Device for packing and sealing surgical sutures and wounds, especially rectal end-to-end anastomosis

Abstract

The invention relates to a device (1) for packing an annular anastomosis at both ends of the large intestine, for example produced during surgical resection of rectal cancer, in a manner that provides sealing protection and simultaneously discharges feces, wherein a thin-walled balloon body (5) is placed in the area of ​​the anastomosis and the packing balloon (5) is filled with a filling medium in a certain manner so that the pressure required for sealing the anastomosed intestinal section is continuously maintained at a minimum and the nominal pressure set by the user is maintained as continuously as possible even in the event of peristaltic contractions of the rectosigmoid colon, wherein a sufficiently high volume flow of the medium fed into and discharged from the balloon (5) is achieved so that in all segments of the balloon body, during the peristaltic contraction wave from the sigmoid colon to the anus, the balloon (5) is maintained in sealing contact with the intestinal wall.

Description

Technical Field

[0001] The present invention relates to a device and a method for sealingly packing and protecting a surgically formed circular anastomosis between the oral end and the anti-oral end of the large intestine, especially the rectum or sigmoid colon, or other sutures or injuries produced in this part of the intestine, while having the function of draining feces through the anastomosed or injured or surgically or other intervened intestinal segment and subsequently passing the feces through the anal sphincter. Background Art

[0002] In tumor resections in the rectum and sigmoid colon, a circular suture is usually formed to connect the oral end of the intestine cut during the resection to the anti-oral end "end to end". In most cases, the anastomosis is performed by metal clips arranged in a ring, which connect the two intestinal ends and reconstruct a continuous intestinal cavity. The clamping is performed by an instrument (so-called stapler) inserted through the patient's anus into the area of ​​the intestine to be connected. It is known that in about 10% of all end-to-end anastomoses performed in this way, so-called insufficient suture occurs, usually due to poor vascular perfusion in the clamped area. In the worst case, necrotic local ischemia occurs in the intestinal wall near the anastomosis, and the intestinal contents enter the abdominal cavity, which usually causes serious life-threatening inflammatory complications. Therefore, as a preventive measure, in the resection of large intestine segments, especially in the deep rectal area, a so-called palliative ostomy is performed. In this case, above the rectum, usually in the area of ​​the small intestine, the intestinal contents are guided through the abdominal cavity to a collecting bag through an artificial intestinal outlet (so-called stoma) created by surgery. This prevents feces from entering the intestine anastomosed by the circular sutures, thereby avoiding accumulation of feces that would burden the anastomosis or possible expansion of the anastomosed intestinal ends. After the anastomosis has healed, the stoma is reduced and normal excretion is resumed. The surgical creation and reduction of the stoma, as well as the ostomy itself, are not without complications and in many cases require surgical revision.

[0003] Therefore, for the care of rectal resection patients, an alternative technique is desired in which in principle no protective stoma can be created.

[0004] By continuously modifying the patient's feces into a thin fluid, it is now possible to drain the feces through a catheter-like fecal drainage device that is placed in the patient's rectum. This so-called "indwelling drainage" system usually has a roughly annular balloon located in the rectum, and a hose for draining feces is installed at the end. This simple first-generation system is mainly composed of silicone. In recent years, more complex systems composed of polyurethane have been added to the prior art. In the PUR-based structural type, the balloon body is dumbbell-shaped, wherein the center part with reduced diameter is positioned in the anal canal or is passed through the anal canal. The dumbbell-shaped balloon is equipped with a shaft hose that can be elastically deformed in the anal canal. Therefore, in the transanal section of the PUR-based device, the shaft hose and the tapered balloon part are concentric with each other, so that the sealing of the anal canal is achieved synchronously with the sphincter. While the inner hose layer is conducting the feces through the anus, the transanal balloon section rests on the anal mucosa in a manner that provides a continuous seal, spontaneously and adaptively following the corresponding position of the anal sphincter. The forces required for adaptive transanal sealing are absorbed by the rectal section of the dumbbell-shaped balloon body. These novel systems are filled with a balloon volume that is preset in a defined manner, wherein a relaxed, non-inflated state of the balloon is achieved according to the concept. The pressure in the transanally positioned balloon adjusts itself in interaction with the current rectal motility or current rectal forces. A device of this type for the uninterrupted conduction of feces is described, for example, in PCT / EP2012 / 003534. However, this case involves an overall passive arrangement in which the pressure in the balloon is reduced compared to a silicone-based balloon; in applications immediately after a resection, in order to place such a balloon in the colon in a sufficiently sealed manner, it is still necessary to select a pressure that is usually too high due to the peristalsis there, which can lead to damage to highly sensitive tissue after the resection intervention. Summary of the invention

[0005] In view of the above-mentioned disadvantages of the prior art, the object of the present invention is to find a solution with which it is possible in principle to avoid creating a protective stoma without causing damage to the freshly operated tissue in the anastomotic region.

[0006] The solution used by the present invention to achieve this goal is: at least one thin-walled balloon body, which is preferably made of a material with low expandability and is completely molded into a working size during the manufacturing process, is used to be arranged in the area of ​​the anastomosis so that the proximal end of the balloon or a proximal segment of the balloon extends in the area of ​​the patient's rectum or sigmoid colon or also beyond the sigmoid colon on the oral side relative to the anastomosis, wherein the balloon body surrounds a flexible and / or elastically deformable hose element, which passes through the balloon body from the distal end or oral end or corresponding segment of the balloon body to the proximal end or anti-oral end or corresponding segment and is connected to or can be connected to an extracorporeal hose, wherein the packing gas The balloon body is connected to an extracorporeal device via a hose-like feed line and a discharge line, which actively controls or passively allows the feeding of the filling medium into and the discharge of the filling medium from the balloon body in a certain way, so that a filling pressure as small as possible is always maintained in the filling balloon body, which is sufficient filling pressure required for sealing the anastomosed intestinal part without causing damage to the tissue in the anastomotic area, and continuously compensates for the mass movements (Massenbewegungen) of the abdomen and especially the peristaltic contractions of the intestine, thereby continuously maintaining the filling and sealing contact between the balloon body and the intestinal wall without damaging the intestinal wall in the anastomotic area.

[0007] The distal or oral end of the balloon body should be at the oral end relative to the anastomosis, thereby protecting the anastomosis from feces by the sealed termination of the colon upstream of the anastomosis, while the position of the proximal or anti-oral end of the balloon body is not limited to a specific position. In the case of a significantly shortened balloon body, its proximal end can also be at the oral end relative to the anastomosis. In this case, the internal shaft hose generally extends within the colon.

[0008] In the case of adopting this layout, the shaft hose still follows the preset position of the balloon body. It needs to have sufficient structural stability to pass the position defined from the anus to the balloon body in the rectum or sigmoid colon. At the same time, the shaft hose also needs to have sufficient flexibility to follow the curvature of the colon.

[0009] On the other hand, in order to reliably prevent contact between the shaft hose and the anastomosis, the present invention proposes to arrange the proximal end of the airbag at least at the abductor end relative to the anastomosis, or extend it to the anus, or even arrange it in front of the anus.

[0010] Therefore, the present invention provides a device for draining liquid feces with a packing effect, which is inserted into the patient's rectum that has just been resected and anastomosed through the anus, and receives the liquid modified feces at 5 to 15 cm, preferably 10 cm above the anastomosis according to the corresponding postoperative position, and passes through the anus in a normal way, in a way that passes by the anastomotic suture, to a container for collecting feces outside the body. The device is generally composed of the following: a hose membrane or a film-like hose assembly that matches and follows the anatomical axial extension of the intestine, spontaneously elastically straightens into a contour formed during the manufacturing process, receives feces and guides feces. The elastically deformed and straightened film hose carries a diaphragmatic thin-walled cylindrical balloon body, which is either also equipped with a colon bag-like annular constriction and extends from the bottom of the rectum to the patient's sigmoid colon, or also crosses the sigmoid colon. The balloon body has been manufactured to a complete working size during the manufacturing process. Its diameter corresponds to the diameter of the fully expanded rectum and / or sigmoid colon. In a preferred case, the diameter of the balloon body exceeds the diameter of the rectosigmoid colon to be treated and has a so-called excess size. In a preferred embodiment, the balloon also has a transanal segment, which is adjacent to the rectal segment. The transanal segment is positioned in the anal canal and continues the balloon body through the anal canal. The diameter of the transanal balloon portion preferably corresponds to the diameter of the fully opened anus or exceeds this diameter. Therefore, when the sphincter is partially opened, the sheath wall with excess diameter is advantageously radially folded. In front of the anus, the balloon body can be optionally expanded to a spherical or disc-shaped pre-anal segment. In the pre-anal balloon segment, an independently fillable inner balloon that plays an anchoring role, or other forms of thrust bearing elements that play an anchoring role accordingly, can be installed. As an alternative to fixing the device in the area of ​​the perianal skin based on the balloon, within the scope of the present invention, a planar adhesive fixing that acts as a thrust bearing can also be used.

