Auxiliary medical device, method of reducing a size of an implant, and method of implanting an implant

Abstract

The invention relates to an auxiliary medical device (40) for delivery of an implant (I) into a patient. The implant may be a duodenal anchor (20) and / or a gastric anchor (10). The auxiliary medical device comprises at least one wing member (81, 82), a support member (90), a release line (50), and a contraction mechanism (60). The at least one wing member (81, 82) and the support member (90) are releasably connected or connectable by the release line (50) such as to form a substantially loop-shaped cross-section. The contraction mechanism (60) is adapted to contract the loop-shaped cross-section at least partially. The release line (50) is arranged such that the connection between the at least one wing member (81, 82) and the support member (90) is released when the release line (50) is pulled.

Description

[0001] Auxiliary Medical Device , Method of Reducing a Size of an Implant , and Method of Implanting an Implant

[0002] The invention relates to an auxiliary medical device , a method of reducing the si ze of an implant , and a method of implanting an implant into according to the preamble of the independent claims .

[0003] Auxiliary medical devices , for example crimping devices for reducing a si ze of an implant before delivery into a patient are known .

[0004] US 2023 / 0078757 Al discloses apparatuses which may comprise crimping devices for compressing an implant prior to deployment to a portion of a subj ect .

[0005] US 10 123 894 B2 discloses a method of crimping a stent on a catheter delivery assembly .

[0006] Known crimping devices may prove cumbersome because oftentimes , further steps are required to maintain a crimped element in a crimped state for implantation . Furthermore , it may require additional steps to remove the crimping device .

[0007] It is an obj ective of the invention to overcome the disadvantages of the prior art , in particular to provide a more versatile and more flexible device for crimping . In particular, devices are needed which require less manipulation .

[0008] This and other obj ectives are achieved by the devices and methods according to the characteri zing portion of the independent claims of the invention . According to the invention, an auxiliary medical device for delivery of an implant into a patient is provided . The implant may comprise or consist of a duodenal anchor and / or a gastric anchor . The auxiliary medical device comprises at least one wing member, a support member, a release mechanism . The release mechanism may be a release line . The at least one wing member and the support member are releasably connected or connectable by the release line such as to form a substantially loop-shaped cross-section . The release mechanism, preferably the release line , is arranged such that the connection between the at least one wing member and the support member is released when the release mechanism is activated, in particular when the release line is pulled .

[0009] Preferably, the auxiliary medical device comprises a contraction mechanism . The contraction mechanism is adapted to contract the loop-shaped cross-section at least partially .

[0010] The auxiliary medical device may be si zed such as to contract at least a portion of the implant , in particular the duodenal anchor and / or the gastric anchor .

[0011] Preferably, the contraction mechanism is pre-arranged such as to form a substantially loop-shaped cross-section before crimping and wherein the contraction mechanism is adapted to reduce a dimension along a circumference of said loop . The contraction of the contraction mechanism may be , but does not have to be , irreversible .

[0012] Preferably, the release line is pre-arranged and connects , in a secure manner, the support member with the wing member . Preferably, the support member and the wing member comprise or consist of the same material . Particularly preferably, the auxiliary medical device part comprises a first and a second wing member, which may be formed integrally and / or connected to an elongated delivery shaft . The support member may be arranged between two free ends of the first and second wing member . The support member may be connected, along a first edge of the support member extending along a longitudinal axis , to the first wing member by the contraction mechanism . Additionally or alternatively, the support member may be connected, along a second edge of the support member extending along the longitudinal axis , to the second wing member by the release line .

[0013] As a result , an implant such as a duodenal anchor and / or a gastric anchor may be placed in an inner volume of the auxiliary medical device . The inner volume may generally be large enough that the implant may be placed without pre-crimping . The crimping may be ef fectuated by the contraction mechanism . The auxiliary medical device may be adapted to be brought into a patient ' s body, e . g . to an implantation site . The implant may be released by pulling the release line and the auxiliary medical device subsequently removed .

[0014] In order to facilitate the delivery of an implant , such as a duodenal anchor or a gastric anchor, it is advantageous to reduce a si ze , especially a radial si ze , of the implant , in particular i f the implantation is done minimally-invasively and / or via natural ori fices having a limited diameter . For example , for transoral implantation via the oesophagus , it may be necessary to reduce the si ze of an implant to fit through the oesophagus and / or the pylorus . The auxiliary medical device may comprise one wing member having a shape of hal f a tube , i . e . one hal f of a tube cut along its longitudinal axis , and one support member also having a shape of hal f a tube .

[0015] The contraction mechanism may be any mechanism configured to contract the at least one wing member and / or the support member and / or a distance between the at least one wing member and the support member . The wing member itsel f may contract , for example based on the working principle of heat shrinking tubes , or the wing member, in particular an edge of the wing member, may be brought closer to an edge of the support member by external means , for example by a crimping line arranged in a shoe-lace pattern .

[0016] The substantially loop-shaped cross-section may be partially formed by the contraction mechanism, preferably by a crimping line , and / or by the release line , and / or by otherwise not completely closed surfaces .

[0017] The wing member and the support member being releasably connected or connectable by the release line allows for an easy, fast and reliable disconnection of the at least one wing member and the support member in response to a pulling force applied to a first end of the release line . Disconnecting the at least one wing member and the support member may result in the release of the implant from a crimped state .

