Articulated shaft for steerable catheter system and method of manufacturing

Abstract

The present invention relates to an articulating shaft for a steerable catheter system, which may be suitable for minimally invasive procedures, such as endovascular medical systems. The present invention also relates to a method of manufacturing such a shaft using 3D printing to achieve the features required to allow articulation while also maintaining a sealed lumen. The shaft includes a tubular body (114, 214) having a longitudinal central axis (130), the tubular body (114, 214) having at least one sealed lumen (106, 206) having a distal opening and a proximal opening, and a plurality of wire support elements (110, 210) for supporting at least one actuation wire, wherein each wire support element (110, 210) includes at least one feed-through opening (112, 212) for receiving the actuation wire, wherein two opposing wire support elements (110, 210) are separated from each other in the axial direction by a slot (118, 218), and the body (114, 214) and the wire support elements (110, 210) are integrally formed from a single piece.

Description

Technical Field

[0001] The present invention relates to an articulated shaft for a steerable catheter system, which may be suitable for minimally invasive procedures, such as intravascular medical systems, and a method of manufacturing such a shaft. Background Art

[0002] Endovascular medical procedures allow treatment at multiple locations in the patient's body, while only requiring relatively small access incisions. For example, endovascular surgery can eliminate the need for open heart surgery, thereby reducing the risks, costs and time associated with open heart surgery. Endovascular surgery can also shorten recovery time and reduce associated costs and risks of complications. An example of endovascular surgery that can greatly reduce the surgical process, shorten recovery time and reduce costs compared to traditional open surgery is a heart valve replacement or repair surgery, in which an artificial valve or valve repair device is guided to the heart through the patient's vascular system. For example, a catheter is inserted into the patient's vascular system and guided to the inferior vena cava. Then, by applying force longitudinally to the catheter, the catheter is pushed toward the heart through the inferior vena cava. When entering the heart from the inferior vena cava, the catheter enters the right atrium. The distal end of the catheter can be deflected by one or more deflection mechanisms, which can be achieved by tensioning cables or other mechanisms positioned inside the catheter. Precise control of the distal end of the catheter allows more reliable and faster positioning of medical devices and / or implants and other improvements in surgery. In addition to structural heart applications, catheters are used in minimally invasive procedures such as neurovascular, coronary, structural heart, peripheral vascular, or endoscopic procedures for gastrointestinal procedures or other uses.

[0003] Devices delivered intravascularly require precise placement to ensure proper placement of the medical device, which is critical to its function as it can be difficult to reposition the device after it is fully deployed from the delivery system. Additionally, the catheter is required to have the ability to turn or rotate the distal end of the catheter through the same kind of movement of the proximal portion or catheter handle. This is achieved by transmitting torque along the length of the shaft. For example, a single turn to traverse anatomical challenges. At the same time, the catheter is required to achieve movement of each section of the catheter independently of the rest of the catheter. The design of the catheter shaft is an important factor in determining the formation of curves, deflection angles, and the level of steerability. The choice of material determines the level of pushability, torque, and flexibility, and can be manipulated along the length of the catheter in a variety of ways to achieve the desired results.

[0004] The catheter shaft needs to be precisely placed to ensure the correct positioning of the medical device. Multiple lumens can be formed in the catheter to allow the passage of guidewires, catheters, fluids and gases. The number of lumens depends on the material and cross-sectional area. The shape of the lumen can meet the user's requirements. Reinforcement ribs (or wires) and pull wires can be inserted into the lumen. A core lumen is usually provided to receive the catheter with the medical device. In order to protect the medical device, this core lumen needs to be hermetically sealed.

