US20120253382A1 - Emboli protection devices and related methods of use - Google Patents

Abstract

An embolic protection system and method of treating occluded vessels which reduces the risk of distal embolization during vascular interventions is provided. The embolic protection system includes a guide catheter, a multi-lumen tube having a sealing surface on the distal end and an interventional device. A method of treating a blood vessel includes providing a guide catheter and a multi-lumen elongate member having proximal and distal ends, evacuation and inflation lumens extending therebetween and a sealing surface on the distal end. The elongate member is advanced through the guide catheter into a blood vessel that supplies blood to the heart proximal a lesion. The sealing surface is expanded to engage the endoluminal surface of the blood vessel and stop antegrade flow. An interventional device is advanced through the evacuation lumen to treat the lesion.

Description

• This is a divisional of U.S. patent application Ser. No. 12/786,305, filed 24 May 2010, now pending, which is a continuation of U.S. application Ser. No. 11/337,126, filed 19 Jan. 2006, now U.S. Pat. No. 7,867,216, which is a continuation of U.S. application Ser. No. 09/845,162, filed 1 May 2001, now U.S. Pat. No. 7,422,579, which are hereby expressly incorporated by reference in their entirety.
FIELD OF THE INVENTION
• The present invention relates to apparatus and methods used to prevent the introduction of emboli into the bloodstream during and after surgery performed to reduce or remove blockage in blood vessels.
BACKGROUND OF THE INVENTION
• Narrowing or occlusion of blood vessels, such as the walls of an artery, inhibit normal blood flow. Such blockages, whether partial or full, can have serious medical consequences, depending upon their location within a patient's vascular system. Narrowing or blockage of the coronary vessels that supply blood to the heart, a condition known as atherosclerosis, may cause damage to the heart. Heart attacks (myocardial infarction) may also result from this condition. Other vessels are also prone to narrowing, including carotids, renals, cerebrals, and other peripheral arteries.
• Various surgical procedures are currently used to reduce or remove the blockage in blood vessels. Such procedures include balloon angioplasty, which involves inserting a balloon catheter into the narrowed or occluded area, expanding the balloon in the narrow or occluded area, and if necessary, placing a stent in the now expanded area to keep it open. Another common procedure used is atherectomy where the lesion is cut away and removed from the vessel, or abrasively ground, sending the small particulates downstream. Other endovascular procedures make use of thrombectomy, drug delivery, radiation, stent-grafts, and various diagnostic devices.
• Another alternative is bypass surgery in which a section of vein is removed from, for example, the patient's leg, e.g., a saphenous vein, to be used as a graft to form a pathway to bypass the occluded area. The saphenous vein graft (SVG), however, is also susceptible to becoming occluded in a manner similar to that of the bypassed vessel. In such a case, angioplasty (with or without the use of a stent) or atherectomy is often used on the SVG to remove or reduce the blockage.
• Each of the above described procedures carries with it the risk that some of the treated plaque will he disrupted, resulting in embolic particulates released in the bloodstream. These emboli, if allowed to flow through the vascular system, may cause subsequent infarctions or ischemia in the patient. SVGs treated by angioplasty or atherectomy carry a particularly high risk of this result, but such problems are also encountered in the other types of procedures mentioned, such as carotids, or native coronary arteries, particularly those whose lesions include thrombus.
• Several systems to prevent emboli being released into the bloodstream during such procedures have been tried. One system uses a balloon to totally occlude the artery distal (downstream) to the area of blockage to be treated. In this system, a guidewire with a balloon is introduced into the narrowed or occluded area, and passes through the narrowed or occluded area to a position downstream of the blockage. The balloon is inflated, the blockage is reduced or removed, and then the blood proximal to the balloon is withdrawn from the blood vessel to remove any particles or emboli which have resulted from the reduction of the blockage. While this system has shown a decrease in emboli related complications in patients undergoing such treatments, the event rate remains significant. One particular problem with this system is passing the guidewire and balloon through the narrowed or occluded area prior to occlusion with the balloon, creating the risk that emboli will be produced as the balloon passes through the blockage. Thus, any particulate or plaque disturbed during this passage which forms emboli prior to inflation of the balloon is free to flow through the vascular system, increasing the risk for infarction or ischemia. Also, any debris or particulate matter which gathers around the edges of the balloon may slip downstream during deflation and retrieval of the balloon, addition, this system requires that blood flow be totally occluded in the vessel for relatively prolonged intervals that may induce adverse cardiac events. Although this may not be a problem clinically, many patients perceive the occlusion of blood flow for this period of time as problematic.
• Another system used to prevent emboli being released into the bloodstream during surgical intervention is a filter. As with the occlusion balloon, the filter must pass through the narrowed or occluded area and is deployed distal (downstream) to the blockage. The filter then catches any particulate material generated during the removal of the blockage. The filter offers the benefit that blood flow is not totally occluded. However, because the filter must pass through the blockage, it suffers from the same drawback as the previous system—risk of the creation of emboli during passage of the filter through the blockage. In addition, it is difficult to deploy the filter securely against the walls of the vessel to prevent flow around the filter and any debris or particulate matter which gathers around the edges of the filter may slip downstream during its retrieval. Also, in order to allow blood flow during the procedure, the pores of the filter should he at least 100 microns in diameter. The majority of emboli have a diameter between about 40 microns and about 100 microns. Thus, the filter will not catch the majority of emboli, which may flow downstream and cause an infarction or ischemia. The filter also cannot prevent the passage of certain neurohumoral or vasoactive substances which are released into the blood during the procedure and may contribute to generalized vasospasm of the distal coronary tree.
• Thus, there is a need for an improved system and method of treating occluded vessels which can reduce the risk of distal embolization during vascular interventions. There is also a need for a system which reduces the amount of time that total occlusion of the blood flow is necessary.
SUMMARY OF THE INVENTION
• In accordance with the invention, methods and apparatuses for reducing or removing a blockage within a vessel without permitting embolization of particulate matter are provided. The methods and apparatuses occlude blood flow for a minimal amount of time and capture particulate matter created during each step of the surgical process.
• According to one aspect of the invention, a method of treatment of a blood vessel is provided. The method includes advancing an evacuation sheath assembly into the blood vessel, prior to advancing a device across a stenosis to be treated, stopping normal antegrade blood flow in the blood vessel proximate to the stenosis, treating the stenosis while blood flow is stopped, and inducing retrograde blood flow within the blood vessel to carry embolic material dislodged during treating into the evacuation sheath assembly.
• According to another aspect of the invention, a method for treating a diseased blood vessel is provided. The method includes positioning a guide catheter proximate to the diseased blood vessel, positioning an evacuation sheath assembly within the diseased blood vessel, prior to advancing a device across a diseased area of the blood vessel, stopping normal antegrade blood flow in the blood vessel proximate to the diseased area, advancing a guidewire through the guide catheter and the evacuation sheath assembly across the diseased area of the blood vessel while the blood flow is stopped, causing retrograde flow of blood within the diseased blood vessel to remove embolic debris dislodged by advancement of the guidewire, advancing an interventional catheter into the blood vessel to treat the diseased area of the blood vessel, and causing retrograde flow of blood within the vessel to remove embolic debris dislodged by advancement of the interventional catheter.
• According to another aspect of the present invention, a method of performing a procedure on a blood vessel is provided. The method includes positioning a guide catheter proximate to the blood vessel, positioning an evacuation sheath assembly within the guide catheter, measuring pressure in the blood vessel to obtain a first pressure measurement, creating a seal between the evacuation sheath assembly and the blood vessel, measuring pressure in the blood vessel to obtain a second pressure measurement, and comparing the first and second pressure measurements.
• According to yet another aspect of the invention, a method of isolating fluid communication between a catheter and a blood vessel to facilitate visualization of the blood vessel is provided. The method includes advancing a catheter proximate to the blood vessel, advancing an evacuation sheath assembly including a sealing surface through the catheter and partially into the blood vessel, expanding the sealing surface to create a seal between the blood vessel and the evacuation sheath assembly thereby stopping normal blood flow in the vessel, and injecting contrast dye into the blood vessel while the normal blood flow is stopped.
• According to one aspect of the present invention, an evacuation sheath assembly is provided. The evacuation sheath assembly includes a tube having first and second lumens and first and second sealing surfaces, wherein, the first lumen is an evacuation lumen configured to be placed in fluid communication with a bloodstream and wherein the second lumen is an inflation lumen in fluid communication with at least one of the first and second sealing surfaces, and a shaft in fluid communication with the inflation lumen and configured to connect to an inflation source.
• According to another aspect of the invention, evacuation sheath assembly is provided. The evacuation sheath assembly includes an elongated tube defining an expandable evacuation lumen having a compressed delivery configuration and an expanded operational configuration, and a first sealing surface configured to form a seal within a catheter and a second sealing surface configured to form a seal with a blood vessel.
• According to yet another aspect of the present invention, a combination for isolating fluid communication between a blood vessel and a catheter is provided. The combination includes a catheter having a lumen, and an evacuation sheath assembly configured to move within the lumen of the catheter and having an evacuation lumen and first and second sealing surfaces.
