Apparatus for compressing compressible component of conduit pump

Abstract

The present invention relates to a system comprising a catheter apparatus having a radially compressible component, a sleeve, and means for compressing the radially compressible component and introducing the radially compressible component into the sleeve, and methods of using the same.

Description

[0001] This application is a divisional application filed again with respect to the divisional application No. 202310169273.8 filed on August 22, 2018. Divisional application No. 201880054823.9, filed on August 22, 2018, is entitled "Apparatus for Compressible Components of a Compression Conduit Pump". Technical Field

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

[0003] Therefore, it can be applied in the field of minimally invasive medicine, such as blood pumps for cardiac assistance, and can also be used in agitators or drive components. Background Technology

[0004] The present invention can demonstrate particular advantages through its potential for miniaturization in the medical field. Techniques for introducing fluid pumps, particularly those for introducing fluid pumps into natural body cavities, are well-known prior art. Therefore, the Seldinger technique for introducing an infeeding sheath into the vascular system is also referenced.

[0005] For example, EP2399639 or EP2606920 disclose compressible or expandable conduit pumps in which radially compressible components, such as rotors and rotor housings, can be transferred into a sleeve or sheath. A sleeve is disposed around the conduit, and the compressible components are drawn into the sleeve such that compression occurs when the compressible components enter the sleeve. As described in EP2399639, the sleeve can be, for example, a peelable sheath facilitating insertion of the conduit pump into its lumen, or it can be any other type of sleeve, such as a cannula associated with the conduit itself.

[0006] Although this scalable pump is a current technology and allows for minimally invasive introduction into the human body, there are many drawbacks to its operation.

[0007] To ensure proper pump operation, compressible components must not be transported or supplied in a compressed state. The compression time for compressible components should be kept to a minimum, as flexible components will begin to creep if kept in a compressed state for too long.

[0008] According to existing technology, conduit devices are provided in an deployed state. For example, by applying tension to the proximal end of the conduit of the conduit device, a compressible component is pulled into a sleeve located at the proximal end of the compressible component. Therefore, compression acts on the end of the sleeve and begins from the proximal end of the compressible component. When the compressible component is squeezed into the sleeve, initially, primarily axial forces act on the rotor and housing, causing severe deformation of the compressible component. This process can induce stress and strain in the compressible component and may lead to kinking of the compressible component.

[0009] Furthermore, during compression, compressible components often undergo elongation; that is, in a pump where the rotor is located within the casing, both the casing and the rotor can expand axially while being compressed radially. If the rotor and casing are pulled into the sleeve and compressed from one end, axial extension is impeded in the direction of the sleeve. In particular, the already compressed casing 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 illustrates a rotor housing that includes fewer struts at one end to minimize damage to the blood. However, the larger gaps between the struts increase the risk of the rotor getting stuck or squeezed between the struts during compression of the housing and rotor.

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

[0012] In principle, compression of compressible components of catheter devices can be accomplished using a stent crimper, as described in EP0873731. However, the use of stent crimpers in catheterization lab or hospital settings is problematic because stent crimpers are precision and complex tools that are difficult to clean and sterilize after use. Summary of the Invention

[0013] Therefore, the purpose of this application is to provide a simple method for quickly, safely and reproducibly compressing the compressible component of a tubing pump and inserting the compressible component into a sleeve, which is also feasible in a tubing chamber.

[0014] The system according to this application at least partially solves the above-mentioned problems and requirements. Further advantageous embodiments are given by various embodiments of this application or disclosed in the specification and drawings.

[0015] The system according to this application includes a catheter device with a compressible component. Typically, 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 for insertion into a patient, while the proximal portion of the catheter remains outside the patient. A motor connected to the proximal end of the catheter device can drive the rotor at the distal end of the catheter device via a drive shaft. The rotor, for example, is positioned in the left ventricle of the heart and is driven to achieve blood flow along the proximal direction of the catheter device, for example, flowing out of the left ventricle and into the aorta. A downstream tube can be disposed on the proximal side of the rotor in the portion requiring passage through the aortic valve. The compressible housing of the rotor prevents cardiac tissue from becoming entangled with the rotor during operation. The catheter device may further include a distal shaft. The distal shaft may include an elongated portion for rotatably mounting the drive shaft. Preferably, it is designed as a flexible shaft. The catheter device may further include an atraumatic tip having an elongated flexible portion. The atraumatic tip is preferably designed as a pigtail. In some embodiments, a flexible polymer component including an atraumatic tip or a pigtail tip may include the distal shaft.

[0016] The system also includes a sleeve into which the compressible component is inserted. The sleeve can be a peel-away sheath that abuts to the infeed sheath and is removed and discarded after the compressible component has been transferred to the infeed sheath. Depending on the intended use of the catheter pump, it can also be any other type of sleeve, such as a cannula that is part of the catheter itself or a separately configured sleeve.

[0017] Furthermore, the system includes a compression tube. The compression tube includes movable vanes designed to accommodate a radially compressible component. The movable vanes have an open state and a closed state. In the open state, the vanes 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 vanes allows the vanes to contact an axial portion of the housing located between the distal and proximal ends of the housing compression, preferably the axial portion to which the rotor extends in the expanded state. If the vanes are now moved to the closed state, the radially compressible component is compressed and a compressive force is applied to the axial portion, wherein this force has a radial component.

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

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

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

[0021] The gap formed between adjacent vanes can extend axially along the length of the compression tube. However, the gap can also extend radially, such that it extends helically along the compression tube. The helically extending gap can extend around the circumference of the compression tube and extend radially, for example, between 40 and 100 degrees, particularly between 90 degrees. In addition to gaps, slits can also be provided. Slits can be provided as a continuation of the gaps, or they can be provided between the gaps, wherein the gaps extend axially or helically. When slits are provided, the compression tube can be further opened, exhibiting smoother compression behavior. By having additional slits and / or by having helically extending gaps, compression of components of the conduit device can be avoided.

[0022] In one embodiment, the end of the radially displayed slit axially overlaps with the end of the gap and / or the axially aligned slit.

[0023] Preferably, the vanes in the closed state are confined to 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, up to 1 mm, preferably up to 0.5 mm, such that the compressible component can easily slide from between the vanes into the sleeve in the closed state. In some embodiments, the compressible component is expected to undergo further compression as it slides from between the vanes into the sleeve.

