Device for delivering a medical implant, guide wire and catheter

Abstract

A device for delivering a medical implant into a hollow organ in the body, the device having a guidewire (10) and a compressible and expandable medical implant (11) configured as a tube, wherein the implant (11) in a compressed state is detachably connected to the guidewire (10) by at least one engaging element (12) for force transmission in the axial direction, wherein the engaging element (12) has at least one protrusion (13) extending radially outward and engaging in the implant (11), and wherein the implant (11) in a at least partially expanded state can be released by relative movement between the engaging element (12) and the implant (11) in a disengagement direction, characterized in that the engaging element (12) has at least one sliding surface (14) that is inclined and / or bent in the disengagement direction and works in conjunction with the protrusion (13) to release the implant (11).

Description

[0001] This invention relates to a device for delivering a medical implant into a hollow organ, the device having a guidewire and a compressible and expandable medical implant configured in a tubular shape. In a compressed state, the implant is detachably connected to the guidewire via at least one engaging element for force transmission in the axial direction, wherein the engaging element has at least one radially outwardly extending protrusion engaging into the implant. In a at least partially expanded state, the implant can be released by relative movement between the engaging element and the implant in a disengagement direction. The invention also relates to a guidewire and catheter for delivering a medical implant into a hollow organ.

[0002] The aforementioned device is known, for example, from the applicant's WO 2013 / 107783 A1. A guidewire having the features of the preamble of claim 14 is also known from this prior art.

[0003] This device or guidewire has proven highly effective in practice and enables the safe delivery of implants (e.g., stents or flow diverters) to the treatment site via catheter. Upon release from the catheter, the implant detaches from the guidewire and remains at the treatment site. The guidewire is then withdrawn through the catheter.

[0004] At the treatment site, the implant is released via axial relative movement between the catheter and the implant. The implant dislodged from the catheter unfolds or expands, with the expansion movement gradually advancing proximally as release increases. As the implant expands in the region of the interlocking element, it is released from the guidewire via radially outward movement, and the implant and interlocking element separate. The implant is fully released and expands at the desired location within the vessel to be treated.

[0005] If the radial outward movement of the implant is restricted in the treatment area, for example due to the patient’s specific vascular characteristics, resulting in a smaller radial distance between the implant and the engagement element, then releasing the implant may become more difficult.

[0006] Therefore, the object of the present invention is to improve known devices so that implants can be released as safely as possible, even under difficult conditions. Another object of the present invention is to provide corresponding guidewires and catheters.

[0007] According to the present invention, the objective regarding the device is solved by the subject matter of claim 1, the objective regarding the guidewire is solved by the subject matter of claim 14, and the objective regarding the catheter is solved by the subject matter of claim 15.

[0008] Specifically, this objective is achieved by a device for delivering a medical implant into a hollow organ within the body, the device having a guidewire and a compressible and expandable medical implant configured in a tubular shape. In a compressed state, the implant is detachably connected to the guidewire via at least one engaging element for force transmission in the axial direction. The engaging element has at least one radially outwardly extending protrusion that engages with the implant. In at least a partially expanded state, the implant can be released by relative movement between the engaging element and the implant in a disengagement direction. According to the invention, the engaging element has at least one sliding surface that is inclined and / or bent in the disengagement direction. The sliding surface works in conjunction with the protrusion to release the implant.

[0009] The advantage of this invention is that even when the distance between the engaging element and the implant is relatively small, the engaging element and the implant can be safely disengaged because the implant can slide on the sliding surface during release, thereby supporting the disengagement of the implant from the guidewire. Snagging between the implant and the engaging element is avoided, and the guidewire can be safely withdrawn back into the catheter. This is achieved through the inclined and / or curved sliding surface.

[0010] The sliding surface and the protrusion work together to release the implant. Therefore, the sliding surface is adapted or fitted to support the release of the implant. Advantageously, the sliding surface and the protrusion are constructed as a single piece or integrally formed. The sliding surface and the protrusion can also be constructed as two pieces. In this case, the sliding surface and the protrusion are two separate components, such as two sleeves arranged directly in sequence in the axial direction, but other embodiments are also possible.

[0011] The protrusion and the sliding surface work together in such a way that the sliding surface facilitates or at least helps to bring the implant to a desired height position beyond the protrusion. This height position may, but does not necessarily, be the radial outer surface of the protrusion. The sliding surface and the protrusion are arranged in the axial direction of the implant or guidewire so that the implant can achieve a movement transition, for example, when the sliding surface and the protrusion are connected or connectable, allowing the sliding surface to transition directly into the protrusion. Other embodiments are also possible.

[0012] Due to the inclination and / or curvature, the sliding surface extends away from the vertical side of the protrusion. Since the inclination or curvature direction extends in the disengagement direction, the disengagement process is supported by the sliding surface.

[0013] The disengagement direction is the direction in which the implant is released through relative movement between the engagement element or guidewire and the implant. For example, when the implant is fixed in place and the guidewire is withdrawn into the catheter in the proximal direction, the disengagement direction of the implant extends in the distal direction. The implant is located proximally to the catheter tip before release and distally to the catheter tip after release. The sliding surface is then also oriented distally so that the implant can slide on the sliding surface when the engagement element moves in the proximal direction.

[0014] The direction of detachment is not limited to the longitudinal direction of the implant.

