Distal outflow cage of blood pump

Abstract

To provide a blood outflow cage for intravascular blood pump assemblies, sized for passage through the patient's vascular lumen. [Solution] A distal cap having a substantially conical, substantially curved conical, or substantially dome-shaped outer surface; a diffuser having a substantially conical or substantially curved conical outer surface and positioned proximal to the distal cap; two or more blood drainage openings, each defined on its inner and outer surfaces by two struts, each strut having a rounded inner edge and outer edge and a rounded joint with the diffuser, and the proximal end of each blood drainage opening having a rounded corner, and a peripheral wall having a blood drainage opening and a first cylindrical section adjacent to the proximal end of each strut.

Description

Technical Field

[0001] Cross - Reference to Related Applications This application claims priority to U.S. Provisional Patent Application No. 62 / 955,603, filed on December 31, 2019, the entire disclosure of which is incorporated herein by reference.

[0002] Technical Field The present disclosure relates to a blood pump assembly. More specifically, the present disclosure relates to an outflow cage component disposed at the distal end of a blood pump assembly.

Background Art

[0003] Background Blood pump assemblies, such as intracardiac blood pump assemblies, are introduced into the heart to deliver blood into the arteries from the heart. For example, when used for right - heart support, the blood pump assembly may draw blood from the inferior vena cava and eject blood into the pulmonary artery. In some cases, the blood pump assembly may be inserted by a catheter technique through the femoral vein, into the inferior vena cava, through the right atrium, across the tricuspid valve, into the right ventricle, through the pulmonary valve, and into the pulmonary artery. This insertion path is serpentine and requires the blood pump assembly to pass through several bends, which can impose stress on the patient's vasculature, particularly through contact with the distal end of the blood pump assembly. In addition, pumping of blood through the blood pump assembly can potentially damage the blood or cause hemolysis as blood is drawn through the blood pump assembly. Further, since the blood outflow cage described herein incorporates a diffuser at its distal end, the junction between the struts of the blood outflow cage and the diffuser can further interfere with blood flow and can also be complex to manufacture.

Summary of the Invention

[0004] Summary The devices and methods of manufacture and implementation described herein provide a blood pump assembly with an outflow cage component designed to reduce stress on the patient's vascular structure, reduce hemolysis and blood damage, and improve ease of manufacture. The blood pump assembly includes a blood outflow cage designed to discharge blood from the distal end of the blood pump assembly. The blood outflow cage has rounded edges, corners, and joints. This offers several benefits. Rounding the outer edges of the blood outflow cage reduces stress and abrasion on the vascular structure when the blood pump assembly is inserted into the patient's body and advanced to the operating position. Rounding the inner and outer edges of the blood outflow cage also leads to a significant reduction in hemolysis, as described in U.S. Patent No. 9,433,713, incorporated herein by reference. In addition, since the blood drainage cage described herein incorporates a diffuser at its distal end, the use of fillets on the joints between the strut and the diffuser (i.e., the corners at the intersection of the strut and the diffuser) further improves blood flow around these joints. This also reduces the number of red blood cells that rupture as blood flows through the blood drainage cage, resulting in further reduction of hemolysis. Furthermore, the rounded edges, corners, and joints of the blood drainage cage described herein also improve the ease of manufacturing the blood drainage cage. In particular, these features facilitate manufacturing using automated machining processes and allow the entire blood drainage cage to be formed from a single workpiece.