[0005] It is known to use single or multiple lumen shafts and braids, coils or other layers disposed thereon to enhance torquability and flexibility. Reinforcement ribs and pull wires may be placed in situ during the braiding process. The lack of symmetry in the braided reinforcement layers due to the presence of varying wire height thicknesses results in suboptimal and often poor torque performance over the entire length of the catheter shaft. Additionally, problems may arise during the manufacturing process with respect to the integration of reinforcements or pull wires in the lumen, and further, a complex braider apparatus must be provided to assemble the additional braid layers, thereby increasing manufacturing costs.

[0006] There remains a need for an articulating shaft having improved mechanical properties and allowing for a hermetic sealing of the core lumen while improving the manufacturing process and reducing production costs. Summary of the invention

[0007] The above mentioned objects are solved by the subject matter of the independent claims. Advantageous embodiments of the invention are subject matter of the dependent claims.

[0008] The present invention is based on the idea that an articulated shaft for a steerable catheter is manufactured as a single piece so that the central lumen for inserting the catheter is completely sealed along the entire length of the shaft. The central lumen may also be referred to as a "main lumen" or "core lumen". In order to allow steering of the shaft, at least one steering wire (hereinafter also referred to as a "pull wire" or "actuation wire") may be inserted into a steering wire lumen formed by a plurality of aligned openings provided in the wire support elements. These wire support elements are separated from each other by grooves to facilitate bending of the shaft. These grooves may also be referred to as "notches". The outer wall of the shaft contains such notches to allow the shaft to contract and bend on that side.

[0009] In particular, the present invention provides an articulating shaft for a steerable catheter system, the shaft comprising a tubular body having a longitudinal central axis, the tubular body having at least one sealed (i.e., radially closed) lumen having a distal opening and a proximal opening, and a plurality of wire support elements for supporting at least one actuation wire. Each wire support element comprises at least one feed-through opening for receiving an actuation wire, wherein two opposing wire support elements are separated from each other in an axial direction by a slot, and wherein the body and the wire support elements are integrally formed from a single piece.

[0010] The advantage of this solution is that a hermetic sealing of the core lumen can be easily achieved without an additional cover or sheath. Moreover, due to the one-piece design of the shaft, the assembly process is facilitated.

[0011] According to an advantageous embodiment of the invention, the grooves extend at least 45° around the body in radial direction. Thus, a sufficiently large section of the shaft has sufficient flexibility to facilitate the turning process. For example, each groove can be arranged to extend around approximately half of the circumference of the shaft. The depth of each groove in radial direction can gradually decrease towards the peripheral area of ​​the groove around the circumference of the shaft. This design allows an optimized force distribution when bending the shaft.

[0012] In order to further enhance the flexibility of the shaft in bending caused by the actuation wire, each wire support member can be formed to include at least one bracket, which is separated from the body by a gap and wherein the feed-through opening is arranged at the bracket. Advantageously, the bracket is symmetrically shaped with respect to a mirror plane that intersects the cross section of the shaft and the central longitudinal axis orthogonally. In particular, the feed-through opening is advantageously arranged in the middle of the bracket.

[0013] In order to allow the shaft to be used with a bidirectional steering system (i.e., the shaft is pulled in two different directions, preferably opposite directions, with two pull wires), the shaft may include a first and a second row of wire support elements extending axially along the longitudinal axis and having first and second feed-through openings, respectively, the rows being arranged opposite each other in a radial direction, wherein the first feed-through openings are aligned opposite the second feed-through openings. Likewise, the wire support member may be configured as a bracket with a gap between the feed-through openings and the body.

[0014] According to an advantageous example, the shaft has a circular radial profile. Such a design is compatible with existing steering systems and allows an optimal force distribution.

[0015] In the case of bidirectionally steerable shafts, it is advantageous to arrange the closed main lumen concentrically within the contour of the shaft.

[0016] On the other hand, for an articulated shaft that only needs to bend in one direction, it is advantageous to arrange the main lumen offset from the central axis so that the closed lumen is arranged within the contour of the shaft with its central axis spaced from the longitudinal central axis of the shaft. In this case, a larger portion of the cross section of the shaft can be used for the wire support element.

