Abstract:
The general purpose of the present invention is to provide a catheter for removal of an organized embolic thrombus, preferably in conjunction with a distal occlusion balloon guidewire. The present invention consists of three main components including a capture/delivery sheath, a capture sleeve of mesh attached to a tube and a grasping mechanism attached to another tube which is central to the other components. Operative structures in the form of manifolds are connected to such components in order to manipulate and control the relative positions of the capture/delivery sheath, the capture sleeve and the grasping mechanism. An embolic thrombus is engaged by the deployable automatically expanding serrated fingers of a grasping mechanism in combination with a deployable automatically expanding mesh capture sleeve. The capture/delivery sheath is maneuvered to cause compression of the serrated fingers and of the mesh capture sleeve for subsequent removal of the embolic thrombus.

Description:
CROSS REFERENCES TO RELATED APPLICATIONS 
     This application claims priority from the earlier filed U.S. Provisional Application No. 60/934,268 filed Jun. 12, 2007, entitled “Catheter for Removal of Organized Embolic Thrombus”, and is hereby incorporated into this application by reference as if fully set forth herein. 
     This patent application is related to patent application Ser. No. 11/581,613 filed on Oct. 16, 2006, entitled “Occlusive Guidewire System Having an Ergonomic Handheld Control Mechanism Prepackaged in a Pressurized Gaseous Environment and a Compatible Prepackaged Torqueable Kink-Resistant Guidewire With Distal Occlusive Balloon”, which is pending. The prior application is hereby incorporated into this application by reference as if fully set forth herein. 
    
    
     BACKGROUND OF THE INVENTION 
     1. Field of the Invention 
     Tough organized embolic thrombus found in the vasculature of the human body may evolve from various origins. A trial thrombus that forms and organizes over the course of days or weeks can dislodge and create an acute arterial blockage. Another example would be a patient with peripheral arterial disease with thrombus in various stages of organization. An intervention procedure could dislodge organized thrombotic debris. The challenge with this debris is that it can be large and difficult to remove with currently available interventional tools. Balloons can smash the debris against the vessel wall if it can be located. Alternatively, there is a class of patients with acute peripheral occlusions, which patients are often immediately referred to surgery for an embolectomy procedure (Fogarty balloon) since this is an efficacious means of addressing the occlusion. The purpose of this invention is to make a practical device to enable an interventional alternative to this surgical embolectomy procedure. The present invention used in conjunction with other interventional equipment is capable of removing a tough and organized embolic thrombus in an interventional procedure. The present invention describes an intravascular catheter and procedure used for purposes of removing an organized embolic thrombus. The catheter generally consists of a grasping mechanism, a mesh capture sleeve, a capture/delivery sheath and housings which catheter is used for relative positioning of the grasping mechanism, the mesh capture sleeve, and the capture/delivery sheath. The catheter of the present invention is delivered over a guidewire. Typically, the guidewire would have a distal occlusion balloon for purposes of drawing the embolic material to within the grasping mechanism. 
     2. Description of the Prior Art 
     Surgical embolectomy is a viable method of removing a tough embolic thrombus. However, this surgical procedure is more invasive than an interventional procedure. In general, reducing the invasiveness of the procedure reduces the associated complications. With respect to interventional alternatives, the methods can range from infusion catheters which drip fibrinolytics to balloon procedures which compress the debris against the vessel wall to aspiration with large guide catheters. The debris is generally too tough for removal by mechanical thrombectomy catheters. Fibrinolytic infusion is a viable technique but not guaranteed to be successful. In addition, fibrinolytics are associated with adverse complications such as bleeding or hemorrhagic stroke. With respect to compressing the debris with a balloon or stent, this technique includes deficiencies. First, the debris is not always easily found via fluoroscopy. Second, stenting a thrombus does not remove it from the body and just ballooning and compressing the material will not guarantee that the debris would not further embolize distally. 
