System for an endoscopically assisted transesophageal application of a device which permanently remains in the body for a transduodenal bypass-like passage of stomach contents

Abstract

A system for a bypass-like, transduodenal passage of stomach contents, comprising: a transduodenal bypass unit (BE), itself comprising a transduodenal assembly (TDG) having a tubular film (7) for the passage of stomach contents into the jejunum, and also comprising a transpyloric assembly (TPG) having a hose-like or tubular shaft component (2); a transesophageal positioning unit (PE) having a tubular shaft component (9), the outer diameter of said shaft component being smaller, at least in a distal region, than the inner diameter of the shaft component (2); and an extracorporeally controllable coupling device (KE) which selectively fixates the shaft component (2) to the shaft component (9) for coupling purposes or releases the same for decoupling purposes.

Description

[0001] System and method for endoscopically assisted, trans-esophageal application of a permanently implantable device for transduodenal, bypass-like passage of gastric contents

[0002] The invention describes a system for a bypass-like, transduodenal passage of stomach contents into the higher parts of the jejunum, with

[0003] a) a transduodenal bypass unit remaining in the body, comprising (i) a transpyloric assembly for fixing the unit in the region of the pyloric sphincter, and (ii) a transduodenal assembly for the passage of gastric contents into the jejunum, and

[0004] b) a positioning unit for the application of the trans-duodenal bypass unit, i.e. for its trans-esophageal passage or insertion, its trans-pyloric positioning, and its trans-duodenal unfolding of a tubular film ensuring the bypass function.

[0005] Obesity, and especially its associated diseases such as type 2 diabetes and fatty liver disease, represent a growing medical and socioeconomic problem worldwide. The number of people with diabetes alone is currently estimated at approximately 600 million worldwide, the vast majority of whom are directly attributable to obesity. Despite comprehensive global efforts in prevention and treatment, the number of overweight people has been increasing for decades.

[0006] A complicating factor for medical treatment is that the causes of obesity and its pandemic spread are largely unexplored. A genetic predisposition for obesity is considered established. However, the role of the gut microbiome in the development of overweight is not yet fully understood.

[0007] Current therapeutic options for treating obesity are based on:

[0008] Dietary and physical measures: This involves reducing the energy balance by decreasing energy intake on the one hand and increasing energy expenditure through sport and exercise programs on the other; the success of this concept is low;

[0009] Drug treatment: While pancreatic enzyme blockers have not found widespread use due to their side effects, newly developed insulin analogs such as semaglutide are currently the focus of interest. Reliable weight loss of up to 35% was achieved in the approval studies, but sustained effects were not demonstrated. The medications would have to be taken for life, and little is yet known about their side effects.

[0010] Surgical procedures: These are based either on reducing the size of the stomach (restriction) or on shortening the absorptive portion of the small intestine (malabsorption), always bypassing the duodenum (duodenal bypass). These procedures are invasive and irreversible. Since the extent of their effectiveness cannot be predicted in individual cases, many patients require lifelong follow-up care. However, for grade III obesity (morbid obesity with a BMI > 40), surgical procedures have demonstrated high efficacy in terms of weight loss and improved quality of life, as well as long-term survival and the prevention of secondary diseases, including diabetes and malignant tumors.

[0011] In recent years, endoscopically based therapeutic techniques have become increasingly established for the treatment of obesity, making it possible to combine the effectiveness of surgical procedures with the low invasiveness of flexible endoscopic interventions, which access the gastrointestinal tract via natural body openings.

[0012] The oldest historically based endoscopic procedure is the implantation of a gastric balloon with a volume of approximately 450-750 cc, intended to ensure sustained gastric fullness and thus create a feeling of satiety during food intake. Data on the long-term success of this method are lacking. In the past three to five years, various procedures have also been developed to reduce stomach volume using endoscopically placed sutures. Based on previous studies comparing laparoscopic (i.e., performed via abdominal endoscopy) gastric plication and partial gastrectomy, the latter has been found to be superior. Therefore, even assuming that the endoscopic sutures were permanently durable, endoscopic gastric plication would not be recommended.

[0013] Creating a bypass endoscopically is inherently more difficult and therefore not yet clinically established. Initial approaches involve various procedures for thermal ablation of the duodenal mucosa to eliminate carbohydrate absorption as a trigger for insulin release.

[0014] Procedures for intraluminal bypass of the duodenum, which allow a transduodenal bypass of food through a non-permeable foil tube remaining in the body, come closest to the surgical principle of bypass surgery. The product-neutral term "gastrointestinal liner" has become established for this procedure and is also used in the International Classification of Procedures in Medicine (OPS).

[0015] The first commercially available implant of this type, available until 2018, was the "Endo-Barrier" (now "Reset") product from Gl Dynamics (now "Morphic Medical"). Aside from the problematic method of fixing this implant in the duodenum using sharp-edged metal hooks that penetrated the duodenal mucosa, one of the fundamental application problems lay in the unrolling, or rather the complete axial unfolding, of the foil tube providing the bypass into the duodenum. A radiopaque sphere was used for the transduodenal placement of the tube, but its passage into the jejunum was very time-consuming and required fluoroscopy with corresponding radiation exposure. Due to the enormous difficulty of this maneuver, the manufacturer also required all users to first complete several procedures in animal trials, which is no longer acceptable under current animal welfare laws.The history of endoscopically applied gastrointestinal liner devices has shown the following performance characteristics to be critical or essential for the success of the application in clinical practice:

[0016] The devices must be able to be used quickly and safely, even by inexperienced users;

[0017] The application should be performed without radiological guidance or control; the device must be able to remain in the patient for periods of several months in a manner that is as atraumatic and as non-irritating as possible;

[0018] The fixation of the device in the transition area from the stomach to the duodenum must be reliable or reliably prevent dislocations of the device;

[0019] The axial unfolding of the preferably foil-like thin-walled bypass tube over the entire length of the duodenum must be as simple, quick and uncomplicated as possible.

[0020] The complete axial, transduodenal unfolding of the tubular film enabling the bypass of food presents a difficult, time-consuming and potentially insurmountable challenge, especially for users with little endoscopic experience.

[0021] A simplified transduodenal deployment of the bypass tube component is achieved within a generic system through the combined application of a bypass unit remaining in the patient with a structurally and functionally compatible, catheter-like positioning unit, whereby the bypass unit to be applied can be coupled to or uncoupled from the positioning unit by an extracorporeally operable mechanism.

[0022] The present invention describes a balloon-based, transpyloric fixation system that securely anchors the bypass unit, which remains in the patient, across the gastric sphincter, preventing displacement. The corresponding transpyloric assembly of the unit has a duodenal balloon positioned immediately post-pylorically. In the gastric, pre-pyloric position, two concentrically arranged balloons face the duodenal balloon. While the duodenal balloon prevents displacement of the assembly into the stomach, the two gastric balloons prevent the bypass device from slipping or dislocating into the duodenum.

[0023] The transduodenal component of the bypass unit essentially consists of a thin-walled, approximately 60 to 70 cm long foil tube with a consistently cylindrical diameter of approximately 20 to 30 mm, as is typical for comparable transduodenal bypass devices of this design and dimension. The length of the foil tube component allows the distal end to be positioned beyond the duodenojejunal flexure (ligament of Treitz), thus ensuring the passage and delivery of gastric contents into the upper portions of the jejunum. According to general clinical experience, once the ligament of Treitz has been crossed, reflux of intestinal contents into the postpyloric duodenum or stomach is no longer expected. Propulsive peristalsis is then sufficient to ensure the directed transport of gastric contents into the lower portions of the small intestine.

[0024] The complete trans-duodenal axial unfolding of the tubing component, guided or controlled extracorporeally, is made particularly difficult by the membrane-like thinness of the tubing film.

[0025] Established instruments, such as flexible endoscopes (gastroscopes, enteroscopes), can, with sufficient user practice, reach the anatomical area around the ligament of Treitz with their tip and thus transport the tubing beyond the ligament. However, during application, they generate such high frictional resistance that when the endoscope shaft is withdrawn from an axially unfolded tubing component, the tubing is usually pulled out with it or adheres to the endoscope shaft, losing its transduodenal unfolded position. Therefore, direct, endoscopically guided axial unfolding of the bypass tube is only of very limited use in routine clinical practice.

[0026] Techniques that forego endoscopically based or otherwise shaft-based transduodenal insertion of the bypass unit and use only a wire-based component for advancing the bypass tube component through the duodenum are described in the prior art, but have the disadvantage of low shear stiffness and are therefore difficult to control extracorporeally.

[0027] The present invention describes a simplified design of a bypass device, similar to one already disclosed in WO 2016 / 067087 A2. That document presents an advantageous design and function for dynamically adaptive sealing and atraumatic, organ-compatible transpyloric fixation, wherein the bypass device has at least one balloon component mounted on a transpyloric shaft component such that, when inflated or pressurized, the balloon component performs a rolling motion towards the pylorus, while simultaneously limiting the radial expansion, particularly of the duodenal balloon body, to the adjacent tissues as much as possible, thus reducing the likelihood of pressure-induced damage to the respective organ structures.

[0028] Within the scope of WO 2016 / 067087 A2, special embodiments of the "axially counter-rolling design" are described, in which a transpyloric, shaft-like conveying element is equipped with balloons arranged both duodenally and gastrically. The disclosure presents, among other things, balloon arrangements in which two balloons are arranged concentrically or in which an inner balloon is completely enclosed by an outer balloon. The concentrically arranged balloons can each be filled separately. Furthermore, indicator dyes optionally deposited in the balloons are described, which, upon release, are absorbed via the intestine and excreted reniferously, recognizable to the user as a color change in the urine. Similar designs with several balloons mounted on a central, conveying shaft element are described in WO 2005 / 120363 A1. In the figure therein...Figure 21A shows a concentric balloon arrangement. Only the inner of the two balloons has a position-securing, holding function, while the outer balloon is structurally designed for the containment and release of pharmacologically active substances. The outer balloon's casing is permeable and not suitable for the permanent containment of media. Unlike WO 2016 / 067087 A2, WO 2005 / 120363 A1 does not address the aspect of position stabilization by a redundant, securing second balloon.

[0029] WO 2016 / 067087 A2 describes a special form of endoscopic placement of a balloon-based, trans-pylorically fixed, transduodenal bypass device. In this procedure, the entire bypass device to be applied is mounted on the surface of the distal endoscope shaft. The endoscope shaft is inserted into the central lumen of the bypass device, and fixation is achieved by an extracorporeally inflatable coupling balloon component between the endoscope shaft and the wall of the bypass unit's ducting lumen. The coupling balloon ensures that the bypass unit can be safely fixed and advanced through the esophagus into the stomach and from there into its transpyloric anchor position. The described coupling technique is also discussed and further elaborated in US 10,667,936 B2.

[0030] In WO 2016 / 067087 A2, the coupling element is relaxed or emptied after the transpylorically retained assembly has been filled, and the resulting freed endoscope is advanced further through the lumen of the bypass device into the duodenum. In this state of the art, the complete axial unfolding or unrolling of the bypass tube over the ligament of Treitz is achieved by means of a wire connected to the distal end of the tubing film. This wire is guided over the working channel of the endoscope or extended beyond the tip of the endoscope, thus carrying the bypass tubing film with it. After the tubing film reaches its target position, the wire is retracted into the endoscope shaft or removed from the endoscope. The endoscope shaft is then withdrawn from the unfolded tubing film into the stomach.A cutting, forceps-like instrument is then inserted through the now-open working channel of the endoscope into the stomach to sever the tubing leading to the balloon components of the delivery unit. Finally, the endoscope is completely removed from the patient.

