An intravascular blood pump in combination with a catheter configured to control the position of the pump within a patient's heart - Patents.com

Abstract

A drive component and rotor housing for use in an intravascular blood pump, such as a blood pump, configured to make the pump section more resistant to bending, kinking, and / or plastic deformation in combination with a catheter that controls the position of the intravascular blood pump to mitigate suction events that may occur due to the proximity of the pump section to the patient's vasculature.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to and the benefit of U.S. Provisional Patent Application No. 63 / 238,999, filed August 31, 2021, and U.S. Provisional Patent Application No. 63 / 245,308, filed September 17, 2021, the disclosures of which are incorporated by reference in their entireties into this document. [Background technology]

[0002] background

[0002] An intravascular blood pump may be surgically or percutaneously introduced into a patient and used to pump blood from one location in the heart or circulatory system to another location in the heart or circulatory system. For example, when deployed in the left heart, an intravascular blood pump may pump blood from the left ventricle into the aorta. Similarly, when deployed in the right heart, an intravascular blood pump may pump blood from the inferior vena cava into the pulmonary artery. An intravascular blood pump may be powered by a motor located outside the patient's body via an elongated drive shaft or by an internal motor located inside the patient's body. Some intravascular blood pump systems may operate in parallel with the natural heart to supplement cardiac output and partially or fully offload the cardiac components.

[0003]

[0003] Intravascular blood pumps for percutaneous insertion are typically delivered to a patient connected to a catheter. The catheter may extend from a distal end to a proximal end along a longitudinal axis, with the pump device attached to the catheter at the end remote from an operator, such as a surgeon. The pump device may be inserted through the femoral artery or aorta into the patient's left ventricle by manipulation of the catheter. Blood pumps are often equipped with an atraumatic tip at their more distal end (i.e., distal to the pump device). The atraumatic tip reduces any damage to the patient's soft tissues when the blood pump is positioned in the patient's heart.

[0004]

[0004] Once a blood pump is inserted into a patient's heart, the pumping device of the blood pump typically positions itself near the ventricular wall (i.e., the septum) or near the mitral valve of the heart. Although the positioning of the pumping device is itself atraumatic to the patient's vasculature and the heart itself, when the blood pump operates in this position, it may cause suction against the walls of the heart, the heart valve (e.g., the mitral valve), or any other anatomical structure in the heart. Furthermore, a pumping device positioned near the septum may generate vibrations in the pump system, cannulae, and catheters, and such vibrations may cause cardiac rhythm abnormalities. Positioning the pumping device in the ventricular apex (away from the septum and mitral valve) is thought to alleviate the above-mentioned problems, but precise positioning of the pumping device in the ventricular apex is difficult to achieve. Summary of the Invention [Problem to be solved by the invention]

[0005]

[0005] Therefore, a need exists for a blood pump having a catheter configured to allow control of the position of the pumping apparatus of the blood pump when inserted into a patient's heart. [Means for solving the problem]

[0006] overview

[0006] The present technology relates to improved drive components and rotor housings for use in intravascular blood pumps, such as blood pumps, configured to make the pump section more resistant to bending, kinking, and / or plastic deformation in combination with a catheter that controls the position of the intravascular blood pump to mitigate suction events due to the proximity of the pump section to the patient's vasculature. In some embodiments, the disclosed intravascular blood pumps may include a motor located outside the patient's body, and the rotor is driven by a flexible drive shaft. The intravascular blood pumps may also include motors located inside the patient's body, those without expandable and compressible rotor housings, those with rigid drive shafts, those with shorter flexible drive shafts, etc.

[0007]

[0007] Further described herein is a sleeve configured to control the position of a blood pump while the catheter is in the patient's heart. The sleeve may include a plurality of annular rings, at least two connectors arranged between each of the plurality of annular rings to connect each of the plurality of annular rings, and a plurality of openings formed between each annular ring and arranged in a repeating and optionally alternating manner. The sleeve may be adapted to be monolithically integrated with or placed over a predefined bending region of a catheter at a proximal end of a pumping device of the blood pump.

[0008]

[0008] Also described herein is a blood pump comprising the above-mentioned sleeve. The blood pump may include a catheter having a predefined bending region, a pumping device connected to the catheter, and a sleeve configured to control the position of the blood pump while the catheter is in the patient's heart. The sleeve may be adapted to be monolithically integrated with or placed over the predefined bending region of the catheter at the proximal end of the pumping device of the blood pump.

[0009] In one aspect, the present disclosure describes an intravascular blood pump including: a catheter; a housing in which a rotor is housed, the housing attached to a distal end of the catheter; and a drive shaft extending through the catheter and connected to the rotor, at least a portion of the drive shaft being flexible and including an outer layer of wound or braided wire, an inner layer of wound or braided wire, and a reinforcing element disposed within at least the outer layer of wound or braided wire, the drive shaft being rotatably supported in a proximal bearing located proximal to the rotor and a distal bearing located distal to the rotor, and the reinforcing element extending from at least a point in the proximal bearing to a point in the distal bearing. In some aspects, the reinforcing element extends from a point proximal to the proximal bearing to a point in the distal bearing. In some aspects, the proximal bearing includes a bearing sleeve attached to the drive shaft and an outer bearing ring attached to the housing, the bearing sleeve configured to rotate within the outer bearing ring. In some aspects, the intravascular blood pump further includes a restrictive element attached to the housing and located proximal to the proximal bearing and configured to prevent the bearing sleeve from being removed from the outer bearing ring. In some aspects, the reinforcing element includes a stepped proximal end with a smaller diameter portion and a larger diameter portion. In some aspects, the smaller diameter portion extends from a point at or substantially near where the catheter attaches to the housing to a point in the restrictive element. In some aspects, the smaller diameter portion extends from a point in the restrictive element to a point in the proximal bearing. In some aspects, the larger diameter portion extends from a point in the restrictive element to a point in the distal bearing. In some aspects, the inner layer of wound or braided wire is omitted between the point in the restrictive element and the point in the distal bearing. In some aspects, the larger diameter portion extends from a point in the proximal bearing to a point in the distal bearing. In some aspects, the inner layer of wound or braided wire is omitted between the point in the proximal bearing and the point in the distal bearing. In some aspects, the reinforcing element includes Nitinol or Ultra-Stiff Nitinol. In some embodiments, the housing includes a cage surrounding the rotor, the cage having a plurality of struts.In some embodiments, at a first point proximal to the rotor, each of the plurality of struts has a circumferential width and a radial thickness, the circumferential width being 1.2 to 1.8 times the radial thickness. In some embodiments, at a first point proximal to the rotor, each of the plurality of struts has a circumferential width and a radial thickness, the circumferential width being 1.2 to 1.3 times the radial thickness. In some embodiments, at a first point proximal to the rotor, each of the plurality of struts has a circumferential width and a radial thickness, the circumferential width being about 1.26 times the radial thickness. In some embodiments, at a second point distal to the rotor, each of the plurality of struts has a circumferential width and a radial thickness, the circumferential width being 1.2 to 1.8 times the radial thickness. In some embodiments, at a second point distal to the rotor, each of the plurality of struts has a circumferential width and a radial thickness, the circumferential width being 1.2 to 1.3 times the radial thickness. In some embodiments, at a second point distal to the rotor, each of the plurality of struts has a circumferential width and a radial thickness, the circumferential width being about 1.26 times the radial thickness. In some embodiments, at a third point proximal to the rotor and distal to the first point, each of the plurality of struts has a circumferential width and a radial thickness, the circumferential width being 1.0 to 1.6 times the radial thickness. In some embodiments, at a third point proximal to the rotor and distal to the first point, each of the plurality of struts has a circumferential width and a radial thickness, the circumferential width being 1.0 to 1.15 times the radial thickness. In some embodiments, at a third point proximal to the rotor and distal to the first point, each of the plurality of struts has a circumferential width and a radial thickness, the circumferential width being about 1.26 times the radial thickness. In some embodiments, at a third point proximal to the rotor and distal to the first point, each strut of the plurality of struts has a circumferential width and a radial thickness, the circumferential width being about 1.09 times the radial thickness. In some embodiments, at a fourth point distal to the rotor and proximal to the second point, each strut of the plurality of struts has a circumferential width and a radial thickness, the circumferential width being 1.0-1.6 times the radial thickness. In some embodiments, at a fourth point distal to the rotor and proximal to the second point, each strut of the plurality of struts has a circumferential width and a radial thickness, the circumferential width being 1.0-1.15 times the radial thickness.In some embodiments, at a fourth point distal to the rotor and proximal to the second point, each strut of the plurality of struts has a circumferential width and a radial thickness, the circumferential width being about 1.26 times the radial thickness. In some embodiments, at a fourth point distal to the rotor and proximal to the second point, each strut of the plurality of struts has a circumferential width and a radial thickness, the circumferential width being about 1.09 times the radial thickness. In some embodiments, the housing comprises Nitinol or Ultra-Stiff Nitinol. In some embodiments, the larger diameter portion is configured to fit within an outer layer of wound or braided wire in a portion of the drive shaft where the inner layer of wound or braided wire is omitted.

[0010]

[0010] In another aspect, the present disclosure describes a blood pump comprising: (1) a catheter having a distal end and a predefined bend region positioned proximal to the distal end; (2) a pumping device connected to the distal end of the catheter; and (3) a sleeve configured to control the position of the pumping device within a patient's heart, the sleeve comprising: a plurality of annular rings; at least two connectors disposed between each of the plurality of annular rings for connecting each of the plurality of annular rings, the at least two connectors being offset from adjacent connectors; and a plurality of openings formed between each of the rings, the sleeve being configured to be monolithically integrated with or placed over the predefined bend region of the catheter, thereby providing the catheter with a predefined elastic bend at the predefined bend region. In some aspects, the blood pump further comprises an atraumatic tip at the distal end of the blood pump. In some embodiments, the predefined bend region of the catheter is adapted to contact the endothelium of the aorta when the blood pump is inserted into the patient's heart, thereby supporting the pump device and aligning the atraumatic tip with the aortic valve of the patient's heart, thereby positioning the pump device within the patient's ventricle. In some embodiments, the atraumatic tip is out of plane at 110-140 degrees, optionally 120-130 degrees, and optionally 130 degrees, relative to the plane in which the sleeve lies when bent. In some embodiments, the plurality of openings are formed in radially matching pairs that define a 180 degree semicircle around the sleeve. In some embodiments, each of the openings extends approximately halfway around the sleeve, and each opening has a connector at the end of the opening. In some embodiments, the radially corresponding pairs of openings share a common axis and are laterally offset from one another in an alternating manner. In some embodiments, the plurality of annular rings are spaced apart by a uniform distance when the sleeve is in a straight configuration. In some embodiments, the length of the sleeve corresponds to the length of a predefined bend region on the catheter.

[0011]

[0011] In another aspect, the present disclosure describes a catheter sleeve comprising: a plurality of annular rings; at least two connectors disposed between each of the plurality of annular rings to connect each of the plurality of annular rings, the at least two connectors being offset from at least one adjacent connector; and a plurality of openings formed between each of the annular rings and arranged in an alternating manner, the sleeve being configured to be monolithically integrated with or placed over a predefined bending region of the catheter, thereby providing a predefined elastic bend in the catheter. [Brief description of the drawings]

[0012] BRIEF DESCRIPTION OF THE DRAWINGS [Figure 1] 1 illustrates an exemplary intravascular blood pump positioned within the left ventricle in accordance with an aspect of the present disclosure. [Diagram 2]

[0013] 1 illustrates an exemplary intravascular blood pump according to aspects of the present disclosure. [Diagram 3]

[0014] 1 illustrates a cross-sectional view of an exemplary configuration of a proximal end of a pump section of an intravascular blood pump according to an aspect of the present disclosure. [Figure 4A]

[0015] 1 illustrates a cross-sectional view of an exemplary configuration of a pump section of an intravascular blood pump according to aspects of the present disclosure. [Figure 4B]

[0015] A cross-sectional view of an exemplary configuration of a pump section of an intravascular blood pump according to an aspect of the present disclosure is shown. [Figure 5A]

[0016] 1 illustrates a cross-sectional view of an exemplary configuration of a pump section of an intravascular blood pump according to aspects of the present disclosure. [Figure 5B]

[0016] A cross-sectional view of an exemplary configuration of a pump section of an intravascular blood pump according to an aspect of the present disclosure is shown. [Figure 6A]

[0017] FIG. 2 illustrates a side view of an exemplary pump housing according to aspects of the present disclosure. [Figure 6B]

[0018] 6B shows a cross-sectional view of the pump housing of FIG. 6A taken along line AA. [Figure 7A]

[0019] 1 shows an intravascular blood pump with a catheter placed into the aorta and into the patient's heart. [Figure 7B]

[0020] 1 shows an intravascular blood pump with a catheter and a sleeve placed thereon. [Figure 7C]

[0021] FIG. 7C is a bottom view of an intravascular blood pump with the catheter of FIG. 7B. [Figure 8]

[0022] 7B shows the portion of the catheter of FIG. 7A with a sleeve in place. [Figure 9]

[0023] 7B is a perspective view of a first embodiment of a sleeve configured for use with the catheter of the intravascular blood pump of FIG. 7A. [Figure 10]

[0024] 10 is another perspective view of the sleeve of FIG. 9. [Figure 11]

[0025] FIG. 10 is a top view of the sleeve of FIG. [Figure 12]

[0026] 7B is a perspective view of a second embodiment of a sleeve configured for use with the catheter of the intravascular blood pump of FIG. 7A. [Figure 13]

[0027] 13 is another perspective view of the sleeve of FIG. 12. [Figure 14]

[0028] FIG. 13 is a top view of the sleeve of FIG. 12. [Figure 15]

[0029] 7B is a perspective view of a third embodiment of a sleeve configured for use with the catheter of the intravascular blood pump of FIG. 7A. [Figure 16]