     SUMMARY OF THE INVENTION 
     The general purpose of the present invention is to provide a catheter for removal of an organized embolic thrombus and method of use. The present invention consist of three main parts: (a) a capture/delivery sheath; (b) a capture sleeve of mesh attached to a tube; and (c) a grasping mechanism attached to another tube which is central to the other two components. Other structures in the form of manifolds attach to such tubes to control the relative positions of the a capture/delivery sheath, the capture sleeve, and the grasping mechanism. Preferably, the invention is used with a 0.014″ distal occlusion balloon guidewire (Guard Dog®) of the previously referenced patent application Ser. No. 11/581,613 or with another suitable pulling device, such as by the inventors or others. The inflatable balloon of the distal occlusion balloon guidewire is advanced past the debris, the balloon is inflated, and the balloon is retracted toward the present invention (analogous to a Fogarty procedure except that a Fogarty procedure uses a surgical opening to withdraw the material). The present invention provides a procedure for the successful capture of the debris. The present invention is introduced into the vasculature to the site of embolic thrombus material, also referred to herein as debris, and then telescoped appropriately along the length of the invention. The capture sleeve is advanced and automatically deployed outwardly beyond the capture/delivery sheath. The grasping mechanism is advanced and automatically deployed outwardly beyond the capture sleeve. In the anticipated procedure, the balloon of the distal occlusion balloon guidewire is inflated and used to pull the debris into the outwardly deployed serrated fingers of the grasping mechanism. Both the serrated fingers of the grasping mechanism and the inflated balloon of the distal occlusion balloon guidewire are pulled into the capture sleeve. Then, the inflatable balloon of the distal occlusion balloon guidewire is either advanced out of the capture sleeve or deflated. At this point, the capture/delivery sheath is advanced over the capture sleeve and grasping mechanism to capture the embolic material therein. As the capture/delivery sheath is advanced, the embolic material (debris) is squeezed downwardly and forwardly past the serrated teeth of the fingers. The serrations help tear and reduce the embolic material to smaller pieces as it is finally contained within the fingers and capture sleeve when the capture/delivery sheath is deployed fully thereover. The capture sleeve and the grasping mechanism along with the captured embolic material is withdrawn proximally along the length of the capture/delivery sheath, whereupon the embolic material can be removed from the vasculature and detached from the grasping mechanism. Another capture sleeve and grasping mechanism can be introduced or the same capture sleeve and the grasping mechanism can be cleaned and reintroduced into the vasculature via the capture/delivery sheath if required. 
     According to one or more embodiments or illustrations of the present invention, there is provided a catheter for removal of an organized embolic thrombus which is telescopeable along the length thereof including a capture/delivery sheath attached to a capture/delivery sheath operator in the form of a manifold, a capture sleeve of preformed memory shape mesh and attached capture sleeve positioning tube and capture sleeve operator in the form of a manifold, and a grasping mechanism having preformed memory shape serrated fingers and an attached grasping mechanism positioning tube and a grasping mechanism operator in the form of a manifold. 
     One significant aspect and feature of the present invention is the use of a catheter for the removal of an organized embolic thrombus during interventional procedures. 
     One significant aspect and feature of the present invention is the use of an organized embolic thrombus capture device which is preferably used in combination with a 0.014″ distal occlusion balloon guidewire. 
     One significant aspect and feature of the present invention is the intention for use with a distal occlusion balloon, a distal filter or a distal cage on a guidewire for pulling debris to engage the present invention. 
     One significant aspect and feature of the present invention is the use of a catheter for the removal of an organized embolic thrombus, which catheter comprises a telescoping capture mechanism having (a) a capture/delivery sheath and a capture/delivery sheath operator; (b) a grasping mechanism, a grasping mechanism positioning tube and a grasping mechanism operator; and (c) a capture sleeve (mesh), a capture sleeve positioning tube and a capture sleeve operator. 
     One significant aspect and feature of the present invention is the use of a capture sleeve made from a nitinol and polyester mesh. 
     One significant aspect and feature of the present invention is the use of a thermal or laser source to stop the open end of the mesh capture sleeve (a nitinol/polymer weave) from fraying by melting the polymer ends thereof. 
     Another significant aspect and feature of the present invention is the use of nitinol for the grasping mechanism. 
     One significant aspect and feature of the present invention is the use of heat treated stainless steel for the grasping mechanism. 