[0018] The at least one wing member preferably has a thickness between 0 . 1 mm and 1 . 0 mm . The auxiliary medical device according to the invention therefore provides a separation of contraction mechanism and a release mechanism . Mechanisms to contract and / or expand may be reversible and therefore combined . However, the reversible function ( e . g . expansion after contraction) may be cumbersome and / or di f ficult to perform, in particular in vivo . Therefore , by providing a separate contraction mechanism and a separate release mechanism overcomes this limitation in that the release mechanism (which may be cumbersome to contract ) may be pre-arranged before crimping and / or the contraction mechanism (which may be di f ficult to release , in particular in vivo ) may not need to be released again . Therefore , the auxiliary medical device may allow for both an easy and fast contraction of the auxiliary medical device as well as an easy and fast release of the implant device from the contracted auxiliary medical device using the release line .

[0019] The provision of separate contraction mechanism and a release mechanism may further allow for more flexible implementation of these mechanisms for any given application . For example , i f a certain mechanism of contraction is desirable for a given application, said mechanism may be implemented without concerns about its releasability .

[0020] The wing member may be able to contract itsel f , for example the wing member may be a part of a heat shrinking tube and / or comprise the same material as a heat shrinking tube . The wing member itsel f may also be contracted by external means

[0021] The wing member may comprise and / or consist of a soft material , preferably a polymer, more preferably silicone . The support member may comprise and / or consist of the same material as the wing member .

[0022] In a preferred embodiment , the contraction mechanism is configured as a crimping line . Preferably, the at least one wing member and the support member are , particularly preferably separately from the release mechanism, connected or connectable by the crimping line .

[0023] Having a crimping line as contraction mechanism allows for easy and fast si ze adj ustment and in particular crimping of the auxiliary medical device . By pulling on the crimping line , the si ze of the auxiliary medical device can be reduced such to contract the implant surrounded by the auxiliary medical device . To keep the implant in the contracted state , both ends of the crimping line may also be knotted together, though generally no further securing may be necessary as the friction between the crimping line and the auxiliary medical device material may be suf ficient . However, where a knot is desired for additional safety, the auxiliary medical device is advantageous in that the knot does not need to be easy to loosen because release may be done using the release line . The crimping line may thus be secured irreversibly, i f desired, without af fecting the overall function of the auxiliary medical device .

[0024] The crimping line may be operated in an operation room before an operation takes place . The crimping line may be operated by the medical staf f preparing and / or conducting the medical operation . Therefore , the crimping line allows for greater flexibility regarding the preparation of a medical operation, for example because it may be used directly on site . In a preferred embodiment , the crimping line is arranged in a shoe-lace pattern .

[0025] The shoe-lace pattern may, for example , be a Criss-Cross pattern, a Straight-Lace pattern, a Heel-locking pattern, a Straight-Lace pattern, or a Lattice pattern . Such patterns are known in the art .

[0026] Generally, any pattern which leads to a contraction between edges attached to the crimping line , without releasing the crimping line , may be suitable .

[0027] The shoe-lace pattern allows to quickly and reliably and / or homogeneously contract the auxiliary medical device . The contraction may advantageously be done by pulling on both ends of the crimping line arranged in the shoe-lace pattern, in order to achieve a uni form crimping along pulled edge , but it will be understood that pulling on one end of the crimping line may be suf ficient for crimping . The contraction may be kept by knotting both ends of the crimping line together when in the contracted state .

[0028] In a preferred embodiment , the at least one wing member and the support member are connected, by the release line and / or the contraction mechanism, such as to form an at least partially tube-like shape .

[0029] The support member may have four edges . The support member may have a rectangular shape and / or be bent . A first edge region of the support member may be connected to the at least one wing member by the release line . A second edge region of the support member, wherein the second edge region is located opposite of the first edge region, may be connected to the at least one wing member by the contraction mechanism, preferably by the crimping line .

[0030] In a preferred embodiment , the loop-shaped cross-section has a diameter between 2 cm and 10 cm in a configuration where the contraction mechanism is not contracted, preferably between 3 and 5 cm . As a result , typical implants , in particular duodenal anchors and / or gastric anchors of bariatric implants , may fit in the auxiliary medical device without pre-contraction .

[0031] Preferably, the loop-shaped cross-section has a diameter which is smaller than 2 cm when the contraction mechanism is at least partially, preferably fully, contracted, in particular with an implant crimped therein .

[0032] In a preferred embodiment , the auxiliary medical device further comprises a retrieval tail connected or connectable to the at least one wing member . The retrieval tail may also be attached or attachable to a shaft of a delivery device . The retrieval tail may be formed integrally with the wing member or wing members .

[0033] The retrieval tail and / or any wing member and / or support member may have a thickness between 0 . 1 mm and 2 . 0 mm .

[0034] The retrieval tail may allow for an easy and reliable attachment of a crimped implant to a delivery device , e . g . to a shaft . The retrieval tail may be si zed and shaped to be extended away, e . g . in a longitudinal direction, from the crimped implant to allow for attachment at a location away from the implant .

[0035] The retrieval tail may comprise or consist of the same material as the at least one wing member . Forming at least a portion of the retrieval tail of the same material as the wing member may reduce the complexity and cost of the production and may further improve the durability of the auxiliary medical device. Further, the retrieval tail may comprise or consist of the same material as the support member.

[0036] In a preferred embodiment, the at least one wing member comprises or consists of a polymer. Preferably, the at least one wing member comprises or consists of silicone.

[0037] Particularly preferably, the at least one wing member, in particular when comprising or consisting of silicone, is coated with perylene. The perylene coating may have a thickness between 0.5 to 2.0 pm.

