Arrangement for delivering a medical implant, wire, catheter, and arrangement

Abstract

The invention relates to a first arrangement for delivering a medical implant into a hollow organ in the body, the first arrangement comprising a wire (10) and a compressible and expandable medical implant (11) which is tubular, wherein the implant (11), in its compressed state, is detachably connected to the wire (10) by means of at least one engagement element (12), wherein the engagement element (12), in an engaged state (I), has at least one projection (13) which extends radially outward and engages in the implant (11), characterised in that the engagement element (12) is designed to cause at least one relative movement between the projection (13) and the implant (11) in a radial direction away from one another in order to assume a release state (II) for releasing the implant (11). The invention also relates to a wire for delivering a medical implant into a hollow organ in the body, to a catheter, and to a second arrangement.

Description

[0001] Arrangement for delivering a medical implant, wire, catheter and arrangement

[0002] Description

[0003] The invention relates to a first arrangement for delivering a medical implant into a hollow body organ, comprising a wire and a compressible and expandable medical implant that is tubular in shape. In the compressed state, the implant is releasably connected to the wire by at least one engagement element, wherein the engagement element, in an engaged state, has at least one projection that extends radially outward and engages the implant. The invention further relates to a wire for delivering a medical implant into a hollow body organ, a catheter, and a second arrangement.

[0004] The arrangements mentioned above are known, for example, from WO 2013 / 107783 A1, which originates from the applicant. A wire having the features of the preamble of claim 14 is also known from this prior art.

[0005] Such an arrangement or wire has proven extremely effective in practice and enables the safe delivery of an implant, such as a stent or flow diverter. The implant is first transported to the treatment site via a catheter and then released at the treatment site. Upon release from the catheter, the implant is detached from the wire and remains at the treatment site. The wire is then retracted through the catheter.

[0006] The implant is deployed by a relative movement between the catheter and the implant in the axial direction at the treatment site. The implant emerging from the catheter unfolds or expands, with the expansion movement gradually progressing in the proximal direction of the implant as the release progresses. As the implant expands in the area of ​​the engagement element, the radial outward movement releases the implant from the wire, and the implant and engagement element are separated. The implant is fully deployed and expanded at the desired location in the vessel to be treated.

[0007] If the radial outward movement of the implant is restricted, for example, by patient-specific vascular properties in the area of ​​the treatment site, so that the radial distance between the implant and the interventional element is small, the release of the implant can be made more difficult.

[0008] The invention is therefore based on the object of improving the known arrangement so that the implant can be released as safely as possible, even under difficult conditions. The invention is further based on the object of providing a corresponding wire and catheter.

[0009] According to the invention, the object is achieved with regard to the first arrangement by the subject matter of claim 1, with regard to the wire by the subject matter of claim 14, with regard to the catheter by the subject matter of claim

[0010] 15 and with regard to the second arrangement by the subject matter of the claim

[0011] 16 solved.

[0012] Specifically, the problem is solved by a first arrangement for delivering a medical implant into a hollow body organ, comprising a wire and a compressible and expandable medical implant that is tubular in shape. In the compressed state, the implant is releasably connected to the wire by at least one engagement element. In an engaged state, the engagement element has at least one projection that extends radially outward and engages the implant. The engagement element is designed to effect at least one relative movement between the projection and the implant, directed away from each other in a radial direction, in order to assume a release state for releasing the implant.The first arrangement according to the invention is therefore based on the idea of ​​facilitating the release of the implant by allowing the engagement element to change from the engaged state to a state specifically intended for releasing the implant, namely the release state. In the engaged state, the projection engages the implant in order to transmit a force in the axial direction when transporting the implant to the treatment site. The transition from the engaged state to the release state occurs through a relative movement between the projection and the implant. The relative movement is directed away from each other, at least in the radial direction of the implant or the wire. The projection and the implant therefore move away from each other, at least in the radial direction, during the transition from the engaged state to the release state. In this way, the implant is at least partially released from engagement with the engagement element, i.e.The overlap between the implant and the protrusion is reduced. In other words, the protrusion engages less deeply in the implant in the released state than in the engaged state. This allows the implant to be safely released from the engaging element even with a relatively small distance between the engaging element and the implant. The risk of the implant becoming caught on the engaging element is reduced, and the wire can be safely retracted into the catheter.

[0013] Since the engagement element can each assume a dedicated state for transporting the implant and for releasing the implant, these two functions are structurally decoupled. Due to this functional separation, the engagement element can be optimized for releasing the implant in the release state without impairing the transport of the implant. Likewise, the invention allows the engagement element to be optimized for transporting the implant in the engaged state without impairing the release of the implant.

[0014] When the implant is being transported, the engagement element is in the engaged state. The projection of the engagement element engages with the implant so that the implant is positively connected to the wire, at least in the axial direction of the wire. Due to the positive connection, the projection transfers a force to the implant when the wire is moved, so that the implant moves along with the wire. In this way, the implant can be safely transported to the treatment site. During use, the engagement element is connected to the wire so that it can rotate or is fixed against rotation. In the engaged state, the projection is therefore fixed on the wire, at least in the axial direction, and when the implant is fed in, it takes the implant with it when the wire is moved axially. This means that the implant can be safely transported to the treatment site by moving the wire.

