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

Abstract

The invention relates to an auxiliary medical device (40) for delivering an implant (I) into the body of a patient. The implant may be a duodenal anchor (20) and / or a gastric anchor (10). The auxiliary medical device includes at least one wing member (81, 82), a support member (90), a release wire (50), and a narrowing mechanism (60). The at least one wing member (81, 82) and the support member (90) are releasably connected or connectable together by a release wire (50) to form a generally annular cross-section. A narrowing mechanism (60) is adapted to at least partially narrow the annular cross-section. The release wire (50) is arranged such that when the release wire (50) is pulled, the connection between the at least one wing member (81, 82) and the support member (90) is released.

Description

Technical Field

[0001] This invention relates to an assistive medical device, a method for reducing the size of an implant, and a method for implanting an implant into the body as described in the preamble of the independent claim. Background Technology

[0002] Known assistive medical devices, such as gripping devices, are used to reduce the size of implants before they are delivered into the patient's body.

[0003] US2023 / 0078757A1 discloses a device that may include a gripping instrument for compressing an implant prior to deployment into a portion of a subject.

[0004] US10123894B2 discloses a method for gripping a vascular stent on a catheter delivery assembly.

[0005] Known gripping devices can be cumbersome to operate because they often require further steps to hold the gripping element in a gripping position for implantation. Additionally, extra steps may be needed to remove the gripping device. Summary of the Invention

[0006] The purpose of this invention is to overcome the shortcomings of the prior art, and in particular to provide a more versatile and flexible instrument for gripping. Specifically, an instrument requiring less manipulation is needed.

[0007] This and other objectives are achieved by the apparatus and method described in the characterizing portion of the independent claims according to the invention.

[0008] According to the present invention, an assistive medical device for delivering an implant into a patient is provided. The implant may include or consist of a duodenal anchor and / or a gastric anchor. The assistive medical device includes at least one wing member, a support member, and a release mechanism. The release mechanism may be a release line. At least one wing member and the support member are releasably connected or can be connected together by the release line to form a generally annular cross-section. The release mechanism, preferably the release line, is arranged such that when the release mechanism is activated, particularly when the release line is pulled, the connection between at least one wing member and the support member is released.

[0009] Preferably, the assistive medical device includes a narrowing mechanism. The narrowing mechanism is adapted to at least partially narrow the annular cross-section.

[0010] The size of the assistive medical device can be set such that at least a portion of the implant is narrowed, particularly the duodenal anchor and / or gastric anchor.

[0011] Preferably, the narrowing mechanism is pre-arranged to form a generally annular cross-section before pressing, and wherein the narrowing mechanism is adapted to reduce the dimension along the circumference of the annulus. The narrowing of the narrowing mechanism may be irreversible, but is not necessarily irreversible.

[0012] Preferably, the release line is pre-arranged and the support member is connected to the airfoil member in a safe manner.

[0013] Preferably, the support member and the wing member are made of the same material or are constructed of the same material. Particularly preferably, the auxiliary medical device component includes a first wing member and a second wing member, which may be integrally formed and / or connected to an elongated delivery shaft. The support member may be disposed between two free ends of the first and second wing members. A first edge of the support member extending along its longitudinal axis may be connected to the first wing member via a narrowing mechanism. Additionally or alternatively, a second edge of the support member extending along its longitudinal axis may be connected to the second wing member via a narrowing mechanism.

[0014] Thus, implants such as duodenal anchors and / or gastric anchors can be placed within the internal volume of an assistive medical device. The internal volume is typically large enough that the implant can be placed without pre-gripping. Gripping can be achieved through a narrowing mechanism. The assistive medical device can be adapted for insertion into the patient's body, such as at the implantation site. The implant can be released by pulling a release line, and the assistive medical device can then be removed.

[0015] To facilitate the delivery of implants such as duodenal or gastric anchors, especially when implantation is performed via minimally invasive surgery and / or through natural orifices of limited diameter, reducing the size of the implant, particularly its radial dimensions, is advantageous. For example, for implantation via the esophagus or orally, it may be necessary to reduce the size of the implant to fit through the esophagus and / or pylorus.

[0016] Assistive medical devices may include an airfoil member having a semi-tubular shape, i.e., half of a tube cut along its longitudinal axis, and a support member also having a semi-tubular shape.

[0017] The narrowing mechanism can be any mechanism configured to narrow at least one airfoil member and / or support member and / or the distance between at least one airfoil member and support member. The airfoil member itself can be narrowed, for example, based on the working principle of heat shrink tubing, or the airfoil member, in particular the edge of the airfoil member, can be pulled closer to the edge of the support member by external means, such as by a grip line arranged in a shoelace pattern.

[0018] The essentially annular cross-section can be partially formed by a narrowing mechanism, preferably by a gripping line, and / or by a release line, and / or by other partially closed surfaces.

[0019] The wing member and the support member are releasably or connectably connected via a release line, allowing for simple, quick, and reliable disconnection of at least one wing member from the support member in response to a tension applied to a first end of the release line. Disconnection of at least one wing member and the support member allows the implant to be released from a gripped state.

[0020] At least one airfoil member preferably has a thickness between 0.1 mm and 1.0 mm.

