Motorized motion-canceling suture tool holder

An apparatus for open-heart surgery includes a suture-needle holding tip (10) or a stapler and a handle (100). The tip is driven to oscillate relative to the handle in the same motion as the surface of the heart, which is being operated on. This cancels the motion of the heart, effectively stopping it, so that the surgeon (S) need not compensate for heart beats. The tip can grasp or release the needle (N) with a mechanism (300) under control of a switch (330) through a flexible cable 120. Independently, a drive mechanism 200 causes a cam (230) to be turned by a motor 213 for driving the needle-holding tip by means of a flexible cable 120. The cam is shaped so that the pattern of the platform oscillation follows the beating heart's motion. A momentary-contact switch triggers a pacer, which paces the heart to beat in synchrony with the motion of the needle-holding tip. The rate is set slightly above the un-paced heart beat rate.

FIELD OF THE INVENTION 
The invention relates to a hand-held suture tool holder for surgery. More 
specifically, it relates to a holder for the suturing tool (e.g., needle 
or stapler) moving in synchronization with a surface of a moving organ, 
such as the heart, so that the surgeon can more easily operate at that 
surface. 
DESCRIPTION OF THE RELATED TECHNOLOGY 
In many surgical operations work must be done on a moving organ, such as a 
beating heart. This requires not only manipulations to perform the 
operation which would be required in any case (even if the organ were 
still), but also requires correction of the surgeon's hand motions to 
compensate for the organ motion so as to keep the surgeon's hands still 
relative to the work area. 
One such operation which has recently been gaining in popularity is known 
as minimally invasive coronary artery bypass grafting. As described by 
Calafiore et al., "Minimally Invasive Coronary Artery Bypass Grafting", 
Ann. Thorac. Surg., 62:1545-1548 (1996), minimally invasive coronary 
artery bypass (MICAB) is defined as an intervention that does not require 
median sternotomy or the use of cardiopulmonary bypass (CBP). The incision 
in the chest wall is small, and the aorta, in any portion, is not the 
direct source of inflow of blood supply to the bypass grafts. MICAB 
promises to become an important addition to the surgical treatment of 
coronary artery disease. 
In this technique, the patient is anesthetized and intubated with a single 
endotracheal tube and hemodynamic monitoring. Short-acting anesthetic 
agents are used, as extubation of the patient in the operating room is 
routine. The chest is opened through a fourth or fifth intercostal space 
incision and the pericardium is opened longitudinally. The left anterior 
descending coronary artery (LAD) is identified and inspected. The LIMA is 
harvested through the same incision with or without the aid of a 
thoracoscope. One or more costal cartilages may be resected to achieve 
better visualization and dissection of the full length of the LIMA. The 
artery can be harvested as a pedicle or as a skeletonized vessel. 
The patient is heparinized (1 mg/kg), and diluted papaverine is injected 
into the pedicle and intraluminally into the LIMA through a blunt-tipped 
cannula. Traction sutures are applied to the edges of the pericardium. 
After selection of a site for construction of the anastomosis and 
assessment of the length of the LIMA, distal and proximal control of the 
LAD is required. A snare of 4/0 PROLENE (Ethicon, Somerville, N.J.) or 
silicone suture can be applied proximally and distally to the site 
selected for the anastomosis. Alternatively, the vessel can be opened and 
a FLOW-RESTER placed intraluminally. The surgical blower (VISU-FLOW, 
Research Medical, Midvale, Utah) is used for visualization. 
Electrocardiographic changes, arrhythmias, and ventricular fibrillation 
are rare events during occlusion of the LAD. Traction sutures can be 
applied to the visceral pericardium lateral to the LAD, thereby allowing 
for better stabilization of the artery. Alternatively, a suction device 
(Medtronic Inc., Minneapolis, Minn.) or a stabilizer (CTS Inc.) can be 
used. Short-acting .beta.-blockers or calcium channel blockers are used to 
reduce heart rate when necessary. 
The LAD to LIMA anastomosis is performed using a 7/0 or 8/0 running PROLENE 
suture, either as a single suture or as two strategically placed sutures 
at the toe and heel of the LIMA. Some surgeons prefer interrupted sutures. 
At completion of the anastomosis, heparin is reversed with protamine 
sulfate. Closure of the chest is as in any standard thoracotomy, leaving a 
pleural tube for drainage. An intrapleural catheter is placed for pain 
control. The patient is extubated in the operating room or shortly 
thereafter. Patency of the artery is confirmed by standard Doppler 
(velocity) echocardiography intraoperatively and by duplex scanning of the 
LIMA early and late postoperatively in every patient. This is usually done 
2 to 3 hours postoperatively and 24 hours after operation. Diastolic flow 
predominates in a patent LIMA. Most centers report early discharge from 
hospital and significant cost savings associated with this procedure. 
It has been reported that by mid-1996 at least 200 MICAB procedures had 
been performed in various universities and private hospitals in the United 
States and several hundred more in Europe and South America (Hartz, 
"Minimally Invasive Heart Surgery", Circulation, 94:2668-2670 (1996)). For 
other respects about such surgery, see also Calafiore et al., "Left 
Anterior Descending Coronary Artery Grafting Via a Left Anterior Small 
Thoracotomy Without Cardiopulmonary Bypass", Ann. Thorac. Surg., 
61:1659-1665 (1996); Stanbridge et al., "Minimal-Access Surgery for 
Coronary Artery Revascularization", Lancet, 346:837 (1995); Acuff et al. 
"Minimally Invasive Coronary Artery Bypass Grafting", Ann. Thorac. Surg., 
61:135-137 (1996), and Subramanian et al. "Minimally Invasive Coronary 
Artery Bypass Surgery: A Multi-Center Report of Preliminary Clinical 
Experience", Circulation, 92 (Suppl. 2):645 (1995). 
While such operations have been successfully performed in many different 
centers, substantial risks are involved in performing surgery on a beating 
heart. In such operations the arteries are small, the stitches fine, and 
the sutures are liable to rip due to the heart motion. The risk to the 
patient is considerable. There have been cases in which the arterial walls 
were ripped, requiring the operation to be aborted and causing 
complications. 
