US20050228439A1 - Delivery and recovery system for embolic protection system - Google Patents

Abstract

A system for enabling the insertion and removal of an embolic protection device, for capturing and retaining embolic debris which can be created during the performance of a therapeutic interventional procedure in a stenosed or occluded region of a blood vessel. The system, in an embodiment thereof, is capable of enabling at least one operator to control the delivery and removal of an embolic protection device to a position in a patient's vasculature distal to an interventional procedure site, to enable the exchange of the delivery and recovery system. The system, in another embodiment thereof, includes a delivery system and a recovery system which are capable of enabling the delivery and recovery of an embolic protection device so as to maintain a clinically acceptable profile and flexibility through the patient's vasculature.

Description

CROSS-REFERENCES TO RELATED APPLICATIONS
• This is a divisional application of co-pending application Ser. No. 09/872,692, filed Jun. 1, 2001, whose contents are hereby incorporated by reference.
BACKGROUND OF THE INVENTION
• The present invention relates generally to improvements in embolic protection systems and methods. In particular, it relates to an improved system and method for enabling at least one operator to effectively deliver an embolic protection device to a position in a patient's vasculature distal to an interventional procedure site. The deployment of the embolic protection device is enabled so as to filter the blood in a blood vessel, to capture embolic material that may be created and released into the bloodstream during the performance of the interventional procedure in a stenosed or occluded region of a blood vessel. The invention also enables the operator to efficiently remove the embolic protection device from the interventional procedure site with the captured embolic material therein.
• The present invention further particularly relates to an improved system and method for maintaining a clinically acceptable profile and flexibility during the delivery and removal of the embolic protection device through the patient's vasculature. The systems and methods of the present invention are particularly useful when performing balloon angioplasty, stenting procedures, laser angioplasty or atherectomy in critical vessels, such as the carotid, renal, and saphenous vein graft arteries, where the release of embolic debris into the bloodstream could possibly occlude the flow of oxygenated blood to the brain or other vital organs which can cause devastating consequences to the patient.
• A variety of non-surgical interventional procedures have been developed over the years for opening stenosed or occluded blood vessels in a patient caused by the build up of plaque or other substances on the walls of the blood vessel. Such procedures usually involve the percutaneous introduction of the interventional device into the lumen of the artery, usually through a catheter. One widely known and medically accepted procedure is balloon angioplasty in which an inflatable balloon is introduced within the stenosed region of the blood vessel to dilate the occluded vessel. The balloon catheter is initially inserted into the patient's arterial system and is advanced and manipulated into the area of stenosis in the artery. The balloon is inflated to compress the plaque and press the vessel wall radially outward to increase the diameter of the blood vessel.
• Another procedure is laser angioplasty which utilizes a laser to ablate the stenosis by super heating and vaporizing the deposited plaque. Atherectomy is yet another method of treating a stenosed blood vessel in which a cutting blade is rotated to shave the deposited plaque from the arterial wall. A vacuum catheter may be used to capture the shaved plaque or thrombus from the blood stream during this procedure.
• In another widely practiced procedure, the stenosis can be treated by placing a device known as a stent into the stenosed region to hold open and sometimes expand the segment of the blood vessel or other arterial lumen. Stents are particularly useful in the treatment or repair of blood vessels after a stenosis has been compressed by percutaneous transluminal coronary angioplasty (PTCA), percutaneous transluminal angioplasty (PTA) or removal by atherectomy or other means. Stents are usually delivered in a compressed condition to the target site, and then are deployed at the target location into an expanded condition to support the vessel and help maintain it in an open position.
• In the past, stents typically have fallen into two general categories of construction. The first type of stent is expandable upon application of a controlled force, often through the inflation of the balloon portion of a dilatation catheter which, upon inflation of the balloon or other expansion means, expands the compressed stent to a larger diameter to be left in place within the artery at the target site. The second type of stent is a self-expanding stent formed from, for example, shape memory metals or super-elastic nickel-titanum (NiTi) alloys, which will automatically expand from a compressed state when the stent is advanced out of the distal end of the delivery catheter into the body lumen. Such stents manufactured from self-expandable materials allow for phase transformations of the material to occur, contributing to the expansion and contraction of the stent.
• The above non-surgical interventional procedures, when successful, avoid the necessity of major surgical operations. However, there is one common problem associated with all of these non-surgical procedures, namely, the potential release of embolic debris into the bloodstream which can occlude distal vasculature and cause significant health problems to the patient. For example, during deployment of a stent, it is possible that the metal struts of the stent can cut into the stenosis and shear off pieces of plaque which become embolic debris that can travel downstream and lodge somewhere in the patient's vascular system. Pieces of plaque material can sometimes dislodge from the stenosis during a balloon angioplasty procedure and become released into the bloodstream. Additionally, while complete vaporization of plaque is the intended goal during a laser angioplasty procedure, particles are not always fully vaporized and may enter the bloodstream.
• When any of the above-described procedures are performed for example in the carotid arteries, the release of emboli into the circulatory system can be extremely dangerous to the patient. Debris that is carried by the bloodstream to distal vessels of the brain may cause these cerebral vessels to occlude, resulting in a stroke, and in some cases, death. Therefore, although carotid percutaneous transluminal angioplasty has been performed in the past, the number of procedures performed has been limited due to the justifiable fear of causing an embolic stroke should embolic debris enter the bloodstream and block vital downstream blood passages.
• Medical devices have been developed to attempt to deal with the problem created when debris or fragments enter the circulatory system following treatment utilizing any one of the above-identified procedures. One approach which has been attempted is the cutting of any debris into minute sizes which pose little chance of becoming occluded in major vessels within the patient's vasculature. However, it is often difficult to control the size of the fragments which are formed, and the potential risk of vessel occlusion still exists, making such procedures in the carotid arteries a high-risk proposition.
• Other techniques which have been developed to address the problem of removing embolic debris include the use of catheters with a vacuum source which provides temporary suction to remove embolic debris from the bloodstream. However, as mentioned above, there have been complications with such systems since the vacuum catheter may not always remove all of the embolic material from the bloodstream, and a powerful suction could cause problems to the patient's vasculature.
• Further techniques which have had some limited success include the placement of an embolic protection device such as a filter or trap downstream from the treatment site to capture embolic debris before it reaches the smaller blood vessels downstream. Such embolic protection devices are adapted to enable the filtering of embolic debris which may be released into the bloodstream during the treatment to the vessel, and yet allow a sufficient amount of oxygenated blood to flow past the device to supply vital organs downstream from the treatment site.
