Patent Abstract:
This is in the general field of surgical instruments and is specifically a delivery catheter with a flexible, proximally-manipulated hinge or joint region. The inventive catheter may have a balloon region. The catheter may have a shaft of varying flexibility which contains several lumen. The inner, or delivery, lumen generally may be used with a guidewire to access target sites within the body via the flexible, small diameter vessels of the body. The delivery lumen may be also used for placement of occlusive materials, e.g., in an aneurysm. Inflation of the micro-balloon, located near the distal tip of the catheter, is effected using the inflation lumen. The push/pull wire lumen contains a wire, which when manipulated, flexes the catheter&#39;s distal tip. The push/pull wire tubing may have a variable thickness to aid in adjusting the degree of flexibility. Moreover, the delivery catheter may be capable of twisting in a helical or corkscrew-like manner for traversing certain vasculature. This may be accomplished by winding the push/pull wire within the catheter and fixedly attaching it. The catheter may further include an entry in the catheter wall to allow for the insertion of a guidewire; this may facilitate the rapid exchange of catheter devices as desired by the user.

Full Description:
RELATED APPLICATIONS  
       [0001]     This is a continuation-in-part of U.S. patent application Ser. No. 09/643,085 entitled “MANIPULATABLE DELIVERY CATHETER FOR OCCLUSIVE DEVICES” filed Aug. 21, 2000, now pending and incorporated by reference in its entirety. 
     
    
     FIELD OF THE INVENTION  
       [0002]     This invention is in the general field of surgical instruments and is specifically a catheter having a flexible, proximally-manipulated hinge region. The inventive catheter may include a balloon. The catheter may have a shaft of varying flexibility which contains several lumen. The inner, or delivery, lumen generally may be used with a guide wire to access target sites within the body through the flexible, small diameter vessels of the body. The delivery lumen may be also used for placement of occlusive materials, e.g., in an aneurysm. Inflation of the optional micro-balloon, located near the distal tip of the catheter, is effected using the inflation lumen. The push/pull wire tubing contains a wire, which when manipulated, flexes the catheter&#39;s distal tip.  
       BACKGROUND OF THE INVENTION  
       [0003]     Endovascular therapy has been used to treat different conditions, such treatments including control of internal bleeding, occlusion of blood supply to tumors, and occlusion of aneurysm. Often the target site of the malady is difficult to reach. Because of their ability to access remote regions of the human body and deliver diagnostic or therapeutic agents, catheters are increasingly becoming components of endovascular therapies. Vascular catheters may be introduced into large arteries, such as those in the groin or in the neck, and then pass through narrowing regions of the arterial system until the catheter&#39;s distal tip reaches the selected delivery site. To be properly utilized, catheters are often stiffer at their proximal end to allow the pushing and manipulation of the catheter as it progresses through the body but sufficiently flexible at the distal end to allow passage of the catheter tip through the body&#39;s blood vessels without causing significant trauma to the vessel or surrounding tissue.  
         [0004]     Microcatheters, such as those shown in U.S. Pat. Nos. 4,884,579 and 4,739,768, each to Engleson, allow navigation through the body&#39;s tortuous vasculature to access such remote sites as the liver and the arteries of the brain. Although other methods of causing a catheter to proceed through the human vasculature exist (e.g., flow directed catheters), a guidewire-aided catheter is considered to be both quicker and more accurate than other procedures. Catheters with deflectable or variable stiffness distal ends (which increase the flexibility of the catheter&#39;s distal end) have been disclosed in U.S. Pat. No. 6,083,222, to Klein et al; U.S. Pat. No. 4,983,169, to Furukawa; U.S. Pat. No. 5,499,973, Saab; and U.S. Pat. No. 5,911,715, to Berg et al.  
         [0005]     The addition of a fluid-expandable balloon on the distal end of the catheter and a coupler-on the proximal end allows various percutaneous medical treatments such as pressure monitoring, cardiac output and flow monitoring, angioplasty, artificial vaso-occlusion, and cardiac support. Balloon catheters generally include a lumen that extends from the proximal end and provides fluid to the balloon for inflation. Examples of balloon catheters are disclosed in U.S. Pat. No. 4,813,934 to Engleson et al and U.S. Pat. No. 5,437,632 to Engelson et al. A balloon catheter with an adjustable shaft is shown in U.S. Pat. No. 5,968,012, to Ren et al.  
