Blood pump

Abstract

The present invention relates to a blood pump (10) comprising a pumping section (12) configured to be placed in a human body and a catheter (20). The catheter (20) comprises a distal end (42), a proximal end (44), a main body (48) extending between the distal end (42) and the proximal end (44), an intravascular portion (50) and a residual portion (52). The distal end (42) of the catheter (20) is connected to the pumping section (12). The intravascular portion (50) is directly adjacent to the residual portion (52) and extends from the residual portion (52) to the distal end (42). The intravascular portion (50) has a first stiffness and the residual portion (52) at least partially has a second stiffness, wherein the first stiffness is higher than the second stiffness.

Description

[0001] NEW PCT application Abiomed Europe GmbH 215040 PWO October 28, 2025

[0002] 1 / 30

[0003] BLOOD PUMP

[0004] The present invention relates to a blood pump. In particular, the present invention relates to an intravascular blood pump for percutaneous insertion into a patient’s blood vessel, to support a blood flow in a patient’s blood vessel. The blood pump may also be an intracardiac blood pump or any other kind of ventricular assist device.

[0005] BACKGROUND OF THE INVENTION

[0006] Various blood pumps are known from the prior art e.g., axial blood pumps, centrifugal (i.e., radial) blood pumps or mixed-type blood pumps, where the blood flow is caused by axial forces as well as by radial forces. The blood pump can be advanced through a patient’s blood circulatory system, i.e., veins and / or arteries, to a position in the patient’s heart or elsewhere within the patient’s vasculature. Such a blood pump is typically disposed at the end of a catheter, which is used to insert and position the pump, and later to withdraw the pump. Once in position, the pump may be used to pump blood through the circulatory system and, therefore, temporarily reduce workload on the patient’s heart, such as to enable the heart to recover after a heart attack.

[0007] Therefore, a blood pump typically comprises a pumping section with a pump housing having a blood flow inlet and a blood flow outlet connected by a blood flow passage, a pump element in form of an impeller disposed in said pump housing being rotatable about an axis of rotation for conveying blood from the blood flow inlet to the blood flow outlet along the blood flow passage. Further, such blood pumps comprise a drive unit configured to rotate the impeller.

[0008] However, to place the blood pump in the designated position within the human body, for instance the left ventricle in case the blood pump is a left ventricular support device, at least a distal portion of the catheter needs to be stiff and configured to transmit rotation to maneuver the pumping section e.g., through the hemostasis valve, along the bends within the patient’s vasculature like the aortic arch, through the aortic valve and into the left ventricle. After placement, the catheter needs to be stable and stiff enough to maintain the correct position of the pumping section over time, especially the distal portion of the catheterthat reaches from the hemostasis valve to the pumping section. In addition, sufficient stiffness needs to be warranted in case the blood pump is to be repositioned after a certain period of time e.g., due to movement of the patient. On the other hand, the portion of the catheter upstream or proximal of the hemostasis valve is preferably soft so that the anatomical fit of the catheter and the transition to the skin exit site is easy to create, safe and not prone to infections or inflammations. The skin transition itself is also preferably as soft as possible to avoid risk of infection, inflammation and prohibitive effects to wound healing and ingrowth of tissue to an element at the catheter or cable respectively. NEW PCT application Abiomed Europe GmbH 215040 PWO October 28, 2025

[0009] 2 / 30

[0010] Herein, "proximal" and "distal" are seen relative to the physician. Thus, proximal designates something which is relatively close to the physician whereas distal designates something which is relatively far away from the physician when the blood pump is placed at the designated position within the human body.

[0011] Accordingly, there is the need for an ameliorated blood pump allowing for a facilitated placement within the human body and facilitated repositioning.

[0012] SUMMARY OF THE INVENTION

[0013] According to a first aspect, a blood pump comprises a pumping section and a catheter. The pumping section is configured to be placed in a human body, in particular in the vasculature or the heart of a patient. The catheter comprises a distal end, a proximal end, a main body extending between the distal end and the proximal end, an intravascular portion and a residual portion. The distal end of the catheter is connected to the pumping section. The blood pump may comprise a connector connected to the proximal end of the catheter. The intravascular portion may be directly adjacent to the residual portion and may extend from the residual portion to the distal end. The residual portion may extend from the intravascular portion to the proximal end of the catheter. At least a part of the intravascular portion may be configured to be disposed distally of a skin exit site when the pumping section is deployed. The intravascular portion may have a first stiffness and the residual portion may at least partially have a second stiffness, wherein the first stiffness is higher than the second stiffness. Stiffness in the sense of the present disclosure can be understood to mean lateral stiffness, torsional stiffness, shear stiffness or tensile stiffness as well as a combination of the aforementioned stiffnesses.

[0014] According to the first aspect, the distal portion of the catheter i.e., the intravascular portion, has a higher stiffness than at least a part of the remaining portion, which thus allows the pumping section to be easily advanced to the designated position during placement of the blood pump into the human body and to secure the position of the pumping section once placed in the designated position with the human body. Preferably, the intravascular portion is totally or at least in large parts downstream of the hemostasis valve when the pumping section is in its designated position within the human body. Accordingly, the residual portion is largely located upstream of the hemostasis valve and is less stiff than the intravascular portion which thus allows for a better anatomical fit and a facilitated penetration through the skin exit site. Furthermore, placement of the pumping section is facilitated for the physician. In addition, this allows for a softer portion of the catheter at the skin transition, which avoids the risk of infection, inflammation and prohibitive effects to wound healing and ingrowth of tissue to the catheter. Furthermore, a repositioning of the pumping section is easily possible due to the increased stiffness of the intravascular portion. NEW PCT application

[0015] Abiomed Europe GmbH 215040 PWO October 28, 2025

[0016] 3 / 30

[0017] The main body of the catheter may be another catheter, a cable having several wires with or without a coating, a cable bundle, a purge catheter or any other structure suitable.

[0018] The catheter may comprise an outer sheathing providing the first stiffness. The outer sheathing may be provided about an outer circumferential surface of at least a part of the main body and may extend from the distal end of the catheter in a direction of the proximal end of the catheter. The outer sheathing may be configured to be removable at least in parts, so that the residual portion at least partially is formed by removing a part of the outer sheathing. This allows for a variation of the length of the intravascular portion and the residual portion, as the outer sheathing may be removed to a desired degree. Preferably, the parts of the outer sheathing are removed after the pumping section is placed in the designated position within the human body.

[0019] The outer sheathing may comprise at least one longitudinal tear structure at least partially extending along the outer sheathing. The at least one tear structure may extend along the outer sheathing in a longitudinal direction of the outer sheathing. The tear structure may be configured to be mechanically torn open. The outer sheathing preferably comprises two longitudinal tear structures at least partially extending along the outer sheathing in parallel. The at least one longitudinal tear structure thus provides a “peel away” possibility of that portion of the outer sheathing to be removed to form at least a part of the residual portion. Thus, forming the residual portion by removing a part of the outer sheathing is facilitated.

[0020] The at least one tear structure is thus configured to separate the outer sheathing. In this regard, it has to be noted that the tear structure may be mechanically torn open or may be mechanically broken, which is equivalent in sense of the present disclosure.

[0021] The blood pump may comprise at least one tear-off aid, wherein movement of the at least one tear-off aid relative to the main body tears open the at least one tear structure. This facilitates the removal of the part of the outer sheathing so as to form at least a part of the residual portion.

[0022] The mechanical force to be applied for separating the outer sheathing into two parts may include a relative movement of the to be separated parts, wherein the mechanical force preferably includes at least one of twisting or pulling apart. The outer sheathing may thus comprise at least one predefined breaking portion, where the outer sheathing is separated into the two parts when said two parts are mechanically moved relative to each other. Preferably, the outer sheathing comprises a plurality of predefined breaking portions so that the length of the residual portion can be adjusted by separating the outer sheathing into two parts at one desired breaking portion of the plurality of breaking portions.

