blocked bydistal region52 ofguide wire50.Delivery sheath20,guide wire50 andfilter element60 then are removed from the vessel with any emboli trapped within the contracted filter element.
• In a preferred embodiment of the apparatus of FIGS.[0062]4,guide wire50 has a suitable length for transluminal percutaneous applications and a diameter in a range of about 0.006 to 0.025 inches , and more preferably 0.012 inches.Distal region52 ofguide wire50 has a diameter larger than the diameter ofguide wire50, and preferably in a range of about 0.010 to 0.038 inches, more preferably 0.018 inches.
• While[0063]filter element60 may comprise any length suitable for an intended application, in one preferred embodiment,filter element60 has a deployed length of 3.5 cm and a maximum deployed diameter of 12 mm. For this embodiment, length L₁ofdistal region52 preferably is 5.0 cm. For a guide wire having a diameter of 0.012 inches and distal region having a diameter of 0.018 inches,capture ring62 preferably has an inner diameter of 0.014 inches and an outer diameter of 0.018 inches. In this casedistal ring65 preferably has an inner diameter of 0.0181 inches and an outer diameter of 0.024 inches.
• Referring now to FIGS.[0064]5,apparatus90 of an alternative embodiment of the present invention comprisesguide wire100 andfilter element102.Filter element102 preferably is constructed in accordance withfilter element30 of FIGS.1-3. Specifically,filter element102 comprises funnel-shapedfilter sac105 coupled to plurality of self-expandingstruts103 at a proximal end andelastomeric cone106 at a distal end.Struts103 are affixed to capturering104, as described in detail hereinabove with respect to FIGS. 2. Optionally,filter element102 also may comprisecylindrical sleeve63, as described hereinabove with respect to FIGS.4, disposed betweenstruts103 andsac105.
• [0065]Guide wire100 comprisesproximal stop110 anddistal region112.Distal region112 serves as a distal stop that limits the distal movement offilter element102 alongguide wire100, as described hereinabove.Proximal stop110 has proximal anddistal ends114 and115 and taper111 disposed therebetween, as shown in FIG. 5A. Taper111 ofguide wire110 spans fromproximal end114, which preferably has a guide wire diameter of about 0.018 inches, todistal end115, which preferably has an enlarged diameter of about 0.022 inches.Proximal stop110 anddistal region112 are spaced apart such a distance that filterelement102, when deployed therebetween, will not be disturbed by incidental longitudinal movements ofguide wire100.
• [0066]Apparatus90 of FIGS.5 preferably is deployed in the manner described hereinabove with respect toapparatus10 of FIGS.1-3, except as noted below. In a first step,guide wire100 is percutaneously and transluminally inserted into treatment vessel V under fluoroscopy, withproximal stop110 preferably being disposed just distal of stenosis S. In a next step,filter element102 is advanced alongguide wire100 in a contracted state, preferably being contracted withinlumen24 ofcatheter21, as described hereinabove with respect to FIG. 3B. Pushtube25 of FIG. 3B then is advanced distally so that a distal end ofpush tube25 abutscapture ring104 and advances filterelement102 distally overguide wire100.
• As[0067]push tube25 advances filterelement102,elastomeric cone106 is pushed distally overproximal stop110 ofguide wire100.Elastomeric cone106 is configured to be flexible enough to radially expand over the enlarged diameter ofdistal end115 ofproximal stop110. After being advanced overdistal end115,elastomeric cone106 then substantially seals itself aboutguide wire100 to prevent emboli from subsequently escaping when a medical procedure is performed.
• As[0068]push tube25 further is advanced,capture ring104 then is advanced overproximal stop110.Capture ring104 also is compliant enough to expand over the enlarged diameter ofdistal end115 when advanced distally, and then substantially seals itself aboutguide wire100 after it passes overproximal stop110. Oncefilter element102 is disposed betweenproximal stop110 anddistal region112,filter element102 is deployed, e.g., by proximally retractingcatheter21 while holdingpush tube25 stationary. The catheter and push tube then may be removed from the patient's vessel.
• Once deployed,[0069]filter element102 preferably is provided in a central position betweenproximal stop110 anddistal region112, as depicted in FIG. 5A, either by proximally retracting or distally advancingguide wire100 under fluoroscopy. In this central position, incidental movements ofguide wire100 will not substantially disturbfilter element102.
