Heart pump assembly with pump housing configured to reduce hemolysis
Patent Information
- Application Number
- JP2026521873
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2023-10-12
- Filing Date
- 2024-10-11
- Publication Date
- 2026-10-22
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Figure 2026535064000001_ABST
Abstract
Description
TECHNICAL FIELD
[0001] (CROSS-REFERENCE TO RELATED APPLICATIONS) This application claims the priority benefit of U.S. Provisional Patent Application No. 63 / 589,719 filed on October 12, 2023, the entire disclosure of which is incorporated herein by reference in its entirety.
[0002] (FIELD OF THE INVENTION) A heart pump assembly, more specifically a heart pump assembly having a pump housing configured to reduce hemolysis during use, is described herein.
BACKGROUND ART
[0003] Heart pumps such as percutaneous intra-cardiac heart pump assemblies can be inserted into the heart to deliver blood from the heart to the arteries. When deployed in the heart, the heart pump assembly draws blood from the left ventricle of the heart and expels it into the aorta, or draws blood from the right ventricle and expels it into the pulmonary artery. Specifically, for left ventricular support, blood enters the heart pump assembly via a blood inlet located at the distal end of the heart pump assembly, travels through the cannula of the heart pump assembly, and exits via a plurality of outlets defined on the pump housing located at the proximal end of the heart pump assembly.
SUMMARY OF THE INVENTION
MEANS FOR SOLVING THE PROBLEMS
[0004] This specification describes a percutaneously insertable blood pump assembly comprising: a pump section; a catheter attached to the proximal end of the pump section; a first open section distal to the pump section and in fluid communication with the pump section; a cannula fixed to and in fluid communication with the first open section; and a second open section distal to the cannula and in fluid communication with the cannula. One of the first and second open sections may be a blood outlet from the cannula. The blood outlet may have a body portion, an open section, and a ring portion. Multiple struts of the open section may extend from the body portion to the ring portion, and the body portion may be joined to the ring portion. The struts may be asymmetrical along at least a portion of the length of the strut from the body portion of the outlet to the ring portion of the outlet.
[0005] In one alternative embodiment, the blood outlet may be a first opening section. In another alternative embodiment, the blood outlet may be a second opening section.
[0006] In any of the above embodiments, the asymmetric strut has a cross-section having a leading edge and a trailing edge, the leading edge forming a first angle and the trailing edge forming a second angle. In any of the above embodiments, the main body portion of the blood outlet may have an outer circumference and an inner circumference, the leading edge of the strut may be removed from the outer circumference of the main body portion, and the trailing edge portion may be removed from the inner circumference of the main body portion. In any of the above embodiments, the first angle and the second angle form an acute angle. In one embodiment, the first angle may be about 10 degrees to about 70 degrees. In a further embodiment, the first angle may be about 20 degrees to about 45 degrees. In a further embodiment, the first angle may be about 30 degrees to about 40 degrees.
[0007] In another embodiment, the second angle may be about 5 degrees to about 45 degrees. In yet another embodiment, the second angle may be about 20 degrees. In yet another embodiment, at least one of the leading edge and trailing edge may be filleted, rounded, or a combination of filleted and rounded. In one embodiment, the fillet has a radius of about 1.25 mm.
[0008] In any of the above embodiments, both the leading and trailing edges are filleted, rounded, or a combination of filleted and rounded shapes. In a further embodiment, the strut has a hydrofoil-like cross-section along at least a portion of the strut's length from the outlet body portion to the outlet ring portion. In an alternative example of any of the above embodiments, the strut has a hydrofoil-like cross-section along its entire length from the outlet body portion to the outlet ring portion.
[0009] In any of the above embodiments, the multiple openings may have dimensions, and the dimensions of each opening are approximately the same.