[0005] In one aspect, the present disclosure describes a blood outflow cage for an intravascular blood pump assembly and sized for passage through a patient's vascular lumen. The assembly includes a distal cap having a substantially conical, substantially curved conical, or substantially dome-shaped outer surface; and a diffuser having a substantially conical or substantially curved conical outer surface. The diffuser is positioned proximal to the distal cap. The assembly has a circumferential wall having an inner surface, an outer surface, and two or more blood outflow openings, each defined by two struts; where each strut has a rounded inner edge and an outer edge, and a rounded joint with the diffuser. The proximal end of each blood outflow opening has a rounded corner and a first cylindrical section adjacent to the proximal end of each strut. The blood outflow cage optionally has an aperture through the diffuser and the distal cap. In some aspects, the circumferential wall tapers in thickness from a first thickness in the strut to a second thickness in the first cylindrical section, where the first thickness exceeds the second. In some aspects, the circumferential wall also has a second cylindrical section adjacent to the first cylindrical section, where the outer diameter of the second cylindrical section is smaller than that of the first cylindrical section. The blood outflow cage optionally has a flexible tubular extension connected to a distal cap. In some aspects, the distal end of the flexible tubular extension is curved in its relaxed state. The blood outflow cage optionally has a fillet between the inner surface of each strut and the diffuser. In some aspects, the fillet has a radius of approximately 0.30 mm. In some aspects, the inner edges of the struts of the blood drainage cage have a first radius of 0.07 mm to 0.21 mm, and the outer edges of the struts of the blood drainage cage have a second radius of 0.07 mm to 0.21 mm. In some aspects, the blood drainage cage is manufactured from a single piece of metal or polymer.

[0006] In another aspect, the present disclosure describes a blood pump assembly sized for passage through a patient's vascular lumen. The blood pump assembly includes a pump; an impeller blade rotatably coupled to the pump; a blood inflow cage extending around the axis of rotation of the impeller blade and having at least two blood inlet openings; a cannula fluidizing a first housing, with the proximal end of the cannula coupled to the blood inflow cage; and a blood outflow cage coupled to the distal end of the cannula. The blood drainage cage includes a distal cap having a substantially conical, substantially curved conical, or substantially dome-shaped outer surface; a diffuser having a substantially conical or substantially curved conical outer surface and positioned proximal to the distal cap; and a circumferential wall; the circumferential wall having an inner surface and an outer surface; and two or more blood drainage openings, each defined by two struts, each having a rounded inner edge and an outer edge, and a rounded joint with the diffuser, and the proximal end of each blood drainage opening having a rounded corner; and a first cylindrical section adjacent to the proximal end of each strut. The blood pump assembly optionally includes an aperture through the diffuser and distal cap of the blood drainage cage. In some aspects, the circumferential wall of the blood drainage cage tapers in thickness from a first thickness in the struts to a second thickness in the first cylindrical section, where the first thickness is greater than the second thickness. In some aspects, the peripheral wall of the blood outflow cage has a second cylindrical section adjacent to a first cylindrical section, where the outer diameter of the second cylindrical section is smaller than the outer diameter of the first cylindrical section. The blood pump assembly optionally includes a flexible tubular extension connected to the distal cap of the blood outflow cage. In some aspects, the distal end of the flexible tubular extension is curved in its relaxed state. The blood pump assembly may further include a fillet between the inner surface of each strut of the blood outflow cage and the diffuser. In some aspects, the fillet has a radius of approximately 0.30 mm.In some aspects, the inner edges of the struts of the blood drainage cage have a first radius of 0.07 mm to 0.21 mm, and the outer edges of the struts of the blood drainage cage have a second radius of 0.07 mm to 0.21 mm. In some aspects, the blood drainage cage is manufactured from a single piece of metal or polymer. [Brief explanation of the drawing]

[0007] [Figure 1] A blood pump assembly based on various aspects of this disclosure is shown. [Figure 2] A fluoroscopic view of the blood outflow cage based on the aspects of this disclosure is shown. [Figure 3] A fluoroscopic view of the blood outflow cage based on the aspects of this disclosure is shown. [Figure 4] A cross-sectional view of the blood outflow cage based on the aspects of this disclosure is shown. [Figure 5] Figures 5A and 5B show isometric views of a blood outflow cage based on the aspects of this disclosure. [Figure 6] A cross-sectional view of the blood outflow cage based on the aspects of this disclosure is shown. [Modes for carrying out the invention]

[0008] Detailed explanation This technology will be described in relation to the following exemplary systems and methods.

