EP3914331A1 - Dispositif de protection étanche par tamponnage de sutures chirurgicales et de plaies, en particulier d'anastomoses de bout en bout du rectum - Google Patents

Dispositif de protection étanche par tamponnage de sutures chirurgicales et de plaies, en particulier d'anastomoses de bout en bout du rectum

Info

Publication number
EP3914331A1
EP3914331A1 EP20708166.2A EP20708166A EP3914331A1 EP 3914331 A1 EP3914331 A1 EP 3914331A1 EP 20708166 A EP20708166 A EP 20708166A EP 3914331 A1 EP3914331 A1 EP 3914331A1
Authority
EP
European Patent Office
Prior art keywords
balloon
pressure
balloon body
segment
filling
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
EP20708166.2A
Other languages
German (de)
English (en)
Inventor
Fred GÖBEL
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Advanced Medical Balloons GmbH
Original Assignee
Creative Balloons Maschinenbau GmbH and Co KG
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Creative Balloons Maschinenbau GmbH and Co KG filed Critical Creative Balloons Maschinenbau GmbH and Co KG
Publication of EP3914331A1 publication Critical patent/EP3914331A1/fr
Pending legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M25/1018—Balloon inflating or inflation-control devices
    • A61M25/10184—Means for controlling or monitoring inflation or deflation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/02—Holding devices, e.g. on the body
    • A61M25/04—Holding devices, e.g. on the body in the body, e.g. expansible
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/11—Surgical instruments, devices or methods for performing anastomosis; Buttons for anastomosis
    • A61B17/1114—Surgical instruments, devices or methods for performing anastomosis; Buttons for anastomosis of the digestive tract, e.g. bowels or oesophagus
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices ; Anti-rape devices
    • A61F5/44—Devices worn by the patient for reception of urine, faeces, catamenial or other discharge; Colostomy devices
    • A61F5/445—Colostomy, ileostomy or urethrostomy devices
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M25/1002—Balloon catheters characterised by balloon shape
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M25/1011—Multiple balloon catheters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M27/00—Drainage appliance for wounds or the like, i.e. wound drains, implanted drains
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12027—Type of occlusion
    • A61B17/1204—Type of occlusion temporary occlusion
    • A61B17/12045—Type of occlusion temporary occlusion double occlusion, e.g. during anastomosis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/12136—Balloons
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/11—Surgical instruments, devices or methods for performing anastomosis; Buttons for anastomosis
    • A61B2017/1132—End-to-end connections
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
    • A61B2017/12004—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord for haemostasis, for prevention of bleeding
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M25/1002—Balloon catheters characterised by balloon shape
    • A61M2025/1004—Balloons with folds, e.g. folded or multifolded
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M2025/1043—Balloon catheters with special features or adapted for special applications
    • A61M2025/1059—Balloon catheters with special features or adapted for special applications having different inflatable sections mainly depending on the response to the inflation pressure, e.g. due to different material properties
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M2025/1043—Balloon catheters with special features or adapted for special applications
    • A61M2025/1072—Balloon catheters with special features or adapted for special applications having balloons with two or more compartments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2210/00—Anatomical parts of the body
    • A61M2210/10—Trunk
    • A61M2210/1042—Alimentary tract
    • A61M2210/1064—Large intestine
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2210/00—Anatomical parts of the body
    • A61M2210/10—Trunk
    • A61M2210/1042—Alimentary tract
    • A61M2210/1067—Anus
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M3/00—Medical syringes, e.g. enemata; Irrigators
    • A61M3/02—Enemata; Irrigators
    • A61M3/0279—Cannula; Nozzles; Tips; their connection means
    • A61M3/0295—Cannula; Nozzles; Tips; their connection means with inflatable balloon