[0031] Although the application of the device described in WO 2016 / 067087 A2 has proven practical, undesirable retractions or stomach-directed carry-along of the tubing film occur when withdrawing the endoscope shaft from the unfolded tubing film component of the bypass device, which is extended to its entire length, due to the overall excessive friction and adhesion effects.

[0032] The present invention therefore aims to provide a technical solution to the problem of applying or intracorporeally inserting and positioning a trans-duodenal bypass device, which should be largely independent of an endoscope.

[0033] The solution according to the invention is instead based on a coupled combination of a specifically designed positioning catheter, which ensures safe guidance of the application from outside the body, with a structurally and functionally congruent bypass unit.

[0034] In particular, the invention describes structural features and specific functionalities enabled by these features, which allow adhesion and friction effects between the positioning shaft components of the positioning unit guided inside the film tube and the inner surface of the film tube to be reduced advantageously, largely avoiding retraction or carry-along effects.

[0035] The presented embodiment of the indwelling bypass unit is relatively specific with regard to its preferred design and balloon components. It preferably features a single, discoid-shaped balloon for post-pyloric placement in the duodenal bulb and a double, concentrically enclosing balloon arrangement for securing its position on the pre-pyloric, gastric side. The inner balloon of the balloon arrangement has a redundant securing function, ensuring that in the event of loss of the outer balloon or its retaining function, duodenal displacement of the trans-pyloric bypass unit, resulting in acute occlusion of the duodenal lumen, can be avoided.

[0036] In the preferred embodiment, the segment receiving the sphincter muscle between the duodenal and gastric balloons has only one centrally passing, tube-like segment that is directly exposed to the pylorus without any further balloon foil portion lying between the tube and the pylorus.

[0037] The present bypass unit features a simple, particularly low-complexity, and loss-free filling method for the balloon components located on the duodenal and gastric sides. Specifically designed, ring-shaped sealing components are used for this purpose. These components rest against the inlet and filling openings to the interior of the balloons under elastic tension, creating a surface seal. The respective valve ring is preferably made of a material with special, fatigue-resistant, permanently elastic properties, such as those provided by polyurethanes or silicones. The individual components are preferably manufactured using injection molding to ensure maximum circumferential consistency of the ring wall thickness, maximum flatness of the sealing surfaces, and consistency of the elastic properties.The surface of the respective shaft components carrying the rings preferably has embedding, circularly extending structures that grip the rings in a trough-like manner and hold them in the required, sealing position above the supply openings.

[0038] For optimized transduodenal unrolling and / or unfolding of the foil tube component of the bypass unit, the tube component can be provided at the distal end with a loop- or handle-like formation, which is directly received by the distal tip of the respective shaft body of the positioning unit that transports the foil into the duodenum.

[0039] Such a handle-like formation preferably has an apical or central perforation through which a guide wire can be passed. Thus, as the positioning unit is advanced, the foil tube can be inserted into or passed through the duodenum with its distal, free end first.

[0040] Similarly, the handle-like formation can also be received and transported by a suitable abutment component located at the tip of a separate catheter unit, which, in optional designs, can be guided through the shaft body of the positioning unit and has special bending properties adapted to the duodenal passage.

[0041] To enable the smoothest possible retraction of the positioning unit from the bypass unit, the sum of the adhesive effects of the outer wall of the foil tube to the exposed intestinal mucosa should exceed the sum of the adhesive and frictional effects between the inner wall of the foil tube and the shaft parts of the positioning device moving within it, so that when the distal part of the positioning unit is withdrawn from the duodenally unfolded foil tube of the bypass unit, the tube is not pulled along towards the stomach.

[0042] The adhesive and frictional effects between the inner wall of the foil tube and the shaft portion of the positioning device moving within it can be reduced by introducing friction- and adhesion-reducing substances into the interior of the foil tube. The introduction of friction-reducing substances can also be achieved, in particular, by their continuous supply during the retraction process.

[0043] The design of the invention further enables the adhesive effects between the outer wall of the foil tube and the exposed intestinal mucosa to be increased or maximized by temporarily applying moderate pressure to the interior of the foil tube. The resulting complete radial unfolding of the foil tube within the intestinal lumen causes the entire outer surface of the tube to conform fully to the mucosa, thereby achieving the greatest possible adhesion effect.

[0044] To ensure proper filling, the positioning unit can be equipped with functions or components that enable both a proximal and (additionally) a distal, temporary closure of the foil tube lumen, so that an all-round enclosed lumen section can be realized, which can then be subjected to increased pressure, for example.

[0045] The invention recommends that the bypass unit remaining in the patient has a trans-pyloric shaft component made of an elastic polymer, so that it can adapt to the local anatomy and motility of the pylorus.

[0046] The shaft component of the bypass unit is preferably manufactured by blow molding, e.g., from an extruded tube blank. It is possible to incorporate a corrugation into the shaft component of the bypass unit, e.g., to optimize its elastic properties.

[0047] Alternatively, the shaft component of the bypass unit can also be manufactured by injection molding. This allows for the shaft of the bypass unit to be equipped with shaft-integrated lumens for inflating the balloon components carried by the shaft.

[0048] The transpyloric assembly of the bypass unit carries a balloon component on its distal segment for positioning in the duodenal bulb. This component is preferably made of thermoplastic polyurethane (TPU). In the preferred embodiment, the distal balloon component is pre-molded to its required working dimension or beyond during manufacturing, so that no forceful stretching of the balloon shell is required for inflation or for setting the required in-situ working diameter. The duodenally positioned balloon component is preferably filled with a volume corresponding to 80 to 90% of the volume of the balloon component mounted on the shaft when freely unfolded without tension outside the body. The balloon wall thus remains in a tension-free, slack, unstretched state. The unfolding orIn this way, the balloon can be placed within the duodenal bulb with particularly gentle, atraumatic inflation pressures that closely correspond to the physiological pressure values ​​prevailing in the duodenal bulb. The duodenal balloon component is preferably filled with liquid media.

[0049] The transpyloric assembly further comprises a proximal balloon arrangement positioned on the stomach side. It preferably includes two balloon components arranged concentrically within one another, such that the inner balloon provides a safety redundancy that prevents the bypass unit from slipping into the intestine in the event of structural failure or other deflation of the outer balloon. The inner of the two concentric balloon components preferably consists of a single-layer thermoplastic polyurethane (TPU). It is preferably filled with water or other biocompatible fluids, including, for example, oil-based solutions.

[0050] The outer balloon component preferably consists of a two-layer material, with the outer layer of the balloon being particularly resistant to acids and hydrolysis, thus enabling it to remain in the acidic environment of the stomach for extended periods of up to 12 months. Polyamide- or Pebax-based polymers are used for this purpose. The multi-layer balloon component is preferably manufactured by blow molding from a correspondingly multi-layer extruded tube. The inner layer preferably consists of a thermoplastic polyurethane TPU, with higher Shore hardnesses such as 95A or 55D to 60D being used, which are characterized by greater acid stability.

[0051] In addition to the external gastric balloon, the duodenal balloon can also be made from a suitable two-layer material. The balloons of the transpyloric assembly are inflated via long, transesophageally routed tubing lines that are permanently attached to the assembly at its proximal end, allowing for extracorporeal inflation of the balloon components. The tubing lines are designed to be cut with endoscopically applied cutting instruments at the gastric end face of the bypass unit.

[0052] All balloon components of the trans-pyloric assembly are preferably filled with liquid media, wherein all balloons are preferably shaped or pre-shaped to their working dimensions or beyond, as described above, and are only partially filled, so that the balloons assume a tension-free, unstretched state, thereby improving in particular the patient's wearing comfort and / or reducing peripyloric irritation.

[0053] The balloons can be filled separately via individual supply lines. Alternatively, the filling process can be configured so that two of the three balloons, for example the duodenal and the inner gastric balloon, are filled together via a single line.

[0054] The invention further provides for a filling process in which the duodenal and the inner gastric balloon are each filled separately, and in which the outer gastric balloon passively follows the inner balloon during the latter's filling process and does not itself have its own supply line or filling option.

[0055] During storage, transesophageal insertion, and transpyloric placement of the bypass unit, the tubular film component that creates or maintains the bypass is gathered to a compact length of, for example, approximately 3 to 5 cm. To maintain the gathered state of the film during storage of the bypass device, or to accommodate the gathered film, a special receiving cone can be used, which is inserted into the distal end of the transpyloric shaft component. It is removed immediately before application. All structural embodiments described within the scope of the invention preferably rely on the initial placement of an endoscopically positioned, splinting guidewire. The standard diameter of guidewires in clinical endoscopy is 0.038 inches, which corresponds to 0.96 mm.The wires are usually equipped with a flexible tip and, when guided endoscopically or inserted via the working channel of an endoscope, ensure relatively safe positioning of the wire up to about 30 cm into the jejunum.

[0056] The present invention largely separates the process of transesophageal and transpyloric passage, as well as the transduodenal unrolling of the bypass tubing, from the use of endoscope-like devices. Endoscopes are used during the application only for the initial insertion of a guide wire that supports the coupled assembly of the bypass and positioning unit. Beyond this, endoscopes have only one function: monitoring all steps of the application by providing a view of the pylorus and the transpyloric assembly positioned there from the stomach side. Endoscopes are also used to sever the supply lines to the balloon components.

[0057] The bypass unit is coupled to the positioning unit in a specific manner via an assembly integrated between the units within the device. In this stably coupled arrangement, the unit assembly is advanced transesophageally into the stomach, over the previously endoscopically placed, splinting guide wire, through the mouth and pharynx.

[0058] The shaft body of the catheter-like positioning device possesses the necessary rigidity to overcome resistance during both esophageal and subsequent pyloric passage. The shaft body has a preferred outer diameter of approximately 8 to 12 mm, allowing for easy manual gripping and guidance by the user. In particular, extracorporeal rotational movements of the shaft are reliably transmitted to the distal portion. The device's advancement, mediated by the shaft body and in conjunction with the guide wire running within the central shaft lumen, occurs without significant compression or kinking.Another fundamental design measure for reducing adhesive and friction-induced retraction of the duodenally deployed tubular film consists of structurally reducing the contact area between the respective transduodenally maneuvered shaft component of the positioning unit and the inner surface of the tubular film component. In endoscopic positioning, shaft diameters of approximately 10 mm, in relation to tubular film inner diameters of approximately 20 to 30 mm, have a detrimental effect in practical application due to the sum of the resulting friction and adhesion effects.In contrast, the present invention preferably uses embodiments in which the outer diameter of the shaft body of the positioning unit is only about 3 to 7 mm, preferably between 4 and 6 mm, i.e. about 1 / 4 to 1 / 5 of the diameter of the trans-duodenalally applied tubular film, which has a diameter of about 20 to 30 mm in the fully radially unfolded state.

[0059] As a further possibility to reduce the adhesive and frictional effects between the inner wall of the foil tube and the shaft parts of the positioning device moving within it, a medium such as water or air can be infused or insufflated into the interior of the tube at the moment of maneuvering or controlled relative movement of the shaft body within the foil tube, so that the foil tube partially or completely straightens itself under slight pressure within the duodenum, thereby lifting the foil tube away from the positioning device in a contact-reducing manner.

