Catheter device
Patent Information
- Authority / Receiving Office
- JP · JP
- Patent Type
- Patents
- Current Assignee / Owner
- ECP ENTWICKLUNGSGMBH
- Filing Date
- 2024-09-18
- Publication Date
- 2026-07-31
Smart Images
Figure 0007898486000001 
Figure 0007898486000002 
Figure 0007898486000003
Abstract
Description
[Technical Field]
[0001] This application relates to a catheter device having a rotor and a drive shaft, as described in the first part of the main claim. [Background technology]
[0002] Such catheters are typically used as blood pump devices. These devices are placed inside the body of a person or animal and generate or transmit torque or rotational motion to cause blood flow to a rotor. The drive shaft extends axially along the longitudinal range of the catheter, between the drive region and the distal end region. The drive region is usually located in the proximal end region, which remains outside the body and is connected to a drive motor. Therefore, the drive shaft should maintain flexibility and suppleness even under load.
[0003] In many applications, the rotor, located at the distal end of the catheter, needs to be guided along a intended path within the body, such as along or within a blood vessel, to position it in a desired location within the body, such as within or near the ventricle, for the duration of its application. After positioning, the rotor and drive shaft are rotated in a rotational direction according to the intended application to generate, for example, blood flow in a proximal direction away from the patient's heart. To guide the catheter into the lumen, the catheter device can be designed as an expandable pump, in which case the rotor may be designed as a radially compressible rotor and housed in a radially compressible housing. Both the rotor and housing can be moved into a cannula, which is usually located proximal to the rotor and has an inner diameter smaller than the diameter of the rotor and housing when expanded. For example, by applying a tensile force to a flexible sheath provided to surround the drive shaft at the proximal end of the catheter device, the compressible rotor and housing can be moved, at least partially, into the cannula and thereby compressed.
[0004] For example, blood delivery may require rotational speeds of 10,000 revolutions per minute, 20,000 revolutions per minute, or even 30,000 revolutions per minute. In many cases, this rotational motion must be maintained for extended periods, such as several days or weeks.
[0005] Depending on the configuration, it is beneficial to provide a distal bearing to stabilize the distal end of the drive shaft. In some embodiments, the distal bearing may comprise an elongated polymer section on which the drive shaft is mounted. The polymer section may be made of, for example, Pebax® or polyurethane. Furthermore, an additional bearing, for example made of ceramic, may be provided within the elongated polymer section.
[0006] Typically, this type of catheter device features a flexible, non-traumatic tip to avoid damaging the patient's tissues. The non-traumatic tip may be made of a medical-grade flexible polymer such as Pebax® or polyurethane. The flexible, non-traumatic tip is preferably designed as a pigtail.
[0007] Depending on the embodiment, an elongated polymer end and a flexible, non-traumatic tip may form a single polymer end.
[0008] Particularly high levels of mechanical and chemical load resistance are required for catheters, drive shafts, and distal bearings. Distal bearings, in particular, may be subjected to physical forces that cause severe abrasion and wear due to their potential contact with the rotating shaft. High rotational speeds generate frictional heat, sometimes exceeding 160°C, which in turn exceeds the melting point of some medical-grade polymers used to form the polymer ends mentioned above. Under these circumstances, distal bearings constructed from such materials will melt.
[0009] The fatigue and damage processes of materials in the drive shaft, distal bearings, and other parts should proceed as slowly as possible, and should be as predictable and controllable as possible, because they not only damage the catheter device but also cause health problems for the patient by moving wear fragments into the bloodstream and the patient's body. The risk of fracture and damage to the drive shaft or distal bearing, or the risk of melting the distal bearing, should be minimized. In particular, bearings should be designed to minimize friction and heat generation, which are key factors in wear and fracture.
[0010] Friction and heat generation can damage the pump itself, but it should also be considered that blood consists of several components, such as blood cells, which can be mechanically damaged when in contact with the rotor and shaft or other parts of the catheter device, or thermally damaged, for example, by denaturation, when exposed to the heat generated within the catheter device.
[0011] Furthermore, damage to patient tissues caused by rotating elements should be avoided. For example, in the case of an intraventricular pump, cardiac tissues such as chordae tendineae or structures associated with the mitral valve could be sucked into the pump or caught in the rotating parts, potentially damaging the heart.
[0012] To avoid tissue entanglement by rotating parts, Patent Document 1 discloses a polyurethane drive shaft cover that isolates the rotating drive shaft from blood. For this purpose, the gap between the drive shaft and the drive shaft cover is made extremely small. However, this can cause more wear and breakage, especially when a flexible metal drive shaft is used. On the other hand, a rigid tubular drive shaft cover requires precise centering of the flexible drive shaft within the drive shaft cover. Patent Document 2 discloses a flexible pump that allows bending of the pump head.
[0013] However, in the device described in Patent Document 2, especially in relation to the flexible polymer end at the distal end of the pump head, the rigid drive shaft cover may cause torsion in the drive shaft when the catheter device is bent. Specifically, torsion may be formed in the region between the rigid drive shaft cover and the rotor, which may cause serious damage to the drive shaft.
[0014] In such a configuration, friction causes significant heat generation between the drive shaft and the bearing, and in some cases, it may cause both damage to the blood and melting of the plastic of the pigtail tip. The amount of heat released is not particularly large, but it is highly concentrated in a small area. Therefore, the resulting energy density is significant, and local high temperatures occur.
Prior Art Documents
Patent Documents
[0015]
Patent Document 1
Patent Document 2
Summary of the Invention
Problems to be Solved by the Invention
[0016] The object of the present application is to address the above-mentioned problems and to address at least one or more of the following points. - Avoid damage to the surrounding tissue by the rotating parts of the pump, especially in the distal end region. - Provide sufficient flexibility so that the pump head can be bent without causing torsion in the drive shaft. - Provide sufficient resistance to wear and breakage and reduce or prevent the movement of wear debris to the patient's body. - Enable the provision of a flexible plastic tip, such as a pigtail, at the distal end of the pump. - To enable the transfer of the generated frictional heat to the surrounding blood in order to avoid local overheating. The above can be achieved by the catheter device according to the independent claims. Advantageous embodiments are presented by the dependent claims and the examples in the specification.
Means for Solving the Problem
[0017] The catheter device according to the present application can include a drive shaft composed of a plurality of coaxial windings. Those coaxial windings preferably have different winding directions, particularly preferably alternating winding directions, and extend spirally so as to surround a cavity extending axially along the drive shaft. The drive shaft, for example, can include two coaxial windings having opposite winding directions, and the outer diameter of the drive shaft can be 0.4 mm to 2 mm, preferably 0.6 mm to 1.2 mm, and particularly preferably 0.8 mm to 1.0 mm.
[0018] In some embodiments, the drive shaft is reinforced in the distal end region by a reinforcing element, such as a metal wire or a carbon wire, provided in a cavity extending axially along the drive shaft. In one embodiment, the reinforcing element extends from a region near the proximal end of the rotor housing, specifically from the proximal bearing structure of the rotor housing, to the distal end of the drive shaft. In one embodiment, the metal wire is made of 1.4310 stainless steel.
[0019] In one embodiment, the distal bearing of the catheter device described above includes a drive shaft cover which can be provided to surround the drive shaft distal to the rotor. The drive shaft cover may include a flexible tube made of a flexible material such as silicone, Pebax®, PU, or PET. The drive shaft may be rotatably mounted inside the drive shaft cover. In one embodiment, the flexible tube of the drive shaft cover is a heat-shrinkable tube. The flexible tube of the drive shaft cover may be provided outside the polymer end so as to extend beyond the polymer end proximal to the polymer end. Alternatively, or in addition to this, the flexible tube of the drive shaft cover may be provided partially inside the polymer end and extend beyond the polymer end proximal to the polymer end. The sufficient flexibility of the drive shaft cover when the drive shaft bends during operation prevents twisting of the drive shaft located between the drive shaft cover and the rotor.
[0020] In one embodiment, the drive shaft cover further includes a helical sleeve inside the flexible tube that supports the drive shaft. The helical sleeve supports the flexible tube of the drive shaft cover from the inside while maintaining its flexibility. Such a helical sleeve can reduce friction between the drive shaft and the drive shaft cover, and further reduce wear and damage to the drive shaft cover.
