Annuloplasty device

Abstract

The invention relates to an annuloplasty device for use on the posterior annulus of a mitral valve, comprising at least first and second anchoring units, preferably a plurality of anchoring units, the anchoring units being deployable to the mitral valve by means of a vascular delivery device such as a catheter, and being positionable along the annulus in a row, comprising anchoring means arranged on each of the first and second anchoring units, wherein the first and second anchoring units are interconnected by connecting means defining a distance between the first and second anchoring units, further comprising a pulling means for reducing the distance between the first and second anchoring units in order to pull the annulus together, wherein the anchoring units are arranged to be rotatable relative to each other about a longitudinal axis extending along the row.

Description

Technical Field

[0001] This invention relates to an annuloplasty device for the posterior annulus of the mitral valve, comprising at least first and second anchoring units, preferably multiple anchoring units, which can be deployed to the mitral valve by means of a vascular delivery device such as a catheter, and can be positioned in a row along the annulus, including anchoring devices disposed on each of the first and second anchoring units. Furthermore, this invention relates to a delivery device for delivering and deploying the annuloplasty device to the annulus of the mitral valve. Background Technology

[0002] The annulusoplasty device according to the invention is alternatively used on the tricuspid valve, preferably on the parietal leaflet of the tricuspid valve.

[0003] The mitral valve is located in the left side of the heart, between the left atrium and left ventricle. It consists of two leaflets, the anterior and posterior leaflets, separated by two commissures: the anterolateral commissure and the posteromedial commissure. The anterior leaflet is divided into three regions, A1, A2, and A3, and the posterior leaflet is divided into three regions, P1, P2, and P3. The opening of the mitral valve is surrounded by the mitral annulus, a fibrous ring attached to the leaflets. The mitral annulus is saddle-shaped and contracts during systole, reducing its surface area to help the leaflets close completely. Pathological expansion of the annulus can lead to maljunction of the leaflets, meaning the leaflets cannot close properly, which in turn leads to mitral regurgitation.

[0004] Under normal circumstances, blood flows through the open mitral valve during the diastolic phase of left atrial contraction and closes during the systolic phase of left ventricular contraction. The valve opens and closes due to the pressure difference in the heart; that is, the mitral valve opens when the pressure in the left atrium is greater than the pressure in the ventricle, and closes when the pressure in the ventricle is greater than the pressure in the atrium.

[0005] The shape and size of the mitral valve annulus change during the cardiac cycle. Due to the contraction of the left atrium surrounding it, the mitral valve annulus is smaller at the end of atrial systole, acting like a sphincter, which is important for the proper engagement of the mitral valve leaflets as the left ventricle contracts and pumps blood.

[0006] Leaking valves can be corrected through mitral valve annuloplasty, the purpose of which is to restore proper leaflet adjustment. The annuloplasty device is attached to the annulus of the mitral valve, preferably to the posterior annulus, and is typically used to shorten the circumferential length of the pathologically stretched annulus of the mitral valve by 20-30%, thereby allowing proper mitral valve engagement.

[0007] WO2008 / 088716A1 discloses a valve annuloplasty device, which includes a support and a tether. The support has a plurality of anchoring units arranged at equal intervals. The tether is connected to the support and the plurality of anchoring units and is configured to pull proximally to reduce the circumference of the mitral valve.

[0008] The main drawback of the device disclosed in WO2008 / 088716A1 is that securing the device to the valve annulus of the human heart is unreliable because the anchoring unit is secured solely by pushing and / or pulling the unit along the valve annulus, thus allowing the anchoring unit to self-attach to the tissue during movement. Since the attachment of the unit to the tissue is therefore unpredictable and does not typically occur in all anchoring unit cases, the device disclosed in WO2008 / 088716A1 tends to detach from the heart tissue, or even worse, the detachment of the entire device occurs simultaneously with the detachment of a portion of the heart tissue, which in turn leads to the continued presence of mitral regurgitation.

