An insertion device comprising a ureteral stent and an introduction component for introducing a ureteral stent, an introduction component and an insertion unit - Patents.com

Abstract

The present invention relates to an insertion device (10) comprising a ureteral stent (20) comprising a ureteral stent base (30) and a housing (40) coupled to the ureteral stent base (30) by at least one coupling element (22) of the ureteral stent (20), and an introduction component (50) for holding the ureteral stent (20) and guiding the ureteral stent (20) along a flexible guide element (110) through a patient's ureteral cannula (HL). The ureteral stent (20) is movable along the flexible guide element (110) in opposite directions of movement (R1, R2) by the introduction component (50), and the introduction component (50) is configured to guide the ureteral stent base (30) and housing (40) during movement in each of the directions of movement (R1, R2). Another aspect of the present invention relates to an introduction component (50) and an insertion unit (100) for such an insertion device (10).

Description

[Technical field]

[0001] The present invention relates to an insertion device comprising a ureteral stent comprising a ureteral stent base, a housing connected to the ureteral stent base by at least one connecting element of the ureteral stent, and an introduction component for holding the ureteral stent and guiding it along a flexible guide element through the ureter of a patient. Another aspect of the invention relates to an introduction component and an insertion unit for such an insertion device. [Background technology]

[0002] To insert a ureteral stent, a guidewire is often introduced into the patient's kidney via the urethra, also called the urinary drainage duct, the bladder, and the ureter, also called the ureter. The ureteral stent can then be positioned via the guidewire with the help of an introducer. After the ureteral stent is positioned, the introducer and the guidewire are removed. The withdrawal of the guidewire usually causes a shape change, often a rolling movement, at the distal or both ends of the ureteral stent. This shape change serves to prevent the ureteral stent from undesirably backing out, thereby anchoring the ureteral stent in the patient's urinary system.

[0003] In order to avoid the need for a cystoscope to retrieve the ureteral stent, the ureteral stent may be equipped with a magnet at its distal end, which can be magnetically coupled to a catheter, in particular a Thiermann catheter, with an end that attracts the magnet. The magnetic force acting between the magnet and the attracting end of the catheter is sufficient to retrieve the ureteral stent, which is connected to the catheter via the magnet, by the catheter in the shortest possible time.

[0004] From DE 69731027 T1 a stent is known for implantation in the ureter between the bladder and the kidney, intended to prevent the reflux of urine into the kidney. The stent comprises an elongated tubular body with a bladder end section and a kidney end section, a fluid passage in the kidney end section and means in the kidney end section and in the bladder end section for bending the ends of the stent through at least a part of the tubular body, so that the ends of the stent are held in the renal pelvis and the bladder. The stent further comprises means for restricting the flow of urine from the bladder to the kidney through the stent. The stent does not have a penetration or includes a penetration in the bladder end section, which penetration in the bladder end section is closed after implantation of the stent and the bladder end section forms the restriction means.

[0005] The device described in DE 10 2015 001 505 A1 looks almost like a bladder catheter, however it consists of an outer hose section and a tip section, which is arranged at the bladder-side end of the outer hose section via a guide wire which is centrally located in the outer hose section, such that the tip section can be pushed out translationally from the outer hose section and rotated relative to it by operating the guide wire in the gripping element, whereby in its pushed-out working position the tip section releases the grip section which is provided with elastically deformable gripping arms and which are fixed to the guide wire, which grip and wind up a pulling thread or thread loop arranged on the outside in the distal end region of the double J ureteral stent when the gripping sections are rotated. Summary of the Invention [Problem to be solved by the invention]

[0006] The object of the present invention is to improve the inserter device, the introduction component and the inserter unit in the manner described at the beginning, in such a way that a simple alignment of the ureteral stent can be achieved during introduction in the direction of the kidney. [Means for solving the problem]

[0007] This problem is solved by the subject matter of the independent claims. Advantageous developments of the invention are disclosed by the features of the dependent claims, the following description and the drawings.

[0008] A first aspect of the present invention relates to an insertion device comprising a ureteral stent comprising a ureteral stent base, a housing connected to the ureteral stent base by at least one connecting element of the ureteral stent, and an introduction component for holding the ureteral stent and guiding the ureteral stent through the patient's ureter along a flexible guide element.

[0009] According to the invention, it is specified that the ureteral stent can be moved along the flexible guide element by the introduction component in mutually opposite directions of movement, the introduction component being configured to guide the ureteral stent base and the housing during the movement in each direction of movement. This has the advantage that the ureteral stent and thus the ureteral stent base and the housing can be shifted together with the introduction component in relation to the flexible guide element and in mutually opposite directions of movement. This allows a particularly precise orientation and thus alignment of the ureteral stent during the introduction of the ureteral stent towards the kidney of the patient. Thus, the pushing and pulling of the ureteral stent in the urethra, bladder, ureter or kidney can be performed by the introduction component during the movement in each opposite direction of movement.

[0010] The ureteral stent can also be called a ureteral stent. The ureteral stent base can also be called a stent, i.e. a medical implant for keeping a blood vessel or a hollow organ open. The introduction component can also be called a "pusher". The guide element can preferably be formed as a guidewire, i.e. a wire for guiding an insertion device. In principle, the formation of the guide element as a plastic wire or tube is also conceivable. The guide element can be introduced into the kidney of the patient via the urethra, also called the urethral meatus, the bladder and the ureter, also called the ureter. The ureteral stent can then be introduced into the kidney along the guide element together with the introduction component as well and thus guided through the ureter. The ureteral stent can be held in the introduction component via a flexible guide element, which can then be guided through the ureteral stent and the introduction component.