     Another significant aspect and feature of the present invention is a grasping mechanism with two or more serrated fingers. 
     One significant aspect and feature of the present invention is a grasping mechanism operable within or extended from a mesh capture sleeve. 
     Yet another significant aspect and feature of the present invention is the use of a capture/delivery sheath for capturing an embolic thrombus or debris within a grasping mechanism and capture sleeve. 
     One significant aspect and feature of the present invention is the use of serrated fingers as the grasping mechanism in conjunction with the squeezing down and forward motion of a capture/delivery sheath in breaking up and reducing the size of the embolic debris, and wherein the serrations of the fingers act like teeth. 
     One significant aspect and feature of the present invention is the sequence in which the capture/delivery sheath, the grasping mechanism and a capture sleeve are used together in an optimal way of operating such a device. 
     An additional significant aspect and feature of the present invention is that using a CO 2  inflated balloon guidewire maximizes the internal space within the distal end of the invention available for debris capture since the gas inflated balloon guidewire occupies a small space. 
     Having thus briefly described one or more embodiments of the present invention, and having mentioned some significant aspects and features of the present invention, it is the principal object of the present invention to provide a catheter for removal of organized embolic thrombus and method of use. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       Other objects of the present invention and many of the attendant advantages of the present invention will be readily appreciated as the same becomes better understood by reference to the following detailed description when considered in connection with the accompanying drawings, in which like reference numerals designate like parts throughout the figures thereof and wherein: 
         FIG. 1  is an isometric overview of the catheter for removal of an organized embolic thrombus, the present invention; 
         FIG. 2  is an exploded isometric view of the components located at the distal region of the invention; 
         FIG. 3  illustrates a section of the woven mesh of a capture sleeve comprised of nitinol strands and multiple polymer strands; 
         FIG. 4  is an assembled view of the components of  FIG. 2 ; 
         FIG. 5  is a cross section side view of a grasping mechanism; 
         FIG. 6  is an isometric view in cutaway of the components of  FIG. 2 ; 
         FIG. 7  is a segmented cross section view of the capture/delivery sheath operator, the capture sleeve operator, and the grasping mechanism operator, each in the form of a manifold; 
         FIG. 8  is a partial cross section view of the distal end of the catheter for the removal of an organized embolic thrombus; 
         FIG. 9  is a cross section view in partial cutaway of the components of  FIG. 8 ; and, 
         FIGS. 10-15  are cross section side views illustrating the use of the invention for the removal of an embolic thrombus from a vessel. 
     
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS 
       FIG. 1  is an isometric overview of the catheter  10  of the present invention for removal of an organized embolic thrombus. Fully or partially visible components of the present invention include a multiple function capture/delivery sheath  12 , a distally located capture sleeve  14  shown in memory shape consisting of a nitinol and polymer mesh (shown in  FIG. 3 ) extending distally from within the capture/delivery sheath  12 , serrated fingers  16 ,  18  and  20  of a grasping mechanism  22  ( FIG. 2 ) shown in memory shape, a capture/delivery sheath operator  24  in the form of a manifold attached to the proximal end of the capture/delivery sheath  12 , a capture sleeve operator  26  in the form of a manifold in general longitudinal alignment with the capture/delivery sheath operator  24 , and a grasping mechanism operator  28  in the form of a manifold in general longitudinal alignment with the capture sleeve operator  26 . 
       FIG. 2  is an exploded isometric view of the components located at the distal region of the invention. The components maintain a coaxial relationship along and about the longitudinal axis of the invention consisting of inner, middle and outer components. The inner components consist of a grasping mechanism  22  having a memory shape preferably of nitinol or heat treated stainless steel and an attached grasping mechanism positioning tube  30  of braided polyimide or alternatively of flexible stainless steel, the middle components consist of the capture sleeve  14  and an attached capture sleeve positioning tube  32 , and the outer component consists of a capture/delivery sheath  12  made of a flexible plastic material or some other suitable flexible material. The inner, middle and outer components maintain a coaxial relationship and are also attached to the capture/delivery sheath operator  24 , the capture sleeve operator  26 , and the grasping mechanism operator  28 , respectively. More precisely, the grasping mechanism  22  is attached to the grasping mechanism operator  28  by the mutually attached grasping mechanism positioning tube  30 ; the capture sleeve  14  is attached to the capture sleeve operator  26  by a mutually attached capture sleeve positioning tube  32 , and the capture/delivery sheath  12  is connected directly to the capture/delivery sheath operator  24 . 
