Rotor for a pump, produced with a first elastic material
11702938 · 2023-07-18
Assignee
Inventors
Cpc classification
A61M60/122
HUMAN NECESSITIES
A61M60/237
HUMAN NECESSITIES
A61M60/808
HUMAN NECESSITIES
A61M60/226
HUMAN NECESSITIES
F01D5/02
MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
A61M60/13
HUMAN NECESSITIES
A61M60/414
HUMAN NECESSITIES
International classification
F04D29/18
MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
A61M60/122
HUMAN NECESSITIES
A61M60/13
HUMAN NECESSITIES
A61M60/226
HUMAN NECESSITIES
A61M60/237
HUMAN NECESSITIES
A61M60/808
HUMAN NECESSITIES
F01D5/02
MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
F04D29/02
MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
Abstract
A rotor for a pump has a housing and a rotor, and has at least one blade. The rotor is able to be actuated to rotate about an axis of rotation in order to convey a fluid in the axial or radial direction, and the rotor is able to be deformed in the radial direction between a first, radially compressed state and a second, radially expanded state. At a maximum speed of rotation of the rotor at which the power of the pump is at a maximum, the blade is essentially radially oriented, and/or the rotor has its maximum diameter.
Claims
1. A blood pump comprising: a helical rotor blade configured to be rotated to convey a fluid through the blood pump, the helical rotor blade having a compressed state, a deployed state, and an operational state, and wherein the helical rotor blade is radially expanded in the operational state; a housing surrounding the helical rotor blade, the housing including an expandable suction cage at a distal end of the housing and apertures at a proximal end of the housing, the apertures being proximal of the helical rotor blade; and a rotor hub to which the helical rotor blade is coupled, wherein the helical rotor blade is configured to expand from the deployed state to the operational state when rotated, such that the helical rotor blade has its maximum diameter in the operational state, wherein a plurality of helical rotor blades are spaced apart from each other and distributed axially over a length of the rotor hub, and wherein each of the plurality of helical rotor blades and the rotor hub are made of an elastic material, wherein the elastic material is selected from a foam polyurethane, a solid polyurethane, a thermoplastic elastomer, a rubber, a superelastic material, or superelastic polymer, and wherein the elastic material comprises a polyurethane based on a diisocyanate.
2. A blood pump comprising: a helical rotor blade configured to be rotated to convey a fluid through the blood pump, the helical rotor blade having a compressed state, a deployed state, and an operational state, and wherein the helical rotor blade is radially expanded in the operational state; a housing surrounding the helical rotor blade, the housing including an expandable suction cage at a distal end of the housing and apertures at a proximal end of the housing, the apertures being proximal of the helical rotor blade; and a rotor hub to which the helical rotor blade is coupled, wherein the helical rotor blade is configured to expand from the deployed state to the operational state when rotated, such that the helical rotor blade has its maximum diameter in the operational state, wherein a plurality of helical rotor blades are spaced apart from each other and distributed axially over a length of the rotor hub, and wherein each of the plurality of helical rotor blades and the rotor hub are made of an elastic material, wherein the elastic material is produced with a polyether polyol.
3. A blood pump comprising: a helical rotor blade configured to be rotated to convey a fluid through the blood pump, the helical rotor blade having a compressed state, a deployed state, and an operational state, and wherein the helical rotor blade is radially expanded in the operational state; a housing surrounding the helical rotor blade, the housing including an expandable suction cage at a distal end of the housing and apertures at a proximal end of the housing, the apertures being proximal of the helical rotor blade; and a rotor hub to which the helical rotor blade is coupled, wherein the helical rotor blade is configured to expand from the deployed state to the operational state when rotated, such that the helical rotor blade has its maximum diameter in the operational state, wherein a plurality of helical rotor blades are spaced apart from each other and distributed axially over a length of the rotor hub, and wherein each of the plurality of helical rotor blades and the rotor hub are made of an elastic material, wherein the elastic material is produced with an organically filled polyol selected from a graft-, SAN- or polymer polyol or a PHD polyol.
4. A blood pump comprising: a helical rotor blade configured to be rotated to convey a fluid through the blood pump, the helical rotor blade having a compressed state, a deployed state, and an operational state, and wherein the helical rotor blade is radially expanded in the operational state; a housing surrounding the helical rotor blade, the housing including an expandable suction cage at a distal end of the housing and apertures at a proximal end of the housing, the apertures being proximal of the helical rotor blade; and a rotor hub to which the helical rotor blade is coupled, wherein the helical rotor blade is configured to expand from the deployed state to the operational state when rotated, such that the helical rotor blade has its maximum diameter in the operational state, wherein a plurality of helical rotor blades are spaced apart from each other and distributed axially over a length of the rotor hub, and wherein each of the plurality of helical rotor blades and the rotor hub are made of an elastic material, wherein the elastic material is configured as a thermoplastic elastomer selected from a polyamide TPE, a copolyester TPE, a styrene TPE, a urethane TPE, or a thermoplastic elastomer with crosslinked rubber.
