Surgery – Instruments – Cutting – puncturing or piercing
Reexamination Certificate
2001-03-05
2003-03-25
Yuen, Henry C. (Department: 3754)
Surgery
Instruments
Cutting, puncturing or piercing
C606S185000, C604S264000
Reexamination Certificate
active
06537290
ABSTRACT:
BACKGROUND OF THE INVENTION
Presently, a variety of surgical procedures require the insertion of surgical devices into an arterial or venous vessel, a viscus region, or alternatively, into the heart of a patient. These procedures include diagnostic procedures, radiological procedures, coronary and peripheral angioplasties, thorascopic, laparoscopic, or endoscopic surgeries. Generally, these procedures require accessing the area of interest, forming an incision through the exterior wall of a body vessel or organ, and inserting an implement, commonly a trocar or other catheter-like surgical device, through the opening. Considerable care must be exercised during the insertion process to avoid introducing air into the viscus region, blood vessel, or heart. Furthermore, the quantity of blood loss through the incision should be limited.
Commonly, cannula devices are used to avoid the risk of air embolism and limit blood loss through the incision, while providing access into the blood vessel or organ. Typically, an incision closing device, for example a purse string suture, is applied to the tissue surrounding the incision. Thereafter, the cannula is inserted into the incision and the incision closing device is used to sealably engage the cannula. The above disclosed insertion method may result in the unwanted application of pressure to the incision area and could result in damage to the tissue located within the blood vessel or body organ.
Current cannula devices encounter additional problems in surgeries involving a beating heart. For example, there is an increased risk of damage to the beating heart during the insertion of the cannula. Generally, the heart is comprised of four chambers separated by artrio-ventricular valves. The insertion process disclosed above may result in compressive force being applied to the heart, thereby causing a disruption in normal circulatory function. Of equal concern is an increased risk of damaging the internal tissues and valves of the beating heart. Additionally, the internal pressure exerted during a cardiac cycle commonly results in chronic seepage or leakage at the incision-cannula interface. While excessive bleeding is common with a person having a normal blood-clotting response, this problem is magnified in persons utilizing anticoagulation medication. These medications are commonly prescribed to persons suffering from some forms of heart disease, for example, hypertension. As such, an interventional surgical procedure may be required should these medications fails to adequately address the patient's heart condition.
Thus, there is a need for a cannula system for use on viscus regions and hollow organs of a body. Furthermore, the system would be capable of attaching to a beating heart or other vessel or organ and provide a stable working environment on a dynamic organ, while reducing the blood loss through and around the cannula.
BRIEF SUMMARY OF THE INVENTION
The present invention solves the problem of gaining access to a viscus region or hollow organ of a patient while limiting excess blood loss through the access incision. Additionally, the present invention reduces or eliminates the likelihood of damage to the internal components of the organ during cannula insertion. The present invention is particularly well suited for procedures involving the heart. More particularly, the present invention permits access to the internal region of the heart without requiring the heart to be arrested. Additionally, the present invention permits remote cannulization of a hollow organ or viscus region.
In one aspect, the present invention provides an access system comprising a tissue stabilizer capable of attachment to the viscus region or hollow organ, and a sealing cannula. A puncture device is inserted into the tissue stabilizer and forms a puncture hole in the tissue. Thereafter a sealing device is inserted into the tissue stabilizer and sealably engages the tissue around the puncture hole. A cutting trocar may then introduced into the puncture hole to enlarge the orifice to receive the sealing cannula. A sealing cannula is inserted into the orifice and a purse string suture is applied, thereby sealing the cannula/tissue interface.
In another aspect of the present invention, a tissue stabilizer is disclosed herein. The tissue stabilizer comprises a central lumen in communication with a receiving flange and an attachment flange having a vacuum port positioned thereon. The vacuum port is in communication with a vacuum chamber located within the attachment flange. In an alternate embodiment a purse string template is positioned on the attachment flange.
In yet another embodiment, the present invention discloses a sealing cannula having a device body in communication with a device lumen. The device body comprises a sealing washer and a guide member positioned within a receiving lumen, and a sealing member in communication with said receiving lumen and the device lumen.
The present invention also discloses a method of providing access to a viscus region or hollow organ. Other objects and further features of the present invention will become apparent from the following description when read in conjunction with the attached drawings.
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Adams Leland R.
Allen William J.
Bachman Alan B.
Chapolini Robert
Reed Scott
Condino Debra D.
Edwards Lifesciences Corporation
Fristor John
James John Christopher
Yuen Henry C.
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