WO2023186764A1

WO2023186764A1 - Anastomosis plug and application device for an anastomosis plug

Info

Publication number: WO2023186764A1
Application number: PCT/EP2023/057762
Authority: WO
Inventors: Matthias Birth
Original assignee: Matthias Birth
Priority date: 2022-03-28
Filing date: 2023-03-27
Publication date: 2023-10-05
Also published as: DE102022107302A1

Abstract

The invention relates to an anastomosis plug for producing a surgically attached connection (anastomosis) of hollow organs, in particular a surgical connection between the pancreatic duct or bile duct and the small intestine or stomach, for both a conventional open access by means of an abdominal incision as well as for a minimally invasive application using laparoscopy or catheter and/or endoscopic methods. The invention additionally relates to an application device for an anastomosis plug.

Description

title

ANASTOMOTIC DOWEL AND APPLICATION DEVICE FOR AN ANASTOMOTIC DOWEL

Reference to previous registration

This application claims the priority of German patent application No. 10 2022 107 302.5 with a filing date of March 28, 2022, the content of which is hereby incorporated in its entirety by reference.

Field of invention

The invention relates to an anastomotic plug for producing a surgically created connection (anastomosis) of hollow organs, in particular a surgical connection of the pancreatic duct or bile duct with the small intestine or stomach, both for a conventional open access via an abdominal incision and for a minimally invasive use using laparoscopy or catheter - and/or endoscopy procedures. The invention further relates to an application device for an anastomotic dowel.

Background of the invention

Malignant tumor diseases of the pancreas such as: B. Pancreatic cancer is increasing worldwide and is now the second largest cause of tumor-related mortality. Surgical tumor removal alone offers at least a potential chance of recovery. Since the vast majority of pancreatic tumors affect the head of the pancreas, an en bloc resection of the head of the pancreas, duodenum and distal bile ducts is required, also known as the Kausch-Whipple operation.

In order to preserve the digestive function of the pancreas, the second step of the operation requires reconstruction of the outflow of pancreatic juice into the intestinal tract. This occurs through a connection between the body and tail of the pancreas with a loop of small intestine or the stomach. This connection (anastomosis) is currently done using surgical sutures.

Laparoscopic operations, in which operations are carried out within the abdominal cavity using an endoscope and extended, specially designed surgical instruments, are generally preferred due to their less invasive nature. In laparoscopic pancreatic surgery, however, the creation of the anastomosis is particularly important This is a crucial surgical step that cannot be carried out with conventional techniques with the same quality and safety as after laparotomy on the open abdomen. The anastomosis of the pancreas and small intestine represents the main obstacle, which is why the laparoscopic procedure has not yet become established, although in principle it is associated with the well-known advantages of minimally invasive surgery.

Despite various variations in surgical technique, pancreatic anastomosis is associated with a relatively high percentage of up to 25% of partial or complete insufficiency. The consequences of insufficiency are potentially dramatic and are associated with significantly higher postoperative mortality for affected individuals.

A similar problem also exists after complex liver resections due to malignant tumors of the liver (liver carcinoma), liver metastases or abscesses as well as malignant tumors of the gallbladder (gallbladder carcinoma) with removal of parts of the liver and bile ducts, including the need to create anastomoses between bile ducts and the small intestine.

Against this background, the inventor has already proposed an anastomotic plug in DE 20 2015 004700 Ul, which, however, only partially alleviates the aforementioned difficulties, so that anastomosis continues to be the Achilles' heel, particularly in pancreatic resection.

It is therefore an object of the present invention to provide an improved anastomotic plug which contributes to a further solution to the known problem. It is a further object of the present invention to provide an improved application device for an anastomotic dowel for laparoscopic creation of an anastomosis.

These tasks are solved by the subject matter of the independent claims. Preferred embodiments of the invention are the subject of the dependent claims and the following description.

Description of the invention

An anastomotic plug is provided which is expandable from a radially compressed configuration to a radially expanded configuration. The type of expansion is not particularly limited and can e.g. B. include self-expansion or balloon-assisted expansion. The anastomotic dowel has a dowel body with a head section in which a proximal dowel body opening is located and an end section in which a distal dowel body opening is located. A shaft section is arranged between the head section and the end section, which extends along a central longitudinal axis of the dowel body and thereby connects the proximal dowel body opening and the distal dowel body opening to one another in a tubular or hollow cylindrical shape. The terms “proximal” and “distal” refer to the relative position of the elements to one another, with “proximal” meaning a position closer to the user and “distal” meaning a position further away from the user. The shaft part can be designed essentially like a vascular stent. Such vascular stents are well known to those skilled in the art.

In the radially expanded configuration, the head section of the dowel body has a wall contact that is configured so that it forms a contact of the anastomotic dowel against an organ or vessel wall. The wall system can e.g. B. be designed like a flange. This makes it possible for the dowel head to come into engagement during anastomosis, for example with the inner intestinal wall in the peripheral area of an enterotomy or to form a contact surface with the immediate tissue edges of the enterotomy and to fix this by compression, while the end section and at least part of the shaft section are transmural be inserted into the pancreatic duct or a bile duct. In this way, the dowel is prevented from slipping through the opened intestinal wall and the organ sections can be connected to one another very quickly and tightly, which drastically reduces the manipulation of the pancreas during anastomosis, especially after a pancreatic head resection, and effectively prevents local pancreatitis. Preferably, the wall system extends at least in sections at an angle of at least 75 degrees, preferably at least 80 degrees, preferably approximately 90 degrees to the longitudinal axis radially beyond the shaft section and the end section. The wall system can also extend, at least in sections, beyond an angle of 90 degrees radially to the longitudinal axis, i.e. H. it extends at least in sections obliquely or curvedly away from the proximal dowel body opening in the direction of the distal dowel body opening.

To clarify, the dowel body is equipped with the wall system on one side, ie the head section forms a one-sided wall system of the dowel body. The end section is formed essentially parallel or aligned with the shaft section, ie the end section and the shaft section together form a straight hollow cylinder or rotary cylinder which extends with a substantially constant outer radius from the head section to the distal dowel body opening. The term “essentially constant” here means that the outer radii of the end section and shaft section do not differ from each other by more than 10%, preferably not more than 5%, preferably not more than 2%, particularly preferably not more than 1%. This is essential so that the end section and at least one Part of the shaft section e.g. B. after a pancreatic resection in a so-called end-to-side connection of the pancreatic body and small intestine or jejunum, it is inserted unhindered into the mouth of the pancreatic duct, which is open on the resection surface, and is transversely cut along the resection line and advanced transversely to the resection surface or resection line inside the pancreatic duct can be. This is e.g. B. with so-called tissue lumen stents for connecting hollow organs that have an enlarged outer circumference at both ends is not possible. In particular, the wall system has a radial outer diameter that is at least 1.5 times or at least 2 times larger than the shaft section and the end section.