• According to another aspect of the present invention, an evacuation sheath assembly comprises an elongated tube defining an evacuation lumen having proximal and distal ends, a proximal sealing surface at a proximal end of the tube configured to form a seal with a catheter, and a distal sealing surface configured to form a seal with a blood vessel.
• According to a further aspect of the present invention, an evacuation sheath assembly is provided. The evacuation sheath assembly includes an elongated tube defining an evacuation lumen having open proximal and distal ends and an inflation lumen having an open proximal end and a closed distal end, and a first sealing region on a proximal portion of the evacuation lumen and a second sealing region on a distal portion of the evacuation lumen, wherein at least one of the first and second sealing regions is in fluid communication with the inflation lumen, and wherein the first sealing region is expandable to a first diameter and the second sealing region is expandable to a second diameter different than the first diameter.
• According to another aspect of the present invention, an evacuation sheath assembly is provided and includes an elongated tube defining an inflation lumen and an expandable evacuation lumen having a compressed configuration and an expanded configuration, and a plurality of expandable surfaces along a length of the tube, wherein a most proximal expandable surface forms a proximal sealing surface and wherein a most distal expandable surface forms a distal sealing surface, and wherein expansion of the plurality of expandable surfaces expands the evacuation lumen from the compressed configuration to the expanded configuration.
• According to another aspect of the present invention, an evacuation sheath assembly is provided. The evacuation sheath assembly includes an elongated sheath defining an evacuation lumen having open proximal and distal ends, wherein the sheath is expandable from a delivery configuration to an operational configuration, a proximal hollow shaft connected to a proximal end of the sheath, and an actuation wire connected to a distal end of the sheath, the actuation wire being movable within said shaft from a distal position to a proximal position to expand said sheath.
• According to one aspect of the present invention, a method of treatment of a blood vessel is provided. The method includes advancing a guide catheter proximate to the blood vessel, advancing an evacuation sheath assembly through the guide catheter and into the blood vessel while retaining a proximal portion of the evacuation sheath assembly within the guide catheter, creating a first seal between the proximal portion of the evacuation sheath assembly and the guide catheter, creating a second seal between a distal portion of the evacuation sheath assembly and the blood vessel, stopping normal antegrade blood flow within the blood vessel, treating a stenosis within the blood vessel, causing retrograde flow within the blood vessel to thereby remove embolic material dislodged during the treating and carried by the retrograde flow into the evacuation sheath assembly, and re-establishing normal antegrade blood flow within the blood vessel.
• According to another aspect of the present invention, an evacuation sheath assembly is provided. The evacuation sheath assembly includes an elongated tube defining an expandable evacuation lumen having first a first delivery configuration and a second operational configuration, and a sealing surface on a distal portion of the evacuation lumen, the sealing surface having a non-sealing configuration that corresponds to the first delivery configuration and a sealing configuration that corresponds to the second operational configuration, wherein the sealing configuration is configured to create a seal with a blood vessel.
• According to another aspect of the present invention, an evacuation sheath assembly is provided. The evacuation sheath assembly includes an elongated tube defining an evacuation lumen having open proximal and distal ends and an inflation lumen having an open proximal end and a closed distal end, at least one inflatable sealing surface in fluid communication with the inflation lumen, and a soft steerable tip on a distal end of the elongated tube.
• According to yet another aspect of the present invention, an evacuation sheath assembly includes an elongated tube defining an evacuation lumen having open proximal and distal ends and an inflation lumen having an open proximal end and a closed distal end, and at least one inflatable sealing surface in fluid communication with the inflation lumen, wherein the open distal end of the evacuation lumen is angled.
• According to another aspect of the present invention, an evacuation sheath assembly is provided and includes an elongated tube defining an evacuation lumen having open proximal and distal ends and an inflation lumen having an open proximal end and a closed distal end, and first and second sealing surfaces on the tube, wherein the open proximal end of the evacuation lumen is angled.
• According to a further aspect of the present invention, an evacuation sheath assembly includes an elongated tube defining an evacuation lumen having open proximal and distal ends and an inflation lumen having an open proximal end and a closed distal end, and at least one inflatable sealing surface in fluid communication with the inflation lumen, wherein the evacuation lumen is shorter than the inflation lumen.
• According to another aspect of the invention, an evacuation sheath assembly is provided and includes an elongated tube defining an evacuation lumen having open proximal and distal ends and an inflation lumen having an open proximal end and a closed distal end, and at least one inflatable sealing surface in fluid communication with the inflation lumen, wherein a proximal portion of the evacuation lumen has a first diameter and a distal portion of the evacuation lumen has a second diameter larger than the first diameter.
• According to another aspect of the present invention, a method for treating a diseased blood vessel is provided. The method includes positioning a guide catheter within the ostium of a target vessel, advancing an evacuation sheath assembly through the guide catheter and beyond a major side branch of the target vessel, forming a first seal between the target vessel and a distal portion of the evacuation sheath assembly, forming a second seal between the catheter and a proximal portion of the evacuation sheath assembly, and advancing an interventional device through a lumen of the evacuation sheath assembly to treat the target vessel.
• Additional objects and advantages of the invention will be set forth in part in the description which follows, and in part will be obvious from the description, or may be learned by practice of the invention. The objects and advantages of the invention will be realized and attained by means of the elements and combinations particularly pointed out in the appended claims.
• It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the invention, as claimed.
BRIEF DESCRIPTION OF THE DRAWINGS
• The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate several embodiments of the invention and together with the description, serve to explain the principles of the invention. In the drawings,
• FIG. 1A is a cross-sectional side view of a partial length evacuation sheath according to one embodiment of the present invention;
• FIG. 1B is a cross-sectional view of the partial length evacuation sheath taken along line1B-1B ofFIG. 1A;
• FIG. 1C is a cross-sectional side view of an alternative embodiment of a partial length evacuation sheath according to one embodiment of the present invention;
• FIG. 1D is a cross-sectional view of the partial length evacuation sheath taken alongline1D-1D ofFIG. 1C;
• FIG. 2A is a cross-sectional side view of an expandable evacuation sheath, shown in an unexpanded state, according to another embodiment of the present invention;
• FIG. 2B is a cross-sectional view of the unexpanded expandable evacuation sheath taken alongline2B-2B ofFIG. 2A;
• FIG. 2C is a cross-sectional side view of the expandable evacuation sheath ofFIG. 2A in an expanded state;
• FIG. 2D is a cross-sectional view of the expanded expandable evacuation sheath taken along line2D-2D ofFIG. 2C;
• FIG. 2E is a cross-sectional view of the expanded evacuation sheath taken a long line2E-2E ofFIG. 2C.
• FIG. 3A is cross-sectional side view of a full-length evacuation sheath according to another embodiment of the present invention;
• FIG. 3B is cross-sectional view of the full-length evacuation sheath taken along line3B-3B ofFIG. 3A;
• FIG. 4A is cross-sectional side view of a guiding catheter/evacuation sheath combination according to yet other embodiment of the present invention;
• FIG. 4B is cross-sectional view of the guiding catheter/evacuation sheath combination taken along line4B-4B ofFIG. 4A;
• FIG. 5A is cross-sectional view of the partial evacuation sheath ofFIGS. 1A and 1B deployed within a vessel;
• FIG. 5B is cross-sectional view of the expandable evacuation sheath ofFIGS. 2A-2D deployed within, a vessel;
• FIG. 5C is cross-sectional view of the full-length evacuation sheath ofFIGS. 3A and 3B deployed within a vessel;
• FIG. 5D is cross-sectional view of the guiding catheter/evacuation sheath combination ofFIGS. 4A and 4B deployed within a vessel;
• FIGS. 6A-6I are cross-sectional views of the partial length evacuation sheath ofFIGS. 1A and 1B as employed in a method according to one aspect of the present invention;
• FIGS. 7A-7I are cross-sectional views of the expandable evacuation sheath ofFIGS. 2A-2D as employed in a method according to another aspect of the present invention;
• FIGS. 8A-8I are cross-sectional views of the full-length evacuation sheath ofFIGS. 3A and 3B as employed in a method according to a further aspect of the present invention;
• FIGS. 9A-9H are cross-sectional views of the guiding catheter/evacuation sheath ofFIGS. 4A and 4B as employed in a method according to yet another aspect of the present invention;
• FIG. 10A is a cross-sectional side view of another embodiment of an evacuation sheath assembly enclosed in a delivery sheath and being delivered through a guiding catheter;
• FIG. 10B is a cross-sectional side view of a braided sheath forming an evacuation head of the evacuation sheath assembly ofFIG. 10A in an unexpanded state with the delivery sheath removed;
• FIG. 10C is a cross-sectional side view of the braided sheath ofFIG. 10B in the expanded state; and
• FIG. 10D is cross-sectional view of the guiding/evacuation lumen of the evacuation sheath assembly ofFIGS. 10A-10C deployed within a blood vessel.
DESCRIPTION OF THE EMBODIMENTS
• Reference will now be made in detail to the present embodiments of the invention, examples of which are illustrated in the accompanying drawings. Wherever possible, the same reference numbers will be used throughout the drawings to refer to the same or like parts.
• The present invention provides a system and method for evacuating emboli, particulate matter, and other debris from a blood vessel, and particularly from an occluded blood vessel. As used herein, an “occlusion,” “blockage,” or “stenosis” refers to both complete and partial blockages of the vessels, stenoses, emboli, thrombi, plaque, debris and any other particulate matter which at least partially occludes the lumen of the blood vessel.
• Additionally, as used herein, “proximal” refers to the portion of the apparatus closest to the end which remains outside the patient's body, and “distal” refers to the portion closest to the end inserted into the patient's body.