[0060] To maximize this effect, the invention provides an application option that allows the outer surface of the foil tube to lie completely flat against the intestinal mucosa, thus creating the greatest possible adhesion between the film and the intestine. For this purpose, the interior space within the foil tube is closed or sealed at its proximal and distal ends to such an extent that it can be subjected to moderate pressure, e.g., in the range of 10 to 50 mbar.

[0061] The application of the bypass unit can be optimized by combining all previously described measures to reduce the adhesive and frictional effects between the inner wall of the foil tube and the shaft portion of the positioning device moving within it during application.

[0062] The invention optionally incorporates a bypass device design as described in WO 2016 / 067087 A2. That patent describes a particularly advantageous design and function for dynamically adaptive sealing and atraumatic, organ-compatible transpyloric fixation, wherein the device has at least one balloon component mounted on a transpylorically permeable shaft component such that, during inflation or pressurization, the balloon component performs a rolling motion towards the pylorus, while simultaneously limiting radial expansion, particularly of the duodenal balloon body, to the adjacent tissues and structures as much as possible. The bypass device described within the scope of the present invention can optionally include the feature of an axially directed, sealing, and fixing balloon or abutment function.

[0063] The shaft body of the positioning unit may further have a design wherein the catheter-like shaft body has a continuous profile and / or a continuous diameter from oral to jejunal, and / or an identical arrangement of the lumens integrated in the shaft, and / or a uniform shaft material.

[0064] On the other hand, the shaft body of the positioning unit can also consist of several segments of different dimensions made of different materials, for example, several segments with different bending and stiffness properties adapted to their function. In this case, the proximal segments, which extend into the stomach and pylorus, have relatively larger diameters than the distal segments, which are advanced into the duodenum and jejunum during application.

[0065] The design of the shaft body can, in principle, also include shaft components arranged concentrically to each other or running into one another, whereby a distal, inner, relatively flexible, axially bendable segment runs through a proximal, outer, larger in diameter, relatively rigid segment that ensures kink-resistant trans-esophageal and trans-pyloric advancement.

[0066] The distal shaft segment exhibits bending properties designed to facilitate passage through the typical C-shaped curve of the duodenum and the flexure-like transition over the ligament of Treitz. Elastic restoring forces during axial bending of the distal shaft segment should be avoided as much as possible, even with sharp bends of up to 180 degrees, while simultaneously preventing accordion-like compression effects during axial propulsion of the segment.

[0067] The proximal segment of the positioning unit's shaft body is dimensioned and constructed with respect to its diameter and materials such that its outer surface can accommodate the respective bypass unit to be applied. The shaft body's outer diameter is selected to form a gap with the transpyloric assembly's through-channel, in which a coupling unit can be placed.

[0068] Another embodiment of the device can be structurally based on a shaft body of the positioning unit that does not extend beyond the upper duodenum and does not accommodate an internal catheter, but in which the advancement of the tubular film is effected by an exclusively wire-based component that picks up the anterior, distal edge of the tubular film or the handle-like structure attached there by means of a tool or abutment attached to the wire and thus guides the tubular film along during advancement.

[0069] Such a guide wire allows for a further development of the invention in that, together with the guide wire or following the endoscopic placement of the wire, an additional small-bore catheter is inserted. This catheter optimizes the required bending and guiding properties of the wire during the application of the device or its units and segments within the body. The corresponding small-bore, modifying catheter can optionally be equipped with a sealing and anchoring balloon component that can be inflated extracorporeally. The inflated balloon stabilizes the connection between the catheter and the wire in its respective terminal position. The balloon can also optionally be used to seal the foil tube for filling the tube's interior or for pressurizing it.

[0070] The distal tip formation of the positioning unit can have an atraumatic, for example rounded conical shape, which prevents injury to the organ wall during transluminal advancement.

[0071] The shaft of the positioning unit can have a total length of at least 150 cm in order to reach the areas aboral to the ligament of Treitz when guided extracorporeally. The guide wire used should exceed the length of the positioning unit by at least 150 to 200 cm.

[0072] Furthermore, the invention – independent of an overall system with the other components according to the invention – also relates to a trans-duodenal bypass device as such, comprising: (i) a trans-pyloric assembly in the form of a balloon-based unit for the long-term, atraumatic, organ-compatible fixation of the bypass device in the region of the pyloric sphincter, and (ii) a trans-duodenal assembly in the form of a foil tube unit for the bypass-like, trans-duodenal passage of gastric contents into the upper parts of the jejunum, wherein the bypass device placed in the patient can be decoupled from the positioning device used for insertion in a controllable manner from outside the body.

[0073] According to the invention, it can further be provided that the filling supply lines to retaining balloon components arranged on the duodenal and gastric side are connected via ring-shaped sealing components that are under elastic tension against the surface of the conveying shaft component of the conveying unit of the bypass device.

[0074] Furthermore, such a bypass device can have one, several, or all of the features of the bypass unit according to the attached claims. For example, the annular sealing components could be made of a material with permanent, non-fatiguing elastic elongation properties, e.g., polyurethane or silicone, and / or bear in a sealing manner against the respective opening(s) in the shaft component of the bypass device associated with the respective balloon component, preferably overlapping the edges of the respective opening(s) on all sides. For example,The sections of the shaft component of the bypass device that support those ring-shaped sealing components could each have two circumferential protrusions on the respective outer side of the shaft component, which have a mutual distance corresponding to the width of the respective ring-shaped sealing component, and which securely embed the respective ring-shaped sealing component between them.

[0075] Furthermore, it is possible that the shaft component of such a bypass device has an internal shaft structure made of an elastic polymer, preferably bias-molded or injection-molded, preferably with molded corrugations and / or with integrated openings and / or lumens for filling balloon components provided on the outside of the shaft component.

[0076] Such a bypass device can have a distal balloon component for positioning in the duodenal bulb, preferably made of TPU, which can be fully formed and, in its flaccid state, is inflated to approximately 80 to 90% of its preformed or freely unfolded volume, and is preferably filled with a gas, e.g., air.

[0077] Furthermore, such a bypass device may have a proximal balloon arrangement for positioning in the stomach, e.g. with two balloons that are preferably enclosed inside each other.

[0078] The inner proximal balloon can preferably consist of a single layer, in particular of a thermoplastic polyurethane (TPU).

[0079] The distal and / or the outer proximal balloon can each consist of a two-layer material, preferably acid-resistant. While the inner proximal balloon is preferably filled with a liquid, the outer proximal balloon can preferably be filled with a gas, e.g., air, or remain unfilled.

[0080] On the other hand, the tubular film of the transduodenal assembly (TDG) of such a bypass device may, preferably in the region of its distal end, have a loop or a handle- or loop-like formation, which makes it easier to unfold. This respective loop or handle formation may have an apical punch for the passage of a guide wire component or a finger-like receiving component of the tip of a positioning device.

[0081] Finally, it is also possible to provide the outside of a foil tube component with an adhesive and / or friction-enhancing coating, e.g. with a gel or the like.

[0082] Furthermore, the invention proposes – also independently of an overall system with the other components according to the invention – a trans-esophageal positioning device for the endoscopically assisted, trans-esophageal insertion and trans-pyloric fixation of a trans-duodenal bypass device, wherein the trans-esophageal positioning device has a proximal portion for inserting the bypass device into the stomach and fixing it in the region of the pyloric sphincter or in the anatomically adjacent area to the pylorus, and optionally a distal portion for unfolding or tightening a tubular film for the bypass-like, trans-duodenal passage of gastric contents into the upper parts of the jejunum, wherein the positioning device can be decoupled from the placed bypass device in a controllable manner from outside the body.

[0083] Such a positioning device according to the invention makes it possible, beyond the specific designs of the bypass unit described within the scope of the invention, to accommodate various other designs of trans-pyloric conveying and fixation units and to insert them into the duodenal lumen and to position them trans-pylorically, as well as to unroll or unfold their tubular film unit into the jejunal lumen and subsequently to retract the positioning unit comfortably or with only a slight retrograde effect of the unfolded tubular film.

[0084] Within the scope of the invention of such a positioning device as such, it is ensured that, during the retraction of the portion of a positioning device used for placement in the patient from the duodenal and jejunal unfolded foil tube of the bypass device, a pull-along or orally directed gathering of the foil tube is avoided by ensuring that the sum of the adhesive and / or friction-causing effects between the outer wall of the foil tube and the intestinal mucosa exposed to it exceeds the sum of the adhesive and / or friction-causing effects between the inner wall of the foil tube and the shaft portion of the positioning device moving within it.

[0085] Furthermore, such a positioning device can have one, several or all features of the positioning unit according to the attached patent claims.

[0086] For example, the positioning device could have a central lumen to be advanced trans-esophageally along a guide wire previously placed using an endoscope.

[0087] Furthermore, the adhesive and / or frictional effects between the inner wall of the tubular film of a bypass device and the shaft portion of a positioning device according to the invention moving within it could be reduced by a device for introducing friction- and / or adhesion-reducing substances into the interior of the tubular film, and / or by a device for insufflating water or air into the interior of the tubular film, which reduces the adhesive and frictional effects between the inner wall of the tubular film and the shaft portion of the positioning unit moving within it.

[0088] Another measure to increase the adhesive and frictional effects of the outer wall of a bypass tube on the exposed intestinal mucosa is to temporarily apply moderate pressure to a completely enclosed space within the bypass tube. This ensures that, when the tube is fully deployed within the intestinal lumen, the outer surface of the tube adheres completely to the mucosa, thus creating the greatest possible adhesion effect.

[0089] This is achieved by a device within the positioning device for applying moderate pressure to a closed interior space within the film tube, and / or by a device for temporarily closing the proximal and distal ends of the film tube so that the enclosed interior space within the film tube can be subjected to moderate pressure.

[0090] The latter can be achieved by having a distal shaft component of the positioning device carry at least one distal balloon which can act as an anchor and / or close the distal lumen of the foil tube component, and / or guide or move a handle-like structure aborally at the distal end of the foil tube of a bypass device.

[0091] The shaft component of a positioning device according to the invention can consist of a single element with a continuous profile, or be composed of several segments with different profiles.

[0092] This aspect of the invention can be further pursued by having a segment at the distal end of the shaft component of the positioning device have a higher degree of flexibility or elasticity than one or more segments arranged proximally to it, and / or by having two segments of the shaft component of the positioning device with different profiles arranged telescopically within each other and being displaceable relative to each other.

[0093] The following figures describe the basic design and operation of the present invention using various specific technical embodiments. Figure 1 shows a device according to the invention, consisting of a transpylorically positioned bypass unit remaining in the body, an application-supporting positioning unit, and a unit that reversibly couples the two units.

