HK40003657A - Catheter device - Google Patents

Description

The invention relates to a catheter device, in particular a catheter device with an extended drive shaft.

The width of the range of applications of such pumps depends on the ease of introduction into the body, on the feasible technical characteristics and especially on the feasible reliable operating life of the pump systems. Ideally, such a pump should be operational for short-term treatment without any surgical intervention.

In cardiogenic shock, the left ventricle's ejection capacity is significantly reduced. The reduced coronary supply can lead to irreversible heart failure. The use of a temporary left ventricular support system is intended to partially or largely take over the left ventricle's pumping function and improve the coronary supply.

The intra-aortic balloon pump or intra-aortic counter-pulsation is a mechanical system that is also used to support the pumping power of the heart in patients with cardiogenic shock. A catheter with a cylindrical plastic balloon is pushed through the groin into the thoracic aorta (aorta), so that the balloon is located below the exit of the left collar artery (arteria subclavia sinistra). There, the balloon is closed with a very active rhythmic pump with diastolic inhibition in the ventricle with helium A3 and is then pumped back out of the body in a way that improves blood flow to the heart muscle. This improves the blood flow through the left ventricle and into the heart muscle.

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The axial pump has a flexible compressible tube that forms the pump housing. The tube contains a radially compressible rotor. The rotor's drive shaft passes through a catheter. The catheter can be drawn in together with the tube and the rotor into a cover tube. The radial compressibility of the components allows the realization of a small puncture diameter acceptable for a percutaneous implantation in Seldinger technique.

US 4.753.221 describes a catheter with an integrated blood pump, which has folding wings. The blood pump is an axial pump arranged inside a catheter tube, at the end of which there is a balloon that can be inflated to unfold the pump cap and to close the flow path leading to the pump, thus fixing the pump in the blood vessel. Another example involves placing a cup-shaped end of the catheter in a tubular guide catheter, retracting it, thus unfolding the cup-shaped end.

The DE 10 059 714 C1 is a pump with an intravascular pump. The pump has a drive part and a pump part, which are so small in diameter that they can be pushed through a blood vessel. A flexible cannula is attached to the pump part. To reduce the flow resistance, the cannula can be enlarged to a diameter larger than that of the drive part or pump part. To introduce the pump into the body by puncture of the blood vessel in the Seldinger technique, the cannula is strapped in the constricted state in which it has a small diameter. In the blood it is enlarged there to provide a lower flow resistance for the blood flow to pump.

The JP 4126158 and EP 0 445 782 A1 describe an artificial heart that can be implanted into the body. The artificial heart has a pump section and a drive section to drive the pump section. The pump section is relatively small and is designed to accommodate an axial throttle pump. The axial throttle pump is designed as a screw-spindle pump.

EP 0 364 293 A2 describes a catheter with an integrated blood pump. A flexible edge extends over a tubular section of the catheter and contacts the walls of the aorta, thus ensuring that all the blood within the aorta flows through the pump.

The US 5,376,114 has a cannula pump that can be temporarily inserted through a small incision in the heart. The pump has a wing wheel that is driven by a wave. The wave is firmly connected to a motor magnet. The motor magnet is surrounded by magnet coils that can generate a rotating magnetic field, so that the motor is put into motion.

WO 01/17581 A2 shows an intravascular blood pump, which consists of a drive shaft coupled to a clutch by means of a cylindrical element with a longitudinal hinge on its outer surface.

The US 5, 376, 114 A has a temporary heart pump, which has a drive shaft with a rod-shaped coupling at the proximal end, which is incorporated into a motor.

WO 89/05668 A2 reveals a propulsion mechanism for intravascular blood pumps. According to this document, a rotor is attached to a shaft, the shaft having a non-circular conductive opening in its centre. In this conductive bore a gear is formed to which one end of a flexible cable, which forms the propulsion shaft, is attached. This is to allow a limited axial movement of cable 32 in relation to a propulsion unit in order to compensate for the bending-induced change in length of the cable shell during operation.

US 6, 245,007 D1 has a blood pump and a pump mechanism with impellers for such a pump.

The present invention is based on the task of creating a catheter device with a drive shaft extending almost over the entire catheter device, which can be reliably driven at high speed.

The problem is solved by a catheter device as described in Section 1.

The catheter device consists of a motor at the proximal end of the catheter device and a drive shaft extending from the proximal end of the catheter device to the distal end of the catheter device to drive a rotating element at the distal end of the catheter device. The drive shaft is connected to the motor at the proximal end of the catheter device by a clutch. The clutch is a magnetic coupling with a proximal and a distal magnet unit. The proximal magnet unit is connected to the motor unit and the distal magnet unit to the drive shaft. The distal magnet unit is housed in a cupping gasket and is arranged by a wall separately from the proximal magnet unit.

The separation of the clutch elements from the catheter's downstream side to the distal end avoids the need to conduct the drive shaft outwards through a hole. Such an arrangement would require a seal. However, such a seal limits the speed.

The magnetic ring bearing or magnetic connection of the two magnetic units limits the contribution of the transmittable torque.

Preferably, the catheter device comprises a tubular catheter enclosing the drive shaft and extending from the proximal to the distal end of the catheter device.

A flush hole in the clutch housing allows the introduction of a flush medium to lubricate the drive shaft and the downstream clutch elements, preventing blood from entering the area between the drive shaft and the catheter and affecting the rotation of the drive shaft.

Preferably, a clutch on the downward side supporting the distal magnetic unit is housed in a sliding bearing, which allows the distance between the two magnetic units to be determined precisely.

According to a further training, an additional magnetic ring bearing is provided, which on the one hand provides a further, mainly radial, bearing of the downward-facing coupling element and, on the other, can counteract the forces exerted by the magnetic units, so that the force with which the downward-facing coupling element is pushed against the sliding bearing is reduced.

The maximum torque transmitted by the magnetic coupling is adjusted by the distance between the two magnetic units determined by the sliding bearing and by the force applied to the coupling element by the magnetic ring bearing in the axial direction.

The diameter of the drive shaft may be in the range of 0,3 mm to 1 mm and preferably about 0,4 mm to 0,6 mm. The smaller the diameter of the drive shaft, the greater the speed at which the drive shaft is driven by the motor.

The element rotating by means of the drive shaft may be a rotor, a milling tool or any other tool.

The rotor and the pump housing are formed from a shape memory material according to a preferred embodiment.

The combination of such a self-extending pump head with the magnetic coupling described above forms a catheter device which, on the one hand, achieves a high pumping power due to the high speed and the large rotor and, on the other hand, achieves a long service life of several hours to several days.

The following illustrations illustrate the invention in more detail and are shown in diagrams: 1a perspective representation of a catheter device according to the invention,Fig. 2a blast drawing of a catheter device according to the invention,Fig. 3a shaft cap of the catheter device in a side-cut view,Fig. 4a distal piece of catheter device in a side-cut view,Fig. 5a connecting box of the catheter device in a side-cut view,Fig. 6a pump section of the catheter device with storage in a side-cut view,Fig. 7a linear cross-section of the A-A line through the connecting catheter section,Fig. 7a linear cross-section of the catheter section,Fig. 8a linear cross-section of the catheter section,Fig. 8a linear cross-section of the catheter section,Fig. 9a linear cross-section of the catheter section,Fig. 8a linear cross-section of the catheter section,Fig. 9a linear cross-section of the catheter section,Fig. 8a linear cross-section of the catheter section,Fig. 9a linear cross-section of the catheter section,Fig. 9a linear cross-section of the catheter section,Fig. 9a linear cross-section of the catheter section,Fig. 9a linear cross-section of the catheter section,Fig. 9a linear cross-section of the catheter section,Fig.10a drive shaft with guide spiral and catheter device wave protection,Fig. 11a frame structure of a rotor of a catheter device pump,Fig. 11a further frame structure of the catheter device pump rotor,Fig. 12a rotor of the catheter device pump in perspective view,Fig. 13a drainage tube of the catheter device in perspective view,Fig. 14a frame structure of a catheter device pump in perspective,Fig. 15a frame structure of the catheter device in perspective,Fig. 18a frame structure of the catheter device in perspective,Fig. 16a frame structure of the catheter device in perspective,Fig. 18a frame structure of the catheter device in perspective,Fig. 18a frame structure of the catheter device in perspective,Fig. 18a frame structure of the catheter device in perspective,Fig. 18a frame structure of the catheter device in perspective,Fig. 16a frame structure of the catheter device in perspective,Fig. 18a frame structure of the catheter device in perspective,Fig. 18a frame structure of the catheter device in perspective,Fig. 17a frame structure of the catheter device in perspective,Fig. 18a frame structure of the catheter device in perspective,Fig. 18a frame structure of the catheter device in perspective,Fig. 18a frame structure of the catheter device in perspective,Fig. 18a frame structure of the catheter device in perspective,Fig. 18a frame structure of the catheter device in perspective,Fig. 18a frame structure of the catheter device in perspective,Fig. 18a frame of the catheter device in perspective,Fig. 18a frame of the catheter device in perspective,Fig. 18a frame of the catheter device in perspective,Fig. 18a frame of the catheter device in perspective,Fig. 18a frame of the catheter device in perspective,Fig. 18a frame of the catheter,Fig. 18a frame of the catheter,Fig. 18a frame of the catheter, in the catheter,Fig.Fig. 20a ball-headed ball of the catheter device coupling in a side view,Fig. 21a centrifugal pin of the catheter device coupling in a side view,Fig. 22a motor take-up of the catheter device in a side view,Fig. 23the coupling element with the square rod arranged in it in a spiral view,Fig. 24the catheter device positioned in the body, andFig. 25schematic alternative embodiments of the catheter device.

