Surgery – Instruments – Internal pressure applicator
Reexamination Certificate
1998-08-27
2001-02-06
Buiz, Michael (Department: 3731)
Surgery
Instruments
Internal pressure applicator
C606S198000, C604S096010
Reexamination Certificate
active
06183492
ABSTRACT:
BACKGROUND
1. Field of the Invention
This invention relates generally to devices for controlling the flow of body fluids in body conduits and more specifically to such devices which can be remotely controlled in a less-invasive procedure.
2. Discussion of the Prior Art
The human body is composed of a labyrinth of body conduits generally organized into various systems of the body. By way of example, a labyrinth of body conduits including the urethra, form the urinary system of the body. Various blood vessels, including the inferior vena cava, are interconnected to form the vascular system of the body. Regardless of the system involved or the particular conduits forming that system, there are many surgical procedures which can benefit from a flow isolator to control flow of a body fluid within the particular system. In general, the flow isolator might function to facilitate the flow of the body fluid in a primary conduit, while inhibiting the flow of that fluid into a secondary conduit. By way of example, hepatic surgery generally requires that the portal vein and hepatic veins be occluded. In the past, this occlusion has been accomplished with cross-clamps which stop the back-flow of blood into the hepatic veins after the portal vein has been clamped.
Unfortunately, there is a significant risk involved in total occlusion of the inferior vena cava. For this reason, this surgery in the past has required that the vena cava be dissected above and below the liver, with the placement of clamps on both sides of the dissection. This has been a time-consuming and a technically challenging part of the procedure. Shunts have also been used to isolate the hepatic veins in similar procedures involving hepatic resection or liver trauma, for example. This procedure is merely representative of many surgical procedures where it is desirable to maintain flow within one body conduit while inhibiting flow in an intersecting conduit.
SUMMARY OF THE INVENTION
The device for the present invention consists of a catheter that is placed intraluminally, either percutaneously or endoluminally. A catheter is disclosed with two primary components, a flow isolator, and an obturator or introducer which facilitates operation of the isolator. In hepatic surgery of the type previously discussed, the catheter is placed into a vessel through a relatively small opening in the wall of the vessel by means of the obturator or introducer which serves to stretch the flow isolator length wise and thereby reduce its profile or diameter. The flow isolator is operatively disposed in the primary conduit, such as the inferior vena cava, and across an intersection with a secondary conduit, such as the hepatic vein. The flow isolator is configured for movement from a low-profile state to a high-profile state which facilitates flow through the primary conduit while inhibiting flow through the secondary conduit. In this manner, primary flow can be facilitated in the primary conduit while inhibiting flow into side-branches, bifurcations, communicating vessels, openings, or wounds.
In one embodiment, the catheter consists of a balloon bonded to a woven or braided tubular structure. The tubular structure serves to support a profusion lumen of the catheter while the balloon is inflated to occlude side-branches or communicators of the vessel. In another embodiment, the flow isolator is in the form of a sleeve having a relatively large opening at its proximal end and a relatively small opening at its distal end. The differential in the size of these openings increases the pressure of the body fluid within the sleeve, opening the sleeve within the primary conduit, but pressing the sleeve against the intersection thereby inhibiting flow in the secondary conduit. In this manner, the sleeve functions as a “wind-sock” as the body fluid itself functions to inflate the sleeve and force it into intimate contact with the inner surface of the primary conduit. While facilitating flow in the primary conduit, the flow isolator inhibits flow into the secondary conduit in order to isolate organs, wounds, or defects such as aneurysms.
Inflation of the sleeve can also be accomplished by providing the sleeve in the form of a plurality of chambers inflatable by an external pressurizing source. Chambers disposed longitudinally of the isolator can be inflated to provide the isolator with a high-profile state. A single circumferential chamber may also be provided at the proximal end in order to enlarge the first opening, thereby facilitating flow of the body fluid into the sleeve.
In another aspect of the invention, a flow isolator is adapted for use in controlling the flow of the body fluid in a primary conduit and a secondary body conduit forming an intersection with the primary body conduit. The flow isolator includes a sleeve having a flexible wall with a proximal end, and a distal end which is preferably disposed to face in the direction of flow of the body fluid in the primary body conduit. The sleeve is adapted for operative disposition within the primary conduit and across the intersection with the secondary body conduit. First portions of the sleeve at the proximal end form a first opening in the wall which facilitates flow of the body fluid into the sleeve. Second portions of the sleeve at the distal end form a second opening in the wall which facilitates flow of the body fluid out of the sleeve. The second opening is smaller than the first opening so as to increase the pressure of the body fluid within the sleeve. This pressure results in inflation of the sleeve whereby the wall is expanded outwardly into contact with the inner surface of the primary conduit. This increases the patency of the primary body conduit facilitating the flow of body fluid within that conduit. It also tends to occlude the intersection with the secondary conduit thereby inhibiting the flow of body fluid within that conduit. In this embodiment, the sleeve is formed to facilitate inflation by the body fluid. Alternatively, it can be formed with chambers which are inflatable to facilitate the high-profile state of the flow isolator.
A further aspect of the invention includes a method for controlling the flow of fluid in a primary conduit, and a secondary conduit forming an intersection with the primary conduit. The method includes the steps of positioning a flow isolator with its proximal ends and distal end disposed on opposing sides of the intersection, and its distal end facing in the direction of normal body fluid flow in the primary conduit. The method further comprises the step of pressurizing the sleeve to force the sleeve against the primary conduit thereby facilitating flow of body fluid within the primary conduit while inhibiting flow of the body fluid in the secondary conduit. In accordance with this method, multiple inflatable chambers can be provided with the method further comprising steps for inflating the chambers to achieve the high-profile state of the flow isolator.
These and other features and advantages of the invention will become more apparent with the description of preferred embodiments and reference to the associated drawings.
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Ashby Mark
Brustad John R.
Hansen Paul D.
Hart Charles C.
Hilal Said
Buiz Michael
Lewis William
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