GASTROINTESTINAL IMPLANT AND POSITIONING APPARATUS THEREFOR

Abstract

A gastrointestinal implant comprising a tube-shaped element, embodied to transport chyme through at least one section of the human intestine and a first fastener connected to the tube-shaped element and having a first contact surface. The first fastener is embodied to be positioned in a section of the duodenum adjacent to the pylorus. A second fastener connected to the tube-shaped element or to the first fastener has a second contact surface. The second fastener is embodied to be positioned in the gastric antrum. A connecting element connects the first fastener or the tube-shaped element to the second fastener. The connecting element is embodied such that the first and second fasteners are pressed against one another with the first and second contact surface thereof, respectively, in the position of the fasteners in the duodenum and in the gastric antrum, respectively, with the pylorus positioned therebetween, without the fasteners being lifted off of the pylorus.

Claims

1.-29. (canceled)

30. A positioning apparatus for positioning a gastrointestinal implant with two essentially annular fasteners and a tube-shaped element in a human gastrointestinal tract, comprising: an outer vessel comprising a first longitudinal axis; an inner supporting body, which is positionable within the outer vessel, comprising a second longitudinal axis, wherein the inner supporting body enables a sliding-on of the annular fasteners; a first mounting position for the first fastener, which is arranged between the outer vessel and the inner supporting body; and a second mounting position for the second fastener, which is arranged between the outer vessel and the inner supporting body, wherein the outer vessel is removable from the inner supporting body, preferably axially detachable in a direction of the second longitudinal axis wherein the first and second mounting positions each comprise an outer limit formed by the outer vessel and an inner limit formed by the inner supporting body in order to clamp the fasteners in their mounting positions, whereby the distance between the mounting positions corresponds at least the thickness of the pylorus.

31. The positioning apparatus according to claim 30, wherein the inner supporting body comprises a surface having two grooves for at least partially accommodating the annular fasteners, respectively, and wherein a minimum distance between the grooves is at least one of: 3 mm-70 mm, or 5 mm-30 mm.

32. The positioning apparatus according to claim 30, wherein the outer vessel is embodied in a sleeve shape and a distal end region of the outer vessel is embodied to be closed and at least one of removable or openable.

33. The positioning apparatus according to claim 32, wherein the outer vessel comprises a structural weakness, preferably in the form of a predetermined breaking point, which enables the removal or opening of the distal end region from a remaining part of the outer vessel.

34. The positioning apparatus according to claim 32, wherein an end region of the inner supporting body located closer to the distal end region of the outer vessel comprises an aligning section for a section of the tube-shaped element, which comprises a preferably cup-shaped holding volume in which a portion of the tube-shaped element can be accommodated in an invaginated manner.

35. The apparatus according to claim 34, wherein the inner supporting body comprises a through channel having an outlet opening in the aligning section.

36. The apparatus according to claim 30, wherein the inner supporting body comprises a section have a reduced cross-section compared to adjacent sections, and the reduced cross-section section comprises at least one support surface running in the direction of the second longitudinal axis for supporting frontal sections of the annular fasteners.

37. A gastrointestinal implant system comprising: a gastrointestinal implant that comprises: a tube-shaped element, embodied to transport chyme through at least one section of a human intestine; a first fastener, which is connected to the tube-shaped element, comprising a first pass-through opening, the first fastener being embodied to be positionable in a section of a duodenum adjacent to a pylorus; a second fastener, which is connected to at least one of the tube-shaped element or to the first fastener, comprising a second pass-through opening, the second fastener being embodied to be positioned in a gastric antrum; and a connecting element that connects the at least one of the first fastener or the tube-shaped element to the second fastener; and an apparatus that is configured to position the gastrointestinal implant in a human gastrointestinal tract and comprises: an outer vessel comprising a first longitudinal axis; an inner supporting body, which is removably positionable in the outer vessel, comprising a second longitudinal axis; a first mounting position for the first fastener, which first mounting position is positioned between the outer vessel and the inner supporting body; and a second mounting position for the second fastener, which second mounting position is positioned between the outer vessel and the inner supporting body, wherein the first and second fasteners are slidable onto the inner supporting body to be position-fixed in the first and second mounting positions, respectively, and to at least one of be compressed to a first size or assume a first position, and wherein the outer vessel is removable from the inner supporting body, preferably axially detachable in a direction of the second longitudinal axis, and wherein, the inner supporting body, when removed from the outer vessel, the first and second fasteners to at least one of expand to a second size or assume a position different from the first position.

38. The system according to claim 37, wherein the connecting element is embodied to bias the first and second fasteners toward one another so that, with respective first and second contact surfaces of the first and second fasteners being respectively positioned in the duodenum and in the gastric antrum, with the pylorus positioned therebetween, the first and second fasteners are not lifted off of the pylorus.

39. The system according to claim 37, wherein the outer vessel is embodied in a sleeve shape and a distal end region of the outer vessel is embodied to be closed and at least one of removable or openable.

40. The system according to claim 37, wherein the tube-shaped element comprises a second end region that is embodied to be closed and removable, preferably made of a material that can be absorbed in the intestine.