[0023] The outer sheathing may also be removed in parts though other suitable methods e.g., melting away. NEW PCT application

[0024] Abiomed Europe GmbH 215040 PWO October 28, 2025

[0025] 4 / 30

[0026] The main body may comprise a lumen configured to receive at least one elongated stiffness increasing member. The lumen may extend from the distal end in a direction of the proximal end. At least one elongated stiffness increasing member providing the first stiffness may be disposed in the lumen. The at least one elongated stiffness increasing member may extend within the lumen along the intravascular portion.

[0027] The at least one elongated stiffness increasing member may comprise a first portion providing the first stiffness and a second portion providing a stiffness different from the first stiffness. The second portion may provide the second stiffness. The first portion of the elongated stiffness increasing member may extend along the intravascular portion and the second portion of the elongated stiffness increasing member may extend along the residual portion. The first portion may be directly adjacent the second portion. Alternatively, an intermediate portion may be provided between the first portion and the second portion providing a gradual transition from the first stiffness to the second stiffness along the intermediate portion. This allows for a variation of the length of the intravascular portion and the residual portion, as the elongated stiffness increasing member may be shortened to a desired length or length ratio respectively of the first portion and the second portion.

[0028] The at least one elongated stiffness increasing member may comprise an anti-rotation lock. This warrants torsion resistance.

[0029] The blood pump may comprise a set of different elongated stiffness increasing members having different stiffnesses at the first portion and the second portion. This allows the physician to choose the correct elongated stiffness increasing member for the anatomy of the patient.

[0030] The residual portion may comprise a transition portion and a normal portion, wherein the transition portion is disposed between the normal portion and the intravascular portion. The stiffness of the transition portion may gradually decrease in a direction from the intravascular portion to the normal portion. The stiffness decrease is preferably continuous and the stiffness of the transition portion is preferably always lower than the stiffness of the intravascular portion and always higher than the stiffness of the normal portion. Accordingly, the stiffness of the catheter is highest distally and gradually decreases over the transition portion in a proximal direction.

[0031] At least the part of the main body in the residual portion may comprise a mechanical property changing material, wherein the mechanical property changing material is configured to change its stiffness. Preferably, the mechanical property changing material is configured to change its stiffness induced by a trigger. The trigger may include one or more of application of UV- light, application of a base, application of an acid, application of electrical energy, application of heat, application of mechanical energy, application of ultrasonic energy, and application of moisture. Preferably, the mechanical property changing material is configured to lower its stiffness induced by the trigger. NEW PCT application Abiomed Europe GmbH 215040 PWO October 28, 2025

[0032] 5 / 30

[0033] Hence, the blood pump is initially placed in the designated position within the human body with the main body of the catheter having a virtually constant and high stiffness. After the blood pump is placed at its designated position, the trigger is applied and the stiffness of the residual portion is reduced at least in parts of the residual portion. Thus, this allows for a facilitated placement of the blood pump and an ameliorated anatomical fit of the residual portion.

[0034] The mechanical property changing material may be a polymer, preferably a thermoplastic polyurethan or a thermoplastic elastomer, more preferably an amorphous or semi-crystalline thermoplastic polyurethan (TPU) or thermoplastic elastomer (TPE), and even more preferably a polycarbonate- based aliphatic thermoplastic polyurethan. The mechanical property changing material may be a hygroscopic polymer.

[0035] Depending on the trigger to be applied, the mechanical property changing material may be provided. If the trigger includes application of UV- light, the mechanical property changing material may be one of a polymer based on coumarin, ortho-nitrobenzyl, spyropyran or azobenzene derivatives including liquid crystalline polymers. If the trigger includes application of a base or an acid, the mechanical property changing material may be one of a pH sensitive polymer with acidic groups (such as -COOH and -SO3H) or one of pH sensitive polymer with basic groups (-NH2). If the trigger includes application of electrical energy, the mechanical property changing material may be one of a electro-responsive polymer including those from the conjugated polymer family like poly(pyrrole) (PPy), polyaniline (PANI), poly(3,4-ethylene dioxythiophene) (PEDOT), or an electrical field responsive polymer, like ionic or dielectric electro-active polymers (EAPs). If the trigger includes application of (additional) heat, in particular application of heat higher than the body temperature, the mechanical property changing material may be one of amorphous or semi-crystalline TPUs or TPEs. If the trigger includes application of mechanical energy like pressure, bending or cyclic loading, the mechanical property changing material may be one of a mechanoresponsive polymer with force-activated mechanophores into the polymer chains. If the trigger includes application of moisture, the mechanical property changing material may be one of a hygroscopic polymer like nylon, acrylonitrile butadiene styrene (ABS), acrylic, polyethylene terephthalate (PET), polybutylene terephthalate (PBT), polyurethane or polycarbonate. If the trigger includes application of ultrasonic energy e.g., high-intensity focused ultrasound (HIFU), the mechanical property changing material may be a polymer like polyethylene (PE), poly(methylmethacrylate) (PMMA), Polycarbonate (PC), polystyrene (PS), Nylon-6 (PA-6) or polypropylene (PP).

[0036] At least a part of the elongated stiffness increasing member may comprise mechanical property changing material as described above in terms of the main body.

[0037] According to the present disclosure, the first stiffness may be a first stiffness range. The first stiffness range may be between 30D and 70D durometer hardness measured according to ASTM D2240. NEW PCT application

[0038] Abiomed Europe GmbH 215040 PWO October 28, 2025

[0039] 6 / 30

[0040] According to the present disclosure, the second stiffness may be a second stiffness range. The second stiffness range may be between 20A and 80A durometer hardness measured according to ASTM D2240.

[0041] Preferably, at least a part of the main body in the residual portion has a smaller diameter than the part of the main body in the intravascular portion. Preferably, the smaller diameter portion is provided in the area of the skin exit site and forms a skin passage portion. Thus, this further reduces the risk of inflammations and infections at the skin exit site.

[0042] The main body of the catheter may comprise a skin passage portion. The skin passage portion may be configured to be disposed in the area of the skin exit site when the pumping section is deployed. The skin passage portion may be a smaller diameter portion. Here, smaller diameter portion refers to a portion having a smaller diameter than the intravascular portion. The skin passage portion may comprise an anti-bacterial or anti-microbial agent. The anti-bacterial or anti-microbial agent may be a sustained silver ion releasing coating for instance comprising Ag-containing polymers or nanoparticles. Another possibility is to provide a surface functionalization of the skin passage portion with antimicrobial Peptides (AMPs), which can be amphipathic and hydrophobic helices, p sheet peptides and small proteins, peptides with thioether rings, peptides with unique amino acid compositions like anchor peptide LCI and / or lipopeptides terminating in an amino alcohol and macro-cyclic knotted peptides. Further possibilities are a biomimetic nitric Oxide releasing coating using NO donors or selenium functional polymers, a surface modification of the skin passage portion by Azetidinium couplers, and a surface modification by polyzwitterionic polymers.

[0043] A barrier may be disposed about the skin passage portion. The barrier may comprise an anti-bacterial or anti-microbial agent as stated above. The barrier may be of a fleece-like material, like Dacron velour.

[0044] At least a part of the main body of the catheter may comprise a base body and a transparent sheathing covering at least a part of the base body. The base body may comprise markings on an outer peripheral surface. The markings may be formed by laser marking and / or printing. Thus, the markings are covered by the transparent sheathing, which secures the markings from damage. In addition, it can thus be prevented that the markings contact blood, which is preferable in terms of hemocompatibility.

[0045] BRIEF DESCRIPTION OF THE DRAWINGS

[0046] 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 NEW PCT application

[0047] Abiomed Europe GmbH 215040 PWO October 28, 2025

[0048] 7 / 30 illustrating the present disclosure, reference is made to the drawings. However, the scope of the disclosure is not limited to the specific embodiments disclosed in the drawings.