[0009] Figure 1 depicts an exemplary blood pump assembly 100 adapted for right heart support. The blood pump assembly 100 includes a catheter 102, a blood pump 104, a blood inflow cage 106, a cannula 108, a blood outflow cage 110, and a pigtail extension 112. The blood pump 104 is connected to the proximal end of the cannula 108 via the blood inflow cage 106. In some cases, the blood inflow cage 106 may enclose part or all of the blood pump 104 and / or be integrated within the housing of the blood pump 104. The distal end of the cannula 108 is further connected to the blood outflow cage 110. The pigtail extension 112 is connected to the distal end of the blood outflow cage 110. The catheter 102 is also connected to the proximal end of the blood pump 104.

[0010] The blood pump 104 includes a rotatable impeller blade (not shown) which may be driven by an internal motor. For example, the blood pump 104 may include an internal electric micro-axial pump having a pumping capacity of more than 4 L / min and a diameter of 21 or 22 Fr. The blood pump 104 may also be driven by a remote drive source, such as a motor located outside the patient's body and connected to a flexible drive shaft running through the catheter 102.

[0011] The catheter 102 may house wires connecting the motor of the blood pump 104 to one or more electrical controllers or other sensors. The catheter 102 may also house other components, such as a conduit for purge fluid and / or other conduits configured to receive a guidewire.

[0012] The blood inflow cage 106 includes one or more apertures or openings configured to allow blood to be drawn into the cannula 108 when the blood pump 104 is in operation.

[0013] The cannula 108 may include an elongated, flexible hose portion. For example, the cannula 108 may be composed at least partially of a polyurethane material. The cannula 108 may further include a shape memory coil, such as a nitinol coil. The cannula 108 may be formed to include one or more bends or curves in the relaxed state, or it may be configured to be straight in the relaxed state. The cannula 108 may have any preferred diameter, but is generally similar in diameter to that of the blood pump 104.

[0014] The blood drainage cage 110 includes one or more apertures or openings configured to allow blood to flow from the cannula 108 and exit the blood pump assembly 100. The blood drainage cage 110 may be composed of any suitable biocompatible material. For example, the blood drainage cage 110 may be formed from a biocompatible metal such as stainless steel or titanium, or a biocompatible polymer such as polyurethane. In addition, the surface of the blood drainage cage 110 may be treated in a variety of ways, including, but not limited to, etching, texturing, coating, or plating with another material. For example, the surface of the blood drainage cage 110 may be laser texturized. The blood drainage cage 110 may be manufactured from multiple pieces, but the designs described in more detail below help to manufacture the blood drainage cage from a single piece of metal or polymer, for example, by using automated machining processes. The blood drainage cage 110 may also be manufactured using rapid prototyping or injection molding. Further features of the blood drainage cage 110 will be described in detail below with reference to examples in Figures 2-6.

[0015] The pigtail extension 112 assists in stabilizing and positioning the blood pump assembly 100 in the correct position within the pulmonary artery. The pigtail extension 112 may be solid or tubular. If tubular, the pigtail extension 112 may be configured to allow a guide wire to pass through in order to further assist in the positioning of the blood pump assembly 100. The pigtail extension 112 may be of any preferred size. For example, the pigtail extension may have an outer diameter in the range of 4 to 8 Fr. The pigtail extension 112 may be composed of at least partially flexible material and may be configured from a straight configuration to a partially curved configuration. The pigtail extension 112 may also have sections with different rigidities. For example, the pigtail extension 112 may include a proximal section that is rigid enough to prevent buckling, thereby keeping the blood outflow cage 110 in a desired position; and a distal section that is softer and less rigid, thereby providing a non-traumatic tip for contacting the pulmonary artery wall and enabling guidewire loading. In such cases, the proximal and distal sections of the pigtail extension 112 may be composed of different materials, or of the same material treated to provide different rigidities.