[0094] Fig. 2 shows a structural embodiment, wherein the distal segment of the shaft body of the positioning unit is provided with a wavy profile that modifies the bending properties;

[0095] Fig. 3a shows a coupling unit connecting the bypass and positioning units, designed as a structurally separated, foil-based hollow cylinder;

[0096] Fig. 3b shows a coupling balloon component that is firmly attached to the shaft body of the positioning unit;

[0097] Fig. 3c shows a further coupling balloon component that is fixed to the surface of the shaft body of the positioning unit, or is freely detachable and inserted in the gap between the bypass and the positioning unit;

[0098] Fig. 4 shows a design of a device in which the positioning unit consists of a large-lumen proximal shaft segment and is supplemented by an additional catheter unit that is guided therein, distal, freely movable, small-lumen, unfolding the tubing film of the bypass unit;

[0099] Fig. 4a shows a loop-like formation for receiving the distal end of the trans-duodenally unfolded foil tube component, in conjunction with a small-lumen catheter unit transporting the foil jejunally;

[0100] Fig. 4b shows a further combination of the distal arrangement of the foil tube component and a catheter unit transporting the foil jejunally;

[0101] Fig. 5 shows a lumen-occluding balloon component for sealing in the distal segment of the foil tube component;

[0102] Fig. 6 shows a transverse cross-section through a section of the duodenum, with a bypass foil tube placed therein in a flat, adhesion-maximizing manner;

[0103] Fig. 7 specific structural features of the bypass unit remaining in the body;

[0104] Fig. 8 shows the schematic arrangement of the device and its units in the gastrointestinal tract; as well as

[0105] Fig. 9 shows a measuring function integrated into the bypass unit that quantitatively records the outflow of stomach contents into the duodenum, and optionally determines the qualitative composition of the chyme, and wirelessly transmits the measured values ​​to an evaluating and displaying extracorporeal system unit.

[0106] Fig. 1 shows a preferred embodiment of a bypass device 1 according to the invention, consisting of a bypass unit BE remaining in the patient, a positioning unit PE supporting the transduodenal, transpyloric, and transduodenal placement of the bypass unit, and a coupling unit KE that securely connects the bypass unit to the positioning unit during the endoscopically controlled transesophageal and transpyloric insertion of the device. The device further comprises a guide wire GW, which is positioned endoscopically at the beginning of the application or advanced over the ligament of Treitz into the jejunum, which adjoins the duodenum.

[0107] The indwelling bypass unit BE has a central, tube-like shaft component 2, preferably made of injection-molded, elastically deformable and self-righting thermoplastic polyurethane (TPU). The shaft component has surfaces at both its distal and proximal ends for the fixation of molded balloon components 3, 4, and 5. These surfaces are structurally reinforced to withstand the inflation pressures prevailing in the respective balloons and to prevent lumen-narrowing reduction or lumen-occluding collapse of the channel through which the shaft component passes.

[0108] The balloon components are filled via channel-like structures, which are preferably integrated into the wall of the shaft component and transition at the stomach-side, proximal end of the shaft component into tube-like supply lines 6a and 6b, which extend extracorporeally and through which the balloons can be filled with suitable media, preferably non-compressible liquids.

[0109] The balloon components 3, 4, and 5 preferably consist of a multi-layered, extruded, spherically or discoidally shaped, film-like material formed by blow molding. The inner film layer is preferably made of a thermoplastic polyurethane, and the outer layer is preferably made of a polymer with particularly hydrolysis-resistant properties, such as polyamide-based or polyamide-related materials, like Pebax. The balloon films are preferably fixed to the shaft component by bonding the inner, polyurethane-based layer of the balloons to the surface of the shaft component. This results in better adhesive bonding properties than are generally possible with hydrolysis-resistant materials.In particular, when connecting the inner TPU layer to a similarly TPU-based shaft component, solvent-based bonding is possible, which avoids the use of acid-sensitive, potentially brittle, adhesive adhesives.

[0110] The bypass unit BE is placed transpylorically, meaning it extends across the pyloric sphincter (the muscle that closes and opens the stomach outlet). It comprises two components. The transpyloric component TPG includes the shaft component 2, balloon components 3, 4, and 5, and their tubular leads 6a, 6b, and optionally 6c, if each of the three balloon components is to be inflated separately. The unit is positioned so that the pyloric sphincter PYL lies between the concentrically arranged gastric balloons 4 and 5 and the duodenal balloon 3.

[0111] The trans-duodenal assembly (TDG) of the bypass unit (BE) comprises a large-bore, thin-walled, foil-like tube (7) with a loop (8) attached to its distal end. The foil tube connects directly to the distal end of the shaft component of the trans-pyloric assembly. The loop is attached to the distal, open end of the foil tube in a handle-like fashion. It has a perforation at the apical end through which the guide wire (GW) of the device is threaded. While the trans-pyloric assembly secures the bypass unit in its pyloric position against duodenal or gastric dislocation, the trans-duodenal assembly ensures the bypass-like passage of gastric contents through the duodenum into the subsequent jejunum.

[0112] The positioning unit PE is located in the central lumen of the bypass unit BE, which receives and conveys the gastric contents. The unit has a catheter-like structure and comprises a shaft component 9, the length of which is dimensioned to extend from the ligament of Treitz, which marks the transition from the duodenum to the jejunum, to the pre-oral region or approximately 30 to 50 cm beyond. The shaft component 9 has at least one inner lumen that accommodates the guide wire GW, over which the device is advanced transorally and transesophageally into the stomach during application. The bypass unit, which remains in the patient, is then advanced from the stomach into a trans-pyloric position, fixed by pre- and post-pyloric balloon components. From the trans-pyloric position of the unit, the transduodenal assembly TDB is advanced, again following the guide wire.whose foil tube, gathered to a short, compact size, is unfolded axially or extended axially to its entire length.

[0113] During transesophageal passage and transpyloric fixation, the two units BE and PE are arranged and positioned relative to each other in a specific manner, as shown in the figure. The bypass unit sits on the anterior, distal end of the positioning unit, with the shaft component of the positioning unit passing through the central lumen of the bypass unit and the distal tip of the positioning unit extending a few centimeters beyond the distal end of the shaft component of the transpyloric assembly. This specific position is secured by a coupling unit KE that can be operated extracorporeally. The coupling unit preferably consists of a balloon component with low elasticity and / or high shape stability.It can be pressurized with the sufficiently high pressure required for a powerful coupling, with the dimensions of the balloon, as formed during manufacturing, only slightly exceeded when pressurized. The reliable coupling of the two units thus withstands the sometimes considerable frictional and stretching resistances that arise during esophageal and pyloric passage. The shaft component of the positioning unit exhibits sufficient stiffness and kink resistance for manual, extracorporeally guided insertion. The kink resistance can be further increased for transesophageal and / or transpyloric passage by an optional, additional tube- or hose-like stabilizing component that can be inserted into the lumen of the shaft component.After transpyloric fixation of the coupled assembly of the bypass unit with the positioning unit, this can be completely or partially removed or withdrawn, thereby enabling, in the event of further advancement of the positioning unit into the duodenum, a resistance-reduced bending or trauma-reducing conformation of the shaft component to the C-shaped, loop-like course of the duodenum.

[0114] The tubular film of the trans-duodenal assembly TDG is, in its ready-to-use state or during esophageal and pyloric passage, threaded onto the shaft portion of the positioning unit, which extends beyond the trans-pyloric assembly, in a compactly gathered, package-like state. The distal tip of the positioning unit receives the handle-like loop 8 of the bypass tubular film. The loop is secured to the distal tip of the PE unit by the guide wire exiting the tip, which passes through a hole-like perforation at the apex of the loop. Following the trans-pyloric fixation of the device or the coupled assembly of the bypass and positioning units by inflating the balloon components of the trans-pyloric assembly TPG, the present invention offers the user several options for the axial unfolding of the film-like bypass tube:

[0115] The axial unfolding of the foil tube can be achieved by the duodenal advancement of the positioning unit PE, whereby the foil-like tube component 7 rests on the shaft tip of the unit PE and is carried along or transported into the duodenum during its advancement. To enable the advancement of the unit PE and its free relative movement, the coupling of the two units is released by deflating the balloon component of the coupling unit.

[0116] The deployment of the foil tube can also be achieved by maintaining the coupled state of the bypass and positioning units after transpyloric fixation of the device, and by advancing the bypass foil duodenally through a small-lumen catheter guided within the shaft of the positioning unit PE, following the guide wire GW. This catheter has a resistance-providing contact surface for the handle-like loop 8, which is attached to the end of the foil tube component 7. The axial deployment of the bypass foil, due to the bending and conforming properties of the correspondingly small-lumen catheter adapted to the duodenal passage, can thus offer an advantage, particularly for inexperienced users.

[0117] If, due to resistance or a presumed risk of injury, only incomplete axial unfolding of the transduodenal foil tube is possible, the remaining, unfolded portion of the foil can be flushed into the inner lumen of the foil by a rinsing fluid, which axially "unrolls" or fully unfolds the foil. The generously sized rinsing fluid, which flows through the foil tube towards the small intestine, carries the foil tube with it. Backflow of the foil towards the stomach or entanglement of the foil tube during flushing can be prevented by guiding the wire running within the lumen of the foil tube.

[0118] The rinsing fluid is supplied through one or more openings 14 into a lumen within the shaft component 9 of the positioning unit. The supply openings are located directly below or distal to the transpyloric assembly TPG in order to capture the film components stored there in a gathered manner with the fluid flow generated at the same level.

[0119] To avoid gastric outflow during such a hose-expanding irrigation, the coupling balloon 11 of the KE unit can be used during the irrigation for a temporary gastric seal of the bypass lumen.

[0120] To ensure maximum ease of use and the lowest possible risk of injury during application of the device, the axial bending and kinking properties of the catheter-like shaft component 9 or the shaft components of the positioning unit are adjusted such that the catheter shaft, in conjunction with the wire guided in its shaft lumen, enables, on the one hand, an extracorporeally guided, kink-resistant advancement of the coupled device components BE and PE through the esophagus, stomach and pyloric sphincter, and on the other hand, also allows the most flexible, smooth, and low-friction passage possible of the decoupled shaft of the positioning unit or its shaft components through the relatively narrow, C-shaped loop of the duodenum.To ensure appropriate bending properties of the positioning unit's shaft during transesophageal and transpyloric advancement, guide wires with a larger diameter and higher axial stiffness or kink resistance are preferred. In clinical practice, working channel diameters of up to 3.8 mm are common in gastroscopes, although in this case, wires with diameters up to 3 mm are used. As an alternative to larger-diameter wires, a combination of a small-diameter guide wire (e.g., 1 mm diameter) and a catheter unit with an outer diameter of approximately 3 mm, which adjusts or modifies the stiffness of the combination, can be used for guiding the device or its segments. Such a guide wire and catheter arrangement can be inserted directly through the endoscope's working channel, saving time.

[0121] Alternatively, in a step following the endoscopy, a catheter unit modifying the bending properties of the splinting component can be pushed over a small-lumen guide wire initially inserted endoscopically, whereby in this case outer diameters are possible that exceed common working channel diameters and allow additional lumens integrated into the modifying catheter unit.

[0122] The invention also provides segmented, splint-like "guides" for the application of the device, wherein the proximal segment, which facilitates esophageal and pyloric passage, has a higher stiffness than the distal segment, whose stiffness or flexibility is adapted for duodenal passage. The two segments of the catheter unit are axially rigidly connected to each other and are stabilized in their inner lumen by a small-diameter guide wire.

[0123] Optionally, the bending or stability-modifying catheter units have an externally fillable balloon component at the distal end, which, when filled, can secure the connection between the guide wire and the stenting catheter within the jejunum or in its respective distal position against dislocation.