[0015] The relative movement between the protrusion and the implant during the transition from the engaged state to the released state can occur in various ways. For example, the protrusion can be moved radially inward, with the implant remaining essentially stationary in the radial direction, i.e., essentially not moving in the radial direction. Likewise, the implant can be moved radially outward, with the protrusion remaining essentially stationary in the radial direction. A combination of these, in which both the protrusion and the implant are moved radially inward, is also possible.

[0016] The relative movement can be effected by the engagement element in various ways. For example, the engagement element can be designed to effect the relative movement independently, i.e., without active external influence. This can occur, for example, in the form of an independent expansion of the engagement element upon exiting the catheter. It is also possible for the engagement element to effect the relative movement as a result of an external influence on the engagement element, for example, by a treating physician using a corresponding actuating device.

[0017] The engagement element can change from the engaged state to the released state. In addition, the engagement element can also be configured to change from the released state back to the engaged state. Furthermore, the engagement element can also be configured such that it can assume additional states in addition to the engaged state and the released state.

[0018] The invention is suitable for self-expanding medical implants. The medical implant of the first arrangement can therefore be self-expanding. Such implants are known and are usually made of a shape-memory material.

[0019] The implant may preferably have a lattice structure, in particular a tubular wall made of a lattice structure.

[0020] The lattice structure can be a mesh of braided filaments or wires, or a single braided filament or wire. The mesh forms meshes. The lattice structure can also be a monolithic lattice structure made up of webs, for example, a laser-cut lattice structure. The monolithic lattice structure forms cells.

[0021] The invention is not limited to a specific type of intervention. The wire can be connected to the implant in various ways. For example, the engaging element can engage the lattice structure, specifically meshes or cells of the lattice structure, in the engaged state. It is also possible for the engaging element to be detachably connected to end loops, end meshes, or end diamonds of the implant in the engaged state. Detachable connections between the implant and the engaging element in the engaged state can also be provided by additional components, in particular X-ray markers. These can be, for example, crimped marker sleeves.

[0022] The first arrangement according to the invention comprising an implant and a wire is treated as an assembly that is disclosed and claimed independently of the catheter with which the arrangement is transported to the treatment site. In addition, the combination of a catheter and the first arrangement is also disclosed and claimed. Within the scope of the invention, the wire for delivering the medical implant as such, i.e., without an implant and without a catheter, is also disclosed and claimed. The wire is suitable for achieving the advantages explained above in connection with the delivery of an implant and, for this purpose, has a modified engagement element that is described above. Such a wire is also referred to as a transport wire.

[0023] Preferred embodiments of the first arrangement according to the invention are claimed or specified in the dependent claims. In a preferred embodiment of the first arrangement, the engagement element is completely released from engagement with the implant in the release state. In this embodiment, the relative movement between the projection and the implant thus occurs at least to the extent that, in the release state, the projection no longer engages the implant, i.e., the projection and the implant no longer overlap. This minimizes the risk of the implant becoming caught on the projection during release.

[0024] In a further preferred embodiment of the first arrangement, the relative movement occurs at least partially through a deformation of the engagement element. In this embodiment, it is therefore provided that during the transition from the engaged state to the released state, at least a part of the engagement element deforms, in particular elastically and / or plastically, in such a way that, as a result of this deformation, the projection and the implant move away from each other at least in the radial direction. Complicated and error-prone adjustment mechanisms for implementing the relative movement can thus be at least partially eliminated, thereby simplifying the structure and increasing safety. Preferably, the relative movement occurs entirely through a deformation of the engagement element, so that such adjustment mechanisms can be completely eliminated.

[0025] In a particularly preferred embodiment of the first arrangement, the deformation of the engagement element includes a deformation of the projection. This eliminates the need for additional deformable elements or parts of the engagement element, further simplifying the design of the engagement element. It is particularly preferred if the deformation of the projection causes at least part of the relative movement, i.e., results in at least a radial movement of the projection and / or the implant.

[0026] The engagement element preferably has at least one web which, in the engaged state, forms the at least one projection and is adapted to bend radially outwards or inwards to bring about the relative movement. The web combines the deformable part of the engagement element required for deformation and the projection in one component and thus simplifies the construction of the engagement element. Preferably, the web is adapted to bend radially outwards during the transition from the engaged state to the released state such that the implant is raised, i.e. moved radially outwards, or to bend radially inwards such that the projection is lowered, i.e. moved radially inwards. A combination of these is possible.

[0027] In a preferred embodiment of the first arrangement, the web extends transversely to the longitudinal direction of the wire and has two end sections, each forming a projection in the engaged state, wherein the web is adapted to bend radially outwards in order to lift the implant. This has several advantages. The two projections improve the transmission of force in the axial direction from the wire to the implant and thus increase the security of the connection between wire and implant. Such a web also simplifies the design of the engagement element, since the deformation of just one element, namely the bending of the web radially outwards, is sufficient for the relative movement between the two projections and the implant. In particular, the web is adapted to bend radially outwards independently, so that additional actuating devices can be omitted and the handling of the first arrangement is simplified.In this embodiment, the relative movement preferably occurs entirely by lifting the implant, with the projections being substantially stationary in the radial direction. The web is preferably designed to bend the implant to a radial height required to overcome the projections. To further increase security against snagging, the web can be curved radially outward in the released state, so that it has a radial outer contour, specifically an outer surface, that is substantially free of projections.

