Abstract:
Inventive subject matter disclosed herein includes a coil assembly for treating a vascular malformation, comprising: a flat wire coil comprising Palladium, having an optimum packing density, that is coiled and that is detachable attachable to the flat wire coil.

Description:
CLAIM OF PRIORITY 
       [0001]    This application claims the benefit of U.S. Provisional Patent Application Ser. No. 61/776,465, filed on Mar. 11, 2013, the benefit of priority of which is claimed hereby, and which is incorporated by reference herein in its entirety. 
     
    
     FIELD 
       [0002]    Inventive subject matter disclosed herein relates to a flat wire palladium (Pd) embolization coil for occluding malformations within the human vasculature. 
       BACKGROUND 
       [0003]    The prior art includes methods for occluding vessel openings. However, the methods are catheter based and employ a very thin wall compliant balloon on a distal tip of the catheter to achieve occlusion. These devices also require the use of a guidewire to track to a desired location. In addition, because of the thin wall, when the distal balloon is inflated with contrast media, the balloon is susceptible to rupture as well as being susceptible to rupture in use. 
       SUMMARY 
       [0004]    Inventive subject matter disclosed herein includes a coil assembly for treating a vascular malformation. The coil assembly includes a flat wire coil comprising Palladium and or Platinum in a thickness and width ranging from 0.0005 inches by 0.003 inches coiled to a pitch of 0.000 to 0.012 inches, a cut width in a range 0.0001 to 0.005 inches and a length of 10 cm to 90 cm, having an inner diameter in a range from of 0.004 to 0.0016 inches and an outer diameter within a range of 0.006 to 0.018 inches. The coil assembly also includes a detacher that is detachably attachable to the flat wire coil. 
         [0005]    Inventive subject matter also includes a coil assembly for treating a vascular malformation. The coil assembly includes a flat wire coil comprising Palladium or other such metal, having an optimum packing density, coiled to a pitch of 0.001 inches, a cut width of 0.0007 inches and a length of 90 cm, having an inner diameter of 0.012 inches and an outer diameter within a range of 0.006 to 0.018 inches. The coil assembly also includes a detacher that is detachably attachable to the flat wire coil. 
     
    
     
       DESCRIPTION OF THE DRAWINGS 
         [0006]      FIG. 1  illustrates a side view of a coil for treating a vessel malfunction. 
           [0007]      FIG. 1A  illustrates a side view of another embodiment of a distal coil segment. 
           [0008]      FIG. 1B  illustrates a side view of a safety tether of  FIG. 1 . 
           [0009]      FIG. 1C  illustrates a longitudinal cross-sectional view of a mechanical detachment system for a coil for treating a vessel malfunction. 
           [0010]      FIG. 2A  illustrates a side cross-sectional view of a mechanical detachment system for the coil of  FIG. 1 . 
           [0011]      FIG. 2B  illustrates a side cross-sectional view of a mechanical detachment system for the coil of  FIG. 1 . 
           [0012]      FIG. 3  illustrates a side cross-sectional view of a mechanical detachment system for the coil of  FIG. 1 . 
           [0013]      FIG. 4A  illustrates a side cross-sectional view of a magnetic detachment system for the coil of  FIG. 1  when magnets have no current passing through them. 
           [0014]      FIG. 4B  illustrates a side cross-sectional view of a magnetic detachment system for the coil of  FIG. 1  when current passes through a tether magnet. 
       