[0030] FIG. 16 is another perspective view of the sleeve of FIG. [Figure 17]

[0031] 7B is a perspective view of a fourth embodiment of a sleeve configured for use with the catheter of the intravascular blood pump of FIG. 7A. [Figure 18]

[0032] 7B is a perspective view of a fifth embodiment of a sleeve configured for use with the catheter of the intravascular blood pump of FIG. 7A. [Figure 19]

[0033] 7B is a perspective view of a sixth embodiment of a sleeve configured for use with the catheter of the intravascular blood pump of FIG. 7A. [Figure 20]

[0034] FIG. 20 is a side view of the sleeve of FIG. 19. [Figure 21]

[0035] 7B is a perspective view of a seventh embodiment of a sleeve configured for use with the catheter of the intravascular blood pump of FIG. 7A. [Figure 22]

[0036] FIG. 22 is a side view of the sleeve of FIG. 21. [Figure 23]

[0037] 7B is a perspective view of an eighth embodiment of a sleeve configured for use with the catheter of the intravascular blood pump of FIG. 7A. [Figure 24]

[0038] FIG. 24 is a side view of the sleeve of FIG. 23. [Diagram 25]

[0039] 1 is a perspective view of a portion of a sleeve having a strain relief section according to some embodiments. [Figure 26]

[0040] FIG. 26 is a side view of the sleeve of the strain relief section of the sleeve of FIG. 25. [Figure 27]

[0041] 13 is a perspective view of a sleeve having a strain relief section according to another embodiment. FIG. [Figure 28]

[0042] FIG. 28 is an enlarged side view of the tension relief section of FIG. 27. [Figure 29]

[0043] 1 shows an intravascular blood pump with a catheter and sleeve portion. [Diagram 30]

[0044] 1 illustrates another embodiment of an intravascular blood pump comprising a catheter and sleeve portion. [Diagram 31]

[0045] 1 shows an intravascular blood pump placed in a patient's heart via a catheter passing through the aorta. [Diagram 32]

[0046] FIG. 28 is another view of the blood pump of FIG. 27 installed within a patient's heart. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0013] Detailed Description

[0047] The present technology will now be described with reference to several exemplary systems, methods, and devices. In that regard, it should be understood that the exemplary systems, methods, and devices disclosed herein are intended merely to illustrate examples of the present technology, which may be realized in various forms. As such, well-known functions or structures will not be described in detail to avoid obscuring the present disclosure in unnecessary detail. Similarly, specific structural and functional details disclosed herein should not be construed as limitations, but merely as a representative basis for the claims and for teaching those skilled in the art to use the present disclosure in other suitable structures. In that regard, although various examples may illustrate specific medical procedures and / or uses of intravascular blood pumps, it will be understood that the present technology may be used in any suitable context.

[0014]

[0048] The terms "proximal" and "distal" as used herein refer to the location of the intravascular blood pump relative to a physician or operator. Thus, "proximal" refers to a location closer to or toward a physician or operator, and "distal" refers to a location away from or toward a physician or operator. Additionally, the terms "bearing sleeve," "outer sleeve," and "sleeve" as used herein are three separate items. Specifically, the "bearing sleeve" and "outer sleeve" are structures disposed within the intravascular blood pump, while the "sleeve" is a structure positioned on the outside of the intravascular blood pump. In this disclosure, reference numbers shared between drawings are meant to identify similar or identical elements.

[0015]

[0049] FIG. 1 illustrates an exemplary use of an intravascular blood pump 1 to support the left ventricle 2 of a human heart 3. The intravascular blood pump 1 may include a catheter 5 and a pump section 4 attached to a distal end region of the catheter 5. The intravascular blood pump 1 may be placed in the human heart 3 using percutaneous, transluminal techniques. For example, the intravascular blood pump 1 may be introduced through the femoral artery. Similarly, the intravascular blood pump 1 may be introduced through other blood vessels, for example through the subclavian artery. As shown in FIG. 1, the catheter 5 may be pushed into the aorta, allowing the pump section 4 to pass through the aortic valve and into the heart.

[0016]

[0050] The pump section 4 may further include a rotor (not shown in FIG. 1 ) that allows blood to flow from a blood inlet 6 at a distal end of the pump section 4 to a blood outlet 7 located proximal to the blood inlet 6. By locating the blood inlet 6 in the left ventricle 2 and the blood outlet 7 in the aorta, the intravascular blood pump 1 may support a patient's systemic blood circulation. If the intravascular blood pump 1 is configured and located differently, for example, it may instead be used to support a patient's pulmonary blood circulation.

[0017]

[0051] Catheter 5 may further house a drive shaft (not shown in FIG. 1 ) configured to be driven by an electric motor 8, which may be positioned outside the patient's body. The drive shaft may be configured to drive a rotor (not shown in FIG. 1 ) contained within pump section 4.

[0018]

[0052] 1 and 2, the pump section 4 may also have a flexible atraumatic tip 9 at its distal end. The flexible atraumatic tip 9 may have any suitable shape, such as a pigtail or J-shape, and may be configured to facilitate placement of the intravascular blood pump 1 by aiding in navigation within the patient's vascular system. Additionally, the flexibility of the flexible atraumatic tip 9 may be configured to enable the pump section 4 to atraumatically support itself against the wall of the left ventricle 2.

[0019]

[0053] FIG. 2 illustrates an exemplary intravascular blood pump 1 according to certain aspects of the present disclosure. As shown in FIG. 2, rotor 10 may be located within housing 11, and housing 11 may form a cage around rotor 10. Both rotor 10 and housing 11 may be made compressible, such that intravascular blood pump 1 may be inserted into and / or through a patient's vasculature while both rotor 10 and housing 11 are in their compressed states, and rotor 10 and housing 11 may be expanded once pump section 4 is positioned at or near its target location within the patient's heart. For example, in some embodiments, expansion may occur when housing 11 is in the ventricle, ascending aorta, or descending aorta. Similarly, in some embodiments, expansion may occur immediately after housing 11 is introduced into the patient's vasculature, and then housing 11 is moved in its expanded state to its target location within the patient's heart. As will be appreciated, expansion may occur at any suitable location within the patient's vasculature, for example, at a portion of the patient's vasculature having a diameter greater than the diameter of the expanded housing 11. In some embodiments, the rotor 10 and the housing 11 may be formed from any suitable material or materials. For example, in some aspects of the present technology, the rotor 10 and / or the housing 11 may be produced at least in part from polyurethane, silicone rubber, a shape memory material such as Nitinol or Ultra-Stiff Nitinol ("USN"), or the like.

[0020]

[0054] The drive shaft 12 may extend through the entire catheter or only a portion thereof. In some embodiments, the drive shaft 12 is hollow along all or a portion of its length. The drive shaft 12 or portions thereof may be formed from a cable, a solid shaft, a hollow shaft, or a combination thereof. In that regard, the drive shaft 12 may be a flexible cable formed with any suitable number of differently oriented fiber layers (e.g., two layers, three layers, four layers, etc.). For example, the drive shaft 12 may be formed from multiple coaxial windings each with a different or alternating winding direction. In such an example, the different or alternating winding directions may extend helically around a lumen extending axially along the drive shaft. In some embodiments of the present technology, the drive shaft 12 may include two coaxial windings each with an opposite winding direction, and the outer diameter of the drive shaft may be 0.4 mm to 2 mm, preferably 0.6 mm to 1.2 mm, and particularly preferably 0.8 mm to 1.0 mm. Where the drive shaft 12 has at least one outer and / or inner layer including one or more windings, each wire of the winding may include, for example, one strand or several strands that may be twisted together. In some cases, the windings of a given layer may form a single helix. Likewise, in some cases, the windings of a given layer may include two or more helices, preferably axially shifted, similar to a multiple start thread. In some cases, the drive shaft 12 may include one or more layers of braided wire, similar to the outer sheath of a kernmantle rope. In all cases, the wire or wires of a given layer may be formed from any suitable metal or other material, and may further include one or more surface coatings.

[0021]

[0055] In some aspects of the present technology, a drive shaft 12 having one or more layers (e.g., as described herein) may be at least partially embedded or coated with a sealant that impregnates at least one layer. In some embodiments, such a sealant may be positioned to minimize and / or prevent the seepage of fluids (e.g., purge fluids, bodily fluids) through the respective layers of the drive shaft. In some aspects, the sealant may impregnate all layers. Any suitable sealant may be used in this regard. For example, in some aspects of the present technology, a sealant may be selected based on its ability to penetrate, as a fluid, into, between, and across layers and then harden. Any suitable material may be used as a sealant, such as an adhesive, a polymer, and / or a thermoplastic.

[0022]

[0056] Further, in some aspects of the present technology, a drive shaft 12 having one or more layers (e.g., as described herein) may be at least partially embedded or coated with two or more different adhesives. Thus, in some aspects, a first adhesive or sealant may be used to saturate one or more layers. For example, this first adhesive may be a sealant (as described herein) and may be selected to have a particularly low viscosity so that it can saturate the outer and / or inner windings completely. In that regard, the viscosity of the first adhesive may range from 80 cPs to 200 cPs before curing. A second adhesive may then be used to connect other members (e.g., rotor 10, bearing sleeve 30 (see below), restricting member 33 (see below)) to the drive shaft 12. In some aspects of the present technology, the second adhesive may have a higher viscosity than the first adhesive and thus a paste-like consistency. In some cases, the first adhesive and the second adhesive are both two-part epoxy resins (of the same or different types).

[0023]

[0057] As shown in the example of FIG. 2, the proximal end of the drive shaft 12 may be attached to an electric motor 8 outside the body. In such a configuration, the drive shaft 12 may extend through the catheter 5, protrude from the distal end of the catheter 5, and serve to transmit torque from the electric motor 8 to the rotor 10 at the distal end of the drive shaft 12. In some aspects of the present technology, the drive shaft 12 may include a stiff, rigid, and / or reinforced section at its distal end onto which the rotor 10 is mounted within the housing 11 to provide stability to the rotor. The rotor 10 may be configured such that, as it is rotated by the drive shaft 12, blood is drawn into the blood flow inlet 6 at the distal end of the housing 11 and pumped through the housing 11 into the downstream tube 20, which is attached to the housing 11 and extends proximally. The blood may then be discharged from the downstream tube 20 through a blood flow outlet 7 provided in the downstream tube 20. The blood flow outlet 7 may have a single opening or any suitable number of openings.

[0024]

[0058] In some aspects of the present technology, the downstream tube 20 may be made of one or more flexible materials such that it may be compressed by the aortic valve as the patient's heart beats. Similarly, in some aspects of the present technology, the downstream tube 20 may be configured to expand as a result of blood flow generated by the rotor 10 during rotation.

[0025]

[0059] FIG. 3 shows a cross-sectional view of an exemplary intravascular blood pump 1 including a housing 11 and a rotor 10 mounted on a drive shaft 12. The example of FIG. 3 employs a proximal bearing 13 disposed within a proximal end of the housing 11. As shown in FIG. 3, the proximal bearing 13 may include a bearing sleeve 30 rotatably supported within an outer bearing ring 32. The bearing sleeve 30 may be secured to the drive shaft 12 in any suitable manner. For example, in some aspects of the present technology, the drive shaft 12 may be joined with the bearing sleeve 30 using a suitable glue, weld, solder, or bonding material. Similarly, in some aspects, the bearing sleeve 30 may be crimped or cold secured to the drive shaft 12.

[0026]

[0060] The bearing sleeve 30 and the outer bearing ring 32 may be formed from any suitable material or materials. For example, in some embodiments of the present technology, the bearing sleeve 30 and / or the outer bearing ring 32 may be formed from one or more ceramics. Similarly, in some embodiments of the present technology, the bearing sleeve 30 and / or the outer bearing ring 32 may be formed from one or more metals, such as MP35, 35NLT, Nitinol, or stainless steel. Furthermore, when the bearing sleeve 30 and / or the outer bearing ring 32 are made from one or more metals, they may further include a hard coating, such as a coating made from diamond-like carbon ("DLC").

[0027]

[0061] The drive shaft 12 may take any of the forms described above with respect to FIG. 2 (e.g., a flexible cable formed of any suitable number of differently oriented fiber layers). In the example of FIG. 3, the drive shaft 12 further includes a lumen into which the reinforcing element 35 is inserted. The reinforcing element 35 may be formed from any suitable material or materials and configured in any suitable manner. For example, in some embodiments of the present technology, the reinforcing element 35 may be a solid rod or wire coaxially disposed within the drive shaft 12, made from, for example, spring steel, 1.4310 stainless steel, carbon wire, super-elastic or hyper-elastic materials such as Nitinol, Ultra-Stiff Nitinol, and the like. Similarly, in some embodiments of the present technology, the drive shaft 12 and / or the reinforcing element 35 may be hollow along some or all of its length such that it may also act as a conduit for the purge fluid. For example, in some cases, the reinforcing element may include a hollow tube.

[0028]

[0062] Additionally, the reinforcing element 35 may be of any suitable length and may be based on criteria including, but not necessarily limited to, optimizing the stiffness of the pump section, preventing plastic deformation during insertion, and / or reducing vibration during operation. For example, in some aspects of the present technology, the reinforcing element 35 may be configured to extend from a point proximal to the proximal bearing 13 to a distal end of the rotor 10 (not shown in FIG. 3). Similarly, in some aspects, the reinforcing element 35 may be configured to extend from a point proximal to the proximal bearing 13 to a point in the distal bearing (not shown in FIG. 3), for example, as shown in and described below with respect to FIGS. 4A, 4B, 5A, and 5B. Additionally, the reinforcing element 35 may be configured to extend from a point at or within the proximal bearing 13 to a point in the distal bearing.