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

[0025] The tube may include a groove for the pig's tail, which is advantageous if positioning of the tube around the atraumatic tip is required. This allows the pig's tail to be in a curled position, rather than remaining in an extended and taut position, eliminating the need for distal tube shortening when the tube is around the slender portion of the tip, which would complicate tubing handling. This is particularly useful when transporting the catheter device with the tube in a compressed position. Allowing the pig's tail to curl in the groove prevents the tube from falling off the distal end of the catheter device.

[0026] The system may also include a reducer tube for compressing the movable vane from an open state to a closed state in a smooth and radially isotropic manner.

[0027] The reducer is designed as a tube with a tapered section and a cylindrical section, wherein the tapered section is the part of the reducer whose inner wall has a conical surface, and the cylindrical section is the part of the reducer whose inner wall has a constant diameter. In the tapered section, the inner diameter of the reducer increases with increasing distance from the cylindrical section. The opening angle of the inner wall of the tapered section relative to the inner wall of the cylindrical section can be, for example, between 6° and 10°.

[0028] A reducing tube can be positioned around the conduit device, proximal to the compressible component and distal to the sleeve into which the compressible component is inserted. Thus, the tapered portion is located distal to the cylindrical portion. Therefore, as the reducing tube moves distally relative to the conduit device and the compressible tube, the compressible tube and the compressible component in the conduit device positioned between the vanes of the compressible tube slide into the distal opening of the reducing tube to the tapered portion of the reducing tube. This relative movement can be achieved, for example, by manually pushing the compressible component and the reducing tube together, or by grasping the reducing tube and pulling it proximal to the conduit. Whether the vanes or the tube slides into the distal opening of the reducing tube first depends on the configuration used. As the relative movement continues, and the vanes enter the tapered portion of the reducing tube, the vanes begin to be compressed as the radius of the tapered portion of the reducing tube decreases in the direction of the relative movement of the compressible tube relative to the reducing tube. Therefore, the compressible component positioned between the vanes is also compressed. Preferably, the compressive force mediated by the compressible vanes acts on the axial portion of the compressible component extending from the rotor. Thus, the compressive force has a radial component, which facilitates the compression of the rotor without causing kinking. The compression tube and the compressible component disposed within it then slide further into the reducer tube and into its cylindrical portion. Compression is complete upon reaching the cylindrical portion. The vanes are now fully compressed, and the radially compressible component is compressed to the desired radius. Preferably, in the compressed state, a gap is maintained between adjacent movable vanes to avoid squeezing the compressible component or downstream tube. This can be further aided by providing a membrane, preferably an elastic membrane or skin, between adjacent movable vanes. As the relative movement of the compression tube and conduit device relative to the reducer tube continues, the compression tube and compressible component slide toward the proximal opening of the reducer tube. Two opposing stops can be provided near the proximal port. The sleeve into which the compressible component is inserted then abuts against the first stop on the proximal side of the proximal opening. The stop restricts the movement of the sleeve relative to the reducer in the distal direction. The compression tube strikes a second stop, opposite the first stop, on the distal side of the proximal opening within the reducer. This restricts the movement of the compression tube relative to the reducer in the proximal direction. The catheter device can now be pulled out of the compression tube, for example, by applying a pulling force to the proximal end of the catheter. The compressible component of the catheter device then slides out of the compression tube, through the proximal opening of the reducer, and into the sleeve. The distal shaft and / or atraumatic tip also pass through the proximal openings of the compression tube and the reducer. The reducer and compression tube then fall from the distal end of the catheter device and can be discarded.

[0029] In a proposed embodiment of the reducer, the sleeve and / or compression tube may each have an additional stop for abutting against the reducer, preferably against the outer side of the reducer end. The stop may be positioned such that the end of the sleeve and / or the end of the compression tube has a gap with the interior of the reducer. This prevents the conduit device from being squeezed between the sleeve and the reducer, or between the compression tube and the reducer, or between the sleeve and the compression tube.

[0030] As an alternative described so far, the reducer and compression tube can be rotated 180° such that the reducer is positioned at the distal end of the compressible component, while the compression tube is positioned at the proximal end. A sleeve can then be positioned either at the proximal end of the compression tube or the distal end of the reducer. For pumps inserted into the right ventricle, the latter option may be advantageous, as the pump may have a downstream tube located at the distal end of the rotor.

[0031] A compressible tube with a conduit device positioned between the vanes is inserted into the tapered portion of a reducer, for example, by manually sliding the compressible tube into the reducer. Compression ends when the compressible vanes reach the cylindrical portion of the reducer. Preferably, a stop is provided to restrict relative movement between the reducer and the compressible tube, such that the movable vanes remain in the cylindrical portion and the compressible tube cannot pass through the reducer. In the next step, a sleeve is abutted against a second stop associated with the reducer, or directly against the compressible tube, which can serve as a stop for the sleeve. By gripping the sleeve and pulling the conduit, the compressible component can slide out of the compressible tube and into the sleeve.

[0032] Both the compression pipe and the reducing pipe are made of materials such as PTFE, PE, or POM, which minimizes friction between them.

[0033] The conduit assembly can be delivered pre-installed with a compression tube and a reducer. The compression tube and reducer can be single-use parts, disposable after use. An additional stop can be provided, for example, in the tapered section of the reducer to allow pre-installation of the compression tube in such a way that the compressible vanes with radially compressible components are already in an uncompressed state within the tapered section of the reducer and cannot slip out due to the stop. In this way, the compressible components are protected between the reducer and the compression tube.