[0010] In any of the above embodiments, the percutaneously insertable blood pump assembly may have a non-traumatic tip distal to the second opening section. [Brief explanation of the drawing]
[0011] [Figure 1] This is a perspective view of a cardiac pump assembly according to one embodiment described herein. [Figure 2] Figure 1 is a partial perspective view of the open end of the pump housing of the cardiac pump assembly. [Figure 3] Figure 2 shows a partial cross-sectional view along line AA at the intersection of the strut and the main body of the pump housing end with an opening. [Figure 4] This is a partial perspective view of an exemplary prior art opening end of a pump housing for a cardiac pump assembly. [Figure 5]Figure 4 shows blood flow recirculation at the outlet of the open portion of the pump housing. [Figure 6] Figure 2 shows blood flow recirculation at the outlet of the open portion of the pump housing. [Figure 7] This shows the wall shear stress when blood passes through the outlet of the open portion of the pump housing shown in Figure 4. [Figure 8] This shows the wall shear stress when blood passes through the outlet of the open portion of the pump housing shown in Figure 2. [Modes for carrying out the invention]
[0012] The embodiments of this disclosure are described in detail with reference to the drawings, in which similar reference numerals identify similar or identical elements. It should be understood that the embodiments disclosed are merely examples of the disclosure and can be embodied in various forms. Well-known functions or structures are not described in detail to avoid obscuring the disclosure with unnecessary detail. Therefore, the specific structural and functional details disclosed herein should not be construed as restrictive, but rather as representative grounds for the claims and for teaching those skilled in the art how to use the disclosure in various ways in substantially any appropriately detailed structure.
[0013] A cardiac pump assembly can be inserted percutaneously into the heart through the aorta. A blood inlet may be positioned beyond the aortic valve in the left ventricle to draw blood from the left ventricle and drain it into the aorta. Blood enters the cardiac pump assembly through a blood inlet located at the distal end of the cardiac pump assembly, travels through the cannula of the cardiac pump assembly, and is drained through multiple outlets defined on the pump housing located at the proximal end of the cardiac pump assembly. The inventors recognize and understand that the currently available pump housing designs for cardiac pump assemblies result in high wall shear stress on the blood and large blood flow recirculation as blood is drained through the outlets of the pump housing, thereby causing hemolysis in the bloodstream.
[0014] The cardiac pump assemblies described herein provide cardiac pump assemblies having improved pump housings. The pump housings may be configured and designed to prevent or reduce wall shear stress on the blood and to prevent large blood flow recirculation as the blood passes through the outlet of the pump housing. The reduction of wall shear stress and large blood flow recirculation thereby reduces hemolysis in the bloodstream, as described in detail below.
[0015] Figure 1 illustrates a cardiac pump assembly 10 having an improved open portion of the pump housing 12 according to the present technology. Referring to the embodiment illustrated in Figure 1, the open portion of the pump housing may be a blood outlet 17. The blood outlet 17 is shown at the distal end of the pump housing 12. The blood outlet 17 may be integral with the pump housing 12 or may be attached to the pump housing 12. The cardiac pump assembly 10 includes a pump housing 12 having an opening or outlet opening 30 for the blood outlet 17, a cannula 14, a blood inlet 16, and a non-traumatic tip 18 for stabilizing the cardiac pump assembly 10 within the ventricle of the heart. The cardiac pump assembly 10 may vary in various ways. For example, the embodiment of Figure 1 herein may include a motor (not shown) within the pump housing 12, or it may be positioned outside the patient's body and operably coupled to a rotor (not shown) via a drive shaft or cable (currently shown).
[0016] Referring again to Figure 1, the cannula 14 extends between its proximal end 20 and its distal end 22. At the distal end 22 of the cannula 14, the cannula 14 and the blood inlet 16 are connected to each other and are in fluid communication. The proximal end 20 of the cannula 14 may also be connected to the blood outlet 17 of the pump housing 12. The blood inlet 16 may also be connected to the non-traumatic tip 18. Thus, the blood inlet 16, the cannula 14, the pump housing 12, and the non-traumatic tip 18 are all connected to form the cardiac pump assembly 10. The pump housing 12, the blood inlet 16, the cannula 14, and the blood outlet 17 are all in fluid communication with each other. In another embodiment, for example, in the case of a blood pump positioned on the right side of the heart, the blood inlet may be proximal to the insertion site of the blood pump, and the blood outlet may be distal.