[0009] Furthermore, because the device disclosed in WO2008 / 088716A1 causes uniform contraction of the valve annulus, and the distance between each anchoring unit is reduced to an equal value due to the uniformly selected distance between the anchoring parts of the device, it cannot take into account the individual needs of patients caused by changes in the annulus's anatomy or pathological expansion patterns. Therefore, implantation of the device disclosed in WO2008 / 088716A1 can result in excessive contraction in one region of the valve annulus and insufficient contraction in another region. Therefore, adequate valvular function cannot be guaranteed after implantation of the device disclosed in WO2008 / 088716A1. Summary of the Invention

[0010] Therefore, one object of the present invention is to provide an improved valve annulus reconstruction device that provides a reliable and permanent attachment to the valve annulus and takes into account changes in the anatomical shape or pathological changes in the shape of the valve annulus, thereby effectively simulating a surgical procedure in which sutures are knotted to reconstruct the valve annulus while avoiding extensive surgery.

[0011] To achieve the stated objective, the valve annulusoplasty apparatus according to the invention includes at least first and second anchoring units, whereby the first and second anchoring units are interconnected by a connecting means that defines a distance between the first and second anchoring units, and further includes a traction means for reducing the distance between the first and second anchoring units in order to pull the valve annulus together, wherein the anchoring units are arranged to be rotatable relative to each other about a longitudinal axis extending along the row.

[0012] By arranging the anchoring units so that they are rotatable relative to each other, the anchoring units can be rotated one after another to a position for engagement with the valve annulus, thereby attaching each unit sequentially to the valve annulus. Specifically, the anchoring units can be arranged in a row within the vascular delivery device and deployed sequentially from the device, such that the anchoring units can be fixed to the valve annulus in a row according to the shape of the valve annulus. Thus, each anchoring unit has a longitudinal axis extending along the row of units, wherein each anchoring unit is arranged to be rotatable about said longitudinal axis.

[0013] In the context of this invention, the contraction occurs by reducing the distance between the two anchoring units, thereby shrinking the intermediate tissue.

[0014] As mentioned above, human valve annulus can exhibit varying degrees of extensibility and / or different anatomical shapes. For example, in patients with posterior wall infarction, the valve annulus in the P3 region of the posterior leaflet is more dilated than that in the P1 region. Therefore, to provide individual adaptation properties for the different shapes of the individual valve annulus, the connecting device defines a distance between at least the first and second anchoring units, wherein said distance is adaptable to the individual characteristics of the valve annulus.

[0015] The normal length of an undilated valve annulus is between 18 and 32 mm. Therefore, if the length is greater than this range, i.e., >32 mm, the valve annulus is classified as dilated.

[0016] For example, in the case of low expansion of the annulus, the distance between the anchoring units can preferably be selected between 1 and 2.5 mm. In the case of high expansion, the distance can preferably be selected between 2.5 mm and 4 mm. The length of the anchoring unit can preferably be selected between 2 and 10 mm.

[0017] The connection means provided for interconnecting the first and second anchoring units are configured to allow the units to rotate relative to each other about their longitudinal axis as desired.

[0018] The traction device provides appropriate traction, i.e., appropriate movement of the anchoring units toward each other, which in turn causes appropriate contraction of the petioles in the region between the units. In the case of multiple anchoring units comprising at least two pairs of anchoring units, each traction device is arranged to apply tension between two anchoring units in a pair of anchoring units, wherein the pairs of anchoring units are connected to each other without a traction device.

[0019] According to the invention, the anchoring units are arranged to rotate relative to each other, thus enabling reliable and permanent attachment of the annulusoplasty device to the annulus. As the anchoring units rotate relative to each other, the anchoring devices arranged on each of the first and second anchoring units move toward the annulus, thereby allowing the anchoring devices to insert themselves into the tissue, which significantly facilitates device attachment to the annulus.

[0020] Preferably, the anchoring units are arranged to rotate relative to each other about 45-120°, more preferably 80-100°, about the longitudinal axis. This type of rotation angle allows the anchoring device arranged on the anchoring unit to rotate between a first angular position and a second angular position, wherein the anchoring device is positioned to disengage from the lobed ring at the first angular position and to engage with the lobed ring at the second angular position.

[0021] To save space and provide a reliable connection to the tissue, the traction device and the connecting device are preferably integrally formed with each other. The space-saving design is particularly advantageous in allowing the device to be properly placed inside the vascular delivery device.

[0022] More preferably, the connecting device is formed as a spring and / or made of a shape memory alloy, preferably nitinol. The spring or other flexible element is deformable to apply tension between their connection points, advantageously combining the functions of a traction device and a connecting device. The spring applies a predetermined tension to the anchoring unit to which it is connected, while the shape memory alloy can be used to control the tension through instructed and controlled deformation of the shape memory material. Furthermore, when deployed from the delivery device, the connecting device also allows the anchoring units to rotate relative to each other.