         [0006]     For certain vascular malformations and aneurysms, it may be desirable to create an endovascular occlusion at the treatment site. A catheter is typically used to place a vaso-occlusive device or agent within the vasculature of the body either to block the flow of blood through a vessel by forming an embolus or to form such an embolus within an aneurysm stemming from the vessel. Formation of an embolus may also involve the injection of a fluid embolic agent such as microfibrillar collagen, Silastic beads, or polymeric resins such as cyanoacrylate. Ideally, the embolizing agent adapts itself to the irregular shape of the internal walls of the malformation or aneurysm. Inadvertent embolism due to an inability to contain the fluid agent within the aneurysm is one risk which may occur when using fluid embolic agents.  
         [0007]     Mechanical vaso-occlusive devices may also be used for embolus formation. A commonly used vaso-occlusive device is a wire coil or braid which may be introduced through a delivery catheter in a stretched linear form and which assumes an irregular shape upon discharge of the device from the end of the catheter to fill an open space such as an aneurysm. U.S. Pat. No. 4,994,069, to Ritchart et al, discloses a flexible, preferably coiled, wire for use in a small vessel vaso-occlusion.  
         [0008]     Some embolic coils are subject to the same placement risks as that of fluid embolic agents in that it is difficult to contain the occlusive coil within the open space of the aneurysm. A need exists for a delivery system which accurately places the occluding coil or fluid and ensures that the occluding coil or fluid does not migrate from the open space within the aneurysm. The delivery catheter must have a small diameter, have a highly flexible construction which permits movement along a small-diameter, tortuous vessel path, have a flexible method of placement to ensure accuracy, and must have a method to prevent coil or embolizing agent leakage.  
       SUMMARY OF THE INVENTION  
       [0009]     This invention is a catheter or catheter section. Although it desirably has a balloon region located from distal of an inflatable member to proximal of that inflatable member, where the inflatable member is within the balloon region, it need not have a balloon region or an inflatable member. The inventive catheter has a flexible joint region located generally in the distal area of the catheter, often within that balloon region. The catheter includes a wire configured to flex the flexible joint region. Where the catheter includes an inflatable member, the flexible joint may variously be distal of the inflatable member, within the inflatable member, or proximal of the inflatable member. The flexible joint region preferably has a flexibility of up to about 90°. The flexible joint region, because the catheter wire may be too rigid, may also be manipulatable in a circular direction relative to the axis of the catheter.  
         [0010]     The wire may be slidingly held, e.g., within a separate tubing. This tubing may potentially be used to aid in adjusting the flexibility of the joint region. This may be accomplished by several different variations. One variation utilizes a wire tubing having collinear consecutive sections of decreasing wall thickness. Alternatively, the wire tubing may be tapered according to the desired degree of joint flexibility. The tubing itself may be a braided tubing which may be of varying flexibility.  
         [0011]     The flexible joint itself may be, for instance, a coil member, perhaps having a section with a pitch which is larger than adjacent coil pitches. The flexible joint may instead be a braid, perhaps with a section with a pic which is larger than the pic of one or more adjacent sections. The flexible joint may also be made up of a polymer tubing with a section which is softer than adjacent tubing polymers or a region having a wall thickness that is thinner than adjacent wall thickness.  
         [0012]     In taking advantage of the flexibility and capabilities of the present invention, a variation capable of twisting in a helical or corkscrew-like manner may be accomplished with or without an inflatable member or balloon region. This variation is particularly useful in traversing tortuous vasculature and in making difficult approaches to aneurysms. This alternative varation utilizes a wire which may be wound about the guidewire or inner tubing and fixedly attached. It is thus possible to wind the wire any number of times or just a few degrees off the wire axis depending upon the vasculature being traversed and the degree of flexibility or twisting desired. Moreover, different variations may be developed capable of twisting in a left or right handed orientation.  
         [0013]     The present invention may also incorporate various rapid exchange variations.  
         [0014]     The inflatable member or balloon may be of a material selected from the group consisting of elastomers such as silicone rubber, latex rubber, natural rubber, butadiene-based co-polymer, EPDM, and polyvinyl chloride or thermoplastic polymers such as polyethylene, polypropylene, and nylon. 
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0015]      FIGS. 1A, 1B , and  1 C are external views of several variations of the inventive catheter device.  
         [0016]      FIG. 2A  depicts a cross sectional view of a proximally placed hinge region in a variation of the distal region of the inventive catheter.  
         [0017]      FIG. 2B  depicts a cross sectional view of a mid-balloon hinge region placement for a variation of the distal region of the inventive catheter.  
         [0018]      FIG. 2C  depicts a cross sectional view of a distally placed hinge region in a variation of the distal region of the inventive catheter.  