[0015] More precisely, the disengagement direction generally refers to the relative movement between the engagement element and the implant, which is superimposed on the expansion movement of the implant, so as to disengage the implant and engagement element in the radial direction. The disengagement direction may extend in the longitudinal direction of the implant or in the circumferential direction of the implant. These two alternatives are the subject of preferred embodiments of the invention and will be described in more detail below.

[0016] The sliding surface even allows the implant itself to disengage from the guidewire in a partially dilated state, where the implant and the engagement element overlap, i.e., still in a partially engaged state. This is achieved by tilting and / or bending the sliding surface in the disengagement direction. As the guidewire is withdrawn into the catheter in the proximal direction, the implant slides on the sliding surface and is pushed radially outward. Thus, the implant is released from the guidewire.

[0017] The mechanism described above for the partially expanded state of partial engagement also applies to the following partially expanded state: in which the radial distance between the engagement element and the implant is small enough that engagement can occur upon release.

[0018] This invention relates to self-expanding medical implants. Therefore, the medical implant for this device can be self-expanding. Such implants are known and are typically made of shape memory materials.

[0019] The implant may preferably have a mesh structure, particularly a tubular wall composed of a mesh structure.

[0020] A mesh structure can be a woven fabric made of braided filaments or guide wires, or a woven fabric made of single braided filaments or single guide wires. The woven fabric forms a mesh. A mesh structure can also be a one-piece mesh structure composed of connecting ribs, such as a laser-cut mesh structure. A one-piece mesh structure forms a lattice.

[0021] This invention is not limited to a specific type of connection method. The guidewire can be connected to the implant in a variety of ways. For example, the connection element can be connected to a mesh structure. The connection element can also be detachably connected to the end loops, end meshes, or end diamond-shaped holes of the implant. The detachable connection between the implant and the connection element can also be provided by additional components, particularly radiopaque markers. For example, these additional components can be crimped marking sleeves.

[0022] The coupling element may have multiple protrusions. Each protrusion works in conjunction with a sliding surface to release the implant.

[0023] The device according to the invention, consisting of an implant and a guidewire, is considered a component independently of the catheter used for its delivery to the treatment site and is disclosed and claimed. Additionally, combinations consisting of a catheter and the device according to the invention are also disclosed and claimed. Within the scope of the invention, the guidewire itself for delivering medical implants, i.e., a guidewire without an implant and catheter, is also disclosed and claimed. This guidewire is adapted to achieve the aforementioned advantages related to implant delivery and for this purpose has the aforementioned improved engagement element according to the invention. Such a guidewire is also referred to as a delivery guidewire.

[0024] Preferred embodiments of the present invention are claimed or provided in the dependent claims.

[0025] Therefore, the sliding surface can be tilted and / or bent in the longitudinal direction of the implant, particularly in the distal longitudinal direction. This implementation has the advantage that the disengagement direction extends parallel to the guidewire. Thus, during the relative movement between the axially moving guidewire and the positioned implant, the guidewire can be withdrawn back into the catheter. This corresponds to the typical disengagement process, where the implant is anchored in position at the treatment site and the guidewire is withdrawn in the proximal direction. The tilting of the sliding surface in the distal longitudinal direction means that a spatial component of the sliding surface extends in the distal direction. This is not the case for a surface orthogonal to the longitudinal axis of the guidewire. When the guidewire with the engagement element is pulled in the proximal direction, the sliding surface moves relative to the implant, causing relative movement between the engagement element and the implant, thereby disengaging the engagement element and the implant from each other, or preventing accidental re-engagement.

[0026] Preferably, the inclined sliding surface includes a chamfer, which is formed at least in the region of the outer edge of the protrusion. Since only the outer edge of the protrusion needs to be machined, the chamfer can be simply manufactured. It is not necessary to process the entire side of the protrusion. The chamfer only needs to be provided or chamfered on a portion of the protrusion, i.e., in the region of the outer edge of the protrusion, which is where the distance between the engaging element and the implant is insufficient, and where snagging with the implant may occur.

[0027] In another embodiment, the chamfer may begin at the base of the protrusion. Therefore, the chamfer extends along the entire side of the protrusion. The advantage of this is that it creates a sliding surface of maximum length, improving anti-snagging safety.

[0028] The engaging element may have a tapered profile at at least one axial end, the tapered profile having a correspondingly inclined protrusion that forms an inclined sliding surface. An advantage of this embodiment is that the engaging element, along with the protrusion, is inclined, so that no edge that could potentially hinder disengagement is formed in the disengagement direction. This minimizes the risk of snagging. The protrusion, and therefore the sliding surface, is part of the tapered circumferential surface of the engaging element and is thus inclined according to the taper of the axial end of the engaging element.

[0029] In another preferred embodiment, the engaging element is curved in the axial direction of the implant, particularly in the distal direction of the implant, wherein the protrusion is constructed with a corresponding curvature on the outer curved portion of the engaging element and forms a curved sliding surface. This means that the entire engaging element, together with the protrusion, is curved, and therefore also lacks edges that could potentially hinder the disengagement process. This minimizes the risk of snagging. The protrusion is part of the curved engaging element and is therefore also correspondingly curved. The engaging element can be, for example, cut from tubing and shaped accordingly.

[0030] In another particularly preferred embodiment, the inclined and / or curved sliding surface comprises a tube covering the coupling element. This embodiment has the advantage of being particularly simple and flexible in production. No machining of the coupling element is required. The tube can be, for example, a flexible tube or a heat-shrink tubing.

