Surgery – Instruments – Sutureless closure
Reexamination Certificate
1999-06-17
2001-02-06
Buiz, Michael (Department: 3731)
Surgery
Instruments
Sutureless closure
Reexamination Certificate
active
06183497
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The invention relates to an absorbable sponge, and more particularly, the invention relates to the delivery of a contrasting agent to a specific area or site in a mammal after a surgical or interventional procedure. The contrasting agent facilitates the location of the area or site even weeks or months after the initial procedure.
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.
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. 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.
During the biopsy, a mechanic clip device is often attached to the site where tissue is removed, so that if further treatment is later required the location of the site can be identified. Unfortunately, the time period between the biopsy and treatment may be weeks during which time the clip may become dislodged thereby making it difficult to relocate the site.
Accordingly, it would be desirable to provide a reliable technique for identifying biopsy sites or puncture wound sites.
SUMMARY OF THE INVENTION
The present invention is based in part on the discovery that adding a contrasting agent (e.g, radiopaque agent) to an absorbable sponge provides for a material that not only facilitates hemostasis of a biopsy tract or other puncture wound but also permits precise identification of the site's location.
Accordingly, in one aspect, the invention is directed to a method for marking a bodily site in a patient that includes the steps of:
identifying the bodily site; and
positioning a pledget of absorbable sponge material adjacent the bodily site wherein the absorbable sponge material includes a contrasting agent.
With the present invention, the exact location of the bodily site can be located many weeks or longer following positioning of the absorbable sponge material.
In another aspect, the invention is directed to a method for performing a biopsy that included the steps of:
removing tissue from a vascular tissue site; and
positioning a pledget of absorbable sponge material adjacent the vascular tissue site wherein the absorbable sponge material includes a contrasting agent.
In another aspect, the invention is directed to a liquid permeable, absorbable, gelatin sponge that is prepared by a process that includes the steps of:
(a) preparing an aqueous gelatin solution;
(b) adding an organic solvent in the aqueous gelatin solution to form a second solution;
(c) incubating the second solution;
(d) forming a foam from the second solution wherein a contrasting agent is added to the second solution at any step prior to forming the foam; and
(e) drying the foam.
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Ashby Mark
Chi Sing Eduardo
Buiz Michael
Burns Doane Swecker & Mathis L.L.P.
Sub-Q Inc.
Trinh (Vikki) Hoa B.
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