Surgery – Instruments – Sutureless closure
Patent
1995-02-16
1997-02-11
Schmidt, Jeffrey A.
Surgery
Instruments
Sutureless closure
604 12, 604 73, 604 82, 604164, 604264, 604280, A61B 1700
Patent
active
056016034
DESCRIPTION:
BRIEF SUMMARY
BACKGROUND OF THE INVENTION
1. Field of the Invention
This invention relates to the use of endogenous blood coagulants obtained from plasma protein in the form of a two-component fibrin sealant, said components being mixed at the instant they are delivered.
This invention also relates to a device for introducing the two-component fibrin sealant into a puncture channel in the vicinity of an arterial or venous puncture point.
2. Description of Prior Art
Many operations in human or veterinary medicine require puncturing of vessels. With percutaneous transluminar coronary angioplasty (PTCA), heart operations and catheterizations of the heart, in particular, it is necessary to close the punctured vessels again with great care. In most cases, this is performed by direct compression of up to one hour and a compression bandage which must be applied up to 24 hours and requires hospitalization of one to two days. Accordingly, there is the desire to find a means for a more rapid and secure closure of the puncture point.
A method by the name of Vasoseal was introduced during a meeting of the American Heart Association on 17 Nov. 1992 in New Orleans. In accordance with this method, two collagen plugs made of bovine collagen are pushed into the puncture channel as far as the puncture point. It was noted during the meeting that, besides the somewhat rare rejection reaction of the exogenous collagen, there are various other disadvantages or risks. It was also noted that this system is ineffective in many cases and that there is a certain danger of emboli. In approximately 46% of all cases, hematomas of an order of magnitude between 2 to 6 cm were formed. Weeks or months go by before the bovine collagen is completely resorbed. In addition, the method leads to increased scar formation which makes an ultrasonic examination more difficult. Finally, although hospitalization did not become superfluous, it was reduced by at least 24 hours. However, one of the most essential problems lies in the handling, that is, the introduction of the collagen plugs into the puncture channel. Because it is necessary to push two collagen plugs successively into the puncture channel, the user finds the penetration depth, for example, hard to determine. If the collagen plugs are pushed in too deeply, the collagen plug may be pushed through the puncture point into the vessel, resulting in an obstruction in the vessel or the vessel itself being pushed closed.
SUMMARY OF THE INVENTION
Accordingly, it is an object of this invention to provide a novel method for closing such puncture points rapidly, dependably and without the above mentioned disadvantages.
It has been shown that when endogenous blood coagulants obtained from plasma protein in the form of a two-component fibrin sealant, whose components are mixed at the instant they are delivered, are used, and this mixture is introduced into a puncture channel as close as possible to a vessel during or directly following an intravascular intervention, an optimal vessel seal is created. Histological tests have proven these facts.
It is a further object of this invention to provide a device by which fibrin sealant can be introduced into a puncture channel in the vicinity of an arterial or venous puncture point.
These and other objects are attained by a device in accordance with one embodiment of this invention comprising a sealing cannula through which a work cannula passes axially from top to bottom, wherein the work cannula which is used for the intravascular introduction of an instrument into a vessel is surrounded at a distance by the sealing cannula, so that the fibrin sealant is conducted between the sealing cannula and the work cannula from a connector to at least one radially oriented outlet opening in the sealing cannula.
BRIEF DESCRIPTION OF THE DRAWINGS
These and other features and objects of this invention will be better understood from the following detailed description taken in conjunction with the drawings wherein:
FIG. 1 is a side view of the device in accordance with one embodime
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Schmidt Jeffrey A.
White Spot AG
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