Surgery – Body protecting or restraining devices for patients or infants – Drapes
Reexamination Certificate
2002-03-13
2004-04-27
Brown, Michael A. (Department: 3764)
Surgery
Body protecting or restraining devices for patients or infants
Drapes
C128S853000
Reexamination Certificate
active
06725864
ABSTRACT:
FIELD OF THE INVENTION
The invention relates to the field of surgical equipment. In particular, the invention pertains to arthroscopic surgical drapes having pouches which collect and contain fluids.
BACKGROUND OF THE INVENTION
During surgical procedures, it is often desirable to create a sterile field surrounding the surgical site in order to reduce the likelihood of infection in the patient. Sterile materials such as surgical drapes have been used to create such a sterile field while allowing openings to be created or formed in the material to permit access by the surgeon to the surgical site. Surgical drapes function to prevent bacterial and viral contamination of the practitioner by the patient, as well as contamination of the patient by the staff and environment during surgery.
Some surgical procedures including many arthroscopic techniques generate a large volume of fluid as a result of exiting body fluids or irrigation of the surgical site. Thus, the collection, containment and disposal of such fluids is often necessary during the procedure. Fluid collection pouches are often used during such procedures for this purpose.
Arthroscopic and orthopedic surgeries typically involve anatomy-specific procedures. Often the surgical instruments and equipment used in these procedures are adapted for the particular anatomy of the surgical site. Anatomy specific fluid collection pouches and drape assemblies are known. For example, Reyes U.S. Pat. No. 5,494,050 discloses an arthroscopy pouch specifically adapted for use in knee surgery. An arthroscopy pouch and drape assembly adapted for use with the knee, however, would not necessarily contain structural features suitable for use with other parts of the body.
There exists a need in the surgical field for improved surgical pouches and drape assemblies having features thereon which accommodate the patient's natural anatomical geometry at the shoulder while preserving the sterility requirements and enhance the practitioner's performance of the procedure.
SUMMARY OF THE INVENTION
The invention is an improved shoulder drape comprising a pouch which can be used in arthroscopic surgery. The shoulder drape contains a combination of advantageous structural features uniquely adapted to accommodate the anatomy of the shoulder and surrounding area while at the same time permits the desired surgical access to the site during arthroscopic surgery. The shoulder drape and pouch assembly of the invention comprises a conformable strip positioned within the front portion of the pouch to enhance conformability to the pouch in addition to the wire drawstring. The pouch portion is affixed to a drape likewise having a single opening, thereby eliminating the need to further cut or create seams in the drape portion, or otherwise structurally modify the shoulder drape. Furthermore, the shoulder drape of the invention is adapted for use with either the left or right shoulder without the need for structural modifications. The shoulder drape is constructed such that in use, the drape covers the remaining part of the patient's body and equipment, and effectively forms an anesthesia screen.
The invention provides for a surgical shoulder pouch for use with a drape, said pouch comprising:
a) a single folded sheet of flexible fluid impermeable material having a front distal portion and a rear proximal portion relative to the patient's body, and top portion and bottom portion;
b) a central region located on said rear portion of the flexible sheet having an opening;
c) an elastomeric sheet covering said opening in the flexible sheet, the elastomeric sheet having a contoured opening therethrough smaller in size than the opening in the flexible sheet, the perimeter portion of said elastomeric sheet being fixed to the perimeter portion of the opening of the flexible sheet so that the flexible sheet circumscribes the perimeter of the elastomeric sheet;
d) a longitudinal wire having a middle portion inside of a seam running along the upper edge of the top portion of the front portion of the pouch, and having ends exiting the front portion of the pouch proximal to the rear portion of the pouch; and
e) a conformable strip positioned at the central region of the front portion of the pouch adjacent the upper edge.
The elastomeric sheet and contoured opening therethrough are adapted to accommodate the natural geometry of the patient's anatomy at the shoulder region and to create a seal surrounding the shoulder when the patient's arm is inserted through the opening. In a preferred embodiment of the invention, the opening in the elastomeric sheet is pear-shaped to accommodate the natural anatomy of the shoulder. The longitudinal wire and conformable strip each function cooperatively to permit adjusting of the configuration of the front upper edge of the pouch and maintain such configuration during the surgical procedure.
The invention also provides for a surgical shoulder drape comprising a pouch, said pouch comprising:
a) a single folded sheet of flexible fluid impermeable material having a front distal portion and a rear proximal portion relative to the patient's body, and top portion and bottom portion;
b) central region located on said rear portion of the flexible sheet having an opening;
c) an elastomeric sheet covering said opening in the flexible sheet, the elastomeric sheet having a contoured opening therethrough smaller in size than the opening in the flexible sheet, the perimeter portion of said elastomeric sheet being fixed to the perimeter portion of the opening of the flexible sheet so that the flexible sheet circumscribes the perimeter of the elastomeric sheet;
d) a longitudinal wire having a middle portion inside of a seam running along the upper edge of the top portion of the front portion of the pouch, and having ends exiting the front portion of the pouch proximal to the rear portion of the pouch; and
e) a conformable strip positioned at the central region of the front portion of the pouch adjacent the upper edge;
wherein the exterior of the rear portion of said pouch is affixed to a surgical drape having an opening in alignment with said opening in the elastomeric sheet of the pouch.
In a preferred embodiment, the drape portion comprises a patient-contacting surface comprising at least one adhesive portion adapted to adhere the drape onto the patient's body.
REFERENCES:
patent: 4974604 (1990-12-01), Morris
patent: 5002069 (1991-03-01), Thompson et al.
patent: 5143091 (1992-09-01), Patnode et al.
patent: 5383476 (1995-01-01), Peimer et al.
patent: 5494050 (1996-02-01), Reyes
patent: 5513655 (1996-05-01), Peimer et al.
patent: 5618278 (1997-04-01), Rothrum
patent: 5871014 (1999-02-01), Clay et al.
patent: 6032670 (2000-03-01), Miller
Ewonce John E.
Reyes Rogelio
Allegiance Corporation
Brown Michael A.
Rozycki Andrew G.
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