[0031] Therefore, the sliding surface is formed by an additional element (i.e., a tube) arranged on and covering the engagement profile core. The tube, together with the engagement profile core, forms the engagement element, specifically forming one or more protrusions with sliding surfaces. The covering engagement profile core is the core of the tube and stabilizes it. The outer contour of the engagement element is determined by the shape of the tube.

[0032] For the core of the joint profile, known joint elements can be used, which are modified by combining with the tube to create one or more protrusions (depending on the core of the joint profile) that have inclined and / or curved sliding surfaces through the tube. Therefore, production is simple and can be carried out flexibly using known joint elements.

[0033] The tube covers the mating element in a geometrically undefined manner. The tube essentially conforms to the contour of the mating element; that is, the tube does not directly follow the contour and does not fit tightly against the mating element. The outer edge of the mating element is covered by the tube, where the tube forms a rounded sliding surface or rounded sliding surface segment. In the radially outer region of the mating element, the tube fits the contour more closely than in the radially inner region. Therefore, the tube forms a coarse contour of the mating element. The sliding surface forms a smooth or continuous transition from the radially inner to the radially outer region.

[0034] When multiple engagement elements are arranged circumferentially on the guidewire, the tube conforms to the height profile thus formed in the circumferential direction, allowing the engagement elements to engage in an inverted implant, such as a mesh structure.

[0035] The tube forms an inclined and / or curved sliding surface in such a way that it extends substantially obliquely relative to the tubular shape of the implant, deviating from the vertical direction, or from the vertical sidewall or side of the engagement contour core. The tube may be partially oblique and curved to varying degrees. Throughout its extension in the disengagement direction, the tube forms an oblique, free-form surface for releasing the implant. The free-form surface acts as the sliding surface.

[0036] In contrast, chamfers create geometrically defined, particularly straight, inclined sliding surfaces. The basic concept is the same as that of chamfers or the curved shape of connecting elements: by deorbiting the orientation of the sliding surface from the vertical, it supports the disengagement process between the implant and the guidewire.

[0037] The tube can be flexible or pliable, such as a polymer tube. Through flexibility, the tube is tensioned onto the core of the joining profile. Thus, the flexible tube adapts to the coarse profile of the core of the joining profile. Alternatively, the tube can be a heat-shrink tube, which is tensioned onto the core of the joining profile by heat treatment or other means, and thus adapts to the coarse profile of the core of the joining profile.

[0038] Heat shrink tubing, particularly through heat treatment, can transition from an initial state to a compressed state. The ratio of the outer diameter of the tubing in the initial state to that in the compressed state is preferably between 2:1 and 6:1, particularly between 3:1 and 6:1, particularly between 4:1 and 6:1, and particularly between 5:1 and 6:1. Preferably, the outer diameter of the tubing in the initial state is at least two times, particularly at least three times, and particularly at least four times, the outer diameter of the tubing in the compressed state.

[0039] The tubing, particularly heat shrink tubing, is preferably made of plastic, such as PTFE, PE, PVC, and / or FEP. Other materials are also acceptable. In particular, the tubing is made of a material that allows a ratio of the outer diameter of the tubing in its initial state to the outer diameter of the tubing in its compressed state of 2:1 to 6:1.

[0040] The thickness of the tube, especially the thickness of the heat shrink tubing, or the wall thickness of the tube in the radial direction, is preferably between 20µm and 200µm, especially at least 50µm, especially at least 100µm, especially at least 150µm. Tubes of different thicknesses are also acceptable.

[0041] Alternatively or additionally, the length of the protrusion in the radial direction of the joining element may be the thickness of the tube, particularly the thickness of the heat shrink tubing, or at least 1.5 times, particularly at least 2 times, particularly at least 2.5 times, the wall thickness of the tube in the radial direction.

[0042] Multiple coupling elements may be arranged spaced apart from each other on the transmission guide wire. The coupling elements may have different outer diameters and / or be spaced apart from each other by intermediate elements having different outer diameters from the coupling elements. The inner diameter of the heat shrink tubing is preferably configured such that it can be adapted to the outer diameter of all the coupling elements and / or intermediate elements arranged on the transmission guide wire, or to the transmission guide wire itself, even if the coupling elements, intermediate elements, and transmission guide wire have different outer diameters.

[0043] Multiple tubes, particularly multiple heat shrink tubes, can be arranged on the transfer guide wire. The number of coupling elements and the number of heat shrink tubes can be the same or different. For example, tubes can extend on all coupling elements. Alternatively, one tube can be provided for each coupling element.

[0044] Heat shrink tubing can advantageously conform to the contours of the bonding elements, such that the tubing does not directly follow the contours and does not adhere tightly to the bonding elements. This should preferably be understood as the existence of gaps between the bonding elements and the heat shrink tubing. These gaps can be filled with UV-cured and / or heat-cured adhesives.

[0045] In another embodiment of the invention, the sliding surface is inclined and / or bent in the circumferential direction of the implant. This allows the disengagement process to be actively supported by rotating the guidewire. By rotating the guidewire, a relative movement in the circumferential direction is generated between the implant and the engagement element. Here, the implant slides on the sliding surface in the circumferential direction and is radially pushed outward due to the inclination or bending of the sliding surface. If the distance between the implant and the engagement element is too small and overlaps due to insufficient expansion movement, the physician can force disengagement by rotating the guidewire. When the implant and guidewire are disengaged by rotation, the guidewire can be withdrawn back into the catheter in the proximal direction as usual.