[0011] The introduction component may particularly preferably be configured to hold the ureteral stent base and the housing apart, in particular at a fixed distance from each other, independent of the movement in the opposite directions of movement. This advantageously avoids contact between the housing and the ureteral stent base, which may occur during introduction in the direction of the kidney, and for example the resulting tilting of the housing relative to the ureteral stent base. This avoids complications during introduction of the ureteral stent, or in other words, avoids relative movements between the ureteral stent base and the housing, which may occur during movement.

[0012] The introduction component, which may also be referred to as an introduction aid, may preferably be formed in one piece, which allows a particularly easy handling of the introduction component to be achieved, in particular because this makes it unnecessary to have additional mechanisms for separating the introduction component from the ureteral stent after the proper positioning of the latter in the urinary system.

[0013] In one advantageous development of the invention, the housing has ferromagnetic properties, or in other words, the housing can be at least partially formed as a ferromagnetic body. This allows the housing to be attracted, for example, by a magnet that can be contained in or part of a catheter, in particular a Thiermann catheter. Alternatively, the housing can also be at least partially formed as a magnetic body and thus be magnetic in itself. The magnetic attractability and the magnetic design facilitate the removal of the ureteral stent, in particular so that the housing can be coupled correspondingly quickly to a catheter (Thiemann catheter) due to correspondingly acting magnetic forces and can be rapidly removed, in particular withdrawn, from the urinary system.

[0014] In another advantageous development of the invention, the ureteral stent base together with the housing can be rotated relative to the flexible guide element by means of the introduction component, which has the advantage that in this way the orientation and thus the alignment of the ureteral stent during its introduction can be further improved. The introduction component can in particular be configured to hold the ureteral stent base and the housing such that both can be rotated synchronously by the introduction component, i.e. without any rotational deviation.

[0015] In another advantageous development of the invention, at least one coupling element is embodied in a flexible or pliable manner. This has the advantage that the housing can be particularly easily pulled towards the catheter, in particular a Thiermann catheter, when the ureteral stent is subsequently removed. The coupling element can then be deformed, in particular with only a small force, so that the magnetic coupling between the housing and the catheter can be easily brought about.

[0016] In another advantageous development of the invention, at least one coupling element is tensioned by the introduction component when the ureteral stent is held in the introduction component. This has the advantage that the ureteral stent is held in the introduction component in a particularly loss-proof manner. For example, it can be particularly advantageously specified that the introduction component is partially clamped between the receiver and the ureteral stent base via the coupling element, which can particularly advantageously prevent unintentional release of the ureteral stent from the introduction component. In other words, the coupling element can be held under mechanical tension via the introduction component when the ureteral stent is held in the introduction component.

[0017] In another advantageous development of the invention, at least one of the connecting elements is formed as a thread or wire element. This has the advantage that, in this configuration, the connecting element requires particularly little space and therefore does not unnecessarily complicate the introduction of the ureteral stent in the direction of the kidney. Furthermore, forming the connecting element as a thread or wire element allows a particularly simple deformation of the connecting element, so that the connecting element does not prevent the magnetic coupling between the receiving body and the catheter for the removal of the ureteral stent.

[0018] In another advantageous development of the invention, the introduction element is provided with a recess for introducing and holding the container, which has the advantage that the container can be arranged in the recess in a particularly space-saving manner and that any undesirable dropping out of the container can be easily prevented by means of the recess, whereby the recess can form, so to speak, a receiving section for the container.

[0019] In another advantageous development of the invention, the introduction component comprises at least two tubular sections into which the flexible guide element can be introduced and at least one connecting region for connecting the at least two tubular sections to one another, the at least two tubular sections and the at least one connecting region defining a notch. This has the advantage that, when configured in this way, the introduction component has a specific outer contour, which makes it particularly suitable for introduction into the respective passage of the urinary system, for example the urethra or ureter. Due to the possibility of introducing the flexible guide element into the tubular sections, the introduction component can be introduced along the flexible guide element, in particular in a loss-proof manner, for example into the patient's bladder. The tubular sections can have respective tube through-openings through which the flexible guide element can be passed through.

[0020] In another advantageous development of the invention, a first of the at least two tubular sections is formed as a proximal end of the introduction component, into which the distal base end of the ureteral stent base, directed towards the receiver, is at least partially introduced, at least when the ureteral stent is held in the introduction component. This has the advantage that the introduction of the distal base end provides a particularly loss-proof and separable fixation of the distal base end and thus of the ureteral stent base in the introduction component. The distal base end can also be called the distal end of the ureteral stent base. In other words, the distal base end and the proximal end of the introduction component (pusher) as a whole can come into contact with each other when the ureteral stent is held in the introduction component. By proximal end of the respective elements of the insertion device is meant the end of the insertion device that is respectively located closer to the body center, and by distal end is meant the element of the insertion device that is respectively remote from the body center.