[0021] In another embodiment, the drive shaft cover comprises one or more heat conductors configured to conduct and remove heat from the drive shaft and / or distal bearings. The heat conductors may be configured to, for example, transfer heat to the patient's blood during operation, disperse heat, or both, in order to avoid the occurrence of localized hot spots.
[0022] One or more heat conductors have an inner surface facing the drive shaft and an outer surface facing away from the drive shaft.
[0023] The heat conduction section is preferably designed as a tube surrounding the drive shaft. The heat conduction section can also be designed as, for example, one or more metal plates or tongues located near the drive shaft.
[0024] The helical sleeve and the heat conduction section or heat conduction tube can each be provided in separate embodiments, for example, in combination with a flexible tube. Embodiments comprising both a helical sleeve and a heat conduction section designed as a tube may be particularly advantageous.
[0025] The helical sleeve can be provided, for example, in combination with a heat conduction section, and in that case, a flexible tube may or may not be used. For example, the helical sleeve can be placed at least partially within a heat conduction section designed as a tube, typically extending outward from that tube.
[0026] The helical sleeve can be made of, for example, a wound round wire or flat tape. In this case as well, the drive shaft is rotatably mounted within the helical sleeve. The supporting helical sleeve is preferably made of a metal such as MP35N® or 35NLT®, or a ceramic. The supporting helical sleeve avoids twisting between the distal bearing and the rotor by maintaining the flexibility of the drive shaft cover so as to allow bending of the pump head, and provides sufficient resistance to wear and breakage. In one embodiment, the flexible tube is provided to surround the entire length of the helical sleeve. In one embodiment, the flexible tube is provided to surround only the proximal portion of the helical sleeve. In one embodiment, the flexible tube is provided to surround the outside of a portion of the polymer end and to surround a portion of the helical sleeve extending from the polymer end.
[0027] Alternatively, an embodiment is possible in which, instead of a spiral, multiple metal rings are arranged preferably with gaps between them. These multiple rings or sleeves are preferably made of flat tape. The rings can be made of the same material as the spiral sleeve described above.
[0028] The helical sleeve or ring supporting the drive shaft has an inner diameter of 0.4 mm to 2.1 mm, preferably 0.6 mm to 1.3 mm, and particularly preferably 0.8 mm to 1.1 mm. The tape constituting the helical sleeve or ring has a thickness of 0.05 mm to 0.4 mm. The tape constituting the helical sleeve or ring has a width of, for example, 0.4 mm to 0.8 mm. The gap between the ring or windings is, for example, 0.04 mm to 0.2 mm.
[0029] The winding angle of the spiral sleeve and the thickness of the flexible tube affect the flexibility of the drive shaft cover, and it is preferable to select values that allow the rotor to be maintained in the desired position when the catheter device is bent.
[0030] The thickness of the flexible tube can be 5 μm to 100 μm, and preferably 10 μm to 50 μm.
[0031] In one embodiment, in order to rotatably install the drive shaft, avoid vibrations, and ensure that at most a small amount of blood enters the gap region, the inner diameter of the helical sleeve or ring is selected to be 0.01 mm to 0.08 mm larger than the outer diameter of the drive shaft, preferably 0.01 mm to 0.05 mm larger.
[0032] In one embodiment, the proximal end of the helical sleeve or ring is positioned close to the rotor in its extended state. To avoid the rotor contacting the drive shaft cover or helical sleeve during operation, the proximal end of the helical sleeve or ring can be designed to be, for example, 0.2 mm to 0.7 mm, preferably 0.25 mm to 0.4 mm, away from the rotor in its extended state.
[0033] To prevent the rotor from contacting the flexible housing during operation, the flexibility of the drive shaft cover is preferably such that it maintains the drive shaft and rotor in a more central position within the flexible housing when the pump head is bent.
[0034] In one embodiment, the rotor hub extends less than 0.5 mm distally beyond the rotor blades, and this configuration allows the rotor blades to be positioned close to the distal bearings without the possibility of the hub contacting any parts of the distal bearings. Preferably, the hub extends less than 0.1 mm distally beyond the rotor blades, and particularly preferably, the hub does not extend distally beyond the rotor blades at all.
[0035] In one embodiment, when viewed from the proximal end to the distal end of the support sleeve, the winding direction of the helical sleeve when tracing the sleeve winding distally is opposite to the preferred rotation direction of the drive shaft when viewed along the drive shaft toward the distal end of the drive shaft. This prevents the tapered or pointed end of the helical sleeve from damaging the rotor, which is rotating in the preferred rotation direction, if the rotor comes into contact with the helical sleeve in the event of a malfunction. The preferred winding direction can be the same as the winding direction of the outermost coaxial winding of the drive shaft, or it can be opposite to the winding direction of the outermost coaxial winding of the drive shaft.
[0036] The ends of the spiral sleeve are preferably ground flat, and the edges, including at least the edges at both ends, are rounded and smooth, with a 10-point average roughness R in accordance with ISO 1302 standard.z The value of R z It is preferable that the size is ≤2 μm.
[0037] In order to move the rotor and housing into the cannula under compression, a force is applied to the proximal end of the catheter device, and it is preferable that the spiral sleeve is positioned so that when a relative movement of the drive shaft with respect to the distal bearing and thus the spiral sleeve occurs, the distal end of the drive shaft is maintained within the distal bearing. In other words, in some embodiments, the distal end is prevented from coming out of the drive shaft cover, spiral sleeve, ceramic bearing, or heat conduction tube.
[0038] In one embodiment, an additional ceramic bearing is provided within the distal bearing, positioned distal to the helical sleeve.
[0039] As described above, the catheter device may include a heat conduction section or heat conduction tube in addition to the helical sleeve, or the catheter device may include a heat conduction section or heat conduction tube in combination with bearings only.
[0040] When a heat conduction section or heat conduction tube is provided without a helical sleeve, a ceramic bearing, such as a ring bearing, can be installed inside the distal bearing.
[0041] If a heat conduction section or heat conduction tube is provided in addition to the helical sleeve, it is possible to provide it so as to surround at least a portion of the helical sleeve.
[0042] The heat conduction section or heat conduction tube can be located partially inside the polymer end and partially outside the polymer end. This allows heat transfer from inside the distal bearing to the patient's blood. In one embodiment, the heat conduction section or heat conduction tube extends 0.5 mm to 2 mm from the polymer end, preferably 1 mm to 1.5 mm.
[0043] The flexible tube of the drive shaft cover can be positioned inside the heat conduction section or heat conduction tube, surrounding the spiral sleeve. In this case, the outer surface of the heat conduction section or heat conduction tube can be in direct contact with the patient's blood.
[0044] The flexible tube may also be provided to surround the outside of a portion of the polymer end, the outside of a portion of the heat conduction section or heat conduction tube that extends from the polymer end, and a portion of the helical sleeve that extends beyond the heat conduction section or heat conduction tube. In this latter configuration, the portion of the heat conduction section or heat conduction tube that extends from the polymer end cannot come into direct contact with the blood. Instead, the flexible tube comes into direct contact with the blood. In this configuration as well, heat is transferred from the heat conduction section or heat conduction tube to the blood, but through the thin wall of the flexible tube.
[0045] The heat conduction section or heat conduction tube may be entirely located within the polymer end, thereby allowing heat to be redistributed within the distal bearing and also transferred and removed from the helical sleeve or ring.
[0046] The heat conduction section or heat conduction tube is made of medical-grade stainless steel, such as 1.4441 stainless steel, and has higher thermal conductivity than polymer ends or ceramic bearings.
[0047] The inner diameter of the heat conduction section designed as a tube can be 0.5 mm to 2.6 mm, preferably 0.7 mm to 1.8 mm, and particularly preferably 0.9 mm to 1.6 mm.
[0048] The thickness of the heat conduction section or heat conduction tube can be between 0.05 mm and 0.5 mm.
[0049] The outer surface of the heat conduction part or heat conduction tube, the portion configured to come into contact with the patient's blood, is preferably smooth. In one embodiment, the ten-point average roughness R of the outer surface of the heat conduction part, according to ISO 1302 standard, is specified for that portion. z The value of R z The size is ≤1.2 μm.
