Surgery – Internal organ support or sling
Reexamination Certificate
2002-09-05
2004-05-25
Winakur, Eric F. (Department: 3736)
Surgery
Internal organ support or sling
Reexamination Certificate
active
06740029
ABSTRACT:
FIELD OF THE INVENTION
The invention relates generally to medical surgical devices, and more particularly to a device and method of stabilizing a surgical site during cardiac or cardiovascular surgery.
BACKGROUND OF THE INVENTION
Heart disease and associated cardiovascular problems have become so common in the United States that over 400,000 open heart surgeries are performed each year. Traditionally, physicians would open the chest and stop the heart before performing a surgical procedure on the heart. However, medical practices have improved, and physicians now recognize that there are advantages to performing surgery on a beating heart. For example, performing surgery on a beating heart avoids the necessity to expose the heart to filters, oxygenators, tubes, and other devices. This decreases the trauma associated with stopping the heart, as well as avoids other dangers that stopping the heart poses to a patient. In addition, by avoiding the use of these devices, the physician can lower the expense of an operation. Furthermore, performing surgery on a beating heart lowers the risk of ischemic damage to heart and surrounding tissue.
Unfortunately, there are many difficulties and challenges which must be overcome to successfully perform surgery on a beating heart. For example, every time the heart beats, the heart moves. This makes it difficult to isolate a specific site on the heart for surgery. Furthermore, physicians typically must develop great skill and expertise to accommodate the movement of the heart with existing instruments which were designed for use with a heart that is stopped. Because of the increased demands of performing surgery on a beating heart, surgery on a beating heart often takes longer than surgery on a stopped heart. Fortunately, devices and methods are being developed which decrease the amount of time and expertise it takes to identify and isolate a target vessel and thus, reduce the time it takes to perform open heart surgery.
One family of instruments which have been developed to facilitate surgery on a beating heart are known as cardiac immobilization devices or heart stabilizers (devices). A number of these devices function by attaching to the heart at two or more points. The points are then moved further apart, thus stretching the surface area of the heart about which surgery is to be performed (surgical site). The devices typically grip the heart surface by suction. Unfortunately, there are a number of disadvantages associated with these methods of isolating a surgical site.
Some cardiac immobilization devices often appear to be little more than steak tongs or clamps which have been slightly altered to attach to a heart surface. Other devices use flex links or rods to attach to a retractor and then use a metallic foot to stabilize the heart surface. Suction devices may comprise a plurality of suction cups, or may have at least one hollow cylinder with holes in it, which is then attached to a pump which pulls a vacuum at the holes.
FIG. 1A
(prior art) shows a cardiac immobilization device
130
attached to a heart surface
140
. To perform open heart surgery, typically a chest retractor
110
is braced within a rib cage and used to maintain an opening in the chest wall
112
which provides access to the heart surface
140
. A stabilizing member, such as a flexible arm assembly
120
is used to securely locate a cardiac immobilization device
130
upon the heart surface
140
. Accordingly, the stabilizing member
120
is coupled to the retractor
110
via a clamp
126
and holds the cardiac immobilization device
130
in a predetermined position.
The flexible arm assembly
120
includes a flexible arm
124
which may be bent and twisted into various shapes and geometries to access different locations on the heart surface
140
. At the end of the flexible arm
124
closest to the heart surface
140
is a socket
128
for attaching the flexible arm
124
to the cardiac immobilization device
130
. At the other end of the flexible arm
124
is a handle
122
which when turned tightens a cable (not shown) within the flexible arm
124
. The tightening of the cable makes the flexible arm
124
rigid and immobile. The tightening of the cable also tightens the socket
128
, allowing the socket
128
to grip an object, such as a ball
132
(the ball
132
is part of the cardiac immobilization device
130
).
The shown cardiac immobilization device
130
uses suction to attach to a surface of the heart
140
. To attach the cardiac immobilization device
130
to the heart surface
140
, the cardiac immobilization device
130
utilizes a foot plate
136
with holes thereunder (not shown) on which a vacuum is placed. The vacuum is maintained by air hoses
134
which are attached to an air pump (not shown) and the foot plate
136
. Thus, the cardiac immobilization device
130
is held stationary on the heart surface
140
at the end of the flexible arm
124
of the flexible arm assembly
120
so that the heart surface
140
located within the foot plate
136
can be isolated.
One disadvantage of many tong type attachments is that they provide an uneven spread (the heart surface closest to the tong's hinge point is spread a smaller distance than the heart surface at the end of the tong).
There are also many disadvantages associated with using suction to isolate a surgical site. For example, many patients have a heart which is surrounded with fatty tissue. Since the fat surrounding the heart moves, when a physician uses a suction device to isolate a heart surface, the suction cups or suction holes attach to the fat (rather than the heart surface). The operative result of the device attaching to the fatty tissue is that the heart surface can still beat underneath the fatty tissue, which means that isolation and stabilization of the surgical site is poor. Furthermore, the fatty tissue may be drawn into the device (at a hole, for example) by the suction, and may clog the suction device thereby stopping suction at the holes which are further along and at the end of the device. In addition, after attachment to the heart is made with a suction device, the ability to spread the heart surface is limited by the force of suction on the heart surface. Should the suction break, the device must be repositioned and reattached to the heart, which consumes time and is a nuisance to the physician. Furthermore, when strong enough suction is applied to the heart surface to achieve adequate spreading and to prevent slippage, the suction can cause blood to accumulate and clot just beneath the heart surface, a hematoma (this condition is also commonly referred to as a “heart hickie”).
Therefore, what is needed is a device and method of isolating a surgical site for cardiac and cardiovascular surgery. The device should contact a minimal surface of the heart, accommodate the non-planar geometry of the heart, grip the heart firmly, yet gently, and should be easy to apply to and to remove from a beating heart.
Blood in arteries can spew out from the anastomosis site during surgery, which reduces visualization for the surgeon. Periodically, blood must be manually removed by an assistant typically with a blower. The surgeon, therefore, must stop the procedure so that blood can be removed. What is needed, therefore, is a stabilization device integral with a blower device so that the blower could be operated remotely without interfering with the procedure.
SUMMARY OF THE INVENTION
A device and method is provided for isolating a heart surface, particularly, the surface of a beating heart during cardiovascular surgery. The device utilizes rotation to attach to the heart surface and then spread the heart which isolates the spread portion of the heart for surgery.
Disclosed is a device for isolating a cardiac surgical site. The device generally comprises a first finger (which may be cylindrical) having a clinging accessory for attaching the first finger to a heart. Furthermore the device could comprise a second finger having a clinging accessory for attaching the second finger to the heart,
Austin Samuel Lynn
Baker Clyde
Davis Albert
Keyes, Jr. Charles R.
Rogers Danny Carpenter
Chase Medical L.P.
Meyertons Eric B.
Meyertons Hood Kivlin Kowert & Goetzel P.C.
Veniaminov Nikita R.
Winakur Eric F.
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