• This method and apparatus are particularly suited to be used in diseased blood vessels that have particularly fragile lesions, or vessels whereby the consequences of even small numbers of small emboli may be clinically significant. Such blood vessels include diseased SVGs, carotid arteries, coronary arteries with thrombus, and renal arteries. However, it is contemplated that the method and apparatus can be adapted to be used in other areas, such as other blood vessels.
• As embodied herein and shown inFIG. 1A, anevacuation sheath assembly100 is provided.Evacuation sheath assembly100 includes an evacuation head and a shaft. As embodied herein and shown inFIG. 5A, theevacuation sheath assembly100 is sized to fit inside a guide catheter to advance a distal end of the evacuation sheath assembly into a blood vessel to treat a stenosis.
• Although described herein with respect to coronary artery intervention, it is contemplated thatevacuation sheath assembly100 may be suitable for use in other surgical procedures in other vessels, where reduction or removal of a blockage in a blood vessel is beneficial. Additionally, although the method of use of the evacuation sheath assembly will be described with respect to placing a stent within a vessel, theevacuation sheath assembly100 can be used during other therapies, such as angioplasty, atherectomy, thrombectomy, drug delivery, radiation, and diagnostic procedures.
• As shown inFIG. 1A, anevacuation head132 is provided.Evacuation head132 includes amulti-lumen tithe138. Themulti-lumen tube138 is preferably made of a relatively flexible polymer such as low-density polyethylene, polyurethane, or low durometer Pebax® material. Alternatively, themulti-lumen tube138 can be made of a composite polymer and metal material or from other suitable biocompatible materials exhibiting appropriate flexibility, for example. Themulti-lumen tube138 preferably includes first and second lumens. The first and preferably larger of the lumens, anevacuation lumen140, is designed to allow for the passage of interventional devices such as, but not limited to, stent delivery systems and angioplasty catheters. Theevacuation lumen140 is also designed to allow for fluid flow, such as blood, blood/solid mixtures, radiographic dye and saline, within theevacuation lumen140. This flow of fluid may occur regardless of whether an interventional device is within theevacuation lumen140. The proximal anddistal ends140a,140bof theevacuation lumen140 are preferably angled to allow for smoother passage of theevacuation sheath assembly100 through a guide catheter, and into a blood vessel, and to facilitate smoother passage of other therapeutic devices through theevacuation lumen140 of theevacuation head132. The larger area of the angled open ends also allows for larger deformable particulate matter to pass through the lumen more smoothly.
• The second and preferably smaller lumen of themulti-lumen tube138 is an inflation lumen142 (having an openproximal end142aand a closeddistal end142b) designed to provide fluid to inflate balloons on theevacuation head132. The fluid may be either gas or liquid in form.
• An alternative construction of themulti-lumen tube138 of theevacuation head132 is shown inFIG. 1C. Depending on the tortuosity of the curves of the guide catheter and the blood vessel through which theevacuation head132 is to be advanced, it may be desirable to incorporate a kink resisting structure. As embodied herein and shown inFIG. 1C, acoil139 may be embedded within themulti-lumen tube138. Acoil139 may be positioned on the inside surface defining theevacuation lumen140. Thecoil139 can be “wound-down” initially, then re-expanded to make contact with the inner surface ofevacuation lumen140. A covering of polyurethane can then be applied to contain thecoil139, and secure it in position withinevacuation lumen140. The polyurethane may be applied by a solvent casting of polyurethane in an appropriate solvent. Alternatively, the structure may be formed by coextruding the shaft tube together with a coil or braid or by other suitable means. A further alternative may include positioning the coil on the outer surface of themulti-lumen tube138.
• According to one aspect of the invention, the evacuation head includes at least one expandable sealing surface. As embodied herein and shown inFIG. 1A, two expandable sealing surfaces are provided. A first proximal sealing surface is configured to form a seal within the guide catheter which delivers theevacuation sheath assembly100 to the surgical site, as will be described. First proximal sealing surface is preferably aproximal sealing balloon134. A second distal sealing surface is configured to form a seal within the blood vessel, as also will be described. Second distal sealing surface is preferably adistal sealing balloon136. As shown inFIG. 1A, it is preferable that thedistal sealing balloon136 be larger in size than theproximal sealing balloon134. Theproximal balloon134 and thedistal balloon136 are in fluid communication with theinflation lumen142 ofevacuation head132.Inflation lumen142 is in fluid communication with a balloon inflation device199 (seeFIG. 5A). Although only asingle inflation lumen142 is shown, it is possible to use more than one inflation lumen. In such an embodiment, themulti-lumen tube138 would comprise three lumens, two inflation lumens, each one in fluid communication with one of the sealing balloons134,136, and one evacuation lumen. Each lumen would be in fluid communication with its own lumen extending proximally to an inflation device (not shown).
• Preferably, the proximal anddistal balloons134,136 are formed of an elastomer such as polyurethane or silicone. It is preferable to utilize elastomeric balloons, particularly for thedistal sealing balloon136, to allow the balloon to have a range of inflated diameters, depending on the volume of fluid infused into the balloon. Each sealingballoon134,136 includes two waist portions, one proximal134a,136aand one distal134b,136bof a body portion of the balloon. Thewaists portions134a,134b,136a,136bare preferably secured to an exterior of themulti-lumen tube138 using heat welding, solvent bonding, or other suitable adhesive bonding techniques.
• Although use of separate proximal and distal sealing balloons134,136 is preferred, it is possible to instead use a single elastomeric tube extending nearly the full length of themulti-lumen tube138. The single elastomeric tube would be secured to the outside of themulti-lumen tube138 at the distal and proximal ends140b,140aofevacuation lumen140, as well as in the middle region of theevacuation lumen140. In this manner, two expandable sealing surfaces are provided by the two regions of the single elastomeric tube which are not secured to the exterior of the shaft tube, i.e., the region between theproximal end140aand the middle region would form a proximal sealing surface, and the region between thedistal end140band the middle region would form a distal sealing surface.
• As embodied herein, theballoons134,136 may be blow molded from tubing or dip molded to approximate the shape and minimum anticipated diameter of their final inflated condition. Particularly for thedistal sealing balloon136, further inflation would further increase the diameter, as the balloon is preferably elastomeric. Alternatively, however, the balloons need not be pre-molded to the expanded shape. In such a variation, eachballoon134,136 is preferably a uniform diameter tube between the twoballoon waists134a,134b,136a,136b.As the uniform diameter tubes are preferably elastomeric materials, they can be elastically expanded to the same shape and size as the alternative pre-molded balloons. The non-pre-molded balloons would require a higher inflation pressure to expand to a particular dimension. Furthermore, the non-pre-molded elastomeric balloons would deflate more easily, as the elasticity would help to force the inflation fluid from the interior of the balloons. To improve the range of expandability of the elastomeric balloons, it is preferable for the body portion of eachballoon134,136 to have a length at least as great as the maximum inflated diameter, and more preferably several times longer, for example about 3-4 times longer.
• While it is preferred to provide the two expandable sealing surfaces of twoelastomeric balloons134,136, as described above, it is possible to fabricate theproximal sealing balloon134 of a non-elastomeric polymer molded to the shape and size as shown inFIG. 1A. Since theproximal balloon134 is intended to be inflated within the guide catheter, it is only necessary for theproximal balloon134 to be inflated against the internal diameter of the guide catheter. Thedistal sealing balloon136, however, preferably has a relatively wide range of expanded diameters, and therefore benefits from being elastomeric. Additionally, if thedistal sealing balloon136 is elastomeric, and theproximal sealing balloon134 is fabricated of a pre-molded thin-walled polymer such as PET or nylon, and if both balloons are inflated from acommon inflation lumen142, then theproximal sealing balloon134 will expand against the internal surface of the guide catheter, causing a seal, prior to any significant expansion of thedistal sealing balloon136 beyond its initial dimension.
• As discussed earlier, theevacuation sheath assembly100 is configured to be used with a guiding catheter160 (seeFIGS. 6A and 6A). The guidingcatheter160 performs an evacuation function in combination with theevacuation lumen140. The guidingcatheter160 also maintains a contrast delivery function. Theevacuation head132, with its two sealingballoons134,136 inflated, is intended to isolate fluid communication of the internal lumen of theguide catheter160 to theblood vessel150 in which it is inserted. Preferably, proximal and distalradiopaque markers146a,146bare placed at the site of eachballoon134,136. Alternatively, two markers may be placed proximally and distally adjacent to eachballoon134,136. The proximal and distalradiopaque markers146a,146ballow the operator to radiographically position the two sealingballoons134,136 in the proper location within the guidingcatheter160 and theblood vessel150.
• In use, thedistal balloon136 is intended to be positioned distal of the distal tip of a guidingcatheter160 and inflated against the inside surface of theblood vessel150 causing a fluid tight seal between theblood vessel150 and theballoon136. Theproximal balloon134 is intended to be positioned proximal of the distal end of the guidingcatheter160 and inflated against the guidingcatheter160 causing a fluid tight seal.
• The preferred inflated diameters of the sealing balloons134,136 are thus determined by the intended application. For example, if theevacuation sheath assembly100 is intended to be used in a diseased saphenous vein bypass graft, (SVG), a guiding catheter of 8 French may be utilized. Theproximal sealing balloon134 will therefore require an inflated diameter capable of sealing against the inside of the guiding catheter, typically in the range of about 0.088-0.096 inches. Thedistal sealing balloon136 will need to be capable of sealing against the inside of the SVG, which typically has an inside diameter ranging from about 2.5-6 mm.