         [0019]      FIG. 2D  depicts a cross sectional view of an additional mid-balloon hinge region placement for one variation of the distal region of the inventive catheter.  
         [0020]      FIG. 3A  depicts a cross-sectional view of an alternate hinge region construction for the distal region of the inventive catheter. The hinge region of  FIG. 3A  is composed of a section of material which is surrounded by regions of greater stiffness.  
         [0021]      FIG. 3B  depicts a cross-sectional view of an alternate hinge region construction for the distal region of the inventive catheter. The hinge region of  FIG. 3B  is composed of a coil of varying pitch.  
         [0022]      FIG. 3C  depicts a cross-sectional view of an alternate hinge construction for the distal region of the inventive catheter. The hinge of  FIG. 3C  is composed of a region of thinned tubing wall surrounded by regions of thickened tubing wall.  
         [0023]      FIG. 3D  depicts a cross-sectional view of an alternate hinge region construction for the distal region of the inventive catheter. The hinge region of  FIG. 3B  is composed of a braided region which is flanked by regions of higher braid density.  
         [0024]      FIGS. 4A-4H  are cross-sectional views of catheter shafts displaying the various relative positions of the push/pull wire lumen, inflation lumen, and delivery lumen.  
         [0025]      FIG. 5  depicts the positions of the radio-opaque markers positioned within the distal end of the catheter tip.  
         [0026]      FIG. 6A  depicts the relative position of the distal end of the catheter tip when not flexed.  
         [0027]      FIG. 6B  depicts the relative position of the distal end of the catheter when flexed by pulling the push/pull motion wire.  
         [0028]      FIG. 6C  depicts the relative position of the distal end of the catheter when flexed by pushing the push/pull motion wire.  
         [0029]      FIG. 7A  depicts a variation having a push/pull wire tubing with consecutively smaller cross-sections.  
         [0030]      FIG. 7B  depicts an alternative variation having a tapering push/pull wire tubing.  
         [0031]      FIG. 7C  depicts a cross-sectional view of the sectioned push/pull wire tubing from  FIG. 7A .  
         [0032]      FIG. 7D  depicts a cross-sectional view of the tapered push/pull wire tubing from  FIG. 7B .  
         [0033]      FIG. 8A  depicts a variation where the push/pull wire may be partially wound about the guidewire tubing.  
         [0034]      FIG. 8B  depicts a cross-section of  FIG. 8A  where the push/pull wire is wound in a right-handed orientation.  
         [0035]      FIG. 8C  depicts a cross-section of  FIG. 8A  with an alternative variation where the push/pull wire is wound in a left-handed orientation.  
         [0036]      FIG. 9  depicts a variation having a catheter tip which may be rotated by a twisting push/pull wire.  
         [0037]      FIGS. 10A, 103B , and  10 C are external views of several variations of the inventive catheter device incorporating a rapid exchange variation.  
         [0038]      FIGS. 11A, 11B ,  11 C, and  11 D depict the steps of using the inventive catheter by respectively inserting the distal end of the inventive catheter into a blood vessel, placing a vaso-occlusive device within an aneurysm, and removing of the catheter.  
     
    
     DETAILED DESCRIPTION OF THE INVENTION  
       [0039]     This invention involves a multi-lumen, catheter having a manipulatable distal tip and is for the delivery of vaso-occlusive materials or implants. The inventive catheter may include one or more distally placed balloon members. The device is shown in detail in the Figures wherein like numerals indicate like elements. The catheter preferably includes a shapeable, flexible distal section. The flexible section, or “hinge region”, preferably is manipulated from outside the body during the process of delivering the verso-occlusive device or material. The terms “hinge region”, “hinge”, or “flexible joint” may be used interchangeably for our applications.  
         [0040]      FIG. 1A  shows a catheter assembly  23  made according to one variation of the invention. This variation of the catheter assembly  23  includes a catheter shaft  25  comprised of a flexible, thin walled body or tube  26  having an inner lumen which extends between proximal and distal catheter ends  24 ,  37 , respectively. The tube  26  is preferably a generally nondistensible polymer having the appropriate mechanical properties for this application, and preferably polyethylene (e.g., HDPE, LDPE, LLDPE, MDPE, etc.), polyesters (such as Nylon), polypropylene, polyimide, polyvinyl chloride, ethylvinylacetate, polyethylene terephthalate, polyurethane (e.g. Texin such as that made by Bayer Corporation), PEBAX, fluoropolymers, mixtures of the aforementioned polymers, and their block or random co-polymers.  