• If it becomes necessary to advance[0070]filter element102 distally during the medical procedure,guide wire100 may be advanced distally by a physician untildistal end115 ofproximal stop110 abutscapture ring104 and gently urgesfilter element102 distally, as shown in FIG. 5B. Advantageously, this enablesfilter element102 to be advanced distally without having to remove angioplasty or stenting apparatus, then having to advance a push tube over then length ofguide wire100. Upon repositioning offilter element102,guide wire100 preferably is repositioned to the central position depicted in FIG. 5A, so that incidental movements ofguide wire100 do not disturbfilter element102.
• When treatment of the stenosis is completed and any emboli are captured within[0071]sac105 offilter element102, delivery sheath20 (withpush tube25 removed) may be advanced to a location just proximal offilter element102.Guide wire100 then is retracted proximally so thatdistal region112 passes throughelastomeric cone106 and bears againstcapture ring104, as described hereinabove with respect to FIG. 3E. A lumen ofcone106 seals itself afterdistal region112 passes through to prevent emboli from escaping downstream.Distal region112 then abutscapture ring104 and pullsfilter element102 in a proximal direction. With the catheter held stationary, struts103 are forced radially inward by the distal edge of the catheter to causefilter element102 and any emboli captured therein to be removed via the catheter.
• Advantageously, the one-way stop feature of[0072]proximal stop110 allowsguide wire100 to be advanced through a patient's vasculature without havingfilter element102 disposed on the guide wire. This facilitates advancement ofguide wire100 through a patient's tortuous vasculature. Then, whenguide wire100 is properly positioned in a vessel unencumbered,filter element102 may be advanced distally overproximal stop110, and securely positioned betweenproximal stop110 anddistal region112 during the medical procedure.
• Referring now to FIGS.[0073]6, an alternative embodiment ofproximal stop110 of the embodiment of FIGS.5 is described. In FIG. 6A,guide wire120 preferably is provided substantially in accordance withguide wire11 of FIG. 1, and comprises enlarged diameterdistal region122, which acts as a distal stop to limit travel offilter element102 in the distal direction, as described hereinabove.Guide wire120 further comprisesproximal stop130, which includes at least onedepressible tab131 havingproximal end133 anddistal end134, as shown in FIGS.6B-6C.
• [0074]Proximal end133 ofdepressible tab131 is affixed to guidewire120, e.g., using a solder, whiledistal end134 is biased to extend slightly radially outward fromguide wire120 in a relaxed state, as shown in FIG. 6B.Depressible tab131 may comprise a slight concave curvature to causedistal end134 to be biased radially outward or, alternatively,proximal end133 may be affixed to guidewire120 in such a manner that allowsdistal end134 to be biased radially outward in the relaxed state.
• [0075]Depressible tab131 is flexible so that it may be transformed between the relaxed state, shown in FIG. 6B, and a contracted state, as shown in FIG. 6C. In the contracted state, external compressive forces causedepressible tab131 to be substantially flush with an exterior surface ofguide wire120.Guide wire120 optionally may comprise a shallow slot (not shown) disposed in a lateral surface that is adapted to receivedepressible tab131 in the contracted state. Whendepressible tab131 is contracted, as shown in FIG. 6C, the shallow slot serves to ensure thatdepressible tab131 does not extend radially beyondguide wire120.
• [0076]Apparatus110 of FIGS.6 preferably is deployed in the manner described hereinabove with respect toapparatus10 of FIGS.1-3, except as noted below. In a first step,guide wire120 is percutaneously and transluminally inserted untilproximal stop130 is disposed just distal of a stenosis. In a next step,filter element102 is advanced alongguide wire120 in a contracted state, preferably being contracted withinlumen24 ofcatheter21, as described hereinabove with respect to FIG. 3B. Pushtube25 of FIG. 3B then is advanced distally so that a distal end ofpush tube25 abutscapture ring104 and advances filterelement102 distally.
• As[0077]push tube25 advances filterelement102,elastomeric cone106 is pushed distally overproximal stop130.Depressible tab131 assumes the contracted state, depicted in FIG. 6C, asfilter element102 is advanced distally to facilitate advancement ofelastomeric cone106 overproximal stop130.Elastomeric cone106 also may radially expand overproximal stop130, if necessary, and then substantially seal itself aboutguide wire120 after it passes overproximal stop130. Aspush tube25 further is advanced,capture ring104 then is advanced overproximal stop130 in the same manner aselastomeric cone106.
