Surgery – Instruments – Sutureless closure
Reexamination Certificate
2000-06-06
2002-08-27
Jackson, Gary (Department: 3731)
Surgery
Instruments
Sutureless closure
C604S015000, C604S264000, C604S265000
Reexamination Certificate
active
06440151
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The invention relates to a wound closure device, and more particularly, the invention relates to a device and method for facilitating hemostasis of a biopsy tract or other puncture wound by injection of an absorbable sponge.
2. Brief Description of the Related Art
Percutaneous needle biopsy of solid organs is one of the most common interventional medical procedures. Millions of percutaneous needle biopsies are performed annually in the United States and throughout the world. Percutaneous biopsy is a safe procedure which has supplanted surgical biopsy for many indications, such as skin biopsy and liver biopsy.
Possible complications of needle biopsy include bleeding at the biopsy site. The amount of bleeding is related to a number of factors including needle size, tissue sample size, patient's coagulation status, and the location of the biopsy site. Vascular organs such as the liver, a common biopsy target, may bleed significantly after needle biopsy. To minimize bleeding from a biopsy site, small-gauge needles are typically used. Small gauge needles, however, produce less satisfactory biopsy specimens but frequently are favored over larger bored needles because of their perceived safety. In order to minimize the chance of internal bleeding after biopsy, external pressure is applied and patients are often asked to lie in uncomfortable positions, such as the lateral decubitus position, for a number of hours, particularly after liver biopsy.
Sterile sponges, such as Gelfoam, are prepared in dry sterile sheets which are used as packing material during surgery for control of bleeding. The sponge sheets are left in the surgical site after surgery to stop bleeding and are absorbed by the body in 1 to 6 weeks. A number of techniques have used these absorbable sterile sponge materials to plug a biopsy tract to minimize or prevent bleeding. The absorbable sponge provides a mechanical blockage of the tract, encourages clotting, and minimizes bleeding though the biopsy tract. Despite the advantages of using absorbable sponge to plug a biopsy tract this technique has not achieved widespread use because of difficulty in preparing and delivering the sponge material into the biopsy tract.
One example of a biopsy wound closure device using an implantable sponge is described in U.S. Pat. No. 5,388,588. According to this patent, a circular sponge of an absorbable foam material is precut and inserted into a biopsy site by an applicator rod having the sponge positioned on the end. Once the sponge is implanted, the sponge absorbs blood and swells to fill the tract preventing further bleeding at the biopsy site. However, the sponge is difficult to deliver and expands slowly once delivered. In addition, this delivery method can only deliver a sponge of a limited size which provides less local compression than desired and may incompletely fill the target site.
Accordingly, it would be desirable to provide a device and method which will permit the delivery of an absorbable sponge to a biopsy tract in a simple and reliable manner.
SUMMARY OF THE INVENTION
The present invention relates to a device and method for facilitating hemostasis of a biopsy tract or other puncture wound by injecting an absorbable sponge. The system according to the present invention allows the sponge to be delivered in a hydrated state through the biopsy needle or other cannula directly into the puncture wound.
In accordance with one aspect of the present invention, a system for facilitating hemostasis of a puncture wound by injecting an absorbable sponge includes a cannula for delivering the absorbable sponge in the hydrated state to the puncture wound, an adapter connectable to the cannula, and a syringe for injecting fluid into the adaptor to hydrate and deliver the absorbable sponge. The adaptor includes a tapered lumen with a large diameter end and a small diameter end, wherein the small diameter end is connectable to the cannula.
In accordance with an additional aspect of the present invention, an adaptor for delivering a hydrated absorbable sponge to a cannula for facilitating hemostasis of a puncture wound includes an elongated member having a first end, a second end and a lumen extending from the first end to the second end. A luer connector is provided at the second end of the elongated member for connection to a cannula. A tapered section of the lumen tapers from a first diameter at the first end to a second diameter at the second end which is smaller than the first diameter such that a dry sponge pledget having a width larger than the second diameter is compressable, when hydrated, into the second diameter.
In accordance with a further aspect of the invention, a method of facilitating hemostasis of a puncture wound by injecting an absorbable sponge through a cannula into the puncture wound includes the steps of inserting a pledget of an absorbable sponge into an adaptor having a tapered lumen with a large diameter end and a small diameter end; hydrating the pledget by injection of fluid into the adaptor; connecting the adaptor to a cannula; and delivering the hydrated absorbable sponge through the cannula to facilitate hemostasis of the puncture wound.
In accordance with an additional aspect of the present invention, a method of facilitating hemostasis of a biopsy tract includes steps of removing a tissue biopsy through a cannula, and injecting a hydrated absorbable sponge pledget through the cannula without fully removing the cannula from the biopsy tract to facilitate hemostasis of the biopsy tract.
According to another additional aspect of the present invention, a kit for facilitating hemostasis of a puncture wound includes a pledget forming device, an adaptor connectable to a cannula for hydrating and delivering an absorbable sponge pledget to the cannula, the adapter having a tapered lumen with a large diameter end and a small diameter end, wherein the small diameter end is connectable to the cannula, and a syringe connectable to the adaptor for delivering fluid to the adaptor.
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Ashby Mark
Brenneman Rodney
Cragg Andrew H.
Jackson Gary
Kreba Robert E.
Sub-Q Inc.
Thelen Reid & Priest LLP
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