Device for Compressing a Compressible Component of a Catheter Pump

Abstract

The present invention relates to a system comprising a catheter device having a radially compressible member, a sleeve, and means for compressing the radially compressible member and introducing the radially compressible member into the sleeve, and a method of using the system.

Description

[0001] This application is a divisional application of the application with the application date of August 22, 2018, application number 2018800548239, and invention name "Device for Compressing a Compressible Component of a Catheter Pump". Technical Field

[0002] The present invention relates to a system comprising a catheter pump having a radially compressible component and a device for compressing the compressible component, and a method of using the system.

[0003] Thus, on the one hand, applications can be provided in the field of minimally invasive medicine, such as blood pumps for cardiac assistance, and on the other hand, it can also be applied in mixers or drive elements. Background Art

[0004] Through possible miniaturization in the medical field, the present invention can exhibit special advantages. The techniques for introducing fluid pumps, especially the techniques for introducing fluid pumps into natural body cavities, are well-known prior arts in detail. Therefore, reference is also made to the Seldinger technique for introducing an introducer sheath into the vascular system.

[0005] For example, compressible or expandable catheter pumps are disclosed in EP2399639 or EP2606920, where radially compressible components such as rotors and rotor housings can be transferred into a sleeve or sheath. A sleeve is provided around the catheter, and the compressible component is pulled into the sleeve such that compression occurs when the compressible component enters the sleeve. As described in EP2399639, the sleeve can be, for example, a peelable sheath facilitating the insertion of the catheter pump into the inner cavity, or can be any other type of sleeve, such as a cannula related to the catheter itself.

[0006] Although such expandable pumps are current prior arts and allow minimally invasive introduction into the human body, there are many disadvantages regarding the operation of such pumps.

[0007] To ensure the normal operation of the pump, the compressible component should not be transported and provided in a compressed state. The compression time of the compressible component should be kept shortest because flexible components will start to creep when kept in a compressed state for too long.

[0008] According to the prior art, the catheter device is provided in an expanded state. For example, by applying a tensile force on the proximal end of the catheter conduit of the catheter device, the compressible component is pulled into a sleeve provided at the proximal end of the compressible component. Thus, the compression acts on the end of the sleeve and starts from the proximal end of the compressible component. When the compressible component is squeezed into the sleeve, a force that is initially mainly an axial component acts on the rotor and the housing, causing strong deformation of the compressible component. This process causes stress and strain on the compressible component and may cause the compressible component to kink.

[0009] In addition, during compression, the compressible component often undergoes elongation. That is, in a pump where the rotor is located within the housing, both the housing and the rotor can expand axially while being compressed radially. If the rotor and the housing are pulled into a sleeve and compressed from one end, the axial extension will be hindered in the direction of the sleeve. In particular, the already compressed housing hinders the axial elongation of the rotor in the direction of the sleeve. This can lead to additional strain or kinking when the rotor folds.

[0010] EP3153190 shows a rotor housing that includes fewer struts at one end of the housing to minimize damage to the blood. However, due to the relatively large gaps between the struts, this increases the risk that the rotor will get stuck or squeezed between the struts when the housing and the rotor are compressed.

[0011] Therefore, it is advantageous to introduce a compressive force onto the rotor housing such that the compressive force, especially the initial compressive force, is applied more concentratedly on the rotor and has a greater radial component. By applying the force at a central portion of the compressible housing that is between the distal end and the proximal end of the housing, that is, at or near the axial portion where the rotor is located within the housing, uneven folding or squeezing of the rotor between the struts can be avoided. If the force is applied in this way rather than only from one end, the rotor can axially elongate and / or axially move in the proximal and distal directions. Thus, the rotor can fold smoothly around its hub.

[0012] In principle, the compression of the compressible component of the catheter device can be accomplished using a stent crimper, such as that described in EP0873731. However, using a stent crimper in a catheterization laboratory or a hospital environment is problematic because a stent crimper is a precision and complex tool that is difficult to clean and disinfect after use. SUMMARY OF THE INVENTION

[0013] Accordingly, an object of the present application is to provide a simple method for quickly, safely, and reproducibly compressing the compressible component of a catheter pump and inserting the compressible component into a sleeve, which is also feasible in a catheterization laboratory.

[0014] The system according to the present application at least partially addresses the above problems and requirements. Further advantageous embodiments may be given by the embodiments of the present application or disclosed in the specification and the drawings.

[0015] The system according to the present application includes a catheter device having a compressible component. Generally, the compressible component includes a compressible rotor and a housing for the rotor. The compressible component is located near one end of the catheter pump defined as the distal end, which is configured to be inserted into a patient's body, while the proximal portion of the catheter remains outside the patient's body. A motor connected to the proximal end of the catheter device can drive the rotor at the distal end of the catheter device through a drive shaft. The rotor, for example, is positioned in the left ventricle of the heart and is driven to achieve blood flow in the direction of the proximal end of the catheter device, such as flowing out of the left ventricle and into the aorta. A downstream tube can be provided on the proximal side of the rotor in a portion where passage through the aortic valve is required. The compressible housing of the rotor can prevent entanglement of heart tissue with the rotor during operation. The catheter device can further include a distal shaft. The distal shaft can include an elongated portion for rotatably mounting the drive shaft. It is preferably designed as a flexible shaft. The catheter device can further include an atraumatic tip having an elongated flexible portion. The atraumatic tip is preferably designed as a pigtail. In some embodiments, the flexible polymer component including the atraumatic tip or the pigtail tip can include the distal shaft.

[0016] The system further includes a sleeve into which the compressible component is to be inserted. The sleeve can be a peel-away sheath that docks to an introducer sheath and is removed and discarded after transferring the compressible component to the introducer sheath. Depending on the desired use of the catheter pump, it can also be any other type of sleeve, such as a cannula belonging to the catheter itself or an additionally provided sleeve.

[0017] Furthermore, the system includes a compression tube. The compression tube includes movable flaps that are designed to accommodate a radially compressible component. The movable flaps have an open state and a closed state. In the open state, the flaps can be positioned around at least a portion of the radially compressible component in an uncompressed state. In the open state, the opening angle of the compressible flaps is such that the flaps can contact an axial portion of the housing that is between the distal and proximal ends of the housing compression, preferably, the axial portion is the axial portion to which the rotor extends in the expanded state. If the flaps are now transferred to the closed state, the radially compressible component is compressed and a compressive force is applied on the axial portion, where the force has a radial component.

[0018] In one embodiment, the compression tube includes two to ten movable flaps. In particular, the compression tube can include three movable flaps or four movable flaps.

