Surgery – Instruments – Suture – ligature – elastic band or clip applier
Reexamination Certificate
1999-10-28
2001-04-24
Recla, Henry J. (Department: 3731)
Surgery
Instruments
Suture, ligature, elastic band or clip applier
Reexamination Certificate
active
06221083
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to surgical instruments, especially instruments with suturing or stapling tools.
REVIEW OF THE RELATED TECHNOLOGY
Surgical operations on most of the body's organs are uncomplicated by motion of that organ, but heart surgery is an exception. Heart operations are made much more difficult and dangerous by the heart's incessant beating.
The present inventor's U.S. Pat. No. 5,871,017, which is entirely incorporated herein by reference, shows a moving platform for supporting the arm of a surgeon who is operating on the heart. The platform moves in synchrony and isometrically with the motion of a point on the surface of the heart, carrying the surgeon's arm and operating hand with it and “stopping” the heart by eliminating the relative heart-hand motion. The heart is triggered by a pacemaker to keep its beating regular (this provides synchrony), and the platform driving mechanism is adjusted so that the platform and the surgeon's hand stay the same distance from the operation site on the heart during (providing isometry).
By virtually stopping the heart, the platform allows precise operation by the surgeon just as if both the hand and heart were still. This avoids the great expense and danger of actually stopping the heart with a heart-lung machine. In addition, the platform can be used with small “keyhole” chest openings; the heart does not need to be entirely exposed and the rib cage need not be opened.
The commercially-available Heartport system uses a small chest opening, but it requires stopping the heart and the use of a heart-lung machine. The
Wall Street Journal
of May 5, 1999, reported that the Heartport system has not lived up to expectations and is being abandoned by many cardiac surgeons trained in its use.
While the present inventor's moving platform is a significant advance, it has the minor drawbacks that the heart must be triggered for synchrony and that isometry can only be achieved by careful adjustment of both the platform hinge angle (base) to line up the motion vector and the platform driver mechanism (e.g., by selecting the proper one of various driving cams) to achieve synchrony and isometry. It is large and bulky, with numerous parts.
A variation on the theme of the moving platform is another invention of the present inventor, the motorized motion-canceling needle holder, disclosed in U.S. patent application Ser. No. 09/132,409, filed Aug. 11, 1998, the contents of which are entirely incorporated herein by reference. The motorized motion-canceling needle holder is a hand-held device about the size and shape of a small flashlight, with a protruding arm at one end. The arm tip is provided with suture needle-holding jaws, a stapler, or some other surgical tool. The arm automatically oscillates relative to the barrel or handle, driven via a flexible cable coupled to a drive mechanism. While the surgeon's hand holds the flash-light shaped handle stationary relative to the patient's chest, the drive mechanism causes the protruding tip of the arm to oscillate in synchrony and isometry with the motion of the heart; again the heart's motion is virtually, but not actually, stopped. The path of the tip can be made to follow any path by suitable curving the oscillating arm, which slides through guide holes; if the arm is curved near the guide hole, the tip will follow a non-linear path which matches the path of the site on the heart surface to be operated on. The motorized motion-canceling needle holder has no provision for changing the path of the tip while the device is oscillating.
The drive mechanism which oscillates the tip is generally similar to that which drives the moving platform (although the drive is indirect, through a cable). As with the moving platform, the heart is triggered by a pacer coupled to the drive mechanism. Unlike the platform, the orientation and positioning of the oscillation vector is not fixed, but is controlled by the hand of the surgeon holding the handle. The surgeon manipulates the handle to determine the angle and position at will. The surgeon activates the needle-clutching jaws or stapler device at the tip of the moving arm via a remote control, e.g., a foot switch.
As noted in the copending application on the motion-canceling needle holder, one limitation of the moving platform is that only the anterior surface of the heart is readily operated on because the lateral surfaces are buried deeply in the chest and when the platform is angled over far enough to align the platform motion vector with the heart surface motion vector, the other organs are in between the heart and the platform. The hand-held motion-canceling needle holder can be used in, for example, a quadruple bypass operation, where the platform cannot.
Despite the many advantages of the moving platform and the motion-canceling holder, these inventions are not as simple as is possible and therefore they are more costly than is optimum (although their cost is much less than that of many medical devices). In some cases, such as for patients in third-world countries, the reduced cost of the present invention might make the difference in saving a life.
Another disadvantage of the previous devices is that they are dependent on outside power (e.g. line current), which can fail or be interrupted while reserve generators are being activated.
Perhaps the greatest drawback of the previous devices is the need for careful adjustment in order to exactly follow the motion of the operation site on the heart. A new operation, or any change from one site to another during a single operation, may require a long and time-consuming adjustment. In the case of the moving platform, the base on which the platform is pivoted will need to be set up, the drive cam changed, the oscillation amplitude adjusted, and the pacer phase tweaked; for the motorized motion-canceling needle holder, a new arm having a different curvature may need to be substituted, and the same adjustments made to the drive mechanism as with the moving platform.
Besides the work of adjusting, the degree of adjustment possible with the previous inventions is limited. It may not be possible to completely eliminate all relative motion. The complexity of motion of the heart surface, any point of which does not move in a straight line or exhibit uniform acceleration, can be difficult to match, so that the platform or arm tip is not driven to follow the heart's motion exactly with absolute precision. Even with a selection of drive cams and bent arms, a perfect match to the actual motion cannot be achieved; there will always be some small decrement of the motion which must be compensated by the surgeon, making the operation more difficult and risky.
The prior art does not disclose an instrument for working on the surface of a moving organ such as the heart which is completely simple, reliable, inexpensive, and compact; which requires no outside power; and which requires no adjustment.
SUMMARY OF THE INVENTION
The invention thus provides such an instrument by using the heart (or other organ) surface to drive the instrument. A light-weight armature (arm), preferably made of hollow stainless steel tubing, “floats” within a hollow barrel in an arrangement which permits the tip of the armature (the operating portion) to move in any direction relative to the barrel. The forward end of the barrel, which is preferably tubular, is open; at the rear end is a plug, preferably of slippery plastic such as DELRIN, with a central guide hole through which the armature can slide, and which acts as a pivot point. Pivoting of the armature about the fulcrum of the guide hole is limited by the forward rim of the barrel.
A portion of the armature is encircled by a long coil spring. One end of the spring is fixed to the armature at a point back from the tip, the other end of the spring rests against (or is fastened to) the plug. Thus, when the tip of the armature is pressed backward the armature slides rearward through the hole in the plug, the spring is comp
Browdy and Neimark
Ho (Jackie)Tan-Uyen T.
Recla Henry J.
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