EP4262639A1 - Implant gastro-intestinal - Google Patents

Implant gastro-intestinal

Info

Publication number
EP4262639A1
EP4262639A1 EP20838949.4A EP20838949A EP4262639A1 EP 4262639 A1 EP4262639 A1 EP 4262639A1 EP 20838949 A EP20838949 A EP 20838949A EP 4262639 A1 EP4262639 A1 EP 4262639A1
Authority
EP
European Patent Office
Prior art keywords
section
implant
inverted
flow channel
longitudinal section
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
EP20838949.4A
Other languages
German (de)
English (en)
Inventor
Alexander BUTZ
Viktor GRABLOWITZ
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Individual
Original Assignee
Individual
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Individual filed Critical Individual
Publication of EP4262639A1 publication Critical patent/EP4262639A1/fr
Pending legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
    • A61F5/0003—Apparatus for the treatment of obesity; Anti-eating devices
    • A61F5/0013—Implantable devices or invasive measures
    • A61F5/0076—Implantable devices or invasive measures preventing normal digestion, e.g. Bariatric or gastric sleeves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
    • A61F5/0003—Apparatus for the treatment of obesity; Anti-eating devices
    • A61F5/0013—Implantable devices or invasive measures
    • A61F5/003—Implantable devices or invasive measures inflatable
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
    • A61F5/0003—Apparatus for the treatment of obesity; Anti-eating devices
    • A61F5/0013—Implantable devices or invasive measures
    • A61F5/0036—Intragastrical devices
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
    • A61F5/0003—Apparatus for the treatment of obesity; Anti-eating devices
    • A61F5/0089—Instruments for placement or removal
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2210/0057—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof stretchable
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0008—Fixation appliances for connecting prostheses to the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0025—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2220/0075—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0063—Three-dimensional shapes
    • A61F2230/0069—Three-dimensional shapes cylindrical
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0004—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof adjustable
    • A61F2250/0007—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof adjustable for adjusting length
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0004—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof adjustable
    • A61F2250/0008—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof adjustable for adjusting a position by translation along an axis or two perpendicular axes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for