The catheter device 1 of the invention is a pump. The catheter device 1 has a pump head 3 at a distal end 2.

The pump head 3 has a rotor 3.2 to transport a medium in the conveyor direction 5 connected to a drive shaft 4; the conveyor direction 5 is directed from the distal end 2 to a proximal end 6; at the proximal end 6 away from the pump head 3 is a motor 7. The drive shaft 4 is surrounded by a catheter 8 and is connected to the motor 7 by a clutch 9 forcefully.

The pump head 3 is described in detail below, comprising a shaft cap 10 at the distal end, a rotor 3.2 on the drive shaft 4, a pump housing 3.1 and a drain hose 18.

The shaft cap 10 is formed from a ball 10.1 with a cylindrical section 10.2 attached. For example, the shaft cap 10 is formed from stainless steel (Fig.2, Fig.3). The shaft cap 10 could also be formed from polyethylene PE, polypropylene PP, polyether ketone PEEK, polyvinyl chloride PVC, Teflon PTFE, acrylic glass, epoxy resin, polyurethane, PU carbon fiber, coated materials, composite materials, PEBAX, a polyether block amide. Promptuously, all hematoxylin-based materials are suitable, as only a mechanical load is applied to this hinge.

The diameter of the ball 10.1 is approximately 3.2 mm. The cylindrical section 10.2 is approximately 5.5 mm long and has a diameter of approximately 2.2 mm. The total length of the shaft cap is approximately 7.0 mm.

The cylindrical section 10.2 has a through hole 10.3 at its distal end, in the area of contact with ball 10.1, located transversely to the conveyor direction 5. Furthermore, the cylinder 10.2 has an axial bore 10.4 extending from the proximal end of the cylindrical section 10.2 to ball 10.1, so that a communicating passage is formed from the through hole 10.3 to the proximal end of the shaft cap 10. In the area of the axial bore 10.4, a step 10.5 is formed so that the axial bore is extended towards the proximal end.

The through hole 10.3 prevents the shaft cap from forming a sack hole and allows the thread to be inserted to help compress the pump head 3.

The sphere 10.1 of the shaft cap 10 may also be replaced by a pigtail, a spiral, a conical wire with a spherical tip or an atraumatic fibre bundle.

The tip of the shaft cap 10 is an atraumatic ball to protect the heart muscle (endocard).

A tube- or tube-shaped, distal catheter 8.1 is inserted into the shaft cap 10 from the proximal end to the level. The distal catheter 8.1 is inserted into the axial bore 10.4 and is fixed there (Fig. 4). The distal catheter 8.1 is made of polyurethane or another suitable material, in particular an elastic plastic material (e.g. PE, PVC, Teflon, elastomer). The distal end of the distal catheter 8.1 is connected to the shaft cap 10. The connection may be made as a small connection by means of, for example, cyanoacrylate or it may be made as a welding adhesive or a piston-type binding agent. This is a basic connecting agent, and therefore, this description does not apply to any other component of the catheter.

The distal catheter 8.1 forms a straight but slightly flexible connection between the shaft cap 10 and the pump housing 3.1. The straight connection creates a coaxial connection between all the components (driving shaft, shock shield, housing, connecting sockets) arranged in it.

The distal catheter piece 8.1 is used in conjunction with the shaft cap 10 to assist in positioning the pump head 3 when inserted into a vessel or the heart.

The catheter 8.1 in this example has a length of about 25 mm, an outer diameter of about 1.9 mm and an inner diameter of about 1.3 mm.

At the proximal end of the distal catheter 8.1 there is a distal tube-shaped connecting socket 12.1 (Fig. 5, Fig. 6). The distal connecting socket 12.1 has a larger inner diameter in the distal area than in the proximal area. In the distal area of the connecting socket 12.1 the proximal end of the distal catheter 8.1 is fitted and fixed precisely. In the proximal area of the distal connecting sockets 12.1 a distal connection section 3.1.1 of the pump body 3.1 is fitted. The distal connection section 3.1.1 of the pump body 3.1 is connected to the distal connecting socket 12.1 and the proximal end of the catheter 8.1 (Fig. 7a, Fig. 7b).

The distal connecting plug 12.1 has a length of about 5 mm and an outer diameter of about 2.2 mm. In the distal region the diameter is about 2 mm and in the proximal region about 1.5 mm. The shorter the connecting plug, the less stiffening it causes.

The distal and an analogously formed proximal connecting plug 12.1, 12.2 are, for example, made of stainless steel, copper, brass, titanium or another suitable metal, polyethylene (PE), polypropylene (PP), teflon (PTFE), PEBAX, a polyether block amide, or another suitable material.

The expandable or compressible pump housing 3.1 is a tubular lattice structure 3.1.6 made of nitinol or another suitable memory alloy or another memory material, e.g. plastic, iron alloy, copper alloy. The pump housing 3.1 is divided into five sections from distal to proximal (Fig. 8). The first distal section is a tubular distal connection section 3.1.1. A second section is a conical 5 conical extension suction section 3.1.2. At the application section 3.1.2 a conical connection 3.1.3 is added. The tubular pump connection takes the maximum length of the rotor 3.1.3. The inner diameter of the pumping outlet 3.1.3.1 is 3.11.5 mm. The average diameter of the pumping outlet 3.1.3.1 is 3.1.3.3 mm. The average diameter of the pumping outlet 3.1.1.5 is about 3.15 mm. It is approximately 5 mm. It is formed in a roughly parallel direction and is not more than 3 mm. It is not possible to draw a straight line between the conical connection and the rotor.

The grating structure 3.1.6 of the pump housing 3.1 has openings 3.1.7 between the grating strands (Fig. 8, Fig. 9). The openings are formed as a polygon 3.1.7 which are rods in the present embodiment. In the pump section 3.1.3 small rods 3.1.7.1 are provided. In the transition areas from the pump section 3.1.3 to the intake section 3.1.2 and the outlet section 3.1.4 of the tubular grid structure 3.1.6, the small rods 3.1.7.1 are gradually merged into larger rods. Adjacent to a small rod is a larger rod with double edge lengths. This doubling of edge lengths is often repeated until the openings have increased in height.In the transitional areas from the intake section 3.1.1.2 and the outlet section 3.1.4 to the distal and proximal connecting section 3.8.1, 3.1.5 of the tubular lattice structure 3.1.6, the large rails 3.1.7.2 are combined into smaller rails. In the distal and proximal connecting section, medium-sized rails 3.1.7.3 are combined into smaller rails, which have about twice the edges of the small rails 3.1.7.1 (Fig. 9).The main difference between the two is that the two are not very similar.

The lattice structure 3.1.6 of the pump body 3.1 is tensioned in the pump section 3.1.3 with a PU tension 3.1.8 which makes the lattice openings liquid-tight.