     The geometrically configured flexible capture sleeve  14  is generally tubular in shape and consists of a woven mesh preferably consisting of single nitinol strands  34  and multiple polymer strands  36 , a representative section of which is shown in  FIG. 3 . All or a greater portion of the capture sleeve  14  is heat treated or otherwise treated to have an expanded memory shape. A constant diameter proximal section  38  of the capture sleeve  14  is attached to the distal end of the flexible capture sleeve positioning tube  32  of braided polyimide or alternatively of flexible stainless steel, by an adhesive, a weldment, or other suitable method. The capture sleeve  14  also includes a flared section  40  extending from the proximal section  38  and a tubular distal section  42  extending distally from the flared section  40  where such tubular distal section  42  can assume an expanded constant diameter or which may be conformal. The distal annular edge  44  of the capture sleeve  14  is prevented from fraying by melting the ends of the polymer strands  36  with a thermal or laser source or some other suitable method. The grasping mechanism  22  which can consist of nitinol, stainless steel or some other suitable material is also shown and further described in  FIG. 4 . 
       FIG. 4  is an assembled view of the components of  FIG. 2  showing the capture sleeve  14  in dashed lines, and  FIG. 5  is a cross section side view of the grasping mechanism  22 . In the illustration of  FIG. 4 , the capture/delivery sheath  12  is shown retracted from over the capture sleeve  14  in order to allow the outward expansion of the capture sleeve  14  into its memory or conformal shape. Shown, in particular, in  FIGS. 4 and 5  is the one-piece grasping mechanism  22  which includes serrated fingers  16 ,  18  and  20 , each of which extends distally from a tubular section  46  of the grasping mechanism  22 . The serrated fingers  16 ,  18  and  20  of the one-piece grasping mechanism  22  are shown in the memory shape partially extending from the distal end of the capture sleeve  14 . The distal end of the grasping mechanism positioning tube  30  is fitted within the interior of the tube section  46  and secured therein, such as by a weldment, an adhesive, or another suitable method. The serrated fingers  16 ,  18  and  20  can be arcuate in cross section or may be any other suitable profile. The similarly configured serrated fingers  16 ,  18  and  20  have like features including flexible joint sections  48  transitioning between the tubular section  46  and the serrated fingers  16 ,  18  and  20 . Each of the similarly configured serrated fingers  16 ,  18  and  20  includes a serrated edge  50 , an adjacent shorter smooth edge  52 , an opposed serrated edge  54 , and an adjacent shorter smooth edge  56 , the fingers extending distally from the flexible joint sections  48 . A smooth surface  58  is located between the opposed smooth edges  52  and  56 , and an elongated smooth surface  60  is located between the serrated edges  50  and  54 . The surfaces  58  and  60  are preferably smooth surfaces, but such surfaces could include multi-dimensional frictional surfaces for assistance in gripping, grasping or otherwise frictionally engaging an embolic thrombus, such as, but not limited to, surfaces having grooves, serrations, cross hatches, teeth, gritty surfaces, perforations, and the like. Although serrations are located along serrated edges  50  and  54  of the serrated fingers  16 ,  18  and  20 , other configurations which could grasp, cut, tear, sever or otherwise act to separate embolic thrombus debris can also be used. 
     One method of forming the serrations would be to provide a series of closely spaced holes in end to end tangency or near tangent alignment and then cutting them with a laser or by slicing or otherwise providing for separation of the holes along the tangency or near tangency whereby the remaining semi-circles provide lines of opposing serrated edges. Although semi-circular serrations are shown, other geometric serration like configurations could include, but are not limited to, a saw tooth configuration, grooves, crosshatch surfaces, teeth, gritty surfaces, perforations and the like. 