• However, there have been problems associated with embolic protection devices, particularly during the insertion, expansion, deployment, and removal of the embolic protection device within the blood vessel. The manipulation of the guide wire and the catheter employed in the insertion and removal of the embolic protection device usually requires two operators, one for manipulating the guide wire, and one for manipulating the catheter. This can sometimes prove to be a somewhat inefficient and inconvenient method for inserting and removing filtering systems. Also, a long guide wire was required previously for the delivery and removal of the embolic protection device, since the guide wire had to be held until the entire catheter was removed from the body, so that the guide wire could be grabbed as it exited the body and the catheter could be removed from the guide wire. Further, very substantial pullback force on the guide wire and catheter was required, due to the operation of frictional forces and the interaction thereof. Also, the insertion and removal of embolic protection devices through a patient's vasculature, if not properly implemented, subjected the patient's vasculature to potential trauma and would interfere with the treatment of the stenosis while increasing the likelihood of damage thereto.
• Therefore, the present invention provides improved systems and methods for treating stenosis in blood vessels which enable at least one operator to manipulate the guide wire and the catheter, so as to efficiently and effectively deliver an embolic protection device to a position distal to an interventional procedure site for deployment thereof. The operator also can remove the embolic protection device with captured embolic material therein from the interventional procedure site. The improved systems and methods of the present invention further enable the treatment of a stenosis in blood vessels while maintaining a clinically acceptable profile and flexibility during the delivery and removal of the embolic protection device through the patient's vasculature. Moreover, the systems and methods are adapted to be relatively easy for a physician to use, while enabling the effective delivery and recovery of a filtering system capable of removing embolic debris released into the bloodstream. The inventions disclosed herein satisfy these and other needs.
SUMMARY OF THE INVENTION
• The present invention, in general, provides a system and method for the insertion and removal of a filtering system for capturing and retaining embolic debris from a blood vessel. The embolic debris may be created during the performance of a therapeutic interventional procedure, such as a balloon angioplasty or stenting procedure. The filtering system is adapted to prevent the embolic debris from lodging and blocking blood vessels downstream from the interventional site. The present invention is particularly useful for enabling an interventional procedure to be performed in vital arteries, such as the carotid arteries, in which critical downstream blood vessels can become blocked with embolic debris, including the main blood vessels leading to the brain or other vital organs. As a result, the present invention provides the physician with a higher degree of confidence in the efficient delivery and recovery of a filtering system for the collection and removal of embolic debris from the blood vessel when performing high-risk interventional procedures.
• The present invention enables a filtering system to be deployed in the blood vessel at a location distal to the area of treatment in the interventional procedure site. It also enables the blood to pass therethrough to enable blood to flow past the filter. It further enables the blood to be filtered to capture and retain any embolic debris which may be created during the interventional procedure.
• More particularly, for example, in an embodiment of the present invention, a system is adapted to enable at least one operator to control the delivery of an embolic protection device to a position in a patient's vasculature distal to an interventional procedure site, for deployment of the embolic protection device. The present invention also enables the operator to control the removal of the delivery system from the patient's vasculature, to enable the exchange of the delivery and recovery system. It further enables the operator to control the position of a deployed embolic protection device within the patient's vasculature during an exchange of interventional devices.
• The delivery system includes a guide wire, having a distal end, and adapted to be positioned within the blood vessel and to extend to a position distal to the interventional procedure site. The guide wire is further adapted to include an embolic protection device mounted on the distal end thereof. The system also includes a catheter, having a distal end, wherein the catheter has a lumen therein extending in the catheter to the distal end thereof. The guide wire and the embolic protection device are adapted to extend in and through the lumen in the catheter. The catheter and the guide wire are adapted to enable the embolic protection device to be delivered and deployed distal to the interventional procedure site. The catheter includes a manipulation-enabling element for enabling the operator to manipulate the guide wire and the catheter independently so as to enable removal thereof from the patient's vasculature.
• The system in such embodiment further includes a system for enabling the at least one operator to control the recovery of the embolic protection device, from the delivered and deployed position thereof, for the exchange of the recovery system. The recovery system includes the catheter, including the manipulation-enabling element, for enabling the operator to independently manipulate the guide wire and the catheter, so as to enable removal of the catheter and the embolic protection device recovered thereby from the patient's vasculature.
• In another embodiment of the present invention, for example, a delivery system is adapted to enable the delivery of an embolic protection device to a position in a patient's vasculature distal to an interventional procedure site, through the patient's vasculature, for deployment of the embolic protection device. The delivery system is adapted to maintain a clinically acceptable profile and flexibility during the delivery and removal thereof through the patient's vasculature.
• The delivery system includes a guide wire, including a distal end, adapted to be positioned within the blood vessel and to extend to a position distal to the interventional procedure site, and to include an embolic protection device mounted on the distal end thereof. The delivery system further includes a delivery sheath, including a distal end, and a lumen therein extending in the delivery sheath to the distal end thereof, and wherein the guide wire and the embolic protection device are adapted to extend in and through the lumen. The delivery sheath and the guide wire are adapted to enable the embolic protection device to be delivered and deployed distal to the interventional procedure site. The delivery sheath comprises dimensions and materials adapted to provide a low profile, flexibility for enabling tracking thereof through the patient's vasculature, and rigidity for enabling pushing thereof through the patient's vasculature, so as to maintain a clinically acceptable profile and flexibility during the delivery and removal thereof through the patient's vasculature.
• The system in such other embodiment also includes a recovery system, adapted to enable the recovery of the embolic protection device from the position in the patient's vasculature distal to the interventional procedure site, for removal of the embolic protection device. The recovery system is adapted to maintain a clinically acceptable profile and flexibility during the delivery and removal of the recovery system through the patient's vasculature.
• The recovery system includes an inner catheter, including a distal end. The inner catheter has a lumen therein extending in the inner catheter to the distal end thereof, and wherein the inner catheter is adapted to extend over the guide wire, and the distal end of the inner catheter is adapted to be positionable adjacent the embolic protection device. The inner catheter comprises dimensions and materials adapted to enable a smooth transition for movement thereof along the guide wire, to inhibit kinking of the guide wire during the delivery and removal of the inner catheter, and to maintain a clinically acceptable profile and flexibility during the delivery and removal thereof through the patient's vasculature.
