Patent Publication Number: US-2009222035-A1

Title: Intraluminal Mass Collector

Description:
The present invention relates generally to minimally invasive intravascular devices and, more particularly, to devices used to disconnect, collect, and remove an intraluminal mass from a luminal aspect of a blood vessel. 
     The present invention is related to U.S. patent application Ser. No. 11/290,450, filed on Dec. 1, 2005 and to U.S. Provisional Patent Application No. 60/726,618, filed on Oct. 17, 2005, both which are incorporated by reference as if fully set forth herein. 
    
    
     FIELD AND BACKGROUND OF THE INVENTION 
     Aortic Arch Protruding Thrombus (AAPT) is a unique clinical entity involving a thrombus that emerges off the aortic luminal wall along the proximal aorta; including the ascending segment, arch segment, and proximal descending segment of the aorta. AAPT is associated with life threatening emboli of occluding blood clots that are shed from the AAPT into arteries of the brain, internal organs and extremities. 
       FIG. 1A  is a representation of an aorta  100  connected to a heart  144 , showing an AAPT  170  in a proximal aorta  140 . AAPT  170  typically projects into a blood vessel lumen  148  from a thin stalk  172  attached to a luminal aspect  152  of proximal aorta  140 . 
     In a study of 22 cases, most AAPT&#39;s  170  were located in a distal arch  199 . Five were located adjacent to an innominate  130  artery, a left carotid  120  artery or a left subclavian  110  artery. (“Mobile Thromboses of the Aortic Arch Without Aortic Debris”, Theirry Laperche et al, “Circulation” 1997; 96: 288-294) 
     AAPT  170  comprises a typical thrombus composition, including fibrin, platelets, and blood cells. Due to the blood motion and beating of heart  144 , AAPT  170  partially disintegrates, shedding one or more fragments as embolus  180 . Embolus  180  may lodge, for example, in a celiac artery  132 , a superior mesenteric  124  artery, a renal artery  122 , or other organ-related blood vessel, causing tissue necrosis in associated organs, for example the spleen or intestine. 
     In  FIG. 1A , an embolus  182  is shown entering a superior mesenteric  124  artery, thereby blocking circulation to a portion of the upper intestines (not shown), likely causing ischemia and necrosis of a portion of the intestines. Necrosis of a portion of any internal organ is a medical emergency that typically requires open surgery and resection of the necrotic tissue. 
     AAPT  170  is considered responsible for approximately 3% of all peripheral emboli originating from a central source. AAPT  170  generally occurs in relatively young people that have no history of coronary or peripheral atherosclerosis, but may have high blood pressure, an undiagnosed tendency for arterial thrombosis and/or may be heavy smokers. 
     The pathogenesis of AAPT  170  has been attributed to rupture of a soft shallow atherosclerotic plaque located in the aortic arch and appears to be related to the exposure of necrotic core components to the blood stream; the core components including tissue factor, PAI-1 and ox-LDL. Formation of emboli from AAPT  170  can be compounded by pre-existing thrombophilia or a transitory pro-thrombotic state. 
     AAPT  170  is often first diagnosed on an ultrasound image that is made following a serious embolic incident, for example necrosis of a portion of the intestine or other internal organs. Systemic therapy with anticoagulants has not proven beneficial in preventing further emboli after the initial embolic episode. 
     To ensure that AAPT  170  does not cause further necrosis of other organ tissue, within a short period following removal of the necrotic organ tissue, the patient must be subjected to an open chest surgery to remove AAPT  170 . Open chest surgery is a major cardiovascular surgical procedure that includes cardiopulmonary bypass, deep hypothermia and arrest of the systemic circulation, all associated with high morbidity and mortality. 
     U.S. patent application Ser. No. 11/290,450, filed 1 Dec. 2005, of the inventor, teaches a method for disconnecting an AAPT using, inter alia, a large balloon catheter. The catheter is used to disconnect AAPT  170  from luminal aspect  152  of proximal aorta  140  so that AAPT  170  passes in a direction  118  through lumen  148  along with the blood flowing through lumen  148 . AAPT  170  is then collected downstream, typically in a common iliac artery  194  branch, for example a right  134  or a left  135  femoral artery. 
     A very real concern of the catheter procedure is that AAPT  170  may break up during or following detachment from stalk  172  and lodge in a critical branch of the aorta, causing, for example, organ necrosis. This is of particular concern when the procedure is performed by an inexperienced surgeon or when AAPT  170  is located in an irregularly shaped aorta  100 , making disconnection difficult. 
