Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Patent
1992-07-02
1994-05-17
Rosenbaum, C. Fred
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
604102, 606197, A61M 2900
Patent
active
053123433
DESCRIPTION:
BRIEF SUMMARY
The present invention concerns a technique for the diagnosis of disease and also pharmacokinetic studies of the colon and rectum based on analyses of cells, secretions and intestinal fluids achieved by perfusion/aspiration of the large intestine by neutral or provocative fluids and a device for performing this procedure. The invention also concerns a procedure for local treatment of diseases in the large intestine.
A refined diagnostic technique of disease in the large intestine with the prospect of identifying inflammatory and other mediators which are released from or through the intestinal wall is not at hand. The diagnostic methods today are based on x-ray, endoscopy and examination of tissue specimens taken in connection with endoscopy or surgery. These methods are limited by the fact that certain mediators cannot be measured. Open systems with dialysis bags in rectum can measure certain mediators but only those with a small molecular size.
An example of a situation where improved diagnostic techniques could be valuable is in the preoperative investigation of patients with inflammatory bowel disease. The pouch procedure, where a reservoir of the small intestine is prepared when the diseased large intestine has been removed, is the surgical treatment of choice in ulcerative colitis. However, if a patient with Crohn's disease located to the large intestine is treated with the same procedure this will inevitably lead to recurrent disease and a situation where the reservoir has to be removed. With a loss of vital part of intestine a risk of dangerously short bowel can occur. With currently available techniques it is difficult to separate these diseases in 20-30% of the cases.
Another situation where a system for segmental perfusion is useful is in the study of the release of pharmacologic substances in the large intestine. Many substances for treatment of disease of the large intestine are taken by the oral route but not released until it reaches the target organ. By measuring concentrations of pharmacological preparations in closed segments of the large intestine new possibilites of testing these preparations will appear.
A third application is the local treatment of diseases in the large intestine. Drugs can be given as local treatment, i.e. enemas or suppositories. However, when the disease is localised to certain parts of the intestine either low concentrations in the involved area or risk of side effects with higher doses are problems not possible to solve with the presently available administration forms.
The invention makes it possible to give doses with high local concentrations in the involved area of a closed segment without risking dangerous side effects.
Perfusion and aspiration studies from the small intestine with analysis of intestinal contents of inflammatory markers has been described in SE B 455 368, which refers to a catheter for intestinal use, not including the large intestine. The construction of the known catheter makes this application impossible. This catheter is 1.6 m long and is introduced through the mouth or nose. A catheter introduced by the oral route aimed for investigations of the large intestine has to be very long (6 meters or more), still flow in the channels would not be possible because of high flow resistence depending on channel length and the consistency of secretions from the large intestine. The jejunal catheter cannot be introduced by the anal route as this should imply blind introduction into the intestinal tract against peristalsis with risk for intestinal damage. The catheter would also be expelled by the peristaltic wave as it is to weak and lacks an anchoring device.
The purpose of the present invention is to improve diagnostic accuracy, to study the local effect of pharmacological preparations given orally or rectally and to increase the possibilites of giving potent treatment to localised disease processes and thereby avoiding serious side effects. To achieve these goals the following requirements have to be fulfilled:
1. A physiologically closed segment
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patent: 4180076 (1979-12-01), Betancourt
patent: 4368739 (1983-06-01), Nelson, Jr.
patent: 4484579 (1984-11-01), Meno et al.
patent: 4527549 (1985-07-01), Gabbay
patent: 4983167 (1991-01-01), Sahota
Hallgren Roger
Knutson Lars
Krog Michael
Raab Yngve
Hallgren Roger
Krog Michael
Maglione Corrine
Raab Yngve
Rosenbaum C. Fred
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