41. The system according to claim 37, wherein the first mounting position for the first fastener and the second mounting position for the second fastener comprise an outer limit formed by the outer vessel and an inner limit formed by the inner supporting body and the distance between the limits is thereby selected such that the two fasteners are clamped between the outer vessel and the inner supporting body.

42. The system according to claim 37, wherein the inner supporting body comprises a surface having two grooves for at least partially accommodating the annular fasteners, respectively, and wherein a minimum distance between the grooves is at least one of: 3 mm-70 mm, or 5 mm-30 mm.

43. The system according to claim 37, wherein the fasteners are folded down in direction of the longitudinal axes.

44. The system according to claim 43, wherein a section of the inner supporting body is thereby embodied with a cross-sectional area that is reduced compared to the regions adjacent thereto and the folded down fasteners are positioned within this section.

45. The system according to claim 37, wherein an end region of the inner supporting body located closer to a distal end region of the outer vessel comprises an aligning section for a section of the tube-shaped element, which comprises a preferably cup-shaped holding volume.

46. The system according to claim 45, wherein the inner supporting body comprises, at least in sections, a channel having an outlet opening in the aligning section.

47. The system according to claim 45, wherein the tube-shaped element comprises a region which is pulled over the aligning section that is preferably embodied in a cup shape.

48. The system according to claim 47, wherein the region of the tube-shaped element which is pulled over the aligning section is in flow connection with the outlet opening.

49. The system according to claim 47, wherein the inner supporting body further comprises a cup-shaped aligning section, and wherein a section of the tube-shaped element not pulled over the aligning section is invaginated, at least in sections, preferably completely, in the cup-shaped holding volume and is arranged therein preferably in a folded manner.

50. A method for inserting a gastrointestinal implant in a part of an intestine, the gastrointestinal implant including a tube-shaped element configured to transport chyme through at least a section of the intestine, a first compressible fastener, connectable to the tube-shaped element, having a first pass-through opening, a second compressible fastener, connectable to at least one of the tube-shaped element or to the first fastener, having a second pass-through opening, and a connecting element that connects the at least one of the first fastener or the tube-shaped element to the second fastener, the method comprising: sliding the first and second compressible fasteners onto an insertion end of an inner supporting body; inserting the inner supporting body into an outer vessel, wherein the first and second compressible fasteners are positioned between the inner supporting body and the outer vessel in respective first and second mounting positions; guiding the outer vessel and inserted inner supporting body to position the insertion end within a pylorus between a duodenum and a gastric antrum; removing the outer vessel from insertion end so a contact surface of the first compressible fastener is in the duodenum and a contact surface of the second compressible fastener is in the gastric antrum; and biasing the first and second compressible fasteners toward each another to clamp the pylorus between the first and second compressible fasteners.

51. The method according to claim 50, wherein, before or during sliding the first and second compressible fasteners onto the insertion end, compressing the compressible first and second fasteners, whereby the compressible first and second fasteners in the respective first and second mounting positions are held in a compressed state.

52. The method according to claim 51, wherein, when removing the outer vessel from the insertion end, the compressible first and second fasteners expand to an expanded state.

53. The method according to claim 50, wherein the inner supporting body includes a holding volume, and the method further comprises folding and inserting a portion of the tube-shaped element into the holding volume

54. The method according to claim 50, wherein the tube-shaped element comprises an open end and the inner supporting body includes a fluid channel communicating with the open end, the method further comprising supplying a fluid through the fluid channel to expand the tube shaped element.

55. The method according to claim 50, wherein the outer vessel has a closed end to facilitate the guiding of the insertion end within the pylorus, and the method further comprises at least one of opening or removing the closed end after the insertion end is within the pylorus.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0081] The present invention will now be described in greater detail with the aid of one or more figures illustrating exemplary embodiments. In this matter:

[0082] FIG. 1 shows a gastrointestinal implant comprising a tube-shaped element and two fastening means

[0083] FIG. 2 shows a gastrointestinal implant arranged in the human gastrointestinal tract

[0084] FIG. 3 shows an embodiment of a fastening means of a gastrointestinal implant with magnetic sections

[0085] FIG. 4 shows an embodiment of a fastening means with a supporting element that has a variable length

[0086] FIG. 5 shows an embodiment of a fastening means with coil spring elements as supporting elements

[0087] FIG. 6 shows an embodiment of a fastening means with a coil spring element as supporting elements

[0088] FIG. 7 shows an embodiment of a fastening means

[0089] FIG. 8 shows an embodiment of a fastening means

[0090] FIG. 9 shows a first embodiment of an apparatus for positioning a gastrointestinal implant in the human gastrointestinal tract before the removal of the outer vessel

[0091] FIG. 10 shows a second embodiment of an apparatus for positioning a gastrointestinal implant in the human gastrointestinal tract before the removal of the outer vessel

[0092] FIG. 11 shows different possible embodiments of grooves on the inner supporting body

[0093] FIG. 12 shows the first embodiment of the apparatus for positioning a gastrointestinal implant in the human gastrointestinal tract with an applied gastrointestinal implant

[0094] FIG. 13 shows the second embodiment of the apparatus for positioning a gastrointestinal implant in the human gastrointestinal tract with an applied gastrointestinal implant

[0095] FIG. 14 shows a detailed view of a section of the inner supporting body with oblique grooves

[0096] FIG. 15 shows another detailed view of a section of the inner supporting body with straight grooves

