# US 8,784,602 B2 · Balloon catheter for delivering a therapeutic agent > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 8,784,602 B2 - Document ID: US8784602B2 - Status: Granted - Kind: B2 - Application number: 13/477,774 - Filed: 2012-05-22 - Published: 2013-02-28 - Granted: 2014-07-22 - Earliest claimed: 2007-09-12 - Assignees: Cook Medical Technologies LLC - Applicants: Darin G. Schaeffer; David Christian Lentz - Inventors: Darin G. Schaeffer; David Christian Lentz - Web page: https://patentgrep.com/patent/US8784602B2 ## CPC - A61M 25/10: Balloon catheters ({A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02;} inflatable balloons for placing stents or stent-grafts A61F2/958 {; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00}) - A61M 25/1027: {Making of balloon catheters} - A61M 2025/0004: {having two or more concentrically arranged tubes for forming a concentric catheter system} - A61M 2025/1013: {with concentrically mounted balloons, e.g. being independently inflatable} - A61M 2025/105: {having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes} - A61M 2025/1056: {having guide wire lumens outside the main shaft, i.e. the guide wire lumen is within or on the surface of the balloon} - Y10T 29/49865: by temperature differential [e.g., shrink fit] - A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)} - Y10T: TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION ## Abstract Catheter balloon assemblies (10) for delivering a therapeutic agent to a body vessel are provided, as well as related methods of manufacturing and methods of treatment. The catheter balloon assemblies may include a concentrically disposed dual balloon assembly at the distal portion of the catheter having an inner balloon (44), a porous outer balloon (42) concentrically arrayed around the inner balloon and a catheter shaft (30) adapted to deliver a therapeutic agent to the body vessel through the apertures in the outer balloon. Radial outward expansion of the inner balloon may urge the outer balloon into contact with the wall of a body vessel, where the therapeutic agent may be delivered from the catheter shaft through apertures in the outer balloon directly to the wall of the body vessel. Preferably, the catheter balloon assemblies include a stiffening' member (210) within the proximal portion and/or a plurality of lumens lined with a fluorinated hydrocarbon to independently inflate the inner balloon, deliver the therapeutic agent through the outer balloon and house a wire guide (50). The catheter balloon assemblies may provide improved tractability and/or pushability characteristics. ## Claims ### Claim 1 A method for making a balloon catheter, comprising: (a) forming a catheter shaft, said forming including: disposing a first fluorinated hydrocarbon tube in a first lumen of a thermoplastic polymer sleeve material, the first fluorinated hydrocarbon tube having a melting point higher than that of the thermoplastic polymer sleeve material; disposing a second fluorinated hydrocarbon tube in a second lumen of the thermoplastic polymer sleeve material, the second fluorinated hydrocarbon tube having a melting point higher than that of the thermoplastic polymer sleeve material; heating the thermoplastic polymer sleeve material, with the first and second fluorinated hydrocarbon tubes disposed in the first and second lumens, to provide a heated catheter shaft assembly in which the thermoplastic polymer sleeve material is molten; and compressing the heated catheter shaft assembly so as to cause the molten thermoplastic polymer sleeve material to flow around and join together the first fluorinated hydrocarbon tube and the second fluorinated hydrocarbon tube; and (b) mounting a balloon on the catheter shaft with an interior of the balloon in fluid communication with a lumen defined by the first fluorinated hydrocarbon tube. ### Claim 2 (depends on 1) The method of claim 1, wherein said thermoplastic polymer is comprised of a polyether block amide. ### Claim 3 (depends on 1) The method of claim 1, wherein said first and second fluorinated hydrocarbon tubes are each comprised of a polytetrafluoroethylene tube. ### Claim 4 (depends on 1) The method of claim 1, also comprising disposing heat shrink tubing around said thermoplastic polymer sleeve material, and wherein said heating is also sufficient to shrink the heat shrink tubing so as to cause said compressing. ### Claim 5 (depends on 4) The method of claim 4, wherein said