[0017] In the illustrated embodiment, the blood inlet 16 extends between its distal end 24 and its proximal end 26. The blood inlet 16 includes a number of defined and positioned openings 28 between the distal end 24 and the proximal end 26, allowing blood to enter through the interior and move through the cannula 14. As shown in Figure 1, a non-traumatic tip 18 may be connected to the distal end 24 of the blood inlet 16.
[0018] The non-traumatic tip 18 may be molded as a flexible extension with a curved end, as shown in Figure 1. Alternatively, the non-traumatic tip 18 may be configured as a straight extension or as a ball. The non-traumatic tip 18 may also include a lumen for the guidewire to pass through. The non-traumatic tip 18 functions as a mechanical spacer, providing a gap between the multiple openings 28 of the blood inlet 16 and the tissue forming the inner surface of the heart. This gap prevents the multiple openings 28 from being drawn into the heart wall, heart valves (e.g., mitral valve), or any other anatomical structure within the heart. This may reduce the risk of occlusion of one or more of the multiple openings 28 of the blood inlet 16, thereby reducing or preventing damage to cardiac tissue.
[0019] The pump housing 12 is configured to accommodate an impeller (not shown) and a motor (not shown) therein. The motor is used to rotate the impeller to draw blood from the heart into the heart pump assembly 10. Specifically, rotation of the blades of the impeller generates suction through the cannula 14, causing blood to flow into the heart pump assembly 10. Blood enters the cannula 14, travels through the interior of the cannula 14, and exits the heart pump assembly 10 through a plurality of outlet openings 30 defined in the outlet portion 17 of the pump housing 12 positioned at the proximal end of the cannula 14.
[0020] Referring to FIG. 1 and FIG. 2, the pump housing 12 extends between its distal end 32 and proximal end 34, and includes a plurality of outlet openings 30 in the outlet portion 17 defined and positioned between the distal end 32 and the proximal end 34. The plurality of outlet openings 30 are radially oriented along the circumference of the outlet portion 17 of the pump housing 12, with substantially equal spacing provided between each of the plurality of outlet openings 30. Each outlet opening of the plurality of outlet openings 30 has an associated length measured parallel to axis X, a width measured radially relative to the X axis, and an area. For example, each outlet opening 30 has a length, a width, and an area through which blood from the cannula 14 can flow out of the heart pump assembly 10. In one aspect, each outlet opening of the plurality of outlet openings 30 is similarly dimensioned (e.g., in length, width, and area) such that the outlet openings 30 are substantially identical in shape and size. The plurality of outlet openings 30 may have any suitable shape that allows blood to exit the heart pump assembly 10. For example, the plurality of outlet openings 30 may be oblong, elliptical, square, teardrop-shaped, circular, or any other suitable shape.
[0021] Referring particularly to Figure 2, each of the multiple outlet openings 30 may be bounded by edges 36 and 38 and separated from each other by struts 46. Collectively, the edges 36 define the end ring 40 of the outlet portion 17 of the pump housing 12. Collectively, the edges 38 define the end 42 of the outlet portion 17 of the pump housing 12, from which the outlet openings 30 and struts 46 extend. The struts 46 have an outer edge 44. In one embodiment, the outer edge 44 is either filleted, rounded, or a combination of filleted and rounded shapes.
[0022] Referring to FIGS. 2 and 3, each of the plurality of struts 46 extends between edges 36 and 38 in an asymmetric or non-linear shape relative to edges 36 and 38. In one aspect, the strut 46 has a cross-section that may be hydrofoil-shaped along the entire length of the strut from edge 38 to edge 36. The hydrofoil-shaped cross-section extends to the end ring 40. Referring to FIG. 2, cross-section A-A of strut 46 allows the cross-sectional profile of strut 46 to be understood relative to edge 38 from which strut 46 extends. In this aspect, the horizontal cross-section of each strut 46 has a hydrofoil-shaped contour as illustrated in FIG. 3. While the applicant does not wish to be bound by any particular theory, the hydrofoil-shaped cross-section of the struts 46 of the pump housing 12 may reduce high wall shear stress of blood flowing through the outlet openings 30, and may prevent significant blood recirculation as blood exits through the plurality of outlet openings 30 of the pump housing 12 of the heart pump assembly 10. This, in turn, may reduce hemolysis that may result from the placement of the struts in the flow of blood flowing from the plurality of outlet openings 30 of the outlet portion 17 of the pump housing 12 of the heart pump assembly 10. Stated another way, the outlet portion 17 of the pump housing 12 having the strut configurations described herein may impart less turbulence to blood flowing past the struts as compared to conventional strut designs that lack a hydrofoil-shaped contour with filleted leading and trailing edges. Those skilled in the art will recognize that reducing flow turbulence may result in laminar flow of blood flowing past struts 146, which exerts less stress on red blood cells in the blood and reduces hemolysis.