[0028] Preferably, a driver element is provided, which is arranged on the wire next to the engagement element and has at least one projection that extends radially outward and engages the implant in the compressed state. The driver element supports the engagement element during transport of the implant by transferring axial forces from the wire to the implant. Additionally, the driver element can also be designed to support the engagement element in the axial direction, i.e., to absorb axial forces to assist in transporting the implant. This support further increases the security of the connection between the wire and the implant.For the security of the connection, it is particularly advantageous if at least one projection of the engagement element and the projection of the driver element are at least partially aligned in the axial direction of the wire and are adapted to one another in such a way that the projection of the driver element axially supports the projection of the engagement element during transport of the implant. To release the implant, it is further advantageous if the web is designed to bend the implant in a radially outward direction to a radial height required to overcome both the projections of the engagement element and the at least one projection of the driver element.

[0029] In a further preferred embodiment of the first arrangement, it is provided that the web extends in the longitudinal direction of the wire and has a central section which forms the projection in the engaged state, wherein the web is adapted to bend inwards in order to lower the projection. By lowering the projection, the radial height of the implant which is required to overcome the projection is reduced. The implant therefore does not need to be as expanded in order to be able to be released from the engagement element. This allows the implant to be released safely even when the radial outward movement of the implant is particularly severely restricted in the region of the treatment site. In this embodiment, the relative movement preferably takes place entirely by lowering the projection, wherein the implant is essentially stationary in the radial direction. It is particularly advantageous if the projection can be lowered completely, i.e.is retractable into the engagement element, so that the engagement element is essentially free of protrusions in the deployed state. This further reduces the radial height of the implant required to overcome the protrusion and further increases security against snagging.

[0030] The web is preferably adapted to be bent radially inwards due to an external influence on the engagement element, for example by a treating physician. For a simple design, it is advantageous if the engagement element has a pushing element for this purpose which is arranged to be displaceable in the axial direction of the wire and is adapted to be pushed over the web in order to bend the web radially inwards. The pushing element can, for example, comprise a sleeve with at least one opening, in particular a slot, for the projection of the engagement element in the engaged state. Due to the curved shape of the web in the radially outward direction, the pushing element can slide on the projection when pushed and in the process press the projection radially inwards, so that the web is bent radially inwards and the projection is lowered, in particular countersunk.

[0031] The engagement element can have at least one support section that is connected to the wire in a rotatable or rotationally fixed manner and supports the at least one bar. Connecting the support section to the wire achieves a fixed arrangement of the bar, and thus of the projection, in the axial direction relative to the wire. This allows the implant to be securely moved with the wire. The support section can, for example, be annular or sleeve-shaped and have a central through-opening through which the wire extends during use.

[0032] It is advantageous if the web is formed integrally with the support section. The support section and the web can thus advantageously be manufactured in one piece. For example, the support section and the web can be manufactured by mechanical processing, such as milling or laser material processing, or additive manufacturing, such as 3D printing. The support section and the web can be formed monolithically.

[0033] Preferably, the engagement element has a plurality of projections, in particular a plurality of webs, distributed along the circumferential direction of the wire. This improves the security of the connection between the engagement element and the implant and achieves a more uniform force transmission in the circumferential direction from the wire to the implant.

[0034] It is advantageous if the engagement element is formed at least partially from a shape memory material, in particular a nickel-titanium alloy. Such materials tend to assume a previously imprinted shape. This advantageously supports an independent transition from the engaged state to the released state and / or from the released state to the engaged state. A further subordinate aspect of the invention relates to a second arrangement for introducing a medical implant into a hollow body organ, comprising a wire and a compressible and expandable medical implant that is tubular in shape. In the compressed state, the implant is detachably connected to the wire by at least one driver element, wherein the driver element has at least one projection that extends radially outward and engages the implant.A shielding element is provided which is arranged on the wire next to the driver element and is designed to lift the implant radially outwards in order to release the implant from engagement with the projection.

[0035] The second arrangement of implant and wire is thus disclosed and claimed independently of the first arrangement. Furthermore, the combination of a catheter and the second arrangement is also disclosed.

[0036] The second arrangement according to the invention is based on the idea of ​​facilitating the release of the implant by means of an element specifically provided for releasing the implant, namely the shielding element. For this purpose, the shielding element is arranged on the wire next to the driver element and is designed to lift the implant radially outwards for release. In this case, the implant is moved to a radial height which is necessary to overcome the projections. In this way, the implant is at least partially, in particular completely, released from engagement with the driver element, i.e. the overlap of implant and projection is at least reduced. As a result, the implant can be safely released from the driver element even when the distance between the engagement element and the implant is relatively small. Catching of the implant with the driver element is avoided and the wire can be safely retracted into the catheter.