5. A blood pump comprising: a helical rotor blade configured to be rotated to convey a fluid through the blood pump, the helical rotor blade having a compressed state, a deployed state, and an operational state, and wherein the helical rotor blade is radially expanded in the operational state; a housing surrounding the helical rotor blade, the housing including an expandable suction cage at a distal end of the housing and apertures at a proximal end of the housing, the apertures being proximal of the helical rotor blade; and a rotor hub to which the helical rotor blade is coupled, wherein the helical rotor blade is configured to expand from the deployed state to the operational state when rotated, such that the helical rotor blade has its maximum diameter in the operational state, wherein a plurality of helical rotor blades are spaced apart from each other and distributed axially over a length of the rotor hub, and wherein each of the plurality of helical rotor blades and the rotor hub are made of an elastic material, wherein the elastic material is configured as a natural or synthetic rubber, wherein the natural or synthetic rubber is selected from R-rubber, M-rubber, O-rubber, Q-rubber, T-rubber, or D-rubber.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
(1) In the following, the invention is shown in a drawing and described subsequently with reference to an embodiment.
(2) There are thereby shown
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DETAILED DESCRIPTION OF THE INVENTION
(17)
(18) The pump 5 has a suction cage 8 on its front, distal side, through which, symbolised by the arrows 6, 7, blood is suctioned in. This is expelled through openings 9 at the proximal end of the pump or a discharge hose into the blood vessel 2. By means of the conveying function of the pump 5, this assists the heart pump activity or replaces it partially.
(19) In order that the pump 5 is expandable radially inside the ventricle 1 after transport through the blood vessel 2, both the rotor and the pump housing or the discharge hose are radially compressible and expandable in the illustrated example.
(20) These are illustrated in more detail in
(21) A suction cage 16 is disposed at the distal end of the housing 12. Blood is suctioned in through this. A so-called pigtail 19 which forms a spacer as a flexible continuation is disposed at the distal end of the pump 5 in order to prevent, in the suction operation or during transport, impact against heart walls or vascular walls or being suctioned against inner surfaces and in order to stabilise the position of the pump.
(22) The hub 14, 15 is connected to the flexible actuatable shaft 11 at the proximal end of the pump.
(23) A discharge hose 17 is drawn over the housing 12 of the pump, into which discharge hose the pump 5 pumps the blood and through which it can flow past the heart valve into the aorta or the blood vessel 2. It is expelled there through discharge openings 18 out of the discharge hose into the blood vessel.
(24) The rotor 13 is illustrated in more detail in
(25) The rotor is hence designed such that the occurring shear, tensile or pressure deformations take place inside the proportional range of Hooke's straight line. This can be achieved by suitable design and a correspondingly chosen operating point of the deformation.
(26) In
(27) In addition to the radially extending reinforcing fibres, reinforcing fibres which extend at right angles hereto can also be provided, which reinforcing fibres can also be woven with the first reinforcing fibres to form a flat woven material.
(28) Also reinforcing fibres 26 which are configured as woven material made of two groups of fibres extending perpendicularly to each other are illustrated by way of example on the blade 20, all the fibres extending at an angle of for example 45° relative to the axis of rotation 27.
(29) The reinforcing fibres 25, 26, can be configured for example as glass fibres or as polyamide fibres or carbon fibres. They are mixed in during production of the rotor either with the injection moulding material during the extrusion, in particular if short fibres are involved which need not necessarily be orientated or they are inserted into an injection moulding—or casting mould and extrusion-coated by means of a material. This material can be for example a polyurethane, a thermoplastic elastomer or a rubber.
(30) In
(31)
(32) The individual blades 29, 30, 31, 32 can consist respectively of the same elastomeric material and also be connected in one piece to the hub. They can be reinforced by means of a pulverulent, granulate or fibrous additive up to the desired rigidity.
(33) All the explanations in the present applications with respect to the angle α and β (see in particular patent claim 16 as originally filed and associated description) and also the “unwinding” or “gradient” of the blades are valid also for blade arrangements which, as for example in
(34) The material of the hub 28a can also be reinforced by inserting reinforcing fibres or other additives.
