PUMP, IN PARTICULAR A BLOOD PUMP
20230270994 · 2023-08-31
Assignee
Inventors
Cpc classification
A61M60/237
HUMAN NECESSITIES
A61M60/808
HUMAN NECESSITIES
A61M60/825
HUMAN NECESSITIES
A61M2205/0238
HUMAN NECESSITIES
A61M60/13
HUMAN NECESSITIES
A61M60/414
HUMAN NECESSITIES
International classification
A61M60/414
HUMAN NECESSITIES
A61M60/825
HUMAN NECESSITIES
A61M60/13
HUMAN NECESSITIES
A61M60/808
HUMAN NECESSITIES
Abstract
The present invention relates to a pump, in particular a blood pump having a proximal and a distal end and a pump housing arranged therebetween, a driveshaft arranged in an interior of the pump housing along the longitudinal direction, a conveying element arranged on the driveshaft, and a cannula. Here, the pump housing, the shaft arrangement and the conveying element are coordinated with one another in such a way that these guarantee the best possible efficiency and longevity of the pump.
Claims
1. A pump, in particular a blood pump (1), having a proximal and a distal end and a pump housing (2; 20; 40; 80) arranged therebetween, a driveshaft (4; 21; 48; 71) arranged in an interior of the pump housing along a longitudinal direction, a conveying element (5; 22; 49; 73) arranged on the driveshaft, and a cannula (3; 30; 47), wherein the pump housing is formed in such a way that the pump housing can be transferred at least in part into the cannula under application of a force acting at the proximal end of the pump, and in doing so is transferred at least along a radial direction extending transversely to the longitudinal direction from an expandable state into a compressed state; and wherein the pump housing also has at least one portion which in the expanded state comprises structures (27; 46, 50; 82, 87) extending along the longitudinal axis helically around the longitudinal axis and wound in a first direction as considered from the proximal to the distal end of the pump; and wherein the conveying element comprises at least one foldable segment (22, 23; 54, 55; 76, 77), wherein the structures extending helically are formed in such a way that when the pump housing is transferred from the expanded into the compressed state a torque (31; 51) directed against the first direction acts on the foldable segment.
2. The pump according to claim 1, wherein the foldable segment of the conveying element is formed in such a way that the torque is directed in the same direction as a rotational direction (34; 59) of the conveying element for conveying a fluid from the distal to the proximal end of the pump.
3. The pump according to claim 1, wherein the foldable segment of the conveying element is formed in such a way that the torque is directed opposite to a conveying direction of the conveying element for conveying a fluid from the distal to the proximal end of the pump.
4. The pump according to one of the preceding claims, wherein an unfolding direction (33; 57) of the at least one foldable segment extends in the first direction during the unfolding.
5. The pump according to one of claims 1 to 3, wherein an unfolding direction of the at least one foldable segment extends in a direction opposite to the first direction during the unfolding.
6. The pump according to one of the preceding claims, wherein the pump housing is produced from memory-shape material.
7. The pump according to one of the preceding claims, wherein the pump housing comprises a pump-receiving portion (41; 85) and a proximal portion (44; 84) arranged proximally of the pump-receiving portion, wherein an inner diameter of the proximal portion is reduced from a diameter of the pump-receiving portion in the expanded state of the pump housing towards a proximal end of the proximal portion.
8. The pump according to claim 7, wherein the helical structures are arranged in the proximal portion.
9. The pump according to claim 7, wherein the helical structures are arranged in the pump-receiving portion.
10. The pump according to one of claims 7 to 9, wherein the pump housing comprises a further, distal portion (42; 86) arranged distally of the pump-receiving portion, the inner diameter of said further, distal portion is preferably reduced from a diameter of the pump-receiving portion 1.n the expanded state of the pump housing towards a distal end of the distal portion.
11. The pump according to claim 10, wherein the helical structures are arranged in the distal portion.
12. The pump according to one of the preceding claims, wherein the driveshaft is pivoted at least in a region of a proximal end (45; 83) of the pump housing.
13. The pump according to claim 12, wherein the driveshaft is pivoted additionally in a region of a distal end (43; 87) of the pump housing.
