Surgery – Instruments – Means for inserting or removing conduit within body
Reexamination Certificate
2000-12-13
2002-09-17
Reip, David O. (Department: 3731)
Surgery
Instruments
Means for inserting or removing conduit within body
C600S585000
Reexamination Certificate
active
06451026
ABSTRACT:
BACKGROUND
This invention relates to the field of guidewires for advancing intraluminal devices such as stent delivery catheters, balloon dilatation catheters, atherectomy catheters and the like within a patient's body, specifically, within a patient's vasculature.
In a typical percutaneous procedure in a patient's coronary system, a guiding catheter having a preformed distal tip is percutaneously introduced into a patient's peripheral artery, e.g., femoral, radial or brachial artery, by means of a conventional Seldinger technique and advanced therein until the distal tip of the guiding catheter is seated in the ostium of a desired coronary artery. There are two basic techniques for advancing a guidewire into the desired location within the patient's coronary anatomy, the first is a preload technique which is used primarily for over-the-wire (OTW) devices and the bare wire technique which is used primarily for rail type systems. With the preload technique, a guidewire is positioned within an inner lumen of an OTW device such as a dilatation catheter or stent delivery catheter with the distal tip of the guidewire just proximal to the distal tip of the catheter and then both are advanced through the guiding catheter to the distal end thereof. The guidewire is first advanced out of the distal end of the guiding catheter into the patient's coronary vasculature until the distal end of the guidewire crosses the arterial location where the interventional procedure is to be performed, e.g., a lesion to be dilated or a dilated region where a stent is to be deployed.
The catheter, which is slidably mounted onto the guidewire, is advanced out of the guiding catheter into the patient's coronary anatomy over the previously introduced guidewire until the operative portion of the intravascular device, e.g. the balloon of a dilatation or a stent delivery catheter, is properly positioned across the arterial location. Once the catheter is in position with the operative means located within the desired arterial location, the interventional procedure is performed. The catheter can then be removed from the patient over the guidewire. Usually, the guidewire is left in place for a period of time after the procedure is completed to ensure reaccess to the arterial location if it is necessary. For example, in the event of arterial blockage due to dissected lining collapse, a rapid exchange type perfusion balloon catheter such as described and claimed in U.S. Pat. No. 5,516,336 (McInnes et al), can be advanced over the in-place guidewire so that the balloon can be inflated to open up the arterial passageway and allow blood to perfuse through the distal section of the catheter to a distal location until the dissection is realtached to the arterial wall by natural healing.
With the bare wire technique, the guidewire is first advanced by itself through the guiding catheter until the distal tip of the guidewire extends beyond the arterial location where the procedure is to be performed. Then a rail type catheter, such as described in U.S. Pat. No. 5,061,273 (Yock) and the previously discussed McInnes et al. which are incorporated herein by reference, is mounted onto the proximal portion of the guidewire which extends out of the proximal end of the guiding catheter which is outside of the patient. The catheter is advanced over the guidewire, while the position of the guidewire is fixed, until the operative means on the rail type catheter is disposed within the arterial location where the procedure is to be performed. After the procedure the intravascular device may be withdrawn from the patient over the guidewire or the guidewire advanced further within the coronary anatomy for an additional procedure.
Conventional guidewires for angioplasty, stent delivery, atherectomy and other vascular procedures usually comprise metallic elongated core member with one or more tapered sections near the distal end thereof and a flexible body such as a metallic helical coil or a tubular body of polymeric material disposed about the distal portion of the core member. A shapable member, which may be the distal extremity of the core member or a separate shaping ribbon which is secured to the distal extremity of the core member, extends through the flexible body and is secured to the distal end of the flexible body by soldering, brazing or welding which forms a rounded distal tip. Torquing means are provided on the proximal end of the core member to rotate, and thereby steer, the guidewire while it is being advanced through a patient's vascular system.
Further details of guidewires, and devices associated therewith for various interventional procedures can be found in U.S. Pat. No. 4,748,986 (Morrison et al.); U.S. Pat. No. 4,538,622 (Samson et al.): U.S. Pat. No. 5,135,503 (Abrams); U.S. Pat. No. 5,341,818 (Abrams et al.); U.S. Pat. No. 5,345,945 (Hodgson, et al.) and U.S. Pat. No. 5,636,641 (Fariabi) which are hereby incorporated herein in their entirety by reference thereto.
Conventional metallic guidewires using tapered distal core sections as discussed above can be difficult to use with sensitive imaging systems such as Magnetic Resonance Imaging (MRI) and the like because the metal content of the guidewire can create imaging artifacts that obscure the image produced, and can be heated or moved around by the strong MRI magnetic field. MRI compatible alloys or metals have lower magnetic susceptibilities. Such alloys include certain grades of stainless steel, Elgiloy and Nitinol. What has been needed is a guidewire that is compatible for use with sensitive imaging systems and methods such as MRI and the like.
SUMMARY
The invention is directed to an intracorporeal guiding device which can be in the form of a guidewire. The device includes an elongate member having a proximal section and a distal section. The distal section is made at least partially of a fiber composite matrix and has at least one segment with increasing flexibility in a distal direction. The fiber composite matrix can be configured to have little or no metal content so as to avoid creating imaging artifacts with sensitive imaging systems such as MRI and the like. In one embodiment, a flexible body is disposed about the distal section of the elongate member. The flexible body can have a variety of configurations, including a helical coil and a polymer layer. In a particular embodiment, the flexible body which consists of a polymer layer can be doped with a radiopaque material in order to improve visualization of the device under fluoroscopic imaging and the like.
In another embodiment, the elongate intracorporeal guiding device can have an elongate core disposed within a core lumen of the elongate member. The elongate core can be fixed or secured within the core lumen, or it may be moveable in an axial direction. Movement of the elongate core within the core lumen of the device may be used to adjust the flexibility of the distal section.
In another embodiment, a shapeable segment can be secured to the distal end of the elongate member with the flexible body disposed at least partially about the shapeable segment. In some embodiments, the shapeable segment is comprised of metal which can be flattened to provide improved shapeability in a specified orientation.
The invention is also directed to a method of making an elongate intracorporeal guiding device. The method includes disposing at least one layer of thin fiber about a mandrel. This can be done by winding, stranding, braiding or any other suitable method. A binding agent is then applied to the fiber material. If necessary, the binding agent can then be cured. Alternatively, a binding agent may be present on a thin fiber prior to disposing the thin fiber on the mandrel.
Furthermore, the invention is directed to a method of advancing an elongate intracorporeal guiding device within a patient's body. The method includes providing an elongate intracorporeal guiding device having a distal section configured so as not to create imaging artifacts when used with MRI i
Bajaj Shruti
Biagtan Emmanuel C.
Cornish Wayne E.
D'Aquanni Peter J.
Gosiengfiao Brandon
Advanced Cardiovascular Systems Inc.
Fulwider Patton Lee & Utecht LLP
Reip David O.
Woo Julian W.
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