Definitions

  • the present invention relates to the field of obesity and the associated secondary diseases such as diabetes mellitus, arterial hypertension and the associated increased risk of stroke, heart attack and cancer, but also secondary diseases of the spine and the musculoskeletal system.
  • the length of the hose can be chosen individually and influences the speed and the maximum extent with which the weight reduction should progress. Weight reductions of >70% are possible in one year. In addition, as expected, type II diabetes mellitus is already in remission in 80% of patients after 3 months, as has been determined in various studies and is known from bariatric surgery. Arterial hypertension, cardiac arrhythmia, diseases of the musculoskeletal system and other comorbidities improve significantly after such a weight reduction and are even fashionable
  • an applicator is required on the one hand, which initially protects the gastrointestinal implant during insertion into the small intestine and then enables expansion of the implant in the intestine and subsequent fixation, but on the other hand also more suitable Fastening means that allow a reliable, essentially non-displaceable fixation of the implant gastro-intestinal tract.
  • Such implants and applicators are known, for example, from US 2012/0065571 or WO 2020/141023 A1. These documents both show implants with tubular sections which have elastic, ring-shaped fastening means connected by means of elastic elements in one end region. These fasteners are positioned on either side of the pylorus to clamp it. In this way, the implant can be fixed in position on the pylorus.
  • tubular section of the implant into the intestine after it has been fixed in position on the pylorus, so that it is lined by the tubular section over the desired length.
  • the length of the section of intestine to be lined depends on the severity of the obesity and the desired avoidance of food absorption.
  • WO 2020/141023 A1 proposes putting the end area of the implant and an area of the tubular section over a cup-shaped end area of the applicator having a receiving volume and stuffing the protruding section into the receiving volume so that it is folded there.
  • the tubular implant By introducing a fluid, preferably air, into the cup-shaped end area, the tubular implant can be expanded into the small intestine by the section that has been invaginated into the accommodation volume being pushed out of the accommodation volume again.
  • a fluid preferably air
  • this object is achieved with an implant for arrangement and expansion in the human intestine for the purpose of lining a section of the intestine to prevent the absorption of food supplied in this section, with a first end section which, as a fastening section, enables the implant to be fixed in the human gastrointestinal tract and/or or on an applicator, and a tubular section adjoining the first end section, comprising a longitudinal section extending in the intended direction of expansion, and a transitional section adjoining the longitudinal section, and an adjoining inverted section, which runs counter to the intended direction of expansion within the longitudinal section, as well as a second end section, characterized in that a region of the inverted section and a region of the longitudinal section delimit a flow channel via which a blown into the tubular section allowing fluid to penetrate to the transition section to apply pressure thereto and wherein the inverted section radially defines a cavity and has a closure section forming the second end section which axially defines the cavity.
  • the design according to the invention enables the inverted section to be gradually rolled out of the longitudinal section due to a fluid blown into the tubular section.
  • the transition section but, on the other hand, the closure section forming the second end section also offers a contact surface for the fluid.
  • the cavity delimited radially by the inverted section on the one hand and the generally essentially ring-shaped flow channel formed between the inverted section and the longitudinal section on the other hand allow the inverted section to roll out in the intended direction of expansion and along the intestinal wall, similar to the carriage of a tank but without Casters and prevents the inverted
  • Section knotted or blocked The formation of the two contact surfaces for the fluid to be blown in also brings about an equalization of the Unrolling process of the inverted section and prevents the second end section from being pushed through the cavity before the entire inverted section has been unrolled from the longitudinal section.
  • closure section is flat, in particular if the formed surface is perpendicular to the longitudinal axis of the inverted or longitudinal section.
  • a flat design of the closure section offers a particularly good contact surface for the fluid to be blown into the tubular section.
  • flat is understood not only as a flat surface but also as a curved surface.
  • An alternative embodiment of the invention provides for the closure section to be produced by gathering a region of the inverted section that is at a distance from the transition section.
  • gathering is understood to mean the pressing together of the material of the second end section in the axial direction, as a result of which irregular, kinked and compressed material webs are formed in this area.
  • Such a closure section is easier to produce than a flat one.
  • the closure section is arranged within the longitudinal section, i.e. it does not overlap with the fastening section, whereby the connection of the fastening section to an applicator cannot be impeded by the inverted section.
  • the area of the inverted section delimiting the flow channel has means for stiffening at least in sections, preferably in its entirety.
  • the means for stiffening are particularly preferably folds.
