Abstract:
Apparatus for hemostasis of an artery having a puncture after arterial catheterization, the apparatus includes a catheter introducer having a forward end and a hemostasis device including an elongate flexible hollow shaft having an inflatable anchor balloon at a forward end thereof and an inflatable peripheral balloon adjacent the forward end of the flexible hollow shaft, the hemostasis device being arranged to be insertable into an artery via the catheter introducer.  
     A method for hemostasis of an artery having a puncture after arterial catheterization is also disclosed.

Description:
FIELD OF THE INVENTION  
         [0001]    The present invention relates to catheterization systems and methodologies generally and more particularly to post-catheterization closure.  
         BACKGROUND OF THE INVENTION  
         [0002]    Applicant&#39;s U.S. Pat. No. 5,728,134 and Published PCT Patent application WO 98/11830 describe a method and apparatus for hemostasis which greatly simplifies hemostasis and thus greatly reduces patient discomfort following arterial catheterization. The prior art referenced in Applicant&#39;s Published PCT Patent application WO 98/11830 and U.S. Pat. No. 5,728,134 is considered to represent the state of the art.  
         SUMMARY OF THE INVENTION  
         [0003]    The present invention seeks to provide improved systems and methodologies for post-catheterization closure.  
           [0004]    There is thus provided in accordance with a preferred embodiment of the present invention an apparatus for hemostasis of an artery having a puncture after arterial catheterization. The apparatus includes a catheter introducer having a forward end and a hemostasis device including an elongate flexible hollow shaft having an inflatable anchor balloon at a forward end thereof and an inflatable peripheral balloon adjacent the forward end of the flexible hollow shaft, the hemostasis device is arranged to be insertable into an artery via the catheter introducer.  
           [0005]    There is provided in accordance with another preferred embodiment of the present invention an apparatus for hemostasis of an artery having a puncture after arterial catheterization. The apparatus is adapted for use with a catheter introducer having a forward end and includes a hemostasis device, an elongate flexible hollow shaft having an inflatable anchor balloon at a forward end thereof and an inflatable peripheral balloon adjacent the forward end of the flexible hollow shaft, the hemostasis device is arranged to be insertable into an artery via the catheter introducer.  
           [0006]    Further in accordance with a preferred embodiment of the present invention the flexible hollow shaft includes a central bore.  
           [0007]    Preferably, the flexible hollow shaft includes a wall having an asymmetric cross section, with a relatively thick cross sectional region and a relatively thin cross-sectional region. Typically, there is formed in the relatively thick cross sectional region, a peripheral bore which extends to a peripheral balloon inflation location exterior of the wall and communicates thereat with an interior of the peripheral balloon.  
           [0008]    Still further in accordance with a preferred embodiment of the present invention the central bore extends to an anchor balloon inflation location communicating with an interior of the inflatable anchor balloon.  
           [0009]    Additionally in accordance with a preferred embodiment of the present invention the anchor balloon and the central bore are configured such that when the anchor balloon is deflated it can be withdrawn into the central bore at the anchor balloon inflation location. Preferably, the anchor balloon is configured such that when it is inflated, it extends beyond the end of the flexible hollow shaft.  
           [0010]    Further in accordance with a preferred embodiment of the present invention the apparatus for hemostasis also includes a rod which is displaceable longitudinally inside and along the central bore. The rod which extends through the flexible hollow shaft and terminates at a first end in a manually engageable handle portion. At a second end, the rod is typically attached to the anchor balloon.  
           [0011]    Still further in accordance with a preferred embodiment of the present invention the rod includes a multistrand cable surrounded by a plastic cylindrical seal and is attached at an extreme end thereof to an inner surface of the anchor balloon.  
           [0012]    Moreover in accordance with a preferred embodiment of the present invention the apparatus for hemostasis also includes a stopcock and associated conduit, communicating with an interior of a head element to which the flexible hollow shaft is fixed at a rearward end thereof.  
           [0013]    Further in accordance with a preferred embodiment of the present invention the interior of the head element communicates with the central bore of the flexible hollow shaft and thus communicates with the interior of the anchor balloon at the anchor balloon inflation location.  
           [0014]    Still further in accordance with a preferred embodiment of the present invention, the apparatus for hemostasis also includes a stopcock and associated conduit, communicating with an interior the peripheral bore and thus communicates with the interior of the peripheral balloon.  