[0049] In the drawings:

[0050] Fig. 1 is a cross sectional detailed view of a pumping section of a blood pump;

[0051] Fig. 2 is a schematic side view of a blood pump system having a blood pump according to a first embodiment;

[0052] Fig. 3 is a schematic side view of a blood pump system having a blood pump according to a second embodiment;

[0053] Fig. 4 is a schematic side view of a blood pump system having a blood pump according to third embodiment;

[0054] Fig. 5 is a schematic side view of a blood pump system having a blood pump according to a fourth embodiment; and

[0055] Fig. 6 a cross section through a main body of a catheter of a blood pump.

[0056] DETAILED DESCRIPTION

[0057] Fig. 1 depicts a cross sectional view of a pumping section 12 of a blood pump 10 of a blood pump system. The pumping section 12 comprises a pump housing 14 with a blood flow inlet 16 and at least one blood flow outlet 18. In this exemplary embodiment, the blood pump 10 is an intravascular pump, also called catheter pump, and the pumping section 12 is placed in a human body. In particular, the pumping section is deployed into a patient’s blood vessel by means of a catheter 20. In this exemplary embodiment, the blood pump is a left ventricle assist device, meaning that the pumping section 12 is at least partially to be placed within the left ventricle of the heart of the human body.

[0058] In this exemplary embodiment, the catheter is provided in the form of a cable 20. The blood flow inlet 16 is disposed at an end of a flexible cannula 22 which may be placed through a heart valve, such as the aortic valve, during usage of the blood pump 10. The at least one blood flow outlet 18 is disposed in a side surface of the pump housing 14 and may be placed in a blood vessel, such as the aorta. The blood pump 10 is electrically connected with a plurality of electric wires 24 extending through the catheter 20 for supplying the blood pump 10 with electric power in order to drive the blood pump 10 by means of a drive unit 26. It has to be noted that the plurality of electric wires 24 are only schematically shown in Fig. 1 . In addition, a lumen 40 is provided within the catheter 20 to supply a purge solution to the pumping section 12. NEW PCT application

[0059] Abiomed Europe GmbH 215040 PWO October 28, 2025

[0060] 8 / 30

[0061] If the blood pump 10 is intended to be used in long term applications i.e., in situations in which the blood pump 10 is placed into the patient’s body for a longer period of time (e.g., several weeks or even months), electric power is preferably supplied by means of a battery. This allows a patient to be mobile because the patient is not connected to a base station. The battery can be carried by the patient and may supply electric energy to the blood pump 10 in a conventional manner.

[0062] A pump element 28 in form of an impeller is provided for conveying blood along a blood flow passage 30 connecting the blood flow inlet 16 and the blood flow outlet 18. As depicted in Fig. 1 , the impeller 28 is disposed within the pump housing 14 and is rotatable about an axis of rotation AR via a first bearing 32 and a second bearing 33. The axis of rotation AR is preferably the longitudinal axis of the impeller 28. Both bearings 32, 33 are contact-type bearings in this exemplary embodiment.

[0063] The drive unit 26 comprises a plurality of posts 34, such as six posts 34, only two of which are visible in the cross-sectional view of Fig. 1 . The posts 34 are disposed in parallel to the axis of rotation AR, more specifically, a longitudinal axis of each of the posts 34 is parallel to the axis of rotation AR. Coil windings 36 are disposed about the posts 34. The coil windings 36 are sequentially controlled by a control to create a rotating magnetic field. The impeller 28 comprises at least one magnet 38. The magnet 38 is disposed at the end of the impeller 28 facing the drive unit 26. The magnet 28 is configured to interact with the rotating magnetic field so as to cause rotation of the impeller 28 about the axis of rotation AR.

[0064] For placing the blood pump 10 and in particular for advancing the pumping section 12 through the vasculature of the patient as well as for repositioning of the pumping section 12 after placement, a sufficiently stiff cable 20 is preferable, at least in a distal portion of the cable 20. In addition, it is further preferable to have that portion of the cable 20 being outside the vasculature to be less stiff to allow for an ameliorated anatomical fit and skin exit. Next, respective embodiments according to the present disclosure will be described.

[0065] Fig. 2 depicts a schematic side view of a blood pump system having a blood pump 10 according to a first exemplary embodiment. It should first be noted that Fig. 2 is not drawn to scale. As shown in Fig. 2, the blood pump 10 comprises the catheter 20. The catheter 20 has a distal end 42 and a proximal end 44. The pumping section 12 is connected to the distal end 42 of the catheter 20. A connector 46 is connected to the proximal end 44 of the catheter 20. The connector 46 is configured to connect the catheter 20 to further devices, like a battery or an external controller (not shown).

[0066] In this exemplary embodiment, the catheter 20 comprises a main body 48, an intravascular portion 50 and a residual portion 52. The residual portion 52 comprises a transition portion 54 and a normal portion 56. The intravascular portion 50 extends from the distal end 42 of the catheter 20 in a direction towards the proximal end 44 of the catheter 20 and merges directly into the transition portion 54. The NEW PCT application

[0067] Abiomed Europe GmbH 215040 PWO October 28, 2025

[0068] 9 / 30 transition portion 54 extends from the intravascular portion 50 towards the proximal end 44 of the catheter 20 and merges directly into the normal portion 56.

[0069] When the blood pump 10 is placed in the human body, the intravascular portion 50 is disposed within the vasculature of the patient e.g., largely within the aorta. The approximate vascular transition VT is denoted by a bold dashed line in this exemplary embodiment. The hemostasis valve (not shown) is disposed also approximately in the area of the vascular transition VT.

[0070] A skin passage portion 58 denoted by dashed lines is provided within the normal portion 56. When the blood pump 10 is placed within the human body, the skin exit site ES is disposed about the skin passage portion 58. The skin exit site ES may be formed by a hemostasis valve 90. In Fig. 2, the skin exit site ES and / or the hemostasis valve 90 are schematically denoted by a bold dashed line. Therefore, the catheter 20 preferably has a smaller diameter at the skin passage portion 58 compared to the rest of the normal portion 56. An optional barrier 60 is disposed about the skin passage portion 58. The barrier may comprise an anti-bacterial or anti-microbial agent and is composed of a fleece-like material, such as Dacron velour. The reduced diameter, the softness and the high flexibility of the skin passage portion 58 and the barrier 60 greatly reduce the risk of infections or inflammations at the skin exit site.

[0071] In addition or as an alternative to the barrier 60, the skin passage portion 58 may comprise with an anti-bacterial or anti-microbial agent. The anti-bacterial or anti-microbial agent may be a sustained silver ion releasing coating for instance comprising Ag-containing polymers or nanoparticles. Another possibility is to provide a surface functionalization of the skin passage portion 58 with anti- microbial Peptides (AMPs), which can be amphipathic and hydrophobic helices, p sheet peptides and small proteins, peptides with thioether rings, peptides with unique amino acid compositions like anchor peptide LCI and / or lipopeptides terminating in an amino alcohol and macro-cyclic knotted peptides. Further possibilities are a biomimetic nitric Oxide releasing coating using NO donors or selenium functional polymers, a surface modification of the skin passage portion 58 by Azetidinium couplers, and a surface modification by Polyzwitterionic polymers. The intravascular portion 50 has a first stiffness and the normal portion 56 has a second stiffness, with the first stiffness being higher than the second stiffness. In this exemplary embodiment, the first stiffness is in the range of 30D to 70D durometer hardness and the second stiffness is in the range of 20A to 80A durometer hardness. The stiffness of the transition portion 54 is not constant, but it gradually decreases in a continuous manner from the intravascular portion 50 towards the normal portion 56. The variation in stiffness of the catheter 20 can be achieved during manufacturing of the catheter 20 or the main body 48 e.g., during extrusion or over-molding. Suitable biocompatible materials are chosen which also match the further requirements. As the intravascular portion 50 is disposed within the vasculature, a blood- compatible and antithrombogenic material is chosen having the required stiffness. The material for the intravascular portion 50 may thus comprise a polymer, such as polycarbonate-based aliphatic NEW PCT application

[0072] Abiomed Europe GmbH 215040 PWO October 28, 2025

[0073] 10 / 30 thermoplastic polyurethane. The normal portion 56 is largely placed subcutaneous or extracorporeal so that the material is chosen to focus on reducing the risk for inflammations or infections and further to allow for resistance against the prevailing extracorporeal conditions, like mechanical stress or UV radiation due to sunlight. The material for the normal portion 56 may thus comprises a polymer, such as a polycarbonate-based aliphatic thermoplastic polyurethane. Compared to the intravascular portion 50, the material of the normal portion 56 may have different properties, like a lower shore hardness. Further, no softening effects are required for the material of the normal portion. The transition portion 54 is then directly formed during manufacturing of the catheter 20.