Definitions

  • the invention relates to a device and a method for sealing, tamponing protection of a surgically applied circular anastomosis between an oral and an aboral end of the large intestine, in particular the rectum or sigma, or another suture or lesion existing in this section of the intestine, with the same time chair-guiding function through the anastomosed or injured or surgically or otherwise interventionally supplied segment of the intestine, and then passing the chair through the anal sphincter.
  • circular sutures are usually created, which connect the oral and aboral end of the intestine cut through during the resection “end-to-end”.
  • the anastomosis is carried out by means of metal clips arranged in a ring shape, which connect the two ends of the intestine and restore the continuous lumen of the intestine.
  • the clipping is carried out by special applicators, so-called staplers, which are inserted through the anus of the patient into the area of the intestine to be connected.
  • suture insufficiencies which are usually caused by reduced vascular perfusion in the clipped area.
  • necrotic ischemia of the intestinal wall near the anastomosis and the contents of the intestine escape into the abdominal cavity, which as a rule causes serious, life-threatening inflammatory complications.
  • relief neostomies are therefore carried out when resecting segments of the large intestine, particularly in the area of the deep rectum.
  • the intestinal contents are drained into a collecting pouch far above the rectum, usually in the area of the small intestine, through the abdominal wall, via a surgically created artificial intestinal exit, a so-called stoma.
  • the penetration of stool into the intestine anastomosed with the wreath seam is thus prevented, one that Aenastomosis-causing stool collection or possible dilatation of the joined intestinal ends is thus avoided.
  • the stoma is moved back and excreted again in the normal way. Surgical placement and relocation of a stoma, as well as the course of a stoma therapy, are not without complications and in many cases require surgical revision.
  • the dumbbell-shaped balloon sits on a shaft tube that is elastically deformable in the anal canal.
  • the shaft tube and the tapered balloon portion are thus arranged concentrically to one another, which enables a sealing of the anal canal that is synchronous with the pleural muscles.
  • the trans-anal balloon segment of the anal mucosa remains clinging in a continuously sealing function, spontaneously and adaptively following the respective position of the anal sphincter.
  • the force required for the adaptive, transanal seal is absorbed by the rectal segment of the dumbbell-shaped balloon body.
  • the new types of systems are filled with a defined, predetermined balloon volume, with the conceptual setting of a sagging, unexpanded state of the balloon.
  • the pressure prevailing in the trans-anal positioned balloon is in interaction with the current rectal motility or the currently acting rectal forces.
  • a corresponding device of this type for continuous stool dissipation is described in PCT / EP2012 / 003534.
  • PCT / EP2012 / 003534 There, however, it is a largely passive arrangement, the pressure within the balloon being reduced in relation to silicone-based balloons; for use in a freshly performed resection, a regularly too high pressure would have to be selected for a sufficiently sealing placement of such a balloon within the colon due to peristaltic movements there, which would damage the highly sensitive tissue after the resection procedure.
  • At least one thin-walled balloon body made of a material with preferably low volume extensibility for placement in the region of the anastomosis during manufacture, in such a way that its distal end of the balloon or its distal balloon segment orally the anastomosis in the region of the rectum or sigma of the patient or also extends beyond the sigma, the balloon body enclosing a flexibly and / or elastically deforming tube element which penetrates the balloon body from its distal or oral end or balloon segment to its proximal or aboral end or balloon segment and there is connected or connectable to an extracorporeal tube, the tamponing balloon body being connected via a tube-shaped inlet and outlet to an extracorporeal device which is so active in the inlet and outlet of a filling medium to and from the balion body controls or passively allows the tamponing balion body to maintain a filling pressure that is as small as possible, but also sufficient for the sealing tamponade of the
  • the distal or oral end of the balloon body is to be located orally to the anastomosis so that it is protected from stool by the sealing end of the colon upstream of the anastomosis, the position of the proximal or aboral end of the balloon body is not restricted to a specific position.
  • the proximal end of it can also be located orally to the anastomosis. In such a case, the inner tubing would extend largely exposed inside the colon.
  • the invention recommends placing the proximal end of the balloon at least aborally of the anastomosis or extending it to the anus or even providing it pre-anal.
  • the invention thus provides a drainage-like, tamponing device for draining liquid stools, which is inserted trans-anal into the patient's freshly resected and anastomosed rectum, and liquid-modified stool, depending on the respective post-operative site, 5 to 15 cm, preferably 10 cm above the anastomosis, and through the anus, in a normal way, past the anastomosis suture, into a stool-collecting vessel outside the body.
  • the device essentially consists of a tubular film or film-like tubular component that adapts itself to the anatomical, axial course of the intestine and follows, spontaneously elastically straightens up on its respective profile formed during manufacture, and absorbs and dissipates the chair.
  • the elastically deforming and straightening Foil tube carries a membrane-like thin-walled, cylindrical or even with Haustren-like, circular constrictions, which extends from the rectum floor to the patient's sigma or even beyond the sigma.
  • the balloon body is shaped to its full working dimension during manufacture. Its diameter corresponds to the diameter of the respective, freely unfolded, completely atonous rectum and / or sigma. In the preferred case, the diameter of the balloon body exceeds the assumed rectosigmoidal diameter, and then has a so-called residual dimension.
  • the balloon also has a transanal segment which adjoins the rectal segment. The trans-anal segment is positioned within the anal canal and continues the balloon body through the anal canal.
  • the transanal balloon portion is preferably provided with a diameter which corresponds to or exceeds a fully opened anus. In the case of a partial opening of the sphincter, there is therefore an advantageous, radial folding in of the residual sleeve wall, which is excess in diameter.
  • the balloon body In front of the anus, the balloon body optionally expands into a spherical or discoid shaped pre-anal segment.
  • a separately fillable, anchoring inner balloon or a correspondingly anchoring, differently designed abutment element can be installed as an alternative to a balloon-based fixation of the
  • a device in the area of the peri-anal skin can be a surface adhesive fixation which acts as an abutment.
  • the dumbbell-shaped balloon body is filled by a volume reservoir or a mechanical exciter outside the body through a particularly large-lumen, hose-like feed line.
  • the filling is carried out by a rapid, high-flow regulating valve system which is driven by a correspondingly dimensioned pressure gradient, actively conveys volume into the balloon and / or actively removes volume from the balloon.
  • the prevailing filling pressure within a balloon that tampons the intestinal lumen or closes the intestinal cross-section is preferably continuously recorded by an electronic pressure sensor within the tamping or sealing balloon body.
  • peristaltic contractions of the sigmoid and rectum are compensated for by adapting the balloon filling volume, and thus in the course of the peristaltic contraction in the tampon balloon, a tamponing or sealing target inflation pressure specified by the user can be maintained or passively, critically high inflation pressures can be avoided.