• After[0078]elastomeric cone106 andcapture ring104 are advanced distally overproximal stop130,depressible tab131 returns to the relaxed state, depicted in FIG. 6B.Filter element102 then is deployed betweenproximal stop130 anddistal region122, e.g., by proximally retractingcatheter21 while holdingpush tube25 stationary. The catheter and push tube then may be removed from the patient's vessel.
• Once deployed,[0079]filter element102 preferably is provided in a central position betweenproximal stop130 anddistal region122 by proximally retracting or distally advancingguide wire120 under fluoroscopy. If it becomes necessary to advancefilter element102 distally during a medical procedure,guide wire120 may be advanced distally to causedistal end134 ofdepressible tab131 toabut capture ring104 and gently urgefilter element102 distally. Upon completion of the medical procedure,catheter21 may be advanced distally overguide wire120 to causefilter element102 and any emboli captured therein to be removed via the catheter, as described in detail hereinabove with respect to FIG. 3E.
• Referring now to FIGS. 7, a further alternative embodiment of the present invention is described, whereby[0080]guide wire11 of FIG. 1 is slightly bent to comprise a one-way proximal stop mechanism.Guide wire150 of FIG. 7A comprises enlarged diameterdistal region152, which acts as a distal stop to limit travel offilter element102 in the distal direction.Guide wire150 further comprisesproximal stop160, which includesbent section161 ofguide wire150 havingproximal taper163 anddistal taper164.Proximal taper163 comprises angle a with respect tolongitudinal axis170 ofguide wire150, whiledistal taper164 comprises angle β with respect tolongitudinal axis170, as depicted in FIG. 7B.
• [0081]Proximal stop160 is configured to facilitate distal advancement offilter element102 overbent section161 ofguide wire150 viaproximal taper163, while inhibiting movement offilter element102 in a proximal direction overbent section161 viadistal taper164. In a preferred embodiment, angle β is greater than angle α, as illustratively shown in FIG. 7B, to permit advancement offilter element102 in a distal direction only.
• [0082]Proximal stop160 ofguide wire150 is flexible enough so that proximal anddistal tapers163 and164 may assume substantially flat configurations, i.e., substantially parallel tolongitudinal axis170 ofguide wire150, whenelastomeric cone106 andcapture ring104 are advanced distally overbent region161. Oncefilter element102 is advanced distally overproximal stop160, proximal anddistal tapers163 and164 return to the bent configurations depicted in FIG. 7A.
• [0083]Apparatus140 of FIGS.7 preferably is deployed in the manner described hereinabove with respect toapparatus10 of FIGS.1-3, except as noted below. In a first step,guide wire150 is percutaneously and transluminally inserted untilproximal stop160 is disposed just distal of a stenosis. In a next step,filter element102 is advanced alongguide wire150 in a contracted state, preferably being contracted withinlumen24 ofcatheter21, as described hereinabove with respect to FIG. 3B. Pushtube25 of FIG. 3B then is advanced distally so that a distal end ofpush tube25 abutscapture ring104 and advances filterelement102 distally.
• As[0084]push tube25 advances filterelement102,elastomeric cone106 is pushed distally overproximal taper163 ofguide wire150. Proximal anddistal tapers163 and164 may assume substantially flat configurations, i.e., substantially parallel tolongitudinal axis170, to facilitate distal advancement ofelastomeric cone106. Aspush tube25 further is advanced distally,capture ring104 then is advanced overproximal stop160 in the same manner aselastomeric cone106.
• Once[0085]filter element102 is disposed betweenproximal stop160 anddistal region152,filter element102 is deployed, as described hereinabove.Filter element102 preferably is provided in a central position betweenproximal stop160 anddistal region152, as shown in FIG. 7A, by proximally retracting or distally advancingguide wire150 under fluoroscopy. If it becomes necessary to advancefilter element102 distally during a medical procedure,guide wire150 may be advanced distally untildistal taper164 ofproximal stop160 abutscapture ring104 and gently urgesfilter element102 distally.Proximal stop160 ofguide wire150 is configured to retain the bent shape depicted in FIGS.7 asdistal taper164 urgesfilter element102 distally. Upon completion of the medical procedure,catheter21 may be advanced distally overguide wire150 to causefilter element102 and any emboli captured therein to be removed via the catheter, as described in detail hereinabove with respect to FIG. 3E.
• While preferred illustrative embodiments of the invention are described above, it will be apparent to one skilled in the art that various changes and modifications may be made. The appended claims are intended to cover all such changes and modifications that fall within the true spirit and scope of the invention.[0086]