[0074] Fig. 3 depicts a schematic side view of blood pump system with a blood pump 10 according to a second exemplary embodiment. It should first be noted that Fig. 3 is not drawn to scale and only the differences compared to the second embodiment shown in Fig. 2 will be described in detail below.

[0075] In this exemplary embodiment, the transition portion 54 comprises a mechanical property changing material. The mechanical property changing material is configured to change its stiffness upon application of a trigger. In particular, the mechanical property changing material of the transition portion 54 has a higher stiffness before application of the trigger and it is further configured to lower its stiffness after application of the trigger. Thus, the transition portion 54 may also have the first stiffness during placement of the blood pump 10, which may be in the range of e.g., 30D to 70D. After placement of the blood pump 10, the trigger is applied to reduce the stiffness of the transition portion 54 down to e.g., the second stiffness which may be in a range of 20A to 80A.

[0076] Depending on the trigger to be applied, a suitable mechanical property changing material may be chosen. If the trigger includes application of UV- light, the mechanical property changing material may be one of a polymer based on coumarin, ortho-nitrobenzyl, spyropyran or azobenzene derivatives including liquid crystalline polymers. If the trigger includes application of a base or an acid, the mechanical property changing material may be one of a pH sensitive polymer with acidic groups (such as -COOH and -SO3H) or one of pH sensitive polymer with basic groups (-NH2). If the trigger includes application of electrical energy, the mechanical property changing material may be one of a electro- responsive polymer including those from the conjugated polymer family like poly(pyrrole) (PPy), polyaniline (PANI), poly(3,4-ethylene dioxythiophene) (PEDOT), or an electrical field responsive polymer, like ionic or dielectric electro-active polymers (EAPs). If the trigger includes application of (additional) heat, in particular application of heat higher than the body temperature, the mechanical property changing material may be one of amorphous or semi-crystalline TPUs or TPEs. If the trigger includes application of mechanical energy like pressure, bending or cyclic loading, the mechanical property changing material may be one of a mechanoresponsive polymer with force-activated mechanophores into the polymer chains. If the trigger includes application of moisture, the mechanical property changing material may be one of a hygroscopic polymer like nylon, acrylonitrile butadiene styrene (ABS), acrylic, polyethylene terephthalate (PET), polybutylene terephthalate (PBT), NEW PCT application

[0077] Abiomed Europe GmbH 215040 PWO October 28, 2025

[0078] 11 / 30 polyurethane or polycarbonate. If the trigger includes application of ultrasonic energy e.g., high- intensity focused ultrasound (HIFU), the mechanical property changing material may be a polymer like polyethylene (PE), poly(methylmethacrylate) (PMMA), Polycarbonate (PC), polystyrene (PS), Nylon-6 (PA-6) or polypropylene (PP).

[0079] Preferably, the trigger includes the application of moisture so that the reduction of the stiffness of the transition portion 54 happens “automatically” after placement of the blood pump 10 due to the increased humidity level within the human body. It may also be preferable to use temperature as a trigger, as the placement of the blood pump 10 usually occurs at normal room temperature (of well below 30°C), whereas the body temperature of the patient is usually above 35°C.

[0080] It is also possible that the intravascular portion 50 comprises the mechanical property changing material. In this particular case, additional stiffening elements are to be used to maintain the first stiffness of the intravascular portion 50 e.g., a stiffening increasing coating or longitudinal stiffeners embedded or disposed in the main body. Also, the normal portion 56 may additionally comprise the mechanical property changing material. It is then possible to apply the trigger locally only to the normal portion 56 before placement of the blood pump 10 so that the normal portion 56 has the second stiffness prior to the placement of the blood pump.

[0081] Fig. 4 depicts a schematic side view of a blood pump system with a blood pump 10 according to a third exemplary embodiment. It should first be noted that Fig. 4 is not drawn to scale and only the differences compared to the first embodiment shown in Fig. 2 and the second embodiment shown in Fig. 3 will be described in detail below.

[0082] In this exemplary embodiment, the main body 48 is composed of only one material providing the second stiffness, which is in the range of 20A to 80A. Hence, the material for the entire main body 48 may thus comprise a polymer, such as a polycarbonate-based aliphatic thermoplastic polyurethane having a low shore hardness and glass transition temperature to allow for a softening effect when maintained at body temperature of approximately 37° C.

[0083] As shown, the catheter 20 comprises an outer sheathing 62 disposed about the main body 48. The outer sheathing 62 has a tubular like shape and extends from the distal end 42 towards the proximal end 44. Before placement of the blood pump 10, the outer sheathing 62 extends over the expected vascular transition VT and it may extend up to the skin passage portion 58. The outer sheathing 62 provides the first stiffness to that portion of the catheter 20 where the outer sheathing 62 is disposed about the main body 48. The outer sheathing may thus comprise a polymer, such as a polycarbonate- based aliphatic thermoplastic polyurethane having a high shore hardness to provide the first stiffness in the range of 30D to 70D. NEW PCT application

[0084] Abiomed Europe GmbH 215040 PWO October 28, 2025

[0085] 12 / 30

[0086] The outer sheathing 62 is configured to be shortened by the physician to a desired length in that the outer sheathing 62 is at least partially removable. By removing a detachable part 66 of the outer sheathing 62, the intravascular portion 50 is formed in that an intravascular part 64 of the outer sheathing 62 remains disposed about the main body 48.

[0087] The detachable part 66 may be removed by using an appropriate tool 68 such as a scissor or a specific wire stripper. In one embodiment, the outer sheathing 62 comprises a plurality of breaking structures 70 disposed in intervals along the outer sheathing 62 e.g., in regular intervals. The breaking structures 70 are configured to separate the outer sheathing 62 into the detachable part 66 and the intravascular part 64 in that mechanical force is applied e.g., bending, twisting or any other suitable relative movement between the intravascular part 64 and the detachable part 66.

[0088] To remove the detachable part 66 after it has been separated from the intravascular part 64, the outer sheathing 62 comprises a longitudinal tear structure 72. As shown in Fig. 4, the tear structure 72 extends along the longitudinal direction of the outer sheathing 62. In Fig. 4, the tear structure 72 is drawn to extend up to the distal end 42 of the catheter 20, but the tear structure 72 may also terminate somewhere between the vascular transition VT and the distal end 42 of the catheter 20. The tear structure 72 is configured to be mechanically torn open so that a slit or gap is established which allows the detachable part 66 to be removed.

[0089] The blood pump 10 may comprise a tear-off aid 74 such as a tear tab. The tear-off aid 74 is schematically denoted in Fig. 4 by a bold dashed element. Moving the tear-off aid 74 relative to the main body 48 along the longitudinal direction of the detachable part 66 opens the tear structure 72, as shown for the detachable part 66 in Fig. 4. Of course, the tear-off aid 74 may also be an individual element such as a slide to be moved along the tear structure 72 to tear open the tear structure 72.

[0090] In addition, the outer sheathing 62 may also comprise an identical second longitudinal tear structure 72 with both tear structures 72 being arranged in parallel. The second tear structure 72 allows the detachable part 66 to be separated into two parts which facilitates removal of the detachable part 66.