  • Appropriate regulation of the filling volume in the balloon also prevents the peristaltic expulsion of the device from the recto-sigmoid or a dislocation from its transanal position required for the protective function.
  • the volume and pressure regulating mechanism connected to the device ensures a constant target pressure in the tampon balloon, which is predetermined by the user and is required for the protection of the anastomosis, during a peristaitic contraction of the terminal colon.
  • the regulating mechanism supplies the balloon body with filling volume controlled in such a way that the set pressure specified by the user and thus the tamponing, protective effect of the balloon envelope on the anastomosed intestinal wall is maintained throughout the entire course of the contraction.
  • the supply and discharge of volume to and from the balloon is preferably carried out by particularly quickly and precisely regulating, electronically controlled proportional valves.
  • a relatively simply constructed, extracorporeal reservoir balloon that can be comfortably carried by the patient can be connected to the filling line to the tamponing-draining device.
  • the reservoir has a special, specifically volume-expandable balloon made of, for example, isoprene-like material, which enables an almost isobaric pressure curve over a certain stretching range of the balloon wall or filling state of the balloon.
  • Filling medium can thus between the balloon body of the catheter device and the regulating reservoir in both directions be displaced without a maximum pressure in the overall system determined by the reservoir being mechanically stretched becomes.
  • This simple execution of a regulating component is preferably used in the later, post-operative care phase, in which the seam area has already stabilized and a particularly precise and rapid control is no longer the focus of the requirement.
  • the invention discloses a method and a system for sealingly protective, simultaneously stool-wiping or draining tamponade of a circular anastomosis of two ends of the large intestine, such as results from the surgical resection of a rectal carcinoma, whereby after anastomosis is applied by a circular suture or a circular staple clipping, the operator inserts a catheter-like device into the post-operative site, consisting of a diameter that corresponds to or exceeds the diameter of the atonic colon, with the balloon already being manufactured to its required dimension for the tamponade according to the invention is formed, and wherein the balloon body has a taper-like taper suitable for transanal positioning of the device, and has a spherical enlargement pre-anal, which houses a pre-anal retaining element, and wherein the Colon he stretching portion of the balloon body at least fills the rectum of the patient, but optionally also the entire recto-sigmoid.
  • the balloon body is carried by a flexibly bendable shaft tube that follows the turns of the recto-sigmoidal intestine as tension-free as possible, which, particularly in the transanal segment, folds up and straightens in an elastic manner in an elastic manner.
  • the balloon of the tamponing device is connected to an electronically controlled control unit, which applies a set pressure selected by the user to the balloon, and this pressure, peristaltic contractions and mass movements of the abdomen through rapid Compensating supply or removal of filling medium, consistently maintained.
  • the target pressure is typically in the range from 5 to 30 mbar, preferably 10 to 15 mbar.
  • Figure 1 shows an inventive device in a schematic overview, comprising an intra-corporal, tampon balloon catheter for dynamic controlled adaptation to changing volumes and pressures in the intestinal lumen, and an extracorporeal regulator unit connected to the balloon catheter, and a stool collecting vessel.
  • 1a shows an embodiment of the invention with sequentially arranged, separately fillable balloon segments
  • 1 b shows an embodiment which, in the area of the anastomosis, has a special, waisted area which almost conforms to the inner shaft tube;
  • 1c shows a special embodiment of the invention for the peri-anal adhesive fixation of the catheter device
  • FIG. 2a shows the balloon body of a device according to the invention in the state of a sigmo-rectal, peristaltic contraction
  • FIG. 2b shows a transverse section plane of the rectum in order to illustrate the folding behavior of a residual sized balloon positioned in the rectum
  • 2c shows a special structure of a shaft tube carrying the balloon, with hose lines embedded in the hose profile, for supplying and / or discharging hose lines for filling the catheter balloon and for stabilizing the recto-sigmoidal position of the balloon tamponade;
  • 2d shows a further embodiment of a shaft tube
  • 2e shows a special design of a tampon balloon, provided with circular constrictions
  • 3 shows a controller unit according to the invention in a schematic illustration; 3a shows a simplified controller unit;
  • FIG. 4a shows a portable embodiment of an isobarically regulating reservoir constructed in accordance with FIG. 4;
  • the device 1 for protective tamponade of end-to-end connected, anastomosed intestinal portions, the anastomosis being produced by an iumen-containing surgical suture or a surgical clipping or stacking of the intestinal segments to be connected, consisting of the catheter portion 2, an extracorporeal controller unit 3, and a chair-deriving and chair-collecting vessel 4.
  • the catheter portion 2 remains in the patient's body for the entire duration of use of the device.
  • it consists of a dumbbell-shaped balloon element 5, which is seated on a flexible, flexible tube element 8 which follows the turns of the rectosigmoid colon and which, when subjected to a corresponding force through the intestine, or with corresponding mass movements of the body or the like
  • the abdomen elastically collapses and, when the force decreases, resiliently straightens up to its respective profile specified by the manufacture.
  • the tube element carries a retaining element 5a in the immediately pre-anal position, which in the preferred embodiment of the device is completely enclosed by the envelope of the balloon 5.
  • the retaining element can also connect to the proximal end of the balloon element 5, the proximal end of the balloon body then being approximately at the same height as the outer opening of the anus.
  • the retention element 5a can be a balloon-like body but can also consist of gel-like or foam-like materials.
  • the element ensures that the device remains in the position required for its protective and draining function and does not dislocate from the transanal position into the rectum.
  • the trans-anal taper TA of the balloon element is placed in the patient across the sphincter or within the anal canal.
  • the elastically deformable hose element 6 merges extracorporeally into a dissipative hose 7, which connects the head part of the device to the collector 4.
  • the draining tube is preferably made of a film tube-like material, so it can collapse into a flat, band-like structure when the patient is under load or when the patient is lying on it.
  • the balloon element 5 is filled by a large-lumen, flexibly bendable, lumen-stable feed line 8, the diameter and length of which are dimensioned such that the gas volumes required for the dynamic tamponade desired according to the invention are sufficiently rapid and not impeded by excessive flow resistance derived from the balloon, as well as can be introduced into the balloon.
  • the feed line 8 has an inner diameter of 4 to 8 mm, preferably of 5 to 6 mm, within the baiion-bearing portion of the device.
  • the flow-effective diameter can be increased to 7 to 12 mm, preferably 7 to 8 mm.
  • the feed line 8 can be stabilized, for example, by a reinforcing helix integrated into the wall of the feed line.
  • Your wall can also be provided with a special, wavy profile, which gives the hose the necessary bending properties with simultaneous kink stability.
  • a pressure-absorbing element 9 is integrated in the balloon 5, preferably in the area of the rectal segment of the device.
  • the element 9 merges into a cable 9a, which establishes the connection to the extracorporeal controller unit 3.
  • Pressure-absorbing components which can be converted into an electronic signal are also conceivable, which, with or without their own integrated energy source, direct the pressure prevailing in the balloon to the controller of the controller unit.