At first blush it might appear that the heart's motion, being regular, 
could be easily compensated for by the surgeon. However, the heart motion 
amplitude is about a half inch (1.3 cm), and this is quite large compared 
to the precision required of the surgeon's manipulations. The rhythm is 
erratic. The motion tends to sudden pulsations rather than a 
smoothly-varying motion such as a sinusoidal motion. 
Thus, the acceleration of the heart surface changes rapidly. During the 
intervals of high acceleration the surgeon is substantially unable to do 
anything beyond keeping the instruments near their positions relative to 
the heart, so that no suture rips or unintended punctures occur. The 
operation is actually performed intermittently during the lulls of low 
acceleration. 
Because of these difficulties, the heart is often artificially slowed down 
during operations, as discussed above, such as by means of short acting 
.beta.-blockers or calcium channel blockers. This improves the surgeon's 
situation in proportion to the change in rate, but for obvious reasons the 
degree of improvement is limited. 
Moreover, the heart (like most organs) responds to stimulation. A suture 
needle prick often causes this muscular organ to twitch strongly, which is 
very difficult to compensate for. Twitching will not be lessened by 
slowing the heart down. 
Calafiore et al., supra, report that stabilization of the heart during 
construction of the anastomosis is an important aspect of the procedure, 
and devices are being developed that will aid the surgeon during this 
critical part. However, physically immobilizing the heart is a less than 
desirable technique as it could damage the heart or impair circulation 
during this period. 
Devices for surgery on a beating heart were reported in a front-page story 
in the Wall Street Journal of Apr. 22, 1997. The story said that 
CardioThoracic Systems, Inc. is marketing a device resembling a 
two-pronged fork which is pressed against the beating heart to stabilize 
the pressed region and allow the surgeon to operate. The cost is $1850 per 
operation. Another device, sold by Medtronic, is called the "Octopus"; it 
costs $10,000. Others are expected to be marketed soon by Baxter Inc. and 
U.S. Surgical Corp. 
The CardioThoracic system can only be used in about 20% of all bypass 
operations, according to the article. Triple and quadruple bypass and 
valve repairs require stopping the heart. 
Pressing on the heart naturally will affect the blood flow through it, and 
the amount of pressure is limited. The problem of twitching is not 
overcome, and it appears that the heart surface cannot be immobilized 
completely. 
The new devices "set off intense debate over safety and economics", 
according to the article. "Some surgeons are particularly skeptical that 
joining tiny blood vessels on the surface of the heart can be done as 
successfully while the heart is beating--the CardioThoracic way--as when 
it is stopped. . . . During a recent [stopped-heart] operation, Dr. Colvin 
[of New York University Medical Center] peered through magnifying goggles 
as he performed the delicate task of joining the replacement vessel to a 
coronary artery, using a tiny needle and barely visible sutures. `At this 
point, if you're doing it "beating-heart" you're cursing a mile a minute`, 
he remarked." 
The article also reported on a stopped-heart kit which is being 
aggressively marketed in competition with the CardioThoracic device. 
Produced by Heartport Inc., it costs $5000 per kit. It has been used in 
about 500 cases. Like the CardioThoracic method, the Heartport method 
avoids opening the ribcage, instead using a smaller opening. Because 
opening the ribcage is a traumatic and painful operation, patients are 
more likely to chose an operation which requires only a smaller opening. 
However, the Heartport method involves stopping the heart with a balloon in 
the aorta and drugs, and using a heart-lung machine to keep the patient 
alive during the operation. 
The article noted that stopping the heart is stressful and dangerous, and 
is impossible if the patient is too sick. The cost of using the heart-lung 
machine is as much as $2,300 (the machines cost about $150,000) and about 
6% of patients suffer complications, including stroke, depression, and 
severe infections. The ideal heart operation would need only a small 
incision, like the Heartport and CardioThoracic operations; avoid the 
expense and risk of a heart-lung machine, like the CardioThoracic 
operation; and stop the heart so the surgeon can safely operate on the 
delicate arteries, as in the Heartport operation. None of the available 
operations or devices achieve all these. 
The prior art has not solved these problems of working on a moving organ, 
despite the great need for improvement. 
Known hand-held sewing machines cannot provide a solution. One early 
example is disclosed in U.S. Pat. No. 0,850,779 to Peacock, showing a 
hand-held awl with a sewing needle automatically moving in and out at the 
tip of a shank. The needle motion, coaxial with the shank, is adapted to 
puncturing into a surface perpendicular to the shank and there is no 
provision for timing the needle motion. 
Conventional sewing machines (machines forming stitches) which are 
miniaturized for hand-held use are known, and are used in the medical 
area. Skaller, in U.S. Pat. No. 2,580,964, shows a swinging arm 37 with a 
needle 43 at its tip. The needle 43 moves transversely as the arm 
oscillates around pivot pin 38. The needle is removably secured to the arm 
by a screw 44. A bicycle-type sheathed cable is used for actuating the 
device, with the cable motion being rotary. The arm motion is solely for 
sewing, and the needle oscillates "in timed relation with the rotation of 
the looper shaft 28" (column 2, lines 31-34) and their motions are 
coordinated (lines 42-48). 
Conventional technology, as illustrated in these patents, does not provide 
any apparatus or method for canceling relative motion when an organ such 
as the heart moves. In the case of a moving organ, such as the beating 
heart, the surgeon must compensate not only for the motion of the heart 
but also for the motions of the needle which are completely uncorrelated 
to the organ motion. Apparently hand-held sewing machines, or devices with 
moving needles or other suturing tools, have never been used to operate on 
a beating heart, and the reason is probably the near impossibility of 
compensating for two motions at once. 
Co-pending application No. 60/047,349 of the present invention describes a 
hand-supporting platform which cancels relative motion, for use primarily 
in MICAB heart surgery. The entire contents of this application are 
entirely incorporated herein by reference. 
In the invention described in said co-pending application, the platform is 
driven by a specially-shaped cam to move up and down in synchronization 
with the surface of the heart (or other organ or part). The heart's motion 
is effectively canceled relative to the platform. The surgeon's fore-arm 
rests on the moving platform but the operating hand must dangle at least 
in part over the end of the platform in order that the surgeon may work. 
