|
1. A device (1) for the sealing protection, with tamponading action, of a surgically applied circular anastomosis (AS) between an oral end and an aboral end of the large intestine, in particular the rectum (R) or sigma(S), or some other suture or lesion present in this portion of the intestine, at the same time with a stool-discharging function through the segment (AS) of the intestine that is anastomosed, injured, or treated surgically or via some other intervention, and with subsequent passage of the stool through the anal sphincter (TA), characterized by at least one thin-walled balloon body (5), formed completely to its working dimensions during manufacture and made of a material with low volume expandability, for placement in the region of the anastomosis (AS) in such a way that a distal balloon end or a distal balloon segment (5b) of the at least one balloon body (5) is situated orally with respect to the anastomosis (AS), the balloon body (5) enclosing a flexibly and/or elastically deforming tube element (6) that passes through the balloon body (5) from the distal balloon end or the distal balloon segment (5b) to a proximal end or a proximal balloon segment (5c) of the at least one balloon body (5), where the tube element (6) is connected or connectable to an extracorporeal tube (7), spontaneously elastically straightens from an axially deformed state into an initial state preformed during manufacture and has a structural stability sufficient to allow a position, determined by a positioning relative to the anus, to be passed on to the distal balloon end or distal balloon segment (5b) of the at least one balloon body (5, 5b, 5c), and, under high enough radial load, elastically collapses from a profile preformed during manufacture into a radially deformed state, but when the load diminishes, the tube element (6) elastically returns into the profile preformed during manufacture, the balloon body (5, 5b, 5c) being connected to an apparatus that controls the supply and discharge of a filling medium to and from at least a portion of the balloon body (5, 5b, 5c) in such a way that in the tamponading balloon body (5, 5b, 5c), a lowest possible filling pressure necessary for the sealing tamponade of at least a portion of the intestine distally and/or orally with respect to the anastomosis, but also a pressure that is sufficient to continuously compensate for mass movements of the abdomen and in particular peristaltic contractions of the intestine, is continually maintained, so that the balloon body (5) is configured to effect consistent tamponading sealing contact with the intestinal wall, and critically high back pressures within the balloon body (5, 5a, 5b, 5c) that endanger the integrity of the anastomosis (AS) are avoided.
|