The shaft section of the anastomotic dowel has a proximal shaft region and a distal shaft region along the longitudinal axis of the dowel. It is essential for the invention that the proximal shaft area is suitable for body fluids such as: B. pancreatic juice or bile juice is radially impermeable, d. H. Body fluids cannot escape from the inside of the proximal shaft area, i.e. from the lumen surrounded by the proximal shaft area, to the outside, while the distal shaft area is designed to be radially permeable to body fluids and thus in particular allows entry of body fluids from outside the anastomotic dowel into the area surrounded by the distal shaft area Lumen allows.

This embodiment according to the invention is based, among other things, on the knowledge that the problems and complications of conventional anastomosis are due to an inadequate seal at the transition between the resection surface and the organ wall to be anastomosed. This means that it is precisely at this transition that body fluids such as: B. the aggressive pancreatic juice or bile juice and their leakage into the free abdominal cavity, which has been recognized as a major cause of the known and potentially life-threatening complications of conventional anastomosis. To make matters worse, it has been shown that with the anastomotic dowel known from DE 20 2015 004 700 Ul, prolapse of the intestinal mucosa into the lumen of the dowel can reduce or even block the outflow of body fluids into the intestinal lumen and thus significantly increase the risk of insufficiency. In particular, if, due to individual factors and circumstances, there is no immediate adhesion of the joined organ areas, which is a frequent problem in pancreatic surgery, there is a risk of life-threatening insufficiency developing.

These problems are solved by the inventive design of the shaft section of the anastomotic dowel. The liquid-impermeable design of the proximal shaft area seals the transition area between the opened organ sections, e.g. B. between the pancreatic incision edge and the intestinal wall or stomach wall, reliably for liquids and effectively prevents the leakage of body fluids, especially pancreatic juice or bile juice, into the free abdominal cavity. At the same time, the intestinal mucosa can no longer prolapse into the dowel lumen, so that unhindered drainage of body fluids through the anastomotic dowel into the intestine is guaranteed. Due to the advantageous interaction of these effects, the percentage of partial or complete insufficiency can be reduced, e.g. B. in pancreatic anastomoses, even in the event of healing disorders, can be significantly reduced, especially to less than 5% or less.

At the same time, it is crucial that the distal shaft area is designed to be radially permeable to liquid, because the inventor has recognized that a liquid-impermeable distal shaft area, which lines the main duct of the pancreas over a longer distance, closes small gland ducts that open into the main duct and thus itself can provoke inflammation. The combination according to the invention of a proximal liquid-impermeable shaft section and a distal liquid-permeable shaft section is therefore an essential prerequisite for improving the success of treatment during anastomosis using the anastomotic dowel according to the invention.

In preferred embodiments, the proximal shaft region has an axial length that is at most 70% of a total axial length of the shaft section. As the term is used here, the axial length refers to the length of the shaft section along the longitudinal axis of the dowel. The proximal shaft region preferably has an axial length which is at most 60%, at most 50%, at most 40%, at most 30% or at most 25% of the total axial length of the shaft section. In this form, a particularly advantageous interaction of reliable sealing of the anastomosis in the critical transition area between the intestinal or stomach wall and the resection surface is achieved while at the same time secure self-fixation of the distal shaft area, e.g. B. in the pancreas or bile duct and the least possible impairment of the secretion flow is guaranteed. In this way, the invention enables a liquid-tight creation of a pancreatic or biliary tract anastomosis with increased safety and a lower insufficiency rate.

The overall axial length of the shaft section can be approximately 20 millimeters to approximately 100 millimeters. A total length in the range from about 25 millimeters to about 80 millimeters, in particular from about 30 millimeters to about 50 millimeters, is preferred. It has been shown that these length ranges represent a particularly advantageous combination of reliable sealing of the anastomosis while at the same time securely connecting the organ sections through the self-fixing forces of the dowel. The outer diameter of the shaft section can be adapted to the natural diameter of the pancreatic duct or bile duct, which is typically in a range of about 2 millimeters to about 12 millimeters. In the expanded configuration, the shaft portion preferably has an outer diameter of at least about 2 millimeters, at least about 2.5 millimeters, or at least about 3 millimeters. Preferably, the shaft portion in the expanded configuration has an outer diameter of at most about 12 millimeters, at most about 10 millimeters, at most about 8 millimeters, at most about 7 millimeters or at most about 6 millimeters. Particularly preferably, the shaft section in the expanded configuration has an outer diameter of about 2 millimeters to about 10 millimeters or from about 2 millimeters to about 5 millimeters. It goes without saying that these outer diameters apply accordingly to the end section which is shaped parallel to the shaft section.

In preferred embodiments, the proximal shaft region is designed to extend on both sides of the transition between the organ sections, for example between the outer intestinal or stomach wall and the pancreatic section, by at least approximately 5 millimeters, at least approximately 8 millimeters or at least approximately 10 millimeters. This ensures a good seal of the anastomosis on the resection surface side. At the same time, the proximal shaft area extends over the entire small intestine or intestinal wall into the lumen of the small intestine or stomach, so that the secretions can flow out unhindered.

In preferred embodiments, the proximal shaft region has an axial length of at least about 10 millimeters, at least about 15 millimeters, or at least about 20 millimeters. The proximal shaft region preferably has an axial length of at most about 50 millimeters, at most about 40 millimeters or at most about 30 millimeters. In particular, the proximal shaft region can have an axial length of about 10 millimeters to about 40 millimeters, in particular from about 15 millimeters to about 30 millimeters. Accordingly, the distal shaft region preferably has an axial length of at least about 10 millimeters, at least about 15 millimeters or at least about 20 millimeters. The distal shaft region preferably has an axial length of at most about 50 millimeters, at most about 40 millimeters or at most about 30 millimeters. In particular, the distal shaft region can have an axial length of about 10 millimeters to about 40 millimeters, in particular from about 15 millimeters to about 30 millimeters.

In preferred embodiments, the proximal shaft region has a liquid-impermeable jacket, also referred to below as a partial covering, in order to make the proximal shaft region impermeable to body fluids. The liquid-impermeable jacket can be designed as an inner jacket that covers the proximal Shaft area lined radially all around on the inside, or as an outer jacket which encloses the proximal shaft area on the outside radially all around. Combinations of these embodiments are also possible. The proximal shaft region preferably has a liquid-impermeable, radially circumferential outer jacket. It has been shown that an outer jacket in the expanded configuration of the dowel can be applied very closely to the inner wall of pancreatic or bile ducts, thereby enabling a particularly reliable seal of the anastomosis with a particularly low risk of insufficiency.

Preferably, the liquid impermeable jacket comprises a stretchable polymeric membrane. The liquid-impermeable jacket can also consist of a stretchable polymer membrane. The stretchable polymer membrane may contain a polymer selected from the group consisting of polyester, polyurethane, polyethylene, polypropylene, polytetrafluoroethylene, polyvinyl alcohol, polylactide, polycaprolactone and any combinations and block and/or copolymers thereof.