[0038] A perylene coating, in particular on an interior surface for contacting the implant, may provide a reduced risk of sticking of parts of the auxiliary device (e.g. of the wing member) to parts of the implant, such as a balloon membrane. Sticking may create a fusion over time and alter the mechanical properties of the medical device. Furthermore, a perylene coating, in particular on an external surface for contacting a tissue surface, may reduce the friction with the anatomy (e.g. oesophagus, stomach and / or pylorus) during implant delivery, resulting in an easier and safer delivery procedure.

[0039] In a preferred embodiment, the at least one wing member is at least partly supple.

[0040] The at least one wing member being at least partly supple, preferably supple, may reduce the risk of injuries when inserted into a patient and may allow the at least one wing member to adapt to the surface of the implant. In a preferred embodiment , the auxiliary medical device further has a second wing member, the second wing member being connected or connectable to the support member by the contraction mechanism .

[0041] The first and the second wing member may be arranged on opposite sides , e . g . with respect to the retrieval tail and / or the longitudinal axis . The first and the second wing member may also be formed integrally .

[0042] In a preferred embodiment , the release line is arranged in a chain-stitch pattern .

[0043] Generally, any stitch pattern which may be disassembled by pulling on an end of the release line is suitable . A chain-stitch pattern generally comprises a series of loops , wherein one loop is held and blocked by the respective next loop passing therethrough . Therefore , when a string is pulled, a loop is pulled through the loop which is being held, which is in turn released .

[0044] The chain stich pattern may reliably connect the at least one wing member to the support member . The chain stitch pattern may be released by applying a pulling force on a free end of the release line .

[0045] Preferably, the release mechanism is adapted in its length so as to extend through the patient ' s oesophagus and / or through a delivery tube .

[0046] As explained above , the release mechanism may be a release line , in particular a release line which is formed as an extension of of stitch pattern, in which case the release line may be long enough to extend from the auxiliary medical device , when positioned at a target site for implantation, to an end of a delivery tube which may be placed at or in proximity of the patient ' s mouth .

[0047] Additionally or alternatively, the release mechanism may include a cable ( e . g . for data transmission or transmission of an electric impulse ) , a hydraulic or pneumatic tube for activating a release mechanism, and / or a release line which is not an extension of a stitch pattern (but , for example , connected to and adapted to pull on a release mechanism such as a zipper ) .

[0048] The delivery tube may be a part of a delivery device .

[0049] It will be understood that the length of an oesophagus may vary from patient to patient , but the skilled person understands that the patient ' s oesophagus may of an average length known to the skilled person . As such, the length of the release mechanism, e . g . a release line , may correspond to an average length of a human oesophagus , for example at least 10 cm, at least 20 cm, at least 25 cm, at least 30 cm, or at least 35 cm . To avoid entanglement and improve the ease of use , the release mechanism may also have a maximum length, for example less than 200 cm, less than 150 cm, or less than 130 cm . Thereby, the release mechanism can be activated in proximity to the other parts of a delivery device .

[0050] In certain embodiments the release mechanism may be combined with and / or be formed as a part of a delivery device . The invention is thus directed to a delivery device with a releasable auxiliary medical device , wherein the release mechanism ( such as a release line ) extends to a proximal end ( arranged on an opposite end of the auxiliary medical device ) of the delivery device , preferably through a tube of the delivery device .

[0051] A medical implant , preferably one of a gastric anchor and a duodenal anchor, or an implant comprising a gastric anchor and / or a duodenal anchor, wherein the implant is at least partially held in a crimped configuration by an auxiliary medical device as previously described . Preferably, the duodenal anchor and / or the gastric anchor are held in a crimped configuration .

[0052] The medical implant may be or comprise a duodenal anchor and / or a gastric anchor . Preferably, the implant is an inflatable duodenal anchor and / or an inflatable gastric anchor .

[0053] An implant held in a crimped configuration by the auxiliary medical device may be easier to introduce into a patient due to a reduced si ze of the implant in the crimped configuration .

[0054] The invention is further directed to a method of reducing a si ze of an implant for implantation . The implant may comprise or consist of a duodenal anchor and / or a gastric anchor . The method is therefore suitable to prepare an implant for a therapeutic procedure . The implant may be crimped and / or deflated to perform the method . The method comprises providing an auxiliary medical device , preferably the auxiliary medical device as previously described, having a release mechanism and optionally a contraction mechanism . The release mechanism may be a release line . The implant is loaded into the auxiliary medical device , in particular into an inner volume having a substantially tubular shape .

[0055] The si ze of the implant is optionally reduced by contracting the contraction mechanism of the auxiliary medical device , which may in particular pull together a wing member and a support member as described above so as to reduce the diameter of the inner volume , preferably such as to contract at least a portion of the implant , in particular the duodenal anchor and / or the gastric anchor . It will be understood that the method may also be performed, in some embodiments and in particular where the auxiliary medical device does not comprise a contraction mechanism, by reducing the si ze of the implant before arranging the implant in the auxiliary medical device . For example , the implant may be compressed using a separate device and / or by hand and then placed in the auxiliary medical device .

[0056] In a preferred embodiment of the method of reducing a si ze of an implant , the auxiliary medical device is arranged on a delivery device before loading the implant into the auxiliary medical device and / or before the contraction mechanism is contracted .

[0057] For example , the auxiliary device may be pre-mounted on a delivery device ( e . g . on a shaft of a delivery device ) . This may allow to reduce the preparation time needed by medical staf f to prepare a crimped implant before implantation into a patient .

[0058] The invention is further directed to a method of implanting an implant into a patient . The method comprises arranging the implant in an auxiliary medical device . The auxiliary medical device may be an auxiliary medical device as previously described . The si ze of the implant is reduced, preferably using the method as previously described . The implant is introduced into the patient , preferably via the mouth into a patient ' s gastric tract , using a delivery device . The implant is released from the auxiliary medical device by activating a release mechanism, for example by pulling on a release line , and particularly preferably by pulling on a free end of the release line . The release line may have any combination of the properties , related to the release line , mentioned in the previous embodiments .