[0017] According to an advantageous example, the shaft is manufactured from a 3D-printed biocompatible material. 3D printing has become an increasingly cost-effective and precise technology for producing medical materials. 3D printing is an additive manufacturing (AM) process, which is defined as the process of combining materials to make an object according to 3D model data, usually layer by layer, as opposed to subtractive manufacturing methods such as traditional machining. 3D printing can provide parts with very complex geometries without the need for post-processing, made from customized materials and composites, with almost zero material waste, while being suitable for a wide range of materials, including smart materials such as shape memory polymers, and other stimuli-responsive materials or biocompatible materials. Therefore, 3D printing is a technology that allows designers and engineers to create unique products that can be produced in small batches in a cost-effective manner. In the field of medical engineering, 3D printing even allows the production of customized shafts and fit to specific patients.

[0018] According to another advantageous example, the shaft further comprises at least one reinforcement lumen for receiving a reinforcement wire. The reinforcement wire assembled into these lumens can be made of steel or nitinol or other suitable material with a certain elasticity. The reinforcement wire can also be called a "neutral axis support wire".

[0019] When the actuation wire is attached to the distal end of the assembly and a tensile load is applied, the wire shortens. This causes the notch to close, causing the assembly to bend in the direction of the notch. The neutral axis support wire, also attached to the distal end, bends to allow the assembly to bend. The neutral axis support wire also carries some of the articulation axial load. The wire keeps the segments aligned and in place and maintains tension on the assembly, preventing the segments from separating.

[0020] To facilitate bending, the reinforcement lumen may be segmented through the peripheral region of the slot.

[0021] Furthermore, according to the present invention, other lumens may be provided at the shaft, for example for cables etc. These lumens may be connected to the inner surface of the unsealed outer wall, or may be connected to the outer surface of the sealed inner wall.

[0022] The present invention also relates to a method of manufacturing a shaft for a steerable catheter system using 3D printing to achieve the features required to allow articulation while also maintaining a sealed lumen, the method comprising:

[0023] providing a tubular body having a longitudinal central axis, the tubular body having at least one closed lumen having a distal opening and a proximal opening,

[0024] A plurality of wire support elements for supporting at least one actuation wire are manufactured, wherein each wire support element comprises at least one feed-through opening for receiving the actuation wire, wherein two adjacent wire support elements are separated from each other in an axial direction by a slot, and wherein the body and the wire support elements are integrally formed from a single piece.

[0025] As described above, the airtight sealing of the core lumen can be easily achieved without the need for an additional cover or sheath. Moreover, due to the one-piece design of the shaft, the assembly process is easy.

[0026] As mentioned above, if the shaft is produced by a 3D printing process, a particularly high degree of design freedom can be achieved at low cost. However, the shaft can also be produced by an extrusion process or an injection molding process. These processes are advantageous for high-volume production at low cost.

[0027] According to an advantageous embodiment, the shaft is made of a polymer material having a hardness in the range of 30 Shore A to 70 Shore A. It is particularly advantageous if the shaft is made of a polymer material having a hardness in the range of 35 Shore A to 40 Shore A. For example, polyamide is a possible material. However, the shaft can also be made of any other suitable material. If lower tensile forces and a soft surface are required, a material with a relatively low hardness is desirable; if increased stiffness is required, a harder material is advantageous. BRIEF DESCRIPTION OF THE DRAWINGS

[0028] The accompanying drawings are incorporated into the specification and form a part of the specification to illustrate several embodiments of the present invention. These drawings, together with the description, are used to explain the principles of the present invention. These drawings are only for the purpose of illustrating preferred and alternative examples of how to make and use the present invention, and should not be interpreted as limiting the present invention to only the embodiments shown and described. In addition, several aspects of the embodiments can be combined individually or in different combinations to form solutions according to the present invention. Therefore, the embodiments described below can be considered individually or in any combination thereof. Further features and advantages will become apparent from the following more specific description of various embodiments of the present invention, as shown in the accompanying drawings, in which the same reference numerals refer to the same elements, and in which:

[0029] Figure 1 is a schematic perspective view of a shaft according to a first example;

[0030] Figure 2 yes Figure 1 Details;

[0031] Figure 3 yes Figure 1 a front view of the shaft shown;

[0032] Figure 4 yes Figure 1 a first side view of the shaft shown;

[0033] Figure 5 yes Figure 1 Another side view of the shaft shown;

[0034] Figure 6 yes Figure 5 A first schematic cross-sectional view is shown;

[0035] Figure 7 yes Figure 5 Another schematic cross-sectional view shown;

[0036] Figure 8 yes Figure 5 Another schematic cross-sectional view shown;

[0037] Fig. 9 is a schematic perspective view of a shaft according to a second example. DETAILED DESCRIPTION

[0038] Reference will now be made to the drawings and first to Figure 1 and Figure 2 The present invention is explained in more detail.

[0039] Figure 1 shows a schematic perspective view of an articulated shaft 100 according to a first example of the present invention, Figure 2 1 is an enlarged view of the distal end 102 of the shaft 100. The shaft 100 has a distal end 102 with a distal opening and a proximal end 104 with a proximal opening. As used herein, the terms "proximal" and "distal" are to be understood relative to a user using the disclosed delivery device. "Proximal" should be understood as relatively closer to the user, while "distal" should be understood as relatively farther away from the user.

[0040] The main lumen 106 extends along the entire length of the shaft 100. According to the present invention, the main lumen is defined by an inner wall that is closed along the length of the shaft 100. Therefore, the main lumen can be hermetically sealed by connecting the distal end 102 and the proximal end 104 to corresponding sealing fittings or connectors (not shown in the figure).

[0041] according to Figure 1 In the example shown, the articulated shaft 100 includes a wire support element 110 having a feed-through opening 112. The feed-through openings are arranged linearly in the longitudinal direction of the shaft 100, thereby forming a segmented lumen for the steering wire. It should be noted that the steering wire and other elements inserted into the various lumens are not shown in the drawings. Each wire support element 110 is formed as a bracket, which is separated from the body 114 of the shaft 100 by a gap 116.

[0042] Slots 118 separate each bracket 110 from adjacent brackets. These slots 118 facilitate bending of the articulated shaft 100 if a pull wire is inserted into the row of feed-through openings 112 and a bending force is applied to the shaft 100. The presence of voids 116 further enhances the flexibility and pliability of the shaft 100.

[0043] The shaft 100 according to the first example also includes a reinforcement lumen 120 for receiving reinforcement ribs or wires (not shown in the figures). These reinforcement wires can be made, for example, of steel, nitinol or other suitable materials with some elasticity. The reinforcement wires can also be called neutral axis support wires because they stabilize the segments formed by the grooves 118 in their alignment and position. When a tensile load is applied, the actuation wire shortens and closes the notch 118, thereby causing the assembly to bend in the direction of the notch 118. The neutral axis support wire arranged in the reinforcement lumen 120 also bends to allow the assembly to move. The reinforcement wires also bear some of the articulation axial loads and maintain tension on the assembly, thereby preventing the segments from separating.

[0044] In the illustrated embodiment, two reinforcement lumens 120 are provided. However, it will be apparent to those skilled in the art that any other number of lumens may also be provided. In addition, additional lumens may also be provided for cables or fluid passages.

[0045] like Figure 1 As shown, a fluid connector 122 can be provided at the proximal end 104 for sealing connection with, for example, a rigid portion of a catheter or a handle (not shown in the figures). Of course, a similar fluid connector can also be provided at the distal end 102. Thus, a complete seal of the main lumen 106 can be achieved. If the shaft is intended to contain a cable, the connector 122 can also include means for forming an electrical connection.