[0097] FIG. 16 shows another detailed view of a section of the inner supporting body with recesses

[0098] FIG. 17 shows a positioning apparatus with an applied gastrointestinal implant shortly after the transoral insertion

[0099] FIG. 18 shows a positioning apparatus with an applied gastrointestinal implant with a pulled-back outer vessel

[0100] FIG. 19 shows a positioning apparatus with an applied gastrointestinal implant with a detached distal end region of the tube-shaped element

[0101] FIG. 20 shows a positioning apparatus with an applied gastrointestinal implant with an expanded first fastening means

[0102] FIG. 21 shows a positioning apparatus with an applied gastrointestinal implant with an expanded second fastening means

[0103] FIG. 22 shows an embodiment of an outer vessel with a limit stop

[0104] FIG. 23 shows an embodiment for an inner supporting body

[0105] FIG. 24 shows an embodiment for an inner supporting body

WAYS OF EMBODYING THE INVENTION

Gastrointestinal Implant

[0106] FIG. 1 shows a gastrointestinal implant 17 according to the invention, comprising a tube-shaped element 1 and two fastening means 3 and 4 that are connected to one another via a connecting element 6 and are used to position the tube-shaped element 1 in the intestine. It has the task of transporting the chyme entering the intestine via the stomach through at least one section of the human intestine without the chyme being digested. Preferably, the tube-shaped element 1 is, at least in sections, made of silicone or fluorosilicone or another biocompatible material that is capable of dwelling in the stomach or intestine for a longer period without decomposing and which exhibits adequate flexibility to be transported into the gastrointestinal tract via the mouth and esophagus, preferably in a folded/invaginated state.

[0107] The length of the tube-shaped element 1 can vary depending on the purpose of use. The longer the tube-shaped element 1 is embodied to be, the longer the region of the intestine through which the chyme can be transported without absorption, and therefore the larger and more quickly attained the weight reduction that is to be achieved. The wall thickness of the tube-shaped element 1 can also vary in sections, in order to possibly increase the resistance to the natural peristalsis movements of the gastrointestinal tract.

[0108] FIG. 1 shows the tube-shaped element 1 in an unfolded state. The one (distal) end 1b thereof is therefore—initially—closed, and at the other (proximal) end 1a thereof, the tube-shaped element is tightly connected to or fabricated in a single piece with the first fastening means 3, so that no chyme can pass between the fastening means 3 and the tube shaped element 1. As will be described in greater detail below, the closed end 1b is initially used to unfold the tube-shaped element 1 to its intended length in the intestine.

[0109] The position-fixing of the tube-shaped element 1 in the intestine occurs via the fastening means 3 and 4, or the contact surfaces 33 (fastening means 3) and 34 (fastening means 4), which are used to clamp the pylorus 7 therebetween and thus to enable an anchoring of the gastrointestinal implant in the gastrointestinal tract. For the clamping function to be performed, it is provided that the two fastening means 3 and 4 are connected to one another via a connecting element 6. The connecting element 6 is embodied to be elastic and is made of, and is preferably composed of a number of bands 6a, or alternatively of a tube-shaped connecting element (not illustrated). Both bands 6a and also the tube-shaped connecting element are embodied to be guided through the opening of the pylorus. The elasticity of the connecting element 6 is thereby chosen such that, if a distance between the two contact surfaces 33 and 34 is exceeded, which distance is slightly smaller than the typical thickness of the pylorus, a pulling force acts on the two fastening means 3, 4 and therefore on the contact surfaces 33 and 34, which force—regardless of the gastrointestinal tract movements caused by peristalsis and regardless of the closing and opening movements of the pylorus—prevents the detachment of the respective contact surface 33, 34 from the distal and/or proximal face of the pylorus, so that the contact surfaces 33, 34 bear against the faces 31, 32 of the pylorus with sustained pressure.

[0110] Preferably, the fastening means 3, 4 are also embodied to be adequately elastic so that an adaptation to the different dimensions of the gastrointestinal tract, and to the previously mentioned movements due to peristalsis and the closing and opening movements of the pylorus, is possible. It is thereby provided that the two fastening means 3, 4 have in a relaxed state a roughly annular shape, so that on the one hand adequate contact surface is available to clamp the pylorus on both sides, but so that on the other hand the fastening means 3, 4 also have an adequately sized flow opening 10, 11 to allow unimpeded passage of the chyme into the small intestine, specifically the duodenum. It should be noted, however, that larger temporary deviations from the circular shape do not significantly impair the functionality of the fastening means 3, 4. Preferably, the fastening means 3, 4 are embodied to be circular.

[0111] In alternative embodiment of the invention, it can be provided that the inner diameter of the approximately annular fastening means 3, 4, which diameter defines the flow opening 10, 11, is not greater than 5 mm, so that passage of the chyme from the stomach into the intestinal tract is delayed to allow the more rapid onset of a feeling of satiation.

[0112] Preferably, the two fastening means 3, 4 and also the connecting element 6 are made of the same material as the tube-shaped element 1. However, due to the requirements according to the invention for the connecting element 6, it is also conceivable that said element is composed of a material different from the fastening means 3, 4.

[0113] In principle, however, all materials that are adequately elastic and biocompatible are conceivable for embodying the fastening means 3, 4 and/or the connecting element 6.