[0046] Implementations that combine sliding surfaces that are inclined and / or bent in the circumferential and longitudinal directions of the implant can be combined. For example, the sliding surfaces can be arranged in a spiral shape with a gradually increasing diameter. This creates a helical action in which the engaging element rotates and simultaneously performs a pushing motion relative to the implant. The height position of the implant and the relative position of the guidewire and the implant in the axial direction change simultaneously.

[0047] In another embodiment, multiple coupling elements, particularly two coupling elements, may be arranged axially spaced apart from each other in the longitudinal direction of the guidewire. Each coupling element has at least one sliding surface, wherein the sliding surfaces of the coupling elements are oriented in the same direction. This multiple connection improves the safety of the implant-guidewire connection. Here, disengagement is maintained. To this end, the sliding surfaces are disposed on the two coupling elements and oriented in the same direction, such that the sliding surfaces support the disengagement process in the same direction during relative movement between the guidewire and the implant.

[0048] The engagement element may be provided with a proximal stop (also called a push sleeve) that is axially spaced from the engagement element in the longitudinal direction of the guidewire, forming a gap. This basic structure of the device is designed to accommodate additional components, such as radiopaque markers, and is described in the aforementioned prior art document; however, the engagement element of this application is modified for easier disengagement. This embodiment can be combined with all other embodiments or examples of this application, and such combinations are also disclosed and claimed.

[0049] Preferably, the connecting element has a plurality of protrusions distributed circumferentially on the connecting element, each protrusion having at least one sliding surface and forming a connecting segment. This improves connection security and achieves uniform force transmission from the guidewire to the implant circumferentially on the connecting element. The sliding surfaces of the protrusions are oriented in the same direction. This does not preclude the provision of additional sliding surfaces oriented in other directions.

[0050] The coupling element can have multiple coupling sections in the longitudinal direction of the guidewire, wherein the protrusions of each coupling section are staggered in the circumferential direction. This increases the connection security due to the increased number of protrusions, and improves uniform force transmission due to the staggered arrangement of the protrusions in the circumferential direction.

[0051] The protrusion of the first engagement segment may have a sliding surface at least in the proximal direction, and the protrusion of the second engagement segment may have a sliding surface at least in the distal direction. Therefore, the engagement element can achieve disengagement in both axial directions. This may be advantageous if the disengagement of the implant particularly requires strong support from the axial movement of the guidewire and therefore the axial movement of the engagement element.

[0052] Overall, each protrusion is joined to an individual mesh or pore in the grid structure.

[0053] The present invention will now be described in more detail based on embodiments and with reference to the accompanying drawings. In these drawings: Figure 1 A perspective view (without implants) of a device having two engaging elements according to an embodiment of the present invention is shown. Figure 2 It shows the method for using according to Figure 3 A perspective view of the connecting elements of the device; Figure 3 A view of a device (without implant) having a coupling element and a stop element according to another embodiment of the present invention is shown. Figure 4 It shows that according to Figure 3 Side view of the joining element; Figure 5 A perspective view of the joining element of a device having multiple joining sections according to another embodiment of the present invention is shown; Figure 6 A perspective view of the joining element of a device having two joining sections according to another embodiment of the present invention is shown; Figure 7 A perspective view of the engaging element of a device having a rounded sliding surface according to another embodiment of the present invention is shown; Figure 8 A perspective view (without implant) of a device with heat shrink tubing according to another embodiment of the present invention is shown. Figure 9 A side view (without implant) of a device having a coupling element according to claim 8 is shown. Figure 10 A front view of a device according to another embodiment of the invention is shown, wherein the disengagement direction extends in the circumferential direction of the implant; Figure 11 It shows that according to Figure 10 The state of the device when the implant is released; Figure 12 It shows the method for using according to Figure 1 A perspective view of the connecting elements of the device; and Figure 13 It shows the method for using according to Figure 3 A perspective view of the coupling element of the device, the coupling element having a larger than Figure 2 Greater curvature.

[0054] Figure 1An embodiment of a device according to the invention for delivering a medical implant 11 into a hollow organ in the body is shown, which is particularly, but not exclusively, suitable for treating neurovascular diseases, such as stroke treatment.

[0055] The device includes a guidewire 10 and an implant 11, the guidewire 10 also referred to as a delivery guidewire or a retention guidewire. The device, consisting of the guidewire 10 and the implant 11, forms an assembly pre-installed in a catheter (not shown). Within the scope of this application, this assembly and the guidewire 10 without the implant 11 are disclosed and claimed. Additionally, combinations of catheters and devices or assemblies are disclosed and claimed, which typically form commercial units placed on the market.

[0056] The implant 11 is tubular and can be compressed and expanded in a manner known per se for delivery via a catheter to the lesion site to be treated. The implant 11 is preferably self-expanding. This is typically achieved by the implant 11 being made of a shape memory material (e.g., nitinol). The invention is not limited to specific implant materials. Other implant materials are also feasible.

[0057] The tubular implant 11, specifically its wall, is formed of a mesh structure. The mesh structure can be constructed as a braid or a monolithic mesh structure. For details, please refer to the description in the introduction of this application. Examples of such implants are stents or flow diverters. Other implants 11 that can be detachably connected to the guidewire 10 are also feasible.

