The present invention relates to catheterization systems and methodologies generally and more particularly to post-catheterization closure.
Applicant""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""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.
The present invention seeks to provide improved systems and methodologies for post-catheterization closure.
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.
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.
Further in accordance with a preferred embodiment of the present invention the flexible hollow shaft includes a central bore.
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.
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.
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.
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.
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.
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.
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.
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.
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:
inserting into an artery a catheter introducer having a forward end,
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.
inflating the inflatable anchor balloon inside the artery, causing the inflatable anchor balloon to assume an inflated state,
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,
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,
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,
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,
deflating the inflatable anchor balloon,
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
following hemostasis, deflating of the peripheral balloon and removal of the hemostasis device from the patient.
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.
Still further in accordance with a preferred embodiment of the present invention the step of inflating the peripheral balloon includes:
initially inflating the peripheral balloon and
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.