     Small vessel embolic debris collection devices are known, but would not be effective in disconnecting, collecting and removing AAPT  170 . U.S. Pat. No. 4,873,978 to Ginsburg, for example, teaches a collection device, without a means of disconnecting AAPT  170 , which must be retracted into a small diameter catheter, likely causing a disastrous breakup of AAPT  170 . 
     U.S. patent application Ser. No. 10/854,920, published as US 2005/0277976 to Galdonik et al., teaches a three-dimensional matrix designed to filter and route small amounts of embolic debris into a tiny catheter opening. 
     If the Galdonik device were used for AAPT disconnection, collection and removal, the filtering matrix would likely cause breakup of AAPT  170 . Since the filtering matrix does not fully span the lumen, chunks of AAPT  170  would easily bypass the filter causing the above-noted disastrous consequences. Additionally, the Galdonik filter matrix is not collapsible so enlarging the filtering matrix would require open chest surgery and introduction directly into the aorta, the very procedure that must be avoided in dealing with AAPT  170 . 
     In spite of the need for a minimally invasive device for disconnecting, collecting and removing AAPT  170 , there are presently no such devices available. The lack of an appropriate device allowing rapid disconnection, collection and removal of AAPT  170  means that by default, open chest surgery, with its high associated risks of morbidity, remains the procedure of choice. 
     SUMMARY OF THE INVENTION 
     The present invention successfully addresses at least some of the shortcomings of the prior art by providing a device configured for the capture of an AAPT. 
     According to the teachings of the present invention, there is provided a catheter for disconnecting, collecting and removing an intraluminal mass from a luminal aspect of a blood vessel, comprising an elongate catheter body having a proximal portion and a distal portion, an elongate tubular element extending proximally from an end of the proximal catheter body portion, and an intraluminal mass collector configured for collecting an intraluminal mass from a blood vessel. 
     In a embodiments, the catheter has a body portion connected to the proximal portion of the catheter body and a radially expandable portion extending in a proximal direction from the body portion and surrounding at least a portion of the elongate tubular element, the expandable portion having a reduced diameter configuration with a reduced cross sectional size and at least one expanded diameter configuration, each expanded diameter configuration having a respective expanded cross sectional size. Additionally, in embodiments the catheter comprises a disconnector configured for disconnecting an intraluminal mass from a luminal aspect of a blood vessel, the disconnector connected to a proximal portion of the elongate tubular element at a distance from the collector. 
     In embodiments, the collector is configured to strain an intraluminal mass from the blood when in the expanded diameter configuration. 
     In embodiments, the catheter includes a catheter sleeve slidably associated with at least a portion of the catheter body and configured to surround at least a portion of the collector in the reduced diameter configuration, prior to deployment. 
     In embodiments, the collector includes at least two substantially resilient rays extending from the collector body portion in a proximal direction towards an end of the radially expandable portion. 
     In embodiments, the collector has a diameter that is configured to span the large diameter of the aorta, typically between three and five centimeters and gently conforms to the often highly irregular aortic shape. 
     In embodiments, the body portion of the intraluminal mass collector comprises a ring-shaped component connected to the catheter body. 
     In embodiments, the at least two rays are attached to the ring using a process selected from the group including welding, adhesion, gluing and riveting. 
     In embodiments, proximal portions of each of the at least two rays are configured to resiliently flex outward to form at least one expanded cross sectional diameter; the extent of the outwards flexing is configured to be limited by the walls of a vessel in which the collector is deployed. In embodiments, the each of the at least two rays is configured to resiliently flex outward to form the at least one expanded cross sectional diameter. 
     In embodiments, the collector is configured to effectively collect a large AAPT and, accordingly, includes a sheet material operatively associated with the at least two rays, the material preferably forming a substantially conical shape pointing in a distal direction when the at least two rays are in an expanded diameter configuration. In embodiments, each of the rays has an internal and an external aspect and the material is attached to at least one of the internal aspects and the external aspects. 
     In embodiments, the material is attached to at least one of the at least two rays using a process selected from the group of sewing, adhesion, gluing, suturing, riveting and welding. 
     The collector is preferably configured to allow blood flow through the lumen while in the expanded state. In embodiments, the sheet material is selected from the group consisting of meshes and nets. 
     In embodiments, the material extends proximally beyond at least one of the at least two rays. 