[0059] The si ze of the implant may be reduced before or after arranging the implant in the auxiliary medical device . For example , an auxiliary medical device with a contraction mechanism may be used, wherein the implant is placed in the auxiliary medical device and subsequently compressed by the auxiliary medical device using the contraction mechanism . Alternatively, the implant may be compressed using a separate device and / or by hand and then placed in the auxiliary medical device .

[0060] Preferably, the method further comprises a step of removing the auxiliary medical device from within a patient by pulling on a retrieval tail , preferably wherein the retrieval tail is attached to the delivery device and pulled via the delivery device .

[0061] Particularly preferably, the auxiliary medical device is removed by pulling on a line which is attached or attachable to the retrieval tail via connecting member and / or a snare and / or bracelet .

[0062] The invention is further directed to an auxiliary medical device which has a connection member arranged on an end portion of the auxiliary medical device . The connection member is attached or attachable to a delivery device , an endoscope , and / or a retraction line . The auxiliary medical device may be adapted for delivery of an implant into a patient . For example , the implant may be a duodenal anchor and / or a gastric anchor . The auxiliary medical device may, in particular, be any auxiliary device as described herein .

[0063] The connection member may be formed of the same material as remaining parts of the auxiliary medical device or formed of a di f ferent material . The connection member and the auxiliary medical device may be formed integrally .

[0064] The connection member may be formed in a dumbbell shape and / or have a groove for receiving a suture loop, a snare , a wire , or similary means .

[0065] The invention is further directed to an auxiliary medical device which having a marker for indicating a reference position, preferably positioned at least partially circumferentially along a longitudinal axis .

[0066] Preferably, the marker may indicate a position of an implant , arranged in the auxiliary medical device , which is to be placed at a certain anatomical position . For example , the marker may be an at least partially circumferential line which indicates a position to be placed at a patient ' s pylorus .

[0067] The auxiliary medical device may be adapted for delivery of an implant into a patient . For example , the implant may be a duodenal anchor and / or a gastric anchor . The auxiliary medical device may, in particular, be any auxiliary device as described herein .

[0068] The invention is further directed to a method of producing a medical device . The medical device may be an auxiliary medical device as described herein . The method may comprise any number (for example, one or two or all) of the following steps, in any order :

[0069] 1. A first substantially flat part may be injection-molded. Said first part may have a plurality of holes on at least one first edge region. The first part may be a wing member. The first part may also have two opposing edge regions arranged substantially in parallel, to one another and / or to a longitudinal axis, and each having a plurality of holes. The holes may be formed by injection molding as well, i.e. by using a mold providing such holes. Particularly preferably the first part comprises a retrieval tail and / or a connecting member. Alteran- tively, a tube may be produced (by injection molding or extrusion) and cut in an appropriate way to obtain a wing member.

[0070] 2. A second substantially flat part may be injection-molded. The second part may be a support member and may, in particular, have a plurality of holes on at least one second edge region.

[0071] The second part may also have two opposing edge regions arranged substantially in parallel, to one another and / or to a longitudinal axis, and each having a plurality of holes. The holes may be formed by injection molding as well, i.e. by using a mold providing such holes.

[0072] 3. Additionally or alternatively, a plurality of holes may be punched on any of the edge regions, in particular the first and / or the second edge region of the first and / or second part.

[0073] 4. The first edge region and the second edge region may be connected with a release line, for example in a chain-stitch pattern. It is also possible to connect two edge regions the first part together, either by a release line or any other releasable means so as to form an auxiliary medical device without a support member.

[0074] 5. A connection member may be injection-molded, preferably integrally with the first and / or second part.

[0075] Any in ection-moldable material may be used to perform the method. Particularly preferably, any stretchable material and / or a rubber is used, for example a silicone rubber. Any one or more of the following materials may be used to perform the method:

[0076] - Silicone,

[0077] - Fluoropolymers, such as polytetrafluoroethylene (PTFE) , fluorinated ethylene propylene (FEP)

[0078] - Polyvinyl chloride (PVC) ,

[0079] - Polychloroprene / Neoprene,

[0080] - Fluoroelastomers such as Viton™,

[0081] - Polyurethanes.

[0082] Heat-shrinkable materials (such as fluoropolymers, PVC, Neoprene, and Viton™) may be used to form heat shrink tubes.

[0083] Polyurethane is particularly suitable to form expandable tubes.

[0084] It will be understood that any of the materials listed above is preferably used as a medical-grade material.

[0085] Injection molding may provide a particularly economic way of producing the above-described parts. Additionally or alternatively, flat parts suitable to be used for forming auxiliary medical devices may also be formed by extruding a tube and cutting the flat part to form a sheet. A plurality of holes may then punched into the sheet, in particular in edge regions as described above. In particular, a jacket as described herein may be formed in this way.

[0086] It will also be understood that injection molding, extruding, and other methods may be combined. For example, a jacket maybe formed from extruded parts and a support member may be formed by injection molding.

[0087] The invention is further directed to a loading device and a kit comprising a loading device and an auxiliary medical device as described herein. The loading device may be formed as a slotted tube and / or comprise a tip, preferably a detachable tip. The loading device may be formed of a low-friction material, i.e. a material having a low friction coefficient on polymer materials of which an implant and / or an auxiliary medical device may be formed .

[0088] The skilled person will understand that any part of the auxiliary medical devices described herein may comprise or consist of one of the materials mentioned above.