This tension or the sealing of the lattice structure 3.1.6 may also be formed, for example, by a PU hose placed on the surface externally or internally.

A non-PU coating, such as PE, PP, silicone or parylene, may also be used provided that it meets the mechanical and geometrical requirements.

Selection of individual openings 3.1.71, in particular the medium and larger openings 3.1.7.3, 3.1.7.2 which are not coated, allows the performance parameters including bleed damage to the pump to be controlled specifically.

The polygonal structure and special design of the PU tension result in a nearly round cross-sectional shape for the pump housing 3.1. In combination with the round rotor 3.2, this results in a very small gap between rotor 3.2 and pump housing 3.1. This results in comparatively low blood damage, low leakage currents and a good efficiency. The grid structure 3.1.6 results in very good radial and axial stability as well as very good axial compressibility and expandability. The special structure allows very easy adjustment of length and diameter to the performance requirements.

The proximal connecting section 3.1.5 of the pump housing 3.1 is included in and connected to the proximal connecting socket 12.2 and, in analogy to the distal connecting socket 12.1, a tubular proximal catheter piece 8.2 is included and connected to the proximal connecting socket 12.2 (Fig. 7a, Fig. 7b).

Within the distal and proximal catheters 8.1, 8.2 a distal and proximal waveguard 13.1 and 13.2 are positioned in the axial direction (Fig. 6).

The distal shock shield 13.1 extends in conveyor direction 5 from just before the distal connecting socket 12.1 to the distal end of the pump section 3.1.3 of the pump body 3.1, i.e. to the rotor 3.2.

The distal and proximal wave protection 13.1, 13.2 are connected to these in the two areas where they are located within the distal and proximal connecting sockets 12.1, 12.2 and the distal and proximal catheter section 8.1, 8.2 respectively.

The two connecting sockets 12.1, 12.2 together with the components arranged in them (wave cover, pump housing, catheter) form a storage area for the drive shaft 4.

Within the distal and proximal shaft shields 13.1, 13.2 and 3.1 respectively, the drive shaft 4 is positioned in the axial direction. The drive shaft 4 has three sections in the conveyor direction 5. A distal section of the drive shaft 4.1 in the shaft cap area 10. A pump section of the drive shaft 4.2 on which the rotor 3.2 is rotated and a proximal section of the drive shaft 4.3 extending from the pump section 3.1.3 to the coupling 9. The rotor 3.2. is interlaced with the drive shaft. However, other strong connections such as welding or clamping may also be provided.

The proximal wave shield 13.1 (Fig. 2, Fig. 6) separates the proximal section 4.3 of the drive shaft 4 from the pump medium to protect against blood damage by the rotational motion of the drive shaft 4 and attachment of blood components to the drive shaft 4. This does not create shear forces. There is no direct interaction between the drive shaft 4 and the blood through the very small gap and only minimal blood transport is possible through this gap. The displacement and proximal wave shield 13.1, 13.2 center and support the drive shaft 4 during operation and compression and expansion.

The drive shaft 4 may have a different number of ropes and wires and may have a smaller or larger diameter. The diameter of the drive shaft may be in the range of 0.3 mm to 1 mm and is preferably about 0.4 mm to 0.6 mm. The smaller the drive shaft diameter, the higher the speed, because the smaller the drive is, the faster the drive is moving, but the smaller the drive is, the more stable the drive is. A problem arises when the drive is moving in the direction of its rotation and the smaller the speed it is moving in.

In the opposite direction of the winding of the drive shaft 4 - in this example it is wrapped to the left - an opposite wrapped (here: right-turning) spiral guiding spiral 14 is arranged in an axial direction around the distal and proximal sections of the drive shaft 4.1, 4.3 in order to minimize friction of the drive shaft 4, to avoid wall impact of the drive shaft 4 with the proximal catheter 8.2 and to prevent the bending of the drive shaft 4 as a result of bending. The guide spiral 14 guides and stabilizes the drive shaft 4 (F. 14 and F. 10). The guide spiral 13 can be formed in an elliptical direction and can also be rotated with the direction of the guide shaft 13.2 and 13.2.

The drive shaft 4 extends from the distal end of the distal wave protection 13.1 in conveyor direction 5 behind the distal connecting plug 12.1 to coupling 9.

The proximal catheter piece 8.2 in conjunction with the guide coil 14 provides a longitudinal and torsional connection between pump head 3 and coupling 9.

At the proximal end of the distal shock shield 13.1 a bearing disc 15 is placed (Fig. 6). The bearing disc 15 is fitted with a through hole 15.1. The diameter of the through hole 15.1 is approximately the outer diameter of the drive shaft 4. The bearing disc 15 is placed on the drive shaft 4 in such a way that it accommodates the proximal end of the distal shock shield 13.1 and is bounded in the conveyor direction 5.

The bearing disc 15 is made of stainless steel, Teflon, ceramic or other suitable material, and is connected to the fixed wave protection by a cyanate adhesive, and can therefore absorb axial forces in the direction opposite to the conveyor 5 (binding agents and similar).

In the pump section 4.2 of drive shaft 4, the spiral expandable rotor 3.2 is fixed on the drive shaft 4. In the present embodiment, the rotor 3.2 is a two-wing, combed frame structure 3.2.1 made of nitinol or another shape-memory material, e.g. plastic (s.o.), coated with or surrounded by a PU skin (Fig. 11a).

The frame structure 3.2.1 has a circular, screw-shaped or spiral outer boundary frame 3.2.2 with several rotor blades with the boundary frame 3.2.2 and radially inward-curving 3.2.3 (Fig. 12).

The distal end of the rotor 3.2 is attached to the bearing disc 15 with a distal end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-end-

The rotor 3.2 can be either single-piece (Fig. 11b) or have multiple frame structures (Fig. 11a). One frame structure forms a rotor wing. In Fig. 11b and 12 a frame structure 3.2.1 is shown for a rotor 3.2 which forms two rotor wings. If necessary, several rotor wings and accordingly several frame structures 3.2.1 can also be arranged on a rotor 3.2.

The distance between two adjacent rings 3.2.4 is less than the corresponding section of the spiral boundary frame 3.2.2. The greater the difference between the distance between two rings 3.2.4 and the corresponding section of the spiral boundary frame 3.2.2, the greater the slope of the rotor. The length of the spacing sleeves 16 thus allows the slope of the rotor 3.2 to be determined. It can vary within a rotor 3.2.

The length or number of spacing sleeves 16 in relation to the dimension of the circular, spiral outer boundary frame 3.2.2 between two rotor strokes 3.2.3 determines the slope of the rotor 3.2.

The rotor 3.2 has a high form stability with flexible design and minimal material use (e.g. thin frame structure). Maximum stiffness and stability is achieved. Nevertheless, the combination of the frame structure with the tension, which further supports the properties of the frame structure by stabilization, allows for a very strong compression. This leads to the very good compressibility and expandability of the rotor.

The rotor 3.2 has, in the compressed state, approximately the internal diameter of the compressed pump housing 3.1.

In the expanded state, the spiral outer boundary frame 3.2.2 of the rotor 3.2 is slightly spaced to the inside surface of the pump housing 3.1. The distance between the outer boundary frame 3.2.2 and the inside surface of the pump housing 3.1 is approximately between 0.01 mm and 0.5 mm. The smaller the distance between the frame structure 3.2.1 and the inside surface of the pump housing 3.1, the higher the conveying power of the rotor 3.2.

At the distal end-shaft 16 of the rotor, the bearing disc 15 attached to the distal wave shield 13.1 and the distal end-shaft 16, both located on the drive shaft 4, touch each other. By rotating the rotor 3.2 through the drive shaft 4, the distal spacing shell 16 of the rotor 3.2 contacts the bearing disc 15 in a sort of sliding bearing. A distal rotor bearing 17 is thus formed (Fig. 6).

In the pumping process, the rotor 3.2 is subjected to an axial force against the direction of conveyance 5 due to the propulsion of the pumping medium, which is transmitted to the bearing disc 15 via the distal end spacer shell 16.

To lubricate the distal rotor bearing, blood or serum is drawn from the through hole 10.3 of the shaft cap 10, the spaces between the distal shock shield 13.1 and the drive shaft 4 and the spaces between the drive shaft and the bearing disc 15.

