Fluid sprinkling – spraying – and diffusing – Combining of separately supplied fluids – Including whirler device to induce fluid rotation
Reexamination Certificate
1998-12-18
2001-12-11
Scherbel, David A. (Department: 3752)
Fluid sprinkling, spraying, and diffusing
Combining of separately supplied fluids
Including whirler device to induce fluid rotation
C239S106000, C239S123000, C239S304000, C239S492000, C239S494000, C222S145500, C604S304000
Reexamination Certificate
active
06328229
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to the field of mixing and dispensing reactive components. In particular, the present invention relates to an apparatus and method for mixing and dispensing a plurality of fluid components that together form a tissue adhesive, such that clogging of the apparatus is avoided.
BACKGROUND OF THE INVENTION
A surgical adhesive is used in lieu of physical means, such as sutures or staples, to bind together two edges or sides of a laceration. Biologically and non-biologically based surgical adhesives are made by mixing a first reactive fluid component (e.g., fibrinogen) with a second reactive fluid component (e.g., thrombin), which react with each other to harden into the adhesive. Upon contact the two fluid components react relatively quickly, in the order of seconds, to harden into the tissue adhesive. If it is only partially mixed, the adhesive will not sufficiently harden over the entire area to which it is applied thus, resulting in weak spots. It is, therefore, desirable to apply a thoroughly mixed solution to the target site before the solution has gelled or hardened. Furthermore, it is desirable to minimize the amount of time required to thoroughly mix the fluid components together, thereby minimizing the amount of contact time between the two substances prior to delivery to the target site.
Several methods and devices exist for mixing and applying biologically based and synthetic tissue adhesives. One method is to directly apply a layer of the first fluid component to the target site, directly apply a layer of the second fluid component on top of the first fluid component layer, mechanically mix the two fluid components together using a surgical instrument and spread the mixed adhesive over the target area. A variation of this method is to premix the two fluid components, immediately thereafter draw the adhesive mixture into a delivery syringe and apply the mixture to the target site. Both of these methods suffer from multiple deficiencies, not the least of which is that it is very difficult to thoroughly mix the fluid components and apply the mixed adhesive before the adhesive begins to gel and harden, resulting in a nonuniform adhesive layer with weak spots.
More recent devices and methods utilize one device for bringing the fluid components together, mixing the fluid components and applying the mixed adhesive in either an aerosol or a stream form to the target site. The more recent devices and methods can be broken down into two general types: 1) devices that bring the two fluid components together, mix them within the device and then dispense the mixed adhesive; and 2) devices that separately atomize the two fluids outside the device such that the atomized fluids contact and mix together before being deposited on the target site.
An example of the first type is described in U.S. Pat. No. 4,735,616 to Eibl et al. This device has two parallel fluid component syringes fluidly connected to two channels that extend through a manifold into a mixing needle. The two fluid components flow through their respective channels and enter the mixing needle, where they contact for the first time. The high surface area within the mixing needle creates turbulents that cause the fluid components to become thoroughly mixed within the needle. A second example of this type of device is described in U.S. Pat. No. 5,116,315 to Copozzi et al. This device has two parallel fluid component syringes connected to one end of a Y-manifold and a mixing assembly detachably locked onto the second end of the Y-manifold. The mixing assembly has two separate and adjacent parallel channels, each separately fluidly connected to the two fluid component syringes, via the Y-manifold, and both of which terminate into a single annular channel within the mixing assembly. The annular channel is connected to a disk shaped mixing space having three inclined vanes disposed about an exit orifice. In use, the two fluid components pass through the Y-manifold, through the two separate parallel channels in the mixing assembly, through the singular annular channel, where the fluid components first contact and begin mixing, through the mixing space, where the fluid components impinge upon the vanes that impart a spiraling motion to the fluids causing the fluids to become thoroughly mixed, and out of the exit orifice in an atomized spray. A problem experienced with these types of devices is that they typically become clogged after a short period of non-use, because the un-ejected, mixed or partially mixed, adhesive hardens within the device.
An example of the second type of devices is described in U.S. Pat. No. 5,368,563 to Lonneman et al. Similar to the first type of devices, Lonneman et al. disclose a device having two parallel syringes connected to a manifold. However, the manifold has two separate exit orifices adjacent and in close proximity to each other. In use, the two fluid components exit from the corresponding exit orifices in a swirling atomized spray. The atomized fluid components mix with each other while airborne without the need for an internal mixing chamber. While the Lonneman et al. design alleviates the clogging problem of the first type of devices, it has been found that it does not adequately mix the two fluids, particularly at the peripheries of the two atomized spray cones, thus resulting in an adhesive layer having weak spots.
There thus remains a need in the art for a device that can thoroughly mix the reactive fluid components of a tissue adhesive and deliver the mixed adhesive to a target site without clogging after only a single use.
SUMMARY OF THE INVENTION
The present invention is directed towards an apparatus for mixing and ejecting a multi-component fluid mixture, such as a medical adhesive, which will not become clogged after only a single use. The device has a body portion having a mixing space defined therein. The mixing space is defined by at least an upper wall, a side wall and an exit orifice. The side wall defines at least two entry ports to the mixing space. The device further has at least two fluid component sources fluidly connected to the at least two entry ports and a means for forcing the at least two fluid components into the mixing space. The at least two fluid components separately enter the mixing space through the at least two entry ports; the side wall imparts rotational motion to the at least two fluid components; the at least two fluid components become thoroughly mixed into the multi-component fluid mixture; and the multi component mixture exits the mixing space from the exit orifice. Alternatively, a valve stem, with a distal end and a proximal end and movably extending through the body portion into the mixing space, may be provided. The distal end of the valve stem is configured and dimensioned to substantially occupy the mixing space when the stem is in a closed position. In the closed position the distal end seals the at least two entry ports and forces substantially all fluid components remaining in the mixing space out through the exit orifice. In the open position the distal end is withdrawn from the mixing space, thereby allowing the at least two fluid components to enter the mixing space as previously described.
REFERENCES:
patent: 2890836 (1959-06-01), Gusmer et al.
patent: 3563459 (1971-02-01), Kautz
patent: 3746216 (1973-07-01), Frederick
patent: 4377256 (1983-03-01), Commette et al.
patent: 4523696 (1985-06-01), Commette et al.
patent: 4735616 (1988-04-01), Eibl et al.
patent: 4867346 (1989-09-01), Faye et al.
patent: 5116315 (1992-05-01), Capozzi et al.
patent: 5368563 (1994-11-01), Lonneman et al.
patent: 5397059 (1995-03-01), Baudin
patent: 5478323 (1995-12-01), Westwood et al.
patent: 5501371 (1996-03-01), Schwartz-Feldman
patent: 5665067 (1997-09-01), Linder et al.
Lefebvre, 1989, “Atomization and Sprays”, Hemisphere Publishing Corporation, 105-117.
Duronio James
Schoenberg Stephen
Cohesion Technologies, Inc.
Nguyen Dinh Q.
Pennie & Edmonds LLP
Scherbel David A.
LandOfFree
Low volume mixing spray head for mixing and dispensing of... does not yet have a rating. At this time, there are no reviews or comments for this patent.
If you have personal experience with Low volume mixing spray head for mixing and dispensing of..., we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Low volume mixing spray head for mixing and dispensing of... will most certainly appreciate the feedback.
Profile ID: LFUS-PAI-O-2586414