[0050] In one embodiment, the inner surface of the heat conduction part or heat conduction tube is configured to be bonded to a spiral sleeve. To facilitate bonding the inner surface of the heat conduction part or heat conduction tube to the spiral sleeve, the inner surface of the part or tube may be roughened. For example, the arithmetic mean surface roughness of the inner surface of the heat conduction part or heat conduction tube is the average surface roughness R according to the ISO 1302 standard. a vR a It can be expressed as ≥0.8 μm.
[0051] In one embodiment, the inner diameter of the heat conduction section designed as a tube is selected to be 0.04 mm to 0.1 mm larger than the outer diameter of the helical sleeve or ring, thereby allowing adhesive to be applied to the gap.
[0052] Catheter pumps equipped with a heat conduction section or heat conduction tube, as described above, can be used to shift the temperature hotspot. For example, the hotspot can be shifted from the region of the drive shaft located within the polymer end to a region closer to the proximal end of the polymer end, or to a region located outside the polymer end. Furthermore, the above-described device configuration can achieve a lower maximum temperature. For example, it is possible to achieve a maximum temperature 20°C to 60°C lower than the maximum temperature in a device configuration without a heat conduction section. Specifically, the maximum temperature at the hotspot can be maintained below the melting point of Pebax® or other medical-grade polymers.
[0053] It is also possible to provide a catheter device that includes a heat conduction section or heat conduction tube as disclosed in this application, while not including a helical sleeve or ring in the distal bearing.
[0054] Examples of the catheter device and embodiments according to the present application are shown in Figures 1 to 7. [Brief explanation of the drawing]
[0055] [Figure 1] This diagram shows a catheter device placed in the left ventricle of the heart. [Figure 2] This figure shows the distal end region of a catheter device. [Figure 3] This figure shows a magnified view of the distal end region of a catheter device. [Figure 4a] This is a schematic diagram showing a portion of the distal end region of a catheter device. [Figure 4b] This is a schematic diagram showing a portion of the distal end region of a catheter device. [Figure 5a] This is a schematic diagram showing a portion of the distal end region of a catheter device. [Figure 5b] This is a schematic diagram showing a portion of the distal end region of a catheter device. [Figure 6] This is a diagram showing a spiral sleeve. [Figure 7a] This figure shows the rotor and rotor housing in their expanded state. [Figure 7b] This figure shows the compression state of the rotor and rotor housing. [Modes for carrying out the invention]
[0056] Figure 1 shows a catheter device 1 used as a blood pump. The catheter device 1 is inserted into the patient such that a portion of the distal end region 8 of the catheter device 1 is positioned within the left ventricle 18.3 of the patient's heart 18.1. A motor 17 for driving a drive shaft 4 is provided in a drive region 16 that can be located outside the patient's body. A portion of the drive shaft 4 is covered by a flexible sheath 5. The drive shaft 4 and flexible sheath 5 extend from the drive region 16 to the distal end region 8, where a rotor 2, preferably configured as a compressible rotor, is driven by the drive shaft 4. The compressible rotor 2 is located within a compressible housing 3. The compressibility of the rotor 2 and housing 3 is useful for inserting the rotor into the patient's body. During operation, the rotor 2 and housing 3 are in an expanded state. The housing 3 prevents cardiac tissue from being sucked into the rotor 2 or caught in the rotor 2 or drive shaft 4, thus preventing damage to cardiac tissue, such as chordae tendineae. The distal end of the drive shaft 4 is located within a distal bearing 9. The distal bearing comprises a drive shaft cover 11 and a polymer end 10, preferably composed of Pebax® or other medical-grade flexible polymer. The polymer end includes an elongated portion 10.1 provided to surround a portion of the drive shaft cover 11. The polymer end 10 further includes a pigtail-shaped tip 10.2 to prevent damage to the heart 18.1. The rotor 2 and drive shaft 4 can rotate in rotational direction 4.1, thereby generating blood flow away from the distal end towards the proximal end, i.e., blood flow leaving the left ventricle 18.3 and going to the aorta 18.2 and other areas of the patient's body. A downstream tubing 6 is provided on the proximal side of the rotor 2 and rotor housing 3. The downstream tubing has a downstream opening 6.1 located proximal to the aortic valve 18.4, thereby allowing blood to pass through the aortic valve within the downstream tubing 6 and then flow into the aorta 18.2. The downstream tubing 6 is made of a flexible material so that it can be compressed by the aortic valve 18.4 while the patient's heart 18.1 continues to pump.
[0057] Figure 2 shows a cross-section of the distal end region 8 of the catheter device 1. The distal bearing 9 comprises a polymer end 10 including a pigtail-shaped tip 10.2 and an elongated portion 10.1. At the proximal end, the elongated portion 10.1 is provided to surround a portion of the drive shaft cover 11. The drive shaft 4 extends into the distal bearing 9 and is supported by the drive shaft cover 11. The rotor 2 is located near the proximal side of the drive shaft cover 11. The downstream tubing 6 is attached to the rotor housing 3 and extends in the proximal direction. The proximal end of the downstream tubing 6 is attached to the flexible sheath 5.
[0058] Figure 3 shows a magnified portion of the distal end region 8 of the catheter device 1. Specifically, it shows a portion of the distal bearing 9 that includes the drive shaft cover 11. The drive shaft cover 11 extends from inside to outside the polymer end 10 and into the rotor housing 3. The drive shaft 4 is composed of one or more layers of coaxial windings, which extend spirally around a cavity that extends axially at the center of the drive shaft. The winding direction of the coaxial windings can be alternated between layers. This configuration improves the flexibility of the drive shaft. The outer diameter of the drive shaft is in the range of about 0.4 mm to about 2 mm. Preferably, the outer diameter is 0.6 mm to 1.2 mm, and particularly preferably 0.8 mm to 1.0 mm. The drive shaft cover 11 is designed to support the drive shaft 4 and includes a sleeve having a lumen into which the drive shaft 4 is inserted. The sleeve is preferably designed as a spiral sleeve 14 made of a flat tape 14.1. The tape can be made of, for example, MP35N®, 35NLT®, or ceramic. The inner diameter of the helical sleeve 14 is selected to allow the drive shaft 4 to be installed while maintaining its rotational ability, and to prevent a large amount of blood from entering the gap between the drive shaft 4 and the helical sleeve 14. The inner diameter of the helical sleeve 14 is selected to be, for example, 0.01 mm to 0.08 mm larger than the outer diameter of the drive shaft 4, preferably 0.01 mm to 0.05 mm larger than the outer diameter of the drive shaft 4. The inner diameter of the helical sleeve 14 is 0.4 mm to 2.1 mm, preferably 0.6 mm to 1.3 mm, and particularly preferably 0.8 mm to 1.1 mm. The thickness of the helical sleeve 14 is 0.05 mm to 0.4 mm. Such a helical sleeve 14 provides flexibility, especially in the region extending from the polymer end 10. The flexibility of the drive shaft cover 11 is preferably such that it prevents twisting in the drive shaft when the distal end region 8 of the catheter device 1 is bent.Furthermore, the flexibility of the drive shaft cover 11 is preferably such that it maintains the drive shaft 4 in a central position within the housing 3 and prevents the rotor 2 from contacting the housing 3. The proximal end of the helical sleeve is preferably ground flat, and both ends of the helical sleeve are preferably ground flat. Furthermore, the edges of both ends of the helical sleeve are rounded and smooth, with a ten-point average roughness of R according to the ISO 1302 standard. z The thickness is preferably ≤2 μm. The drive shaft cover 11 may further include a heat conduction section 13. The heat conduction section 13 may be designed as a tube that surrounds a portion of the helical sleeve 14. The heat conduction tube or heat conduction section 13 is made of a material having higher thermal conductivity than the polymer end 10, and can be made of medical-grade stainless steel such as 1.4441 stainless steel, for example. If the heat conduction section 13 is designed as a tube, it is provided to surround at least a portion of the helical sleeve 14 that is located within the polymer end 10. In some embodiments, the heat conduction section 13 or heat conduction tube extends from the polymer end 10 to a region within the housing 3 that can be configured to be in direct contact with the patient's blood. Specifically, the heat conduction section 13 designed as a tube may extend 0.5 mm to 2 mm from the polymer end, preferably 1 mm to 1.5 mm. The heat conduction section 13 or heat conduction tube may have a thickness of 0.05 mm to 0.5 mm. The inner diameter of the heat conduction tube can be 0.5 mm to 2.6 mm, preferably 0.7 mm to 1.8 mm, and particularly preferably 0.9 mm to 1.6 mm. If the heat conduction part 13 or the heat conduction tube is configured such that a portion of the outer surface 13'' of the heat conduction part 13 or the heat conduction tube is in direct contact with the patient's blood, the region of the outer surface (13'') of the heat conduction part 13 or the heat conduction tube that is in direct contact with the patient's blood is preferably smooth, for example, with a ten-point average roughness R according to the ISO 1302 standard. zIt has a size of ≤ 1.2 μm. The outer surface 13” of the heat conduction part 13, which is located within the polymer end part and configured to contact the polymer end part, is preferably roughened by, for example, laser texturing or knurling, and has an average surface roughness R according to ISO 1302 standard a It preferably has a size of ≥ 0.8 μm. A rotor 2 provided with a rotor hub 2.1 is provided on the proximal side of the drive shaft cover 11 so as to surround the drive shaft 4. In the extended operating state of the rotor, a distance of 0.2 mm to 0.7 mm, preferably 0.25 mm to 0.4 mm, is maintained between the rotor hub 2.1 and the drive shaft cover. The hub 2.1 of the rotor is designed such that the rotor blade 2.2 can be arranged closer to the drive shaft cover 11. The hub 2.1 extends less than 0.5 mm, preferably less than 0.1 mm or not at all, in the distal direction beyond the rotor blade.