[0091] With the exemplary embodiment shown in Fig. 4 it is possible to have a length adaptable intravascular portion 50, as the intravascular part 64 of the outer sheathing 62 may be individually shortened so as to better account for the individual anatomical conditions of the patient. In addition, having the entire outer sheathing 62 disposed about the main body 48 during placement of the blood pump 10 allows for a facilitated advancing of the pumping section 12, as the outer sheathing 62 extends over the vascular transition VT even after the pumping section 12 is in the designated position within the human body. After the pumping section 12 is in the designated position, the detachable part 66 of the outer sheathing 62 can be removed as described above to reduce the stiffness of that part of the catheter 20 being subcutaneous down to the second stiffness to allow for a better anatomical fit. NEW PCT application

[0092] Abiomed Europe GmbH 215040 PWO October 28, 2025

[0093] 13 / 30

[0094] Fig. 5 depicts a schematic side view of a blood pump system with a blood pump 10 according to a fourth exemplary embodiment. It should first be noted that Fig. 5 is not drawn to scale and only the differences compared to the first embodiment shown in Fig. 2, the second embodiment shown in Fig. 3 and the fourth embodiment shown in Fig. 4 will be described in detail below.

[0095] In this exemplary embodiment, the main body 48 is composed of only one material. Hence, the material for the entire main body 48 may thus comprise a polymer, such as a polycarbonate-based aliphatic thermoplastic polyurethane having a low shore hardness and glass transition temperature to allow for a softening effect when maintained at body temperature of approximately 37° C.

[0096] As shown, the main body 48 comprises a (additional) lumen 76 extending between the distal end 42 and the proximal end 44 of the main body 48. The lumen is configured to receive an elongated stiffness increasing member 78. In this exemplary embodiment, the elongated stiffness increasing member 78 is depicted with a dotted line and it extends along the lumen 76 from the distal end 42 of the main body to the barrier 60. Of course, the elongated stiffness increasing member 78 may also extend up to the proximal end 46 of the main body 48.

[0097] The elongated stiffness increasing member 78 comprises a first portion 80 extending from the distal end 42 toward the proximal end 44. A second portion 82 is provided at the other end of the elongated stiffness increasing member 78. An intermediate portion 84 is disposed between the first portion 80 and the second portion 82. The intermediate portion 84 may also be omitted i.e., the second portion 82 may also be provided directly adjacent the first portion 80.

[0098] The elongated stiffness increasing member 78 may comprise at least one anti-rotation lock 86 which warrants torsion resistance. As shown in Fig. 5, the elongated stiffness increasing member 78 may comprise more than one anti-rotation lock 86.

[0099] As shown, the first portion 80 extends within the lumen 76 at least along the intravascular portion 50. The first portion 80 provides the first stiffness in the range of 30D to 70D. The second portion provides the second stiffness which is in the range of 20A to 80A. Alternatively, the elongated stiffness increasing member 78 may only comprise the first portion and the main body 48 may be composed of only one material providing the second stiffness in the range of 20A to 80A. In the embodiment shown, the stiffness in the intermediate portion 84 gradually decreases from the first stiffness to the second stiffness.

[0100] Depending on the anatomy of the patient, the physician may thus choose a suitable elongated stiffness increasing member 78 and may cut the first portion 80 and the second portion 82 to the desired length so that the length of the intravascular portion 50 and the residual portion 52 may be adapted. NEW PCT application

[0101] Abiomed Europe GmbH 215040 PWO October 28, 2025

[0102] 14 / 30

[0103] The elongated stiffness increasing member 78 may also comprise a mechanical property changing material as described above in terms of the second embodiment.

[0104] Fig. 6 depicts a cross section through the main body 48 of the catheter 20, in particular through the intravascular portion 50. At least a part of the main body 48 of the catheter 20 comprises a base body 92 having an outer peripheral surface 98. A plurality of markings 96 are provided on the outer peripheral surface 98 of the base body 92. The markings may be formed by laser marking and / or printing and may contain information for the physician.

[0105] A transparent sheathing 94 covers the base body 92. Thus, the markings 96 are not provided on the outer peripheral surface of the main body 48 of the catheter 20, but are embedded in the transparent sheathing 94 or covered by the transparent sheathing 94 respectively. This secures the markings 96 from damage. In addition, it can thus be prevented that the markings 96 contact blood, which is preferable in terms of hemocompatibility. In addition, the markings 96 are still recognizable by the physician.

[0106] EXEMPLARY IMPLEMENTATIONS

[0107] As already described, the technology described herein may be implemented in various ways. In that regard, the foregoing disclosure is intended to include, but not be limited to, the systems, methods, and combinations and subcombinations thereof that are set forth in the following exemplary implementations. Preferred embodiments are described in the following paragraphs:

[0108] A1 Blood pump comprising a pumping section configured to be placed in a human body and a catheter, wherein the catheter comprises a distal end, a proximal end, a main body extending between the distal end and the proximal end, an intravascular portion and a residual portion.

[0109] A2 Blood pump according to paragraph A1 , wherein at least a part of the intravascular portion is configured to be disposed distally of a skin exit site when the pumping section is deployed.

[0110] A3 Blood pump according to paragraph A1 or A2, wherein at least a part of the residual portion (is configured to be disposed proximally of the skin exit site when the pumping section is deployed.

[0111] A4 Blood pump according to any one of the preceding paragraphs A1 to A3, wherein the distal end of the catheter is connected to the pumping section.

[0112] A5 Blood pump according to to any one of the preceding paragraphs A1 , wherein the blood pump comprises a connector connected to the proximal end of the catheter. NEW PCT application

[0113] Abiomed Europe GmbH

[0114] 215040 PWO

[0115] October 28, 2025

[0116] 15 / 30

[0117] A6 Blood pump according to any one of the preceding paragraphs A1 to A5, wherein the intravascular portion is directly adjacent to the residual portion and extends from the residual portion to the distal end.

[0118] A7 Blood pump according to any one of the preceding paragraphs A1 to A6, wherein the intravascular portion has a first stiffness and the residual portion at least partially has a second stiffness, wherein the first stiffness is higher than the second stiffness.

[0119] A8 Blood pump according to any one of the preceding paragraphs A1 to A7, wherein the pumping section is configured to be placed in the vasculature or the heart of a patient.

[0120] A9 Blood pump according to any one of the preceding paragraphs A1 to A8, wherein the main body of the catheter is another catheter, a cable having several wires with or without a coating, a cable bundle or a purge catheter.

[0121] A10 Blood pump according to any one of the preceding paragraphs A1 to A9, wherein the catheter comprises an outer sheathing providing the first stiffness.

[0122] A11 Blood pump according to paragraph A10, wherein the outer sheathing is be provided about an outer circumferential surface of at least a part of the main body

[0123] A12 Blood pump according to paragraph A10 orA11 , wherein the outer sheathing extends from the distal end of the catheter in a direction of the proximal end of the catheter.

[0124] A13 Blood pump according to any one of the preceding paragraphs A10 to A12, wherein the outer sheathing is configured to be removable at least in parts, so that the residual portion at least partially is formed by removing a part of the outer sheathing.

[0125] A14 Blood pump according to paragraph A13, wherein the parts of the outer sheathing are removed after the pumping section is placed in the designated position within the human body.

[0126] A15 Blood pump according to any one of the preceding paragraphs A10 to A14, wherein the outer sheathing comprises at least one longitudinal tear structure at least partially extending along the outer sheathing.

[0127] A16 Blood pump according to paragraph A15, wherein the at least one tear structure extends along the outer sheathing in a longitudinal direction of the outer sheathing.

[0128] A17 Blood pump according to paragraph A15 or A16, wherein the at least one tear structure is configured to be mechanically torn open. NEW PCT application

[0129] Abiomed Europe GmbH

[0130] 215040 PWO

[0131] October 28, 2025

[0132] 16 / 30

[0133] A18 Blood pump according to any one of the preceding paragraphs A15 to A16, wherein the outer sheathing comprises two longitudinal tear structures at least partially extending along the outer sheathing in parallel.