At the proximal end-gap 16 of the rotor 3.2, the drive shaft 4 is received by analogy from a proximal connecting plug 12.2.

At approximately the proximal end of the pump section 3.1.3 of the pump housing, a tubular elastic outlet tube 18 is arranged (Fig. 1, Fig. 13). The outlet tube 18 is made of PU. The outlet tube 18 has a length of about 70 mm, a diameter of about 10 mm and a wall thickness of about 0.01 mm to 0.1 mm and preferably about 0.03 mm. The two ends of the outlet tube 18 are conical in shape, with a cylindrical section arranged at the proximal conical end of the outlet tube.

The distal conical end of the outlet tube 18 closes tightly with the PU tension of the pump section 3.1.3 of the pump housing 3.1. The cylindrical proximal section is firmly connected to the proximal catheter section 8.2.

At the proximal end of the outflow tube 18, several outlet openings 18.1 are arranged radially around the outlet. The outlet openings 18.1 can be formed in the conveyor direction 5 oval. It can also be provided to form the outlet openings round, crescent shaped or in any geometry to generate other outflows. The outlet openings 18.1 swirl the blood exiting into the bulbus aorticus. This prevents a laminar flow and thus the water jet pumping effect against the coronary arteries.

The outflow tube 18 conducts the pump volume from the left ventricle through the aortic valve into the aorta. In this case, the outflow tube 18 acts as a reverse valve. At a positive pressure difference between outflow tube 18 and the aorta, the outflow tube 18 is more or less open according to the flow rate generated by the pump. At zero or negative pressure difference, outflow tube 18 closes due to its high flexibility just like the aortic valve and closes tightly to the proximal catheter section 8.2.

At the proximal end of catheter 8.2, the coupling 9 and motor 7 are located. The distance between the pump head 3 and the coupling 9 or the length of the proximal catheter 8.2 may vary depending on the patient and is approximately 90 to 150 cm.

The rotor expansion procedure 3.2 is described below.

Above the catheter device 1 is a tubular cover tube 29 designed to surround the compressed pump head 3 and the proximal catheter piece 8.2 and to keep the pump head 3 in its compressed state.

After correct positioning of the pump head 3, the cover tube 29 is withdrawn from the fixed catheter device 1 until the pump head 3 is free. Pump housing 3.1 and rotor 3.2 develop radially outwards due to the spring force of the elastic material. That is, the grid structure 3.1.6 of the pump housing 3.1 and the frame structure 3.2.1 of the rotor 3.2 expand on them until they reach their specified diameter.

To remove the catheter device 1, the cover tube 29 is pushed forward to the shaft cap 10, compressing the rotor 3.2 and the pump housing 3.1 and drawing them into the cover tube, which is then extracted through the puncture site.

The coupling 9 and the engine 7 are explained below.

The clutch 19 is a magnetic clutch (Fig. 14, Fig. 15). The clutch 9 has a clutch housing 19 with a distal magnetic unit 23.1. The clutch housing 19 is connected to the proximal catheter 8.2, which forms a continuous cavity. The clutch housing 19 hermetically separates the proximal catheter 8.2 from a motor arrangement 30. The motor arrangement 30 has a proximal magnetic unit 23.2. The proximal magnetic unit 23.2 is connected by force to the motor 7. The magnetic unit 23.1 is connected to the drive shaft 4 via a clutch 22 coupling.

The distal magnetic unit 23.1 and the proximal magnetic unit 23.2 are connected by magnetic forces, ensuring a force-closed connection between the two magnetic units 23.1, 23.2 and a contactless rotary force transmission.

The coupling housing 19 has a distal cylindrical section 19.1 from distal to proximal, a conical expansion section 19.2, a second cylindrical section 19.3 and a proximal cylindrical section 19.4.

In the distal cylindrical section 19.1, a central axial bore is formed, which extends through the entire clutch housing 19.

From the distal end of the distal cylindrical section 19.1, the passageway is narrowed in three steps from a first catheter shaft intake section 19.5 to a second guide coil intake section 19.6 and a third drive wave intake section 19.7.

The bore diameter of the catheter shaft intake section 19.5 is approximately 1.9 mm, that of the guide coil intake section 19.6 approximately 1.28 mm and that of the third bore section approximately 1.0 mm.

The proximal end of the proximal catheter is located in the catheter shaft intake section 19.5 of the coupling housing 19 and is firmly connected to it.

The drive shaft 4 extends through the through bore of the drive shaft through section 19.7 of the distal cylindrical section 19.1 and the conically expanding section 19.1, 19.2.

The fourth bore section passes into a hollow cylindrical storage section 19.9 at the beginning of the second cylindrical section 19.9. In the distal end of the storage section 19.9 an outer ring magnet 20.1 is located. The outer ring magnet 20.1 is fixed by a press fit in the bore of the storage section 19.9 and may be additionally or alternatively fixed by an adhesive.

The storage compartment 19.9 has a diameter of approximately 10 mm.

At the beginning of the proximal cylindrical section 19.4 of the clutch case 19, the bore of the storage section 19.9 passes into a larger sixth distal clutch section 19.10.

The flush bore is connected to a pump (not shown) for introducing a medium, e.g. NaCl, glucose solution, ring solution, plasma expander, etc.

The bore of the distal clutch section 19.10 passes into a larger proximal clutch section 19.11. In the section 19.12 formed between the distal and proximal clutch section 19.10, 19.11 radially symmetrical 8 x M 1.6 threaded bore 19.13 are formed. At the proximal end of the proximal section 19.4 are arranged three L-shaped grooves 19.14 distributed on the perimeter.

The distal coupling 19.10 has a diameter of approximately 22 mm, the sink 19.15 has a diameter of approximately 6.5 mm and the proximal coupling 19.11 has a diameter of approximately 30 mm.

The proximal end of drive shaft 4 is rotary, tensile and compressive (force-resistant) connected to a square shaped square rod 21 (Fig.17). In the axial direction, the square rod 21 has a 21.1 exception to accommodate the proximal end of drive shaft 4. The drive shaft 4 is fixed in the exception. The square rod 21 is formed, for example, of brass, which has good lubricating properties. All other suitable materials are extruded or spanning materials, such as PE, PP, PTFE, gold, silver, titanium, diamond, etc.

The square bar 21 has a length of approximately 19,4 mm and a cross-section of approximately 2,88 mm x 2,88 mm.

The square shaft 21 transmits the rotational motion of the motor to the drive shaft. The square shaft 21 can have any geometric shape that allows a statically determined force input.

The square rod 21 is taken up by an axial bore 22.1 within a rotationally symmetrical clutch element 22 which can be moved axially (Fig. 23). This enables it to compensate for length differences in the axial direction (Fig. 18).

The arrangement of the holes provides four axially running double contact edges. The exception 22.1 is located within a cylindrical section 22.2 of the coupling 22 and extends from the distal end of the coupling 22 to just before a disc-shaped proximal section 22.3 of the coupling 22.

The cylindrical section 22.2 has an outer diameter of approximately 8 mm and the disc-shaped section 22.3 has an outer diameter of approximately 18 mm.

The exception 22.1 is so designed that the square bar 21 is fixed radially or perimeterally and is raised axially by moving. The radial fixation of the square bar 21 is achieved by contacting all four longitudinal edges of the square bar 21 with one of the four double-sided edges of the exception 22.1.

The number of edges may be more or less; for example, instead of a square bar, a triangular or five-edged bar or a profile bar may be provided with a cross-sectional area which is uniform in any longitudinal direction of the bar.

At the distal outer end or circumference of the cylindrical section 22.2 of the coupling element 22 a section 22.4 is formed. On this section 22.4 a second inner ring magnet 20.2 is placed. Section 22.4 accommodates the ring magnet 20.2 in such a way that its outer surface closes in a finely closed manner with the shell of the cylindrical section 22.2. This, in conjunction with the outer ring magnets 20.1 in the storage section 19.9 of the coupling housing 19 correspondingly surrounding it, forms a magnetic ring bearing 20.3.