[0124] The proximal segment of the shaft component 9, which extends from the pylorus PYL to the extracorporeal region, has a length of approximately 1.3 to 1.5 m. In the illustrated design, all shaft components of the positioning unit are derived from a single, continuous shaft tube component. Alternatively, designs of the shaft component 9 are optional, in which the shaft tube consists of joined segments of varying material hardness, material types, diameters, and wall thicknesses.

[0125] The gap, measured in diameter, that forms between the guide wire GW and the inner lumen of the shaft component 9 which receives the wire, should not be less than 1.5 mm and should not exceed 4.0 mm in order to limit frictional resistances and to avoid buckling compression of the wire within the lumen of the shaft component.

[0126] Fig. 2 shows an embodiment of the device in which the shaft component of the positioning unit PE extends beyond the distal end of the transpyloric assembly TPG in the area of ​​coupling with the bypass unit and has a corrugated profile PR in the protruding area. The corrugated shaft portion provides the distal end of the unit PE with advantageously stress-reduced axial flexibility of up to approximately 180 degrees as it passes through the duodenal turns, thus facilitating duodenal advancement. Furthermore, the reduction of elastic restoring forces in the anterior shaft region reduces undesirable frictional effects and the associated drag on the bypass tubing during retraction of the shaft from the deployed tubing.

[0127] The corrugated profile or PR of the distal shaft portion can be imprinted into the shaft wall, for example, by a blow molding process. In this process, the respective shaft portion is heated, pressurized, reshaped while hot, and then fixed in its corrugated form by cooling. Besides reshaping the distal shaft portion extending beyond the TPG assembly, the catheter shaft corrugation can also be applied to the entire intracorporeally applied shaft body or limited to specific, selected areas that are advantageous for stress-reduced passage of the positioning unit.

[0128] To retain the option of mechanical, displacement-preventing coupling or lumen-sealing sealing of the positioning unit PE within the transpyloric assembly TPG of the bypass unit BE, regardless of the respective relative position of the units, the coupling unit KE is not rigidly connected to the surface of the shaft body 9 of the PE unit in this design. Instead of being glued or welded to the surface of the shaft with both balloon ends, the coupling balloon is manufactured as a self-contained hollow cylinder 11, through whose inner cavity or central channel the shaft of the positioning unit can be guided. The shaft can thus be mechanically fixed within the TPG assembly by the user. Furthermore, the remaining lumen of the channel of the TPG assembly can be sealed to prevent leakage.

[0129] To prevent displacement of the coupling unit KE during displacement of the shaft 9 within the TPG assembly, the hollow cylindrical balloon body 11 is equipped during its formation with two terminal, shoulder-like extensions 11a and 11b that serve as stops. The design of the coupling unit requires that the coupling hollow cylinder can be filled via a separate, free hose supply line 12 that is not integrated into the shaft wall of the positioning unit.

[0130] The wall of the shaft body 9 has an optional lumen 13, which can be used to supply air or adhesion- and friction-reducing substances into the interior of the bypass tubular film 7. The lumen opens into the interior of the transduodenal film tubular assembly via an opening 14.

[0131] The figure further shows the balloon components 3, 4 and 5 in the unfilled state on the shaft element of the TPG assembly.

[0132] Fig. 3a shows a design of a coupling unit KE, based on a balloon body designed as a hollow cylinder, which forms a continuous channel K in its center that accommodates the respective positioning unit PE. The hollow cylinder 11 is positioned in the gap between the surface of the positioning unit PE and the surface of the through-channel of the transpyloric assembly TPG. The hollow cylinder 11 of the coupling device KE is not structurally connected to either the bypass unit BE or the positioning unit PE. The position of the coupling device KE between the units BE and PE, which is necessary for the free relative displacement of the units KE, BE, and PE, is supported by special bead- or collar-like projections 11a and 11b formed in the balloon body 11 in the region of the end faces of the hollow cylinder 11.

[0133] The coupling unit is preferably filled with a liquid medium. The supply from the extracorporeal side is provided via a separate hose line 12.

[0134] Under pressure, the outer and inner walls 11c and 11d of the hollow cylinder 11 bear against the shaft body 9 of the positioning unit PE on the one hand, and against the inner surface of the through-channel in the shaft body 2 of the bypass unit BE on the other. The "floating," non-fixed design of the coupling device KE ensures that, after the TPG assembly has been placed in the pylorus PYL, the positioning unit PE can move freely within the bypass unit BE, without the coupling device KE being drawn into the duodenum DU or stomach ST during the advancement or retraction of the positioning unit PE. This allows the coupling device KE to fulfill its coupling and / or sealing function within the trans-pyloric assembly TPG.

[0135] The balloon body of the coupling unit preferably consists of a material with low volumetric elongation (compliance), for example a thermoplastic polyurethane with a Shore hardness of 90A to 99A or 55D to 65D. The wall thickness of the hollow cylinder is approximately 10 to 40 µm, preferably 15 to 30 µm.

[0136] Fig. 3b shows an embodiment of the coupling unit KE, wherein the coupling balloon 11 is structurally fixed to the surface of the positioning unit at both ends. The balloon can have a spherical extension 11e in its central segment, allowing the filled sphere to be used for a sealing closure even outside the channel of the assembly TPG, i.e., within the inner lumen of the bypass tubing film. This enables a seal to be created in a proximal position to the introduced medium during flushing of the film lumen or when the tubing is intentionally pressurized. Filling is achieved via lumens integrated into the respective shaft bodies of the unit PE.

[0137] Fig. 3c shows another embodiment of a coupling function in a transverse cross-section, wherein the coupling component consists of a simple, cylindrical balloon body 11f, which is positioned in the gap between the PE and BE units. Due to its small size, the coupling balloon can be permanently attached to the positioning device PV or bonded to the shaft body of the PE unit at its cylindrical side surface. It can optionally also be installed in a freely movable and separable manner. Inflation is carried out via corresponding lumens in the shaft body of the positioning unit or via freely extending hose lines.

[0138] Fig. 4 shows an embodiment of the device 1 in which the relatively rigid shaft body 9 of the positioning unit PE, which ensures kink-resistant advancement of the device through the esophagus and pylorus, terminates at the distal end of the trans-pyloric assembly TPG, and the axial unfolding of the transesophageal tubing film 7 of the assembly TDG is effected by a separate catheter unit 15 of smaller diameter guided within the shaft 9, wherein the separate catheter unit has increased axial flexibility relative to the shaft body 9, thereby facilitating its duodenal passage during advancement and also the retraction of the catheter.The lumen of the shaft body 9, which guides the catheter 15, is dimensioned with such precision that it accommodates the outer diameter of the catheter 15 with a gap of approximately 0.2 to 0.5 mm in total diameter. This allows for free mutual displacement and also provides a proximally directed sealing effect in the event of pressurization of the interior of the tubing film 7 or irrigation of the tubing film interior from proximal to distal, thus supporting the axial expansion of the bypass tubing film. The outlet of the irrigation solution or the pressurized medium occurs at the distal end of the shaft body 9 through one or more openings 9a. The medium is supplied via an extracorporeal connector 13.

[0139] The proximal portion of the positioning unit's shaft body, extending into the region of the duodenal segment of the transpyloric assembly, can be made, for example, from a polyurethane with a Shore hardness of 80A to 95A, with an outer diameter of approximately 7 to 10 mm and shaft wall thicknesses of approximately 1.5 to 2.5 mm, preferably 1.8 to 2.2 mm. A PVC version of the proximal shaft body is also possible.

[0140] The shaft of the catheter-like unit 15 guided inside the shaft body 9 preferably consists of a rigid polymer, for example PBAX or polyamide types, which also exhibit kink-resistant properties in the low wall thickness range of, for example, 0.2 to 0.3 mm and in particular prevent accordion-like compression of the catheter wall when the catheter unit 15 is advanced through the lumen of the shaft body 9.

[0141] Fig. 4a The catheter unit 15 carries at its front end a preferably elastically expanding and retracting balloon 16, made, for example, of isoprene-based polymers with high volumetric elongation (compliance), which, when inflated, firstly facilitates the advancement of the catheter tip or its free, resistance-reduced movement through the duodenum, and secondly, in a design extended accordingly proximally into the front end of the foil tube, can seal the distal end of the foil tube component 7 in a lumen-closing manner when fully inflated.

[0142] The figure further describes the handle-like component 8. The two ends of the component are attached to the distal edge of the film tube 7 at a position offset by 180 degrees. The loop-like formation is dimensioned in length such that it forms a vertex above the distal edge of the film tube, which, in its free, undeformed state, is at least 30 mm away. The component consists of a material with low elastic erection properties in order to prevent undesirable, anchoring effects within the intestinal lumen. The ends of the strip-shaped loop would otherwise erect elastically and press against the intestinal wall, thus potentially impairing free axial unwinding or axial alignment of the film tube.

[0143] Fig. 4b In an alternative embodiment of the catheter 15, the terminal balloon body 16 is omitted. The tip of the shaft component of the catheter, however, is provided with a formation 17 upon which the handle-like loop 8 rests with its apical apex in a saddle-like manner, the relative position of the tip to the loop being secured by the guide wire GW, which is passed through an opening 18 located apically in the loop.

[0144] The necessary inclusion of loop 8 during duodenal advancement of the catheter is ensured by the placement of the loop on the saddle-like formation.

[0145] A corresponding saddle-shaped, distal terminal formation 17 can also be applied to the catheter shaft 15 in combination with a terminal balloon component. The corresponding balloon component 16 can be arranged directly proximal to the saddle-shaped formation, or spaced far enough proximal to it that the balloon component is positioned in the region of the distal tubing film end of the TDG assembly and can create a temporary sealing closure of the distal bypass lumen there.

[0146] Fig. 5 shows the distal end of a positioning unit PE in conjunction with the distal end of the bypass tubing 7, wherein the shaft tip of the unit PE is equipped with a lumen-sealing balloon element 16 that can be inflated and deflated extracorporeally. The balloon component is made of micro-thin-walled polyurethane material, which, when deflated, collapses so minimally on the shaft surface of the positioning unit PE that, during retraction of the positioning unit PE from the transduodenally deployed bypass tubing 7, the deflated balloon shell develops low frictional resistance and low adhesion to the inner surface of the tubing. This reduces the likelihood of the duodenally deployed tubing 7 detaching from the adjacent intestinal mucosa during the particularly critical retraction of the positioning unit PE.Resistance and adhesion-related effects during the retraction of the PE unit can be further reduced by introducing air or liquid media into the filled interior of the tubular film 7 at the moment of retraction, which, for example, have a lubricating effect and / or reduce or inhibit surface adhesion, thus enabling opposing sliding movements of the PE unit on the one hand and the tubular film component 7 on the other, in a manner that reduces overall resistance.

[0147] Fig. 6 describes further structural options and features of the device that increase the adhesive adhesion of the foil tube component 7 to the intestinal mucosa DS by, for example, coating the surface of the tube component facing the intestinal mucosa with a water-based, gel-like substance 21 or, alternatively, by applying a fat-based, ointment-like substance to its surface. Furthermore, dry cellulose-based coatings of the foil surface are conceivable, which swell to a gel-like consistency upon absorbing water and, when wetted, develop an adhesive effect that exceeds the adhesive effect of a physiological, aqueous, or mucosa-typical, mucin-containing film.