[0134] A19 Blood pump according to any one of the preceding paragraphs A15 to A18, wherein the at least one tear structure is configured to separate the outer sheathing.

[0135] A20 Blood pump according to any one of the preceding paragraphs A15 to A19, wherein the blood pump comprises at least one tear-off aid, wherein movement of the at least one tear-off aid relative to the main body tears open the at least one tearing structure.

[0136] A21 Blood pump according to any one of the preceding paragraphs A10 to A20, wherein the mechanical force to be applied for separating the outer sheathing into two parts includes a relative movement of the to be separated parts.

[0137] A22 Blood pump according to any one of the preceding paragraphs A10 to A21 , wherein the outer sheathing comprises at least one predefined breaking portion, where the outer sheathing is separated into the two parts when said two parts are mechanically moved relative to each other.

[0138] A23 Blood pump according to paragraph A22, wherein the outer sheathing comprises a plurality of predefined breaking portions so that the length of the residual portion can be adjusted by separating the outer sheathing into two parts at one of desired breaking portions of the plurality of breaking portions.

[0139] A24 Blood pump according to any one of the preceding paragraphs A1 to A22, wherein the residual portion comprises a transition portion and a normal portion, wherein the transition portion is disposed between the normal portion and the intravascular portion.

[0140] A25 Blood pump according to paragraph A24, wherein the stiffness of the transition portion gradually decreases in a direction from the intravascular portion to the normal portion.

[0141] A26 Blood pump according to paragraph A25, wherein the stiffness decrease is continuous.

[0142] A27 Blood pump according to any one of the preceding paragraphs A24 to A26, wherein the stiffness of the transition portion is always lower than the stiffness of the intravascular portion.

[0143] A28 Blood pump according to any one of the preceding paragraphs A24 to A27, wherein the stiffness of the transition portion is always higher than the stiffness of the normal portion. NEW PCT application

[0144] Abiomed Europe GmbH

[0145] 215040 PWO

[0146] October 28, 2025

[0147] 17 / 30

[0148] A29 Blood pump according to any one of the preceding paragraphs A1 to A28, wherein the main body comprises a lumen.

[0149] A30 Blood pump according to paragraph A29, wherein the lumen is configured to receive an elongated stiffness increasing member.

[0150] A31 Blood pump according to paragraph A30, wherein the blood pump comprises an elongated stiffness increasing member disposed in the lumen.

[0151] A32 Blood pump according to paragraph A31 , wherein the elongated stiffness increasing member provides the first stiffness.

[0152] A33 Blood pump according to paragraph A31 or A32, wherein the elongated stiffness increasing member comprises a first portion and a second portion, wherein the second portion provides a stiffness different from the first stiffness.

[0153] A34 Blood pump according to paragraph A33, wherein the second portion provides the second stiffness.

[0154] A35 Blood pump according to paragraph A33 or A34, wherein the first portion of the elongated stiffness increasing member extends along the intravascular portion.

[0155] A36 Blood pump according to any one of the preceding paragraphs A33 to A35, wherein the second portion of the elongated stiffness increasing member extends along the residual portion.

[0156] A37 Blood pump according to any one of the preceding paragraphs A33 to A35, wherein the first portion is adjacent the second portion.

[0157] A38 Blood pump according to any one of the preceding paragraphs A33 to A35, wherein an intermediate portion is disposed between the first portion and the second portion.

[0158] A39 Blood pump according to paragraph A38, wherein the intermediate portion provides a gradual transition from the first stiffness to the second stiffness.

[0159] A40 Blood pump according to any one of the preceding paragraphs A33 to A39, wherein the elongated stiffness increasing member comprises an anti-rotation lock.

[0160] A41 Blood pump according to any one of the preceding paragraphs A33 to A40, wherein the elongated stiffness increasing member comprises a mechanical property changing material. NEW PCT application

[0161] Abiomed Europe GmbH

[0162] 215040 PWO

[0163] October 28, 2025

[0164] 18 / 30

[0165] A42 Blood pump according to any one of the preceding paragraphs A1 to A41 , wherein at least the part of the main body in the residual portion comprises a mechanical property changing material.

[0166] A43 Blood pump according to paragraph A41 or A42, wherein the mechanical property changing material is configured to change its stiffness.

[0167] A44 Blood pump according to any one of the preceding paragraphs A41 to A43, wherein the mechanical property changing material is configured to change its stiffness induced by a trigger.

[0168] A45 Blood pump according to paragraph A44, wherein the trigger includes one or more of application of UV- light, application of a base, application of an acid, application of electrical energy, application of heat, application of mechanical energy, application of ultrasonic energy, and application of moisture.

[0169] A46 Blood pump according to paragraph A44 or A45, wherein the mechanical property changing material is configured to lower its stiffness induced by the trigger.

[0170] A47 Blood pump according to any one of the preceding paragraphs A41 to A46, wherein the mechanical property changing material is a polymer, preferably a thermoplastic polyurethan or a thermoplastic elastomer, more preferably an amorphous or semi-crystalline thermoplastic polyurethan (TPU) or thermoplastic elastomer (TPE), and even more preferably a polycarbonate-based aliphatic thermoplastic polyurethan. T

[0171] A48 Blood pump according to any one of the preceding paragraphs A41 or A46, wherein the mechanical property changing material is a hygroscopic polymer.

[0172] A49 Blood pump according to any one of the preceding paragraphs A44 to A46, wherein the trigger includes application of UV- light and the mechanical property changing material is one of a polymer based on coumarin, ortho-nitrobenzyl, spyropyran or azobenzene derivatives including liquid crystalline polymers.

[0173] A50 Blood pump according to any one of the preceding paragraphs A44 to A46, wherein the trigger includes application of a base or an acid and the mechanical property changing material is one of a pH sensitive polymer with acidic groups (such as -COOH and -SO3H) or one of pH sensitive polymer with basic groups (-NH2).

[0174] A51 Blood pump according to any one of the preceding paragraphs A44 to A46, wherein the trigger includes application of electrical energy and the mechanical property changing material is one of a electro-responsive polymer including those from the conjugated polymer family like NEW PCT application

[0175] Abiomed Europe GmbH 215040 PWO October 28, 2025

[0176] 19 / 30 poly(pyrrole) (PPy), polyaniline (PANI), poly(3,4-ethylene dioxythiophene) (PEDOT), or an electrical field responsive polymer, like ionic or dielectric electro-active polymers (EAPs).

[0177] A52 Blood pump according to any one of the preceding paragraphs A44 to A46, wherein the trigger includes application of heat, in particular application of heat higher than the body temperature, the mechanical property changing material is one of amorphous or semi-crystalline TPUs or TPEs.

[0178] A53 Blood pump according to any one of the preceding paragraphs A44 to A46, wherein the trigger includes application of mechanical energy like pressure, bending or cyclic loading and the mechanical property changing material is one of a mechanoresponsive polymer with force- activated mechanophores into the polymer chains.

[0179] A54 Blood pump according to any one of the preceding paragraphs A44 to A46, wherein the trigger includes application of moisture and the mechanical property changing material is one of a hygroscopic polymer like nylon, acrylonitrile butadiene styrene (ABS), acrylic, polyethylene terephthalate (PET), polybutylene terephthalate (PBT), polyurethane or polycarbonate.

[0180] A55 Blood pump according to any one of the preceding paragraphs A44 to A46, wherein the trigger includes application of ultrasonic energy e.g., high-intensity focused ultrasound (HIFU), and the mechanical property changing material is a polymer like polyethylene (PE), poly(methylmethacrylate) (PMMA), Polycarbonate (PC), polystyrene (PS), Nylon-6 (PA-6) or polypropylene (PP).

[0181] A56 Blood pump according to any one of the preceding paragraphs A41 to A55, wherein the intravascular portion comprises the mechanical property changing material and stiffening elements maintaining the first stiffness after application of the trigger.

[0182] A57 Blood pump according to any one of the preceding paragraphs A1 to A56, wherein the first stiffness is a first stiffness range.