[0034] In one embodiment, in addition to the conduit device, reducer, and compression tube, a disc device with holes, such as a plate or membrane, is provided. The disc device is disposed around the conduit, between the reducer and compression tube, allowing it to slide along the conduit. The disc device may have a slit connecting the holes and the outer edge of the disc device, allowing it to be clamped onto the conduit. In another embodiment, the slit is connected only to the holes and not to the outer edge of the disc device to prevent loss of the disc device. The edges of the disc device, especially the edges of the slits and holes, are smooth and / or made of a flexible material to prevent damage to the conduit and to provide good sliding characteristics on the conduit. 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 its uncompressed state. The disc device is made of a flexible material, such as PTFE, PE, or silicone, allowing it to elastically deform and provide good sliding characteristics when sliding along the conduit device. As the reducer moves relative to the conduit assembly and the compression tube, the reducer pushes a disc along the conduit assembly, the disc being positioned close to the distal end of the reducer. In one embodiment, the disc closes the distal opening of the tapered portion. When the disc abuts the compressible component, the conduit assembly, the disc assembly, and the reducer move relative to the compression tube.

[0035] If the compression tube is configured to first enter the reducer through the vanes, then as the reducer moves toward the compression tube, the portion of the reducer near the distal opening will abut against the disc. As movement continues, the disc device presses against the compressible portion and pushes the compressible component between the vanes. Therefore, the disc device helps position the radially compressible component in a position favorable for subsequent compression. Continuing the relative movement of the reducer and compression tube, as the disc device is pushed through or into the tapered portion of the reducer, the disc device loosens or breaks off, allowing the compression tube to slide in and through the tapered portion of the reducer. Attached Figure Description

[0036] exist Figures 1 to 16 Examples of various aspects and embodiments of the system according to this application are illustrated below.

[0037] Figure 1 A catheter device located in the left ventricle of the heart is shown;

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

[0039] Figure 3a and Figure 3b The distal region of a conduit device with a compression tube and a reducing tube is shown;

[0040] Figure 4The compressible component of a conduit device is shown being pulled into a sleeve without a compression tube or reducer.

[0041] Figure 5a and Figure 5b The compression tube is shown from two different angles;

[0042] Figure 6a and Figure 6b The reducer is shown from two different angles;

[0043] Figure 7 The cut through the reducer is shown;

[0044] Figure 8 Compressed tubing and reducer tubing without conduit equipment are shown;

[0045] Figure 9a and Figure 9b The distal region of a conduit assembly with a compression tube, a reducing tube, and a disc device is shown.

[0046] Figure 9c It shows Figure 9a and Figure 9b Disc-shaped equipment;

[0047] Figure 10 Shown as Figure 2 The setup shown has the compression tube configured differently;

[0048] Figure 11a and Figure 11b The rotor and housing are shown in both expanded and compressed states.

[0049] Figure 12 A compression tube, a reducing tube, and a conduit assembly are shown, wherein the compressible components are in a compressed state;

[0050] Figure 13 The rotor housing is shown, which has fewer struts near the proximal end;

[0051] Figure 14a and Figure 14b A sleeve and compression tube introduced into a reducer tube are shown, the sleeve and compression tube having additional stops.

[0052] Figure 15 An embodiment of a compression tube with an additional slit is shown; and

[0053] Figure 16 Examples of the compression tube shown in (a)-(e) illustrate different configurations of the gap between the vanes.

[0054] Reference tag list

[0055] 1. Catheter equipment

[0056] 1.1 Radial compressible components

[0057] 1.1.a Area of ​​intense deformation

[0058] 1.1.b Areas of intense deformation

[0059] 1.1.1 Radial compressible rotor

[0060] 1.1.1 Radial compressible rotor (compressed state)

[0061] 1.1.2 Radial compressible housing

[0062] 1.1.2' Radial 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 shell

[0066] 1.1.4' Length of the radially compressible shell (in compressed state)

[0067] 1.1.5 Supports for compressible shells (low density)

[0068] 1.1.5' Compressible shell support (high density)

[0069] 1.2 Distal Shaft

[0070] 1.2.1 Slender portion of the distal shaft

[0071] 1.2.2 Pig tail

[0072] 1.3 Conduit / Pipeline

[0073] 1.4 Downstream pipe

[0074] 1.4.1 Downstream opening

[0075] 1.5 drive shaft

[0076] 2 compression tubes

[0077] 2.1 Pipeline

[0078] 2.1.1 Groove

[0079] 2.2 Movable winglets

[0080] 2.2.1 Front part of the movable wing

[0081] 2.2.2 Gap between adjacent movable vanes

[0082] 2.3 Stop block

[0083] 2.4 Slit

[0084] 2.5 gap

[0085] 2.6 Transition Zone

[0086] 2.7 Slit

[0087] 3 reducer

[0088] 3.1 Proximal cylindrical portion

[0089] 3.1.1 Proximal opening

[0090] 3.1.2 Cylindrical inner wall

[0091] 3.1.3 First stop

[0092] 3.1.4 Second block

[0093] 3.2 Distal conical portion

[0094] 3.2.1 Distal opening

[0095] 3.2.2 Conical inner wall

[0096] 3.2.3 Opening angle of the conical inner wall

[0097] 3.3 Third stop

[0098] 3.4 Disc Equipment

[0099] 3.4.1 Hole

[0100] 3.4.2 Slit

[0101] 4 sleeves

[0102] 4.1 Stop block

[0103] 5.1 Heart

[0104] 5.2 Aorta

[0105] 5.3 Left ventricle

[0106] 5.4 Aortic valve

[0107] 6 motors. Detailed Implementation

[0108] Figure 1A catheter device 1, used as a blood pump, is shown. The catheter device 1 is introduced into the patient's body such that a portion 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 may be located outside the patient's body, a motor 6 is provided for driving a drive shaft 1.5. A portion of the drive shaft 1.5 is covered by a catheter conduit 1.3. The drive shaft 1.5 and the catheter conduit 1.3 extend from the drive region to a distal region where a radially compressible rotor 1.1.1 is driven by the drive shaft 1.5. The compressible rotor 1.1.1 is located within a 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 cardiac tissues such as chordae tendineae by preventing tissue from being drawn 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 an atraumatic tip, for example designed as a pigtail tip 1.2.2. The atraumatic tip 1.2.2 may, for example, be made of... Made of PU or another flexible medical-grade polymer, and may include elongated portions 1.2.1. Figure 3a In the illustrated embodiment, the distal end of the drive shaft is located in the elongated portion 1.2.1. However, the distal shaft 1.2 and the atraumatic tip can also be separated. The rotor 1.1.1 and the drive shaft 1.5 are rotatable, thereby enabling blood flow from distal to proximal, i.e., blood flows out of the left ventricle 5.3, into the aorta 5.2, and to other areas of the patient's body. A downstream conduit 1.4 is provided on the proximal side of the rotor 1.1.1 and the rotor housing 1.1.2. The downstream conduit 1.4 has a downstream opening 1.4.1 located proximal to the aortic valve 5.4, allowing blood to pass through the aortic valve within the downstream conduit 1.4 and then flow into the aorta 5.2. The downstream conduit 1.4 is made of a flexible material so that the aortic valve 5.4 can compress the downstream conduit as the patient's heart 5.1 continues to pump.

