Abstract:
Braid-balls suitable for aneurysm occlusion and/or parent vessel occlusion/sacrifice (e.g., in treating neurovascular defects) are disclosed. Especially for aneurysm treatment, but also for either one of the aforementioned treatments, the form of the ball is very important. In particular, the density of the device is paramount in applications where braid itself is intended to moderate or stop blood flow—allowing thrombosis within a volume formed by the ball.

Description:
CROSS REFERENCE TO RELATED APPLICATIONS 
     This filing is a continuation of U.S. patent application Ser. No. 12/911,034, filed Oct. 25, 2010 now U.S. Pat. No. 9,039,726, which is a continuation of U.S. patent application Ser. No. 12/427,620 filed Apr. 21, 2009 now U.S. Pat. No. 8,142,456 which claims the benefit of each of: U.S. Patent Application Ser. Nos. 61/046,594 and 61/046,670, both filed Apr. 21, 2008; U.S. Patent Application Ser. Nos. 61/083,957 and 61/083,961, both filed Jul. 28, 2008; and U.S. Patent Application Ser. No. 61/145,097, filed Jan. 15, 2009. Each of the foregoing applications is incorporated herein by reference in its entirety. 
    
    
     FIELD OF THE INVENTION 
     The present invention is directed to braid-balls suitable for aneurysm occlusion and/or parent vessel occlusion/sacrifice (e.g., in treating neurovascular defects). 
     BACKGROUND 
     Especially for aneurysm treatment, but also for either one of the aforementioned treatments, the form of the ball is very important. In particular, the density of the device is paramount in applications where braid itself is intended to moderate or stop blood flow—allowing thrombosis within a volume formed by the ball. 
     According to the present invention, braid-ball type implants are provided in braid of sufficient density is provided to moderate blood flow within the volume of the implant. Upon thrombosis, flow thereto is stopped. Alternatively, a blood-barrier covering can be applied to the filamentary structure to immediately stop blood flow into the vascular site, in which the implant volume is set. 
     In either case, to form thrombosis within the volume of the ball, the filaments of the braid matrix permit filling of the implant with blood when emplaced at a vascular treatment site. This blood then thromboses due to the flow-disruption effect(s). 
     Unlike Nitinol tube-cut cages that may be suitable for (or assist) in coil retention, the ball devices are adapted to work alone—or in combination with each other to effect a complete treatment. As such, high density braid/mesh is typically required. Namely, braid having at least about 48 ends, typically set at about 90 degrees or greater, in diameters from about 4 to about 8 mm may be employed. At larger diameters (e.g., about 6 to 12 or more), more wire ends (e.g., 64, 72 and upwards) may be employed in forming the balls. 
     Suitable braid for constructing the balls may be obtained from Secant Medical, Inc. Wire diameters may be in the range of about 0.001 to about 0.003 inches, depending on desired delivery profile (which is typically less than about 0.050 inches). The braid forming the balls may incorporate only one size wire, or may be formed with multiple sizes. 
     The wire is preferably superelastic NiTi alloy. The metal may be a binary alloy or a ternary alloy to provide additional radiopacity. Alternatively, radiopaque platinum fibers may be included in the braid, or the wire may comprise platinum or gold cord Nitinol DFT. Otherwise, wraps or bands (preferably Pt) used to secure the braid wire may serve as the sole radiopaque feature(s). 
     In any case, the construction approaches described herein enable producing these useful devices. Whether comprising braid alone, or incorporating some further blood-barrier covering (such as a thin urethane film as may be applied by Hantel, Inc. or others) the use of braid presents numerous challenges in managing the termination of multiple wires and in forming the desired structures. 
     Also included in the invention are detachable implant pushers that utilize a resistance wire heater to thermally sever a suture associated with the implant to effect release. As distinguished from known approaches where an implant is retained by a loop connected back to a delivery system pusher that is withdrawn with the devilry system, the present invention contemplates a leave-behind tether. 