(35)
(36) In
(37) The second state (state A2) shows the unfolded/decompressed rotor which is still unloaded by fluid pressure. This state occurs for example if an intraventricular blood pump has been removed from the sheath after introduction into the human heart.
(38) The third state (A3) is the state in which the rotor moves. A rotation of the rotor in clockwork direction is hereby effected in
(39) The initial state is in turn B1, state B2 is produced after the unfolding, Conveyance of fluid is effected however here in anticlockwise direction so that rather the rotor is folded in radially again. This means that the unfolding force between states B1 and B2 must be so great that the fluid conveying operation does not cause the rotor to collapse such that the latter can no long operate properly.
(40) These geometric ratios are clarified once again in
(41) A compressed embodiment (first state “A1”, see also
(42) For comparison, once again the second state “A2” is shown in
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(48) It can hereby be seen that the hub of the rotor is essentially longitudinally stable. This is normal according to prior art, since the relatively solid hub shows essentially no lengthening/shortening due to application of the rotor blades.
(49) It should be noted that the “axial direction” mentioned below is the “x-direction” which is shown in
(50) However, it can be seen that, from the point, shown furthest left in the axial direction, of the blades 42/blade assembly/blade (in
(51) The above-described lengthening takes place, for example in the case of helically-shaped blades, also however in the case of blades disposed axially one behind the other. The effect is advantageous in particular also in the case of blades which have a gradient which changes over the rotor longitudinal axis since, as a result, local excessive strains are avoided.
(52) In
(53) In the sense of the present application, the angles α or β are determined as follows.
(54) As in particular can be seen from
(55) The same is true for the angle β which likewise is determined on the pressure side of the end edge; the corresponding tangent is applied to the initial region of this end edge, as shown in
(56) Generally, the mentioned tangents to the initial gradient will be skewed straight lines relative to the rotor central axis (represented in dot-dash lines in
(57) The rotor blade has a continuous surface, the gradient between the entry angle and the exit angle following the function of a specific function (just as the unwinding of the gradient of a normal thread follows a straight line, the unwinding of the gradient of the blade preferably follows a parabola).
(58) The parabola shape, in particular that of the quadratic parabola, has hereby proved advantageous, since the blood particles in contact with the rotor blade experience a constant uniform acceleration, which avoids acceleration peaks with correspondingly increased blood-damaging shear forces. In addition, the parabola shape leads to a blade which can be compressed readily in one direction, whereas it stabilises under flow pressure in the opposite direction.
(59) In the sense of the present application, there is therefore understood by a parabola shape not a quadratic parabola (y=ax.sup.2+bx+c) in the strict sense, but any shape which deviates from a straight line. Preferably this is a quadratic parabola (i.e. determinable by the term y=ax.sup.2+bx+c, wherein the parameter x in this term is not necessarily the same as the x-direction shown in
(60) For the individual blades, it applies however for the present application in every case that these should correspond in their “unwound” shape to such a non-straight shape. This applies in particular also for the case that a plurality of blades distributed over the length of the rotor is provided, i.e. not only the case, mainly observed in the Figures, of two blades which are oppositely situated distributed over the entire length of the rotor.
(61) In the case of a cylindrical hub, the above-mentioned “unwinding” is relatively simple. Here, as mentioned, the corresponding line is observed preferably starting from the centre of the course of the blade (in the boundary region to the cylindrical hub).
(62) This system applies slightly modified also for hub shapes which are not circular cylindrical, for example such as are shown in
(63) Firstly, a line is drawn or modelled at the height of the hub surface (i.e. of the transition region from hub to blade) in the centre of the blade. A conical or bale-shaped structure is hereby produced (for example with reference to
(64) Subsequently, the subjects of claims 16. ff. as originally filed, which represent patentable subjects per se, are explained once again in somewhat more detail. It hereby concerns firstly a rotor for a pump, having at least one blade, the rotor being able to be actuated to rotate about an axis of rotation in order to convey a fluid in the axial or radial direction, the rotor being deformable in the radial direction between a first, radially compressed state and a second, radially expanded state, and the blade having, in an operating state, an entry angle of the blade β and an exit angle of the blade α, the exit angle β deviating.
(65) This aspect is very important and actually surprising. In the case of the blood or another body fluid to be conveyed, it indeed concerns an essentially incompressible fluid. Nonetheless however, due to the different angles α and β, i.e. by a change in the gradient of the blade (in the case of a plurality of blades: the blade assembly), an acceleration should be effected. It has been shown in lengthy experiments that this has a less-damaging effect on the blood. It is particularly advantageous to adopt the values set here in a compressible rotor (which thus can be pressed together in the radial direction) since, in this manner, also the pressed-together total volume can possibly be kept lower and also the rigidity behaviour of the rotor is more favourable, which permits smaller forces during compression with still high rigidity in the expanded state.