[0114] FIG. 2 shows the gastrointestinal implant arranged in its final position in the gastrointestinal tract. The tube-shaped element 1 is thereby already located, in a completely unfolded manner, in the intestine 35, starting with its proximal end 1a in the duodenum 2. The two fastening means 3, 4 are arranged distally from and proximally to the pylorus 7, respectively. The connecting element 6, which is composed of multiple bands 6a, is embodied such that it pulls the two fastening means 3, 4 to one another in the illustrated final position of the gastrointestinal implant 17, so that the contact surfaces 33, 34 of said means continuously bear against the proximal 31 and distal 32 faces of the pylorus 7, respectively, and permanently clamp it between them on both sides, without the contact surfaces 33, 34 lifting off of the proximal 31 and/or 32 distal face of the pylorus 7.

[0115] In this final position, the distal end 1b of the tube-shaped element 1 is already open, so that chyme can fully pass through the tube-shaped element 1.

[0116] The two fastening means 3, 4 can comprise magnetically acting sections 29, 30 which act in such a way that they support the pulling force of the connecting element 6 and therefore the clamping effect. Furthermore, the magnetic sections 29, 30 facilitate the position-fixing of the fastening means 3,4 such that the flow openings 10, 11, regardless of the peristalsis and opening and closing movements of the pylorus 7 taking place, essentially remain in constant concentric alignment, or in the case of deformed, non-circular flow openings, remain aligned such that the passage of the chyme is not impeded or even blocked. The radial shifting, even temporarily, of the fastening means 3, 4 can thereby be prevented.

[0117] FIG. 3 shows fastening means 3, 4 having magnetic sections 29, 30, wherein in this exemplary embodiment, each of the fastening means 3, 4 respectively comprises a magnetic section 29, 30 that spans the entire circumference of the fastening means 3, 4. However, it is also conceivable that, on each fastening means 3, 4, multiple magnetic sections are provided which are then accordingly sized to be smaller and, for example, are separated from one another by non-magnetically acting sections.

[0118] In the exemplary embodiment illustrated, each section 29, 30 comprises multiple individual magnets 29a, 30a which are arranged such that the individual magnets 29a of the first fastening means 3 and the individual magnets 30a of the second fastening means 4 attract one another and thus support the clamping effect (see arrow with reference numeral 36).

[0119] At the same time, the illustrated arrangement renders it possible that the individual magnets 29a and 30a repel one another (see arrow with reference numeral 37). In this manner, it is possible to support the specified shape, preferably the specified ring shape, and counteract shape changes that would arise as a result of the compression of the fastening means 3, 4 (for example, due to peristalsis), such as undesired torsion.

[0120] Notwithstanding the above, the surface of the fastening means 3, 4 can also be roughened in order to increase the torsion resistance.

[0121] Because the pylorus 7 is a sphincter, it is, as mentioned above, advantageous if the two fastening means 3, 4 also assume an approximate ring shape in their final position in the gastrointestinal tract, in which position the gastrointestinal implant 17 is secured, so that the contact surfaces 33, 34 of said means can bear to the best possible extent against the proximal and distal faces 31, 32 of the pylorus 7, respectively. It should thereby be kept in mind that, for the purposes of transoral insertion of the gastrointestinal implant 17 via the esophagus, the fastening means 3, 4 must initially be compressed, at least in sections, which is normally accompanied by a shape change. The fundamentally elastic embodiment of the fastening means 3, 4 allows on the one hand the required compression and shape change thereof, but on the other hand also the expansion thereof into a final state in which the clamping of the pylorus is to occur.

[0122] In a first embodiment, it is thereby provided that the fastening means 3, 4 are respectively composed of an elastic ring of biocompatible material, such as silicone or fluorosilicone or the like, for example, which satisfies the elasticity requirements described above.

[0123] In another alternative embodiment it is provided that the elastic ring of one or both fastening means 3, 4 is made of biocompatible material such as silicone, fluorosilicone or the like, for example, and comprises an interior volume in which a supporting element 41, for example made of polyethylene (PE), is arranged.

[0124] The supporting element 41 has the task of shaping the fastening means 3, 4 such that said means has greater dimensional stability in its intended final position, and to thus optimize the clamping effect.

[0125] To nevertheless allow an adequate compression during the transoral insertion of the gastrointestinal implant, it can be provided according to this alternative embodiment that a supporting element 41 of this type is embodied in a divided manner and comprises a first end section 41a with an interior volume 38 in which the second end section 41b resulting from the division is displaceably held. The second end section 41b has for this purpose a smaller cross section than the remaining supporting element 41, so that it can easily be inserted into the first end section 41a comprising an interior volume 38 for this purpose, as can be seen in FIG. 4.

[0126] In this manner, the fastening means 3, 4 are easier to compress and can therefore be better adapted to peristalsis and the opening and closing movement of the pylorus 7.

[0127] To optimize the clamping capacity of a fastening means 3, 4 in this embodiment, it can be provided that the end section 41b is surrounded by a coil spring element 40 which constantly pulls the end section 41b as far as possible out of the interior volume 38, in order to constantly keep the circumference of the annular fastening means 3, 4 as large as possible, and to thus make available the largest possible contact surface 33, 34 for clamping the faces 31, 32 of the pylorus 7.