[0148] While the lumen-sealing closure of the interior of the tubular film in the proximal region is achieved by, for example, a hollow cylindrical coupling unit KE within the transpyloric assembly of the bypass unit, or by the balloon component 11 within the duodenum, the lumen closure in the distal region of the tubular film is achieved by balloon elements 16, which are either part of the shaft component of the positioning unit or a separate balloon catheter 15 guided through the catheter shaft of the unit PE. The required relative position between the lumen-sealing balloon and the distal end of the tubular film 7 is ensured by the aborally directed advancement of the positioning unit, whereby the tip of the respective advancing, catheter-like component engages the loop-like formation 8 or places it under an aborally directed tensile stress.The distal edge of the tubular film can thus be, for example, 4 to 5 cm away from the distal shoulder of the balloon 16, which allows the filled balloon to develop a sufficient contact surface and prevents it from slipping out of the opening of the tubular film.

[0149] When the enclosed space within the tubular film is pressurized, the film's cross-section unfolds completely, adhering to the mucosa with the largest possible surface area. When the pressure is released, the radial force of the small intestine reduces the intestinal cross-section or diameter, causing portions of the film's wall to fold into a "residual" fold within the intestinal lumen, without being exposed to the intestinal mucosa. The initial complete unfolding and subsequent folding of the film's outer layer into a radially inverted "reserve fold" maximizes the potential adhesion area between the film and the intestine. This maintains the tubular film in its transduodenal, permeable position and ensures the axial, non-torqued alignment of the film required for the unimpeded passage of gastric contents.

[0150] The figure schematically illustrates the interplay of adhesion and friction effects between the intestinal mucosa DS, the foil tube component of the transduodenal assembly, and the components of the positioning unit PV. The components, which move or are displaced relative to one another, are depicted in a schematic, transverse cross-section through the lumen of the duodenum DU. In the air-filled state or when pressurized with moderate air pressure, the surface of the foil tube 7 lies flat against the intestinal mucosa DS, which is moistened with natural secretions. The adhesive bond between the foil tube and the intestinal mucosa can be enhanced by the application of adhesive pastes, gels, or gel-like swelling substances 21 between the foil tube and the intestinal mucosa. The distal shaft portion of the device's positioning unit runs inside the foil tube.The figure further shows a surface-active substance 20 that reduces adhesive and frictional effects between the inner surface of the tubing film and the surface of the components of the PE unit located or moving inside the tubing film. For example, soap-like, oil-based, or silicone oil-based substances are used. The outer diameter of the shaft body of the positioning unit PE can be approximately 5 mm, which is about 1 / 4 to 1 / 5 of the diameter of the transduodenally applied tubing film 7, which has a diameter of approximately 20 to 30 mm when fully radially unfolded. In this case, the calculated circumference of the tubing film is approximately 63 to 94 mm. The circumference of the catheter is correspondingly about 15 mm. The ratio of the two circumferences is approximately 4.2 to 1 and approximately 6.3 to 1, respectively.For an advantageous force ratio between adhesion and friction that avoids detachment of the foil tube from the intestinal mucosa, the invention proposes a circumferential ratio of 4:1 to 6:1 for intra- or trans-duodenal shaft bodies with outer diameters of approximately 5 mm, which should not be undercut.

[0151] The invention prefers the combination of the described circumferential conditions with a simultaneous reduction of the adhesion and friction effects by means of appropriate substances introduced into the interior of the tubular film, as well as the additional increase of the adhesive effect of the tubular film on the intestinal mucosa by means of, for example, gel- or ointment-like substances, in order to improve the efficiency or stability of the transduodenal positioning of the tubular film, and thus to avoid detachment of the tubular film unfolded in the intestinal lumen during the retraction of the positioning unit from the bypass unit of the device remaining in the patient.

[0152] Fig. 7 describes structural details of the bypass unit BE remaining in the patient. The unit comprises a transpyloric assembly TPG, which is equipped with several balloon components 3, 4, and 5 that secure the bypass unit in its transpyloric position. The balloon components are mounted on a tube-like stem component 2. A transduodenal assembly TDG, essentially based on a film, is attached to the distal end 2a of the stem component. This unit comprises an approximately 60 cm long film tube component 7, at the distal end of which a handle-like, film-like formation 8 is attached.

[0153] The bypass unit BE features a spherically or discoidally shaped balloon 3 in the post-pyloric segment of the trans-pyloric assembly. When inflated, this balloon expands into the duodenal bulb, providing a counter-support against the pyloric sphincter and preventing gastric dislocation of the bypass unit. In the pre-pyloric, gastric segment of the assembly, the shaft component of the delivery unit carries two concentrically arranged balloon components. The outer balloon component 5 completely encloses the inner component 4. The inner component serves as a redundant counter-support in case of partial or complete deflation of the outer balloon component during long-term placement.The discoid-shaped balloon 4, preferably filled with a liquid, prevents the passage unit from slipping into the duodenum and jejunum, thus preventing intestinal obstruction. The balloon is therefore preferably equipped with its own independent filling line 4a. The outer balloon 5 is filled via the filling line 5a, and the duodenal balloon 3 via the filling line 3a. Alternatively, balloons 3 and 5 can also be filled with a gaseous or liquid medium through a common channel and tube supply.

[0154] The invention further proposes a special, simplified design in which the duodenal balloon and the inner gastric balloon are filled via separate lines, and the outer gastric balloon passively follows the inner balloon. It serves merely as a protective shell or barrier, preventing direct contact between the anchoring inner balloon and the acidic, hydrolytic secretions of the stomach. The outer balloon's shell is preferably equipped with a two-layer wall, the outer layer of which is polyamide- or Pebax-based. Should the outer balloon fail, a dye stored therein leaks out and is detected in the patient's urine. If the inner balloon fails, its filling volume transfers to the outer balloon, thereby maintaining the anchoring properties of the gastric balloon arrangement.

[0155] To indicate to the patient the structural failure or injury of one of the liquid- or gas-filled balloons, a renally excretable dye in liquid or dry form can be introduced into the respective balloon, which is absorbed by the intestine upon exiting the balloon envelope and can ultimately be detected by the patient in the urine.

[0156] The respective supply lines to the balloons are routed through the esophagus to the outside. Inflation with the respective medium is preferably volume-controlled, using conventional syringes. The volume is preferably selected such that the balloon components, which have direct contact on all sides with adjacent tissues, particularly in the region of the duodenal bulb, remain in a partially inflated, tension-free, and relaxed state. The respective volume administered should be approximately 80 to 90% of the balloon's volume when fully inflated, without tension or stretching of the balloon's envelope, and mounted on the shaft.

[0157] The distal segment of the supplying tubes 3a, 4a, and 5a can be preformed in the transition region 3b, 4b, and 5b to the shaft component of the transpyloric assembly, for example, its wall thickness can be reduced, so that it can be severed by a scissor- or forceps-like instrument inserted into the stomach via the working channel of the endoscope and manipulated from the outside, thus decoupling it from the bypass unit remaining in the body. The balloon components of the bypass unit are inflated via particularly simple, self-sealing valve components. In preferred embodiments, the self-sealing closure is achieved by flat, rubber-like elastic ring components that rest against the respective supplying openings in the balloon-bearing shaft under elastic tension, overlapping laterally and sealingly.The sealing ring components 2b preferably consist of materials with durable, non-fatigue elastic elongation properties, such as those provided by polyurethane or silicone. The valve-bearing shaft sections optionally each have two circular, lateral protrusions that securely embed and receive the sealing ring between them.

[0158] The central, tubular or tube-like shaft segment 2, located between the duodenal and gastric balloons, accommodates the pyloric sphincter muscle PYL. The shaft wall can optionally be shaped in a corrugated manner 2c to improve the axial bending properties of the pylorically perforating segment and to prevent lumen-occluding kinking of the shaft.

[0159] The foil tube component 7 of the bypass unit consists of acid-resistant, hydrolysis-resistant material, preferably with thin walls in the range of 10 to 40 µm, more preferably 15 to 25 µm. In particular, TPU-based materials with higher Shore hardness are used, for example, in the hardness range of 90A to 95A and 55D to 65D. Alternatively, Teflon-based or polyolefin-based polymers can be used. The freely unfolded diameter of the tube component is between 20 and 45 mm, preferably 25 and 35 mm. The foil tube can be corrugated, which reduces the tendency for axial twisting or torsion and facilitates the compact gathering or folding of the foil at the distal tip of the shaft component of the positioning unit.

[0160] Fig. 8 describes the application or insertion of the transduodenal bypass device according to the invention into the patient's digestive tract, illustrating in particular the relative position of the various units of the device to the adjacent anatomical structures. The figure further describes the functional interaction of the bypass unit BE remaining in the patient with an exemplary positioning unit PE, which is removed after the complete insertion or deployment of the bypass unit, and an endoscope EN positioned in the stomach ST to observe or support the application.

[0161] The endoscope is positioned approximately parallel to the shaft of the positioning unit (PE) in the stomach. The endoscope's optics are aligned within the stomach to visualize the antrum (AT) and the pyloric sphincter (PYL). This direct view allows the user to confirm the transpyloric position of the transpyloric assembly (TPG) and rule out any dislocations during the various phases of application, insertion, and manipulation. The stomach can also be inflated with air via the endoscope's working channel to enhance visualization of the pylorus.

[0162] The figure shows an axially unfolded tubular film 7 of the transduodenal assembly TDG, extending completely through the duodenum DU and into the subsequent jejunum JE. The figure also shows an optional balloon component 15 positioned within the tubular film, which, when inflated, provides a lumen-closing seal at the distal end of the tubular film and, in conjunction with a proximal seal of the tubular film in the region of the transpyloric assembly, enables a pressurized, congestive filling of the tubular film's interior. This causes the tubular film to unfold radially, stretching the exposed intestine. After decompression, the interior is released into a tension-free state, forming radial invaginations of the tubular film adapted to the respective lumen of the intestine and conforming to the intestinal mucosa on all sides.

[0163] Once the tubular film has been fully deployed into the duodenal or jejunal intestinal lumen, the components of the positioning unit are removed from the jejunum, duodenum, stomach and esophagus by traction from outside the body.

[0164] Following removal of the positioning unit PE, a scissor- or forceps-like device is inserted into the stomach via the working channel of the endoscope, which remains in the stomach. This device is used to sever the inflation lines of the balloons of the transpyloric assembly in close proximity to the assembly. The inflation lines, along with the endoscope, are then removed from the patient.

[0165] Figure 9 describes a particularly advanced design of the bypass device, which integrates a continuous volumetric measurement function as a key feature. The device measures the amount of gastric contents that flows through the pylorus of the stomach into the duodenum, which follows the stomach, per unit of time. The device's special features also include the option of qualitative and, if necessary, quantitative or semi-quantitative measurement of the respective fat, protein, and / or carbohydrate content. Ultrasound-based sensor technology can be used for the continuous volumetric measurement. Such sensors are known in the art and are used, for example, in the volumetric measurement of urine.

[0166] Near-infrared (NIR) technologies can be used for the qualitative or combined qualitative / quantitative determination of specific molecules or groups of substances, whereby different substances can be detected simultaneously using infrared optics over a spectrum of several different wavelengths.

[0167] The sensing or measuring components X are preferably arranged in the gastric segment of the trans-pyloric assembly TPG. The required electronic and optical components are, for example, arranged in a ring around the shaft component of the gastric shaft segment 2, within the interior of the gastric balloons 4 or 5.

[0168] To enable optimized volumetric measurement, the associated sensor X can also be arranged within the pylorus or in the area of ​​the duodenal bulb, or installed accordingly in the shaft component 2 of the unit.