  • a separate, tubular channel 9b can be integrated into the device, which is connected to a pressure-absorbing sensor 9c outside the patient, which in turn communicates with the controller via a cable connection 9d.
  • connection of the patient-side unit 2 of the device to the extracorporeal, regulating mechanism 3, in particular the connection for the supply and discharge of volume to the balloon, takes place in each case by specifically designed connector components which prevent confusion.
  • the controller 3 has a programmable control unit C which is provided with corresponding control algorithms. It has a terminal function T for the input of control parameters by the user. It also contains an assembly which preferably consists of two separate pressure and / or flow regulating valve units Vi for the inflow and Vo for the outflow.
  • the regulator can also contain a module M upstream of the respective valve units with a reservoir function and / or pump function and / or a connection to an external pressure or vacuum source.
  • FIG. 1 a shows a special, axially segmented embodiment of the rectal or rectosigmoidal balloon body, as a result of which the tampon-sealing device in the area immediately exposed in the anastomosis in a particularly adapted, perfusion-protecting manner or with particularly low pressure values which maintain the blood flow to the anastomosis can be filled. Pressure-related infarctions in the area of the anastomosed intestinal ends can be optimally prevented.
  • the embodiment thus has a relative high-pressure segment 5b and a relative low-pressure segment 5c. In the low pressure segment, for example, tamponing pressures of only 5 mbar above the internal organ pressure prevailing in the resection area can be set.
  • the low-pressure segment 5c preferably extends through the anal canal and encloses the pre-anal abutment element 5a.
  • the high pressure segment 5b is positioned distal to the low pressure segment. His job is to look after one orally from the anastomotic portion of the intestine to produce a sealing function. The vascular blood flow in this section of the intestine is unimpaired and thus allows higher filling pressures that optimize the sealing efficiency of the balloon tamponade.
  • the two segments 5c and 5b are shaped in the area of contact of their balloon shoulders in such a way that they lie against one another with the smallest possible upper and lower shoulder radii, thus avoiding pocket-like spaces for the accumulation of intestinal contents between the balloon segments.
  • the segments 5c and 5b each have their own separate feed lines 8h and 8n.
  • the associated controller 3 is supplemented for the second balloon segment to be controlled with corresponding additional inputs, valve units, input and control functions and outputs.
  • the device is equipped both in the high-pressure and in the low-pressure segment with an electronic pressure sensor or a pressure-absorbing unit that converts into an electrical signal.
  • Fig.lb shows two variants of one compared to the embodiment. 1 modified design, wherein the baiion segment 5d exposed to the anastomosis AS is approximately reduced in diameter to the diameter of the inner shaft tube 6.
  • the remaining gap between the segment 5d and the diameter of the shaft tube is 3 to 10 mm, preferably 3 to 5 mm.
  • the balloon segment Sd changes into a diameter that corresponds to the opened, relaxed, largely atonic anal canal, or has a diameter that exceeds this up to 50%, preferably up to 25%.
  • the balloon segment 5d can enclose a pre-anal abutment element 5a, but can also end flush pre-anal with the outer opening of the anal canal, and there change into a pre-anal attached, film-like adhesive fixation or such, if possible without forming a space, be affiliated.
  • the distally terminal balloon segment 5e can also be used the proximal segment 5d, which is tapered relative to this, and optionally also with the pre-anal segment 5a, in a freely continuous, freely communicating manner so that a constant pressure equalization is possible between all balloon segments 5a, 5d, 5e.
  • the balloon segments 5a, 5d, 5e are all supplied only via one or more common filling lines 8.
  • the wall thickness of the balloon envelope is increased in segment 5d with the diameter tapered relative to segment 5e, which means that the radial expansion of the envelope near the anastomosis occurs even with higher inflation pressures Segment 5d can be avoided.
  • Anastomotic area AS does not have a tamponing function that lies flat against the anastomosis and avoids the perfusion-preventing direct contact of the balloon body with the anastomosed balloon ends.
  • the tapered segment Sd also protects the shaft tube and prevents direct mechanical irritation of the seam area due to the chair tube that is significantly thicker than the baiion body.
  • the device In order to be able to derive wound secretions produced by the anastomosis from the area of the tapered segment 5d, the device is provided with a special drainage line DL, which absorbs wound secretions in the area of the anastomosis and leads them extracorporeally via a hose line 7a.
  • the proximal, tapered segment 5d can also be structurally and functionally separate from the distal, sealing segment. Such an arrangement is shown in Fig. 1b in the left half of the catheter 2. There is no flow connection between the distal or oral balloon segment 5e and the proximal or aboral balloon segment 5d, so that the respective pressures in both balloon segments 5d, 5e can be specified and / or regulated separately. In particular, the pressure in the distal balloon segment 5e can then be set higher than in the proximal balloon segment 5d.
  • FIG. 1c shows an embodiment of the device with a special pre-anal fixing component, whereby instead of or in addition to an abutment element 5a, a foil-like fastening FB is used, which is glued flat onto the perl-anal skin areas PH of the patient.
  • the film fixation preferably consists of thin-walled, thermoplastic film made of polyurethane, as used for example for the fixation of wound dressings or for direct skin protection.
  • the film can be coated over the entire area, or only in sections with an adhesive, for example also a PUR-based, strongly adhesive gel, which enables adhesion to the skin surface that extends over several days of use.
  • the fastening film is preferably designed as a double-winged, propeller-like shape, the wing surfaces being glued to the inner surfaces of the anal fold.
  • 2 shows the patient-side unit 2 of the device in trans-anal positioning in the patient's body.
  • the circular anastomosis AS is above the anal canal TA.
  • the balloon element 5 extends from pre-anal PA through the anal canal TA, through the rectum R, optionally into the area of the sigma S. If there is a contraction of the sigmoid, the rectum or the anus, the preferably gaseous filling medium becomes or compresses the air filling in the balloon element, which increases the pressure in all other segments of the tamponing balloon body.
  • This change in pressure is recorded by the sensor 9 and causes the control unit C to open the valve Vo.
  • the valve continuously releases volume from the balloon in the course of the force exerted on the body of the balloon, so that a certain target pressure set by the user is maintained as constant as possible in the balloon. If the tone of the contraction subsides and the intestinal lumen opens, the valve VI supplies the balloon with volume in a corresponding manner, in order to maintain the desired pressure. This interaction allows a peristaltic contraction of the recto-sigmoidal colon to be compensated in such a way that the balloon inflation pressure does not, on the one hand, produce critically high pressure values that endanger the anastomosis.
  • the filling medium in the balloon does not compress like a bolus before the contraction wave, and that the entire device, such as intestinal contents, is expelled from the rectum, the device remains in the specific tamponade position required for its function.
  • the pressure-sensing electronic sensor 9 is attached to the surface of the shaft tube in the area of the anastomosis. It thus ensures that critical prints are measured as precisely as possible and recorded with the least possible delay.