     In embodiments, the material is from the group including a synthetic biostable polymer, a natural polymer, and an inorganic material. 
     In embodiments, the natural polymer is selected from the group consisting of cotton, linen and silk. 
     In embodiments, the catheter further includes at least one elongate flexible biasing element, having a first end attached to a first portion of the catheter sleeve, a second end attached to a second portion of the catheter sleeve, and a body between the first and second ends, the body being operatively associated with a proximal portion of each of the at least two rays. 
     In embodiments, the at least one flexible biasing element is configured to bias at least one of the at least two rays from an expanded diameter configuration to a smaller diameter configuration. 
     In embodiments, the biasing element is selected from the group consisting of wires, strings, threads, springs, ribbons, filaments, cables, yarn, and ropes. 
     In embodiments, a passage is operatively associated with a proximal portion of the at least one ray through which the body of the at least one elongate flexible biasing element passes. 
     In embodiments, the passage is formed from at least one of a bending of the proximal portion of the ray, and a shaped component attached to the proximal portion of the ray. 
     In embodiments, the catheter body includes a continuous aspiration channel from the distal portion and emerging into the collector body portion. 
     In embodiments, the catheter further includes a collector ray converger comprising a curved wall that slidingly substantially encircles a portion of the distal portion of the catheter body. 
     In embodiments, the collector ray converger is additionally configured to encircle at least a portion of at least one of the collector, and the catheter sleeve. 
     In embodiments, the collector ray converger is configured to provide a radially inward force on at least one of the at least two rays. 
     In embodiments, the collector ray converger is configured to reduce an intraluminal mass diameter, when the mass has been collected in the collector. 
     In embodiments, the catheter further comprises a balloon used in disconnecting an AAPT from a luminal aspect of a blood vessel. Preferably but not necessarily, the disconnector balloon is configured to inflate by introduction of a fluid through an inflation channel running through the catheter body and the elongate tubular element. 
     In embodiments, the balloon comprises a material from the group including rubber, silicon rubber, latex rubber, polyethylene, polyethylene terephthalate, and polyvinyl chloride. 
     In embodiments, the catheter body includes a substantially coaxial guide wire channel. 
     According to the teachings of the present invention, there is also provided a method for collecting emboli shed into circulation within the vascular system, the method comprising expanding an expandable lumen blocker on a first side of shed emboli within the vascular system, opening a collector on a second side of the emboli, moving the lumen blocker to contact the shed emboli so as to move shed emboli toward the collector, collecting the emboli within the collector, and closing the collector, thereby containing the shed emboli within the collector. 
     In embodiments of the method, the first side is proximal and the second side is distal. Alternatively, the first side is distal and the second side is proximal. 
     In embodiments, the method further includes treating a portion of a stenosed region using dilation. 
     In embodiments, the method further includes treating a portion of a stenosed region using laser ablation. 
     In embodiments, the method further includes treating a portion of a stenosed region by atherectomy. 
     In embodiments, the method further includes aspirating the shed emboli from the collector. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The invention for safely disconnection of an AAPT using a minimally invasive vascular surgical technique is described by way of example with reference to the accompanying drawings. With specific reference now to the drawings in detail, it is stressed that the particulars shown are by way of example and for purposes of illustrative discussion of the preferred method of the present invention only, and are presented in the cause of providing what is believed to be the most useful and readily understood description of the principles and conceptual aspects of the invention. In this regard, no attempt is made to show structural details of the invention in more detail than is necessary for a fundamental understanding of the invention, the description taken with the drawings making apparent to those skilled in the art how the methods of the invention may be embodied in practice. 
         FIG. 1A  (prior art) is a representation of an in situ AAPT, in accordance with an embodiment of the present invention; 
         FIGS. 1B ,  2 A- 2 C and  3 A- 3 C are representations of portions of a catheter for collecting an in situ AAPT, in accordance with an embodiment of the present invention; 
         FIG. 4A  is a representation of a Transoesophageal Echocardiograph (TEE) setup in accordance with an embodiment of the present invention; 
         FIGS. 4B ,  5 ,  6 ,  7 ,  8  and  9  demonstrate a minimally invasive technique using the a catheter based collector tool shown in  FIG. 3B , in accordance with an embodiment of the present invention; 
         FIGS. 10 ,  11  and  12  are cross sectional representations of the apparatus shown in  FIG. 5 , in accordance with an embodiment of the present invention; and 
         FIG. 13  is an alternative embodiment of the collector shown in  FIG. 5 , in accordance with an embodiment of the present invention. 