[0011] The dumbbell-shaped balloon body is filled by means of a volume reservoir or a mechanical regulator located outside the body, with the aid of a hose-like feed line, in particular of a large chamber. In a preferred embodiment of the invention, the regulation is carried out by means of a valve system that is regulated rapidly with a high flow rate, which actively feeds the volume into the balloon and / or actively extracts the volume from the balloon, driven by a pressure gradient of a corresponding degree. Preferably, the filling pressure in the balloon that fills the intestinal cavity or closes the intestinal cross section is continuously detected by an electronic pressure sensor located inside the balloon body for filling or sealing. A main feature of the device is that the peristaltic contractions of the sigmoid colon and the rectum are compensated by adjusting the balloon filling volume, whereby the nominal filling pressure for filling or sealing set by the user is maintained in the filling balloon during the peristaltic contraction, or a temporary critical high filling pressure is avoided. By correspondingly adjusting the filling volume in the balloon, it is also possible to avoid the device being expelled from the rectosigmoid colon due to peristalsis or to avoid the device moving out of its transanal position required for the suture protection function.

[0012] During the peristaltic contraction of the terminal colon, the volume and pressure regulating mechanism connected to the device ensures a constant, user-set nominal pressure in the packing balloon required to protect the anastomosis. In the event of a reduction in the peristaltic contraction or a reduction in the hyperperistalsis of the intestinal wall and a corresponding expansion of the intestinal cavity, the regulating mechanism delivers the filling volume to the balloon body under control, so that the user-set nominal pressure is continuously maintained throughout the contraction process, thereby maintaining the packing and protection effect of the balloon mask on the anastomosed intestinal wall. The volume is preferably delivered to and from the balloon via an electronically controlled, particularly rapidly regulating proportional valve.

[0013] As an alternative to the technically relatively complex electronic regulation of the balloon volume and the balloon filling pressure, a relatively simple-structured external storage balloon that can be comfortably carried by the patient can be connected to the device for its tamponade-drainage effect via a filling line. The reservoir has a special balloon whose volume can be expanded in a specific manner, for example, it is composed of an isoprene-based material, which achieves a nearly isobaric pressure curve within a specific expansion range of the balloon wall or within a range of filling states of the balloon. As a result, the filling medium can move in two directions between the balloon body of the catheter device and the regulating reservoir without exceeding the maximum pressure defined by the expansion mechanism of the reservoir in the entire system.

[0014] This simple embodiment of the adjustment assembly is preferably used in a later postoperative care phase, when the suture area has stabilized and extremely precise and rapid adjustment is no longer important.

[0015] The invention also discloses a method and a system for packing an annular anastomosis at both ends of the large intestine, such as is produced during surgical resection of rectal cancer, in a sealed and protective manner while allowing the discharge and passage of feces, wherein, after the anastomosis has been created by annular suturing or clamping, the surgeon inserts a catheter-like device into the postoperative area, the device consisting of a balloon with a diameter corresponding to or exceeding the diameter of the colon, wherein the balloon is already manufactured to the dimensions required for the packing according to the invention during the manufacturing process, wherein the balloon body has a narrowing in the transanal section suitable for transanal positioning of the device and has a spherical expansion in the anal section which encloses a preanal retaining element, and wherein the part of the balloon body that protrudes into the colon packs at least the patient's rectum, but optionally also the entire rectosigmoid colon. The balloon body is carried by a flexible, flexible shaft tube that follows the curvature of the rectosigmoid intestine as stress-free as possible, and which is folded and straightened in an elastic manner, in particular in the transanal section. After the device has been placed in the appropriate transanal position by the surgeon, the balloon of the packing device is connected to an electronically controlled control unit, which applies a nominal pressure selected by the user to the balloon and continuously maintains this pressure in a manner that compensates for peristaltic contractions and group movements of the abdomen by rapidly delivering or withdrawing the filling medium. The nominal pressure is usually in the range of 5 to 30 mbar, preferably 10 to 15 mbar. BRIEF DESCRIPTION OF THE DRAWINGS

[0016] For more features, details, advantages and effects based on the present invention, please refer to the following description of preferred embodiments of the present invention and the drawings. Among them:

[0017] Figure 1 It is a schematic overview of the device of the present invention, which includes a balloon catheter for packing in vivo for dynamically adapting to the changing volume and pressure in the intestinal cavity, a regulating unit in vitro connected to the balloon catheter, and a stool collection container;

[0018] Figure 1a An embodiment of the present invention is shown, comprising independently inflatable balloon segments arranged in sequence;

[0019] Figure 1b An embodiment is shown which has a special constriction in the anastomosis region which lies almost against the inner shaft tube;

[0020] Figure 1c A specific embodiment of the present invention for perianal adhesive fixation of a catheter device is shown;

[0021] Figure 2 One embodiment of the present invention is shown in situ, in a transanal positioning position;

[0022] Figure 2a The balloon body of the device of the present invention is shown in a state of peristaltic contraction of the sigmoid colon;

[0023] Figure 2b A cut plane of the rectum R is shown in order to clearly demonstrate the folding of the remaining balloon located in the rectum;

[0024] Figure 2c A special design of a balloon-carrying shaft hose is shown, including feed and / or discharge hose lines embedded in the hose contour, which are used to fill the catheter balloon and to stabilize the rectosigmoid position of the balloon tampon;

[0025] Figure 2d Another embodiment of the shaft hose is shown;

[0026] Figure 2e A special structural form of the tampon balloon is shown, which is provided with an annular constriction;

[0027] Figure 3 is a schematic diagram of a regulating unit of the present invention;

[0028] Figure 3a A simplified regulating unit is shown;

[0029] Figure 4 A mechanically acting extracorporeal pressure source is shown for ensuring isobaric pressure characteristics in the tamponade balloon;

[0030] Figure 4a Show the basis Figure 4 A portable embodiment of an isobaric regulating reservoir is constructed; DETAILED DESCRIPTION

[0031] Figure 1 A device 1 for protective packing of end-to-end connected anastomosed intestinal segments is shown, wherein the anastomosis is established by surgical suturing or surgical clipping of the cavity or by anastomosis of the intestinal segments to be connected, and the device consists of a catheter part 2, an extracorporeal regulation unit 3 and a container 4 for draining and collecting feces.

[0032] During the whole use time of the device, the catheter part 2 stays in the patient's body. In the illustrated embodiment, the catheter part is composed of a dumbbell-shaped balloon element 5, which is equipped with a flexible flexible hose element 6 that follows the twisting of the rectosigmoid colon, which elastically collapses under the corresponding force of the intestinal tract or also under the corresponding group movement of the body or abdomen, and elastically recovers its corresponding contour given by manufacturing under the force of decay. In the pre-anal position, the hose element carries a retaining element 5a, which is completely surrounded by the cover of the balloon 5 in the preferred embodiment of the device. In the modified structure of the device, the retaining element can also be connected to the proximal end of the balloon element 5, wherein in this case, the proximal end of the balloon body terminates roughly at the same height as the external opening of the anus. The retaining element 5a can be a balloon-shaped body, but can also be composed of a gel-like or foam-like material. The element ensures that the device stays in the position required for protection and drainage functions, and does not move into the rectum from the transanal position. The transanal tapering of the balloon element is arranged in the patient's body in a manner that it crosses the sphincter or is in the anal canal. The elastically deformable hose element 6 transitions to a discharge hose 7 toward the outside of the body, which connects the head of the device to the collector 4. The discharge hose is preferably made of a thin film tubular material, that is, it can collapse into a flat strip-like structure under load or under the force applied by the patient.

