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Device and method for partially occluding blood vessels using flow-through balloonRelated Patent Categories: Surgery, Instruments, Internal Pressure Applicator (e.g., Dilator), Inflatable Or Expandible By Fluid, Inserted In Vascular SystemDevice and method for partially occluding blood vessels using flow-through balloon description/claimsThe Patent Description & Claims data below is from USPTO Patent Application 20060052813, Device and method for partially occluding blood vessels using flow-through balloon. Brief Patent Description - Full Patent Description - Patent Application Claims
PRIORITY CLAIM [0001] This application is a continuation-in-part of U.S. patent application Ser. No. 09/080,823 filed on May 18, 1998, which claims the benefit of U.S. Provisional Application No. 60/046,977 filed May 19, 1997. BACKGROUND OF THE INVENTION [0002] 1. Field of the Invention [0003] This invention relates to a device and method for creating a region of hemostasis along a wall of a blood vessel without interrupting the flow of blood through the blood vessel. The device may be used, for example, for creating a working area along the aorta for performing a cardiac bypass procedure or for isolating an aneurysm. [0004] 2. Background Discussion [0005] Coronary artery diseases are often caused by atherosclerosis or narrowing of the small arteries between the aorta and the heart muscles. There are several ways to provide blood flow around occluded segments of arteries or veins, however, the known methods cause a large amount of trauma to the patient. One method is to perform an "open heart surgery," which is cracking open the chest and exposing the heart and treating the vessel directly. However, the large incision and surgically cut sternum take a long time to heal. [0006] Another method is to perform a bypass operation wherein a section of the saphenous vein, or a suitable substitute, is grafted, usually between the ascending aorta just above the heart and one or more of the coronary arteries beyond the points of blockage. The bypass operation is performed with the patient connected to a heart-lung machine and the heart is stopped. Because the heart is stopped, the heart-lung bypass can damage blood cells. Additionally, the patient's internal body temperature is reduced while on a heart-lung bypass to reduce basil metabolism and then the body temperature is increased to normal when the procedure is over. This thermal change to a person's body can cause damage to the intestinal track as well as causing additional stress to the patient. [0007] If the patient is not placed on a heart-lung bypass, the aorta is typically partially clamped along its axis to create an area of blood stasis and a small channel for blood flow. However, clamping the aorta can cause injury to the aorta and can also cause plaque formations to break off into the blood stream and cause vascular accidents such as strokes and emboli. [0008] What is needed therefore is a device and method for performing a cardiac bypass procedure without the need to clamp the aorta or place the patient on a heart-lung bypass machine. SUMMARY OF THE INVENTION [0009] The present invention involves a device for partially occluding a blood vessel such that an area of hemostasis within the blood vessel is created without interrupting the blood flow through the blood vessel. In one embodiment, the device includes a flow-through balloon that is adapted to be introduced into the aorta through an incision. The balloon includes a tubular connector having first and second partially occlusive members which extend radially therefrom. When the balloon is inflated, a region of hemostasis is created along an outside wall of the tubular connector while blood continues to flow through the tubular connector. The device thus creates an anastomosis site along a wall of the aorta without the need to stop the patient's heart, use a cross clamp, or connect the patient to a heart-lung machine. [0010] In accordance with one aspect of the invention, the device comprises first and second inflatable occlusive members for partially occluding a blood vessel, each occlusive member having an opening therein for passage of blood and a tubular connector having a diameter smaller than that of the occlusive members extending between the openings of the occlusive members. The tubular connector is comprised of inner and outer tubular portions, one of the tubular portions within the other of the tubular portions, the inner tube portion forming a lumen for blood flow, the tubular portions being attached to each other. Furthermore, the occlusive members and the tubular portions are of a single piece construction comprised of a single material. In addition, the device further includes an inflation tube, a portion of which is disposed between the tubular portions. [0011] In accordance with an additional aspect of the invention, the material used in the balloon device is a low compliance material that stretches by no more than about 10-20% upon inflation. [0012] In accordance with another aspect of the invention, the device comprises a single piece of material configured to form first and second occlusive members with a tubular connector therebetween, the tubular connector being having a diameter less the diameter of the blood vessel and the occlusive members having a diameter approximately equal to the blood vessel. In accordance with an additional aspect of the invention, the material for the balloon is expandable upon inflation to increase the diameter of the occlusive members by no more than about 20%, such that the occlusive members have an unexpanded diameter which is at least about 80% of the diameter of the vessel. [0013] In accordance with another aspect of the invention, a surgical method is provided for forming an incision in the aorta of a patient, inserting an occlusive device through the incision into the aorta and utilizing the occlusive device to create an area of hemostasis without interrupting blood flow through the aorta. The utilizing step includes positioning the occlusive device at a selected location in the aorta and activating the occlusive device after the device is positioned by pressurizing an inflation tube connected to the occlusive device. Furthermore, the positioning step includes using a marker on the inflation tube to determine the position of the device within the aorta. [0014] In accordance with another aspect of the invention, a method of treating an aneurysm is provided for inserting an occlusive device into the blood vessel and utilizing the occlusive device to create an area of hemostasis along the length of the aneurysm without interrupting blood flow through the blood vessel. The utilizing step includes positioning portions of the device on opposite sides of the aneurysm and activating the device. [0015] In accordance with another aspect of the invention, a method of manufacturing an occlusive device is provided for providing a mandrel, applying a low compliance biocompatible material to the mandrel, removing the material from the mandrel as a single piece tubular structure, and inserting one portion of the tubular structure inside another portion of the tubular structure to form a tubular structure with a double wall. Furthermore, the method of manufacturing the occlusive device further comprises inserting an inflation tube between the double wall. [0016] In accordance with another aspect of the invention, the device comprises a tubular structure having first and second occlusive members connected by a tubular member, the tubular structure configured to create an area of hemostasis in a blood vessel without interrupting blood flow through the vessel and a length of material attached to the tubular structure in a purse string arrangement such that force on the length of material collapses at least a portion of the tubular structure to facilitate removal of the structure from the blood vessel. [0017] In accordance with another aspect of the invention, the device comprises a first and second inflatable occlusive members for partially occluding a blood vessel that are spaced apart from each other and a tubular connector having a diameter smaller than that of the occlusive members extending between the occlusive members, wherein inflation of said occlusive members creates an area of hemostasis between an outer surface of said tubular connector and an inner wall of the blood vessel while blood continues to flow through said tubular connector. The device further includes an indicator marker overlaid on top of the blood vessel, which corresponds to the placement of the occlusive members and the tubular connector such that the position of the occlusive members and tubular connector is locatable. In accordance with an additional aspect of the invention, the first and second occlusive members and the tubular connector are separate chambers. BRIEF DESCRIPTION OF THE DRAWINGS [0018] These and other features of the invention will now be described with reference to the drawings of a preferred embodiment, which is intended to illustrate and not to limit the invention, and in which: [0019] FIG. 1 is a perspective view of a device for partially occluding blood vessels using flow-through balloon in accordance with the invention. [0020] FIG. 2 generally illustrates the use of the device as used in a blood vessel, with the device shown in a deflated state. Continue reading about Device and method for partially occluding blood vessels using flow-through balloon... 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