[0109] Figure 2 The distal region of a catheter device having a radially compressible component 1.1 is shown. The radially compressible component 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 a drive shaft 1.5 to allow fluid to flow axially in a proximal direction from the distal end to a downstream tube 1.4 located on the proximal side of the rotor, and exit from a downstream opening 1.4.1 of the downstream tube 1.4, for example, into the human aorta. At the distal end of the compressible component 1.1, a distal shaft 1.2 is provided. This 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 Shown as Figure 1 The distal region of the catheter device shown has an additional compression tube 2 and a reducer 3 to facilitate insertion of the catheter device, particularly the compressible component 1.1, into the sleeve 4. The sleeve 4 is positioned around the catheter device 1 and on the proximal side of the compressible component 1.1. The compression tube 2 is positioned around a portion of the compressible component 1.1, with a movable flap 2.2 surrounding the distal portion of the compressible component 1.1, and the tube 2.1 of the compression tube 2 extending distally thereto. The tube 2 surrounds an elongated portion 1.2.1 of the distal shaft 1.2, with a groove 2.1.1 in the compression tube 2 allowing the pigtail 1.2.2 of the distal shaft 1.2 to remain in a coiled position. The reducer 3 is positioned proximal to the compression tube. The proximal portion of the reducer 3 is a cylindrical portion 3.1, while the distal portion of the reducer 3 is a tapered portion 3.2, with its radius increasing distally. The aperture angle of the tapered portion 3.2 can be, for example, between 6° and 10°. The reducing tube can now move distally relative to the conduit device 1 and the compression tube 2. The distal opening 3.2.1 of the reducing tube 3 is large enough to allow the movable vane 2.2 to slide into the distal opening 3.2.1 in the open state. Friction and / or the pigtail 1.2.2 residing in the groove 2.1.1 ensure that the compression tube 2 does not cause the conduit device 1 to slide distally. As the relative movement continues, the movable vane 2.2 passes through the tapered portion 3.2 of the reducing tube 3, contacts the tapered inner wall 3.2.2 of the tapered portion 3.2 of the reducing tube 3, and is thus continuously compressed. As the movable vane 2.2 is compressed, the radially compressible member 1.1 disposed between the movable vanes 2.2 is also compressed, and the compressive force preferably acts in the axial portion where the rotor is located. Compression is completed as the proximal end of the compression tube 2 enters the cylindrical portion 3.1. The compression tube 2 slides further until the front portion 2.2.1 of the movable vane impacts the second stop 3.1.4 near the proximal opening 3.1.1 of the reducer 3, which is opposite to the first stop 3.1.3. At this point, the compression tube 2 can no longer move along the proximal direction on the conduit device 1. The sleeve 4 can now be positioned against the first stop 3.1.3 or against the front portion 2.2.1 of the movable vane 2.2. By gripping the sleeve 4 and pulling the proximal end of the conduit, the compressible component 1.1 is pulled out of the compression tube 2 through the proximal opening 3.1.1 of the reducer 3 and enters the sleeve 4.

[0111] Figure 3b It shows the relationship with Figure 3a The same setup, but with an additional set of stops 3.3 for holding the compression tube 2 in an uncompressed state relative to the reducer tube 3. The catheter device 1 can be packaged and delivered to the physician in this configuration, where the compressible rotor 1.1.1 and housing 1.1.2 are in an uncompressed state, but the compression tube 2 and reducer tube 3 are in a... Figure 3b The configuration shown is designed to protect the compressible components.

[0112] Figure 4 The distal region of the conduit device 1, according to the prior art, is being pulled into the sleeve 4. Consequently, the housing 1.2 and rotor 1.1 are compressed when pressed into the sleeve 4. The compressive force is mediated directly by the edge of the sleeve, causing severe deformation of the compressible component, at least in regions 1.1.a and 1.1.b shown in FIG. 3. Furthermore, the force acting on the compressible component 1.1 acts in the distal direction, thus the rotor 1.1.1 is pushed distally and cannot expand axially in the proximal direction during compression. This may result in improper rotor folding or rotor kinking during compression.

[0113] Figure 5a and Figure 5b The compression tube 2 is shown from two different angles. The compression tube 2 comprises three movable flaps 2.2, shown in the open position. In the open position, there is a gap 2.2.2 between adjacent flaps. The movable flaps 2.2 are preferably designed such that the gap 2.2.2 is not completely closed during compression, particularly during compression through the reducer 3 as shown in FIG. 3. When the flaps are closed, due to the residual gap 2.2.2, the compressible component 1.1 or other components of the conduit device, such as the downstream tube 1.4, will not be squeezed or jammed between the flaps. Figure 5a In the design, the groove 2.1.1 is visible, allowing the pigtail 1.2.2 to remain in a coiled position when the compression tube 2 is positioned around the distal shaft 1.2 or the pigtail 1.2.2. Therefore, conduit devices of different sizes with distal shafts of different lengths can be accommodated. Furthermore, positioning the pigtail 1.2.2 within the groove, rather than allowing it to protrude beyond the distal end of the compression tube, protects at least part of the pigtail 1.2.2 from lateral bending. Figure 5b In the middle, the front part 2.2.1 of the movable wing 2.2 is visible, which is designed to impact the second stop 3.1.4 of the variable diameter tube 3.

[0114] Figure 6a and Figure 6b The reducer 3 is shown from two different angles. The reducer 3 includes a cylindrical portion 3.1 and a tapered portion 3.2. The reducer is typically positioned around the conduit device 1 such that the cylindrical portion is located at the proximal end of the tapered portion. The inner radius of the tapered portion 3.2 increases from the cylindrical portion 3.1 toward the distal opening 3.2.1.