[0037] Since a dedicated element is provided for transporting the implant and for releasing the implant, these two functions are structurally decoupled. Due to this functional separation, the shielding element can be optimized for releasing the implant without compromising the transport of the implant. Likewise, the invention allows the driver element to be optimized for transporting the implant without compromising the release of the implant.

[0038] During transport of the implant, the shielding element is in a transport state in which it rests detached from the implant, with the projection of the driver element engaging the implant, so that the implant is positively connected to the wire, at least in the axial direction of the wire. Due to this positive connection, the projection transfers a force to the implant when the wire is moved, so that the implant moves along with the wire. This allows the implant to be transported safely to the treatment site.

[0039] To release the implant, the shielding element assumes a release state, lifting the implant radially outward during the transition from the transport state to the release state. The transition from the transport state to the release state can occur, for example, through deformation, particularly radial expansion, of the shielding element.

[0040] During use, the driver element is connected to the wire in a rotatable or rotationally fixed manner. When engaged, the projection is therefore fixed to the wire, at least in the axial direction, and, when the implant is inserted, carries the implant along as the wire is moved. This allows the implant to be safely transported to the treatment site by advancing the wire.

[0041] For the effect and advantages of the implant of the second arrangement, reference is made to the explanations in connection with the implant of the first arrangement.

[0042] The invention will be explained in more detail below using exemplary embodiments with reference to the accompanying drawings.

[0043] Fig. 1 is a front view of a first arrangement according to an embodiment of the invention with an engagement element in the engaged state; Fig. 2 is a front view of the arrangement of Fig. 1 with the engagement element in the released state (without implant);

[0044] Fig. 3 is a perspective view of the arrangement of Fig. 1 with the engagement element in the engaged state (without implant);

[0045] Fig. 4 is a perspective view of the arrangement of Fig. 1 with the engagement element in the released state (without implant);

[0046] Fig. 5 is a perspective view of a first arrangement according to a further embodiment of the invention with an engagement element in the engaged state (without implant);

[0047] Fig. 6 is a perspective view of the arrangement of Fig. 5 with the engagement element in the released state (without implant);

[0048] Fig. 7 is a perspective view of an engagement element of a first arrangement according to a further embodiment of the invention;

[0049] Fig. 8 is a perspective view of an engagement element of a first arrangement according to a further embodiment of the invention; and

[0050] Fig. 9 is a perspective view of a thrust element of the arrangement of Fig. 8.

[0051] Fig. 1 shows an embodiment of a first arrangement according to the invention for introducing a medical implant 11 into a hollow body organ, which is particularly, but not exclusively, suitable for the treatment of neurovascular diseases, such as, for example, stroke treatment.

[0052] The arrangement comprises a wire 10, which may also be referred to as a transport wire or a holding wire, and the implant 11. The arrangement of wire 10 and implant 11 forms an assembly that is preloaded in a catheter 22. Within the scope of the application, the assembly is disclosed and claimed, as is the wire 10 without the implant 11. Furthermore, the combination of catheter 22 and arrangement or assembly, which typically forms the economic unit that is marketed, is disclosed and claimed.

[0053] The implant 11 is tubular and compressible and expandable in a conventional manner to be transported through the catheter 22 to the lesion to be treated. The implant 11 is preferably self-expanding. This can typically be achieved by making the implant 11 from a shape-memory material, such as a nickel-titanium alloy. The invention is not limited to specific implant materials. Other implant materials are possible.

[0054] The tubular implant 11, specifically its wall, is formed from a lattice structure. The lattice structure can be embodied as a mesh or as a monolithic lattice structure. Reference is made to the explanations in the introduction to the description of the application. Examples of such implants 11 are stents or flow diverters. Other implants 11 are possible that can be detachably connected to the wire 10.

[0055] In the preloaded state, ie, in the catheter 22, the implant 11 is compressed and releasably connected to the wire 10 by at least one engagement element 12. The connection between the wire 10 and the implant 11 is releasable to decouple the implant 11 from the wire 10 when the implant 11 is released from the catheter 22 at the treatment site.

[0056] The engagement element 12 has a support section 20. The support section 20 is ring-shaped or sleeve-shaped and has a central through-opening through which the wire 10, specifically the core of the wire 10, extends in the installed state. The engagement element 12, specifically the support section 20, is connected to the wire 10 in a rotatable or rotationally fixed manner.

[0057] In Fig. 1, the engagement element 12 is shown in an engaged state I. In the engaged state I, the engagement element 12 has at least one projection 13 that extends radially outward and engages the implant 11. Thus, in the engaged state I, the projection 13 protrudes at least partially radially into the implant 11, so that the implant 11 and the projection 13 overlap. The projection 13 positively connects the implant 11 to the wire 10, at least in the axial direction of the wire 10.

[0058] In engagement state I, the engagement element 12 engages meshes or cells of the lattice structure of the implant 11. It is also possible for the engagement element 12 to be detachably connected to end loops, end meshes, or end diamonds of the implant 11 in engagement state I. Detachable connections between the implant 11 and the engagement element 12 in engagement state I can also be provided by additional components, in particular X-ray markers. These can be, for example, crimped marker sleeves. Other engagement types are possible.