[0021] In another advantageous development of the invention, the at least partially introduced distal base end can be held in an introduction position by the guide element in the first tubular section when the ureteral stent is held on the introduction component, and the distal base end is configured to autonomously transform from the introduction position of the distal base end to a basic position and thereby move outward from the first tubular section when the guide element is separated from the ureteral stent base, thereby moving outward from the first tubular section. That is to say, the guide element can hold the distal base end in an introduction position. This has the advantage that the distal base end can be introduced, for example, into the urethra with particularly little resistance in this introduction position, and that when the guide element is separated from the ureteral stent base, i.e., pulled out of the ureteral stent base and thus separated from the ureteral stent base, in particular when it is spaced apart from the ureteral stent base, it can be transformed, so to speak, autonomously from the introduction position to the basic position without further assistance. As a result of the transformation from the introduction position to the base position, the distal base end can autonomously move outwardly from the first tubular section, or in other words, the guide element can hold the at least partially introduced distal base end in the introduction position when the ureteral stent is held by the introduction component, where the distal base end is configured to autonomously transform from the introduction position to the base position and thereby move outwardly from the first tubular section when the guide element is separated from the ureteral stent base.

[0022] The distal base end in the basic position may preferably have a greater radial extension than in the introduction position. In this way, it is possible to prevent, for example, the ureteral stent base being guided through the ureter from slipping out or sliding out in an undesirable manner in the basic position. The ureteral stent base can be held in the ureter in a correspondingly secure manner. In contrast to the introduction position, the distal base end may preferably be twisted in the basic position. The same can be said for the proximal base end of the ureteral stent base opposite the distal base end. In other words, it may be specified that the proximal base end opposite the distal base end can also be autonomously transformed from the introduction position to the basic position. The proximal end may also preferably be twisted in the basic position. In particular, the two opposite base ends of the ureteral stent base may each be twisted in a J-shape in their respective basic positions. The opposing base ends may be stretched and preloaded in their respective introduction positions relative to the base position. In summary, the distal base end and / or the proximal base end may be transformed from the introduction position to the base position by separation of the guide element from the ureteral stent base. The distal base end and / or the proximal base end may be preloaded and held in the introduction position by the guide element. In summary, the distal base end and / or the proximal base end may preferably be twisted when transformed from the introduction position to the base position.

[0023] In another advantageous development of the invention, the distal base end is configured to pull the receptacle out of the recess via at least one coupling element upon movement of the distal base end outward from the first tubular section and by deformation from the introduction position to the base position. This has the advantage that, in this configuration, the receptacle can be separated from the introduction component by deformation of the distal base end and via the coupling element without further assistance. During the movement outward from the first tubular section, the distal base end is supported on the first tubular section during its deformation from the introduction position to the base position, so that the receptacle can be moved outward from the recess via the at least one coupling element.

[0024] In particular, the flexible guide element can first be pulled out of at least the first tubular section, whereby the distal base end can be transformed from an introduction position to a base position and can move autonomously outward from the first tubular section, whereby the distal base end is supported on the first tubular section and the receiving body can be pulled out of the recess via the coupling element, i.e. the distal base end can be automatically moved outward from the first tubular section by the transformation from the introduction state to the base state.

[0025] In another advantageous configuration of the insertion device according to the invention, the proximal first tubular section of the introduction component has a constriction in the proximal end region, the inner diameter of which is smaller than the outer diameter of the distal end of the ureteral stent base. It is also possible for the proximal first tubular section of the introduction component to be tapered in the proximal end region, such that the inner diameter of the constriction is smaller than the outer diameter of the distal end of the ureteral stent base. This ensures, according to the invention, that the distal end of the ureteral stent base cannot penetrate into the introduction component at all or too much. This reliably prevents the occurrence of difficulties in separating the two elements from each other.

[0026] In another advantageous configuration of the insertion device according to the invention, the proximal first tubular section of the introduction component may have a first tube through-opening, the diameter of which is reduced in the direction of the housing so that it is approximately equal or equal to the diameter of the through-opening of the housing. However, it is also possible that a tube is arranged in the proximal first tubular section of the introduction component, the tube having a tube through-opening, the diameter of which is reduced in the direction of the housing so that it is approximately equal or equal to the diameter of the through-opening of the housing. It is further possible that the tube has a tube through-opening, the diameter of which is approximately equal or equal to the diameter of the through-opening of the housing. The above-mentioned embodiment ensures a reliable and easy penetration and mobility of the guide element inside the respective through-openings of the ureteral stent base, the introduction component and the housing. A corresponding adaptation of the diameters can reliably prevent the guide element from colliding, for example, with an end face of the housing, and thus from moving further through the introduction component and the housing.

[0027] In another advantageous configuration of the insertion device according to the invention, the notch in the introduction component can have at least one bevel and / or at least one step in the end region on the side of the first tubular section, in which the diameter of the notch increases. The aforementioned bevel or step can also be formed by a distal end region of a tube arranged in the first tubular section proximal to the introduction component. The formation of such a bevel or step facilitates the sliding out of the housing from the notch when the ureteral stent base, the introduction component and the guide element are withdrawn from the housing.

[0028] In another advantageous configuration of the insertion device according to the invention, the proximal end region of the first tubular section of the introduction component is provided with at least one notch or edge cutout for receiving and guiding the connecting element, for example in the notch the ends of a thread-like or wire-like connecting element are guided together and at least partially held. Preferably, such a configuration prevents the distal end of the ureteral stent or of the ureteral stent base from being inadvertently separated from the proximal end of the introduction component.

[0029] In another advantageous configuration of the insertion device according to the invention, the proximal end region of the proximal first tubular section of the introduction component is formed in a hopper shape to accommodate the distal base end. It is also possible for the hopper shape to be formed by the proximal end region of a tube arranged in the proximal first tubular section of the introduction component. The hopper shape facilitates immobile docking of the distal ureteral stent base at the proximal end of the introduction component.