[0089] The invention is now described with reference to certain embodiments and figures which show:

[0090] Fig. 1: an embodiment of an auxiliary medical device.

[0091] Fig. 2a-2c: a detailed view of a crimping line corresponding to panels A and B of Fig. 1.

[0092] Fig. 3a-3c: schematically the working principle of the contraction and release mechanisms.

[0093] Fig. 4a-4b: a detailed view on a release line. Fig. 5: a delivery device with an implant.

[0094] Figs. 6a-6b: the crimping of the implant on delivery device of

[0095] Fig. 5.

[0096] Fig. 7: a further embodiment of an auxiliary medical de- vice .

[0097] Fig. 8: the embodiment of Fig. 7 when used with an implant and a delivery device.

[0098] Figs. 9a-9b: schematically a method of producing an auxiliary medical device.

[0099] Fig. 10: an implant being delivered using an auxiliary medical device as described herein.

[0100] Figs, lla-llc: further embodiments of auxiliary medical devices.

[0101] Fig. 12a-12d a loading device.

[0102] Fig. 13a-13d illustration of a method of use of a loading device .

[0103] Fig. 1 shows a crimping jacket 40 which is suitable as an auxiliary medical device for bariatric implants. Here, the crimping jacket 40 is shown in the contracted state. The crimping jacket 40 comprises a first wing member 81 and a second wing member 82. A support member 90 is arranged between the two wing members 81, 82 and is formed as longitudinal rectangle of the same material as wing members 81, 82. First wing member 81 and support member 90 are separated by a slit 91 and attached to one another by a crimping suture 60 arranged in shoe-lace pattern . Support member 90 and second wing member 82 overlap, i . e . an edge area of wing member 82 is arranged on top of an edge area of support member 90 , and attached to one another by a release line 50 . While the functioning principle will be described in detail below, the release line 50 is seen to have a first loop 51 ' and a free end 52 . Pulling on the free end 52 releases release line 50 and detaches the support member 90 from second wing member 82 . The release line 50 and the crimping suture 60 are generally stitched in a direction parallel to a longitudinal axis L . An inner volume 41 is formed inside the wing members 81 , 82 and support member 90 , which form a generally circular cross-section with a diameter of 2 cm . It will be understood that the diameter may vary, e . g . between 17-20 mm, when crimped . A retrieval tail 70 is formed integrally with the first and second wing member 81 , 82 of medical-grade silicone and have a material thickness of 0 . 7 mm ( ± 0 . 1 mm) .

[0104] Figure 2 shows a detailed view of a crimping line 60 of panel B of Fig . 1 . The crimping line 60 is arranged in a shoe-lace pattern . The first wing member 81 has a plurality of stitching holes 80 through which the crimping line 60 extends . The support member 90 has a second plurality of stitching holes 91 . The crimping line 60 forms an end loop 66 which extends through the first one of the plurality of stitching holes 80 , 91 in both the support member 90 and the first wing member 81 , respectively .

[0105] The crimping line 60 then forms an "X" 61 and connects a portion going through the first of stitching holes 91 in the support member with the stitching holes 80 in the first wing member, and vice versa . Subsequently, a next "X" 62 is formed which is arranged on an opposite side , here inside , of the wing member 81 and support member 90 . First and second "X" 61 , 62 form a repeating unit 65 . As a result , support member 90 and first wing member 81 are connected and crimping line 60 bridges slit 83 therebetween .

[0106] Fig. 2b shows a proximal end of the crimping line 60 with a shoe-lace pattern. The two free ends 67 ’ , 67' ’ of the crimping line 60 are arranged opposite of the first pattern end 66. The crimping jacket is generally crimped by pulling on one or both of free ends 67 ’ , 67 ’ ’ . It will be understood that generally, leaving both ends 67 ’ , 67' ’ free and pulling on both ends 67 ’ , 67' ’ is advantageous and provides the most uniform constriction of the implant. However, if desired, it is also possible to fixedly attach free end 67 ’ to e.g. wing member 81 and only pulling on second end 67' ’ (or vice versa) . After crimping, the two free ends 67 ’ , 67' 'of the crimping line 60 may be knotted, glued, or otherwise secured together (not shown) .

[0107] Fig. 2c shows, schematically, the shoe-lace pattern of Figs. 2a- 2b before constriction. Support member 90 and wing member 81 are arranged at a distance and slit 83 forms a larger gap. By pulling on free ends 67 ’ , 67' ' , the wing member 81 and the support member 90 can be pulled together and the width of gap 83 is reduced to form the slit shown in Fig. 2a-2b.

[0108] Fig. 3a shows a cross-section of an auxiliary medical device 40, similar to, for example, the crimping jacket as shown in Fig. 1, before constriction. Here, the device 40 comprises only a first wing member 81 and a support member 90 connected via a release line 50 on one end and connected via contraction mechanism 60. Inner volume 41 has a diameter of 5 cm and allows insertion of a bariatric anchor assembly (not shown) . Fig. 3b shows the device 40 of Fig. 3a after contraction of the contraction mechanism 60. Inner volume 41 has a smaller diameter of 2 cm .

[0109] Fig. 3c shows the device 40 of Figs. 3a and 3b after release of the release line 50. As a result, the device 40 is opened and an implant (not shown) may be released. Release of release line 50 does not require further manipulation of contraction mechanism 60 which remains in the same state as shown in Fig. 3b.