[0059] When transporting the implant 11 to the treatment site, the projection 13 of the engagement element 12 engages the implant 11 in the engagement state I, so that the implant 11 is positively connected to the wire 10, at least in the axial direction of the wire 10. Due to the positive connection, the projection 13 transmits a force to the implant 11 when the wire 10 is moved, so that the implant is moved along with the wire 10. In this way, the implant 11 can be safely transported to the treatment site.

[0060] To release the implant 11 at the treatment site, the engaging element 12 can change from the engaged state I to a state specifically designed for releasing the implant, namely the release state II. The engaging element 12 in the release state II is shown in Fig. 2.

[0061] In order to move from the engagement state I to the release state II, the engagement element 12 is designed to cause at least one relative movement between the projection 13 and the implant 11, directed away from each other in the radial direction. Thus, the projection 13 and the implant 11 move away from each other at least in the radial direction during the transition from the engagement state I to the release state II.

[0062] This relative movement at least partially disengages the implant 11 from the engagement element 12, specifically the projection 13, i.e., the overlap of the implant 11 and the projection 13 is reduced. This allows the implant 11 to be safely disengaged from the engagement element 12 even when the distance between the engagement element 12 and the implant 11 is relatively small. This prevents the implant 11 from becoming caught in the engagement element 12, and the wire 10 can be safely retracted into the catheter 22.

[0063] In release state II (see Fig. 2), the engagement element 12 is completely disengaged from the implant 11 (not shown). In other words, in release state II, the projection 13 is positioned completely outside the mesh of the implant 11. The projection 13 therefore no longer engages the implant 11.

[0064] This prevents the implant 11 from becoming caught in the projection 13 when the implant 11 is released, so that the implant 11 can be safely released from the engagement element 12 even when there is a relatively small distance between the engagement element 12 and the implant 11.

[0065] The relative movement between projection 13 and implant 11 occurs through a deformation of the engagement element 12, as illustrated by comparing Fig. 1 with Fig. 2. At least a portion of the engagement element 12 deforms during the transition from the engagement state I to the release state II in such a way that, as a result of this deformation, the projection 13 and the implant 11 move away from each other, at least in the radial direction. During this deformation, among other things, the projection 13 is also at least partially deformed, thereby causing at least part of the relative movement.

[0066] The engagement element 12 is formed at least partially from a deformable material. Specifically, the engagement element 12 is made of a shape memory material, in particular a nickel-titanium alloy. Other materials are possible.

[0067] The engagement element 12 has a plurality of webs 14, which are distributed in the circumferential direction of the wire 10 and each form at least one projection 13. Specifically, the engagement element 12 has three webs 14. The engagement element 12 can have a different number of webs 14, in particular more than three webs 13. The webs 14 extend in a plane transverse to the longitudinal direction of the wire 10 and radially outward from the support section 20. They each have two end sections 15, which are spaced apart from one another in the circumferential direction. The end sections 15 are connected to one another at one end by a central section 18, with the other end being connected to an outer side of the support section 20. The support section 20 thus supports the webs 14.

[0068] In the engaged state I (see Fig. 1), the end sections 15 each form a projection 13. For this purpose, the web 14 is bent radially inward in the region of the central section 18, in particular curved, so that the end sections 15 protrude radially outward relative to the central section 18. The web 14 thus has a radial indentation or depression for receiving filaments or wires of the implant 11, which is formed between the projections 13 in the region of the central section 18.

[0069] In engagement state I, the projections 13 engage in meshes of the lattice structure of the implant 11. The filaments or wires of the implant 11 are arranged around the projections 13. Two adjacent projections 13 of different webs 14 can engage in a common mesh, as shown in Fig. 1, so that the filaments or wires are arranged exclusively in the indentations. It is also possible for the projections 13 to each engage in a separate mesh, so that filaments or wires are arranged both in the indentations and between two adjacent webs 14. A combination of these is possible.

[0070] The webs 14 are each adapted to bend radially outward in order to bring about the relative movement between the projections 13 and the implant 11 required for the transition from the engaged state I to the released state II. The relative movement thus occurs through a deformation of the webs 14, whereby the webs 14, which are bent radially inward in the engaged state I, bend, in particular bulge, radially outward. In the process, both the central sections 18 and the end sections 15, and thus also the projections 13, are deformed. The radially outward bending of the webs 14 can also be referred to as a radial expansion of the webs 14. As a result of the bending, the central sections 18 are moved radially outward and brought into a radial height position that essentially corresponds to the radial height position of the end sections 15, and thus of the projections 13.

[0071] By bending the webs 14, the implant 11 is moved radially outward relative to its position in engagement state I, i.e., lifted. The projections 13 are deformed, but not moved radially, and are thus essentially stationary in the radial direction. The relative movement is thus entirely achieved by lifting the implant 11.

[0072] Due to the relative movement, the implant 11 is brought to a height that essentially corresponds to the radial outer surface of the projections 13. The filaments or wires of the implant 11 are thereby lifted or pushed out of the recesses. The implant 11 expands, and the projections 13 no longer engage with the implant 11. The implant 11 is thus completely released from engagement with the engagement element 12 in release state II.