• The length of theevacuation head132 is dependent on the application for which theevacuation sheath assembly100 is intended to be used. It is intended that theevacuation head132 be long enough for theproximal sealing balloon134 to be sealingly inflated within theguide catheter160, and thedistal sealing balloon136 to be sealingly inflated within the blood vessel of interest. In many applications, therefore,evacuation head132 can be relatively short. For example, in the case of an SVG application, this length may be on the order of 2 to 5 cm. However, in a native coronary artery application, particularly in the left coronary circulation, it may be desired to have theevacuation head132 longer, such that thedistal sealing balloon136 is positioned beyond the first or other main bifurcation. For example, it may be desired to position thedistal sealing balloon136 within the left anterior descending artery, distal of the left main artery. For this application, theevacuation head132 is preferably about 5 to about 20 cm in length.
• The diameter of theevacuation head132 is also dependent on the intended application. As an example, preferred dimensions are described here with respect to an application in SVGs, with use of an 8 French guide catheter whose inner diameter is about 0.090 inches. Theevacuation lumen140 may be approximately 0.061 inches, which will allow the passage of most therapeutic devices such as angioplasty catheters, stent delivery catheters, atherectomy catheters, drug delivery catheters, etc. Theinflation lumen142 may have a dimension of about 0.005 inches at the widest portion of the crescent (vertical direction inFIG. 1B). The wall thickness for most of themulti-lumen tube wall138 may be about 0.002 inches, and the balloon waist thickness may be approximately 0.002 inches. These dimensions create anevacuation head132 having a maximum diameter (in delivery condition) of about 0.076 inches, less than the inner diameter of theguide catheter160.
• According to another aspect of the invention, theevacuation sheath assembly100 includes a shaft. As embodied herein and shown inFIG. 1A, the shaft includes aproximal shaft portion110, anintermediate shaft portion120, and a distal shaft portion130 (not shown inFIG. 1A, shaft portion130 includes evacuation head132).
• Proximal shaft portion110 forms a hollow tube. Preferably,proximal shaft portion110 is made of stainless steel, however, other structures and materials, such as polymer and metallic composites, (e.g., braid reinforced polymer tubes), nickel-titanium alloy, or other suitable materials exhibiting appropriate biocompatibility and flexibility properties may be used. Theproximal shaft portion110 provides fluid communication between an inflation apparatus (not shown) and the intermediate anddistal shaft portions120,130. Theproximal shaft portion110 may also be coated with a polymer sleeve or spray coating for lubricity.
• Preferably, theproximal shaft portion110 includesmarkers115 on its exterior surface. Thesemarkers115 are positioned to indicate to a user that theevacuation sheath assembly100 has been advanced through the guidingcatheter160 to a location where the distal end of theevacuation sheath assembly100 is just proximal to the distal end of the guidingcatheter160. Theproximal shaft portion110 is preferably secured to aluer hub105, for example by an overlapping weld or adhesive bond joint. Theluer hub105 allows theevacuation sheath assembly100 to be connected to an inflation apparatus for the inflation of the sealing balloons134,136. Any suitable inflation device may be used, including those resident in hospital cath labs.
• Anintermediate shaft portion120 is secured to the proximal anddistal shaft portions110,130, preferably by an overlapping weld or bond joint.Intermediate shaft portion120 forms a hollow tube.Intermediate shaft portion120 is preferably formed of polyethylene or Pebax, however, other polymers and polymer metallic composites, such as polyimide with an incorporated braid of stainless steel wire, or other suitable material exhibiting appropriate biocompatibility and flexibility characteristics, may be used. Theintermediate shaft portion120 provides fluid communication between theproximal shaft portion110 and the distal shaft portion130. Theintermediate shaft portion120 also transmits longitudinal force from theproximal shaft portion110 to the distal shaft portion130. Theintermediate shaft portion120 is preferably more flexible than theproximal shaft portion110, to allow navigation of the curves within the distal region of the guiding catheter, as are often present, particularly in cardiac related applications.
• A distal end of theintermediate shaft portion120 is connected to a distal shaft portion130, preferably by welding or bonding. Distal shaft portion130 includes theinflation lumen142 ofmulti-lumen tube138 and a softdistal tip portion144. As shown inFIG. 1A, theinflation lumen142 is in fluid communication with theproximal shaft portion110 andintermediate shaft portion120. The distal end ofinflation lumen142 ends in a solid portion forming the distal end of the distal shaft portion130. The distal end of the distal shaft portion130 is tapered to formsoft tip144. Thesoft tip144 may comprise a more flexible polymer secured to the distal end of themulti-lumen tube138 of theevacuation head132. For example, if themulti-lumen tube138 is fabricated of high density polyethylene, thesoft tip144 may be fabricated of a low durometer polyurethane or Pebax. Thesoft tip144 allows theevacuation sheath assembly100 to be placed atraumatically into the blood vessel, even if the blood vessel exhibits tortuosity.
• The shaft of the evacuation sheath assembly preferably includes astiffness transition member135.Stiffness transition member135 is attached to the distal end of theproximal shaft portion110, for example by welding or bonding. Thestiffness transition member135 is preferably made of stainless steel, but other metals such as nickel titanium alloy or polymers may be used. Thestiffness transition member135 is located co-axially in the inflation lumen142 (as shown inFIG. 1B) and extends from theproximal shaft portion110 to thesoft tip144. Adistal end137 of thestiffness transition member135 preferably includes a spring tip embedded into the material of thesoft tip144. Embedding the spring tip into thesoft tip144 allows thestiffness transition member135 to prevent longitudinal stretching or compressing of theevacuation sheath assembly100.
• Alternatively, thedistal end137 of thestiffness transition member135 can have an enlarged welded ball or other shape which can serve to mechanically interlock thestiffness transition member135 within thesoft tip144. The portion of thestiffness transition member135 within thetip144 of theevacuation sheath assembly100 also serves to allow the tip to be formed in a “J-bend”, similar to that for coronary guide wires. Thestiffness transition member135 can then transfer rotational forces and motion imparted from the proximal region of theevacuation sheath assembly100 to thetip144, to facilitate steering and navigation of theevacuation head132 to a desired site in the blood vessel.
• The stiffness transition member's bending stiffness decreases gradually from the proximal end to the distal end of thestiffness transition member135. Preferably, this is accomplished by reducing the cross sectional area of themember135 as shown inFIG. 1A, wherestiffness transition member135 includes three portions of decreasingdiameter135a,135b,135cfrom proximal to distal end. However, this can also be accomplished by changes in shape and/or materials. Thestiffness transition member135 allows for a gradual stiffness reduction in theevacuation sheath assembly100, which allows it to more smoothly navigate the curves of the guiding catheter and the blood vessel. This shaft construction is exemplary only, and is not intended to limit the invention.
• As mentioned, although described herein with respect to stent placement in an SVG or coronary artery having a stenosis,evacuation sheath assembly100 may be used in other surgical procedures and with other therapeutic devices, such as balloon angioplasty, atherectomy, thrombectomy, drug delivery, radiation, and diagnostic procedures.
• As embodied herein and shown in simplified drawingFIG. 6A, the lumen of ablood vessel150 is accessed with the distal end of a guidingcatheter160, which is well known in the art and typical for coronary-type procedures. Acoronary guide wire170 then is advanced to a location just proximal to the distal tip of the guidingcatheter160. Blood flow at this point remains in the direction of normal arterial blood flow. The blood is flowing around and past the distal tip of the guidingcatheter160 and through thestenosis180 as indicated byarrows190.
• As shown inFIG. 6B, theevacuation sheath assembly100 then is advanced over theguide wire170 and positioned within thevessel150 with the distalradiopaque marker146bdistal of the distal tip of the guiding catheter160 (i.e., within the vessel150) and theproximal marker146aproximal of the distal tip of the guiding catheter160 (i.e., within catheter160), as determined through appropriate imaging techniques known in the art. Alternatively, theguide catheter160 may be positioned within the ostium of the target vessel, and theevacuation sheath assembly100 may be advanced through the catheter and beyond a major side branch of the target vessel.
• Blood flow continues to be in the direction of normal arterial blood flow as shown byarrows190. Because theassembly100 has as relativelyshort evacuation head132, the entireevacuation sheath assembly100 can be advanced over a conventional lengthcoronary guide wire170 after theguide wire170 has been placed within theguide catheter160.
• Once theevacuation head132 is positioned with its distal end within thevessel150 while its proximal end remains in thecatheter160, the distal and proximal sealing balloons136,134 are inflated as shown inFIG. 6C. Thedistal sealing balloon136 provides a fluid tight seal between the sealingballoon136 and theblood vessel150 and theproximal sealing balloon134 provides a fluid tight seal between the sealingballoon134 and the interior diameter of the guidingcatheter160. Asuitable valve184, such as a touhy borst valve, attached to the guiding catheter160 (shown inFIG. 5A) provides a fluid tight seal against theguide wire170 and theproximal shaft portion110 of theevacuation sheath assembly100. The three fluid tight seals establish fluid communication between the distal end of theevacuation sheath assembly100 and a fluid collection chamber, filter, andvacuum source188, which is attached to the Y-adaptor (conventional)184 shown inFIG. 5A. Ablood pressure transducer192 is commonly connected in fluid communication with the lumen of the guide catheter160 (through additional stop cocks or manifolds as is well-known in the art) to monitor arterial blood pressure. As the sealing balloons134,136 are inflated to establish the fluid communication of the evacuation sheath assembly and guidecatheter160 with the collection chamber, filter, andvacuum source188, the blood pressure waveform can be observed to change from a relatively high pressure and pulsatile waveform of the artery, to a relatively low and constant waveform of the venous pressure. This pressure observation is an important indicator that the sealingballoons134,136 have effectively isolated fluid communication to the coronary artery. With the three fluid tight seals in place, a normal antegrade flow within the artery is stopped. Thus, there is substantially no blood flow within thevessel150, as indicated by the lack of arrows inFIG. 6C.