[0059] For example, when other types of bearings are assumed or when it is assumed that no additional sleeve for supporting the drive shaft 4 is provided, the heat conduction part (13), which can be designed as a tube, can be provided within the polymer end part 10 regardless of the spiral sleeve 14.
[0060] Figure 4a shows a schematic diagram of a portion of the distal end region 8 of the catheter device 1. A portion of the helical sleeve 14 extends from the polymer end 10. The inner surface 13' of the heat conduction section is in direct contact with the helical sleeve 14 and can be roughened to facilitate adhesion of the helical sleeve 14 to the inner surface 13' of the heat conduction section 13. The exposed portion of the helical sleeve 14 that extends from the polymer end 10 is highly flexible and can follow even the large bending movements of the drive shaft 4 during operation. A portion of the heat conduction section 13 also extends from the polymer end 10 to allow heat transfer. In this embodiment, heat is transferred directly from the heat conduction tube 13 to the blood. The heat conduction tube 13 can also extend further into the distal bearing 10 to cover at least all of the region of the helical sleeve 14 that is located within the polymer end 10. In another embodiment, the heat conduction tube 13 is not included, while all other features are similar.
[0061] Figure 4b shows a schematic diagram of the same portion of the distal end region 8 of the catheter device 1 as in Figure 4a. The drive shaft cover 11 further includes a flexible tube 12' provided to surround the outside of the helical sleeve, or a portion of the outside of the helical sleeve. In the embodiment shown in Figure 4b, the flexible tube 12' extends to surround the proximal portion of the polymer end 10, a portion of the outer surface 13" of the heat conduction section 13 that extends from the polymer end 10, and a portion of the helical sleeve 14 that extends from the polymer end 10. The inner surface 13' of the heat conduction section is in direct contact with the helical sleeve 14 and can be roughened to facilitate adhesion of the helical sleeve to the inner surface 13' of the heat conduction section 13. The flexible tube can be constructed as a heat shrink tube and can be made of, for example, silicone, Pebax®, PU, or PET. The tube can have a small wall thickness, for example, less than 0.2 mm, and especially less than 0.02 mm. In this embodiment, heat is transferred from the heat conduction tube 13 to the blood via the flexible tube 12'. In embodiments with the flexible tube 12', a plurality of rings made of flat tape can be provided inside the flexible tube 12' instead of a helical sleeve. The rings can be made of, for example, MP35N®, 35NLT®, or ceramic, and can have the same thickness and inner diameter as the helical sleeve. In embodiments that can be realized with rings, the plurality of rings are arranged with gaps between them.
[0062] Figure 5a shows the same portion as Figure 4b, but includes a flexible tube 12” provided in a different configuration. The flexible tube 12” can also be configured as a heat-shrinkable tube and can be made of, for example, silicone, PEBAX®, PU, or PET. To obtain good thermal conductivity, the flexible tube can have a small wall thickness, which is, for example, less than 0.2 mm, and especially less than 0.02 mm. The flexible tube 12” is provided on the outside of the helical sleeve 14 and extends along the inner surface 13' of the heat conduction section 13 or the heat conduction tube and the inside of the polymer end 10. In the embodiment shown in this figure, the flexible tube 12” extends to the distal end of the helical sleeve 14. In this configuration, when the catheter device 1 is inserted into the patient, a portion of the outer surface 13” of the heat conduction section 13 is configured to be in direct contact with the patient's blood. That portion is smooth and has a ten-point average roughness R according to, for example, ISO 1302 standard. z The value of R z The size is ≤1.2 μm.
[0063] Figure 5b shows a configuration similar to Figure 5a, where the flexible tube 12” is provided on the outside of the helical sleeve 14 and extends along the inner surface (13') of the heat conduction section 13 and the inside of the polymer end 10. However, unlike Figure 5a, the flexible tube 12” does not extend to the distal end of the helical sleeve 14, so the distal end of the helical sleeve is not covered by the flexible tube 12”. On the other hand, the heat conduction section 13 extends further to the distal end of the helical sleeve 14, and therefore a portion of its inner surface 13' is configured to be in direct contact with the helical sleeve 14. In this configuration, it is possible to bond this portion of the inner surface 13' of the heat conduction section 13 to the outer portion of the helical sleeve 14. It is advantageous to provide a roughened surface on the inner surface 13' of the heat conduction section 13, for example, with an average surface roughness R according to ISO 1302 standard. a It has a diameter of ≥0.8 μm. Furthermore, in order to allow adhesive to be applied between the heat conduction part 13 and the helical sleeve 14, the heat conduction part 13, when designed as a tube, can have an inner diameter that is 0.04 mm to 0.1 mm larger than the outer diameter of the helical sleeve 14.
[0064] Figure 6 shows the helical sleeve 14. Both ends are ground flat and smooth. The flat tape 14.1 is shown in cross-sectional view. When viewed distally, the winding direction of the winding 14.2 from proximal to distal is opposite to the preferred rotation direction 4.1 of the drive shaft 4. This prevents the rotating parts from being damaged or caught by the sharp tip of the proximal end of the helical sleeve 14.
[0065] Figure 7 shows the rotor 2, housing 3, and cannula 15 in two states, a and b. The rotor 2 and housing 3 are configured to move into the cannula 15, for example, by applying force to the proximal end of the flexible sheath 5. As they move into the cannula, the rotor 2' and housing 3' are radially compressed from expanded states 2,3 to compressed states 2',3'. The cannula 15 can be a cannula attached to the catheter device 1 itself, or it can be a peel-away type sheath that assists in the insertion of the catheter device 1 into the patient's body. In the expanded state, the housing 3 has a length of 3.1. As the housing 3 is compressed to the compressed state 3', its length increases to a length of 3.1'. As the length changes, the relative position of the distal bearing 9 attached to the housing 3 with respect to the drive shaft 4 changes. The drive shaft cover 11 is designed so that the distal end of the drive shaft 4 is maintained within the drive shaft cover 11 as the housing 3 undergoes a change in length.
