Detachable balloon embolization device and methods

Abstract

A balloon embolization apparatus, system and method include a detachable balloon device mounted to the distal end of a catheter or microcatheter. The balloon device includes an elongated cannula having first and second axial lumens defined in the cannula, one lumen which allows for travel over a wire, an inflatable balloon disposed on the cannula, and a valve sleeve disposed between the balloon and the cannula. An inflation port on the cannula allows fluid to be introduced to the balloon via a channel in the catheter. The valve sleeve includes a vent offset from the inflation port in the cannula. The valve sleeve allows the introduced fluid to inflate the balloon, but prevents the fluid from escaping, thereby forming a check valve. Once inflated, the catheter is detached from the balloon apparatus. When the catheter is withdrawn, the balloon remains in place to allow for embolization.

What is claimed is: 
     
         1 . A balloon embolization apparatus, comprising:
 a cannula comprising
 a guide wire lumen, and 
 an inflation lumen; 
   an inflation port defined in the cannula, wherein the inflation port is in fluid communication with the inflation lumen;   a balloon disposed on the cannula; and   a valve sleeve disposed between the balloon and the cannula, the valve sleeve defining a vent in fluid communication with the balloon,   wherein the vent is angularly and axially offset relative to the inflation port.   
     
     
         2 . The apparatus of  claim 1 , further comprising:
 a first marker band disposed around the balloon, the valve sleeve, and the cannula at a first end of the cannula; and   a second marker band disposed around the balloon, the valve sleeve, and the cannula at a second end of the cannula opposite the first end.   
     
     
         3 . The apparatus of  claim 2 , wherein the first marker band and the second marker band each form a gas-tight seal between the balloon, the valve sleeve, and the cannula. 
     
     
         4 . The apparatus of  claim 2 , wherein the first marker band and the second marker band each further include a device visible under fluoroscopy. 
     
     
         5 . The apparatus of  claim 1 , wherein the balloon comprises an endothelial wall inflammation-enhancing material coating. 
     
     
         6 . The apparatus of  claim 1 , wherein:
 the cannula further includes a deflation lumen; and   the apparatus further includes a deflation port defined in the cannula, wherein the deflation port is in fluid communication with the deflation lumen.   
     
     
         7 . A balloon embolization system, comprising:
 a catheter including a distal end having a plug protruding from the catheter;   an inflatable balloon device detachably mounted to the catheter, wherein the inflatable balloon device includes a cannula having an axial lumen, wherein the plug is received in the axial lumen;   an inflation port defined in the cannula and in fluid communication with the axial lumen;   a balloon disposed on the cannula; and   a valve sleeve disposed between the balloon and the cannula, the valve sleeve defining a vent in fluid communication with the balloon,   wherein the vent is angularly and axially offset relative to the inflation port, and   wherein the inflatable balloon device is detachable from the catheter.   
     
     
         8 . The apparatus of  claim 7 , wherein the cannula further comprises an inflation channel in fluid communication with the axial lumen via the plug. 
     
     
         9 . The apparatus of  claim 8 , wherein the inflation channel is configured to receive at least one of a pressurized liquid or a pressurized gas for inflation of the balloon. 
     
     
         10 . The apparatus of  claim 9 , further comprising:
 a catheter marker band disposed on the catheter; and   a first balloon marker band and a second balloon marker band, wherein the first and second balloon marker bands are disposed on the inflatable balloon device.   
     
     
         11 . The apparatus of  claim 7 :
 wherein the cannula further includes a deflation lumen; and   further comprising
 a deflation port defined in the cannula and in fluid communication with the deflation lumen, and 
 a wire disposed in the deflation lumen, wherein the wire includes a preformed bend disposed proximate the deflation port. 
   
     
     
         12 . The apparatus of  claim 11 , wherein the preformed bend of the wire is configured to engage the valve sleeve in response to a transformation event. 
     
     
         13 . The apparatus of  claim 12 , wherein:
 the wire comprises a nickel titanium wire; and   the transformation event comprises heating the wire to a predetermined temperature.   
     
     
         14 . A method of embolization, comprising:
 (a) providing a catheter including a detachable balloon device disposed on a distal end of the catheter;   (b) inserting the detachable balloon device and the catheter into vasculature of a patient and locating the detachable balloon device in or near a target location;   (c) introducing a fluid through the catheter into the detachable balloon device, thereby inflating the detachable balloon device at the target location;   (d) sealing the detachable balloon device during inflation such that the fluid becomes trapped inside the inflated detachable balloon device;   (e) detaching the catheter from the inflated detachable balloon device; and   (f) withdrawing the catheter from the vasculature while leaving the detached and inflated detachable balloon device at or near the target location inside the vasculature.   
     
     
         15 . The method of  claim 14 , wherein the detachable balloon device comprises:
 a cannula with a first axial lumen and a second axial lumen;   a tubular balloon disposed on the cannula; and   a valve sleeve disposed between the tubular balloon and the cannula, wherein the valve sleeve includes a vent.   
     
     
         16 . The method of  claim 15 , wherein the detachable balloon device is detachably secured to the catheter in a friction fit. 
     
     
         17 . The method of  claim 15 , wherein introducing the fluid through the catheter into the detachable balloon device comprises:
 the valve sleeve expanding to permit the fluid to travel inside a local plenum formed between the valve sleeve and the cannula; and   the fluid passing through the vent into the tubular balloon.   
     
     
         18 . The method of  claim 17 , wherein sealing the detachable balloon device during inflation comprises forming a positive pressure inside the tubular balloon that further presses the valve sleeve against the cannula. 
     
     
         19 . The method of  claim 14 , wherein introducing the fluid through the catheter comprises introducing at least one of:
 a pressurized liquid; or   a gas.   
     
     
         20 . The method of  claim 14 , further comprising manipulating a nickel titanium wire disposed in the catheter, thereby partially deflating the inflated detachable balloon device.