[0019] In one embodiment, adjacent flaps are connected by a flexible membrane or skin to avoid squeezing the compressible component or the downstream tube.

[0020] In the open state, a gap is formed between adjacent flaps. When the flaps transition from the open state to the closed state, the size of the gap decreases. In one embodiment, in the closed state, the gap between adjacent flaps persists to prevent radial compressible components, downstream tubes, or other components of the catheter device from being squeezed or trapped between the flaps.

[0021] The gap formed between adjacent flaps can extend axially along the length of the compression tube. However, the gap can also extend with a radial component such that it spirally extends along the compression tube. The spirally extending gap can stretch around the circumference of the compression tube and extend radially, for example, between 40 degrees and 100 degrees, particularly between 90 degrees. In addition to the gap, slits can be provided. The slits can be provided as a continuation of the gap or can be provided between the gaps, where the gaps extend axially or spirally. When the slits are provided, the compression tube can be further opened and exhibit a smoother compression behavior. By having additional slits and / or by having a spirally extending gap, squeezing of the components of the catheter device can be avoided.

[0022] In one embodiment, the ends of the radially disposed slits axially overlap the ends of the gap and / or the axially aligned slits.

[0023] Preferably, the flaps in the closed state limit a cylindrical space. In one embodiment, the diameter of the cylindrical space is less than or greater than the inner diameter of the sleeve into which the compressible component is to be inserted by up to 1 mm, preferably up to 0.5 mm, such that in the closed state the compressible component can easily slide into the sleeve from between the flaps. In some embodiments, when the compressible component slides from between the flaps into the sleeve, the compressible component is expected to undergo further compression.

[0024] The compression tube can further include a tube or tubular portion designed to be positioned around the catheter device. The flaps are attached to one end of the tube. When the flaps are positioned around the compressible component, there are two possible configurations: the tube can be positioned on the proximal side of the flaps and the compressible part, around a portion of the catheter, or the tube can be positioned on the distal side of the movable flaps and the compressible component, around a portion or all of the distal shaft or the atraumatic tip or the pigtail tip.

[0025] The tube can include a groove for the pigtail, which would be advantageous if the tube needs to be positioned around the atraumatic tip. Thereby, the pigtail can be in a coiled position rather than remaining in an extended and taut position, and when the tube is around the elongated portion of the tip, it is not necessary to shorten the tube distally, which would complicate the handling of the tubing. This is particularly useful when the catheter device is transported with the compression tube in place. Allowing the pigtail to coil in the groove can prevent the tube from falling off the distal end of the catheter device.

[0026] The system may further include a reducing pipe, which is used to compress the movable flap from the open state to the closed state in a smooth and radially isotropic manner.

[0027] The reducing pipe is designed as a pipe with a tapered portion and a cylindrical portion, where the tapered portion is the part where the inner wall of the reducing pipe is a conical surface, and the cylindrical portion is the part where the inner wall of the reducing pipe has a constant diameter. In the tapered portion, the inner diameter of the reducing pipe increases as the distance from the cylindrical portion increases. The opening angle of the inner wall of the tapered portion relative to the inner wall of the cylindrical portion may be, for example, between 6° and 10°.

[0028] A reducing tube can be arranged around the catheter device, on the proximal side of the compressible member and on the distal side of the sleeve inserted into the compressible member. Thus, the tapered portion is located at the distal end of the cylindrical portion. Thus, when the reducing tube moves in the distal direction relative to the catheter device and the compression tube, the compressible member in the catheter device between the compression tube and the fins provided on the compression tube slides into the distal opening of the reducing tube to the tapered portion of the reducing tube. The relative movement can be achieved, for example, by pushing the compression member and the reducing tube together by hand, or by holding the reducing tube and pulling it in the proximal direction at the proximal end of the catheter. Whether the fins of the compression tube slide into the distal opening of the reducing tube first or the tube slides into the distal opening of the reducing tube depends on the configuration used. As the relative movement continues and the fins enter the tapered portion of the reducing tube, as the radius of the tapered portion of the reducing tube decreases in the direction of the relative movement of the compression tube relative to the reducing tube, the fins begin to be compressed. Thus, the compressible member provided between the fins is also compressed. Preferably, the compression force mediated by the compressible fins acts on the axial portion of the compressible member extending from the rotor. Thus, the compression force has a radial component that facilitates compressing the rotor without causing kinking. Then, the compression tube and the compressible member provided in the compression tube further slide into the reducing tube and into the cylindrical portion of the reducing tube. When the cylindrical portion is reached, the compression is complete. The fins are now in a fully compressed state, and the radially compressible member is compressed to the desired radius. Preferably, in the compressed state, a gap is left between adjacent movable fins to avoid squeezing the compressible member or the downstream tube. This can be further assisted by providing a membrane, preferably an elastic membrane or skin, between adjacent movable fins. As the relative movement of the compression tube and the catheter device relative to the reducing tube continues, the compression tube and the compressible member slide towards the proximal opening of the reducing tube. Two opposing stops can be provided near the proximal opening. Then the sleeve into which the compressible member is inserted abuts against the first stop on the proximal side of the proximal opening. The stop limits the movement of the sleeve relative to the reducing tube in the distal direction. The compression tube strikes the second stop on the distal side of the proximal opening, opposite the first stop, inside the reducing tube. Thus, the movement of the compression tube relative to the reducing tube in the proximal direction is limited. Now the catheter device can be pulled out of the compression tube, for example, by applying a pulling force at the proximal end of the catheter. Then, the compressible member of the catheter device slides out of the compression tube, through the proximal opening of the reducing tube and into the cannula. The distal shaft and / or the atraumatic tip also pass through the proximal openings of the compression tube and the reducing tube. Then, the reducing tube and the compression tube fall off the distal end of the catheter device and can be discarded.

[0029] In an embodiment of the envisaged reducing tube, the sleeve and / or the compression tube may each have additional stops for abutting against the reducing tube, preferably against the outside of the end of the reducing tube. The stops may be positioned such that there is a clearance between the end of the sleeve and / or the end of the compression tube and the inside of the reducing tube. In this way, the catheter device cannot be squeezed between the sleeve and the reducing tube or between the compression tube and the reducing tube or between the sleeve and the compression tube.

[0030] As an alternative to what has been described so far, the reducing tube and the compression tube may be rotated 180° such that the reducing tube is arranged at the distal end of the compressible member and the compression tube is arranged at the proximal end of the compressible member. The sleeve may then be arranged at the proximal end of the compression tube or at the distal end of the reducing tube. For a pump inserted into the right ventricle, the latter option may be advantageous, which pump may have a downstream tube located distal to the rotor.