[0110] Figure 4a shows a detailed view of a release line 50 with a chain-stitch pattern. An end loop 56 is formed on release line 50 and fixedly arranged by anchoring (e.g. by gluing) the end of release line 50 on itself at an anchor point 57. Line 50 then passes through loop 56 forming another loop, as will be shown in detail in Fig. 4b. Release line passes through stitching holes 92 which coincide on both support member 90 and second wing member 82.

[0111] Fig. 4b shows a detailed view of proximal region of release line 50. Release line has a free end 52 which is folded over itself to form proximal loop 51' . Loop 51 passes through a distal-next loop 51' ' . From loop 51' ' , free end extends away in a first direction, while the remaining portion of release line is passed in the opposite direction where loop 51' ’ is formed in the same manner as loop 51' and passes through loop 51, , ,. Therefore, loop 51' holds loop 51' ’ in place, which in turn holds loop 51' ' ' in place, forming repeating unit 55. When free end 52 of release line 50 is pulled, the loop 51' is pulled back through loop 51' , leaving behind loop 51' ’ as the proximal-most loop. Further pulling pulls loop 51' ’ through loop 51' ' ' in the same manner, eventually removing the entire chain-stitch pattern and thus releasing support member 90 from wing member 82 which are held together by release line.

[0112] Fig. 5 shows a delivery device 1 having a handle 2, a shaft 4 and a distal portion 3. An implant I is mounted on the distal portion 3 of the delivery device 1. The shaft 4 has a length of approximately 100 cm (or 130 cm including distal portion 3) .

[0113] Figure 6a shows a detailed view of panel C of Fig. 5. The implant I comprises a gastric anchor 10 and a duodenal anchor 20 which are mounted on a delivery device 1. The shaft passes through an inner channel of gastric anchor 10 and duodenal anchor 20.

[0114] Fig. 6b shows the delivery device 1 of Fig. b (i.e. panel C of Fig. 5) after the gastric anchor 10 and the duodenal anchor 20 being contracted by an auxiliary medical device 40 as shown in Fig. 1. The implant I further has a duodenal sleeve 21. As a result of the contraction with the auxiliary medical device, the gastric anchor 10 and the duodenal anchor 20 have a reduced size and may be delivered trans-orally to be implanted in a pyloric region of a patient.

[0115] Fig. 7 shows a further embodiment of an auxiliary medical device 40. The embodiment shown here is similar to the one shown in Fig. 1 and similar features are not described repeatedly for clarity. The embodiment shown here has several aspects.

[0116] In one aspect, the device 40 comprises a connection element 110 formed as a dumbbell made of silicone. The dumbbell 110 has two thicker portions 111' , 111' ' which are formed as silicone balls connected by a middle portion 112. The connection element 110 is formed integrally. A tubular sheath 113 with a groove 114 is arranged on the middle portion 112 and is particularly suited to be attached to a snare (not shown) . It will be understood that a snare may also be attached without sheath 113 but that a sheath may provide additional safety against rupture. The sheath 113 may be made of the same material, or a different material, as the rest of the connection element 110.

[0117] In a second aspect, a marker 101 is arranged on the auxiliary medical device 40. The marker is formed as black, colored band on a circumference of the auxiliary medical device 40. The portion of an implant may be placed in a certain position relative to the marker 101, thereby allowing an operator (while implanting the implant) to position the implant with respect to the anatomy without necessarily seeing the implant. It will be understood that the marker 101 may also be formed in different colors, in a different orientation (e.g. along a longitudinal axis or at a certain angle) , in different shapes (e.g. dots, lines, or similar) , and / or of a material that is detectable by other means than vision (e.g. radio-opaque materials) . Furthermore, the marker may also be formed by an imprint in the material of the auxiliary medical device 40.

[0118] In another aspect, the auxiliary medical device 40 has two contraction lines 60', 60' ' which allow a user to individually compress two portions of an implant (not shown) .

[0119] In a further aspect, a free end 52 of the release line 50 extends beyond the end of the release line 50. For clarity, the free end 52 is shown in a length corresponding to about half the auxiliary medical device 40, but it will be understood that it may be formed to extend, e.g. through a delivery tube (see Fig. 8 and 5) to be held at proximal end and / or handle of a delivery device .

[0120] The skilled person understands that the above-described aspects may be combined together or individually with any other embodiment shown herein.

[0121] Fig. 8 shows the embodiment of Fig. 7 when holding an implant I on a delivery device 1 with a delivery tube 120. A retraction line 121 is shown which holds the connection element 112 with a snare 122. The connection element 112 is formed integrally with a retrieval tail 70 of the auxiliary medical device 40. The marker 101 is arranged in between a duodenal portion and a gastric portion (not visible) of the implant I. Thus, the operator may use the marker 101 to accurately place a transpyloric portion at the patient's pylorus.

[0122] Figs. 9a shows a first flat part 81, 82 and a second flat part 90 formed by injection molding which may be used to form an auxiliary medical device 40, as e.g. shown in Figs. 1 and / or 7. Both the first flat part 81, 82 as well as the second flat part 90 are made of in ection-molded silicone and have two edge regions each, each edge region having a plurality of holes 84' , 84' ' , 94' , 94' ' . Thus, a method of producing an auxiliary medical device may include a step of injection molding a first part 81, 82 and / or a second part 90 as shown here. The first part may be connected to the second part by threads or lines, as e.g. shown in Figs. 1 and 7, said threads or line being used to form a release mechanism and / or a contraction mechanism. Here, the first flat part 81, 82 has a marker 101 (see Fig. 7) . Any one, or all, of the pluralities of holes may be formed directly by injection molding, but in some circumstances they may be formed by punching as well. In an exemplary fashion, the method shown and described here is with respect to the embodiment of an auxiliary medical device as shown in Fig. 7, but the skilled person will understand the that same method may be employed to also produce other embodiments shown herein, in particular Fig. 1.