The platform oscillation is matched to the heart surface in oscillation 
profile, amplitude, and phase. However, the heart surface also has a 
displacement direction (generally, perpendicular to the heart surface) 
which is approximated as a straight-line motion in the related 
application; the platform has a motion which is approximately linear. The 
motion vector of the platform must be aligned with the motion of the 
heart, or the surgeon's hand will be jiggled side-to-side, relative to the 
heart, during the operation. A laser may be used to align the platform, 
which is supported on an adjustable multi-angle base support attached to a 
base of the platform. The base angle, and thus the platform motion angle, 
are adjusted prior to operation. Then the base support, which resembles 
the adjustable head of a photographic tripod, is locked into position. 
This related invention is valuable and is expected to save many lives, but 
it has certain limitations which are overcome in the present invention. 
One limitation 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. Thus, for example, a quadruple 
bypass operation could not easily be performed with the motion-canceling 
platform. 
Another limitation is that the platform motion is essentially linear. (To 
be precise, it is an arc of large radius; but with the small amplitude of 
heart beats the chord is negligible.) The heart surface motion is close to 
a straight line, but it is of course not exactly a straight line (or for 
that matter a circle of large radius). Therefore the needle, held 
stationary relative to the platform by the surgeon's hand, deviates 
laterally from the heart even when the platform and heart motions are 
otherwise precisely matched. If the lateral heart motion is roughly 
circular, a closer match might be made with the platform; but rotating the 
platform is impractical because of the way it is supported, so the lateral 
deviation may be in the wrong lateral direction. 
SUMMARY OF THE INVENTION 
Accordingly, the present invention has an object, among others, to overcome 
deficiencies in the prior art such as noted above. 
The invention relates to a needle holder which overcomes the problems of 
conventional devices and methods by providing a suturing tool holder, with 
a handle, that is easily rotated to any angle; and an oscillating needle 
holder attached to the handle portion. This permits the needle 
oscillations to be rapidly and easily adjusted for direction, and to be 
disposed at any angle because the needle-holding portion is small. In 
addition, the motion of the needle or stapler can be accurately matched to 
the motion of the heart, both longitudinally and laterally; the heart 
motion is mimicked. 
The heart's motion is thus effectively canceled and delicate operations can 
be performed with much more ease, and much less risk, than formerly. 
In the needle-suturing embodiment the holder of the present invention 
preferably includes a hooked barrel and a pressing rod for grasping the 
needle. The rod is pressed against the hook of the barrel through a 
flexible cable, similar to a bicycle brake cable, which is remotely 
operable by a mechanism controlled by a pedal or a microswitch on the 
handle. 
A second flexible cable is used to oscillate the entire needle holder 
within the handle, so that the tip, holding the needle or stapler, moves 
for operating on the heart. The second cable sheath is fastened to the 
inside of the handle; at the other end the cable is driven relative to the 
sheath by a suitable apparatus, preferably including a specially-shaped 
systole/diastole cam, a mechanism for varying the amplitude to match that 
of the particular heart surface being worked on, and a trigger switch for 
driving a heart pacer. Pacing the heart is an important feature of the 
present invention. A clutch or solenoid may be used for starting and 
stopping the oscillation by disengaging the cable from the driver. 
As noted, the suture tool holder of the invention can be manipulated to any 
angle and therefore it can be used on the sides of the heart, not only on 
the anterior surface. Because different areas of the heart have different 
motions, the cams of this invention should be interchangeable so that 
different heart motion cam profiles can be used. 
Alternatively, a single cam with selectable regions can be used; a 
quadruple bypass operation would require a four-region cam. Sub-regions 
could also be provided with different shapes for different body types. 
To prevent rotation of the needle holder relative to the handle, a portion 
of the holder is of non-circular, preferably square, cross section and 
slides in a similarly shaped opening inside the handle. The non-circular 
cross section portion of the needle holder is axially straight. 
To provide lateral motion adjustment (because the motion of the heart 
surface is not exactly linear) an arcuate portion of the needle holder 
slides through a second hole or orifice as the needle holder oscillates to 
and fro. Since the needle holder is also held by the straight square 
portion within the square hole, the motion of the arcuate portion through 
the orifice causes a lateral excursion of the tip. 
The tip motion can be adjusted precisely to the motion of the heart surface 
by aligning the angle and the position of the handle, adjusting the 
oscillation amplitude, selecting the proper cam, and rotating the handle 
so that the lateral excursion of the tip is aligned with the excursion of 
the heart surface. 
Rather than driving the tool holder according to the heart's motion, which 
would require complex electronics, sensors, and servo-motors, the present 
invention preferably drives the heart according to the predetermined 
motion of the needle or stapler. The heart is paced by electric signals 
timed to the oscillations of the tool holder, as detected by a simple 
momentary-contact switch which is closed once in each oscillation. The 
switch may be closed by a cam on the cable-driving mechanism which 
oscillates the needle holder or stapler. Switch closure (or opening) 
generates a trigger pulse to conventional pacer circuitry, which may 
provide for an adjustable delay between the trigger pulse and the heart 
stimulus. Electronic and/or mechanical means to adjustably advance or 
retard the pacing signal can be used. 
The paced heart rate avoids any twitchiness in the heart muscle, which 
might otherwise cause it to move unexpectedly when touched or pricked. The 
heart is preferably triggered at a rate slightly above the heart rate to 
which the heart has been slowed to naturally beat without pacing. It has 
been found that when the heart is driven at a slightly higher rate, 
twitchiness is eliminated. Because the present invention is able to easily 
compensate for heart motion regardless of the beating rate, the operation 
becomes easier when the heart is paced to beat faster than would otherwise 
be the case. 
Pacing the heart also improves the regularity of the beats and stabilizes 
the heart oscillation amplitude, because blood flows into the heart 
chambers at a constant rate and if the filling time for any two beats is 
identical, then so will the amounts of blood pumped on those beats be 
identical, and hence also the amplitudes. 
Because the heart's motion is non-sinusoidal (as noted above), the present 
invention uses a rotary cam, driven by an ordinary electric motor, 
oscillating the tool holder drive mechanism full systole to full diastole. 
The cam profile is adjusted to match the heart's surface motion. In a 
preferred embodiment, the drive mechanism includes a platform hinged to a 
base and the cam position is adjustable relative the hinge position to 
adjust the amplitude of the platform motion for different sizes of heart. 
