Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
2001-07-26
2004-04-20
Mendez, Manuel (Department: 3763)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
C604S191000, C222S135000, C222S145400, C222S145500
Reexamination Certificate
active
06723067
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
Applicant's invention relates to an apparatus for delivering a biocompatible adhesive, more particularly aerosolized fibrin, endoscopically to a wound.
2. Background Information
Endoscopy is a surgical technique that involves the use of an endoscope, a special viewing instrument that allows a surgeon to see images of the body's internal structure through very small incisions. The endoscope itself consists of two basic parts. The first is a tubular probe fitted with a tiny camera and a bright light which is inserted through the small incision and the second is a viewing screen which magnifies the transmitted images of the body's internal structures from the camera. During surgery, the surgeon watches the screen while moving the tube of the endoscope through the surgical area. The endoscope functions as a viewing device only. To perform the surgery, a separate surgical instrument, such as a scalpel, scissors, or forceps, must be inserted through a different point of entry and manipulated within the tissue.
In a typical endoscopic procedure only a few small incisions, each preferably less than one inch long, are needed to insert the endoscope tube and other instruments. Since the incisions are shorter with endoscopy, the risk of sensory loss from nerve damage is decreased. Also, bleeding, bruising and swelling may be significantly reduced.
However, with these advantages it is still necessary, as with traditional long incision surgery, that a fibrin glue be used at the surgical site to hold the tissue together for healing promoting hemostasis and sealing of air leaks. Fibrin in the human body is the product of an activated coagulation system. It is an insoluble protein formed in the extravascular space from fibrinogen by the proteolytic action of thrombin during the normal clotting of blood.
Fibrin glue delivery systems that mimic this natural body process exist for traditional long incision surgery. Typically in these systems, the thrombin and fibrinogen are kept in separate containers. When the fibrin glue seal is needed to seal a surgical site, preferably equally amounts of the fibrinogen and thrombin are combined and the enzymatic action of the thrombin on the fibrinogen forms the fibrin. The reaction is nearly instantaneous. Due to the reaction kinetics, both the delivery and mixing of the precursor fibrin components to the wound or surgical site must occur rapidly and accurately before the reaction occurs to form the fibrin.
This rapid rate of reactivity to form the fibrin does not typically present difficulties when applied to traditional long incision surgery, but does present a problem in endoscopic surgeries. Sealing a surgical site with a fibrin glue after endoscopic surgery requires delivering the fibrin endoscopically through a small surgical incision, over an enclosed distance underneath the skin, for ultimate delivery to a remote surgical site. Unfortunately, none of the existing fibrin delivery systems appear to be able to accommodate delivery of aerosolized fibrin endoscopically to a remote surgical site. Aerosolized fibrin mixes the two components (thrombin and fibrinogen) more effectively than existing endoscopic delivery systems. The more effective the mixing, the more effective the glue (sealing action). The present invention was designed to satisfy this long felt need of a more effective (fibrin) biologic sealant in endoscopic surgery.
SUMMARY OF THE INVENTION
It is an object of the present invention to provide a novel apparatus for delivering aerosolized fibrin endoscopically to a wound.
It is another object of the present invention to provide a novel apparatus for delivering aerosolized fibrin endoscopically to a wound having a novel mixing chamber.
Yet another object of the present invention is to provide a novel apparatus for delivering fibrin endoscopically to a wound that incorporates a carrier gas (CO
2
or nitrogen, etc.) to convert the fibrin precursor solutions into aerosolized solutions which are mixed more efficiently and create a more effective sealant.
Another object of the present invention is to provide a novel apparatus for delivering fibrin endoscopically to a wound that incorporates a specialized mixing chamber for the carrier gas with the separate fibrin precursors.
It is another object of the present invention to provide a novel apparatus for delivering fibrin endoscopically to a wound that permits a surgeon to introduce an aerosolized fibrin seal into a remote endoscopic surgical site.
Still another object of the present invention is to provide a novel apparatus for delivering fibrin endoscopically to a wound that alleviates the risk of the aerosolized fibrin precursors reacting prematurely to form fibrin while still within the delivery tube which would clog the tube.
An additional object of the present invention is to provide a novel apparatus for delivering aerosolized fibrin endoscopically to a wound that carries the fibrin precursor solutions through the delivery tube before they react to form fibrin.
In satisfaction of these and related objectives, Applicant's present invention provides for an apparatus for delivering aerosolized fibrin endoscopically to a wound. Applicant's invention permits its practitioner to introduce an aerosolized fibrin seal into a remote endoscopic surgical site without the risk of the fibrin precursors combining prematurely within the the delivery tube. Aerosolization provides for better mixing of the fibrin precursors (thrombin and fibrinogen) which creates more effective fibrin for sealing air leaks and hemostatis.
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Evans Michelle
Gunn & Lee , P.C.
Han Mark K.
Mendez Manuel
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