[0183] A58 Blood pump according to paragraph A57, wherein the first stiffness range is between 30D and 70D durometer hardness measured according to ASTM D2240.

[0184] A59 Blood pump according to any one of the preceding paragraphs A1 to A58, wherein the second stiffness is a second stiffness range.

[0185] A60 Blood pump according to paragraph A59, wherein the second stiffness range is between 20A and 80A durometer hardness measured according to ASTM D2240. NEW PCT application

[0186] Abiomed Europe GmbH

[0187] 215040 PWO

[0188] October 28, 2025

[0189] 20 / 30

[0190] A61 Blood pump according to any one of the preceding paragraphs A1 to A60, wherein at least a part of the main body in the residual portion has a smaller diameter than the part of the main body in the intravascular portion.

[0191] A62 Blood pump according to paragraph A61 , wherein the smaller diameter portion is provided in the area of the skin exit site and forms a skin passage portion.

[0192] A63 Blood pump according to paragraph A61 or A62, wherein a barrier is disposed about the smaller diameter portion.

[0193] A64 Blood pump according to paragraph A63, wherein the barrier comprises an anti-bacterial agent.

[0194] A65 Blood pump according to paragraph A63 or A64, wherein the barrier is of a fleece-like material.

[0195] A66 Blood pump according to any one of the preceding paragraphs A63 to A65, wherein the barrier is of Dacron velour.

[0196] A67 Blood pump according to any one of the preceding paragraphs A1 to A66, wherein the residual portion comprises a skin passage portion.

[0197] A68 Blood pump according to paragraph A67, wherein the skin passage portion is configured to be disposed in the area of the skin exit site when the pumping section is deployed.

[0198] A69 Blood pump according to paragraph A67 or A68, wherein the skin passage portion comprises an anti-bacterial or anti-microbial agent.

[0199] A70 Blood pump according to paragraph A69, wherein the anti-bacterial or anti-microbial agent is a sustained silver ion releasing coating.

[0200] A71 Blood pump according to paragraph A70, wherein the sustained silver ion releasing coating comprises Ag-containing polymers or nanoparticles.

[0201] A72 Blood pump according to paragraph A69, wherein the anti-bacterial agent or anti-microbial agent is a surface functionalization of the skin passage portion with anti- microbial Peptides (AMPs).

[0202] A73 Blood pump according to paragraph A72, wherein the anti- microbial Peptides (AMPs) are amphipathic and hydrophobic helices, and / or p sheet peptides and small proteins, and / or peptides with thioether rings, and / or peptides with unique amino acid compositions like NEW PCT application

[0203] Abiomed Europe GmbH 215040 PWO October 28, 2025

[0204] 21 / 30 anchor peptide LCI and / or lipopeptides terminating in an amino alcohol and macro-cyclic knotted peptides.

[0205] A74 Blood pump according to paragraph A69, wherein the anti-bacterial or anti-microbial agent is a biomimetic nitric Oxide releasing coating using NO donors or selenium.

[0206] A75 Blood pump according to paragraph A69, wherein the anti-bacterial or anti-microbial agent is a surface modification of the skin passage portion by Azetidinium couplers.

[0207] A75 Blood pump according to paragraph A69, wherein the anti-bacterial or anti-microbial agent is a surface modification of the skin passage portion by polyzwitterionic polymers.

[0208] A76 Blood pump according to any one of the preceding paragraphs A1 to A75, wherein the catheter comprises a base body and a transparent sheathing covering at least a part of the base body.

[0209] A77 Blood pump according to paragraph A76, wherein the base body comprises markings on an outer peripheral surface.

[0210] A78 Blood pump according to paragraph A77, wherein the markings are formed by laser marking and / or printing.

[0211] B1 Blood pump system comprising a blood pump according to any one of the preceding paragraphs A1 to A78.

[0212] B2 Blood pump system according to paragraph B1 , wherein at least a part of the intravascular portion is disposed distally of the skin exit site when the pumping section is deployed.

[0213] B3 Blood pump system according to paragraph B1 or B2, wherein at least a part of the residual portion is disposed proximally of the skin exit site when the pumping section is deployed.

[0214] B4 Blood pump system according to any one of the preceding paragraphs B1 to B3, wherein the blood pump system comprises a hemostasis valve which forms the skin exit site.

[0215] As utilized herein, the terms “approximately”, “about”, “substantially” and similar terms are intended to have a broad meaning in harmony with the common and accepted usage by those of ordinary skill in the art to which the subject matter of this disclosure pertains. It should be understood by those of skill in the art who review this disclosure that these terms are intended to allow a description of certain features described without restricting the scope of these features to the precise numerical ranges provided. Accordingly, these terms should be interpreted as indicating that insubstantial or inconsequential modifications or alterations of the subject matter described and are considered to be NEW PCT application

[0216] Abiomed Europe GmbH

[0217] 215040 PWO

[0218] October 28, 2025

[0219] 22 / 30 within the scope of the disclosure. The terms „at least partially”, “at least a part” or “partially” as used herein mean both partial and entirely or complete respectively. Furthermore, terms like “first” or “second” do not imply a specific order, but are only intended to allow for linguistic differentiation between the elements.

[0220] NEW PCT application Abiomed Europe GmbH 215040 PWO October 28, 2025

[0221] 23 / 30

[0222] List of reference signs

[0223] 10 blood pump

[0224] 12 pumping section

[0225] 14 pump housing

[0226] 16 blood flow inlet

[0227] 18 blood flow outlet

[0228] 20 catheter / cable

[0229] 22 cannula

[0230] 24 electrical wire

[0231] 26 drive unit

[0232] 28 impeller

[0233] 30 blood flow passage

[0234] 32 first bearing

[0235] 33 second bearing

[0236] 34 post

[0237] 36 coil winding

[0238] 38 magnet

[0239] 40 lumen

[0240] 42 distal end

[0241] 44 proximal end

[0242] 46 connector

[0243] 48 main body

[0244] 50 intravascular portion

[0245] 52 residual portion

[0246] 54 transition portion

[0247] 56 normal portion

[0248] 58 skin passage portion

[0249] 60 barrier

[0250] 62 outer sheathing

[0251] 64 intravascular part

[0252] 66 detachable part

[0253] 68 tool

[0254] 70 breaking structure

[0255] 72 longitudinal tear structure

[0256] 74 tear-off aid

[0257] 76 lumen NEW PCT application Abiomed Europe GmbH 215040 PWO

[0258] October 28, 2025

[0259] 24 / 30

[0260] 78 elongated stiffening member

[0261] 80 first portion

[0262] 82 second portion

[0263] 84 intermediate portion

[0264] 86 anti-rotation lock

[0265] 90 hemostasis valve

[0266] 92 base body

[0267] 94 transparent sheathing

[0268] 96 markings

[0269] 98 outer peripheral surface of base body

[0270] AR axis of rotation

[0271] ES skin exit site

[0272] VT vascular transition

Claims

NEW PCT applicationAbiomed Europe GmbH215040 PWOOctober 28, 202525 / 30CLAIMS1 . Blood pump (10) comprising: a pumping section (12) configured to be placed in a human body and a catheter (20), wherein the catheter (20) comprises a distal end (42), a proximal end (44), a main body (48) extending between the distal end (42) and the proximal end (44), an intravascular portion (50) and a residual portion (52), wherein the distal end (42) of the catheter (20) is connected to the pumping section (12), wherein the intravascular portion (50) is directly adjacent to the residual portion (52) and extends from the residual portion (52) to the distal end (42), wherein at least a part of the intravascular portion (50) is configured to be disposed distally of a skin exit site (ES) when the pumping section (12) is deployed, wherein at least a part of the residual portion (52) is configured to be disposed proximally of the skin exit site (SE) when the pumping section (12) is deployed, and wherein the intravascular portion (50) has a first stiffness and the residual portion (52) at least partially has a second stiffness, wherein the first stiffness is higher than the second stiffness.

