Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
2001-06-05
2003-02-04
Bockelman, Mark (Department: 3762)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
C604S513000
Reexamination Certificate
active
06514236
ABSTRACT:
FIELD OF THE INVENTION
This invention relates generally to a method for treating or studying a cardiovascular condition of a patient by employing a vascular interventional device that may be introduced over a guidewire into a vessel of the cardiovascular system of a patient. More particularly, the invention relates to use of a vascular interventional device that functions both as a vascular entry sheath and as a diagnostic or therapeutic catheter. Such a device is capable of delivering both diagnostic and/or therapeutic agents, as well as other interventional devices, to a specific target portion of the cardiovascular system of a patient.
EXPLANATION OF TECHNICAL TERMS
As used herein, a vascular interventional device or interventional device is any device that may be passed through a portion of the cardiovascular system of a patient for diagnostic or therapeutic purposes, including diagnostic and therapeutic catheters. The term also includes components of such devices and other instruments that may be used to facilitate the passage of such devices within the cardiovascular system, such as guidewires, dilators and sheaths.
As used herein, a patient may be a human or another mammal.
As used herein, vessels of the cardiovascular system of a patient or blood vessels include arteries and veins and branches thereof or therefrom, and other tubes, chambers and ducts that carry blood.
As used herein, a vessel of entry is a vessel that is entered from outside the body of the patient.
As used herein, a target vessel or branch of a vessel is a portion of the cardiovascular system of a patient that is targeted for diagnosis or therapy, or that provides a pathway to such portion from a vessel of entry. A target vessel may also be a vessel of entry.
As used herein, a vascular segment is a portion of a vessel.
As used herein, a vascular interventional device or a component thereof may be adapted to selectively engage a target vessel or branch of a vessel. Such a device or component may be shaped, formed or manipulated so that when it is advanced to a location adjacent to the target vessel or branch, further advancement will cause the distal end of the device to enter the target vessel or branch.
As used herein, a guidewire is a device that may be used in positioning and moving a diagnostic or therapeutic vascular interventional device.
As used herein, a sheath is a tube that may be used to facilitate the passage of a vascular interventional device within the cardiovascular system of a patient.
As used herein, a dilator is a vascular interventional device or a component thereof that may be used to dilate a portion of one or more vessels of the cardiovascular system so as to facilitate entry or passage of another vascular interventional device or component thereof.
As used herein, a catheter is a vascular interventional device that may be used for diagnostic or therapeutic purposes.
As used herein, a fluid agent is a drug or other fluid that may be injected into a portion of the cardiovascular system for therapeutic or diagnostic purposes.
As used herein, a fluid agent is delivered to a target portion of the cardiovascular system of a patient at a clinically effective rate or an effective rate when said agent is delivered at a flow rate that is suitable for the effective use of the fluid agent and at a velocity that is unlikely to cause injury or damage to the target portion of the cardiovascular system.
As used herein, a contrast agent, medium or fluid is a radiopaque fluid agent that may be used to provide a contrast in density with tissue, structures or another object for x-ray or other radiological examination.
As used herein, the French scale is a measurement system that may be used to indicate the diameter of a vascular interventional device or a component thereof. Each unit on the scale is equal to 1/&pgr; millimeters.
BACKGROUND AND DESCRIPTION OF THE PRIOR ART
In conventional practice, access to a vessel of the cardiovascular system of a patient may be obtained using a vascular entry sheath. Generally, a needle is used to puncture a blood vessel of entry (such as an artery), and a guidewire is passed through the needle to a desired location in the vessel. The needle is withdrawn and the guidewire is maintained in position in the vessel. Then a short sheath is advanced into the vessel over the guidewire to facilitate introduction of a diagnostic or therapeutic catheter. A catheter is advanced through the sheath, and the guidewire may then be removed. Once the distal end of the catheter is advanced to the target vessel, diagnostic or therapeutic procedures may be carried out. Depending on the type of catheter employed, fluid agents may be injected through the catheter for diagnostic or therapeutic purposes. However, if it is necessary or desirable to inject an x-ray contrast agent into a target vessel, a large caliber catheter must be advanced through the sheath to the target vessel, so as to provide for sufficiently high flow rates to displace blood with contrast agent. In most cases, the sheath itself may not serve as the conduit for delivery of contrast agent because conventional sheaths are usually quite short and are not adapted to selectively engage a vessel of the cardiovascular system. Furthermore, conventional sheaths have only a single end hole, and fluid injected therethrough in volumes sufficient for a contrast agent would likely flow from the end hole at such a velocity that tissue damage might occur. Consequently, a conventional sheath is used only to provide access to the vessel of entry, and a catheter is advanced through the sheath to reach a target vessel. If it is desired to deliver a fluid agent such as contrast fluid to a segment of the target vessel, it is generally necessary to employ a diagnostic catheter. If it is desired, after imaging of the target area, to employ another therapeutic or diagnostic device, the diagnostic catheter must first be removed, so that a second interventional device may be advanced to the target area.
Various catheters for distribution of fluid agents (sometimes referred to as infusion catheters) are known. For example, U.S. Pat. No. 5,021,044 of Sharkawy describes a vascular catheter having an inner lumen for receiving a guidewire and at least one concentrically disposed outer lumen for delivery of a fluid agent. The outer lumen is provided with a number of flow passageways to maintain a desired flow pattern to the target site, typically of about 0.1-1.5 cm
3
/hour. U.S. Pat. No. 5,599,324 of McAlister et al. and U.S. Pat. No. 5,709,874 of Hanson et al. describe similar multi-lumen catheters. U.S. Pat. No. 5,380,307 of Chee et al. and U.S. Pat. No. 5,425,723 of Wang describe perfusion catheters that are designed to deliver a fluid agent through side holes uniformly along a perfusion portion of the catheter. These devices operate to deliver fluid to a target point within a vessel at low flow rates that are useful for introduction of pharmacological agents such as thrombolytic drugs, but are wholly insufficient for proper introduction of a contrast agent. Furthermore, these devices do not accommodate or facilitate the introduction of a second interventional device into the cardiovascular system of a patient.
U.S. Pat. No. 5,569,197 of Helmus et al. describes a hollow infusion guidewire over which a catheter may be introduced into a vessel. Preferably, the Helmus guidewire has an outer diameter that is comparable to that of a standard coronary guidewire, typically about 0.014 inch. It also has a plurality of openings or perforations in the sidewall near its distal end for dispersal of a drug therethrough. However, since it is sized to function as a guidewire too, it may only be used to disperse fluid at the target location at a very low rate, thereby limiting its use to the delivery of drugs only.
Many of the known infusion guidewires include complicated multi-lumenal structures and valve arrangements that are difficult and expensive to manufacture. Furthermore, these devices generally operate to deliver fluid agents to a target site at l
Bockelman Mark
Chambliss Bahner & Stophel P.C.
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