[0128] FIG. 5 shows an embodiment of a fastening means 3, 4 similar to the embodiment illustrated in FIG. 4, with the difference that, instead of the divided supporting element 41 with telescoping end sections 41a and 41b, it comprises two coil spring elements 43, 44 that function as supporting elements.

[0129] Alternatively, it is also possible to provide only a single coil spring element 45 that is embodied in a divided manner corresponding to the supporting element 41 of the embodiment according to FIG. 4, as is illustrated in FIG. 6.

[0130] FIG. 7 and FIG. 8 each show alternative embodiments of a fastening means 3, 4 with additional supporting elements 42, for example, made of PE (polyethylene).

Positioning Apparatus for Positioning a Gastrointestinal Implant in the Gastrointestinal Tract and System Comprising a Gastrointestinal Implant and a Positioning Apparatus

[0131] In order to transport the gastrointestinal implant as described in FIGS. 1 through 8 into its final position in the gastrointestinal tract, a positioning apparatus 18 is provided. In principle, the positioning apparatus 18 described below can also be used for the positioning of other gastrointestinal implants which differ from those depicted in FIGS. 1 through 8, provided that these other gastrointestinal implants comprise two essentially annular fastening means that are intended to bear against the distal and proximal faces of the pylorus, in particular also for gastrointestinal implants in which the connecting element 6 is not embodied according to the invention and therefore allows a lifting-off of the contact surfaces 33, 34 from the distal and/or proximal face 31, 32 of the pylorus 7.

[0132] FIG. 9 shows a positioning apparatus according to the invention, composed of an outer vessel 8 with an interior volume in which an inner supporting body 9 is arranged. The outer vessel 8 has the option 8a for fastening a guide wire, the purpose of which will be explained further below.

[0133] The distal end region 12 of the outer vessel 8, that is, the end region which is arranged in the frontal position in the course of the transoral insertion into the esophagus, is for the purposes of insertion embodied to be rounded, formed in a cartridge shape and closed, but removable or at least openable. The removability can be achieved in that the end region 12 is made of a biocompatible, absorbable (dissoluble) material. The openability is rendered possible in that the outer vessel can comprise a structural weakness, preferably in the form of a predetermined breaking point, which allows the removal of the distal end region 12 from the remaining outer vessel through an application of pressure to the end region 12 from the inside. A structural weakness of this type can, for example, be achieved in that the distal end region 12 is connected to the rest of the outer vessel 8 via a perforated section or a section having a thinner wall cross section. In a preferred embodiment of the invention, it is provided that the structural weakness does not run across the entire circumference of the outer vessel 8, but rather only across a section of the circumference and enables a partial detachment of the distal end region.

[0134] The proximal end region 13 is used to introduce the inner supporting body 9 and, in a preferred embodiment, comprises limit stops (not shown) in order to place the outer vessel 8 and inner supporting body 9 in a defined position relative to one another.

[0135] The inner supporting body 9 preferably comprises a circular cross section in order to allow the sliding-on of the fastening means 3, 4.

[0136] The distance between the outer vessel 8 and inner supporting body 9 is selected such that the fastening means 3, 4 can be clamped between the two components and thus position-fixed. In this manner, a first mounting position 3a for the first fastening means 3 and a second mounting position 4a for the second fastening means 4 are formed. These are shown purely by way of example in FIG. 9.

[0137] In an alternative embodiment as shown in FIG. 10, the first and second mounting positions 3a, 4a are formed by grooves 15, 16 on the surface of the inner supporting body 9, in which the two fastening means 3, 4 can be at least partially accommodated, that is, the fastening means 3, 4 can either be completely arranged in the grooves 15, 16 or only partially arranged in said grooves and protrude past them. The distance of the grooves 15, 16 from one another is preferably between 3 mm and 70 mm, in particular preferably between 5 mm and 30 mm. The embodiment of the mounting positions 3a, 4a as grooves has the advantage that the position-fixing does not occur in a frictional engagement, but rather by means of a positive fit, whereby an inadvertent shifting of the fastening means 3, 4 can in principle be eliminated and the exact distance between the fastening means 3, 4 on the inner supporting body 9 is also easier to set.

[0138] The course of the grooves 15, 16 on the surface of the inner supporting body 9 must be matched to the embodiment and/or sizing and/or elasticity of the fastening means 3, 4 and to the required/desired degree of compression.

[0139] Thus, according to a preferred embodiment of the invention, it can be provided that the grooves 15, 16 run on planes that are arranged perpendicularly to the longitudinal axis 20 of the inner supporting body 9 in a top view and/or side view. According to another embodiment of the invention, however, it can also be provided that the grooves 15, 16 run on planes that are arranged obliquely to the longitudinal axis 20 of the inner supporting body 9 in a top view and/or side view. It is also conceivable that one of the grooves runs on a plane that is perpendicular to the longitudinal axis 20 of the inner supporting body 9 in a top view and/or side view, while the other groove runs on a plane that is oblique to the longitudinal axis 20 of the inner supporting body 9 in a top view and/or side view. The oblique positioning of the grooves 15, 16 renders possible a lesser degree of compression of the fastening means 3, 4.

