CANNULLA FOR INTRAVASCULAR BLOOD PUMP

Abstract

A method of manufacturing a cannula (4) for an intravascular blood pump comprises the steps of forming a first axial section (13) and a second axial section (15) of an elongate tubular body of the cannula (4) by dispensing a first liquid material and a second liquid material, respectively, onto a mandrel (7) by means of at least one dispenser (8). The mandrel (7) is rotated and the dispenser (8) moves relative to the mandrel (7) in an axial direction during dispensing of the liquid materials. The first and second axial sections (13, 15) are formed so as to have different bending stiffnesses. The first and second liquid materials are dispensed onto the mandrel (7) such that the first and second liquid materials blend into each other to form a smooth transition area (14).

Claims

1. A method of manufacturing a cannula for an intra vascular blood pump for percutaneous insertion into a patient's blood vessel, the cannula having an elongate tubular body with a blood flow inlet and a blood flow outlet, the method comprising the steps of: forming a first axial section of the elongate tubular body by dispensing a first liquid material onto a mandrel by means of at least one dispenser, while the mandrel and the dispenser move relative to each other in an axial direction and a circumferential direction of the mandrel, forming a second axial section of the elongate tubular body by dispensing a second liquid material onto the mandrel by means of the at least one dispenser, while the mandrel and the dispenser move relative to each other in an axial direction and a circumferential direction of the mandrel, wherein the first and second axial sections are formed so as to have different bending stiffnesses, and wherein the first and second liquid materials are dispensed onto the mandrel such that the first and second liquid materials blend into each other to form a transition area.

2. The method of claim 1, wherein the first and second liquid materials are dispensed onto the mandrel to form a first wall thickness of the first axial section and a second wall thickness of the second axial section, respectively, wherein the first wall thickness, when dried, is different from the second wall thickness, when dried, and the different bending stiffnesses result from the different wall thicknesses.

3. The method of claim 1, wherein the first and second liquid materials are different and the different bending stiffnesses result from the different materials.

4. The method of claim 1, wherein the mandrel is rotated about its longitudinal axis, preferably at a speed of about 10 to 15 rpm, preferably about 12 rpm.

5. The method of claim 1, wherein the dispenser is moved in an axial direction along the mandrel while dispensing the first and second liquid materials.

6. The method of claim 1, further comprising the step of forming a base layer that extends along the entire length of the cannula's body by dispensing a third liquid material onto the mandrel, wherein the base layer is preferably formed by dispensing a substantially uniform amount of the third liquid material with respect to the length of the mandrel, wherein the base layer preferably has a thickness of about 50 μm to 100 μm, when dried.

7. The method of claim 1, further comprising the step of forming a stiffening structure by dispensing a fourth liquid material in a helical path on the mandrel, wherein the first and second liquid materials are preferably dispensed both before and after dispensing the fourth material so as to embed the stiffening structure in the cannula's body.

8. The method of claim 1, wherein at least one of the first and second liquid materials comprises a solvent that evaporates after dispensing the first and second liquid materials, respectively, wherein the proportion of the solvent is at least 70 vol %, preferably at least 80 vol %, more preferably at least 90 vol %.

9. The method of claim 1, wherein at least one of the first and second axial sections is formed by dispensing at least five, preferably at least ten, up to twenty layers of the first and second liquid materials, respectively.

10. The method of claim 1, wherein the mandrel has a circumferential shoulder interconnecting two axially adjacent parts of the mandrel with different diameters, wherein the two axially adjacent parts of the mandrel are preferably separated from each other to remove the cannula from the mandrel.

11. The method of claim 1, further comprising the step of forming at least one marking arranged on the cannula's body, wherein the at least one marking is visually perceptible or radiopaque, wherein the at least one marking is preferably formed by dispensing a liquid material by means of the dispenser.

12. The method of claim 1, further comprising the step of forming a lumen extending in the wall of the cannula's body by embedding an elongate element in the wall of the cannula's body.