[0169] The associated electronics preferably have a power source that can be wirelessly recharged inductively at intervals of, for example, 24 or 48 hours. The electronics continuously record the relevant parameters. The user can retrieve the parameter history, for example, via a mobile phone using a corresponding Bluetooth function or other wireless technology.

[0170] Volumetric measurement allows users to objectively track their food intake and compare it with their food diary. This provides users with an overview of their actual food frequency, and in many cases, frequent meals are a significant contributing factor to the development of obesity and diabetes.

[0171] The following describes the application process of an exemplary embodiment of the device, in which the bypass unit on the gastric side of its trans-duodenal arrangement has a concentric, double balloon arrangement, but only the inner balloon is inflated. The shaft body of the positioning unit is manufactured as a single, continuous piece and, upon deployment of the tubular film component, is decoupled from its position within the trans-pyloric assembly and advanced into the duodenum.

[0172] 1. The application of the device begins with the endoscopically guided placement of a guidewire. For this purpose, the endoscope is advanced, if possible, to the ligament of Treitz (duodenojejunal flexure). From there, a guidewire is inserted as deeply as possible into the jejunum, which follows the duodenum. Alternatively, according to the invention, a combination of a wire and a catheter unit that modifies the bending properties of the wire can be applied via the working channel of the endoscope. The catheter unit can be equipped with a distally located, extracorporeally inflatable balloon component that secures the splinting connection between the wire and catheter in the respective intestinal segment against dislodgement.

[0173] 2. After the wire is placed, the endoscope is withdrawn from the stomach. Following the separation of the endoscope from the guide wire, the endoscope is reinserted into the stomach to rule out any possible entanglement of the wire within the stomach.

[0174] . Before the transesophageal insertion of the device into the stomach, the two units of the device, the bypass unit BE and the positioning unit PE, are connected to each other in a stable, shift-proof manner by filling the coupling balloon component of the coupling unit KE.

[0175] . Subsequently, the proximal end of the guide wire or of the assembly of a wire with a catheter modifying the bending properties of the wire is guided through the apical opening of the handle-like formation 8 and pushed through the wire-guiding lumen of the shaft component 9 of the positioning unit.

[0176] The actual insertion of the device now takes place. The combined unit, PE and BE, is generously lubricated and then inserted over the guide wire to a depth of approximately 70 cm. The shaft of the positioning unit has corresponding depth markings for this purpose. The patient's anterior teeth serve as the reference for the insertion depth. With a preferred overall length of 1.55 m for the positioning unit, approximately 85 cm of the shaft length remains in front of the teeth, i.e., outside the body. The position of the device in the stomach should then be checked using an endoscope, which is advanced to the lower part of the stomach.

[0177] Under endoscopic guidance, the device is advanced further until the duodenal balloon reaches its postpyloric position. The gastric portion of the transpyloric bypass unit remains in the stomach.

[0178] The balloon is then filled with liquid, for example, approximately 10 ml of NaCl solution. This filling process is performed under endoscopic control.

[0179] The inner gastric balloon 4 is then filled with 2 ml of 0.5% methylene blue, supplemented with approximately 52 ml of NaCl solution. Filling the inner balloon causes the outer balloon to inflate or align itself. The correct transpyloric position of the assembly is then documented endoscopically.

[0180] Subsequently, the coupling balloon of the coupling unit is deflated, allowing the PE unit to be detached and advanced duodenally. Advancement continues until perceptible resistance is felt. The proximal end of the positioning unit's shaft then protrudes only about 10 to 20 cm beyond the dental arch. The foil tube of the trans-duodenal assembly is now fully axially deployed. The position of the trans-pyloric assembly is then checked again endoscopically.

[0181] 10. Before withdrawing the PE unit from the axially unfolded foil tube, 50 ml of air followed by 100 ml of NaCl solution are introduced into the interior of the foil tube via a channel-like inlet in the shaft of the PE unit. Then, the PE unit and the guide wire are simultaneously and completely withdrawn from the patient.

[0182] 11. The endoscope is then inserted into the inlet area of ​​the TPG assembly and the bypass unit is flushed with 50 ml of NaCI solution via the instrument channel to check its patency.

[0183] 12. Finally, the filling tubes of the bypass unit remaining in the patient are individually cut with a tube punch or other suitable endoscopic element and the connections are pulled out.

[0184] The described method can be modified within the scope of the present invention in such a way that the adhesive effects of the tubular film on the intestinal mucosa adjacent to it are maximized by

[0185] Prior to transesophageal insertion of the device, a water- or fat-based substance is applied to the package-like gathered foil tube, which improves the adhesion of the foil to the mucosa;

[0186] Before the positioning unit is retracted from the axially unfolded tubular film, a proximally and distally effective, lumen-sealing seal is created within the inner lumen of the tubular film. This is followed by the lumen being pressurized with a moderate inflation pressure, causing the tubular film to fully unfold radially and achieve the largest possible adhesive contact area with the mucosa within the intestinal lumen. Alternatively or additionally, adhesive and frictional effects between the wall of the tubular film and the positioning unit within it can be minimized by...

[0187] Substances that have a lubricating and / or anti-adhesive effect are introduced into the interior of the foil tube;

[0188] an advantageous ratio of the respective circumferences of the tubular film and the circumference of the shaft or shaft portion of the positioning unit guided therein of 3.5:1 to 7:1 is not undercut;

[0189] at the moment of retraction or immediately beforehand, a liquid or gaseous medium is introduced into the interior of the foil tube, leading to a temporary, partial separation of the contact surfaces between the tube and the PE unit.

[0190] Once approximately 75% of the bypass tube component is unfolded, the remaining, still gathered portion of the foil-like tube can be fully expanded by flushing the tube lumen with water. The flushing fluid exits the shaft body of the positioning unit, or an integrated fluid supply lumen within it, through one or more sufficiently large openings distal to or below the coupling balloon, into the interior of the bypass tube and flows into the deeper duodenum. The outflowing volume carries the still gathered bypass tube with it and fully expands it.

[0191] If the irrigation fluid supply does not achieve complete axial expansion of the tube, an additional catheter unit can optionally be advanced over the guide wire, through the central lumen of the positioning unit's shaft, to the distal end of the bypass tube. The catheter unit has an extracorporeally inflatable balloon component at its distal end. After the catheter exits the distal opening of the positioning device, this balloon is filled with fluid and inflated to a diameter of approximately 10 to 20 mm. Upon contact with the handle-like extension of the bypass tube, the tube is fully extended as the catheter unit is advanced. (Reference numeral list)

[0192] System 11e Spherical extension Shaft component 11 f Cylindrical balloon body a Sealing component 12 Hose supply

[0193] b Sealing component 13 lumens

[0194] c Corrugation 14 Opening Balloon component 15 Catheter, catheter unit a Leading tube 16 Balloon, balloon body b Transition area 17 Formation Balloon component 18 Opening

[0195] a) Hose 20 Surface-active substance b) Transition area 21) Gel-like substance Balloon component 22) “Residual” folding

[0196] a Inlet hose

[0197] b Transition area

[0198] a hose-like supply line

[0199] b hose-like supply line

[0200] Hose, tubular film

[0201] loop

[0202] shaft component

[0203] an opening

[0204] 0 connector

[0205] 1 coupling balloon

[0206] an extension

[0207] b Extension

[0208] c wall

[0209] d Wall AT Antrum area

[0210] BE Bypass Unit

[0211] DS intestinal mucosa

[0212] DU Duodenum

[0213] EN Endoscope

[0214] ES Esophagus

[0215] GW guide wire

[0216] JE Jejunum

[0217] K Channel

[0218] KE coupling device

[0219] OE opening

[0220] PE Positioning Unit

[0221] PR profiling

[0222] PV Positioning Device PVS Tip Formation

[0223] PY Pylorus

[0224] ST stomach

[0225] TPG Transpyloric assembly TDG Transduodenal assembly X Measuring component, sensor

Claims

Patent claims 1. System (1) for bypass-like, transduodenal passage of gastric contents into the upper portions of the jejunum (JE) of a patient, comprising a) a transduodenal bypass unit (TU) remaining in the patient's body, comprising (i) a transduodenal assembly (TDG) with a foil tube (7) for bypass-like, transduodenal passage of gastric contents into the upper parts of the jejunum (JE), and (ii) a transpyloric assembly (TPG) with a tube- or tube-like shaft component (2) for fixation or anchoring of the bypass unit (TU) in the region of the pyloric sphincter, and b) for the application of the trans-duodenal bypass unit (BE), i.e., for its trans-esophageal passage or insertion, its trans-pyloric positioning, and its trans-duodenal unfolding of a tubular film ensuring the bypass function, a transesophageal positioning unit (PE) with a preferably tubular shaft component (9), the length of which is dimensioned such that it extends extracorporeally through the esophagus, the stomach and at least to the ligament of Treitz in the region of the aboral end of the duodenum, and the outer diameter of which is smaller at least in a distal region than the inner diameter of the shaft component (2) of the trans-pyloric assembly (TPG) of the bypass unit (BE), characterized by an extra-corporeally controllable coupling device (CD) which selectively fixes or uncouples the trans-duodenal bypass unit (BE), in particular its shaft component (2), on the trans-esophageal positioning unit (PE), in particular its shaft component (9).

2. System (1) according to claim 1, characterized in that the coupling device (KE) has a preferably hollow cylindrical preformed balloon (11) exhibits which can be placed and filled within the annular gap between a distal area of ​​the shaft component (9) of the positioning unit (PE) on the one hand and the shaft component (2) of the trans-pyloric assembly (TPG) of the bypass unit (BE) on the other hand, in order to secure the bypass unit (BE) on the positioning unit (PE) in a dislocation-proof manner.

3. System (1) according to claim 2, characterized in that the hollow cylindrical preformed balloon (11) of the coupling device (KE) consists of a material with low volumetric elongation (compliance), e.g. a thermoplastic polyurethane with a Shore hardness of 90A to 99A or of 55D to 65D.

4. System (1) according to claim 2 or 3, characterized in that the hollow cylindrical preformed balloon (11) of the coupling device (KE) has a wall thickness of at least 10 pm, preferably a wall thickness of 15 pm or more, and / or a wall thickness of at most 40 pm, preferably a wall thickness of 30 pm or less.

5. System (1) according to one of claims 2 to 4, characterized in that the hollow cylindrical preformed balloon (11) of the coupling device (KE) can be filled with a liquid medium, e.g. with water or a water-based liquid, in particular via a filling hose or lumen provided only for this purpose.

6. System (1) according to one of claims 2 to 5, characterized in that the hollow cylindrical preformed balloon (11) of the coupling device (KE) is neither integrated nor connected to the bypass unit (BE).

7. System (1) according to one of claims 2 to 6, characterized in that the hollow cylindrical preformed balloon (11) of the coupling device (KE) is integrated or connected with the positioning unit (PE), in particular at least partially adhesively fixed to the distal region of the shaft component (9) of the positioning unit (PE), wherein the The surface of the balloon (11) is either tubular with open ends and can be fixed to the shaft component (9) of the positioning unit (PE) in the area of ​​the tube ends, or is toroidal and closed and can be fixed to the shaft component (9) of the positioning unit (PE) in the area of ​​its inside.