[0058] The guide wire 10 is constructed in a manner known per se and has, for example, arranged in the core wire (see...). Figure 3 The coil on the guide wire 10. Other embodiments of the guide wire 10 are also feasible.

[0059] In its pre-loaded state, i.e., within the catheter, the implant 11 is compressed and detachably connected to the guidewire 10. Therefore, according to... Figure 1 The device includes multiple, specifically two, engagement elements 12 that engage with the mesh structure of the implant 11 to enable force transmission from the guidewire 10 to the implant 11 in the axial direction. The connection between the guidewire 10 and the implant 11 is detachable so that the implant 11 disengages from the guidewire 10 when it is released from the catheter at the treatment site. The implant 11, in at least a partially dilated state, can be released by relative movement between the engagement elements 12 and the implant 11 in the disengagement direction.

[0060] The relative movement between the connecting element 12 and the implant 11 differs from the radial expansion of the implant 11, in which the implant 11 moves radially outward. The implant 11 first disengages from the guidewire 10 and its connecting element 12 via radial expansion, and then finally disengages again via further movement of the guidewire 10 relative to the implant 11. Therefore, relative movement occurs when the guidewire 10 moves relative to the implant. This relative movement occurs in the longitudinal direction of the implant and / or the circumferential direction of the implant 11. According to... Figures 1 to 9 In the example, relative motion occurs in the longitudinal direction of implant 11. According to... Figure 10 , Figure 11 In the example, the relative motion occurs at least initially in the circumferential direction of implant 11. Combinations are feasible. This will be explained in more detail below.

[0061] The following is based on 1. Figure 12 A more detailed description is provided of one or two engagement elements 12, which are modified to achieve secure separation from the implant 11.

[0062] exist Figure 1 In this configuration, the two bonding elements 12 are substantially identical in structure. Deviations are due to manufacturing techniques. Other combinations are feasible. The following description applies to both bonding elements 12.

[0063] The coupling element 12 is configured as a sleeve. This also applies to... Figures 3 to 11 An embodiment. The coupling element 12 has a central opening through which the guide wire 10, specifically the core wire of the guide wire 10, extends in the installed state. This allows for... Figure 1 , Figure 3 As can be clearly seen, the coupling element 12 can be rotatably or anti-rotationally connected to the guide wire 10.

[0064] The engaging element 12 has multiple, specifically three, radially outwardly extending protrusions 13. The function of these protrusions 13 is that, when the implant 11 is arranged in a compressed state on the guidewire 10, the protrusions engage with the implant 11, specifically the mesh structure of the implant 11. The protrusions 13 may also be referred to as crowns, nasal protrusions, wing-like structures, or teeth. Different numbers of protrusions 13, particularly more than three, are feasible.

[0065] Each protrusion 13 has a sliding surface 14 in the form of a chamfer 15, which is inclined in the disengagement direction. According to... Figure 1 In the example, the sliding surfaces 14 of the two connecting elements 12 are inclined in the same direction.

[0066] The disengagement direction is determined by the relative motion between the engagement element 12 or guide wire 10 and the implant 11 during implant release. For details on the disengagement direction, please refer to the description and definitions in the introduction section of the instruction manual.

[0067] According to Figure 1 In the example, chamfer 15 is in the distal direction ( Figure 1 (From right to left) Inclined. In other words, the distance between the sliding surface 14 and the guidewire 10 increases in the distal direction. The chamfer 15, or the sliding surface 14, forms a substantially flat surface and serves as an infeed ramp on which the implant 11, specifically its mesh structure, can slide when it overlaps with the engagement element 12 during release. Thus, the guidewire 10 can continue to be pulled in the proximal direction without the implant obstructing this movement. More precisely, the implant 10 is radially pushed outward by the inclined sliding surface 14, thereby disengaging from the engagement element 12.

[0068] As in Figure 12 As can be seen, the entire proximal end face of the engagement element 12, i.e., the inner ring 20 on which the protrusion 13 is arranged, is also inclined. Therefore, the engagement element 12 has a tapered profile at its proximal axial end, with a correspondingly inclined protrusion 13. This profile can also be referred to as a truncated cone. Here, the sliding surface 14 begins at the height of the guide wire 10 and extends to the outer edge of the corresponding protrusion 13, which is formed on the outer diameter of the tapered profile. After the tapered profile, the engagement element 12 continues to extend with a cylindrical body (inner ring 20) and a toothed outer profile, as... Figure 1 and Figure 12 As shown.

[0069] The sliding surface 14 has at least two sections: a first common sliding surface section 14a in the end face region of the inner ring 20 and a second sliding surface section 14b forming a transition from the inner ring 20 to the protrusion 13. The two sections 14a and 14b transition smoothly to each other.

[0070] like Figure 1 , Figure 12 As shown, the protrusion 13 and the sliding surface 14 can be constructed as a single piece. Alternatively, the engaging element 12 can be constructed as a two-piece piece. The first common sliding surface section 14a can be constructed as a separate sleeve that abuts against the end face of the inner ring 20. The transition between the two sections 14a and 14b corresponds to... Figure 12 .

[0071] Alternatively, the proximal end face of the protrusion 13 may be configured as the sliding surface 14. The sliding surface 14 begins at the root of the protrusion 13, i.e., at the outer diameter of the inner ring 20. The end face of the inner ring 20 is vertical.