The cam may be interchangeable for different profiles, if needed. 
The lobed cam may be replaced by an equivalent of more general motion 
capability, such as an electrically-controlled actuator driven according 
to a voltage, digital signals, or the like, and having a pattern that is 
adaptable to different heart motion amplitudes, phases, or patterns. 
To adjust the excursion (oscillation amplitude) and optionally also the 
synchronization (pacer timing advance or retard), the present invention 
may employ another simple but effective innovation. Thus, a capacitor may 
be formed between the heart and the tool holder, and the capacitance of 
this capacitor will vary with the distance to the heart surface. An 
electrical oscillating circuit is arranged to use the capacitor as part of 
an LC circuit resonating in the audible range (or at a frequency that can 
be sub-divided to reach the audible range). Using conventional circuitry, 
power supply, and loudspeaker or earphone, the invention can provide an 
audible tone whose frequency is very nearly proportional to the 
heart-holder distance. 
It is well-known that the ear can hear very slight frequency changes, and 
because of this a surgeon listening to the tone generated in the 
heart-holder capacitor circuit will be aware of distance variations of 
less than one percent. Adjacent keys on the piano differ by six percent. 
The surgeon can then adjust the drive and/or the pacer electronics to 
minimize the frequency variation of the audible tone. When the motion is 
completely synchronized with the heart, then the tone will be flat, of 
constant pitch. 
The oscillation is thus matched to the heart surface in oscillation 
profile, amplitude, and phase, which is a complete specification of the 
vibratory motion. To align the motion vectorially to the heart, the 
surgeon merely adjusts the angle with his or her wrist and/or rotates the 
handle. 
The present invention solves a life-threatening problem which has not been 
even partially solved before (except by the Applicant's related platform 
invention) by eliminating relative motion between a moving organ and a 
surgeon's hand. The extreme simplicity of the invention is facilitated by 
the innovation of driving the heart to follow a mechanical oscillation. 
The consequent reliability, ease of use, and low cost and reliability are 
very unusual in the medical field and are great advantages. The present 
invention permits operating on areas of the heart other than the anterior 
surface that is accessible to the motion-canceling platform.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT 
Here, and in the following claims: 
"Synchrony", "synchronously", and related forms of this word mean at the 
same frequency, but not necessarily at the same amplitude, pattern, or 
phase. 
"Pattern" of an oscillation relates to the repeating shape of a graph of 
the oscillation as plotted against time. For example, if the displacement 
(in inches or centimeters) in a certain direction of one portion of the 
surface of a beating heart were to be graphed as a function of time, the 
graph over the period of one beat would be a pattern. Graphs could also be 
made of heart surface velocity or acceleration, and these also would 
represent patterns. 
"Vector" in reference to heart oscillation (or a matching oscillation) 
means a line drawn between the position of a point on the heart surface at 
full diastole and the position of the same point at full systole. 
FIG. 1 shows the present invention in relation to a patient's chest C and 
heart H, which is being operated on by the hand of a surgeon S holding a 
handle 100 of the motion-canceling present invention. A coronary artery A, 
which is the site of an anastomosis, is shown on the surface of the heart 
H. The chest C is shown in cross section, but the heart H, handle 100, and 
surgeon S are not. A rib R is partially removed. 
The heart H is beating during the operation and its surface, with the 
artery A, is moving up and down in a heart oscillation which has a certain 
motion pattern (wave-form), amplitude (displacement over one beat cycle), 
and frequency (beating rate). The heart oscillation is indicated in FIG. 1 
by an arrow labeled OH, which is offset from the artery A, the motion of 
which it describes, for clarity. 
The invention includes a driving mechanism 200 which moves up and down in 
an oscillation which mimics the heart oscillation OH in pattern, 
amplitude, and frequency. Because the oscillation follows the heart 
oscillation OH, the surgeon S can easily operate on the moving heart. The 
oscillation mechanism is adapted to cancel the relative motion between the 
surgeon S and any particular place on the heart H, whose surface motion 
varies with surface location. 
At the tip 10 of the handle 100 is a suturing needle N which is used for 
anastomosis of the artery A. While the hand of the surgeon S remains 
stationary, the needle N oscillates in coordination with the artery A, so 
that the surgeon S need not compensate for the motion of the heart H. 
While the preferred embodiment is illustrated in which the tool in a 
suturing needle, it should be understood that the present invention 
comprehends the use of other tools for suturing, such as staplers, lasers, 
adhesive applicators, and so on; the present invention further comprehends 
the use of non-suturing surgical tools, such as a scalpel, for any other 
sort of task to be performed on a moving organ. 
The tip 10 of the handle 100 is coupled to a tool-drive mechanism 200 and 
to a tool-grip mechanism 300, preferably via a compound bicycle-type cable 
123 which contains two distinct cables 120 and 130, into which it 
preferably splits once away from the operating area. The bicycle-type 
coaxial cables include a sheath that is flexible but resistant to kinking 
and collapse, and an internally movable element, such as wire rope, which 
can transmit push-pull forces and/or rotational forces along its length 
when held within the sheath. The invention can equally well use hydraulic, 
pneumatic, electric, electronic, or other conventional actuators in place 
of the bicycle cables. 
The tool-grip mechanism 300 causes the tip 10 to grip and release the 
needle N. It includes a solenoid 320 adapted to pull on the central wire 
of the cable 130, to release the needle N as explained below, whenever the 
surgeon's foot F steps on a foot switch 330, wired to the solenoid 320. 
(The necessary electric power source is not shown in FIG. 1, but this is 
strictly conventional). A return spring 322 is rigged to push the central 
wire into the sheath of the cable 130, causing the tip 10 to grip the 
needle N. 
The whole mechanism 300 constitutes a means for releasing the needle N when 
the switch 330 is depressed, and gripping the needle N at other times. In 
alternative embodiments gripping, rather than release, could be the 
passive or non-activated action. 
An alternative to the foot switch F, a finger-activated microswitch 110 on 
the handle 100, is shown in FIG. 2. Any other sort of control, including 
voice control, is within the scope of the invention. 