[0023] The traction device preferably includes an electromagnet and / or an electroactive polymer and / or a pneumatic device and / or a vacuum chamber and / or a line, all of which are capable of attracting an anchoring unit to its adjacent anchoring unit.

[0024] The traction device can be connected to a mechanical or electrical command line that extends through a delivery device, such as a catheter, to an external control device that allows a medical operator to initiate and control the traction action applied by the traction device. In the case where the traction device is configured as a line, the line can extend through the delivery device to the external control device, where the medical operator can pull the line to constrict the valve annulus in the area between the various anchoring units.

[0025] The anchoring device is preferably anything that can properly secure the device to the heart tissue, such as needles and / or hooks and / or clips and / or rivets, which are preferably barbed.

[0026] To effectively prevent tissue tearing and to effectively prevent the anchoring unit from separating from the tissue, the anchoring device preferably has a trident shape, which allows the anchoring unit to be firmly attached to the heart tissue.

[0027] To further enhance the attachment properties of the device, preferably at least one anchoring device, and more preferably multiple anchoring devices, are arranged on each of the first and second anchoring units. The more anchoring devices fixed to each anchoring unit, the more attachment points are established between the anchoring unit and the cardiac tissue, which makes the connection between the anchoring unit and the tissue more reliable.

[0028] The anchoring device is preferably deployable from a first position to a second position, in which the anchoring device is retracted and positioned within the delivery device, and in the second position, the anchoring device is deployed. Since the device is implanted into the heart via, for example, a catheter, the smaller the diameter of the catheter, the less invasive the applicable methods for introducing the annulusoplasty device into the heart. The retracted position of the anchoring device helps to achieve a space-saving embodiment of the device, which is easy to assemble into the catheter. The anchoring device is deployed when pushed out of the delivery device and attaches to the tissue as the anchoring units rotate about their longitudinal axis.

[0029] To provide initial and more reliable connection to the annulus, the distal end of the annulusoplasty device preferably carries a fixing device for securing the distal end of the annulusoplasty device to the annulus. Since the fixing devices are attached to the distal end of the device, their attachment to the annulus occurs before the first anchoring unit is deployed, thus defining the starting point for the anchoring unit deployment.

[0030] The fixation device can be attached to one and / or both ends of the valve annulus and / or the middle of the valve annulus, which allows the device to be deployed according to the anatomical shape of the valve annulus.

[0031] More preferably, the fixation device is formed by clamps and / or pliers. Both clamps and pliers are used to grasp the valve annulus. In the case of pliers, tissue can also be penetrated, thereby achieving a more secure fixation of the device to the valve annulus.

[0032] As previously described, the valve annuloplasty device according to the present invention is deployed by means of a delivery device.

[0033] Accordingly, in one independent aspect of the invention, a delivery device for delivering and deploying an annulusoplasty device to the annulus of the mitral valve is provided, comprising at least one flexible tube in which the annulusoplasty device is housed prior to delivery; a guide wire for guiding the flexible tube to the annulus; and a retraction device for retracting the flexible tube relative to at least first and second anchoring units of the annulusoplasty device to sequentially release the anchoring units from the flexible tube.

[0034] Implantation of annulusoplasty devices is achieved, for example, via catheter delivery, whereby a flexible tube containing the annulusoplasty device is delivered to the implantation site in the human heart. The flexible tube is guided precisely to the annulus by a guide wire connected to the delivery device and / or the annulusoplasty device, and can be manipulated by the catheter. Upon reaching the implantation site, the flexible tube must be retracted, achieved by a retraction device, which can also be manipulated by the catheter. The retraction of the flexible tube causes the anchoring units housed within the tube to be successively released to the implantation site, where the anchoring devices of the anchoring units are successively attached to the cardiac tissue by induced rotation about their longitudinal axis.

[0035] To enable the annulusoplasty device to be simultaneously attached to the annulus from both ends toward its intermediate segment, or from the intermediate segment toward both ends of the annulus, it is preferable to provide first and second flexible tubes, wherein, prior to delivery, the first segment of the annulusoplasty device is housed in the first flexible tube, and the second segment of the annulusoplasty device is housed in the second flexible tube.