• The recovery system further includes an outer catheter, including a distal end, wherein the outer catheter has a lumen therein extending in the outer catheter to the distal end thereof. The outer catheter is adapted to extend over the inner catheter. The outer catheter comprises dimensions and materials adapted to enable a smooth transition for movement thereof along the inner catheter, to enable the capturing of the embolic protection device, and to inhibit trauma to the patient's vasculature, so as to maintain a clinically acceptable profile and flexibility during the delivery and removal thereof through the patient's vasculature.
• The above objects and advantages of the present invention, as well as others, are described in greater detail in the following description, when taken in conjunction with the accompanying drawings of illustrative embodiments.
BRIEF DESCRIPTION OF THE DRAWINGS
• FIG. 1 is a side elevational partly broken view of a first form of a delivery version of a first embodiment of the present invention, including a guide wire and a delivery catheter.
• FIG. 2 is a top plan view of the first form of a delivery version of the first embodiment shown inFIG. 1.
• FIG. 3 is a similar view of the first form of the delivery version of the first embodiment shown inFIG. 1, without a handle at the proximal end of the delivery catheter.
• FIG. 4 is an elevational fragmentary partly-sectional view of the first delivery version of the first embodiment shown inFIG. 1, disposed within the internal carotid artery of a patent, including the distal end of the guide wire and the delivery catheter.
• FIG. 5 is a similar view of the first form of the delivery version of the first embodiment seen inFIG. 1, with a different-shaped distal tip of the delivery catheter.
• FIG. 6 is a similar view of the distal end of the first form of the delivery version of the first embodiment illustrated inFIG. 4, including a cross-section of the tip of the delivery catheter, a guide wire, and an embolic protection device.
• FIG. 7 is a cross-sectional view taken along line7-7 ofFIG. 6.
• FIG. 8 is a side elevational partly-broken view of a second delivery version of the first embodiment of the present invention.
• FIG. 9 is a similar view of the second delivery version of the first embodiment shown inFIG. 8, including a guide wire, and an embolic protection device at the distal end of the delivery catheter.
• FIG. 10 is a side elevational view of a first form of a recovery version of a first embodiment of the present invention, including an inner catheter
• FIG. 11 is a cross-sectional view taken along the line11-11 ofFIG. 10.
• FIG. 12 is a side elevational view of the first form of the recovery version of the first embodiment of the present invention, including an outer catheter.
• FIG. 13 is a cross-sectional view taken along the line12-12 ofFIG. 11.
• FIG. 14 is a side elevational partly-sectional assembly view of the first form of the recovery version of the first embodiment shown inFIGS. 10-13, depicting the outer catheter extending about the inner catheter.
• FIG. 15 is a side elevational partly-sectional partly-broken view of the first form of the recovery version of the first embodiment shown inFIG. 14, disposed within the internal carotid artery of a patient, including the guide wire, the inner catheter, the outer catheter, and an embolic protection device.
• FIG. 16 is a side elevational partly-broken view of a second form of the recovery version of the first embodiment of the present invention, including a guide wire, an inner catheter, an outer catheter, and an embolic protection device, disposed within the internal carotid artery of a patient.
• FIG. 17 is a side elevational view of a third form of a recovery version of the first embodiment of the invention, including a guide wire, and an embolic protection device proximate the distal end of the recovery catheter.
• FIG. 18 is a similar view of the third form of the recovery version of the first embodiment seen inFIG. 16, with the embolic protection device captured in the expanded tip of the recovery catheter.
• FIG. 19 is a side elevational view of a delivery version of a second embodiment of the present invention, including a delivery sheath.
• FIG. 20 is a cross-sectional view taken along the line20-20 ofFIG. 19.
• FIG. 21 is a side elevational view of a recovery version of the second embodiment of the present invention, including an inner catheter.
• FIG. 22 is a cross-sectional view taken along the line22-22 ofFIG. 21.
• FIG. 23 is a side elevational view of a recovery version of the second embodiment of the present invention, including an outer catheter.
• FIG. 24 is a cross-sectional view taken along the line24-24 ofFIG. 23.
• FIG. 25 is a side elevational partly-sectional assembly view of the recovery version of the second embodiment shown inFIGS. 21-24, depicting the outer catheter extending about the inner catheter.
• FIG. 26 is a side elevational partly-sectional partly-broken view of the recovery version of the second embodiment shown inFIG. 25, disposed within the internal carotid artery of a patient, including the guide wire, the inner catheter, the outer catheter, and an embolic protection device.
DETAILED DESCRIPTION OF THE INVENTION
• The present invention is directed to an improved system and method for enabling at least one operator to control the delivery of an embolic protection device to a position in a patient's vasculature distal to an interventional procedure site for deployment of the embolic protection device. It is also adapted to enable the operator to control the removal of the delivery system from the patient's vasculature, in an efficient and effective manner, for the exchange of the delivery and recovery system. It further enables control of the position of a deployed embolic protection device within the patient's vasculature by the operator during an exchange of interventional devices. The system and method are also adapted to enable the at least one operator to control the recovery of the embolic protection device, from the delivered and deployed position thereof, for the exchange of the recovery system.
• The present invention is further directed to an improved system and method for enabling the delivery of an embolic protection device to the position in a patient's vasculature distal to the interventional procedure device for the deployment of the embolic protection device, so as to maintain a clinically acceptable profile and flexibility during the delivery and removal thereof through the patient's vasculature. It is further adapted to enable the recovery of the embolic protection device from the position in the patient's vasculature distal to the interventional procedure site, for removal of the embolic protection device, while maintaining the clinically acceptable profile and flexibility during the delivery and removal of the recovery system through the patient's vasculature.
• The embodiments of the improved system and method are illustrated and described herein by way of example only and not by way of limitation. While the present invention is described as applied to the carotid arteries of the patient, those skilled in the art will appreciate that it can also be used in other body lumens as well, such as the coronary arteries, renal arteries, saphenous veins and other peripheral arteries. Additionally, the present invention can be utilized when performing any one of a number of interventional procedures, such as stenting, balloon angioplasty, laser angioplasty or atherectomy.
• With respect to the drawings, wherein like reference numerals denote like or corresponding parts throughout the drawing figures, and particularly toFIGS. 1-26, in the embodiments of the system and method in accordance with the invention, for example, asystem10 is provided for enabling an interventional procedure to be performed in ablood vessel12 at an area oftreatment14. Thesystem10 is adapted to be atraumatic. It includes aguide wire16 adapted to enable thesystem10 to be positioned distal to the area oftreatment14. Thesystem10 is placed within thecarotid artery18 or other blood vessel of the patient, and is guided into position by theguide wire16. Theguide wire16 includes a coiledtip20 at adistal end22 thereof. Thecarotid artery18 has the area oftreatment14 therein, which comprises the interventional procedure site, whereinatherosclerotic plaque24 has built up against theinside wall26 which decreases the diameter of thecarotid artery18. As a result, blood flow is diminished through this area.
