Thromboplastic system

Details Thromboplastic system Thromboplastic system

2000-09-26

2002-09-10

Russel, Jeffrey E. (Department: 1653)

Drug, bio-affecting and body treating compositions

Preparations characterized by special physical form

Web, sheet or filament bases; compositions of bandages; or...

C128SDIG008, C604S290000, C604S306000

Reexamination Certificate

active

06447799

ABSTRACT:

BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to systems for accelerating the clotting of blood. More particularly, the present invention relates to a foam pack kit for applying thrombin or a similar clotting agent to a wound.
2. Description of the Prior Art
Every week, 360,000 Americans undergo hemodialysis three (3) times a week. Most, if not all, of those patients have a tube under the skin to establish a fluid transfer path. In order to complete the flow path through the dialysis machine, two openings or wounds must be made in the patient in order to connect the tube to the machine. Specifically, the tube, sometimes referred to as a graft, connects an artery and vein. The connection, when pressurized, creates an artificial high-flow conduit that can be repeatedly punctured with large bore needles to allow dialysis. In many other cases, a surgical connection is established between the artery and vein. The surgical connection is known as a fistula. It accomplishes substantially the same function as the graft. Therefore, on the three-per-week dialysis schedule, each patient must be accessed through graft or fistula openings six times per week.
The graft and fistula structures function nearly at systemic blood pressure. Therefore, when they are removed, considerable bleeding occurs. Traditionally, fingertip pressure is applied by healthcare personnel, in some cases for a minimum of 10 minutes, and often longer, in order to stem the bleeding. Under repeated dialysis procedures, the fistula and grafts may not easily be re-opened in that they often become clotted or narrowed. It therefore becomes necessary to use larger bore needles and tubes to establish an appropriate fluid pathway. The larger wounds associated with these larger openings often translate into longer time periods to halt bleeding when the devices are removed.
Isolated efforts have been made to improve the hemostasis process. In one instance, the present inventor developed and employed in limited circumstances in some healthcare facilities, a system for that purpose. Initially, the effort involved simply applying a gelatin foam sponge to the wound site, with pressure, to accelerate hemostasis, or clotting, at the puncture site. This reduced the time to clotting, but the time required was still considerable. Recently, thrombin, a protein agent that accelerates clotting, was added to the sponge. The particular system involves cutting the sponge and applying to that sponge a mixture of the two components used to create the commercially available thrombin. The combination results in a gel-like solid structure that may be applied directly to the wound. The combination accelerates the clotting very well. In addition, a small square of a non-stick gauze pad, such as a Telfa™ pad, may be placed on the surface of the foam/thrombin combination to prevent unintended sticking of the foam prior to application to the wound.
Unfortunately, while the combination described above works well as a thromboplastic system, it is a jury-rig arrangement requiring as much or more time to make as it does to clot the blood using hand pressure. Moreover, there may be inconsistency in the amount of thrombin applied to the foam, the adequacy of the size of the foam pad, and the opportunity to forget the application of the non-stick pad. Therefore, what is needed is a ready-to-use system for conveniently and adequately establishing hemostasis, whether after a dialysis procedure or in regard to clotting any wound. Also, given the scope of the problem—many thousands of wounds daily throughout the world requiring clotting—such a system must be relatively inexpensive to obtain and relatively easy to use.
SUMMARY OF THE INVENTION
In view of the foregoing, it is an object of the present invention to provide a ready-to-use system for conveniently and adequately establishing hemostasis in a wound. It is also an object of the invention to provide such a thromboplastic system that is relatively inexpensive to obtain and relatively easy to use.
These and other objects are achieved with the present invention, which is a three-part kit for establishing hemostasis. The kit includes a pre-packaged combination of the sponge foam, pre-cut into an array of selectable sizes, to which the non-stick gauze is attached. A thrombin-containing device, such as a small blister or tear-through bubble pack, is included in the kit. It may be affixed to the side of the foam that is not coupled to the gauze. Alternatively, two small blisters or packets may be affixed to that side of the foam; one packet containing lyophilized (freeze-dried) thrombin and the other a thrombin diluent.
In the process associated with use of the present system to protect a wound, either the single thrombin-containing device is opened, or the two bubbles are pinched or pressed together and mixed. The thrombin or the thrombin/diluent mixture then enters the foam directly to create a gel/foam combination that may be applied directly to the wound. Pressure is then applied to the gauze side that does not stick to the pressure-applying structure. That structure may be a sterile stick or a healthcare provider's covered fingers.
The present invention eliminates the need to have three different products, the need to cut individual foam and gauze pieces, and the need to obtain and manipulate a thrombin bottle. It also eliminates the need to stick a syringe under sterile conditions into the bottle, pull it out, squirt the thrombin onto the foam, make a sandwich with the gauze and only after all that stick the combination on the wound. The present invention reduces supplies, waste, and accidental needle sticks. Given the cost of the individual components, the kit would be relatively inexpensive in comparison to the excess materials and healthcare provider's time involved in making each part.
In summary, the present invention is a self-contained small packet or kit with one or more pieces of an absorptive foam, one side of which is backed with a non-stick material, such as gauze, to reduce adherence on the opposing side, and one or more breakably sealed blisters on the other side. The blister or blisters are manipulated to activate the thrombin reagent and deliver it to the foam. The impregnated foam may then be applied to the wound site.
These and other advantages of the present invention will be understood upon review of the drawings, the detailed description, and the appended claims.


REFERENCES:
patent: 3580254 (1971-05-01), Stuart
patent: 4292972 (1981-10-01), Pawelchak et al.
patent: 4363319 (1982-12-01), Altshuler
patent: 4453939 (1984-06-01), Zimmerman et al.
patent: 4899739 (1990-02-01), Konishi

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