[0016] However, the pigtail extension 112 is an optional structure. This technology may also be used with blood pump assemblies that include extensions of different types, shapes, materials, and qualities. Similarly, this technology may be used with blood pump assemblies that do not have any type of extension beyond the distal end of the blood outflow cage 110.

[0017] The blood pump assembly 100 may be inserted percutaneously. For example, when used for right heart support, the blood pump assembly 100 may be inserted by catheterization so that it passes through the femoral vein, enters the inferior vena cava, passes through the right atrium, crosses the tricuspid valve, enters the right ventricle, passes through the pulmonary valve, and enters the pulmonary artery. When positioned in this manner, the blood pump assembly 100 delivers blood from the blood inflow cage 106 located inside the inferior vena cava, through the cannula 108, to the blood outflow cage 110 located inside the pulmonary artery.

[0018] Figures 2-6 depict exemplary blood drainage cages 110 based on various aspects of this technology. All reference numbers common to Figures 2, 3, 4, 5A, 5B, and 6 represent the same features.

[0019] Figure 2 shows a perspective view of the blood outflow cage 110. The distal end of the blood outflow cage 110 includes a diffuser 212 that transitions into a dome-shaped end cap 214. At its proximal end, the blood outflow cage 110 is constructed of a circumferential wall having inner and outer surfaces; a cylindrical section 200; another cylindrical section 201; and five struts 202, 204, 206, 208, and 210. The cylindrical section 200 is fitted to connect to a cannula 108, and the cylindrical section 201 is slightly larger in diameter than the cylindrical section 200. The distal end of the cylindrical section 201 transitions into five struts 202, 204, 206, 208, and 210, which define five openings through which blood may exit the blood outflow cage 110. The exemplary blood outflow cage 110 in Figure 2 is shown with five struts, but any number of struts, two or more, may be used. Struts 202, 204, 206, 208, and 210 are connected to the distal end of the diffuser 212.

[0020] The diffuser 212 is adapted to direct the blood flow out of the blood outflow cage 110. Thus, the diffuser 212 has a curved conical shape in the examples of FIGS. 2-6, although other shapes such as a conical shape without curvature may be used. Similarly, the diffuser 212 is shown as having a smooth surface in FIGS. 2-6, but may include vanes, fins, or other features adapted to further assist the blood flow exiting the blood outflow cage 110. Further, the diffuser 212 is shown as having a blunt proximal tip in FIGS. 2-6, but alternatively, may be pointed in options where there is no aperture (such as aperture 410 in FIG. 4) traveling through the distal end of the blood outflow cage 110.

[0021] The end cap 214 is depicted as having a dome shape. However, the end cap 214 may have any shape that aids in inserting the blood pump assembly 100 into the patient's vasculature lumen, such as a conical or curved conical shape, or a cylindrical profile with rounded edges.

[0022] The inner and outer edges of struts 202, 204, 206, 208, and 210 are rounded. For example, in Figure 2, rounded outer edges 218a, 218b, 218c, and 218d are seen on struts 202, 204, and 206, respectively. Similarly, rounded inner edges 220a, 220b, 220c, and 220d are seen on struts 210 and 208, respectively. Rounding the outer edges of the blood outflow cage 110 reduces stress and abrasion on the vascular structure when the blood pump assembly is inserted. This is particularly beneficial in embodiments in which the blood pump assembly 100 is inserted percutaneously and used for right heart support; in such embodiments, the blood pump assembly 100 needs to be advanced through a meandering path as it passes through the heart to reach its operational position. In addition, rounding the inner and outer edges of the blood outflow cage 110 also leads to a significant reduction in hemolysis, as described in U.S. Patent No. 9,433,713. The outer edges (e.g., 218a, 218b, 218c, and 218d) and inner edges (e.g., 220a, 220b, 220c, and 220d) are filleted and may have any preferred radius. For example, but not limited to, in the case of a blood outflow cage 110 with an outer diameter of 21 Fr (7 mm), the edges of each strut may be rounded to a radius of 0.07 mm to 0.21 mm. In this regard, the inner and outer edges do not need to have the same radius. For example, the inner edge of each strut may be rounded to a radius of approximately 0.08 mm, and the outer edge may be rounded to a radius of approximately 0.20 mm.