2. Blood pump (10) according to claim 1 , wherein the catheter (20) comprises an outer sheathing (62) providing the first stiffness, wherein the outer sheathing (62) is provided about an outer circumferential surface of at least a part of the main body (48) and extends from the distal end (42) in a direction of the proximal end (44), wherein the outer sheathing (62) is configured to be removable at least in parts (66), so that the residual portion (52) is at least partially formed by removing a part (66) of the outer sheathing (62).

3. Blood pump (10) according to claim 2, wherein the outer sheathing (62) comprises at least one longitudinal tear structure (72) at least partially extending along the outer sheathing (62), wherein the tear structure (72) is configured to be mechanically torn open, wherein the outer sheathing (62) preferably comprises two tear structures (72) at least partially extending along the outer sheathing (62) in parallel.

4. Blood pump (10) according to claim 3, wherein the blood pump (10) comprises at least one tear-off aid (74), wherein movement of the at least one tear-off aid (74) relative to the main body (48) tears open the at least one tear structure (72).NEW PCT application Abiomed Europe GmbH 215040 PWO October 28, 202526 / 305. Blood pump (10) according to any one of the preceding claims 2 to 4, wherein the outer sheathing (62) comprises at least one circumferential breaking structure (70), wherein the breaking structure (70) is configured to break open and to separate the outer sheathing (62) into two parts (64, 66) when a mechanical force is applied.

6. Blood pump (10) according to claim 5, wherein the mechanical force to be applied for separating the outer sheathing (62) into two parts (64, 66) includes a relative movement of the to be separated parts (64, 66), wherein the mechanical force preferably includes at least one of twisting or pulling apart.

7. Blood pump (10) according to any one of the preceding claims, wherein the residual portion (52) comprises a transition portion (54) and a normal portion (56), wherein the transition portion (54) is disposed between the normal portion (56) and the intravascular portion (50), wherein the stiffness of the transition portion (54) gradually decreases in a direction from the intravascular portion (50) to the normal portion (56).

8. Blood pump (10) according to claim 7, wherein the stiffness decrease in the transition portion (54) is continuous and the stiffness of the transition portion (54) is always lower than the stiffness of the intravascular portion (50) and always higher than the stiffness of the normal portion (56).

9. Blood pump (10) according to any one of the preceding claims, wherein the main body (48) comprises a lumen (76), wherein the lumen (76) is configured to receive at least one elongated stiffness increasing member (78).

10. Blood pump (10) according to claim 9, wherein at least one elongated stiffness increasing member (78) providing the first stiffness is disposed in the lumen (76).11 . Blood pump (10) according to claim 9 or 10, wherein the elongated stiffness increasing member (78) comprises a first portion (80) and a second portion (82), wherein the second portion (82) provides a stiffness different from the first stiffness.

12. Blood pump (10) according to claim 11 , wherein the second portion (82) provides the second stiffness.

13. Blood pump (10) according to claim 11 or 12, wherein an intermediate portion (84) is provided between the first portion (80) and the second portion (82), the intermediate portion (84)NEW PCT applicationAbiomed Europe GmbH215040 PWOOctober 28, 202527 / 30 providing a gradual transition from the first stiffness to the second stiffness along the intermediate portion (84).

14. Blood pump (10) according to any one of the preceding claims, wherein at least the part of the main body (48) in the residual portion (52) at least partially comprises a mechanical property changing material, wherein the mechanical property changing material is configured to change its stiffness.

15. Blood pump (10) according to claim 9, wherein the mechanical property changing material is configured to change its stiffness induced by a trigger.

16. Blood pump (10) according to claim 10, wherein the trigger includes one or more of application of UV- light, application of a base, application of an acid, application of electrical energy, application of heat, application of mechanical energy, application of ultrasonic energy, and application of moisture.

17. Blood pump (10) according to any one of the preceding claims 9 to 11 , wherein the mechanical property changing material is configured to lower its stiffness induced by the trigger.

18. Blood pump (10) according to any one of the preceding claims 9 to 12, wherein the mechanical property changing material is a polymer, preferably a thermoplastic polyurethan or a thermoplastic elastomer, more preferably an amorphous or semi-crystalline thermoplastic polyurethan or thermoplastic elastomer, and even more preferably a polycarbonate-based aliphatic thermoplastic polyurethan.

19. Blood pump (10) according to any one of the preceding claims 9 to 13, wherein the mechanical property changing material is a hygroscopic polymer.

20. Blood pump (10) according to any one of the preceding claims, wherein at least a part of the main body (48) in the residual portion (52) has a smaller diameter than the part of the main body (48) in the intravascular portion (50).21 . Blood pump (10) according to any one of the preceding claims, wherein the first stiffness ranges between 30D and 70D durometer hardness measured according to ASTM D2240.NEW PCT applicationAbiomed Europe GmbH215040 PWOOctober 28, 202528 / 3022. Blood pump (10) according to any one of the preceding claims, wherein the second stiffness ranges between 20A and 80A durometer hardness measured according to ASTM D2240.

23. Blood pump (10) according to any one of the preceding claims, wherein the main body (48) of the catheter (20) comprises a skin passage portion (58) configured to be disposed in the area of the skin exit site when the pumping section (12) is deployed.

24. Blood pump (10) according to claim 23, wherein the skin passage portion is a smaller diameter portion having a smaller diameter than the intravascular portion (50).

25. Blood pump (10) according to claim 23 or 24, wherein the skin passage portion (58) comprises an anti-bacterial or anti-microbial agent.

26. Blood pump (10) according to claim 25, wherein the anti-bacterial or anti-microbial agent is a sustained silver ion releasing coating.

27. Blood pump (10) according to claim 26, wherein the sustained silver ion releasing coating comprises Ag-containing polymers or nanoparticles.

28. Blood pump (10) according to claim 25, wherein the anti-bacterial or anti-microbial agent is a surface functionalization of the skin passage portion (58) with anti- microbial peptides.

29. Blood pump (10) according to claim 28, wherein the anti-microbial peptides are amphipathic and hydrophobic helices, or p sheet peptides and small proteins, or peptides with thioether rings, or peptides with unique amino acid compositions like anchor peptide LCI, or lipopeptides terminating in an amino alcohol and macro-cyclic knotted peptides.

30. Blood pump (10) according to claim 25, wherein the anti-bacterial or anti-microbial agent is a biomimetic nitric Oxide releasing coating, preferably using NO donors or selenium functional polymers.31 . Blood pump (10) according to claim 25, wherein the anti-bacterial and anti-microbial agent is a surface modification of the skin passage portion (58) by Azetidinium couplers or a surface modification of the skin passage portion (58) by polyzwitterionic polymers.

32. Blood pump (10) according to any one of the preceding claims 23 to 31 , wherein a barrier (60) is disposed about the skin passage portion (58).NEW PCT application Abiomed Europe GmbH 215040 PWO October 28, 202529 / 3033. Blood pump (10) according to claim 32, the barrier (60) comprises an anti-bacterial or antimicrobial agent.

34. Blood pump (10) according to claim 32 or 33, wherein the barrier (60) is of a fleece- like material, preferably of Dacron velour.

35. Blood pump (10) according to any one of the preceding claims, wherein least a part of the main body (48) of the catheter (20) comprises a base body (92) and a transparent sheathing (94) covering at least a part of the base body (92).

36. Blood pump (10) according to claim 35, wherein the base body (92) comprises markings (96) on an outer peripheral surface (98), wherein the markings (96) are preferably formed by laser marking and / or printing.

37. Blood pump system a blood pump (10) according to any one of the preceding claims, wherein at least a part of the intravascular portion (50) is disposed distally of the skin exit site (ES) when the pumping section (12) is deployed, and wherein at least a part of the residual portion (52) is disposed proximally of the skin exit site (ES) when the pumping section (12) is deployed.

38. Blood pump system according to claim 37, wherein the blood pump system comprises a hemostasis valve which forms the skin exit site (ES).

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