[0036] Furthermore, the flexible tubing and / or annulusoplasty device may be equipped with multiple push wires attached to a ring at its proximal end. This ring surrounds and is axially movable over the guide wire of the catheter, and the push wires are secured to the flexible tubing and / or annulusoplasty device at their distal ends, thereby allowing the ring and therefore the push wires to be manipulated by the catheter. Upon reaching the implantation site, the ring moves toward the implantation site, and the push wires are pushed apart by the axial movement of the ring, spanning 30-100°, thus resembling the shape of a valve annulus before the annulusoplasty device is actually implanted.

[0037] Fixation using a fixation device positioned at the distal end of the annulusoplasty device defines the delivery origin as the endpoint and / or intermediate segment of the annulus, which in turn helps to predefine the desired device attachment pattern, i.e., a pattern similar to the anatomy of the annulus.

[0038] Preferably, the wall of the tube has a shape-fitting cross-sectional profile on its inner side that corresponds to the cross-sectional profile of the outer surface of the anchoring unit, to prevent the anchoring unit from rotating when disposed within the flexible tube. As long as the anchoring unit is disposed within the tube, the shape-fitting profile secures the anchoring unit in its first angular position. When the anchoring unit is deployed from the tube, it is released from the shape-fitting profile and freely rotates to its second angular position. This rotation can be controlled externally by a suitable control device such as a control line, or automatically induced by an active guiding device disposed within the tube, such as a guide surface, which cooperates with the anchoring unit to forcibly control the rotation in response to its longitudinal displacement. When the anchoring unit is released from the retracted tube, the rotation of the anchoring unit causes the anchoring devices of the anchoring unit to successively attach to the tissue along the retraction path of the tube.

[0039] To facilitate individual adaptation of the annulusoplasty device housed within the tube and to increase the likelihood of reliable attachment of the device to tissue, the tube preferably includes an axial extension whose internal cross-sectional profile allows the anchoring unit to rotate about 45-120°, preferably 80-100°, about a longitudinal axis, wherein the cross-sectional profile preferably includes a stop surface for limiting the rotational movement of the anchoring unit. Therefore, the rotational movement of the device can be individually adapted to the structure of the annulus, thereby suiting the individual needs of the patient.

[0040] In addition, the annulusoplasty device can preferably be connected to another device for mitral valve repair, such as an artificial leaflet. Attached Figure Description

[0041] The present invention will be described below by way of some exemplary embodiments.

[0042] Figure 1a This is a side view of an exemplary embodiment of the annulusoplasty device according to the present invention. Figure 1b Is it like this? Figure 1a Top view of the embodiment shown. Figures 2a-2c Cross-sectional, perspective, and side views of an exemplary embodiment of a delivery device according to the present invention are shown, the delivery device accommodating annulusoplasty equipment prior to delivery to cardiac tissue. Figures 3a-3c The diagram shows a cross-section, perspective view, and side view of the delivery device, in which the first anchoring unit of the annulustomosis device exits the tube and before its rotation. Figures 4a-4c Cross-section, perspective, and side views of the delivery device are depicted, with the first anchoring unit of the valve annulusop apparatus in its position as shown in Figure 4, but rotated. Figures 5a-5d Views of delivery devices with annuloplasty equipment are shown at different implantation stages. Detailed Implementation

[0043] exist Figure 1a and 1b In the accompanying drawings, exemplary embodiments of the annulusoplasty device according to the present invention are described with reference numeral 1. The annulusoplasty device 1 includes first, second, third, and fourth anchoring units 2, 3, 4, and 5 positioned in a row. Anchoring units 2 and 3 are interconnected by spring devices 6, and anchoring units 4 and 5 are interconnected by spring devices 7. Anchoring unit pairs 2, 3 and 4, 5 are interconnected via connecting devices 8. Each anchoring unit 2, 4, and 5 includes anchoring devices 9, 10, 11, and 12 having a trident shape, which are arranged on the ends of anchoring units 2, 3, 4, and 5 opposite to the springs 6 and 7. Anchoring units 2, 3, 4, and 5 are rotatable about their longitudinal axis according to arrow X.

[0044] Figure 2a A cross-sectional view showing an exemplary embodiment of the flexible tube 13 of the delivery device according to the present invention is shown. Figure 2b Showing its perspective view, and Figure 2c The image shows a side view of the flexible tube that houses the annulusoplasty device before it is delivered to the heart tissue.

[0045] With targeting Figure 1a -1c has already described that the corresponding parts are equipped with the same reference numerals.