     
    
    
     DESCRIPTION OF THE PREFERRED EMBODIMENTS 
     In broad terms, the present invention relates to an apparatus for disconnecting, collecting and removing an AAPT using a minimally invasive vascular surgical technique. 
     The principles and uses of the teachings of the present invention may be better understood with reference to the accompanying description, figures and examples. In the figures, like reference numerals refer to like parts throughout. 
     Before explaining at least one embodiment of the invention in detail, it is to be understood that the invention is not limited in its application to the details set forth herein. The invention can be implemented with other embodiments and can be practiced or carried out in various ways. It is also understood that the phraseology and terminology employed herein is for descriptive purpose and should not be regarded as limiting. 
     Generally, the nomenclature used herein and the laboratory procedures utilized in the present invention include techniques from the fields of biology, engineering, material sciences, medicine and physics. Such techniques are thoroughly explained in the literature. 
     Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the invention belongs. In addition, the descriptions, materials, methods, and examples are illustrative only and not intended to be limiting. Methods and materials similar or equivalent to those described herein can be used in the practice or testing of the present invention. 
     As used herein, the terms “comprising” and “including” or grammatical variants thereof are to be taken as specifying the stated features, integers, steps or components but do not preclude the addition of one or more additional features, integers, steps, components or groups thereof. This term encompasses the terms “consisting of” and “consisting essentially of”. 
     The phrase “consisting essentially of” or grammatical variants thereof when used herein are to be taken as specifying the stated features, integers, steps or components but do not preclude the addition of one or more additional features, integers, steps, components or groups thereof but only if the additional features, integers, steps, components or groups thereof do not materially alter the basic and novel characteristics of the claimed composition, device or method. 
     As used herein, “a” or “an” mean “at least one” or “one or more”. The use of the phrase “one or more” herein does not alter this intended meaning of “a” or “an”. 
     The term “method” refers to manners, means, techniques and procedures for accomplishing a given task including, but not limited to, those manners, means, techniques and procedures either known to, or readily developed from known manners, means, techniques and procedures by practitioners of the chemical, pharmacological, biological, biochemical and medical arts. Implementation of the methods of the present invention involves performing or completing selected tasks or steps manually, automatically, or a combination thereof. 
     As used herein, the terms proximal and proximally refer to positions and movement respectively toward the heart. As used herein, the terms distal and distally refer to positions and movement respectively away from the heart. 
       FIGS. 1B ,  2 A- 2 C and  3 A- 3 C are representations of portions of an AAPT collector  200  of the present invention.  FIG. 3A  is a cut-away of a catheter  168 , showing a cross-section of catheter sheath  176 , catheter body  114  and collector  200 , in an expanded state. Collector  200  comprises multiple rays  210  projecting upward and radially outward from a base  260  at the proximal end of catheter body  114 . Spanning rays  210  is a mesh  230 . During collection of an AAPT, collector  200  preferably disrupts blood flow as little as possible and to this end, mesh  230  includes relatively large openings  252 , for example 1×1 (1 mm 2 ) millimeter each, that allow substantial flow of blood there through while collector  200  is expanded. An aerial view of collector  200  in an expanded state, in a cross section of proximal aorta  140 , is seen in  FIG. 10 . 
     As seen in  FIG. 1B , each ray  210 , attached to base  260 , includes an eye  214  comprising a guide passage for strings  220  and  222 . As seen in  FIG. 2A , an aerial view of collector  200 , a first string  220  passes through four eyes  214  and a second string  222  passes through four eyes  214 . The two ends of each of strings  220  and  222  pass through a central collector opening  216 .  FIGS. 11 and 12  are cross sections of upper and lower catheter body  114  portions respectively. String conduits  322  and  320  demonstrate an exemplary embodiment of the upper portion of catheter body  114 . Both upper and lower portions of catheter body  114  include a guide wire channel  268 , a saline channel  146  and an optional aspirator channel  272 . 
     As seen in  FIG. 3B , strings  220  and  222  pass from the internal to external portion of base  260  through string conduits  320  and  322  respectively, and attach to an edge  218  of a catheter sheath  276 . By pulling sheath  276  in direction  118 , strings  220  and  222  cause rays  210  to bend radially inward toward a guide wire  157  and thereby trap an AAPT  170 . 