Examples of suitable membranes are: B. Nonwovens based on non-woven natural or artificial polymers have been proven. The polymer membrane can in principle be resorbable or non-resorbable. For example, the stretchable polymer membrane can be based on non-woven polyurethane fibers, polyethylene fibers, polypropylene fibers, polytetrafluoroethylene fibers, polyester fibers, especially polyethylene terephthalate fibers, or polyvinyl alcohol fibers. Combinations of these fibers are also possible. The liquid-impermeable jacket preferably consists at least predominantly of non-woven polyurethane fibers. In certain embodiments, the polymer membrane is based on a resorbable polymer, in particular a polylactic acid-based polymer such as. E.g. poly(lactide-co-glycolide) (PLGA), poly(lactic acid) (PLA, PDLA, PLLA) or polycaprolactone (PCL). The polymer membrane may have a thickness of less than 50 micrometers or less than 40 micrometers, preferably less than 30 micrometers, particularly preferably less than 20 micrometers or less than 10 micrometers.

In preferred embodiments, the dowel body has a basic structure made up of several interconnected and/or interwoven struts. The struts can be connected and/or intertwined in a grid, net or mesh-like manner or in some other way. Otherwise, the design of the struts is not particularly limited. In particular, the struts can have a rounded or oval, angular or irregularly shaped cross-sectional area. Suitable basic frameworks are well known to those skilled in the field of vascular stents.

Preferably, in the radially expanded configuration, the struts or a portion thereof form a collar in the head portion which forms the wall abutment or a portion thereof. In particular The collar can become radially wider along the longitudinal axis of the dowel in the direction of the proximal dowel body opening. A collar is referred to here as a radial projection or a radially projecting part of the dowel body, which projects radially beyond the shaft section and the end section. The collar preferably encloses the proximal dowel body opening in a radially circumferential manner. Due to the collar, the head section has a larger outer diameter than the shaft section and the end section, the outer diameter of the collar or the head section preferably having at least 1.5 times or 2 times the outer diameter of the shaft and/or end section. In this way, a reliable wall contact of the head section in the peripheral area of the gastrotomy or enterotomy is achieved, which makes simple and safe use of the anastomotic dowel possible, especially in laparoscopic, robotic or endoscopic use. Preferably, the outer diameter of the collar or the head section should not be more than 5 times, in particular not more than 4 times, the outer diameter of the shaft and/or end section.

In preferred embodiments, the outer diameter of the collar or head portion in the expanded configuration may be at least about 5 millimeters, at least about 8 millimeters, at least about 10 millimeters, or at least about 12 millimeters. Preferably, the outer diameter of the collar or head section in the expanded configuration is at most about 30 millimeters, at most about 25 millimeters or at most about 20 millimeters. A suitable outside diameter is e.g. B. in the range of about 8 millimeters to about 20 millimeters.

In preferred embodiments, the collar has a prestressing area in which the struts, viewed from the proximal dowel body opening, are at least partially oblique, i.e. H. an angle greater than 90 degrees and less than 180 degrees, extend to the longitudinal axis in the direction of the distal dowel body opening or are curved in the direction of the distal dowel body opening. The preload area is preferably designed to be resilient. In this way, the anastomosis using the anastomosis dowel according to the invention maintains an advantageous pretension on the contact surfaces of the organ sections to be connected, which additionally counteracts a loosening of the connection between the organ sections and the associated risk of insufficiency.

In preferred embodiments, at least a portion of the struts terminate at the proximal end in an integral loop or eyelet. These allow a simple and durable suture fixation of the anastomotic dowel to the inner wall of the intestine or stomach and, if necessary, also to the pancreas. The basic structure can in principle be designed to be self-expanding or balloon-expandable. It is particularly advantageous for the basic structure to be designed to be self-expanding. It has been shown that a self-expanding framework enables particularly simple anastomosis and secure fixation of the anastomotic dowel in the pancreatic or bile duct, especially in the area of minimally invasive surgery.

The material of the basic framework is initially not subject to any particular restrictions, so e.g. B. any material that is known and suitable to the person skilled in the art in the field of vascular stents can generally be considered. The basic structure can in principle consist of a metallic material or a polymer material. The metallic material can be a pure metal or a metal alloy. Non-limiting examples of suitable metallic materials are stainless steels or stainless steels, nickel-titanium alloys (also known as Nitinol), chromium, in particular cobalt-chromium or platinum-chromium, and other metal alloys, in particular cobalt-nickel and magnesium-based ones Governments, d. H. Alloys that usually consist of over 90% magnesium and, for example, B. aluminum and rare earth metals such as. B. contain cerium, praseodymium, neodymium, yttrium and / or zirconium. Non-limiting examples of suitable polymer materials include: B. Nylon, polyurethane, polycaprolactone, poly-glycol and poly-lactic acid-based polymers such as PLLA or PDLA. In addition, it is possible for the basic structure to consist partly of a metallic material and partly of a polymer material. A coating of a metallic base structure with a polymer material, in particular a bioabsorbable and/or drug-releasing material, is also provided.

In preferred embodiments, the basic structure consists at least partially of a resorbable material, whereby a “resorbable material” is understood to mean a material that dissolves on its own in the body after a certain time. The inventor has recognized that conventionally designed basic frameworks e.g. B. metal alloys due to long-term contact with the ductal epithelium with simultaneous pressure load tend to cause foreign body reactions in the sense of induction of scar tissue and fibrosis, which can lead to narrowing or even closure of the ducts after anastomosis and, especially in the case of the main pancreatic duct, to a subsequent, potentially can lead to life-threatening inflammation or atrophy of the pancreatic tissue. A comparable fibrosis and foreign body reaction has also been shown when using metal stents in bile ducts. Examples of suitable resorbable materials are: B. resorbable magnesium alloys, iron alloys and zinc alloys as well as polycarbonates, poly-glycol (PGA) and poly-lactic acid-based polymers (PLA, PLLA, PDLA) as well as block and / or copolymers thereof such as. B. Poly (lactide-co-glycolide) (PLGA) has been proven. The use of resorbable materials according to the invention enables a longer-term Contact of the anastomotic plug with the duct epithelium is prevented and the risk of life-threatening secondary diseases is significantly reduced.

A special feature is that the anastomotic plug according to the invention, unlike e.g. B. conventional vascular stents, do not have to stop the narrowing of the vessel, but are only required until the anastomosis has healed, usually around two to four weeks. The inventor uses this property to his advantage by preferably using significantly thinner struts and/or more quickly absorbable materials for the basic structure.

In preferred embodiments, the struts have a diameter of at most about 120 micrometers, at most about 100 micrometers, at most about 80 micrometers, at most about 60 micrometers, at most about 50 micrometers or at most about 40 micrometers. Diameters of at most about 60 micrometers or less are particularly preferred.

Preferably, the material of the skeleton has a half-life in the human body of at least about 14 days, at least about one month or at least about 2 months. Furthermore, the material of the basic structure preferably has a half-life in the human body of at most about 12 months, at most about 6 months, at most about 4 months or at most about 2 months. The half-life indicates the time required on average for half of the basic structure material to be broken down in the organism. A half-life of about 14 days to about 2 months is particularly preferred. In further preferred embodiments, the basic structure can be completely absorbed in the human body within about 2 to about 24 months, in particular within about 3 to about 6 months.

In preferred embodiments, a resorbable basic structure is combined with a membrane designed as described above for partially covering the proximal shaft area, which also consists of a resorbable material. Suitable resorbable materials for the membrane correspond to those of the basic structure.