[0031] The compression tube of the compressible member having the catheter device arranged between the flaps is inserted into the tapered portion of the reducing tube, for example by manually sliding the compression tube into the reducing tube. Compression ends when the compressible flaps reach the cylindrical portion of the reducing tube. Preferably, stops are provided to limit the relative movement between the reducing tube and the compression tube such that the movable flaps remain in the cylindrical portion and the compression tube cannot pass through the reducing tube. In the next step, the sleeve is abutted against a second stop associated with the reducing tube or directly against the compression tube, which compression tube may serve as a stop for the sleeve. By holding the sleeve and pulling on the catheter tubing, the compressible member can be slid out of the compression tube and into the sleeve.

[0032] The compression tube and the reducing tube are both made of, for example, PTFE, PE or POM such that the friction between the compression tube and the reducing tube is minimized.

[0033] The catheter device may be delivered pre-mounted on the catheter assembly together with the compression tube and the reducing tube. The compression tube and the reducing tube may be single-use parts and may be discarded after use. Additional stops may be provided, for example, in the tapered portion of the reducing tube to allow pre-mounting of the compression tube in such a way that the compressible flaps of the radially compressible member are already arranged in the tapered portion of the reducing tube in an uncompressed state and cannot slide out due to the stops. In this way, the compressible member is protected between the reducing tube and the compression tube.

[0034] In one embodiment, in addition to the catheter device, the reducer, and the compression tube, a disc device, such as a plate or membrane, having a hole is provided. The disc device is positioned around the catheter tube, between the reducer and the compression tube, so that it can slide along the catheter tube. The disc device may have a slit connecting the hole and the outer edge of the disc device, allowing the disc device to be clamped to the catheter. In another embodiment, the slit is connected only to the hole and not to the outer edge of the disc device to prevent the disc device from being lost. The edges of the disc device, particularly the slit and the hole, are smooth and / or made of a flexible material to protect the catheter from damage and to ensure that the disc device has good sliding properties on the catheter tube. The radius or radial extension of the disc device is greater than the radius of the cylindrical portion of the reducer. Preferably, the radius or radial extension of the disc device is greater than the radius of the circular plane circumscribed by the front portion of the movable vane in its uncompressed state. The disc device is made of a flexible material, such as PTFE, PE, or silicone, to enable it to elastically deform and have good sliding properties when sliding along the catheter device. As the reducer moves relative to the catheter device and the compression tube, the reducer pushes the disc, which is positioned proximate to the distal end of the reducer, along the catheter device. In one embodiment, the disc closes the distal opening of the tapered portion. When the disc abuts the compressible member, the catheter device, the disc device, and the reducer move relative to the compression tube.

[0035] If the compression tube is configured to initially enter the reducer through the tabs, as the reducer moves toward the compression tube, the component of the reducer proximal to the distal opening will abut the disc. As movement continues, the disc device abuts the compressible portion and pushes the compressible component between the tabs. Thus, the disc device helps position the radially compressible component in a position conducive to subsequent compression. As the relative movement of the reducer and compression tube continues, the disc device may loosen or break as it is pushed through or into the tapered portion of the reducer, allowing the compression tube to slide into and through the tapered portion of the reducer. BRIEF DESCRIPTION OF THE DRAWINGS

[0036] exist Figures 1 to 16 Various aspects and embodiments of the system according to the present application are illustrated in FIG.

[0037] Figure 1 The catheter device is shown positioned within the left ventricle of the heart;

[0038] Figure 2 The distal region of the catheter device is shown;

[0039] Figure 3a and Figure 3b The distal region of the catheter device is shown having a compression tube and a reducer;

[0040] Figure 4Shows a compressible component of a catheter device being pulled into a cannula without a compression tube and a reducing tube;

[0041] Figure 5a and Figure 5b Shows the compression tube from two different perspectives;

[0042] Figure 6a and Figure 6b Shows the reducing tube from two different perspectives;

[0043] Figure 7 Shows an incision through the reducing tube;

[0044] Figure 8 Shows the compression tube and the reducing tube without the catheter device;

[0045] Figure 9a and Figure 9b Shows the distal region of a catheter device having a compression tube, a reducing tube, and a disc device;

[0046] Figure 9c Shows Figure 9a and Figure 9b the disc device;

[0047] Figure 10 Shows a setup as Figure 2 shown, where the compression tube is arranged in another configuration;

[0048] Figure 11a and Figure 11b Shows the rotor and the housing in the expanded state and the compressed state;

[0049] Figure 12 Shows the compression tube, the reducing tube, and the catheter device, where the compressible component is in the compressed state;

[0050] Figure 13 Shows a rotor housing that has fewer struts near the proximal end;

[0051] Figure 14a and Figure 14b Shows a sleeve and a compression tube introduced into the reducing tube, the sleeve and the compression tube having additional stoppers.

[0052] Figure 15 Shows an embodiment of a compression tube having additional slits; and

[0053] Figure 16 (a)-(e) in shows embodiments of the compression tube that demonstrate different configurations for the gap between the fins.

[0054] List of reference numerals

[0055] 1 Catheter device

[0056] 1.1 Radially compressible component

[0057] 1.1.a Strongly deformed area

[0058] 1.1.b Strongly deformed area

[0059] 1.1.1 Radially compressible rotor

[0060] 1.1.1 Radially compressible rotor (compressed state)

[0061] 1.1.2 Radially compressible housing

[0062] 1.1.2’ Radially compressible housing (compressed state)

[0063] 1.1.3 Length of the radially compressible rotor

[0064] 1.1.3’ Length of the radially compressible rotor (compressed state)

[0065] 1.1.4 Length of the radially compressible housing

[0066] 1.1.4’ Length of the radially compressible housing (compressed state)

[0067] 1.1.5 Struts of the compressible housing (low density)

[0068] 1.1.5’ Struts of the compressible housing (high density)