[0029]

[0063] As shown in FIG. 3, a restricting member 33 may be located proximal to the proximal end of the bearing sleeve 30 to strengthen the assembly and prevent the bearing sleeve 30 from backing out and / or being removed from the outer bearing ring 32. The restricting member 33 and the outer bearing ring 32 may be secured to the bearing sleeve 30 in any suitable manner. For example, in some embodiments of the present technology, the restricting member 33 and the outer bearing ring 32 may be press-fitted into the proximal end of the housing 11. Similarly, in some embodiments, the restricting member 33 and the outer bearing ring 32 may be joined to the proximal end of the housing 11 using a suitable glue, weld, solder, or bonding material. Furthermore, the restricting member 33 may also be secured to the catheter 5 in any suitable manner. Thus, in some embodiments of the present technology, the restricting member 33 may be press-fitted into the catheter 5 or may be joined to the catheter 5 using a suitable glue, weld, solder, or bonding material. In this manner, the restricting member 33 also serves to connect the housing 11 and the catheter 5.

[0030]

[0064] As shown in FIG. 3, the proximal end of the housing 11 may include one or more through holes 34. In some embodiments, the through holes 34 may have any suitable shape and / or size. For example, in some aspects of the present technology, the through holes 34 may be round holes of a suitable diameter (e.g., 0.5 mm to 1 mm). Furthermore, in some aspects of the present technology, the through holes 34 may have a grooved shape extending in the circumferential direction, as shown, for example, in the left-most and center through holes 34 in FIG. 6A. Similarly, in some aspects of the present technology, the through holes 34 may be diamond pattern holes, as shown, for example, in the right-most through hole 34 in FIG. 6A. Furthermore, the outer bearing ring 32 and / or the restricting member 33 may also each include one or more recesses or grooves 36 corresponding to one of the through holes 34.

[0031]

[0065] The through holes 34 may increase the resiliency of the proximal end of the housing 11 to allow the outer bearing ring 32 and / or the restricting member 33 to be press-fit into the housing 11. Additionally, the through holes 34 and corresponding recesses / grooves 36 may be used during manufacturing to ensure that the outer bearing ring 32 and / or the restricting member 33 are properly positioned (e.g., such that a gap remains between the proximal end of the outer bearing ring 32 and the distal end of the restricting member 33).

[0032]

[0066] Additionally, the through holes 34 may be used to allow glue, welding, solder, or adhesive to be used to fixedly connect the outer bearing ring 32 and / or restricting member 33 to the housing 11. In such cases, the recesses / grooves 36 of the outer bearing ring 32 and / or restricting member 33 may also be configured to receive any glue, welding, solder, or adhesive used through the through holes 34 and / or to assist in allowing it to flow within the proximal end of the housing 11, increasing the surface area of ​​the resulting joint. In some aspects of the present technology, it may be advantageous to ensure that the glue, welding, solder, adhesive, or additional sealant can fill the entirety of any through holes 34 and / or recesses / grooves 36 to ensure that no fluid can pass through or out of them. For example, if a purge fluid is applied to the proximal bearing 13, filling and / or sealing the through holes 34 and grooves 36 may serve to prevent leakage of the purge fluid intended to flow between the bearing sleeve 30 and the outer bearing ring 32.

[0033]

[0067] As can be seen from FIG. 3, the bearing sleeve 30 includes a proximal portion 30a located proximally of the outer bearing ring 32 and a distal portion 30b extending distally from the proximal portion 30a into the outer bearing ring 32. The proximal portion 30a forms an axial bearing with the proximal surface of the outer bearing 32, while the distal portion 30b forms a radial bearing with the radial inner surface of the outer bearing ring 32. Thus, in the example of FIG. 3, the proximal bearing 13 includes both an axial bearing and a radial bearing. However, as will be appreciated, in some aspects of the present technology, the bearing sleeve 30 may be configured not to contact any proximal surface of the outer bearing ring 32, in which case the proximal bearing 13 may include only a radial bearing between the distal portion 30b of the bearing sleeve 30 and the radial inner surface of the outer bearing ring 32.

[0034]

[0068] In some aspects of the present technology, the intravascular blood pump 1 may be configured to provide a purge fluid to the proximal bearing 13, for example, to lubricate and / or cool it. In such a case, the purge fluid may be pumped distally to the proximal bearing 13, first passing the proximal portion 30a of the bearing sleeve 30 along its radially outer surface, then flowing radially inward between the distal surface of the proximal portion 30a and the proximal surface of the outer bearing ring 32, and then flowing distally between the distal portion 30b of the bearing sleeve 30 and the radially inner surface of the outer bearing ring 32. The bearing gaps between the distal surface of the proximal portion 30a and the proximal surface of the outer bearing ring 32, and between the distal portion 30b of the bearing sleeve 30 and the radially inner surface of the outer bearing ring 32, may be configured such that, upon application of a suitable pressure, the purge fluid flows through the bearing gaps in a precisely controllable manner. For example, in some embodiments of the present technology, the bearing gap between the distal portion 30b of the bearing sleeve 30 and the radially inner surface of the outer bearing ring 32 may be 1 μm to 10 μm wide, such as 2 μm to 8 μm wide, such as 3.5 μm wide.

[0035]

[0069] Additionally, in some aspects of the present technology, one or more radial notches (not shown) are provided in the proximal face of the stationary outer bearing ring 32 to provide additional space for purge fluid to flow when the bearing sleeve 30 is pulled distally. For example, in some aspects of the present technology, the rotor 10 and / or drive shaft 12 may be configured such that during operation, the rotor 10 has a tendency to pull and / or turn the drive shaft 12, causing the bearing sleeve 30 to move distally and thus press against the proximal face of the outer bearing ring 32.

[0036]

[0070] 4A and 4B show cross-sectional views of an exemplary configuration of a pump section of an intravascular blood pump according to an embodiment of the present disclosure. For example, FIG. 4A shows a portion of the distal end of intravascular blood pump 1, and FIG. 4B shows an enlarged view of the proximal end of housing 11. Except as described in detail below, elements in FIG. 4A and 4B that share the same reference numbers as those in FIG. 1-3 are intended to identify the same structure as described above. As such, any of the features and options described above with respect to such elements may apply to the exemplary configuration of FIG. 4A and 4B as well.

[0037]

[0071] In the example of Figures 4A and 4B, the reinforcing element 35 has a stepped proximal end and includes a smaller diameter portion 35a and a larger diameter portion 35b that extends from a point within the restricting member 33 to the distal end of the drive shaft 12. The drive shaft 12 may include an outer layer 12a of wound or braided wire, an inner layer 12b of wound or braided wire, and a lumen 12c. In Figure 4A, both the proximal end of the flexible atraumatic tip 9 and the distal bearing 39 are visible. In this example, the distal bearing 39 may include an outer sleeve 37 that houses a spiral bearing 38, which is configured to surround the drive shaft 12. Figure 4A also shows an optional mesh 41 placed over the blood flow inlet 6. Additionally, in some embodiments, another spiral bearing may also surround a portion of the drive shaft 12 proximal to the restricting member 33. For example, the spiral bearing may surround the drive shaft 12 from a point at or near the proximal end of the housing 11 to a point at or near the proximal end of the catheter 5 and may be configured to prevent the drive shaft 12 from rubbing against the inner surface of the catheter 5 as it rotates.

[0038]

[0072] In some embodiments, the reduced diameter portion 35a may begin and end anywhere within the proximal section 11a of the housing 11. For example, as shown in FIGS. 4A and 4B, the reduced diameter portion 35a at the proximal end of the reinforcing element 35 may extend from a point at or near (e.g., substantially near) where the catheter 5 is coupled to the proximal end of the housing 11 to a point within the restricting member 33. However, as will be appreciated, in some aspects of the present technology, the reduced diameter portion 35a may begin at a point distal to where the catheter 5 is coupled to the proximal end of the housing 11 and extend to a point proximal or distal to the restricting member 33. Additionally, as shown in FIGS. 4A and 4B, this reduced diameter portion 35a may be configured to be inserted within the lumen 12c, while the larger diameter portion 35b may be configured to fit within the outer layer 12a in the portion of the drive shaft 12 where the inner layer 12b is omitted.

[0039]

[0073] As will be appreciated, when the drive shaft 12 includes three or more layers of windings, a single stage reinforcing element, as shown in Figures 4A and 4B, may be arranged such that its smaller diameter portion 35a and larger diameter portion 35b are surrounded by any suitable combination of layers of windings. For example, in some embodiments, in a drive shaft having n layers, the smaller diameter portion 35a may be surrounded by the innermost layer 1, and the larger diameter portion 35b may be surrounded by layers 2 through n. Similarly, in some embodiments, in a drive shaft having three layers, the smaller diameter portion 35a may be surrounded by layer 2, and the larger diameter portion 35b may be surrounded by the outermost layer 3. Further, in some embodiments, in a drive shaft having three layers, the smaller diameter portion 35a may be surrounded by the innermost layer 1, and the larger diameter portion 35b may be surrounded by the outermost layer 3, such that there is a larger step between the smaller diameter portion 35a and the larger diameter portion 35b. It will also be appreciated that where drive shaft 12 includes more than two layers of windings, the reinforcing element may also be configured with more than two stages. Thus, for example, in a drive shaft having three layers, a two-stage reinforcing element may be used, with its narrowest portion surrounded by layer 1, its second widest portion surrounded by layer 2, and its widest portion surrounded by layer 3.

[0040]

[0074] Further, in some embodiments of the present technology, the proximal end of the reduced diameter portion 35a may also begin at a point proximal to the proximal end of the housing 11 or proximal to where the catheter 5 is bonded to the proximal end of the housing 11 (e.g., proximal to an area of ​​polymer reinforcement (not shown) on the outer periphery of the catheter 5 where the assembly may be stiffer) and extend to a point distal to the area where the catheter 5 is bonded to the proximal end of the housing 11 (e.g., distal to such area of ​​polymer reinforcement on the outer periphery of the catheter 5).

[0041]

[0075] In some applications, the reinforcing arrangement shown in Figures 4A and 4B may allow the large diameter portion 35b to be thicker than the lumen 12c, thereby increasing the stiffness of that portion of the drive shaft 12 than could be achieved with a smaller outer diameter reinforcing element (e.g., as shown in the example of Figure 3). In some embodiments, this allows the reinforcing element 35 to be manufactured from a material that may otherwise be too flexible and / or too soft if the entire reinforcing element 35 needs to fit within the lumen 12c. Thus, the present technology may expand the options for reinforcing the drive shaft 12 with materials such as Nitinol and Ultra-Stiff Nitinol, which are particularly resistant to plastic deformation because they are superelastic, and yet remain sufficiently stiff to control vibrations and prevent contact of the rotor 10 with the housing 11 (when the reinforcing element 35 is configured as shown in Figures 4A and 4B).

[0042]

[0076] In addition to the above, the stepped proximal end of the reinforcing element 35 may provide a more gradual transition in stiffness between the unreinforced and fully reinforced portions of the drive shaft 12, which may make the drive shaft 12 more resistant to kinking at or near the proximal end of the reinforcing element 35. Additionally, the reduced diameter portion 35a may provide an interface between the reinforcing element 35 and the inner layer 12b, which may facilitate bonding. In that regard, in some aspects of the present technology, the reinforcing element 35 may be secured within the drive shaft 12 using a suitable glue, weld, solder, or other suitable bonding material (not shown). Similarly, as shown in FIGS. 4A and 4B, the distal end of the reinforcing element 35 may be secured to the distal end of the drive shaft 12 using a suitable glue, weld, solder, or other suitable bonding material 40.

[0043]

[0077] 5A and 5B similarly illustrate cross-sectional views of an exemplary configuration of a pump section of an intravascular blood pump according to an embodiment of the present disclosure. In particular, FIG. 5A illustrates a portion of the distal end of intravascular blood pump 1, and FIG. 5B illustrates an enlarged view of the proximal end of housing 11. Except as described in detail below, elements in FIGS. 5A and 5B that share the same reference numbers as those in FIGS. 1-4B are meant to identify the same structure as described above. As such, any of the features and options described above with respect to such elements may apply to the exemplary configuration of FIGS. 5A and 5B as well.

[0044]

[0078] As in FIGS. 4A and 4B, the example of FIGS. 5A and 5B also includes a reinforcing element 35 with a stepped proximal end. Again, the smaller diameter portion 35a may begin and end anywhere within the proximal section 11a of the housing 11. Thus, as shown in the example of FIGS. 5A and 5B, the smaller diameter portion 35a may extend from a point within the restricting member 33 to a point within the proximal bearing 13, and the larger diameter portion 35b may extend from a point within the proximal bearing 13 to the distal end of the drive shaft 12. However, as will be appreciated, in some aspects of the present technology, the smaller diameter portion 35a may begin proximal or distal to the restricting member 33 and extend to a point proximal or distal to the proximal bearing 13. Again, the smaller diameter portion 35a may be configured to be inserted within the lumen 12c, while the larger diameter portion 35b may be configured to fit within the outer layer 12a in the portion of the drive shaft 12 where the inner layer 12b is omitted. Therefore, the arrangement of Figures 5A and 5B may provide the same advantages as those discussed above with respect to Figures 4A and 4B, however, by locating the transition between the smaller diameter portion 35a and the larger diameter portion 35b within the proximal bearing 13, and by locating the proximal end of the reinforcing member 35 within the restricting member 33, the example shown in Figures 5A and 5B may also reduce bending of these portions of the drive shaft 12, and therefore more resistant to kinking.

[0045]

[0079] Fig. 6A shows a side view of an exemplary pump housing according to an embodiment of the present disclosure, and Fig. 6B shows a cross-sectional view of the pump housing of Fig. 6A taken along line AA.