[0030] In another advantageous development of the invention, the at least one connecting region is provided in such a way that at least two tubular sections are tilted relative to one another by the at least one connecting region, so that they can be deformed between a release position in which the recess is at least partially widened for releasing the container and a holding position in which the recess is narrowed compared to the release position for holding the container. This has the advantage that, when configured in this way, the deformation of the connecting region from the holding position to the release position allows the container to be easily slid out of the recess. In other words, in the holding position the container can be held in the recess so that it is not lost, whereas in the release position the container can be particularly easily removed from the recess. Due to the deformation of the connecting region from the holding position to the release position, the central axes of each of the tubular sections can be tilted relative to one another and thus form an angle with one another. In the non-tilted state, the central axes of each of the tubular sections can be oriented parallel or coaxially with one another. The at least one connecting region can be particularly elastically deformable between the holding position and the release position.

[0031] In another advantageous development of the invention, the at least one connecting region can be held in a holding position by the guide element when the ureteral stent is held by the introduction component and when the guide element is introduced into the at least two tubular sections, and an elastic deformation of the at least one connecting region from the holding position to the release position can be prevented by the introduced guide element. This has the advantage that, when configured in this way, an elastic deformation of the connecting region from the holding position to the release position can be brought about only by separating the guide element from the introduction component. Accordingly, the separation of the guide element from the introduction component can also simultaneously support the separation of the ureteral stent, i.e. of the ureteral stent base and the housing, from the introduction component.

[0032] Thus, for example, a mechanical preload can be applied to the at least one coupling element in the holding position by means of a flexible guide element, which can be released by leading out the flexible guide element from the first tubular section, thereby allowing the coupling region to be deformed autonomously and elastically from the holding position to the release position.

[0033] The introduced guide element can thereby prevent elastic deformation of the coupling region from the holding position to the release position and accordingly can keep the coupling region under tension in its holding position.

[0034] In another advantageous configuration of the insertion device according to the invention, the coupling element is at least partially guided on the outer surface of the proximal end of the introduction component when the ureteral stent is held on the introduction component, such an arrangement of the coupling element being preferably structurally simple to produce.

[0035] In another advantageous embodiment of the insertion device according to the invention, the insertion device comprises an assembly sleeve, the inner diameter of which is equal to or greater than the outer diameter of the introduction component, which serves to fix the receptacle in the recess of the introduction component, so that the receptacle can be reliably held or fixed in the recess, in particular before the guide element is passed through the corresponding through-openings of the introduction component and the receptacle.

[0036] The second aspect of the invention relates to an introduction component for an insertion device according to the first aspect of the invention. The features and advantages disclosed in relation to the inventive insertion device according to the first aspect of the invention apply correspondingly to the inventive introduction component according to the second aspect of the invention and vice versa.

[0037] The third aspect of the invention relates to an insertion unit comprising an insertion device according to the first aspect of the invention and a flexible guide element to which a ureteral stent and an introduction component are attached. The features and advantages disclosed in relation to the inventive insertion device according to the first aspect of the invention and the inventive introduction component according to the second aspect of the invention apply correspondingly to the inventive insertion unit according to the third aspect of the invention, and vice versa. The flexible guide element may in particular be guided through the through openings of the ureteral stent base and the housing, respectively, and through the introduction component.

[0038] Further features of the invention are set out in the claims, the examples and the drawings. The features and combinations of features mentioned above in the specification and those described below in the examples can be used not only in the respective combinations mentioned, but also in other combinations without departing from the scope of the invention. [Brief description of the drawings]

[0039] [Figure 1] FIG. 2 is a schematic perspective view of an insertion unit including an insertion device and a flexible guide element along which a ureteral stent and an introduction component of the insertion device can be guided and shifted. [Diagram 2] FIG. 1 is a schematic side view of an insertion unit showing opposing movement directions along which the ureteral stent can be translated by the introduction component and relative to the flexible guide element, and also showing opposing rotational directions along which the ureteral stent can be rotated by the introduction component relative to the flexible guide element. [Figure 3a] FIG. 1 is a schematic plan view of a patient's urinary system. [Figure 3b] FIG. 13 is a plan view showing the introduction of a flexible guide element in the urinary system towards the kidney. [Figure 3c] FIG. 13 is a plan view showing the positioning of a ureteral stent through a guide element using an introduction component. [Figure 3d] FIG. 13 is a plan view showing removal of the guide element and introduction component. [Figure 3e] FIG. 2 is a plan view showing the desired position of a ureteral stent during proper use. [Figure 4] FIG. 2 is a schematic perspective view of an introduction component, the introduction component having a coupling region in a released position; [Diagram 5] FIG. 2 is a schematic side view of the introduction components. [Figure 6] FIG. 1 is a schematic perspective view of a distal base end of a ureteral stent base of a ureteral stent and a housing of the ureteral stent, the housing being connected to the distal base end via a connecting element of the ureteral stent. [Figure 7] FIG. 2 is a schematic side view of a distal base end and a housing coupled to the distal base end via a coupling element. [Figure 8a]1A-1D show schematic diagrams of different embodiments of an introduction component of an insertion device according to the invention; [Figure 8b] 1A-1D show schematic diagrams of different embodiments of an introduction component of an insertion device according to the invention; [Figure 8c] 1A-1D show schematic diagrams of different embodiments of an introduction component of an insertion device according to the invention; [Figure 9a] 13A-13C show schematic diagrams of yet another embodiment of an introduction component of an insertion device according to the invention. [Figure 9b] 13A-13C show schematic diagrams of yet another embodiment of an introduction component of an insertion device according to the invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0040] In the following figures, equal reference numbers relate to identical or equivalent features of the various embodiments of the insertion device 10.