  • an implant according to the invention for arrangement and expansion in the human intestine for the purpose of lining a section of the intestine to prevent the absorption of food supplied in this section, with a first end section, which is Fastening section the fixation of the implant in the human gastrointestinal tract and/or on an applicator and a tubular section adjoining the first end section, comprising a longitudinal section extending in the intended expansion direction, and a transition section adjoining the longitudinal section, as well as an adjoining inverted section, which is opposite the intended direction of expansion runs within the longitudinal section, and a second end section, a region of the inverted section and a region of the longitudinal section delimit a flow channel, via which a fluid blown into the tubular section can penetrate to the transition section in order to exert pressure on it and which the flow channel )
  • Delimiting region of the inverted section has means for stiffening at least in sections.
  • the means for stiffening can also be sections with a greater wall thickness or areas which are made of a different, more rigid material than the remaining areas of the inverted section.
  • stiffening improves the implant's ability to unroll the inverted portion from the longitudinal portion and also improves the implant's ability to radially outwardly confine the cavity and flow channel toward the cavity.
  • the area of the inverted section delimiting the flow channel loosely contacts, in particular detachably contacts, the area of the longitudinal section delimiting the flow channel in sections. This ensures, on the one hand, that the radial expansion of the implant is kept small, but, on the other hand, that the fluid to be injected is able to detach the areas from one another and reach the transition section. From what has been said, it follows that the flow channel can be interrupted where areas of the longitudinal section and areas of the inverted section touch, but such an interruption is basically in the operating state during the Rolling out of the inverted section does not exist or only temporarily due to the injected fluid, the rolling out is not hindered in any case.
  • the area of the inverted section delimiting the flow channel runs at a distance from the area of the longitudinal section delimiting the flow channel, with the advantage that in this case the fluid to be injected does not first have to break any contact between the areas.
  • the inverted section is shorter than the longitudinal section, so that an overlap with the fastening section and thus a complication of the connection to an applicator can be ruled out.
  • the closure section forming the second end section is gathered but open. While the opening during the unrolling of the inverted section from the longitudinal section due to the gathering nevertheless sufficiently closes the end section for the purposes of pressure build-up by the fluid to be injected and forms a corresponding contact surface for the fluid to be injected, the opening in the fully expanded state of the implant causes that this is immediately ready for use and no further measures need to be taken to open the second end section.
  • the closure section (second end section of the implant) is cup-shaped and/or balloon-shaped and protrudes into or out of the cavity in the intended direction of expansion.
  • This alternative embodiment offers advantages in that, due to the pot or balloon shape, the closure section can be filled with the fluid to be injected and can thus support the rolling out in the intestine.
  • the second end section of the implant in the embodiment with an auxiliary section leaves the longitudinal section earlier and not as the last area of the inverted section.
  • Fig. 1a shows a first embodiment of an implant according to the invention at the time of introduction into the gastrointestinal tract
  • Fig. lb a second embodiment of an implant according to the invention at the time of introduction into the gastrointestinal tract
  • Fig. lc a third embodiment of an implant according to the invention at the time of introduction into the gastrointestinal tract
  • Fig. Id a fourth embodiment of an implant according to the invention at the time of introduction into the gastrointestinal tract
  • Fig. 2 shows the first embodiment of the implant according to the invention during expansion into the gastrointestinal tract
  • Fig. 3 shows the first embodiment of an implant according to the invention shortly before the end of the expansion into the gastrointestinal tract
  • Fig. 4 shows the first embodiment of an implant according to the invention after complete expansion into the gastrointestinal tract
  • Fig. 6 is a sectional view along the line AA from FIG. 5
  • Fig. 7 is a sectional view along line BB of FIG. 5
  • Fig. 8 is a sectional view along line CC of FIG. 5
  • Fig. 10a is a detailed view from FIG. 10
  • FIG. 1a shows a sectional view of a first embodiment of a gastrointestinal implant according to the invention at the time of introduction into the gastrointestinal tract and before the start of the expansion process.
  • the arrow marked with E points in the intended expansion direction of the implant, i.e. the direction in which the implant expands after it has been positioned in the human or animal gastrointestinal tract by means of an applicator by being filled with a fluid in order to line the intestinal wall.
  • the gastrointestinal implant is designed to be first attached to an applicator in the form shown in FIG.
  • the gastrointestinal implant is preferably made of silicone and/or fluorosilicone and/or PE or another biocompatible material from which a wide variety of product shapes can be produced using known manufacturing processes, and has several sections, namely a first, open end section 1, which serves as a fastening section for the purpose of attachment/fixation both in the gastrointestinal tract and on an applicator.
  • the first end section 1 can be formed by two essentially ring-shaped fastening elements 1a, 1b, both of which are connected to one another by elastic bands 1c, with one ring-shaped fastening element 1b being intended for intestinal contact with the pylorus and the other ring-shaped fastening element 1a for gastric attachment to the pylorus.
