Apparatus for establishing and maintaining a positive...

Surgery – Respiratory method or device – Means for supplying respiratory gas under positive pressure

Reexamination Certificate

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Details

C128S202120, C128S202160, C128S849000, C604S290000, C600S021000

Reexamination Certificate

active

06199551

ABSTRACT:

BACKGROUND OF THE INVENTION
1. Field of the Invention
This invention relates to a surgical apparatus which functions during surgical procedures to reduce blood loss that would otherwise normally occur from cut or similarly exposed blood vessels, especially veins and capillaries by imposing upon these capillaries an amount of air pressure sufficient to interfere with the passage of blood through and out of the damaged blood vessels.
2. Description of the Related Art
Currently there exist several techniques and apparatuses which are used to aid in decreasing blood loss during surgical procedures. Primary of these are the bulky and intrusive direct pressure means which usually consist of the application of direct physical pressure upon a wound by the surgeon's hand, gauze, or bandage. In addition techniques exist which provide for the cauterization and ligation of blood vessels.
One such means for applying direct pressure to a wound is known as a M.A.S.T. suit which is most commonly used as a military anti-shock trouser. This device is essentially an inflatable trouser which is most commonly placed over the lower two-thirds of a person. Once in place, the trouser is inflated to a predetermined pressure thereby preventing further blood loss from the wounded member and squeezing blood from the peripheral to the central blood system. Unlike the present invention, the M.A.S.T. suit does not provide for the additional ability to access the wound site by a surgeon or other medical personnel. Before the wound can be further accessed for proper dressing or additional medical procedures the anti-shock trouser must be deflated and removed, thus allowing the bleeding to begin anew.
Several well-known methods exist for establishing a chamber that increases the barometric pressure within the chamber. Such chambers, most notably the various hyperbaric chambers as disclosed by Gamow et al. in U.S. Pat. Nos. 5,109,837; 5,467,764 and 5,398,678, create a generally short term sealed high pressure environment suitable for an individual to sleep in or to alleviate the conditions associated with high altitude environments commonly known as mountain sickness. In these chambers, the entire patient is inside the chamber and the increased pressure, being system-wide has no effect on bleeding control. U.S. Pat. No. 4,550,713 discloses a system for preventing deformation of an eye when incised that includes a ring sewn to the eye and a means to raise the pressure at the eye to counteract the pressure within the eye.
The present invention overcomes the shortcomings of these prior art methods by providing increased air pressure to be placed on the wound site of the individual contained in an enclosure or around the entire surgical suite, by means of a gas pressure field which limits blood loss. Furthermore, the present invention provides for a means to regulate and provide a variety of gases at various flow rates and mixtures. Also the present invention provides for a means to allow individuals to readily pass into and out of the enclosure.
The art described in this section is not intended to constitute an admission that any patent, publication or other information referred to herein is “prior art” with respect to this invention, unless specifically designated as such. In addition, this section should not be construed to mean that a search has been made or that no other pertinent information as defined in 37 C.F.R. §1.56(a) exists.
SUMMARY OF THE INVENTION
In accordance with the present invention a positive pressure surgical field for use in reducing bleeding during surgical procedures provides an enclosure having an opening which allows the enclosure to be placed over or around a wound site. In the preferred embodiment the enclosure is self-supporting and is constructed out of transparent plastic.
The enclosure is filled with a positive flow of gas. The resulting flow results in the interior of the enclosure having a higher pressure relative to the outside standard room air pressure. This enclosed positive pressure field is applied to an operation site via the aforementioned opening. In one embodiment, the opening may be of sufficient size to allow nearly the entire patient to be exposed to the positive pressure field, with the exception of the head and upper chest of the patient. In this preferred embodiment the surgical team may be enclosed in the field as well, to allow for easier access to the patient. In an alternate embodiment, the enclosure is of a size sufficient to allow only a small area of the patient to be exposed to the positive pressure field. In such an embodiment the surgeons access the operation site through several openings in the sides of the enclosure.
Since the patient is breathing air at a pressure lower than that within the positive pressure surgical field, pressure is applied to the blood vessels, collapsing or partially collapsing these vessels to limit oozing blood loss. The pressure may be adjusted until the bleeding ceases.
Both forms of the invention may be readily transported and used outside of surgical theaters to provide the benefits of the invention, as well as providing a generally sterile environment. Thus, bleeding and contamination may be controlled in the field by the use of the enclosures of the invention.


REFERENCES:
patent: 2385683 (1945-09-01), Burton
patent: 2700384 (1955-01-01), Ivory
patent: 3094983 (1963-06-01), Macleod
patent: 4467798 (1984-08-01), Saxon et al.
patent: 4550713 (1985-11-01), Hyman
patent: 4893615 (1990-01-01), Khabirova
patent: 5060644 (1991-10-01), Loori
patent: 5109837 (1992-05-01), Gamow et al.
patent: 5316541 (1994-05-01), Fischer
patent: 5327904 (1994-07-01), Hannum
patent: 5398678 (1995-03-01), Gamow et al.
patent: 5467764 (1995-11-01), Gamow
patent: 5503143 (1996-04-01), Marion et al.
patent: 5797403 (1998-08-01), DiLorenzo
patent: 5848998 (1998-12-01), Marasco, Jr.
patent: 5975081 (1999-11-01), Hood et al.

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