[0021] The assistive medical device according to the invention achieves the separation of a narrowing mechanism and a release mechanism. Mechanisms for narrowing and / or extending may be reversible and thus can be combined. However, reversible functions (e.g., extension after narrowing) can be cumbersome and / or difficult to perform, especially in vivo. Therefore, by providing separate narrowing and separate release mechanisms, the limitation that the release mechanism (which may be difficult to narrow) can be pre-positioned before gripping and / or the narrowing mechanism (which may be difficult to release, especially in vivo) may not need to be released again is overcome. Thus, the assistive medical device can allow for simple and rapid narrowing of the assistive medical device and simple and rapid release of the implanted device from the narrowed assistive medical device using a release line.

[0022] Providing separate narrowing and releasing mechanisms further allows for more flexible implementation of these mechanisms for any given application scenario. For example, if a certain narrowing mechanism is required for a given application scenario, it can be implemented without considering its releasability.

[0023] The airfoil itself can be narrowed; for example, the airfoil can be part of a heat shrink tubing and / or include the same material as the heat shrink tubing. The airfoil itself can also be narrowed by external means.

[0024] The airfoil component may include and / or be made of soft materials, preferably polymers, and more preferably silicone.

[0025] The support member may include the same material as the airfoil member and / or be made of the same material as the airfoil member.

[0026] In a preferred embodiment, the narrowing mechanism is configured as a gripping line. Preferably, at least one wing-shaped member and a support member are connected or can be connected via the gripping line, and particularly preferably, this connection is separate from the release mechanism.

[0027] The gripping line, acting as a narrowing mechanism, allows for simple and rapid sizing adjustments, particularly for assistive medical devices. By pulling the gripping line, the size of the assistive medical device can be reduced, thereby narrowing the implant surrounded by the device. To maintain the implant in a narrowed state, the two ends of the gripping line can also be knotted together, although further tightening is usually unnecessary as friction between the gripping line and the assistive medical device material is often sufficient. However, in cases where knotting is required for added safety, it is advantageous that the knot does not need to be easily untied, as it can be released using a release line. Therefore, if necessary, the gripping line can be irreversibly secured without affecting the overall function of the assistive medical device.

[0028] The crimping suture can be operated in the operating room before the procedure. The crimping suture can be operated by medical personnel preparing for and / or performing the medical procedure. Therefore, the crimping suture allows for greater flexibility in preparing for medical procedures, for example, because it can be used directly on-site.

[0029] In a preferred embodiment, the grip lines are arranged in a shoelace pattern.

[0030] Shoelace patterns can be, for example, crisscross, straight, heel-lock, straight, or grid patterns. These patterns are known in the art.

[0031] Generally, any style that can achieve a narrowing between the edges attached to the crimping line without loosening the crimping line is applicable.

[0032] The shoelace pattern allows for quick and reliable and / or uniform narrowing of the assistive medical device. Narrowing can advantageously be achieved by pulling on both ends of the grip line in the shoelace pattern arrangement to achieve uniform grip along the pulled edge; however, it is understood that pulling on one end of the grip line is sufficient for gripping. In the narrowed state, narrowing can be maintained by tying the two ends of the grip line together.

[0033] In a preferred embodiment, at least one wing-shaped member and a support member are connected by a release line and / or a narrowing mechanism, for example forming a shape that is at least partially tubular.

[0034] In a preferred embodiment, in the un-narrowed configuration of the narrowing mechanism, the annular cross-section has a diameter between 2 cm and 10 cm, preferably between 3 cm and 5 cm. Thus, typical implants, particularly duodenal and / or gastric anchors for weight-reduction implants, can be adapted into assistive medical devices without prior narrowing.

[0035] Preferably, when the narrowing mechanism is at least partially, preferably completely, narrowed, especially when the implant is gripped therein, the annular cross section has a diameter of less than 2 cm.

[0036] In a preferred embodiment, the assistive medical device further includes a retrieval tail that is connected to or can be connected to at least one airfoil member. The retrieval tail may also be attached to or can be attached to the shaft of the delivery device. The retrieval tail may be integrally formed with one or more airfoil members.

[0037] The tail section and / or any wing-shaped components and / or support components may have a thickness between 0.1 mm and 2.0 mm.

[0038] The retrieval tail allows for simple and reliable attachment of the gripped implant to a delivery device, such as a shaft. The size and shape of the retrieval tail can be configured, for example, to extend from the gripped implant in the longitudinal direction to allow attachment at locations remote from the implant.

[0039] The recovery tail may include or be made of the same material as at least one airfoil member. Using the same material as the airfoil member to form at least a portion of the recovery tail can reduce manufacturing complexity and cost, and can further improve the durability of the assistive medical device. Furthermore, the recovery tail may include or be made of the same material as the support member.

[0040] In a preferred embodiment, at least one airfoil component comprises or is composed of a polymer. Preferably, at least one airfoil component comprises or is composed of silicone.

[0041] Particularly preferably, at least one airfoil member, especially when comprising or composed of silicone, is coated with perylene. The thickness of the perylene coating can be between 0.5 micrometers and 2.0 micrometers.

[0042] Perylene coatings, particularly on the inner surfaces that come into contact with the implant, can reduce the risk of accessory device components (e.g., wing-shaped components) adhering to implant components (e.g., balloon membranes). Adhesion can lead to fusion over time and alter the mechanical properties of the medical device. Furthermore, perylene coatings, especially on the outer surfaces that come into contact with tissue surfaces, can reduce friction with anatomical structures (e.g., the esophagus, stomach, and / or pylorus) during implant delivery, making the delivery process easier and safer.

