Surgery – Instruments – Suture – ligature – elastic band or clip applier
Reexamination Certificate
1999-09-14
2001-02-20
Jackson, Gary (Department: 3731)
Surgery
Instruments
Suture, ligature, elastic band or clip applier
C606S139000, C606S148000
Reexamination Certificate
active
06190396
ABSTRACT:
CROSS-REFERENCES TO RELATED APPLICATIONS
The present application is related to commonly assigned, copending U.S. patent application Ser. No. 08/824,031 filed on Mar. 26, 1997, U.S. Pat. No. 6,036,699 Ser. No. 08/883,246 pending filed on Jun. 26, 1997, and Ser. No. 09/395,901 filed on the same day as the present application. The full disclosures of each of these applications are incorporated herein by reference.
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 and end-to-end 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 coronary artery bypass graft surgery (“CABG”), a graft blood vessel may be anastomosized to an arterial wall of an artery to supply blood downstream of a blockage in another blood vessel. The proximal end of the blood vessel graft is typically connected to a pressurized arterial blood supply, such as the aorta, 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 in 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, require 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 devices, methods, and kits for use with a body duct. The present invention improves and simplifies suture placement through the body duct is particularly useful for placing multiple sutures in the end of a body duct in a manner which is useful for forming an anastomotic attachment to the side or end of another body duct. The present invention is particularly useful in performing anastomotic attachments as part of coronary artery bypass grafting (CABG) procedures in a variety of environments including to both stopped heart and beating heart procedures. The present invention may be used in open surgical procedures as well as in minimally invasive procedures using percutaneous access such those developed by Heartport, Inc. of Redwood City, Calif. and by CardioThoracic Systems, Inc. of Cupertino, Calif.
The present invention preferably provides for the delivery of a plurality of needles through the body duct in a single continuous motion by the user. Advantageously, this simplified needle delivery reduces the overall amount of time spent on performing a body duct connection such as an anastomosis. Although not limited in this manner, the invention provides for rapid and consistent placement of both needles and sutures through the body duct. The present invention preferably allows the sutures to be easily organized to facilitate the tying off of the sutures during an anastomosis procedure. 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 duct in a desired pattern, typically in an evenly-spaced manner, which thus improves the quality of the anastomosis by having a consistent suture pattern and a calculated tissue capture.
In one aspect of the present invention, a device is provided for use with a body duct. The device of the present invention comprises a shaft structure for holding the end of the body duct on a portion of the structure and a suture organizer mounted about the shaft structure. A plurality of needles are arranged on the shaft structure where each of the needles can be advanced along a path in a radially outward direction from the shaft structure, through the end of the body duct, and into a suture organizer. The suture organizer is preferably movable relative to the shaft structure so that the organizer can be moved away from the shaft structure to facilitate placement of the body duct over the structure. The suture organizer can then be moved back into place over the body duct to be in position to receive the needles and/or suture, as described in more detail below. After capturing the needles/suture, the suture organizer can then be moved or removed from the shaft to permit access to the suture ends which are to be tied off. Typically, after the sutures have been positioned through the body duct, they may be tied off with sutures from a target body duct or tissue, where the tying off of the sutures will join the body duct to the targeted area. The suture organizer can hold the needle and sutures to facilitate the tying off of ind
Isbell Lewis
Whitin Kate
Jackson Gary
Perclose, Inc.
Townsend and Townsend / and Crew LLP
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