[0073] In release state II (see Fig. 2), the webs 14 have a radial outer surface that is essentially free of projections. The webs 14 extend at least partially in the circumferential direction, thus forming a curved or rounded radial outer surface.

[0074] The curved radial outer surface of the webs 14 in release state II prevents the implant 11 from becoming caught on the webs 14 when the implant 11 is released.

[0075] The engagement element 12 is designed to bring about the relative movement independently, i.e. without active external influence. The webs 14, which are bent radially inwards in the engagement state I, therefore bend radially outwards independently, i.e. under their own force, during the transition to the release state II. This can be achieved, for example, by the webs 14 being designed to be self-expanding, i.e. they always strive for the release state II. When the implant 11 is transported to the treatment site, the self-expanding webs 14 are held in the radially compressed state, i.e. in engagement state I, by the catheter 22. As soon as the engagement element 12 emerges from the catheter 22 and the compression force of the catheter 22 thus ceases, the webs 14 bend outwards independently due to their urge to expand. The independent bending of the webs 14 can also be activated in other ways, for example by a certain temperature.

[0076] The webs 14 are arranged in a manner distributed in the circumferential direction of the wire 10 such that two adjacent end sections 15 of different webs 14 are adjacent to one another. Specifically, these end sections 15 are connected to one another, forming a radially outwardly open notch between the end sections 15. The end sections 15 can also be connected to one another such that they jointly form a projection 13. It is also possible for two adjacent end sections 15 of different webs 14 to be spaced apart from one another in the circumferential direction.

[0077] The webs 14 are essentially uniform in both the engaged state I and the released state II. The webs 14 can also be differently designed.

[0078] The end sections 15, including the projections 13, and the central section 18 have a rounded, in particular curved, radial outer surface both in the engaged state I and in the released state II. The shape of the radial outer surface can also be described as curved. The radial outer surface is essentially free of edges, corners, or the like. This advantageously protects the implant 11, the catheter 22, and / or the hollow body organ from unwanted damage. The radial outer surface can have other geometries.

[0079] The webs 14 are formed integrally with the support section 20. The engagement element 12 is thus made from a single piece. The engagement element 12 can also be formed from multiple pieces.

[0080] A perspective view of the arrangement of Fig. 1 is shown in Fig. 3 (engagement state I) and Fig. 4 (release state II), wherein the implant 11 is not shown for the sake of clarity.

[0081] As can be seen from Figs. 3 and 4, the engagement element 12 essentially has the geometry of a plate with cutouts that correspond to the negative image of the webs 14 and the support section 20. The engagement element 12 thus has a substantially uniform extension in the longitudinal direction of the wire 10, wherein the extension in the longitudinal direction is smaller than the extension transverse to the longitudinal direction. The support section 20 is thus annular, with the webs 14, specifically the end sections 15, protruding radially on the radial outer side of the ring. Both the annular support section 20 and the webs 14 have the geometry of a square profile.

[0082] In Figs. 5 and 6, a perspective view of the first arrangement according to a further embodiment of the invention without an implant is shown, wherein the engagement element 15 corresponds to the engagement element 15 from Figs. 1 to 4. In Fig. 5, the engagement element 12 is shown in the engaged state I and in Fig. 6 in the released state II.

[0083] In this embodiment, a driver element 16 is provided, which is arranged on the wire 10 next to the engagement element 12. The driver element 16 is sleeve-shaped. The driver element 16 has a central through-opening through which the wire 10, specifically the core of the wire 10, extends in the installed state. The driver element 16 can be connected to the wire 10 in a rotatable or rotationally fixed manner.

[0084] The driver element 16 has a cylindrical body and several, specifically three, projections 17 that extend radially outward from the cylindrical body and engage with the implant 11 in the compressed state. The projections 17 can also be referred to as the points of a crown, as lugs, wings, or teeth. A different number of projections 17, in particular more than three projections 17, is possible.

[0085] The projections 13 and the cylindrical body are formed as a single piece. Alternatively, the engagement element 12 can be formed in two parts.

[0086] The driver element 16 serves to assist the engagement element 12 in transporting the implant 11 to the treatment site in order to increase the security of the connection between the implant 11 and the wire 10. For this purpose, the projections 17 engage the lattice structure of the implant 11 in the compressed state. As a result, the implant 11 is positively connected to the driver element 16, at least in the axial direction of the wire 10. Due to the positive connection, the projections 17 transmit a force to the implant 11 when the wire 10 is displaced, so that the implant 11 is moved along with the projections 17.

[0087] In addition, the driver element 16 supports the engagement element 12 during transport of the implant 11 by supporting the engagement element 12 in the axial direction. For this purpose, the driver element 16 is arranged on the wire 10 such that it interacts with the engagement element 12 in the axial direction during transport of the implant 11 in order to absorb axial forces. In this case, the projections 13 of the engagement element 12 in the engaged state I and the projections 17 of the driver element 16 can be at least partially aligned in the axial direction of the wire 10 and adapted to one another such that the projections 17 of the driver element 16 axially support the projections 13 of the engagement element 12 during transport of the implant. In order to avoid mutual twisting and / or axial movement apart, it is advantageous if the engagement element 12 and the driver element 16 are connected to the wire 10 or to each other in a rotationally fixed manner.