[0043] In a preferred embodiment, at least one airfoil member is at least partially flexible.

[0044] At least one wing member is at least partially flexible, preferably flexible, which can reduce the risk of injury when inserted into the patient and allow at least one wing member to adapt to the surface of the implant.

[0045] In a preferred embodiment, the assistive medical device further includes a second wing member, which is connected to or can be connected to a support member via a narrowing mechanism.

[0046] The first and second airfoil members can be arranged on opposite sides, for example, relative to the recovery tail and / or longitudinal axis. The first and second airfoil members can also be integrally formed.

[0047] In a preferred embodiment, the release line is arranged in a chain-like pattern.

[0048] Generally, any stitch pattern that can be disassembled by pulling one end of the release line is suitable. Chain stitch patterns typically consist of a series of loops, one of which is held and locked by passing through the corresponding next loop. Thus, when the line is pulled, a loop is pulled through the loop holding it in place and is released sequentially.

[0049] The chain stitch pattern reliably connects at least one airfoil member to the support member. The chain stitch pattern can be untied by applying tension to the free end of the release line.

[0050] Preferably, the length of the release mechanism is adapted to extend through the patient's esophagus and / or through the delivery catheter.

[0051] As mentioned above, the release mechanism can be a release line, particularly a release line formed as an extension of a stitch pattern. In this case, the release line should be long enough to extend from the device to the end of a delivery catheter that may be located in or near the patient's mouth when the assisting medical device is positioned at the target implantation site.

[0052] Additionally or alternatively, the release mechanism may include a cable (e.g. for data transmission or electrical pulse transmission), a hydraulic or pneumatic tube for activating the release mechanism, and / or a release line that is not a pin pattern extension (but, for example, connected to and adapted to be pulled by a release mechanism such as a zipper).

[0053] The conveying pipe can be part of the conveying device.

[0054] It should be understood that the length of the esophagus can vary from patient to patient, but those skilled in the art will understand that a patient's esophagus may have an average length known to them. Thus, the length of the release mechanism (e.g., the release line) may correspond to the average length of a human esophagus, 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 tangling and improve 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. Therefore, the release mechanism can be activated when it is close to other parts of the delivery device.

[0055] In some embodiments, the release mechanism may be combined with and / or formed as part of the delivery device. Therefore, the present invention relates to a delivery device having a releasable assistive medical device, wherein the release mechanism (e.g., a release line) preferably extends through a tube of the delivery device to the proximal end of the delivery device (located at the opposite end of the assistive medical device).

[0056] 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, as described above, wherein the implant is at least partially secured in a gripping structure by an assistive medical device. Preferably, the duodenal anchor and / or the gastric anchor are secured in the gripping structure.

[0057] The medical implant may be or include a duodenal anchor and / or a gastric anchor. Preferably, the implant is an inflatable duodenal anchor and / or an inflatable gastric anchor.

[0058] Because of the reduced size of the implant in the gripper structure, implants held in the gripper structure by assistive medical devices may be more easily introduced into the patient.

[0059] The present invention also relates to a method for reducing the size of an implant for implantation. The implant may include or consist of a duodenal anchor and / or a gastric anchor. Therefore, the method is suitable for preparing implants for therapeutic procedures. The implant may be squeezed and / or deflated to perform the method. The method includes providing an auxiliary medical device having a release mechanism and an optional narrowing mechanism, preferably an auxiliary medical device as described above. The release mechanism may be a release line. The implant is loaded into the auxiliary medical device, particularly into an internal volume having a generally tubular shape. The size of the implant may be reduced by narrowing the narrowing mechanism of the auxiliary medical device, which may, particularly as described above, pull the wing member and support member together to reduce the diameter of the internal volume, preferably, for example, narrowing at least a portion of the implant, particularly the duodenal anchor and / or gastric anchor. It should be understood that in some embodiments, particularly where the auxiliary medical device does not include a narrowing mechanism, the method may also be performed by reducing the size of the implant before it is placed in the auxiliary medical device. For example, the implant may be compressed using a separate device and / or manually before being placed in the auxiliary medical device.

[0060] In a preferred embodiment of the method for reducing implant size, the assistive medical device is positioned on the delivery device before the implant is loaded into the assistive medical device and / or before the narrowing mechanism narrows it.

[0061] For example, the assistive device can be pre-installed on the delivery device (e.g., on the shaft of the delivery device). This can allow for a reduction in the preparation time required for medical personnel to prepare the pressure-grip implant before it is implanted into the patient.

[0062] The present invention also relates to a method for implanting an implant into a patient's body. The method includes placing the implant in an assistive medical device. The assistive medical device may be as described above. Preferably, the method described above is used to reduce the size of the implant. The implant is introduced into the patient's body using a delivery device, preferably through the mouth into the patient's gastrointestinal tract. The implant is released from the assistive medical device by activating a release mechanism, for example by pulling a release line, and particularly preferably by pulling the free end of the release line.

[0063] The release line can have any combination of characteristics associated with the release line mentioned in the foregoing embodiments.