In further preferred embodiments, the basic structure has at least partially a drug coating, for example with an immunosuppressant, in particular with a fibrosis inhibitor such as. B. an mTor inhibitor, in particular sirolism (CAS no. 53123-88-9) or everolimus (CAS no. 159351-69-6) and a pharmaceutically acceptable salt, hydrate or derivative thereof. In this way, the medium to long-term side effects described above, such as: B. local pancreatitis, which can be caused by the dowel body in the main pancreatic duct or in the bile ducts, can be effectively suppressed. A particularly safe application can be achieved with a basic framework that consists of both an absorbable material and a coating with an immunosuppressant.

A suitable dose of active ingredient can e.g. B. in the range of about 0.1 to about 5 micrograms per square millimeter, in particular about 1 to about 3 micrograms per square millimeter of the framework surface. Alternatively, the active ingredient dose can be measured according to the length of the framework, with suitable doses being in the range from about 5 micrograms to about 25 micrograms per millimeter, in particular about 10 to about 20 micrograms per millimeter.

In certain embodiments, an asymmetrical drug coating is provided, wherein the base structure in the distal shaft region has a drug coating according to the above statements and the proximal shaft region has no drug coating.

The dowel body can also have one or more radiopaque marking elements. At least one radiopaque marking element is preferably attached to the head section and/or the end section. Furthermore, at least one radiopaque marking element can also be attached in the shaft section, in particular in the transition region between the proximal shaft region and the distal shaft region. In this way, the anastomotic dowel can be positioned quickly and safely in minimally invasive use, but in particular the position of the anastomotic dowel can be checked and documented postoperatively.

An anastomotic plug according to the above description can be used with advantage in a, in particular minimally invasive, surgical procedure for the medical treatment of diseases of the pancreas or liver. One embodiment of the invention therefore also relates to a medical method for treating a disease of the pancreas or liver of a sick person, wherein the treatment involves endoscopic, laparoscopic and / or robotic creation of a connection between the pancreas and the small intestine or stomach or between a bile duct and the small intestine or Stomach of the sick person is included and the connection is made using the anastomotic plug described above. Of course, the connection between the pancreas and the small intestine or stomach or between the bile duct and the small intestine or stomach can also be created on the open stomach or via an abdominal incision.

In one embodiment, the disease includes a cancer or a tumor disease of the pancreas or liver. In particular, the disease can include a tumor disease of the pancreas, in particular pancreatic carcinoma, since the anastomotic system is created using the anastomotic plug according to the invention Manipulation of the pancreas and the risk of aggressive pancreatic juice escaping are significantly reduced and can therefore significantly reduce postoperative morbidity and mortality.

In some embodiments, the treatment requires or includes the surgical procedure a pancreatic head resection, i.e. H. a surgical removal (“resection”) of the head of the pancreas.

In some embodiments, the treatment or surgical procedure requires an end-to-side connection of the body of the pancreas and the small intestine or jejunum, i.e. H. One end of the pancreatic body is connected to a laterally opened section of the small intestine, in particular the jejunum. Preferably, in the radially compressed configuration, the anastomotic plug is introduced transmurally into a pancreatic duct that is transversely severed on a resection surface of the pancreatic body from the intestinal lumen through a, in particular point-shaped, intestinal wall incision or enterotomy and is advanced transversely to the resection surface inside the pancreatic duct, so that the head section or the wall contact of the anastomotic dowel lies at least partially against the inner intestinal wall after the radially compressed configuration has been transferred into the radially expanded configuration, and the end section and the shaft section extend with the distal shaft region and at least part of the proximal shaft region inside the pancreatic duct. The pancreatic duct is preferably the main duct of the pancreatic body.

One embodiment of the invention therefore relates to an anastomotic plug according to the above description for use in a surgical procedure for treating a tumor disease of the pancreas, in particular a pancreatic carcinoma, of a sick person, the treatment requiring a pancreatic head resection with subsequent anastomosis of the small intestine and pancreatic body of the person or in which a pancreatic head resection was performed on the sick person and the following steps are indicated for the surgical procedure or the surgical procedure comprises the following steps: a) providing access to the small intestinal lumen, for example by opening the small intestinal lumen by means of a surgical incision; b) creating a lateral, for example point-shaped, small intestine enterotomy, in particular a jejunotomy; c) introducing the anastomotic dowel in the radially compressed configuration from the small intestine lumen through the lateral small intestine enterotomy, ie transmurally, into a pancreatic duct transversely severed at a resection surface of the pancreatic body; d) arranging the dowel body with the end section, the distal shaft region and at least a part of the proximal shaft region of the shaft section inside the pancreatic duct and with at least a part of the head section in the small intestine lumen, e) transferring the anastomotic dowel from the radially compressed configuration into the radially expanded configuration such that the wall system of the anastomotic plug rests at least partially on an inner wall of the small intestine.

Step e) preferably additionally includes applying a contact pressure acting in the direction of the resection surface to the inner wall of the small intestine while the anastomotic dowel is transferred from the radially compressed configuration to the radially expanded configuration.

This treatment cannot generally be carried out with flexible endoscopy. Preferably, steps a) to e) are carried out laparoscopically, robotically or on the open stomach of the sick person.

A further embodiment of the invention relates to an application device for an anastomotic dowel, in particular according to the above description, for the production of an anastomosis, in particular endoscopically or laparoscopically or robotically.

The application device comprises a, preferably flexible, catheter part for positioning and releasing the anastomotic plug, the catheter part comprising a tubular outer catheter and an inner catheter which is arranged in the tubular outer catheter. The inner catheter can be tubular or closed or rod-shaped. A tubular inner catheter is preferred because in this way a guide wire can also be guided through the inner catheter, which can facilitate the positioning of the anastomotic dowel. In addition, the guide wire can be used to create a punctate enterotomy. A distal support portion of the catheter is configured to support the anastomotic plug in a radially compressed configuration between the inner catheter and the outer catheter. The outer catheter is movable in the axial direction of the catheter part relative to the inner catheter, so that by pulling back the outer catheter in the proximal direction relative to the inner catheter, the anastomotic dowel can be released starting from the end section towards the head section, i.e. h can be transferred from the radially compressed configuration to the radially expanded configuration. The catheter part according to the invention additionally has a pressure device with a pressure element that extends radially outwards on the outside of the outer catheter and is movable in the axial direction of the catheter part relative to the outer catheter. In this way, it is possible to use the pressure element to apply a, preferably circular, contact pressure to two organ sections or hollow organ sections that are connected to one another through the anastomosis, in particular the intestinal wall and the resection surface of the pancreas body, during the release of the anastomotic dowel from the distal support section and thereby particularly to be connected firmly and tightly, thereby achieving improved healing of the anastomosis and a lower postoperative insufficiency rate. It is possible for the pressure element to be arranged movable or immovable, ie fixedly spaced, in the axial direction of the catheter part relative to the inner catheter and/or the distal carrier section. Preferably, the pressure element is arranged at a fixed, predefined distance in the axial direction of the catheter part relative to the inner catheter or the distal support section. In particular, the pressure element is rigidly connected in the axial direction to the inner catheter and/or the distal support section. It has been shown that this embodiment enables a particularly reliable tactile feedback control and control of the positioning and release of the anastomotic dowel by combining the pressure element as a mechanically acting abutment with a simultaneously predefined distance between the pressure element and the support section, so that, for example, X-ray supported positioning can be dispensed with entirely.