[0046]

[0080] The exemplary pump housing 11 of FIGS. 6A and 6B may be used with any of the examples shown and / or described herein. In this example, the housing 11 may include struts whose circumferential width exceeds their radial thickness. For example, in some embodiments of the present technology, at point 11a, the circumferential width w of the strut may be about 1.2-1.8 times its radial thickness t. For example, in some embodiments, at point 11a, the circumferential width w of the strut may be about 1.2-1.3 times its radial thickness t. In further embodiments, at point 11a, the circumferential width w of the strut may be about 1.26 times its radial thickness t. In some embodiments of the present technology, the struts of the housing 11 may have these same ratios (e.g., the circumferential width w is 1.2-1.8 times its radial thickness t) at each of points 11b, 11c, and 11d. Similarly, in some embodiments of the present technology, the struts at points 11a and 11d may have the same ratio of width w to radial thickness t, respectively, while the struts at points 11b and 11c may have a slightly more squared-off ratio. For example, in some embodiments, the circumferential width w of the struts at points 11a and 11d may be about 1.2-1.8 times the radial thickness t, while the circumferential width w of the struts at points 11b and 11c may be about 1.0-1.60 times the radial thickness t. In some embodiments, the circumferential width w of the struts at points 11a and 11d may be about 1.2-1.3 times the radial thickness t, while the circumferential width w of the struts at points 11b and 11c may be about 1.0-1.15 times the radial thickness t. In further aspects, the circumferential width w of the struts at points 11a and 11d may be about 1.26 times the radial thickness t, and the circumferential width w of the struts at points 11b and 11c may be about 1.09 times the radial thickness t. In this regard, in some aspects of the present technology, the radial thickness t may be constant throughout the housing 11, but the circumferential width w of the struts may vary along the length of the housing 11.

[0047]

[0081] As will be appreciated, increasing the strut cross-sectional area as described herein may result in pump housing 11 being substantially stiffer and therefore more resistant to kinking and / or plastic deformation, particularly around points 11a and 11d, which in turn may reduce the risk of drive shaft kinking as it passes through these same points. Additionally, while increasing the strut circumferential width w may reduce the area through which blood enters and exits housing 11 during pump operation, it has been found that the strut circumferential width can be increased in the ranges described herein without substantially increasing flow resistance and hemolysis. Additionally, it has been found that the strut circumferential width w can be increased in the ranges described herein without substantially increasing the force required to compress the pump housing and associated implantation forces that may in some cases be correlated to the elastic recoil of the compressed pump housing.

[0048]

[0082] As also described herein, the catheter may be configured to control the position of the intravascular blood pump when deployed within the patient's body. For example, a sleeve 22 may be placed over a portion of the catheter connected to the proximal end of the intravascular blood pump 1, as described and illustrated in FIG. 7A. In some embodiments, the sleeve may be proximal and adjacent to the outlet of the pump section of the intravascular blood pump. As described above, the intravascular blood pump may be percutaneously inserted into the heart through the aorta. In such cases, the intravascular blood pump may generally be positioned in the left ventricle beyond the aortic valve to draw blood from the left ventricle and expel blood into the aorta. In some embodiments, an atraumatic tip 9 on the more distal end of the intravascular blood pump may help space the pumping section of the blood pump from the heart wall. Thus, in some cases, the pumping section may be positioned near the wall of the heart or various heart structures, such as the mitral valve. As described in detail below, the sleeves described herein can be adapted to provide better and more precise control over the position of the pump section of an intravascular blood pump when inserted into a patient's heart (e.g., allowing positioning of the pump section within the ventricular apex (away from the septum and mitral valve)).

[0049]

[0083] 7A shows an intravascular blood pump 1 inserted into a ventricle V of a patient's heart H via an aorta AO. As shown in this figure, a catheter 5 may have a distal end attached to a proximal end of the pump section of the intravascular blood pump 1 and a proximal end (not shown) located outside the patient's vasculature and extending therebetween. An impeller (not shown) is provided in the pump section to drive blood from a blood flow inlet to a blood flow outlet. The impeller may be driven by a motor that is either inside the patient and monolithically integrated with the pump section 4 of the intravascular blood pump 1 or outside the patient's body.

[0050]

[0084] In some embodiments, the catheter 5 has a lumen (not shown) extending therethrough. The catheter 5 may have an inner diameter sufficient to provide space for the drive shaft with a small gap between the drive shaft and the inner wall of the catheter 5, for example, about 1.57 mm (corresponding to about a 5 French dimension). The catheter 5 may have an outer diameter of about 2.75-3.1 mm (corresponding to about an 8-9 French dimension).

[0051]

[0085] Referring again to FIG. 7A, the catheter 5 may include a bend region 19 formed by the sleeve 22 being placed thereon. In some embodiments, the bend region 19 may affect the position of the pump section 4 of the intravascular blood pump 1 when inserted into the patient's heart H. Specifically, when the intravascular blood pump 1 is inserted through the aorta AO, the sleeve 22 may conform to the plane of the aortic arch, and the bend region 19 may contact the endothelium of the aorta AO, as shown in FIG. 7A, to support the intravascular blood pump 1 and to position the pump section 4 within the apex of the ventricle V of the heart H, allowing the atraumatic tip 9 to be properly aligned with the aortic valve. To properly position the atraumatic tip 9 within the apex of the ventricle V of the heart H, the sleeve 22 may need to be placed as close as possible to the pump section 4, and oriented relative to the atraumatic tip 9 such that delivery through the valve is easiest by directing the atraumatic tip 9 toward the center of the aortic valve. Such orientation of the atraumatic tip 9 may be approximately 110 degrees to 150 degrees (e.g., 120 degrees to 140 degrees) relative to the sleeve 22, as shown in Figures 7B and 7C. In other words, the atraumatic tip 9 may be out of plane (plus or minus) 110 degrees to 150 degrees, optionally 120 degrees to 140 degrees, and optionally 130 degrees relative to the plane in which the bending sleeve lies. This can be easily observed in Figure 7B, where the plane of the sleeve 22 is in the plane of the page, and the plane of the atraumatic tip 9 is out of the plane of the page and not perpendicular to the page. Figure 7C from the perspective of the atraumatic tip 9 reveals that the pigtail extends at an angle from the plane of the sleeve 22. Although the orientation described above shows the atraumatic tip 9 as being out of plane relative to the plane of the bending sleeve 22, it is contemplated that the atraumatic tip 9 and the bending sleeve 22 may be disposed in the same plane, with that planar relationship being maintained by the sleeve 22 when the intravascular blood pump 1 is inserted into and positioned in a patient.

[0052]

[0086] In some embodiments, as will be appreciated in view of the above, the atraumatic tip 9 may also be positioned out-of-plane relative to the bend in the catheter. In other embodiments, the atraumatic tip 9 may also be positioned in-plane of the bend in the catheter.

[0053]

[0087] The relaxed state of the bend region 19 defined on the catheter 5 is maintained using a deformable sleeve 22 placed in the bend region when the intravascular blood pump 1 is inserted into the aorta AO. The relaxed state preserves both the bending of the catheter 5 in its plane and the out-of-plane relationship between the sleeve 22 and the atraumatic tip 9. The deformable sleeve 22 is designed and configured to be placed in or on the bend region 19 of the catheter 5 during operation of the intravascular blood pump 1 to support the catheter 5 throughout the surgical procedure and during operation of the intravascular blood pump 1. In this regard, the deformable sleeve 22 may be placed across the bend region 19 of the catheter. The deformable sleeve may also be embedded in the wall of the catheter 5 at the bend region 19 (i.e., on the interior of the catheter). In some embodiments, the sleeve may be placed over the exterior of the catheter. In some embodiments, a polymer tube may be attached to the catheter and the sleeve is placed around the polymer tube and the exterior of the catheter.

[0054]

[0088] 8, in embodiments where the sleeve 22 is coupled to the catheter 5 (e.g., attached to the exterior of the catheter), the inner diameter of the sleeve 22 may be slightly larger than the outer diameter of the catheter 5, allowing the sleeve 22 to be moved axially along the length of the catheter 5 by application of an axial force to locate the sleeve 22 in the bend region 19. Once the sleeve 22 is in the bend region 19, the sleeve 22 may be securely attached to the catheter 5 by suitable means, such as, for example, gluing, sonic welding, etc. Those skilled in the art will know suitable means for securely fastening the sleeve to the catheter. In other embodiments, the sleeve 22 may be embedded in the catheter 5, as described below. In some embodiments, the sleeve 22 may be embedded in the polymeric material (e.g., polyurethane) used to form the catheter 5. As will be appreciated, catheter construction is well known and will not be described in detail herein. In one example, the catheter 5 may be formed of polyurethane extruded over a mandrel. In one example, a braided metal (e.g., stainless steel, nitinol, etc.) may be overlaid on the extruded polyurethane and melted into the tube. The sleeve 22 is then placed over this structure. Additional polymer (e.g., polyurethane) may then be formed over this structure. In some aspects of the present technology, the sleeve 22 may be embedded in (or covered by) a material that is different from adjacent sections of the catheter 5. For example, the catheter 5 may include a polymer sleeve made primarily of a harder, stiffer polymer (e.g., having a hardness of 95A-72D, e.g., Carbothane 72D), but which includes a middle section of a softer polymer (e.g., having a hardness of 55D-65D) that partially or entirely overlaps the sleeve 22. In some cases, the sleeve 22 may be sandwiched between inner and outer layers of polymer, where both the inner and outer layers, with the middle section, are made primarily of the harder polymer.In some embodiments, the middle section of the inner layer may be staggered relative to the sleeve 22, and the sleeve 22 may further be staggered relative to the middle section of the outer layer, resulting in a more gradual change in the overall stiffness of the assembly. Similarly, in some embodiments, the middle section of the inner layer may be a different length than the middle section of the outer layer, such that the sleeve 22 may be fully overwrapped (or underwrapped) by the middle section of one layer, but extend beyond one or both ends of the other layer. As will be appreciated, in some embodiments of the present technology, the catheter 5 may employ additional sections beyond those just described, such as sections on one or both sides of the middle section having intermediate hardness (e.g., 65D-72D). The catheter 5 may also employ additional layers of polymer in one or more of these sections.

[0055]

[0089] The sleeve 22 may have a pre-made bend that may be straightened when placed into a catheter under construction. In one example, the sleeve 22 is bent by annealing the sleeve into a bent configuration. Other heat treatments for forming the sleeve are contemplated. In one example, the sleeve 22 may be heated over a mandrel to introduce a bend into the sleeve 22. The sleeve 22 may have a pre-made bend that may be straightened when placed into a catheter under construction. After fabrication, the sleeve 22 relaxes back into its pre-made bend.

[0056]

[0090] In some embodiments, the sleeve 22 allows the catheter 5 to maintain the predefined bend region 19 so that placement of the pump section 4 of the intravascular blood pump 1 in a desired position can be achieved when inserted into the patient's heart. Specifically, as described above, the predefined bend region 19 on the catheter 5 having the sleeve 22 thereon can contribute to the desired alignment of the atraumatic tip 9 with the aortic valve during insertion and also contribute to positioning the atraumatic tip 9 within the apex of the ventricle V. The sleeve 22 also stabilizes the pump section 4 and prevents it from rotating as it travels through the aortic arch. The sleeve 22 also avoids the need to further torque the catheter 5 after introduction into the heart to properly position the pump section 4 within the heart, as such torquing may cause tissue damage to the patient's vasculature or heart.

[0057]

[0091] 9-11, in one embodiment, the illustrated sleeve 22 is configured to be placed and disposed over, within, or on the bend region 19 of the catheter 5. FIG. 9 is a perspective view of the sleeve 22, where the plane of the bend is viewed. FIG. 10 is a perspective view from above, where the bend of the sleeve 22 occurs into the plane of the page. FIG. 11 is a top view of the sleeve 22, where the bend is viewed in the plane of the page. The sleeve 22 may be annular and may extend between a first open end 24 and a second open end 26 (see FIG. 9). The sleeve 22 may define a partially open lumen 25 that extends between the first open end 24 of the sleeve 22 and the second open end 26 of the sleeve 22. The lumen 25 may be sized such that the sleeve 22 may slide axially along the catheter 5 (at some stage of catheter construction) and be disposed in the designated bend region 19 of the catheter 5. In other embodiments, lumen 25 is sized such that it may be embedded in the outer layer of catheter 5. As described herein, the designated bend region 19 may be proximal to pump section 4. In one embodiment, bend region 19 may be proximal and adjacent to pump section 4. In other embodiments, bend region 19 is proximal to, but not adjacent to, pumping section 4.

[0058]

[0092] The sleeve 22 shown in FIGS. 9-11 may include a series of spaced apart annular rings 28, where adjacent rings 28 are connected by at least one pair of connectors 29. In some embodiments, the connectors 29 are not aligned, but instead may be offset from one ring pair to the next. As such, a plurality of openings 31 may be formed between each pair of rings on the sleeve 22, and may be arranged in an alternating pattern. Specifically, the plurality of openings 31 may be formed in radially matching pairs that define a 180 degree semicircle around the sleeve 22. Each of the openings 31 may extend approximately halfway around the sleeve 22, and be separated by a connector 29. As mentioned above, a plurality of pairs of openings 31 may be circumferentially offset from one ring pair to the next on the sleeve 22, as shown in FIGS. 9 and 10, to form a pattern, where the plurality of pairs of openings 31 are parallel, but offset from one another in alternating directions. The radius of each opening 31 at the end of the opening connector is non-uniform. For example, the radius at each corner of opening 31 (where the connector and ring connect) is different than the radius of connector 29 and ring 28 along the ends of opening 31 .

[0059]

[0093] The non-uniform radii of the openings 31 can be easily observed in FIG. 11. In some embodiments, there are two connectors per ring pair. The connectors are offset 90 degrees for each ring pair such that only the top connector 29 is visible on one set of ring pairs, but two connectors 29 are visible on the other ring pair. As will be appreciated, in other embodiments, one or more connectors may be used between ring pairs. As will be further appreciated, the number of connectors may vary between ring pairs, although the same number of connectors may be used between all ring pairs.