           [0015]    There is further provided in accordance with a preferred embodiment of the present invention, a method for hemostasis of an artery having a puncture after arterial catheterization, the catheterization using a catheter introducer. The method includes the steps of:  
           [0016]    inserting into an artery a catheter introducer having a forward end,  
           [0017]    following arterial catheterization and removal of a catheter from the catheter introducer, introducing into the artery via the catheter introducer, a hemostasis device, which includes an elongate flexible hollow shaft having an inflatable anchor balloon at a forward end thereof and an inflatable peripheral balloon adjacent the forward end,  
           [0018]    inflating the inflatable anchor balloon inside the artery, causing the inflatable anchor balloon to assume an inflated state,  
           [0019]    retracting the hemostasis device relative to the catheter introducer, until the anchor balloon in the inflated state engages the forward end of the catheter introducer,  
           [0020]    retracting the hemostasis device and the catheter introducer until the anchor balloon in the inflated state sealingly engages an inner wall surface of a wall of the artery about the catheter introducer,  
           [0021]    thereafter retracting the catheter introducer such that the forward end thereof lies outside the wall of the artery, while the anchor balloon in the inflated state blocks blood flow from the artery,  
           [0022]    inflating the peripheral balloon adjacent the forward end of the catheter introducer as it lies outside an outer surface of the wall of the artery, thereby causing the peripheral balloon to assume an inflated state,  
           [0023]    deflating the inflatable anchor balloon,  
           [0024]    thereafter, withdrawing the forward end of the flexible hollow shaft from the artery, while the peripheral balloon seals a region outside the artery and surrounding an aperture in the artery through which the forward end of the flexible shaft was withdrawn, allowing hemostasis to occur thereat and  
           [0025]    following hemostasis, deflating of the peripheral balloon and removal of the hemostasis device from the patient.  
           [0026]    Further in accordance with a preferred embodiment of the present invention the method also includes injecting a hemostatic agent via the hemostasis device to a location external of the artery.  
           [0027]    Still further in accordance with a preferred embodiment of the present invention the step of inflating the peripheral balloon includes:  
           [0028]    initially inflating the peripheral balloon and  
           [0029]    thereafter, further inflating the peripheral balloon sufficiently to cause the forward end of the flexible hollow shaft to be withdrawn completely from the wall of the artery and simultaneously to prevent blood flow from the artery through the artery wall. 
       
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0030]    The present invention will be understood and appreciated more fully from the following detailed description, taken in conjunction with the drawings in which:  
         [0031]    [0031]FIG. 1 is a simplified illustration of post catheterization closure apparatus constructed and operative in accordance with a preferred embodiment of the present invention;  
         [0032]    [0032]FIGS. 2A and 2B are sectional illustrations, taken along lines  2 A- 2 A and  2 B- 2 B of FIG. 1; and  
         [0033]    FIGS.  3 A- 3 L are simplified illustrations of a preferred mode of operation of the apparatus of FIGS. 1, 2A and  2 B. 
     
    
     DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS  
       [0034]    Reference is now made to FIGS. 1, 2A and  2 B, which are simplified illustrations of a hemostasis device  100  for producing hemostasis following arterial catheterization, in accordance with a preferred embodiment of the present invention. The hemostasis device  100  is suitable for insertion via a conventional catheter introducer (not shown) following completion of catheterization and removal of the catheter from the catheter introducer.  
         [0035]    In accordance with a preferred embodiment of the present invention hemostasis device  100  comprises a main shaft  102 , which preferably has an asymmetric wall  104 , typically as shown in FIG. 2A, having a relatively thick region, designated generally by reference numeral  106  and a relatively thin region, designated generally by reference numeral  108 . Extending along the wall  104  of the main shaft  102  at the relatively thick region there is preferably formed a bore  110  which extends to an peripheral balloon inflation location  112  exterior of wall  104 .  
         [0036]    Surrounded by asymmetric wall  104  is a central bore  120  which terminates at an anchor balloon inflation location  122 .  
         [0037]    Disposed at an end of main shaft  102  at anchor balloon inflation location  122  is an anchor balloon  124 . It is a particular feature of the present invention that anchor balloon  124  is able to be withdrawn within bore  120  when deflated and extends beyond the end of main shaft  102  when inflated. Withdrawal of the anchor balloon, when deflated, into the end of central bore  120  adjacent inflation location  122  is preferably assisted by a rod  126  which is displaceable longitudinally inside and along bore  120  and which extends through main shaft  102  and terminates in a manually engageable handle portion  128 . Rod  126  preferably comprises a multistrand cable  130  surrounded by a plastic cylindrical seal  132  and is attached at an extreme end thereof, designated by reference numeral  134  to an inner surface of balloon  124 .  
         [0038]    Anchor balloon  124  is selectably inflated via a stopcock  136  and associated conduit  138 , communicating with the interior of a head element  140  to which main shaft  102  is fixed at an end thereof opposite to the end at which balloon  124  is located. The interior of head element  140  communicates with central bore  120  in main shaft  102 , which in turn communicates with the interior of the anchor balloon  124  at anchor balloon inflation location  122 .  
         [0039]    Disposed adjacent the end of bore  110  in communication with peripheral balloon inflation location  112 , exterior of wall  104  is a peripheral balloon  150 , which is selectably inflated via bore  110 , as via a stopcock  152  and associated conduit  154  which communicates with bore  110  via head element  140  as seen in FIG. 1.  