[0023] The shape of the openings defined by struts 202, 204, 206, 208, and 210 can also be rounded. For example, in the opening defined by struts 202 and 204, the proximal end has rounded corners 216a and 216b, and the distal end has rounded junctions 222a and 222b where the struts transition to diffuser 212. Similarly, in the opening defined by struts 204 and 206, the proximal end has rounded corners 216c and 216d, and the distal end has rounded junctions 222b and 222c where the struts transition to diffuser 212. Rounded junctions 222a, 222b, and 222c flare fan-shaped in both the tangential and radial directions so that all surfaces and edges of the struts have a smooth transition to diffuser 212. Rounding the shape of the openings of blood outflow cage 110 in this manner further improves blood flow. In particular, using a filleted junction between the strut and the conical surface of diffuser 212 avoids sharp corners and pockets that can exert shear stress on blood cells and cause hemolysis. The rounded corners of the openings may have any suitable shape and dimensions. For example, but not limited to, in the case of blood outflow cage 110 having an outer diameter of about 21 Fr (7 mm), the proximal side corners (e.g., 216a, 216b, 216c, and 216d) may have an asymmetric radius where the major radius of about 2 mm transitions to a minor radius of about 1.431 and the conical Rho is about 0.35. Additionally, the rounded junctions (e.g., 222a, 222b, and 222c) may have a radius of about 0.3 mm. Using an asymmetric radius can create a compound shape that provides a smooth transition surface as blood flow exits the window. However, the window may also be formed using one or more constant radii.

[0024] The rounding of the edges, corners, and joints of the blood drainage cage described herein leads to improved manufacturability in addition to the advantages mentioned above. In particular, these features are helpful for manufacturing using automated machining processes, as automated machining processes rely on the rotation of milling bits and cutting tools. In addition, by using filleted transitions at the joints between struts 202, 204, 206, 208, 210 and diffuser 212, the joints become more robust, making automated machining more feasible and allowing the blood drainage cage 110 to be machined from a single workpiece without the need for welding or other joining methods.

[0025] Figure 3 shows a second perspective view of the blood drainage cage 110 as depicted in Figure 2. Specifically, Figure 3 depicts the exemplary blood drainage cage 110 from Figure 2, rotated so that strut 202 is at the top of the blood drainage cage 110. As a result of this orientation, only struts 202, 204, and 206 are visible. In this figure, struts 208 and 210 are hidden behind struts 206 and 204, respectively.

[0026] Figure 4 depicts a cross-sectional view of the blood drainage cage 110, oriented as shown in Figure 3 and sectioned centrally along the plane indicated by reference line 4-4 in Figure 3. This sectioning makes struts 204 and 206 no longer visible, while struts 208 and 210 are visible. In addition, in this figure, the aperture 410 is visible as it runs through the distal end of the blood drainage cage 110. Specifically, the aperture 410 runs from the proximal opening 408 in the diffuser 212 to the distal opening 412 in the end cap 214. The aperture 410 is adapted to allow a guidewire to pass through the distal end of the blood drainage cage 110. In addition, the distal section of the aperture 410 has a larger diameter and is adapted to connect with the tubular pigtail extension 112. However, like the pigtail extension 112, the aperture 410 is an optional feature, and this technology may be used with a blood outflow cage that does not include the aperture 410 or includes an aperture with a different configuration.