  • a sensor 10 working with infrared diode light which detects a certain segment K of the anastomosed intestine, can be fixed at the level of the anastomosis to be protected, and in generates a plethysmographically usable electronic signal in this segment or in a cone-like section of the intestinal wall.
  • the tampon-sealing device in the area of the anastomosis can be equipped with one or more light sources 10a mounted inside the balloon body, preferably on the shaft tube, the light quality and output of which can be adjusted such that the blood-filled vessels are located in the anastomosis area Contrast well enough to allow the surgeon to assess the local perfusion directly in situ within the operating field. It is also possible to use special light which illuminates substances which are intravascularly supplied to the patient, as is customary, for example, in the fluorescence-angiographic display of vessels.
  • the balloon 5 extends into the anal canal and, in the preferred embodiment, over its entire longitudinal extent to the outer opening of the anus.
  • the balloon body that extends through the anus extends pre-anal as a spherically discoid compartment, for example Retaining element 5a completely or only partially encloses or encloses.
  • the diameter of the baiion 5 in the transanal segment TA is preferably selected during manufacture such that it can follow the currently sealed lumen of the anal canal without an expansion of the wall of the transanal balloon segment being necessary, which is indicated by a corresponding residual dimensioning of the diameter in this baiion segment can be guaranteed.
  • the expected fluctuations in the diameter of the anal canal can be compensated for in a sufficiently sealing manner from the folding of the residual dimensioned balloon wall in situ within the anal canal.
  • the force which the balloon envelope acts as a seal against the mucous membrane of the anal canal corresponds to the respective force absorbed recto-sigmoidally by the balloon body.
  • trans-anal balloon diameter exceeds the respective diameter of the anus, a trans-anal sealing pressure continuously corresponding to the recto-sigmoidal pressure can be produced in the described embodiment.
  • a force-intensive stretching of the balloon cover for the sealing closure of the anal canal can thus be avoided until the residual reserve fold that has been trans-anally turned over completely.
  • a balloon component is preferably used as the retention element 5a, the shaped balloon dimension of which is adapted for mechanically effective retention or securing of the device in front of the anus.
  • the element consists, for example, of a material that is only slightly expandable in volume. It has a diameter of 25 to 50 mm, preferably 30 to 40 mm.
  • the balloon 5a is preferably made from a PUR hardness according to Shore 90A to 95A or 55D to 65D. Alternatively, it is filled with a gaseous or liquid medium, whereby the filling volume is dimensioned such that the balloon is only partially filled and changes into a slack, unstretched state, i.e.
  • the retaining element can alternatively consist of a gel-like or foam-like voile material.
  • the distal radius of the balloon 5 in the region of the transition 6a to the shaft tube can be stabilized by a circular, foil-like stiffening 6b, which the balloon body is glued flat, for example.
  • the distal end of the tube can be provided with an olive or mushroom-shaped element that extends beyond the front balloon radius.
  • the shaft tube 6 preferably consists of a PUR hardness according to Shore 8 ⁇ A to 95A, or also 55D to 60D. It is preferably equipped with a wavy profile which provides the hose with an axial flexibility which maintains the draining hose lumen, bends of the hose axis of 90 to 135 degrees which are as stress-free as possible are possible.
  • the tube has a diameter of 12 to 20 mm, preferably 14 to 16 mm. Depending on the material durometer used, the wall thickness is approx. 0.3 to 0.8 mm.
  • the corrugation amplitude is approximately 0.8 to 2.0 mm, the wavelength is approximately 1 to 3 mm, preferably 2 to 2.5 mm.
  • the corrugation of the hose profile assists in the spontaneous erection of a under load radially and axially deformed state in the pre-formed each at 'the production initial state.
  • the corrugation of the tube also enables an overall advantageous, particularly thin-walled, foil-like design of the tube and supports its spontaneous, elastic, axial unwinding or prevents lumen-occluding axial torsions.
  • the shaft tube preferably does not receive any corrugation, but is supplemented here with a lumen-preserving, for example sleeve-like, cylindrical stiffening 6c.
  • FIG. 2a shows the device described in FIG. 2 in situ, in interaction with a peristaltic contraction P of the intestinal wall acting in the area of the recto-sigmoidal transition between the rectum R and the Sigma S.
  • the sigmoidal balloon section above the contraction remains clinging to the intestinal wall in a tampon-sealing manner.
  • the pressure Ps which is in the balloon segment above the contraction that propagates in a wave-like manner to the anus, corresponds to the pressure Pr below the contraction wave.
  • the invention ensures that a predetermined tamponade pressure is maintained in both balloon portions, ie above and below the contraction wave, and the wall of the body of the balloon remains reliably sealed to the wall of the intestine.
  • the section plane SE through the rectum R is shown in Fig. 2b.
  • the balloon 5, which is of residual diameter, turns over into the reserve fold 5b.
  • the folding ensures that the balloon wall clings to the respective cross-section of the intestinal lumen without tension, and the physiological intestinal state is thus preserved.
  • the balloon 5 preferably consists of a thermoplastic PUR with a Shore hardness of 85A to 95A, preferably 90A to 95A. In the area of the rectum and sigma, it has a shaped diameter of 50 to 100 mm, preferably 50 to 70 mm.
  • the wall thickness of the balloon is in the rectosigmoidal range 7 to 35 mm, preferably 10 to 20 mm.
  • the diameter of the balloon 5 is preferably dimensioned in relation to the diameter of the rectum or sigma in such a way that the balloon envelope turns into a reserve fold 5b when placed in situ.
  • FIG. 2c shows a special cross-section 6d of a tube element 6 provided with a corrugated, corrugated, lumen-stabilizing profile.
  • the tube cross-section has trough-like depressions 8e at one, but preferably at two opposite positions in the tube circumference, into which the balloon 5 is filled
  • Supply lines 8 are fixedly or detachably connected or embedded with these.
  • the supply lines have a series of openings 8a over the entire length of the shadow hose carrying the balloon.
  • the feed lines 8 embedded in the recesses 6e can also be used for the axial
  • Stiffening or stabilization of the shaft tube contribute, whereby the Even in the case of a peristaltic contraction of the colon running over the device, the shaft tube does not kink or fold in axially, or possibly also fold axially over an angle of more than 90 degrees, but follows the course of the intestinal coils.
  • the feed lines preferably consist of a material of greater Shore hardness and / or greater wall thickness than the materials used for the shaft tube.
  • one of the two feed lines 8 can lead to the distal balloon segment 5b, the other lead to the proximal balloon segment 5c, and fill them separately.
  • FIG. 2d shows a cross section through a specially designed shaft tube 6 of the device.
  • the tube is surrounded by a concentrically arranged, outer enveloping tube 16, which remains spaced from the circumference of the shaft tube 6 by means of a spacer element 17 that cannot or only partially collapses, and thus creates a certain, non-closable space 19 between the tube layers.
  • a spacer element 17 that cannot or only partially collapses, and thus creates a certain, non-closable space 19 between the tube layers.
  • filling medium from the peristaltically loaded portions of the balloon 5 is taken up through numerous, sieve-like openings 18 of the Hüil tube and is displaced across the space 19 into the sections of the balloon above the contraction wave, which are again moved by the Contraction are exposed.
  • the enveloping tube 16 preferably extends over the entire recto-sigmoidal extension of the shaft tube.