[0023] Figure 3 shows a portion of a cross-sectional view of a strut 46 extending from the edge of the main body 42 at the outlet portion 17 of the pump housing 12. The strut 46 spans between a leading edge 48 and a trailing edge 50. In one embodiment, both edges 48 and 50 are fillet-shaped. The fillet-shaped edges reduce blood flow loss as blood flows through the strut, which can obstruct blood flow and induce hemolysis. The fillet-shaped edges can also reduce hemolysis of red blood cells that are carried to come into contact with the strut as blood flows through it. For reference, the upper outer circumference 41 of the edge of the main body 42 is referred to as the upper side of the cross-section of the strut 46. The lower outer circumference 43 of the edge of the main body 42 is referred to as the bottom side of the cross-section of the strut 46. As can be seen in Figure 3, the upper side of the leading edge 48 of the strut 46 can be shaped so that the leading edge extends away from the upper outer circumference 41 of the edge of the main body 42. Similarly, the trailing edge 50 may be shaped to extend away from the lower outer circumference 43 of the edge of the main body 42, thereby allowing each strut 46 to have a hydrofoil contour.
[0024] As can be seen from the cross-sectional view in Figure 3, the cross-sectional shape of the strut 46 resembles a hydrofoil contour at least over the leading edge portion 52 and the trailing edge portion 54 of the strut 46. As shown, the strut 46 may have a rounded shape at the leading edge 48, then widen towards the rear, extending from the outer circumference 41 to the inner circumference 43 of the edge of the body 42, and then narrow towards the trailing edge 50, which may also have a rounded shape. Both the leading edge 48 and the trailing edge 50 are shaped so that they define or form an acute angle. Specifically, the angle of the leading edge 48 of the strut 46 may be represented by tangents T1 and T2 extending from both sides of the leading edge 48. Lines T1 and T2 extend to form a vertex, and the leading edge angle is angle B. In one embodiment, the strut 46 may be configured such that the leading edge angle B is about 30 degrees to about 70 degrees. As used herein, “approximately” means approximately 10 percent of the value to which this term applies. In one embodiment, the leading edge angle B may be approximately 20 to approximately 45 degrees. In further embodiments, the leading edge angle may be approximately 30 to approximately 40 degrees. Tangential lines T3, T4 extending from both sides of the trailing edge 50 extend to form a vertex to illustrate the trailing edge angle C, which in one embodiment may be approximately 5 to approximately 45 degrees. The trailing edge angle C may be smaller than the leading edge angle B. Such angles of the struts balance the strength of the struts 46 with the benefit of reducing wall shear stress on the blood flow over the struts. In one embodiment, each fillet of the leading edge 48 and trailing edge 50 has a radius of approximately 0.05 inches (approximately 1.25 mm). In the illustrated embodiments, the outlet 17 of the pump housing 12 includes three struts 46, but it is intended that the outlet 17 of the pump housing 12 may include any preferred number of struts 46.
[0025] The cardiac pump assembly 10 is made from one or more materials having properties suitable for the desired application, including strength, weight, and rigidity. In one embodiment, a thermoplastic resin (e.g., polypropylene, polyethylene, etc.) is used to form the blood inlet 16, the non-traumatic tip 18, and the pump housing 12.
