Surgery – Instruments – Suture – ligature – elastic band or clip applier
Reexamination Certificate
1999-09-14
2002-03-19
Recla, Henry J. (Department: 3731)
Surgery
Instruments
Suture, ligature, elastic band or clip applier
C606S144000, C606S148000
Reexamination Certificate
active
06358258
ABSTRACT:
BACKGROUND OF THE INVENTION
The present invention relates generally to devices and methods for suturing body tissue. More particularly, the present invention is useful for performing end-to-side attachments of body ducts, such as in suturing coronary blood vessel grafts.
In many medical procedures today, it is desirable to connect a body duct, such as a hollow organ or blood vessel, to a targeted piece of tissue. In coronary surgery, this type of attachment is commonly referred to as an anastomosis. In certain heart operations where coronary artery bypass graft surgery (“CABG”) is performed as shown in
FIG. 1A
, a graft blood vessel G may be affixed to a port or aperture in an arterial wall of an artery to supply blood downstream of a blockage in another blood vessel V. The proximal end of the blood vessel graft is typically connected to a pressurized arterial blood supply, such as the aorta A, while the distal end is coupled to the vessel lumen downstream of the blockage. The amount of time spent performing these anastomosis procedures to connect blood vessel grafts between blocked arteries and pressurized blood supplies is critical to patient mortality and morbidity. In conventional CABG surgery, three critical determinates that affect the outcome of a bypass surgery are (1) time the patient spends on cardiopulmonary bypass, (2) time the patient spends with a clamped aorta, and (3) the quality of the anastomosis. It is generally understood that the risk of patient morbidity rises significantly after a threshold time of one hour on cardiopulmonary bypass. Continual circulation of blood through the mechanical apparatus of the bypass machine can cause various degradations to the blood. Perhaps the most prevalent complication arising from prolonged cardiac bypass is the high risk of distal thrombosis, which can embolize into the neurovasculature and potentially cause a stroke.
A critical factor in reducing the amount of time a patient spends on bypass is directly related to the time spent anastomosing the blood vessel grafts used during surgery. The average time for suturing one anastomosis is approximately seven to ten minutes. It is believed that an average CABG procedure involves approximately five anastomoses. Therefore, the average time for graft suturing ranges from thirty-five to fifty minutes, which is a significant portion of the sixty-minute threshold for patient morbidity. Patients treated with conventional coronary surgery and placed on cardiopulmonary bypass would benefit from reducing the amount of time spent performing each anastomosis.
In “off pump” procedures where patients are not placed on cardiopulmonary bypass and the heart remains beating, the difficulty of suturing an anastomosis graft on a moving surface of the heart may degrade the quality of such grafts completed on patients. “Off pump” procedures do not use cardiopulmonary bypass pumps or devices and thus reduces the blood damage associated with bypass devices. “Off pump” procedures, however, requires a higher degree of expertise to perform coronary artery bypass grafts on a beating or moving object. An anastomosis differs from straight line suturing in that each suture has a different orientation that is based on its position around the cross-sectional circumference of the blood vessel graft. It can be appreciated that some of the sutures are easily made from on top of the conduit or blood vessel graft, while others are more difficult to complete as they are beneath the conduit. It can be further appreciated that performing such complex suturing procedures on a moving platform, such as the beating heart, further increases the difficulty associated with such suturing procedures. Improperly connecting blood vessel grafts to the patient may present substantial post-operative complications and/or increase operating room time spent correcting the improperly connected graft.
Accordingly, it would be desirable to provide improved devices and methods that simplify anastomosis graft procedures performed on patients, particularly where multiple graft procedures are to be performed. Simplifying the anastomosis procedure would typically reduce the time spent on each graft and thus minimize the time a patient spends on cardiopulmonary bypass. Additionally, it would desirable to provide a device that improves the consistency of the suture pattern created during each anastomosis graft.
SUMMARY OF THE INVENTION
The present invention comprises systems, methods, and kits for facilitating the suturing of one body duct to another body duct or tissue surface. The present invention simplifies suture delivery, reducing the amount of time required for performing an anastomosis and facilitating the delivery of suture needles through blood vessels. The present invention may be used in a variety of environments and is applicable to both stopped heart and beating heart procedures. The prevent invention may be used in a minimally invasively environment using percutaneous ports such those developed by Heartport, Inc. of Redwood City, Calif. or retractor systems developed by CardioThoracic Systems of Cupertino, Calif. Of course, the present invention may also be used in an open surgery environment.
The present invention preferably allows the delivery of a plurality of needles through both body ducts in a single continuous motion by the user. Advantageously, this simplified needle/suture delivery reduces the amount of time spent on performing body duct connections such as an anastomosis. In situations where the invention is used with a beating heart, the invention allows for rapid actuation once the device is properly positioned, reducing the likelihood that movement of the beating heart may misposition the device during actuation. The present invention further allows for the simultaneous delivery of a plurality of needles through the body ducts in an evenly-spaced manner which thus improves the quality of the anastomosis by having a consistent suture pattern and a calculated tissue capture. The present invention is also particularly useful when targeting a pressurized blood vessel when it is desirable to maintain hemostasis at the targeted suture site.
In one aspect of the present invention, a device is provided for suturing one end of a first body duct to a hole in the side of a second body duct. When performed during coronary surgery, such connections of the body ducts are known as end-to-side anastomoses. The device according to the present invention includes a structure for holding the end of the first body duct and positioning the end adjacent to the hole in the side of the second body duct. The structure of the device is typically a shaft having a surface adapted to receive the first body duct. The first body duct used during anastomosis is typically some type of tubular graft such as a saphenous vein while the second body duct is the targeted blood vessel. Further examples of first and second body ducts are provided in the detailed description below.
A plurality of needles are arranged on the structure to be advanced along a plurality of paths.
FIG. 1B
depicts preferred paths according to the present invention. Each needle path first passes radially into and forwardly out of the end of the first body duct and into the hole of the second body duct. The path then everts so that the needles and associated sutures will pass outwardly through tissue peripheral to the hole when the end of the first body duct is on the structure adjacent to the hole in the second body duct. The needles preferably travel along such paths when they are advanced forward. The structure of the device typically includes a plunger which may be translated to advance the needles forward through the first body duct. The plunger may include suture storage area for sutures attached to the needles.
The needle paths of the present invention may be defined in a variety of manners. In one embodiment of the present invention, a plurality of guide channels are provided to define the path of the needles. The channels may be integrally formed in the device structu
Arcia Rovil P.
Lichtenstein Sam
Mehl Douglas
Abbott Laboratories
Burns Doane , Swecker, Mathis LLP
Recla Henry J.
Woo Julian W.
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