[0033] The balloon segment 5 is filled by a large-chamber, flexibly bendable and chamber-stable feed line 8, which has a certain diameter and length so that the gas volume required for the dynamic filling sought by the present invention can be discharged from the balloon and introduced into the balloon sufficiently quickly and without high flow resistance. In the part of the device that carries the balloon, the feed line 8 has an internal diameter of 4 to 8 mm, preferably 5 to 6 mm. In the proximal area of ​​the feed line, that is, in the pre-anal transition area to the extracorporeal part of the device, the flow-effective diameter can be increased to 7 to 12 mm, preferably 7 to 8 mm. For example, the feed line 8 can be stabilized by a spiral wire integrated into the wall of the feed line that serves as a reinforcement and support. However, the wall of the feed line can also be provided with a special corrugated profile, which gives the hose the required bending properties while achieving anti-kinking properties.

[0034] In order to fill the anorectally placed balloon as accurately as possible via a closed control loop, a pressure sensing element 9 is integrated in the balloon 5, preferably in the region of the rectal section of the device. In the case of an electronic sensor assembly, the element 9 transitions to a cable 9a, which establishes the connection to the external regulation unit 3. It is also conceivable to use a device that senses the pressure and converts it into an electronic signal, with or without its own integrated energy source, to transmit the pressure in the balloon to the control system of the regulation unit.

[0035] As an alternative to an electronic measuring sensor, a separate hose-like channel 9b can be integrated into the device, which is connected to a pressure sensing sensor 9c located outside the patient, which in turn communicates with the regulator via a cable connection 9d.

[0036] The connection between the patient-side unit 2 and the extracorporeal regulating mechanism 3 of the device, in particular, the connection of the feed-in line and the discharge line from the volume to the air bag, are all carried out through a specially designed connector assembly to prevent confusion.

[0037] The regulator 3 has a programmable control unit C equipped with a corresponding regulation algorithm. It has a terminal function T for the user to input the regulation parameters. The regulator also includes a component, which is preferably composed of two independent pressure and / or flow regulating valve units Vi (for inflow) and Vo (for outflow). The regulator can also include a module M arranged upstream of the corresponding valve unit, which has a reserve function and / or a pump function and / or includes a connection with an external pressure source or a negative pressure source.

[0038] Figure 1a A special axial segmentation of the rectum or rectosigmoid is shown, whereby the device acting as a packing seal is filled in a specially adjusted manner to facilitate perfusion in the immediate area of ​​the anastomosis or at a particularly low pressure value to maintain the blood supply of the anastomosis. In this way, infarctions caused by pressure are prevented to the greatest extent possible in the area of ​​the anastomosed intestinal ends. That is, the embodiment has a relatively high-pressure section 5b and a relatively low-pressure section 5c. In the low-pressure section, for example, a packing pressure can be set that is only 5 mbar higher than the internal organ pressure in the resection area.

[0039] The low-pressure segment 5c preferably passes through the anal canal and surrounds the pre-anal thrust bearing element 5a. The high-pressure segment 5b is positioned distally to the low-pressure segment. Its purpose is to establish a sealing function in a portion of the intestine that is spaced a certain distance from the anastomosis toward the oral end. In this intestinal portion, the vascular blood supply is not negatively affected, so that a higher filling pressure can be achieved, which optimizes the sealing efficiency of the balloon packing.

[0040] The two segments 5c and 5b are shaped in the contact region of their balloon shoulders such that they abut against each other with the smallest possible upper and lower shoulder radii, thereby avoiding the formation of a cavity between the balloon segments in which intestinal contents could accumulate.

[0041] Segments 5c and 5b have their own independent feed lines 8h and 8n, respectively. For the second airbag segment to be regulated, the regulator 3 is provided with corresponding additional inputs, valve units, input and control functions and outputs. In a preferred embodiment, the device is equipped with electronic pressure sensors in both the high-pressure segment and the low-pressure segment, or with units that sense pressure and convert it into an electrical signal.

[0042] Figure 1b Shows more Figure 1 Two variants of the embodiment are shown, in which the diameter of the balloon segment 5d exposed relative to the anastomosis AS is reduced approximately to the diameter of the internal shaft tube 6. The remaining gap between the diameter of the segment 5d and the shaft tube is 3 to 10 mm, preferably 3 to 5 mm. In the region of the anal canal, the balloon segment 5d transitions to a diameter that corresponds to the open, relaxed anal canal or has a diameter that is at most 50% higher, preferably at most 25% higher. The balloon segment 5d can surround the pre-anal thrust bearing element 5a, but can also end in a manner flush with the external opening of the anal canal in front of the anus and transition there to a film-like adhesive fixation placed in front of the anus, or be incorporated without forming an intermediate cavity as much as possible.

[0043] As in Figure 1b As shown in the right half of the catheter 2 in FIG. 1 , within the scope of this embodiment, the distal balloon segment 5e can be connected to the proximal segment 5d tapering relative thereto, and optionally also to the preanal segment 5a, in a freely flowing, freely communicating manner, so that a constant pressure balance can be achieved between all balloon segments 5a, 5d, 5e. The balloon segments 5a, 5d, 5e are supplied only via one or several common filling lines 8.

[0044] If the airbag is formed by a blow molding process, for example using a PUR-based hose material, the wall thickness of the airbag cover is increased in segment 5d (having a reduced diameter relative to segment 5e), so that radial expansion of the cover sleeve in segment 5d near the anastomosis can be avoided even when higher filling pressures pass.

[0045] With this structural form, the continuous balloon body does not play a packing function applied to the anastomosis in a planar manner in the anastomotic region AS, and avoids direct contact between the balloon body and the anastomosed balloon end that hinders perfusion. In addition, the tapered segment 5d protectively encapsulates the shaft hose and prevents direct mechanical stimulation of the suture region caused by the stool guide shaft hose whose wall thickness is much greater than that of the balloon body.

[0046] In order to discharge the wound exudate produced at the anastomosis from the region of the tapered section 5d, the device is equipped with a special drainage discharge line DL which receives the wound exudate in the region of the anastomosis and discharges it to the outside of the body via the hose line 7a.

[0047] According to the airbag body Figure 1a In the structural form shown, the tapered proximal segment 5d can also be separated structurally and functionally from the distal segment that performs the sealing function. Figure 1b In the left half of the catheter 2, this arrangement is shown. Here, there is no fluid connection between the distal or oral balloon segment 5e and the proximal or anti-oral balloon segment 5d, so that the pressure in the two balloon segments 5d, 5e can be set and / or adjusted separately. In particular, the pressure in the distal balloon segment 5e can be set higher than that in the proximal balloon segment 5d.

[0048] Figure 1c An embodiment of the device is shown, comprising a special component for pre-anal fixation, in which, as an alternative or in addition to the thrust bearing element 5a, a film-like fixation FB is used, which is applied flatly to the main part PH of the patient's perianal area. The film fixation is preferably composed of a thin-walled thermoplastic polyurethane film, which is used, for example, for fixing bandages or for direct skin protection. The film can be coated with an adhesive, for example a highly adhesive gel based on PUR, in a flat manner as a whole or only locally, which achieves adhesion to the skin surface for several days. This fixing film is preferably implemented in the form of a two-bladed propeller, in which the blade surfaces are respectively bonded to the inner surface of the gluteal fold.

[0049] Figure 2The patient-side unit of the device is shown, which is located in the patient's body in a transanal position. The anastomosis AS extending in an annular manner is located above the anal canal TA. The balloon element 5 extends from the anus PA through the anal canal TA through the rectum R, optionally to the area of ​​the sigmoid colon S. If the sigmoid colon, rectum or anus also contract, the preferably gaseous filling medium or air in the balloon element is filled and compressed, so that the pressure in all other segments of the tampon balloon body increases. This pressure change is recorded by the sensor 9 and the control unit C is prompted to open the valve Vo. During the application of force to the balloon body, the valve continuously discharges volume from the balloon, so that a specific set pressure set by the user is maintained in the balloon as constantly as possible. If the contraction weakens and the intestinal cavity opens, the valve Vi feeds the volume to the balloon in a corresponding manner, thereby maintaining the set pressure. Based on this cooperation, the peristaltic contraction of the rectosigmoid colon can be compensated, so that the balloon filling pressure does not reach a critical level during the contraction, which endangers the anastomosis. On the other hand, it ensures that the filling medium in the balloon is not compressed before the contraction wave and prevents the entire device from being expelled from the rectum like the field contents, but rather keeps the device in the specific tamponade position required for function.