[0060]

[0094] Looking at the space "L" between two rings, it can be seen that there is a tighter, smaller radius at the corner of the transition of ring 28 and connector 29 than between the two corners of the rings. That is what is meant by the reference to the non-uniform radius of opening 31. The multiple annular rings 28 can be spaced apart at a uniform length L when in a straight configuration. FIG. 11 shows the longitudinal length L measured between the longitudinal center points of adjacent rings 28. In some cases, the longitudinal length L is approximately constant between all adjacent rings 28 along the length of sleeve 22 when sleeve 22 is in a straight position.

[0061]

[0095] As shown in FIG. 10, each of the plurality of openings 31 may be approximately equal in size (e.g., length, width, and area), such that the plurality of openings 31 are also substantially identical when the sleeve 22 is in a straight position. The length of the sleeve 22 may be dimensioned to extend the length of the predefined bend region 19 on the catheter 5. As shown in FIG. 11, bending the sleeve 22 introduces a spacing variation at the apex of the bend, such that the spacing L is larger on the outside of the bend and the spacing L is smaller on the inside of the bend. The configuration and design of the plurality of rings 28 and connector 29 may be configured to allow the sleeve 22 to bend in different directions.

[0062]

[0096] 12-14, in a second embodiment, the structure of the sleeve 122 may include a series of spaced apart annular rings 124 connected by two axial spines 126 that extend the length of the sleeve (i.e., without offset). As such, the sleeve 122 includes a plurality of first openings 128 and a plurality of second openings 130 on either side of the axial spine 126. That is, the sleeve 122 is symmetrical. As shown, each of the first and second openings 128, 130 is defined on the sleeve 122 and extends approximately halfway around the circumference of the sleeve 122, although this arrangement is merely for illustrative purposes. Configurations with one spine or three or more spines 126 are also contemplated. The spines 126 may be spaced approximately 180 degrees apart from one another as shown. However, in an embodiment with two spines, the angular spacing is a matter of design choice with angular separations of 45 degrees to 180 degrees being contemplated. As shown, the plurality of first openings 128 may be parallel to one another, and the plurality of second openings 130 may also be parallel to one another, as shown in FIG.

[0063]

[0097] 13, for example, each of the plurality of first openings 128 can be defined in a first, e.g., left, portion 132 of the sleeve 122, while each of the plurality of second openings 130 can be defined in a second, e.g., right, portion 134 of the sleeve 122. As shown in FIGS. 12 and 13, the plurality of openings 128, 130 can be positioned transversely to and equally spaced along the length of the sleeve 122 (or the longitudinal axis of the sleeve), forming a plurality of rings 124 between the plurality of openings 128, 130.

[0064]

[0098] As shown, each of the plurality of openings 128, 130 may be approximately equal in size (e.g., length, width, and area), and the plurality of openings 128, 130 are also substantially identical when the sleeve 122 is in a straight position. The length of the sleeve 122 may be dimensioned to extend the length of a predefined bend region 19 on the catheter 5.

[0065]

[0099] 14, each of the plurality of rings 124 may be interconnected with a pair of spines (or support members) 126. Each spine 126 may be substantially straight in configuration and substantially parallel to a longitudinal axis of the sleeve 122. The spines 126 may extend along a length of the sleeve 122, such as between a first open end 138 of the sleeve 122 and a second open end 140 of the sleeve 122, and are positioned diametrically opposite one another.

[0066]

[0100] The annular rings 124 may be spaced apart by a uniform length distance D when in a straight configuration, as shown. FIG. 14 illustrates the longitudinal length distance D measured between the longitudinal center points of adjacent rings 124. Generally, when the sleeve 122 is in a straight position, the longitudinal length distance D is approximately constant between all adjacent rings 124 along the length of the sleeve 122. However, it is understood that in other embodiments, the longitudinal length distance D may vary between adjacent rings. In some embodiments, the spine 126 may define the arc of the curve of the sleeve 122, while the openings 128, 130 and the rings 124 allow the sleeve 122 to bend left and right. As discussed above, in a bent position, the distance D may be slightly greater on the outside of the bend compared to the distance D on the inside of the bend. A catheter may be formed using the sleeve shown in FIGS. 12-14 in the manner described above.

[0067]

[0101] Figures 15 and 16 show a different sleeve where a bend can be seen in the plane of Figure 15 and extend into the plane of Figure 16 (both Figures 15 and 16 are top perspective views). Referring to Figures 15 and 16, in a third embodiment, a sleeve 222 can include a series of spaced apart annular rings 224 connected by a single axial spine 226. A plurality of openings 228 can be defined between each annular ring 224 throughout the length of the sleeve 222, apart from the spine 226 which intersects each opening 228 between each annular ring 224. A catheter can be formed using the sleeve shown in Figures 15 and 16 in the manner described above.

[0068]

[0102] 17, in a fourth embodiment, a sleeve 322 (shown as unbent) may include a series of spaced apart annular rings 324 connected by a plurality of connectors 326 disposed between each of the annular rings 324. As in other embodiments described herein, the connectors 326 may be circumferentially offset from one another for each pair of rings, resulting in offsets in the openings between the pairs of rings 324. As will be appreciated, the sleeve 322 may include alternative embodiments of the embodiments shown in FIGS. 9-11. In some embodiments, a catheter may be formed using the sleeve shown in FIG. 17 in the manner described above.

[0069]

[0103] 18, in a fifth embodiment, a sleeve 422 (shown as curved) may include a plurality of diamond shaped apertures 424 formed by helical ribs that traverse the length of the sleeve 422. The helical patterns may overlap and intersect to define a pattern of apertures 424. The plurality of apertures 424 may be formed on the sleeve 422 to allow bending of the sleeve 422, yet still provide axial stiffness and maintain axial strength. A catheter may be formed using the sleeve shown in FIG. 18 in the manner described above.

[0070]

[0104] 19 and 20, in a sixth embodiment, a sleeve 522, shown as being similarly curved, may include a series of open cradle structures 524 (each structure having an open top and an open bottom) connected together. In such an embodiment, the cradle structures 524 of the sleeve 522 may not surround the catheter, but may instead be located on only one side of the catheter. As such, the open sides of the cradle structures 524 may curve towards each other to fit snugly against the catheter. As shown in FIG. 20, each structure 524 may have an arch-like form that allows the cradle structures to partially surround the catheter. A catheter may be formed using the sleeve shown in FIG. 19 and 20 in the manner described above.

[0071]

[0105] 21 and 22, in a seventh embodiment, a sleeve 622 shown as bent may include a series of interconnected, more closely spaced cradle structures 624, each having an open top and an open bottom. As shown in FIG. 22, each structure 624 may include an arch that, in side view, is more U-shaped than the arches of the cradle structures of FIGS. 19 and 20. In some embodiments, a catheter may be formed using the sleeve shown in FIGS. 21 and 22 in the manner described above.

[0072]

[0106] 23 and 24, in an eighth embodiment, a sleeve 722, shown as bent, may include a series of annular ring structures 724 (each structure having an open top) connected to one another by U-shaped connectors. In such an embodiment, the connectors may all be located on the same side of the sleeve 722. In some embodiments, a catheter may be formed using the sleeve shown in FIGS. 23 and 24 in the manner described above.

[0073]

[0107] The sleeve 22, 122, 222, 322, 422, 522, 622, 722 is made of one or more materials having suitable properties for a desired application, such as, for example, strength, weight, stiffness, etc. The sleeve may have flexible regions to allow the sleeve to bend into a predetermined configuration or may have malleable regions to allow the user to tailor the support structure to the patient's individual needs.

[0074]

[0108] The sleeve 22, 122, 222, 322, 422, 522, 622, 722 may be made of a conventional biologically compatible material (e.g., stainless steel). Optionally, the sleeve may include or be made of a shape memory material (e.g., a shape memory alloy, particularly Nitinol). The sleeves described herein may be formed in any conventional manner (e.g., laser cutting). Due to this material, the sleeve is elastically deformed, allowing the catheter to bend, i.e., with a bending radius of 15 mm to 90 mm, or 18 mm to 60 mm, or 21 mm to 31 mm. The bending radius is measured relative to the central axis of the catheter. The desired bending stiffness properties result primarily from the superelastic Nitinol.

[0075]

[0109] In some embodiments, one or more sleeves may be used to shape the catheter at the desired location. As will be appreciated, other methods may be used to impart a desired shape (e.g., bend) to a portion of the catheter. For example, a nitinol wire without a sleeve may be used. In other embodiments, the catheter may be pre-bent. In yet other embodiments, Kevlar fibers may be used to maintain the desired shape (e.g., bend).

[0076]

[0110] 25-28, in some embodiments, a sleeve (e.g., sleeve 850 of FIGS. 25-28 and / or any one of sleeves 22, 122, 222, 322, 422, 522, 622, 722 of FIGS. 7A-24) may be formed with a strain relief section at one or both of the proximal and distal ends of the sleeve. In such embodiments, the strain relief section may help reduce peaks in stress in the material of catheter 5 at the points where the ends of the sleeve are bonded. Such a strain relief section may be of any suitable length compared to the overall length of the sleeve. For example, in some embodiments, the sleeve may be 15-30 mm, with the strain relief section being 3-5 mm of that.

[0077]

[0111] In some embodiments, the strain relief section allows the sleeve, and thus the catheter 5, to be more flexible. The stiffness of such a strain relief section can be configured in a number of ways, such as by selecting a particular length, maintaining a particular ratio of that length to its diameter (e.g., setting the length to be at least 0.5 times that diameter, at least 1 time that diameter, at least 1.5 times that diameter, etc.), selecting how many struts to use, selecting the thickness of such struts, selecting the pitch of the struts (if helical struts are used), and / or by embedding or covering the struts with a material of a particular hardness or flexibility.

[0078]

[0112] Further, in some embodiments, the strain relief section may be configured to vary in stiffness over the length of the strain relief section. In some embodiments, the stiffness of the strain relief section may be configured to decrease continuously from the end of the main section of the sleeve (e.g., comprising one or more annular ring sections) to the end of the strain relief section. In some embodiments, this may be accomplished by using one or more helical struts in the strain relief section, where the width of the struts varies over the length of the strain relief section. In that regard, in the example of FIGS. 25 and 26, each of the three struts 854 is shown to be continuously thinner in thickness as they approach the end 856. In some embodiments, the stiffness of the strain relief section may vary over the length of the strain relief section by continuously varying the pitch of one or more helical struts (e.g., struts 854). In still other embodiments, the stiffness of one end of the strain relief section may be further adjusted based on how each helical strut terminates. For example, as shown in Figures 27 and 28, each helical strut 854 may terminate in a loop 858 that connects to another strut, which may be less stiff at that end than by terminating each strut in a complete ring as shown at end 856 in Figures 25 and 26. Additionally, in some embodiments, the stiffness of the strain relief section may vary over the length of the strain relief section by changing the material of the catheter 5 over the length of the strain relief section. For example, in some embodiments, a harder and / or stiffer type of polymer may be used to cover the sleeve at one end of the strain relief section than at the other end of the strain relief section. Similarly, in some embodiments, a thicker layer of polymer may be used to cover the sleeve at the other end of the strain relief section than at the other end of the strain relief section.

[0079]

[0113] The strain relief section 852 of Figures 25-28 may be formed in any suitable manner, such as using any of the methods described above in connection with the sleeve 22, 122, 222, 322, 422, 522, 622, 722 of Figures 7A-24. Thus, for example, in some embodiments, the strain relief section 852 may be formed by laser cutting a sheet or tube of a suitable raw material (e.g., a shape memory alloy, such as Nitinol) into a straight form. The sheet or tube may then be processed, such as by heat treatment, to achieve the desired heat treatment.

[0080]

[0114] 29 and 30 show additional examples of intravascular pumps 1000 according to other embodiments of the present design. As shown in these figures, and similar to other pumps described herein, the pump 1000 may include a catheter 1005 and a pump section 1004 attached to a distal region of the catheter 1005. The pump section 1004 may include a rotor (not shown) that may allow blood to flow from a blood flow inlet 1006 to a blood flow outlet 1007. As shown in FIGS. 29 and 30, the pump may also include a flexible atraumatic tip 1009, such as a pigtail, which may be configured to facilitate placement of the pump in the vascular system of a patient. In some embodiments, the pigtail may include a straight configuration, as shown in FIG. 29. Similarly, in some embodiments, the pigtail may include a curved configuration, as shown in FIG. 30.

[0081]

[0115] 29 and 30, the pump 1000 can include a downstream tube 1020 through which the catheter 1005 is disposed. As described above, the downstream tube 1020 can be made of one or more flexible materials such that it can be compressed by the aortic valve as the patient's heart beats. For example, the downstream tube 1020 can include a balloon. Similarly, in some embodiments, the tube 1020 can be configured to expand as a result of blood flow generated by the rotating rotor.

[0082]

[0116] The downstream tube and catheter may have any suitable shape and configuration. For example, as shown in FIG. 2, the downstream tube 20 and catheter 5 may include a straight configuration. In other embodiments, as shown in FIG. 29 and FIG. 30, the catheter 1005 may include a curved configuration. In such embodiments, the downstream tube 1020 may also include a curved configuration, with the curved catheter 1005 extending through the curved downstream tube 1020. As will be appreciated, in some embodiments, the catheter 1005 may also include one or more straight regions (e.g., downstream or upstream of a bend), with the downstream tube 1020 also having a corresponding straight region.

[0083]

[0117] In embodiments in which the catheter 1005 and the downstream tubing 1020 are both bent, the bend angle (e.g., radius) of the catheter and the bend angle (e.g., radius) of the downstream tubing may be the same (e.g., 45°±10°). In other embodiments, the bend angle of the catheter and the bend angle of the downstream tubing may be different. For example, the bend angle of the catheter may include 45°±10°, while the bend angle of the downstream tubing may include 30°±10°. In such embodiments, the difference in bend angles may account for differences in the materials of the catheter and the tubing and how the catheter and the tubing behave within the patient's body.