[0046] In the example shown, the shaft 100 has a substantially circular outer contour. However, any other cross-sectional contour may be chosen, such as an elliptical or polygonal contour. As shown here, all openings forming the lumen also have a circular cross section. This is not necessarily the case; any other suitable cross section may also be used, such as an elliptical or polygonal shape.

[0047] According to an advantageous aspect of the invention, the articulation shaft 100 is formed as a 3D-printed component, additively accumulating the component along the longitudinal axis of the shaft 100 .

[0048] exist Figures 3 to 8 Described in Figure 1 and Figure 2 Further views of the articulation axis of the illustrated example.

[0049] As from Figure 3 As can be seen from the front view of FIG. 1 , the main lumen 106 has a center 128 that is offset relative to the center 126 through which the longitudinal axis 130 of the shaft passes. Therefore, more space can be given to the bracket 110 including the feed-through opening 112, and the flexibility of the shaft 100 can be enhanced.

[0050] The first and second lumens 120 for the neutral axis support wire are arranged at the body 114 such that they are directly opposite each other along a diameter passing through the center 126 of the shaft 100 .

[0051] Figure 4 and Figure 6 The slots 118 separating the multiple segments formed by the wire support element 110 are shown to be directed around the center 126 of the shaft 100 to cover a relatively large angle, such as 270°. Only the wall 132 forming the main lumen 106 remains continuously closed along the entire length of the shaft 100 to provide a sealed inner lumen 106.

[0052] When the shaft bends in the direction towards the feedthrough opening 112 , the notch 118 closes, but if necessary, the support 110 formed by the gap 116 may also be deformed, thereby reducing the distance between the feedthrough opening 112 and the wall 132 .

[0053] Fig. 9 A second example of an articulating shaft 200 according to the invention is shown. The shaft 200 has a distal end 202 with a distal opening and a proximal end (not shown in this figure) with a proximal opening.

[0054] The main lumen 206 extends along the entire length of the shaft 200. According to the present invention, the main lumen is bounded by an inner wall 208, which is closed along the length of the shaft 200. Therefore, the main lumen 206 can be hermetically sealed by connecting the distal and proximal ends to corresponding sealing fittings or connectors (not shown in the figure).

[0055] like Fig. 9 In the example shown, the articulated shaft 200 comprises a first wire support element 210 having a first feedthrough opening 212 and a second wire support element 211 having a second feedthrough opening 213. The feedthrough openings 212, 213 are arranged linearly in the longitudinal direction of the shaft 200, thereby forming a segmented lumen for the two steering wires. Fig. 9 The shaft 200 shown provides a bi-directionally steerable conduit.

[0056] Likewise, it should be noted that the steering wires and other elements inserted into the various lumens are not shown in the drawings. Each wire support element 210 is formed as a stent that is separated from the body 214 of the shaft 200 by a gap 216.

[0057] Slots 218 separate each bracket 210 from adjacent brackets. These slots 218 facilitate bending of the articulated shaft 200 if a pull wire is inserted into the row of feed-through openings 212, 213 and a bending force is applied to the shaft 200. The presence of the gaps 216 further enhances the flexibility and pliability of the shaft 200.

[0058] The design of the shaft 200 further differs from that of the shaft 100 in that the cross section is symmetrical, in other words, the center of the main lumen 106 is coaxial with the central axis of the shaft 200 .

[0059] When the shaft 200 is bent in a direction towards one of the rows of feedthrough openings 212 , the notches 218 close, but the bracket 210 formed by the gaps 216 may also be deformed if necessary, thereby reducing the distance between the feedthrough openings 212 and the wall 232 .