[0050] In a preferred embodiment of the device, the pressure-sensing electronic sensor 9 is arranged on the surface of the shaft tube in the anastomotic region. This ensures that the critical pressure is measured as accurately as possible and that this pressure is sensed with the least possible delay. In order to detect the perfusion-reducing effect of the potential critical pressure on the vascular bed in the region of the anastomosed intestinal ends, a sensor 10 operating with infrared diode light can be fixed on the shaft tube at the height of the anastomosis to be protected, which detects a specific segment K of the anastomosed intestine and generates an electronic signal used for plethysmography in this segment or in a conical segment of the intestinal wall. With the help of this signal, it is possible to detect the wavy capillary blood flow in the area of ​​the wound, identify relative changes in perfusion and failures, and issue a warning accordingly. As an alternative or supplement, the device acting as a packing seal can be equipped with one or more light sources 10a installed in the balloon body, preferably on the shaft tube, in the anastomotic region, the light quality and power of which can be adjusted in a certain way so that the congested blood vessels are clearly visible enough in the anastomotic region so that the surgeon can directly evaluate the local perfusion in situ in the surgical field. It is also possible to use special lights that cause substances delivered to the patient intravascularly to illuminate, as is customary, for example, in fluorescein angiography of blood vessels.

[0051] In order to ensure a particularly efficient seal of the intestinal cavity that is dynamically matched with the current forces in the patient's pelvis and abdomen with as little delay as possible, the airbag 5 extends into the anal canal and in a preferred embodiment extends to the external opening of the anus across its entire longitudinal extension. As an optional structural variant, the airbag body extending through the anus is expanded into a disc-shaped isolation chamber before the anus, wherein this airbag body completely or only partially surrounds or surrounds the holding element 5a. During the manufacturing process, it is preferred to select the diameter of the airbag 5 in the transanal segment TA in a certain way so that the airbag follows the current chamber to be sealed of the anal canal without stretching the wall of the transanal airbag segment, which can be ensured by the diameter remaining size in this airbag segment. In the case of a prefabricated diameter of the airbag segment TA of 20 to 35mm, based on the in-situ folding of the airbag wall with size remaining in the anal canal, the expected fluctuation of the anal canal diameter is compensated in a fully sealed manner. Wherein, the force that makes the airbag cover seal against the mucosa of the anal canal corresponds to the force absorbed by the airbag body in the rectosigmoid colon. If the diameter of the transanal balloon exceeds the corresponding diameter of the anus, a transanal sealing pressure that continuously corresponds to the rectosigmoid pressure can be established in this embodiment, whereby the balloon wall does not need to be stretched significantly to seal the anal canal until the remaining reserved folds of the transanal invagination are completely smoothed out.

[0052] As a retaining element 5a, preferably a balloon assembly is used, the balloon size of which is suitable for mechanically retaining or locking the load in front of the anus. The element is, for example, made of a material whose volume can only be slightly stretched. It has a diameter of 25 to 50 mm, preferably 30 to 40 mm. The balloon 5a is preferably supported by PUR with a Shore hardness of 90A to 95A or 55D to 65D. As an alternative, this balloon is filled with a gaseous or liquid medium, wherein the filling volume makes the balloon only partially filled and transitions to a relaxed, non-stretched state, i.e., as a flexible, soft body against the anus, and only when the device moves axially relative to the patient, it transitions to a full, in this case, retaining state. As an alternative, the retaining element can be made of a gel-like or foam-like solid material.

[0053] In order to center the distal end of the shaft tube 6 for receiving and guiding feces and to keep it axially aligned and open toward the upstream intestinal cavity, the distal radius of the balloon 5 in the region of the transition 6a to the shaft tube can be stabilized by an annular film-like reinforcement 6b, which is for example flatly bonded to the balloon body. In order to prevent the distal drainage opening from being blocked by the part of the balloon wall temporarily located above the shaft tube opening, this distal shaft end can be provided with an olive-shaped or mushroom-shaped element that protrudes beyond the front balloon radius.

[0054] The shaft hose 6 is preferably made of PUR with a Shore hardness of 80A to 95A or 55D to 60D. The shaft hose is preferably provided with a corrugated profile, which imparts axial flexibility to the hose, thereby obtaining a hose chamber for drainage, in which the hose axis can be bent by 90 to 135 degrees as stress-free as possible. The diameter of the hose is 12 to 20 mm, preferably 14 to 16 mm. Depending on the material used, the wall thickness is approximately 0.3 to 0.8 mm. The corrugation amplitude is approximately 0.8 to 2.0 mm, the corrugation length is approximately 1 to 3 mm, preferably 2 to 2.5 mm.

[0055] The corrugations of the hose contour promote a spontaneous transition from a radially and axially deformed state under load to a starting state prefabricated during the manufacturing process. Due to the corrugations of the hose, an overall advantageous, film-like embodiment of the hose with very thin walls can also be achieved and a spontaneous elastic axial kink-proofing of the hose or an axial twisting that would close the chamber is promoted. In the region of the retaining element 5a, the shaft hose preferably has no corrugations, but instead a cylindrical reinforcement 6c, for example in the form of a sleeve, is added there.

[0056] Figure 2a In situ display Figure 2 The device is combined with a peristaltic contraction P of the intestinal wall that acts in the rectosigmoid transition area between the rectum R and the sigmoid colon S. The sigmoid balloon section located above the contraction lies against the intestinal wall in a packing-tight manner. The pressure Ps in the balloon segment above the contraction that propagates in a wave-like manner toward the anus corresponds to the pressure Pr below the contraction wave. The invention ensures that a preset packing pressure is maintained in both balloon sections, i.e. above and below the contraction wave, and that the wall of the balloon body lies reliably and sealingly against the intestinal wall.

[0057] Figure 2b The section plane SE of the rectum R is shown. The balloon 5 with the remaining diameter is inwardly indented with a reserved fold 5b. This fold ensures that the balloon wall is stress-free against the corresponding cross section of the intestinal cavity, thereby maintaining the intestinal physiological state.

[0058] The balloon 5 is preferably made of thermoplastic PUR with a Shore hardness of 85A to 95A, preferably 90A to 95A. Its diameter in the area of ​​the rectum and sigmoid colon is 50 to 100 mm, preferably 50 to 70 mm. In the rectosigmoid region, the balloon wall thickness is 7 to 35 μm, preferably 10 to 20 μm. The balloon 5 is preferably sized relative to the diameter of the rectum or sigmoid colon so that the balloon cover is indented with the reserved fold 5b when placed in situ.

[0059] Figure 2cA special cross section 6d of a hose element 6 is shown which is provided with a corrugated profile which stabilizes the chamber. The hose cross section has crater-like recesses 6e at one position, but preferably at two mutually opposite positions, on the hose circumference, to which feed lines 8 for filling the airbag 5 are fixedly or releasably connected or engaged. The feed lines have a series of openings 8a over the entire length of the shaft hose carrying the airbag.

[0060] The inlay groove 6e feed line 8 also helps to axially reinforce or stabilize the shaft hose so that even if the peristaltic contraction of the colon passes over the device, the shaft hose will not axially kink or fold, or axially flip over an angle of more than 90 degrees, but follow the extension of the intestine. The Shore hardness and / or wall thickness of the material of the feed line is preferably greater than the material used for the shaft hose.

[0061] in accordance with Figure 1a As well as the completely mutually independent balloon segments 5b, 5c arranged in sequence shown there, one of the two feeding lines 8 can lead to the distal balloon segment 5b and the other to the proximal balloon segment 5c, and these balloon segments can be filled independently.

[0062] Figure 2d The cross-sectional view of the shaft tube of the device in a special embodiment is shown. The tube is surrounded by a concentrically arranged outer sheath tube 16, which is spaced from the periphery of the shaft tube 6 by non-collapsible or only partially collapsible spacing elements 17, thereby creating a specific non-closable space 19 between the tube layers. In the event of peristaltic contraction, the filling medium is received from the peristaltically loaded part of the balloon 5 through a large number of sieve-like openings 18 of the sheath tube into this space and is fed across the space 19 into the section of the balloon located above the contraction wave, which is no longer contracting. The sheath tube 16 preferably extends over the entire rectosigmoid of the shaft tube. It serves to achieve a local redistribution of the filling medium within the balloon and thereby reduce potential anastomotic pressure peaks in the balloon region below the contraction wave or to help prevent the device from being pressed out of the transanal position due to bolus-artig compression of the filling medium in the rectal segment of the balloon.