  • the elastic bands 1c are dimensioned in such a way that the two ring-shaped fastening elements 1a, 1b are able to clamp the pylorus.
  • the annular fasteners have a diameter of between 25mm and 30mm. Other diameters are entirely conceivable depending on specific anatomical circumstances.
  • the two ring-shaped fastening elements 1a, 1b are also used for fastening to the applicator, via which the implant is introduced into the gastrointestinal tract, expanded and fixed, preferably in this order.
  • the end section 1 is followed by a tubular section whose diameter is typically between 12mm and 25mm lies. Deviations are also possible here, depending on specific anatomical conditions.
  • the tubular section is connected, preferably glued, to one of the ring-shaped fastening means, preferably the one provided for fastening on the intestinal side, and comprises an open longitudinal section 2, a transition section 3, within which the implant changes its direction of extension, and a transition section 3 that continues in the opposite direction intended expansion direction E extending, inverted section 4.
  • the length L L of the longitudinal section 2 at the time the implant is inserted into the gastrointestinal tract depends on the material of the implant and/or its overall length or the desired weight reduction over time and to the extent. Optionally, the length can also depend on anatomical conditions in the gastrointestinal tract.
  • the length L L of the longitudinal section 2 at the time of introduction into the gastrointestinal tract can be 1 cm to 7 cm, the fully expanded tubular section typically has a total length of 70 cm to 300 cm, depending on the therapeutic application.
  • the length L L of the longitudinal section 2 at the time of introduction into the gastrointestinal tract can also be only a few mm or less. This is particularly the case when the transition section 3 adjoining the longitudinal section 2 in the direction of expansion E almost directly adjoins the end section 1, as is shown in a fourth embodiment according to FIG.
  • the subsequent section 4 of the implant runs at the time of introduction into the gastrointestinal tract inverted to the longitudinal section 2, i.e. inverted into it, and is intended to be rolled out into the intestine in the intended expansion direction E.
  • the transition section 3 connects the longitudinal section 2 with the inverted section 4.
  • Its length Li at the time of introduction into the gastrointestinal tract depends in turn on the overall length of the implant and/or the length L L of the longitudinal section 2 and/or the anatomical conditions of the Gastrointestinal tract, but is preferably chosen so that it runs completely within the longitudinal section 2, so LI ⁇ L L applies.
  • the inverted section 4 is longer than the longitudinal section 2, ie LI>L L applies, and protrudes into the first end section 1 or, counter to the intended direction of expansion E, over it protrudes, if special anatomical conditions require this and as shown in FIG. Id.
  • Longitudinal section 2 and inverted section 4 delimit, at least along one area, a flow channel 5 between them, via which a fluid blown into longitudinal section 2, for example through end section 1, can advance to transition section 3.
  • the area of the inverted section 4 delimiting the flow channel 5 can either detachably contact the area of the longitudinal section 2 delimiting the flow channel 5 (in sections or along the entire area) or these two areas can run at a distance from one another. In the latter case, the flow channel 5 that forms as a result of the inversion of the section 4 is essentially annular in shape.
  • detachable contact means that by blowing a fluid into the longitudinal section 2, the inverted section 4 and the longitudinal section 2 detach from one another where they may contact, so that the injected fluid can reach the transition region 3.
  • the inverted section 4 radially delimits a cavity 6 that is open in the expansion direction E and has a closure section 7 that axially delimits the open cavity 6 at its end opposite the opening 6a.
  • the closure section 7 of the inverted section 4 is at the same time the second end section 8 of the implant.
  • the closure section can be flat, as shown in FIG. 1 with a solid or dashed line.
  • dashed line the closure section is planar, but curved counter to the intended direction of expansion E.
  • closure section can also be produced by gathering, as shown in a second embodiment according to FIG form compressed webs of material.
  • the closure section 7 is made by gathering, it can also be designed to be open, ie. that the closure section 7, as the second end section 8 of the implant, is already open in the unrolled, fully expanded state and no further opening measures are required, while before the inverted section 4 is completely unrolled from the longitudinal section 2, the inverted section 4 is closed due to the gathering sufficient for the purposes of Pressure build-up closed by the fluid to be blown into the longitudinal section 2 and therefore axially delimits the cavity 6 and seals it against the intended direction of expansion.
  • the closure section 7 (second end section 8 of the implant) according to a third embodiment, as shown in FIG Opening 6a protrude from this (dashed line).
  • This alternative embodiment offers advantages in that, due to the pot or balloon shape, the closure section 7 (second end section 8 of the implant) can be filled with the fluid to be injected and can thus support the rolling out in the intestine.
  • the second end section 8 of the implant does not remain in the longitudinal section 2 until the entire inverted section 4 has been unrolled/expanded.
  • the region of the inverted section 4 delimiting the flow channel 5 has means 9 for stiffening, at least in sections.