13. The method of claim 1, further comprising the step of forming at least one aperture in the cannula's body by dispensing a liquid material onto the mandrel, optionally without rotating the mandrel while dispensing said liquid material.

14. The method of claim 1, further comprising the step of attaching the cannula to a housing of a pumping device of an intravascular blood pump.

15. A cannula for an intra vascular blood pump, obtainable by the method of claim 1, the cannula having an elongate tubular body with a blood flow inlet and a blood flow outlet, the body comprising a first axial section comprising a first material and a second axial section comprising a second material, wherein the first and second axial sections have different bending stiffnesses, and wherein the first and second materials blend into each other in a transition area.

16. The cannula of claim 15, wherein the first axial section has a first wall thickness, and the second axial section has a second wall thickness, the first and second axial sections differing in at least one of the material and the wall thickness, wherein the different bending stiffnesses result from at least one of the differing materials and the differing wall thicknesses.

17. The cannula of claim 15, wherein the first and second materials are different and axially overlap in the transition area.

18. The cannula of claim 15, wherein the first axial section is a proximalmost section or a distalmost section of the cannula's body and has a greater bending stiffness than the second axial section or the rest of the elongate tubular body.

19. The cannula of claim 15, wherein the elongate tubular body comprises an embedded stiffening structure made of a plastic material.

20. The cannula of claim 15, wherein the elongate tubular body comprises a helical wire, preferably made of metal, more preferably made of Nitinol.

21. The cannula of claim 15, comprising at least one marking extending on or embedded in the elongate tubular body, wherein the at least one marking is visually perceptible or radiopaque.

22. The cannula of claim 15, wherein the elongate tubular body has a circumferential shoulder interconnecting two axially adjacent sections of the elongate tubular body with different diameters.

23. The cannula of claim 15, wherein the elongate tubular body comprises at least one lumen extending in a wall of the elongate tubular body.

24. The cannula of claim 15, wherein the elongate tubular body has a wall thickness in the range from about 50 μm to about 500 μm.

25. The cannula of claim 15, attached to a housing of a pumping device of an intravascular blood pump.

26. An intravascular blood pump for percutaneous insertion into a patient's blood vessel, comprising a cannula having an elongate tubular body with a blood flow inlet and a blood flow outlet, the body comprising a first axial section comprising a first material and a second axial section comprising a second material, wherein the first and second axial sections have different bending stiffnesses, and wherein the first and second materials blend into each other in a transition area.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0024] The foregoing summary, as well as the following detailed description of preferred embodiments, will be better understood when read in conjunction with the appended drawings. For the purpose of illustrating the present disclosure, reference is made to the drawings. The scope of the disclosure is not limited, however, to the specific embodiments disclosed in the drawings. In the drawings:

[0025] FIG. 1 shows a patient's heart with an intravascular blood pump inserted through the aorta into the left ventricle.

[0026] FIG. 2 shows an enlarged view of the interface between the cannula and the housing of the pumping device of an intravascular blood pump.

[0027] FIGS. 3a to 3d show steps of a method of manufacturing the cannula.

[0028] FIGS. 4a to 4d show steps of a method of manufacturing the cannula according to another embodiment.

[0029] FIGS. 5a to 5d show steps of a method of manufacturing the cannula according to still another embodiment.

[0030] FIG. 6 shows a layer of the cannula before and after evaporation of a solvent.

[0031] FIG. 7 shows a cannula with a stiffening structure.

[0032] FIG. 8 shows a cannula with a marking.

[0033] FIG. 9 shows a cannula on a mandrel having a circumferential shoulder.

[0034] FIG. 10 shows a detail of the cannula during manufacture of a lumen in the cannula.

[0035] FIG. 11 shows a perspective view of a 3D printing process of an inflow cage of the cannula.