    
    
     DETAILED DESCRIPTION 
       [0015]    The following detailed description includes references to the accompanying drawings, which form a part of the detailed description. The drawings show, by way of illustration, specific embodiments in which the invention may be practiced. These embodiments, which are also referred to herein as “examples,” are described in enough detail to enable those skilled in the art to practice the invention. The embodiments may be combined, other embodiments may be utilized, or structural, and logical changes may be made without departing from the scope of the present invention. The following detailed description is, therefore, not to be taken in a limiting sense, and the scope of the present invention is defined by the appended claims and their equivalents. 
         [0016]    In this document, the terms “a” or “an” are used to include one or more than one and the term “or” is used to refer to a nonexclusive “or” unless otherwise indicated. In addition, it is to be understood that the phraseology or terminology employed herein, and not otherwise defined, is for the purpose of description only and not of limitation. Furthermore, all publications, patents, and patent documents referred to in this document are incorporated by reference herein in their entirety, as though individually incorporated by reference. In the event of inconsistent usages between this document and those documents so incorporated by reference, the usage in the incorporated reference should be considered supplementary to that of this document; for irreconcilable inconsistencies, the usage in this document controls. 
         [0017]    Inventive embodiments disclosed herein include a coil assembly  10  that includes a detachable coil  20  and pusher assembly  12 , such as is shown in  FIGS. 1 and 1A , effective for use in the treatment of vascular malformations such as, but not limited to, cerebral aneurysms and the like. Said coil assembly  10  has an outer diameter ranging from 0.006″ to 0.018″. The coil assembly  10  includes a distal tip  23  and a proximal end  13 . 
         [0018]    The distal tip  23  of the coil assembly device  10  is part of the detachable distal coil  20 , shown in  FIGS. 1 and 1A . The detachable coil  20  is fabricated with flat wire at a specified pitch and gap specification. A safety tether  15  extends from the distal tip  23  to proximal end  21  of the detachable coil  20 . The tether  15  prevents the detachable coil  20  from unwinding if it becomes caught. A detachment point  19  is positioned into the proximal end  21  of the coil body  20  and distal end  16  of the pusher  12 . For this embodiment, detachment is achieved by conventional inductive heating to melt a polymer tether, or magnetic detachment or mechanical detachment. The mechanical and magnetic systems are discussed herein. 
         [0019]    Finally, the pusher assembly  12  is connected to the detachable coil  20  which is used to provide axial force for the delivery of the detachable coil  20  to a desired location in a living being. It is believed that by using the flat wire configuration, the detachable coil  20  is positioned in such a manner while being deployed so as to improve the packing density of the deployed coil as compared to conventional round wire GDC coils. 
       Mechanical Detachment: 
       [0020]    The coil assembly inventive embodiment disclosed herein at  10  in  FIG. 1  is configured with the pusher assembly  12  having an outer tube within which a tether tube  15  is placed. On a distal end  16  of the tether tube  15  a flanged retainer  18  with an inner diameter is positioned into the end  16  of the tether tube  15  and affixed in an appropriate manner known in the art. See (A-A) and (B-B) in  FIGS. 1C and 2B . The flanged retainer  18  is affixed to the detachable coil body  20 , having proximal end  21  and distal end  23 . On the proximal end  21  of the detachable coil body  23 , is an assembly that includes a cylindrical marker  22  into which a smaller canister  24  with a septum  26  is placed so as to allow the septum  26  to be facing the flanged retainer  18 . When the flanged retainer  18  is pushed through the septum  26 , a secure joint is formed, as shown in  FIG. 2B . To detach the detachable coil body  20 , the pusher tube  12  is held and a tether actuator dial  30  is rotated from its locked position and the flanged retainer  18  is withdrawn proximately through the septum  26 , thereby releasing the detachable coil  20  from the pusher assembly  12 , as shown in  FIG. 3 . A new coil may now be placed on the coil assembly  10  in the same manner. 
         [0021]    In another embodiment, instead of a septum, the flanged retainer tube is bonded into place at the proximal end of the detachable coil, using the appropriate material. Detachment occurs, when the canula tube is used to buttress the detachment point of the coil while the tether tube is withdrawn resulting in separation. Then, the entire pusher assembly is removed from the microcatheter leaving the coil in the desired location. It should be noted that the flanged retainer can be mounted to a catheter or microcatheter or mounted to be integral a solid round wire as well. The illustration provided in  FIG. 3  shows a tubular design. 
         [0022]    In one embodiment, the detachable coil body has a pitch of 0.001 inches, a cut width/thickness of 0.0007 inches, a length of 90 cm, an inner diameter of 0.012 inches and an outer diameter of 0.0135 inches. The wire was a Pd flat wire, 304V SST flat wire (0.001in. to 0.003 in.) In one embodiment, the wire has rounded edges. 
       Magnetic Detachment: 
       [0023]    In another embodiment, a pusher assembly illustrated at  40  in  FIG. 4  employs a small magnet  42  encapsulated and mounted to a distal end  44  of a tether tube  46 . A second sealed magnet  44  is placed within a proximal end of a coil body  48 , as shown in  FIG. 5 . Detachment can be achieved by either employing a current supplied to the tether magnet  42  in order to alter the polarity, whereby matching the same polarity on both magnets (++ or −−)  42  and  44  resulting in repulsion and separation. See (C-C) in  FIG. 4 . Alternatively, magnet canisters can be assembled in the same manner, however a cylindrical magnet has a (++) half and a (−−) half. When in the (+/−−) orientation between the tether and coil magnets  42  and  44 , there is attachment. When the tether/tether magnet  42  is manually rotated 180° resulting in a (++) (−−) of the two halves of the tether magnet relative to the coil magnet  44 , repulsion and separation occur. See (D-D) shown in  FIG. 5 . 