  • Balloons can be pressed out of the trans-anal position.
  • FIG. 2e shows two variants of a tamponing balloon body 5, which is provided with completely circular or also partially circular waistlines 5c which cut into the circumference of the balloon over the longitudinal axis of the balloon body 5.
  • the incisive waistlines 5c improve the placement properties of the Balloons in situ, especially in the area of a flexure or bend of the colon, as is typically shown in the sigmoid of the colon.
  • the incisive waists 5c reduce the tendency of the balloon to be spontaneously aligned along its longitudinal axis when the balloon is filled, thus giving the filled balloon an advantageous axial flexibility or bendability.
  • the elastic restoring forces that axially align the balloon are largely achieved when a single or multiple-clicked-in balloon body 5 is placed avoid.
  • the multi-waisted balloon body 5 with circular constrictions of at least 180 degrees of the balloon circumference at a distance of 3 to 4 cm improves the compatibility with the colon and the comfort of the patient.
  • FIG. 2e A variant can be seen in Fig. 2e on the right, the incisive waists 5c not extending to the central shaft tube 6, but ending at a distance from the latter, so that the balloon 5 is not divided into individual chambers and together by a single one Filling hose 8 can be filled or emptied.
  • Sn Fig. 2e shows another variant, the incisive waists 5c extending completely to the central shaft tube 6 and being fixed there in an airtight manner.
  • the balloon 5 is divided into a plurality of chambers which are lined up one behind the other along the shaft tube 6. Since these chambers do not communicate with one another, they have 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 a pressure equalization between different chambers of the balloon 5 is possible at any time through the filling line 24, in particular in the case of a peristaltic contraction.
  • the filling line 25 can be inserted in a depression running longitudinally along the shaft tube, or it can have other, in particular radially acting stiffeners.
  • the programmable control unit C which is provided with a control algorithm, has a socket-like connection 9aa for connecting the cable connection to Pressure sensor 9 mounted inside the balloon .
  • the controller has a cable with a terminal pressure sensor 9c, for the case of measuring the tamponade pressure, a separate measuring tube 9b integrated into the device, the proximal end of which connects to the pressure sensor becomes.
  • the connection is made as close as possible to the device, preferably not more than 20 cm from it.
  • the valve units Vi and Vo preferably consist of piezo-electric valves, which allow both a very precisely adjustable regulation and also sufficiently high flows. Two valves are preferably installed, one valve allowing volume to flow out of the balloon.
  • the controller can accelerate the removal of volume by means of an integrated, a negative pressure generating mechanism V or an externally generated negative pressure Qo.
  • the delivery of volume to the balloon through the valve Vi also takes place on the basis of that provided in front of the valve! Pressure gradients, the filling medium in a reservoir R being raised, for example by an integrated pump P, to a specific pressure level to be maintained there.
  • the required pressure gradient can alternatively be established by an external source Qi.
  • the control unit also has a manual setting function 11 for the therapeutically required inflation pressure, which is to be maintained continuously in the balloon, as well as an adjustment option 13 for the respective regulating flow or the speed of the pressure compensation or the displacement of filling medium to the patient and / or from the patient to make adjustable.
  • the unit also has an alarm function 12 which displays pressure values within the balloon that exceed the selected tamponade pressure.
  • the inlet 8o from the balloon 5 to the regulator valve Vo and the outlet 8i from the regulator valve VI to the balloon 5 can be brought together to form a single lumen 8 via a Y-piece 8c.
  • the lines to and from the proportional valves can be routed separately to the catheter device, and there in the case of two separate supply tubes 8ii and integrated in the tube jacket 8oo, each connected to the corresponding hose lines. In this way, volume can be simultaneously fed to and discharged from the balloon during the regulation.
  • FIG. 3a shows a simplified regulator unit 3a, consisting of a piezoelectrically operating valve Voi, which both shifts volume towards the tamponing balloon and also releases volume from it.
  • the connection to the catheter is made via a single-lumen hose connection 8 and a connector 8oi.
  • An electronic pressure-measuring component 21 which continuously detects the pressure in the body of the body and supplies it to the control unit C, is connected upstream of the valve to the patient.
  • the controller unit 3a has no connection and reading function of a pressure measured electronically in the balloon.
  • Upstream of the valve on the side facing away from the patient is either a pressure reservoir R integrated in the device or an external pressure source Qi, which keeps the filling medium in stock, for example, in the pressure range of 1 to 2 bar .
  • the piezo valve reduces this pressure to approx. 10 to 20 mbar sealing pressure in the balloon. If there is an increase in pressure in the balloon, this is measured by component 21.
  • the valve then discharges filling medium, following the respective gradient, to the surroundings via an opening 20.
  • the unit also has a setting option 11 for the target pressure and a possibility for setting 13 the respective volume flow to or from the balloon 5.
  • FIG. 4 shows a balloon-like reservoir 14 made of a specific volume-expandable material which, when filled with air, preferably changes into a specific mechanical expansion range in which, at constant pressure, filling medium can be taken up 14b into the reservoir balloon or released 14a therefrom.
  • the balloon thus has a certain filling pressure defined by the specific volume expansion of the balloon, so to speak, "isobaric".
  • the balloon is preferably made of isoprene-like or TPE-based material. It is in open communication with the recto-sigmoidally placed tampon pad 5 via the supply line 8, both towards the patient and away from the patient.
  • the isobaric volume range of the reservoir is determined during manufacture by the specific choice of material and the dimensioning of the regulator Balloon component preferably set such that depending on Technical design of the balloon Set isobaric pressure plateaus from 10 to 30 mbar.
  • the reservoir balloon is acted upon by a simple filling valve 15 into the isobaric expansion area.
  • FIG. 4a shows a portable version 22 of an isobarically regulating volume reservoir designed according to FIG. 4.
  • the reservoir is at your disposal! a pot-like space 22a, which is closed with a lid-like structure 22b.
  • the space accommodates, for example, a TPE-based balloon 14, which, starting from an unfilled, partially shaped basic state 23a, is expanded into a filled state 23b.
  • the balloon is fixed on the cover 22b, its inner space merges into the feed line 8 to the catheter balloon.
  • the reservoir balloon is pressurized with air and pressure via a one-way valve 23.
  • the invention also describes a method for the post-operative care of patients after the application of a surgical end-to-end anastomosis in the area of the terminal colon, whereby a protective application of an artificial intestinal exit (stoma), which was previously mandatory and required to prevent seam insufficiency, has been dispensed with , and instead a permanently placed, bypass-like drainage device is inserted into the lumen of the recto-sigmoid colon, this liquid-modified stool taking up a stool-like device in an intestinal segment above, ie orally from the anastomosis, and the stool conducts through the anastomosed intestinal section and the adjoining anal canal into a chair-collecting container attached outside the body.
  • stoma artificial intestinal exit