       FIG. 6  is an isometric cutaway view of the components of  FIG. 2  where the distal portion of the capture/delivery sheath  12  is shown over and about and compressing the capture sleeve  14  and the grasping mechanism  22 . The relative positioning of the components, such as shown, is suitable for transitional use with a guidewire along the central tubular axis of such components. Especially noted is the compressed position of the arcuate serrated fingers  16 ,  18  and  20  of the grasping mechanism  22  which provides for a tubular passageway in combination with the tubular section  46  for direct guidewire passage therethrough. Such a guidewire can also pass directly through the grasping mechanism positioning tube  30  and indirectly through other closely associated components along the central tubular axis including the compressed capture sleeve  14 , the capture sleeve positioning tube  32 , and indirectly through the capture/delivery sheath operator  24 , the capture sleeve operator  26 , and the grasping mechanism operator  28 . 
       FIG. 7  is a segmented cross section view of the capture/delivery sheath operator  24 , the capture sleeve operator  26 , and the grasping mechanism operator  28 , each in the form of a manifold found commonly in the art. The capture/delivery sheath operator  24 , the capture sleeve operator  26 , and the grasping mechanism operator  28  are used in an end-to-end alignment, such as shown in  FIG. 1 , and are used to telescopingly position distally located components at the distal end of the invention using coaxially aligned tubular structures, the relationship of which is described with reference to  FIG. 2 . Briefly described, each operator includes a manifold body  62 , a central passageway  64  extending along the manifold body  62 , a seal  66 , a hemostasis valve  68 , a Luer connector  70 , a tubular extension  72  (including a tubular passageway  73 ) extending through the Luer connector  70 , a branch passageway  74 , and a cap  76  which may be in the form of a Luer fitting. 
     The proximal end of the capture/delivery sheath  12  extends partially along the central passageway  64  of the capture/delivery sheath operator  24  and is positionally fixed therein by the use of an adhesive or another suitable method at the annular junction of the capture/delivery sheath  12  and the tubular extension  72  in the Luer connector  70  of the capture/delivery sheath operator  24 . Generally, the capture/delivery sheath  12  can be positionably, telescopingly and variably aligned directly over and about portions of the capture sleeve positioning tube  32  and over and about the connected capture sleeve  14 , and indirectly over and about portions of the grasping mechanism positioning tube  30  and over and about the connected distally located grasping mechanism  22 . 
     The proximal end of the capture sleeve positioning tube  32  extends partially along the central passageway  64  of the capture sleeve operator  26  and is positionally fixed therein by the use of an adhesive or another suitable method at the annular junction of the capture sleeve positioning tube  32  and the tubular extension  72  in the Luer connector  70  of the capture sleeve operator  26 . Additionally, the capture sleeve positioning tube  32  extends distally to enter the hemostasis valve  68 , the seal  66  and the central passageway  64  of the capture/delivery sheath operator  24 , and thence through the capture/delivery sheath  12  to connect to the distally located capture sleeve  14 . The capture sleeve operator  26  can be used to slidingly position the capture sleeve positioning tube  32  (having the connected capture sleeve  14 ) along and within the capture/delivery sheath  12  in order to longitudinally position the capture sleeve  14  out of the influence of the capture/delivery sheath  12  or to return the capture sleeve  14  into the influence of the capture/delivery sheath  12 . The seal  66  of the capture/delivery sheath operator  24  provides a slight pressure, which can easily be overcome, against the circumference of the capture sleeve positioning tube  32  in order to maintain the adjustable position of the capture sleeve positioning tube  32  with respect to the capture/delivery sheath operator  24  and to other associated telescopic components. Generally, the capture sleeve  14 , connected to a capture sleeve positioning tube  32 , can be positionably, telescopingly, and variably aligned directly over and about the grasping mechanism positioning tube  30  and connected grasping mechanism  22 . 