[0041] 1 and 2 show different views of an insertion unit 100, which comprises an insertion device 10 and a flexible guide element 110, which may for example be formed as a guidewire, on one side of which the ureteral stent 20 can be arranged and on the other side of which the introduction component 50 of the insertion device 10 can be arranged.

[0042] The ureteral stent 20 comprises a ureteral stent base 30 and a housing 40 which is connected to the ureteral stent base 30 by at least one connecting element 22 of the ureteral stent 20. The at least one connecting element 22 is in this embodiment formed to be flexible or pliable and is formed as a thread element. However, an alternative configuration of the connecting element 22 as a wire element is also conceivable. As can be seen from the figures, the connecting element 22 is at least partially guided on the outer surface of the proximal end of the introducing component 50 when the ureteral stent 20 is held in the introducing component 50.

[0043] The introduction component 50 of the insertion device 10 serves to hold the ureteral stent 20 and to guide it, for example along the flexible guide element 110, through the ureter HL, visible in Figures 3a-3e, of the patient's urinary system. The urinary system is shown diagrammatically in Figure 3a without the insertion unit 100 or without the insertion device 10 and includes the urethra HR, the bladder BL, the ureter HL and the kidney NI.

[0044] To insert the ureteral stent 20 into the urinary system, as can be seen in FIG. 3b, first a flexible guide element 110 (here a guidewire) can be introduced into one of the kidneys NI via the urethra HR, the bladder BL and the ureter HL.

[0045] 3c shows how the ureteral stent 20 can then be pushed by the introducing component 50 along the guide element 110 through the bladder BL in the direction of the left ureter HL in the drawing plane and thus in the direction of the left kidney NI in the drawing plane. To enable this, the guide element 110 is introduced on the one hand into the base through-opening 31 assigned to the ureteral stent base 30 and on the other hand into the housing through-opening 42 assigned to the housing 40. Furthermore, the guide element 110 is guided through the respective tube through-openings 62, 72 of the introducing component 50 while the ureteral stent 20 is held in the introducing component 50.

[0046] From Fig. 3d it can be seen how the guide element 110 is removed as soon as the ureteral stent 20 has been partially introduced into the (left) kidney NI on the one hand and partially into the bladder BL on the other hand. Fig. 3e finally shows the predefined position of the ureteral stent 20 for its proper use. For the proper use of the ureteral stent 20, the opposing base ends of the ureteral stent base 30 are respectively bent in a J-shape at their respective use positions 36, so that undesirable slippage of the ureteral stent 20 inside the urinary system can be avoided.

[0047] The ureteral stent 20 can be translationally shifted inside the urinary system in opposite directions of movement R1, R2 by the introduction component 50. The opposite directions of movement R1, R2 are indicated by straight arrows pointing in opposite directions in FIG. 2. The introduction component 50 is further configured to guide the ureteral stent base 30 and the housing 40 in their respective directions of movement R1, R2 along the guide element 110 and inside the urinary system during the movement. Furthermore, the ureteral stent base 30 together with the housing 40 can be rotated in opposite directions of rotation D1, D2 synchronously and relative to the flexible guide element 110 by the introduction component 50. The rotation directions D1, D2 are indicated by curved arrows pointing in opposite directions in FIG. 2.

[0048] 1 and 2 further make it possible to see that at least one connecting element 22 (here a thread) is tensioned by the introducing component 50 when the ureteral stent 20 is held by the introducing component 50.

[0049] 1, 4 and 5 together, it is particularly clear that the introduction component 50 includes a notch 52 for introducing and holding the receptacle 40. The notch 52 serves as a receptacle for the receptacle 40. The introduction component 50 includes in this embodiment two tubular sections, a first tubular section 60 and a second tubular section 70, into which the flexible guide element 110 can be introduced, as already described in connection with FIG. 3c. The introduction component 50 further includes a connecting region 80, which connects the tubular sections 60, 70 to one another. The two tubular sections 60, 70 and the connecting region 80 together define the notch 52, as can be seen in particular in FIGS. 4 and 5.

[0050] The first tubular section 60 is formed in this embodiment as the proximal end of the introducing component 50, into which the distal base end 32 of the ureteral stent base 30, directed towards the housing 40, is partially introduced when the ureteral stent 20 is held in the introducing component 50 (see FIG. 1). The guide element 110, guided through the introducing component 50, the housing 40 and the ureteral stent base 30, holds the partially introduced distal base end 32 in tension, in particular in an extended state, in the introducing position 34. Moreover, the first tubular section 60, into which the distal base end 32 is introduced, also serves to hold the distal base end 32 in tension. That is to say, the first tubular section 60 can at least support the holding of the distal base end 32 in the introducing position 34 when the ureteral stent 20 is held in the introducing component 50. The distal base end 32 is configured to autonomously transform the distal base end 32 from the introduction position 34 to a base position 36, which is particularly clearly visible in FIG. 3e and in FIGS. 6 and 7, thereby autonomously moving the distal base end 32 outward from the first tubular section 60. In the base position 36 of the distal base end 32, the distal base end 32 is relaxed compared to the introduction position 34. By looking together at FIG. 2, in which the introduction position 34 of the distal base end 32 is particularly clearly visible, and at FIG. 7, which shows the base position 36 of the distal base end 32, it can be seen that the distal base end 32 is twisted differently in its base position 36 than in the introduction position 34, and thus has a greater radial extension than in the introduction position 34. The base position 36 avoids undesirable slippage of the ureteral stent base 30, and thus the entire ureteral stent 20, inside the urinary system.