[0066] This application further relates to the following aspects. 1. Catheter device (1), The rotor (2) located in the distal end region of the catheter device (1), A drive shaft (4) extends from the drive region (16) of the catheter device (1) to the distal end region (8) of the catheter device, The drive shaft is supported by a distal bearing (9), A catheter device wherein the distal bearing (9) comprises a helical sleeve (14) including a winding, and the helical sleeve (14) is configured to rotatably accommodate the distal end of the drive shaft (4) inside. 2. A catheter device (1) according to Embodiment 1, wherein the spiral sleeve (14) is made of a flat tape (14.1). 3. A catheter device (1) according to embodiment 1 or 2, The drive shaft (4) has a cavity extending axially along the drive shaft (4), and is equipped with a plurality of coaxial windings that extend spirally around the cavity of the drive shaft (4), and the windings in the plurality of different coaxial layers have opposite winding directions. The outer diameter of the drive shaft is in the range of approximately 0.4 mm to approximately 2 mm. The catheter device preferably comprises a drive shaft (4) with a reinforcing element partially provided within the cavity of the drive shaft (4) in the distal end region. 4. A catheter device (1) according to any one of embodiments 1 to 3, wherein both ends of the helical sleeve (14) are ground flat, and all edges of both ends are rounded and smooth, preferably with a ten-point average roughness R z A catheter device having a diameter of ≤2 μm. 5. A catheter device (1) according to any one of embodiments 1 to 4, wherein a flexible tube (12, 12') is provided so as to surround a portion of the outer part of the helical sleeve, and the flexible tube is preferably designed as a heat-shrinkable tube. 6. A catheter device (1) described in any one of embodiments 1 to 5, The rotor (2) and the drive shaft (4) are configured to rotate in the rotational direction (4.1) such that when the catheter device (1) is brought into contact with the fluid, a proximal flow of the fluid is generated. A catheter device in which, when viewed along the drive shaft (4) toward the distal end of the drive shaft, the winding direction of the helical sleeve (14) from the proximal end to the distal end of the helical sleeve (14) is opposite to the rotation direction (4.1) of the rotor (2) and the drive shaft (4) when viewed along the drive shaft toward the distal end of the drive shaft. 7. A catheter device (1) according to any one of embodiments 1 to 6, wherein the helical sleeve (14) is made of MP35N®, 35NLT®, or ceramic. 8. A catheter device (1) according to any one of embodiments 1 to 7, wherein the inner diameter of the helical sleeve (14) is 0.4 mm to 2.1 mm, and the thickness of the helical sleeve is 0.05 mm to 0.4 mm. 9. A catheter device (1) according to any one of embodiments 1 to 8, wherein the helical sleeve (14), or if a flexible tube according to any one of embodiments 5 to 8 is provided, the helical sleeve (14) and / or the flexible tube (12, 12') are at least partially in contact with the heat conduction part (13), and the heat conduction part (13) is configured to allow heat transfer from the distal bearing (9) and / or the helical sleeve (14). 10. A catheter device according to embodiment 9, wherein the heat conduction portion (13) is designed as a tube surrounding a portion of the helical sleeve (14). 11. A catheter device according to embodiment 9 or 10, wherein the heat conduction portion or heat conduction tube (13) extends from the distal bearing to a region configured to come into contact with the fluid, thereby enabling heat transfer from the distal bearing (9) to the fluid. 12. A catheter device (1) according to any one of embodiments 1 to 11, wherein the distal bearing (9) comprises a polymer end (10), or the distal bearing (9) comprises a polymer end including a region designed as a pigtail (10.2). 13. A catheter device (1) according to any one of embodiments 9 to 12, A portion of the outer surface (13") of the heat conduction part (13) that is configured to come into contact with the fluid is smooth, preferably with a ten-point average roughness R z Having ≤1.2μm, The inner surface (13') of the heat conduction portion (13) is roughened to facilitate adhesion of the helical sleeve (14) to the inner surface (13') of the heat conduction portion (13), and the inner surface (13') of the heat conduction portion or heat conduction tube (13) preferably has an arithmetic mean surface roughness R a A catheter device having a diameter of ≥0.8 μm. 14. A catheter device according to embodiment 13, wherein a further portion of the outer surface (13") of the heat conduction part or heat conduction tube (13) configured to be located within the polymer end is roughened, preferably having an arithmetic mean surface roughness R a A catheter device having a diameter of ≥0.8 μm. 15. A catheter device according to any one of embodiments 9 to 14, wherein the inner diameter of the heat conduction portion (13) designed as a tube is 0.5 mm to 2.6 mm, or the thickness of the heat conduction portion is 0.05 mm to 0.5 mm, or both. 16. A catheter device according to any one of embodiments 9 to 15, wherein the heat conducting part (13) is made of medical-grade stainless steel, preferably 1.4441 stainless steel. 17. A catheter device (1) according to any one of embodiments 1 to 16, which is designed as an expandable pump, A cannula is provided so as to surround a portion of the drive shaft (4) located near the rotor (2), A catheter device wherein the rotor (2) is located within a housing (3), the housing (3) and the rotor (2) are configured to move at least partially into the cannula (15), and the housing (3) and the rotor (2) are compressed from an expanded state to a compressed state at least along the radial direction transverse to the longitudinal direction. 18. A catheter device (1) according to any one of embodiments 1 to 17, When force is applied to the proximal end of the catheter, and / or when the housing and rotor are compressed, the relative movement of the drive shaft (4) with respect to the distal bearing (9) is performed. A catheter device in which the drive shaft and the distal bearing are configured such that the distal end of the drive shaft is maintained within the helical sleeve when the housing (3) and the rotor (2) are compressed. 19. A catheter device (1) according to any one of embodiments 1 to 18, wherein the hub (2.1) attached to the rotor (2) extends less than 0.5 mm beyond the rotor blade (2.2) in the direction toward the distal end of the catheter device, preferably by less than 0.1 mm. [Note] [1] Catheter device (1), The rotor (2,2') located in the distal end region (8) of the catheter device (1), A drive shaft (4) extends from the drive region (16) of the catheter device (1) to the distal end region (8) of the catheter device (1), The drive shaft (4) is supported by a distal bearing (9), A catheter device comprising a distal bearing (9) and a heat conduction section (13) configured to enable heat transfer from the distal bearing. [2] A catheter device as described in [1], wherein the heat conduction portion (13) is designed as a tube surrounding the drive shaft. [3] A catheter device (1) according to [1] or [2], wherein the drive shaft (4) has a cavity extending axially along the drive shaft, and comprises a plurality of coaxial windings extending spirally around the cavity of the drive shaft, the windings in the plurality of different coaxial layers having opposite winding directions, The outer diameter of the drive shaft is in the range of approximately 0.4 mm to approximately 2 mm. The catheter device preferably comprises a drive shaft with a reinforcing element partially provided within the cavity of the drive shaft in the distal end region. [4] A catheter device (1) according to any one of [1] to [3], wherein the heat conduction portion (13) extends from the distal bearing (9) to a region configured to come into contact with the fluid, thereby enabling heat transfer from the distal bearing (9) to the fluid. [5] A catheter device (1) according to any one of [1] to [4], wherein the distal bearing (9) comprises a polymer end (10), or the distal bearing (9) comprises a polymer end including a region designed as a pigtail (10.2). [6] A catheter device (1) according to any one of [1] to [5], wherein the heat conduction part (13) is made of medical-grade stainless steel, preferably 1.4441 stainless steel. [7] A catheter device (1) according to any one of [1] to [6], wherein the inner diameter of the heat conduction part (13) designed as a tube is 0.5 mm to 2.6 mm, or the thickness of the heat conduction part (13) is 0.05 mm to 0.5 mm, or both. [8] A catheter device (1) according to any one of [1] to [7], wherein a spiral sleeve (14) having a winding is disposed within the distal bearing (9) to rotatably position the distal end of the drive shaft inside the spiral sleeve (14), so that the spiral sleeve (14) is at least partially located inside the heat conduction section (13) designed as a tube, or a portion of the spiral sleeve (14) is in direct contact with a portion of the inner surface (13') of the heat conduction section (13), or both. [9] A catheter device (1) according to any one of [1] to [8], wherein a spiral sleeve (14) having a winding is disposed within the distal bearing (9) to rotatably position the distal end of the drive shaft inside the spiral sleeve (14), so that a portion of the spiral sleeve (14) and a portion of the heat conduction portion (13) are separated only by a thin flexible tube (12, 12') provided so as to surround a portion of the outer portion of the spiral sleeve, the flexible tube (12, 12') preferably designed as a heat shrink tube.
[10] A catheter device (1) as described in [8] or [9], wherein the spiral sleeve (14) is made of a flat tape (14.1).
[11] A catheter device (1) described in any one of [1] to
[10] , A portion of the outer surface (13") of the heat conduction part (13) that is configured to come into contact with the fluid is smooth, preferably with a ten-point average roughness R z Having ≤1.2μm, The inner surface (13') of the heat conduction portion (13) is roughened to facilitate adhesion of the helical sleeve (14) to the inner surface (13') of the heat conduction portion (13), and the inner surface (13') of the heat conduction portion or heat conduction tube (13) preferably has an arithmetic mean surface roughness R a A catheter device having a diameter of ≥0.8 μm.