[0072] The sliding surface 14 may also terminate below the upper edge or radial outer edge of the protrusion 13.

[0073] according to Figure 2 , Figure 3 and Figure 4 Implementation examples and according to Figure 1 and Figure 2 The structures of the embodiments are similar. The main difference is that, according to Figure 2 , Figure 3 and Figure 4 In the embodiment, the sliding surface 14 is curved. Figure 13 The middle has a different curvature. Regarding the connecting element 12, according to Figure 1 and Figure 2 Other features of the above embodiments can be reused.

[0074] Specifically, the entire engagement element 12 is curved in the axial direction of the implant 11. The proximal anterior side of the engagement element 12 is convexly curved.

[0075] During the manufacturing process, the joining elements are cut from the side of the fitting or hollow cylinder, particularly by laser cutting. The convex bends are created from the outer diameter of the fitting. The concave bends of the joining elements, arranged opposite each other on their distal sides, are created from the inner diameter of the fitting. The joining mechanism or protrusion is also cut from the side of the fitting or hollow cylinder.

[0076] exist Figure 13 The convex bend can be clearly seen in the middle.

[0077] By producing and orienting the protrusion 13 or the wing, curved sections of different sizes are created.

[0078] Figure 13 The upper protrusion 13 has the greatest curvature. This protrusion has a sharp edge on its distal side, which is cut away to form a mating chamfer 21. The other two protrusions 13, which have less curvature, do not require a mating chamfer.

[0079] Alternatively, the engaging element 12 can be formed as a cam or a hollow spherical segment, which is uniformly curved around a center with a radius r. This results in a uniformly curved outer portion of the engaging element 12, forming a curved sliding surface 14. As in the previous embodiment, a protrusion 13 is provided on the outer diameter of the engaging element 12 and forms the engagement mechanism required for anchoring the implant 11. The outer curved portion of the engaging element 12 extends uniformly in the region of the protrusion 13, such that the desired curved sliding surface 14 is also formed there.

[0080] according to Figure 3 The embodiments illustrate how the coupling element 12 can be used for different connection types. According to... Figure 3In the example, the engaging element 12 is combined with a stop 17 disposed proximally to the engaging element 12 and used to push the implant 11 distally within the catheter when the catheter is withdrawn, or to hold the implant 11 in place. A gap 18 is formed between the engaging element 12 and the stop 17, in which radiopaque markers, for example, are disposed proximally to the implant 11 and serve as a locking mechanism in addition to positioning the implant.

[0081] Other connection types are also possible. For example, according to Figure 2 , Figure 3 , Figure 4 and Figure 13 The bent joint element 12 can be as follows: Figure 1 The example uses it as a double connector, either as a woven material or, typically, as a mesh structure of implant 11.

[0082] Figure 5 , Figure 6 and Figure 7 Different embodiments of the engaging element 12 are shown, particularly a sleeve-shaped engaging element 12 having a plurality of protrusions 13 forming engaging sections 19, 19a, 19b, and 19c, respectively. The engaging sections 19, 19a, 19b, and 19c form a continuous ring, which are arranged sequentially in the axial direction along the longitudinal axis of the engaging element 12.

[0083] The protrusions 13 of the corresponding engagement sections 19, 19a, 19b, and 19c are staggered in the circumferential direction. This achieves particularly reliable locking and uniform force transmission of the implant 11.

[0084] According to Figure 5 In the example, three junction segments 19a, 19b, and 19c are provided, which are arranged sequentially in the longitudinal direction of the implant 11. The protrusion 13 of each junction segment 19a, 19b, and 19c is staggered in the circumferential direction of the junction element 12 relative to the protrusions 13 of the other two junction segments 19a, 19b, and 19c.

[0085] according to Figure 5 , Figure 6 and Figure 7 The common feature of the embodiments is that the protrusion 13 of the first engagement section 19a has a sliding surface 14 in the proximal direction, while the protrusion 13 of the second engagement section 19b has a sliding surface 14 in the distal direction. The first engagement section 19a and the second engagement section 19b are arranged at the proximal or distal end of the engagement element 12.

[0086] Therefore, the corresponding sliding surfaces 14 at the protrusions 13 of the first and second engagement sections 19a and 19b form axially outer contact surfaces that contact the implant, specifically the implant's mesh structure. This allows the implant to move in two axial directions, namely, proximal and distal, on the sliding surfaces 14. In other words, the guidewire 10 and the accompanying engagement element 12 can move in both proximal and distal directions to radially push the implant outward on the sliding surfaces 14.

[0087] According to Figure 5 In the example, the inner-facing end face of the protrusion 13 opposite the sliding surface 14 is arranged perpendicular to the guide wire 10. This is not a problem because the opposing sliding surfaces 14 are inclined, thus allowing the implant to be lifted away from the engagement element 12.

[0088] According to Figure 5 In the example, a third engagement segment 19c is provided, which is arranged between the first engagement segment 19a and the second engagement segment 19b. The protrusion 13 of the third engagement segment 19c has a vertical end face, i.e., no sliding surface 14. In addition, the protrusion 13 of the third engagement segment 19c is shorter in the axial direction than the protrusions 13 of the first engagement segment 19a and the second engagement segment 19b, specifically, approximately shorter by the longitudinal component of the sliding surface 14. Thus, as explained above with respect to the inner end face, a disengagement function is provided (when the mesh structure of the implant 11 is approximately constant).

