Surgery – Instruments – Sutureless closure
Reexamination Certificate
2000-05-02
2001-11-13
Chaudhuri, Olik (Department: 2814)
Surgery
Instruments
Sutureless closure
Reexamination Certificate
active
06315787
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates generally to a vessel plug which provides occlusion to an opening in a blood vessel. Sutures may be placed on the blood vessel around the plug. Alternatively, the opening in the vessel may be occluded without sutures.
BACKGROUND OF THE INVENTION
Blood vessels, either veins or arteries, are often punctured or incised to allow insertion of a cannula, catheter, or endovascular instruments during surgical or interventional procedures. For example, during open-heart coronary bypass grafting surgeries, venous return cannulas are often inserted in the superior vena cava, inferior vena cava, or the right atrium, whereas an arterial cannula is inserted in the femoral artery to complete cardiopulmonary bypass. During minimally invasive cardiac surgeries, various endoscopic instruments and cannulas are inserted in a patient's ascending aorta through the chest wall to establish cardiopulmonary bypass and cardioplegia. After removal of these medical devices, the blood vessel is often left with an open wound. Sutures are generally required around the opening due to the large diameter of these medical devices.
The most common technique for quickly occluding vessel holes is the finger of an operator, who can quickly and easily locate the source of the leakage and occlude it with the tip of his or her finger. Disadvantages to this method are that (1) one hand of the operator is occupied holding the blood vessel, (2) having the operator's hand around the vessel opening reduces space available for suturing the blood vessel, and (3) vessel visualization and vessel access are compromised around the vessel opening due to crowding from the operator's hand and arm.
Another common method of occluding an opening on a blood vessel employs a mechanical clamp (partial occlusion clamp). A clamp, when positioned and closed over an opening of a vessel, can isolate the vessel hole from blood flow. Disadvantages associated with this method are that (1) not all vessels have sufficient space around the opening to position a clamp, (2) a blood vessel may be damaged from clamping its wall, and (3) a diseased blood vessel may shower emboli, and /or may be dissected, creating a false lumen.
A need exists for space conserving devices that provide sutureless occlusion of an opening of a blood vessel and provide minimum vessel manipulation and deformation during use.
SUMMARY OF THE INVENTION
The present invention provides a sutureless vessel plug for maintaining hemostasis of a blood vessel having an open wound. The plug may be used to occlude cavities other than vessels, such as abdominal fistula and the like. Moreover, the plug may be constructed of materials suitable for permanent implantation.
In one embodiment, the vessel plug includes a handle having a proximal end and a distal end. A flange is attached to the distal end of the handle. A tip, which extends distally beyond the flange, is shaped to engage the vessel opening to block blood flow. In certain embodiments, the handle may include a lumen that is closed at the distal end. A preformed mandrel, adapted for insertion into the lumen of the handle, may be used to adjust the angle of the tip relative to the handle, so that the contour of the plug and the tip may be manipulated to provide optimal insertion into the vessel or cavities.
In another embodiment, the plug may include a tip that is deformable to engage an interior of a vessel. Certain tip embodiments allow the deformation to be actuated by struts and a spring, an inflatable member, or a phase transition within a shape memory material. The tip may further operate to expand radially outward to engage the interior wall of a vessel.
In other embodiments, the flange is rectangular, oval, H-shaped, star shaped, ratchet shaped, or other geometric shapes. The flange allows the plug to be sutured onto the vessel or allows sutures be placed around the vessel opening. The flange may be flat, curved, tapered, or ridged to conform to the surface of a vessel. In another embodiment, the flange may be made of both stiff and soft material, optionally with adhesive on one surface to engage the wall of the vessel. Certain flange embodiments may include a plurality of suction ports, which operate to engage the vessel wall by vacuum, the ports communicating with a vacuum tube carried by the handle. During use, this flange is tightly bound to the vessel wall under negative pressure, thereby negating the need for sutures.
The methods of the present invention include maintaining hemostasis of a blood vessel having an opening using the sutureless vessel plug as described above. After an open wound on a blood vessel, such as an aorta, carotid artery, or vein, is located, the tip of the plug is inserted into the vessel opening, so that the flange engages the wall of the vessel, thereby blocking the flow of blood through the opening. The plug may be preformed and restrained prior to introduction via an introducer sheath. In embodiments that include a preformed mandrel, the methods further include the step of inserting the mandrel into a lumen of the handle to adjust the angle of the tip relative to the handle during insertion of the plug into the vessel opening.
It will be understood that there are several advantages in using the vessel plug as disclosed herein. For example, (1) the plug does not require suturing and may be self attaching or held in place; (2) the plug may be introduced remotely or directly onto a vessel; (3) the plug is space conserving; (4) vessel manipulation and deformation is minimized, thereby reducing risk of vessel damage and emboli generation; (5) the plug provides open access to the vessel near the insertion site; (6) the plug can be used in minimally invasive surgical procedures; and (7) the plug may be used to occlude body cavities other than vessels.
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Lilly Richard
Tsugita Ross S.
Chaudhuri Olik
Embol-X Inc.
Lyon & Lyon LLP
Trinh (Vikki) Hoa
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