[12]
[11] The catheter device (1) described above, wherein a further portion of the outer surface (13") of the heat conduction part or heat conduction tube (13) that is configured to be located within the polymer end (10) is roughened, preferably having an arithmetic mean surface roughness R a A catheter device having a diameter of ≥0.8 μm.
[13] A catheter device (1) according to any one of [8] to
[12] , wherein both ends of the helical sleeve (14) are ground flat, and all edges of both ends are rounded and smooth, preferably with a ten-point average roughness R z A catheter device having a diameter of ≤2 μm.
[14] A catheter device (1) as described in any one of [8] to
[13] , wherein the inner diameter of the helical sleeve (14) is 0.4 mm to 2.1 mm, and the thickness of the helical sleeve is 0.05 mm to 0.4 mm.
[15] A catheter device (1) described in any one of [8] to
[14] , The rotor (2) and the drive shaft (4) are configured to rotate in the rotational direction (4.1) such that when the catheter device (1) is brought into contact with the fluid, a proximal flow of the fluid is generated. A catheter device in which, when viewed along the drive shaft toward the distal end of the drive shaft, the winding direction of the helical sleeve (14) from the proximal end to the distal end of the helical sleeve (14) is opposite to the rotation direction (4.1) of the rotor (2) and the drive shaft (4) when viewed along the drive shaft (4) toward the distal end of the drive shaft (4).
[16] A catheter device (1) as described in any one of [8] to
[15] , wherein the helical sleeve (14) is made of MP35N®, 35NLT®, or ceramic.
[17] A catheter device (1) described in any one of [1] to
[16] , which is designed as an expandable pump, A cannula (15) is provided so as to surround a portion of the drive shaft (4) located near the rotor (2), A catheter device wherein the rotor (2) is located within a housing (3), the housing (3) and the rotor (2) are configured to move at least partially into the cannula (15), and the housing (3) and the rotor (2) are compressed from an expanded state to a compressed state at least along the radial direction transverse to the longitudinal direction.
[18] A catheter device (1) as described in
[17] , wherein when a force is applied to the proximal end of the catheter and / or when the housing (3) and the rotor (2) are compressed, the drive shaft (4) moves relative to the distal bearing (9), A catheter device in which the drive shaft (4) and the distal bearing (9) are configured such that when the housing (3) and the rotor (2) are compressed, the distal end of the drive shaft (4) is maintained within the distal bearing (9), or within the heat conduction section (13) designed as a tube, or within the helical sleeve (14).
[19] A catheter device (1) according to any one of [1] to
[18] , wherein the hub (2.1) attached to the rotor (2) extends less than 0.5 mm beyond the rotor blade (2.2) in the direction toward the distal end of the catheter device, preferably by less than 0.1 mm.
[20] Catheter device (1), The rotor (2) located in the distal end region of the catheter device (1), A drive shaft (4) extends from the drive region (16) of the catheter device (1) to the distal end region (8) of the catheter device (1), The drive shaft is supported by a distal bearing (9), A catheter device wherein the distal bearing (9) comprises a helical sleeve (14) including a winding, and the helical sleeve (14) is configured to rotatably accommodate the distal end of the drive shaft (4) inside. [twenty one] A catheter device (1) as described in
[20] , wherein the spiral sleeve (14) is made of a flat tape (14.1). [twenty two] A catheter device (1) as described in
[20] or
[21] , The drive shaft (4) has a cavity extending axially along the drive shaft (4), and is equipped with a plurality of coaxial windings that extend spirally around the cavity of the drive shaft (4), and the windings in the plurality of different coaxial layers have opposite winding directions. The outer diameter of the drive shaft is in the range of approximately 0.4 mm to approximately 2 mm. The catheter device preferably comprises a drive shaft (4) with a reinforcing element partially provided within the cavity of the drive shaft (4) in the distal end region. [twenty three] A catheter device (1) as described in any one of
[20] to
[22] , wherein both ends of the helical sleeve (14) are ground flat, and all edges of both ends are rounded and smooth, preferably with a ten-point average roughness R z A catheter device having a diameter of ≤2 μm. [twenty four] A catheter device according to any one of
[20] to
[23] , wherein a flexible tube (12,12') is provided so as to surround a portion of the outer part of the helical sleeve, and the flexible tube is preferably designed as a heat-shrinkable tube. [twenty five] A catheter device (1) described in any one of
[20] to
[24] , The rotor (2) and the drive shaft (4) are configured to rotate in the rotational direction (4.1) such that when the catheter device (1) is brought into contact with the fluid, a proximal flow of the fluid is generated. A catheter device in which, when viewed along the drive shaft (4) toward the distal end of the drive shaft, the winding direction of the helical sleeve (14) from the proximal end to the distal end of the helical sleeve (14) is opposite to the rotation direction (4.1) of the rotor (2) and the drive shaft (4) when viewed along the drive shaft toward the distal end of the drive shaft.
[26] A catheter device (1) as described in any one of
[20] to
[25] , wherein the helical sleeve (14) is made of MP35N®, 35NLT®, or ceramic.
[27] A catheter device (1) as described in any one of
[20] to
[26] , wherein the inner diameter of the helical sleeve (14) is 0.4 mm to 2.1 mm, and the thickness of the helical sleeve is 0.05 mm to 0.4 mm.
[28] A catheter device (1) according to any one of
[20] to
[27] , wherein the helical sleeve (14) and / or the flexible tube (12, 12') are at least partially in contact with a heat conduction part (13), and the heat conduction part (13) is configured to allow heat transfer from the distal bearing (9) and / or the helical sleeve (14).
[29] A catheter device as described in
[28] , wherein the heat conduction portion (13) is designed as a tube surrounding a portion of the helical sleeve (14).
[30] A catheter device according to
[28] or
[29] , wherein the heat conduction portion or heat conduction tube (13) extends from the distal bearing to a region configured to come into contact with the fluid, thereby enabling heat transfer from the distal bearing (9) to the fluid.
[31] A catheter device (1) according to any one of
[20] to
[30] , wherein the distal bearing (9) comprises a polymer end (10), or the distal bearing (9) comprises a polymer end including a region designed as a pigtail (10.2).
[32] A catheter device (1) described in any one of
[28] to
[31] , A portion of the outer surface (13") of the heat conduction part (13) that is configured to come into contact with the fluid is smooth, preferably with a ten-point average roughness R z Having ≤1.2μm, The inner surface (13') of the heat conduction portion (13) is roughened to facilitate adhesion of the helical sleeve (14) to the inner surface (13') of the heat conduction portion (13), and the inner surface (13') of the heat conduction portion or heat conduction tube (13) preferably has an arithmetic mean surface roughness R a A catheter device having a diameter of ≥0.8 μm.
[33]
[32] The catheter device described above, wherein a further portion of the outer surface (13") of the heat conduction portion or heat conduction tube (13) configured to be located within the polymer end is roughened, preferably having an arithmetic mean surface roughness R a A catheter device having a diameter of ≥0.8 μm.
[34] A catheter device according to any one of
[28] to
[33] , wherein the inner diameter of the heat conduction portion (13) designed as a tube is 0.5 mm to 2.6 mm, or the thickness of the heat conduction portion is 0.05 mm to 0.5 mm, or both.
[35] A catheter device according to any one of
[28] to
[34] , wherein the heat conducting part (13) is made of medical-grade stainless steel, preferably 1.4441 stainless steel.
[36] A catheter device (1) described in any one of
[20] to
[35] , which is designed as an expandable pump, A cannula is provided so as to surround a portion of the drive shaft (4) located near the rotor (2), A catheter device wherein the rotor (2) is located within a housing (3), the housing (3) and the rotor (2) are configured to move at least partially into the cannula (15), and the housing (3) and the rotor (2) are compressed from an expanded state to a compressed state at least along the radial direction transverse to the longitudinal direction.
[37] A catheter device (1) described in any one of
[20] to
[36] , When force is applied to the proximal end of the catheter, and / or when the housing and rotor are compressed, the relative movement of the drive shaft (4) with respect to the distal bearing (9) is performed. A catheter device in which the drive shaft and the distal bearing are configured such that the distal end of the drive shaft is maintained within the helical sleeve (14) when the housing (3) and the rotor (2) are compressed.