  • the tube element that takes up the stool in the intestine and dissipates it through the intestine via naturalis consists of a flexible tube material that is bendable as tension-free as possible, which collapses elastically, band-like and / or elastically, in one or more ways radially with correspondingly strong radial load, and when the load decreases, in turn acts in an elastic manner in the profile of its respective manufacturing state.
  • the hose element is structurally designed such that the transition from, for example, the circular diameter of the manufacturing state to the elastically deformed state requires a certain initial force to be overcome. Is the respective force overcome or the stable manufacturing cross section of the Leaving the hose, further deformation or folding of the hose is possible with a smaller force relative to the initial force.
  • a corresponding shaft mechanism can be produced or set, for example, by a helical or ring-like, corrugated corrugation of the hose wall.
  • the tube element carries as an essential component a completely molded to the required working dimensions, preferably membrane-like thin-walled balloon body, from the upper, oral mouth of the tube, over the abortionally adjacent segments of the colon, through the anal canal of the patient, into the immediately pre -anal region extends where it encloses an optional pre-anal retaining element, or such directly adjoins the pre-anal end of the balloon aborai.
  • the balloon body is preferably dimensioned in such a way that it corresponds to the diameter of the atonous colon or rectum or exceeds its atonous diameter by up to 50%.
  • the balloon which is tamped without tension, is filled with a preferably gaseous medium by the regulating, extracorporeal part of the device or is applied with tamponing pressure in such a way that within the balloon body, responsive to the current tone of the intestine or its contraction state, a consistent, sets the filling pressure specified by the user, which ranges, for example, in a range of approx. 5 to 30 mbar and maintains the capiilar perfusion in the area of the vascularly supplied, end-to-end connected intestinal ends, transmural from the balloon to the vascular bed of the intestine acting force therefore does not result in a critical lower perfusion.
  • the filling volume is actively removed or removed from the balloon by the regulating mechanism when the setpoint specified by the user begins to be exceeded its passive outflow from the balloon initiated.
  • the regulating unit fills the balloon with filling medium in such a way that the specified target pressure is maintained throughout remains.
  • the dynamic displacement of filling medium from and into the tamponizing lumen-closing balloon enables the catheter-like device to be held stationary in the intestine and to prevent peristaltic expulsion or excretion of the device from the intestine or the device in the manner required for its specific function to hold the anastomotic position.
  • the colo-rectal tamponade can also be produced by, for example, two sequentially arranged cylindrical balloons, both balloon components having the same or approximately the same diameter, and both segments being able to be filled individually.
  • the orifice positioned near the mouth has a higher set pressure for its primary sealing function than the specification, while in the aborally positioned balloon, which is exposed to the anastomosis, there is a relatively smaller pressure that is as gentle as possible on the perfusion.
  • the entire body is in one piece, but its oral segment is relatively enlarged in diameter in relation to the aboral segment, which is exposed to the anastomosis. While the oral segment has a primary sealing function, the part of the balloon body adjoining after the oral function has which is exposed to the anastomosed segment, a primary protective function. A mechanical erosive effect of the shaft tube on the anastomosis is avoided. Furthermore, the segment does not exert any direct pressure on the anastomosis and thus ensures that secretions released from the suture can flow unhindered and without resistance into the lumen of the intestine.
  • the balloon envelope which is reduced in diameter to approximately the size of the shaft tube, thus allows a certain space that can hold up secretions and allow the secretions to passively drain out from there.
  • the segment is provided with a separate, draining opening in the secretion-receiving space, the secretion received in the seam area being drained off through a separate hose line into a collecting container attached outside the body.
  • two serially arranged, separately fillable baiion compartments are again conceivable.
  • the filling of the balloon body is preferably regulated via two, separately manufactured hose feeds, which are offset by 180 degrees and integrated in the circumference of the hose element by means of corresponding openings.
  • hose feeds which are offset by 180 degrees and integrated in the circumference of the hose element by means of corresponding openings.
  • the material type, wall thickness and wall profile are designed in such a way that they give the device placed in the patient, colo-rectally, the necessary axial stability in order to ensure a continuous axial alignment of the shaft tube, avoiding kinks and twists, following the lumen of the intestine.
  • the filling pressure is regulated extracorporeally by two conceptual types of mechanism.
  • the governor can consist of a special, volume-elastic balloon material that keeps a filling medium in stock at a certain, mechanically defined pressure over a certain filling area or expansion area of its balloon wall. The displacement of the medium towards or away from the patient takes place in such a way that a pressure is established in the entire system that is filled with filling pressure, which corresponds to the tamponade pressure to be inflated and does not exceed this atraumatic, perfusion-maintaining pressure.
  • the volume reservoir which acts isobarically over a certain volume range, is preferably used in the later postoperative phase when the heating process in the anastomotic area has already progressed.
  • electronically regulating mechanisms are preferably used; in the preferred case, the prints are already inside the tamponized balloon envelope by means of corresponding electronic sensor components detect and thus enable an optimal control behavior, the displacement of filling medium in and out of the tampon balloon body follows a higher pressure gradient or differential pressure accelerating the respective inflow or outflow.
  • the inflow and / or outflow of medium is thus driven by extracorporeal pressure on the regulator, which go beyond the atraumatic maximum pressure in the colourectal balloon body.
  • pressures of 100 to 200 mbar can be present at the inlet of the regulating valve.
  • the regulation via such a pressure gradient allows flow resistances in the system filling the balloon to be optimally compensated for.
  • the respective flows directed towards and away from the balloon are preferably controlled by piezo-electrically driven valve units.
  • the user has the option of specifying the target pressure within relatively narrow limits, and by increasing the differential pressure between the intracorporeal balloon and the extracorporeal regulator, the response time of the sealing tamponade is minimized.
  • the device for protective tamponade of an anastomotic suture is placed intra-operatively by the surgeon through the anus of the patient after the end-to-end joining of the intestinal ends in such a way that the distal, stool-receiving end of the tamponade is about 5 to 10 cm above the Anastomosis is positioned.
  • the pre-anal retention balloon is then filled and / or the device is fixed gluteally with an adhesive tape.
  • the tamponing, chair-draining drainage is then connected to an electronic controller in the initial phase of the supply, for example for about three to four days, and is preferably filled with air as the filling medium and a target pressure of approximately 10 to 30 mbar adjusted, preferably 15 to 25 mbar.
  • the isobaric Pressure control can be manufactured in a portable form, thus allowing the patient the best possible free movement
  • the efficiency of the tampon seal is produced by oral-medicinal, continuous stool liquefaction, which keeps the stool in the thin consistency required for drainage for the required supply period.
  • the total supply period is approximately 5 to 7 days.
  • the drainage is then pulled over the anus, preventing the creation of a stoma.

