Catheter system for the isolation of a segment of blood vessel

Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...

Reexamination Certificate

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C604S099010

Reexamination Certificate

active

06176844

ABSTRACT:

BACKGROUND OF THE INVENTION
The present invention relates to the art of transcatheter interventional procedures. It finds particular application in conjunction with thrombectomies, and will be described with particular reference thereto. However, it is to be appreciated that the present invention is also amenable to other analogous applications where isolation of a segment of a blood vessel or other tubular organ is desired.
Generally, catheters are well known in the medical arts. In the course of transcatheter interventional procedures, it is often desirable to isolate a segment of a blood vessel or other tubular organs temporarily. This allows for localized infusion of medications and treatment. Moreover, with different medical procedures, often various equipment, tools, and/or instruments are employed such that repeated access to a diseased site is desirable. In the past, catheter systems lacked these features.
In the case of blood vessels, a thrombectomy often involves the maceration of a thrombus and removal of debris. However, in previous procedures there existed the risk of embolization of the debris.
In one type of thrombectomy, the Folgerty-type, a Folgerty balloon is passed beyond the thrombus, inflated, and then pulled back while still inflated. This pulls the thrombus out with the balloon. However, the drawback to this technique is that it is relatively invasive and destructive. That is to say, typically, an arteriotomy is performed through which the Folgerty balloon is pulled to remove the thrombus. Generally, minimally invasive procedures are preferred.
With peripheral vascular grafts, such as those in the legs, often the graft is either a vein or Teflon. After time, a clot may form in the graft up to, in some cases, ten inches long. Commonly, such a clot is opened up by dripping a thrombolytic drug onto the clot. However, this technique is lengthy and requires that a catheter remain inserted, in some cases, up to 24 to 48 hours. Generally, relatively long procedures are undesirable where they may be avoided.
The present invention contemplates a new and improved catheter system and technique for the isolation of a segment of a blood vessel or other tubular organ which overcomes the above-referenced problems and others.
SUMMARY OF THE INVENTION
In accordance with one aspect of the present invention, a catheter for isolating a segment of a blood vessel is provided. It includes a guiding catheter having a proximal end and a distal end. The guiding catheter has a major lumen and minor lumen arranged in parallel. A first expandable latex balloon is attached circumferentially to an outside of the guiding catheter at the distal end thereof. The first expandable latex balloon is connected via the minor lumen to a first inflation port arranged at the proximal end of the guiding catheter. Fluid injected through the first inflation port expands the first expandable latex balloon. A proximal assembly is connected to the major lumen at the proximal end of the guiding catheter. The proximal assembly includes an aspiration port coupled to the major lumen for evacuating material from the major lumen. A guidewire extends through the major lumen. The guidewire includes a hollow tube having a proximal end and a distal end. A solid segment of wire with a shapable core is attached to the distal end of the hollow tube forming a seal therewith. A plug is selectively inserted into the proximal end of the hollow tube to form a seal therewith. A second expandable latex balloon is circumferentially attached to the distal end of the hollow tube such that the second expandable latex balloon expands as fluid is received therein from a hole in the hollow tube. A detachable manifold holds the proximal end of the hollow tube and the plug in alignment with one another when the plug is not inserted into the proximal end of the hollow tube. The detachable manifold includes a second inflation port through which fluid is injected into the hollow tube thereby expanding the second expandable latex balloon.
In accordance with another aspect of the present invention, a catheter system for isolating a segment of a tubular organ is provided. It includes a guiding catheter having proximal and distal ends. The guiding catheter includes a major lumen and a first balloon that is selectively expandable. The first balloon is attached to the outside of the guiding catheter at the distal end thereof. A guidewire extends through the major lumen. The guidewire includes a hollow tube having proximal and distal ends. A second balloon that is selectively expandable is attached to the hollow tube at the distal end thereof. A plug is selectively joined with the proximal end of the hollow tube forming a seal therewith. A manifold holds the proximal end of the hollow tube and the plug in alignment with one another when the plug is not joined with the proximal end of the hollow tube.
In accordance with a more limited aspect of the present invention, the manifold is independently detachable from the proximal end of the hollow tube and the plug.
In accordance with a more limited aspect of the present invention, the manifold further includes fittings that hold the proximal end of the hollow tube and the plug. The fittings are independently adjustable for selectively forming seals around the proximal end of the hollow tube and around the plug.
In accordance with a more limited aspect of the present invention, the second balloon is circumferentially attached to the distal end of the hollow tube and is coupled thereto via a hole in a side of the hollow tube.
In accordance with a more limited aspect of the present invention, the manifold further includes an inflation port which is coupled to the hollow tube when the manifold holds the proximal end of the hollow tube and the plug is not joined therewith. Pressure applied through the inflation port expands the second balloon.
In accordance with a more limited aspect of the present invention, the plug is joined with the proximal end of the hollow tube to maintain the pressure applied to the second balloon such that the second balloon remains expanded after the manifold is detached from the proximal end of the hollow tube and the plug.
In accordance with a more limited aspect of the present invention, the guiding catheter further includes an aspiration port arranged at the proximal end of the guiding catheter. The aspiration port is coupled to the major lumen for evacuation of material therefrom.
In accordance with a more limited aspect of the present invention, the guiding catheter further includes a minor lumen arranged in parallel with the major lumen. The minor lumen couples the first balloon to an inflation port arranged at the proximal end of the guiding catheter such that pressure applied through the inflation port expands the first balloon.
In accordance with a more limited aspect of the present invention, the guiding catheter further includes a fitting arranged at the proximal end of the guiding catheter. The fitting has the guidewire inserted therethrough. The fitting is independently adjustable for selectively forming a seal around the guidewire.
In accordance with another aspect of the present invention, a method for isolating a segment of a tubular organ is provided. The method includes inserting a first end of a guide tube through a wall of the tubular organ. The first end of the guide tube is positioned at a first end of the segment being isolated. A first end of a guidewire is passed through the guide tube and positioned at a second end of the segment being isolated opposite the first end of the segment being isolated. An outer diameter of the first end of the guide tube is expanded until it forms a seal with the wall of the tubular organ. An outer diameter of the first end of the guidewire is expanded until it forms a seal with the wall of the tubular organ.
In accordance with a more limited aspect of the present invention, the method further includes holding a second end of the guidewire opposite the first end of the guidewire with a manifold. Pressure is applied th

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