[0123] Fig. 10 shows a device assembly as shown in Fig. 8 when being implanted in a patient's pylorus P. Notably, the marker 101 is placed at the level of the pylorus P. As shown here, the implant I is still retained by the auxiliary medical device 40. An operator may release the implant I by pulling on a release line (not visible) which extends through the delivery tube 120.

[0124] Fig. Ila shows a further embodiment of a flat part having first and second wing members 81, 82. First wing member 81 may be connected to the second wing member 82 to form a tube in which a medical implant (not shown) may be placed. In this embodiment, no contraction mechanism is present. Thus, an operator may choose to compress an implant before placing it in the tube.

[0125] Additionally or alternatively, a combined contraction and release mechanism may be used, i.e. a mechanism which can reversibly contract and expand to decrease or increase the tube size. Thereby, an implant may be placed in the tube, contracted, and then released again. Optionally, a pusher element may be used to push the implant out during implantation and preferably after increasing the tube size.

[0126] Even when a contraction mechanism is combined with the release mechanism, the release mechanism may detach wing members 81, 82 from one another. For example, the contraction mechanism may be usable only once to compress, and upon release detaches wing members 81, 82 from one another.

[0127] Fig. 11b shows the embodiment of Fig. Ila wherein wing members 81, 82 are connected by zipper mechanism 151.

[0128] Fig. 11c shows another embodiment, similar to the one in Fig. 11b, wherein the wing members 81, 82 are connected by magnetic release mechanism.

[0129] It will be understood that the different release mechanisms of Figs. 11b and 11c can be combined with any embodiment shown herein, e.g. with or without a contraction mechanism.

[0130] Fig. 12a shows a loading device 200 which may be used to compress an implant (not shown) and assist with loading in a delivery device (not shown) . For example, the loading device 200 may assist in loading an implant in an auxiliary medical device as shown in Figs. 1, 7, or lla-llc. The loading device 200 comprises a generally tube-shaped body 201 which has an open slot 202 in a side wall. The body 201 is made of PTFE in this embodiment, which is preferable because of its chemical and biological inertness and low friction with other materials. However, other medical-grade materials are conceivable as well. Here, the slot 202 is elongated and extends along a longitudinal axis of the body 201 in an exemplary fashion. It will be understood, however, that other shapes and orientations are conceivable. The body 201 has a length L of approximately 15 cm in this embodiment. The body length may of course be adapted to the implant that is to be compressed. For example, the length may also be 6- 12 cm for duodenal anchors and / or gastric anchors, or longer for combinations of anchors. Fig. 12b shows a cross-section of the loading device 200 of Fig. 12a. A shown here, the body 201 is generally C-shaped with an inner diameter D and a slot width d, and a wall thickness w which may be adapted to any given application. Generally speaking, the body 201 is preferably dimensioned such that the body may be elastically deformed to place an implant therein.

[0131] Fig. 12c shows a tip 300 adapted to be placed on the loading device 200 of Fig. 12a. The tip 300 has a first portion 301 adapted to be attached to the loading device (not shown here) and a second portion 302 which conically tapers toward a tip area 303.

[0132] Fig. 12d shows a cross-section of tip 300 of Fig. 12c. As can be seen here, first portion 301 has an outer diameter D which corresponds to inner diameter D of loading device (see Fig. 12a) . Therefore, the tip 300 may be placed on loading device. Because an outermost diameter of the tip forms a step with a width of w (corresponding to the wall thickness of the loading device, see Fig. 12b) , the resulting outer diameter of the tip 300 is the same as of the loading device. When assembled, the loading device and the tip thus form a flush connection.

[0133] Figs. 13a-13d show, schematically, a use case of the loading de- vice / tip of Figs. 12a-12d.

[0134] Fig. 13a shows a cross-sectional view of an implant I in an noncompressed configuration. The implant I here is an implant as shown in Fig. 6a, but it will be understood that other implants may be used as well. As shown in Fig. 13b, the implant I may be placed in the loading device 200 and held, temporarily by the loading device 200, in a compressed configuration.

[0135] Optionally (not shown in Fig. 13b) , a tip (see Fig. 12c) may be placed on the loading device 200. The use of a tip is preferred as it may facilitate the insertion into an auxiliary device. However, the skilled person will understand that a loading device may also be introduced into an auxiliary medical device without a tip.

[0136] Fig. 13 shows the loading device 200 after its insertion into an auxiliary medical device 40. The loading device 200 holds the implant I in a compressed configuration suitable to easily introduce the implant / loading device assembly into the auxiliary medical device 40. Here, the auxiliary medical device 40 has a release line 50 but no compression mechanism (see Fig. 1) . Because the implant I may be compressed before insertion in the auxiliary medical device 40 and no separate additional compression is necessary in the shown example. The auxiliary medical device may be one as shown in Figs, lla-llc, for example.

[0137] Fig. 13d shows the implant I arranged in the auxiliary medical device 40 after removal of the loading device 200. Due to the removal of the loading device 200, implant I expands until the auxiliary medical device 40 is under slight tension. The loading device 200 may be made of a low-friction material or coated such as to reduce friction on the implant I and / or auxiliary medical device 40.

Claims

Claims1. An auxiliary medical device (40) for delivery of an implant(I) , preferably a duodenal anchor (20) and / or a gastric anchor (10) , into a patient, comprising:- at least one wing member (81, 82) ,- a support member (90) ,- a release mechanism (50, 151, 152) , preferably a release line ( 50 ) , and wherein the at least one wing member (81, 82) and the support member (90) are releasably connected or connectable by the release line (50) such as to form a substantially loopshaped cross-section, wherein the release mechanism, preferably the release line (50) , is arranged such that the connection between the at least one wing member (81, 82) and the support member (90) is released when the release mechanism is activated, preferably when the release line (50) is pulled.