[0046] In the depicted embodiment, a first anchoring unit 2 is shown prior to delivery from the tube 13 of the delivery device. Anchoring devices 9 are fixed to the ends of the anchoring units 2 for rotation about axis 9b and are shown in their retracted position. The wall of the tube 13 has a cross-sectional profile on its inner side that provides a form fit with a corresponding cross-sectional profile of the outer surface of the anchoring unit 2, which includes the anchoring devices 9 in its retracted position, thereby preventing rotation of the anchoring unit 2 as long as it is arranged within the flexible tube 13. To provide the form fit, the tube 13 includes two longitudinal grooves 29, in which the noses 30 of the anchoring units 2 are each guided.

[0047] Furthermore, the tube 13 includes an extension 14 having an internal transverse cross-sectional profile different from that of the tube 13, so as to allow the anchoring unit 2 to rotate once the anchoring unit is removed from the tube 13. The extension 14 includes a stop surface 15 that restricts the rotational movement of the anchoring unit 2 after its deployment (see [link to documentation]). Figures 4a-4c ).

[0048] Figure 3a It shows Figures 2a-2c A cross-sectional view of an exemplary embodiment of the flexible tube 13 of the delivery device depicted in the figure. Figure 3b Its perspective view is shown, and Figure 3c A side view is shown, in which the first anchoring unit 2 of the annulusoplasty device has been removed from the tube 13 and positioned in the extension 14 before rotation. Figures 3a-3c It can be seen that the anchoring devices 9 have been deployed to their second unretracted position by rotational movement about axis 9b, which occurs immediately after the entire anchoring device 9 has left the shape-fitting profile 16 of tube 13.

[0049] Figure 4a A cross-section of the delivery device having the first anchoring unit 2 of the valve annuloplasty apparatus according to Figure 2 is depicted. Figure 4b Its perspective view was depicted, and Figure 4cA side view is depicted, but in which the anchoring unit 2 has been rotated. The rotation is induced by the spring device 6, which generates its rotational force after the anchoring unit 2 has been fully delivered beyond the form-fitting portion 16 of the tube 13. In its rotated position, as shown in FIG4, the anchoring device 9 engages with the petal ring, thereby securing the anchoring unit 2 to the petal ring.

[0050] Figures 5a-5d Views are depicted of delivery devices carrying annulusoplasty devices at different implantation stages. From Figures 5a-5d As can be seen, the delivery device 17 includes a first flexible tube 13 and a second flexible tube 18, a guide wire 29, multiple push wires 30, and a conduit cannula 19. The flexible tubes 13 and 18, the guide wire 29, and the push wires 30 are used to deliver the product to… Figure 5a The position shown was previously accommodated in the catheter cannula.

[0051] exist Figure 5a In the middle, the flexible tubes 13 and 18 of the delivery device 17, a portion of the guide wire 29, and the push wire 30 have been released from the conduit sleeve 19, thereby... Figure 5b In this configuration, flexible tubes 13 and 18 have an anatomical shape resembling a valve annulus, achieved via a movable ring 31 to which a pusher wire 30 is attached proximally, from which... Figure 5a The position shown is moved along its axis according to arrow X to, as... Figure 5b The position shown. Axial movement of ring 31 causes push line 30 to be pushed open at a 90° angle.

[0052] Fixation devices 27 and 28 are attached to the distal ends of the annulusoplasty devices 1 and 20 for fixing the distal ends of the annulusoplasty devices 1 and 20 to cardiac tissue (not shown), wherein the fixing occurs before the release of the first anchoring units 2 and 21, respectively.

[0053] After the fixation devices 27 and 28 are attached, the push wire 30 can be retracted from the implantation site via the axially moving ring 31 in the direction of arrow Z. Figure 5c ).

[0054] The deployment of anchoring units 2, 3, 4, 5 of annulusoplasty device 1 and anchoring units 21, 22, 23, 24 of annulusoplasty device 20 begins from the free ends 25, 26 of tubes 13, 18.

[0055] Figure 5c Anchoring units 2, 3 and 21, 22 are shown, which have been successively released from tubes 13, 18 and have been successively rotated, thus attaching to the valve ring (not shown).

[0056] Figure 5dAnchoring units 2, 3, 4, 5 and 21, 22, 23, 24 are shown, which have been successively released from tubes 13, 18 and have been successively rotated, thereby enabling the anchoring devices 9, 10, 11, 12 on anchoring units 3, 4 and 5 to be attached to cardiac tissue (not shown).