In an alternative embodiment gripping and release of the needle N, or a 
stapling operation, might be actuated by a two-portion slidable handle in 
which a palm portion and a sliding finger portion are relatively moved, by 
finger motions, to grasp a needle (or close a staple). This embodiment is 
not illustrated in the drawing, but is related to the Applicant's 
co-pending application entitled "Coaxial Needle Holder", serial number not 
yet assigned, the contents of which are entirely incorporated herein by 
reference. 
FIG. 2 shows the inside of the handle 100, including a handle housing 101 
into which the cables 120 and 130 couple at the right side of the drawing 
and from which the tip 10 emerges at left. The outer sheath 121 of cable 
120 is fastened to the handle at end stop 151 of the handle 100, so that 
sheath 121 cannot slide through the end stop 151. On the other hand, the 
sheath 131 of cable 130 is free to slide through the end stop 151. 
The wire 122 of cable 120 extends to a carrier 133 which is fastened to the 
outer sheath 131 of cable 130. Carrier 133 is axially forced to and fro by 
the wire 122 and slides within the middle stop 153. This moves the carrier 
133 and the tubular sections 135 and 137, which continue the bore of the 
sheath 131 but are preferably rigid. 
The inner wire continues through the bore from cable 130 to the tip 10, 
where it terminates in a rigid portion 132'. The rigid portion may be 
formed, for example, by soldering the end of the wire 132 or by fastening 
a solid tip portion onto the wire. The rigid portion 132' protrudes into a 
transverse slot 137' at the end of the tube portion 137, which is closed 
at the very tip end, so that the needle N may be inserted and held when 
the rigid portion 132' presses the needle N against the side of the slot 
137' farthest from the handle housing 101. This gripping action is 
controlled through the mechanism 300, as discussed further elsewhere. 
The illustrated structure allows the entire tip assembly (tip 10 with slot 
137', tube portion 137, tube portion 135, carrier 133, and cable sheath 
131), pushed by wire 122, to slide so that the tip 10 moves in a generally 
axial direction for motion cancellation; the needle N is able to be 
grasped and released independently of the cancellation motion. Thus, the 
surgeon can grasp and release the needle N at will, using cable 130, while 
the tip 10 is moved by cable 120 so as to cancel all relative motion and 
effectively "stop" the heart. 
Preferably both the carrier 133 and the hole in the middle stop 153 are 
square (or otherwise non-circular) in cross section so that the carrier 
133 cannot rotate about the axis of the handle 100. The fit is close, and 
this locates the transverse position of the carrier 133 at the middle stop 
155. The carrier 133 extends into a tube 135 which is bent into a 
particular shape. This shape is adapted to refine the lateral motion of 
the tip 10, as follows: 
The tube 135 passes, in a close-fitting but freely movable manner, through 
a hole in a front stop 155 which is fixed to the handle 100. This hole, 
along with the square hole in the middle stop 153, fixes the orientation 
of the relatively rigid tip assembly comprising the tube 135 and the 
carrier 133. Because the tube 135 is (preferably) curved, the tip 10 moves 
laterally as the tip assembly slides axially through the two holes in 
stops 153 and 155. The lateral motion of the tip 10, at the end of tube 
137 (which is merely the continuation of tube 135) is amplified due to the 
length of tube 137. The hole in middle stop 155 is optionally offset from 
the center line of the housing 101 as shown. 
This structure adapts the motion of the tip 10 to any heart surface motion, 
not just a straight-line motion. This is useful because the heart is not a 
simple object like a balloon, expanding and contracting in a simple way: 
it is complex in structure and also in motion. A point on the surface of 
the heat, such an anastomosis site, may not move radially inward and 
outward in a straight line; it might instead move generally in and out, 
but with a lateral digression, in a curve. 
If the tube 135 is perfectly straight, and also parallel to a line joining 
the centers of the two holes through stops 153 and 155, then the tip 10 
will oscillate in a straight line, and will follow the heart surface if it 
moves along a straight vector. 
If on the other hand the tube 135 is not straight but curved, then the tip 
10 will follow a curved path, with a lateral deviation from a straight 
line. Any desired deviation motion can be easily be achieved by choosing 
the appropriate curve for the tube 135 where it passes through the middle 
stop 153; and the motion of the tip 10 can be made to follow any heart 
surface motion with any curvature at all. 
Moreover, the curvilinear motion can be adjusted by moving the stop 155 
along the inside of the housing 101. As the stop engages different 
portions of the curve of the tube 135 the shape varies and so does the tip 
10 motion. 
The present invention comprehends each of centered stop holes, straight 
tube portions, and straight vector tip motions as particular cases of the 
lateral-deviation structures for general curved motions of the tip 10. 
In use the handle 100 is rotated about its longitudinal axis to bring the 
lateral deviation of the needle N in line with the lateral deviation of 
the heart H. That is, once the handle 100 is aligned with the vector of 
the heart motion, i.e. is parallel to the straight line connecting the 
inmost stopping point and the outermost stopping point, then the lateral 
deviation of curved motion of the tip is likely to be in the wrong 
direction. When the handle 100 is rotated about its longitudinal axis, the 
deviation of the tip 10 and the deviation of the heart can be aligned. The 
handle 100 is preferably cylindrical for this reason. However, the present 
invention comprehends handles of other shapes such as pistol-grip, curved, 
T-shaped, and so on. 
Alternatively, the front stop 155 can be eliminated in favor of the 
constriction at the front end of the handle 100, which in the illustrated 
embodiment is large enough to freely pass the tube 137 without contact but 
which may be made the same size as the hole in stop 155, i.e., slightly 
larger than the outer diameter of tube 137. The tube portion labeled 137 
would then be curved to produce the desired motion of the tip 10 and the 
needle N. 
The housing 101 is preferably of metal or engineering plastic material, and 
may be made in two halves for easy cleaning and sterilization. The tube 
portions 135 and 137 are preferably of stainless steel or other strong, 
sterilizable material. The stops 153 and 155, on which the tubes 135 and 
137 rub, may be of low-friction material such as nylon to avoid any need 
for lubrication. The bicycle type-cables 120 and 130 are preferably made 
with materials adapted to easy disassembly and sterilization as well as to 
low friction. They may include low-friction sheaths to avoid lubricants. 
