Surgery – Instruments – Cutting – puncturing or piercing
Reexamination Certificate
1999-03-17
2001-09-18
Recla, Henry J. (Department: 3731)
Surgery
Instruments
Cutting, puncturing or piercing
C606S185000
Reexamination Certificate
active
06290709
ABSTRACT:
FIELD OF THE INVENTION
The present invention pertains to the field of catheters and, in particular, to those having mechanical cutting tips.
BACKGROUND OF THE INVENTION
A number of techniques are available for treating cardiovascular disease such as cardiovascular by-pass surgery, coronary angioplasty, laser angioplasty and atherectomy. These techniques are generally applied to by-pass or open lesions in coronary vessels to restore and increase blood flow to the heart muscle. In some patients, the number of lesions are so great, or the location so remote in the patient vasculature that restoring blood flow to the heart muscle is difficult. Transmyocardial revascularization (TMR) has been developed as an alternative to these techniques which are directed at by-passing or removing lesions. TMR is performed by boring channels directly into the myocardium of the heart.
In one procedure, a laser catheter is advanced into the left ventricle. Laser radiation is then focused on the myocardium to create a channel. It has been found that creating several channels may be helpful. Lasers used to performed TMR can be costly and the depth of the channels can be difficult to control.
TMR has been performed by forming channels with laser energy as described above. TMR has also been performed by cutting a channel with a sharpened probe or blade. The channels cut by laser have a width proportional to the width of the focused laser radiation used to make the channels. When a laser is used, tissue is vaporized to form the channel, when the procedure is performed with a blade, tissue is not removed, but is merely pierced or cut.
Removing, or in the case of TMR laser techniques, vaporization of tissue is believed to enhance of the success of the TMR procedure. Removing tissue, however, by mechanical means has proved difficult.
SUMMARY OF THE INVENTION
The present invention pertains to an apparatus and method for performing TMR using a rotating cutting tip which has a lumen extending therethrough. The apparatus and method of the present invention provides a means for performing TMR by creating channels in the myocardium of the patient's heart which can vary in length and width. The depth of the channels is directly proportional to the distance which the cutting tip of the present invention is advanced into the patient's myocardium. The width of the channel can be varied by varying the diameter and width of the cutting tip.
A preferred embodiment of the TMR catheter in accordance with the present invention includes an elongate drive shaft having a proximal end, a distal end and a longitudinal axis. A cutting tip is disposed at the distal end of the shaft. The tip has a distally disposed cutting edge and longitudinally extending lumen therethrough. A motor is coupled to the drive shaft for rotation of the cutting tip.
The shaft can include a proximal portion and a distal portion, the distal portion being relatively more flexible than the proximal portion. The proximal portion can be a hypotube. The distal portion can include an elongate coil or elongate metallic braid reinforcing. The shaft can define a longitudinally extending lumen in fluid communication with the tip lumen. Dye or drugs may be infused through these lumens or fluid aspirated therethrough.
The cutting edge of the tip can be disposed at an acute angle to the longitudinal axis of the shaft. In such a case, the tip can be a hypodermic needle tip.
The TMR catheter can be used in conjunction with an elongate guide tube having a proximal end, distal end and a longitudinal axis. The guide tube defines a longitudinally extending lumen therethrough. The guide tube can include an inner tube and an outer tube longitudinally slidable with respect to each other. The inner tube and/or the outer tube can have curved distal ends. Each of the curves can extend approximately 60° to 120° from the longitudinal axis of the guide tube.
In the method in accordance with the present invention, the cutting edge of a TMR catheter, such as the one described above, while spinning, is advanced into engagement with the heart wall. (This helps to prevent the cutting edge from grabbing the tissue while it increases rpms.) Rotation of the tip will disintegrate the myocardium tissue through which the tip passes.
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Press Release date
Ellis Louis
Hendrickson Gary L.
Kenyon & Kenyon
Recla Henry J.
Troung Kevin
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