[0063] Figure 2eTwo variants of a packing balloon body 5 are shown, which are provided with a complete or incomplete annular constriction 5c within the longitudinal axis of the balloon body 5, which is cut into the balloon in the circumferential direction. The cut constriction 5c improves the in-situ placement characteristics of the balloon, especially in the folded or curved areas of the colon, which are common in the sigmoid colon. The cut constriction 5c reduces the tendency of the balloon to spontaneously orient itself through its longitudinal axis in the filled state of the balloon, thereby giving the filled balloon a favorable axial flexibility or bendability. In the case of placing a balloon body 5 that has been cut once or multiple times, elastic restoring forces that axially align the balloon are avoided to the greatest extent possible. In particular, in the case of a balloon body 5 that has been multiple-narrowed and has annular constrictions spaced 3 to 4 cm apart, compatibility with the colon and the patient's carrying comfort can be improved.

[0064] exist Figure 2e A variant is shown on the right, in which the cut-in constriction 5 c does not extend to the central axis tube, but ends freely at a distance therefrom, so that the airbag 5 is not divided into chambers and the airbag can be filled or emptied together via a single filling hose 8 .

[0065] exist Figure 2e On the left side, a further variant is shown, in which the cut-in constriction 5c extends completely to the central shaft hose 6 and is fixed there in an airtight manner. In this case, the airbag 5 is thus divided into several chambers, which are arranged one after the other along the shaft hose 6. Since these chambers are not connected to each other, they need to be filled individually, which can be done via a filling line 24, which has an opening 25 in each chamber. This embodiment also has the advantage that pressure equalization between the chambers of the airbag 5 can be carried out at any time via the filling line 24, especially in the event of peristaltic contractions. In order to ensure this balanced flow, the filling line 25 can be placed in a groove extending longitudinally on the shaft hose or have other grooves that act in particular radially.

[0066] Figure 3 An exemplary structure of the regulating unit 3 is shown in detail. The programmable control unit C equipped with the control algorithm has a socket-mounted connector 9aa for making a cable connection to the pressure sensor 9 installed in the airbag. Alternatively, or in combination with this, the regulator has a cable, which contains a pressure sensor 9c at the end for measuring the filling pressure through a separate measuring hose 9b integrated in the device, the proximal end of which is connected to the pressure sensor. The connection is made as close to the device as possible, preferably not more than 20 cm away from the device.

[0067] The valve units Vi and Vo are preferably formed by piezoelectric valves, which allow both very precise regulation and sufficiently high flow rates. Preferably, two valves are installed, one of which, Vo, allows the volume to flow out of the airbag. The volume extraction can be accelerated by the regulator, by means of an integrated negative pressure generating mechanism V or an externally generated negative pressure Qo.

[0068] Likewise based on the pressure gradient provided upstream of the valve, the volume is delivered to the gas bag via the valve Vi, wherein the filling medium in the reservoir R is raised to the pressure level to be achieved, for example by an integrated pump P. Alternatively, the required pressure gradient can be established by an external source Qi.

[0069] The control unit also has a manual adjustment function 11 for the pressure required for treatment to be continuously maintained in the balloon, and a setting option 13 for adjusting the regulating flow or speed of the pressure balance or the movement of the filling medium to and / or from the patient. The unit also has an alarm function 12, which displays the pressure value in the balloon that exceeds the selected tamponade pressure.

[0070] The inlet 8o from the airbag 5 to the regulating valve Vo and the outlet 8i from the regulating valve Vi to the airbag 5 can be brought together into a single chamber 8 via a Y-piece 8c. Alternatively, the lines to the proportional valve and the lines from the proportional valve can be led independently to the catheter device and connected to the corresponding hose lines respectively by using two independent feed hoses 8ii and 8oo integrated into the hose sleeve. In this way, the volume can be fed into and out of the airbag synchronously during the regulation process.

[0071] Figure 3a A simplified regulating unit 3a is shown, which consists of a piezoelectrically operated valve Voi, which both moves volume toward the tamponade and discharges volume from it. The connection to the catheter is achieved via a single-chamber hose connection 8 and a connector 8oi. On the side facing the patient, the valve is connected to an electronic pressure measuring component 21, which continuously detects the pressure in the body of the balloon and transmits it to the control unit C. The regulating unit 3a does not have a connection function and a reading function for the pressure measured electronically in the balloon. On the side facing away from the patient, the valve is connected to a pressure accumulator R or an external pressure source Qi integrated in the device, which stores a filling medium in a pressure range of 1 to 2 bar, for example. The piezo valve reduces this pressure to a sealing pressure of about 10 to 20 mbar in the balloon. If the pressure in the balloon rises, it is measured by the component 21. In this case, the valve discharges the filling medium through the opening 20 toward the surroundings following the corresponding gradient. The unit also has the function 11 of regulating the nominal pressure and the function 13 of regulating the volume flow to or from the balloon 5.

[0072] Figure 4A balloon-shaped reservoir made of a specifically stretchable material, which transitions to a specific mechanical stretch range when preferably filled with air, within which a filling fluid can be received 14b into the storage balloon or released 14a from the storage balloon at a constant pressure. In this way, the balloon stores a filling pressure defined by the specific stretchability of the balloon in a so-called "isobaric" manner. The balloon is preferably made of an isoprene-based or TPE-based material. Both in the direction toward the patient and in the direction away from the patient, the balloon is connected to a packing balloon 5 placed in the rectosigmoid colon via a feed line 8. During the manufacturing process, the isobaric volume range of the reservoir is preferably set by a specific material selection and by adjusting the size specifications of the balloon component, so that, depending on the embodiment of the balloon, an isobaric pressure platform of 10 to 30 mbar is achieved. The storage balloon is fed into the isobaric stretch range via a simple filling valve 15.

[0073] Figure 4a Shown corresponding to Figure 4 A portable embodiment 22 of a reservoir for isobaric regulation. The reservoir has a cup-shaped space 22a which is closed by a cover-shaped structure 22b. The space accommodates a balloon 14, for example based on TPE, in a protective manner, which balloon is extended from an initial state 23a of the unfilled part to a filled state 23b. The balloon is fixed to the cover 22b, and its inner space transitions to a feed line 8 leading to a catheter balloon. Air and pressure are applied to the storage balloon via a one-way valve 23.