[0051] The distal base end 32 is configured to pull the receiving body 40 out of the recess 52 via the coupling element 22 upon (autonomous) outward movement of the distal base end 32 from the first tubular section 60 and by deformation from the introduction position 34 to the base position 36. For this purpose, the flexible guide element 110 can first be pulled out of at least the first tubular section 60 and thus from the first tube through-opening 62, whereby the distal base end 32 elastically and thus autonomously deforms from the introduction position 34 to the base position 36 and thereby moves autonomously outward from the first tubular section 60. During the deformation, the distal base end 32 is supported on the first tubular section 60 and the receiving body 40 can be pulled out of the recess 52 via the coupling element 22. That is, the distal base end 32 is configured to pull the container 40 out of the notch 52 via the coupling element 22 upon its outward guiding from the first tubular section 60 and upon deformation from the introduction position 34 to the basic position 36.

[0052] In order to facilitate the withdrawal of the container 40 from the recess 52, the connection area 80 is elastically deformable between a release position 84 shown in Figures 4 and 5, in which both tubular sections 60, 70 are tilted relative to one another by the connection area 80, whereby the recess 52 is partially widened to release the withdrawal of the container 40, and a retention position 86 shown in Figures 1 and 2, in which the recess 52 is narrowed compared to the release position 84 to retain the container 40.

[0053] As long as the flexible guide element 110 (guide wire) is guided through both tube through-openings 62, 72 of each tubular section 60, 70 of the introduction component 50 and through the base through-opening 31 and the housing through-opening 42, the flexible guide element 110 prevents elastic deformation of the coupling region 80 from the holding position 86 of the coupling region 80 to the release position 84 of the coupling region 80, in particular holds the coupling region 80 with a preload in the holding position 86. However, as soon as the flexible guide element 110 is completely withdrawn at least from the base through-opening 31 and the first tube through-opening 62, the flexible guide element 110 no longer prevents elastic deformation of the coupling region 80 from the holding position 86 of the coupling region 80 to the release position 84 of the coupling region 80, whereby the coupling region 80 can elastically deform autonomously from the holding position 86 to the release position 84. The resulting inclination of the two tubular sections 60, 70 widens the notch 52, as can be seen particularly clearly in FIGS.

[0054] That is, the bonding region 80 is thereby preloaded and held in the holding position 86 by the guide element 110 when the ureteral stent 20 is held by the introducing component 50 and when the guide element 110 is introduced into the tubular sections 60, 70. An elastic deformation of the bonding region 80 from its holding position 86 to its release position 84 can then be prevented by the introduced guide element 110, as long as the guide element 110 is introduced in particular into the first tube through-opening 62 of the first tubular section 60 and into the base through-opening 31 of the ureteral stent base 30.

[0055] In summary, the introduction component 50 allows the movement of the ureteral stent 20 (i.e., the ureteral stent base 30 and the housing 40 connected to the ureteral stent base 30 via the linking element 22), i.e., rotational movement D1, D2 and translational movement along different directions of movement R1, R2 relative to the flexible guide element 110 (guidewire), thereby allowing the positioning of the ureteral stent 20 by pushing and pulling back the ureteral stent 20 and by rotating the ureteral stent 20 during insertion of the ureteral stent 20 into the urinary system.

[0056] That is to say, the introducing component 50, which may also be called an introducing aid, serves to position the ureteral stent 20, and the introducing component 50 does not require any additional mechanisms, and in particular no special movements are required to separate the ureteral stent 20 from the introducing component 50 after its positioning. Based on the special configuration of the introducing component 50, it is sufficient to pull out the flexible guide element 110 from the ureteral stent 20 and the introducing component 50, whereby separation of the ureteral stent 20 from the introducing component 50 can be performed.

[0057] The connection between the introduction component 50 (pusher) and the ureteral stent 20 can in particular be separated autonomously upon withdrawal of the flexible guide element 110, without movements specifically made for that purpose.

[0058] The bond between the ureteral stent 20 and the introducing component 50 can in particular be separated by a spring-elastic movement of the distal base end 32 from an introducing position 34 of the distal base end 32 to a base position 36 of the distal base end 32 and another spring-elastic movement of the bonding region 80 from a holding position 86 of the bonding region 80 to a release position 84 of the bonding region 80. The bonding region 80 can be assigned to a proximal end of the introducing component 50.

