Prosthesis and method for lowering abdominal pressure

Abstract

A two-sheet fascial expander prosthesis for temporary use and method of using it to treat abdominal hypertension and associated organ system function impairment, in which each flat sheet is attached to the fascia only at opposite sides of an incision. One side of each sheet is armed with mating fastening elements that bond when united to bring about high tensile shear strength and low tensile peeling-off resistance permitting easy separation for diagnostic and therapeutic abdominal entry. The invention is useful because it expands the fascia and adds compliance to the envelope of the abdominal cavity by bridging the gap between free borders of the incised fascia containing intra-abdominal organs without strangulating their blood supply and retaining some tension on the fascia to prevent retraction and bringing the edges closer together as healing progresses, and permitting final removal of the patch and fascia-to-fascia closure. The method of producing and testing biocompatibility of the two-sheet fascia prosthesis also is disclosed.

Description

CROSS REFERENCE TO RELATED APPLICATIONS[0001]This application claims priority based on Provisional Patent Application No. 0 / 230,202 filed Sep. 5, 2000. U.S. Pat. No. 5,893,368 Apr. 13, 1999 Sugerman (128 / 898; 601 / 11); U.S. Pat. No. 6,039,741 Mar. 21, 2000 Meislin (606 / 72); U.S. Pat. No. 4,452,245 Jun. 5, 1984 Usher (128 / 334 R) Continuation-in-part Application 37 CFR 1.53(b) (and Amendment 2).[0002]Sir, in response to Office Action of May 8, 2003, please file a continuation-in-part application. A hard copy of this Continuation-in-Part Application has been submitted Aug. 6, 2003 by snail mall. That copy was resubmitted Mar. 20, 2004. This is a technically slightly enhanced version of said Continuation-in-Part application using PTO electronic filing system PASSAT and ePAVE. Remarks / Arguments: Reconsideration of the application is respectfully requested. The application has been amended to more clearly define my invention considering the examiners objection regarding introduction of new...

AI Technical Summary

Benefits of technology

[0019]The objects of the present invention are to provide a simple, effective, and improved method and fascial prosthesis device for decompressing increased abdominal pressure, bridging fascial gap, protecting abdominal contents, temporarily closing the incision so that it can be subsequently opened and re-closed as needed, and finally closing the abdomen fascia to fascia without need for prosthetic material and preventing bacterial contamination during the decompression and reclosure period at the same time.

[0022]In the methods of the present invention, one edge of the first sheet (loop sheet) is attached with the top of the sheet with its mating surface with loops facing upward, and the relatively smooth bottom facing downward. The loop sheet is sutured to the fascia and the free end is inserted between the opposite parietal peritoneum and the intestines so that the first sheet protects any exposed abdominal contents. The second flexible, trimmable sheet (hook sheet) is then similarly sutured to the opposite fascia of the abdominal wound with the bottom-mating surface of hook structures facing downward. To temporarily close the wound a slight pulling is exerted on each of the two sheets to put the fascia under minimal tension, and the mating surfaces are brought together to close the incision. Intra-abdominal organs may be protected during the process by covering the mating surfaces of the second sheet with a towel, as long as the abdomen is open.

[0023]Subsequently, when the abdominal re-exploration is performed, the bonds between the mating surfaces are broken and the sheets folded back to open the previously closed incision. If the wound must be closed again temporarily the process is reversed conferring minimal tension both abdominal wall fascias so that they do not retract. When the prosthesis is reclosed, and the fascias can be pulled closer together than during the previous abdominal entry, the sheets may be tailored to the proper size by trimming them with scissors to fit the new fascial gap. The opening and reclosing may be repeated until the abdomen is ready to be closed permanently. Now the remainders of the two sheets are removed and the incised ends of the fascia are joined by a continuous suture or other traditional fascia closing technique. During the entire procedure that may last several days, the abdominal opening with the fascial prosthesis is protected from becoming contaminated by applying a self-adhesive plastic sheet cover onto a 20 cm skin area that surrounds the abdominal opening. To collect accumulating peritoneal fluid from the abdominal cavity above said prosthesis and underneath the self-adhesive plastic sheet, negative pressure is applied using a drain and an external suction pump. The combination of the two seals the abdominal aperture hermetically.

[0024]The novel method of the present invention is simple to handle and cost effective as it better uses hospital resources and reduces both mortality and morbidity by decompression of the abdominal compartment syndrome. Decompression is achieved by temporarily adding compliance to the abdominal envelope (abdominal fascia) to terminate strangulation of intra-abdominal organs and vessels. Decompression reverses multi system organ dysfunction and impairment of venous and arterial blood flow from sustained abdominal hypertension.

[0026]Without said fascial expander prosthesis fascias on both sides of the abdominal aperture would retract laterally resulting in permanent huge abdominal hernias that disable the patient. Said prosthesis prevents hernia formation.

[0027]Without said fascial expander prosthesis bowel would be exposed to atmospheric pressures without any counter pressure. In the closed abdomen the abdominal envelope exerts some pressure naturally. Higher bowel perforation and fistula rates are seen when bowel is exposed to lower atmospheric pressure particularly when the bowel is friable from inflammation and bowel distension. Fistula formation is greatly reduced when said prosthetic device is used to provide tailored pressure from the outside.

Problems solved by technology

Increased intra-abdominal pressure or abdominal hypertension from any cause occurring acutely may lead to abdominal compartment syndrome because the abdominal cavity with its content is contained within an envelope of limited compliance.

Diminished blood flow to vital organs invariably leads to tissue hypoxia and sequential organ system dysfunction and, if not treated, to death.

Leaving the abdomen open, however, is invariably associated with high mortality rates, fistula formation, and large incisional hernias.

Plastic meshes, however, need to be reopened and often replaced for abdominal re-entry.

Re-uniting the fascias is rarely possible using prior art devices and high rates of abdominal hernias develop in most cases even when meshes are used to cover the open abdomen.

The use of available meshes (U.S. Pat. No. 4,452,245) to bridge the gap between fascias is also associated with high complications and mortality rates similar to the “leaving the abdomen open” technique.

Closing the abdomen forcefully in such situations over increased intra-abdominal volumes will increase intra-abdominal pressure, and lead to multi-system organ failure and death.

As treatment progresses and edema lessens most of the prior art devices cannot accommodate decreases in abdominal distention and have to be replaced by a similar member and resutured.

Images