Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
1999-01-15
2001-04-03
Kennedy, Sharon (Department: 3763)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
C604S509000, C604S103020
Reexamination Certificate
active
06210392
ABSTRACT:
FIELD OF THE INVENTION
The present invention pertains generally to medical devices useful for treating a vessel of a patient. More specifically, the present invention pertains to a medical device inserted into a vessel of a patient's cardiovascular system which is useful for injecting a fluid directly into a vessel wall. Additionally, the present invention relates to a number of alternate methods for treating a vessel.
BACKGROUND
Stenosis and/or diseases are a common problem in vessels of a patient. Angioplasty is one procedure used to treat a stenosis within a body vessel of a human being. During an angioplasty procedure, a medical catheter having an inflatable balloon attached to a catheter shaft is advance in the vessel until the balloon is adjacent to the stenosis. Subsequently, the balloon is inflated. This causes the site of the stenosis to compress into the arterial wall and the body vessel to dilate.
However, the angioplasty procedure is not always successful in treating the stenosis in the vessel. Further, the angioplasty procedure can simulate the vessel thereby causing a subsequent restenosis of the vessel. As a result thereof, a number of other devices have been suggested for use in conjunction with an angioplasty procedure. For example, one such device utilizes a balloon to position a plurality of apertures against the vessel wall. Subsequently, the medication is released from the apertures against the endothelium.
Unfortunately, this device has also proved not to be entirely satisfactory. Specifically, with this device, a majority, if not all of the fluid does not penetrate the vessel wall and is washed away into the blood stream. Due to the toxic nature of some fluids, this procedure jeopardizes the health of the patient. Further, because the fluid is washed away, the treatment on the vessel is relatively ineffective.
In light of the above, it is an object of the present invention to provide a device and method useful for treating a stenosis de novo, inhibiting a stenosis from occurring and/or inhibiting a restenosis caused by trauma from an intravascular procedure. It is another object of the present invention to provide a device for treating a vessel having a mechanism for penetrating the vessel wall that is separate from a mechanism which injects a fluid into the vessel wall. Another object of the present invention is to provide a device which can selectively vary the force and depth that is used to penetrate the vessel wall. Still another object of the present invention is to provide a device for treating a vessel which is easy to use, and relatively simple and inexpensive to manufacture. Still another object of the present invention is to provide a device and method for treating a vessel which minimizes the risk to the patient.
SUMMARY
The present invention is directed to a device and method, which satisfies these needs. The device is designed for injecting a fluid from a fluid source into a treatment area of a wall of a vessel. The device includes an expanding member and one or more dispensers. As provided below, the expanding member selectively and accurately controls the movement of the dispensers and the fluid source selectively provides a pressurized supply of fluid to the dispensers. Thus, the mechanism which causes the dispensers to penetrate the vessel wall is separate from the mechanism which releases the fluid into the vessel wall.
Importantly, the present invention can be used to safely treat a stenosis de novo, inhibit a restenosis and/or inhibit a stenosis in a vessel, while minimizing the risk to the patient. Additionally, the present invention is site specific and allows the physician to precisely deliver the fluid only to a precise area of the vessel. This is important because many fluids may have harmful effects on other areas of the body. For example, some fluids may cause blindness.
In a first version of the present invention, the expanding member includes a balloon which is expandable from a contracted, first configuration to an expanded second configuration. The dispensers extend radially from the balloon and move with the balloon between the first configuration and the second configuration. The dispensers preferably penetrate an endothelium layer of the vessel at the treatment area and selectively release the fluid when the balloon is at the second configuration. With this configuration, the depth of penetration of the dispensers into the vessel wall and force used to penetrate the vessel wall is precisely controlled. This allows the present invention to deliver the fluid to the appropriate area of the vessel wall while minimizing trauma to the vessel wall. Further, the balloon can be used to simultaneously dilate the vessel.
At least one fluid passageway connects the fluid source in fluid communication with the dispensers. For example, the fluid passageway can include a flexible tubular sleeve which substantially encompasses and encloses at least a portion of an outer surface of the balloon. The fluid source includes a fluid pump which is in fluid communication with the fluid passageway for selectively providing a pressurized supply of fluid from the fluid source to the dispensers.
Each dispenser can be a substantially tubular protrusion having an attachment end and an invaginating section for invaginating the wall of the vessel. The attachment end includes a base plate which mounts directly onto the tubular sleeve. In some of the embodiments provided herein, the invaginating section is defined by an open edge of the dispenser. In other embodiments, each dispenser can include a porous section or an opening through the dispenser wall which defines the invaginating section.
Depending upon the fluid and the desired treatment, the fluid can be released substantially simultaneously with the dispenser penetrating the treatment area or there can be a time delay between the dispenser penetrating the treatment area and the release of the fluid from the dispensers.
A second version of the expanding member includes a multi-lumen catheter, a grommet, a plurality of flexible tubes which connect the grommet to the catheter and one or more dispensers secured to the flexible tubes. The grommet is movable relative to the catheter to reposition the flexible tubes near the vessel wall.
The invention is also a method for expanding the treatment area and delivering fluid from the fluid source to the treatment area. The method includes advancing the expanding member in the vessel, expanding the expanding member in the vessel and selectively releasing the fluid from the dispenser into the treatment area. The expansion of the expanding member causes the open end of each dispenser to penetrate the treatment area. Additionally, the expansion of the expanding member can also cause simultaneous dilation of the vessel.
The present invention is also a method for treating a wall of a living vessel. The method includes the steps of providing a fluid, advancing an expanding member in the vessel, moving the expanding member to a second configuration so that an invaginating section of a dispenser contacts at least a portion of the wall of the vessel and invaginating at least a portion of the wall of the vessel by selectively releasing the fluid from the invaginating section into the wall of the vessel.
The fluid can be forced from each dispenser into the wall of the vessel at a rate sufficient to create a localized swelling in the wall of the vessel. This allows the fluid to disperse in the wall of the vessel to distribute the fluid in the vessel wall. Preferably, in this embodiment, the dispensers are properly spaced apart to create a plurality of spaced apart localized swellings which subsequently disperse the fluid substantially around a circumference of the wall of the vessel.
The type of fluid can be varied to suit the specific needs of the patient. More specifically, the fluid can be designed to treat a stenosis or disease de novo, inhibit a restenosis by minimizing the effects of a previous intravascular procedure and/or inhibit a stenosis in a vessel. For
Barath Peter
Reiss Robert E.
Vigil Dennis M.
Interventional Technologies Inc.
Kennedy Sharon
Maynard Jennifer
Nydegger & Associates
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