[0115] exist Figure 7The cut through the reducer 3 is shown in the diagram. The distal opening 3.2.1 of the tapered portion 3.2 of the reducer 3 is shown on the left. The inner radius of the tapered portion 3.2 decreases away from the distal opening 3.2.1, so that the inner wall 3.2.2 delineates a portion of the tapered 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 delineates a cylindrical surface. The opening angle 3.2.3 of the wall 3.2.2 of the tapered portion 3.2.2 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 to it on the distal side. The reducer 3 is designed such that the movable vane 2.2 can be introduced into the distal opening 3.2.1 in an uncompressed or nearly uncompressed state. If the compression tube 2 slides along the reducer 3 in the proximal direction, the movable vane 2.2 is radially isotropically compressed as it passes through the tapered portion 3.2 of the reducer 3. Once the movable vane 2.2 reaches the cylindrical portion 3.1, compression is complete. The vane 2.2 can then slide further until it encounters the second stop 3.1.4. Preferably, the diameter of the cylindrical space contained in the compressed movable vane 2.2 differs from the inner diameter of the proximal opening 3.1.1 by less than 1 mm, particularly preferably less than 0.5 mm, so that the compressible component 1.1 can slide out of the cylindrical space and enter the sleeve 4 through the proximal opening 3.1.1. Thus, the sleeve 4 can be positioned at the proximal end of the reducer 3, abutting against the first stop 3.1.3.

[0116] Figure 8 A compression tube 2 and a reducer 3 without the conduit device 1 are shown; a movable vane 2.2 has been inserted into the tapered portion 3.2 of the reducer 3 through the distal opening 3.2.1 of the reducer, i.e., the vane 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 vane 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, having a proximal opening 3.1.1, a first stop 3.1.3, and a second stop 3.1.4, can be seen.

[0117] Figure 9a and Figure 9b The diagram shows a conduit device 1, a compression tube 2, and a reducing tube 3, as well as an additional disc device 3.4 or membrane with holes.

[0118] exist Figure 9aIn this configuration, a disc device 3.4 is positioned between the reducing tube 3 and the compressible component 1.1, surrounding the drive shaft 1.5 and the conduit 1.3. As the reducing tube 3 moves toward the compression tube 2 and the compressible component, the front portion of the reducing tube 3, near the distal opening 3.2.1 of the reducing tube, contacts the disc device 3.4, thereby pushing the disc device 3.4 toward the compression tube 2 and the compressible component 1.1. As the disc device 3.4 approaches the compressible component 1.1, it pushes the compressible component 1.1 between the movable vanes 2.2 of the compression tube, thereby positioning the compressible component such that the compressive force during subsequent compression can act at the desired location. The movable vanes 2.2 and the distal opening 3.2.1 of the reducing tube 3 are designed such that when the uncompressed radially compressible component 1.1 is in the desired position, the movable vanes 2.2 smoothly enter the distal opening 3.2.1 of the reducing tube. As the reducer 3 and the disc device 3.4 continue to move relative to the compression tube 2, the disc device 3.4 loosens or breaks, causing the radially compressible component 1.1 in the compression tube 2 to be accommodated between the tapered portions of the reducer.

[0119] Figure 9b Showing with Figure 9a A similar setup, but the disc device 3.4 is attached to the reducer 3. The disc device 3.4 is positioned in the distal opening 3.2.1 of the reducer. This process is similar to that in... Figure 9a The process is described in the context of the following. When the reducer 3 and the disc device 3.4 approach the compression tube 2 and the radially compressible component 1.1, the radially compressible component is first pushed between the movable vanes 2.2 and positioned in the desired location, wherein the movable vanes 2.2 begin to slide into the tapered portion of the reducer 3, but are not yet compressed or are only slightly compressed. As the reducer 3 continues to move relative to the compression tube 2, the disc loosens or breaks, and thus, the radially compressible component 1.1 is compressed as it passes through the tapered portion of the reducer 3.

[0120] Figure 9c It shows Figure 9a and 9bThe disc device 3.4 is preferably configured as a thin plate. For example, it may be made of PTFE, PE, or silicone. The disc device 3.4 includes a hole 3.4.1 at or near its 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 3.4, 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 the conduit device 1 or the conduit 1.3 will not be damaged when the disc device 3.4 is clamped. The disc device, particularly the edge of the hole 3.4.1, is designed to give the disc good sliding characteristics on the conduit. The disc device 3.4 may 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 at the front of the movable flap in the uncompressed state. The disc device 3.4 is flexible, allowing it to loosen and / or fall off when it is pushed into the tapered section of the reducer 3.

[0121] Figure 10 Similar to Figure 3, the distal region of the conduit device with compression tube 2 and reducing tube 3 is shown. However, in Figure 10 In this configuration, the compression tube is arranged in a different alternative configuration. The configuration of the compression tube 2 is the opposite of that in Figure 3. Now, the movable flap 2.2 of the compression tube is positioned around the compressible component 1.1 from the proximal side, such that the tube 2.1 surrounds the portion of the conduit device 1 located proximal to the compressible component 1.1, and the distal shaft 1.2 is exposed. The reducer 3 is positioned around the compression tube 2, with the tapered portion 3.2 located distal to the cylindrical portion 3.1. Now, the conduit device 1 and the compression tube 2 are moved proximal to the reducer 3, such that the tube 2.1 enters the reducer first. Compression of the compressible component 1.1 begins when the movable flap 2.2 with the compressible component enters the tapered portion 3.2 of the reducer. In this configuration, the compressible component 1.1 is pulled into the compression tube 2 when a pulling force is applied to the proximal end of the conduit tube 1.3. Therefore, unlike the configuration in Figure 3, friction is not required to maintain the relative positions 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 mounted on the proximal end of the compression tube 2. For example... Figure 2 As shown in Figures 6 and 7, a configuration with a stop is also feasible. Then, the cylindrical portion 3.1 of the reducer should be long enough to fully accommodate the compression tube 2, i.e., the pipe 2.1 and the movable vane 2.2, so that the movable vane 2.2 can fully enter the cylindrical portion 3.1 of the reducer 3 and be fully compressed.