DETAILED DESCRIPTION

[0036] In FIG. 1 is illustrated a blood pump inserted into a patient's heart H. More specifically, the blood pump comprises a pumping device 1 attached to a catheter 10 by means of which the pumping device 1 is inserted into the left ventricle LV of the patient's heart H via the aorta AO, including the descending aorta DA and the aortic arch AA. The catheter 10 has a distal end 10a and a proximal end 10b. The pumping device 1 has a blood flow outlet 3 that is disposed outside the patient's heart H in the aorta AO, while a blood flow inlet 2 is in flow communication with a cannula 4 placed inside the left ventricle LV. An impeller (not shown) is provided in a housing la of the pumping device 1 to cause the blood flow from the blood flow inlet 2 to the blood flow outlet 3. At the distal end of the blood pump, a soft tip 5, such as a pigtail or J-tip, is arranged to facilitate insertion of the blood pump into the patient's heart H without causing any harm to the surrounding tissue. Also, the soft tip 5 helps to keep soft tissue away from the cannula 4.

[0037] FIG. 2 shows an enlarged schematic cross-sectional view of the interface 6 between the housing 1a of the pumping device 1 and the cannula 4. The housing 1a and the cannula 4 are stepped at their respective ends 22, 23 which are to be attached to one another. While the housing 1a of the pumping device 1 may be made of metal, the cannula 4 may be made of a plastic material, such as silicone, polyethylene or polyurethane. At the interface 6 between the relatively hard material of the housing 1a of the pumping device 1 and the relatively soft material of the cannula 4 the loads during operation of the blood pump may cause cracks in the material of the cannula 4. Therefore, it is desirable to increase the bending stiffness of the cannula 4 in the region of the interface 6. However, the rest of the cannula 4 should be softer to avoid damages to the surrounding tissue, such as the leafs of a cardiac valve.

[0038] A method of manufacturing a cannula 4 that can exhibit different characteristics along its length, in particular different bending stiffnesses, is shown schematically in FIGS. 3a to 3d. The core idea of the method is that the cannula is produced by dispensing liquid material onto an elongate element, such as a mandrel, rather than attaching different sections to one another. The following steps are shown schematically and not true to scale for illustrative purposes. In particular, for the sake of simplicity, the steps are shown only for a single layer in each axial section. It will be appreciated, however, that more than one, up to 20 layers or more, may be applied in each axial section.

[0039] In a first step, shown in FIG. 3a, a base layer 10 is applied onto a mandrel 7. In order to create the base layer 10, a liquid material is applied onto the mandrel 7 by means of a dispenser 8 having at least one nozzle 9 to dispense the liquid material. During dispensing the liquid material, the mandrel 7 is rotated about its longitudinal axis L, which is coincident with the longitudinal axis L of the cannula 4. The mandrel 7 may be rotated by means of a suitable apparatus, such as a lathe (not shown). The speed of rotation may be about 12 rpm. The dispenser 8 is moved in an axial direction along the length of the mandrel 7. The axial speed of the dispenser 8 and the rotational speed of the mandrel 7 are chosen such that a continuous layer of liquid material can be applied along the length and about the circumference of the mandrel 7. The final base layer 10, i.e. after drying and curing, may have a thickness of about 50 μm to 100 μm.

[0040] After the base layer 10 is fully applied onto the mandrel 7 and at least dried to a desired degree, as will be explained in more detail below with respect to FIG. 5, a layer 11 of a liquid material is applied in the same manner as the base layer 10, i.e. by moving the dispenser 8 along the longitudinal direction of the mandrel 7, while the mandrel 7 is rotated, as shown in FIG. 3b. The liquid material of the layer 11 may be the same material as the material of the base layer 10 or a different material. The same dispenser 8 may be used. In particular, if the material is different, it may be dispensed by another nozzle of the dispenser 8 or possibly another dispenser. The layer 11 is part of a first axial section 13 of the cannula 4 (see FIG. 3d) and is applied only along a part of the length of the mandrel 7.