[0069] 1.2 Distal shaft

[0070] 1.2.1 Elongated portion of the distal shaft

[0071] 1.2.2 Pigtail

[0072] 1.3 Conduit pipe

[0073] 1.4 Downstream pipe

[0074] 1.4.1 Downstream opening

[0075] 1.5 Drive shaft

[0076] 2 Compression tube

[0077] 2.1 Pipe

[0078] 2.1.1 Groove

[0079] 2.2 Movable flap

[0080] 2.2.1 Front part of the movable flap

[0081] 2.2.2 Gap between adjacent movable flaps

[0082] 2.3 Stopper

[0083] 2.4 Slit

[0084] 2.5 Gap

[0085] 2.6 Transition Zone

[0086] 2.7 Slit

[0087] 3 Reducing Pipe

[0088] 3.1 Proximal Cylindrical Portion

[0089] 3.1.1 Proximal Opening

[0090] 3.1.2 Cylindrical Inner Wall

[0091] 3.1.3 First Stopper

[0092] 3.1.4 Second Stopper

[0093] 3.2 Distal Tapered Portion

[0094] 3.2.1 Distal Opening

[0095] 3.2.2 Tapered Inner Wall

[0096] 3.2.3 Opening Angle of the Tapered Inner Wall

[0097] 3.3 Third Stopper

[0098] 3.4 Disc Device

[0099] 3.4.1 Hole

[0100] 3.4.2 Slit

[0101] 4 Sleeve

[0102] 4.1 Stopper

[0103] 5.1 Heart

[0104] 5.2 Aorta

[0105] 5.3 Left Ventricle

[0106] 5.4 Aortic Valve

[0107] 6 Motor Detailed Implementation Manner

[0108] Figure 1The catheter device 1 used as a blood pump is shown. The catheter device 1 is introduced into a patient's body such that a part of the distal region of the catheter device 1 is located within the left ventricle 5.3 of the patient's heart 5.1. In a drive region that can be located outside the patient's body, a motor 6 for driving the drive shaft 1.5 is provided. A part of the drive shaft 1.5 is covered by the catheter conduit 1.3. The drive shaft 1.5 and the catheter conduit 1.3 extend from the drive region to the distal region, in which the radially compressible rotor 1.1.1 is driven by the drive shaft 1.5. The compressible rotor 1.1.1 is located within the compressible housing 1.1.2. The compressibility of the rotor 1.1.1 and the housing 1.1.2 facilitates the introduction of the rotor into the patient's body. During operation, the rotor 1.1.1 and the housing 1.1.2 are in an expanded state. The housing 1.1.2 prevents damage to heart tissue such as chordae tendineae, as it prevents tissue from being sucked into the rotor 1.1.1 or becoming entangled with the rotor 1.1.1 or the drive shaft 1.5. The distal end of the drive shaft 1.5 is located within the distal shaft 1.2. The catheter device 1 may further include a non-invasive tip, such as a pigtail tip 1.2.2 designed. The non-invasive tip 1.2.2 may be made of, for example, PU or another flexible medical-grade polymer, and it may include an elongated portion 1.2.1. In Figure 3a the illustrated embodiment, the distal end of the drive shaft is located within the elongated portion 1.2.1. However, the distal shaft 1.2 and the non-invasive tip may also be provided separately. The rotor 1.1.1 and the drive shaft 1.5 can rotate, thereby enabling blood flow from the distal to the proximal direction, that is, blood flows out of the left ventricle 5.3, enters the aorta 5.2, and flows to other regions of the patient's body. A downstream tube 1.4 is provided on the proximal side of the rotor 1.1.1 and the rotor housing 1.1.2. The downstream tube 1.4 has a downstream opening 1.4.1 on the proximal side of the aortic valve 5.4 such that blood passes through the aortic valve within the downstream tube 1.4 and then can flow into the aorta 5.2. The downstream tube 1.4 is made of a flexible material, so that the aortic valve 5.4 can compress the downstream tube when the patient's heart 5.1 continues to pump.

[0109] Figure 2 The distal region of the catheter device having the radially compressible member 1.1 is shown. The radially compressible member 1.1 includes a radially compressible rotor 1.1.1 and a radially compressible housing 1.1.2. The rotor 1.1.1 can be inserted, for example, into the left ventricle of a human heart and is designed to be driven by the drive shaft 1.5 so that fluid flows from the distal shaft in the proximal direction to the downstream tube 1.4 provided on the proximal side of the rotor and exits from the downstream opening 1.4.1 of the downstream tube 1.4, for example, into the aorta of a human. At the distal end of the compressible member 1.1, a distal shaft 1.2 is provided. The shaft includes an elongated portion 1.2.1 for rotatably mounting the drive shaft 1.5 and a flexible pigtail 1.2.2.

[0110] Figure 3a shows the distal region of a catheter device as Figure 1 shown, which has an additional compression tube 2 and a reducing tube 3 to assist in inserting the catheter device, in particular the compressible part 1.1, into the sleeve 4. The sleeve 4 is arranged around the catheter device 1 and is located on the proximal side of the compressible part 1.1. The compression tube 2 is arranged around a part of the compressible part 1.1, where the movable flap 2.2 surrounds the distal part of the compressible part 1.1, and the duct 2.1 of the compression tube 2 extends towards its distal end. The tube 2 surrounds the elongated part 1.2.1 of the distal shaft 1.2, where the groove 2.1.1 of the compression tube 2 allows the pigtail 1.2.2 of the distal shaft 1.2 to remain in the coiled position. The reducing tube 3 is arranged on the proximal side of the compression tube. The proximal part of the reducing tube 3 is a cylindrical part 3.1, while the distal part of the reducing tube 3 is a conical part 3.2, whose radius increases in the distal direction. The aperture angle of the conical part 3.2 can be, for example, between 6° and 10°. The reducing tube can now be moved relative to the catheter device 1 and the compression tube 2 in the distal direction. The distal opening 3.2.1 of the reducing tube 3 is large enough for the movable flap 2.2 to slide into the distal opening 3.2.1 in the open state. The frictional force and / or the pigtail 1.2.2 residing in the groove 2.1.1 ensure that the compression tube 2 does not cause the catheter device 1 to slide distally. As the relative movement continues, the movable flap 2.2 passes through the conical part 3.2 of the reducing tube 3, contacts the conical inner wall 3.2.2 of the conical part 3.2 of the reducing tube 3, and is thus continuously compressed. When the movable flap 2.2 is compressed, the radially compressible part 1.1 arranged between the movable flaps 2.2 is also compressed, and the compression force preferably acts on the axial part where the rotor is located. As the proximal end of the compression tube 2 enters the cylindrical part 3.1, the compression is completed. The compression tube 2 slides further until the front part 2.2.1 of the movable flap hits a second stop 3.1.4 near the proximal opening 3.1.1 of the reducing tube 3, which is opposite to the first stop 3.1.3. At this point, the compression tube 2 can no longer move proximally on the catheter device 1. Now the sleeve 4 can be set against the first stop 3.1.3 or against the front part 2.2.1 of the movable flap 2.2. By holding the sleeve 4 and pulling the proximal end of the catheter duct, the compressible part 1.1 is pulled out of the compression tube 2 through the proximal opening 3.1.1 of the reducing tube 3 and into the sleeve 4.