[0088] The webs 14 of the engagement element 12 are designed to bring the implant 11 into a radial height position by bending in the radially outward direction, which is necessary to overcome both the projections 13 of the engagement element 12 and the projections 17 of the driver element 16.

[0089] The combination of driver element 16 and wire 10 shown in Figs. 5 and 6 can serve separately from the engagement element 12 as driver element 16 of the second arrangement according to the invention.

[0090] Fig. 7 shows a perspective view of an alternative engagement element 12 of the first arrangement according to a further embodiment of the invention. The basic features, functions, and effects of the engagement element 12 correspond to those of the engagement element 12 according to Figs. 1 to 6. Therefore, reference is made in this context to the above explanations, and only the differences between these two embodiments are discussed below.

[0091] Like the embodiment according to Figs. 1 to 6, the engagement element 12 of the present embodiment also has a plurality of webs 14, which are distributed in the circumferential direction of the wire 10 and each form the at least one projection 13. Specifically, the engagement element 12 has four webs 14. The engagement element 12 can also have more or fewer than four webs 14.

[0092] The webs 14 extend in a plane that runs in the longitudinal direction of the wire 10. They each have a central section 18, which is connected via end sections 15, on the one hand, to the support section 20 and, on the other hand, to a sliding section 21. The webs 14 thus extend between the support section 20 and the sliding section 21 and connect them. The support section 20 is rotatably or non-rotatably connected to the wire 10 and thus supports the webs 14. The sliding section 21 is displaceable in the longitudinal direction of the wire 10 and is arranged at a distance from the support section 20.

[0093] Fig. 7 shows the engagement element 12 in the engaged state I. The middle sections 18 of the webs 14 each form a projection 13 in the engaged state I. For this purpose, the webs 14 are bent radially outwards so that the middle sections 18 protrude radially outwards relative to the end sections 15, the support section 20 and the displacement section 21.

[0094] In engagement state I, the projections 13 each engage in a separate mesh of the lattice structure of the implant 11. The filaments or wires of the implant 11 are arranged between the projections 13.

[0095] The webs 14 are each adapted to bend radially inward in order to effect the relative movement between the projections 13 and the implant 11 required for the transition from the engagement state I to the release state II. The relative movement thus occurs through a deformation of the webs 14, whereby the webs 14, which are bent radially outward, in particular curved, in the engagement state I, bend radially inward. As a result of this bending, the webs 14, which are bent radially outward in the engagement state I, are stretched longitudinally, i.e., deformed toward a non-bent or straight shape. In this process, the displacement section 21 is displaced longitudinally away from the carrier section 20.

[0096] Due to the bending of the webs 14, the projection 13 is moved radially inward, i.e., lowered, relative to its position in engagement state I. The implant 11 is not moved in the radial direction, and is therefore essentially stationary in the radial direction. The relative movement is thus entirely achieved by lowering the projections 13.

[0097] Due to the relative movement, the central sections 18, and thus the projections 13, are brought to a height that essentially corresponds to the radial height of the support section 20, the displacement section 21, and the end sections 15. The projections 13 are thus completely pulled out of the meshes of the implant 11, so that the implant 11 is completely released from engagement with the engagement element 12 in the release state II.

[0098] In release state II (not shown), the webs 14, the support section 20, and the displacement section 21 have a common radial outer surface that is essentially free of projections. The webs 14 are thus elongated such that they are completely recessed between the support section 20 and the displacement section 21.

[0099] The webs 14 are essentially uniform in both the engaged state I and the released state II. The webs 14 can also be differently designed.

[0100] The webs 14, the support section 20, and the sliding section 21 are formed as a single piece. They can also be formed as multiple pieces.

[0101] The support section 20 is sleeve-shaped. The displacement section 21 has essentially the same shape as the support section 20. The webs 14 essentially have the geometry of a square profile. Fig. 8 shows a perspective view of the first arrangement according to another embodiment of the invention without an implant, wherein the engagement element 15 corresponds to the engagement element 15 of Fig. 7 and is in the engaged state I.

[0102] The webs 14 are adapted to be bent radially inward due to an external influence on the engagement element 12. For this purpose, the engagement element 12 has a thrust element 19. The thrust element 19 is also shown individually in Fig. 9.

[0103] The pushing element 19 is sleeve-shaped and has a central through-opening in which the support section 20 and the displacement section 21 are arranged coaxially. The pushing element 19 has openings for the projections 13 in the engaged state I. The openings are slot-shaped and adapted to the positions and shape of the projections 13. The pushing element 19 is displaceable relative to the support section 20 and the displacement section 21. The implant 11 (not shown) is arranged on the outer surface of the pushing element 19 in the compressed state.

[0104] In the engagement state I, as shown in Fig. 8, the projections 13 protrude from the openings of the pushing element 19 and engage in the implant 11, so that the implant 11 is connected to the wire 10 in the axial direction.