         [0041]     This variation of the inventive catheter assembly generally has several overall functions: a.) access through the vasculature to the brain (or other vascular site) often, but not necessarily, using a guide wire; b.) inflation of the inflatable member or balloon to close or to restrict an artery or the mouth of an aneurysm prior to or during placement of a vaso-occlusive device, thereby requiring a fluid pathway for inflation of the inflatable member; c.) flexion of a “hinge region” in the neighborhood of the distal end of the catheter by a wire extending proximally through the catheter; and d.) introduction of a vaso-occlusive device or material for eventual placement in the vasculature, thereby requiring a pathway or storage region for the vaso-occlusive device. These functions may be achieved by features found at the proximal and distal regions of the catheter.  
         [0042]     The proximal catheter end  24  may be provided with a fitting  18  (e.g., a “LuerLok”) through which fluid may be supplied to the catheter&#39;s inflation lumen through a side port  16 . The proximal end of the catheter is provided with a second port  20  and a fitting  22  through which a push/pull wire may be used to manipulate the hinge region  32  in the distal catheter tip. The proximal end fitting  18  includes an axially extending port  14  which communicates with the catheter&#39;s delivery/guide wire lumen. The optional guide wire  12  may have any suitable construction for guiding the flexible catheter to its intended site within the body. The proximal end of the guide-wire  12  may be equipped with a handle  10  for applying torque to the guide wire  12  during catheter operation. The guide-wire may have a variable stiffness or stepped diameter along its length which typically, e.g., a larger-diameter, stiffer proximal region and one or more smaller-diameter, more flexible distal regions.  
         [0043]     The distal portion  35  of the catheter is made of an inflatable member  30 , typically a balloon, a hinge region  32 , and an opening or aperture  36  for delivery of the vaso-occlusive device or material. This opening  36  may also be used for delivery of drugs and the vaso-occlusive device to the selected vascular site. The distal end region  35  of the catheter  25  is provided with an inflatable balloon  30  which, when inflated, aids in the placement of vaso-occlusive materials or devices by blocking the entrance to the aneurysm or the artery adjacent to the aneurysm.  
         [0044]     The balloon wall section (discussed in greater detail below) is preferably formed from a thin sleeve of polymeric material and attached at its opposite sleeve ends to a relatively more rigid tube section.  FIGS. 1A, 1B , and  1 C display various configurations of the distal catheter tip  35  positioning based on the placement of the flexible hinge region.  FIGS. 1A, 1B , and  1 C respectively show variations of the inventive catheter  23  in which the hinge region  32  is placed proximal to ( FIG. 1A ), within ( FIG. 1B ), and distal to ( FIG. 1C ) the inflatable member region  30 . Flexion of the hinge region is achieved through remote manipulation of the push/pull wire  21 .  
         [0045]      FIGS. 2A through 2D  illustrate variations of the distal end region  35  and hinge region  32  of the catheter illustrated in  FIG. 1A, 1B , and  1 C.  
         [0046]     The catheter tube  40  of  FIG. 2A  has an inflatable member  44 , preferably a balloon, which is formed by an inflatable sleeve secured at its ends  41 ,  43  to the catheter tube wall  40 . The inflatable member or balloon  44  may be of a shape, thickness, and material as is typical of balloons used in neurovascular balloon catheters. Preferably, though, the inflatable member or balloon  44  is formed of a thin polymeric material, and preferably an elastomeric, stretchable material such as silicone rubber, latex rubber, polyvinyl chloride, complex co-polymers such as styrene-ethylene butylene-styrene copolymers such as C-FLEX, or alternatively, a non-stretchable film material such as polyethylene, polypropylene, or polyamides such as Nylon. Attachment of the sleeve ends to the catheter tube may be by gluing, heat shrinkage, mechanical fastener, or other suitable method. The inflation lumen  42  allows communication between the inflation fluid source and the balloon  44  through at least one opening  50  formed in the catheter tube  40 . Inflation and deflation of the balloon are effected by the passage of radio-opaque fluid, saline, or other fluid. The push/pull wire tubing  60  extends throughout the catheter tube  40  and protects the passage of the push/pull wire  62  which is connected to the inner wall of the catheter tube  40 . To assist in preventing collapse of the tube  60  enclosing the push/pull wire  62  and to prevent kinking or bulging during actuation, the push/pull wire tubing  60  may have additional structure preferably provided by a layer of higher stiffness polymer (e.g., a polyimide), a support coil, or a support braid.  