[0064] The size of the implant can be reduced before or after placement within an assistive medical device. For example, an assistive medical device with a narrowing mechanism can be used, in which the implant is placed within the assistive medical device and subsequently compressed by the assistive medical device using the narrowing mechanism. Alternatively, the implant can be compressed using a separate device and / or manually before being placed within the assistive medical device.

[0065] Preferably, the method further includes the step of removing the assistive medical device from the patient by pulling the retrieval tail, wherein the retrieval tail is attached to and pulled via the delivery device.

[0066] Particularly preferred is the removal of the assistive medical device by pulling a line, which is attached to or can be attached to a retrieval tail via a connecting member and / or a snare and / or a collar.

[0067] The present invention also relates to an assistive medical device having a connecting member disposed at an end of the assistive medical device. The connecting member is attached to or may be attached to a delivery device, an endoscope, and / or a retractable tubing.

[0068] Assistive medical devices can be used to deliver implants into a patient's body. For example, the implant can be a duodenal anchor and / or a gastric anchor. Assistive medical devices can specifically be any assistive device as described herein.

[0069] The connecting component can be made of the same material as the rest of the assistive medical device or of a different material. The connecting component and the assistive medical device can be integrally formed.

[0070] The connecting member may be formed in the shape of a dumbbell and / or have a groove for receiving a suture loop, snare, thread or similar device.

[0071] The present invention also relates to an assistive medical device having markings for indicating reference positions, preferably positioned at least partially circumferentially along a longitudinal axis.

[0072] Preferably, the marker may indicate the location of an implant disposed within the assistive medical device, which will be positioned at a specific anatomical location. For example, the marker may be at least a partially circumferential line indicating the location to be positioned at the patient's pylorus.

[0073] Assistive medical devices can be used to deliver implants into a patient's body. For example, the implant can be a duodenal anchor and / or a gastric anchor. Assistive medical devices can specifically be any assistive device as described herein.

[0074] This invention also relates to a method for manufacturing a medical device. The medical device may be an auxiliary medical device as described herein. The method may include any number of the following steps (e.g., one, two, or all), and the steps may be performed in any order:

[0075] 1. A first generally flat component may be injection molded. The first component may have a plurality of holes in at least one first edge region. The first component may be an airfoil member. The first component may also have two opposing edge regions arranged generally parallel to each other and / or generally parallel to the longitudinal axis, and each edge region may have a plurality of holes. The holes may also be formed by injection molding, i.e., by using a mold that provides such holes. Particularly preferably, the first component includes a retractable tail and / or connecting member. Alternatively, a tube may be produced (by injection molding or extrusion) and cut in a suitable manner to obtain an airfoil member.

[0076] 2. A second, generally flat component may be injection molded. The second component may be a support member, and in particular may have a plurality of holes in at least one second edge region. The second component may also have two opposing edge regions arranged generally parallel to each other and / or generally parallel to the longitudinal axis, and each edge region may have a plurality of holes. The holes may also be formed by injection molding, i.e., by using a mold that provides such holes.

[0077] 3. Additionally or alternatively, multiple holes may be punched in any edge region, particularly in the first and / or second edge regions of the first and / or second components.

[0078] 4. The first and second edge regions can be connected to a release line, for example, in a chain-like pattern. Alternatively, the two edge regions of the first component can be connected together by a release line or any other releasable device to form an auxiliary medical device without supporting members.

[0079] 5. The connecting component can be injection molded, preferably integrally molded with the first and / or second component.

[0080] Any injection-moldable material can be used to implement this method. Particularly preferred are any stretchable material and / or rubber, such as silicone rubber. This method can be implemented using any one or more of the following materials:

[0081] -Silicone resin,

[0082] - Fluoropolymers, such as polytetrafluoroethylene (PTFE) and fluoroethylene propylene (FEP).

[0083] - Polyvinyl chloride (PVC),

[0084] - Polychloroprene / chloroprene rubber

[0085] - Fluoroelastics, such as Viton™,

[0086] - Polyurethane.

[0087] Heat-shrinkable materials (such as fluoropolymers, PVC, neoprene, and Viton) can be used to form heat-shrink tubing.

[0088] Polyurethane is particularly suitable for forming expandable tubes.

[0089] It should be understood that any of the materials listed above are preferably used as medical-grade materials.

[0090] Injection molding offers a particularly economical method for manufacturing the aforementioned components. Additionally or alternatively, flat portions suitable for forming auxiliary medical devices can also be formed by extruding tubing and cutting the flat portions to form sheets. Multiple holes can then be punched in the sheet, particularly in the edge regions as described above. In particular, sheaths as described herein can be formed in this manner.

[0091] It should also be understood that injection molding, extrusion, and other methods can be combined. For example, a sheath can be formed by extrusion, and support components can be formed by injection molding.

[0092] The present invention also relates to insertion devices as described herein and kits including insertion devices and assistive medical devices. Insertion devices may be formed as slotted tubes and / or include tips, preferably detachable tips. Insertion devices may be formed of low-friction materials, i.e., materials having a low coefficient of friction on polymeric materials forming implants and / or assistive medical devices.

[0093] Those skilled in the art will understand that any part of the assistive medical device described herein may include or be constituted by one of the above-described materials. Attached Figure Description

[0094] The present invention will now be described with reference to specific embodiments and accompanying drawings, wherein:

[0095] Figure 1 An example of an assistive medical device.

