Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
2002-01-14
2004-08-10
Casler, Brian L. (Department: 3763)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
C604S070000, C606S213000
Reexamination Certificate
active
06773414
ABSTRACT:
CROSS REFERENCE TO RELATED APPLICATIONS
This application claims priority from Swedish Patent Application No. 0100091-8, filed Jan. 12, 2001, the content of which is incorporated herein by reference in its entirety.
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates in general to a device for dispensing at least two mutually reactive components. In particular, but not exclusively, the present invention is related to a device for applying an accurately mixed solution of reactive sealant components, such as fibrinogen and thrombin, to biological tissue, for example for effecting hemostasis or for achieving any other therapeutic objective.
The invention also relates to a method for dispensing at least two mutually reactive components.
2. Description of Related Art
Various kinds of apparatuses are known for applying a two-component sealant mixture of fibrin or fibrinogen and thrombin to a human tissue in order to stop bleeding or to close blood vessels.
For example, U.S. Pat. No. 5,322,510 discloses an injection-type apparatus for injecting at least two mutually reactive sealant components, wherein the apparatus comprises a hollow needle member having parallel, coaxially extending or side-by-side arranged lumens for each sealant component. The components are supplied to the injection needle through a corresponding number of hoses, which, at a proximal end thereof, are provided with syringe coupling connections for the supply of the respective reactive components. The distal end orifices of the lumens all lie in a common plane so that a mixing and a reaction of the components will commence as they emerge therefrom thereby forming a fibrin glue at the site of delivery. However, due to the fact that the number of outlet lumens are equal to the number of reactive components to be mixed, an optimal or sufficient mixing of the components will not always be ensured.
Many previously known devices for dispensing a mixture of various fluids, i.a. reactive liquids and gaseous media, (see, e.g., WO 97/17133, WO 00/18469, SE-B-432 059) are provided with at least two primary inlet channels for supplying respective fluids to be mixed to a mixing member which divides the fluid streams from the primary inlet channels into a plurality of smaller secondary fluid streams, which may cross each other at outlet orifices of the mixing member so as to be efficiently mixed in a separate mixing chamber downstream thereof before the mixture is delivered to the site of its application. However, in such devices clogging may occur in the mixing chamber and at the outlet opening thereof between the cycles of application, which necessitates either an ejection of the solidified material therein or a removal and change of the tip end piece before it can be reused.
EP 0 858 775 A1 discloses a fibrin sealant applicator (
FIG. 15
) for mixing two different fluid components, one supplied through a plurality of radially inwardly directed holes of a circular conduit, and the other supplied through a single axial orifice of a central conduit. This structure does not have a distributor between each primary component supplying channel and respective secondary component discharging channels, wherein each distributor multiplies the number of respective primary channels with at least a factor 2, such that adjacent ones of the secondary channels are adjoined to primary channels intended for supply of reactive components of different kind.
SUMMARY OF THE INVENTION
An object of the present invention is to solve the above-mentioned problems of the previously known devices and to provide an improved two- (or more) component applicator which is capable of dispensing a plurality of discrete adjacent streams of the components and to bring the same to be accurately mixed and cured at target site of application on various occasions and at timely spaced intervals without any clogging problems occurring at the outlet of the device.
According to the present invention these problems are solved by a device for dispensing at least two mutually reactive components, such as fibrinogen and thrombin, comprising a component supplier having a primary channel for supplying a respective one of said at least two reactive components to a component dispenser having secondary channels for separately discharging said reactive components at a distal end orifice thereof opening into a free target area for external intimate mixing of the respective reactive components outside a distal tip end of said dispenser, wherein a distributor is interposed between said supplier and said dispenser for multiplying the number of the respective primary channels with at least a factor 2, and adjacent ones of said secondary channels are adjoined to primary channels intended for supply of reactive components of different kind.
The method of the present invention for dispensing at least two mutually reactive components so as to allow for an intimate and accurate mixture and reaction thereof upon reaching a target site for their application is characterized by the steps of: feeding a primary flow of said at least two reactive components through respective primary conduits, and dispensing through distal end orifices of secondary conduits a plurality of secondary flows of said reactive components, derived from each of said primary flows of reactive components, in a pattern such that different reactive components are dispensed in close proximity through adjacent secondary conduit end orifices.
Other features and structural details of the device and the method of the present invention are disclosed in the following description and set forth in the accompanying dependent claims with reference to the attached drawings.
REFERENCES:
patent: 4978336 (1990-12-01), Capozzi et al.
patent: 5605541 (1997-02-01), Holm
patent: 5800538 (1998-09-01), Slepian et al.
patent: 6033427 (2000-03-01), Lee
patent: 6179862 (2001-01-01), Sawhney
patent: 6331172 (2001-12-01), Epstein et al.
patent: 6475182 (2002-11-01), Hnojewyj et al.
patent: 0 424 068 (1991-04-01), None
patent: 0 858 755 (1998-08-01), None
patent: WO 96/39212 (1996-12-01), None
Biovitrum AB
Casler Brian L.
Fish & Richardson P.C.
Maiorino Roz
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