  • the means 9 for stiffening are preferably folds, preferably in the manner of an accordion, as is also shown in the figures.
  • the length Li merely describes the extent of the inverted section in the intended direction of expansion, ie. the length Li is identical for an inverted section 4 without folds and an inverted section 4 with folds.
  • the means 9 for stiffening can also be a reinforced section of the implant, which is arranged in such a way that at the time of introduction into the gastrointestinal tract it completely forms the inverted section 4 or one Area of it forms, ie that area delimiting the flow channel 5 .
  • the reinforced section can be formed, for example, from a different, stronger material than the remaining sections of the implant or from the same material but with a thicker wall.
  • the implant is connected to an applicator 10 as in FIG.
  • the implant has one of the forms shown in FIGS. 1a to 1d.
  • the implant is preferably arranged on the front side of an applicator, as is shown in FIGS. 5, 9 and 10.
  • FIG. 5 shows an embodiment in which an implant according to FIG.
  • the following explanations also apply analogously to the connection of an implant according to FIG. 1b or 1c to the applicator 10 shown in FIG 11 are grooves 13a, 13b, which are designed to receive the fasteners la, lb.
  • the section 14 of the inner support body 11 extending between the fastening elements 1a, 1b is surrounded by the straps 1c connecting the fastening elements 1a, 1b, as is also shown in the sectional view in FIG.
  • Both the inner support body 11 and the outer shell 12 are preferably largely cylindrical in shape, with that of the inner support body 12 having a smaller diameter in the region of the grooves 13a, 13b than in the other sections.
  • the diameter of the outer shell 12 is selected in such a way that it is in any case larger than the largest diameter of the inner support body 11 .
  • the oversize is also chosen so that the essentially ring-shaped fastening elements 1a, 1b arranged in the grooves 13a, 13b are radially compressed. This is illustrated in FIGS. 5, 9 and 10 by the cut surfaces of the fastening elements 1a, 1b having different shapes.
  • the fastening elements 1a, 1b preferably also contact the bottoms 13c of the grooves 13a, 13b, so that the fastening elements 1a, 1b are clamped between the groove bottoms 13c and the outer shell 12, as is shown in the sectional views according to FIGS that she at axially pulling the outer shell 12 from the inner support body 11 expand radially.
  • radial expansion is also possible if the fastening elements 1a, 1b do not contact the groove bottoms 13c but only the outer shell 12.
  • the supporting body 10 has no grooves and the fastening means 1a, 1b are nevertheless clamped between the supporting body 10 and the outer shell 12.
  • the front end section of the applicator 10 which points in the direction of insertion that corresponds to the imaginary direction of expansion E when the implant is inserted into the gastrointestinal tract, is designed as a cup-shaped holding section 16a, which serves to hold the inverted section 4 of the implant and via which the Longitudinal section 2 of the implant is turned over, so that the cup-shaped holding section 16a is located within the longitudinal section 2 and in the flow channel 5 .
  • the inner support body 12 can be hollow or can be provided with an inner channel, via which a fluid flow 15 can be introduced into the longitudinal section 2 in order to flow onto the closure section 7, which is flat in Fig. 5, and via the flow channel 5 can also exert pressure on the transition section 3.
  • the inverted section 4 of the implant has means for stiffening 9 in the form of an accordion-like fold, which allows the inverted section 4 to project relatively stiffly and with the formation of a cavity 6 into the interior of the holding section. They also enable a stable formation of the end section 7 and its alignment essentially normal to the imaginary direction of expansion E, to form a contact surface for the fluid flow 15.
  • FIGS. 9 and 9a show an alternative possibility of connecting the first embodiment of the implant according to the invention according to FIG 10, which differs from that shown in FIG. 5 by a different front-shaped end region.
  • the front end section 16b of the applicator 10 which points in the direction of introduction when the implant is being introduced into the gastrointestinal tract, does not have a cup-shaped holding section, but ends in a blunt manner, ie. the end section 16b lying in the intended insertion direction does not offer any possibility Invaginate/invaginate sections of the implant.
  • Distributed on the front end section 16b of the implant are outlets 20 through which the fluid can flow into the longitudinal section 2 .
  • FIG. 17b In addition and independently of the design of the front end section of the applicator 10, it is also shown in FIG. 17b are clamped between the inner support body 11 and the outer shell 12, while the unfolded sections are arranged to run in grooves 13a, 13b.
  • the applicator 10 has a reduced cross-section compared to the remaining sections along a section 18 in which the folded-over sections 17a, 17b rest on the inner support body 11, as is shown in 9a is shown.
  • the sections 17a, 17b are arranged lying completely in a recess 19 of the inner support body 11, so that they do not protrude beyond the circumference of the inner support body, unlike the case in the exemplary embodiment according to FIG.
  • the unfolded portions are arranged to run in grooves 13a, 13b.
  • the folded-over sections 17a, 17b of the fastening elements 1a, 1b in the exemplary embodiment according to FIG. can also be combined with one another. It is thus conceivable that, in the case of an applicator 10 with a cup-shaped holding section, as shown in FIG.
  • the inner support body 11 can also have one or more sections 18 with a reduced cross-section, against which the folded-over sections 17a, 17b can rest. This one or more sections 18 can form one or more indentations 19 which completely accommodate/accommodate the sections 17a, 17b, so that they do not protrude beyond the circumference of the inner support body.