[0140] FIG. 11 shows, by way of example, different ways of embodying the grooves 15, 16 on the inner supporting body 9.

[0141] The mounting positions 3a, 4a can also be formed by a combination of the embodiments described above, so that the fastening means 3, 4 accommodated sectionwise in the grooves 15, 16 can be simultaneously clamped between the inner supporting body 9 and the outer vessel 8.

[0142] Irrespective of the specific embodiment of the mounting positions, the distance between the mounting positions 3a, 4a is always chosen such that it is embodied to be slightly larger than the thickness of the pylorus 7 and such that, when the two fastening means 3, 4 are located at the mounting positions 3a, 4a, the connecting element 6 is already tensioned and a pulling force is exerted on each of the two fastening means 3, 4.

[0143] In reference to FIGS. 9 and 10, it can be provided according to the embodiments illustrated therein that the inner supporting body 9, at the distal end region 22 thereof, comprises an aligning section 27 for the tube-shaped element 1, as is specifically illustrated in FIG. 10. The aligning section 27 is used to initially allow the tube-shaped element 1 to be accommodated in a compact, space-saving state in order to enable or facilitate the transoral insertion of the gastrointestinal implant. However, the aligning section 27 is also subsequently used to enable the complete unfolding of the tube-shaped element 1 out of the compact state.

[0144] For this purpose, the aligning section 27 can, according to a preferred embodiment of the invention, be provided with a preferably cup-shaped holding volume 27a, as is illustrated in FIGS. 9 and 10, wherein the open end of the holding volume 27a points in the direction of the distal end of the outer vessel 8.

[0145] The application of a gastrointestinal implant on the positioning apparatus 18 is shown in FIGS. 12 and 13, wherein FIG. 12 shows the application on a positioning apparatus 18 as illustrated in FIG. 9, and FIG. 13 shows the application on a positioning apparatus 18 as illustrated in FIG. 10.

[0146] The gastrointestinal implant 1, as illustrated for example in FIGS. 1 through 8, is thereby initially slid onto the inner supporting body 9. In the event that the inner supporting body 8 is provided with grooves 15, 16, the fastening means 3, 4 are mounted with at least a portion of their cross section in these grooves 15, 16, which form the mounting positions 3a, 4a. Regardless of whether the mounting positions 3a, 4a are formed by grooves 15, 16 or else solely by the distance between the outer vessel 8 and the inner supporting body 9 as is illustrated in FIG. 12, the fastening means 3, 4 are in this state compressed, since the outer vessel 8 prevents the expansion thereof to a larger diameter.

[0147] FIGS. 14 and 15 show, purely by way of example, the region of the grooves 15, 16 in an enlarged illustration, wherein the grooves 15, 16 in FIG. 14 are embodied obliquely to the longitudinal axis 20 and in FIG. 15 are embodied to be straight. In FIG. 15, also purely by way of example, the one fastening means 4 is embodied helically, in order to demonstrate that the fastening means 3, 4 can in principle also have shapes different from those previously illustrated. Whereas fastening means 3, 4 in the illustrated embodiments have a circular cross section, other cross section geometries are also conceivable, for example, rectangular cross sections. In this case, it is also conceivable to embody the grooves 15, 16 with a rectangular cross section.

[0148] With the sliding of the implant 17 onto the inner supporting body 9, the tube-shaped element 1 is automatically pulled over the aligning section 27, so that it envelops said section. That section of the tube-shaped element 1 which protrudes past the aligning section 27, that is, which can no longer be slid on, is initially invaginated. This invaginated section can then be either left in front of the aligning section 27 or stuffed into the holding volume 27a and therein accommodated preferably in a folded or differently compressed manner.

[0149] Additionally, it can be provided to envisage recesses 46 on the surface of the inner supporting body 9, in which recesses 46 sections of the tube-shaped element 1 can be accommodated in a gathered manner. Recesses 46 of this type are illustrated purely by way of example in FIG. 16, and are used as a tension release in the event that the tube-shaped element 1 is unfolded prior to the securing of the gastrointestinal implant 17 on the pylorus 7 by means of the fastening means 3, 4, since in this case no tension that negatively affects the expansion of the fastening means 3, 4 can be exerted by the tube-shaped element 1 on the fastening means 3, 4.

[0150] A particularly preferred embodiment of the inner supporting body 9 is illustrated in FIG. 23. A section 49 of the inner supporting body 9 is thereby embodied with a cross-sectional area 52 that is reduced compared to the regions 50, 51 adjacent thereto. The grooves 15, 16 are arranged in this section 49. The missing cross-sectional area 53 enables the accommodation of sections 54 of the fastening elements 3, 4 in this region, that is, one section 54 each of the fastening elements 3, 4 is folded in the direction of the longitudinal axis 20, as is illustrated in FIG. 23. The raising of the sections 54 is prevented by the outer vessel 8, which is not illustrated in this figure.

[0151] With a corresponding sizing of the reduced cross-sectional area 52 in relation to the cross sectional area 55 of the adjacent regions 50, 51 and the fastening elements 3, 4 as well as the grooves 15, 16, the fastening elements 3, 4 can be folded such that they are completely arranged within the cross-sectional area 55 of the adjacent regions 50, 51 and do not protrude past said area, whereby a particularly pronounced compression is possible.