(66) Advantageously, the blade has (either each individual blade or the one or two complete blades) a continuous surface. This means that here there are no “step-like” jumps.
(67) This is particularly the case if no carrier structure is provided, i.e. if the plastic material is made of a uniform rubber or plastic material, possibly with partially hardened regions, but made of the same initial material, but also if support structures, if there are any, are embedded in such a manner that the impeller blade is not substantially thinner between these support structures than in the region of the support structures. As a result, very smooth surfaces are possible, which once again further reduce damage to the blood.
(68) It is advantageous that, in a special embodiment, the angle α is greater than B. In such an embodiment the impeller blade is compressed very easily. When the rotor during compression is drawn into an enclosing sheath together with the pump housing or separately and, in being so drawn, is moved in x-direction (according to
(69) In specific areas of application or other embodiments it is advantageous that the angle α is smaller than the angle β. In such a design the impeller blade enters the fluid at an especially shallow angle so that minimized shear forces occur between rotor and fluid in this region. This causes especially slight damage to the blood in this region. Furthermore, such an embodiment is advantageous if the rotor during compression is inserted into a sheath, the rotor (with or without housing) thus moving against the x-direction (according to
(70) A further embodiment provides that the gradient of the blade follows a parabola shape. The interpretation of the term “parabola” was effected as further back both for circular cylindrical hub bodies and conical hub bodies or bale-shaped hub bodies. What is important is that here above all the unwound central line in the “foot region” of the blade, i.e. towards the hub, does not represent a straight line, but rather a curved shape, preferably any parabola of a higher order, for particular preference one which can be described with the term y=ax.sup.2+bx+c.
(71) It should of course be understood that these embodiments mentioned in claims 16 to 20 as originally filed can be combined with all the features of claims 1 to 15 as originally filed; in order to avoid repetition, explicit repetition of the wording is therefore avoided.
(72) The present application relates in addition to a pump comprising a housing and a rotor situated therein, the rotor having at least one blade, and the rotor being able to be actuated to rotate about an axis of rotation in order to convey a fluid in the axial or radial direction, the rotor being able to be deformed in the radial direction between a first, radially compressed state and a second, radially expanded state, and the blade being orientated essentially radially at the speed of rotation of the motor at which the power of the pump is at a maximum and/or the rotor at this speed of rotation having its maximum diameter.
(73) The underlying idea is that the pump is generally designed from a design point at which the pump power is at its greatest; this speed of rotation can be in the range between 10,000 rotations per minute and 50,000 rotations per minute. What is now important is that, at this maximum speed of rotation, also the radial projection of the rotor is at its highest; in this way, it can be ensured that no “scratching” of the rotor on the housing is possible, i.e. with a corresponding design of the housing, indeed a pump gap can be minimised, though damage to the housing or the rotor is precluded. It is hereby advantageous that the blade points in essentially radial direction if this speed of rotation is reached; with elastic rotors, therefore a corresponding pre-curving in the non-moving but expanded state can be provided, so that at the highest speed of rotation (and the corresponding fluid counter-pressure) the blade then points radially outwards relative to the rotor axis.
(74) The present application relates in addition to a pump according to one of the originally filed patent claims 1 to 25, there consequently being effected, between a radially compressed state and a radially expanded state of the rotor, a lengthening of the blade assembly, such that the maximum spacing between the most proximal point of the blade assembly and the most distal point of the blade assembly in the compressed state is at least 5%, preferably at least 10%, greater than the maximum spacing between the most proximal point of the blade assembly and the most distal point of the blade assembly in the expanded state.
(75) These points are shown once again in
(76)
(77) In the compressed state there is a different picture, see
(78) The rotors shown in
(79) Aspects of the invention are inter alia:
(80) 1. Rotor (13) for a pump, having at least one blade (19, 20, 22, 29, 30, 31, 32), the rotor being actuated to rotate about an axis of rotation (21) in order to convey a fluid in the axial or radial direction, and the rotor being able to be deformed reversibly elastically in the radial direction between a first, radially compressed state and a second, radially expanded state.
(81) 2. Rotor according to aspect 1, characterised in that the rotor consists at least partially of a first, elastic material in the form of a foam polyurethane, a solid polyurethane, a thermoplastic elastomer, a rubber or a superelastic material, in particular superelastic polymer.
(82) 3. Rotor according to aspect 2, characterised in that the first material comprises a polyurethane based on a diisocyanate.