[0096] Figures 2a to 2c Corresponding to Figure 1 Detailed view of the gripping lines in areas A and B of the middle section.

[0097] Figures 3a to 3c : Schematic diagram of the working principle of the narrowing and releasing mechanism.

[0098] Figures 4a to 4b Detailed view of the release line.

[0099] Figure 5 : A delivery device for implants.

[0100] Figures 6a to 6b Press the implant firmly. Figure 5 A schematic diagram of the conveying device shown.

[0101] Figure 7 Another embodiment of an auxiliary medical device.

[0102] Figure 8 : Figure 7 The illustrated embodiment is used in conjunction with the implant and delivery device.

[0103] Figures 9a to 9b : Schematic diagram of a method for manufacturing auxiliary medical devices.

[0104] Figure 10 Implants delivered using medical assistive devices as described in this article.

[0105] Figures 11a to 11c Other embodiments of assistive medical devices.

[0106] Figures 12a to 12d : Loading device.

[0107] Figures 13a to 13d : A schematic diagram illustrating the usage of the loading device. Detailed Implementation

[0108] Figure 1A gripper sleeve 40 is shown, suitable as an assistive medical device for weight reduction implants. The gripper sleeve 40 shown here is in a narrowed state. The gripper sleeve 40 includes 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 a longitudinal rectangle having the same material as the wing members 81, 82. The first wing member 81 and the support member 90 are separated by a slit 91 and attached to each other by gripper seams 60 arranged in a shoelace pattern. The support member 90 and the second wing member 82 are stacked, i.e., the edge region of the wing member 82 is arranged on top of the edge region of the support member 90 and attached to each other by a release line 50. Although the functional principle will be described in detail below, it can be seen that the release line 50 has a first loop 51' and a free end 52. Pulling the free end 52 releases the release line 50 and separates the support member 90 from the second wing member 82. The release line 50 and the gripping suture 60 are typically sewn in a direction parallel to the longitudinal axis L. An internal volume 41 is formed within the wing members 81, 82 and the support member 90, forming a generally circular cross-section with a diameter of 2 cm. It is understood that the diameter can vary, for example, between 17 and 20 mm when gripped. The recovery tail 70 is integrally formed with the first and second wing members 81, 82 made of medical-grade silicone and has a material thickness of 0.7 mm (±0.1 mm).

[0109] Figure 2 shows Figure 1 A detailed view of the grip line 60 in square B. The grip line 60 is arranged in a shoelace pattern. The first wing member 81 has a plurality of stitch holes 80 through which the grip lines 60 extend. The support member 90 has a second plurality of stitch holes 91. The grip line 60 forms an end loop 66 that extends through the first of the plurality of stitch holes 80, 91 in both the support member 90 and the first wing member 81. Then, the grip line 60 forms an “X” 61, connecting the portion passing through the first stitch hole 91 in the support member to the stitch hole 80 in the first wing member, and vice versa. Next, another “X” 62 is formed, which is arranged on the opposite side of the wing member 81 and the support member 90, here on the inside. The first and second “X” 61, 62 form a repeating unit 65. Thus, the support member 90 is connected to the first wing member 81, and the grip line 60 bridges the gap 83 between them.

[0110] Figure 2bThe proximal end of a gripping line 60 with a shoelace-like pattern is shown. The two free ends 67', 67'' of the gripping line 60 are arranged opposite the first-pattern end 66. The gripping sheath is typically gripped by pulling one or both of the free ends 67', 67''. It is understood that it is generally advantageous to allow both ends 67', 67'' to move and pull both ends 67', 67'', and provides the most uniform narrowing of the implant. However, if desired, the free end 67' can also be fixedly attached to, for example, the wing member 81, and only the second end 67'' can be pulled (or vice versa). After gripping, the two free ends 67', 67'' of the gripping line 60 can be knotted, glued, or otherwise secured together (not shown).

[0111] Figure 2c schematically shown Figures 2a to 2b The shoelace pattern before narrowing. The support member 90 and the wing member 81 are arranged at a distance, and the slit 83 forms a larger gap. By pulling the free ends 67', 67'', the wing member 81 and the support member 90 can be pulled together, and the width of the gap 83 decreases to form a shape like... Figures 2a to 2b The slit shown.

[0112] Figure 3a A cross-section of the assistive medical device 40 is shown, for example, similar to... Figure 1 The gripping sleeve is shown before narrowing. Here, device 40 includes only a first wing member 81 and a support member 90, which are connected at one end by a release line 50 and by a narrowing mechanism 60. The internal volume 41 has a diameter of 5 cm and allows for the insertion of a weight-reducing anchoring assembly (not shown).

[0113] Figure 3b The image shows the result after narrowing by the narrowing mechanism 60. Figure 3a The device 40 in the middle has an internal volume 41 with a smaller diameter of 2 cm.

[0114] Figure 3c This shows the effect after release line 50 is released. Figure 3a and Figure 3b Device 40 is then activated, and the implant (not shown) can be released. Release of the release line 50 does not require further operation of the narrowing mechanism 60, which remains as described above. Figure 3b The same state as shown.