• The therapeutic interventional procedure comprises implanting an expandable interventional instrument at theinterventional procedure site14, to press the build-up ofplaque24 of the stenosis against theinside wall26, to increase the diameter of theoccluded area14 of theartery18, and to help restore sufficient flow of blood to the downstream vessels leading to the brain. The expandable interventional instrument not only helps increase the diameter of the occluded area, but helps prevent restenosis in the area oftreatment14. The expandable interventional instrument is adapted to be expanded and deployed at theinterventional procedure site14.
• Thesystem10 of the present invention is adapted to enable the delivery of anembolic protection device28 to a location distal to the area oftreatment14, and to enable the removal of theembolic protection device28 from the delivered position thereof. Theembolic protection device28 is adapted to filter the blood in theblood vessel12, so as to pass blood therethrough and capture embolic material which may be released in theblood vessel12 during the interventional procedure. Theembolic protection device28 is adapted to be secured to thedistal end22 of theguide wire16, such that manipulation of theguide wire16 enables theembolic protection device28 to be placed within thecarotid artery18 or other blood vessel of the patient and guided into position distal to the area oftreatment14.
• Referring toFIGS. 1-18, in a first embodiment of a system pursuant to the present invention, for example, thesystem10 is adapted to enable at least one operator to control of the delivery of theembolic protection device28 to the position in a patient'sblood vessel12 distal to the area oftreatment14, for deployment of theembolic protection device28. Thesystem10 is further adapted to enable the at least one operator to control the removal of thedelivery system10, to enable the exchange of the delivery system, and to enable the control of the position of a deployedembolic protection device28 within the patient'svasculature12 during an exchange of interventional devices. Thesystem10 is further adapted to enable the at least one operator to control the removal of theembolic protection device28 through the patient'svasculature12, from the delivered and deployed position thereof, for the exchange of the recovery system.
• As illustrated inFIGS. 1-9, in a delivery version of the first embodiment of the invention, for example, thesystem10 includes theguide wire16, adapted to be positioned within theblood vessel12, and to extend to a position distal to the area oftreatment14, and adapted to include theembolic protection device28 mounted on thedistal end22 thereof. Thesystem10 also includes acatheter30, which includes adistal end32. Thecatheter30 has alumen34 extending therein to thedistal end32 thereof. Theguide wire16 and theembolic protection device28 are adapted to extend in and through thelumen34. Thecatheter30 and theguide wire16 are adapted to enable theembolic protection device28 to be delivered and deployed distal to theinterventional procedure site14.
• Thecatheter30 also includes a manipulation-enablingelement36 for enabling the operator to manipulate theguide wire16 and thecatheter30 independently, so as to enable removal of theguide wire16 and thecatheter30 through the patient'sblood vessel12. Thecatheter30 includes adistal end portion38, extending from thedistal end32 to a location spaced from thedistal end32, aproximal end40, and a distal-proximal portion42, extending from thedistal end portion38 to theproximal end40. Thedistal end portion38 of thecatheter30 is relatively short, for example about twenty centimeters long.
• In a first form of the delivery version of the first embodiment of the invention, as depicted inFIGS. 1-7, the distal-proximal portion42 of thecatheter30 includes aport44 therein, proximate thedistal end portion42 of thecatheter30, for enabling theguide wire16 to exit therefrom and extend therethrough and outside and along the relatively longer length of the distal-proximal portion42 of thecatheter30.
• The manipulation-enablingelement36 extends along the distal-proximal portion42 of thecatheter30. The manipulation-enablingelement40 is adapted to enable theguide wire16 to be peeled away from and extend outside thecatheter30 and along the distal-proximal portion42 thereof. The manipulation-enablingelement36 comprises a slit, extending along the distal-proximal portion42 of thecatheter30. Theslit36 is adapted to enable thecatheter30 and theguide wire16 to be manipulated by the operator, so as to enable theguide wire16 to exit from and extend therethrough and outside and along the distal-proximal portion42 of thecatheter30. After the operator manipulates theguide wire16 such that the major portion thereof exits thecatheter30 through theport44, only a minor portion of theguide wire16 extends in the short length of thedistal end portion38 of thecatheter30, enabling the operator to efficiently manipulate the major portion of the guide wire independent of thecatheter30. Further, with the major portion of theguide wire16 adapted to exit thecatheter16 for independent manipulation thereof by the operator, less overall length ofguide wire16 is required to enable exchanges thereby.
• Thecatheter30 further includes amandrel48 extending therein, as seen inFIG. 4, adapted to support thecatheter30, to enable thecatheter30 to maintain a clinically acceptable profile and flexibility during delivery and removal thereof through the patient'svasculature12. Themandrel48 extends in asecond lumen50 in thecatheter30. Thecatheter30 also includes atip cover52 at thedistal end34 thereof. Thesupport mandrel48 may include a flatteneddistal end54 thereof, adapted to enable the operator to shape thedistal end52. The shapeabledistal end54 of thesupport mandrel48 may be connected to a super elastic distal segment, which is connected to a stainless steel proximal segment. Thecatheter30 also includes ahandle56 at theproximal end40 thereof.
• Thecatheter30 also includes atip58, at thedistal end32 thereof, adapted to be shapeable by the operator, to enable the operator to direct theshapeable tip58 for movement thereof in the patient's vasculature. Theshapeable tip58 enables the operator to track thesystem10 over theguide wire16 and through tortuous anatomy, without having to rely on theguide wire16 therefor. Thetip58 is also radiopaque, for enabling the operator to locate thetip58.
• In a second form of the delivery version of the first embodiment of thesystem10 pursuant to the present invention, for delivery of anembolic protection device28, as shown inFIGS. 8-9, the manipulation-enablingelement36 comprises aprojection46, at a location spaced from theproximal end40 and thedistal end32 of thecatheter30, adapted to communicate with thelumen34, and to enable a minor portion of theguide wire16 to extend into thelumen34 therethrough, and a major portion of theguide wire16 to extend outside thecatheter30 therefrom. Theprojection46 is adapted to enable thecatheter30 and theguide wire16 to be manipulated independently by the operator. Thedistal end32 of thecatheter30 is enlarged for contact with theembolic protection device28.
• As shown inFIGS. 10-18, in a recovery version of the first embodiment pursuant to the present invention, for example, thesystem10 includes theguide wire16, and thecatheter30.
• In a first form of the recovery system of the first embodiment in accordance with the invention, as seen inFIGS. 10-15, which corresponds to the first form of the delivery system of the first embodiment as shown inFIGS. 1-7, thecatheter30 comprises an inner catheter, which includes theslit36, theport44, themandrel48, and theshapeable tip58. Thesystem10 further includes anouter catheter60, adapted to extend about theinner catheter30, and to be extendable in the distal direction by the operator so as to enclose theembolic protection device28 for enabling recovery thereof. Theouter catheter60 also includes theslit36, theport44, themandrel48, and theshapeable tip58. As seen inFIG. 16, in a second form of the recovery version of the first embodiment, which corresponds to the second form of the delivery version of the first embodiment, as depicted inFIGS. 8-9, therecovery system10 includes theinner catheter30, which includes theprojection46, theouter catheter60, and themandrel48. Therecovery system10, in a third form of the recovery version of the first embodiment, as illustrated inFIGS. 17-18, includes thecatheter30, which includes themandrel48, and theshapeable tip58, which is further adapted to be expandable to enable the capture of theembolic protection device28. Thecatheter30 further includes amarker band62, for enabling the operator to track the location thereof.