[0041] As shown in FIG. 3c, a layer 12 of another liquid material is applied axially adjacent the layer 11 onto the mandrel 7 in the same manner as described above, i.e. by moving the dispenser 8 along the longitudinal direction of the mandrel 7, while the mandrel 7 is rotated. The material of the layer 12 may be different from the material of the layer 11. As indicated in FIG. 3c, the layer 12 is thicker than the layer 11. The layer 12 is part of a second axial section 15 of the cannula 4 (see FIG. 3d) and is applied only along a part of the length of the mandrel 7. The layers 11 and 12 overlap and blend into each other to form a smooth transition area 14 between the first and second axial sections 13, 15 that extends over a length of at least 10 μm.

[0042] By appropriately choosing materials and wall thicknesses of the layers 11 and 12, the bending stiffnesses of the first and second axial sections 13 and 15 can be adjusted as desired. It will be appreciated that the first and second axial sections 13, 15 each preferably comprise more than one layer of material. In other words, more than one layer 11 and more than one layer 12 are applied onto the mandrel 7 to form the first axial section 13 and the second axial section 15, respectively. Apart from that, more than two axial sections connected by respective transition areas can be created on the mandrel 7. For example, sections of low bending stiffness may be created so as to alternate with sections of high bending stiffness in order to create a cannula having stiff portions connected by flexing portions. After the desired amount of material has been applied onto the mandrel 7 and sufficiently cured, the mandrel 7 is removed from the cannula 4 as indicated in FIG. 3d.

[0043] FIGS. 4a to 4d show substantially the same method as FIGS. 3a to 3d. The only difference is that the material of the layer 12 is the same material as the material of the layer 11. The different bending stiffnesses of the first axial section 13 and the second axial section 15 result from different wall thicknesses. FIGS. 5a to 5d show substantially the same method as FIGS. 3a to 3d. In this embodiment, the materials of the layers 11 and 12 are different but the wall thickness is constant along the length of the cannula 4, i.e. the wall thicknesses of the first axial section 13 and the second axial section 15 are the same. The different bending stiffnesses result from the different materials. As shown particularly in FIG. 5d, the different materials of the first and second axial sections 13, 15 blend into each other in the transition area 14. Alternatively, also referring to FIGS. 5a to 5d, the materials of the layers 11 and 12 may be the same but may comprise a different proportion of solvent and blend into each other in the transition area. For instance, the layer 11 may comprise less solvent than the layer 12, which would result in different wall thicknesses of the layers 11 and 12 (i.e. the first and second axial sections, 13, 15) after curing (not shown).

[0044] Referring now to FIG. 6, and as already mentioned briefly above, the liquid materials preferably comprise a solvent. The proportion of the solvent in each material may be more than 80 vol %, preferably more than 90 vol %. The principle is exemplarily shown with respect to the layer 11 in FIG. 6. FIG. 6 shows the layer 11 applied on the mandrel 7 before evaporation of the solvent (left) and after evaporation of the solvent (right). After evaporation of the solvent, which can be denoted as “physically drying”, the thickness of the applied is reduced approximately by the amount of the solvent. Using a high proportion of a solvent facilitates manufacture of very thin layers as most of the applied material will evaporate. In other words, a relatively large amount of material can be dispensed, while only a small amount of material will be present in the completed cannula 4. This is easier than applying a small amount without a solvent to create a thin layer and requires less accuracy for the dispenser.

[0045] FIGS. 7 to 11 show different aspects that may be included in a cannula 4 either alone or in any combination. For the sake of simplicity, the cannula 4 is shown as an integral piece in FIGS. 7 to 11. However, the cannula 4 comprises different layers and axial sections as described above.