[0115] Figure 4aA detailed view of a release line 50 with a chain stitch pattern is shown. An end loop 56 is formed on the release line 50 and is secured by anchoring the end of the release line 50 to itself at an anchor point 57 (e.g., by gluing). The line 50 then passes through the loop 56 to form another loop, as will be shown in the diagram. Figure 4b As shown in detail, the release line passes through the thread hole 92, which coincides with both the support member 90 and the second wing member 82.

[0116] Figure 4b A detailed view of the proximal region of the release line 50 is shown. The release line has a free end 52 that folds over itself to form a proximal loop 51'. The loop 51 passes through the next loop 51'' at the distal end. Starting from loop 51'', the free end extends in a first direction while the remainder of the release line passes in the opposite direction, wherein loop 51'' is formed and passes through loop 51''' in the same manner as loop 51'. Thus, loop 51' holds loop 51'' in place, which in turn holds loop 51''' in place to form repeating unit 55. When the free end 52 of the release line 50 is pulled, loop 51' is pulled back through loop 51', leaving loop 51'' as the proximal loop. Further pull the ring 51'' through the ring 51''' in the same manner, and finally remove the entire chain stitch pattern, thereby releasing the support member 90 from the airfoil member 82 held together by the release line.

[0117] Figure 5 A delivery device 1 is shown, comprising a handle 2, a shaft 4, and a distal portion 3. The implant I is mounted on the distal portion 3 of the delivery device 1. The shaft 4 is approximately 100 cm long (or 130 cm, including the distal portion 3).

[0118] Figure 6a It shows Figure 5 Detailed view of the Chinese grid C. Implant I includes a gastric anchor 10 and a duodenal anchor 20 mounted on a delivery device 1. A shaft passes through the internal channels of the gastric anchor 10 and the duodenal anchor 20.

[0119] Figure 6b The conveying device 1 shown in Figure b (i.e. Figure 5 The square C), such as Figure 1 As shown, the gastric anchor 10 and duodenal anchor 20 are narrowed by the assistive medical device 40. The implant I also has a duodenal cuff 21. Due to the narrowing by the assistive medical device, the size of the gastric anchor 10 and duodenal anchor 20 is reduced, allowing for oral delivery to the patient's pyloric region.

[0120] Figure 7 Another embodiment of the assistive medical device 40 is shown. The embodiment shown herein is similar to... Figure 1 Similar features are shown herein, and for clarity, similar features will not be described again. The embodiments shown herein have several aspects.

[0121] In one aspect, the device 40 includes a dumbbell-shaped connecting element 110 formed of silicone. The dumbbell 110 has two thicker portions 111', 111'', which are formed as silicone balls connected by a central portion 112. The connecting element 110 is integrally formed. A tubular sheath 113 with a groove 114 is located on the central portion 112 and is particularly suitable for attachment to a snare (not shown). It should be understood that the snare can also be attached without the sheath 113, but the sheath provides additional security against breakage. The sheath 113 may be made of the same material as the rest of the connecting element 110 or a different material.

[0122] In a second aspect, a marker 101 is disposed on the assistive medical device 40. The marker is formed as a black band around the assistive medical device 40. This portion of the implant can be positioned relative to the marker 101 at a specific location, thereby allowing the operator (during implantation) to position the implant relative to the anatomical structure without having to see the implant. It should be understood that the marker 101 can also be formed in different colors, different orientations (e.g., along the longitudinal axis or at a specific angle), different shapes (e.g., dots, lines, or similar objects), and / or from materials that are detectable in ways other than visual (e.g., radiopaque materials). Furthermore, the marker can also be formed by imprinting in the material of the assistive medical device 40.

[0123] In another aspect, the assistive medical device 40 has two narrowing lines 60', 60'', which allow the user to compress two parts of the implant (not shown) separately.

[0124] On the other hand, the free end 52 of the release line 50 extends beyond the end of the release line 50. For clarity, the length of the free end 52 corresponds approximately to half of the auxiliary medical device 40, but it will be understood that it can be formed as an extension, for example, through a delivery tube (see...). Figure 8 and Figure 5 ), to be held at the proximal end and / or handle of the conveying device.

[0125] Those skilled in the art will understand that the above aspects can be combined together or individually with any other embodiments shown herein.

[0126] Figure 8 It shows Figure 7In one embodiment, the implant I is secured to a delivery device 1 having a delivery tube 120. A retraction line 121 is shown, which secures the connecting element 112 to the snare 122. The connecting element 112 is integrally formed with the retrieval tail 70 of the assistive medical device 40. A marker 101 is positioned between the duodenal and gastric portions (not visible) of the implant I. Thus, the operator can use the marker 101 to accurately place the transpyloric portion at the patient's pylorus.

[0127] Figure 9a The first flat components 81, 82 and the second flat component 90, formed by injection molding, are shown and can be used to form an auxiliary medical device 40, such as... Figure 1 and / or Figure 7 As shown. The first flat components 81, 82 and the second flat component 90 are both made of injection-molded silicone resin, and each has two edge regions, each edge region having a plurality of holes 84', 84'', 94', 94''. Therefore, a method of manufacturing an assistive medical device may include the steps of injection molding the first component 81, 82 and / or the second component 90 as shown herein. The first component can be connected to the second component by threads or wires, as... Figure 1 and Figure 7 As shown, the thread or wire is used to form a release mechanism and / or a narrowing mechanism. Here, the first flat parts 81, 82 have a marker 101 (see...). Figure 7 Any one or all of the holes can be formed directly by injection molding, but in some cases they can also be formed by stamping.