• Referring toFIGS. 19-26, in a second embodiment of a system pursuant to the invention, for example, asystem64 is provided for enabling the delivery and recovery of anembolic protection device28 relative to a position in the patient'svasculature12 distal to aninterventional procedure site14, through the patient'svasculature12, for deployment of theembolic protection device28. Thesystem64 is adapted to maintain a clinically acceptable profile and flexibility during the delivery and removal thereof through the patient'svasculature12. Elements of thesystem64 are comprised of polymer materials such as for example PeBax which is comprised of a thermoplastic polyimide. Also, for the delivery of theembolic protection device28, the materials are such as to provide substantial flexibility for enabling delivery thereof through the patient's anatomy and for preventing theguide wire16 from kinking, while providing sufficient rigidity for enabling substantial pushing force to be exerted for delivery and deployment thereof. Further, the dimensions of the elements of thesystem64 are such as to provide a low profile for the delivery and recovery thereof and of theembolic protection device28, while inhibiting vessel trauma.
• In a delivery version of the second embodiment of the invention, as depicted inFIGS. 19-20, thesystem64 includes aguide wire16, including adistal end22, adapted to be positioned within theblood vessel12 and to extend to the a position distal to theinterventional procedure site14, and adapted to include theembolic protection device28 mounted on thedistal end22 thereof. Thedelivery system64 further includes adelivery sheath66, including adistal end68, and has alumen70 therein extending in thedelivery sheath66 to thedistal end68 thereof. Theguide wire16 and theembolic protection device28 are adapted to extend in a through thelumen70. Thedelivery sheath66 and theguide wire16 are adapted to enable theembolic protection device28 to be delivered and deployed distal to theinterventional procedure site14. Thedelivery sheath66 comprises dimensions and materials adapted to provide a low profile, flexibility for enabling tracking thereof through the patient'svasculature14, and rigidity for enabling pushing thereon through the patient'svasculature14, to maintain a clinically acceptable profile and flexibility during the delivery and removal thereof through the patient's vasculature.
• Thedelivery sheath66 includes atip72 at thedistal end68 thereof, adapted to be necked for providing a profile close to theguide wire16, to inhibit kinking of theguide wire16 during the delivery and removal of thedelivery sheath66. Thedelivery sheath66 also includes amain shaft74, adapted to provide the low profile, flexibility, and rigidity. Themain shaft74 of thedelivery sheath66 is comprised for example of PeBax, of about 72 Durometer. Thetip72 of thedelivery sheath66 is adapted to be necked, for enabling theembolic protection device28 to be loaded therein for delivery thereof, and for enabling the release of theembolic protection device28 for deployment thereof. Thetip72 of thedelivery sheath66 is radiopaque, and is comprised of soft material to prevent vessel trauma. Thedelivery sheath66 further includes aproximal end76, adapted to include a flushing valve including a locking hub.
• Thedelivery sheath66, in an embodiment thereof, is about 140-145 centimeters in overall length, with a working length of about 25-50 centimeters. The inside diameter of themain shaft74 is about 0.020 inches, with an outside diameter of about 0.055 inches. The radiopaquenecked tip72 is a soft tip, comprised of a compound including PeBax, of about 40 Durometer, and bismuth, with a clinically acceptable profile and radiopacity, and is about 10-30 centimeters in length, with a maximum outside diameter of about 0.050 inches.
• As seen inFIGS. 21-26, in a recovery version of the second embodiment of a system pursuant to the invention, thesystem64 is also provided for enabling the recovery of theembolic protection device28 from the position in the patient'svasculature12 distal to theinterventional procedure site14, for removal of theembolic protection device28. Therecovery system64 is adapted to maintain a clinically acceptable profile and flexibility during the delivery and removal thereof through the patient'svasculature12. Therecovery system64 includes aninner catheter78, adapted to be positionable adjacent theembolic protection device28.
• Theinner catheter78 includes adistal end80, amain shaft82, and alumen84 extending in theinner catheter78 through themain shaft82 to thedistal end80 thereof. Theinner catheter78 is adapted to extend over theguide wire16, and thedistal end80 of theinner catheter78 is adapted to be positionable adjacent theembolic protection device28. Theinner catheter78 comprises dimensions adapted to enable a smooth transition for movement thereof along theguide wire16, to inhibit kinking of theguide wire16 during the delivery and removal of theinner catheter78, and to maintain a clinically acceptable profile and flexibility during the delivery and removal thereof through the patient'svasculature12. Theinner catheter78 further includes atip86 at thedistal end80 thereof. Themain shaft82 of theinner catheter78 is comprised for example of PeBax, of about 72 Durometer. Thetip86 of theinner catheter78 is radiopaque. Theinner catheter78 further includes aproximal end88, adapted to include a flushing valve including a locking hub.
• Theinner catheter78, in an embodiment thereof, is about 145-151 centimeters in overall length, with a working length of about 25-50 centimeters. The inside diameter of themain shaft82 is about 0.020 inches, with an outer diameter of about 0.055 inches. Theradiopaque tip86 is comprised of a compound including PeBax, of about 40 Durometer, and bismuth.
• Thesystem64, in the recovery version of the second embodiment thereof, further includes anouter catheter90, including adistal end92, and amain shaft94. Theouter catheter90 has alumen96 therein extending through themain shaft94 in theouter catheter90 to thedistal end92 thereof. Theouter catheter90 is adapted to extend over theinner catheter78. Theouter catheter90 comprises dimensions and materials adapted to enable a smooth transition for movement thereof along theinner catheter78, to enable the capturing of theembolic protection device28, and to inhibit trauma to the patient's vasculature, to maintain a clinically acceptable profile and flexibility during the delivery and removal thereof through the patient'svasculature12. Theouter catheter90 further includes atip98 at thedistal end92 thereof. Themain shaft94 of theouter catheter90 is comprised for example of high density PE. Thetip98 of theouter catheter90 is radiopaque. Theouter catheter90 further includes aproximal end100, adapted to include a flushing valve including a locking hub.
• Theouter catheter90, in an embodiment thereof, is about 140-145 centimeters in overall length, with a working length of 25-50 centimeters. Theouter catheter90 is shorter than theinner catheter78. The inside diameter of themain shaft94 is about 0.065 inches, with an outer diameter of about 0.075 inches. Theradiopaque tip98 is a soft tip, comprised of a compound including PeBax, of about 40 Durometer, and bismuth.
• Theouter catheter90 and theinner catheter78 of thesystem64 interact such that theinner catheter78 is adapted to enable smooth movement thereof over theguide wire16, to enable smooth transition from theguide wire16 to theouter catheter90, and to resist the development of kinks in thesystem64.
• Referring toFIGS. 1-18, in a method for the use of the first embodiment of the invention, for enabling the at least one operator to deliver and remove theembolic protection device28 relative to the position thereof distal to the area oftreatment14 in the patient'sblood vessel12, for example, thesystem10 is positioned in and removed from the patient'svasculature12 by the operator utilizing any one of a number of different methods.