• At this point, it may be desirable to inject a small amount of contrast into the blood vessel, via adye injection apparatus189 in fluid communication with theguide catheter160,evacuation head132, andblood vessel150, to aid in navigation of theguide wire170 across thestenosis180. Theevacuation lumen140 of theevacuation head132 becomes an extension of the guide catheter lumen for this contrast delivery. Because normal antegrade blood flow in the coronary artery has been effectively stopped, the contrast will remain in the coronary artery, rather than quickly washing away. This may be advantageous for the subsequent navigation of theguide wire170.
• Once antegrade flow is stopped, as shown inFIG. 6C, theguide wire170 is advanced across thestenosis180. In most cases, to begin advancing theguide wire170, the touhy borstvalve184 on the Y-adaptor (shown inFIG. 5A) will need to be opened just enough to allow for movement of thewire170, but not so much to allow vigorous backbleeding. In the procedure described here, it is preferred to open the valve only enough such that there is little to no backbleeding, otherwise the venous pressure head in the coronary artery can cause retrograde flow during this step, thereby pushing all of the contrast back into the guide catheter and out of the blood vessel.
• Once the wire has crossed thestenosis180, it may be desirable to cause retrograde flow in the coronary artery (FIG. 6D), as the act of crossing astenosis180 with a wire170 (particularly a fragile lesion (stenosis), such as in an SVG) may in itself dislodge material. Any material dislodged will not travel downstream, as the antegrade flow has already been stopped. Retrograde flow can be used to remove the dislodged material.
• With all seals in place, blood flow may now be established from the distal end of theevacuation head132 to the collection chamber, and filter188 to remove any dislodged material. Retrograde flow is represented inFIG. 6D byarrows195. This retrograde flow is due to the venous pressure head, and will begin once the pressure in thecollection bottle188 is vented to atmospheric pressure. Flow can also be increased by applying vacuum to the collection chamber andfilter188. This retrograde flow will carry any dislodged material out of the patient arid into a collection chamber. The collection chamber may be a simple syringe or may be any other suitable container. If a syringe is used, withdrawal of the plunger automatically causes a vacuum to induce retrograde flow. After enough volume has been removed, the flow can be stopped by closing the valve to atmosphere pressure or by releasing the vacuum. If desired, after any dislodged material has been removed, theballoons134,136 of theevacuation sheath assembly100 may be temporarily deflated, allowing for a period of antegrade blood flow and perfusion of thevessel150.
• After any dislodged material has been removed, and after normal antegrade blood flow has been allowed, if so desired, all seals are again established. With all seals in place, a therapeutic device such as astent delivery system193 is advanced across thestenosis180 with antegrade flow stopped, as shown inFIG. 6E. The touhy borstvalve184 attached to theguide catheter160, which is shown inFIG. 5A, seals against the proximal end of the therapeutic device, theguide wire170 and theproximal shaft portion110 of theevacuation sheath assembly100. Alternatively, advancement of the delivery system may be done with retrograde flow. In a step similar to that for the guide wire advancement, some contrast may be delivered into the vessel, allowing continuous visualization of the vessel and stenosis for more precise placement of thestent delivery catheter193. Again, to effectively keep the contrast in place, the touhy borstvalve184 through which thestent delivery catheter193 passes must be opened just enough to allow for advancement of the device with little to no backbleeding.
• Once thestent delivery system193 is accurately positioned adjacent thestenosis180, a stent delivery balloon is inflated to expand astent194 against the vessel wall, opening a passage for blood flow through the stenosis180 (FIG. 6F). During inflation of the stent balloon, retrograde flow (if present) is discontinued by the occlusion of the blood vessel by the therapeutic device and the stoppage of any applied vacuum.
• After thestent194 is applied to thestenosis180, the stent delivery balloon is deflated and retrograde flow is re-established in thevessel150. Anyembolic material197 dislodged from the therapeutic site is carried back to theevacuation lumen140 of theevacuation head132 by the retrograde flow195 (FIG. 6G). Theembolic material197 may include material dislodged during advancement of the therapeutic device, or during the expansion of thestent194, in the case where the therapeutic device includes astent194. To remove this potentiallyembolic debris197, theretrograde flow195 is re-established when the therapeutic device is no longer occluding the blood flow, and additional vacuum is preferably applied to theevacuation lumen140. The therapeutic device may be left in place while there is retrograde flow, or it may be positioned proximal to thestenosis180, or even brought back within the lumen of theguide catheter160. In some instances, once the particulate197 has been removed, additional contrast delivery to the blood vessel may indicate a need for more therapeutic steps, e.g., further dilation of the stent with the balloon. In this case, it is more convenient to have the balloon catheter already in position for any subsequent use.
• After the embolic material is removed, the therapeutic device is removed from the vessel150 (retrograde flow may or may not be maintained) (FIG. 6H). The distal and proximal sealing balloons136,134 are then deflated (FIG. 6I), establishing normal arterial flow.
• According to another aspect of the present invention, the diameter of an evacuation head may be expandable from a first introduction diameter to a second operational diameter. As embodied herein and shown inFIGS. 2A-2D, anevacuation sheath assembly200 is provided with anexpandable evacuation head232. Many of the elements present in the previous embodiment are also shown inFIGS. 2A-2D and where these elements are substantially the same, similar reference numerals have been used and no detailed description of the element has been provided.
• As shown inFIG. 2B, theevacuation head232 preferably includes aninner layer226 that will serve as an evacuation lumen and anouter layer228 that will serve as the sealing surfaces. Preferably, theinner layer226 is fabricated from polyethylene PET or Pebax, but other suitable materials may be used. Theevacuation head232 has aproximal end232aand adistal end232b.FIGS. 2A and 2B show theevacuation head232 in an unexpanded state andFIGS. 2C,2D, and2E show theevacuation head232 in an expanded state. Theinner layer226 of theevacuation head232 preferably comprises a tube that unfolds to increase in diameter. InFIG. 2C, the increase in diameter assumes a step-wise shape. Thus, preferably, a distal portion of theinner layer226 of the evacuation head has an expanded diameter which is larger than a diameter of aguide catheter260.
• The expanded shape of theinner layer226 of theexpandable evacuation head232 may include a proximal portion having a first diameter and a distal portion having a second diameter, the second diameter being larger than the first such that theinner layer226 of theevacuation head232 has a larger dimension in the region which resides within the blood vessel, as shown inFIG. 2C. Alternatively, the diameters of the proximal and distal portions of theinner layer226 of theevacuation head232 may be the same, such that the diameter of an expandedinner layer226 is the same for the region outside of the guide catheter as the region which resides within the guide catheter. In such an embodiment, it would be necessary to provide the distal portion of theevacuation head232 with a larger or more expansible outer layer, i.e., sealing surface (distal sealing balloon), to ensure a proper seal withblood vessel250.
• The distal and proximal ends of the expandedevacuation head232 may be angled relative to its longitudinal axis, as discussed with respect to the embodiment shown inFIG. 1A, although this is not shown inFIGS. 2A-2D. The low profile folded delivery state of theevacuation head232 may not require such angles. Furthermore, if the distal end of thehead232 is not angled relative to the longitudinal axis, the entire open distal end of theexpandable evacuation head232 is suitable for positioning close to the desired therapy site.
• Theouter layer228 of evacuation head includes multiple spherical balloons (or balloon regions)233, including a proximalmost balloon234 and a distalmost balloon236, with a cylindrical waist between each balloon. The inner andouter layers226,228 of theevacuation head232 may be seam welded or bonded together around the circumference at each waist location, while theinner layer226 is in its expanded condition. Prior to insertion of theevacuation sheath assembly200 into theguide catheter260, theevacuation head232 is folded into its unexpanded condition, as shown inFIGS. 2A and 2B. When fluid, either a gas or liquid, is infused between the inner and outer layers, theouter layer228 expands radially. As theouter layer228 expands intomultiple balloon regions233, it pulls theinner layer226 with it, opening theevacuation lumen240. Thus, the inner and outer layers expand together in the radial direction when inflated.
• As discussed with respect to the embodiment shown inFIGS. 1A-1C, theevacuation head232 comprises a multi-lumen tube238 having anevacuation lumen240 and aninflation lumen242. As in the embodiment shown inFIGS. 1A-1C, theinflation lumen242 is in fluid communication with intermediate andproximal shaft portions210,220 and is in fluid communication with theindividual balloon segments233,234,236, such that when fluid is infused intoinflation lumen242, theevacuation head232 expands. Further infusion of fluid into the inflation lumen of the evacuation sheath assembly will inflate the distal and proximal sealing balloons until they are appropriately sized to cause effective sealing.
• As described previously, in addition tointermediate balloons233, theevacuation head232 includes aproximal sealing balloon234 and adistal sealing balloon236. The proximal sealing balloon is configured to seal with an inner diameter of theguide catheter260 and the distal sealing balloon is configured to seal with the inner walls ofblood vessel250. The remainingballoons233 need only be sized to an inflated diameter sufficient to “pull” open theinner layer226 of theexpandable evacuation head232. Although threeintermediate balloons233 are shown inFIG. 2C, more or fewer balloons may be provided as appropriate, for example depending upon the length of the evacuation head to be expanded. Althoughintermediate balloons233 are intended to “pull”open evacuation lumen240 of theevacuation head232, balloons233 may also provide addition sealing under certain circumstances, as shown inFIG. 2C. However, it is less important that the remainingballoons233 be elastomeric, as they do not necessarily require a range of expanded diameters.
• As shown inFIGS. 2A and 2B, prior to insertion into theguide catheter260, theevacuation head232 is folded into a reduced diameter configuration. As illustrated, this folding may be in a generally “w” type fold; however other folding configurations are contemplated, such as “s” folds or “c” folds. It is also preferable to heat set the foldedevacuation head232 in this configuration. Because the evacuation head has been heat set in a folded configuration, once the sealing balloons and remaining balloons are deflated after a procedure, the evacuation head will refold toward its pre-expanded configuration.