     As seen in  FIG. 3C , to facilitate removal of AAPT  170  from a smaller diameter branch artery, as noted above, a ray converger  350  is included with collector  200  to reduce the diameter of rays  210  as described further on. 
     As shown in  FIGS. 10 through 12 , catheter body  114  optionally includes aspirator channel  272  that may be used to aid in reducing bulk by aspirating all or a portion of AAPT  170 . 
     Aspirated AAPT  170 , having a smaller diameter and/or less bulk, is removed from the branch vessel more easily than with ray converger  230  alone. Due to the closed shape of collector  200  and direction  118  of blood flow, AAPT  170  remains contained within collector  200 . 
       FIG. 4A  is a representation of a Transoesophageal Echocardiograph  102  (TEE) setup used for diagnosing and removal of AAPT  170 . TEE  102  includes an ultrasound echo probe  192  having an ultrasound cable  190  that is passed through an esophagus  112  in a human  166 . In the position shown, probe  192  demonstrates the position of AAPT  170  on a monitor  198 . 
     While TEE  102  is shown in exemplary embodiments, other methods and/or monitoring systems and/or imaging modalities may be utilized, inter alia, intraoperative CT, MRI and nuclear imaging. 
     Prior to beginning the AAPT removal procedure in accordance with the teachings of the present invention, the surgeon typically places a clamp  150  on a left femoral artery  135  and a second, more distal, clamp  151  on a right femoral artery  134 , thereby preventing distal embolization during the procedure. An incision  160  is made proximal to clamp  151 , allowing access to right femoral artery  134  and retrograde maneuvering of guide wire  157  and collector  200  ( FIG. 3B ). 
     In an alternate exemplary embodiment, noted above, internal iliac arteries  136 , (branching off left  194  and common right  188  iliac arteries) are clamped with clamps  150  and  151  respectively and an incision (not shown) is made. 
     As seen in  FIG. 4B , guide wire  157  is central to an inflatable balloon  116  that is used in disconnecting AAPT  170  from luminal aspect  152 . Disconnector balloon  116  is connected to saline channel  146  passing along guide wire  157  and out the base of catheter  114 . 
       FIG. 2B  shows an aerial view of collector  200  in the collapsed state contained within catheter sheath  276 .  FIG. 2C  shows a detail of mesh  230  folded between rays  210  with collector  200  in the collapsed state. 
     In the collapsed state, collector  200  is passed through incision  160 , retrograde to a direction of blood flow  118  until balloon  116  is proximal to AAPT  170 . 
     As seen in  FIG. 5 , with balloon  116  proximal to AAPT  170 , sheath  276  is pulled in a direction  118  with respect to catheter body  114  so that rays  210  gently radially expand against a luminal aspect of proximal aorta  140 . 
     The resilient nature of each ray  210  allows gentle pressure against respective luminal aspects  152 . Additionally, each ray  210  seeks its own outward radial distance from guide wire  157  so that collector  200  easily conforms to aortas  100  having irregular shapes without causing damage to luminal aspect  152 . 
     As noted above, rays  210  comprise a resilient material from the group including titanium, stainless steel, nitinol, shape memory metals, synthetic biostable polymer, a natural polymer, and an inorganic material. The many variations of, for example, polymers being well known to those familiar with the art. 
     Additionally, while eight rays  210  are shown, embodiments of collector  200  include as few as about six rays or as many as about 12 rays  120 . 
     In an exemplary embodiment, mesh  230  includes openings having an area of at least about 0.25 mm 2 , or no more than about 1.5 mm 2 . Further, mesh  230  optionally extends proximally beyond rays  210  to aid in capturing AAPT  170  when collector is collapsed, as well as to provide a gentle interface between rays  210  and luminal aspect  152 . 
     As seen in  FIG. 6 , balloon  116  has been inflated, for example with pressurized sterile saline through channel  146 . After inflation balloon  116  is gently pulled distally (direction  118 ) along guide wire  157  to contact AAPT  170 . As a result of contact between balloon  116  and AAPT  170 , AAPT  170  is disconnected from stalk  172 . 
     In an exemplary embodiment, disconnector balloon  116  has a large diameter to expand sufficiently to fill the large diameter of the lumen of proximal aorta  140  for example, a maximum inflation radius of at least about 2 centimeters, or no more than about 15 centimeters. 