[0128] By way of example, the methods shown and described here are about such Figure 7 The embodiments of the assistive medical device shown herein are illustrated, but those skilled in the art will understand that the same method can be used to produce other embodiments shown herein, particularly... Figure 1 .

[0129] Figure 10 As shown Figure 8 The illustrated device assembly is positioned in the pylorus P of the patient. Notably, marker 101 is placed horizontally at the pylorus P. As shown, implant I is still held in place by assistive medical device 40. The operator can release implant I by pulling the release line (not visible) that extends through delivery tube 120.

[0130] Figure 11aAnother embodiment of a flat component with a first wing member and second wing members 81, 82 is shown. The first wing member 81 can be connected to the second wing member 82 to form a tube in which a medical implant (not shown) can be placed. In this embodiment, no narrowing mechanism is present. Therefore, the operator can choose to compress the implant before placing it into the tube.

[0131] Additionally or alternatively, a combined narrowing and releasing mechanism can be used, i.e., a mechanism that can reversibly narrow and extend to reduce or increase the tube size. Thus, the implant can be placed in the tube, narrowed, and then released again. Optionally, during implantation, preferably after increasing the tube size, a push rod element can be used to push the implant out.

[0132] Even when the narrowing mechanism is combined with the release mechanism, the release mechanism can still separate the airfoil members 81 and 82 from each other. For example, the narrowing mechanism can be used only once to compress and to separate the airfoil members 81 and 82 from each other upon release.

[0133] Figure 11b It shows Figure 11a In one embodiment, the wing-shaped members 81 and 82 are connected by a zipper mechanism 151.

[0134] Figure 11c It shows the relationship with Figure 11b In another similar embodiment, the airfoil members 81 and 82 are connected by a magnetic release mechanism.

[0135] It should be understood that Figure 11b and Figure 11c Different release mechanisms can be combined with any of the embodiments shown herein, such as with or without a narrowing mechanism.

[0136] Figure 12a An insertion device 200 is shown, which can be used to compress an implant (not shown) and assist in insertion into a delivery device (not shown). For example, the insertion device 200 can assist in inserting an implant into an assistive medical device, such as... Figure 1 , Figure 7 or Figures 11a to 11cAs shown. The insertion device 200 includes a generally tubular body 201 with an opening groove 202 in its sidewalls. In this embodiment, the body 201 is made of PTFE, which is preferred due to its chemical and biological inertness and low friction with other materials. However, other medical-grade materials are also considered. Here, the groove 202 is elongated and extends along the longitudinal axis of the body 201 in an exceptional manner. However, it is understood that other shapes and orientations are also considered. In this embodiment, the length L of the body 201 is approximately 15 cm. Of course, the body length can be adapted to the implant to be compressed. For example, the length of the duodenal anchor and / or gastric anchor can also be 6 cm to 12 cm, or the length of a combination of anchors can be longer.

[0137] Figure 12b It shows Figure 12a The cross-section of the implantation device 200 is shown. As illustrated, the body 201 is typically C-shaped, with an inner diameter D and a groove width d, and a wall thickness w that can be adapted to any given application. Generally, the dimensions of the body 201 are preferably such that the body can elastically deform to accommodate the implant.

[0138] Figure 12c It shows a suitable place for placement Figure 12a The tip 300 on the insertion device 200. The tip 300 has a first portion 301 adapted to be attached to the insertion device (not shown here) and a second portion 302 tapering toward the tip region 303.

[0139] Figure 12d It shows Figure 12c The cross-section of the tip 300. As shown in the figure, the outer diameter D of the first part 301 corresponds to the inner diameter D of the device (see figure). Figure 12a Therefore, the tip 300 can be placed on the loading device. Because the outermost diameter of the tip forms a step of width w (corresponding to the wall thickness of the loading device, see...), Figure 12b Therefore, the outer diameter of the tip 300 is the same as the outer diameter of the insert. During assembly, the insert and the tip form a flush connection.

[0140] Figures 13a to 13d schematically shown Figures 12a to 12d The use of the loading device / tip.

[0141] Figure 13a A cross-sectional view of implant I in a non-compression configuration is shown. Implant I here is as follows: Figure 6a The implant shown is an example, but it is understood that other implants may also be used.

[0142] like Figure 13bAs shown, implant I can be placed in insertion device 200 and temporarily kept in a compressed state by insertion device 200.

[0143] Optionally ( Figure 13b (not shown in the image), the tip (see...) Figure 12c The device is placed on the insertion device 200. A tip is preferred because it can facilitate the insertion of the assistive device. However, those skilled in the art will understand that the insertion device can also be used to introduce the assistive medical device without a tip.

[0144] Figure 13 shows the insertion device 200 after insertion into the assistive medical device 40. The insertion device 200 maintains the implant I in a compressed configuration, facilitating easy introduction of the implant / insertion device assembly into the assistive medical device 40. Here, the assistive medical device 40 has a release line 50 but no compression mechanism (see Figure 13). Figure 1 Because implant I can be compressed before insertion of the assistive medical device 40, and in the example shown, no separate additional compression is required. The assistive medical device can be, for example, as... Figures 11a to 11c The auxiliary medical device shown.