     The proximal end of the grasping mechanism positioning tube  30  extends through the seal  66  and along the central passageway  64  of the grasping mechanism operator  28  and is positionally fixed therein by the use of adhesive or other suitable method at the annular junction of the grasping mechanism positioning tube  30  and the passageway  72  in the Luer connector  70  of the grasping mechanism operator  28 . Additionally, the grasping mechanism positioning tube  30  extends distally to enter the hemostasis valve  68 , the seal  66 , and the central passageway  64  of the capture sleeve operator  26 , and thence through the capture sleeve positioning tube  32  to connect to the distally located grasping mechanism  22 . The grasping mechanism operator  28  can be used to slidingly position the grasping mechanism positioning tube  30  (connected to the grasping mechanism  22 ) along and within the capture sleeve positioning tube  32  in order to position the grasping mechanism  22  longitudinally with respect to the capture/delivery sheath  12  and the capture sleeve  14 . The seal  66  of the capture sleeve operator  26  provides slight pressure, which can easily be overcome, against the circumference of the grasping mechanism positioning tube  30  in order to maintain the adjustable position of the grasping mechanism positioning tube  30  with respect to the capture sleeve operator  26  and to other associated telescopic components. 
       FIG. 8  is a partial cross section view of the distal end of the catheter  10  for the removal of an organized embolic thrombus showing the compression of the capture sleeve  14  and of the serrated fingers of the grasping mechanism  22  by the capture/delivery sheath  12  which surrounds them. It is noted that the interior regions of the assembled components provide unrestricted access for use with a guidewire. 
       FIG. 9  is a cross section view in partial cutaway of the components of  FIG. 8  where the capture/delivery sheath  12  has been positioned proximally and where the grasping mechanism  22  has been positioned distally a short distance, but in partial alignment with the capture sleeve  14 . When not under the influence of the capture/delivery sheath  12 , the grasping mechanism  22  and the capture sleeve  14  expand outwardly toward their memory shape positions. 
     MODE OF OPERATION 
     The mode of operation of the catheter  10  for the removal of an organized embolic thrombus is described in steps in  FIGS. 10-15 , preferably with the use of a distal occlusion balloon guidewire  76  having at least an inflation tube  78  and an inflatable distal occlusion balloon  80 , such as, but not limited to, that previously referenced in patent application Ser. No. 11/581,613, or with another suitable pulling device, such as by the present inventors or others. The invention is used in a telescopic fashion, whereby the capture/delivery sheath operator  24 , the capture sleeve operator  26 , and the grasping mechanism operator  28  can be appropriately spaced and positioned longitudinally with respect to each other in order to change, affix, adjust or otherwise suitably influence the positional relationship of the distally located components, such as the capture/delivery sheath  12 , the capture sleeve  14 , the grasping mechanism  22 , and the distal occlusion balloon guidewire  76  with respect to each other, as well as the closely associated and corresponding grasping mechanism positioning tube  30  and the capture sleeve positioning tube  32 . The distal occlusion balloon guidewire  76  is also positionable with respect to the catheter  10 . The capture/delivery sheath operator  24 , the capture sleeve operator  26 , the grasping mechanism operator  28 , and the distal occlusion balloon guidewire  76  can be operated independently one or more at a time in order to effect particular positional and functional relationships. The capture/delivery sheath operator  24 , the capture sleeve operator  26 , the grasping mechanism operator  28  associated with the capture/delivery sheath  12 , the capture sleeve  14  and the grasping mechanism  22  and associated positioning tubes can, as well as the distal occlusion balloon guidewire  76 , be operated individually or unitarily two or more at a time. 
       FIG. 10  is in general a cross section view (except for a the view of the distal portion of the suitable distal occlusion balloon guidewire  76 ) illustrating a step in the use of the catheter  10  with the distal occlusion balloon guidewire  76  where the distal tip of the guidewire  76  has been advanced through a blood vessel  82  and through the body of an embolic thrombus  84  located in the blood vessel  82  in order to position the occlusion balloon  80  a short distance distal to the embolic thrombus  84 . 