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Abstract

L'invention se rapporte à un dispositif (1) de tamponnage protecteur étanche et simultanément s apte à l'évacuation des selles d'une anastomose circulaire (AS) de deux extrémités du gros intestin, comme il s'en produit par exemple lors de la résection chirurgicale d'un cancer du rectum. Un corps de ballon (5) à parois minces complètement formé lors de la fabrication, de préférence en polyuréthane thermoplastique (TPU), est placé dans la zone de l'anastomose (AS), et le ballon de tamponnage (5) rectal ou rectosigmoïde est rempli d'un milieu de remplissage de préférence gazeux de telle sorte qu'une pression nécessaire au tamponnage étanche de la section d'intestin anastomosée aussi basse que possible peut être maintenue en continu, et que, même dans le cas d'une contraction péristaltique du côlon rectosigmoïde, la pression de consigne prédéfinie par l'utilisateur peut être maintenue de manière aussi constante que possible. Des débits volumiques suffisamment élevés du milieu introduit et évacué exerçant une pression sur le ballon (5) peuvent être atteints, si bien que, dans tous les segments du corps de ballon, le contact étanche du ballon (5) avec la paroi de l'intestin peut être maintenu au cours d'une onde de contraction péristaltique allant du côlon sigmoïde (S) à l'anus.
EP20708166.2A 2019-01-24 2020-01-24 Dispositif de protection étanche par tamponnage de sutures chirurgicales et de plaies, en particulier d'anastomoses de bout en bout du rectum Pending EP3914331A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102019000474.4A DE102019000474A1 (de) 2019-01-24 2019-01-24 Vorrichtung zur dichtend tamponierenden Protektion von Darm-Anastomosen
PCT/IB2020/050563 WO2020152640A1 (fr) 2019-01-24 2020-01-24 Dispositif de protection étanche par tamponnage de sutures chirurgicales et de plaies, en particulier d'anastomoses de bout en bout du rectum

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EP3914331A1 true EP3914331A1 (fr) 2021-12-01

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EP20708166.2A Pending EP3914331A1 (fr) 2019-01-24 2020-01-24 Dispositif de protection étanche par tamponnage de sutures chirurgicales et de plaies, en particulier d'anastomoses de bout en bout du rectum

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US (1) US12257408B2 (fr)
EP (1) EP3914331A1 (fr)
CN (1) CN113613591B (fr)
DE (1) DE102019000474A1 (fr)
WO (1) WO2020152640A1 (fr)

Families Citing this family (11)

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Publication number Priority date Publication date Assignee Title
FR2978345B1 (fr) 2011-07-25 2013-08-30 Charam Khosrovaninejad Dispositif chirurgical d'ancrage controle dans l'intestin.
FR3072557B1 (fr) 2017-10-19 2019-11-08 Safeheal Dispositif chirurgical complexe pour la realisation et protection d'une anastomose.
FR3097421A1 (fr) 2019-06-24 2020-12-25 Safeheal Dispositif pour le lavement d’une anastomose intestinale in situ
KR102387339B1 (ko) * 2020-03-25 2022-04-18 주식회사 제이에스알메디컬 변 우회 보조 장치
CN112642013B (zh) * 2021-01-14 2022-04-15 四川大学华西医院 一种密闭式灌肠器
CN112891714B (zh) * 2021-02-07 2024-02-06 武汉真彩智造医疗技术有限公司 一种结、直肠手术用封闭器
CN113101424B (zh) * 2021-03-29 2022-06-10 中国人民解放军陆军特色医学中心 孔径可调肛管装置
US20220355017A1 (en) * 2021-05-05 2022-11-10 SafeHeal SAS Systems and devices for monitoring negative pressure devices
CN115054808B (zh) * 2022-07-05 2024-07-23 浙江象迈医疗科技有限公司 一次性使用灌肠多球囊肛管
WO2024194771A2 (fr) * 2023-03-17 2024-09-26 SafeHeal SAS Systèmes et procédés d'introduction et de surveillance d'un dispositif à pression négative pour protéger une anastomose intestinale
CN119701109B (zh) * 2024-12-20 2026-04-17 中江县人民医院 一种大便引流套件

Family Cites Families (16)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CA2461658C (fr) * 2002-04-09 2007-03-13 Jae-Hwang Kim Dispositif a demeure de deviation des matieres fecales
US8016816B2 (en) * 2003-09-09 2011-09-13 Convatec Technologies Inc. Fecal management appliance and method and apparatus for introducing same
US8529497B2 (en) * 2007-12-04 2013-09-10 Jae-Hwang Kim Apparatus and method for controlling fecal diverting device
US9744069B2 (en) * 2008-05-29 2017-08-29 Advanced Medical Balloons Gmbh Device for stool drainage
DE102012003034A1 (de) 2011-02-21 2012-08-23 Advanced Medical Balloons Gmbh Vorrichtung zur Stuhldrainage
US9039661B2 (en) * 2011-05-24 2015-05-26 Fresenius Kabi Deutschland Gmbh Tube for the enteral feeding of a patient
DE102012008663A1 (de) 2011-08-20 2013-02-21 Advanced Medical Balloons Gmbh Darmrohr
WO2013059242A2 (fr) * 2011-10-18 2013-04-25 American Grease Stick Company Outil pour raccordement de conduites de fluide
EP2780068B1 (fr) * 2011-11-16 2021-06-23 Convatec Technologies, Inc. Appareil pour prévenir un surgonflement du ballonnet de retenue dans des cathéters médicaux et des dispositifs de voies aériennes
CN102671282B (zh) * 2012-05-24 2014-04-09 哈尔滨医科大学 经结肠内三腔气囊封闭引流管套装
CN202590135U (zh) 2012-05-24 2012-12-12 哈尔滨医科大学 经结肠内三腔气囊封闭引流管套装
CN203763646U (zh) * 2014-04-16 2014-08-13 罗琪 一种可冲洗及引流的无痛性可固定的直肠引流管
EP3226949B1 (fr) * 2014-12-04 2019-08-21 Creative Balloons GmbH Dispositif permettant de réaliser l'occlusion d'un organe creux en assurant une étanchéité dynamique ou le tamponnement d'un tel organe par remplissage d'espace
DE102015002995A1 (de) * 2015-03-04 2016-09-08 Creative Balloons Maschinenbau GmbH & Co.KG Vorrichtung und Verfahren zur aspirationspräventiven dynamischen Dichtung der intubierten Trachea bei Patienten mit nicht-assisitierter und assistierter Spontanatmung
WO2017085540A1 (fr) * 2015-11-18 2017-05-26 Creative Balloons Gmbh Dispositif pour l'occlusion étanche dynamique ou le tamponnement par comblement d'un organe creux
CN107376100A (zh) * 2017-08-24 2017-11-24 南宁市妇幼保健院 婴幼儿肛门直肠支撑引流管

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CN113613591B (zh) 2024-12-27
US20220105320A1 (en) 2022-04-07
DE102019000474A1 (de) 2020-07-30
US12257408B2 (en) 2025-03-25
CN113613591A (zh) 2021-11-05
WO2020152640A1 (fr) 2020-07-30

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