The pressure device can comprise a tube part which surrounds at least a part of the tubular outer catheter or in which the tubular outer catheter is arranged. The pressure element can be arranged on an outer surface of the tube part or molded onto it, preferably at the distal end of the tube part. In this way, the pressure device can also be used together with the internal and external catheters over longer distances within the abdominal cavity.

In preferred embodiments, the catheter part, in particular the pressure device, comprises a trigger device coupled to the outer catheter, which is designed to displace the outer catheter relative to the inner catheter in the proximal direction and thereby release the anastomotic plug. It has also proven to be advantageous in practice if the pressure device has a feed element which acts on the pressure element and is arranged proximally of the pressure element. In this way, it is possible to mechanically apply the required contact pressure to the pressure element via the feed element in order to connect the organ sections firmly and tightly to one another using the anastomotic dowel. The inner catheter preferably has a flexible, at least partially tapered tip at the distal end. In the sense of the present invention, “flexible” means dimensionally stable but elastically deformable, ie the tip can deform elastically under the influence of tension or pressure and returns to its original, undeformed shape when the load is relieved. A suitable tip can e.g. B. be formed from an elastomer, for example a vulcanizate of natural rubber or silicone rubber, a polyolefin elastomer or the like. In preferred embodiments, the tip has an axial length of about 5 millimeters to about 50 millimeters, particularly preferably about 10 millimeters to about 30 millimeters. In this way, the shaft section of the anastomotic dowel can be positioned in a targeted manner and, in particular, without causing any lesions, in the sensitive pancreatic or bile duct.

The design of the pressure element is fundamentally not particularly limited, as long as there is a permanent contact pressure between the organ sections to be connected, e.g. B. pancreas and intestine or stomach, can be exercised and at the same time the intraluminary deployment of the anastomotic plug in the intestine or stomach is not impaired. For example, the pressure element can be designed as a substantially circular or plate-shaped pressure plate or a pressure element in a U-shape or V-shape, the legs of which point in the direction of the distal end section of the catheter and thereby enable 2-point pressure. The 2-point pressure form allows an advantageous small lumen opening of the intestine or stomach and easy intraluminal insertion.

In preferred embodiments, the pressure element has a, preferably circular, pressure surface on its side facing the distal support section. The pressure surface can comprise at least 50 square millimeters, preferably at least 100 square millimeters, preferably at least 150 square millimeters, further preferably at least 200 square millimeters, particularly preferably at least 250 square millimeters. A circular or plate-shaped pressure element preferably has a radial outer diameter of at least about 10 millimeters, at least about 15 millimeters, at least about 20 millimeters, at least about 25 millimeters, at least about 30 millimeters or at least about 40 millimeters. Furthermore, the radial outer diameter of the pressure element is preferably at most 50 millimeters. The pressure element preferably has a central, in particular circular, recess or recess on its side facing the distal support section, which forms a receiving space which is designed to at least partially hold the head section or the wall system in the radially expanded configuration. preferably absorbed completely. In this way, the head section of the dowel body can unfold unhindered within the recess or recess, while at the same time the pressure element exerts a permanent contact pressure between the organ sections to be connected. In particularly preferred embodiments, the pressure element can be insufflated like a balloon, in particular as an insufflatable circular pressure plate. The pressure device can z. B. have an access device, for example an inlet or outlet opening, which is fluidly connected to the pressure element and in this way allows the pressure element to be filled with air or a liquid such as. B. contrast medium and / or table salt enables in situ development. This means that the pressure element, as long as it has not yet been unfolded, can be easily inserted via a trocar together with the catheter part during an endoscopic operation and can be advanced until gastrotomy or enterotomy. The pressure element is then expanded, e.g. B. using compressed air or using a syringe filled with contrast agent and / or saline, especially a high-pressure syringe. The pressure element is preferably designed to be subjected to a pressure of at least 2 bar, at least 5 bar or at least 10 bar, in particular between 10 bar and 20 bar. After the anastomotic dowel has been released, the air or liquid is released from the pressure element and the pressure element is withdrawn again via the trocar. In this way, a particularly advantageous, large-area and uniform pressurization of the organ sections to be connected to one another through the anastomosis is possible during the release of the anastomotic dowel, even during the endoscopic production of an anastomosis.

Preferably, the pressure element, in particular in the insufflated state, has a radial outer diameter that is larger than the radial outer diameter of the head section of the anastomotic dowel in the expanded configuration. In particular, the radial outer diameter of the pressure element can be at least about 15 millimeters, at least about 20 millimeters, at least about 25 millimeters, at least about 30 millimeters or at least about 40 millimeters. Furthermore, the radial outer diameter of the pressure element is preferably at most 50 millimeters.

Finally, one embodiment of the invention relates to an application system for producing an anastomosis, preferably endoscopically or laparoscopically.

The application system according to the invention comprises an application device according to the above description, which is equipped with an anastomotic plug described above. Surprisingly, it has been shown that using the application system according to the invention, an anastomosis can be created with comparable or even better quality and safety than with conventional suture fixation after laparotomy on the open abdomen. In addition, laparoscopic anastomosis is significantly simplified. In addition, the application system according to the invention can surprisingly also be used to make problematic anastomoses, especially of soft ones Pancreatic tissue with a delicate pancreatic duct can be performed safely and reliably, which is more difficult to apply in the conventional manner due, among other things, to the lack of support of surgical sutures and is associated with a high risk of leakage and the occurrence of postoperative complications. In this way, the invention contributes to a significant reduction in patient-specific risk factors in anastomosis, particularly in pancreatic surgery.

It is understood that the various embodiments and advantages of the anastomotic dowel according to the invention are also applicable to the medical use of the anastomotic dowel or the medical treatment method, the application device and the application system. Features that are disclosed above and below in connection with the anastomotic plug can therefore also relate to the medical use and the medical treatment method, the application device and the application system and vice versa.

Short description of the characters

The invention will be explained in more detail below using exemplary embodiments and figures. These represent only schematic and not necessarily true to scale and proportion representations of principles and are only to be understood as examples.

For reasons of clarity, recurring features are sometimes not provided with multiple reference symbols in the figures. Under no circumstances should the invention be limited to the figures shown. Show it:

Fig. 1 is a schematic representation of an embodiment of an inventive

Anastomotic dowel in radially expanded configuration;

Fig. 2 is a perspective view of the anastomotic dowel according to the invention from Fig.

