Catheter stylet handle

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

Reexamination Certificate

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Reexamination Certificate

active

06206870

ABSTRACT:

BACKGROUND OF THE INVENTION
This invention is generally directed to a novel ergonomic handle for a catheter stylet useable with a retrograde coronary catheter. More particularly, the invention contemplates a novel handle which can be gripped in a variety of positions by a user, such as a surgeon, for manipulation of the stylet and a cardioplegia catheter mounted upon the stylet to position the catheter within a patient's coronary sinus.
During cardiac surgery, it is essential to have an arrested heart, rather than a beating heart. Cardioplegia solution is delivered to the heart to stop the heart during surgery.
In order to inject the cardioplegia solution into the heart, a cardioplegia catheter is used. A stylet is placed within the catheter and manipulated within the heart by the surgeon to manually place the catheter in the proper position within the coronary sinus. After insertion of the catheter into its proper place within the coronary sinus, the catheter is secured into place, preferably by an inflatable lumen or balloon, and the stylet is withdrawn from the catheter. Cardioplegia solution is then injected into the heart through the catheter to arrest the heart.
One prior art stylet, made by the assignee of the present application, has a flat, generally rectangular handle attached to the end of the rod. Each corner at the distal end of the handle is defined by an arc to form a concave portion of the handle. Each arc that defines each concave portion extends approximately ninety degrees relative to an axis of the handle which is aligned with the rod.
Another prior art stylet has a triangular or pistol-type grip in which the surgeon's thumb or first digit engages a thumb rest at the proximal end of the grip. The proximal thumb rest is specifically provided to reinforce the intended triangular grip. This triangular grip, by virtue of its spaced apart three-point character, almost totally rigidities the handle to a user's hand and forces the employment of wrist action to attain the necessary movement of the curved catheter upon insertion. This form of insertion tends to reduce a user's ability to utilize the more sensitive digits (fingers) for control feedback during insertion. If the catheter is not properly positioned within the heart, cardioplegia delivery is compromised and the patient can suffer serious problems, or at the very least, time is lost and repositioning is required.
The present invention provides a novel, ergonomic handle for a retrograde coronary sinus catheter stylet. Features and advantages of the stylet handle will become apparent upon a reading of the attached specification in combination with a study of the drawings.
OBJECTS AND SUMMARY OF THE INVENTION
A general object of the present invention is to provide a novel ergonomic handle for a retrograde coronary sinus catheter stylet and the method of usage thereof for positioning a cardioplegia catheter into a patient's coronary sinus.
An object of the present invention is to provide a novel handle for a stylet which provides a broad range of grip options for the user.
Another object of the present invention is to provide a novel handle for a stylet which provides a significantly greater additional range of angularity beyond the natural resultant holding angle through digit manipulation than wrist action alone could offer. That is to say, the handle is manipulated primarily with the fingers rather than with wrist action.
Briefly, and in accordance with the foregoing, the present invention discloses a novel ergonomic handle for use in manipulating the position of a retrograde coronary sinus catheter stylet. The handle is provided at a proximal end of a thin curved rod. In use, the stylet is inserted into a retrograde cardioplegia catheter. The stylet handle of the present invention extends from the proximal end of the catheter.
The handle includes a body portion having a proximal end, a distal end and an axis aligned with the rod. In the illustrated embodiment, the handle is substantially planar and generally flat. A first concave recess or pocket is provided at the distal end of the body on one side of the axis and a second concave recess or pocket is provided at the distal end of the body on the opposite side of the axis. Each pocket has a proximal gripping surface, an intermediate gripping surface and a distal abutment surface against which at least one or more of the digits of a user may be placed to manipulate the position of the handle and correspondingly the rod, and thus the catheter. The arc or arcs which defines or define each pocket extends more than ninety degrees relative to said axis such that when the user's digit(s) is placed therein, the digit(s) is/are generally enveloped by the pocket. The handle is pivoted or manipulated in a plane defined by the body of the handle so as to pivot or manipulate the stylet and the attached catheter within the patient's heart for positioning within the coronary sinus. The body also has a third concave pocket which is proximate to the second pocket. At least one of the user's digits can grip the third pocket to provide stability. Most importantly, the manipulation of the body by the user is attained through the use of the user's digits (fingers) which provide sensitive tactile feedback, while wrist action may augment manipulation via the fingers, wrist action is not the primary manner of manipulation of the handle. Also, this manipulation is effected without the employment of a thumb rest, which would tend to rigidify the user's wrist with respect to the stylet handle.


REFERENCES:
patent: 2164926 (1939-07-01), Kleine
patent: 3867945 (1975-02-01), Long
patent: 4529400 (1985-07-01), Scholten
patent: 4790825 (1988-12-01), Berstein et al.
patent: 4808158 (1989-02-01), Kreuzer et al.
patent: 4863430 (1989-09-01), Klyce et al.
patent: 5226427 (1993-07-01), Buckberg et al.
patent: 5344399 (1994-09-01), DeVries
patent: 5360406 (1994-11-01), Boykin et al.
Quest Medical Inc., “Retrograde Cardioplegia Catheter”, Jun. 1996.

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