[0089] According to Figure 5 In the example, the sliding surface 14 is designed with a flat chamfer 15.

[0090] Figure 7 A similar embodiment is shown. Three engagement sections 19a, 19b, and 19c are also provided there, with the protrusions 13 staggered from each other. However, only the protrusion of the middle third engagement section 19c is staggered relative to the other two engagement sections 19a and 19b, while the other two engagement sections are aligned with each other. Another difference is that the sliding surface 14 is a combination of a flat chamfer 15 and a curved section. The protrusions 13 are configured as mounds with flat tops.

[0091] according to Figure 6 The embodiment has two joining sections 19a, 19b, that is, exactly two joining sections 19a, 19b. (Compared to...) Figure 5 Unlike other examples, each protrusion 13 has a sliding surface 14 on both end faces (i.e., proximal and distal). The sliding surface 14 is designed in the form of a chamfer 15. Again, the advantage here is that the engaging element 12 can move in both axial directions to release the implant.

[0092] Figure 5 , Figure 6 and Figure 7 The bonding element 12 can be manufactured, for example, by machining (such as milling, laser material processing) or by additive manufacturing processes (such as 3D printing).

[0093] Figure 8 and Figure 9 Another embodiment is shown, which can be manufactured with particular flexibility.

[0094] In this embodiment, the sliding surface 14 is formed of a heat-shrink tubing 16 that covers the engaging element 12 in both the circumferential and axial directions. The engaging element 12 may have a ring, which is known per se, or a sleeve with an engaging mechanism, which itself has a vertical end face. The engaging mechanism may be constructed as in the prior art. The engaging mechanism serves as the core of the heat-shrink tubing 16 and forms the protrusion 13 together with the core. The engaging mechanism may also be referred to as the engaging profile core.

[0095] Here, the outer contour of the joining element 12 required to achieve the desired effect is determined by the shape of the heat shrink tubing 16. The joining mechanism or joining contour beneath the heat shrink tubing 16 stabilizes the heat shrink tubing and determines the coarse contour of the joining element 12. The shape of the outer contour of the implant 11 in the axial direction can be adjusted by pre-forming the heat shrink tubing 16 and heat treatment, so that the sliding surface 14 has the desired inclination or curvature. This is in Figure 8 and Figure 9 As shown in the image.

[0096] Understandably, the sliding surface 14 on the heat shrink tubing 16 is geometrically less than, for example, according to Figure 1 The chamfer is precisely defined as shown. However, unlike the vertical end face, a smooth transition is formed between the guide wire 10 and the top side of the protrusion 13 via the heat shrink tubing 16, which serves as the sliding surface 14. The sliding surface 14 of the heat shrink tubing 16 can also be considered as inclined and / or curved, meaning that a geometrically precise inclination or curvature is not required, but rather a free-form surface deviating from the vertical end face of the protrusion, which functionally serves as an inlet ramp for the mesh structure of the implant 11.

[0097] Preferably, the heat shrink tubing 16 is adapted to the lateral profile of the joining mechanism or core, i.e., the heat shrink tubing fits more tightly there than at the end face forming the sliding surface 14.

[0098] like Figure 9 As shown, the heat shrink tubing 16 can cover multiple coupling elements 12 or one coupling element 12 and one stop 17. Figure 3 In the latter example, gap 18 is set to accommodate the developing marker. Other connection types are also possible here.

[0099] Flexible tubing, such as polymer tubing, can be used instead of heat shrink tubing.

[0100] The above is based on Figures 1 to 9 The common feature of these embodiments is that the detachment direction extends along the longitudinal direction of the implant 11. In contrast, according to Figure 10 and Figure 11 The example illustrates another embodiment of the invention, wherein the disengagement direction is in the circumferential direction of the implant 11, at least the initial disengagement direction. According to... Figure 10 and Figure 11 The example shows a cross-section of implant 11 (highly schematic).

[0101] The sliding surface 14 is inclined and / or curved in the circumferential direction of the implant 11. If multiple protrusions are present, such as... Figure 10 As shown, the sliding surface 14 of the corresponding protrusion 13 is inclined and / or bent in the circumferential direction of the implant 11. The corresponding sliding surface 14 is oriented in the same circumferential direction, i.e., clockwise or counterclockwise. According to... Figure 10 and Figure 11 In the example, sliding surface 14 is oriented in the counterclockwise direction.

[0102] The sliding surface 14 is configured with a chamfer 15. Other shapes of the sliding surface 14, such as a curved sliding surface 14 or a spiral sliding surface 14, are also possible.

[0103] The engagement element 12 is anti-rotationally connected to the guide wire 10. To operate the engagement element 12, torque is transmitted to it via the guide wire 10, and the engagement element 12 rotates together with the guide wire 10, as... Figure 11 As shown. By rotating the engaging element 12, the sliding surface 14 moves relative to the implant 11, specifically relative to the mesh structure. The implant 11 is thus pushed radially outward and lifted, wherein the mesh structure causes the implant to be lifted as a whole.

[0104] Once the implant 11 is fully lifted, the guide wire 10 is withdrawn from the implant 11 in the proximal direction together with the engagement element 12.

[0105] The device and catheter used in the above example are as follows.

[0106] The implant 11 is released by axial relative movement between the catheter and the implant. Several possibilities exist for this. For example, the catheter can be withdrawn proximally at the treatment site until the implant 11 dislodges from the catheter. The guidewire 10 holds the implant 11 in place at the desired location. Alternatively, the catheter can be fixed in position, while the implant is gently pushed out distally from the catheter using the guidewire.