[0060] In addition, each groove 218 extends along less than 180° of the outer circumference of the shaft 200, leaving two spinous processes 234 for stabilizing the shaft 200. In the example shown, such spinous processes 234 stabilize the neutral axis. However, it is clear to those skilled in the art that one or more additional reinforcing lumens (similar to the reinforcing lumens shown in the first example of the shaft 100) can be embedded in the spinous processes 234 to receive the neutral axis support wires of the tendons. These reinforcing wires can be made of, for example, steel, nitinol or other suitable materials with some elasticity. The reinforcing wires can also be called neutral axis support wires because they stabilize the segments formed by the grooves 218 to be aligned and in place. When a tensile load is applied, the actuating wires on the corresponding side shorten and close the notches 218 on one side of the actuating wires, thereby bending the assembly in the direction of these notches 218. The neutral axis support wires arranged in the reinforcing lumens are also bent to allow the assembly to move. The reinforcing wires also bear some articulated axial loads and maintain tension on the assembly to prevent segment separation.

[0061] Furthermore, additional lumens for cables or fluid passages may be provided.

[0062] Despite Fig. 9 Although not visible in the figure, a fluid connector can be provided at the proximal end of the shaft 200 to sealably connect to, for example, a rigid portion of a catheter or a handle (not shown). Of course, a similar fluid connector can also be provided at the distal end 202. Thus, a complete seal of the main lumen 206 can be achieved. If the shaft is intended to contain a cable, the connector can also include means for forming an electrical connection.

[0063] In the example shown, the shaft 200 has a substantially circular outer profile. However, any other cross-sectional profile may be chosen, such as an elliptical or polygonal profile. As shown here, all openings forming the lumen also have a circular cross section. This is not necessarily the case; any other suitable cross section may also be used, such as an elliptical or polygonal profile.

[0064] According to an advantageous aspect of the invention, the articulating shaft 200 is formed as a 3D printed part, additively accumulating the part along the longitudinal axis of the shaft 200. However, it will be apparent that other techniques for manufacturing the shaft 200 may also be used. Preferably, 3D printing is used to achieve the features required to allow articulation while also maintaining a sealed lumen.

[0065] In summary, the present invention can provide a 3D-printed low-hardness biocompatible material articulated shaft design, which includes a sealed main lumen. The 3D-printed articulated design can include one or more lumens for wires or cables, and the sealed lumen can be placed concentric with the outer diameter or offset from the central axis. The outer wall includes a notch to allow the shaft to shrink and bend on that side.

[0066] Additionally, the wire or cable lumen may be connected to the inner surface of the unsealed outer wall, or may be connected to the outer surface of the sealed inner wall. Additional wires may be assembled into these lumens. These may be steel or nitinol or other suitable material with some elasticity. These will be referred to as neutral axis support wires.

[0067] When these wires are attached to the ends of an assembly and a tensile load is applied, the wires (cables) shorten. This causes the notch to close, allowing the assembly to bend in the direction of the notch. The neutral axis supports the wire bend to allow the assembly to bend. These wires also carry some of the articulation axial loads. The wires keep the segments aligned and in place. The wires can also maintain tension on the assembly, preventing the segments from separating.

[0068] The notches can be configured in a variety of ways and can be turned in one or both directions.