In the magnetic ring bearing 20.3, the two ring magnets 20.1, 20.2 are arranged in such a way that, for example, the north pole of the outer ring magnet is directed distally and the south pole proximal. The north and south poles of the inner ring magnet are opposite. Accordingly, the north and south poles of the two ring magnets can also be reversed. The magnetic ring bearing 20.3 centers the drive shaft 4 in an axial and radial direction.

In the magnetic ring bearing 20.3, the ring magnets 20.1, 20.2 do not touch, i.e. no lubrication is required.

At the proximal end of the coupling element, a magnetic recess 22.5 is formed in the disc-shaped section 22.3 of the magnetic coupling element 22.5 is a central circular milling.

The central circular mill 22.5 has a diameter of about 16.5 mm and a depth of about 3 mm.

The magnetic recorder 22.5 takes the four-segment ring-shaped distal magnetic unit 23.1.

The projection of the ball head 22.7 is formed in the centre of the proximal front side of the coupling 22.7 and the ball head 22.7 is a roughly semi-spherical exception 22.7.

The semi-spherical exception 22.7 has a diameter of approximately 0,5 to 1,3 mm.

The square bar 21 or cylindrical section of the coupling element 22 shall be absorbed by the fourth borehole section 19.8 or storage section 19.9 of the coupling housing 19 respectively.

The clutch housing 19 is hermetically separated from the engine arrangement by a fitting disc 24 (Fig. 19). The clutch housing 19 is gas and liquid-tight except for the 19.15 flush bore in the clutch housing 22 and the spaces between the drive shaft passage 19.7 and the drive shaft 4.

The coupling disc 24 is located on the 19.12 of the coupling housing 19 and is fixed by means of eight screws, which are connected by holes 24.1 located radially symmetrically in the coupling disc 24 and are screwed in the threaded holes 19.13 of the coupling housing 19. This connection is formed to be watertight and gastight. The coupling disc 24 is formed, for example, from polymethyl acrylate (PMMA) or another non-metallic material (such as peek, PEBAX, Teflon, PP, PE, any non-magnetic material that can be sprayed, extruded or spun).

The centre of the shutter has a central thickness of 24.2 on the distal side. In the centre of the shutter there is a borehole 24.3 and a central semi-spherical milling 24.4. In the cutter 24.3 a cylindrical centre pin 24.5 is fixed (Fig.21). On the centre pin 24.5 there is a spherical head 24.6 incorporated in the semi-spherical milling (Fig.15 and Fig.20).

The distal magnetic unit 23.1 is charged proximal to a force, which, in its opposite direction, produces a force which pushes the coupling 22 against the ball head 24.6 and which is adjusted so that the ball head 24.6 is securely secured, while maintaining minimal wear in the ball head bearing.

The ball head 24.6 in combination with the ball head bearing 22.7 of the coupling 22 in the distal position forms a ball head bearing 25. The ball head bearing 25 is a sliding bearing. However, other sliding bearing types are also possible, such as a ball head bearing or a cylinder head bearing, where a cone or cylinder is used instead of the ball. The bearing is adapted accordingly to the shape of the bearing.

The ball head bearing 25 shall, in conjunction with the magnetic ring bearing 20.3, provide axial centering and conduction of the coupling element 22 and the drive shaft 4 located in it within the coupling housing 19.

The axial centering of the magnetic ring bearing 20.3 is achieved by the fact that the inner ring magnet 20.2 is not exactly centered in the outer ring magnet 20.1 in the axial direction, but is slightly attached to the proximal.

To prevent blood and serum from being sucked through the spaces between the drive shaft 4 and the proximal rotor bearing 17.2 due to the rotational motion of the drive shaft 4 and blood from clotting and/or sticking to the drive shaft 4, a flushing medium is introduced through the flush bore in the clutch housing to create a counterpressure to the sucked or pressurized blood stream, lubricating the ball head bearing. 3-20% Glucose solution;5-40% Dextran solution with a molar mass of 5000 to 65,000, in particular 10% Dextran solution MM 40,000 in 0,9% NaCl;Ringer solution: a mixed electrolyte solution with K, Na, Mg;other physiological electrolyte solutions.

The engine layout comprises the proximal magnetic unit 23.2, a proximal magnetic intake 26, a clutch flange 27, an engine intake 7.1, with a cooling fan attached to it and the engine 7 (Fig. 14, Fig. 22).

On the proximal side of the shutter 24 a proximal magnetic unit 23.2 is placed at a distance of about 0.5 to 8 mm and preferably about 1 to 2 mm, axially moving away from the distal magnetic unit 23.1.

The magnetic recorder 26 is disc-shaped and has a central circular groove 26.1 on its distal side. In groove 26.1 four magnetic segments are glued by means of two-component epoxy resin or cyanacrylate adhesives (s.a.) in analogy with the distal magnetic unit 23.1.

The four segments of the distal and proximal magnetic unit 23.1, 23.2 can be formed as curved rod magnets, each having a different polarity at its endpoints. The four segments can also be formed as four quarters of a curved ring magnet. The segments can also be formed as short, axially aligned rod magnets, arranged in a ring shape.

The four segments are arranged four times alternately with their north and south poles, so that the segments of a magnetic unit attract each other. The distal and proximal magnetic units 23.1, 23.2 are arranged so that each complementary pole is arranged opposite to the other.

The central circular mill 26.1 has a diameter of about 16.5 mm and a depth of about 3 mm.

The magnetic socket 26 is connected to a motor shaft 7.2 of the motor 7. The magnetic socket 26 is rotatable within a correspondingly shaped gap in the clutch flange 27 of the motor socket. Three passing pins 27.1 are arranged equally spaced along the outer circumference of the ring-shaped ledge of the socket.

The L-shaped grooves 19.14 of the clutch case 19 connect the clutch case 19 to the pass pins 27.1 of the clutch flange 27 of the engine regulations.

The coupling flange 27 is mounted on a distal front face 7.1.1 of the engine compartment, maintaining axial symmetry.

The motor intake 7.1 has a central borehole 7.1.4 in the axial direction. Through this borehole 7.1.4 the motor shaft 7.2 is conducted. Furthermore, an axially escaping exception 7.1.5 is provided in which the motor 7 is located.

A cooling fan shall be located on a side area 7.1.2 of the square engine compartment 7.1.

A cover tube 29 is placed above the pump head 3 and a distal area of the proximal catheter piece. The cover tube 29 has an inner diameter corresponding to the outer diameter of the non-expanding pump housing in the area of the pump head 3.

The procedure for coupling with magnetic coupling 9 is described below.

The two magnetic units 23.1, 23.2 are separated from each other by the closing disc 24 in the clutch housing 19. The magnetic attraction forces between the two magnetic units 23.1, 23.2 create a force-closing connection.

The ball-head bearing 25 is formed by pressing the ball-head bearing 22.7 of the coupling element 22 onto the ball-head 24.6 of the shutter disc 24. The ball-head bearing centers the axial course of the drive shaft 4. The arrangement of the two ring magnets 20.1, 20.2 of the magnetic ring bearing 20.3 leads the inner ring magnet 20.1 radially, at a constant distance from the outer ring magnets 20.2. In this way the magnetic ring 20.3 is centred and, in conjunction with the ball-head bearing 25 the rotational symmetrical course of the ball-head bearing element 22 or the drive shaft 4 is directed, in order to prevent impact or displacement.

The force-operated connection between the magnetic units 23.1, 23.2 transmits the rotational motion from the engine 7 to the proximal magnetic unit 23.2 via the motor shaft 7.2 to the distal magnetic unit 23.1.

The motor shaft 7.2 rotates at a speed of about 20000 rpm to 40000 rpm and preferably about 32000 rpm to 35000 rpm, which are transferred to the drive shaft 4.

Err1:Expecting ',' delimiter: line 1 column 182 (char 181)

As soon as the rotor 3.2 blocks, twists or shortens, the drive shaft 4 increases in resistance at the distal magnetic unit 23.1. The magnetic fields between the proximal and distal magnetic unit 23.2, 23.1 do not completely overlap in operation, because the distal magnetic unit 23.1 of the proximal magnetic unit 23.2 always decreases slightly.

By moving the clutch 22 distally, the inner ring magnet 20.2 of the clutch 22 is also displaced distally and the north and south poles of the two ring magnets 20.1, 20.2 of the magnetic ring bearing 20.3 do not overlap but repel each other, thus keeping clutch 9 in a decoupled state and permanently disconnecting engine 7 and drive shaft 4.

