Surgery – Instruments – Suture – ligature – elastic band or clip applier
Reexamination Certificate
2000-11-15
2003-11-04
Vanatta, A. (Department: 3765)
Surgery
Instruments
Suture, ligature, elastic band or clip applier
Reexamination Certificate
active
06641592
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to a system (method and apparatus) for wound closure, and in particular to a system for vascular wound closure utilizing a tissue suturing apparatus and a suture securing apparatus. The invention is suitable for applying at least one suture to close a wound, such as a puncture hole in a blood vessel, after an intravascular catheterization procedure. The invention is also suitable for applying a suture to a wound in other bodily tissue, such as the bowel. The term wound generally refers to herein to a hole, puncture, or any opening in tissue requiring closure.
BACKGROUND OF THE INVENTION
When performing catheterization procedures, such an angiography or angioplasty, a catheter is generally introduced percutaneously (i.e., through the skin) into the vascular system by first penetrating the skin and underlying tissue, and then the blood vessel with a sharpened hollow needle. Location of a blood vessel, such as an artery, is typically achieved by feeling for the pulse, since such structures usually cannot be seen through the skin. Next, a guide wire is commonly inserted through the lumen of the hollow needle and is caused to enter the selected blood vessel. Subsequently, the needle is typically slid off the guide wire and a combination of a dilator and sheath are fed over the guide wire and pushed through the skin to enter the vessel. The guide wire and dilator can then be removed and the desired catheter to carry out the procedure is fed through the lumen of the sheath and advanced through the vascular system until the working end of the catheter is appropriately positioned. Following the conclusion of the catheterization procedure, the working catheter will be withdrawn and, subsequently, the sheath can also be removed from the wound, or left in place to facilitate closure.
At this point in the procedure, the vessel leakage must be controlled in order to stem the flow of blood through the puncture. Because it is common practice to administer a blood thinning agent to the patient prior to many of the catheterization procedures, stemming the blood flow can be troublesome. A common method of sealing the wound is to maintain external pressure over the vessel until the puncture naturally seals. This method of puncture closure typically takes at least thirty minutes, with the length of time usually being substantially greater if the patient is hypertensive or anti-coagulated. In some anti-coagulated patients, the sheath is left in place for hours to allow the anti-coagulant to wear off. When human hand pressure is utilized, it can be uncomfortable for the patient and can use costly professional time on the part of the hospital staff. Other pressure techniques, such as pressure bandages, sandbags or clamps, have been employed, but these devices also require the patient to remain motionless for an extended period of time and the patient must be closely monitored to ensure their effectiveness.
Other devices have been disclosed which plug or otherwise provide an obstruction in the area of the puncture. See, for example, U.S. Pat. Nos. 4,852,568 and 4,890,612, wherein a collagen plug is disposed in the blood vessel opening. When the plug is exposed to body fluids, it swells to create a block for the wound in the vessel wall. A potential problem of plugs introduced into the vessel is that particles may break off and float downstream to the point where they may lodge in a smaller vessel, causing an infarct to occur. Collagen material also acts as a nidus for platelet aggregation and, therefore, can cause intraluminal deposition of hemostatic agent, thereby creating the possibility of a thrombosis at the puncture sight. Other plug-like devices are disclosed, for example, in U.S. Pat. Nos. 5,342,393, 5,370,660 and 5,411,520.
Surgical clips and clip appliers are known have also been used in vascular surgery, particularly to join severed vessels. For example, U.S. Pat. No. 4,929,240 describes clips generally arcuate in shape, which have two legs that are biased towards each other by clip applier jaws to capture vessel tissue therebetween. While vascular clips have been successfully used in surgery, the surgical procedures in which the clips are typically used allow the surgeon to view the area to be clipped. In catheter puncture repair procedures, however, the wound is generally not visible, making proper clip application, if attempted, difficult.
The use of suturing instruments to close a puncture at the end of a tissue tract is disclosed in U.S. Pat. No. 5,368,601, wherein one of the instruments has a pair of needles, with the tips or points of the needles oriented in a proximal direction, releasably disposed at a distal end thereof. Once in the puncture wound, the instrument is activated to expose the needles. Thereafter, proximal movement of the instrument causes the needles to pass through the wound edge (from the inside to the outside) on either side of the puncture and the needles are withdrawn. A strand of suture material secured between the blunt ends of the needles is also drawn through the needle puncture holes, thereby leaving a span of suture across the hole on the inside of the vessel. The suture can then be tied to close the puncture. A disadvantage to this approach is the potential for needles to deflect in undesirable directions, and the potential difficultly of retrieving the needle tips. Also, the instruments used in this approach are relatively complex, may be unreliable in small sizes, and are costly to manufacture. A similar instrument is also described in U.S. Pat. No. 5,417,699.
Another suturing instrument is described in U.S. Pat. No. 5,431,666 having a pair of longitudinally movable needles to pick up corresponding ends of suture at a distal end of the instrument. A needle capture mechanism provides two needle receiving portions, called ferrules, having a strand of suture material disposed therebetween, which are initially separated from the needles by a single gap in the instrument. In use, tissue to be sutured is disposed in the gap between the needles and the two needle receiving portions called ferrules. A first needle punctures the tissue, engages one end of the suture, and draws it back through the tissue. The instrument can then be relocated to another portion of tissue and the second needle is actuated to pick up and draw the second end of the suture through the tissue. The suture material can then be tied or otherwise cinched in place to secure the tissue closed. In using this instrument, the surgeon is typically able to view the surgical site.
Typically, the user, such as a surgeon or interventional cardiologist, cannot directly view the percutaneous vascular wound that would otherwise facilitate suture placement on opposite sides of the puncture wound. U.S. Pat. No. 5,766,183 describes a suture instrument for vascular wound closure in which the user does not need to view the wound. The suture instrument has a pair of longitudinally movable needles to pick up corresponding suture ends at a distal end of the instrument. As in U.S. Pat. No. 5,431,666, the strand of suture material can have ferrules at each end. To suture the vascular wound, the instrument is placed through a sheath immediately above vascular wound, or through a tissue tract larger than the vascular wound. One side of the tissue near the wound is punctured by a first needle which engages a ferrule and drawn back through the tissue with the ferrule. The instrument is then rotated to puncture the vascular tissue near another side of the wound with a second needle, which engages the other ferrule and drawn back through the tissue with the other ferrule. After the suture is in place, the instrument is withdrawn leaving the suture behind. Another instrument crimps a sleeve member over the free ends of the suture near the wound and cuts the suture such that the wound is secured closed.
One drawback of the suture instrument of the U.S. Pat. No. 5,766,183 is that since the user does not directly view the site of the vascular wound to be closed, it can
Hammond John F.
Sauer Jude S.
Cantor & Colburn LLP
LSI Solutions, Inc.
Vanatta A.
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