[0145] Figure 13d An implant I is shown disposed in an assistive medical device 40 after the insertion device 200 has been removed. Due to the removal of the insertion device 200, the implant I expands until the assistive medical device 40 is in a slightly taut state. The insertion device 200 may be made of a low-friction material or have a coating to reduce friction on the implant I and / or the assistive medical device 40.

Claims

1. An assistive medical device (40) for delivering an implant (I), preferably a duodenal anchor (20), and / or a gastric anchor (10) into a patient, comprising: -At least one airfoil member (81,82), - Supporting component (90), - Release mechanism (50, 151, 152), preferably release line (50), and The at least one airfoil member (81, 82) and the support member (90) are releasably connected or can be connected together via the release line (50) to form a generally annular cross section. Preferably, the release mechanism of the release line (50) is arranged such that when the release mechanism is activated, preferably when the release line (50) is pulled, the connection between the at least one wing member (81, 82) and the support member (90) is released.

2. The auxiliary medical device (40) according to claim 1 further includes a narrowing mechanism (60), wherein the narrowing mechanism (60) is adapted to at least partially narrow the annular cross section.

3. The assistive medical device (40) according to any one of claims 1 or 2, wherein the narrowing mechanism (60) is configured as a gripping line (60), preferably wherein at least one wing member (81, 82) and the support member (90) are connected or can be connected together via the gripping line (60), particularly preferably, it is separate from the release mechanism (50).

4. The auxiliary medical device (40) according to claim 2, wherein, The grip lines (60) are arranged in a shoelace 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 narrowing mechanism (60) to form a shape that is at least partially tubular.

6. The auxiliary medical device (40) according to any one of the preceding claims, wherein, When the narrowing mechanism (60) is not narrowed, the diameter of the annular cross section is between 2 cm and 10 cm.

7. The assistive medical device (40) according to any one of the preceding claims further includes a retractable tail (70) that is connected to or can be connected to the at least one wing member (81, 82).

8. The assistive medical device (40) according to any one of the preceding claims, wherein the at least one wing-shaped member (81, 82) comprises or is composed of a polymer, preferably comprising or is composed of silicone.

9. The assistive medical device (40) according to any one of the preceding claims, wherein the at least one wing-shaped member (81, 82) is at least partially flexible.

10. The auxiliary medical device (40) according to any one of the preceding claims further comprises a second wing member (82, 81), the second wing member (82, 81) being connected to or connectable to the support member (90) via the narrowing 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-like pattern (51', 51'', 51''', 55).

12. The assistive medical device (40) according to any one of the preceding claims, wherein the release mechanism (50, 151, 152) of the preferred release line (50) is adapted in length to extend through the patient's esophagus and / or through the 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 gripping configuration by an assistive medical device (40) according to any of the preceding claims.

14. A method for reducing the size of an implant (I), preferably a duodenal anchor (20) and / or a gastric anchor (10) for implantation, comprising: An auxiliary medical device (40) is provided, preferably an auxiliary medical device (40) according to any one of claims 1 to 12, said auxiliary medical device (40) having a release mechanism (50, 151, 152) preferably a release line (50) and a narrowing mechanism (60). The implants (10, 20) are inserted into the assistive medical device (40), and The size of the implant is reduced by narrowing the narrowing mechanism (60) of the assistive medical device (40).

15. The method according to claim 14, wherein, The auxiliary medical device (40) is positioned on the delivery device (1) before the implant (I) is inserted into the auxiliary medical device (40) and / or before the narrowing mechanism (60) narrows it.

16. A method of implanting an implant (I) into a patient, comprising: The implant (I) is disposed in an assistive medical device (40), preferably an assistive medical device (40) according to any one of claims 1 to 12. To reduce the size of the implant (I), it is preferable to use the method according to any one of claims 14 or 15. The implant (I) is introduced into the patient's body using a delivery device (1), preferably through the mouth into the patient's gastrointestinal tract. The implant (I) is released from the assistive medical device (40) by activating the release mechanism (50, 151, 152), preferably by pulling the release line (50), and particularly preferably by pulling the free end (52) of the release line (50).

17. The method of claim 16, further comprising the step of removing the assistive medical device (40) from the patient by pulling the retraction tail (70).

18. An assistive medical device (40) for delivering an implant (I), preferably a duodenal anchor (20) and / or a gastric anchor (10) into a patient, preferably an assistive medical device (40) according to any one of claims 1 to 12, further comprising a connecting member (110) disposed at an end of the assistive medical device (40), said connecting member (110) being attached to or capable of being attached to one of a delivery device, an endoscope or a retraction line.

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

20. A method for manufacturing a medical device, preferably an auxiliary medical device according to any one of claims 1 to 11 or 18 to 19, the method comprising any one or more of the following steps, which may be performed in any order: - Injection mold a first generally flat component (81, 82), preferably the first component having a plurality of holes (84', 84'') in at least a first edge region; - Injection mold a second generally flat component (90), preferably wherein the second component has a plurality of holes (94', 94'') in at least one second edge region; - Extruding the tubing and cutting the tubing to form a sheath; - Punch out multiple holes (84', 84'', 94', 94'') in the first edge region and / or the second edge region; - The first edge region and the second edge region are connected by a release line (50) preferably in a chain stitch pattern (51', 51'', 51''', 55); - Injection molding of the connecting component (110), preferably integrally formed with the first component and / or the second component.

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