heat shrink tubing is comprised of a polyether block amide. ### Claim 6 (depends on 1) The method of claim 1, wherein said catheter shaft segment has a generally circular cross section upon completion of said heating and compressing. ### Claim 7 (depends on 4) The method of claim 4, also comprising disposing a third fluorinated hydrocarbon tube within said heat shrink tubing prior to said heating. ### Claim 8 (depends on 7) The method of claim 7, wherein said third fluorinated hydrocarbon tube is disposed within the heat shrink tubing between an inner surface of the heat shrink tubing and an outer surface of the thermoplastic sleeve material. ### Claim 9 (depends on 4) The method of claim 4, also comprising disposing a stiffening member within said heat shrink tubing prior to said compressing. ### Claim 10 (depends on 9) The method of claim 9, wherein said stiffening member is a tapered mandrel. ### Claim 11 (depends on 1) The method of claim 1, wherein the first fluorinated hydrocarbon tube and the first lumen are sized such that void space occurs between the first fluorinated hydrocarbon tube and walls defining the first lumen, the second fluorinated hydrocarbon tube and the second lumen are sized such that void space occurs between the second fluorinated hydrocarbon tube and walls defining the second lumen, and compressing the heated catheter shaft assembly causes the molten thermoplastic polymer sleeve material to fill the void space between the first fluorinated hydrocarbon tube and the first lumen and the void space between the second fluorinated hydrocarbon tube and the second lumen. ### Claim 12 (depends on 1) The method of claim 1, also comprising disposing heat shrink tubing around said thermoplastic polymer sleeve material, and wherein said heating is also sufficient to shrink the heat shrink tubing so as to cause said compressing, wherein said heat shrink tubing is subjected to at least partial cross-linking. ### Claim 13 (depends on 1) The method of claim 1, also comprising disposing heat shrink tubing around said thermoplastic polymer sleeve material, and wherein said heating is also sufficient to shrink the heat shrink tubing so as to cause said compressing, wherein said heat shrink tubing comprises FEP. ### Claim 14 (depends on 1) The method of claim 1, wherein at least one of said first and second fluorinated hydrocarbon tubes is comprised of a polyimide tube. ### Claim 15 (depends on 1) The method of claim 1, wherein said balloon is an inner non-porous balloon, and also comprising an outer porous balloon mounted on the catheter shaft with an interior of the outer porous balloon in fluid communication with a lumen defined by the second fluorinated hydrocarbon tube. ### Claim 16 (depends on 9) The method of claim 9, wherein said stiffening member is disposed within the heat shrink tubing between an inner surface of the heat shrink tubing and an outer surface of the thermoplastic sleeve material. ### Claim 17 (depends on 1) The method of claim 1, wherein said thermoplastic polymer sleeve is a dual-lumen thermoplastic FIG. 8 sleeve. ### Claim 18 (depends on 8) The method of claim 8, wherein a lumen defined by said third fluorinated hydrocarbon tube is adapted to be a wire guide lumen and extends from a point intermediate the balloon and a manifold at a proximal end of the catheter shaft to a point distal from the balloon, and cutting away an aperture in the heat shrink tubing to access a proximal end of the wire guide lumen. ### Claim 19 (depends on 18) The method of claim 18, wherein said thermoplastic polymer sleeve is a dual-lumen thermoplastic FIG. 8 sleeve, also comprising disposing a stiffening member within said heat shrink tubing prior to said compressing, wherein said stiffening member is disposed within the heat shrink tubing between an inner surface of the heat shrink tubing and an outer surface of the thermoplastic sleeve material, said stiffening member is a tapered mandrel, and a proximal end of the third fluorinated hydrocarbon tube overlaps a distal end of the tapered mandrel. ### Claim 20 (depends on 19) The method of claim 19, wherein at least one of said first and second fluorinated hydrocarbon tubes is comprised of a polyimide tube, and said balloon is an inner non-porous balloon, and also comprising an outer porous balloon mounted on the catheter shaft with an interior of the outer porous balloon in fluid communication with a lumen defined by the second fluorinated hydrocarbon tube.