• The low profile of theevacuation head232 in its delivery configuration and thesoft tip244 at the end ofevacuation sheath assembly200 allow the expandableevacuation sheath assembly200 to be passed through smaller and more tortuous lumens and blood vessels. Theexpandable evacuation lumen240 also allows theevacuation sheath assembly200 to be sized more closely to the guidingcatheter260 and larger than the guidingcatheter260 in the portion that is placed distal of the guiding catheter when it is in the expanded state. This larger lumen allows for high evacuation flow rates, and eases the ability for large particles to be removed from the blood vessel during or subsequent to the therapeutic procedure, while having a relatively small collapsed delivery condition.
• In use, theevacuation sheath assembly200 is deployed in a similar manner as discussed with respect toevacuation sheath assembly100. The steps for usingevacuation sheath assembly200 with aguide catheter260 in avessel250 are sequentially depicted inFIGS. 7A-7I.
• As shown inFIG. 7A, guidecatheter260 andguide wire270 are advanced proximate to ablood vessel250. Subsequently,evacuation sheath assembly200, withevacuation lumen240 in its delivery configuration, is advanced over theguidewire270 intoguide catheter260 and blood vessel250 (FIG. 7B). Onceevacuation head232 is properly positioned, as can be verified usingproximal markers115 andmarkers246a,246b,evacuation head232 is expanded (FIG. 7C) untilevacuation lumen240 is open. Fluid continues to be injected into the balloons untilproximal balloon234 creates a seal with the lumen ofguide catheter260 and untildistal balloon236 creates a seal withblood vessel250. After the proper seals are established, thestenosis280 is treated and anyembolic debris297 is removed via retrograde flow295 (FIGS. 7C-7H), as previously described with respect toFIGS. 6C-6H. After treatment,evacuation head232, including proximal and distal sealing balloons234,236, is deflated and then removed from blood vessel250 (FIG. 7I).
• According to another aspect of the present invention, the evacuation head may comprise an elongated multi-lumen tube. As embodied herein and shown inFIGS. 3A and 3B, anevacuation sheath assembly300 is provided with anevacuation head332. Many of the elements present in the previous embodiments are also shown inFIGS. 3A and 3B and where these elements are substantially the same, similar reference numerals have been used and no detailed description of the element has been provided.
• As shown inFIG. 3A,evacuation head332 includes a single elongatedmulti-lumen tube338. The size of thetube338 allows it to be placed through a guidingcatheter360 and into a blood vessel370 (seeFIG. 5C). The tube may be made from a polymer such as polyethylene or Pebax® material or materials described with respect toFIG. 1A. In addition, thetube338 may include a coil or braid, as inFIG. 1C, in all or only portions of the tube. Themulti-lumen tube338 includes twolumens340,342. The larger of the lumens, theevacuation lumen340, is designed to allow for the passage of interventional devices such as, but not limited to stent delivery systems and angioplasty catheters. The lumen is also designed to allow for fluid flow, such as blood, blood/solid mixtures, radiographic dye and saline, within the lumen as discussed with respect toFIGS. 1A-1C.
• A distal end of thetube338 is tapered into asoft tip344, as described in connection with previous embodiments. Thesoft tip344 allows theevacuation sheath assembly300 to be placed more smoothly into the blood vessel. Thetube338 includesinflation lumen342, which allows for fluid communication between the proximal end of theevacuation sheath assembly300 and an expandable sealing surface. The elongatedmulti-lumen tube338 defines theentire evacuation lumen340, unlike the devices shown inFIGS. 1A-2D which make use of a significant length of the lumen of the guide catheter for evacuation. For this reason, only a single expandable sealing surface is required.
• The expandable sealing surface is preferably adistal sealing balloon336.Distal sealing balloon336 may comprise an elastomeric material such as polyurethane or silicone. Thedistal sealing balloon336 is configured be positioned distal of the distal tip of a guidingcatheter360 and inflated against theblood vessel350 causing a fluid tight seal between theblood vessel350 and theballoon336.Radiopaque marker346 is preferably placed at the site of the sealingballoon336. Theradiopaque marker346 allows the operator to radiographically position the sealingballoon336 in the proper location within theblood vessel350. A proximal shaft portion310 of theevacuation sheath assembly300 is sealed against avalve384, such as a touhy borst valve, on theguide catheter360 creating a fluid tight seal against theevacuation sheath assembly300 and the guidingcatheter360.
• Thetube338 includesproximal markers315 placed on the exterior of the proximal portion of thetube338. Thesemarkers315 are positioned to indicate that thetube338 has been advanced through the guidingcatheter360 to a location where the distal end of theevacuation sheath assembly300 is just proximal to the distal end of the guidingcatheter360. A proximal portion of thetube338 is secured to abifurcated luer hub305 by an overlapping weld or bond joint. The bifurcated luerhub305 includes aninflation port302 and avacuum port303 which allows theevacuation sheath assembly300 to be connected to an inflation apparatus and a vacuum source, respectively.
• In use, theevacuation sheath assembly300 is deployed in a similar manner to that discussed with respect toevacuation sheath assembly100. The steps of usingevacuation sheath assembly300 with aguide catheter360 in avessel350 are sequentially depicted in FIGS.8A-8I. The differences between the method discussed with respect toevacuation sheath assembly100 and that forevacuation sheath assembly300 are discussed below.
• Because the lumen inevacuation sheath assembly300 runs the full length ofevacuation sheath assembly300, theevacuation sheath assembly300 should be inserted together with thecoronary guide wire370. Also, because the lumen of theguide catheter360 is more fully obstructed by thisevacuation sheath assembly300, it is preferable to inject contrast directly into the proximal end of theevacuation lumen340 of the evacuation sheath assembly300 (or into bothlumen340 and the lumen of guide catheter360), rather than just into the lumen of thecatheter360. Also, both the guide catheter lumen and theevacuation lumen340 can be used for pressure monitoring, although it is more desirable to use theevacuation lumen340 for pressure monitoring to confirm a tight seal between thedistal balloon336 andblood vessel350 as needed. As opposed to the earlier discussed embodiments, only onesealing balloon336 is used to provide the seal in theevacuation sheath assembly300, as shown inFIGS. 8C-8H.
• Thus, as shown inFIG. 8A, guidecatheter360 is positioned withinblood vessel350. Thenevacuation sheath assembly300 is advanced withguidewire370 into blood vessel350 (FIG. 8B). Proper positioning of a distal end ofevacuation sheath assembly300 may be confirmed usingdistal marker346. Thendistal sealing balloon336 is inflated viainflation port302, stopping blood flow withinblood vessel350. If desired, contrast dye may be injected throughevacuation lumen340 intoblood vessel350 to viewblood vessel350 prior to treatingstenosis380.Stenosis380 is then treated and anyembolic debris397 is removed viaretrograde flow395 through evacuation lumen340 (FIGS. 8C-8H), as previously described with respect toFIGS. 6C-6H. After treatment,distal sealing balloon336 is deflated andevacuation sheath assembly300 is removed from blood vessel350 (FIG. 8I).
• According to another aspect of the present invention, the evacuation sheath assembly may comprise an elongated multi-lumen tube which eliminates the need for a separate guiding catheter. As embodied herein and shown inFIGS. 4A and 4B, an evacuation/guidingsheath assembly400 is provided with an evacuation/guiding lumen440. Many of the elements present in the previous embodiments are also shown inFIGS. 4A and 4B and where these elements are substantially the same, similar reference numerals have been used and no detailed description of the element has been provided.
• As shown inFIG. 4A, evacuation/guidingsheath assembly400 includes a single elongatedmulti-lumen tube438. The size of thetube438 allows it to be used as a combination guiding catheter and evacuation lumen, to deliver interventional devices into ablood vessel450. Themulti-lumen tube438 is preferably formed of a Pebax®, stainless steel and Teflon® composite material, very similar to conventional guide catheters, well known in the art, with the exception that an additional lumen in the wall of the tube is provided.Tube438 can be made of other suitable polymers and metal materials. Themulti-lumen tube438 includes first and second lumens. The larger of the lumens, the evacuation/guiding lumen440, is designed to allow for the passage of interventional devices such as, but not limited to, stent delivery systems and angioplasty catheters. Thelumen440 is also designed to allow for fluid flow, such as blood, blood/solid mixtures, radiographic dye and saline, within the lumen. This flow of fluid is allowed with or without an interventional device in the evacuation/guiding lumen440.
• Thetube438 can be pre-formed in various curvatures during manufacturing to allow for easy access to the ostium of several different blood vessels in a manner similar to conventional guide catheters as known in the art. Note thatFIGS. 4A and 4B do not show these pre-formed curves. The distal end of thetube438 is preferably fitted with a more flexible material, forming a softdistal tip444. Thisflexible tip444 allows the evacuation/guiding lumen440 to be placed more smoothly into the blood vessel. Thetube438 also contains aninflation lumen442, which allows for fluid communication between a proximal end of the evacuation/guidingsheath assembly400 and an expandable sealing surface on a distal end of the evacuation/guidingsheath assembly400.
• Preferably, the expandable sealing surface is aninflatable sealing balloon436. The sealingballoon436 is preferably elastomeric and may comprise polyurethane or silicone, similar to that of the distal sealing balloon ofFIGS. 1A-1C. The sealingballoon436 is intended to be positioned distal of the ostium of theblood vessel450 and inflated against theblood vessel450 causing a fluid tight seal between theblood vessel450 and theballoon436.Radiopaque markers446 are preferably placed at the site of the sealingballoon436 to allow radiographically verifying the position of the sealingballoon436. The proximal portion of thetube438 is sealed against an interventional device by a bifurcated touhy borstvalve484 attached to the evacuation/guidingsheath assembly400 to create a fluid tight seal against the evacuation/guidingsheath assembly400 and the interventional device.
• A proximal portion of thetube338 is secured to the bifurcated touhy burst luerhub484 by an overlapping weld or bond joint. The bifurcated luer hub allows the evacuation sheath assembly to be connected to an inflation apparatus and a vacuum source through aninflation port402 and avacuum port403, respectively.
• The steps of using evacuation/guidingsheath assembly400 are sequentially depicted in simplifiedFIGS. 9A to 9H. Use of evacuation/guidingsheath assembly400 is similar to the method described with respect toevacuation sheath assembly100. The differences between the method discussed with respect toFIGS. 6A-6I and that for evacuation/guidingsheath assembly400 are discussed below.