[0074] The invention also describes a method for postoperative care of a patient after the creation of a surgical end-to-end anastomosis in the region of the terminal colon, wherein the previously indispensable protective creation of an artificial intestinal outlet (stoma) required to prevent inadequate suturing can be omitted, and instead a permanently placed bypass-like drainage device is placed in the cavity of the rectosigmoid colon, wherein in the intestinal segment above the anastomosis, i.e. at the oral end, the liquid-modified feces are received by a device that drains in the form of a hose and is passed through the anastomosed intestinal section and subsequently through the anal canal into a container for collecting feces placed outside the body. The hose element that receives the feces in the intestine and conducts it through the intestine consists of a flexible hose material that can be bent as little as possible without stress, which collapses elastically in a band-like manner under correspondingly large radial loads and / or elastically folds radially once or several times and, when the load is reduced, restores its contour in the manufactured state in a resilient manner. In a preferred embodiment, the hose element is designed such that a certain initial force to be overcome is required to transition from the, for example, rounded diameter in the manufactured state to the elastically deformed state. If the corresponding force is overcome or the stable manufactured cross section of the hose is lost, further deformation or folding of the hose can be achieved with a force that is smaller than this initial force. The corresponding axis mechanism can be established or provided, for example, by spiral or annular corrugations of the hose wall. The hose element carries as a main component a preferably membrane-like, thin-walled balloon body, which is completely manufactured to the required working dimensions and extends from the upper oral end of the hose through the adjacent section of the colon toward the aboral end, through the patient's anal canal, into the preanal region, where it surrounds an optional preanal retaining element, or this retaining element follows the preanal end of the balloon in the aboral section. The balloon body preferably has a certain size so that it is equal to the diameter of the colon or rectum or exceeds this diameter by up to 50%. Thus, when the balloon is filled with a filling medium by means of an extracorporeal regulating device, it is not necessary to cause a significant stretching of the balloon cover in order to seal or abut against the intestinal wall. Instead, abutment can be achieved at a pressure value that does not exceed the physiological pressure inside the intestine or that only exceeds it by a few millibars. The above-mentioned stress-free filling balloon cover is filled or a filling pressure is applied to it by means of the regulating extracorporeal part of the device with a preferably gaseous medium in such a way that a constant filling pressure that can be set by the user, for example in the range of about 5 to 30 mbar, is achieved in the balloon body in response to the hypermotility of the intestine or its contracted state, and capillary perfusion is maintained in the region of the end-to-end intestinal ends where the vascular supply is critical, i.e., the forces acting through the balloon wall on the vascular bed of the intestine do not cause severe perfusion deficiency.In order to avoid pressure peaks in the balloon body that could endanger the integrity of the anastomosis (optionally occurring when peristalsis obtains a segment of the intestine against the balloon), the filling volume is actively withdrawn from the balloon by the regulating mechanism or passively flows out of the balloon when the set value set by the user begins to be exceeded. In this way, the contraction of the chamber extending beyond the intestine in a peristaltic manner is compensated when the nominal pressure is obtained. If the force acting on the balloon body placed in the chamber to fill the intestine decreases and the pressure in the balloon begins to drop, the filling medium is processed again by the regulating unit and delivered to the balloon in a certain way so that the set nominal pressure is always maintained. Due to the dynamic movement of the filling medium out and into the balloon that fills the chamber, the catheter-like device can be kept stationary in the intestine and prevented from being expelled or discharged from the intestine due to peristalsis, or the device is kept in a position beyond the anastomosis required for a specific function.

[0075] As an alternative to a single continuous cylindrical balloon body, for example, a colorectal packing can also be established by sequentially arranged cylindrical balloons, wherein the two balloon components have the same or nearly the same diameter and can independently fill the two segments, wherein the balloon located at the mouth end near the mouth mainly assumes the sealing function and has a higher than preset nominal pressure for this purpose, while the balloon located at the anti-mouth end, which is exposed relative to the anastomosis, has a relatively small pressure that promotes perfusion as much as possible.

[0076] In a preferred embodiment of the balloon body, a continuous one-piece design is adopted, but the diameter of the mouth end segment is relatively increased compared to the segment of the anti-mouth end exposed relative to the anastomosis. This mouth end segment mainly has a sealing function, while the adjacent anti-mouth end portion of the balloon body exposed relative to the anastomosed segment mainly assumes a protective function. The mechanical abrasion effect of the shaft hose on the anastomosis is thereby avoided. In addition, the segment does not exert direct pressure on the anastomosis, thereby ensuring that the secretions released by the suture can be discharged into the cavity of the intestine without hindrance and resistance. Therefore, the balloon cover, which is reduced in diameter to the size of the shaft hose, can realize a certain intermediate cavity, which can accommodate secretions and realize the passive outflow of secretions from there. For this purpose, the segment is equipped with an independent drainage opening into the space accommodating secretions, wherein the secretions contained in the suture area are discharged to a collection container outside the body through an independent hose line. As an alternative to the continuous balloon body of the above design, two balloon compartments that can be filled independently and arranged in series can be considered.

[0077] The filling of the balloon body is preferably regulated by two independently manufactured hose feed lines which are offset by 180 degrees and integrated into the circumference of the hose element via corresponding inlets. These feed lines are designed in such a way with regard to material type, wall thickness and wall profile that the colorectally placed device has the required axial stability to ensure a consistent axial orientation of the shaft hose, which follows the intestinal lumen and avoids kinking and twisting.

[0078] The filling pressure is regulated from outside the body by two types of mechanisms. According to a particularly simple, purely mechanical embodiment of the mechanism, the regulator can consist of a special volume-elastic balloon material which, within a certain filling range or stretch range of its balloon wall, stores the filling medium at a certain pressure defined by the stretch mechanism. The medium is moved toward or away from the patient in such a way that a pressure is achieved in the entire system to which the filling pressure is applied, which is equal to the tamponade pressure to be set, and does not exceed this pressure which prevents damage and maintains perfusion.

[0079] This volume reservoir, which acts isobarically within a certain volume range, is preferably used in a later postoperative phase, when the healing process in the anastomotic region has already achieved some progress.

[0080] In the postoperative phase immediately after the operation, preferably an electronic control mechanism is used, which preferably detects the pressure in the tamponade mask by means of a corresponding electronic sensor assembly and thereby achieves an optimal control behavior, wherein the filling medium is moved into and out of the tamponade mask following a high pressure gradient or pressure difference, which accelerates the inflow or outflow. In other words, the inflow and / or outflow of the medium is driven by the pressure at the external regulator, which pressures exceed the maximum atraumatic pressure in the body of the colorectal balloon. For example, a pressure of 100 to 200 mbar may be present at the input of the control valve. By means of this pressure gradient-based control, the flow resistance in the system for filling the balloon can be optimally compensated. The flow to and away from the balloon is preferably regulated by a piezoelectrically driven valve unit.

[0081] With an electronically regulated system, the user can set a nominal pressure within relatively narrow limits and minimize the response time of the seal plug by increasing the pressure differential between the internal bladder and the external regulator.

[0082] After the intestinal ends are anastomosed end to end, a device for protectively packing the anastomotic sutures is placed by the surgeon through the patient's anus intraoperatively so that the stool-receiving distal end of the packing is positioned approximately 5 to 10 cm above the anastomosis.

[0083] The preanal retention balloon is then inflated and / or secured with tape at the buttocks.

[0084] In a preferred embodiment of the application, in the initial phase of care, for example for about three to four days, the feces drainage plug is connected to an electronic regulator and preferably filled with air as a filling medium and a nominal pressure of about 10 to 30 mbar, preferably 15 to 25 mbar, is set.

[0085] In the event of further care, switch to non-electronic mechanical isobaric regulation. Isobaric regulation can be established in a portable manner, thereby maximizing the freedom of movement of the patient.

[0086] The efficiency of the packing seal is exploited through the liquefaction of stool achieved by oral means, which maintains the stool at the thin consistency required for drainage for the required care period.

[0087] The nursing period is about 5 to 7 days in total. The drain is then removed through the anus, eliminating the need to create a stoma.