[0026] Figure 4 is a perspective view of an exemplary prior art pump housing 56 of a cardiac pump assembly. The prior art outlet portion 56 of the pump housing has a plurality of struts 58 whose length is symmetrical with respect to the body 57 of the outlet 59, rather than being hydrofoil-like in length, as the struts 46 of the outlet 17 of the pump housing 12 described herein. The design of the prior art pump outlet 56 causes greater blood flow recirculation when blood passes through the outlet 60 of the outlet 56 of the pump housing, as shown in position 62 of Figure 5, compared to blood flow recirculation when blood passes through the outlet opening 30 of the improved outlet 17 of the pump housing 12 of the assembly described herein, as shown in position 64 of Figure 6. In addition, the blood flow at the outlet portion of the outlet 56 of the prior art pump housing has some turbulence, as shown in position 62 of Figure 5. Furthermore, the design of the outlet 56 of the prior art pump housing generates higher wall shear stress when blood passes through the outlet 60 of the outlet 56 of the pump housing, as shown in position 66 of Figure 7, compared to the wall shear stress generated by the improved outlet 17 of the pump housing 12 described herein, as shown in position 68 of Figure 8.
[0027] As described above, the design and construction of the multiple struts 46 of the outlet 17 of the pump housing 12 of the cardiac pump assembly 10, as described herein, effectively reduces the wall shear stress of blood and blood flow recirculation that occurs when blood exits through the multiple outlet openings 30 of the outlet 17 of the pump housing 12 of the cardiac pump assembly 10. As described above, the outlet housing having the struts described above can reduce hemolysis in the blood flow. Specifically, the improved design of the pump housing 12 having multiple struts 46, each having a hydrofoil-like contour, can reduce turbulence in the blood flow at the outlet openings 30 of the pump housing 12. This can reduce hemolysis in the patient's blood flow. Such laminar flow within the pump housing 12 of the cardiac pump assembly 10 is illustrated in Figures 6 and 8.
[0028] This specification describes a percutaneously insertable blood pump assembly which may have a pump section, comprising: a catheter attached to the proximal end of the pump section; a first open section distal to the pump section and in fluid communication with the pump section; a cannula fixed to and in fluid communication with the first open section; and a second open section distal to the cannula and in fluid communication with the cannula. In one embodiment, one of the first and second open sections is a blood outlet from the cannula. In a further embodiment, the blood outlet may have a body section, an open section, and a ring section, and the multiple openings of the open section may be separated and defined by multiple struts extending from the body section to the ring section and joining the body section to the ring section. In a further embodiment, the struts are asymmetrical along the length of the struts from the body section of the outlet to the ring section of the outlet.
[0029] In any of the above embodiments, the blood outlet may be a first opening-type section outlet or a second opening-type section. In any of the above embodiments, the asymmetric strut may have a cross section having a leading edge and a trailing edge, the leading edge forming a first angle and the trailing edge forming a second angle. In any of the above embodiments, the main body portion of the blood outlet may have an outer circumference and an inner circumference, the leading edge of the strut is removed from the outer circumference of the main body portion and the trailing edge portion is removed from the inner circumference of the main body portion. In further embodiments, the first angle of the leading edge and the second angle of the trailing edge may form acute angles. In further embodiments, the first angle of the leading edge is about 10 degrees to about 70 degrees, or about 20 degrees to about 45 degrees, or about 30 degrees to about 40 degrees.
[0030] In a further embodiment, the second angle of the rear edge is approximately 5 degrees to approximately 45 degrees or approximately 20 degrees.
[0031] In a further embodiment, a percutaneously insertable blood pump assembly may have at least one of an anterior and posterior edge that is filleted, rounded, or a combination of filleted and rounded.
[0032] In a further embodiment, a percutaneously insertable blood pump assembly may have a filleted edge having a radius of approximately 1.25 mm. In a further embodiment, both the anterior and posterior edges of the percutaneously insertable blood pump assembly may be filleted, rounded, or a combination of filleted and rounded shapes.