     Additionally, balloon  116  includes flexible walls, for example comprising latex or the like, so as to gently conform to the aortic walls to preclude damage thereto. In some embodiments, disconnector balloon  116  has a wall thickness of at least about 0.2 millimeters up to no more than about 0.5 millimeters. The many materials and measurements that are optionally used in the manufacture of balloon  116 , are well known to those familiar with the art. 
     Balloon  116  typically expands to at least about 3.0 centimeters in diameter. In an exemplary embodiment, balloon  116  is in an inflated state or a partially inflated state for no more than 20 seconds, no more than 15 seconds and even no more than about 10 seconds. Such a short time span lowers the chance of hemodynamic instability caused by a significant period of blood flow stoppage. 
     In embodiments of the invention, once released, AAPT  170  floats as one intact mass into expanded collector  200 . As seen in  FIG. 9 , and noted above, pulling sheath  176  in a direction  118  puts tension on strings  220  and  222 , thereby bending rays  210  and trapping AAPT  170  within collector  200 . 
     In exemplary embodiments, catheter  168  (including catheter body  114 , catheter sheath  276 , collector  200 , guide wire  157  and balloon  116 ) is pulled outwards in direction  118  until proximal to right femoral artery  134 . 
     Ray converger  350  is then moved in direction  218  within femoral artery  134  while stabilizing the position of catheter  168  with Ray converger  350  is pressed distally against rays  210 , thereby causing rays  210  to bend and reshape AATP  170  as described above. 
     With rays  210  bent, AAPT  170  is forced to form a longer shape with a narrow diameter, thereby more easily fitting through artery  134  and incision  160 . Those familiar with the art know that artery  134  has the ability to expand to a larger diameter, for example about 6.5 millimeters, thereby additionally facilitating removal of collector  200  from incision  160 . 
     Removal of balloon  116  and guide wire  157  follows removal of AAPT  170 , and incision  160  is closed, for example with a suture or surgical clips in the usual way. 
     In embodiments of the invention, drugs are administered post-operatively to prevent recurrence of an AAPT  170 . 
     Typically, assuming the patient has prothrombotic tendencies, anticoagulant therapy will be administered for life. 
     An alternative collector embodiment  600 , seen in  FIG. 13 , has a short, retractable, collector sheath  630  that maintains collector rays  210  in a collapsed state during insertion. Collector sheath movement is controlled by legs  620  passing through slots  640  in catheter body  114  and internal through the length of catheter body  114 . By pulling legs  620  in direction  118  while catheter body  114  is stabilized, sheath  630  is removed from rays  210 , allowing radial expansion of collector  200 . 
     The closure of collector rays  210  uses strings  220  and  222 , in the same manner as noted above. Additionally, rays  210  of collector  600 , upon reaching a narrower artery, for example right femoral artery ( FIG. 4A ) will be bend radially inward using, for example, converger  250  in the manner shown in  FIG. 9 . 
     Materials and Specifications 
     Attention will be now directed at typical materials and dimensions of a device of the present invention. 
     Generally, collector  200  is configured to span the large diameter of proximal aorta  140 , typically between three and five centimeters and to gently conform to the often highly irregular aortic shape. Thus, there are typically at least about 6, 8 even 10 rays  210 . Typically, there are no more than about 16 or 12 rays  210 . 
     Typically, at least one of rays  210  has a substantially circular cross section having a diameter of at least about 0.1 millimeters, about 0.2 or even about 0.3 millimeters. Typically, at least one of rays  210  has a substantially circular cross section having a diameter of no more than about 0.6 millimeters, about 0.4 millimeters or about 0.5 millimeters. 
     In embodiments, at least one of rays  210  has a cross section having greater and lesser measurements, for example, oval or rectangular. Typically the greater measurement is at least about 0.1 millimeters, about 0.2 millimeters, about 0.3 millimeters, or even about 0.4 millimeters. Typically, the greater measurement is no more than about 0.6 millimeters, about 0.5 millimeters, or even about 0.4 millimeters. 
     Typically the lesser cross sectional measurement is at least about 0.1 millimeters, about 0.2 millimeters, and even at least about 0.3 millimeters. Typically, the lesser cross sectional measurement is no more than about 0.6 millimeters, about 0.5 millimeters, or even about 0.4 millimeters. 
     In embodiments, rays  210  are attached to ring portion  260  of the catheter body using a process selected from the group including welding, adhesion, gluing and riveting. 