[0111] Figure 3b shows the same arrangement as Figure 3a but which has an additional set of stops 3.3 for holding the compression tube 2 in an uncompressed state relative to the reducing tube 3. The catheter device 1 can be packed and delivered to the doctor in this configuration, where the compressible rotor 1.1.1 and the housing 1.1.2 are in an uncompressed state, but the compression tube 2 and the reducing tube 3 are in the configuration as Figure 3b shown, so that the compressible part is protected.

[0112] Figure 4 shows the distal region of the catheter device 1 being pulled into the sleeve 4 according to the prior art. Thereby, it is compressed when the housing 1.2 and the rotor 1.1 are pressed into the sleeve 4. The compressive force is directly mediated by the edge of the sleeve, causing strong deformation of the compressible component at least in the regions 1.1.a and 1.1.b shown in FIG. 3. In addition, the force acting on the compressible component 1.1 acts in the distal direction, so the rotor 1.1.1 is pushed distally and cannot expand axially in the proximal direction when compressed. This may cause incorrect folding of the rotor or kinking of the compressed rotor.

[0113] Figure 5a and Figure 5b shows the compression tube 2 from two different perspectives. The compression tube 2 includes three movable flaps 2.2, which are shown in the open position. In the open position, there are gaps 2.2.2 between adjacent flaps. The movable flaps 2.2 are preferably designed such that upon compression, especially when compressed by the reducing tube 3 as shown in FIG. 3, the gap 2.2.2 is not completely closed. When the flaps are in the closed state, due to the residual gap 2.2.2, the compressible component 1.1 of the catheter device or other components, such as the downstream tube 1.4, will not be squeezed or stuck between the flaps. In Figure 5a the groove 2.1.1 is visible, which allows the pigtail 1.2.2 to remain in the coiled position when the compression tube 2 is arranged around the distal shaft 1.2 or the pigtail 1.2.2. Therefore, different sizes of catheter devices with different lengths of distal shafts can be adapted. Moreover, by arranging the pigtail 1.2.2 in the groove instead of allowing the pigtail to protrude beyond the distal end of the compression tube, at least part of the pigtail 1.2.2 can be protected from lateral bending. In Figure 5b the front part 2.2.1 of the movable flap 2.2 is visible, which is designed to strike the second stop 3.1.4 of the reducing tube 3.

[0114] Figure 6a and Figure 6b shows the reducing tube 3 from two different perspectives. The reducing tube 3 includes a cylindrical part 3.1 and a conical part 3.2. The reducing tube is generally arranged around the catheter device 1 such that the cylindrical part is proximal to the conical part. The inner radius of the conical part 3.2 increases from the cylindrical part 3.1 towards the distal opening 3.2.1.

[0115] In Figure 7In [description], a cut through the reducer tube 3 is shown. The distal opening 3.2.1 of the tapered portion 3.2 of the reducer tube 3 is shown on the left side. The inner radius of the tapered portion 3.2 decreases away from the distal opening 3.2.1, such that the inner wall 3.2.2 depicts a part of a conical surface. On the right side of the tapered portion 3.2, a cylindrical portion is shown. The inner wall 3.1.2 of the cylindrical portion depicts a cylindrical surface. The opening angle 3.2.3 of the wall 3.2.2 of the tapered portion 3.2 relative to the wall 3.1.2 of the cylindrical portion 3.1 can be, for example, between 6° and 10°. The cylindrical portion 3.1 has a proximal opening 3.1.1. Near the proximal opening, a first stop 3.1.3 is provided on the proximal side, and a second stop 3.1.4 is provided opposite thereto on the distal side. The reducer tube 3 is designed such that the movable flap 2.2 can be introduced into the distal opening 3.2.1 in an uncompressed or almost uncompressed state. If the compression tube 2 slides along the reducer tube 3 in the proximal direction, the movable flap 2.2 is compressed radially isotropically when the flap 2.2 passes through the tapered portion 3.2 of the reducer tube 3. Once the movable flap 2.2 reaches the cylindrical portion 3.1, the compression is complete. Now, the flap 2.2 can slide further until it hits the second stop 3.1.4. Preferably, the diameter of the cylindrical space contained in the movable flap 2.2 in the compressed state differs from the inner diameter of the proximal opening 3.1.1 by less than 1 mm, and particularly preferably less than 0.5 mm, such that the compressible member 1.1 can slide out of the cylindrical space and enter the sleeve 4 through the proximal opening 3.1.1. Thereby, the sleeve 4 can be provided at the proximal end of the reducer tube 3, against the first stop 3.1.3.

[0116] Figure 8 The compression tube 2 and the reducer tube 3 without the catheter device 1 are shown; the movable flap 2.2 has been inserted into the tapered portion 3.2 of the reducer tube 3 through the distal opening 3.2.1 of the reducer tube, i.e., the flap 2.2 is slightly compressed due to the tapered inner wall 3.2.2. The compression tube is oriented such that the tube 2.1 is located at the distal end of the movable flap 2.2. A groove 2.1.1 can be seen near the distal end of the tube 2.1. At the proximal end of this arrangement, the cylindrical portion 3.1 of the reducer tube can be seen, having the proximal opening 3.1.1 and the first stop 3.1.3 and the second stop 3.1.4.

[0117] Figure 9a and Figure 9b The catheter device 1, the compression tube 2 and the reducer tube 3 and an additional disc device 3.4 or membrane with holes are shown.

[0118] In Figure 9aIn it, the disc device 3.4 is arranged between the reducing pipe 3 and the compressible member 1.1 around the drive shaft 1.5 and the conduit pipe 1.3. When the reducing pipe 3 moves towards the compression pipe 2 and the compressible member, the front part of the reducing pipe 3 near the distal opening 3.2.1 of the reducing pipe contacts the disc device 3.4, thereby pushing the disc device 3.4 towards the compression pipe 2 and the compressible member 1.1. When the disc device 3.4 thus approaches the compressible member 1.1, the disc device 3.4 pushes the compressible member 1.1 between the movable vanes 2.2 of the compression pipe, thereby positioning the compressible member such that the compression force during subsequent compression can act on the desired position. The movable vanes 2.2 and the distal opening 3.2.1 of the reducing pipe are designed such that when the uncompressed radially compressible member 1.1 is in the desired position, the movable vanes 2.2 smoothly enter the distal opening 3.2.1 of the reducing pipe. As the reducing pipe 3 and the disc device 3.4 continue to move relative to the compression pipe 2, the disc device 3.4 loosens or breaks, such that the radially compressible member 1.1 in the compression pipe 2 is received between the tapered portions of the reducing pipe.