  • the folded sections 17a, 17b can be folded either in the intended direction of expansion E or counter to the intended direction of expansion of the implant.
  • the depression 19 described above can also be provided in combination with sections 17a, 17b folded over in the intended expansion direction E
  • FIG. 10 shows a connection possibility for an implant according to the invention according to the fourth embodiment as shown in FIG.
  • the implant Due to the short longitudinal section 2 at the time of insertion into the gastrointestinal tract and before the start of the expansion process, the implant can be attached far in front of the applicator 10 with its one fastening element 1b seen in the insertion direction. This is followed by the longitudinal section 2 of the implant, which is only one or a few mm long, and then immediately the transition section 3 which initiates the inversion of the implant, so that the entire inverted section 4 runs within the inner support body 11 .
  • FIGS 2 to 4 show the process of unrolling/expansion of an implant according to the invention, the expanded form being shown expanded in a straight line for the sake of simplicity, while in practice the expanded form follows the convolutions of the intestine.
  • the implant fixed to the applicator (not shown) is first transported by means of an endoscope (not shown) via the esophagus into its position in the gastrointestinal tract, preferably in such a way that one of the fastening elements 1a is positioned on the gastric side of the pylorus and the other fastening element 1b intestinal side.
  • the implant fixed to the applicator 10 with its two fastening elements 1a, 1b is also positioned independently of the pylorus in the gastrointestinal tract and is only positioned as a function of the pylorus after the implant has fully expanded in the intestine.
  • a fluid 15, preferably air, is subsequently blown into the longitudinal section 2 via the endoscope in a manner known per se.
  • the air is preferably blown in via the first end section 1 and a channel or cavity guided in the applicator 10 into the tubular section of the implant, with the embodiment shown in FIG 1 protrudes or protrudes through the first end section 1 counter to the intended direction of expansion E, the fluid is said to be blown into the tubular section or longitudinal section 2, although this only begins after the fastening element 1 viewed in the intended direction of expansion E and the fluid is therefore almost impinges directly on the transition section 3 (see Figure 10a).
  • the injected fluid 15 therefore flows in the intended expansion direction E first along the longitudinal section 2 and then on the one hand into the essentially ring-shaped flow channel 5 to the transition area 3 and on the other hand against the closure section 7 forming the second end section 8.
  • the fluid 15 first hits the closure section 7 before it flows into the flow channel 5.
  • the inverted section 4 rolls out in the transition area 3 in a manner similar to the running gear of a tank, but without rollers. This increases the length L L of the longitudinal section 2 while at the same time reducing the length Li of the inverted section 4.
  • these areas are pushed apart by the fluid flow 15 and the contact is broken, so that the fluid 15 can advance to the transition area 3 .
  • the region of the inverted section 4 delimiting the flow channel 5 has means 9 for stiffening in the form of folds running like an accordion. These contribute to the fact that the inverted section is and remains relatively dimensionally stable in the intended expansion direction E, so that the implant according to the invention protrudes from the applicator 10 . Since the longitudinal section 2 surrounding the inverted section 4 in the embodiment shown does not have any means 9 for stiffening, although this is not ruled out in principle, it is to be expected in the embodiment shown in FIGS of the inverted section 4 and areas of the longitudinal section 2 and this contact is broken by the fluid flow 15 .
  • an external force may be applied to the longitudinal section 2, so that it is pressed against the inverted section 2 and contacted him.
  • the pressure with which the fluid 15 is to be blown into the longitudinal section 2 must be selected to be sufficiently large, so that this contact is broken again and the fluid 15 is released
  • Transition section 3 can penetrate. After the implant has been rolled out in the intestine, in those cases in which the closure section 7 is designed to be closed, it must be ensured that it is opened. This can be done in a manner known per se, in which the closure section 7 is made, for example, from a material that dissolves after a predeterminable period of time due to digestive juices, or through a perforation in the area of the closure section 7, which, when the implant is completely unrolled, penetrates the end section due to the fluid pressure 7 detaches from the rest of the implant and thus removes the second end section 8 of the implant.
  • the fastening element 1b on the intestinal side can also be positioned on the intestinal side to the pylorus in a known manner and the outer sleeve 12 can be pulled back in the direction of the stomach to such an extent that initially only the fastening element 1b on the intestinal side expands and/or its folded-over section la folds up / can fold up and attaches itself to the pylorus on the intestinal side.
  • the endoscope together with the applicator 10, with the fastening element 1a still clamped between the inner support body 11 and the outer shell 12, is moved in the direction of the stomach until it is ensured that the fastening element 1a is located on the stomach side of the pylorus. Only then is the outer shell 12 pulled back further in the direction of the stomach, so that the fastening element 1a can also expand and/or its folded-over section 17a can fold up/fold up.