 
       Magnetic Detachment 
       [0024]    In another embodiment the coil  48  is detached by incorporation of two small magnets  42  and  44  in the proximal end of the coil  48  and the distal mating end  41  of the pusher tube  50 , shown in  FIG. 4 . Said magnets  42  and  44  are encapsulated in a biocompatible material to ensure biocompatibility and stability. Detachment occurs by applying a current and changing the polarity on the tether side magnet  42 , whereby resulting in same polarity and repulsion, thus separation of the coil  48  from the pusher.  50 . It should be noted that the magnets  42  and  44  can be mounted onto a solid round wire as well the flat wire disclosed herein. 
       System: 
       [0025]    Magnetic polarity is changed in the wire magnet mechanically as well. Magnetic polarity is changed by using a magnet tipped tether which runs the length of the pusher and which has an actuator that allows the user to rotate the magnet tipped cannula and changing the polarity of the tether magnet, thus again attaining separation, as shown in  FIG. 5  at (D-D). 
         [0026]    Rotational direction of actuator dial  60  may be clockwise or could be counter clockwise 
       Detachment 
       [0027]    Embodiments disclosed herein include a flat wound coil design, wherein coiling is achieved on the flat of the wire or on the edge, both providing different characteristics to the respective coils. The device has an improved packing density as a result of the ribbon like coil. Given the thin thickness of the coil, the coil compresses providing greater capacity for additional material. The device employs flat wire of pure Palladium (Pd), understanding that purity at its best is 99.995 percent in natural ore. Some device embodiments employ aPd/Ti alloy, which has good radiopacity at a lower cost than Pt material. Ti at a fractional concentration. 
         [0028]    The flat wire configuration has a greater surface area that conventional round wire. The flat wire may be precoated prior to coiling to improve platelet aggregation. 
         [0029]    The mechanical concept for detachment eliminates a need for an inductive detachment system. 
         [0030]    Magnetic detachment eliminates a need for an inductive detachment system. 
         [0031]    The embodiments are described in sufficient detail to enable those skilled in the art to practice the invention. Other embodiments may be utilized and formulation and method of using changes may be made without departing from the scope of the invention. The detailed description is not to be taken in a limiting sense, and the scope of the invention is defined only by the appended claims, along with the full scope of equivalents to which such claims are entitled. It will be appreciated by those skilled in the art that changes could be made to the embodiments described above without departing from the broad inventive concept thereof. It is understood, therefore, that this invention is not limited to the particular embodiments disclosed, but it is intended to cover modifications within the spirit and scope of the present invention as defined by the present description.