[0119] Figure 9b shows a setup similar to Figure 9a but the disc device 3.4 is attached to the reducing pipe 3. The disc device 3.4 is arranged in the distal opening 3.2.1 of the reducing pipe. The process is similar to the process described in the context of Figure 9a . When the reducing pipe 3 and the disc device 3.4 approach the compression pipe 2 and the radially compressible member 1.1, the radially compressible member is first pushed between the movable vanes 2.2 and positioned in the desired position, where the movable vanes 2.2 start to slide into the tapered portion of the reducing pipe 3 but are not yet compressed or are only slightly compressed. As the reducing pipe 3 continues to move relative to the compression pipe 2, the disc loosens or breaks, and thus, when the radially compressible member 1.1 passes through the tapered portion of the reducing pipe 3, the radially compressible member 1.1 is compressed.

[0120] Figure 9c illustrates Figure 9a and 9bThe disc device 3.4. The disc device 3.4 is preferably configured as a thin plate. For example, it can be made of PTFE, PE or silicone. The disc device 3.4 includes a hole 3.4.1 at or near the center. The disc device 3.4 may include a slit extending from the hole 3.4.1 to the outer edge of the disc device, such that the disc device can be clamped or mounted around the conduit 1.3. The disc device 3.4 does not include sharp edges at the edge of the hole 3.4.1 or along the slit 3.4.2, such that when the disc device 3.4 is clamped, the conduit device 1 or the conduit pipe 1.3 will not be damaged. The edge of the disc device, especially the edge of the hole 3.4.1, is designed such that the disc exhibits good sliding properties on the conduit. The disc device 3.4 can be, for example, circular. The radius or radial extension of the disc device is greater than the radius of the cylindrical portion of the reducer. Preferably, the radius or radial extension of the disc device is greater than the radius of the circular plane circumscribed by the front portion of the movable flap in the uncompressed state. The disc device 3.4 is flexible such that it can loosen and / or fall off when being pushed into the tapered portion of the reducer 3.

[0121] Figure 10 Similar to FIG. 3, the distal region of the conduit device having the compression tube 2 and the reducer 3 is shown. However, in Figure 10 it, the compression tube is in an alternative configuration. The configuration of the compression tube 2 is opposite to that in FIG. 3. Now, the movable flap 2.2 of the compression tube surrounds the compressible member 1.1 from the proximal side, such that the tube 2.1 surrounds a portion of the conduit device 1 proximal to the compressible member 1.1, and the distal shaft 1.2 is exposed. The reducer 3 surrounds the compression tube 2, and the tapered portion 3.2 is located at the distal end of the cylindrical portion 3.1. Now, the conduit device 1 and the compression tube 2 are moved relative to the reducer 3 in the proximal direction, such that the tube 2.1 first enters the reducer. When the movable flap 2.2 with the compressible member enters the tapered portion 3.2 of the reducer 3, the compression of the compressible member 1.1 begins. In this configuration, when a pulling force is applied to the proximal end of the conduit pipe 1.3, the compressible member 1.1 is pulled into the compression tube 2. Therefore, different from the configuration of FIG. 3, no frictional force is required to maintain the relative position of the conduit device 1 and the compression tube 2. The reducer 3 can be designed without a stop at the proximal opening. Then, the sleeve 4 can be directly provided on the proximal end of the compression tube 2. As Figure 2 shown in FIGS.

[0122] Figure 11a and 11bThe rotor 1.1.1, the housing 1.1.2, and the sleeve 4 are shown in both the uncompressed (a) and compressed (b) states. When the rotor 1.1.1 and the housing 1.1.2 are transferred into the sleeve 4, the rotor 1.1.1 and the housing 1.1.2 are radially compressed and enter their compressed states 1.1.1', 1.1.2' from their expanded states 1.1.1, 1.1.2. The rotor 1.1.1 in the expanded state has an axial length 1.1.3. As the rotor 1.1.1 is compressed to the compressed state 1.1.1', the axial length increases to the length 1.1.3'. Similarly, the housing 1.1.2 in the expanded state has an axial length 1.1.4. When the housing 1.1.2 is compressed to the compressed state 1.1.2', the axial length increases to the length 1.1.4'. The elongation of the rotor enables better compression compared to maintaining a constant length. If the compression force has a large radial component, as in the case of using the compression tube 2 and the stepped tube 3, the rotor 1.1.1 can expand axially. On the other hand, if the rotor is simply pulled into the sleeve 4 as shown in Figure 3, the axial elongation of the rotor 1.1.1 is hindered, which may result in poor folding of the rotor and / or kinking in the rotor.

[0123] Figure 12 A portion of the stepped tube 3, a portion of the compression tube 2, a portion of the sleeve 4, and the radially compressible member 1.1 are shown, where the rotor 1.1.1' and the housing 1.1.2' are in the compressed state. The rotor 1.1.1' and the housing 1.1.2' are disposed between the movable fins 2.2 of the compression tube. The movable fins 2.2 are fully introduced into the cylindrical portion 3.1 of the stepped tube and are thus in the fully compressed position. The front portion 2.2.1 of the movable fin 2.2 abuts against the first stop 3.1.4 of the stepped tube, such that the compression tube 2 cannot pass through the stepped tube 3 all the way. In Figure 12 the illustrated embodiment, the front portion 2.2.1 of the movable fin 2.2 serves as a stop for the sleeve 4 disposed around the drive shaft 1.5 and the conduit tube 1.3. By holding the sleeve 4 and pulling the conduit tube 1.3 in the proximal direction, the compressible member slides out of the compression tube 2 and the stepped tube 3 into the sleeve 4.

[0124] Figure 13A compressible housing 1.1.2 is shown, which has lower density struts 1.1.5 near the proximal end of the housing 1.1.2 and higher density struts 1.1.5' near the distal end of the housing 1.1.5. In a preferred mode of operation, blood flow in the proximal direction is achieved. Due to the low-density struts provided in the proximal region, the collision of blood cells with the struts is minimized, and thus the damage to the blood is minimized. However, in this configuration, if the compression is mediated only by the end of the sleeve 4, if the compressible housing 1.1.2 with the rotor 1.1.1 inside is pulled into the sleeve 4 provided at the proximal end of the housing 1.1.2, the risk of the rotor 1.1.1 being squeezed or jammed may increase. Therefore, if a housing design as shown in Figure 13 is required, the arrangement with the reducing tube 3 and the compression tube 2 as described in the present application is particularly useful.