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

[0123] Figure 12 The diagram shows a reducer 3, a portion of a compression tube 2, a portion of a sleeve 4, and a radially compressible component 1.1, wherein the rotor 1.1.1' and the housing 1.1.2' are in a compressed state. The rotor 1.1.1' and the housing 1.1.2' are positioned between movable vanes 2.2 of the compression tube, which are fully inserted into the cylindrical portion 3.1 of the reducer and are therefore in a fully compressed position. The front portion 2.2.1 of the movable vane 2.2 abuts against a first stop 3.1.4 of the reducer, preventing the compression tube 2 from extending continuously through the reducer 3. Figure 12 In the illustrated embodiment, the front portion 2.2.1 of the movable vane 2.2 serves as a stop for the sleeve 4 disposed around the drive shaft 1.5 and the conduit 1.3. By gripping the sleeve 4 and pulling the conduit 1.3 in the proximal direction, the compressible component slides out from the compression tube 2 and the reducer 3 into the sleeve 4.

[0124] Figure 13A compressible housing 1.1.2 is shown, having 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 in the proximal region, collisions between blood cells and struts are minimized, thus minimizing damage to the blood. However, in this configuration, if compression is mediated solely by the end of the sleeve 4, pulling the compressible housing 1.1.2, which contains the rotor 1.1.1, into the sleeve 4 located near the proximal end of the housing 1.1.2 may increase the risk of the rotor 1.1.1 being squeezed or jammed. Therefore, if it is necessary to... Figure 13 The housing design shown is particularly useful, as described in this application, which includes a reducing tube 3 and a compression tube 2.

[0125] Figure 14a The sleeve 4 and the compression tube 2 introduced into the reducer 3 are shown. The reducer exposes a step inside its cylindrical portion, causing the inner diameter to decrease at the cylindrical end to allow the sleeve to be introduced. Therefore, at the end of the cylindrical portion facing the tapered portion, i.e., in the part where the compression tube is introduced into the cylindrical portion, the inner diameter is slightly larger. In the embodiment shown in FIG. 14, the compression tube 2 has an additional stop 2.3 that abuts against the end of the reducer 3 on the tapered portion side. The stop 2.3 is configured near the end of the movable flap 2.2 of the compression tube, such that a gap 2.5 is maintained between the compression tube and the step disposed inside the reducer 3. In this way, when the conduit device 1 is pulled by the compression tube 2, a portion of the conduit device 1 will not be clamped 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 portion of the reducer 3, such that the end of the sleeve 4 introduced into the reducer 3 is kept at a certain distance from the front side 2.2.1 of the movable vane. In this way, when the sleeve 4 is introduced into the reducer 3, the gap 2.5 still exists.

[0126] The inner diameter of the cylindrical portion of the reducing tube introduced into sleeve 4 is 0.2mm-1mm larger than the outer diameter of sleeve 4, particularly 0.4mm-0.7mm. This allows sleeve 4 to deform when the conduit equipment is pulled into sleeve 4. This is particularly advantageous because sometimes rotor 1.1.1 is compressed to obtain an elliptical shape instead of a circular shape.

[0127] The compression tube 2 does not include the groove for accommodating the pig tail 1.2.2 of the conduit device 1.

[0128] Settings Figure 14a The step on the inner side of the reducer 3 can also be circular or designed as a slope. Figure 14bAn arrangement with a transition zone 2.6 is shown, in which there are no sharp edges. The diameter of the pump head can be further reduced by pulling the pump head over this transition zone 2.6.

[0129] Figure 15 An embodiment of the compression tube 2 is shown, wherein additional slits 2.4 are provided to pierce the compression tube 2 at several locations. The compression tube 2 has four movable flaps 2.2 separated by gaps 2.2.2. The slits 2.4 are all provided as a continuation of the gaps 2.2.2 (i.e., radially aligned with the gaps) and are movable relative to the gaps 2.2.2 (i.e., radially displaced to be located between two gaps 2.2.2). This improves the flexibility of the compression tube, thereby achieving better compression behavior and helping to avoid crushing the components of the conduit device 1.

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

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

[0132] In each case, the compression tube 2 has four movable flaps 2.2. The width of the flaps 2.2 is chosen to be large enough to engage with the struts of the compressible housing of the conduit device 1. That is, for higher strut density, thinner flaps can be provided. Wider flaps are provided when the strut density is low in all components within the housing, and sometimes embodiments with three flaps instead of four flaps are chosen for low-density struts.

[0133] In each case, the compression tube 2 has four movable heat sink fins 2.2. The width of the heat sink fins 2.2 is chosen to be large enough to engage with the supports of the compressible housing of the conduit device 1. That is, for higher support density, thinner heat sink fins can be provided. When the support density is low in all components within the housing, wider heat sink fins are provided; sometimes, embodiments with three heat sink fins instead of four heat sink fins are chosen for low-density supports.

[0134] Figure 16 (a) shows an embodiment in which the gap 2.2.2 separating the heat sink fins 2.2 extends axially along the compression tube.

[0135] Figure 16Figure (b) illustrates one embodiment in which the gap 2.2.2 begins in the longitudinal direction and then extends in a radial component, i.e., in a helical manner. The gap extends approximately 45° around the circumference of the compression tube. The risk of compression of the conduit device can be reduced by having a radial component for the gap 2.2.2.

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

[0137] Figure 16 (d) illustrates an embodiment having an axially extending gap 2.2.2 and an additional slit 2.4. This embodiment is similar to... Figure 15 The embodiment shown is described below. Slit 2.4 is configured to be radially aligned with and spaced apart from gap 2.2.2, and is also positioned between adjacent gaps and spaced apart from the end of the compression tube.

[0138] Figure 16 (e) illustrates an embodiment including two gaps 2.2.2 and an additional slit 2.4, both having radial components. The slits 2.2.2 exhibit the same helix as the gaps 2.2.2, with some slits aligned with the helix of one of the gaps, and others arranged between the helices defined by the gaps 2.2.2. The ends of the radially displaced slits 2.7 axially overlap with the ends of the gaps 2.2.2 and / or the axially aligned slits 2.4 (this also applies to...). Figure 15 and 16 (as shown in the image).