[0105] To move from the engagement state I to the release state II, the pushing element 19 is designed to be pushed over the webs 14 to bend them radially inward. Due to the curved shape of the webs 14 in the radially outward direction, the pushing element 19 can slide on the projections 13 when pushed, thereby pressing the projections 13 radially inward so that they are countersunk between the support section 20 and the displacement section 21.

[0106] In release state II (not shown), the pusher element 19 is pushed completely over the webs 14 and at least partially over the openings of the pusher element 19. Pushing the pusher element 19 can be performed, for example, by the attending physician. For this purpose, an actuating device can be provided that extends from the pusher element 19 to the physician's hand. The actuating device can, but does not have to, comprise a hypertube. Pushing the pusher element 19 can be performed differently.

[0107] List of reference symbols

[0108] 10 Wire (transport wire)

[0109] 11 Implant

[0110] 12 engagement element

[0111] 13 Projection of the engagement element

[0112] 14 jetty

[0113] 15 Final section

[0114] 16 Driving element

[0115] 17 Projection of the driver element

[0116] 18 Middle section

[0117] 19 Shear element

[0118] 20 support section

[0119] 21 Shifting section

[0120] 22 catheters

[0121] I Intervention state

[0122] II Release state

Claims

Claims 1. Arrangement for feeding a medical implant into a hollow body organ, comprising a wire (10) and a compressible and expandable medical implant (11) which is tubular in shape, wherein the implant (11) in the compressed state is detachably connected to the wire (10) by at least one engagement element (12), wherein the engagement element (12) in an engagement state (I) has at least one projection (13) which extends radially outwards and engages the implant (11), characterized in that the engagement element (12) is designed to bring about at least one relative movement directed away from one another in the radial direction between the projection (13) and the implant (11) in order to assume a release state (II) for releasing the implant (11).

2. Arrangement according to claim 1, characterized in that the engagement element (12) is completely released from engagement with the implant (11) in the release state (II).

3. Arrangement according to claim 1 or 2, characterized in that the relative movement occurs at least partially by a deformation of the engagement element (12).

4. Arrangement according to claim 3, characterized in that the deformation of the engagement element (12) comprises a deformation of the projection (13).

5. Arrangement according to claim 3 or 4, characterized in that the engagement element (12) has at least one web (14) which, in the engagement state (I), forms the at least one projection (13) and for this purpose adapted to bend radially outward or inward to effect the relative movement.

6. Arrangement according to claim 5, characterized in that the web (14) extends transversely to the longitudinal direction of the wire (10) and has two end sections (15) which each form a projection (13) in the engaged state (I), wherein the web (14) is adapted to bend radially outwards, in particular independently, in order to lift the implant (13).

7. Arrangement according to claim 6, characterized in that a driver element (16) is provided which is arranged on the wire (10) next to the engagement element (12) and has at least one projection (17) which extends radially outwards and engages the implant (11) in the compressed state.

8. Arrangement according to claim 5, characterized in that the web (14) extends in the longitudinal direction of the wire (10) and has a central portion (18) which forms the projection (13) in the engaged state (I), the web (14) being adapted to bend radially inwards to lower the projection (13).

9. Arrangement according to claim 8, characterized in that the engagement element (12) has a pushing element (19) which is arranged to be displaceable in the axial direction of the wire (10) and is adapted to be pushed over the web (14) in order to bend the web (14) radially inwards.

10. Arrangement according to one of claims 5 to 9, characterized in that the engagement element (12) has at least one carrier section (20), which is rotatably or non-rotatably connected to the wire (10) and carries at least one web (14).

11. Arrangement according to claim 10, characterized in that the web (14) is formed integrally with the support section (20).

12. Arrangement according to one of the preceding claims, characterized in that the engagement element (12) has a plurality of projections (13), in particular a plurality of webs (14), which are arranged distributed in the circumferential direction of the wire (10).

13. Arrangement according to one of the preceding claims, characterized in that the engagement element (12) is formed at least partially from a shape memory material, in particular a nickel-titanium alloy.

14. Wire for feeding a tubular, medical implant (11) into a hollow body organ, wherein the implant (11) is compressible and expandable and, in the compressed state, can be connected to the wire (10) by at least one engagement element (12), wherein the engagement element (12) in an engagement state (I) has at least one projection (13) which extends radially outwards and, in use, engages the implant (11), characterized in that the engagement element (12) is designed to bring about at least one relative movement between the projection (13) and the implant (11) directed away from one another in the radial direction in order to assume a release state (II) for releasing the implant (11).

15. A catheter having an arrangement according to claim 1.

16. Arrangement for introducing a medical implant into a hollow body organ with a wire (10) and a compressible and expandable medical implant (11) which is tubular, wherein the implant (11) in the compressed state is detachably connected to the wire (10) by at least one driver element (16), wherein the driver element (16) has at least one projection (17) which extends radially outwards and into the Implant (11), characterized in that a shielding element (20) is provided, which is arranged on the wire (10) next to the driver element (16) and is designed to lift the implant (11) radially outwards in order to Release from engagement with the driver element (16).

Images