         [0047]     Axial manipulation of the push/pull wire  62  via the proximal wire port ( 20  in  FIG. 1A ) allows flexion of the distal end  35  of the catheter ( 25  in  FIG. 1A ). The guide wire  57  extends through the delivery lumen  55  which lies interior to the catheter tube  40 . The push/pull wire  62  extends through the push/pull wire tubing  60  and may be bonded to the radio-opaque band  67  which surrounds the catheter&#39;s distal end  65 . Radio-opaque bands may be made of any number of conventional radio-opaque materials, e.g., platinum. The hinge region  58  at which the distal catheter tip  65  flexes due to proximal manipulation of the push/pull wire  62  may be located proximal to, within, or distal to the balloon, as displayed respectively in  FIGS. 2A, 2B , and  2 C.  
         [0048]     As shown in  FIG. 2A , when the hinge region  58  is placed proximally of the balloon  44 , the push pull wire tubing  60  extends to a region which is proximal of the distal end of the balloon  44  to allow flexion of the region of the catheter&#39;s distal end  65  which includes the entire balloon  44 . If the hinge region  58  is placed interior to the balloon, as in  FIG. 2B , flexion of the catheter&#39;s distal end  65  occurs such that the point of flexion is within the balloon (also displayed in  FIG. 1 B ).  FIG. 2C  shows the placement of hinge  58  distal to the balloon; flexion during distal-hinge placement occurs such that the manipulatable region of the catheter&#39;s distal end  65  does not include any portion of the balloon  44 .  
         [0049]      FIG. 2D  shows placement of the hinge region  58  interior to the balloon  44 . The balloon  44  extends between the guidewire/delivery tube  56  and the outer catheter tube  40  enclosing the annular inflation lumen  42 . The push/pull wire  62  is attached to the distal end  65  of the guidewire/delivery tube  56 .  
         [0050]     In each of the variations shown in  FIGS. 2A, 2B ,  2 C, and  2 D, the push/pull wire  62  is distally attached to a radio-opaque band  67 . Although this is a preferred variation, other attachment sites for attachment of the push/pull wire  62  distal to the hinge region  58  will be apparent.  
         [0051]     The hinge region may be made up of any material or structural configuration which allows flexion based on remote manipulation by movement of the push/pull wire  62 . Several variations of preferred configuration are shown in  FIGS. 2D, 3A ,  3 B, and  3 C.  
         [0052]     In  FIG. 2D , extension of the delivery tube  56  beyond the end of the inflation lumen  42  allows remote manipulation of the catheter&#39;s distal end  65  if the push/pull wire  62  is attached to a marker or platinum band  67  which is located distal to the end of the inflation lumen. In this configuration, remote manipulation of the push/pull wire allows flexion to occur between the end of the inflation lumen  42  and the marker  67  to which the push/pull wire  62  is attached. The delivery tube  56  may be made of any of the materials listed above with respect to tube  26  in  FIG. 1 .  
         [0053]      FIG. 3A  displays a cross section of the catheter  70  wall. The hinge section of  FIG. 3A  is made from contiguous regions of tubing where one section of the catheter wall  77  is made from a material with a stiffness which is less than the stiffness of the material of the flanking sections of catheter wall  75 ,  79 . These regions of tubing are preferably made through extrusion, by doping, or heat treating a region of the tubing.  
         [0054]      FIG. 3B  displays a hinge region  88  which utilizes a coil  90  of varying pitch imbedded in the catheter wall. Because the variation in pitch of the coil  90  produces regions of varying flexibility, the lower pitch region  88  is more flexible than the region of higher pitch  89 . The higher pitch region  89  is stiffer during manipulation of the push/pull wire  86 .  
         [0055]     As shown in  FIG. 3C , if a thinned region of catheter wall  105  is flanked by regions of greater wall cross-sectional area  100 ,  108 , the section  108  of the catheter wall which is distal to the thinned section  105  will act as a hinge when the distal end of the catheter is manipulated using the push/pull wire  96 . The variations in wall cross sectional area may preferably be created during an extrusion process.  