[0069] Reference numerals

[0070] 100, 200 articulated shaft

[0071] 102, 202 remote

[0072] 104, 204 near end

[0073] 106, 206 main cavity

[0074] 108, 208 Inner wall of the main cavity

[0075] 110, 210 wire support element

[0076] 211 Second line support element

[0077] 112, 212 feed-through openings

[0078] 213 second feedthrough opening

[0079] 114, 214 body

[0080] 116, 216 gaps

[0081] 118, 218 slots

[0082] 120 Enhanced Lumen

[0083] 122 Connectors

[0084] 126 Center of axis

[0085] 128 Center of main cavity

[0086] 130 longitudinal axis

[0087] 132, 232 wall

[0088] 234 spinous process

Claims

1. An articulated shaft for a steerable catheter system, the shaft (100, 200) comprising: A tubular body (114, 214) having a longitudinal central axis (130), the tubular body (114, 214) having at least one radially sealed lumen (106, 206) having a distal opening and a proximal opening, and a plurality of wire support elements (110, 210) for supporting at least one actuation wire, wherein each of the wire support elements (110, 210) comprises at least one feed-through opening (112, 212) for receiving the actuating wire, wherein two adjacent wire support elements (110, 210) are separated from each other in the axial direction by a slot (118, 218), and wherein the body (114, 214) and the wire support elements (110, 210) are integrally formed from a single piece, wherein each wire support element (110, 210) comprises at least one bracket, the bracket being arranged to extend through the feed-through opening (112, 212) and the feed-through opening (112, 212) for receiving the actuating wire A gap (116, 216) is separated from the tubular body (114, 214), the feed-through opening (112, 212) is arranged at the support, and the gap is positioned between the feed-through opening and the radially sealed lumen in the radial direction; wherein the shaft (100, 200) also includes at least one reinforcing lumen (120) for receiving reinforcing ribs or wires, which stabilize the segments formed by the grooves (118, 218) in their alignment and position and are capable of bending.

2. The shaft of claim 1, wherein the groove (118, 218) extends at least 45° around the body (114, 214) in a radial direction.

3. A shaft as claimed in claim 1 or 2, wherein the shaft (200) comprises a first and a second row of wire support elements (210, 211), which extend axially along the longitudinal center axis and have a first and a second feedthrough opening (212, 213) respectively, the rows being arranged opposite to each other in a radial direction, wherein the first feedthrough opening (212) is aligned opposite to the second feedthrough opening (213).

4. The shaft according to claim 1 or 2, wherein the shaft (100, 200) has a circular radial profile.

5. The shaft of claim 4, wherein the radially sealed lumen (206) is arranged concentrically within the contour of the shaft (200).

6. The shaft of claim 4, wherein the radially sealed lumen (106) is disposed within a profile of the shaft (100), the profile having a central axis (128) spaced from a longitudinal central axis (130) of the shaft (100).

7. The shaft of claim 1 or 2, wherein the shaft (100, 200) is made of a 3D printed biocompatible material.

8. The shaft of claim 1 or 2, wherein the reinforcing lumen (120) is segmented by peripheral regions of the groove.

9. A method of manufacturing a shaft (100, 200) for a steerable catheter system, the method comprising: A tubular body (114, 214) having a longitudinal central axis (130) is provided, the tubular body (114, 214) having at least one closed lumen (106, 206) having a distal opening and a proximal opening, A plurality of wire support elements (110, 210) for supporting at least one actuation wire are manufactured, wherein each of the wire support elements (110, 210) comprises at least one feed-through opening (112, 212) for receiving the actuation wire, wherein two adjacent wire support elements (110, 210) are separated from each other in the axial direction by a slot (118, 218), and wherein the body (114, 214) and the wire support elements (110, 210) are integrally formed from a single piece, wherein each wire support element (110, 210) ) comprises at least one bracket, which is separated from the tubular body (114, 214) by a gap (116, 216), the feed-through opening (112, 212) is arranged at the bracket, and the gap is positioned between the feed-through opening and the radially sealed lumen in the radial direction; wherein the shaft (100, 200) also includes at least one reinforcing lumen (120) for receiving reinforcing ribs or wires, which stabilize the segments formed by the grooves (118, 218) in their alignment and position and are capable of bending.

10. The method of claim 9, wherein the shaft (100, 200) is manufactured by a 3D printing process.

11. The method according to claim 9 or 10, wherein the shaft (100, 200) is manufactured by an extrusion process.

12. The method of claim 9 or 10, wherein the shaft (100, 200) is 3D printed from a material having a hardness in the range of 30 Shore A to 70 Shore A.

13. The method of claim 12, wherein the shaft (100, 200) is 3D printed from a polymer material having a hardness in the range of 35 Shore A to 40 Shore A.

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