     Typically, the proximal portions of each of rays  210  are configured to resiliently flex outward to form a maximally expanded cross section of at least about 3 centimeters, about 4 centimeters, or even at least about 5 centimeters. Generally, the expanded cross sectional diameter is no more than about 10 centimeters about 7 centimeters, about 8 centimeters, or even no more about 9 centimeters. The maximum extent of expansion is generally limited by material  230 . 
     Collector  200  is configured to effectively collect an AAPT and, accordingly, includes a sheet material  230  operatively associated with rays  210 . Typically, material  230  is attached to at least one of the internal aspects and the external aspects of rays  210 . Typically, material  230  is attached to at least one of rays  210  using a process selected from the group of sewing, adhesion, gluing, suturing, riveting and welding. 
     Collector  200  is preferably configured to allow blood flow through lumen  148  while in the expanded state. In embodiments, sheet material  230  is selected from the group consisting of meshes and nets. 
     To allow minimal interruption of blood flow, material  230  typically includes relatively large openings  252 . Typically openings  252  have an area of at least about 0.25 mm 2 , about 0.5 mm 2 , about 1.0 mm 2 , about 1.5 mm 2 , about 2.25 mm 2 , or even about 4.0 mm 2 . In embodiments, openings  252  have an area of no more than about 4.0 mm 2 , about 2.25 mm 2  mm 2 , about 1.5 mm 2 , or even about 1.0. 
     In embodiments, material  230  extends proximally beyond at least one of rays  210  by at least about 1.0 millimeter, about 2.0 millimeters, about 3.0 millimeters, or even by at least about 4.0 millimeters. Typically, material  230  extends proximally beyond at least one of rays  210  by no more than about 2.0 millimeters, about 3.0 millimeters, or about 4.0 millimeters. 
     In embodiments, catheter  168  further includes at least one elongate flexible biasing element, for example strings  220  and  222 , configured to bias at least one of rays  210  inwardly causing collector  200  to close from an expanded diameter configuration to a smaller diameter configuration. Typically, biasing element  220  is selected from the group consisting of wires, strings, threads, springs, ribbons, filaments, cables, yarn, and ropes. 
     Typically, a flexible biasing element has a diameter of at least 0.2 millimeters, about 0.3 millimeters, about 0.5 or about 0.6 millimeters. Typically, a flexible biasing element has a diameter of no more than about 0.8 millimeters, about 0.3 millimeters, about 0.5 about 0.6 millimeters, or about 0.7 millimeters. 
     In embodiments, passage  214  is operatively associated with at least one ray  210  through which the body of the at least one elongate flexible biasing element  220 ,  222  passes. 
     In embodiments, passage  214  is formed from at least one of a bending of the proximal portion of the ray, and a shaped component attached to the proximal portion of the ray. 
     In embodiments, catheter  168  further includes a collector ray converger  350  configured to encircle at least a portion of at least one of collector  200 , and the catheter sleeve  276 . 
     In embodiments, collector ray converger  350  has a length of at least about 3 centimeters, about 4 centimeters, about 5 centimeters, or about 6 centimeters. In embodiments, collector ray converger  350  has a length of no more than about 7 centimeters, about 6 centimeters, about 5 centimeters, or even about 4 centimeters. 
     In embodiments, collector ray converger  350  wall has a thickness of at least about 0.3 millimeters, about 0.4 millimeters, or at least about 0.5 millimeters. In embodiments, collector ray converger  350  wall has a thickness of no more than about 0.6 millimeters, about 0.4 millimeters, or even about 0.5 millimeters. 
     In embodiments, catheter  168  further comprises balloon  116  used in disconnecting AAPT  170  from a luminal aspect  148 , comprising a material from the group including rubber, silicon rubber, latex rubber, polyethylene, polyethylene terephthalate, and polyvinyl chloride. 
     In embodiments, balloon  116  has a maximum inflation radius of at least about 2 centimeters, at least about 3 centimeters, about 4 centimeters, about 5 centimeters, about 6 centimeters, or about 7 centimeters. In embodiments, the expanded cross sectional diameter is no more than about 15 centimeters, about 10 centimeters, or about 12 centimeters. 
     In embodiments, the inflatable balloon  116  has a wall thickness of at least about 0.2 millimeters, about 0.3 millimeters, or about 0.4 millimeters. In embodiments, inflatable balloon  116  has a wall thickness of no more than about 0.5 millimeters, about 0.4 millimeters, or even about 0.3 millimeters. 