[0046] The cannula 4 shown in FIG. 7 comprises a stiffening structure 16 embedded in a wall of the cannula 4. The stiffening structure 16 may have a helical shape extending about the cannula 4 or may form any other suitable pattern that strengthens the cannula 4. The stiffening structure 16 may be created by dispensing a liquid material by means of the dispenser 8. However, rather than creating a continuous layer as described above, the liquid material for the stiffening structure 16 is applied along a helical path on the mandrel 7. This material is applied onto previously created layers and covered by subsequent layers such that the stiffening structure 16 is embedded in the wall of the cannula 4. For instance, the stiffening structure 16 may be made of polyurethane, while the surrounding material is polyethylene, which is softer than polyurethane. In particular, the stiffening structure 16 has a higher elastic modulus than the rest of the wall of the cannula 4.

[0047] Alternatively or in addition, the cannula may comprise a stiffening structure formed of a helical Nitinol wire, which is pre-wound and incorporated in the cannula 4 during the dispensing process to be embedded in the wall of the cannula 4. Further alternatively, a polymer thread may be wound about the mandrel between material layers of the cannula. As mentioned above, any above-described stiffening structure is advantageously embedded between layers of the cannula 4. For instance, a first layer of material may be applied followed by the stiffening structure (e.g. liquid material along a path, pre-wound Nitinol wire or polymer thread), which is subsequently covered by one or more further layers of material. This is exemplarily indicated by layers 10 and 11 in FIG. 7. It will be appreciated that the cannula 4 may comprise more layers than the layers 10 and 11 in FIG. 7.

[0048] Referring now to FIG. 8, a cannula 4 is shown having a marking 17 that is visible by the human eye, e.g. by exhibiting a different color than the surrounding material, or that is visible under x-ray, i.e. radiopaque. The marking 17 may be applied on the cannula 4 or embedded in the cannula 4. The marking may extend along a helical path or along any other desired path. It can be manufactured by dispensing a liquid material as described above with respect to the stiffening structure 16. Also, the wire or thread as described above may carry the marking. For instance, the wire or thread may be radiopaque.

[0049] FIG. 9 shows a cannula 4 having a circumferential shoulder 18, i.e. the cannula 4 has sections 25, 26 that differ in their respective inner and outer diameters. Accordingly, the mandrel 7 has a respective circumferential shoulder 24 interconnecting two mandrel parts 7a, 7b with different diameters. In order to facilitate removal of the mandrel 7 from the finished cannula 4, the parts 7a, 7b are separable.

[0050] The cannula 4 shown in FIG. 10 has a lumen 19 extending through the wall of the cannula 4. The lumen 19 can be created by incorporating a filament 20 during the above-described dispensing method. If the filament 20 is solid, it will be pulled out of the cannula 4 after the production of the cannula 4 is finished to form the lumen 19. Alternatively, a hollow filament may be used that is embedded in the cannula 4 to form the lumen 19.

[0051] The method of manufacturing the cannula 4 may further comprise the step of creating at least one opening in the cannula 4, e.g. the aforementioned blood flow inlet 2, as shown in FIG. 11. A cage structure 21 or the like can be created by means of the dispenser 8 to form the openings 2. For this purpose, the mandrel 7 is preferably not rotated or rotated very slowly, depending on the desired shape of the cage structure 21. For instance, the mandrel 7 should not be rotated if longitudinal struts are created. The viscosity of the dispensed material of the cage structure 21 is chosen such that the material will not drop from the mandrel 7 but will blend with the previously or subsequently applied layers of the cannula 4 to form an integral body.

[0052] The method of manufacturing a cannula including the dispensing steps as described above allows manufacture of a cannula with adjustable characteristics along the length of the cannula, including any desired structure. The aforementioned features can be included alone or in combination into a cannula. The wall thickness may be influenced by a variety of parameters, such as type of material, dispensed amount of material, dispensing rate, speed of movement of one or both of the mandrel and the dispenser, and proportion of solvent in the materials etc. It will be appreciated that any desired number, order and arrangement of layers can be included in the cannula. Any number, order and arrangement of axial sections with different characteristics, such as bending stiffness, can be created as desired. The described embodiments are for illustrative purposes and not intended to be limiting. The invention is defined in the appended claims.