[0059] The coupling region 80 first undergoes a reversible shape change upon introduction of the flexible guide element 110, which causes the coupling region 80 to tense and deform from the release position 84 to the retaining position 86. In the retaining position 86, a better fit of the receptacle 40 in the notch 52 of the introduction component 50 is provided than in the release position 84. The reverse deformation of the coupling region 80 from the retaining position 86 back to the release position 84 can be caused by withdrawal of the flexible guide element 110 from at least the base through opening 31 and the first tube through opening 62. In the release position 84, compared to the retention position 86, simple removal of the receptacle 40 from the notch 52 (which is widened in the release position 84 of the coupling region 80) can be performed. The distal base end 32 also undergoes a reversible shape change from the basic position 36 to the introduction position 34 by introduction of the flexible guide element 110 into the base through opening 31. An autonomous, reverse and therefore retrograde elastic deformation of the distal base end 32 from the introduction position 34 to the base position 36 is effected by withdrawal of the guide element 110 from at least the base through opening 31. This retrograde elastic deformation from the introduction position 34 to the base position 36 causes withdrawal of the receiving body 40 by the distal base end 32 via the coupling element 22.

[0060] 8a-8c show different embodiments of the introduction component 50 of the insertion device 10 in schematic form. In FIG. 8a, the introduction component 50 is shown with the receiving body 40 inserted in the recess 52. As can be seen from the figures, the recess 52 has a bevel 88 in the end region facing the first tubular section 60, by means of which the diameter of the recess 52 increases continuously outwardly in the region of the bevel 88. The bevel 88 facilitates the withdrawal of the receiving body 40 from the recess 52 by means of the distal end 32 of the ureteral stent base body 30 (not shown here). As can also be seen from the figures, the connecting element 22 is made thread-like and is arranged extending into the receiving body 40 through a corresponding opening in the receiving body 40.

[0061] In Fig. 8b, another embodiment of the introduction component 50 is shown with the housing 40 inserted in the notch 52. As can be seen, the first proximal tubular section 60 of the introduction component 50 has a constriction 92 in the proximal end region, whereby the inner diameter of the constriction 92 is smaller than the outer diameter of the distal end 32 of the ureteral stent base 30 (not shown here). As can also be seen, the proximal end of the proximal tubular section 60 is hopper-shaped. In Fig. 8c, yet another embodiment of the introduction component 50 is shown with the housing 40 inserted in the notch 52. As can be seen, here the first proximal tubular section 60 of the introduction component 50 is tapered in the proximal end region, whereby the inner diameter of the constriction 92 is smaller than the outer diameter of the distal end 32 of the ureteral stent base 30 (not shown here). These configurations allow the distal end 32 of the ureteral stent base 30 to not penetrate into the introduction component at all or too far, thus potentially preventing difficulty in separating the distal end 32 from the introduction component 50.

[0062] 9a and 9b show a schematic representation of another embodiment of the introduction component 50 of the insertion device 10. In FIG. 9a, the introduction component 50 is shown with the housing 40 inserted in the notch 52. As can be seen from the drawing, according to this embodiment, a tube 94 is arranged in the first proximal tubular section 60 of the introduction component 50, the tube 94 having a tube through-opening 96, the diameter of which is approximately equal to or equal to the diameter of the through-opening 42 of the housing 40. Furthermore, the tube 94 has a beveled portion 88 at its distal end, which increases the diameter of the notch 52. The beveled portion 88 here extends over a length of approximately half the diameter of the tube 94 at an angle of 45°. The proximal end of the tube 94 is shaped like a hopper to receive the distal end 32 of the ureteral stent base 30. As can furthermore be seen from the drawing, the proximal end region of the proximal tubular section 60 is provided with notches 98 for introducing and holding the thread-like connecting element 22, in particular for receiving both ends of the thread-like connecting element 22. Both ends of the thread-like connecting element 22 are fixed to the distal end 32 of the ureteral stent base 30. The insertion device 10 according to this embodiment further comprises an assembly sleeve 90, which is formed in such a way that the inner diameter of the assembly sleeve 90 is equal to or greater than the outer diameter of the introduction component 50. The assembly sleeve 90 serves to fix the housing 40 in the notch 52 of the introduction component 50 before guiding the guide element 110 (not shown here) through the corresponding through-openings 72, 96, 42 of the introduction component 50, the tube 94 and the housing 40. In this way, the housing 40 can be reliably held or fixed in the notch 52.

[0063] The embodiment of the introducing component 50 shown in Fig. 9b corresponds to the embodiment described and shown in Fig. 9a. In contrast to the introducing components described above, the bevel 88 formed in the distal region of the tube 94 extends over the entire diameter of the tube 94. This bevel 88 also serves to expand the diameter of the notch 52 radially outward. As can further be seen from the figures, the introducing component 50 shown in Figs. 9a and 9b is further formed with a rounded proximal end. This configuration results in an advantageous atraumatic tip design of the introducing component 50.

Claims

1. An insertion device (10), comprising: a ureteral stent (20) comprising a ureteral stent base (30) and a housing (40) connected to the ureteral stent base (30) by at least one connecting element (22) of the ureteral stent (20); an introduction component (50) for holding the ureteral stent (20) and guiding the ureteral stent (20) along a flexible guide element (110) through the patient's ureter (HL); An insertion device (10) comprising: the ureteral stent (20) is movable in opposite directions of movement (R1, R2) along the flexible guide element (110) by the introducing component (50); the introduction component (50) is configured to guide the ureteral stent base (30) and the housing (40) during movement in each of the directions of movement (R1, R2); The introduction component (50) comprises a notch (52) for introducing and holding the container (40); the introduction component (50) comprises at least two tubular sections (60, 70) into which the flexible guide element (110) can be introduced and at least one joining area (80) joining the at least two tubular sections (60, 70) to one another, the at least two tubular sections (60, 70) and the at least one joining area (80) defining the notch (52); a first tubular section (60) of the at least two tubular sections (60, 70) is formed as a proximal end of the introduction component (50) into which a distal base end (32) of the ureteral stent base (30) directed towards the housing (40) is at least partially introduced, at least when the ureteral stent (20) is held in the introduction component (50); An insertion device (10).