[38] A catheter device (1) according to any one of
[20] to
[37] , wherein the hub (2.1) attached to the rotor (2) extends less than 0.5 mm beyond the rotor blade (2.2) in the direction toward the distal end of the catheter device, preferably by less than 0.1 mm.
[39] Catheter device (1), The rotor (2) located in the distal end region of the catheter device (1), A drive shaft (4) extends from the drive region (16) of the catheter device (1) to the distal end region (8) of the catheter device, The drive shaft is supported by a distal bearing (9), The distal bearing (9) comprises a helical sleeve (14) including a winding, and the helical sleeve (14) is configured to rotatably accommodate the distal end of the drive shaft (4) inside. A catheter device wherein the helical sleeve (14), or a flexible tube (12, 12') provided to surround a portion of the outer part of the helical sleeve, is at least partially in contact with the heat conduction part (13), and the heat conduction part (13) is configured to allow heat transfer from the distal bearing (9) and / or the helical sleeve (14). [Note 2] [
[25] ] Catheter device (1), The rotor (2) located in the distal end region of the catheter device (1), A drive shaft (4) extends from the drive region (16) of the catheter device (1) to the distal end region (8) of the catheter device (1), The drive shaft is supported by a distal bearing (9), A catheter device wherein the distal bearing (9) comprises a polymer end (10) and a helical sleeve (14) including a winding, and the helical sleeve (14) is configured to rotatably accommodate the distal end of the drive shaft (4) inside. [
[26] ] A catheter device (1) as described in [
[25] ], wherein the spiral sleeve (14) is made of a flat tape (14.1). [
[27] ] A catheter device (1) as described in [
[25] ] or [
[26] ], The drive shaft (4) has a cavity extending axially along the drive shaft (4), and comprises a plurality of windings extending spirally around the cavity of the drive shaft (4), the windings being arranged coaxially with each other, and the windings in the plurality of different coaxial layers having opposite winding directions. A catheter device in which the outer diameter of the drive shaft is in the range of approximately 0.4 mm to approximately 2 mm. [
[28] ] The catheter device (1) described in [
[27] ], The catheter device comprises a drive shaft (4) with a reinforcing element partially provided within the cavity of the drive shaft (4) in the distal end region. [
[29] ] A catheter device (1) according to any one of items [
[25] ] to [
[28] ], wherein both ends of the helical sleeve (14) are ground flat, and all edges of both ends are rounded and smooth, with a ten-point average roughness R z A catheter device having a diameter of ≤2 μm. [
[30] ] A catheter device (1) according to any one of items [
[25] ] to [
[29] ], wherein a flexible tube (12,12') is provided around a portion of the outer part of the spiral sleeve. [
[31] ] A catheter device (1) as described in [
[30] ], wherein the flexible tube is designed as a heat-shrinkable tube. [
[32] ] A catheter device (1) described in any one of items [
[25] ] to [
[31] ], The rotor (2) and the drive shaft (4) are configured to rotate in the rotational direction (4.1) such that when the catheter device (1) is brought into contact with the fluid, a proximal flow of the fluid is generated. A catheter device in which, when viewed along the drive shaft (4) toward the distal end of the drive shaft, the winding direction of the helical sleeve (14) from the proximal end to the distal end of the helical sleeve (14) is opposite to the rotation direction (4.1) of the rotor (2) and the drive shaft (4) when viewed along the drive shaft toward the distal end of the drive shaft. [
[33] ] A catheter device (1) according to any one of items [
[25] ] to [
[32] ], wherein the helical sleeve (14) is made of MP35N®, 35NLT®, or ceramic. [
[34] ] A catheter device (1) according to any one of items [
[25] ] to [
[33] ], wherein the inner diameter of the helical sleeve (14) is 0.4 mm to 2.1 mm, and the thickness of the helical sleeve is 0.05 mm to 0.4 mm. [
[35] ] A catheter device (1) according to any one of items [
[25] ] to [
[34] ], wherein the helical sleeve (14) and / or the flexible tube (12,12') are at least partially in contact with the heat conduction part (13), and the heat conduction part (13) is configured to allow heat transfer from the distal bearing (9) and / or the helical sleeve (14). [
[36] ] A catheter device (1) as described in [
[35] ], wherein the heat conduction portion (13) is designed as a tube surrounding a portion of the helical sleeve (14). [
[37] ] A catheter device according to [
[35] ] or [
[36] ], wherein the heat conduction portion or heat conduction tube (13) extends from the distal bearing to a region configured to come into contact with the fluid, thereby enabling heat transfer from the distal bearing (9) to the fluid. [
[38] ] A catheter device (1) according to any one of items [
[25] ] to [
[37] ], wherein the polymer end (10) includes a region designed as a pigtail (10.2). [
[39] ] A catheter device (1) described in any one of items [
[25] ] to [
[38] ], A portion of the outer surface (13") of the heat conduction part (13) that is configured to come into contact with the fluid is smooth and has a ten-point average roughness R z Having ≤1.2μm, The inner surface (13') of the heat conduction part (13) is roughened to facilitate adhesion of the helical sleeve (14) to the inner surface (13') of the heat conduction part (13), and the inner surface (13') of the heat conduction part or heat conduction tube (13) has an arithmetic mean surface roughness R a A catheter device having a diameter of ≥0.8 μm. [
[40] ] A catheter device as described in [
[39] ], wherein a further portion of the outer surface (13”) of the heat conduction part or heat conduction tube (13) configured to be located within the polymer end is roughened, and has an arithmetic mean surface roughness R a A catheter device having a diameter of ≥0.8 μm. [
[41] ] A catheter device according to any one of items [
[35] ] to [
[40] ], wherein the inner diameter of the heat conduction part (13) designed as a tube is 0.5 mm to 2.6 mm, or the thickness of the heat conduction part is 0.05 mm to 0.5 mm, or both. [
[42] ] A catheter device according to any one of items [
[35] ] to [
[41] ], wherein the heat conduction part (13) is made of medical-grade stainless steel. [
[43] ] A catheter device as described in [
[42] ], wherein the heat conduction part (13) is made of 1.4441 stainless steel. [
[44] ] A catheter device (1) described in any one of items [
[25] ] to [
[43] ], which is designed as an expandable pump, A cannula is provided so as to surround a portion of the drive shaft (4) located near the rotor (2), A catheter device wherein the rotor (2) is located within a housing (3), the housing (3) and the rotor (2) are configured to move at least partially into the cannula (15), and the housing (3) and the rotor (2) are compressed from an expanded state to a compressed state at least along the radial direction transverse to the longitudinal direction. [
[45] ] A catheter device (1) described in any one of items [
[25] ] to [
[44] ], When force is applied to the proximal end of the catheter, and / or when the housing and rotor are compressed, the relative movement of the drive shaft (4) with respect to the distal bearing (9) is performed. A catheter device in which the drive shaft and the distal bearing are configured such that the distal end of the drive shaft is maintained within the helical sleeve (14) when the housing (3) and the rotor (2) are compressed. [
[46] ] A catheter device (1) according to any one of items [
[25] ] to [
[45] ], wherein the hub (2.1) attached to the rotor (2) extends less than 0.5 mm beyond the rotor blade (2.2) in the direction of the distal end of the catheter device. [
[47] ] Catheter device (1), The rotor (2) located in the distal end region of the catheter device (1), A drive shaft (4) extends from the drive region (16) of the catheter device (1) to the distal end region (8) of the catheter device, The drive shaft is supported by a distal bearing (9), A catheter device in which the distal bearing (9) comprises a plurality of metal rings, and the distal end of the drive shaft (4) is rotatably positioned inside the metal rings. [
[48] ] The catheter device (1) described in [
[47] ], A catheter device in which the distal bearing (9) is provided with a polymer end (10). [
[49] ] A catheter device (1) as described in [
[47] ] or [
[48] ], A catheter device in which the aforementioned metal ring is provided inside a flexible tube (12,12'). [
[50] ] Catheter device (1), The rotor (2) located in the distal end region of the catheter device (1), A drive shaft (4) extends from the drive region (16) of the catheter device (1) to the distal end region (8) of the catheter device, The drive shaft is supported by a distal bearing (9), The distal bearing (9) comprises a helical sleeve (14) including a winding, and the helical sleeve (14) is configured to rotatably accommodate the distal end of the drive shaft (4) inside. The flexible tube (12, 12') provided to surround the helical sleeve (14) or a portion of the outer part of the helical sleeve (14) is at least partially in contact with the heat conduction part (13), and the heat conduction part (13) is configured to allow heat transfer from the distal bearing (9) and / or the helical sleeve (14). The heat conduction portion (13) extends from the distal bearing (9), A catheter device in which the helical sleeve (14) extends from the heat conduction part (13). [Explanation of symbols]
[0067] 1. Catheter device 2 rotors 2' Rotor (compressed state) 2.1 Hub 2.2 Rotor Blades 3 Housing 3' Housing (compressed state) 3.1 Housing Length 3.1' Housing length (compressed state) 4 drive shaft 4.1 Direction of rotation of the drive shaft 5 Flexible sheath 6 Downstream Tubing 6.1 Downstream opening 8. Distal region 9. Distal bearing 10 Polymer ends 10.1 Elongated portion at the end of the polymer 10.2 Pigtail 11 Drive shaft cover 12' Flexible tubing (outer structure) 12" Flexible Tube (Internal Construction) 13 Heat conduction section 13' Inner surface of the heat conduction section 13" outer surface of the heat conduction section 14 spiral sleeve 14.1 Flat Tape 14.2 Winding of spiral sleeves 15 Cannulas 16 Drive Range 17 Motor 18.1 Heart 18.2 Aorta 18.3 Left ventricle 18.4 Aortic valve
Claims
1. Catheter device (1), The rotor (2,2') located in the distal end region (8) of the catheter device (1), A drive shaft (4) extends from the drive region (16) of the catheter device (1) to the distal end region (8) of the catheter device (1), The system includes a distal bearing (9) that supports the distal end of the drive shaft (4), The distal bearing (9) includes a polymer end (10) and a heat conduction portion (13) configured to allow heat transfer from the distal bearing. The catheter device wherein the heat conducting portion (13) has a portion that extends inside the polymer end portion (10) and a portion that extends outside the polymer end portion (10).