[0125] Figure 14a The sleeve 4 and the compression tube 2 introduced into the reducing tube 3 are shown. The reducing tube exposes a step inside its cylindrical part, so that the inner diameter is reduced at the cylindrical end, and the sleeve is introduced. Therefore, at the end of the cylindrical part facing the conical part, that is, in the part of the cylindrical part where the compression tube is introduced, the inner diameter is slightly larger. In the embodiment shown in FIG. 14, the compression tube 2 has an additional stop 2.3, which abuts against the end of the reducing tube 3 on the side of the conical part. The stop 2.3 is configured to leave a gap 2.5 between the compression tube and the step provided inside the reducing tube 3 near the end of the movable flap 2.2 of the compression tube. In this way, when pulling the catheter device 1 through the compression tube 2, the part of the catheter device 1 will not be pinched between the front side 2.2.1 of the movable flap 2.2 and the step. The sleeve 4 also has an additional stop 4.1, which abuts against the end of the cylindrical part of the reducing tube 3, so that the end of the sleeve 4 introduced into the reducing tube 3 is kept at a certain distance from the front side 2.2.1 of the movable flap. In this way, when the sleeve 4 is introduced into the reducing tube 3, the gap 2.5 still exists.

[0126] The inner diameter of the cylindrical part of the reducing tube into which the sleeve 4 is introduced is 0.2 mm - 1 mm, especially 0.4 mm - 0.7 mm larger than the outer diameter of the sleeve 4. In this way, when pulling the catheter device into the sleeve 4, the sleeve 4 is allowed to deform. This is particularly advantageous because sometimes the rotor 1.1.1 is compressed to obtain an oval rather than a circular shape.

[0127] The compression tube 2 does not include a groove for accommodating the pigtail 1.2.2 of the catheter device 1.

[0128] The step provided on the inner side of the Figure 14a reducing tube 3 may also have a circular shape or may be designed as an inclined surface. Figure 14bShows an arrangement with a transition zone 2.6, where there are no sharp edges. By pulling the pump head through this transition zone 2.6, the diameter of the pump head can be further reduced.

[0129] Figure 15 Shows an embodiment of the compression tube 2, where additional slits 2.4 are provided, piercing the compression tube 2 at several positions. The compression tube 2 has four movable fins 2.2 separated by gaps 2.2.2. The slits 2.4 are all provided as continuations of the gaps 2.2.2 (i.e., radially aligned with the gaps), and are displaced relative to the gaps 2.2.2 (i.e., radially displaced to be located between two gaps 2.2.2). In this way, the flexibility of the compression tube is improved, thus achieving better compression behavior and helping to avoid squeezing the components of the catheter device 1.

[0130] Figure 15 The shown compression tube 2 also has additional stops 2.3 as shown in and discussed in FIG. 14.

[0131] Figure 16 (a)-(e) therein show different embodiments of the compression tube 2, which differ from each other in the arrangement of the gaps 2.2.2 and the slits 2.4. In each case, additional stops 2.3 are provided. The shown compression tube 2 is in a compressed state.

[0132] In each case, the compression tube 2 has four movable fins 2.2. The width of the fins 2.2 is chosen to be large enough to engage with the struts of the compressible housing of the catheter device 1. That is, for a higher strut density, thinner fins can be provided. When the density of the struts is low in all components within the housing, wider fins are provided, and sometimes an embodiment with three fins instead of four fins is selected for low-density struts.

[0133] In each case, the compression tube 2 has four movable finned fins 2.2. The width of the finned fins 2.2 is chosen to be large enough to engage with the struts of the compressible housing of the catheter device 1. That is, for a higher strut density, thinner finned fins can be provided. When the density of the struts is low in all components within the housing, wider finned fins are provided, and sometimes an embodiment with three finned fins instead of four finned fins is selected for low-density struts.

[0134] Figure 16 (a) therein shows an embodiment, where the gaps 2.2.2 separating the finned fins 2.2 extend axially along the compression tube.

[0135] Figure 16Sub - figure (b) shows an embodiment where the gap 2.2.2 starts in the longitudinal direction and then extends with a radial component, i.e., in a helical manner. The gap extends around the circumference of the compression tube by approximately 45°. The extrusion risk of the catheter device can be reduced by having a radial component for the gap 2.2.2.

[0136] Figure 16 Sub - figure (c) also shows the gap 2.2.2 with a radial component. The gap extends around the circumference of the compression tube, covering approximately 90°.

[0137] Figure 16 Sub - figure (d) shows an embodiment with an axially extending gap 2.2.2 and an additional slit 2.4. This embodiment is similar to Figure 15 the embodiment shown. The slit 2.4 is arranged to be radially aligned with the gap 2.2.2, spaced from the gap, and is also provided between adjacent gaps, spaced from the ends of the compression tube.

[0138] Figure 16 Sub - figure (e) shows an embodiment that simultaneously includes two gaps 2.2.2 with a radial component and an additional slit 2.4. The two gaps 2.2.2 have a radial component and an additional slit 2.4. The slit 2.2.2 shows the same helix as the gap 2.2.2, where some slits are aligned with the helix of a certain gap and other slits are arranged between the helices defined by the gap 2.2.2. The ends of the radially shifted slit 2.7 overlap axially with the ends of the gap 2.2.2 and / or the axially aligned slit 2.4 (which is also shown in Figure 15 and 16 ).

Claims

1. A system for introducing a radially compressible component (1.1) of a catheter device (1) into a sleeve (4), comprising: a sleeve (4), a catheter device (1) comprising a radially compressible component (1.1) configured to be at least partially transferred into the sleeve (4); a compression tube (2) comprising a movable flap (2.2) for receiving the radially compressible component (1.1), the movable flap (2.2) having an open state and a closed state, the system further comprising a reducing tube (3) for radially compressing the movable flap (2.2) of the compression tube (2) and the radially compressible component (1.1) received between the movable flaps (2.2); wherein the reducing tube (3) is designed as a tube having a distal opening (3.2.1) and a proximal opening (3.1.1) and is configured to receive the sleeve (4) and the compression tube (2), wherein the sleeve (4) comprises a stop (4.1) configured to abut one end of the reducing tube (3) when the sleeve (4) is introduced into the proximal opening (3.1.1) of the reducing tube (3).

2. The system according to claim 1, wherein The radially compressible component (1.1) comprises a radially compressible rotor (1.1.1) and a radially compressible housing (1.1.2).

3. The system according to claim 1, wherein The sleeve (4) is a peel-away sheath or the sleeve (4) is a cannula.

4. The system according to claim 3, wherein, The cannula belongs to the catheter device (1) itself.

5. The system according to claim 1, wherein The catheter device (1) comprises at least one of a pigtail (1.2.2) and a distal shaft (1.2), the distal shaft or the pigtail (1.2.2) comprising an elongate portion (1.2.1).

6. The system according to claim 5, wherein, The compression tube (2) comprises a duct (2.1) for receiving the elongate portion (1.2.1) or a portion of the catheter device located on the proximal side or the distal side of the radially compressible component (1.1).

