Imbedded marker and flexible guide wire shaft

Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...

Reexamination Certificate

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Details

C604S529000

Reexamination Certificate

active

06179811

ABSTRACT:

FIELD OF THE INVENTION
The present invention relates to an angioplasty catheter and more particularly to an imbedded marker band creating a flexible guide wire shaft.
BACKGROUND OF THE INVENTION
Percutaneous transluminal coronary angioplasty (PTCA) is used to increase the lumen diameter of a coronary artery partially or totally obstructed by a build-up of cholesterol fats or atherosclerotic plaque. Typically a first guide wire of about 0.038 inches in diameter is steered through the vascular system to the site of therapy. A guiding catheter, for example, can then be advanced over the first guide wire to a point just proximal of the stenosis. The first guide wire is then removed. A balloon catheter on a smaller 0.014 inch diameter second guide wire is advanced within the guiding catheter to a point just proximal of the stenosis. The second guide wire is advanced into the stenosis, followed by the balloon on the distal end of the catheter. The balloon is inflated causing the site of the stenosis to widen. The dilatation of the occlusion, however, can form flaps, fissures and dissections which threaten reclosure of the dilated vessel or even perforations in the vessel wall.
Although the dimensions in the above example are suited to the coronary arteries, any body lumen can be treated by percutaneous transluminal angioplasty (PTA), including the vas deferens, ducts of the gallbladder, prostate gland, trachea, bronchus and liver. The body lumens range in diameter from small coronary vessels of 3 mm or less to 28 mm in the aortic vessel. The invention applies to acute and chronic closure or reclosure of body lumens.
It is advantageous for a catheter to have visible marker bands on the catheter shaft that can be viewed using a fluoroscope machine to position the catheter in relation to the lesions. It is also advantageous for a catheter shaft to have a smooth outer surface with minimal bumps from the marker bands. What is needed is marker bands which can be visible using a fluoroscope and also which do not create a significant increase in diameter so that the catheter can slide easily through the lesion.
U.S. Pat. Nos. 5,489,277 and 5,256,158 to Tolkoff et al. for “Device Having a Radiopaque Marker for Endoscopic Accessories and Method of Making Same” discloses a radiopaque ring that is inserted into an expanded section of tubing, followed by the relaxation of the tube to its original dimensions. U.S. Pat. No. 5,485,667 to Kleshinski for “Method for Attaching a Marker to a Medical Instrument” discloses a marker made of tubular radiopaque shape memory material that is deformed and then slid over or into the tubing and then heated so that the shape memory material returns to its original shape and attaches to the tubing.
SUMMARY OF THE INVENTION
It is an object of the invention to provide a marker band that is imbedded into the guide wire shaft providing a smooth surface.
The present invention is accomplished by providing an apparatus and method of manufacture for a medical catheter, comprising a guide wire shaft having an inner diameter defining an inner lumen and an outer diameter, the guide wire shaft having a proximal portion and a distal portion, an inflation lumen tube defining an inflation lumen, the inflation lumen tube having a proximal end and a distal end, the guide wire shaft extending distal to the inflation lumen tube, an inflatable balloon having a proximal end and a distal end, the balloon distal end being sealingly affixed to the distal end of the inner lumen tube, the balloon proximal end being sealingly affixed to the distal end of the inflation lumen tube, the balloon being in fluid communication with the inflation lumen and at least one marker band being imbedded in the distal portion of the guide wire shaft, the marker band being positioned between the proximal end and the distal end of the inflatable balloon such that the marker band can be viewed under fluoroscopy.


REFERENCES:
patent: 4793359 (1988-12-01), Sharrow
patent: 5256158 (1993-10-01), Tolkoff et al.
patent: 5300025 (1994-04-01), Wantink
patent: 5458639 (1995-10-01), Tsukashima et al.
patent: 5470315 (1995-11-01), Adams
patent: 5480383 (1996-01-01), Bagaoisan
patent: 5485667 (1996-01-01), Kleshinski
patent: 5489277 (1996-02-01), Tolkoff
patent: 5542937 (1996-08-01), Chee et al.
patent: 5545138 (1996-08-01), Fugoso et al.
patent: 5571089 (1996-11-01), Crocker
patent: 5599326 (1997-02-01), Carter
patent: 5769819 (1998-06-01), Schwab et al.
patent: 5827225 (1998-10-01), Ma Schwab
patent: 5871468 (1999-02-01), Kramer et al.
patent: 5876376 (1999-03-01), Schwab et al.

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