Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
2001-02-07
2004-03-30
Jaworski, Francis J. (Department: 3737)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
C606S194000, C600S439000, C600S467000
Reexamination Certificate
active
06712783
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates generally to catheter systems for imaging and treatment of stenoses within a patient's vascular system and more particularly to a catheter system in which a balloon angioplasty device can be delivered along with an imaging or interventional work element to a desired region within a blood vessel.
2. Description of the Background Art
Arteriosclerosis, also known as atherosclerosis, is a common human ailment arising from the deposition of fatty-like substances, referred to as atheroma or plaque, on the walls of blood vessels. Such deposits occur both in peripheral blood vessels that feed limbs of the body and coronary blood vessels that feed the heart. Localized accumulation of deposits within regions of the blood vessels may result in stenosis, or narrowing of the vascular channel. When this occurs, blood flow is restricted and the person's health is at serious risk.
Numerous approaches for reducing and removing such vascular deposits have been proposed, including balloon angioplasty, in which a balloon-tipped catheter is used to dilate a stenosed region within the blood vessel; atherectomy, in which a blade or other cutting element is used to sever and remove the stenotic material; laser angioplasty, in which laser energy is used to ablate at least a portion of the stenotic material; and the like.
In order to apply such intervention techniques more effectively, a variety of vascular imaging devices and methods may be employed. Of particular interest to the present invention, imaging catheters having ultrasonic transducers at their distal ends have been employed to produce images of the stenotic region from within the blood vessel. A number of specific designs for ultrasonic imaging catheters have been described. An early design is illustrated in U.S. Pat. No. 4,794,931, where the mechanical components of the imaging system are located within a housing at the distal end of the catheter. The housing includes a fixed guidewire, which is used to position the catheter within the vascular system, at its distal tip. While the use of such fixed guidewire designs can provide excellent image quality, under some circumstances it is desirable to use an “over-the wire” design where the catheter may be introduced over a separate (movable) guidewire. The use of A movable guidewire offers certain advantages, including improved steering capability through narrow regions and easier catheter exchange, e.g., substitution of an interventional catheter for the imaging catheter.
Exchanging the imaging catheter for an interventional or other catheter within a patient's vascular system is time consuming and may be injurious to the patient. It is desirable therefore to combine imaging and interventional capabilities in a single catheter system. A design for an ultrasonic imaging catheter having a balloon angioplasty device is described in U.S. Pat. No. 5,117,831. One depicted embodiment uses a fixed guidewire and is thus subject to the disadvantages noted above. Another embodiment has a guidewire movable through the ultrasonic imaging transducer and its associated drive shaft. This requires that the transducer and the drive shaft be made hollow and increased in diameter in order to accommodate the guidewire therein. Additionally, the transducer is fixed at the end of the drive shaft and not movable along the length of the catheter.
To be able to cross very narrow lesions, the diameter of the catheter should be as small as possible at its distal end. Furthermore, the need to move the catheter body within the patient should be minimized. The blood vessel interior is delicate, may be weakened by disease, and is therefore susceptible to injury from movement of the catheter body within it.
For the reasons stated above, it would be advantageous to provide a catheter capable of delivering a balloon angioplasty system in combination with an imaging or interventional work element to a region of interest within the vascular system. Such delivery should be accomplished with a minimum repositioning of the catheter body within the blood vessel. Additionally, the catheter should be as narrow as possible at its distal end to allow for entry into and through narrow and tortuous regions of the patient's vascular system.
SUMMARY OF THE INVENTION
The present invention provides a catheter system having the ability to deliver both an angioplasty balloon and another work element for imaging or treating a region within patient's vascular system. The catheter system comprises a catheter body having at least a proximal and a distal region. The proximal region has at least two lumens, one for carrying a movable guidewire and another for carrying a work element. The work element will typically be an ultrasonic imaging transducer but may be another imaging device or even an interventional device for treating the blood vessel in combination with the angioplasty balloon. The distal region of the catheter body has a common lumen connected to and in communication with the two lumens of the proximal region. The angioplasty balloon is disposed about the common lumen of the distal region, and the catheter system further includes an associated means for inflating the balloon, typically an inflation lumen extending from the proximal end of the catheter body to the balloon.
The catheter of the present invention will allow for the performance of rapid and convenient balloon angioplasty and imaging or other treatment of the diseased vessel while minimizing the need to reposition the catheter body between procedures. Additionally, the distal end of the catheter fill be relatively narrow to allow for movement of the catheter into restricted spaces of the patient's vascular system and particularly into narrow regions and stenoses within the coronary arteries.
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Endosonics Corporation, Rancho Cordova, Calif., CathScanner I System.
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Cardiovascular Imaging, Inc.
Jaworski Francis J.
Orrick Herrington & Sutcliffe LLP
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