         [0040]    It is noted that the head element  140  preferably defines interior travel stop surfaces  160  and  162  as well as an interior seal  164 . Interior seal  164  sealingly engages a handle shaft  166  which is fixed to handle portion  128 . Handle shaft  166  is preferably formed with a peripheral travel stop engagement protrusion  168  which is adapted to engage stop surfaces  160  and  162  when the handle portion  128  and thus rod  126 , fixed thereto, is respectively fully extended or fully retracted.  
         [0041]    Reference is now made to FIGS.  3 A- 3 L, which illustrate various steps in a preferred mode of operation of the apparatus of FIGS. 1, 2A and  2 B.  
         [0042]    [0042]FIG. 3A illustrates the hemostasis device  100  about to be inserted into an artery  300  via a conventional catheter introducer assembly  302 , following completion of a catheterization procedure and withdrawal of a catheter (not shown) from the catheter introducer assembly  302 . The catheter introducer assembly  302  conventionally includes a sheath  304  and a conventional hemostasis valve  306  to which is coupled a substance introduction conduit  308  having a control valve  310 .  
         [0043]    [0043]FIG. 3B shows the hemostasis device  100  inserted into the catheter introducer assembly  302  such that the outer end of the main shaft  102  extends into the artery  300  well beyond the end of catheter introducer sheath  304 . As shown with particularity in FIG. 3B, at this stage both anchor balloon  124  and peripheral balloon  150  are deflated, and anchor balloon  124  is preferably fully retracted inside central bore  120  upstream of anchor balloon inflation location  122 , by full retraction of handle portion  128  rearwardly of head element  140 .  
         [0044]    Reference is now made to FIG. 3C, which shows initial extension of anchor balloon  124  outside of central bore  120  by extension of handle portion  128  into engagement with head element  140 . At this stage, both balloons  124  and  150  remain deflated.  
         [0045]    [0045]FIG. 3D illustrates initial inflation of the anchor balloon  124 , preferably by use of a syringe  320  communicating with central bore  120  via the interior of head element  140 , stopcock  136  and associated conduit  138  (FIG. 1). Due to the engagement of extreme end  134  of rod  126  with an inner surface of balloon  124 , the inflated balloon preferably has a cusp-type configuration as seen with particularity in FIG. 3D.  
         [0046]    This cusp-type configuration is associated with a particular feature of the present invention inasmuch as it provides pivotable mounting of the balloon  124  relative to main shaft  102 , thereby to enable the anchor balloon  124  to sealingly align itself with the interior wall of artery  300  notwithstanding that the shaft  102  is normally not aligned perpendicularly thereto, as seen in the drawings.  
         [0047]    Following inflation of the anchor balloon  124 , the hemostasis device  100  is partially retracted such that the inflated anchor balloon  124  rests tightly against the extreme end of the catheter introducer sheath  304 , as seen in FIG. 3E.  
         [0048]    Thereafter, the catheter introducer assembly  302  and the hemostasis device  100  are withdrawn together, such that the catheter introducer sheath  304  is removed from artery  300  only when the anchor balloon  124  already engages the interior wall of artery  300  in sealing engagement with the aperture in the artery  300  through which the catheter introducer shaft  304  is drawn and through which the main shaft  102  presently extends. This stage is shown in FIG. 3F.  
         [0049]    As seen in FIG. 3G, initial inflation of the peripheral balloon  150  is effected, preferably by use of a syringe  340  communicating with bore  110  via head element  140 , stopcock  152  and associated conduit  154 . Thereafter, as seen in FIG. 3H, the anchor balloon  124  is deflated and the peripheral balloon  150  is more fully inflated, which preferably causes the extreme end of the main shaft  102  to be withdrawn from the artery  300  to a location lying just outside the artery wall.  
         [0050]    As shown in FIG. 31, the deflated anchor balloon  124  is then retracted within the central bore  120 , by full retraction of handle portion  128 , allowing for hemostasis to take place in a region  360  outside of artery  300 , which region is delimited by inflated peripheral balloon  150 , as shown in FIG. 3J.  
         [0051]    Once acceptable hemostasis has occurred in region  360 , the peripheral balloon  150  is deflated, as shown in FIG. 3K, preferably by operation of syringe  340  communicating with bore  110  via head element  140 , stopcock  152  and associated conduit  154 .  
         [0052]    Thereafter, the hemostasis device  100  is entirely withdrawn from the patient, leaving a region  360  of hemostasis outside of artery  300 , as shown in FIG. 3L.  
         [0053]    It will be appreciated by persons skilled in the art that the present invention is not limited by what has been particularly shown and described hereinabove. Rather the scope of the present invention includes both combinations and subcombinations of the various features described hereinabove and shown in the drawings as well as modifications and further developments thereof which would occur to a person of ordinary skill in the art upon reading the foregoing description and which are not in the prior art.