4 seen from the proximal end;

3 shows a partial perspective view of a further embodiment of an anastomotic dowel according to the invention, seen from the proximal end;

Fig. 4 is a schematic sectional view through a pancreatic-enteric

Anastomosis created with a state-of-the-art anastomotic dowel (reference);

Fig. 5 is a schematic sectional view through a pancreatic-enteric

Anastomosis using an anastomotic dowel according to the invention; Fig. 6 is a schematic view of an embodiment of an inventive

Application device during the release of an anastomotic plug;

7 shows a schematic sectional view of an embodiment of a further application device according to the invention with an insufflatable pressure element;

Fig. 8 shows a detail of a variant of the application device according to the invention from Fig. 6 with a plate-shaped pressure element when creating a pancreatic-enteric anastomosis. Fig. 4;

Fig. 9 shows schematic cross sections of anastomotic dowels according to the invention in a radially expanded configuration with different embodiments of the wall system.

Detailed description of exemplary embodiments

Fig. 1 shows an exemplary embodiment of an anastomotic dowel 1 according to the invention in a radially expanded configuration. The dowel body 2 consists of a basic structure 24, which is constructed from several struts 26 connected in a grid-like manner. In the example shown, the struts 26 consist of a shape memory alloy such as. B. Nitinol, so that the framework 24 is self-expanding; but balloon-expandable versions of the basic structure 24 are also possible.

The dowel body 2 has a head section 4, in which a proximal dowel body opening 6 is located, and an end section 8, in which a distal dowel body opening 10 is located. Between the head section 4 and the end section 8, a shaft section 12 extends along a central dowel longitudinal axis L of the anastomotic dowel 1, which connects the proximal dowel body opening 6 and the distal dowel body opening 10 to one another in a tubular manner.

In the head section 4, the free ends of the struts 26 are curved radially outwards and thereby form a collar 28 which widens radially in the direction of the proximal dowel body opening 6 and which has a wall contact 14 for abutting the anastomotic dowel 1 on an organ wall 38 (not in Fig. 1 shown). Some of the struts 26 carry an integral eyelet 32 at their free end for attaching suture material.

The shaft section 12 consists of a proximal shaft region 16 and a distal shaft region 18, which in the example shown have approximately the same axial length. The Proximal shaft area 16 is covered with an outer jacket 20 like a sleeve, which z. B. consists of a liquid-impermeable, elastic polyurethane membrane 22. In this way, body fluids cannot escape from the lumen of the proximal shaft region 16 to the outside into the environment. According to a preferred embodiment, the sheath 20 extends in the axial direction into the head section 4 and thereby envelops part of the collar 28, so that it can extend over the entire small intestine or stomach wall into the lumen of the small intestine or stomach in order to To drain body fluids safely and unhindered. In the distal shaft region 18, the basic structure 24 is exposed, so that, on the one hand, body fluid from the outside enters the lumen of the distal shaft region 18 essentially unhindered and, on the other hand, the grid structure enters the epithelial tissue of z. B. the main pancreatic duct or bile ducts can intervene. In this way, even with the partial covering in the proximal shaft area 16, a stable anchoring of the anastomotic dowel 1 in the organ duct and thus a durable connection of the anastomosis itself is guaranteed without additional suture fixation.

Fig. 2 shows a perspective view of the anastomotic dowel 1 from Fig. 1 viewed from the head section 4 looking into the proximal dowel body opening 6. It can be seen that several struts 26 of the basic structure 24 in the head section 4 extend radially outwards and thereby form a Proximal dowel body opening 6 form a circumferential, ring-shaped collar 28, in which the base frame 24 has a larger outer diameter or a larger cross-sectional area than in the shaft section 12.

Fig. 3 shows a detail of a variant of the basic framework 24 from Fig. 2. While in the example shown in Fig. 2 some of the struts 26 end in an integral eyelet 32, in the variant from Fig. 3 some struts 26 form at the proximal end of the Base frame 24 integral loops 30, which on the one hand together form the wall system 14 and on the other hand enable the attachment of suture material. The loop-shaped design increases the bending strength of the struts 26 in the support area and increases the support surface of the wall system 14.

4 shows as a reference a schematic sectional view of an exemplary anastomosis 34 after resection of the pancreatic head, which was created with a conventional anastomotic dowel 1 according to the technical teaching from DE 20 2015 004700 Ul. To produce the anastomosis 34, the anastomotic dowel 1 is inserted transmurally into the main duct of the pancreatic body 40 from the intestinal lumen 36 through a point-shaped incision in the intestinal wall 38, so that the head of the anastomotic dowel 1 rests on the inner intestinal wall 38. In the first few days after the operation, there is no liquid-tight adhesion between the intestinal wall 38 and the resection surface 44, so that with the conventional connection there is a risk that the aggressive pancreatic juice will get between them Structures run into the abdominal cavity (indicated by the arrows in Fig. 4) and can cause life-threatening complications.

In contrast, FIG. 5 shows a schematic sectional view of an exemplary anastomosis 34 after resection of the pancreatic head, which was created with an anastomotic dowel 1 according to the invention. To produce the anastomosis 34, the anastomotic dowel 1 is inserted transmurally into the main duct of the pancreatic body 40 from the intestinal lumen 36 through a punctiform incision of the intestinal wall 38, analogous to FIG and the shaft section 12 with the proximal region 16 and the distal region 18 extends into the main duct 42 of the pancreas 40. A liquid-impermeable jacket 20, here in the form of a membrane-like inner lining of the proximal shaft region 16 and part of the head section 4, extends from the main duct 42 of the pancreas 40 over the entire small intestinal wall 38 into the lumen 36 of the small intestine and thus seals the gap between the intestinal wall 38 and resection surface 44 for liquids to the outside. The aggressive pancreatic juice can only take the desired route from the pancreatic duct 42 into the intestinal lumen 36. In this way, for example, B. achieve a significant reduction in postoperative morbidity and mortality after pancreatic resection.

6 shows a schematic representation of an application device 50 according to the invention for an anastomotic dowel 1 for the, in particular laparoscopic, production of an anastomosis 34. The application device 50 includes a catheter part 52 for positioning and releasing the anastomotic dowel 1 with an external tubular outer catheter 54 and an internal, here tubular, inner catheter 56. A guide wire 64 runs through the inner catheter 56 for introducing, stabilizing and positioning the anastomotic dowel. At the same time, the guide wire 64 can be used to create a punctiform enterotomy. The inner catheter 56 has a flexible, conically tapered tip part 57 made of silicone rubber at the distal end, which supports lesion-free positioning of the shaft section 12 in the pancreatic or bile duct. A carrier section 58 at the distal end of the catheter part 52 is designed to carry the anastomotic dowel 1 in a radially compressed configuration between the inner catheter 56 and the outer catheter 54. In the example shown, the anastomotic plug 1 has already been partially released from the carrier section 58 of the catheter part 52. Furthermore, the catheter part 52 of the application device 50 has a pressure device 60 with a hose part 61 through which the outer and inner catheters 54, 56 run. At the distal end of the tube part 61, a V-shaped pressure element 62 is arranged, which extends radially outwards on the outside of the outer catheter 54 and is movable in the axial direction of the catheter part 52 relative to the outer catheter 54. The two legs of the V-shaped Pressure element 62 faces the distal support section 58, so that they can be brought into contact with the pressure surfaces 69 with the organ wall to be anastomosed. Via the feed element 65, which is arranged proximally of the pressure element 62 and acts on it via the hose part 61, the pressure element 62 can be mechanically subjected to a contact pressure during the release of the anastomotic dowel 1 from the distal support section 58 in order to achieve the pressure through the anastomosis 34 to connect hollow organ sections to bring them into close contact with one another. In this way, the organs can be firmly and securely connected to one another using the anastomotic plug 1, especially laparoscopically. A trigger device 63, which is arranged axially movably on the tube part 61, is connected to the outer catheter 54, for example. B. coupled via a guide slot (not shown here) in the tube part 61, so that by moving the trigger device 63 on the tube part 61 in the proximal direction, the outer catheter 54 is retracted relative to the inner catheter 56 and thereby releases the anastomotic plug 1.