[0084]

[0118] In other embodiments, the difference in bend angle may be used to account for the activity of the pump during insertion. For example, to insert the pump into a patient, the pump may first be retracted into an introducer sheath, after which it may be advanced into the patient's vasculature. In such embodiments, both the catheter and the downstream tube may remain in a straight configuration within the introducer sheath during delivery. Then, when the pump is deployed from the introducer into the patient, the catheter and the downstream tube may not return to the same bend angle. For example, in some embodiments, after deployment, the catheter may not return to a bend angle of 45°±10°. Instead, once deployed from the introducer sheath, the catheter may have a different bend angle. In some embodiments, the initial bend angles of the catheter and the downstream tube may be configured to be different when formed, but similar after deployment in the body (and from the introducer sheath).

[0085]

[0119] The length of the downstream tubing 1020 between the blood flow inlet 1006 and the blood flow outlet 1007 may be longer in some embodiments than in others (compare the amount of downstream tubing 20 between the blood flow inlet 6 and the blood flow outlet 7 in FIG. 2 with the amount of downstream tubing 1020 between the blood flow inlet 1006 and the blood flow outlet 1007 in FIGS. 29 and 30). As can be seen in the pump shown in Figures 31 and 32, a longer region of downstream tubing 1020 between the blood inlet 1006 and the blood outlet 1007 can facilitate properly positioning the pump 1000 across the valve 3102 when the pump is within the patient's body and / or reduce the likelihood that the pump 1000 is inadvertently shifted from its intended position (e.g., shifted so that both the blood inlet 1006 and the blood outlet 1007 end on the same side of the valve 3102, shifted so that the blood inlet 1006 or the blood outlet 1007 become fully or partially covered by the valve 3102, etc.). 31 and 32, placing a bend in the catheter 1005 and / or downstream tubing 1020 may also facilitate ensuring that the pump 1000 is placed stably across the valve 3102 and / or is less likely to be shifted from its intended position when the pump is in the patient's body. For example, in some embodiments, the length of the downstream tubing (e.g., downstream tubing 20, 1020) between the blood flow inlet (e.g., blood flow inlet 6, 1006) and the blood flow outlet (e.g., blood flow outlet 7, 1007) may be greater than 20 mm, greater than 30 mm, greater than 40 mm, greater than 50 mm, greater than 60 mm, greater than 70 mm, or even greater than 80 mm.

[0086]

[0120] The term "about" as used herein is used in accordance with how a person skilled in the art would interpret the term with respect to the dimension or amount or value being described. That is, the term "about" indicates that the value represented may have some variation, but the purpose of the value represented may still be met. Unless otherwise clearly indicated, the term "about" may include ±10% of the value represented.

[0087]

[0121] From the above and with reference to the various drawings, those skilled in the art will understand that certain modifications may be made to the present disclosure without departing from the scope of the present disclosure. Several embodiments of the present disclosure are shown in the drawings, and the present disclosure is not intended to be limited thereto, since the present disclosure is to the same extent as recognized by the art, and the specification is intended to be read in the same manner. Therefore, the above description should not be considered limiting, but merely exemplifications of certain embodiments. Those skilled in the art will envision other modifications within the scope and spirit of the appended claims.

[0088] Example Implementation

[0122] As previously mentioned, the intravascular blood pumps described herein may be implemented in a variety of ways, and in that regard, the above disclosure is intended to include, but is not limited to, the systems, methods, and combinations and subcombinations thereof described in the following categories of exemplary implementations:

[0089]

[0123] Category A: A0. Catheter; A housing in which the rotor is housed, the housing being attached to the distal end of the catheter; and a drive shaft extending through the catheter and connected to the rotor, at least a portion of the drive shaft being flexible and including an outer layer of wound or braided wire, an inner layer of wound or braided wire, and a reinforcing element disposed within at least the outer layer of wound or braided wire. An intravascular blood pump comprising: The drive shaft is rotatably supported in a proximal bearing located proximal to the rotor and a distal bearing located distal to the rotor; the reinforcing element extends from at least a point in the proximal bearing to a point in the distal bearing, the catheter having a distal end and a predefined bend region positioned proximal to the distal end; The catheter includes a sleeve configured to control a position of the pump apparatus within the patient's heart, the sleeve comprising: Multiple annular rings; at least one connector disposed between each of the plurality of annular rings to connect each of the annular rings, the at least one connector being offset from an adjacent connector; and A number of openings formed between each ring Including, An intravascular blood pump, wherein the sleeve is configured to be monolithically integrated with or placed over a predefined bending region of the catheter, thereby providing a predefined elastic bend to the catheter at the predefined bending region.

[0090] A1. Catheter; a housing in which the rotor is housed, the housing being attached to the distal end of the catheter; and a drive shaft extending through the catheter and connected to the rotor, at least a portion of the drive shaft being flexible and including an outer layer of wound or braided wire, an inner layer of wound or braided wire, and a reinforcing element disposed within at least the outer layer of wound or braided wire. An intravascular blood pump comprising: The drive shaft is rotatably supported in a proximal bearing located proximal to the rotor and a distal bearing located distal to the rotor; the reinforcing element extends from at least a point in the proximal bearing to a point in the distal bearing, the catheter having a distal end and a predefined bend region positioned proximal to the distal end; The catheter includes a sleeve configured to control a position of the pump apparatus within the patient's heart, the sleeve comprising: Multiple annular rings; at least two connectors disposed between each of the plurality of annular rings to connect each of the annular rings, the at least two connectors being offset from adjacent connectors; and A number of openings formed between each ring Including, An intravascular blood pump, wherein the sleeve is configured to be monolithically integrated with or placed over a predefined bending region of the catheter, thereby providing a predefined elastic bend to the catheter at the predefined bending region.

[0091] A2. An intravascular blood pump as described in A1, wherein the reinforcing element extends from a point proximal to the proximal bearing to a point within the distal bearing.

[0092] A3. An intravascular blood pump as described in A1 or A2, wherein the proximal bearing includes a bearing sleeve attached to the drive shaft and an outer bearing ring attached to the housing, the bearing sleeve being configured to rotate within the outer bearing ring.

[0093] A4. The intravascular blood pump of A3, further including a restrictive element attached to the housing and positioned proximal to the proximal bearing and configured to prevent the bearing sleeve from being removed from the outer bearing ring.

[0094] A5. The intravascular blood pump of any one of A1 to A4, wherein the reinforcing element includes a stepped proximal end portion having a smaller diameter portion and a larger diameter portion.

[0095] A6. An intravascular blood pump as described in A5, wherein the reduced diameter portion extends from a point at or substantially near where the catheter attaches to the housing to a point within the restrictive element.

[0096] A7. An intravascular blood pump as described in A5, wherein the reduced diameter portion extends from a point in the restrictive element to a point in the proximal bearing.

[0097] A8. An intravascular blood pump as described in A6, wherein the larger diameter portion extends from a point within the restrictive element to a point within the distal bearing.

[0098] A9. An intravascular blood pump as described in A8, wherein the inner layer of wound or braided wire is omitted between a point in the restrictive element and a point in the distal bearing.

[0099] A10. An intravascular blood pump as described in A7, wherein the large diameter portion extends from a point in the proximal bearing to a point in the distal bearing.

[0100] A11. An intravascular blood pump as described in A10, wherein the inner layer of wound or braided wire is omitted between a point in the proximal bearing and a point in the distal bearing.

[0101] A12. An intravascular blood pump according to any one of A1 to A11, wherein the reinforcing element comprises Nitinol or Ultra-Stiff Nitinol.

[0102] A13. An intravascular blood pump according to any one of A1 to A12, wherein the housing includes a cage surrounding the rotor, the cage having a plurality of struts.

[0103] A14. An intravascular blood pump as described in A13, wherein at a first point proximal to the rotor, each strut of the plurality of struts has a circumferential width and a radial thickness, the circumferential width being 1.2 to 1.8 times the radial thickness.

[0104] A15. An intravascular blood pump as described in A13, wherein at a first point proximal to the rotor, each strut of the plurality of struts has a circumferential width and a radial thickness, the circumferential width being 1.2 to 1.3 times the radial thickness.

[0105] A16. An intravascular blood pump as described in A13, wherein at a first point proximal to the rotor, each strut of the plurality of struts has a circumferential width and a radial thickness, the circumferential width being approximately 1.26 times the radial thickness.

[0106] A17. An intravascular blood pump as described in A14, wherein at a second point distal to the rotor, each strut of the plurality of struts has a circumferential width and a radial thickness, the circumferential width being 1.2 to 1.8 times the radial thickness.

[0107] A18. An intravascular blood pump as described in A15, wherein at a second point distal to the rotor, each strut of the plurality of struts has a circumferential width and a radial thickness, the circumferential width being 1.2 to 1.3 times the radial thickness.

[0108] A19. An intravascular blood pump as described in A16, wherein at a second point distal to the rotor, each strut of the plurality of struts has a circumferential width and a radial thickness, the circumferential width being approximately 1.26 times the radial thickness.

[0109] A20. An intravascular blood pump as described in A17, wherein at a third point proximal to the rotor and distal to the first point, each strut of the plurality of struts has a circumferential width and a radial thickness, and the circumferential width is 1.0 to 1.6 times the radial thickness.

[0110] A21. An intravascular blood pump as described in A18, wherein at a third point proximal to the rotor and distal to the first point, each strut of the plurality of struts has a circumferential width and a radial thickness, and the circumferential width is 1.0 to 1.15 times the radial thickness.

[0111] A22. An intravascular blood pump as described in A19, wherein at a third point proximal to the rotor and distal to the first point, each strut of the plurality of struts has a circumferential width and a radial thickness, the circumferential width being approximately 1.26 times the radial thickness.

[0112] A23. An intravascular blood pump as described in A19, wherein at a third point proximal to the rotor and distal to the first point, each strut of the plurality of struts has a circumferential width and a radial thickness, the circumferential width being approximately 1.09 times the radial thickness.

[0113] A24. An intravascular blood pump as described in A20, wherein at a fourth point distal to the rotor and proximal to the second point, each strut of the plurality of struts has a circumferential width and a radial thickness, and the circumferential width is 1.0 to 1.6 times the radial thickness.

[0114] A25. An intravascular blood pump as described in A21, wherein at a fourth point distal to the rotor and proximal to the second point, each strut of the plurality of struts has a circumferential width and a radial thickness, and the circumferential width is 1.0 to 1.15 times the radial thickness.

[0115] A26. An intravascular blood pump as described in A22, wherein at a fourth point distal to the rotor and proximal to the second point, each strut of the plurality of struts has a circumferential width and a radial thickness, the circumferential width being approximately 1.26 times the radial thickness.

[0116] A27. An intravascular blood pump as described in A23, wherein at a fourth point distal to the rotor and proximal to the second point, each strut of the plurality of struts has a circumferential width and a radial thickness, the circumferential width being approximately 1.09 times the radial thickness.

[0117] A28. An intravascular blood pump according to any one of A1 to A28, wherein the housing comprises Nitinol or Ultra-Stiff Nitinol.

[0118] A29. An intravascular blood pump as described in A5, wherein the larger diameter portion is configured to fit within an outer layer of wound or braided wire in a portion of the drive shaft where the inner layer of wound or braided wire is omitted.

[0119] A30. An intravascular blood pump as described in any one of A1 to A29, further comprising an atraumatic tip at a distal end of the blood pump.

[0120] A31. An intravascular blood pump as described in A30, wherein a predefined bending region of the catheter is configured to contact the endothelium of the aorta when the blood pump is inserted into the patient's heart, thereby supporting the pump device and aligning the atraumatic tip with the aortic valve of the patient's heart, thereby positioning the pump device within the patient's ventricle.

[0121] A32. An intravascular blood pump as described in A31, wherein the atraumatic tip is 110-140 degrees out of plane relative to the plane in which the bending sleeve lies when bent, the atraumatic tip further, optionally, 120-130 degrees out of plane relative to the plane in which the bending sleeve lies when bent, and the atraumatic tip further, optionally, 130 degrees out of plane relative to the plane in which the bending sleeve lies when bent.

[0122] A33. An intravascular blood pump as described in any one of A1 to A29, wherein the plurality of openings are formed in radially-matching pairs that define an arc or semicircle about 180 degrees around the sleeve.

[0123] A34. An intravascular blood pump as described in A33, wherein each of the openings extends approximately halfway around the circumference of the sleeve, and each opening has a connector at a terminal end of the opening.

[0124] A35. An intravascular blood pump as described in A34, wherein the radially corresponding pairs of openings share a common axis and are laterally offset from one another in an alternating manner.

[0125] A36. An intravascular blood pump as described in any one of A1 to A29, wherein the multiple annular rings are spaced apart by a uniform distance when the sleeve is in a straight configuration.

[0126] A37. An intravascular blood pump as described in any one of A1 to A29, wherein the length of the sleeve corresponds to the length of a predefined bending region on the catheter.

[0127] A38. An intravascular blood pump as described in any one of A1 to A29, further comprising a tension relief section at the distal and / or proximal end of the sleeve.

[0128] A39. An intravascular blood pump as described in A38, wherein the stiffness of the tension relief section is different from the remainder of the sleeve.

[0129] A40. An intravascular blood pump as described in A39, wherein the tension relief section includes one or more struts.

[0130] A41. An intravascular blood pump as described in A40, wherein the one or more struts include one or more helical struts.

[0131] A42. An intravascular blood pump as described in A39, wherein the shape of the pattern can be formed by winding a flat pattern.