• In a method for enabling the operator to delivery theembolic protection device28 to the position in the patient'svasculature12 distal to theinterventional procedure site14 for deployment of theembolic protection device28, as illustrated inFIGS. 1-11, thedelivery system10 is adapted to maintain a clinically acceptable profile and flexibility during the delivery and removal thereof through the patient's vasculature. Theguide wire16 is inserted into the patient'svasculature12, with theembolic protection device28 secured thereto and thecatheter30 detachably secured to theembolic protection device28. Theguide wire16 is then manipulated by the operator to the area oftreatment14, to cross the stenosis in theblood vessel12, so as to position theembolic protection device28 for capturing embolic material which may be released in theblood vessel12 during the interventional procedure. After theembolic protection device28 is in place, it is deployed by the operator at the position distal to the stenosis in theblood vessel12. The operator then detaches thecatheter30 from theembolic protection device28, and manipulates thecatheter30, holding theguide wire16, so as to remove thecatheter30 from the patient'svasculature12.
• In the first form of the delivery version of the first embodiment as seen inFIGS. 1-7, the operator manipulates thecatheter30 and theguide wire16 independently for removal of thecatheter30, upon peeling away theguide wire16 from thecatheter30 through theslit36 extending along the distal-proximal portion42 of thecatheter30. The operator, in the second form of the delivery version of the first embodiment as shown inFIGS. 8-9, manipulates thecatheter30 and theguide wire16 independently for removal of thecatheter30, upon gripping thecatheter30 and the portion of theguide wire16 extending from theprojection46 in thecatheter30 at the location spaced from theproximal end40 and thedistal end32 of thecatheter30.
• Theembolic protection device28 is recovered by the operator, in the recovery versions of the first embodiment of the invention as illustrated inFIGS. 10-18, for example, after the interventional procedure is performed, by extending a catheter to theembolic protection device28, capturing theembolic protection device28, and removing the catheter and theembolic protection device28 from the patient'svasculature14.
• In a first form of therecovery system64 as seen inFIGS. 10-15, the operator manipulates theguide wire16, which extends through theport44 and through theslit36, to enable removal thereof. The operator, in the second form of therecovery system64 shown inFIG. 16, manipulates the portion of theguide wire16 extending from theprojection46 in theinner catheter30, along with theinner catheter30, with theouter catheter60 extending about thedistal end32 of theinner catheter30, and with theembolic protection device28 enclosed in theouter catheter60. As depicted inFIGS. 17-18, the operator expands theexpandable tip58 of thecatheter30 to capture theembolic protection system28, and recovers thecatheter30 and theembolic protection system28.
• Referring toFIGS. 19-26 in a method for the use of the second embodiment of the invention, for enabling the delivery and removal of theembolic protection device28 in relation to the location thereof distal to theoccluded area14 in the patient's vasculature, for example, thesystem64 may be positioned in and removed from the patient'svasculature12 by utilizing any one of a number of different methods.
• In a method for enabling the delivery of theembolic protection device28 to the position in the patient'svasculature12 distal to theinterventional procedure site14 for deployment of theembolic protection device28, as seen inFIGS. 19-20, thedelivery system64 is adapted to maintain a clinically acceptable profile and flexibility during the delivery and removal thereof through the patient's vasculature. Theguide wire16 is inserted into the patient'svasculature12, with theembolic protection device28 positioned relative to thetip72 of thedelivery sheath66. Thedelivery sheath66 and theembolic protection device28 are delivered through the patient'svasculature12 to the area oftreatment14, to cross the stenosis in theblood vessel12, so as to position theembolic protection device28 for capturing embolic material which may be released in theblood vessel12 during the interventional procedure. Thedelivery sheath66 is adapted to maintain a clinically acceptable profile and flexibility during the delivery thereof.
• After theembolic protection device28 is in place, it is deployed at the position distal to the stenosis in theblood vessel12. Thedelivery sheath66 is then withdrawn from theembolic protection device28, and removed through the patient'svasculature12, while maintaining the clinically acceptable profile and flexibility during the removal thereof.
• Theembolic protection device28 is recovered after the interventional procedure is performed, in the recovery version of the second embodiment of the invention as shown inFIGS. 21-26, by inserting theinner catheter78 into the patient'svasculature12, through the patient's anatomy, to a position adjacent theembolic protection device28. During the inserting thereof, theinner catheter78 is adapted to maintain a clinically acceptable profile and flexibility. Theouter catheter90 is then inserted into the patient'svasculature12 so as to extend about theinner catheter78, to a position extending about and capturing theembolic protection device28 therein. Theouter catheter90 is then removed through the patient'svasculature12, with theinner catheter76 and theembolic protection device28 enclosed therein. A clinically acceptable profile and flexibility is maintained by theouter catheter90, and theinner catheter78, during removal thereof from the patient'svasculature12.
• In accordance with the present invention, the particular embodiments set forth above of thesystem10 and thesystem64 are capable of being positioned in theblood vessel12. However, other forms of thesystem10 and thesystem64 may be utilized with the present invention without departing from the spirit and scope of the invention. For example, thesystem10 and thesystem64 may be comprised of other forms of material. Additionally, while thesystem10 and thesystem64 are shown as in various shapes in the embodiments herein, they can be formed in any one of a number of different shapes depending upon the construction desired.
• Further, the various components may be joined by suitable adhesives such as acrylonitrile based adhesives or cyanoacrylate based adhesives. Heat shrinking or heat bonding may be employed where appropriate. Plastic-to-plastic or plastic-to-metal joints may be effected by a suitable acrylonitrile or cyanoacrylate adhesive. Variations may be made in the composition of the materials to vary properties as needed. Based on the present disclosure, other adhesives and applications may be made known to a person skilled in the art.
• In view of the above, the system and method of the first embodiment of the present invention are adapted to substantially enhance the effectiveness of performing interventional procedures, by enabling at least one operator to deliver an embolic protection device to a position for deployment thereof distal to an interventional procedure site in a patient's vasculature, and to remove the delivery system from the patient's vasculature. The article enables the operator to recover the embolic protection device and to remove the system and the embolic protection device from the patient's vasculature. The system and method of the second embodiment of the present invention substantially enhance the effectiveness of performing interventional procedures, by enabling the delivery of an embolic protection device to the position in the patient's vasculature distal to the interventional procedure site, for deployment thereof. The system also enables the delivery and removal of the delivery system from the patient's vasculature, while maintaining a clinically acceptable profile and flexibility. It also enables the recovery of the embolic protection device and the removal of the system and the embolic protection device, while maintaining the clinically acceptable profile and flexibility during the recovery and removal thereof through the patient's vasculature.
• While the present invention has been described in connection with the specific embodiments identified herein, it will be apparent to those skilled in the art that many alternatives, modifications and variations are possible in light of the above description. Accordingly, the invention is intended to embrace all such alternatives, modifications and variations as may fall within the spirit and scope of the invention disclosed herein.