Claims

1. A system for introducing a radially compressible component (1.1) of a conduit device (1) into a sleeve (4), comprising: 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) includes a conduit (2.1) designed to be positioned around the conduit device (1) and a movable flap (2.2) for receiving the radially compressible component (1.1), the movable flap (2.2) being attached to one end of the conduit (2.1) and having an open state and a closed state, wherein... The radially compressible component (1.1) includes a radially compressible rotor (1.1.1) and a radially compressible housing (1.1.2).

2. A system for introducing a radially compressible component (1.1) of a conduit device (1) into a sleeve (4), comprising: 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) includes 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. In the open state, the opening angle of the movable wing (2.2) is such that the movable wing (2.2) contacts the axial portion of the housing (1.1.2) of the radially compressible member (1.1), the axial portion being located between the distal and proximal ends of the housing (1.1.2), such that when the movable wing (2.2) is moved to the closed state, the radially compressible member (1.1) is compressed and a compressive force is applied to the axial portion, wherein the compressive force has a radial component; The compression tube (2) includes a stop (2.3), which is disposed at the end of the compression tube (2) opposite to the movable wing (2.2). The stop (2.3) is configured near the end of the movable blade (2.2) of the compression tube (2).

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

4. The system according to claim 1 or 2, wherein, The sleeve (4) is a tear-off sheath, or the sleeve (4) is a tube.

5. The system according to claim 4, wherein, The cannula is part of the conduit device (1) itself.

6. The system according to claim 1 or 2, wherein, The catheter device (1) includes at least one of a pig tail (1.2.2) and a distal shaft (1.2), wherein the distal shaft or the pig tail (1.2.2) includes an elongated portion (1.2.1).

7. The system according to claim 6, wherein, The compression tube (2) includes a conduit (2.1) for accommodating the elongated portion (1.2.1) or a portion of the conduit device located on the proximal or distal side of the radially compressible component (1.1).

8. The system according to claim 7, wherein, The conduit (2.1) of the compression tube (2) includes a groove (2.1.1) for receiving the pig tail (1.2.2).

9. The system according to claim 1 or 2, wherein, The compression tube (2) includes two to ten movable blades (2.2).

10. The system according to claim 1 or 2, wherein, The compression tube (2) includes three or four movable vanes (2.2).

11. The system according to claim 1 or 2, wherein, The gap (2.2.2) extending between adjacent movable blades (2.2) extends axially or helically.

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

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

14. The system according to claim 1 or 2, wherein, A gap is left between adjacent movable flaps (2.2) that are in the closed state.

15. The system according to claim 1 or 2, wherein, Adjacent movable flaps (2.2) are connected by a membrane or skin.

16. The system according to claim 1 or 2 further includes a reducing tube (3) for radially compressing the movable vane (2.2) of the compression tube (2) and a radially compressible component (1.1) housed between the movable vanes (2.2).

17. The system according to claim 16, wherein, The reducing pipe (3) is designed as a pipe having a distal opening (3.2.1) and a proximal opening (3.1.1) and is configured to accommodate the sleeve (4) and the compression pipe (2), wherein the sleeve (4) includes a stop (4.1) configured to abut against one end of the reducing pipe (3) when the sleeve (4) is introduced into the proximal opening (3.1.1) of the reducing pipe (3).

18. The system according to claim 17, wherein, The reducing tube (3) is designed as a tube having a distal opening (3.2.1) and a proximal opening (3.1.1), comprising a proximal cylindrical portion (3.1) and a distal tapered portion (3.2) having a constant inner diameter, wherein the inner diameter increases in the distal direction, and the distal tapered portion (3.2) is configured to accommodate the movable vane (2.2) and the radially compressible member (1.1) accommodated by the movable vane (2.2).

19. The system according to claim 17, wherein, The reducing pipe (3) includes a first stop (3.1.3) for limiting the movement of the sleeve (4) relative to the reducing pipe (3) in the distal direction.

20. The system according to claim 19, wherein, The reducing tube (3) includes a second stop (3.1.4) opposite to the first stop (3.1.3) for restricting the movement of the compression tube (2) relative to the reducing tube (3) in the proximal direction.

21. The system according to claim 1 or 2, wherein, The inner diameter of the movable wing (2.2) in the closed state differs from the inner diameter of the sleeve (4) by at most 1 mm.

22. The system according to claim 21, wherein, The inner diameter of the movable wing (2.2) in the closed state differs from the inner diameter of the sleeve (4) by at most 0.5 mm.

23. The system according to claim 18, wherein, The compression tube (2) is disposed around the conduit 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). The device also includes a disc device (3.4) having a hole (3.4.1), characterized in that the disc device (3.4) is disposed around the conduit device (1) in the portion between the proximal cylindrical portion (3.1) of the reducing tube (3) and the radially compressible member (1.1).

24. A method of inserting the radially compressible component (1.1) of the conduit device (1) into the sleeve (4) using the system of claim 17, the method comprising the steps of: The reducing tube (3) is disposed around the conduit device (1) on the proximal side of the radially compressible component (1.1); The sleeve (4) is disposed around the conduit device (1) on the proximal side of the reducing tube (3); The compression tube (2) is arranged around the conduit device (1) such that the radially compressible component (1.1) is located between the movable vanes (2.2); And perform the following steps: Move the reducing tube (3) toward the compression tube (2) so that the compression tube (2) slides into the distal opening (3.2.1) of the reducing tube (3); Continue the relative movement of the compression tube (2) and the reducing tube (3) so that the movable vane (2.2) slides through the distal tapered portion (3.2) of the reducing tube (3) and compresses the movable vane (2.2) from the open state to the closed state, thereby compressing the radially compressible component (1.1); The relative motion continues so that the movable wing (2.2) in the closed state and the compressed radially compressible member (1.1) slide along the proximal cylindrical portion (3.1); as well as The sleeve (4) is abutted against the first stop (3.1.3) of the compression tube (2) or the reducing tube (3) on the proximal side, the first stop (3.1.3) being located on the proximal side of the compression tube (2), and the conduit (1.3) is pulled proximally when the sleeve (4) is gripped, so that at least a portion of the conduit device (1) including the radially compressible member (1.1) slides out of the compression tube (2) and into the sleeve (4).