[0132]

[0124] Category B: B1. Catheter; a housing in which the rotor is housed, the housing being attached to the distal end of the catheter; and a drive shaft extending through the catheter and connected to the rotor, the drive shaft including an outer layer of wound or braided wire, an inner layer of wound or braided wire, and a reinforcing element disposed within at least the outer layer of wound or braided wire. An intravascular blood pump comprising: the drive shaft is rotatably supported in a proximal bearing located proximal to the rotor and a distal bearing located distal to the rotor; and the reinforcing element extends from at least a point in the proximal bearing to a point in the distal bearing; The catheter includes a sleeve configured to control a position of the pump apparatus within the patient's heart, the sleeve comprising: Multiple annular rings; at least two connectors disposed between each of the plurality of annular rings for connecting each of the annular rings, the at least two connectors being offset from adjacent connectors; and A number of openings formed between each ring Including, An intravascular blood pump, wherein the sleeve is configured to be monolithically integrated with or placed over a predefined bending region of the catheter, thereby providing a predefined elastic bend to the catheter at the predefined bending region.

[0133] B2. An intravascular blood pump as described in B1, wherein the reinforcing element extends from a point proximal to the proximal bearing to a point within the distal bearing.

[0134] B3. An intravascular blood pump as described in B1 or B2, wherein the proximal bearing includes a bearing sleeve attached to the drive shaft and an outer bearing ring attached to the housing, the bearing sleeve being configured to rotate within the outer bearing ring.

[0135] B4. The intravascular blood pump of B3, further including a restrictive element attached to the housing and positioned proximal to the proximal bearing and configured to prevent the bearing sleeve from being removed from the outer bearing ring.

[0136] B5. The intravascular blood pump of any one of B1 to B4, wherein the reinforcing element includes a stepped proximal end portion having a smaller diameter portion and a larger diameter portion.

[0137] B6. An intravascular blood pump as described in B5, wherein the reduced diameter portion extends from a point substantially near where the catheter is attached to the housing to a point within the restrictive element.

[0138] B7. An intravascular blood pump as described in B5 or B6, wherein the reduced diameter portion extends from a point in the restrictive element to a point in the proximal bearing.

[0139] B8. An intravascular blood pump as described in any one of B5 to B7, wherein the large diameter portion extends from a point within the restrictive element to a point within the distal bearing.

[0140] B9. An intravascular blood pump as described in any one of B1 to B8, wherein the inner layer of wound or braided wire is omitted between a point in the restrictive element and a point in the distal bearing.

[0141] B10. The intravascular blood pump of any one of B1 to B9, wherein the large diameter portion extends from a point in the proximal bearing to a point in the distal bearing.

[0142] B11. The intravascular blood pump according to any one of B1 to B10, wherein the large diameter portion is configured to fit within the outer layer of the drive shaft in a portion of the drive shaft where the inner layer is omitted.

[0143] B12. An intravascular blood pump as described in any one of B1 to B11, wherein the inner layer of wound or braided wire is omitted between a point in the proximal bearing and a point in the distal bearing.

[0144] B13. An intravascular blood pump according to any one of B1 to B12, wherein the reinforcing element comprises Nitinol or Ultra-Stiff Nitinol.

[0145] B14. The intravascular blood pump according to any one of B1 to B13, wherein the housing includes a cage surrounding the rotor, the cage having a plurality of struts.

[0146] B15. The intravascular blood pump of B14, wherein at a first point proximal to the rotor, each strut of the plurality of struts has a circumferential width and a radial thickness, the circumferential width being approximately 1.26 times the radial thickness.

[0147] B16. An intravascular blood pump as described in B14 or B15, wherein at a second point distal to the rotor, each strut of the plurality of struts has a circumferential width and a radial thickness, the circumferential width being approximately 1.26 times the radial thickness.

[0148] B17. An intravascular blood pump as described in any one of B14 to B16, wherein at a third point proximal to the rotor and distal to the first point, each strut of the plurality of struts has a circumferential width and a radial thickness, and the circumferential width is approximately 1.26 times the radial thickness.

[0149] B18. An intravascular blood pump as described in any one of B14 to B17, wherein at a fourth point distal to the rotor and proximal to the second point, each strut of the plurality of struts has a circumferential width and a radial thickness, and the circumferential width is approximately 1.26 times the radial thickness.

[0150] B19. An intravascular blood pump as described in any one of B14 to B18, wherein at a third point proximal to the rotor and distal to the first point, each strut of the plurality of struts has a circumferential width and a radial thickness, and the circumferential width is approximately 1.09 times the radial thickness.

[0151] B20. An intravascular blood pump as described in any one of B14 to B19, wherein at a fourth point distal to the rotor and proximal to the second point, each strut of the plurality of struts has a circumferential width and a radial thickness, and the circumferential width is approximately 1.09 times the radial thickness.

[0152] B21. The intravascular blood pump according to any one of B1 to B20, wherein at least one of the rotor and the housing includes Nitinol or Ultra-Stiff Nitinol.

[0153] B22. An intravascular blood pump according to any one of B1 to B21, wherein the intravascular blood pump includes a pump section, the pump section including a rotor.

[0154] B23. The intravascular blood pump of B22, wherein the rotor is configured to induce flow of blood from a blood flow inlet at a distal end of the pump section to a blood flow outlet located proximal to the blood flow inlet.

[0155] B24. An intravascular blood pump as described in B22 or B23, wherein the pump section includes a housing.

[0156] B25. An intravascular blood pump as described in any one of B1 to B24, wherein at least one of the rotor and housing are compressible, allowing the intravascular blood pump to be inserted through the patient's vascular system and into the patient's heart while at least one of the rotor and housing are in their compressed state, and allowing the rotor and housing to be expanded once the pump section is positioned at its target location.

[0157] B26. An intravascular blood pump according to any one of B1 to B25, wherein the reinforcing element is a solid rod or wire.

[0158] B27. An intravascular blood pump according to any one of B1 to B26, wherein the reinforcing element is coaxially disposed within the drive shaft.

[0159] B28. An intravascular blood pump according to any one of B1 to B27, wherein the drive shaft and / or the stiffening element are hollow along part or all of their length.

[0160] B29. The intravascular blood pump according to any one of B1 to B28, wherein the distal bearing includes an outer sleeve that houses the spiral bearing.

[0161] B30. The intravascular blood pump of B29, wherein the spiral bearing is configured to surround the drive shaft.

[0162] B31. The intravascular blood pump of any one of B1-B28, further comprising an atraumatic tip at a distal end of the blood pump.

[0163] B32. An intravascular blood pump as described in B31, wherein a predefined bend region of the catheter is configured to contact the endothelium of the aorta when the blood pump is inserted into the patient's heart, thereby supporting the pump device and aligning the atraumatic tip with the aortic valve of the patient's heart, thereby positioning the pump device within the patient's ventricle.

[0164] B33. An intravascular blood pump as described in B32, wherein a predefined bending region of the catheter is adapted to contact the endothelium of the aorta when the blood pump is inserted into the patient's heart, thereby supporting the pump device and aligning the atraumatic tip with the aortic valve of the patient's heart, thereby positioning the pump device within the patient's ventricle.

[0165] B34. An intravascular blood pump as described in B33, wherein the atraumatic tip is 110-140 degrees out of plane relative to the plane in which the bending sleeve lies when bent, the atraumatic tip further, optionally, is 120-130 degrees out of plane relative to the plane in which the bending sleeve lies when bent, and the atraumatic tip further, optionally, is 130 degrees out of plane relative to the plane in which the bending sleeve lies when bent.

[0166] B35. An intravascular blood pump as described in any one of B1 to B28, wherein the plurality of openings are formed in radially coincident pairs that define an arc or semicircle about 180 degrees around the circumference of the sleeve.

[0167] B36. The intravascular blood pump of B35, wherein each of the openings extends approximately halfway around the circumference of the sleeve, and each opening has a connector at a terminal end of the opening.

[0168] B37. The intravascular blood pump of B36, wherein the radially corresponding pairs of openings share a common axis and are laterally offset from one another in an alternating manner.

[0169] B38. An intravascular blood pump as described in any one of B1-B28, wherein the plurality of annular rings are spaced apart a uniform distance when the sleeve is in a straight configuration.

[0170] B39. The intravascular blood pump according to any one of B1 to B28, wherein the length of the sleeve corresponds to the length of a predefined bending region on the catheter.

[0171]

[0125] Category C: C1. Catheter; a housing in which the rotor is housed, the housing being attached to the distal end of the catheter; and a drive shaft extending through the catheter and connected to the rotor, at least a portion of the drive shaft being flexible and including an outer layer of wound or braided wire, an inner layer of wound or braided wire, and a reinforcing element disposed within at least the outer layer of wound or braided wire. An intravascular blood pump comprising: The drive shaft is rotatably supported in a proximal bearing located proximal to the rotor and a distal bearing located distal to the rotor; the reinforcing element extends from at least a point in the proximal bearing to a point in the distal bearing, the catheter having a distal end and a predefined bend region positioned proximal to the distal end; The catheter includes a sleeve, the sleeve comprising: Multiple annular rings; at least two connectors disposed between each of the plurality of annular rings to connect each of the plurality of annular rings, the at least two connectors being offset from at least one adjacent connector; and A plurality of openings formed between each annular ring and arranged in an alternating pattern. Including, The intravascular blood pump, wherein the sleeve is configured to be monolithically integrated with or placed over a predefined bending region of the catheter, thereby providing the catheter with a predefined elastic bending portion.

[0172] C2. The intravascular blood pump of C1, further comprising a tension relief region at the proximal and / or distal end of the sleeve.

[0173]

[0126] Category D: D1. Catheter; A housing in which the rotor is housed, the housing being attached to the distal end of the catheter; and a drive shaft extending through the catheter and connected to the rotor, the drive shaft including an outer layer of wound or braided wire, an inner layer of wound or braided wire, and a reinforcing element disposed within at least the outer layer of wound or braided wire. An intravascular blood pump comprising: the drive shaft is rotatably supported in a proximal bearing located proximal to the rotor and a distal bearing located distal to the rotor; and the reinforcing element extends from at least a point in the proximal bearing to a point in the distal bearing; The catheter includes a sleeve, the sleeve comprising: Multiple annular rings; at least two connectors disposed between each of the plurality of annular rings to connect each of the plurality of annular rings, the at least two connectors being offset from at least one adjacent connector; and A plurality of openings formed between each annular ring and arranged in an alternating pattern. Including, The intravascular blood pump, wherein the sleeve is configured to be monolithically integrated with or placed over a predefined bending region of the catheter, thereby providing the catheter with a predefined elastic bending portion.

[0174]

[0127] Category E: E1. Catheter; a housing in which the rotor is housed, the housing being attached to the distal end of the catheter; and a drive shaft extending through the catheter and connected to the rotor, at least a portion of the drive shaft being flexible and including an outer layer of wound or braided wire, an inner layer of wound or braided wire, and a reinforcing element disposed within at least the outer layer of wound or braided wire. An intravascular blood pump comprising: the drive shaft is rotatably supported in a proximal bearing located proximal to the rotor and a distal bearing located distal to the rotor; and An intravascular blood pump, wherein the reinforcing element extends from at least a point in the proximal bearing to a point in the distal bearing.

[0175] E2. An intravascular blood pump as described in E1, wherein the reinforcing element extends from a point proximal to the proximal bearing to a point within the distal bearing.

[0176] E3. An intravascular blood pump described in any one of items El to E2, wherein the proximal bearing includes a bearing sleeve attached to the drive shaft and an outer bearing ring attached to the housing, the bearing sleeve being configured to rotate within the outer bearing ring.

[0177] E4. The intravascular blood pump of E3, further comprising a restrictive element attached to the housing and positioned proximal to the proximal bearing and configured to prevent the bearing sleeve from being removed from the outer bearing ring.

[0178] E5. An intravascular blood pump as described in any one of E1-E4, wherein the reinforcing element includes a stepped proximal end having a smaller diameter portion and a larger diameter portion.

[0179] E6. An intravascular blood pump as described in E5, wherein the reduced diameter portion extends from a point at or substantially near where the catheter is attached to the housing to a point within the restrictive element.

[0180] E7. An intravascular blood pump as described in E5, wherein the reduced diameter portion extends from a point within the restrictive element to a point within the proximal bearing.

[0181] E8. The intravascular blood pump of E6, wherein the larger diameter portion extends from a point within the restrictive element to a point within the distal bearing.

[0182] E9. An intravascular blood pump as described in E5, wherein the inner layer of wound or braided wire is omitted between a point in the restrictive element and a point in the distal bearing.

[0183] E10. The intravascular blood pump of E7, wherein the larger diameter portion extends from a point in the proximal bearing to a point in the distal bearing.

[0184] E11. The intravascular blood pump of E10, wherein the inner layer of wound or braided wire is omitted between a point in the proximal bearing and a point in the distal bearing.

[0185] E12. The intravascular blood pump of any one of E1 to E11, wherein the reinforcing element comprises Nitinol or Ultra-Stiff Nitinol.

[0186] E13. The intravascular blood pump of any one of E1 to E12, wherein the housing includes a cage surrounding the rotor, the cage having a plurality of struts.

[0187] E14. An intravascular blood pump as described in E13, wherein at a first point proximal to the rotor, each strut of the plurality of struts has a circumferential width and a radial thickness, the circumferential width being 1.2 to 1.8 times the radial thickness.

[0188] E15. An intravascular blood pump as described in E13, wherein at a first point proximal to the rotor, each strut of the plurality of struts has a circumferential width and a radial thickness, the circumferential width being 1.2 to 1.3 times the radial thickness.

[0189] E16. The intravascular blood pump of E13, wherein at a first point proximal to the rotor, each strut of the plurality of struts has a circumferential width and a radial thickness, the circumferential width being approximately 1.26 times the radial thickness.

[0190] E17. An intravascular blood pump as described in E14, wherein at a second point distal to the rotor, each strut of the plurality of struts has a circumferential width and a radial thickness, the circumferential width being 1.2 to 1.8 times the radial thickness.

[0191] E18. An intravascular blood pump as described in E15, wherein at a second point distal to the rotor, each strut of the plurality of struts has a circumferential width and a radial thickness, the circumferential width being 1.2 to 1.3 times the radial thickness.