2. The insertion device (10) according to claim 1, characterized in that the container (40) has ferromagnetic properties.

3. The insertion device (10) according to claim 1 or 2, characterized in that the ureteral stent base (30) together with the housing (40) is rotatable relative to the flexible guide element (110) based on the introduction component (50).

4. The insertion device (10) according to any one of the preceding claims, characterized in that the at least one connecting element (22) is made flexible or pliable.

5. 5. The insertion device (10) according to claim 1, wherein the at least one coupling element (22) is tensioned by the introduction component (50) when the ureteral stent (20) is held on the introduction component (50).

6. 6. The insertion device (10) according to claim 4 or 5, characterized in that the at least one connecting element (22) is formed as a thread or wire element.

7. 7. The insertion device (10) according to claim 1, characterized in that the at least partially introduced distal base end (32) can be held in an introduction position in the first tubular section by the guide element (110) when the ureteral stent (20) is held on the introduction component (50), and the distal base end (32) is configured to autonomously transform from the introduction position (34) of the distal base end (32) to a basic position (36) upon separation of the guide element (110) from the ureteral stent base (30), thereby moving outward from the first tubular section (60).

8. 8. The insertion device (10) of claim 7, wherein the distal base end (32) is configured to pull the housing (40) out of the notch (52) via the at least one coupling element (22) upon movement of the distal base end (32) outward from the first tubular section (60) and deformation from the introduction position (34) to the base position (36).

9. 9. The insertion device (10) according to any one of claims 1 to 8, characterized in that the proximal first tubular section (60) of the introducing component (50) has a constriction (92) in its proximal end region, the inner diameter of which is smaller than the outer diameter of the distal end (32) of the ureteral stent base (30) or the proximal first tubular section (60) of the introducing component (50) is tapered in its proximal end region such that the inner diameter of the constriction (92) is smaller than the outer diameter of the distal end (32) of the ureteral stent base (30).

10. 10. The insertion device (10) according to any one of claims 1 to 9, characterized in that the proximal first tubular section (60) of the introduction component (50) has a first tube through-opening (62) whose diameter is reduced in the direction of the housing (40) so as to be approximately equal to or equal to the diameter of the through-opening (42) of the housing (40).

11. 10. The insertion device (10) according to claim 1, characterized in that a tube (94) is arranged in the first tubular section (60) proximal to the introduction component (50), the tube (94) having a tube through opening (96) whose diameter is reduced in the direction of the housing (40) so as to be approximately equal to or equal to the diameter of the through opening (42) of the housing (40), or the tube (94) has a tube through opening (96) whose diameter is approximately equal to or equal to the diameter of the through opening (42) of the housing (40).

12. 12. The insertion device (10) according to claim 1, characterized in that the recess (52) has at least one inclined portion (88) and / or at least one step in the end region on the side of the first tubular section (60), and the diameter of the recess (52) increases in the region of the inclined portion (88) or the step.

13. 13. The insertion device (10) according to claim 1, characterized in that the proximal end region of the first tubular section (60) proximal to the introduction component (50) is formed with at least one notch (98) or edge cutout for receiving and guiding the coupling element (22).

14. 14. The insertion device (10) according to claim 1, characterized in that a proximal end region of the first tubular section (60) proximal to the introduction component (50) is shaped like a hopper to receive the distal base end (32).

15. 12. The insertion device (10) according to claim 11, characterized in that the proximal end region of the tube (94) is hopper-shaped to receive the distal base end (32) and / or the distal end region of the tube (94) has at least one inclined portion (88) and / or at least one step, the diameter of the notch (52) increasing in the region of the inclined portion (88) or the step.

16. 16. The insertion device (10) according to claim 1, characterized in that the at least two tubular sections (60, 70) are tilted relative to one another by the at least one connecting region (80), whereby the notch (52) is deformable between a release position (84) in which the notch (52) is at least partially widened to release the container (40) and a holding position (86) in which the notch (52) is narrowed compared to the release position (84) to hold the container (40).

17. 17. The insertion device (10) according to claim 16, characterized in that the at least one bonding region (80) can be held in the holding position (86) based on the guide element (110) when the ureteral stent (20) is held by the introduction component (50) and when the guide element (110) is introduced into the at least two tubular sections (60, 70), and elastic deformation of the at least one bonding region (80) from the holding position (86) to the release position (84) can be prevented by the introduced guide element (110).

18. 18. The insertion device (10) according to any one of claims 1 to 17, characterized in that the coupling element (22) is at least partially guided by an outer surface of the proximal end of the introduction component (50) when the ureteral stent (20) is held on the introduction component (50).

19. 19. The insertion device (10) according to any one of claims 1 to 18, characterized in that the insertion device (10) comprises an assembly sleeve (90) formed such that the inner diameter of the assembly sleeve (90) is equal to or greater than the outer diameter of the introduction component (50).

20. An introduction component (50) for an insertion device (10) according to any one of claims 1 to 19.

21. An insertion unit (100) comprising an insertion device (10) according to any one of claims 1 to 19 and a flexible guide element (110) on which the ureteral stent (20) and the introducing component (50) are attached.

Images