Claims (17)

1. A system for enabling the delivery of an embolic protection device to a position in a patient's vasculature distal to an interventional procedure site, for deployment of the embolic protection device, wherein the delivery system is adapted to maintain a clinically acceptable profile and flexibility during the delivery and removal thereof through the patient's vasculature, comprising:

a guide wire, including a distal end, adapted to be positioned within the blood vessel and to extend to a position distal to the interventional procedure site, and to include an embolic protection device mounted on the distal end thereof; and

a delivery sheath, including a distal end, wherein the delivery sheath has a lumen therein extending in the delivery sheath to the distal end thereof, and wherein the guide wire and the embolic protection device are adapted to extend in and through the lumen, the delivery sheath and the guide wire are adapted to enable the embolic protection device to be delivered and deployed distal to the interventional procedure site, and the delivery sheath comprises dimensions and materials adapted to provide a low profile, flexibility for enabling tracking thereof through the patient's vasculature, and rigidity for enabling pushing thereof through the patient's vasculature, so as to maintain a clinically acceptable profile and flexibility during the delivery and removal thereof through the patient's vasculature.

2. The system ofclaim 1, wherein the delivery sheath includes a tip at the distal end thereof, adapted to be necked for providing a profile close to the guide wire, to inhibit kinking of the guide wire during the delivery and removal of the delivery sheath.

3. The system ofclaim 1, wherein the delivery sheath includes a main shaft, adapted to provide the low profile, flexibility, and rigidity.

4. The system ofclaim 1, further comprising a system for enabling the recovery of the embolic protection device from the position in the patient's vasculature distal to the interventional procedure site, for removal of the embolic protection device, wherein the recovery system is adapted to maintain a clinically acceptable profile and flexibility during the delivery and removal of the recovery system through the patient's vasculature, and wherein the recovery system includes an inner catheter, including a distal end, wherein the inner catheter has a lumen therein extending in the inner catheter to the distal end thereof, and wherein the inner catheter is adapted to extend over the guide wire, and the distal end of the inner catheter is adapted to be positionable adjacent the embolic protection device, and wherein the inner catheter comprises dimensions and materials adapted to enable a smooth transition for movement thereof along the guide wire, to inhibit kinking of the guide wire during the delivery and removal of the inner catheter, and to maintain a clinically acceptable profile and flexibility during the delivery and removal thereof through the patient's vasculature.

5. The system ofclaim 2, wherein the tip of the delivery sheath is comprised of material adapted to be soft, to inhibit trauma to the patient's vasculature.

6. The system ofclaim 5, wherein the main shaft of the delivery sheath is comprised of PeBax, of about 72 Durometer.

7. The system ofclaim 4, wherein the recovery system further includes an outer catheter, including a distal end, wherein the outer catheter has a lumen therein extending in the outer catheter to the distal end thereof, the outer catheter is adapted to extend over the inner catheter, and the outer catheter comprises dimensions and materials adapted to enable a smooth transition for movement thereof along the inner catheter, to enable the capturing of the embolic protection device, and to inhibit trauma to the patient's vasculature, so as to maintain a clinically acceptable profile and flexibility during the delivery and removal thereof through the patient's vasculature.