     The other part of this step requires, preferably, that the capture/delivery sheath operator  24 , the capture sleeve operator  26 , and the grasping mechanism operator  28  first are individually positioned longitudinally with respect to each other to mutually align the capture sleeve  14 , the grasping mechanism  22 , and the distal end of the capture/delivery sheath  12  at the distal end of the catheter  10 , as shown in  FIG. 6 , for accommodation by the distal occlusion balloon guidewire  76 , whereby the catheter  10  can be positioned unitarily over and about the distal occlusion balloon guidewire  76 . Subsequent to such mutual alignment, the distal end of the catheter  10  is introduced into the blood vessel  82  over and about the distal occlusion balloon guidewire  76  in order to position the distal end of the capture/delivery sheath  12  at a location proximal to and near the site of the embolic thrombus  84 . The distal occlusion balloon guidewire  76  is slidingly accommodated, either directly or indirectly, within the coaxially aligned components including the tubular like center of the compressed and closely juxtaposed serrated fingers  16 ,  18  and  20  of the grasping mechanism  22 , the tubular section  46  of the grasping mechanism  22 , the compressed capture sleeve  14 , the grasping mechanism positioning tube  30 , and the capture sleeve positioning tube  32 . The distal occlusion balloon guidewire  76  is also slidingly accommodated within the tubular extension  72  of the Luer connector  70 , the central passageway  64 , the seal  66 , the hemostasis valve  68 , and other components associated with each of the following components including the capture/delivery sheath operator  24 , the capture sleeve operator  26 , and the grasping mechanism operator  28  ( FIG. 7 ). 
       FIG. 11  illustrates a step where (1) the capture/delivery sheath operator  24  is positioned proximally to withdraw the distal portion of the capture/delivery sheath  12  from a compressive intimate contact with the capture sleeve  14  and from an indirect compressive transmitted contact with the serrated fingers  16 ,  18  and  20  of the grasping mechanism  22  in order to allow automatic expansion of the capture sleeve  14  and the serrated fingers  16 ,  18  and  20  to their conformal or memory shape; where (2) the grasping mechanism operator  28  is positioned distally to advance the grasping mechanism  22  distally to advance the serrated fingers  16 ,  18  and  20  partially or fully beyond the capture/delivery sheath  12 ; and where (3) the occlusion balloon  80  of the distal occlusion balloon guidewire  76  is inflated for the purpose of contacting and urging the embolic thrombus  84  in a proximal direction. 
       FIG. 12  illustrates a step where the distal occlusion balloon guidewire  76  has been positioned proximally, whereby the proximally moving inflated occlusion balloon  80  intimately contacts and urges the embolic thrombus  84  in a proximal direction, such that the embolic thrombus  84  engages the apex of the serrated fingers  16 ,  18  and  20  and features thereof. The process of such engagement of the embolic thrombus  80  involves the direct contact of the embolic thrombus  84  with the main structure of the serrated fingers  16 ,  18  and  20  including a momentary contact with smooth surfaces  58  and smooth edges  52  and  56  ( FIG. 4 ) of the serrated fingers  16 ,  18  and  20  followed by a lasting contact with the smooth surfaces  60  and the serrated edges  50  and  54  ( FIG. 4 ) of the serrated fingers  16 ,  18  and  20 . Such engagement of the embolic thrombus  84  also involves an outward projection or reformation of the embolic thrombus  84  to extend between and outwardly from the spaces between the main structure of the serrated fingers  16 ,  18  and  20  including at least the serrated edges  50  and  54  of the serrated fingers  16 ,  18  and  20 . Preferably, the inflated occlusion balloon  80  is moved proximally a suitable and appropriate distance to be brought into contact with the smooth surfaces  58  and the smooth edges  52  and  56  of the serrated fingers  16 ,  18  and  20 , but not into contact with the serrated edges  50  and  54  of the serrated fingers  16 ,  18  and  20  in order to prevent an undesirable contacting of the inflated occlusion balloon  80  with the serrated edges  50  and  54 , thus protecting the integrity of the occlusion balloon  80 . 
       FIG. 13  illustrates a step where the grasping mechanism operator  28  and the distal balloon guidewire  76 , including the inflated occlusion balloon  80 , are unitarily positioned proximally, whereby the serrated fingers  16 ,  18  and  20  of the grasping mechanism  22 , the inflated occlusion balloon  80  at the distal end of the distal balloon guidewire  76 , the embolic thrombus  84  engaged between the serrated fingers  16 ,  18  and  20 , and the inflated occlusion balloon  80  are all repositioned within the bounds of the capture sleeve  14 . 
