Hypotube catheter

Abstract

A balloon catheter device ( 300 ) of the present invention includes an elongate catheter shaft ( 301 ) comprising a helically-cut hypotube having a proximal portion and a distal portion. The proximal portion includes a coating that allows the shaft to provide a patent fluid passage, and a part of the distal portion inside a balloon ( 304 ) may be uncoated or otherwise open to the balloon lumen, allowing for passage of fluid through the shaft into the balloon lumen.

1 . A medical balloon catheter, comprising:
 an elongate helically-scored hypotube comprising a longitudinal tube lumen therethrough, a coated proximal portion, and an uncoated distal portion;   an inflatable balloon disposed about the uncoated distal portion such that a lumen of the balloon substantially comprises the uncoated distal portion;   wherein the tube is configured such that the coated proximal portion provides a substantially patent path of fluid communication with the uncoated distal portion and the uncoated distal portion permits fluid communication between the tube lumen and the balloon lumen.   
     
     
         2 . The medical balloon catheter of  claim 1 , wherein the coated proximal portion comprises a coating on an exterior surface of the tube. 
     
     
         3 . The medical balloon catheter of  claim 1 , wherein the coated proximal portion comprises a first coating on a surface of the tube lumen and a second coating on an exterior surface of the tube. 
     
     
         4 . The medical catheter of  claim 3 , wherein the first coating comprises a material different that the second coating. 
     
     
         5 . The medical balloon catheter of  claim 4 , further comprising a wire guide tube,
 wherein the wire guide tube is connected to the hypotube and extends substantially longitudinally parallel with the hypotube from a location proximal of the balloon to a location near the distal end of the balloon; and   wherein the wire guide tube comprises a wire guide lumen.   
     
     
         6 . The medical balloon catheter of  claim 4 , further comprising a sleeve connecting the wire guide tube to the hypotube. 
     
     
         7 . The medical balloon catheter of  claim 1 , further comprising a balloon-deployable stent configured to be deployed from the balloon. 
     
     
         8 . A catheter device, comprising:
 an elongate helically-scored hypotube shaft comprising a shaft lumen extending longitudinally therethrough;   a balloon disposed upon a distal end portion of the shaft such that a intralumenal shaft portion is disposed substantially longitudinally through an interior space of the balloon; and   a coating disposed upon at least one of an exterior shaft surface portion and an interior shaft lumen surface portion,
 wherein the coated surface portion provides a fluid-tight seal of the shaft, and 
   
       wherein the coating does not extend substantially onto the intralumenal shaft portion so as to permit fluid communication between the shaft lumen and the interior space of the balloon. 
     
     
         9 . A medical balloon catheter device configured for use with a wire guide, the catheter comprising:
 an elongate helically-scored hypotube, said tube comprising a proximal tube end, a distal tube end, and a longitudinal tube lumen extending therebetween;   a wire guide lumen structure disposed adjacent the distal tube end and extending distally beyond the distal tube end, said structure comprising a wire guide lumen;   an inflatable balloon disposed adjacent the wire guide lumen structure and attached near the distal tube end such that a lumen of the balloon is in fluid communication with the tube lumen;   wherein the tube is configured such that a coated proximal tube portion provides a substantially patent path of fluid communication between the proximal tube end and the balloon lumen.   
     
     
         10 . The catheter device of  claim 9 , wherein the wire guide lumen structure extends through a portion of the balloon lumen. 
     
     
         11 . The catheter device of  claim 9 , wherein a coating of the coated proximal tube portion comprises a material selected from HDPE, PTFE, PET, polyester block amide, polyether block amide, polyurethane, polyimide, polyolefin, nylon, and any combination thereof. 
     
     
         12 . The catheter device of  claim 11 , further comprising means for preventing fluid communication between the tube lumen and the wire guide lumen. 
     
     
         13 . The catheter device of  claim 12 , wherein the means for preventing fluid communication comprises a polymer sheath disposed around a distal portion of the tube. 
     
     
         14 . The catheter device of  claim 12 , wherein the means for preventing fluid communication comprises a dual-lumen sleeve, a part of which is disposed around a distal portion of the tube. 
     
     
         15 . The catheter device of  claim 9 , wherein the wire guide lumen structure comprises a dual-lumen sleeve, the sleeve comprising the wire guide lumen and a tube-surrounding lumen substantially parallel thereto, said tube-surrounding lumen substantially encompassing a circumferential distal portion of the tube. 
     