(83) 4. Rotor according to aspect 3, characterised in that the first material is produced with a polyether polyol.
(84) 5. Rotor according to aspect 3 or 4, characterised in that the first material is produced with an organically filled polyol, in particular a graft-, SAN- or polymer polyol or a PHD polyol.
(85) 6. Rotor according to aspect 2, characterised in that the first material is configured as a thermoplastic elastomer, in particular as polyamide TPE, as copolyester TPE, as styrene TPE, as urethane TPE or as thermoplastic elastomer with crosslinked rubber or comprises such a material.
(86) 7. Rotor according to aspect 2, characterised in that the first material is configured as natural or synthetic rubber, in particular as R-rubber, as M-rubber, as O-rubber, as Q-rubber, as T-rubber or as U-rubber or comprises such a material.
(87) 8. Rotor according to aspect 2 or one of the following, characterised in that the first material comprises at least one additive which mechanically reinforces the first material.
(88) 9. Rotor according to aspect 2 or one of the following, characterised in that the first material comprises an additive which makes the material mechanically anisotropic.
(89) 10. Rotor according to aspect 2 or one of the following, characterised in that the first material, by the production method of the rotor, has anisotropic mechanical properties.
(90) 11. Rotor according to aspect 2 or one of the following, characterised in that the first material has reinforcing fibres, in particular glass fibres, carbon fibres, plastic material fibres or natural fibres.
(91) 12. Rotor according to aspect 11, characterised in that the fibres are orientated according to a preferential direction.
(92) 13. Rotor according to aspect 2 or one of the following, characterised in that the first material is filled with nanoparticles.
(93) 14. Rotor according to aspect 1, characterised in that the rotor adopts the second state without the effect of external forces.
(94) 15. Rotor according to aspect 14, characterised in that the rotor which is initially actuated to rotate in the second state adopts a third state under fluid loading.
(95) 16. Rotor according to aspect 15, characterised in that the rotor is configured such that, during standstill, it returns from the third state reversibly elastically into the second state.
(96) 17. Rotor according to aspect 14 or 15, characterised in that the latter is configured such that adoption of the first state from the second state and adoption of the third state from the second state are effected in the opposite direction.
(97) 18. Rotor according to aspect 15, characterised in that the rotor, starting from the initial second state during transfer into the first state, subsequently into the third state and finally back into the second state, has a permanent residual strain (ε.sub.H) of preferably less than 8%, particularly preferably less than 3%, very particularly preferred less than 1%. It is hereby assumed that the first state lasted for 0 hours to 12 hours and the third state lasted for 0 hours to 2,000 hours and the temperature was always between 1° C. and 50° C., preferably between 18° C. and 40° C.
(98) 19. Rotor according to one of the preceding aspects, characterised in that the rotor has at least one rotor blade, the rotor blade having a pressure side and a suction side and the pressure side having a monotonically convex cross-section.
(99) 20. Pump, in particular a blood pump, having a housing and a rotor according to one of the preceding aspects, characterised in that the interior of the housing is so large that the housing is not touched, in an expanded operating state even with maximum radial extension of the rotor, in particular with maximum deployment of conveyer elements, by the rotor, in particular not by a conveyor element.
(100) 21. Pump according to aspect 20, characterised in that the housing, in particular in the axial region in which the rotor has conveyor elements, delimits a cylindrical interior.
(101) 22. Intraventricular blood pump comprising a rotor according to one of the preceding aspects and also a sheath, this sheath being configured such that, during penetration of the rotor into the sheath, the rotor is compressed at least radially.
(102) 23. Method for providing an intraventricular blood pump according to aspect 22, characterised in that the sheath and rotor are provided initially unjoined and the rotor is introduced into the sheath only immediately before implantation in a human or animal body. The advantage: no settling of the materials, no adhesion of the rotor to the casing/sheath, function checking before implantation is possible, also, due to the short time, flow and hysteresis effects are minimised.
(103) 24. Rotor according to one of the aspects 1 to 23, characterised in that there is effected, between a radially compressed and a radially expanded state of the rotor, a lengthening of the blade assembly such that the maximum spacing between the most proximal point of the blade assembly and the most distal point of the blade assembly in the compressed state is at least 5%, preferably at least 10%, greater than the maximum spacing between the most proximal point of the blade assembly and the most distal point of the blade assembly in the expanded state.
(104) 25. Rotor according to one of the aspects 1 to 19, characterised in that at least one blade extends essentially over the length of the entire blading (blading assembly) or in that a plurality of blades which are distributed axially over the length of the blading/blade assembly is provided.