2. A catheter device according to claim 1, wherein the distal bearing (9) is located away from the rotor.
3. A catheter device according to claim 1 or 2, wherein the heat conduction portion (13) is designed as a tube surrounding the drive shaft.
4. A catheter device according to claim 1 or 2, wherein the heat conduction portion (13) is designed as one or more metal plates or tongues provided near the drive shaft.
5. A catheter device (1) according to any one of claims 1 to 4, wherein the drive shaft (4) has a cavity extending axially along the drive shaft, and comprises a plurality of windings extending spirally around the cavity of the drive shaft, the plurality of windings are arranged coaxially with respect to each other, and the windings in a plurality of different coaxial layers have opposite winding directions. A catheter device in which the outer diameter of the drive shaft is in the range of approximately 0.4 mm to approximately 2 mm.
6. A catheter device (1) according to claim 5, wherein the drive shaft is provided with a reinforcing element partially provided within the cavity of the drive shaft in the distal end region.
7. A catheter device (1) according to any one of claims 1 to 6, wherein the heat conduction portion (13) extends from the distal bearing (9) to a region configured to come into contact with the fluid, thereby enabling heat transfer from the distal bearing (9) to the fluid.
8. A catheter device (1) according to any one of claims 1 to 7, wherein the polymer end (10) includes a region designed as a pigtail (10.2).
9. A catheter device (1) according to any one of claims 1 to 8, wherein the heat conducting part (13) is made of medical-grade stainless steel.
10. A catheter device (1) according to claim 9, wherein the heat conduction part (13) is made of 1.4441 stainless steel.
11. A catheter device (1) according to any one of claims 1 to 10, wherein the inner diameter of the heat conduction portion (13) designed as a tube is 0.5 mm to 2.6 mm, or the thickness of the heat conduction portion (13) is 0.05 mm to 0.5 mm, or both.
12. A catheter device (1) according to any one of claims 1 to 11, wherein a spiral sleeve (14) having a winding is disposed within the distal bearing (9) to rotatably position the distal end of the drive shaft inside the spiral sleeve (14), so that the spiral sleeve (14) is at least partially located inside the heat conduction section (13) designed as a tube, or a portion of the spiral sleeve (14) is in direct contact with a portion of the inner surface (13') of the heat conduction section (13), or both.
13. A catheter device (1) according to any one of claims 1 to 12, wherein a spiral sleeve (14) having a winding is disposed within the distal bearing (9) to rotatably install the distal end of the drive shaft (4) inside the spiral sleeve (14), and thereby a portion of the spiral sleeve (14) and a portion of the heat conduction portion (13) are separated only by a thin flexible tube (12, 12') provided so as to surround a portion of the outer portion of the spiral sleeve.
14. A catheter device (1) according to claim 13, wherein the flexible tube (12, 12') is designed as a heat-shrinkable tube.
15. A catheter device (1) according to any one of claims 12, 13, or 14, wherein the spiral sleeve (14) is made of a flat tape (14.1).
16. A catheter device (1) according to any one of claims 1 to 15, A portion of the outer surface (13") of the heat conduction portion (13) that is configured to come into contact with the fluid is smooth and has a ten-point average roughness R ｚ Having ≤1.2 μm, The inner surface (13') of the heat conduction part (13) is roughened to facilitate adhesion of the helical sleeve (14) to the inner surface (13') of the heat conduction part (13), and the inner surface (13') of the heat conduction part or heat conduction tube (13) has an arithmetic mean surface roughness R ａ A catheter device having a diameter of ≥0.8 μm.
17. A catheter device (1) according to claim 16, wherein a further portion of the outer surface (13") of the heat conduction part or heat conduction tube (13) configured to be located within the polymer end (10) is roughened, having an arithmetic mean surface roughness R ａ A catheter device having a diameter of ≥0.8 μm.
18. A catheter device (1) according to any one of claims 12 to 17, wherein both ends of the helical sleeve (14) are ground flat, and all edges of both ends are rounded and smooth, with a ten-point average roughness R ｚ A catheter device having a diameter of ≤2 μm.
19. A catheter device (1) according to any one of claims 12 to 18, wherein the inner diameter of the helical sleeve (14) is 0.4 mm to 2.1 mm, and the thickness of the helical sleeve is 0.05 mm to 0.4 mm.
20. A catheter device (1) according to any one of claims 12 to 19, The rotor (2) and the drive shaft (4) are configured to rotate in the rotational direction (4.1) such that when the catheter device (1) is brought into contact with the fluid, a proximal flow of the fluid is generated. A catheter device in which, when viewed along the drive shaft toward the distal end of the drive shaft, the winding direction of the helical sleeve (14) from the proximal end to the distal end of the helical sleeve (14) is opposite to the rotational direction (4.1) of the rotor (2) and the drive shaft (4) when viewed along the drive shaft (4) toward the distal end of the drive shaft (4).
21. A catheter device (1) according to any one of claims 12 to 20, wherein the helical sleeve (14) is made of MP35N®, 35NLT®, or ceramic.
22. A catheter device (1) according to any one of claims 1 to 21, which is designed as an expandable pump, A cannula (15) is provided so as to surround a portion of the drive shaft (4) located near the rotor (2), A catheter device wherein the rotor (2) is located within a housing (3), the housing (3) and the rotor (2) are configured to move at least partially into the cannula (15), and the housing (3) and the rotor (2) are compressed from an expanded state to a compressed state at least along the radial direction transverse to the longitudinal direction.
23. A catheter device (1) according to claim 22, wherein when a force is applied to the proximal end of the catheter and / or when the housing (3) and the rotor (2) are compressed, the relative movement of the drive shaft (4) with respect to the distal bearing (9) is performed. A catheter device in which the drive shaft (4) and the distal bearing (9) are configured such that when the housing (3) and the rotor (2) are compressed, the distal end of the drive shaft (4) is maintained within the distal bearing (9) or within the heat conduction part (13).
24. A catheter device (1) according to any one of claims 1 to 23, wherein the hub (2.1) attached to the rotor (2) extends less than 0.5 mm beyond the rotor blade (2.2) in the direction toward the distal end of the catheter device.