14. The pump according to one of the preceding claims, wherein the helical structures comprise helical struts.
15. A pump, in particular a blood pump, having a proximal and a distal end and a pump housing arranged therebetween, a driveshaft arranged in an interior of the pump housing along a longitudinal direction, and a conveying element arranged on the driveshaft, wherein the conveying element comprises at least one flexible segment, which is formed in such a way that a rotational direction of the conveying element causes a fluid to be conveyed from the distal to the proximal end of the pump; and the pump housing is formed in such a way that the pump housing can be transferred at least in part into a cannula under application of a force acting at the proximal end of the pump, and in doing so is transferred at least along a radial direction extending transversely to the longitudinal direction from an expandable state into a compressed state; wherein an unfolding direction at least one flexible segment when the pump housing is transferred from the compressed into the expanded state is directed against the rotational direction.
16. A pump, in particular a blood pump, having a pump housing, a driveshaft arranged in an interior of the pump housing along a longitudinal axis, and a conveying element arranged on the driveshaft, wherein the pump housing comprises at least one pump-receiving portion and one proximal portion arranged proximally of the pump-receiving portion, and can be transferred in a radial direction extending transversely to the longitudinal direction from a compressed state into an expanded state; and wherein the driveshaft is pivoted in the region of the proximal end of the pump housing in a proximal bearing, wherein the driveshaft is configured in such a way that a bending resistance of the driveshaft in the region of the proximal portion of the pump housing and distally of the proximal bearing is coordinated with a bending resistance of the proximal portion, such that pump housing bends the conveying arranged substantially concentrically within the pump-receiving portion.
17. The pump according to claim 16, wherein the pump housing also comprises a distal portion arranged distally of the pump-receiving portion, wherein the driveshaft is pivoted in the region of the distal end of the pump housing in a distal bearing, and a bending resistance of the driveshaft in the region of the distal portion and proximally of the distal portion is coordinated with a bending resistance of the distal portion in such a way that when the pump housing bends the conveying element is arranged substantially concentrically within the pump-receiving portion.
18. The pump according to claim 16, wherein the bending resistance of the proximal portion is determined substantially by the bending resistance of helical struts extending along the longitudinal axis and/or the pump housing also comprises a distal portion arranged distally of the pump-receiving portion, wherein the driveshaft is pivoted in the region of the distal end of the pump housing in a distal bearing, and a bending resistance of the driveshaft in the region of the distal portion and proximally of the distal portion is coordinated with a bending resistance of the distal portion in such a way that when the pump housing bends the conveying element is arranged substantially concentrically within the pump-receiving portion and the bending resistance of the distal portion is determined substantially by the bending resistance of helical struts extending along the longitudinal axis.
19. The pump according to one of claims 16 to 18, wherein the driveshaft is a hollow shaft which in the region of the pump housing comprises a core.
20. The pump according to one of the preceding claims, wherein an “austentie finish” (A.sub.f) temperature of the pump housing lies below a temperature of 34° C., preferably below 30° C., and particularly preferably below 20° C.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0035] Further aspects will be explained on the basis of the following figures.
[0036] In the figures:
TABLE-US-00001 FIG. 1 shows a schematic overview of a pump arrangement; FIG. 2a to 2d show a variant of a pump housing with conveying element arranged therein on a driveshaft, which is pivoted merely proximally; FIG. 3a to 3d show a variant of a pump with a pump housing and a conveying element mounted on a driveshaft, wherein the driveshaft is pivoted distally and proximally; FIG. 4a and 4b show an exemplary embodiment of a corresponding bending resistance between pump housing and driveshaft; FIG. 5a and 5b show further embodiments of a pump housing and a driveshaft with corresponding bending resistances; FIG. 6a and 6b show embodiments of a driveshaft with core and rotor; FIG. 7a to 7c show embodiments of a pump housing; FIG. 8 shows an embodiment of a distal end of the pump housing with catheter attached therein; FIG. 9 shows an illustration of a pump arrangement with a coordinated combination of pump housing and driveshaft for harmonization of the bending line.