• The lumen of theblood vessel450 is accessed with thedistal tip444 of the evacuation/guidingsheath assembly400. Aguide wire470 is advanced to a location just proximal to thedistal tip444 of the evacuation/guiding sheath assembly400 (FIG. 9A). Blood flow at this point remains in the direction of normal arterial blood flow as shown byarrows490. The evacuation/guidingsheath assembly400 is then positioned with thedistal marker band446 distal of the ostium of theblood vessel450. Once the positioning of thedistal tip444 of the evacuation/guidingsheath assembly400 is verified, thedistal sealing balloon436 is inflated as shown inFIG. 9B to stop normal antegrade flow. Thedistal sealing balloon436 provides a fluid tight seal between the sealingballoon436 and theblood vessel450. Alternatively, thedistal sealing balloon436 may be shaped such that it seals against the aortal surface and the most adjacent portion of the coronary ostium (not shown).
• A touhy borstvalve484 attached to the evacuation/guiding sheath assembly400 (shown inFIG. 5D) provides a fluid tight seal around theguide wire470. The two fluid tight seals establish fluid communication between the distal end of the evacuation/guidingsheath assembly400 and a fluid collection chamber, filter, andvacuum source488, which is attached to the bifurcation lumen of the touhy borstvalve484 shown inFIG. 5D, and stop normal antegrade blood flow withinblood vessel450. Ablood pressure transducer492 is commonly connected in fluid communication with the lumen of the guide catheter to monitor arterial blood pressure.
• If desired, contrast dye may be injected through evacuation/guiding lumen440 intoblood vessel450 prior to treatingstenosis480.Stenosis480 is then treated and anyembolic debris497 is removed viaretrograde flow495 through evacuation/guiding lumen440 (FIGS. 9C-9G) as previously described with respect toFIGS. 6C-6H. After treatment,distal sealing balloon436 is deflated and evacuation/guidingsheath assembly400 is removed from blood vessel450 (FIG. 9H).
• According to another aspect of the present invention, the diameter of an evacuation head may be expandable from a first introduction diameter to a second operational diameter. As embodied herein and shown inFIGS. 10A-10D, anevacuation sheath assembly500 is provided with anexpandable evacuation head532. Many of the elements present in the previous embodiment are also shown inFIGS. 10A-10D and where these elements are substantially the same, similar reference numerals have been used and no detailed description of the element has been provided.
• Theevacuation head532 of the present embodiment is similar to the first and second embodiments previously discussed in that theevacuation sheath assembly500 comprises a relativelyshort evacuation head532.Evacuation sheath assembly500 also makes use of theguide catheter560 to form a part of an evacuation lumen540.
• As shown inFIG. 10A,evacuation head532 includes atube538 having a single expandable lumen, evacuation lumen540.Evacuation head532 may have a naturally unexpanded state. Alternatively,evacuation head532 may be designed to normally be in an expanded state. However, it is preferred to have theevacuation head532 fabricated to have its natural shape and size in the reduced dimension, as shown inFIG. 10B.
• Theevacuation head532 includes two sealingsurfaces534,536. Aproximal sealing surface534 is intended to seal against an inside distal portion of theguide catheter560 and a distal sealing surface is intended to seal against the inside of theblood vessel550, for example a coronary artery or an SVG. Although it is contemplated that theexpandable evacuation head532 could include two balloon-type seals, for example by adding a sealing balloon to each end of atube538 formingevacuation head532, it is preferable to simply allow the outer surface of theexpandable evacuation head532 to create the sealing surfaces534,536.
• Preferably,evacuation tube538 is formed of a braided sheath and a coating or covering over the braided sheath. The braided sheath itself can be made of stainless steel (full hard or spring), Eligiloy™, nickel titanium alloy or other metals or polymers with high elasticity characteristics. Preferably the braided sheath which formstube538 has a length of between about 3 cm and about 20 cm.
• The braided sheath can be coated with a polymer such as polyurethane, silicone and other similar elastomeric materials that can stretch and allow the braided sheath to expand. The covering or coating is preferably a thin and flexible elastomer, which is dip coated on the braided sheath. Since the elastomeric covering or coating is applied to the braided sheath in its reduced dimension, the covering or coating helps to retain the braided sheath in its reduced dimension.
• Alternatively, the braided sheath can be fitted with a fluid tight woven material that has similar expansion qualities as the braided sheath. If the covering is a braided fabric, it is preferably made from polyester or other high strength polymer yarn.
• Alternatively, the covering may be formed of a spun fibers laid down in multiple layers back and forth along the length of the braided sheath. If the fiber layers are laid down at the same helical angle as the primary braided sheath, the covering will behave similarly to the primary braided sheath upon expansion, requiring little or no expansile force to expand the covering from its reduced dimension to its expanded dimension. Each fiber layer will be made of several adjacent fiber windings to create a dense layer. Preferably, there are multiple layers, which together will be relatively impervious to fluid flow, thereby allowing sealing surfaces of theevacuation head532 to effectively isolate fluid communication from the lumen of the guide catheter with the lumen of the blood vessel.
• The braided sheath is preferably fabricated at its desired reduced diameter, for example, as utilized in an SVG with an 8 French guide catheter, about 0.4-1.5 mm. The braided sheath is then coated or covered at this reduced size. The braided sheath which comprises theevacuation head532 is preferably connected to anactuation wire513 by a few of the filaments near the distal end of the braided sheath. A proximalhollow shaft511 is connected to a few of the braid filaments near a proximal end of theevacuation head532 and serves as an anchor point.Actuation wire513 sits within thehollow shaft511 and the braided sheath is preferably bonded or welded to the proximalhollow shaft511 at the proximal end of the braided sheath and to theactuation wire513 on the distal end of the braided sheath. The bonds attach in a manner that does not considerably impede the free movement of the braided sheath during expansion and contraction.
• The proximalhollow shaft511 is a tube, which preferably decreases in stiffness from a proximal end to a distal end thereof. The proximalhollow shaft511 can be made of stainless steel hypotubing, polyethylene, or a composite of polymers and metal.
• Preferably, theevacuation head532 includes asteerable spring tip544 extending from theactuation wire513. Surrounding a portion of thespring tip544 is anose cone543. Thenose cone543 serves as a tapering transition between thespring tip544 and a distal end of adelivery sheath547. Thenose cone543 facilitates smooth advancement of the evacuation sheath assembly through aguide catheter560 and into theblood vessel550.
• Thedelivery sheath547 preferably comprises a tube which covers the entire length of the reduced dimension of theevacuation head532. Thedelivery sheath547 is connected to a wire shaft (not shown), which emerges from a proximal end of theguide catheter560. During evacuation, thedelivery sheath547 may be fully removed from the lumen of theguide catheter560, or can be left in position within theguide catheter560.
• If thedelivery sheath547 is intended to be removed completely from theguide catheter560, it may include a perforated longitudinal line to allow for splitting of thedelivery sheath547 and removal of thedelivery sheath547 from the proximalhollow shaft511 of theevacuation sheath assembly500.
• Alternatively, if the braided sheath has an expanded natural shape and size as shown inFIG. 10C, thereby being self-expanding upon removal of thedelivery sheath547, thedelivery sheath547 would preferably be usable during contracting and removal of the braided sheath. Thus, thedelivery sheath547 could be re-advanced to cover and constrain the braided sheath once the procedure is completed. In this manner, theevacuation sheath assembly500 could be removed from theguide catheter560.
• The proximal end of theevacuation sheath assembly500 may have an adjustable lock to anchor theactuation wire513 to the proximalhollow shaft511, allowing them to be held fixed to one another. This allows the braided sheath to be locked into a set position.
• Theevacuation sheath assembly500, in use, is depicted inFIG. 10D. Use ofevacuation sheath assembly500 is similar to the method described with respect toevacuation sheath assembly100. The differences between the method discussed with respect toFIGS. 6A-6I (evacuation sheath assembly100) and that forevacuation sheath assembly500 are discussed below.
• In use, aguide catheter560 is advanced intoblood vessel lumen550 over a guidewire570.Evacuation sheath assembly500, in a compressed state having a reduced diameter and enclosed indelivery sheath547, is advanced through the lumen ofguide catheter560 over guidewire570 and part way intoblood vessel550. Proper positioning of a distal end ofevacuation sheath assembly500 is confirmed using, for example, marker545,nose cone543, or by viewing the braided sheath through imaging.
• After the positioning is verified, thedelivery sheath547 is removed from theevacuation head532. Theactuation wire513 is then pulled proximally while the proximalhollow shaft511 is held stationary, preferably by a valve. Pulling theactuation wire513 proximally longitudinally compresses the braided sheath forming evacuation lumen540, causing it to expand in diameter. The evacuation lumen540 expands and theproximal sealing surface534 of theevacuation head532 seals against the inside surface of theguide catheter560. The portion of the evacuation lumen540 extending beyond theguide catheter560 and into theblood vessel550 continues to expand until thedistal sealing surface536 of theevacuation head532 seals against the inside surface of theblood vessel550. Similar to previous embodiments, the expansion can be observed with fluoroscopy, and the blood pressure can be monitored592 until the waveform changes from pulsatile arterial pressure to a venous pressure (again, in the example of a coronary or SVG blood vessel).
• With both seals in place, non ml blood flow is stopped. If desired, contrast dye may be injected through the catheter lumen intoblood vessel550 to viewblood vessel550 prior to treatingstenosis580.Stenosis580 is then treated and any embolic debris is removed via retrograde flow590 (FIG. 10D) as previously described with respect toFIGS. 6C-6H. After treatment, theactuation wire513 is re-advanced to allow the braided sheath to contract and be maintained in its reduced dimension prior to withdrawing theevacuation sheath assembly500 fromblood vessel550.
• Other embodiments of the invention will be apparent to those skilled in the art from consideration of the specification and practice of the invention disclosed herein. It is intended that the specification and examples be considered as exemplary only, with a true scope and spirit of the invention being indicated by the following claims.