[0027] A cross-sectional view of the blood drainage cage 110, along with oblique hatching, is shown in Figure 4. This reveals further features of struts 202, 204, 206, 208, and 210. In particular, as shown with respect to the cross-sectional strut 202, the strut includes a tapered section 404. As seen in the figure, the strut 202 has a substantially constant thickness between arrows 414 and 406, and has a tapered section 404 as the strut 202 transitions to the thinner wall thickness of the cylindrical section 201 at arrow 402. This tapered section 404 corresponds to the fan-shaped flaring of the strut 202 at the rounded corners 216e and 216a (not visible in this cross-sectional view) of the adjacent openings. The tapered reduction of the wall thickness, in conjunction with the fan-shaped widening of each strut, allows for a design that minimizes the proximal wall thickness while also enabling the appropriate transfer of stress from the struts to the cylindrical section 201. This tapered section 404 may have any preferred profile and dimensions. For example, the tapered section 404 may be tapered in a straight or curved manner. If curved, the tapered section 404 may be formed using a single radius or by a mixture of two or more radii. Thus, in a design similar to that shown in Figure 4, assuming a blood outflow cage 110 with an outer diameter of approximately 21 Fr (7 mm), the tapered section 404 may include a concave radius of approximately 6.5 mm that transitions to a convex radius of approximately 4.8 mm (from distal to proximal). Similarly, the wall thickness may be tapered from approximately 0.4 mm at or near arrow 406 to approximately 0.2 mm at or near arrow 402.

[0028] Figures 5A and 5B depict isometric views of the blood outflow cage 110 as shown in Figures 2-4. Specifically, Figure 5A depicts an isometric view of the exemplary blood outflow cage 110 shown in Figures 2-4, viewed distally, and Figure 5B depicts an isometric view of the exemplary blood outflow cage 110 shown in Figures 2-4, viewed proximal.

[0029] Figure 6 is a cross-sectional view of the blood outflow cage 110, cross-sectioned along line 6-6 in Figure 5B, viewed in the direction of the arrow, i.e., toward the distal end of the blood outflow cage 110. The cross-sectional surface of each strut of the blood outflow cage 110 is shown by cross-hatching in Figure 6.

[0030] The terms “approximately,” “about,” “substantially,” and similar terms as used herein are intended to have a broad meaning consistent with the common usage accepted by those skilled in the art in which this disclosure pertains. Those skilled in the art should understand that these terms are intended to allow for the description of specific features without limiting the scope of those features to the precise numerical ranges provided. Therefore, these terms should be interpreted as indicating that any non-substantial or trivial modification or alteration of the description is deemed to fall within the scope of this disclosure.

[0031] For the purposes of this disclosure, the term “coupled” means a direct or indirect joining of two members to one another. Such a joining may be static or movable. Such a joining may be realized between two members, or the two members and any additional intermediate members may be integrally formed with each other or between the two members as a single unitary body, or the two members and any additional intermediate members may be attached to each other. Such a joining may be permanent, or it may be removable or detachable.

[0032] It is important to note that the assemblies and arrangements of the apparatus or its components shown in the various exemplary embodiments are illustrative only. Although only a few embodiments are described in detail in this disclosure, it will be readily apparent to those skilled in the art that many modifications are possible without significantly departing from the novel teachings and merits of this disclosure (e.g., variations in the size, dimensions, structure, shape, and proportions of various elements; parameter values; mount arrangement; material use; color; orientation, etc.). For example, elements shown as integrally formed may be assembled from multiple parts or elements, the positions of elements may be reversed or otherwise altered, and the nature or number or position of discontinuous elements may be changed or altered. The order or sequence of any steps of a process or method may be changed or rearranged based on alternative embodiments. Other substitutions, modifications, changes, and omissions in the design, operating conditions, and arrangements of the various exemplary embodiments can also be made without departing from the scope of this disclosure.

