Bioprothesis film strip for surgical stapler and method of...

Electricity: electrical systems and devices – Housing or mounting assemblies with diverse electrical... – For electronic systems and devices

Reexamination Certificate

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C349S150000, C361S776000

Reexamination Certificate

active

06704210

ABSTRACT:

FIELD OF THE INVENTION
In various soft tissue surgery applications such as, for example, the resection of diseased lung tissue, surgeons use linear stapling guns to staple together layers of tissue on each side of a proposed cut along which the diseased tissue is to be severed from the healthy tissue. These stapling guns consist of a pair of elongated jaws which are clamped over, e.g., a lung from which a cancerous lobe is to be removed. One of the jaws carries a cartridge containing parallel rows of biocompatible staples positioned end-to-end, while the other carries parallel rows of anvils for those staples. Once the staples have been placed, a scalpel is drawn lengthwise between the staple rows to sever one stapled lung portion from the other.
Because of the nature of lung tissue, air leakage occurs at the points where the staples pierce the lung tissue, This leakage continues until the lung tissue heals around the staples, thus requiring lengthy hospitalization of the patient. To mitigate this problem, it has been proposed to drive the staples through a bioprosthetic film, which can act as a gasket or sealant to the lung tissue punctured by the staples. Suitable materials for this purpose are natural materials such as glutaraldehyde fixed bovine pericardium, or man-made materials such as collagen absorbable hemostat, vicryl (polygalacrin) mesh, or ePTEE (expanded polytetrafluoroethylene).
A problem arises when strips of these materials are to be applied to the jaws of the stapler in such a way that they can be conveniently released from the jaws after the stapling operation. For example, one prior method involves suturing a strip of bioprosthetic film to a strip of polyethylene backing to form a sleeve. One of these sleeves is then slipped over each jaw of the stapler, with the strip facing inward. After the stapling operation, the edges of the strips must be cut free of the hacking and Sutures, which are discarded. This method requires caution on the part of the surgeon to avoid leaving remnants of the backing or sutures in the patient.
Other methods of attachment have involved the use of glue or adhesive tape, but none of these are simple and satisfactory, A need therefore exists for a method of attaching a bioprosthetic film strip to a stapler jaw which is easy, reliable and allows the strip to be readily severed from the jaw.
SUMMARY OF THE INVENTION
The present invention fulfills the above-identified need by providing a flat bioprosthetic film strip with apertured ends. In one preferred embodiment of the invention, the perforated ends of the strip are simply turned our of the plane of the strip, and the jaw is slipped through them.
After the stapling, the strip can be released from the jaws in the preferred embodiment by cutting the strip adjacent the apertures, and the entire strip can be left in the patient.
In another preferred embodiment of the invention, the scrip can be secured to the jaw at the proximal end or at both ends with the aid of retaining pins from which ft can slip off when the jaws are opened following the stapling procedure.


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Advertisement, “Breath Easy: Your Staple Line is Secure.”, Seamguard Staple Line Reinforcement Material, W.L. Gore & Associates, The Annals of Thoracic Surgery, vol. 62, No. 5, Nov. 1996, ISSN: 0003-4975.

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