2. The auxiliary medical device (40) according to claim 1, further comprising a contraction mechanism (60) , and wherein the contraction mechanism (60) is adapted to contract the loop-shaped cross-section at least partially.

3. The auxiliary medical device (40) according to any one of claims 1 or 2, wherein the contraction mechanism (60) is configured as a crimping line (60) , preferably wherein the at least one wing member (81, 82) and the support member (90) are, particularly preferably separately from the release mechanism (50) , connected or connectable by the crimping line (60) .

4. The auxiliary medical device (40) according to claim 2, wherein the crimping line (60) is arranged in a shoe-lace pattern (61, 62, 65) .

5. The auxiliary medical device (40) according to any one of the preceding claims, wherein the at least one wing member (81, 82) and the support member (90) are connected by the release mechanism (50) and / or the contraction mechanism (60) , such as to form an at least partially tube-like shape .

6. The auxiliary medical device (40) according to any one of the preceding claims, wherein the loop-shaped cross-section has a diameter between 2 cm and 10 cm, when the contraction mechanism (60) is not contracted.

7. The auxiliary medical device (40) according to any one of the preceding claims, further comprising a retrieval tail (70) connected or connectable to the at least one wing member (81, 82) .

8. The auxiliary medical device (40) according to any one of the preceding claims, wherein the at least one wing member (81, 82) comprises or consists of a polymer, preferably comprises or consists of silicone.

9. The auxiliary medical device (40) according to any one of the preceding claims, wherein the at least one wing member (81, 82) is at least partly supple.

10. The auxiliary medical device (40) according to any one of the preceding claims, further having a second wing member (82, 81) , the second wing member (82, 81) being connectedor connectable to the support member (90) by the contrac- tion mechanism (60) .

11. The auxiliary medical device (40) according to any one of the preceding claims, wherein the release line (50) is arranged in a chain-stitch pattern (51' , 51' ' , 51' ' ' , 55) .

12. The auxiliary medical device (40) according to any one of the preceding claims, wherein the release mechanism (50, 151, 152) , preferably the release line (50) , is adapted in length to be extended through the patient's oesophagus and / or through a delivery tube (120) .

13. A medical implant (I) , preferably one of a gastric anchor(10) and a duodenal anchor (20) , wherein the implant (10, 20) is at least partially held in a crimped configuration by an auxiliary medical device (40) according to any one of the preceding claims.

14. A method of reducing a size of an implant (I) , preferably a duodenal anchor (20) and / or a gastric anchor (10) , for implantation, comprising providing an auxiliary medical device (40) , preferably the auxiliary medical device (40) according to any one of claims 1 to 12, having a release mechanism (50, 151, 152) , preferably a release line (50) , and a contraction mechanism (60) , loading the implant (10, 20) into the auxiliary medical dereducing a size of the implant by contracting the contraction mechanism (60) of the auxiliary medical device (40) .

15. The method according to claim 14, wherein the auxiliary medical device (40) is arranged on a delivery device (1) before loading the implant (I) into the auxiliary medical device (40) and / or before the contraction mechanism (60) is contracted .

16. A method of implanting an implant (I) into a patient, comprising arranging the implant (I) in an auxiliary medical device (40) , preferably an auxiliary medical device (40) according to any one of claims 1 to 12, reducing the size of the implant (I) , preferably using the method according to any one of claims 14 or 15, introducing the implant (I) into the patient, preferably via the mouth into a patient's gastric tract, using a delivery device (1) , releasing implant (I) from the auxiliary medical device (40) by activating a release mechanism (50, 151, 152) , preferably by pulling on a release line (50) , particularly preferably a free end (52) of the release line (50) .

17. The method according to claim 16, further comprising the step of removing the auxiliary medical device (40) from within a patient by pulling on a retrieval tail (70) .

18. An auxiliary medical device (40) for delivery of an implant(I) , preferably a duodenal anchor (20) and / or a gastric anchor (10) , into a patient, preferably an auxiliary medicaldevice (40) according to any of one of claims 1 to 12, further having a connection member (110) arranged on an end portion of the auxiliary medical device (40) , said connection member (110) being attached or attachable to one of a delivery device, an endoscope, and a retraction line.

19. An auxiliary medical device (40) for delivery of an implant(I) , preferably a duodenal anchor (20) and / or a gastric anchor (10) , into a patient, preferably an auxiliary medical device (40) according to any of one of claims 1 to 12 or 18, having a marker (101) for indicating a reference position, preferably positioned at least partially circumferentially along a longitudinal axis.

20. A method of producing a medical device, preferably an auxiliary medical device according to any one of claims 1 to 11 or 18 to 19, comprising any one or more of the following steps, in any order:- injection molding a first substantially flat part (81, 82) , preferably wherein said first part having a plurality of holes (84' , 84' ' ) on at least one first edge region;- injection molding a second substantially flat part (90) , preferably wherein said second part having a plurality of holes (94' , 94' ' ) on at least one second edge region;- extruding a tube and cutting said tube to form a jacket;- punching a plurality of holes (84' , 84' ' , 94' , 94' ' ) on the first and / or the second edge region;- connecting the first edge region and the second edge region with a release line (50) , preferably in a chainstitch pattern (51' , 51' ' , 51' ' ' , 55) ;- injection molding a connection member (110) , preferably integrally with the first and / or second part.

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