25. A method of inserting the radially compressible component (1.1) of the conduit device (1) into the sleeve (4) using the system of claim 23, the method comprising the steps of: The reducing tube (3) is disposed around the conduit device (1) on the proximal side of the radially compressible component (1.1); The sleeve (4) is disposed around the conduit device (1) on the proximal side of the reducing tube (3); The compression tube (2) is arranged around the catheter device (1) such that the movable flap (2.2) faces the proximal direction; And perform the following steps: Move the reducing tube (3) and the disc device (3.4) toward the compression tube (2) so that the disc device (3.4) pushes the radially compressible member (1.1) between the movable vanes (2.2) and slides the movable vanes (2.2) into the distal opening (3.2.1) of the reducing tube (3) until the disc device (3.4) loosens or breaks; Continue the relative movement of the compression tube (2) and the reducing tube (3) so that the movable vane (2.2) slides through the distal tapered portion (3.2) of the reducing tube (3) and compresses the movable vane (2.2) from the open state to the closed state, thereby compressing the radially compressible component (1.1); The relative motion continues so that the movable wing (2.2) in the closed state and the compressed radially compressible member (1.1) slide along the proximal cylindrical portion (3.1); as well as The sleeve (4) is abutted against the first stop (3.1.3) of the compression tube (2) or the reducing tube (3) on the proximal side, the first stop (3.1.3) being located on the proximal side of the compression tube (2), and the conduit (1.3) is pulled proximally when the sleeve (4) is gripped, so that at least a portion of the conduit device (1) including the radially compressible member (1.1) slides out of the compression tube (2) and into the sleeve (4).

26. A system for introducing a radially compressible component (1.1) of a conduit device (1) into a sleeve (4), comprising: 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) includes 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. It also includes a reducing tube (3) for radially compressing the movable vane (2.2) of the compression tube (2) and a radially compressible component (1.1) housed between the movable vanes (2.2); The compression tube (2) includes a stop (2.3) configured to be inserted into the distal opening of the reducing tube (3) when the compression tube (2) is introduced into the reducing tube (3). 3.1.2) When abutting one end of the reducing pipe, a gap (2.5) is left between the sleeve (4) and the reducing pipe (2) when the compression pipe (2) and the sleeve (4) are introduced into the reducing pipe.

27. A system for introducing a radially compressible component (1.1) of a conduit device (1) into a sleeve (4), comprising: 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) includes 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. It also includes a reducing tube (3) for radially compressing the movable vane (2.2) of the compression tube (2) and a radially compressible component (1.1) housed between the movable vanes (2.2); The variable diameter tube (3) includes a first stop (3.1.3), which is used to restrict the movement of the sleeve (4) relative to the variable diameter tube (3) toward the distal end. The variable diameter tube (3) includes a second stop (3.1.4) opposite to the first stop (3.1.3) for restricting the movement of the compression tube (2) relative to the variable diameter tube (3) in the proximal direction.

28. A system for introducing a radially compressible component (1.1) of a conduit device (1) into a sleeve (4), comprising: 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) includes 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. It also includes a reducing tube (3) for radially compressing the movable vane (2.2) of the compression tube (2) and a radially compressible component (1.1) housed between the movable vanes (2.2); The variable diameter tube (3) is designed as a tube having a distal opening (3.2.1) and a proximal opening (3.1.1), comprising a proximal cylindrical portion (3.1) and a distal tapered portion (3.2) having a constant inner diameter, wherein the inner diameter increases in the distal direction, and the distal tapered portion (3.2) is configured to accommodate the movable vane (2.2) and the radially compressible member (1.1) accommodated by the movable vane (2.2); The compression tube (2) is arranged around the conduit device (1) such that the movable vane (2.2) faces the compressible component (1.1), and the reducing tube (3) is arranged on the opposite side of the compressible component (1.1) such that the tapered portion (3.2) of the compression tube (3) faces the compressible component (1.1). The device also includes a disc device (3.4) having a hole (3.4.1), characterized in that the disc device (3.4) is arranged around the conduit device (1) in the portion between the cylindrical portion (3.1) of the reducing tube (3) and the compressible component (1.1).

29. A system for introducing a radially compressible component (1.1) of a conduit device (1) into a sleeve (4), comprising: 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) includes 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. It also includes a reducing tube (3) for radially compressing the movable vane (2.2) of the compression tube (2) and a radially compressible component (1.1) housed between the movable vanes (2.2); The variable diameter tube (3) is designed as a tube having a distal opening (3.2.1) and a proximal opening (3.1.1), comprising a proximal cylindrical portion (3.1) and a distal tapered portion (3.2) having a constant inner diameter, wherein the inner diameter increases in the distal direction, and the distal tapered portion (3.2) is configured to accommodate the movable vane (2.2) and the radially compressible member (1.1) accommodated by the movable vane (2.2); The process of inserting the radially compressible component (1.1) of the conduit device (1) into the sleeve (4) includes the following steps: The reducing tube (3) is disposed around the conduit device (1) on the proximal side of the compressible component (1.1); The sleeve (4) is disposed around the conduit device (1) on the proximal side of the reducing tube (3); The compression tube (2) is arranged around the catheter device (1) such that the movable flap (2.2) faces the proximal direction; And perform the following steps: Move the reducing tube (3) and the disc device (3.4) toward the compression tube (2) so that the disc device (3.4) pushes the compressible component (1.1) between the movable vanes (2.2) and slides the movable vanes (2.2) into the distal opening of the reducing tube (3) until the disc device (3.4) loosens or breaks. Continue the relative movement of the compression tube (2) and the reducing tube (3) so that the movable vane (2.2) passes through the distal tapered portion (3.2) of the reducing tube (3) and compresses the movable vane (2.2) from the open state to the closed state, thereby compressing the radially compressible component (1.1); The relative motion continues, causing the movable vane (2.2) in the compressed state and the compressed radially compressible member (1.1) to slide along the proximal cylindrical portion (3.1); and The sleeve (4) is pressed against the compression tube (2) or the first stop (3.1.3), the first stop being located on the proximal side of the compression tube (2), and the conduit (1.3) is pulled proximally when the sleeve (4) is held, so that at least a portion of the conduit 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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