     
         16 . The catheter device of  claim 15 , wherein the wire guide lumen structure further comprises a wire guide aperture near a proximal end of the wire guide lumen structure, said aperture configured to allow passage of a wire guide therethrough. 
     
     
         17 . The catheter device of  claim 15 , wherein the tube-surrounding lumen is bonded to an exterior distal portion of the tube. 
     
     
         18 . The catheter device of  claim 15 , wherein a distal end portion of the balloon is sealed to the wire guide lumen structure to form a fluid-tight seal. 
     
     
         19 . The catheter device of  claim 15 , wherein the wire guide lumen further comprises a lining layer coaxially disposed against a surface of the wire guide lumen. 
     
     
         20 . The catheter device of  claim 19 , wherein the lining layer comprises PTFE. 
     
     
         21 . The medical balloon catheter of  claim 9 , further comprising a balloon-deployable stent configured to be deployed from the balloon. 
     
     
         22 . A medical balloon catheter device configured for use with a wire guide, the catheter comprising:
 an elongate tube formed of a helically-scored hypotube, said tube comprising a proximal tube end, a distal tube end, and a longitudinal tube lumen extending therebetween;   a dual-lumen sleeve structure disposed adjacent the distal tube end, said dual-lumen sleeve structure comprising a first sleeve lumen and a second sleeve lumen; and   an inflatable balloon comprising a balloon lumen, said balloon lumen being in fluid communication with the tube lumen;   wherein the first sleeve lumen comprises a wire guide lumen and extends distally beyond the distal tube end;   wherein the second sleeve lumen comprises a tube-bonding lumen through which is disposed a tube portion adjacent the distal tube end;   wherein a coating covers substantially the exterior surfaces of the tube and the sleeve structure, and provides a patent fluid communication path along the tube lumen between the proximal tube end and the balloon lumen;   wherein a proximal portion of the balloon is connected to the tube and the sleeve structure, and is connected distally to the sleeve structure such that at least a portion of the sleeve structure extends through the balloon lumen;   wherein the first sleeve lumen extends distally beyond a distal end of the balloon; and   wherein a wire guide aperture is disposed on a proximal portion of the wire guide lumen and is configured to provide passage therethrough for a wire guide.   
     
     
         23 . The catheter device of  claim 22 , wherein a coating comprises a material selected from HDPE, PTFE, PET, polyester block amide, polyether block amide, polyurethane, polyimide, polyolefin, nylon, and any combination thereof. 
     
     
         24 . The catheter device of  claim 22 , wherein the wire guide lumen further comprises a lining layer coaxially disposed against a surface of the wire guide lumen. 
     
     
         25 . The catheter device of  claim 22 , further comprising a balloon-deployable stent configured to be deployed from the balloon. 
     
     
         26 . The catheter device of  claim 22 , wherein the helically-scored hypotube comprises a helically-cut hypotube. 
     
     
         27 . A method of making a balloon catheter device comprising
 the steps of:   providing an elongate tube in the form of a helically-scored hypotube having a proximal tube end and a distal tube end with a tube lumen therebetween;   providing a dual-lumen sleeve having an upper sleeve lumen and a lower sleeve lumen, wherein said upper lumen includes a greater distal length than said lower lumen;   directing the distal tube end into the lower lumen until the distal tube end is near a distal end of the lower lumen;   directing a tubular sheath over the tube and the sleeve such that at least a substantial longitudinal portion of the tube and of the sleeve both extend through a sheath lumen of the tubular sheath;   shrinking the sheath around the tube and sleeve such that the sheath forms a coating thereabout;   skiving a wire guide aperture into a proximal portion of the upper lumen;   providing a balloon having a balloon lumen; and   attaching the balloon to the tube such that the tube lumen is in fluid communication with the tube lumen.   
     
     
         28 . The method of  claim 27 , further comprising a step before providing the dual-lumen sleeve, said step comprising providing a barrier sleeve disposed around a distal region of the tube. 
     
     
         29 . The method of  claim 27 ,
 further comprising a step of providing a tubular liner in the upper lumen of the dual-lumen sleeve.   
     
     
         30 . The method of  claim 27 , further comprising a step of providing a mandrel directed through the wire guide aperture and compressing a region immediately proximal thereof to form a ramped surface. 
     
     
         31 . The method of  claim 27 , wherein a portion of the upper lumen that includes the greater distal length than the lower lumen extends through a portion of the balloon lumen.