8. The system ofclaim 5, wherein the tip of the delivery sheath is comprised of a compound including PeBax, of about 40 Durometer, and bismuth.

9. The system ofclaim 7, wherein the outer catheter includes a main shaft, adapted to enable the smooth transition, and to inhibit trauma.

10. The system ofclaim 7, wherein the outer catheter includes a distal end, and a tip at the distal end, adapted to enable the smooth transition, and to capture the embolic protection device, and comprised of material adapted to be soft, to inhibit trauma to the patient's vasculature.

11. The system ofclaim 9, wherein the main shaft of the outer catheter is comprised of a high density PE.

12. The system ofclaim 10, wherein the tip of the outer catheter is comprised of a compound including PeBax, of about 40 Durometer, and bismuth.

13. A method of enabling at least one operator to control the delivery of an embolic protection device to a position in a patient's vasculature distal to an interventional procedure site for deployment of the embolic protection device, to enable the operator to control the removal of the delivery system from the patient's vasculature for the exchange of the delivery system, and to enable control of the position of a deployed embolic protection device within the patient's vasculature during an exchange of interventional devices, in a system which comprises a guide wire, including a distal end, adapted to be positioned within the blood vessel and to extend to a position distal to the interventional procedure site, and to include an embolic protection device mounted on the distal end thereof, and a catheter, including a distal end, wherein the catheter has a lumen therein extending in the catheter to the distal end thereof, and wherein the guide wire and the embolic protection device are adapted to extend in and through the lumen, the catheter and the guide wire are adapted to enable the embolic protection device to be delivered and deployed distal to the interventional procedure site, and the catheter includes a manipulation-enabling element for enabling at least one operator to manipulate the guide wire and the catheter independently so as to enable removal of the catheter from the patient's vasculature, wherein the method comprises:

the at least one operator:

inserting the guide wire with the embolic protection device mounted on the distal end thereof and the catheter into the blood vessel to the position distal to the interventional procedure site;

deploying the embolic protection device at the position thereof distal to the interventional procedure site;

detaching the catheter from the embolic protection device; and

manipulating the guide wire and the catheter independently so as to control the removal of the catheter from the patient's vasculature.

14. The method ofclaim 13, further comprising a system for enabling the at least one operator to control the recovery of the embolic protection device, from the delivered and deployed position thereof, for the exchange of the recovery system, further comprising inserting the catheter through the patient's vasculature to a position adjacent the embolic protection device, capturing the embolic protection device, and manipulating the guide wire and the catheter independently so as to control the removal of the catheter and the embolic protection device from the patient's vasculature.

15. A method of enabling the delivery of an embolic protection device to a position in a patient's vasculature distal to an interventional procedure site, for deployment of the embolic protection device, in a delivery system which is adapted to maintain a clinically acceptable profile and flexibility during the delivery and removal thereof through the patient's vasculature, wherein the delivery system comprises a guide wire, including a distal end, adapted to be positioned within the blood vessel and to extend to a position distal to the interventional procedure site, and to include an embolic protection device mounted on the distal end thereof, and a delivery sheath, including a distal end, wherein the delivery sheath has a lumen therein extending in the delivery sheath to the distal end thereof, and wherein the guide wire and the embolic protection device are adapted to extend in and through the lumen, the delivery sheath and the guide wire are adapted to enable the embolic protection device to be delivered and deployed distal to the interventional procedure site, and the delivery sheath comprises dimensions and materials adapted to provide a low profile, flexibility for enabling tracking thereof through the patient's vasculature, and rigidity for enabling pushing thereof through the patient's vasculature, so as to maintain a clinically acceptable profile and flexibility during the delivery and removal thereof through the patient's vasculature, and wherein the method comprises:

extending the guide wire with the embolic protection device mounted on the distal end thereof through the lumen in the delivery sheath such that the embolic protection device is positioned at the tip of the delivery sheath;

delivering the delivery sheath through the patient's vasculature, so as to enable delivery of the embolic protection device for deployment thereof at the position distal to the interventional procedure site, including enabling the delivery sheath to maintain a clinically acceptable profile and flexibility during delivery thereof; and

removing the delivery sheath through the patient's vasculature, including enabling the delivery sheath to maintain a clinically acceptable profile and flexibility during removal thereof.

16. The method ofclaim 15, further comprising a system for enabling the recovery of the embolic protection device from the position in the patient's vasculature distal to the interventional procedure site, for removal of the embolic protection device, wherein the recovery system is adapted to maintain a clinically acceptable profile and flexibility during the delivery and removal of the recovery system through the patient's vasculature, and wherein the recovery system includes an inner catheter, including a distal end, wherein the inner catheter has a lumen therein extending in the inner catheter to the distal end thereof, the inner catheter is adapted to extend over the guide wire, and the distal end of the inner catheter is adapted to be positionable adjacent the embolic protection device, and the inner catheter comprises dimensions adapted to enable a smooth transition for movement thereof along the guide wire, to inhibit kinking of the guide wire during the delivery and removal of the inner catheter, and to maintain a clinically acceptable profile and flexibility during the delivery and removal thereof through the patient's vasculature, further comprising delivering the inner catheter through the patient's vasculature to the position adjacent the proximal end of the embolic protection device, including maintaining a clinically acceptable profile and flexibility during delivery thereof.

17. The method ofclaim 16, wherein the recovery system further includes an outer catheter, including a distal end, wherein the outer catheter has a lumen therein extending in the outer catheter to the distal end thereof, the outer catheter is adapted to extend over the inner catheter, and the outer catheter comprises dimensions and materials adapted to enable a smooth transition for movement thereof along the inner catheter, to enable the capturing of the embolic protection device, and to inhibit trauma to the patient's vasculature, so as to maintain a clinically acceptable profile and flexibility during the delivery and removal thereof through the patient's vasculature, further comprising delivering the outer catheter through the patient's vasculature so as to extend along the inner catheter and enclose the embolic protection device therein, including maintaining a clinically acceptable profile and flexibility during delivery thereof, and removing the outer catheter through the patient's vasculature with the inner catheter and the embolic protection device enclosed therein, including maintaining a clinically acceptable profile and flexibility during removal thereof.

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