         [0056]      FIG. 3D  displays a hinge which utilizes a braided ribbon  94  with varying braid pitch, that is embedded between outer  101  and inner  103  layers of the catheter wall. The variation in pitch of the braided ribbon  105  produces regions of varying flexibility. If a region of lower braid pitch  92  is flanked by regions of higher braid pitch  90 , the region of greater pitch  89  is stiffer during manipulation of the distal catheter tip. The braid  94  is preferably made from a number of metallic ribbons or wires which are members of a class of alloys known as super-elastic alloys, but may also be made from other appropriate materials such as stainless steel or polymers such as liquid crystal polymers (LCP&#39;s). Preferred super-elastic alloys include the class of titanium/nickel materials known as nitinol. Additional treatment to the braid prior to assembly, such as heat-treatment, may be required or desired to prevent braid unraveling, changes in diameter, or spacing during handling. The braids which may be utilized in this invention are preferably made using commercially available tubular braiders. The term “braid” is meant to include tubular constructions in which the ribbons making up the construction are woven radially in and in-and-out fashion as they cross to form a tubular member defining a single lumen. The braid is preferably made from a suitable number of ribbons or wires.  
         [0057]     Some of the various configurations of the catheter&#39;s lumina (inflation, push/pull, and delivery) are displayed in  FIGS. 4A through 4H . In  FIG. 4A , the inflation lumen  122  and push/pull wire lumen  124  are formed interior to the catheter wall  120 , while the interior catheter wall forms the guide wire lumen  128 . In  FIG. 4B , the catheter wall  120  forms the guide wire lumen  128  which contains the inflation lumen  122  and push/pull wire lumen  124 . The inflation lumen  122  is formed interior to the catheter wall  120  of  FIG. 4C , while the push/pull wire lumen  124  lies within the larger coil lumen  128  (which is formed by the catheter wall  120 ).  FIG. 4D  is a variation of  FIG. 4C  in which the push/pull wire lumen  124  lies interior to the catheter wall  128  while the inflation lumen  122  lies within the larger coil lumen  128 . In  FIG. 4E , the interior catheter wall  120  forms the inflation lumen  122 , and the push/pull wire lumen  124  and the guide wire lumen  128  are found within the inflation lumen  122 . The inflation lumen  122  surrounds the guide wire lumen  128  and lies within the region formed interior catheter wall  120  in  FIG. 4F , while the push/pull wire lumen  124  lies within the catheter wall  120 . In  FIG. 4G , one shared lumen  123  serves as the push/pull and inflation lumen; the shared push/pull and inflation lumen  123  along with the guide wire lumen  128  lie within the catheter wall  120 . Another alternate variation of the lumina positioning, shown in  FIG. 4H , has the push/pull wire lumen  124  lying interior to the inflation lumen  122  which is contained within the catheter wall  120 , while a separate lumina for the guide wire  128  also is contained within the catheter wall.  
         [0058]     The tube constructions, hinge region construction, and other tubing forming the various lumina discussed herein may be created through extrusion, sequential production (in which the parts are manufactured separately and later assembled together), or some other method.  
         [0059]     As displayed in  FIG. 5 , another variation of the present invention may involve the addition of radio-opaque markers  190 . The lengthened distal section  200  may be provided with a number of spaced radio-opaque markers  190 ,  191 ,  192 , and  193 . Balloon markers  195 ,  196  may be provided to indicate the position of the balloon during the vascular procedure. The markers may be spaced, for instance, such that the inter-marker distance corresponds to the length of the coil to be delivered. Markers  195 ,  196  may be spaced apart by a known or predetermined distance, e.g., 3 cm, both proximally and distally of the balloon member. Also, the various markers, particularly those located adjacent the balloon member, may be disposed outside the balloon member, as depicted, or optionally inside.  
         [0060]      FIGS. 6A, 6B , and  6 C show the operation of the inventive flexible distal catheter tip.  
         [0061]     In  FIG. 6A , the remotely-manipulatable distal end  136  extends beyond the hinge  135  and allows greater access to the delivery site of the vaso-occlusive member  137  during surgical procedures. Manipulation of the push/pull wire  143  allows flexion of the catheter distal tip  136 .  
         [0062]     If the push/pull wire  143  is pushed or axially manipuliated, as shown in  FIG. 6B , the distal tip  145  is flexed upward through an angle determined by the pressure applied to the push/pull wire. Generally, the deflection angle of the catheter  140  as the push/pull wire  143  is pushed may approach up to about 90° in one direction.  
         [0063]     If the push/pull wire  143  is pulled as in  FIG. 6C , rotation from the un-manipulated position through an angle up to about 90° opposite the direction shown in  FIG. 6B  is initiated; again, this angle is in a direction which is opposite to that of the pull-manipulation but generally in the same plane. The push/pull wire  143  extends through out the push/pull wire lumen  141  and may be bonded to the radio-opaque band  142  found at the distal end  145  of the catheter  140  tip.  