[0088] Reference numerals list

[0089] 1 Device

[0090] 2 Catheter

[0091] 3 Regulator

[0092] 3a Regulator

[0093] 4 Connectors

[0094] 5 Airbags

[0095] 5a Retaining element

[0096] 5b High pressure segment

[0097] 5c Low pressure segment

[0098] 5d Airbag segment

[0099] 5e Airbag segment

[0100] 6 Hose

[0101] 6a Transition

[0102] 6b Reinforcement

[0103] 6c reinforcement

[0104] 6d Cross section

[0105] 7 Hose

[0106] 7a Hose line

[0107] 8 Feeding line

[0108] 8c Y-shaped piece

[0109] 8h Feeding pipeline

[0110] 8i Output

[0111] 8ii Feed hose

[0112] 8n Feed Pipeline

[0113] 8o Input

[0114] 8oi Connectors

[0115] 8oo Feed hose

[0116] 9 Elements

[0117] 9a Cable

[0118] Channel 9b

[0119] 9c Sensor

[0120] 9d Cable connection

[0121] 10 Sensors

[0122] 10a Light source

[0123] 11 Regulation function, nominal pressure

[0124] 12 Alarm function, pressure value

[0125] 13 Regulation function, volume flow

[0126] 14 Storage

[0127] 14a Release

[0128] 14b Receiving

[0129] 15 Filling valve

[0130] 16 Sheath hose

[0131] 17 Spacer element

[0132] 18 Opening

[0133] 19 Space

[0134] 20 Opening

[0135] 21 Components

[0136] 22 Implementation Plan

[0137] 22a Space

[0138] 22b Cover

[0139] 23 Check valve

[0140] 23a Starting state

[0141] 23b status

[0142] 24 Hose

[0143] 25 Opening

[0144] AS Anastomosis

[0145] C Control Unit

[0146] DL discharge line

[0147] FB Fixtures

[0148] K segment

[0149] M-Module

[0150] P Contraction

[0151] PA Preanal area

[0152] PH Main Parts

[0153] Pr Pressure

[0154] Ps Pressure

[0155] Qi Source

[0156] Qo Negative Pressure

[0157] R Rectum

[0158] S Sigmoid colon

[0159] SE Cutting Plane

[0160] T terminal function

[0161] TA Anal canal

[0162] Vi Inflow valve unit

[0163] Vo Outflow valve unit

[0164] Voi valve

Claims

1. A device (1) for sealing and packing a surgically created circular anastomosis (AS) between the oral and anti-oral ends of the large intestine, i.e. the rectum (R) or sigmoid colon (S), or other sutures or injuries created in a portion of the intestine, with the function of draining feces through the anastomosed or injured or surgically or otherwise intervened intestinal segment and subsequently passing feces through the anal sphincter, characterized in that At least one thin-walled balloon body (5) made of a material with low volumetric expansion and manufactured completely to its working size during the manufacturing process, which is used to be placed in the area of ​​the anastomosis (AS) so that the distal end of the balloon or the distal balloon segment (5b) is located at the oral end relative to the anastomosis (AS), and the proximal end of the balloon or the proximal balloon segment (5c) is located at the oral end or anti-oral end relative to the anastomosis (AS), or extends downward to the anus or even in front of the anus, wherein the balloon body (5) surrounds a flexible and / or elastically deformable hose element (6), which passes through the balloon body (5) from the distal end or oral end of the balloon body or the balloon segment (5b) to the proximal end or anti-oral end of the balloon body or the balloon segment (5c) and extends upward to an extracorporeal hose (7), which is connected or can be connected to an extracorporeal hose (7), wherein the filling balloon body (5, 5b, 5c) is connected to a device that regulates the feeding of a filling medium into or the outlet of a filling medium from at least a portion of the balloon body (5, 5b, 5c), thereby continuously maintaining a filling pressure in the filling balloon body (5, 5b, 5c), the filling pressure being necessary for sealingly filling the intestinal portion that is distal or oral relative to the anastomosis, as well as the intestinal portion that has been anastomosed, but also being able to uninterruptedly compensate for the abdominal group movement and / or peristaltic contraction of the intestine, thereby continuously maintaining the filling sealing contact of the balloon body (5) with the intestinal wall, and avoiding a critically high occlusion pressure in the sealing balloon body (5, 5b, 5c) that endangers the integrity of the anastomosis (AS), and wherein the central hose (6) a) has the ability to bend flexibly so as to follow the curvature of the rectosigmoid colon compliantly and without stress, and b) having structural stability so that the predetermined position is maintained by the balloon body in the rectum or sigmoid colon through a determined position relative to the anus, by a retaining or thrust bearing element (5a) placed in the direct pre-anal position, and / or by a film-like fixing element (FB) planarly bonded to the perianal skin (PH), so that compliance with the predetermined position is achieved through the balloon body shaft hose.

2. The device (1) according to claim 1, characterized in that The portion of the balloon body extending into the colon fills at least the patient's rectum, but also fills the entire rectosigmoid colon, and also covers the portion of the intestine at the rectosigmoid orifice.

3. The device (1) according to claim 1 or 2, characterized in that The balloon body (5, 5a, 5b, 5c) is carried by a shaft hose (6) which follows the curvature of the rectosigmoid colon without stress.

4. The device (1) according to claim 1, characterized in that The shaft hose (6) is flexible and yet inherently rigid, resisting kinking or bending beyond 90°.

5. The device (1) according to claim 1, characterized in that The shaft tube (6) can be radially folded and straightened elastically in the region of the anus or in the region of the transanal balloon section.

6. The device (1) according to claim 1, characterized in that The diameter of the freely deployed balloon body (5, 5a, 5b, 5c) corresponds to the diameter of the corresponding freely deployed relaxed rectum (R) and / or sigmoid colon (S), or exceeds the rectum sigmoid colon diameter to be treated and thus has a so-called residual size.

7. The device (1) according to claim 1, characterized in that The proximal end of the balloon body (5, 5a, 5b, 5c) is located at the oral end relative to the anastomosis (AS).

8. The device (1) according to claim 1, characterized in that The proximal end of the balloon body (5, 5a, 5b, 5c) is located at the aboral end relative to the anastomosis (AS).

9. The device (1) according to claim 1, characterized in that The balloon body (5, 5a, 5b, 5c) has a distal balloon segment (5b) located at the oral end relative to the anastomosis (AS) and a balloon segment (5c) arranged at the proximal end of the distal balloon segment (5b), which extends in the area of ​​the anastomosis (AS) or also extends out of the anastomosed intestinal part in the anti-oral direction and extends into or through the anal canal.

10. The device (1) according to claim 9, characterized in that The proximal balloon segment (5c) of the balloon body (5, 5a, 5b, 5c) has a smaller diameter than the distal balloon segment (5b) located at the mouth end relative to the anastomosis (AS), thereby avoiding contact between the proximal balloon segment (5c) and the anastomosis (AS).

11. The device (1) according to claim 9 or 10, characterized in that In the area of ​​the proximal airbag segment (5c) of the airbag body (5, 5a, 5b, 5c), a hose line (7a) for draining wound secretions is provided or connected.

12. The device (1) according to claim 9 or 10, characterized in that The airbag body (5, 5a, 5b, 5c) is divided into the distal airbag segment (5b) and the proximal airbag segment (5c).

13. The device (1) according to claim 12, characterized in that The two airbag segments (5b, 5c) are not connected to each other and can therefore be set or adjusted to different internal pressures.

14. The device (1) according to claim 13, characterized in that The internal pressure in the distal or oral balloon segment (5b) is greater than the internal pressure in the proximal or anti-oral balloon segment (5c).

15. The device (1) according to claim 1, characterized in that The balloon body (5, 5a, 5b, 5c) has a transanal balloon segment adjacent to the rectal placement portion of the balloon body (5) or adjacent to the proximal or aboral balloon segment (5c).

16. The device (1) according to claim 15, characterized in that The transanal balloon segment is positioned or positionable within the anal canal and continues the balloon body (5) through the anal canal.

17. The device (1) according to claim 1, characterized in that The dumbbell-shaped balloon body (5, 5a, 5b, 5c) is located in the anal area of ​​the patient, wherein the tapered central area of ​​the dumbbell-shaped balloon body (5, 5a, 5b, 5c) can be placed in the anal canal in a transanal position, thereby fixing the balloon body (5, 5a, 5b, 5c) in the patient's intestine.

18. The device (1) according to any one of claims 15 to 17, characterized in that The diameter of the transanal balloon section or the tapered central region of the dumbbell-shaped balloon body (5, 5a, 5b, 5c) corresponds to the diameter of the fully opened anus or exceeds said diameter.

19. The device (1) according to any one of claims 15 to 17, characterized in that The transanal balloon section or the tapered central region of the dumbbell-shaped balloon body (5, 5a, 5b, 5c) is designed such that, when the sphincter is partially opened, an advantageous radial folding of the remaining sheath wall with excess diameter is achieved in the transanal balloon section.

20. The device (1) according to any one of claims 15 to 17, characterized in that The airbag body (5, 5a, 5b, 5c) expands in front of the anus into a spherical or disc-shaped pre-anal airbag segment (5a).

21. The device (1) according to claim 20, characterized in that An independently inflatable inner airbag that plays an anchoring role is arranged in the pre-anal airbag segment (5a), or other forms of thrust bearing elements that play a corresponding anchoring role are arranged.

22. The device (1) according to claim 20, characterized in that The balloon body (5, 5a, 5b, 5c) has another retaining element (5a) in the pre-anal section, which protects the balloon body from slipping into the patient's intestine.

23. The device (1) according to claim 20, characterized in that A planarly bonded fixing element in the region of the preanal balloon segment (5a) is used to fix the balloon body (5, 5a, 5b, 5c) to the perianal skin in a manner that acts as a thrust bearing.

24. The device (1) according to claim 1, characterized in that By adjusting the balloon filling volume, the peristaltic contraction of the intestinal portion exposed relative to the sealing and packing balloon body is compensated, thereby maintaining the nominal filling pressure set by the user for packing or sealing in the packing balloon body (5, 5a, 5b, 5c) during the peristaltic contraction process, or avoiding a short-term critical high filling pressure.