Claims (22)

1. Apparatus for filtering emboli from blood flowing through a vessel, the apparatus comprising:

a guide wire having proximal and distal regions, and proximal and distal stops on the distal region; and

a filter element configured to rotate and translate on the guide wire between the proximal and distal stops,

wherein the filter element and the proximal stop are configured to permit advancement of the filter element from the proximal region by passing in vivo over the proximal stop, the proximal stop thereafter prohibiting proximal retraction of the filter element over the proximal stop.

2. The apparatus ofclaim 1 wherein the distal stop limits translation of the filter element in a distal direction.

3. The apparatus ofclaim 1 wherein the proximal stop has proximal and distal ends and a taper disposed therebetween.

4. The apparatus ofclaim 3 wherein the proximal end has a first diameter that is less than a second diameter of the distal end.

5. The apparatus ofclaim 3 wherein the filter element comprises a compliant member configured to pass over the proximal stop.

6. The apparatus ofclaim 1 wherein the proximal stop and distal stop are spaced apart such a distance that the filter element, when deployed therebetween, will not be disturbed by incidental longitudinal movements of the guide wire.

7. The apparatus ofclaim 1 wherein the proximal stop is configured to abut against a proximal portion of the filter element, after the filter element is moved to the distal region, when the guide wire is advanced.

8. The apparatus ofclaim 1 further comprising a plurality of self-expanding struts coupled between a capture ring and a filter sac.

9. The apparatus ofclaim 1 wherein the proximal stop comprises at least one depressible tab having proximal and distal ends, wherein the proximal end is affixed to the guide wire.

10. The apparatus ofclaim 9 wherein the distal end of the depressible tab is biased radially outward from the guide wire in a relaxed state.

11. The apparatus ofclaim 10 wherein the distal end of the depressible tab is configured to abut against the filter element once the filter element is moved to the distal region.

12. The apparatus ofclaim 10 wherein the depressible tab further comprises a contracted state in which the distal end is substantially flush with an exterior surface of the guide wire.

13. The apparatus ofclaim 9 wherein the depressible tab is configured to facilitate distal advancement of the filter element over the proximal stop in the contracted state.

14. The apparatus ofclaim 1 wherein the proximal stop includes a bent section of the guide wire, the bent section including a proximal taper and a distal taper.

15. The apparatus ofclaim 14 wherein the proximal taper comprises a first angle with respect to a longitudinal axis of the guide wire and the distal taper comprises a second angle with respect to the longitudinal axis, wherein the first angle is less than the second angle.

16. A method for filtering emboli from blood flowing through a vessel, the method comprising:

providing apparatus comprising a guide wire having a distal region including a distal stop, a proximal stop disposed proximal of the distal stop, and a filter element disposed for-translation on the guide wire;

transluminally inserting the guide wire into a vessel;

distally advancing the filter element in a contracted state over the proximal stop; and

deploying the filter element, distal of the proximal stop and proximal of the distal stop, to engage a wall of the vessel and filter emboli out of blood flowing through the vessel.

17. The method ofclaim 16 further comprising advancing a treatment device along the guide wire to treat a portion of the vessel proximal of the location of the filter element, wherein incidental rotation or translation of the guide wire relative to the filter element does not displace the filter element.

18. The method ofclaim 17 further comprising a step of, after use of the treatment device is completed, pulling the guide wire proximally so that the distal stop engages the filter element and causes the filter element to return to the contracted state.

19. The method ofclaim 16 further comprising:

distally advancing the guide wire; and

causing the proximal stop to abut and urge the filter element distally.

20. The method ofclaim 16 wherein providing apparatus comprising a proximal stop comprises providing a taper on the guide wire, the method further comprising:

distally advancing the filter element in the contracted state over the taper; and

causing a distal end of the taper to abut and reposition the filter element when the guide wire is advanced distally by a physician.

21. The method ofclaim 16 wherein providing apparatus comprising a proximal stop comprises providing a bent section of the guide wire having proximal and distal tapers, the method further comprising:

distally advancing the filter element in the contracted state over the proximal and distal tapers; and

causing the distal taper to abut and reposition the filter element when the guide wire is advanced distally by a physician.

22. The method ofclaim 16 wherein providing apparatus comprising a proximal stop comprises providing at least one depressible tab having a proximal end affixed to the guide wire and a distal end, the method further comprising:

providing the depressible tab in a relaxed state wherein the distal end is biased radially outward from an exterior surface of the guide wire;

distally advancing the filter element over the depressible tab to cause the distal end of the depressible tab to be substantially flush with the exterior surface of the guide wire; and

returning the depressible tab to the relaxed state after the filter element is advanced distal of the proximal stop.

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