         [0064]      FIG. 7A  depicts an alternative variation  210  which is similar to that shown in  FIG. 2D . The tubing  56  itself may be a braided tubing which may be of varying flexibility. However, variation  210  depicts a push/pull wire tubing  212  having a stepped distal end  213 . Stepped push/pull wire tubing  212  may be comprised of similar materials and structures as push/pull wire tubing  60  but having a series of successively decreasing cross-sectional areas on stepped distal end  213 . The number of successively decreasing cross-sections and the associated lengths of each decreased section may vary depending upon the degree of flexibility necessary or desired within catheter distal end  65 . Moreover, variation  210  depicts stepped distal end  213  extending into inflatable member  44 ; however, the relative positioning of stepped push/pull wire tubing  212  to inflatable member  44  may be altered again depending on the desired flexibility of catheter  40 . Push/pull tubing  212  may itself be a braided tubing which may be of varying flexibility. Also, the figure depicts push/pull wire tubing  212  as a separate tube, but it may also be in any of the variational cross-sections discussed herein having the push/pull wire tubing  212  disposed, e.g., within the tubing and any braiding or coils, or disposed exteriorly of any braiding or coils.  
         [0065]      FIG. 7C  depicts the cross-sectional view of the stepped push/pull wire tubing  212  from  FIG. 7A . Tubing  212  may be attached or held to tubing  56  by any of the various methods discussed herein, e.g., shrink-wrap. The figure depicts tubing  212  with three sections for illustrative purposes and tubing  212  may comprise any number of sections with variable thickness depending upon the degree of flexibility necessary or desired.  
         [0066]      FIG. 7B  depicts an additional alternative variation  214  which is similar to variation  210 . However, variation  214  depicts push/pull wire tubing  216  having a tapering distal end  217 . Here, the degree of tapering may be varied depending upon the degree of flexibility necessary or desired, as above.  
         [0067]      FIG. 7D  depicts the cross-sectional view of the tapered push/pull tubing  216  from  FIG. 7B . Tubing  216  may also be attached or held to tubing  56  by any of the various methods discussed herein, e.g., shrink-wrap. Tubing  216  may be made to have any degree of tapering again depending upon the degree of flexibility necessary or desired.  
         [0068]      FIG. 8A  depicts another variation  218  which enables a user to not only manipulate catheter distal end  65  within generally one plane, but also to manipulate or to twist catheter distal end  65 , e.g., in a helical or corkscrew-like manner. As illustrated, push/pull wire  62  emerges from push/pull wire tubing  60  and may be rotated about guidewire/delivery tube  56  for attachment to an attachment point, e.g., radio-opaque band  67  as shown, at some point not on the axis with the tubing  60 . Instead it may be attached preferably on an opposite side from where push/pull wire  62  emerges. The attachment point is preferably located distally from push/pull wire tubing  60 , but may vary depending upon the degree of torque desired. Also, attachment of push/pull wire  62  along radio-opaque band  67  may also vary depending upon the desired range of torquing or twisting of catheter distal end  65 . For example, push/pull wire  62  may be placed along, e.g., radio-opaque band  67 , in any location ranging from about 0° where little or no twisting occurs and up to about 180° where full rotation of catheter distal end  65  occurs about a longitudinal axis defined by catheter tube  40  and guidewire/delivery tube  56 . At about 0°, push/pull wire  62  is attached to radio-opaque band  67  at a point in aposition to where wire  62  emerges from tubing  60 . At about 180°, as depicted in  FIG. 8A , push/pull wire  62  is attached to radio-opaque band  67  at a point on an opposite side of guidewire/delivery tube  56  from where wire  62  emerges.  
         [0069]     In variation  218 , push/pull wire tubing  60  may be held relative to guidewire/delivery tube  56  by any conventional shrink-wrap material  220  or by any number of fastening methods discussed herein. Moreover, any number of cross-sectional arrangements described herein for guidewire/delivery tube  56  and push/pull wire tubing  60  may be utilized as well. Also, the arrangement of variation  218  for wire  62  may be utilized with or without inflatable balloon member  44  and is shown in  FIG. 9  without balloon member  44 .  
         [0070]     Although  FIG. 8A  depicts push/pull wire  62  wrapped half-way around guidewire/delivery tube  56 , push/pull wire  62  may be wrapped any number of times around tube  56  before being attached at a desired location on radio-opaque band  67 .  