7. The system according to claim 6, wherein, The duct (2.1) of the compression tube (2) comprises a groove (2.1.1) for receiving the pigtail (1.2.2).

8. The system according to claim 1, wherein, The compression tube (2) comprises two to ten movable flaps (2.2).

9. The system according to claim 1, wherein The compression tube (2) comprises three or four movable flaps (2.2).

10. The system according to claim 1, wherein, A gap (2.2.2) extending between adjacent movable flaps (2.2) extends axially or helically.

11. The system according to claim 10, wherein, A slit (2.4) is provided in the compression tube (2), the slit (2.4) extending axially or helically as a continuation of the gap (2.2.2) or between the gaps (2.2.2).

12. The system according to claim 11, wherein, The end of a radially displaced slit (2.7) axially overlaps at least one of the end of the gap (2.2.2) and the end of an axially designed slit (2.4).

13. The system according to claim 1, wherein A gap is left between adjacent movable flaps (2.2) in the closed state.

14. The system according to claim 1, wherein, Adjacent movable flaps (2.2) are connected by a membrane or skin.

15. The system according to claim 1, wherein, The compression tube (2) includes a stop block (2.3), which is configured to abut against one end of the reducing tube (3) when the compression tube (2) is introduced into the distal opening (3.2.1) of the reducing tube (3), so that when the compression tube (2) and the sleeve (4) are introduced into the reducing tube (3), a gap (2.5) is left between the sleeve (4) and the compression tube (2).

16. The system according to claim 1 or 15, wherein, The reducing tube (3) is designed as a tube having a distal opening (3.2.1) and a proximal opening (3.1.1), and includes a proximal cylindrical portion (3.1) with a constant inner diameter and a distal tapered portion (3.2), wherein the inner radius of the distal tapered portion (3.2) increases from the proximal cylindrical portion (3.1) towards the distal opening (3.2.1), and the distal tapered portion (3.2) is configured to accommodate the movable flap (2.2) and the radially compressible member (1.1) accommodated by the movable flap (2.2).

17. The system according to claim 1 or 15, wherein, The reducing tube (3) includes a first stop block (3.1.3) for restricting the movement of the sleeve (4) relative to the reducing tube (3) in the distal direction.

18. The system according to claim 17, wherein, The reducing tube (3) includes a second stop block (3.1.4) opposite to the first stop block (3.1.3) for restricting the movement of the compression tube (2) relative to the reducing tube (3) in the proximal direction.

19. The system according to claim 1, wherein, The inner diameter of the movable flap (2.2) in the closed state differs from the inner diameter of the sleeve (4) by at most 1 mm.

20. The system according to claim 19, wherein, The inner diameter of the movable flap (2.2) in the closed state differs from the inner diameter of the sleeve (4) by at most 0.5 mm.

21. The system according to claim 16, wherein, The compression tube (2) is disposed around the catheter device (1) such that the movable flap (2.2) faces the radially compressible member (1.1), and the reducing tube (3) is disposed on the opposite side of the radially compressible member (1.1) such that the distal tapered portion (3.2) of the reducing tube (3) faces the radially compressible member (1.1), and further includes a disc device (3.4) having a hole (3.4.1), and is characterized in that the disc device (3.4) is disposed around the catheter device (1) in a portion between the proximal cylindrical portion (3.1) of the reducing tube (3) and the radially compressible member (1.1).

22. A method for inserting the radially compressible member (1.1) of the catheter device (1) into the sleeve (4) using the system according to claim 1 or 15, the method comprising the following steps: Disposing the reducing tube (3) around the catheter device (1) on the proximal side of the radially compressible member (1.1); Disposing the sleeve (4) around the catheter device (1) on the proximal side of the reducing tube (3); Disposing the compression tube (2) around the catheter device (1) such that the radially compressible member (1.1) is located between the movable flaps (2.2); And performing the following steps: Move the reduced-diameter tube (3) towards the compression tube (2) so that the compression tube (2) slides into the distal opening (3.2.1) of the reduced-diameter tube (3); Continue the relative movement of the compression tube (2) and the reduced-diameter tube (3) so that the movable flap (2.2) slides through the distal tapered portion (3.2) of the reduced-diameter tube (3), compressing the movable flap (2.2) from the open state to the closed state, thereby compressing the radially compressible component (1.1); Continue the relative movement so that the movable flap (2.2) in the closed state and the compressed radially compressible component (1.1) slide along the proximal cylindrical portion (3.1) of the reduced-diameter tube (3); And Abut the sleeve (4) against the first stop (3.1.3) of the compression tube (2) or the reduced-diameter tube (3) on the proximal side. The first stop (3.1.3) is located on the proximal side of the compression tube (2). When holding the sleeve (4), pull the catheter (1.3) in the proximal direction so that at least a part of the catheter device (1) including the radially compressible component (1.1) slides out of the compression tube (2) and into the sleeve (4).

23. A method for inserting the radially compressible component (1.1) of the catheter device (1) into the sleeve (4) using the system according to claim 21, the method comprising the following steps: Arrange the reduced-diameter tube (3) around the catheter device (1) on the proximal side of the radially compressible component (1.1); Arrange the sleeve (4) around the catheter device (1) on the proximal side of the reduced-diameter tube (3); Arrange the compression tube (2) around the catheter device (1) so that the movable flap (2.2) faces the proximal direction; And perform the following steps: Move the reduced-diameter tube (3) and the disc device (3.4) towards the compression tube (2) so that the disc device (3.4) pushes the radially compressible component (1.1) between the movable flaps (2.2) and slides the movable flaps (2.2) into the distal opening ( 3.2.1) of the reduced-diameter tube (3) until the disc device (3.4) loosens or breaks; Continue the relative movement of the compression tube (2) and the reduced-diameter tube (3) so that the movable flap (2.2) slides through the distal tapered portion (3.2) of the reduced-diameter tube (3), compressing the movable flap (2.2) from the open state to the closed state, thereby compressing the radially compressible component (1.1); Continue the relative movement so that the movable flap (2.2) in the closed state and the compressed radially compressible component (1.1) slide along the proximal cylindrical portion (3.1) of the reduced-diameter tube (3); And Press the sleeve (4) against a first stop (3.1.3) of the compression tube (2) or the stepped tube (3) on the proximal side, the first stop (3.1.3) being located on the proximal side of the compression tube (2). When holding the sleeve (4), pull the catheter (1.3) in the proximal direction so that at least part of the catheter device (1) including the radially compressible member (1.1) slides out of the compression tube (2) and into the sleeve (4).

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