[0107] Here, as release proceeds gradually, the implant 11 unfolds or expands proximally. When the implant 11 expands in the region of the engagement element 12, it is released from the guidewire 12 and separates from the engagement element 12 via radial expansion. If separation is incomplete and the implant 11 and engagement element 12 overlap, then according to... Figures 1 to 9 In the example, by moving the guidewire 10 in the proximal direction, the implant 11 is radially pushed outward through the sliding surface 14. The guidewire 10 is then safely released. According to... Figure 10 and Figure 11 In the example, guidewire 10 and coupling element 12 are rotated, causing the implant to be pushed outward by sliding surface 14. Then, guidewire 10 can also be withdrawn here.

[0108] The implant is fully released and positioned at the desired location within the blood vessel to be treated.

[0109] Reference tag list 10. Guide wire (transfer guide wire) 11 Implants 12. Connecting elements (sleeves) 13. Protrusion 14 Sliding Surface 14a First sliding surface section 14b Second sliding surface section 15 Chamfer 16 Heat shrink tubing 17 Stop components 18 gaps 19. Joint Section 19a First Joint Section 19b Second Joint Section 19c Third Joint Section 20 Inner Ring 21. Paired chamfer.

Claims

1. A device for delivering a medical implant into a hollow organ within the body, the device comprising a guidewire (10) and a compressible and expandable medical implant (11) configured in a tubular shape, wherein In a compressed state, the implant (11) is detachably connected to the guidewire (10) via at least one engaging element (12) for force transmission in the axial direction, wherein the engaging element (12) has at least one protrusion (13) that extends radially outward and engages with the implant (11), and In at least a partially expanded state, the implant (11) can be released by relative movement between the engaging element (12) and the implant (11) in the disengagement direction. Its features are, The engagement element (12) has at least one sliding surface (14) that is inclined and / or bent in the disengagement direction and works in conjunction with the protrusion (13) to release the implant (11).

2. The apparatus of claim 1, wherein, The sliding surface (14) is inclined and / or bent in the longitudinal direction of the implant (11), particularly in the distal longitudinal direction.

3. The apparatus according to claim 1 or 2, characterized in that, The inclined sliding surface (14) includes a chamfer (15) which is formed at least in the region of the outer edge () of the protrusion (13).

4. The apparatus according to claim 3, characterized in that, The chamfer (15) begins at the root of the protrusion (13).

5. The apparatus according to any one of the preceding claims, characterized in that, The engaging element (12) has a tapered profile at at least one axial end, the tapered profile having a correspondingly inclined protrusion (13) that forms the inclined sliding surface (14).

6. The apparatus according to claim 1 or 2, characterized in that, The connecting element (12) is bent in the axial direction of the implant (11), wherein the protrusion (13) is constructed with a corresponding curvature on the outer curved portion of the connecting element (12) and forms the curved sliding surface (14).

7. The apparatus according to claim 1 or 2, characterized in that, The inclined and / or bent sliding surface (14) includes a tube, particularly a heat shrink tube (16), which covers the coupling element.

8. The apparatus according to any one of the preceding claims, characterized in that, The sliding surface (14) is inclined and / or bent in the circumferential direction of the implant (11).

9. The apparatus according to any one of the preceding claims, characterized in that, Multiple coupling elements (12), particularly two coupling elements (12), are arranged axially spaced apart from each other in the longitudinal direction of the guide wire (10), each coupling element having at least one sliding surface (14), wherein the sliding surfaces (14) are oriented in the same direction.

10. The apparatus according to any one of claims 1 to 9, characterized in that, The coupling element (12) is provided with a proximal stop (17), which is axially spaced from the coupling element (12) in the longitudinal direction of the guide wire (10) to form a gap (18).

11. The apparatus according to any one of the preceding claims, characterized in that, The engaging element (12) has a plurality of protrusions (13) arranged in a distributed manner in the circumferential direction of the engaging element (12), each of the plurality of protrusions having at least one sliding surface (14) and forming an engaging section (19).

12. The apparatus according to claim 11, characterized in that, The coupling element (12) has multiple coupling sections (19a, 19b, 19c) in the longitudinal direction of the guide wire (10), wherein the protrusions (13) of each coupling section (19a, 19b, 19c) are staggered in the circumferential direction.

13. The apparatus according to claim 11 or 12, characterized in that, The protrusion (13) of the first engagement section (19a) has a sliding surface (14) at least in the proximal direction, and the protrusion (13) of the second engagement section (19b) has a sliding surface (14) at least in the distal direction.

14. A guidewire for delivering a tubular medical implant (11) into a hollow organ within the body, having at least one engaging element (12), wherein, The implant (11) is compressible and expandable. In a compressed state, the implant (11) can be connected to the guidewire (10) via the engaging element (12) for force transmission in the axial direction. The engaging element (12) has at least one protrusion (13) that extends radially outward and engages with the implant (11) in use. In at least a partially expanded state, the implant (11) can be released by relative movement between the engaging element (12) and the implant (11) in the disengagement direction. Its features are, The protrusion (13) has at least one sliding surface (14) for releasing the implant (11), the sliding surface being inclined and / or bent in the disengagement direction.

15. A catheter having the device according to claim 1.

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