8. System (1) according to one of claims 2 to 6, characterized in that the hollow cylindrical preformed balloon (11) of the coupling device (KE) is neither integrated nor connected with the positioning unit (PE), in particular is at least partially adhesively fixed to the distal area of ​​the shaft component (9) of the positioning unit (PE) and has a closed shell in the manner of a torus.

9. System (1) according to one of claims 2 to 8, characterized in that the hollow cylindrical preformed balloon (11) of the coupling device (KE) has a preferably circumferential, radially outwardly projecting extension in the area of ​​at least one end face.

10. System (1) according to one of claims 2 to 9, characterized in that the hollow cylindrical preformed balloon (11) of the coupling device (KE) has a preferably circumferential, radially outwardly projecting extension in the area of ​​both end faces.

11. System (1) according to claim 10, characterized in that the distance between the two end-face extensions measured in the direction of the central axis of symmetry of the hollow cylindrical balloon is equal to or greater than the length of the shaft component (2) of the bypass unit (BE).

12. System (1) according to one of the preceding claims, characterized by one or more balloon components (3, 4, 5) attached to the shaft portion of the transpyloric assembly (TPG) for the long-term, atraumatic, organ-compatible fixation or anchoring of the bypass unit (BE) in the region of the pyloric sphincter, wherein the filling lines to the retaining duodenal and The balloon components (3,4,5) arranged on the stomach side are connected via ring-shaped sealing components (2b) that are under elastic tension against the radially outer surface of the transmitting shaft component (2) of the trans-pyloric assembly (TPG) of the bypass unit (BE).

13. System (1) according to claim 12, characterized in that the annular sealing components (2b) consist of a material with permanent, non-fatigue elastic elongation properties, e.g. polyurethane or silicone.

14. System (1) according to claim 12 or 13, characterized in that annular sealing components (2b) which are located in a sealing manner at the respective opening(s) associated with the balloon component (3, 4, 5) in the shaft component (2) of the bypass unit (BE), preferably overlapping the edges of the opening(s) on all sides.

15. System (1) according to one of claims 12 to 14, characterized in that valve-bearing sections of the shaft component (2) of the bypass unit (BE) each have two circumferentially circumferential projections on their respective outer sides, which have a mutual distance corresponding to the width of the respective annular sealing components (2b), and which securely receive the annular sealing components (2b) in an embedding manner between them.

16. System (1) according to one of claims 12 to 14, characterized in that the filling supply lines (3a, 4a, 5a) to the retaining duodenal and gastric balloon components (3,4,5) are connected to the inside of the shaft component (2) of the bypass unit (BE), communicating with an opening in the shaft component (2) of the bypass unit (BE).

17. System (1) according to claim 16, characterized in that the filling The leads (3a, 4a, 5a) to the retaining balloon components (3,4,5) arranged on the duodenal and gastric side in distal areas, preferably near the shaft component (2), are preformed at least in some areas with a reduced wall thickness in order to be able to be cut by a scissor- or forceps-like tool.

18. System (1) according to one of the preceding claims, characterized in that the bypass unit (BE) has a distal balloon component for positioning in the duodenal bulb, preferably made of TPU, which may be fully formed, and is inflated to approximately 80 to 90% of its preformed or freely unfolded volume in a slackly filled state, and is preferably filled with a gas, e.g. with air.

19. System (1) according to one of the preceding claims, characterized in that the bypass unit (BE) has a proximal balloon arrangement for positioning in the stomach, with two balloons which are preferably enclosed in one another.

20. System (1) according to claim 19, wherein the inner proximal balloon preferably consists of a single layer, in particular of a thermoplastic polyurethane (TPU).

21. System (1) according to one of claims 18 to 20, characterized in that the distal and the outer proximal balloon each consist of a two-layer material, which is preferably acid-resistant.

22. System (1) according to one of claims 18 to 21, characterized in that the inner proximal balloon is preferably filled with a liquid, and / or that the outer proximal balloon is preferably filled with a gas, e.g. with air, or remains unfilled.

23. System (1) according to one of the preceding claims, characterized in that the shaft component (2) of the bypass unit (BE) has an internal shaft structure made of an elastic polymer, preferably bias-molded or injection-molded, preferably with molded corrugations and / or with integrated openings and / or lumens for filling balloon components (3,4,5).

24. System (1) according to one of the preceding claims, characterized in that the tubular film (7) of the trans-duodenal assembly (TDG) of the bypass unit (BE), preferably in the region of its distal end, has a loop or a handle- or loop-like formation.

25. System (1) according to claim 24, characterized in that the respective loop or handle formation has an apical punching for the passage of a guide wire component or finger-like receiving component of the tip of the positioning unit (PE).

26. System (1) according to one of the preceding claims, characterized in that the tubular film (7) of the trans-duodenal assembly (TDG) of the bypass unit (BE) is gathered in the unfolded state, preferably to about 10 cm.

27. System (1) according to one of the preceding claims, characterized in that the sum of the adhesive and / or frictional effects of the outer wall of the foil tube to the intestinal mucosa exposed to it exceeds the sum of the adhesive and frictional effects between the inner wall of the foil tube and the shaft portion of the positioning unit (PE) moving therein, thereby preventing an oral-directed gathering of the foil tube during retraction of the distal portion of the positioning unit (PE) from the duodenally and jejunally unfolded foil tube of the bypass unit (BE).

28. System (1) according to claim 27, characterized in that the adhesive and / or frictional effects between the inner wall of the tubular film (7) and the shaft portion of the positioning unit (PE) moving therein are reduced by the introduction of friction- and / or adhesion-reducing agents. Substances can be reduced in the interior of the foil tube.

29. System (1) according to one of claims 27 or 28, characterized by a device for insufflating water or air into the interior of the film tube, which reduces the adhesive and frictional effects between the inner wall of the film tube and the shaft portion of the positioning unit (PE) moving therein.

30. System (1) according to one of claims 27 to 29, characterized in that the sum of the adhesive and / or frictional effects of the outer wall of the tubular film (7) to the intestinal mucosa exposed to it is increased by applying or introducing one or more friction- and / or adhesion-enhancing substances, e.g. one or more pastes, gels or gel-like swelling substances (21), onto the outer surface of the tubular film (7) and / or between the outer surface of the tubular film (7) and the intestinal mucosa (DS).

31. System (1) according to one of claims 27 to 30, characterized in that the adhesive and frictional effects of the outer wall of the tubular film (7) towards the intestinal mucosa exposed to it are increased by a temporary application of moderate pressure to the completely enclosed interior space there, whereby, in the state of complete unfolding of the tubular film (7) within the intestinal lumen, the outer surface of the tubular film (7) lies completely flat against the mucosa and thus a maximum possible adhesion effect is produced.

32. System (1) according to one of claims 27 to 31, characterized by a device for applying moderate pressure to a closed interior space within the foil tube in order to enable complete unfolding of the foil tube within the intestinal lumen, so that the outer surface of the tube lies completely flat against the mucosa and thus produces the greatest possible adhesion effect, wherein the adhesive and frictional effects between the outer wall of the foil tube to maximize.

33. System (1) according to claim 32, characterized by a device for temporarily closing the proximal and distal ends of the foil tube so that the enclosed interior space within the foil tube can be subjected to moderate pressure.

34. System (1) according to one of claims 27 to 33, characterized in that the ratio of the diameter of the outer circumferential or cross-sectional area of ​​the shaft component (9) of the positioning unit (PE) to the diameter of the tubular film (7) of the trans-duodenal assembly (TDG) of the bypass unit (BE) is 1:2 or less, preferably by a ratio of 1:3 or less, in particular by a ratio of 1:4 or less, so that the adhesive and / or frictional effects between the inner wall of the tubular film (7) and the area of ​​the shaft component (9) of the positioning unit (PE) moving within it are reduced.

35. System (1) according to one of claims 27 to 34, characterized in that the shaft component (9) of the positioning unit (PE) consists of a single element with a continuous profile, or is composed of several segments with different profiles.

36. System (1) according to claim 35, characterized in that a segment at the distal end of the shaft component (9) of the positioning unit (PE) has a higher degree of flexibility or elasticity than one or more segments arranged proximally to it.

37. System (1) according to one of claims 27 to 36, characterized in that two segments of the shaft component (9) of the positioning unit (PE) with different profiles are arranged telescopically inside one another and are displaceable relative to each other.

38. System (1) according to one of claims 27 to 37, characterized in that, that an inner shaft component (9) of the positioning unit (PE) carries a distal balloon (16) which can act as an anchor, and / or close the distal lumen of the foil tube component, and / or can lead a handle-like structure (18) aborally at the distal end of the foil tube (7).

39. System (1) according to one of the preceding claims, characterized in that the positioning unit (PE) has an inner lumen in which a guide wire (GW) preferably laid endoscopically can be guided.

40. System (1) according to claim 39, characterized in that the guide wire (GW) is enclosed at least partially by a small-lumen balloon catheter (15) which can be inserted over the guide wire (GW) or together with the guide wire (GW), and which acts as an anchor in the inflated state and can additionally be used to fix the distal tubular film (7) while the positioning unit (PE) is withdrawn.

41. Method for the endoscopically assisted, transesophageal insertion and transpyloric fixation of a transduodenal bypass unit (BU), using a catheter-like positioning unit (PU) with a proximal, esophagogastric portion for receiving the transduodenal bypass unit (BU) and its transpyloric fixation, and a distal, duodenojejunal portion for the contact-avoiding, bypass-like, transduodenal passage of gastric contents into the upper parts of the jejunum, wherein the positioning unit (PU) has a coupling, balloon-based coupling device (CD) which fixes or releases the bypass unit (BU) on the positioning unit (PU) extracorporeally by inflation, and which, when inflated, tightly seals the central lumen of the bypass unit (BU), and which, when uninflated,The non-pressurized state allows free relative displacement of the catheter portion of the positioning unit (PE) by the trans-pylorically fixed bypass unit (BE). characterized by the fact that The transduodenal tubular film of the bypass device (1) is brought into a position aboral to the ligament of Treitz by the positioning unit (PE) advanced in an aboral direction.

42. Method according to claim 41, wherein the lumen of the tubular film is sealed by an occlusion balloon, which can be filled extracorporeally and is attached to the distal end of the positioning catheter, and the interior of the tubular film is filled with air or pressurized with air, and the outer surface of the tubular film, in the filled or unfolded state, conforms to the mucosa in a flat manner and remains there in an adhesive manner.

43. Method according to claim 41 or 42, wherein the surface of the tubular film is coated with an adhesion-promoting substance.

44. Method according to one of claims 41 to 43, wherein a lubricating substance that reduces friction is introduced into the inner lumen.

45. A method according to any one of claims 41 to 44 for the endoscopically assisted, transesophageal insertion and transpyloric fixation of a transduodenal bypass unit (BE) comprising (i) a proximal, transpyloric assembly (TPG) for insertion of the bypass unit (BE) into the stomach and its fixation in the region of the pyloric sphincter or in the anatomically adjacent region to the pylorus, and comprising (ii) a distal, transduodenal assembly (TDG) for the bypass-like, transduodenal passage of gastric contents into the upper portions of the jejunum (JE), wherein the positioning unit (PE) is guided in a guide-like manner over a wire (GW) previously inserted endoscopically, characterized in that the bypass unit (BE) (PV) is connected to the positioning unit by means of a coupling device (KE). (PE) is decoupled from extra-corporeally controlled after the tubular film (7) has been unfolded.

Images