FIGS. 3 and 4 show, in greater detail, an embodiment of tool-drive 
mechanism 200 which causes the tip 10 and the needle N to oscillate for 
motion cancellation. 
An arm 220 is hinged at one end to a base 210 by a hinge 212 and is driven 
into oscillation (indicated by arrow OH) by a rotating cam 230 which bears 
against the underside of the arm 220. The cam 30 is slidably but 
non-rotatably mounted on a cam shaft 231 which is rotated by a motor 213. 
The motor 213 is mounted to the base 210 and is coupled to power and 
control circuitry (not shown in FIGS. 3 and 4). The cam 230 profile is 
chosen so that the oscillation OH has the correct wave-form or temporal 
pattern of displacement, velocity, and acceleration (which is generally 
not a simple sinusoidal shape, although that is within the scope of the 
invention). 
The cam 230 bears against the underside of the arm 220 and pushes the arm 
220 up and lets it fall down, so that the cam 230 and the arm 220 stay in 
contact. A push-down return spring 221 is shown in FIG. 3. Dual opposed 
counter-acting actuators (or a double-acting single actuator), not shown, 
may be used in the invention as an alternative to the cam mechanism. 
The cam 230 may be molded of a strong, low-friction material such as nylon. 
The profile of the cam 230, which creates the pattern of oscillation OH to 
match that of the heart, is visible in FIG. 4. The cam surface appears as 
a curved line; this shape embodies the profile. 
The cam 230 is driven by a cam shaft 231 which may be of square section to 
engage a square hole in the cam 230 (not visible in FIG. 4). The shaft 231 
is supported in bearings in a slider 233, which moves in a channel 235 
rigidly attached to the base 210. The amplitude of oscillation is adjusted 
by moving the slider along the channel (in and out of the plane of the 
paper in FIG. 4, left-to-right in FIG. 3) by means of a threaded rod 237 
which engages a threaded hole in the slider 233. The threaded rod 237 is 
preferably driven by a motor 217 mounted to the base 210 (shown by dashed 
lines FIG. 3, as it is behind the vertical wall of the base 210). 
Thus, the motor 213 turns the cam shaft 231, which rotates the cam 230, 
which drives the arm 220, which is coupled to the wire 122 of the cable 
120 which drives the tip 10 of the handle 100 in the heart-pattern 
oscillation OH. The motor 213 is preferably continuously powered and the 
oscillation OH controlled by a clutch 214 disposed between the motor 213 
and the cam shaft arm 231. When the clutch 214 is disengaged the cam shaft 
231 does not rotate, and neither the cable 122 nor the tip 10 (FIG. 1) 
oscillate with the motion OH. The clutch 214 may be engaged and disengaged 
in any conventional manner using pedals, triggers, switches, etc. 
Because the present invention permits operations on various 
widely-separated areas of the heart, with various patterns of surface 
oscillation OH, different cam profiles may be needed. Accordingly, the cam 
230 may be interchangeable with other cams and/or alternatively may 
include a variety of different shapes which may be chosen for different 
heart areas and different patients, as the heart oscillation pattern 
varies with body type. 
FIG. 5 shows a cam 230 with different sections having different profiles. 
There is no need to vary the radius, because the oscillation amplitude is 
adjusted by the varying the distance of the cam 230 from the hinge 212 
with the motor 217; or the phase, since that can be set in the pacing 
circuitry (described below). Only the shape needs to change. To 
selectively engage just one profile of the cam 230, a tappet 232 or some 
other conventional device can be used. The cam 230 of FIG. 5 may be molded 
in one piece or machined from a single block of material. 
In order to virtually cancel the organ motion the oscillation OH of the 
needle-holding tip 10 should match as precisely as possible the motion of 
the artery A being operated on in phase, amplitude, frequency, and 
pattern. As noted above, the tool-drive mechanism 200 permits adjustment 
of the pattern by cam profile selection, and the amplitude by cam-hinge 
distance. The frequency is determined by the rpm's of the motor 213. The 
phase is preferably adjusted electronically as discussed below. 
A momentary-contact switch 240 is mounted on the channel 235. The switch 
240 provides a trigger signal to a pacer (not shown in FIGS. 3 and 4) 
which drives the heart to beat at a rate preferably slightly higher than 
its rate when not paced. The switch 240 could also be mounted on the 
slider 233 or be incorporated into the base 210, for example in a 
triggering cam coupled to the driven end of the cam shaft 231. Any 
conventional trigger means is comprehended by the present invention, 
including magnetic and optical triggers or triggers coupled to the drive 
circuits of the motor 213. 
FIG. 6 illustrates the control of these parameters. The surgeon first notes 
the heart rate without any pacing stimulus, preferably after slowing the 
heart beat by means of short acting .beta.-blockers or calcium channel 
blockers, and then adjusts a voltage supply 713 driving the motor 213 to 
set the oscillation rate slightly higher than that rate. Motor 213 may be 
a DC motor speed-responsive to applied voltage, or some other type with 
appropriate speed-control circuitry 713. The adjustment is illustrated 
schematically by a hand 70 and a knob 73. The pace circuitry is powered, 
and the heart H is now driven to beat at an elevated rate, which not only 
makes its beating much more regular (i.e., at a precise frequency) but 
also prevents "twitchy" reactions by the heart muscle, which could cause 
an error in the operation. 
Pacing results from the oscillation of the arm 220 activating the switch 
240, which sends a trigger signal to the pace circuit 74, which stimulates 
the heart H once for each trigger signal, i.e., at the frequency of switch 
triggering. The invention optionally includes an adjustable delay circuit 
76 between the switch 40 and pace circuit, as illustrated schematically by 
the hand 70 and a knob 75 on the delay box 76. The delay adjust may be 
either mechanical or electronic. 
Optionally, the needle-holding tip 10, which forms a capacitor with the 
heart surface, may be used to monitor the distance between the heart and 
the tip 10. The heart H preferably is grounded either through the chest C 
and patient supports or by an electrode (not shown). The capacitance value 
of the capacitor formed by the heart H and tip 10 is a function of the 
distance between them. 