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  • Health & Medical Sciences (AREA)
  • Child & Adolescent Psychology (AREA)
  • Obesity (AREA)
  • Nursing (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)

Abstract

L'invention concerne un implant destiné à l'agencement et à l'expansion dans le tractus gastro-intestinal humain dans le but de recouvrir une section du tractus gastro-intestinal afin d'empêcher la résorption de nourriture fournie dans ladite section, ayant une première section d'extrémité (1) qui, en tant que section de fixation, permet la fixation de l'implant dans l'estomac/le tractus gastro-intestinal humain et/ou à un applicateur (10) ; une section tubulaire qui est adjacente à la première section d'extrémité (1), comprenant une section longitudinale (2) qui s'étend dans la direction d'expansion prévue, une section de transition (3) qui est adjacente à la section longitudinale (2), et une section inversée (4) qui s'étend à l'intérieur de la section longitudinale à l'opposé de la direction d'expansion prévue ; et une seconde section d'extrémité (8). Selon l'invention, une zone de la section inversée (4) et une zone de la section longitudinale délimitent un canal d'écoulement (5), par l'intermédiaire de laquelle un fluide (15) soufflé dans la section tubulaire peut pénétrer dans la section de transition (3) pour exercer une pression sur celle-ci, la section inversée (4) délimitant radialement une cavité (6) et présentant une section de fermeture (7) qui forme la deuxième section d'extrémité (8) et délimite axialement la cavité (6).
EP20838949.4A 2020-12-18 2020-12-18 Implant gastro-intestinal Pending EP4262639A1 (fr)

Applications Claiming Priority (1)

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PCT/EP2020/086954 WO2022128117A1 (fr) 2020-12-18 2020-12-18 Implant gastro-intestinal

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EP4262639A1 true EP4262639A1 (fr) 2023-10-25

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Family Cites Families (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7837669B2 (en) * 2002-11-01 2010-11-23 Valentx, Inc. Devices and methods for endolumenal gastrointestinal bypass
US7025791B2 (en) * 2002-12-02 2006-04-11 Gi Dynamics, Inc. Bariatric sleeve
US8109895B2 (en) * 2006-09-02 2012-02-07 Barosense, Inc. Intestinal sleeves and associated deployment systems and methods
US20080255678A1 (en) * 2007-04-13 2008-10-16 Cully Edward H Medical apparatus and method of making the same
US20120065571A1 (en) 2009-04-03 2012-03-15 Metamodix, Inc. Expandable pyloric anchors and methods for securing intestinal bypass sleeves
EP3905994B1 (fr) 2019-01-03 2023-07-26 Butz, Alexander Implant gastro-intestinal et dispositif de positionnement pour celui-ci

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US20240050255A1 (en) 2024-02-15

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