Occlusion, anchoring, tensioning and flow direction...

Surgery – Instruments – Internal pressure applicator

Reexamination Certificate

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Reexamination Certificate

active

06635068

ABSTRACT:

1. Field of the Invention
The present invention relates to medical devices and methods. In particular, the present idea relates to improved guide wires or catheters and method for their use, where the devices have a distal mechanism that acts as a mechanism for: 1. Flow Directed, using the natural flowing fluids, pressure differentials or contractile forces of the body onto the distal mechanism to direct its motion and direction or 2. Anchored, so that once the device is in the desired location, it can be anchored against the tissue where it rests; 3. Tensioned, so that placement of a device, over the guide wire is accomplished with less difficulty and 4. Occluded, so that vessels and aneurysms can be occluded.
BACKGROUND OF THE INVENTION
Guide wire management in the operating room is problematic, and threading the needle of the arteries or other vessels including, but not limited to veins, intestines, fallopian tubes, etc. to reach the area to be treated is difficult. Further, once the guide is in the desired location, it is often difficult to make certain that the it remains in that location. Even further, once the guide wire, catheter, endoscope or other device is in the desired location and another device is placed over, through or along side it, the initially placed device has a tendency to move due to the forces exerted on it when other devices are using it as a guide.
Additionally, other anchors are required for attaching tissue or other matter to improved or different locations within the body.
Even further, vessel occluders are often required for a variety of medical procedures.
The instant invention describes a device that facilitates all of these procedures in a novel fashion.
For these reasons, it is desirable to provide an improved devices and methods for their use, which facilitate 1. using the physiologic motions of the body to help direct the device. In addition, flow pressure differential can be artificially created or enhanced by the technician/physician so that this same technology can be used when physiologic means is unavailable or insufficient. Further, the natural contractile forces of the body (e.g. those of the intestinal tract, gall bladder, esophagus, etc.) can be harnessed so that the device including, but not limited to guide wires, catheters, endoscopes, etc. are moved along with those forces. 2. Even further, it is desirable to provide a device that has an anchoring mechanism on it so that it will not move once in its desired position. 3. And yet even another desired characteristic would be to provide an anchored device that has a tensioning characteristic applied to it for placement of other devices over through or along side the first placed device. 4. And finally, another desired characteristic is that of a simple and effective occlusion system.
There is a continuing need for improved devices to meet at least the following objectives.
The first objective is to reduce cost. This is particularly important in recent years where it is clear for safety and sanitary reasons that these will be single use devices. A device, although it performs a function in some improved manner, will not be widely used if it is considerably more costly than the alternatives available.
A second objective is to provide a device that is simple to use and in a very real sense simple to understand. This will encourage its adoption and use by medical personnel. It will also tend to keep cost low.
The third objective is to provide a device that entails a procedure with which the medical profession is familiar so that the skills that have been learned from previous experience will continue to have applicability.
A fourth objective relates to the effectiveness and thoroughness with which the device is intended.
A fifth objective concerns safety; a matter which is often so critical as to trump the other considerations. It is important to avoid unnecessary tissue trauma.
There are trade-offs in design considerations to achieve the above five interrelated objectives. Extreme simplicity and a very simple procedure might over compromise safety. Addressing all of these considerations calls for some trade-off between the objectives.
Accordingly, a major object of this invention is to provide an improved occlusion, tensioning, anchoring and flow device that achieves the objectives of reduced cost, enhanced simplicity, a standard procedure, high effectiveness and a high degree of safety. Most particularly, it is an object of this invention to achieve these objectives with an enhanced trade-off value for the combined objectives.
For these reasons, it is desirable to provide an improved device that may circumvent some of the problems associated with previous techniques. This improved medical device provides a new configuration that will eliminate some of those problems and methods for their use, which facilitate removal of vascular obstructions in the operating room or interventional suite.
BRIEF DESCRIPTION
In brief, one embodiment of this invention is particularly adapted to the anchoring of wires or tubes within the tubular channels of the body including, but not limited to veins, arteries, intestines, nasal passages, ear canal, etc. Further, this anchoring embodiment has a applicability in applying an anchor to tissues or other matter to areas of the body other than in tubular channels including, but not limited to the face, breast joints, etc. This embodiment has a support wire with an engaging element.
The support wire is a dual element support wire having a core and an annular shell that slides on the core. The distal end of the core is attached to the distal end of the annular braided element and the distal end of the shell is attached to the proximal end of the annular braided element. Thus movement of the core and shell relative to one another moves the braided element from a radially retracted position which is useful for insertion into the body to a radially expanded position which expands it to the sidewall of the tubular channel or against other tissue or matter within the body. When the annular braided element is in its radially compressed (smaller diameter) state, it can be passed through or around occlusions together with the rest of the wire to reside on the distal end of the occlusion in the case of tubular channels with occlusions. It is a preferred embodiment of the instant invention that it can be made very small. When the braided element is expanded and pulled proximally (that is, in a retrograde fashion), it will engage the walls of the tubular channel and the elongate support wire can be put into tension. This distal engaging tubular braid element may or may not be covered by or integrated with a thin film or membrane to create patency or other desirable characteristics.
The instant invention also describes another use of the same device of the instant invention with minor changes. In this case, the tubular braid distal expansile mechanism may be used on the end of a guide wire or catheter so that once deployed in a tubular channel with flow such as arteries and veins, the expanded mechanism can carry the support wire in the direction of the flow. In order to accomplish this flow characteristic of the instant invention, it may be desirable to deploy the distal expanding tubular braid whereby the support wire becomes ‘floppy’ in nature so that it will flow with the expanded ‘umbrella’. The author uses the phrase ‘umbrella’ only as a communication tool in that an umbrella starts out with a small diameter shaft in its un-deployed condition (radially compressed condition) and ends up with a large diameter configuration when deployed. The shape of the expanding mechanism is varied and includes, but is not limited to an umbrella shape, a spheroid shape, an ovoid shape, a conical shape, a disc-shape, etc. The inventors have fabricated at least all of the aforementioned shapes using tubular/annular braid and successfully tested the flow, anchoring, tensioning and occlusion characteristics in both a static and dynamic in vitro environment. Creating the expanded annular

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