Claims (20)

1. An embolic protection system for treating a lesion in a blood vessel, comprising:

a guide catheter having a guide lumen;

an evacuation sheath, comprising:

an evacuation tube having an evacuation lumen, a first sealing surface, and a second sealing surface;

a first actuator connected to the evacuation tube;

wherein the first actuator seals the first sealing surface against an internal surface of the guide lumen and seals the second sealing surface against an internal surface of the blood vessel;

an interventional device movable through the evacuation lumen to treat the lesion distal of the evacuation sheath.

2. The embolic protection system ofclaim 1, wherein the evacuation sheath further comprises a second actuator connected to the evacuation tube at a location proximal of the first actuator.

3. The embolic protection system ofclaim 2, wherein the first actuator is an actuation wire and the second actuator is a hollow shaft.

4. The embolic protection system ofclaim 3, wherein the actuation wire extends through the hollow shaft.

5. The embolic protection system ofclaim 1, wherein the evacuation sheath further comprises a steerable tip.

6. The embolic protection system ofclaim 1, wherein the evacuation sheath further comprises a nose cone extending distally from the evacuation tube.

7. The embolic protection system ofclaim 1, further comprising a delivery sheath movable from a first position covering the evacuation tube when positioning the evacuation tube relative to the guide catheter, and a second position removed from covering the evacuation tube.

8. The embolic protection system ofclaim 2, wherein operating the first and second actuators comprises retracting the first actuator while maintaining an axial position of the second actuator.

9. The embolic protection system ofclaim 1, wherein the evacuation tube comprises a braided sheath.

10. The embolic protection system ofclaim 9, wherein the evacuation tube comprises a coating or covering positioned on the braided sheath.

11. The embolic protection system ofclaim 10, wherein the coating comprises an elastomeric material.

12. The embolic protection system ofclaim 10, wherein the covering comprises at least one layer of spun fibers.

13. The embolic protection system ofclaim 1, wherein the evacuation tube is self-expanding.

14. The embolic protection system ofclaim 1, wherein operating the first actuator expands the evacuation tube.

15. An embolic protection system, comprising:

a guide catheter having a guide lumen;

an evacuation sheath, comprising:

an evacuation tube having an evacuation lumen, a first sealing surface, and a second sealing surface;

a first actuator connected to the evacuation tube;

a second actuator connected to the evacuation tube at a location proximal of a connection point of the first actuator to the evacuation tube;

wherein the first and second actuators seal the first sealing surface against an internal surface of the guide lumen and seals the second sealing surface against an internal surface of the blood vessel,

16. The embolic protection system ofclaim 15, wherein the first actuator is an actuation wire and the second actuator is a hollow shaft.

17. The embolic protection system ofclaim 16, wherein the actuation wire extends through the hollow shaft.

18. The embolic protection system ofclaim 15, wherein operating the first and second actuators includes retracting the first actuator while maintaining an axial position of the second actuator to expand the evacuation tube.

19. A method of treating a lesion within a blood vessel, comprising:

advancing a guide catheter having proximal and distal ends and a guide lumen therebetween to a region of interest within a blood vessel;

advancing an evacuation sheath through the guide lumen to the region of interest within the blood vessel, the evacuation sheath comprising an evacuation tube having an evacuation lumen, a first sealing surface, and a second sealing surface, and at least a first actuator connected to the evacuation tube;

operating the first actuator to seal the first sealing surface against an internal surface of the guide lumen and seal the second sealing surface against an internal surface of the blood vessel;

advancing an interventional instrument through the evacuation lumen into the blood vessel such that the interventional instrument is positioned across the lesion;

treating the lesion with the interventional instrument; and

applying suction to the evacuation lumen to induce retrograde flow within the blood vessel.

20. The method ofclaim 19, wherein the evacuation sheath further comprises a second actuator connected to the evacuation tube at a location proximal of connection point of the first actuator to the evacuation tube, wherein operating the first actuator includes retracting the first actuator and operating the second actuator includes maintaining an axial position of the second actuator thereby expanding the evacuation tube.

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