The magnetic bearing 20.3 or the magnetic connection of the two magnetic units 23.1, 23.2 limits the amount of transmittable torque. Once the set torque is exceeded, the two magnetic units 23.1, 23.2 separate. The distal magnetic unit 23.1 can no longer catch up to the proximal magnetic unit 23.2 due to the rapid rotation, as the magnetic binding forces are no longer sufficient. This causes the north and south poles to overlap and the magnetic units 23.1, 23.2 to push apart. The connection of the magnetic units 23.1, 23.2 is separated and the maximum transmittable torque is limited. The magnetic units 23.1, 23.2 are detached from the 20.3 by the magnetic displacement of the 20.2 magnetic bearing, which is held in the ring.

This condition can be reversed by applying an external magnetic field, and by a magnet passed from distal to proximal to the clutch housing 19, the two magnetic units 23.1, 23.2 can be brought back to their original coupled position.

According to the invention, the clutch case 19 and the motor control 30 are spacially separated from each other, which makes it possible to lubricate the drive shaft 4 through the pump located at the 19.15 flush bore at a rate of approximately 5-10 ml/h despite the high speed to minimize friction.

The small diameter of the drive shaft is advantageous at high speeds of about 32000 rpm. Larger diameters would cause the perimeter speed to be too high and could cause damage to the drive shaft 4 or its adjacent components due to friction.

The spatial separation by the shutter 24 makes it possible to lubricate or seal the drive shaft 4 and no known bearing through which a shaft has passed would be able to keep a tight seal and allow a smooth running at this size and speed.

The position of the ball head fender 25 (slip bearing), the magnetic ring bearing 20.3 (contactless, damping and centrifugal) and the axial gliding bearing between drive shaft 4 and clutch housing 19 gives three stabilization points. This allows the drive shaft 4 to transmit torque even when the axial length changes (extension and shortening). This longitudinal tightening occurs, for example, when the pump head 3 is compressed. The rotor 3.2 is compressed to fuse the drive shaft and is fixed in the housing. The pump tension 3.1 is extended axially. The pump acceleration moves so far away from the axial length (extension and shortening) that it cannot be separated from the flow rate of the catalytic converter.

The catheter head 3 is located in the left ventricle of the heart, so that the outflow tube 18 is located approximately in the middle of the passage from the aorta to the heart, i.e. in the area of the heart valve. The catheter device 1 is preferably designed to display a specific pump pressure in the range of about 100 mm Hg to 150 mm Hg. If the heart lies in systole, the catheter device pumps blood when the pressure from the heart is less than the pump pressure.

Figure 24 shows the positioned catheter device 1 for left-heart support. The pump head 3 is located entirely in the left ventricle. The outflow tube extends through the heart valve.

The catheter tube 1 is inserted through the catheter tube using compressed and cooled pump housing 19 and rotor 3.2 until the catheter tube 1 has reached the • left heart chamber with the pump head 3. The unwinding is carried out by pulling the catheter tube 29 back on the fixed catheter tube 8 until the tip of the catheter tube 29 has released the pump head 3.

To remove the system, the cover tube 29 is pushed forward to the shaft cap 10, bringing the rotor 3.2 and pump housing 3.1 compressed into the cover tube 29 and then extracting it through the puncture site.

In another embodiment of the present invention, a pump medium is designed to be pumped from proximal to distal, i.e. opposite the original conveyor direction 5 (Fig. 25 II). To load the rotor 3.2 in the axial direction and to absorb the load forces, the bearing disc 15 is placed on the proximal side of the rotor 3.2. The conveyor direction to distal can be achieved either by reversing the direction of rotation in relation to the above embodiment or by reversing the slope of the rotor 3.2. The outflow hose 18 is located at the distal end of the pump section 19 of the pump unit and extends in a distal direction beyond the pump head. To stiffen the outflow hose 18 the outflow hose 10 can be shaped into a structure similar to a slit over the end of the pump.

During operation, the pump medium flows through the inlet outlet of the pump housing into the pump housing and through the inlet outlet of the pump housing into the outlet tube 18. The pump medium exits the catheter device 1 through the distal end of the outlet tube.

The example described above may be for use in the right ventricle, for example.

In another embodiment, the catheter device of the invention may also be designed to allow a pump from distal to proximal and from proximal to distal (Fig. 25 III).

In this example, bearing discs 15 are provided at the distal and proximal ends of the rotor 3.2; the outlet tube 18 is located at the distal end of the pump section 3.1.3 of the pump body 3.1 and extends in the distal direction; the outlet tube 18 has a grid structure for stiffening, e.g. similar to the pump body; the grid structure is stretched with a PU skin; the diameter of the outlet tube is approximately the same as that of the expanded pump body.

In operation, a pump medium can enter or exit through the outlet openings of the pump housing. The pump medium then enters the outlet hose through the outlet openings of the pump housing and the inlet openings of the pump housing and exits at the distal end of the outlet hose. In reverse pumping, the flow of the catheter device is inversely proportional. This means that the pump medium enters the outlet hose at the distal end of the outlet hose and through the inlet pressure of the pump housing to the outlet holes of the pump housing. Thus, through the so-called stack-stacked and distilled outlet stream, a flow of 18 or more per litre is possible.

The example described above can be used for drainage or for filling cavities.

The reversal of the conveyor direction can be achieved by reversing the rotor direction and reversing the rotor inclination.

The invention is described above by an example of an embodiment in which the magnetic units each have four curved rod magnets, each with opposite poles placed on top of each other. The magnetic units may also be so designed that the north and south poles of the magnetic units are oriented in an axial direction, with the poles arranged at the axis to distal or proximal points. The magnets are arranged in a ring shape according to the previous examples.

This alignment of the north and south poles of the magnets causes the two magnetic units to attract each other with higher magnetic forces, which makes it possible to transmit higher torque through the clutch.

Such a clutch can be used, for example, to drive a milling head instead of a rotor, and can be used to grind kidney stones or bones minimally.

The number of magnets can be varied as desired.

The radial compressibility of the components allows the realization of a small puncture diameter acceptable for percutaneous implantation in Seldinger technique, due to the very small diameter of the catheter device of about 3 mm. Nevertheless, by expanding the rotor to a diameter of about 15 mm, very high conveying power can be achieved.

The state of the art has shown that expandable catheter pumps (e.g. US 4 753 221) have a propeller with several rigid pump wings. These are rotatable.

The rotor according to WO 99/44651 has an elastic band to connect the ends of a nitinol spindle to a rotation axis. This elastic connection does not center the spindle perfectly.

The rotor frame structure with boundary frames and rotor strokes according to the catheter device 1 makes the rotor more stable, foldable and expandable to almost any large diameter. By allowing almost any length of rotor formation in the longitudinal direction, the radial extension of the rotor is freely selectable. Thus, any very high conveying power can be achieved and it is possible to individually adjust the conveying power for each application.

The rotor can be formed with one or more rotor blades, each of which has a quarter, half, whole or any number of revolutions around the drive shaft. This means that the rotor is variable in size, shape and inclination and can therefore be used for a wide variety of applications.