[0152] As previously explained further above, the inner supporting body 9 has a circular cross section, that is, the cross-sectional areas 55 are preferably circular. The reduced cross-sectional area 52 can in principle have any desired shape, but is preferably embodied in the shape of a circle segment; however, it can also be produced by the removal of one or two, preferably opposing, cross-sectional surface(s) in the shape of a circle segment from a circular cross-sectional area. At any rate, in the latter case at least one very good support surface 56 is formed for the sections 54 or the faces 54a thereof.

[0153] It should be noted, solely for the sake of completeness, that the cross-sectional areas 55 of the sections 50, 51 can also be differently sized.

Functional Principle of Invention

[0154] A detailed description of the functional principle of the invention will now follow below with the aid of FIGS. 17 through 21, which merely illustrate said principle in a schematic manner.

[0155] Initially, the positioning apparatus 18, as is illustrated by way of example in FIG. 12 or 13 with an applied gastrointestinal implant 17, is initially inserted transorally, that is via the mouth and the esophagus, into the gastrointestinal tract until the first fastening means 3 has assumed a position that is distal to the pylorus 7 and the second fastening means 4 has assumed a position that is proximal to the pylorus. This takes place by means of a guide wire (not shown) which is first introduced into the gastrointestinal tract accordingly by means of a gastroscope. Then, the outer vessel 8 is positioned in the intended position in the gastrointestinal tract via the guide wire, and the guide wire is removed again against the direction of insertion.

[0156] To determine the position of the positioning apparatus 18, it is advantageous if the outer vessel 8 and/or the inner supporting body 9 are provided with a marking 49 on their outsides that indicates to the physician performing the operation the insertion depth of the outer vessel 8 and the relative position of the inner supporting body 9 thereto, so that it can be precisely determined when the fastening means 3, 4 have reached their position distal from and proximal to the pylorus 7. Thus, for example, the distance between the patient's tooth row and the pylorus can be gastroscopically measured in advance.

[0157] Alternatively or additionally, limit stops 57 (FIG. 22) can be provided which facilitate the insertion of the outer vessel 8 up to a defined position. The limit stop 57 can, for example, be embodied as an annular balloon that is permanently connected the outer vessel 8 and surrounds said vessel, and which can be filled with air via an insufflation tube 58 that runs on the surface of the outer vessel. When the balloon is in the stomach, it is inflated so that the positioning apparatus 18 can only continue to be advanced until the balloon strikes the pylorus. The position of the balloon on the outer vessel is thereby chosen such that, at this point in time, the first fastening means 3 is in a position in which the expansion thereof can be carried out.

[0158] As previously mentioned at the outset, it is advantageous if, at this point in time, the outer vessel 8 and the inner supporting body 9 are position-fixed relative to one another via securing means (not shown).

[0159] However, the following statements should be considered regardless of how the positioning apparatus 18 was placed in the correct position.

[0160] FIG. 17 shows the point in time after the transoral insertion at which the first fastening means 3 is located distally from the pylorus 7. At this point in time, the distal end 12 of the outer vessel 8 is still closed. The distal end region 1b of the tube-shaped element 1, which region can be located in a more or less invaginated state in the holding volume 27a of the aligning section 27, can also be closed or also open.

[0161] Subsequently, as a result of the slight retraction of the outer vessel 8 in the direction of the arrows 47 and the accompanying impact of the aligning section 27 on the distal end region 12, said region is separated from the remaining outer vessel 8, as is shown in FIG. 18, or else is simply opened, depending on whether the structural weakness 48 facilitating this runs across the entire circumference of the outer vessel 8 or only a section of the circumference. Alternatively, in the event that the distal end region 12 is constructed from absorbable material, time can be allowed to pass until said region dissolves.

[0162] During the retracting of the outer vessel 8, attention should in any case initially be paid that said vessel is not retracted over the position of the first fastening means 3 after the separation or opening of the distal end region 12.

[0163] Subsequently, and as shown in FIG. 19, via a channel 23 running in the interior of the supporting body 9, which channel ends in an outlet opening 24 protruding in the holding volume 27a (see also FIGS. 9 and 10), a fluid, preferably CO2 or air, can be blown into said channel continuously or in a pulsating manner via the open end 1a of the tube-shaped element 1. Through the resulting increasing internal pressure, the section of the hose-shaped element 1 located in the holding volume 27a is transported out of said volume and, similarly to a balloon, inflated until it completely unfolds.

[0164] If the distal end 1b of the tube-shaped element 1 is closed, it must be detached from the remaining tube-shaped element 1 in order to ready said element for use. It can thereby be provided that the distal end 1b is made of absorbable material so the physician performing the operation only needs to wait for a defined period of time.

[0165] Alternatively, the tube-shaped element 1 can be provided in the end region 1b thereof with an opening (not shown) which is closed with a plug (not shown), or can be provided with a structural weakness 14 (see FIG. 1), for example in the form of a perforation or a thinned wall section, which separates the second end region 1b from the remaining tube-shaped element 1. Continuing to blow fluid into the tube-shaped element 1, which at this point in time is already completely unfolded, causes the internal pressure thereof to further rise, whereby the distal end region 1b detaches from the remaining tube-shaped element 1 at the structural weakness and can be naturally discharged.