[0192] E19. The intravascular blood pump of E16, wherein at a second point distal to the rotor, each strut of the plurality of struts has a circumferential width and a radial thickness, the circumferential width being approximately 1.26 times the radial thickness.

[0193] E20. An intravascular blood pump as described in E17, wherein at a third point proximal to the rotor and distal to the first point, each strut of the plurality of struts has a circumferential width and a radial thickness, and the circumferential width is 1.0 to 1.6 times the radial thickness.

[0194] E21. An intravascular blood pump as described in E18, wherein at a third point proximal to the rotor and distal to the first point, each strut of the plurality of struts has a circumferential width and a radial thickness, the circumferential width being 1.0 to 1.15 times the radial thickness.

[0195] E22. An intravascular blood pump as described in E19, wherein at a third point proximal to the rotor and distal to the first point, each strut of the plurality of struts has a circumferential width and a radial thickness, the circumferential width being approximately 1.26 times the radial thickness.

[0196] E23. An intravascular blood pump as described in E19, wherein at a third point proximal to the rotor and distal to the first point, each strut of the plurality of struts has a circumferential width and a radial thickness, the circumferential width being approximately 1.09 times the radial thickness.

[0197] E24. An intravascular blood pump as described in E20, wherein at a fourth point distal to the rotor and proximal to the second point, each strut of the plurality of struts has a circumferential width and a radial thickness, and the circumferential width is 1.0 to 1.6 times the radial thickness.

[0198] E25. An intravascular blood pump as described in E21, wherein at a fourth point distal to the rotor and proximal to the second point, each strut of the plurality of struts has a circumferential width and a radial thickness, the circumferential width being 1.0 to 1.15 times the radial thickness.

[0199] E26. The intravascular blood pump of E22, wherein at a fourth point distal to the rotor and proximal to the second point, each strut of the plurality of struts has a circumferential width and a radial thickness, the circumferential width being approximately 1.26 times the radial thickness.

[0200] E27. An intravascular blood pump as described in E23, wherein at a fourth point distal to the rotor and proximal to the second point, each strut of the plurality of struts has a circumferential width and a radial thickness, the circumferential width being approximately 1.09 times the radial thickness.

[0201] E28. The intravascular blood pump of any one of E1-E27, wherein the housing comprises Nitinol or Ultra-Stiff Nitinol.

[0202] E29. The intravascular blood pump of E5, wherein the larger diameter portion is configured to fit over an outer layer of wound or braided wire in a portion of the drive shaft where the inner layer of wound or braided wire is omitted.

[0203] E30. The intravascular blood pump of E1, further comprising a downstream tube attached to the housing, the catheter being disposed through the downstream tube, the downstream tube being bent.

[0204] E31. The intravascular blood pump of E30, wherein the downstream tube is made of a flexible material such that it may be compressed or expanded.

[0205] E32. The intravascular blood pump of E31, wherein the bend angle of the downstream tube is different from the bend angle of the catheter.

[0206] E33. The intravascular blood pump of E32, wherein the bend angle of the downstream tube is 30°±10° and the bend angle of the catheter is 45°±10°.

[0207] E34. The intravascular blood pump of E30, wherein the bending angle of the downstream tube and the bending angle of the catheter are the same.

[0208] Category F: F1. Catheter; a housing in which the rotor is housed, the housing being attached to the distal end of the catheter; and a drive shaft extending through the catheter and connected to the rotor, the drive shaft including an outer layer of wound or braided wire, an inner layer of wound or braided wire, and a reinforcing element disposed within at least the outer layer of wound or braided wire, the drive shaft being rotatably supported within a proximal bearing located proximal to the rotor and a distal bearing located distal to the rotor. An intravascular blood pump comprising: An intravascular blood pump, wherein the reinforcing element extends from at least a point in the proximal bearing to a point in the distal bearing.

[0209] F2. An intravascular blood pump as described in F1, wherein the reinforcing element extends from a point proximal to the proximal bearing to a point within the distal bearing.

[0210] F3. An intravascular blood pump as described in F1 or F2, wherein the proximal bearing includes a bearing sleeve attached to the drive shaft and an outer bearing ring attached to the housing, the bearing sleeve being configured to rotate within the outer bearing ring.

[0211] F4. The intravascular blood pump of F3, further including a restrictive element attached to the housing and positioned proximal to the proximal bearing and configured to prevent the bearing sleeve from being removed from the outer bearing ring.

[0212] F5. An intravascular blood pump as described in any one of F1 to F4, wherein the reinforcing element includes a stepped proximal end portion having a smaller diameter portion and a larger diameter portion.

[0213] F6. An intravascular blood pump as described in F5, wherein the reduced diameter portion extends from a point substantially near where the catheter is attached to the housing to a point within the restrictive element.

[0214] F7. An intravascular blood pump as described in F5 or F6, wherein the reduced diameter portion extends from a point in the restrictive element to a point in the proximal bearing.

[0215] F8. An intravascular blood pump as described in any one of F5 to F7, wherein the large diameter portion extends from a point within the restrictive element to a point within the distal bearing.

[0216] F9. An intravascular blood pump as described in any one of F1 to F8, wherein the inner layer of wound or braided wire is omitted between a point in the restrictive element and a point in the distal bearing.

[0217] F10. An intravascular blood pump as described in any one of F1 to F9, wherein the large diameter portion extends from a point in the proximal bearing to a point in the distal bearing.

[0218] F11. An intravascular blood pump as described in any one of F1 to F10, wherein the large diameter portion is configured to fit within the outer layer of the drive shaft in a portion of the drive shaft where the inner layer is omitted.

[0219] F12. An intravascular blood pump as described in any one of F1 to F11, wherein the inner layer of wound or braided wire is omitted between a point in the proximal bearing and a point in the distal bearing.

[0220] F13. An intravascular blood pump according to any one of F1 to F12, wherein the reinforcing element comprises Nitinol or Ultra-Stiff Nitinol.

[0221] F14. An intravascular blood pump according to any one of F1 to F13, wherein the housing includes a cage surrounding the rotor, the cage having a plurality of struts.

[0222] F15. An intravascular blood pump as described in F14, wherein at a first point proximal to the rotor, each strut of the plurality of struts has a circumferential width and a radial thickness, the circumferential width being approximately 1.26 times the radial thickness.

[0223] F16. An intravascular blood pump as described in F14 or F15, wherein at a second point distal to the rotor, each strut of the plurality of struts has a circumferential width and a radial thickness, the circumferential width being approximately 1.26 times the radial thickness.

[0224] F17. An intravascular blood pump as described in any one of F14 to F16, wherein at a third point proximal to the rotor and distal to the first point, each strut of the plurality of struts has a circumferential width and a radial thickness, and the circumferential width is approximately 1.26 times the radial thickness.

[0225] F18. An intravascular blood pump as described in any one of F14 to F17, wherein at a fourth point distal to the rotor and proximal to the second point, each strut of the plurality of struts has a circumferential width and a radial thickness, and the circumferential width is approximately 1.26 times the radial thickness.

[0226] F19. An intravascular blood pump as described in any one of F14 to F18, wherein at a third point proximal to the rotor and distal to the first point, each strut of the plurality of struts has a circumferential width and a radial thickness, and the circumferential width is approximately 1.09 times the radial thickness.

[0227] F20. An intravascular blood pump as described in any one of F14 to F19, wherein at a fourth point distal to the rotor and proximal to the second point, each strut of the plurality of struts has a circumferential width and a radial thickness, and the circumferential width is approximately 1.09 times the radial thickness.

[0228] F21. The intravascular blood pump according to any one of F1 to F20, wherein at least one of the rotor and the housing includes Nitinol or Ultra-Stiff Nitinol.

[0229] F22. An intravascular blood pump according to any one of F1 to F21, wherein the intravascular blood pump includes a pump section, the pump section including a rotor.

[0230] F23. The intravascular blood pump of F22, wherein the rotor is configured to induce flow of blood from a blood flow inlet at a distal end of the pump section to a blood flow outlet located proximal to the blood flow inlet.

[0231] F24. An intravascular blood pump as described in F22 or F23, wherein the pump section includes a housing.

[0232] F25. An intravascular blood pump as described in any one of Bl to B24, wherein at least one of the rotor and the housing are compressible, allowing the intravascular blood pump to be inserted through the patient's vascular system and into the patient's heart while at least one of the rotor and the housing are in their compressed state, and allowing the rotor and the housing to be expanded once the pump section is positioned at its target location.

[0233] F26. An intravascular blood pump according to any one of F1 to F25, wherein the reinforcing element is a solid rod or wire.

[0234] F27. An intravascular blood pump as described in any one of F1 to F26, wherein the reinforcing element is coaxially disposed within the drive shaft.

[0235] F28. An intravascular blood pump according to any one of F1 to F27, wherein the drive shaft and / or the reinforcing element are hollow along part or all of their length.

[0236] F29. An intravascular blood pump as described in any one of F1 to F28, wherein the distal bearing includes an outer sleeve that houses the spiral bearing.

[0237] F30. The intravascular blood pump of F29, wherein the spiral bearing is configured to surround the drive shaft.

[0238] F31. The intravascular blood pump of F1, wherein the catheter comprises a curved catheter.

[0239] F31. The intravascular blood pump of F31, further comprising a downstream tube attached to the housing, the catheter being disposed through the downstream tube, the downstream tube being bent.

[0240] F32. An intravascular blood pump as described in F31, wherein the downstream tube is made of a flexible material so that it can be compressed or expanded.

[0241] F33. The intravascular blood pump of F31, wherein the bend angle of the downstream tube is different from the bend angle of the catheter.

[0242] F34. The intravascular blood pump according to F33, wherein the bend angle of the downstream tube is 30°±10° and the bend angle of the catheter is 45°±10°.

[0243] F35. The intravascular blood pump according to F31, wherein the bending angle of the downstream tube and the bending angle of the catheter are the same.

Claims

1. catheter; a housing for housing a rotor, the housing being attached to the distal end of the catheter; and a drive shaft extending through the catheter and connected to the rotor, at least a portion of the drive shaft being flexible and including an outer layer of wound or braided wire, an inner layer of wound or braided wire, and a reinforcing element disposed within at least the outer layer of wound or braided wire. An intravascular blood pump comprising: the drive shaft is rotatably supported in a proximal bearing located proximal to the rotor and a distal bearing located distal to the rotor; and The intravascular blood pump, wherein the reinforcing element extends from at least a point in the proximal bearing to a point in the distal bearing.

2. The intravascular blood pump of claim 1 , wherein the stiffening element extends from a point proximal to the proximal bearing to a point within the distal bearing.

3. 3. The intravascular blood pump of claim 1, wherein the proximal bearing includes a bearing sleeve attached to the drive shaft and an outer bearing ring attached to the housing, the bearing sleeve configured to rotate within the outer bearing ring.

4. 4. The intravascular blood pump of claim 3, further comprising a restrictive element attached to the housing and positioned proximal to the proximal bearing and configured to prevent the bearing sleeve from being removed from the outer bearing ring.

5. The intravascular blood pump of claim 1 , wherein the stiffening element includes a stepped proximal end with a reduced diameter portion and a larger diameter portion.

6. 6. The intravascular blood pump of claim 5, wherein the reduced diameter portion extends from a point at or substantially near where the catheter attaches to the housing to a point within the restrictive element.

7. The intravascular blood pump of claim 5 , wherein the reduced diameter portion extends from a point within the restrictive element to a point within the proximal bearing.

8. The intravascular blood pump of claim 6 , wherein the larger diameter portion extends from a point within the restrictive element to a point within the distal bearing.

9. 6. The intravascular blood pump of claim 5, wherein the inner layer of wound or braided wire is omitted between a point in the restrictive element and a point in the distal bearing.

10. 8. The intravascular blood pump of claim 7, wherein the larger diameter portion extends from a point in the proximal bearing to a point in the distal bearing.

11. 11. The intravascular blood pump of claim 10, wherein the inner layer of wound or braided wire is omitted between a point in the proximal bearing and a point in the distal bearing.

12. The intravascular blood pump of claim 1 , wherein the stiffening element comprises Nitinol or Ultra-Stiff Nitinol.

13. The intravascular blood pump of claim 1 , wherein the housing includes a cage surrounding the rotor, the cage having a plurality of struts.

14. The intravascular blood pump of claim 1 , wherein the housing comprises Nitinol or Ultra-Stiff Nitinol.

15. 6. The intravascular blood pump of claim 5, wherein the larger diameter portion is configured to fit within the outer layer of wound or braided wire in a portion of the drive shaft where the inner layer of wound or braided wire is omitted.

16. 10. The intravascular blood pump of claim 1, further comprising a downstream tube attached to said housing, said catheter being disposed through said downstream tube, said downstream tube being bent.

17. 17. The intravascular blood pump of claim 16, wherein the downstream tube is made of a flexible material so that it can be compressed or expanded.

18. 18. The intravascular blood pump of claim 17, wherein the bend angle of the downstream tube is different from the bend angle of the catheter.

19. 19. The intravascular blood pump of claim 18, wherein the bend angle of the downstream tube is 30°±10° and the bend angle of the catheter is 45°±10°.

20. 17. The intravascular blood pump of claim 16, wherein the bend angle of the downstream tube and the bend angle of the catheter are the same.

21. catheter; a housing for housing a rotor, the housing being attached to the distal end of the catheter; and a drive shaft extending through the catheter and connected to the rotor, the drive shaft including an outer layer of wound or braided wire, an inner layer of wound or braided wire, and a reinforcing element disposed within at least the outer layer of wound or braided wire, the drive shaft rotatably supported in a proximal bearing located proximal to the rotor and a distal bearing located distal to the rotor. An intravascular blood pump comprising: The intravascular blood pump, wherein the reinforcing element extends from at least a point in the proximal bearing to a point in the distal bearing.

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