[0033] While various embodiments have been described and illustrated herein, it is expected that a person skilled in the art will readily conceive of various other mechanisms and / or structures for performing the functions described herein and / or obtaining the results and / or one or more advantages described herein, and each of such variations and / or modifications will be considered within the scope of the inventive embodiments described herein. More generally, unless otherwise noted, the parameters, dimensions, materials, and configurations described herein are intended to be illustrative; and it will be readily apparent to a person skilled in the art that the actual parameters, dimensions, materials, and / or configurations will depend on the specific application in which the teachings of the present invention are used. A person skilled in the art will be able to recognize or confirm numerous equivalents to the specific inventive embodiments described herein by at most routine experimental methods. Therefore, it should be understood that the above embodiments are presented only as examples; and that embodiments of the present invention may be carried out in addition to those specifically described and claimed within the scope of the appended claims and their equivalents. The inventive embodiments of this disclosure cover each of the individual features, systems, articles, materials, kits, and / or methods described herein. In addition, any combination of two or more such features, systems, articles, materials, kits, and / or methods is included within the scope of the inventions of this disclosure, provided that such features, systems, articles, materials, kits, and / or methods are not contradictory to each other.

[0034] In this specification and the appended claims, the indefinite articles “a” and “an” should be understood to mean “at least one” unless explicitly stated to the contrary. In this specification and the appended claims, “or” should be understood to have the same meaning as “and / or” as defined above. For example, when “or” or “and / or” separates items in a list, it should be interpreted as inclusive, that is, including at least one, but also including more than one of several elements or lists of elements, and optionally including additional items not on the list. Only terms that explicitly state the opposite, such as “only one of” or “exactly one of,” refer to including exactly one element of several elements or lists of elements. In general, the term "or" as used herein should be interpreted as referring to an exclusive choice (i.e., "one or the other but not both") only when preceded by an exclusive term such as "either," "one of," "only one," or "exactly one."

[0035] In this specification and the appended claims, the phrase “at least one” used in reference to a list of one or more elements should be understood to mean at least one element selected from any one or more elements in that list of elements. The phrase “at least one” should not be understood to require at least one of each element specifically enumerated in the list of elements. The phrase “at least one” should also not be understood to exclude any combination of elements in the list of elements. This definition also allows for the optional presence of elements other than those specifically identified in the list of elements to which the phrase “at least one” refers, whether or not they are related to those specifically identified elements. Therefore, as a non-restrictive example, “at least one of A and B” (or equivalently “at least one of A or B” or equivalently “at least one of A and / or B”) could refer to, in one embodiment, at least one A comprising any more than one, and B being absent (and optionally comprising elements other than B); in another embodiment, at least one B comprising any more than one, and A being absent (and optionally comprising elements other than A); and yet another embodiment, at least one A comprising any more than one, and at least one B comprising any more than one (and optionally comprising other elements); and so on.

[0036] In both the attached claims and the above specification, all transitional phrases, such as "comprising," "including," "carrying," "having," "containing," "involving," "holding," "composed of," and "such as," are understood to be open-ended, meaning they include non-restrictively.

[0037] The attached claims should not be read as being limited to the order or elements described, unless otherwise stated in their intent. It should be understood that various modifications in form and detail can be made by those skilled in the art without departing from the spirit and scope of the attached claims. All embodiments that fall within the spirit and scope of the attached claims and their equivalents are claimed.

Claims

[Claim 1] A distal cap having a substantially conical, substantially curved conical, or substantially dome-shaped outer surface; A diffuser having a substantially conical or substantially curved conical outer surface, positioned proximal to the distal cap; Inner self, exterior, Two or more blood drainage openings, each defined by two struts, each strut having a rounded inner edge and outer edge, and a rounded joint with the diffuser, and the proximal end of each blood drainage opening having a rounded corner, and First cylindrical section adjacent to the proximal end of each strut A surrounding wall with A blood outflow cage for an intravascular blood pump assembly, sized for passage through the patient's vascular lumen, comprising the following:

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