[0033] In a further embodiment, the strut of a percutaneously insertable blood pump may have a hydrofoil-like cross-section along at least a portion of the length of the strut from the outlet body portion to the outlet ring portion, or may have a hydrofoil-like cross-section along the entire length from the outlet body portion to the outlet ring portion. In a further embodiment, the multiple openings of the percutaneously insertable blood pump may have dimensions, and the dimensions of each opening are substantially the same. In a further embodiment, the percutaneously insertable blood pump assembly may have a non-traumatic tip distal to the second opening section.
[0034] As previously stated herein, if the pump is configured to operate on the right side of the heart rather than the left side, the outlet described herein may be located at the distal end of the assembly and may not be mounted in the pump housing described herein.
[0035] From the foregoing and by reference to the various drawings, a person skilled in the art will understand that certain modifications can be made to this disclosure without departing from the scope of this disclosure. Although several embodiments of this disclosure are shown in the drawings, this disclosure is not intended to be limited to these, and the scope of this disclosure is as broad as the art allows, and this specification is also intended to be read in the same way. Accordingly, the above description should not be construed as limiting, but merely as an example of a particular aspect. A person skilled in the art will envision other modifications within the scope and spirit of the claims appended herein.
[0036] [Implementation Method] (1) A percutaneously insertable blood pump assembly, Pump classification, A catheter attached to the proximal end of the pump section, A first opening-equipped section located distal to the pump section and in fluid communication with the pump section, A cannula fixed to the first opening section and in fluid communication with the first opening section, It comprises a second opening section located distal to the cannula and in fluid communication with the cannula, One of the first opening section and the second opening section is the blood outlet from the cannula. A percutaneously insertable blood pump assembly wherein the blood outlet comprises a main body portion, an open portion, and a ring portion, and the multiple openings of the open portion are separated and defined by a plurality of struts extending from the main body portion to the ring portion and joining the main body portion to the ring portion, and each of the plurality of struts is asymmetrical along the length of each strut from the main body portion of the outlet to the ring portion of the outlet. (2) The percutaneously insertable blood pump assembly according to Embodiment 1, wherein the blood outlet is the first opening section and is the blood outlet. (3) The percutaneously insertable blood pump assembly according to Embodiment 1, wherein the blood outlet is the second opening section. (4) A percutaneously insertable blood pump assembly according to any one of embodiments 1 to 3, wherein the asymmetrical strut has a cross section comprising a leading edge and a trailing edge, the leading edge forming a first angle and the trailing edge forming a second angle. (5) The percutaneously insertable blood pump assembly according to Embodiment 4, wherein the main body portion of the blood outlet comprises an outer circumference and an inner circumference, the leading edge of the strut is removed from the outer circumference of the main body portion, and at least a portion of the trailing edge is removed from the inner circumference of the main body portion.
[0037] (6) A percutaneously insertable blood pump assembly according to any one of embodiments 4 to 5, wherein the first angle and the second angle form an acute angle. (7) A percutaneously insertable blood pump assembly according to any of embodiments 4 to 6, wherein the first angle is approximately 10 degrees to approximately 70 degrees. (8) A percutaneously insertable blood pump assembly according to any of embodiments 4 to 7, wherein the first angle is approximately 20 degrees to approximately 45 degrees. (9) A percutaneously insertable blood pump assembly according to any of embodiments 4 to 8, wherein the first angle is approximately 30 to 40 degrees. (10) A percutaneously insertable blood pump assembly according to any of embodiments 4 to 9, wherein the second angle is approximately 5 degrees to approximately 45 degrees.
[0038] (11) A percutaneously insertable blood pump assembly according to any of embodiments 4 to 10, wherein the second angle is approximately 20 degrees. (12) A percutaneously insertable blood pump assembly according to any one of embodiments 5 to 11, wherein at least one of the anterior and posterior edges is filleted, rounded, or a combination of filleted and rounded. (13) The percutaneously insertable blood pump assembly according to Embodiment 12, wherein the fillet has a radius of approximately 1.25 mm. (14) A percutaneously insertable blood pump assembly according to any of embodiments 5 to 13, wherein both the leading edge and the trailing edge are filleted, rounded, or a combination of filleted and rounded. (15) A percutaneously insertable blood pump assembly according to any one of embodiments 1 to 14, wherein each of the plurality of struts has a hydrofoil-like cross section along at least a portion of the length of each strut from the main body portion of the outlet to the ring portion of the outlet.