8 (left) shows a variation of the pressure element 62 from FIG. The pressure element 62 is designed so that it completely accommodates the head section 4 of the anastomotic dowel 1 and the pressure surface 69 surrounds the wall system 14 all around. The pressure element 62 is shown in section on the right side in FIG. 8. The section through the pressure element 62 shows that it has a central, circular recess 66 on the side facing the distal support section and thereby forms a receiving space 70 which can completely accommodate the wall system 14 in the radially expanded configuration. In this way, the organ sections 38, 40 can be subjected to a contact pressure during the release of the anastomotic dowel 1 from the application device 50, without the head section 4 of the anastomotic dowel 1 being impaired in its unfolding and secure contact with the organ wall 38. Furthermore, reference is made to the explanations for FIG. 4.

Fig. 7 shows a further embodiment, in particular for laparoscopic use, of the application device 50 according to the invention for an anastomotic plug 1. The application device 50 in turn comprises a catheter part 52, shown here in detail, with a tubular outer catheter 54, in which a tubular inner catheter 56 is arranged . In the example shown, there is no guide wire 64, so that the inner catheter 56 can be closed or rod-shaped. It goes without saying that the inner catheter 56 can also be tubular here in order to enable the use of a guide wire 64. In the carrier section 58 at the distal end of the catheter part 52, the inner catheter 56 carries the anastomotic plug 1, which is surrounded by the outer catheter 54 and is held in its compressed form. The pressure device 60 of the embodiment shown in FIG. 7 has a circular, insufflatable pressure element 62 that extends radially outward on the outside of the outer catheter 54 and is movable in the axial direction of the catheter part 52 relative to the outer catheter 54. Via the access device 68, for example a Luer/Lock connection system, which is fluidly connected to the pressure element 62, z. B. using a high-pressure syringe, air or liquid such as. B. a saline solution containing contrast agent can be pressed into the pressure element so that it can be unfolded in situ after endoscopic introduction via a trocar into the abdominal cavity in order to mechanically press the organ sections to be connected together. The pressure element 62 has a central, circumferential recess 66, which allows the organ sections to be subjected to a contact pressure during release without the head section 4 of the anastomotic dowel 1 being impaired in its unfolding and secure contact with the organ wall. After application of the anastomotic dowel 1, the pressure element 62 can be desufflated again and the entire catheter part 52 can be removed again via the trocar.

Finally, Fig. 9 shows schematic cross-sections of anastomotic dowels 1 according to the invention in a radially expanded configuration with different embodiments of the wall system 14 or the collar 28. In the embodiments shown, the wall system 14 or the collar 28 each has a prestressing area 29 in which the Collar 28 extends from the proximal dowel body opening 6 in the direction of the outer collar edge 33 in sections obliquely to the longitudinal axis L in the direction of the distal dowel body opening 10 (see Fig. 9 above) or is curved in the direction of the distal dowel body opening 10 (see Fig. 9 below). In this way, the wall system 14 or the collar 28 is given a spring effect acting in the direction of the distal dowel body opening 10 and thus in the direction of the organ sections to be connected. In cooperation with the pressure element 62 of the application device 50 according to the invention, which applies a contact pressure to the organ sections to be connected during the release of the anastomotic dowel 1, it is possible to have an advantageous preload on the contact surfaces of the organ sections to be connected during anastomosis using the anastomotic dowel 1 according to the invention and thereby promote the growth of the organ sections to be connected over a longer period of time.

The invention is not limited to these by the description based on the exemplary embodiments. Rather, the invention encompasses every new feature and every combination of features, which in particular includes every combination of features in the patent claims, even if this feature or this combination of features itself is not explicitly stated in the patent claims or the exemplary embodiments.

1 anastomotic plug

2 dowel bodies

4 head section

6 proximal dowel body opening

8 end section

10 distal dowel body opening

12 shaft section

14 wall system

16 proximal shaft area

18 distal shaft area

20 liquid-impermeable jacket

22 polymer membrane

24 basic framework

26 struts

28 collars

29 leader area

30 loop

32 eyelet

33 collar edge

34 Anastomosis

36 small intestinal lumen

38 intestinal wall

40 pancreas

42 main course

44 resection area

50 application device

52 catheter part

54 external catheters

56 internal catheters

57 lace part

58 distal support section

60 pressure device

61 hose part

62 pressure element

63 trigger device

64 guide wire

65 feed element 66 recess/recess

68 Access facility

69 pressure surface

70 receiving space L dowel longitudinal axis

Claims

1. An anastomotic dowel (1) with a radially compressed configuration and a radially expanded configuration, comprising a dowel body (2) with a head section (4) in which a proximal dowel body opening (6) is located, an end section (8) in which there is a distal dowel body opening (10) and a shaft section (12) which extends between the head section (4) and the end section (8) along a central dowel longitudinal axis (L) and the proximal dowel body opening (6) and the distal dowel body opening (10 ) connects to one another in a tubular shape, the head section (4) in the radially expanded configuration forming a wall contact (14) for contacting the anastomotic dowel (1) against an organ or vessel wall (38), characterized in that the shaft section (12) extends along the Dowel longitudinal axis (L) has a proximal shaft region (16) and a distal shaft region (8), the proximal shaft region (16) being radially impermeable to body fluids and the distal shaft region (18) being designed to be radially permeable to body fluids.

2. The anastomotic dowel (1) according to claim 1, characterized in that the dowel body (2) is equipped on one side with the wall system (14).

3. The anastomotic dowel (1) according to one of claims 1 or 2, characterized in that the end section (8) and the shaft section (12) together form a straight hollow cylinder which extends from the head section (4) with a substantially constant outer radius. extends to the distal dowel body opening (10).

4. The anastomotic plug (1) according to one of claims 1 to 3, characterized in that the head section (4) has an outer diameter that is at least 1.5 times larger than the shaft section (12) and the end section (8).

5. The anastomotic plug (1) according to one of claims 1 to 4, characterized in that the proximal shaft region (16) has an axial length which is at most 70% of a total axial length of the shaft section (12).

6. The anastomotic plug (1) according to one of claims 1 to 5, characterized in that the shaft section (12) has a total axial length of 20 millimeters to 100 millimeters.

7. The anastomotic dowel (1) according to one of claims 1 to 6, characterized in that the shaft section (12) in the expanded configuration has an outer diameter of at least 2 millimeters and at most 12 millimeters.