     In embodiments, the distance from disconnector balloon  116  to the proximal end of collector  200  in the reduced diameter configuration is at least about 5 centimeters, about 6 centimeters, about 7 centimeters, about 8 centimeters, about 9 centimeters, about 10 centimeters, or about 11 centimeters. In embodiments, the distance from disconnector  116  to the proximal end of collector  200  in the reduced diameter configuration is no more than about 12 centimeters, about 11 centimeters, about 10 centimeters, about 9 centimeters, about 8 centimeters, about 7 centimeters or even about 6 centimeters, or. 
     In embodiments, catheter body  114  includes a substantially circular coaxial guide wire channel  268  having a substantially circular cross section with a typical diameter of at least about 0.4 millimeters, about 0.8 millimeters, or about 1.2 millimeters. In embodiments, guide wire channel  268  has a substantially circular cross section with a diameter of no more than about 1.5 millimeters, about 1.2 millimeters, or about 0.8 millimeters. 
     In a further exemplary embodiment, guide wire channel  268  includes greater and lesser cross sections (e.g., is oval or rectangular). Typically, the greater cross section is at least about 0.1 millimeters, about 0.2 millimeters, or about 0.3 millimeters. In embodiments, the greater cross section is no more than about 0.4 millimeters, about 0.2 millimeters, or about 0.3 millimeters. Typically, the lesser cross section is at least about 0.1 millimeters about 0.2 millimeters, or about 0.3 millimeters. In embodiments, the lesser cross section is no more than about 0.4 millimeters, about 0.2 millimeters, or about 0.3 millimeters. 
     Typically, catheter body  114  has an outside diameter of at least about 3.0 millimeters, about 3.5 millimeters, about 4.5 millimeters, about 5.0 millimeters, or about 5.5 millimeters. In embodiments, catheter body  114  has an outside diameter of no more than about 5.5 millimeters, about 5.0 millimeters, about 4.5 millimeters, or about 4.0 millimeters. 
     Typically, catheter body  114  has a length of at least about 0.8 meters, about 1.0 meter, about 1.2 meters, or about 1.4 meters. In embodiments, catheter body  114  has a length of no more than about 1.5 meters, about 1.0 meter, about 1.2 meters, or about 1.4 meters. 
     In embodiments, sleeve portion  276  of catheter  168  comprises a compliant material. Alternatively, sleeve portion  276  comprises a property selected from the group consisting of, flexible, plastic, and rigid. 
     In embodiments, catheter sleeve  276  has a wall thickness of at least about 0.2 millimeters, about 0.3 millimeters, or about 0.4 millimeters. In embodiments, catheter sleeve  276  has a wall thickness of no more than about 0.5 millimeters, about 0.4 millimeters, or about 0.3 millimeters. 
     Generally, collector  200 , catheter  168 , balloon  116 , and all components thereof noted above, are manufactured using any one of a variety of biocompatible materials, for example, materials from the group including titanium, stainless steel, nitinol, shape memory metals, synthetic biostable polymer, a natural polymer, and an inorganic material. 
     Typical biostable polymers include a polyolefin, a polyurethane, a fluorinated polyolefin, a chlorinated polyolefin, a polyamide, an acrylate polymer, an acrylamide polymer, a vinyl polymer, a polyacetal, a polycarbonate, a polyether, an aromatic polyester, a polyether (ether ketone), a polysulfone, a silicone rubber, a thermoset, or a polyester (ester imide) and/or combinations thereof. 
     Typical polymeric material includes a polyolefin, a polyurethane, a silicone, a polyester or a fluorinated polyolefin. 
     It is expected that during the life of this patent many relevant delivery systems will be developed and the scope of the AAPT collector  200  is intended to include all such new technologies a priori. 
     It is appreciated that certain features of the invention, which are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the invention, which are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable subcombination. 
     Although the invention has been described in conjunction with specific embodiments thereof, it is evident that many alternatives, modifications and variations will be apparent to those skilled in the art. Accordingly, it is intended to embrace all such alternatives, modifications and variations that fall within the spirit and broad scope of the appended claims. All publications, patents and patent applications mentioned in this specification are herein incorporated in their entirety by reference into the specification, to the same extent as if each individual publication, patent or patent application was specifically and individually indicated to be incorporated herein by reference. In addition, citation or identification of any reference in this application shall not be construed as an admission that such reference is available as prior art to the present invention.