The following paragraphs, numbered and inter-referenced where appropriate, describe preferred embodiments: 1. catheter device, including a motor located at the proximal end (6) of the catheter device (1), a drive shaft extending from the proximal end of the catheter device (1) to the distal end (4) to drive a rotating component located at the distal end of the catheter device (1), characterised by: Other that the drive shaft (4) at the proximal end (6) of the catheter device (1) is connected to the motor by a coupling (9) and the coupling (9) is a magnetic coupling with a proximal and a distal magnetic unit (23.1, 23.2), the proximal magnetic unit (23.2) being connected to the motor (7) and the distal magnetic unit (23.3).1) connected to the drive shaft (4) Other and the distal magnetic unit (23.1) is housed in a clutch housing (19) and separated from the proximal magnetic unit (23.2) by a wall (24).2, Catheter device referred to in paragraph 1, Other characterised by: Other that the distal magnetic unit (23.1) is fluid-tightly stored in the coupling housing (19) and a tubular catheter (8) extends from the proximal end to the distal end of the catheter device (1), the catheter (8) being connected to the fluid-tightness of its proximal end to the coupling housing (19). Other characterised by: Other the rotating component is a milling machine or other tool.4. Catheter device according to one of paragraphs 1 or 2;Other Other characterised by: Other the rotating element is a rotor (3.2).5. Catheter device according to paragraphs 1 to 4, Other characterised by: Other the coupling housing (19) has a flush hole (19.15) to connect a pump to introduce a flush medium into the coupling housing (19) and the catheter (8);6. Catheter device according to one of the paragraphs 1 to 5; Other characterised by: Other the distal and proximal magnetic units (23.1, 23.2) are firmly connected in contactless torque transmission.7. Catheter device according to one of paragraphs 1 to 6, Other characterised by: Other the drive shaft (4) is securely attached at its proximal end to a profile bar (21) within the coupling housing (19) and the profile bar (21) is axially displacement but rotationally secured in an exception (22.(1) a coupling element (22) located within the coupling housing (19) is incorporated. Other characterised by: Other that the coupling element (22) is stored via a sliding bearing (25) in the coupling housing (22) in a rotatable manner.9. Catheter device referred to in paragraph 8, Other characterised by: Other the sliding bearing is a ball-head bearing (25) or a cone-head bearing or a cylinder-head bearing.10. Catheter device referred to in paragraph 8 or 9; Other characterised by: Other that the sliding bearing (25) is formed axially in the centre between the proximal end of the coupling element (22) and the inner proximal end of the coupling housing (19).11. Catheter device according to paragraphs 1 to 10, Other characterised by: Other that the coupling element (22) is stored in the coupling housing (22) via a magnetic ring bearing (20.3).12. Catheter device referred to in paragraph 11;Other Other characterised by: Other the magnetic ring bearing (25) has an inner and an outer ring magnet (20.1, 20.2), the outer ring magnet (20.1) enclosing the inner ring magnet (20.2). Other characterised by: Other the outer ring magnet (20.1) is located in the coupling housing (22).14 Catheter device referred to in paragraph 12 or 13; Other characterised by: Other the inner ring magnet (20.2) is located on the coupling element (22).15 Catheter device according to one of paragraphs 1 to 14 Other Other characterised by the proximal and distal magnetic unit (23.1, 23.2) being composed of several circularly arranged curved magnets, each having a different polarity at its end points.16. Catheter device referred to in paragraph 15, Other characterised by: Other The magnetic field is measured at a constant speed of approximately 1 kN.1, 23.2) four ring-segment magnets are placed together to form a closed ring.17. Catheter device referred to in paragraph 15 or 16, Other characterised by: Other the magnets are formed as rod magnets (23.1, 23.2).18 Catheter device according to paragraph 15 or 16; Other characterised by: Other the curved magnets (23.1, 23.2) are magnetised in the axial direction so that the poles are arranged on the axial to distal and proximal points respectively.19. Catheter device according to one of paragraphs 4 to 18, Other characterised by: Other that the rotor (3.2) has a frame structure consisting of a screw-like boundary frame (3.2.2) and radially extending inwards from the boundary frame (3.2.2) and the rotor struts (3.2.3) with their outer edges from the boundary frame (3.2.3);2.2) are attached at distant ends to the drive shaft (4) and an elastic tension is applied between the limiting frame (3.2.2) and the drive shaft (4), the frame being constructed from an elastic material such that the rotor unfolds independently after being subjected to compression. Other characterised by: Other that the frame structure (3.2.1) of the rotor (3.2) is formed of a shape memory material.21. Catheter device according to one of paragraphs 4 to 20, Other characterised by: Other a pump body is provided surrounding the rotor (3.2) with a tubular pump section (3.1.3), the pump body (3.1) being formed by a lattice whose openings are closed by an elastic tension at least in the area of the pump section (3.1.3).22. Catheter device referred to in paragraph 21, Other characterised by: Other the pump housing lattice (3.1) is formed of a shape memory material.23. Catheter device according to one of paragraphs 1 to 22, Other characterised by: Other the drive shaft (4) is formed by several wires, in particular six wires, arranged around a core, either to the left or to the right.24. Catheter device according to one of paragraphs 1 to 23, Other characterised by: Other the drive shaft (4) has an external diameter of approximately 0,3 to 1,0 mm and preferably approximately 0,4 to 0,6 mm.25. Catheter device as defined in paragraph 23 or 24, Other characterised by: Other a directional guide spiral (14) opposite to the driving shaft (4) is arranged.26. Catheter device referred to in paragraph 25; Other characterised by: Other the drive shaft (4) and the guide spiral (14) are surrounded by the catheter (8).Catheter device referred to in paragraphs 1 to 26, Other characterised by: Other that the catheter (8) is formed as a tube of PU.28. Method of operation of a catheter device formed in accordance with one of the following paragraphs 1 to 27: Other characterised by: Other that a flush medium is pumped from the proximal end of the catheter device (1) through the coupling housing (19) and the catheter tube (8) to the distal end of the catheter device (1).29 Procedure in paragraph 28, Other characterised by: Other the rinsing medium is a solution of glucose, dextran and/or electrolyte.30. Method for operating a catheter device designed in accordance with paragraphs 1 to 27, Other characterised by: Other that the catheter device drive shaft is at a speed of 20,000 rpm to .40,000 rpm and preferably about 32.The speed of the engine is between 1 000 and 35 000 rpm.

Other preferred embodiments are listed in paragraphs A to J below: (a) catheter equipment, a motor located at the proximal end (6) of the catheter device (1), a drive shaft extending from the proximal end of the catheter device (1) to the distal end (4) to drive a rotating element located at the distal end of the catheter device (1), Other characterised by: Other a proximal end of the drive shaft (4) is connected to the motor (7) by a rotary and axially displacement device. (B) Catheter device as defined in paragraph A; Other The Commission has not yet adopted a decision. Other The proximal end of the drive shaft (4) is connected to the engine (7) by means of a profile bar (21) located in an exception (22.1), the profile bar (21) being stored in the exception (22.1).(c) catheter device referred to in paragraph (A) or (B); Other characterised by: Other the drive shaft (4) is connected to the engine (7) by means of a coupling (9) and the coupling (9) has a coupling housing (19), with the exception (22.1) formed within the coupling housing (19).D) Catheter device as defined in paragraph B or C; Other characterised by: Other the profile rod (21) has a uniform longitudinal cross-section. (E) Catheter device as defined in paragraph B or C, Other characterised by: Other that the profile rod (21) is a three-, four- or five-edged rod.F) Catheter device as defined in paragraphs B to E, Other characterised by: Other that the exception (22.1) has four double-sided edges running axially, formed by (the arrangement of) holes.Other Other characterised by: Other that the exception (22.1) is formed within a rotationally symmetrical coupling element (22).H) Catheter device according to one of paragraphs C to G, Other characterised by: Other the coupling housing (19) has a flush hole (19.15) to connect a pump to introduce a flush medium into the coupling housing (19) and the catheter (8); Other characterised by: Other that the coupling (9) is a magnetic coupling with a proximal and a distal magnetic unit (23.1, 23.2), where the proximal magnetic unit (23.2) is connected to the engine (7) and the distal magnetic unit (23.1) is connected to the drive shaft (4), and the distal magnetic unit (23.1) is housed in a coupling housing (19) and separated from the proximal magnetic unit (23.3).(j) catheter devices in accordance with one of paragraphs C to I; Other characterised by: Other The distal magnetic unit (23.1) is fluid-tightly stored in the coupling housing (19) and a tubular catheter (8) extends from the proximal end to the distal end of the catheter device (1), the catheter (8) being connected to the coupling housing (19) by its proximal fluid-tight end.

List of reference marks

1Cathedral device2Distal end3Pump headf3.1.Pump housing3.1.1.Distal connection section3.1.2.Inlet section3.1.3.Pump section3.1.4.Delivery section3.1.5.Proximal connection section3.1.6.Grid structure3.1.7.Openings3.1.7.1Small roughness3.1.7.2Large roughness3.1.7.3Medium roughness3.1.8PU Voltage from the pump housing3.2.Rotor 3.2.1.Frame structure3.2.2.Limited connection section3.2.3.Rotor power storage 3.2.4.Rotor power distribution section4.Driver wave transmission section4.1.Driver wave transmission section4.1.Driver wave transmission section14.1.Driver wave transmission section14.1.Driver wave transmission section14.Driver wave transmission section14.Driver wave transmission section15.1.Driver wave transmission section15.1.12.1.Driver wave transmission section15.1.12.1.1.1.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.2.