DETAILED DESCRIPTION
[0037] A schematic overview of a pump arrangement 1 is provided on the basis of
[0038] Various interactions between the housing, the driveshaft, the conveying element and the cannula will be explained on the basis of
[0039] The driveshaft 21 is arranged in the pump housing 20 with the conveying element 22 located on the driveshaft. In the present example the conveying element comprises two flexible segments 23 and 24, which are embodied as rotor blades. The pump housing 20 transfer from the expanded state into the compressed state by pulling the driveshaft in the pulling direction 25, which is parallel to the longitudinal direction 26 of the pump housing. A cross section is illustrated in
[0040] If the pump housing 20 is now drawn into the cannula 30 from the expanded state illustrated in
[0041] In the example illustrated here the subsequent rotational direction of the rotor is in the rotational direction 34, which is opposite to the unfolding direction. A further unfolding of the rotor at higher rotational. speeds can be provided as a result, inter alia. In other variants, however, it is possible to select the rotational direct ion to be consistent with the unfolding direction. A higher rotational speed here ca uses an easy folding of the rotor in the folding direction 32.
[0042] In the present example the driveshaft is made of a nickel-cobalt alloy, such as 35NLT® or MP35N®. The cannula is for example formed from a catheter made of a material known from the prior art, such as silicone or polyurethane. The pump housing may be fabricated for example from nitinol. Here, in the present example the A.sub.f temperature of the pump housing lies at approximately 15°, such that the A.sub.f temperature lies below room temperature. This has advantages in terms of the stability of the pump housing. In the following example the driveshaft is pivoted merely by a proximal bearing sleeve 35. With regard to the used materials for the rotor, the materials described in U.S. Ser. No. 13/261,565 can be used, for example.
[0043] In the example illustrated in
[0044] A variant of a combination of pump housing, conveying element and driveshaft is shown by way of example in
[0045] A difference between the embodiments of
[0046] A difference between the embodiments of
[0047] The pump housing 40 illustrated in F′IG. 3a comprises a pump-receiving portion 41, a portion 42 arranged distally of the pump-receiving portion, and a distal end portion 43 arranged distally of the distal portion. The pump housing also comprises a proximal portion 44 arranged proximally of the pump-receiving portion and an end portion 45 arranged proximally of the proximal portion. The pump housing 40 has, in the proximal portion 44 and the distal portion 42, helical struts 46, which are shown by way of example in
[0048] The embodiment shown in
[0049] The aspects of the corresponding bending resistance of the pump housing and of the shaft will be discussed on the basis of
[0050] A. pump arrangement corresponding to that of
[0051] In
[0052] The bending moment 38 (
[0053] The pump housing may optionally also comprise a proximal portion 202 having helical structures 27 in order to compensate for an effective bending moment and in order to facilitate the compression of the pump housing.
[0054] Further details of the various aspects of the invention will be discussed on the basis of
[0055] Here, the core 75 may produce an improved rigidity compared with other regions of the hollow driveshaft 71. Here, the core may have different rigidities from its distal to its proximal end, such that for example the bending resistance proximally and/or distally of the conveying element is reduced compared with the rigidity of the core in the region of the conveying element. The corresponding rigidity of the shaft in the region of the conveying element, however, may also be achieved by a corresponding design (or coordination) of the rotor hub.
[0056] Further details of a pump housing will be explained on the basis of
[0057] In their embodiment, the two angles are oppositely directed, as illustrated in
[0058] The distal end portion 88 of the pump housing 80 is illustrated on the basis of
[0059] In
[0060] In the region of the proximal end portion 111 there is disposed a proximal bearing/pivoting 112 of the driveshaft, which comprises both a radial bearing and an axial bearing. This bearing is explained in greater detail in the European patent application published as EP 2868289 A1 (having the internal file reference 137EP2457). That application is incorporated fully into this application.
[0061] Between the distal and proximal end portions of the pump housing 101 there are disposed the distal portion 112, the pump-receiving portion 113, and the proximal portion 114. Here, both the distal and the proximal portion have helical struts 115 and 116 respectively, which transition towards the pump-receiving portion into supporting struts 117 and 118 respectively. These supporting struts each split further into struts 119 of the pump-receiving portion. On the inner side of the pump-receiving portion there is located a plastics film 120, which is produced in an exemplary embodiment from a polyurethane. This film improves the conveying effect of the rotor 103.