     Further details, variations, modification and optional features of the invention may be appreciated by review of any of the incorporated patent applications. However, the priority date and subject matter included in the appended claims rely solely on the subject matter filed in U.S. Provisional Patent Application Nos. 61/046,670 and 61/046,594, the earliest patent applications (each filed Apr. 21, 2008) one which U.S. patent application Ser. No. 12/427,620 relies. Selected figures from the &#39;670 and &#39;594 application and all of text from the &#39;594 application—all—incorporated by reference in the parent application hereto is reproduced herein. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  is a photograph taken from U.S. Provisional Patent Application No. 61/046,670 (incorporated herein by reference) demonstrating actual reduction to practice of a single-layer braid ball device made according to the present invention; 
         FIGS. 2A and 2B  are side-sectional views of the braid ball in isolation and in use, respectively; 
         FIG. 3  illustrates a suture-melt resistance heater pusher for implant delivery; 
         FIGS. 4A-4F  illustrate a production path of one implant embodiment encompassed by the current invention; and 
         FIGS. 5A and 5B  are side-sectional views illustrating proximal-flap braid ball implant variations deployed within bifurcation aneurysm locations. 
     
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     Implants 
     Referring to the figures, a filamentary implant  2  is formed out of braid to treat vascular sites. Interwoven filaments  4  form a braid matrix  6  that define a self-expandable occlusion device. 
     As single layer of the braid is provided in which ends of the braid are secured and managed to provide an atraumatic interface. Specifically, ties  10  (as illustrated in  FIG. 1 ) or bands  12  (as illustrated in  FIGS. 2A and 2B ) secure filament the ends  14  of the braid from which the implant is constructed. 
     In the implant variation pictured, the expanded configuration defines an ovoid or roughly spherical shell  18  that is permeable to blood. The braid defining the proximal and distal ends of the implant turns or curves inward to a point where it is secured within the periphery of the shell. 
     The inversion of the braid provides recessed securement of the braid resulting in atraumatic ends of the implant. The braid filaments optionally extend beyond the securing/securement features in order to define wire filament “tufts”  20  that will further promote thrombosis of blood that enters the ball upon deployment within a patient&#39;s vasculature. However configured in regard to braid filament end securement and termination, inset ends of the braid (proximal and distal insets  22 / 24 , respectively) are demonstrated when the implant is in an expanded state to fill an aneurysm  26  off of a vessel  28 . 
     Delivery Systems 
       FIG. 3  illustrates a detachable catheter/pusher  30 , optionally, for use in the present invention. Generally, it includes a resistance wire bridge  32  across insulated conductors  34  (a typical construction). What is unique is that the conductor wires are twinned/twisted along a length of the delivery pusher shaft  38  as shown. This configuration alleviates bending bias/preference. Upon application of voltage, the tip thermally severs the polymer filament (e.g., suture  40 ) in contact therewith. At least the suture portion is received within the implant  2  (e.g., passing through a braid-securing band  12 ). The suture is retained in/with the implant upon actuation to release the implant by cutting through the suture with heat. A ball stop  42  that is tied to the suture retains the filament in/with the implant is also illustrated. Finally, pusher  30  is shown received within a typical microcatheter  44  for vascular access, after passage therethough. Note also, other advantageous delivery system are referenced and described in the incorporated patent application. 
     Methods of Manufacture 
     Included in the intention is a method of manufacture including tying-off or otherwise securing a second end of a braid within an interior volume of a ball where other approaches would be impracticable. The technique may be employed in creating the balls (be they spherical or ovaloid in cross-section, etc.) out of one continuous section of braid. In so doing, joints and other delivery profile-increasing features are avoided—as well as potential areas for failure. Accordingly, the subject implants are extremely robust and fully recoverable to their aneurysmal shape as is required when they are delivered through a catheter in low profile. Robust shape recovery is required in treatments targeting distal vasculature, especially the tortuous neurovasculature encountered in human brains. 