FIG. 6 shows an audio oscillator 82, such as a grid-dip oscillator, used to 
generate a frequency that is a function of the capacitance; this frequency 
is amplified by an amplifier 84 and turned into an audible tone by a 
transducer L (loudspeaker, earphone, etc.); the tone is heard by the ear E 
of the surgeon. The surgeon can detect any mis-match between the 
oscillation OH and the heart motion by listening to the tone, because when 
the oscillations are different the distance will vary and the tone will 
warble. This provides feedback on the synchronization, phase locking, and 
amplitude differences of the oscillation OP and the heart oscillation OH. 
A difference in amplitude will cause a regular pitch variation at the 
common frequency of the heart and tip 10. The surgeon adjusts the position 
of the slider 233 (FIGS. 3 and 4) by driving the motor 217 one way or the 
other, to turn the threaded rod 237 clockwise or counter-clockwise until 
the tone variation is minimized, as illustrated by hand 70 and control 
knob 77. Then the surgeon might also adjust the phase with the pacing 
trigger delay 76 to further reduce warble. 
If the tone changes slowly over a number of beats, this indicates that the 
heart H is not following the pacer or the pacer is not following the 
trigger signals. 
The tone also provides feedback about the shape of the cam, since if the 
profile is not correct then warble will be heard (even if there is no 
mis-match in frequency, phase, or amplitude) because of differences in the 
oscillation patterns. If the profile is adjustable, then the surgeon can 
adjust this as well. 
All the above steps can be done with the handle 100 rigged near the heart 
in a clamp or holder (not shown) so that the surgeon may attend to the 
adjustments with both hands and without having to hold one hand 
stationary. When the tone variation is stable and adjusted to minimum 
variation, then the surgeon is ready to operate. 
When the needle N is grasped in the slot 137' the capacitance between the 
tip 10 and the heart H will of course be much different than when the tip 
10 is empty. This will cause a large shift in the frequency of the 
grid-dip output signal. However, such shifts, and also those resulting 
from the movements of the surgeon's hand (S, FIG. 1) will not hinder the 
operation because the tone will change only in response to the surgeon's 
voluntary motions: these tone changes will actually provide feedback to 
the surgeon, and the superimposed warbling due to imperfections in the 
oscillation OH of the tip 10 will still be audible. 
FIG. 7 shows a possible solution to the problem of the tone disappearing 
when the tip 10 or needle N touches the heart H, shorting out the 
capacitance. An insulated capacitor plate 21 is fixed on the tube 137 but 
is insulated from it and independently connected electrically to the 
oscillator 82. The plate 21 is coupled to a capacitor wire 24, which may 
include a grounded shield (not shown). 
Optionally, a laser of the ordinary laser pointer type (not shown) can be 
used to help in aligning the handle 100. The laser can be held in the 
suturing hand and the laser beam directed along the vector of the heart 
oscillation. The surgeon can watch the motion of the beam on the heart 
surface. When the heart surface is moving perpendicular to the beam, the 
lateral location of the laser spot on the heart will be stationary, even 
though the beam spot moves in and out along the beam line. The 
displacement of the beam spot along the heart surface while the heart is 
beating will be zero. Conversely, if the heart surface is moving at an 
angle to the beam, the beam spot will traverse laterally across the 
surface, regardless of the angle which the heart surface makes with the 
beam. The sideways beam displacement will be readily apparent to the 
surgeon, and the angle can easily be adjusted to align the laser. 
Then, the laser can be replaced with the handle 100. If the two implements 
are the same size, the handle 100 will be pre-aligned once it is grasped. 
Alternatively, the handle 100 can be adapted to emit a laser beam axially, 
which avoids the need for changing implements while holding the hand 
stationary. 
The invention comprehends variations on the preferred embodiment described 
above. 
The present invention allows a surgeon or veterinarian to operate on any 
moving organ, and the operation is not limited to the surface. The 
invention permits canceling of relative motion between a tool holder and 
an exterior or interior portion of a beating heart or any other organ. A 
surface is, of course, only one particular type of portion of an organ. 
The adjustments which the surgeon makes to the oscillation phase and 
amplitude can also be made by automatic equipment. The invention also 
comprehends means for manually or automatically augmenting the cam motion 
or modifying the cam profile. 
The capacitive plate 21 can be projected outward and down from the end of 
the tip 10 to be adjacent the portion of the heart H that is to be 
operated on. In one embodiment, a pattern-remembering computer can be a 
coupled to the capacitance probe circuit which will "learn" the deviations 
between the heart and tip 10 that recur in every cycle and anticipate 
them; this will result in greater accuracy. Known sonar or radar distance 
measuring techniques may be used as alternative to capacitance. 
FIG. 8 shows an embodiment of the invention in which TV imaging is 
included. Preferably, the TV image is stabilized so that the surgeon or a 
technician or nurse can watch the operation as if the heart were still. 
The same motion-canceling principle is applied to the TV image. 
A TV imaging camera 90 is shown in FIG. 8 trained onto the operation; the 
TV image is displayed on a monitor 98. To immobilize the image on the 
monitor 98, the camera 90 may be swung mechanically on a pivot 91 by a 
camera actuator 93 driven in an oscillation OC by a third bicycle-type 
cable from the mechanism 200 (not shown) or by some other conventional 
electro-mechanical device so that the surface of the heart H as seen on 
the screen of the monitor 98 does not move. Alternatively, an electronic 
motion-compensator 95 may be interposed between the camera 90 and the 
monitor 98 which alters the TV signal to accomplish the same end. The 
motion compensator 95 may employ a signal from the mechanism 200 (for 
example, a variable resistor driven by the cam 230) or may employ internal 
circuitry to stop the image from moving vertically on the monitor 98. This 
could be accomplished, for instance, by placing a bright spot into the 
visual field and triggering the sweep of the monitor 98 to the bright 
spot; or by pattern recognition with triggering to some part of the 
pattern. A personal viewing device can be used instead of a monitor. 
A fiber-optic imaging device of the type used in endoscopes (not shown), 
which sends images through fiber bundles to remote TV cameras, can be used 
in place of the full-size camera 90 of FIG. 8. Such a camera could be 
mounted alongside the tip 10 and oscillated in the same pattern OH as the 
tip 10, to stabilize the image. Also, a small mirror (not shown) could be 
similarly mounted alongside the tip 10 at an angle of about 45.degree. to 
the axis of the handle 100. The artery A and needle N can then be viewed 
through a relatively long-focal-distance camera looking parallel to the 
axis of the handle 100. 