         [0071]      FIG. 8B  shows section A-A from  FIG. 8A  depicting push/pull wire  62  wrapped in a right-handed orientation about guidewire/delivery tube  56 . Wire  62  may alternatively be wrapped in a left-handed orientation about guidewire/delivery tube  56 , as shown in  FIG. 8C , which depicts the same cross-section of  FIG. 8B .  
         [0072]     In wrapping push/pull wire  62  about tube  56 , manipulation of catheter distal end  65  forces wire  62  to not only undergo tensile and compressive forces along its longitudinal axis, but also torquing forces about its axis.  FIG. 9  depicts variation  221  without a balloon member. Alternatively, the inventive catheter design also allows twisting of the catheter tip without having to attach push/pull wire  62  along band  67  at variable positions. This may be accomplished by utilizing open area  222 , the area without push/pull wire tubing  60 , and the stiffness of wire  62 . Wire  62  may be torqued or twisted about its own axis at its proximal end by a user to bring about a rotation of the distal end of wire  62  and, in turn, catheter distal end  65 . The degree of torquing or twisting of catheter distal end  65  may be controlled not only by the choice of catheter tubing materials, as discussed herein, but also by the length of open area  222  as well as by the choice of material and desired stiffness of wire  62 . This variation may allow a catheter having a combined ability to not only be pushed and pulled in a single plane, but to also be twisted in a helical or corkscrew-like manner, if desired. Although  FIG. 9  depicts this variation without a balloon member, it may be used with one as described in the other variations herein. Any number of materials having sufficient strength and elasticity may be used for wire  62 . Some materials which may be used include stainless steels, titanium, superelastic alloys (e.g., nitinol), or any of their combinations and alloys.  
         [0073]     As depicted in the Figures, particularly  FIGS. 7A-7B  and  8 A- 8 C, radio-opaque bands  67  may optionally be used in conjunction with the different variations as marking known or predetermined distances between the bands  67 , as discussed above.  
         [0074]      FIG. 10A  depicts variation  230  of the present invention which may incorporate rapid exchange catheter apparatus and methods. A typical rapid exchange catheter is described in detail in U.S. Pat. No. 4,748,982 entitled “Reinforced Balloon Dilatation Catheter with Slitted Exchange Sleeve and Method” by Horzewski et al., which is herein incorporated by reference in its entirety. In this variation  230 , the apparatus and methods of the present invention, as described herein, may be used with guidewire  12 . Rather than having guidewire  12  inserted from the proximal end of the catheter, guidewire  12  may instead be inserted through entry  232 , which may be located along catheter  25  at a predetermined location proximal of distal end  35 . This variation  230  may facilitate rapid exchanges of the inventive catheter assembly from a body lumen with other catheters, as desired by the operator.  
         [0075]      FIGS. 10B and 10C  depict entry  232  and insertable guidewire  12  used in conjunction with the manipulatable balloon catheter.  
         [0076]     A remotely flexible distal tip is particularly useful when treating an aneurysm by placement of a vaso-occlusive device or material in the aneurysm.  FIGS. 11A-11D  depict such a placement.  
         [0077]      FIG. 11A  displays an inventive catheter  156  that has its distal end positioned outside the mouth of an aneurysm  149  to deliver a vaso-occlusive coil. The device is positioned using a guidewire  159 .  
         [0078]     Introduction of the catheter&#39;s distal end  165  into the aneurysm neck  147 , shown in  FIG. 11B , displays the advantages of the inventive remotely manipulatable catheter. Flexion of the catheter&#39;s distal tip using the push/pull wire allows for greater maneuverability when accessing the aneurysm neck and aneurysm sac. The push/pull wire system allows the distal end to be positioned as desired during the procedure, instead of before the procedure begins. Once the distal tip  165  has been properly positioned in the aneurysm neck  147 , inflation of the balloon  157  is then commenced to occlude the aneurysm neck  147 , as shown in  FIG. 11C . Full occlusion of the aneurysm neck is desirable to ensure that the coils  175  do not escape into the vessel when the coils are discharged into the aneurysm sac  149 . Once the coil or coils  175  have been completely discharged  180  into the aneurysm sac  149 , deflation of the balloon  157  allows retraction of the catheter&#39;s distal end  165  from the aneurysm (shown in  FIG. 11D ).  
         [0079]     The applications of the inventive catheter discussed above are not limited to the treatment of aneurysms, but may include any number of vascular maladies. Modification of the above-described methods for carrying out the invention, and variations of the mechanical aspects of the invention that are obvious to those of skill in the mechanical and guide wire and/or catheter arts are intended to be within the scope of the claims.

Technology Classification (CPC): 0