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  Catheter having a funnel-shaped occlusion balloon of uniform thickness and methods of manufactureUSPTO Application #: 20060041228Title: Catheter having a funnel-shaped occlusion balloon of uniform thickness and methods of manufacture Abstract: Methods and apparatus are provided for removing emboli during an angioplasty, stenting or surgical procedure comprising a catheter having a funnel-shaped occlusion balloon of uniform thickness disposed on a distal end of the catheter. The occlusion balloon is fused to the distal end so that it provides a substantially seamless flow transition into a working lumen of the catheter. Additionally, a distal edge of the occlusion balloon is configured to be in close proximity with an inner wall of a vessel to facilitate blood flow into the catheter and efficiently remove emboli. (end of abstract) Agent: Gore Enterprise Holdings, Inc. - Newark, DE, US Inventors: Hung Van Vo, Rainier Betelia USPTO Applicaton #: 20060041228 - Class: 604101040 (USPTO) Related Patent Categories: Surgery, Means For Introducing Or Removing Material From Body For Therapeutic Purposes (e.g., Medicating, Irrigating, Aspirating, Etc.), Treating Material Introduced Into Or Removed From Body Orifice, Or Inserted Or Removed Subcutaneously Other Than By Diffusing Through Skin, Material Introduced Or Removed Through Conduit, Holder, Or Implantable Reservoir Inserted In Body, Having Means Inflated In Body (e.g., Inflatable Nozzle, Dilator, Balloon Catheter, Occluder, Etc.), Having Plural Balloons On Conduit, Balloon On Different Device The Patent Description & Claims data below is from USPTO Patent Application 20060041228. Brief Patent Description - Full Patent Description - Patent Application Claims
REFERENCE TO RELATED APPLICATIONS [0001] The present application is divisional application of Ser. No. 10/187,058 filed Jun. 27, 2002, which is a continuation-in-part of U.S. patent application Ser. No. 09/418,727, filed Oct. 15, 1999, which is a continuation-in-part of U.S. patent application Ser. No. 09/333,074, filed Jun. 14, 1999, now U.S. Pat. No. 6,206,868, which is a continuation-in-part of International Application PCT/US99/05469, filed Mar. 12, 1999, which is a continuation-in-part of U.S. patent application Ser. No. 09/078,263, filed May 13, 1998. FIELD OF THE INVENTION [0002] This invention relates to apparatus and methods for removing emboli during vascular interventions. More particularly, the apparatus and methods of the present invention provide a catheter having an occlusion balloon of uniform thickness that facilitates retrograde flow and removes emboli from a treatment vessel via a funnel-shaped taper of the occlusion balloon. BACKGROUND OF THE INVENTION [0003] Today there is a growing need to provide controlled access and vessel management during such procedures as stenting, atherectomy and angioplasty. Generally during these procedures there is a high opportunity for the release of embolic material. The emboli may travel downstream from the occlusion, lodging deep within the vascular bed and causing ischemia. The resulting ischemia may pose a serious threat to the health or life of a patient if the blockage forms in a critical area, such as the heart, lungs, or brain. [0004] Several previously known apparatus and methods attempt to remove emboli formed during endovascular procedures by aspirating the emboli out of the vessel of interest using a catheter having an occlusion balloon. These previously known occlusion balloons, however, have various drawbacks, including variability in deployment of the balloon to the desired shape, inefficiency in removing emboli, and/or high cost and complicated processes associated with manufacturing the balloon. [0005] In applicant's co-pending U.S. patent application Ser. No. 09/418,727, filed Oct. 15, 1999, which is incorporated herein by reference in its entirety, applicant describes the use of a bell or pear-shaped occlusion balloon disposed on the distal end of an arterial catheter. The occlusion balloon comprises a compliant material having a variable thickness along its length to provide a bell-shape when inflated. The balloon is affixed to distal end of the catheter so that a distal portion of the balloon extends beyond the distal end of the catheter to provide an atraumatic tip or bumper for the catheter. [0006] The balloon of that catheter may be formed using previously known techniques, such as varying the thickness of the balloon wall to achieve the preferred bell-shape in the deployed position. Such processes, however, can lead to variability in the final product due to the manufacturing process. Because variable thickness balloons present greater difficulties during manufacture than balloons having uniform wall thickness, the cost of such balloons may be higher. [0007] In view of the foregoing limitations of previously known devices, it would be desirable to provide an apparatus for removing emboli from a vessel comprising an occlusion balloon of uniform thickness to enhance manufacturability of the occlusion balloon. [0008] It also would be desirable to provide an apparatus for removing emboli from a vessel comprising an occlusion balloon of uniform thickness to reduce manufacturing cost and enhance product yield. [0009] It further would be desirable to provide an apparatus for removing emboli from a vessel comprising a catheter having an occlusion balloon of uniform thickness that facilitates retrograde flow and efficiently removes emboli. SUMMARY OF THE INVENTION [0010] In view of the foregoing, it is an object of this invention to provide an apparatus for removing emboli from a vessel comprising an occlusion balloon of uniform thickness to enhance manufacturability of the occlusion balloon. [0011] It also is an object of the present invention to provide an apparatus for removing emboli from a vessel comprising an occlusion balloon of uniform thickness to reduce manufacturing cost and enhance product yield. [0012] It further is an object of the present invention to provide an apparatus for removing emboli from a vessel comprising a catheter having an occlusion balloon of uniform thickness that facilitates retrograde flow and efficiently removes emboli. [0013] The foregoing objects of the present invention are accomplished by providing interventional apparatus comprising a catheter having proximal and distal ends, a working lumen extending therethrough and an occlusion balloon having proximal and distal ends disposed on the distal end of the catheter. The occlusion balloon has a contracted state suitable for insertion into a vessel and a deployed state configured to occlude antegrade flow in the vessel. [0014] In a preferred embodiment, the catheter comprises an inner layer covered with a layer of flat stainless steel wire braid and a polymer cover. A distal section of the occlusion balloon is melt-bonded to a distalmost end of the inner layer and, optionally, to a distalmost end of the polymer cover to form a substantially seamless transition into the working lumen of the catheter. The proximal end of the occlusion balloon is everted and affixed to the polymer cover to form an inflation chamber between the polymer cover and the balloon. [0015] In the deployed state, the occlusion balloon is configured to extend distal of the catheter and provides a funnel-shaped transition into the working lumen of the catheter. A distal edge of the occlusion balloon is configured to be in close proximity with an inner wall of a vessel to facilitate retrograde flow into the working lumen of the catheter and efficiently remove emboli. Additionally, because the occlusion balloon of the present invention comprises a uniform thickness, the balloon may be more reliable, easier to manufacture and more cost-effective than an occlusion balloon having a variable thickness along its length. [0016] Preferred methods of making and using the apparatus of the present invention also are disclosed. BRIEF DESCRIPTION OF THE DRAWINGS [0017] Further features of the invention, its nature and various advantages will be more apparent from the accompanying drawings and the following detailed description of the preferred embodiments, in which: [0018] FIGS. 1A-1B are, respectively, side and sectional views of a previously known occlusion balloon in contracted and deployed states; [0019] FIGS. 2A-2B are, respectively, a schematic view of apparatus in accordance with the present invention and a cross-sectional view along line A--A of FIG. 2A; Continue reading... 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