[0166] The same thing applies for the embodiment with a plug, which can be formed from starch, for example, and also detaches from the opening as a result of the internal pressure, so that the tube-shaped element is then passable for the chyme.

[0167] In the event that the distal end of the tube-shaped element 1 is not closed, the latter is immediately ready for use after unfolding out of the holding volume 27a. Surprisingly, it became apparent that the folding or compressing of the tube-shaped element 1 in the holding volume 27a is sufficient to enable the unfolding by the insufflation of the fluid, even if the distal end 1b is not closed.

[0168] In one embodiment of the invention, it is provided that an X-ray strip is integrated in the tube-shaped element 1 in order to render the position of the tube-shaped element 1 and/or the complete unfolding thereof visible with X-rays.

[0169] As a next step, the outer vessel 8 can then be retracted over the position of the first fastening means 3 in the direction of the arrows 47, as is illustrated in FIG. 20, so that the first fastening means 3 can be released from its mounting position 3a and an arboreal expansion of the first fastening means 3 occurs. Expediently, the inner supporting body 9 is provided with markings, so that it is easy to recognize how far the outer vessel 8 has already been retracted, and so that it is in turn possible to conclude therefrom whether a fastening means 3, 4 was already able to expand and, if so, which one.

[0170] In the expanded form of the first fastening means 3, the outer vessel 8 can then be further retracted in the direction of the arrows 47, so that the second fastening means 4 also expands, as is illustrated in FIG. 21. At this point in time, the two fastening means 3, 4 are freely movable and are pulled towards one another by the connecting element 6, so that they bear with their contact surfaces 33, 34 against the distal and proximal front faces 31, 32 of the pylorus 7, respectively, and clamp it. The tube reserves accommodated in the recesses 46, where present, support this clamping as a result of the accompanying facilitated mobility of the fastening means 3, 4 in the axial direction. The gastrointestinal implant 17 is thus position-fixed, so that subsequently both the outer vessel 8 and also the inner supporting body 9 can be removed again via the esophagus. What remains is the gastrointestinal implant 17 secured on the pylorus as illustrated in FIG. 2.

[0171] At this junction, it should not go unmentioned that it is also possible to first secure the gastrointestinal implant 17 to the pylorus 7 using the fastening means 3, 4 and to only then effect the unfolding of the of the tube-shaped element 1 by blowing in a fluid via the channel 23.

LIST OF REFERENCE NUMERALS

[0172] 1. Tube-shaped element [0173] 1a. First (proximal) end of the tube-shaped element [0174] 1b. Second (distal) end of the tube-shaped element [0175] 2. Duodenum [0176] 3. First fastening means [0177] 3a. First mounting position [0178] 4. Second fastening means [0179] 4a. Second mounting position [0180] 5. Pyloric antrum [0181] 6. Connecting element [0182] 7. Pylorus [0183] 8. Outer vessel [0184] 8a. Option for accommodating a guide wire [0185] 9. Inner supporting body [0186] 10. Flow opening of the first fastening means [0187] 11. Flow opening of the second fastening means [0188] 12. Distal end region of the outer vessel [0189] 13. Proximal end region of the outer vessel [0190] 14. Structural weakness [0191] 15. First groove [0192] 16. Second groove [0193] 17. Gastrointestinal implant [0194] 18. Apparatus for positioning a gastrointestinal implant in the human gastrointestinal tract [0195] 19. Longitudinal axis of the outer vessel [0196] 20. Longitudinal axis of the inner supporting body [0197] 21. Rotationally symmetrical section of the inner vessel [0198] 22. An end region of the inner supporting body [0199] 23. Channel in the inner supporting body [0200] 24. Outlet opening of the channel [0201] 27. Aligning section for the tube-shaped element [0202] 27a. Holding volume [0203] 29. Magnetic section of the first fastening means [0204] 29a. Individual magnet in a magnetic section [0205] 30. Magnetic section of the second fastening means [0206] 30a. Individual magnet in a magnetic section [0207] 31. Proximal face of the pylorus [0208] 32. Distal face of the pylorus [0209] 33. Contact surface of the first fastening means [0210] 34. Contact surface of the second fastening means [0211] 35. Intestine [0212] 36. Attracting magnetic force [0213] 37. Repelling magnetic force [0214] 38. Interior volume of a supporting element [0215] 40. Coil spring element [0216] 41. Supporting element [0217] 41a. First end section of the supporting element [0218] 41b. Second end section of the supporting element [0219] 42. Supporting element [0220] 43. Coil spring element [0221] 44. Coil spring element [0222] 45. Coil spring element [0223] 46. Recesses on the surface of the inner supporting element [0224] 47. Directional arrows [0225] 48. Structural weakness of the outer vessel [0226] 49. Section of the inner supporting element with reduced cross-sectional area [0227] 50. Section of the inner supporting element adjacent to 49 [0228] 51. Section of the inner supporting element adjacent to 49 [0229] 52. Reduced cross-sectional area [0230] 53. Missing cross-sectional area [0231] 54. Section of the fastening means 3, 4 [0232] 54a. Faces of the sections 54 [0233] 55. Cross-sectional area of the adjacent sections 51, 52 [0234] 56. Support surface [0235] 57. Limit stop [0236] 58. Insufflation tube