Patent Publication Number: US-2007102170-A1

Title: Crimp Hub for Anastomosis Device

Description:
CLAIM TO PRIORITY  
      The present application claims priority to U.S. provisional patent application No. 60/734,929, filed Nov. 9, 2005, and entitled “Crimp Hub for Anastomosis Device.” The identified provisional application is hereby incorporated by reference in its entirety. 
    
    
     FIELD OF THE INVENTION  
      The present invention relates to an anastomosis device for connecting urethra and bladder tissues after a radical prostatectomy and, more particularly, to a crimp hub to maintain the tines of the anastomosis device.  
     BACKGROUND OF THE INVENTION  
      An anastomosis device for the connection of tissues, e.g., urethra and bladder tissues after a radical prostatectomy, is described in U.S. patent application Ser. Nos. 10/646,383, 10/919,775, 10/919,545, 11/356,755, 11/356,556, 11/437,960, and 11/437,963. Each of the identified utility patent applications is hereby incorporated by reference.  
      One embodiment of the anastomosis device described within the noted applications utilizes a tissue approximating structure that has a plurality of tines that can be movably extended from corresponding apertures at the distal end of a catheter body. The tines are used to contact and optionally penetrate into or through the one or more of a tissue of the bladder, bladder neck, urethra, bulbar urethra, urethral stump, or perineal floor, to place opposing severed tissue surface into contact for healing, and preferably also to hold the tissues in contact with each other during the healing period. It is essential that the tines not be able to be separated from the tissue approximating structure, the loosening or separation of a tine could significantly effect the tissue approximating function of the device. As such there is a need to maintain the tines in substantially permanent manner within the device.  
     SUMMARY OF THE INVENTION  
      The needs described above are in large part addressed by the crimp hub for an anastomosis device, or tissue approximating device, of the present invention. The tissue approximating device generally includes the components of a plurality of tissue engaging tines, an actuator, a tine deflector, and a hub. The tissue engaging tines extends through the deflector and into the hub. To maintain the tines within the hub, the external circumference of the hub is crimped, preferably at least two times, to create a pull strength between the tines and hub of at least 4 lbs. The actuator is preferably an actuator wire and is secured to the external surface of the hub through the same crimping motion that secures the tines. The crimping of the actuator to the hub preferably creates a pull strength between the actuator and the hub of at least 8 lbs.  
      With the tines and actuator secured, the tissue approximating structure can be actuated; a first actuation of the actuator causes the tines to extend forward and outward from the deflector while a second actuation of the actuator draws in tines back towards the deflector.  
    
    
     DESCRIPTION OF THE DRAWINGS  
       FIG. 1  is a prior art depiction of a plurality of tines welded to a hub that forms a portion of a tissue approximating structure of an anastomosis device.  
       FIG. 2  is a perspective view of an uncrimped hub of the present invention.  
       FIG. 3  is a side view of the hub having been crimped about a plurality of tines.  
       FIG. 4  is a sectional view taken along line A-A of  FIG. 3 . 
    
    
     DESCRIPTION OF THE PREFERRED EMBODIMENTS  
       FIG. 1  shows a prior art configuration of a portion of the tissue approximating structure  10  wherein an actuating wire  12  extends to a hub  14  from which a plurality of tines  16  extend. The tines  16  extend further into a deflector  18  that enables the tines  16  to be further extended angularly outward therefrom and withdrawn back in. In this configuration the tines  16  are actually welded to the hub  14 , the welds are noted as item numbers  19 .  
      The present invention provides a manner, different from that of welding, of securing the actuation wire and tines to the hub. In the present invention, the tines of the tissue approximating structure are crimped between an inner and outer wall of the hub.  
       FIG. 2  provides a perspective few of the hub  20  of the present invention in an uncrimped configuration. As shown, the hub  20  incorporates an exterior surface  22  and an interior surface  24 . In the wall  26  existing between the exterior surface  22  and the interior surface  24 , a plurality of bores  28  are spaced about the circumference of the hub  20 . The bores  28  are preferably equidistantly spaced about the circumference and each is sized to accommodate the insertion of a tine (not shown). A cavity  29  is formed at the exterior surface of the hub  20  to accommodate passage of an actuation wire (not shown).  
       FIGS. 3 and 4  depict the deflector  30  and the hub  20  of a tissue approximating device  31 . As shown, a plurality of tines  32  have been placed through the deflector  30 , comprising an inner deflector  34  and an outer deflector  36 , and the hub  20 . An actuation wire  38  is placed within cavity  29 . The hub  30  has been crimped (the crimp is noted with item number  40 ) with a crimping tool, preferably two times, to ensure retention of the tines  32 . The pull strength of the crimp between the tines  32  and the hub  20  is preferably 4 lbs minimum. The crimping of the hub  20  to retain the tines  32  also operates to crimp the actuation wire  38  into the cavity  29 . The pull strength of the crimp between the actuation wire  38  and the cavity  29  is preferably 8 lbs. minimum.  
      The above invention has been described with reference to anastomosis device for connecting urethral tissues. It should be noted that the present invention may also be used in other anastomosis applications with tissues other than urethral tissues.  
      The present invention may be embodied in other specific forms without departing from the spirit of the essential attributes thereof; therefore, the illustrated embodiments should be considered in all respects as illustrative and not restrictive, reference being made to the appended claims rather than to the foregoing description to indicate the scope of the invention.