Claims (17)

1. a width of not more than 50 mm, Other

   - a self-extending pump head (3),

   - a drive shaft (4) and

   - a magnetic unit (23.1) of a magnetic coupling (9);

   Other wherein Other

   - the pump head (3) is located at a distal end (2) of the catheter device (1),

   - the pump head (3) has a self-extending pump housing (3.1),

   - incorporating a self-extending rotor (3.2) in the pump housing (3.1),

   - the drive shaft (4) extends from a proximal end (6) of the catheter device (1) to the distal end (2) of the catheter device (1),

   - the drive shaft (4) for propelling the rotor (3.2) is connected to the rotor (3.2) at the distal end (2) of the catheter device (1) and to the magnetic unit (23.1) of the magnetic coupling (9) at the proximal end (6) of the catheter device (1),

   - the magnetic unit (23.1) for propulsion of the rotor (3.2) can be coupled to another magnetic unit (23.2) of the magnetic clutch (9), the other magnetic unit (23.2) of the magnetic clutch (9) being connected to a motor (7),

   - the magnetic unit (23.1) is housed in a clutch housing (19) and is separated from the other magnetic unit (23.2) by a wall (24), and

   - the torque transmitted by the magnetic coupling (9) through the two magnetic units (23.1, 23.2) of the magnetic coupling (9) is limited to a set value.
2. Catheter device according to claim 1, wherein Other

   - the magnetic unit (23.1) for the propulsion of the rotor (3.2) can be coupled without contact with the other magnetic unit (23.2) of the magnetic coupling (9),

   Other and/or Other

   - a torque which, when the catheter device is operated, can be applied by the motor (7) to the further magnetic unit (23.2) of the magnetic coupling (9) is greater than the torque which can be transmitted contactlessly by the magnetic coupling (9).
3. Catheter device according to claim 1 or 2, wherein: Other

   - the magnetic coupling (9) is so designed that the two magnetic units (23.1, 23.2) separate when the transmitted torque is exceeded,

   Other and/or Other

   - the magnetic coupling (9) is so designed that the two magnetic units (23.1, 23.2) separate when the rotor (3.2) is locked.
4. Catheter device according to one of the claims 1 to 3, where: Other

   - the magnetic units (23.1, 23.2) are so formed and the magnetic unit (23.1) so stored that the magnetic unit (23.1) is displaced to the distal side when the transmittable torque is exceeded by magnetic repulsion between the magnetic units (23.1, 23.2).
5. Catheter device according to any of claims 1 to 4, where: Other

   - the torque transmitted by the magnetic coupling (9) is set over a distance between the two magnetic units (23.1, 23.2) of the magnetic coupling (9).
6. Catheter device according to claim 5, wherein Other

   - the distance between the two magnetic units (23.1, 23.2) of the magnetic coupling (9) is set by means of a bearing (25) of a coupling element (22) of the magnetic coupling (9), whereby

   - the coupling element (22) supports the magnetic unit (23.1).
7. Catheter device according to any of claims 1 to 6, where: Other

   - the magnetic unit (23.1) is supported by a coupling element (22),

   - the coupling element is contained in a bearing in the coupling housing, and

   - the two magnetic units (23.1, 23.2) of the magnetic coupling (9) each have a rotational axis, the rotational axes of the two magnetic units (23.1, 23.2) of the magnetic coupling (9) being centred on each other over the bearing (25);
8. Catheter device according to claim 7, wherein Other

   - the magnetic unit (23.1) is incorporated by a coupling element (22) and the coupling element (22) is stored via a bearing (25) in the coupling housing (22) of the magnetic coupling (9) in a rotatable manner

   Other and/or Other

   - the magnetic unit (23.1) is absorbed by a coupling element (22) and a bearing (25) is formed between a proximal end of the coupling element (22) and an inner proximal end of the coupling housing (19), with a sliding surface of the bearing (25) at the coupling element (22) separated in particular by a wall (24) forming the proximal end of the coupling housing (19) in an axial direction of the coupling element (22).
9. Catheter device according to claim 8, wherein Other

   - the bearing is a sliding bearing (25) where one of the bearing bodies of the sliding bearing (25) is in particular spherical, conical or cylindrical,

   Other and/or Other

   - the bearing is a sliding bearing (25) where the sliding bearing (25) is in particular a ball bearing (25) or a cone bearing or a cylinder bearing.
10. Catheter device according to any of claims 1 to 9, where: Other

    - the additional magnetic unit connected to the engine (7) is a proximal magnetic unit (23.2), and

    - the magnetic unit connected to the drive shaft (4) is a distal magnetic unit (23.1).
11. Catheter device according to one of claims 1 to 10, where: Other

    - the magnetic unit (23.1) is fluid-tight in the clutch housing (19), and

    - a tube-shaped catheter (8) extending from the proximal end (6) to the distal end (2) of the catheter device (1),

    - the catheter (8) is connected to the clutch housing (19) by its proximal end,

    Other wherein Other

    - the clutch housing (19) has in particular a flush hole (19.15) for connecting a pump to introduce a flush medium into the clutch housing (19) and the catheter (8)
12. Catheter device according to any of claims 1 to 11, where: Other

    - the drive shaft (4) is securely fixed at its proximal end, in particular within the clutch housing (19) of the magnetic clutch (9), to a profile rod (21), and

    - the profile rod (21) is axially moveable but rotatable in an exception (22.1) of a coupling element (22) placed in particular within the clutch housing (19), where the clutch element (22) accommodates the magnetic unit (23.1).
13. Catheter device according to any of claims 1 to 12, where: Other

    - a coupling element (22) of the magnetic coupling (9) is attached to the magnetic unit (23.1) and

    - the coupling element (22) via a magnetic ring bearing (20.3) in which the coupling housing (22) of the magnetic coupling (9) is housed,

    Other wherein Other

    - the magnetic ring bearing (25) has in particular an inner and an outer ring magnet (20.1, 20.2), the outer ring magnet (20.1) enclosing the inner ring magnet (20.2),

    - the outer ring magnet (20.1) is located in particular in the clutch housing (22),

    - the inner ring magnet (20.2) is placed on the coupling element (22) in particular
14. Catheter device according to any of claims 1 to 13, where: Other

    - the magnetic units (23.1, 23.2) are each composed of several curved magnets arranged in a ring, each having a different polarity at its end points,

    Other wherein Other

    - as bending magnets of the magnetic units (23.1, 23.2) in particular four ring-segment magnets, which are placed together to form a closed ring,

    Other and/or Other

    - Magnets specially designed as rod magnets (23.1, 23.2) and/or

    - the curved magnets (23.1, 23.2) are magnetized in the axial direction in particular, so that the poles are arranged on the distal and proximal points in the axial direction.
15. Catheter device according to any of claims 1 to 14, where: Other

    - the pump housing (3.1) encloses the rotor (3.2) with a tubular pump section (3.1.3) and

    - the pump housing (3.1) consists of a lattice whose openings are closed by an elastic tension at least in the area of the pump section (3.1.3),

    Other wherein Other

    - the grille of the pump housing (3.1) is made of a shape-memory material in particular.
16. Catheter device according to any of claims 1 to 15, where: Other

    - the drive shaft (4) consists of several wires, in particular six wires, which are wound to the left or right and are arranged around a single core,

    Other and/or Other

    - the drive shaft (4) has an external diameter of about 0.3 mm to 1.0 mm, preferably of about 0.4 mm to 0.6 mm.

    Other and/or Other

    - a directional coil (14) is arranged opposite the drive shaft (4) and the drive shaft (4) and the guide shaft (14) are surrounded by a catheter (8) in particular.
17. Catheter device according to any of claims 1 to 16, where: Other

    - the catheter device's drive shaft is operated at a speed of between 20,000 and 40,000 rpm, preferably at a speed of about 32,000 to 35,000 rpm.