     A detailed example of one process path for implant formation is illustrated in  FIGS. 4A-4F . As shown in  FIG. 4F  an final implant  2  may begin as a section  50  of braided material. The tubular braid stock is secured. As shown, it is tied-off with a wire wrap  10 . Such action develops an inset region  24  for the implant body. An opposite end of the braid is then captured in a transfer tube  52 . The tube is passed through the volume of the implant and secured with a second tie  10  at the other side. 
     Additional refinement to the shape over that shown in  FIG. 4E  may be imparted within a shape-setting form  54 . Mandrels  56  including stops  58  received through the securement features may be employed to force apposition of the ball to the shape of the form when pulled apart as indicated by arrows. After shape-setting in the form (as appropriate to the selected material—e.g., as in heat setting superelastic Nitinol) the mandrels are removed and the implant shaping is complete as shown in  FIG. 4F . However, these additional forming steps are not necessary given that (in point of fact) the implant in  FIG. 1  was produced without employing the same. 
     The implants  70 ,  72  shown in  FIGS. 5A and 5B , respectively, may also be dual layer construction. In which case, they would share their distal configuration with the previous implants  20 / 40 / 60  shown in  FIGS. 1A-3C  of U.S. patent application Ser. No. 12/427,620, filed on Apr. 21, 2009. As shown, they are single-layer devices in which the distal end takes the form of an inset hub  74 . 
     Either way, the implants include unique proximal-end configurations. In addition to a ball or bulbous portion  80 , each implant includes a flap  76 ,  78  intended to improve its blood flow disruption potential. Flap  76  included in implant  70  is intended for intra-aneurysmal use. To deliver it as shown, the ball or bulbous portion is first delivered into the aneurysm sac  2 . Then, that portion of the device is compressed while still mounted to pusher  100  to deploy the flap section therein. After final positioning is achieved as shown in  FIG. 5A , then the pusher locking member(s) received within hub  42  are released. Finally, the pusher is withdrawn into the delivery catheter  110 . To assist in the delivery method, one or more additional radiopaque features (such as a band  50  at the proximal end of ball section  80 ) may be provided so that deployment can be visualized at each stage. 
     The implant in  FIG. 5B  requires no such complication in delivery. Because flap  78  is of a size selected only to fill the aneurysm neck, it can be delivered straight-away. Still, intermediate radiopaque features may be desirable to confirm appropriate fit and/or deployment. 
     As pictured, the ball-and-disk variation of the implant shown in  FIG. 5B  may only be applicable to smaller-neck aneurysms as compared to the  FIG. 5A  “acorn” type variation. Generally, the size of the disc will not be significantly larger than the parent/trunk vessel  6  diameter and or that of the bifurcation region  84 . Otherwise, the vasculature will interfere with deployment. As such, the disk may be limited to about 2.5 to about 5 mm in diameter. 
     While understood better in the context of the implant manufacture steps below, flap  78  may be formed using a simple washer or plate over which the braid is heat set. Otherwise, the forming tool may be curved or dished so that flap  78  better follows the contour of the main implant body. 
     Flap  76  in the  FIG. 5A  variation will typically be formed using a concave/convex form in similar fashion. The size of this flap may vary. As shown, its outer extent is roughly the same diameter of the ball portion  80  of the device. It may be smaller and/or cover a lesser extent of the proximal side of implant  70 . Generally, flap  76  will cover at least about a third and as much as one-half of body  80 . In this way, adequate neck coverage is better insured when employed to treat wide-neck aneurysms. 
     Methods of Use 
     Any one of the subject implants is delivered to a target site employing known percutaneous catheter access techniques. The implant may be secured to a pusher (e.g., pusher  30 ) used to advance it through the access catheter (e.g., microcatheter  44 ). Upon emplacement at the treatment site (e.g., cerebral aneurysm  26  as illustrated in  FIG. 2A ), the implant can be detached. With the exemplary system shown in  FIG. 3 , the suture  40  passing through the proximal end of the implant  2  is severed by melting it using a resistance heater. This retention/release fiber remains in and with the implant.