[0039] (16) A percutaneously insertable blood pump assembly according to any one of embodiments 1 to 14, wherein each of the plurality of struts has a hydrofoil-like cross section along its entire length from the main body portion of the outlet to the ring portion of the outlet. (17) A percutaneously insertable blood pump assembly according to any of embodiments 1 to 16, wherein the plurality of openings have dimensions, and the dimensions of each opening are substantially the same. (18) A percutaneously insertable blood pump assembly according to any one of embodiments 1 to 17, further comprising a non-traumatic tip distal to the second opening section.
Claims
1. A percutaneously insertable blood pump assembly, Pump classification, A catheter attached to the proximal end of the pump section, A first opening-equipped section located distal to the pump section and in fluid communication with the pump section, A cannula fixed to the first opening section and in fluid communication with the first opening section, It comprises a second opening section located distal to the cannula and in fluid communication with the cannula, One of the first opening section and the second opening section is the blood outlet from the cannula. A percutaneously insertable blood pump assembly wherein the blood outlet comprises a main body portion, an open portion, and a ring portion, and the multiple openings of the open portion are separated and defined by a plurality of struts extending from the main body portion to the ring portion and joining the main body portion to the ring portion, and each of the plurality of struts is asymmetrical along the length of each strut from the main body portion of the outlet to the ring portion of the outlet.
2. The blood outlet is the first opening section, and is the blood outlet, as described in claim 1, a percutaneously insertable blood pump assembly.
3. The percutaneously insertable blood pump assembly according to claim 1, wherein the blood outlet is the second opening section.
4. The percutaneously insertable blood pump assembly according to claim 1, wherein the asymmetrical strut has a cross section comprising a leading edge and a trailing edge, the leading edge forming a first angle and the trailing edge forming a second angle.
5. The percutaneously insertable blood pump assembly according to claim 4, wherein the main body portion of the blood outlet comprises an outer circumference and an inner circumference, the leading edge of the strut is removed from the outer circumference of the main body portion, and at least a portion of the trailing edge is removed from the inner circumference of the main body portion.
6. The percutaneously insertable blood pump assembly according to claim 4, wherein the first angle and the second angle form an acute angle.
7. The percutaneously insertable blood pump assembly according to claim 4, wherein the first angle is approximately 10 degrees to approximately 70 degrees.
8. The percutaneously insertable blood pump assembly according to claim 4, wherein the first angle is approximately 20 degrees to approximately 45 degrees.
9. The percutaneously insertable blood pump assembly according to claim 4, wherein the first angle is approximately 30 degrees to approximately 40 degrees.
10. The percutaneously insertable blood pump assembly according to claim 4, wherein the second angle is approximately 5 degrees to approximately 45 degrees.
11. The percutaneously insertable blood pump assembly according to claim 4, wherein the second angle is approximately 20 degrees.
12. The percutaneously insertable blood pump assembly according to claim 5, wherein at least one of the anterior and posterior edges is fillet-shaped, rounded, or a combination of fillet-shaped and rounded.
13. The percutaneously insertable blood pump assembly according to claim 12, wherein the fillet has a radius of approximately 1.25 mm.
14. The percutaneously insertable blood pump assembly according to claim 5, wherein both the anterior and posterior edges are fillet-shaped, rounded, or a combination of fillet-shaped and rounded.
15. The percutaneously insertable blood pump assembly according to claim 1, wherein each of the plurality of struts has a hydrofoil-like cross-section along at least a portion of the length of each strut from the main body portion of the outlet to the ring portion of the outlet.
16. The percutaneously insertable blood pump assembly according to claim 1, wherein each of the plurality of struts has a hydrofoil-like cross-section along its entire length from the main body portion of the outlet to the ring portion of the outlet.
17. The percutaneously insertable blood pump assembly according to claim 1, wherein the plurality of openings have dimensions, and the dimensions of each opening are substantially the same.
18. The percutaneously insertable blood pump assembly according to any one of claims 1 to 17, further comprising a non-traumatic tip at the distal end of the second opening section.