[0062] The rotor 103 comprises two flexible rotor blades 130 and 131, which are fastened to a hub 132. In some exemplary embodiments the rotor is a single workpiece made of a plastic, such as polyurethane, for example biresin, or from a silicone or Pebax. For reasons of clarity, the rotor 103 is not shown in a longitudinal sectional illustration.
[0063] The rotor 103 is arranged on a driveshaft 102, which 1s formed as a hollow shaft. Reference is made to the application PMP Ref. 137EP 2457 with regard to further details. The hollow shaft is reinforced by a core 105 between the distal and proximal bearing/pivoting.
[0064] When coordinating the bending line of the pump housing with the bending line of the driveshaft, it should be ensured, in the event of a bending moment 140 (or 141 or 142) acting on the pump housing, that the rotor 103 remains substantially concentric in the pump-receiving portion 113, or that the rotor does not contact the inner face of the pump-receiving portion 113. As a first measure the bending resistance of the pump-receiving portion is more rigid in this exemplary embodiment than the bending resistance of the distal or proximal portion. For the sake of simplicity, the bending resistances of the distal and proximal portion are selected symmetrically in the shown exemplary embodiment. A possibility to influence the bending resistance in the pump-receiving portion 113 is constituted by the density and number of the struts 119 in relation to the considered diameter of the housing. In the present example the distal and proximal portions 112 and 114 respectively each have 10 helical struts, which transition into 20 supporting struts 117 and 118 respectively towards the pump-receiving portion. The supporting struts 117 and 118 split again into 40 struts 119, such that the number of struts in the pump-receiving region is greater here by a factor of 4. In other exemplary embodiments this factor may vary between 0.9 and 20. The bending resistance in the pump-receiving portion is 1.n this way greater than in the distal or proximal region.
[0065] A further possibility for matching (here: making softer) the bending resistances of the distal and proximal portion compared with the pump-receiving portion is constituted by the change of the geometric dimensions of the struts 115-119. In the present example the struts 115 and 116 are thicker by a factor of 2 to 3 than the struts 119. On account of the factor 4 in the ratio of the number of struts, the proximal and distal portion would otherwise be too soft in some exemplary embodiments if the struts 115-119 were of equal thickness.
[0066] A further possibility for matching the bending resistance in the region of the proximal and distal portions is constituted by the selection of the bending angle of the helical. struts.In the present example the helical struts wind by an angle of approximately 30° from the distal to the proximal end of the proximal or distal portion. However, the range may also lie in a range from 5° to 90°.
[0067] A further possibility is to vary the length of the proximal and distal portion. In a method for matching the bending resistance of the pump housing, the shaft arrangement is first measured, and the above-mentioned parameters of the different portions of the pump housing are then calculated, and a suitable pump housing is then produced.
[0068] The bending resistance of the driveshaft may be matched by the rigidity of the hollow shaft, of the core and of the rotor. Since the hollow shaft in some exemplary embodiments may be exposed to strong curvatures, for example in the aortic arch, the hollow shaft must have a bending resistance that allows a curvature of this type and at the same time has a strength so as to be able to operate for as long as possible at high rotational speeds. In some exemplary embodiments the bending resistance of the hollow shaft is therefore adapted primarily to the requirements of the hollow shaft between motor and bearing. However, the rigidity of the core may also be adapted in order to adapt the bending line of the driveshaft to the bending resistance of the pump housing between the proximal and distal bearing.
[0069] Furthermore, the material selection and geometry of the rotor 103 causes a stiffening of the driveshaft in the region of the pump-receiving portion 113, such that the driveshaft arrangement with rotor is softer in the region of the distal and proximal portion than in the region of the pump-receiving portion. Further adaptation possibilities will become clear to a person skilled in the art from the comments made here.
[0070] In a further exemplary embodiment the pump housing has a helical structure, which occurs as a result of a multiplicity of interconnected struts. Due to the selection of the connection point between two struts, although the struts extend at an incline upwardly or downwardly, a helical structure directed in one direction is produced. The bending resistance of this structure may be matched to the bending resistance of the driveshaft by changes to the thickness, number and length of the structure and by changes to the encompassed angle of the structure.
[0071] Further embodiments and variants of the invention will emerge from the combinations specified here and from the combinations apparent to a person skilled in the art.