Surgery – Instruments – Sutureless closure
Reexamination Certificate
1998-12-01
2001-09-11
Recla, Henry J. (Department: 3731)
Surgery
Instruments
Sutureless closure
C606S213000
Reexamination Certificate
active
06287323
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
This invention relates to a method and an associated device for sealing a puncture in a vessel within mammals. In particular, the invention relates to a method and an associated device for delivering a sealant patch and/or tissue adhesive to seal a puncture in a vessel.
2. Description of Related Art
Percutaneously accessing major vascular structures is a key step in a variety of diagnostic and therapeutic procedures, including Percutaneous Transluminal Coronary Angioplasty (PTCA), Percutaneous Coronary Angiography and Percutaneous Coronary Atherectomy. After the procedure is completed, the instruments used to perform the procedure are withdrawn from the vessel leaving a potential source of bleeding.
The most common method used to prevent post-procedure bleeding at the access site involves the application of direct pressure to the perforation site until normal physiologic pathways have sealed the access site. There are several problems with this method. First, the pressure application technique may fail to prevent hemorrhage. Such a hemorrhage may be life-threatening hemorrhage or lead to a large hematoma. A large hematoma in the groin, for instance, may compromise the major nerve supply to the anterior lower extremity.
Secondly, the pressure application technique extends the length of the in-hospital stay. For example, a PTCA may be completed in 2 to 3 hours, but the patient will typically be hospitalized for several additional hours or overnight, simply to allow the access site to seal physiologically. During this extended hospital stay the patient is required to stay immobile, often with a sand bag taped to his thigh (in the case of femoral artery access).
These complication are exacerbated where PTCA procedures are performed in elderly patients which commonly have arteries with reduced natural elasticity. The access perforation in a relatively inelastic artery does not contract or shrink upon itself to the same extent that would occur with an artery of normal elasticity. The resulting, undeflected perforation in a relatively inelastic artery typically is two to three times larger than an access perforation in a normal artery, further complicating the initiation of hemostasis and the normal physiologic sealing of the access site.
More than 500,000 PTCAs were performed worldwide in 1992(Cowen Report, March 1993), as well as several times that number of other procedures requiring accessing major vascular structures percutaneously. Thus, the increased length of in-hospital stay necessitated by the pressure application technique considerably increases the expense of procedures requiring such vascular access.
A technique that would allow faster and safer sealing of a vascular access site would save a significant amount of health care resources. There remains a need for such a technique.
SUMMARY OF THE INVENTION
There is provided in accordance with one aspect of the present invention a method of sealing a vascular perforation. The method comprises the steps of providing a patient having a vascular perforation and a tubular access catheter extending through the perforation and into the vessel. The access catheter is proximally withdrawn until a distal end of the catheter is positioned inside the patient but outside of the perforation adjacent the vessel. A vascular patch is introduced into the proximal end of the access catheter, and the patch is advanced distally through the catheter. The patch is thereafter positioned against the vessel wall to seal the perforation.
Preferably, the method further comprises the step of monitoring blood pressure through the access catheter during the proximally withdrawing the access catheter step. The proximally withdrawing the access catheter step preferably is accomplished while monitoring blood pressure at the distal tip of the access catheter. An abrupt drop in blood pressure indicates that the distal end of the access catheter has been withdrawn through the perforation, and is positioned adjacent the outside wall of the vessel.
In accordance with a further aspect of the present invention, there is provided an alternate method of sealing a vascular perforation. The method comprises the steps of providing a patient having a vascular perforation and a guidewire extending therethrough. A bioabsorbable sealing tube having a central guidewire lumen extending therethrough is provided. The sealing tube is mounted coaxially on the guidewire, and advanced distally over the guidewire until a distal end of the sealing tube encounters resistance to further distal progress as a result of the vessel wall. Preferably, the sealing tube is gently pressed against the vessel wall for a sufficient period of time to seal the vascular perforation, and the guidewire is withdrawn from the patient.
In accordance with a further aspect of the present invention, there is provided a method of percutaneous transluminal coronary angioplasty or angiogram and inhibiting arterial bleeding at the arterial perforation site following the procedure. The method comprises the steps of perforating an artery to provide access to the arterial system, and advancing an introducer sheath through the perforation and into the artery.
An angioplasty catheter is introduced through the introducer sheath and into the artery. The catheter is advanced to a preselected treatment site and the site is treated with the catheter.
The catheter is thereafter withdrawn from the artery, and the introducer sheath is withdrawn from the perforation but left in position against the outside wall of the artery to provide access to the outside wall of the artery surrounding the perforation. A patch having a tissue adhesive thereon is thereafter advanced through the introducer sheath and placed against the wall to seal the perforation.
Further features and advantages of the present invention will become apparent from the detailed description of preferred embodiments which follow when considered together with the attached drawings and claims.
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Hemodynamics, Inc.
Knobbe Martens Olson & Bear LLP
Ngo Lien
Recla Henry J.
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