       FIG. 14  illustrates a step where (1) the occlusion balloon  80  at the distal end the distal occlusion balloon guidewire  76  is deflated; and where (2) the distal occlusion balloon guidewire  76  including the deflated occlusion balloon  80  is repositioned distally a short distance to remove the deflated occlusion balloon  80  from the bounds of the capture sleeve  14 ; or (3) the distal occlusion balloon guidewire  76  including the deflated occlusion balloon  80  is removed distally and withdrawn from the catheter  10  to remove the deflated occlusion balloon  80  from the bounds of the capture sleeve  14 . 
       FIG. 15  illustrates simultaneous steps where (1) the capture/delivery sheath operator  24  is progressively positioned distally, whereby the capture/delivery sheath  12  progressively, directly, forcibly and slideably engages and compresses the capture sleeve  14 ; and where (2) the capture/delivery sheath operator  24  simultaneously, progressively, forcibly and indirectly communicates with and compresses the serrated fingers  16 ,  18  and  20  by a force transmitted through the intermediately located capture sleeve  14  to the serrated fingers  16 ,  18  and  20 . 
     As the capture/delivery sheath  12  is advanced distally, the embolic thrombus  84  (debris) is squeezed and forced in an outward and distal direction past the serrated edges  50  and  54  of the progressively and continuously forced closing of the serrated fingers  16 ,  18  and  20 . The serrated edges  50  and  54  help to tear and reduce the embolic thrombus  84  into smaller pieces as it is progressively and then finally contained within the serrated fingers  16 ,  18  and  20  and capture sleeve  14  when the capture/delivery sheath  12  is distally deployed fully thereover. Subsequent to the compressed capture of the embolic thrombus  84  by the grasping mechanism  22  and the capture sleeve  14 , as previously described, the captured embolic thrombus  84  is removed proximally in another step when the grasping mechanism operator  28  and the capture sleeve operator  26  are simultaneously and unitarily removed proximally whereby the grasping mechanism positioning tube  30 , the compressed associated grasping mechanism  22 , the capture sleeve positioning tube  32  and the compressed associated capture sleeve  14  are all removed from the contact and influence of the capture/delivery sheath  12  and the associated capture/delivery sheath operator  24 . Subsequent to such removal, the embolic thrombus  84  can be removed from the grasping mechanism  22 . Another capture sleeve  14  and grasping mechanism  22  can be introduced or the same capture sleeve  14  and the grasping mechanism  22  can be cleaned and reintroduced into the blood vessel  82  via the capture/delivery sheath  12  and the distal occlusion balloon guidewire  76 , if required. 
     Various modifications can be made to the present invention without departing from the apparent scope thereof. 
     CATHETER FOR REMOVAL OF AN ORGANIZED EMBOLIC THROMBUS 
     Parts List 
     
         
           10  catheter for removal of organized embolic thrombus 
           12  capture/delivery sheath 
           14  capture sleeve 
           16  serrated finger 
           18  serrated finger 
           20  serrated finger 
           22  grasping mechanism 
           24  capture/delivery sheath operator 
           26  capture sleeve operator 
           28  grasping mechanism operator 
           30  grasping mechanism positioning tube 
           32  capture sleeve positioning tube 
           34  nitinol strands 
           36  polymer strands 
           38  proximal section 
           40  flared section 
           42  distal section 
           44  annular edge 
           46  tubular section 
           48  flexible joint section 
           50  serrated edge 
           52  smooth edge 
           54  serrated edge 
           56  smooth edge 
           58  smooth surface 
           60  smooth surface 
           62  manifold body 
           64  central passageway 
           66  seal 
           68  hemostasis valve 
           70  Luer connector 
           72  tubular extension 
           73  tubular passageway 
           73  tubular passageway 
           74  branch passageway 
           76  distal occlusion balloon guidewire 
           78  inflation tube 
           80  occlusion balloon 
           82  blood vessel 
           84  embolic thrombus