Such camera arrangements can be doubled for stereo imaging of the 
operation, which can be useful for very fine suturing as the image will be 
magnified. 
A lamp (not shown) may optionally be mounted on the handle 100 for 
illumination. 
FIG. 9a illustrates a stapler tip 10' which is adapted to hold and crimp 
onto the artery A a staple P when the rigid portion 132' of the cable 130 
moves downward, bending the staple P around the tube extension 137" and 
closing its pointed tips together through the wall of the artery A. FIG. 
9b shows the solenoid 320, spring 322 and cable 130 which are also shown 
in FIG. 1. A rod 332, coupled to wire 132 of cable 130, pushes outward 
when the solenoid 320 is powered to compress the wire 132 and crimp the 
staple P of FIG. 9a. The spring 322 then retracts the wire 132. The wire 
132 may also be placed into tension by activation of the solenoid 320 if 
the stapling tip is adapted to this. An hydraulic actuation for crimping 
the staple P (not shown) is also contemplated for the present invention. 
The present invention also comprehends a tip with automatic staple feed and 
also all other conventional stapling apparatus or methods. Alternative 
tips (not shown) adapted to anastomosis with adhesives, light, heat, 
vibration, other mechanical fasteners, and so on, are within the scope of 
the invention, as well as tools adapted for operations other than 
anastomosis or arterial or venous repairs. 
The present invention may be adapted to operations now performed as 
so-called "open-heart" surgery requiring a heart-lung machine and a 
stopped heart. The narrow tip 10 is able to protrude through a narrow 
incision in a large vein or artery wall or the heart itself, to work on 
valves and other internal structures while the heart is beating. The tip 
may be adapted to include a miniature endoscopic viewer in such cases, 
permitting "stopped-motion" imaging once the tip motion is correlated with 
the organ motion and for adjusting the motion of the tip. Since the tip 
motion includes lateral motion as well as reciprocating vector motion, a 
relatively complex motion like that of a heart valve may be duplicated by 
the present invention; and the provision of cam adjustment and/or 
selection permits varying the motion pattern during an operation. This may 
in the future permit operating on internal parts of the heart without the 
expense and danger of stopping the heart. In such operations the invention 
includes means for reducing blood leakage and for returning to the patient 
blood leaked through the narrow opening for the tip, for example by 
suctioning and then pumping the leaked blood to a vein. 
The invention may also be adapted to virtually eliminate "twitching" of 
organs other than the heart, by incorporating a non-cyclical compensating 
motion activated in response to a twitch sensor. Such motion could be 
provided by the cam 230 and clutch 214 of FIG. 3, where the clutch was 
engaged by a twitch. 
The invention is useful for any operation on a moving organ, and 
particularly for operations on the heart. The present invention may be 
adapted to any surgical tool and for any operation. As long as there is 
motivation to eliminate relative motion between a tool of any kind and an 
oscillating organ in a surgical setting, the apparatus of the present 
invention may be used. 
The "means for causing reciprocation" is intended to encompass the 
disclosed mechanism, including the cam 230 as described herein, as well as 
all other mechanisms which will permit such reciprocation and are thus 
functionally equivalent to such a cam. Thus, once the intended function is 
known to those of ordinary skill in the art, many other mechanisms to 
accomplish the function can be designed and are intended to be part of the 
present invention. For example, the reciprocation may be caused by a 
piston driven by a computer so as to cause the arm 220 to oscillate at a 
predetermined programmed rate. Sensors to determine the relative 
amplitude, angle and pattern of the tip 10 as compared to the oscillating 
organ could feed input to the computer which would then feed back 
adjustments to the piston. While the illustrated means is simple and 
presently preferred, any other mechanism for accomplishing the specified 
function must be considered to be a functional equivalent to the 
illustrated cam. 
The "means for synchronizing" the signalling of the pacer with the 
oscillation OH is preferably the illustrated switch 240 triggered by the 
actual movement of the mechanism. Again, however, any other mechanism for 
accomplishing this function is intended to be an equivalent to the 
illustrated mechanism. Thus, for example, if the movement of the tip 10 is 
computer controlled, the computer can also output the pacing signal. It is 
preferred that the same mechanism which drives the oscillation effectively 
drives the pacing of the heart. 
The claimed means for adjusting one or more of the amplitude, phase or 
pattern of the oscillation is intended to encompass not only the 
illustrated mechanisms, but anything else that may be devised in order to 
accomplish this function. While a capacitance system for generating an 
auditory signal which varies as the distance varies, but becomes constant 
as the amplitude comes into alignment, is a simple and effective means for 
accomplishing this function, those of ordinary skill in the art can 
readily develop other means for accomplishing this function which are 
intended to be equivalent to the auditory mechanism disclosed. Thus, in a 
more complex computer driven system, the distance between the tip and the 
oscillating organ may be measured by other means, such as radar, sonar or 
laser type signals which display the relative distances on a computer 
output with the computer using this signal to adjust the amplitude of 
oscillation to maintain the distance constant. 
The industrial applicability is in medical devices. The problem solved by 
the invention is motion of a moving organ to be operated on. The foregoing 
description of the specific embodiments will so fully reveal the general 
nature of the invention that others can, by applying current knowledge, 
readily modify and/or adapt for various applications such specific 
embodiments without undue experimentation and without departing from the 
generic concept, and, therefore, such adaptations and modifications should 
and are intended to be comprehended within the meaning and range of 
equivalents of the disclosed embodiments. It is to be understood that the 
phraseology or terminology employed herein is for the purpose of 
description and not of limitation. The means, materials, and steps for 
carrying out various disclosed functions may take a variety of alternative 
forms without departing from the invention. Thus the expressions "means to 
. . . " and "means for . . . ", or any method step language, as may be 
found in the specification above and/or in the claims below, followed by a 
functional statement, are intended to define and cover whatever 
structural, physical, chemical or electrical element or structure, or 
whatever method step, which may now or in the future exist which carries 
out the recited function, whether or not precisely equivalent to the 
embodiment or embodiments disclosed in the specification above, i.e., 
other means or steps for carrying out the same functions can be used; and 
it is intended that such expressions be given their broadest 
interpretation.