25. The device (1) according to claim 1, characterized in that By means of in vivo fluid connection between the various regions of the filling balloon body (5, 5a, 5b, 5c), in vivo pressure balance and / or movement of the balloon filling volume between the balloon segments (5a, 5b, 5c) are achieved.

26. The device (1) according to claim 1, characterized in that A fluid channel (19) extending in the area of ​​the shaft hose (6) of the airbag body (5, 5a, 5b, 5c) is connected to different areas of the airbag body (5, 5a, 5b, 5c), thereby achieving fluid connection between the various areas of the airbag body (5, 5a, 5b, 5c), thereby achieving in vivo pressure balance and / or movement of the airbag filling volume between the various airbag segments (5a, 5b, 5c).

27. The device (1) according to claim 1, characterized in that One or more extended filling lines (8) extending in the area of ​​the shaft hose (6) of the airbag body (5, 5a, 5b, 5c) have several openings and can be connected to different areas of the airbag body (5, 5a, 5b, 5c), thereby realizing fluid connection between the various areas of the airbag body (5, 5a, 5b, 5c), thereby realizing in vivo pressure balance and / or movement of the airbag filling volume between the various airbag segments (5a, 5b, 5c).

28. The device (1) according to claim 25 or 26, characterized in that A fluid channel (19) or a filling line (8) extending in the region of the shaft hose (7) of the balloon body (5, 5a, 5b, 5c) is protected by a radially extending region of the shaft hose (7) from closing due to peristaltic contraction.

29. The device (1) according to claim 1, characterized in that The tamponade balloon body (5, 5a, 5b, 5c) is connected to an extracorporeal device for feeding and discharging the filling volume via a hose-like feeding and discharging line (8).

30. The device (1) according to claim 29, characterized in that The chamber of the hose-like feed and discharge line (8) leading to or from the filling balloon body (5) enables the volume flow of the medium fed in and discharged so that the filling and sealing contact of the balloon body (5, 5b, 5c) with the intestinal wall is maintained in all sections of the sealing balloon body (5, 5b, 5c).

31. The device (1) according to claim 30, characterized in that The hose-like feed and discharge lines (8) leading to and from the tampon balloon body (5) have a cross section which is equivalent to a circular cross section with a diameter of 2 to 4 mm.

32. The device (1) according to claim 30 or 31, characterized in that The balloon body (5, 5a, 5b, 5c) can be filled via a hose-like feed line (8) from a mechanical regulator (3) or a volume reservoir (14) located outside the body.

33. The device (1) according to claim 1, characterized in that A regulating unit (3) located outside the patient's body, comprising a pump and / or a pressure unit and a control valve (Vi, Voi) and a regulator acting on the control valve (Vi, Voi), wherein the regulator is constructed so as to be able to fill the packing balloon (5) with a filling medium and / or partially empty it, thereby maintaining in the packing balloon body (5, 5b, 5c) a filling pressure required for sealing the anastomosed intestinal part and continuously compensating for the abdominal group movement and / or the peristaltic contraction of the intestine, thereby continuously maintaining the packing sealing contact of the balloon body (5) with the intestinal wall.

34. The device (1) according to claim 1, characterized in that Filling is performed by a valve system that is rapidly modulated at a high flow rate and that actively delivers volume into the balloon and / or actively extracts volume from the balloon, driven by a pressure gradient of corresponding magnitude.

35. The device (1) according to claim 34, characterized in that An electronically controlled, rapidly and precisely regulating proportional valve controls the feeding and discharge of volume into and from a balloon body (5, 5a, 5b, 5c).

36. The device (1) according to claim 1, characterized in that At least one pressure sensor is arranged in a balloon body (5, 5a, 5b, 5c) that fills the intestinal cavity or closes the intestinal cross section, and continuously detects the filling pressure in the relevant balloon (5) or balloon segment (5, 5a, 5b, 5c).

37. The device (1) according to claim 36, characterized in that A plurality of pressure sensors (9) arranged in each section or segment of the balloon body (5, 5a, 5b, 4c) are used to detect the pressure in the area of ​​the anastomosis (AS) itself and in the distal balloon segment (5, 5b).

38. The device (1) according to claim 37, characterized in that A regulator is used to adjust the pressure in the area of ​​the anastomosis (AS) to a safety value below an upper limit value in order to avoid damage in the area of ​​the anastomosis (AS).

39. The device (1) according to claim 37 or 38, characterized in that A regulator that adjusts the pressure in the balloon segment (5b) at the oral end relative to the anastomosis (AS) to a value higher than a lower limit value in order to ensure sealing relative to the colon at that location.

40. The device (1) according to claim 1, characterized in that A pressure regulating mechanism is connected to the device (1) and ensures a constant nominal pressure set by the user in the packing balloon during peristaltic contractions of the terminal colon, which is required for protecting the anastomosis.

41. The device (1) according to claim 40, characterized in that By adjusting the filling volume in the balloon body (5, 5a, 5b, 5c) accordingly, the device (1) is inhibited from being expelled from the rectosigmoid colon or from the transanal position required for suture protection due to peristalsis.

42. The device (1) according to claim 40 or 41, characterized in that When peristaltic contraction weakens, or the hyperperistalsis of the intestinal wall weakens and the intestinal cavity expands accordingly, the regulating mechanism delivers the filling volume to the balloon body (5, 5a, 5b, 5c) under control, thereby continuously maintaining the nominal pressure set by the user throughout the contraction process, thereby maintaining the filling and protection effect of the balloon cover on the anastomosed intestinal wall.

43. The device (1) according to claim 1, characterized in that A device with a portable structure that can be carried by the patient, which has an integrated pressure source and or a pump-like compression device, which stores pressurized air in a storage container and then ensures a volume flow toward the airbag through a regulating valve within a corresponding pressure difference range to the nominal pressure to be achieved, thereby delivering volume into the airbag.

44. The device (1) according to claim 1, characterized in that The filling pressure is maintained in the filling device by means of a regulator (3) or a reservoir (14) which is regulated in an isobaric manner, ie within a pressure difference range which does not differ much from the nominal pressure.

45. The device (1) according to claim 1, characterized in that An external reservoir (14) that can be carried by a patient is connected or can be connected to a device (1) that performs a tamponade and drainage function via a filling line (8) to adjust the balloon volume and balloon filling pressure.

46. ​​The device (1) according to claim 45, characterized in that The reservoir (14) is in the form of a storage airbag, which has an airbag body made of isoprene material and capable of volume expansion, and realizes a nearly isobaric pressure curve within a stretch range of the airbag wall or a filling state range of the airbag body.

47. Device (1) according to claim 45 or 46, characterized in that The filling medium can move in two directions between the balloon body (5, 5a, 5b, 5c) of the catheter device (2) and the regulating reservoir (14) without exceeding the maximum pressure defined by the reservoir (14) in the entire system with the expansion mechanism.

48. The device (1) according to claim 45 or 46, characterized in that The isobaric regulating reservoir (14) does not have a regulating, inhibiting or flow direction-determining valve for the filling medium, but rather establishes the required volume balance in both directions between the fillings via a feed line, wherein in the static state, the same communicating pressure is achieved in both compartments of the system.

49. The device (1) according to claim 45 or 46, characterized in that The volume reservoir (14) for achieving isobaric regulation is placed in a protective cup-shaped container and is carried by the patient.

50. The device (1) according to claim 1, characterized in that The volume is drawn from the airbag body (5, 5a, 5b, 5c) passively towards the external environment or actively fed into a vacuum upstream of a valve or into a reservoir in which a corresponding negative pressure is stored.

51. The device (1) according to claim 22, characterized in that The balloon body (5, 5a, 5b, 5c) has a thickened element in the pre-anal section, which protects the balloon body from sliding into the patient's intestine.

52. The device (1) according to claim 28, characterized in that A fluid channel (19) or a filling line (8) extending in the region of the shaft hose (7) of the balloon body (5, 5a, 5b, 5c) is protected by radial spacers or spacing elements (17) of the shaft hose (7) from closing due to peristaltic contractions.

53. The device (1) according to claim 36, characterized in that By using pressure sensors located in the region of the anastomosis (AS), at least one pressure sensor continuously detects the filling pressure in the associated balloon (5) or balloon segment (5, 5a, 5b, 5c).

Images