8. The anastomotic plug (1) according to one of claims 1 to 7, characterized in that the proximal shaft region (16) has an axial length of at least 10 millimeters and at most 50 millimeters.

9. The anastomotic plug (1) according to one of claims 1 to 8, characterized in that the proximal shaft region (16) has a liquid-impermeable jacket (20) which lines the proximal shaft region (16) in a radially circumferential manner on the inside and/or radially all around on the outside encloses.

10. The anastomotic plug (1) according to claim 9, characterized in that the liquid-impermeable jacket (20) comprises or consists of a stretchable polymer membrane (22).

11. The anastomotic plug (1) according to claim 10, characterized in that the stretchable polymer membrane (22) is a polymer selected from the group consisting of polyester, polyurethane, polyvinyl alcohol, polyethylene, polypropylene, polytetrafluoroethylene, polylactide, polyglycolide, polycaprolactone and any combinations, Contains block and copolymers thereof.

12. The anastomotic dowel (1) according to one of claims 1 to 11, characterized in that the dowel body (2) has a basic structure (24) made up of several struts (26) which are connected to one another.

13. The anastomotic dowel (1) according to claim 12, characterized in that the struts (26) in the radially expanded configuration in the head section (4) form a collar (28) which widens radially towards the proximal dowel body opening (6). forms the wall system (14) or part of it.

14. The anastomotic plug (1) according to claim 13, characterized in that the collar (28) in the expanded configuration has an outer diameter of at least about 5 millimeters and at most about 30 millimeters.

15. The anastomotic dowel (1) according to one of claims 13 or 14, characterized in that the collar (28) has a prestressing area (29) in which the struts (26) from the proximal dowel body opening (6) towards an outer Collar edge (33) extend at least in sections obliquely to the longitudinal axis (L) in the direction of the distal dowel body opening (10) and / or are curved in the direction of the distal dowel body opening (10).

16. The anastomotic plug (1) according to one of claims 12 to 15, characterized in that at least some of the struts (26) end in an integral loop (30) or eyelet (32) at the proximal end.

17. The anastomotic plug (1) according to one of claims 12 to 16, characterized in that the basic structure (24) is at least partially formed from a resorbable material and / or is at least partially coated with an immunosuppressant.

18. An anastomotic plug (1) according to any one of claims 1 to 17 for use in a surgical procedure for treating pancreatic disease or liver disease in a sick person.

19. The anastomotic plug (1) for use in the surgical procedure according to claim 18, characterized in that the treatment involves laparoscopic creation of a connection between the pancreas (40) and the small intestine (36) or stomach or between a bile duct and the small intestine (36). sick person.

20. The anastomotic plug (1) for use in the surgical procedure according to one of claims 18 or 19, characterized in that the treatment includes a pancreatic head resection.

21. The anastomotic plug (1) for use in the surgical procedure according to one of claims 18 to 20, characterized in that the treatment comprises an end-to-side connection of the pancreatic body (40) and the small intestine.

22. The anastomotic dowel (1) for use in the surgical method according to claim 21, characterized in that the anastomotic dowel (1) in the radially compressed configuration from the small intestine lumen (36) of the diseased person through an intestinal wall incision transmurally into a resection surface ( 44) of the pancreatic body (40) transversely severed pancreatic duct (42) and is advanced transversely to the resection surface (44) inside the pancreatic duct (42), so that the end section (8) and the shaft section (12) with the distal shaft area (18 ) and at least part of the proximal shaft region (16) extends inside the pancreatic duct (42).

23. An anastomotic plug (1) according to one of claims 1 to 17 for use in a surgical procedure for treating a tumor disease of the pancreas (40) of a sick person, wherein the surgical procedure involves an anastomosis (34) of the small intestine and pancreatic body (40). a pancreatic head resection and also has the following steps

Providing access to the small intestine lumen (36),

Creating a lateral enterotomy,

Inserting the anastomotic dowel (1) in the radially compressed configuration from the small intestine lumen (36) through the lateral enterotomy into a pancreatic duct (42) cut transversely on a resection surface (44) of the pancreatic body (40),

Arranging the dowel body (2) with the end section (8), the distal shaft region (18) and at least a part of the proximal shaft region (16) of the shaft section (12) inside the pancreatic duct (42) and with at least a part of the head section (4 ) in the small intestine lumen (36),

Transferring the anastomotic dowel (1) from the radially compressed configuration into the radially expanded configuration such that the wall contact (14) of the anastomotic dowel (1) rests at least partially on an inner wall (38) of the small intestine.

24. The anastomotic plug (1) for use in the surgical procedure according to claim 23, additionally comprising

Applying a contact pressure acting in the direction of the resection surface (44) to the inner wall (38) of the small intestine while the anastomotic dowel (1) is transferred from the radially compressed configuration to the radially expanded configuration.

25. The anastomotic plug (1) for use in the surgical procedure according to one of claims 23 or 24, wherein the surgical procedure is carried out laparoscopically, robotically or on the open abdomen of the sick person.

26. An application device (50) for an anastomotic dowel (1) according to one of claims 1 to 17 for producing an anastomosis (34), with a catheter part (52) for positioning and releasing the anastomotic dowel (1), the catheter part (52) a tubular outer catheter (54) and an inner catheter (56) which is arranged in the tubular outer catheter (54) and has a distal support section (58) which is adapted to hold the anastomotic plug (1) in a radially compressed configuration between the inner catheter (56) and the outer catheter (54), characterized in that the catheter part (52) additionally has a pressure device (60) with a pressure element (62), which on the outside of the outer catheter (54) extends radially outwards and is movable in the axial direction of the catheter part (52) relative to the outer catheter (54) and is designed to connect two hollow organ sections (38, 44) to be connected to one another through the anastomosis (34) during release of the anastomotic dowel (1) from the distal support section (58) with a contact pressure.

27. The application device according to claim 26, characterized in that the pressure element (62) is designed to be insufflatable.

28. The application device according to one of claims 26 or 27, characterized in that the pressure device (60) has a feed element (65) acting on the pressure element (62), which is arranged proximally of the pressure element (62) and is designed to push the pressure element (62) to apply mechanical contact pressure.

29. The application device according to one of claims 26 to 28, characterized in that the pressure element (62) is fixedly arranged in the axial direction of the catheter part (52) relative to the inner catheter (54) and / or fixedly spaced relative to the distal support section (58). is.

30. The application device according to one of claims 26 to 29, characterized in that the pressure element (62) has a pressure surface (69) of at least 100 square millimeters on its side facing the distal support section (58).

31. The application device according to claim 30, characterized in that the pressure surface (69) is circular.

32. The application device according to one of claims 26 to 31, characterized in that the pressure element (62) has a central recess (66) on its side facing the distal support section (58), which forms a receiving space (70) which is designed for this purpose is to at least partially accommodate the head section (4) and/or the wall system (14) in the radially expanded configuration.

33. An application system for the laparoscopic production of an anastomosis (34), comprising an application device (50) according to one of claims 26 to 32, which is equipped with an anastomotic dowel (1) according to one of claims 1 to 17.