[0057] Due to such Figures 5a-5d The annular valvuloplasty device shown includes only 8 anchoring units, namely anchoring units 2, 3, 4, 5, 21, 22, 23, and 24. Therefore... Figure 5d The image shows a fully implanted state, whereby, once this state is achieved, tubes 13 and 18 can be removed from the implantation site via cannula 19 according to arrow Y.

Claims

1. A device for annulusoplasty on the posterior annulus of a mitral valve, comprising at least a first anchoring unit and a second anchoring unit, the anchoring units being deployable to the mitral valve by means of a vascular delivery device and being positioned in a row along the annulus, including anchoring devices disposed on each of the first and second anchoring units, wherein, The first anchoring unit and the second anchoring unit are interconnected by a connecting device that defines the distance between the first anchoring unit and the second anchoring unit, and the anchoring unit also includes a pulling device used to reduce the distance between the first anchoring unit and the second anchoring unit in order to pull the petal rings together, wherein the anchoring units are arranged to be rotatable relative to each other about a longitudinal axis extending along the row.

2. The valve annulusop apparatus according to claim 1, characterized in that, The anchoring units are arranged to be able to rotate relative to each other about the longitudinal axis by 45-120°.

3. The valve annulusop apparatus according to claim 1 or 2, characterized in that, The traction device and the connecting device are integrally formed together.

4. The valve annulusop apparatus according to claim 1 or 2, characterized in that, The traction device includes an electromagnet and / or an electroactive polymer and / or a pneumatic device and / or a vacuum chamber and / or a wire.

5. The valve annulusop apparatus according to claim 1 or 2, characterized in that, The anchoring device includes a needle and / or a hook and / or a clip and / or a rivet.

6. The valve annulusop apparatus according to claim 1 or 2, characterized in that, The anchoring device has a trident shape.

7. The valve annulusop apparatus according to claim 1 or 2, characterized in that, At least one anchoring device is arranged on each of the first anchoring unit and the second anchoring unit.

8. The valve annulusop apparatus according to claim 1 or 2, characterized in that, The anchoring device can be deployed from a first position to a second position, in the first position where the anchoring device is retracted to be arranged within the delivery device, and in the second position where the anchoring device is deployed.

9. The valve annulusop apparatus according to claim 1 or 2, characterized in that, The distal end of the annulusoplasty device carries a fixing device for securing the distal end of the annulusoplasty device to the annulus.

10. The valve annulusop apparatus according to claim 9, characterized in that, The fixing device is formed by clamps and / or pliers.

11. The valve annulusop apparatus according to claim 1 or 2, characterized in that, The valve annuloplasty device includes multiple anchoring units.

12. The valve annulusop apparatus according to claim 1 or 2, characterized in that, The vascular delivery device is a catheter.

13. The valve annulusop apparatus according to claim 7, characterized in that, Multiple anchoring devices are arranged on each of the first anchoring unit and the second anchoring unit.

14. A delivery device having annulusoplasty device according to any one of claims 1 to 13, the delivery device being used to deliver and deploy the annulusoplasty device to the annulus of the mitral valve, the delivery device comprising: At least one flexible tube, in which the annulusoplasty device is housed prior to delivery; A guide wire, used to guide the flexible tube to the valve annulus; And a retraction device, which is used to retract the flexible tube relative to at least a first anchoring unit and a second anchoring unit of the annulusoplasty device so as to successively release the anchoring units from the flexible tube.

15. The delivery device according to claim 14, characterized in that, A first flexible tube and a second flexible tube are provided, wherein, prior to delivery, a first segment of the annulusoplasty device is housed in the first flexible tube, and a second segment of the annulusoplasty device is housed in the second flexible tube.

16. The delivery device according to claim 14 or 15, characterized in that, The wall of the tube has a cross-sectional profile on its inner side, which provides a shape fit with a corresponding cross-sectional profile on the outer surface of the anchoring unit in order to prevent the anchoring unit from rotating within the flexible tube.

17. The delivery device according to claim 14 or 15, characterized in that, The tube includes an axial extension whose internal cross-sectional profile allows the anchoring unit to rotate 45-120° about the longitudinal axis.

18. The delivery device according to claim 17, characterized in that, The cross-sectional profile includes a stop surface for limiting the rotational movement of the anchoring unit.

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