Distal extension for a blood pump system

Abstract

A distal extension for a blood pump may be provided. The distal extension may include a tubular body. A distal end of the tubular body may be coupled to a midpoint on the tubular body to form a closed loop at the distal end of the non-invasive distal extension. The closed loop may define an aperture extending through the closed loop, the closed loop having a central plane parallel to the central axis of the tubular body at its proximal end. In various aspects, the tubular body may include a bend. The bend may define an angle between the central axis of a first substantially straight segment of the tubular body proximal to the bend and the central axis of a second substantially straight segment of the tubular body distal to the bend. In various aspects, the closed loop may be a non-circular closed loop.

Description

[0001] Cross-references to related applications

[0002] This application claims priority to U.S. Provisional Application No. 63 / 543,962, filed October 13, 2023, and U.S. Provisional Application No. 63 / 696,192, filed September 18, 2024, the full text of each of which is incorporated herein by reference. Technical Field

[0003] This disclosure relates to a distal extension for a blood pump system. Background Technology

[0004] Blood pump components (e.g., intracardiac or intravascular blood pumps) can be introduced into the heart to pump blood from the heart into the arteries. Such mechanical circulatory support devices are typically introduced to support cardiac function after a patient has experienced a heart attack. One type of device is a set of devices known as a “ventricular assist device” (VAD) or blood pump. Some blood pump components can be introduced percutaneously through the vascular system during cardiac surgery. Specifically, the blood pump component can be inserted, for example via catheterization, into the ascending aorta through the femoral or axillary / subclavian artery, through the valves, and into the left ventricle. However, once the blood pump is in the patient's body, small structures within the patient's body, including, for example, valves, may be trapped or damaged by the conventional distal extension. Summary of the Invention

[0005] In various aspects, a distal extension for a blood pump can be provided. The distal extension may include a tubular body extending from a proximal end to a distal end. The distal end may be coupled to a midpoint between the proximal and distal ends on the tubular body, thereby forming a closed loop at the distal end of the non-invasive distal extension. The closed loop may define an aperture extending through it. The closed loop may have a central plane parallel to the central axis of the tubular body at the proximal end.

[0006] In some aspects, the tubular body may include a bend. The bend may define an angle between the central axis of a first substantially straight section of the tubular body proximal to the bend and the central axis of a second substantially straight section of the tubular body distal to the bend. In some aspects, the closed loop may be a non-circular closed loop.

[0007] The central axis of the hole can extend through the closed loop in a direction perpendicular to the central plane of the closed loop. The hole can be circular. The hole can be non-circular. The central axis of the hole can be eccentric within the closed loop. The central axis of the hole can be centered within the closed loop.

[0008] The diameter or thickness of the tubular body at its proximal end may differ from the diameter or thickness of the tubular body within the closed loop. The diameter or thickness of the tubular body at its proximal end may be equal to the diameter or thickness of the tubular body within the closed loop. The diameter or thickness of the tubular body at a first point in the closed loop may differ from the diameter or thickness of the tubular body at a second point in the closed loop. The tubular body may have a constant thickness or diameter along the entire closed loop.

[0009] The distal end surface of the tubular body can be connected to the outer surface of the tubular body at the midpoint. The midpoint can be located proximal to the bend. The midpoint can be located distal to the bend.

[0010] The distal extension may have a proximal portion, the stiffness of which is greater than that of the distal portion. The angle defined by the bend may be at least 135 degrees and less than 180 degrees. The closed loop may be defined by a continuous curve. The closed loop may be circular. The closed loop may include one or more substantially straight segments. The closed loop may include a first point farthest from the midpoint, the radius of curvature of which is smaller than the radius of curvature of a second point closer to the midpoint than the first point. The radius of curvature of the first point farthest from the proximal end may be smaller than the radius of curvature of the second point closer to the proximal end than the first point.

[0011] The distal extension may include a lumen extending through at least a portion of the atraumatic distal extension. The lumen may be configured to receive a guidewire. The distal extension may not contain a lumen configured to receive a guidewire.

[0012] In some implementations, the closed loop may be circular. In other implementations, the closed loop may be non-circular.

[0013] In various aspects, a system may be provided. The system may include a pump section having a proximal end and a distal end. The pump section may be configured to allow blood to flow from a blood inlet through a cannula to a blood outlet. The system may include embodiments of a distal extension as disclosed herein, operatively coupled to the distal end of the pump section.

[0014] The system may include a motor section. The motor section may be operatively coupled to the pump section via a drive shaft. The system may include a conduit operatively coupled to a proximal end of the pump section. In some embodiments, the motor section may be coupled to a proximal end of the pump section, and the conduit may be coupled to a proximal end of the motor section. In some embodiments, the conduit may be positioned between the pump section and the motor section.

[0015] In various aspects, a distal extension for a blood pump can be provided. The distal extension for the blood pump may include a tubular body extending from a proximal end to a distal end. The distal end may be coupled to a midpoint between the proximal and distal ends on the tubular body, thereby forming a non-circular closed loop at the distal end of the non-invasive distal extension. The non-circular closed loop may define an aperture extending through it. The non-circular closed loop may have a central plane parallel to the central axis of the tubular body at the proximal end.

[0016] In some embodiments, the central axis of the hole extends through the non-circular closed loop in a direction perpendicular to the central plane of the non-circular closed loop. The hole can be circular. The hole can be non-circular. In some aspects, the central axis of the hole can be eccentric within the non-circular closed loop. The central axis of the hole can be centered within the non-circular closed loop.

[0017] In some embodiments, the diameter or thickness of the tubular body at the proximal end may differ from the diameter or thickness of the tubular body within the non-circular closed loop. The diameter or thickness of the tubular body at a first point in the non-circular closed loop may be equal to the diameter or thickness of the tubular body at a second point in the non-circular closed loop. The diameter or thickness of the tubular body at the first point in the non-circular closed loop may differ from the diameter or thickness of the tubular body at the second point in the non-circular closed loop. The tubular body may have a constant thickness or diameter throughout the non-circular closed loop.

[0018] In some embodiments, the distal end surface of the tubular body may be connected to the outer surface of the tubular body at the midpoint. The midpoint may be located proximal to the bend. The midpoint may be located distal to the bend.

[0019] In some embodiments, the distal extension may have a proximal portion, the stiffness of which may be greater than that of the distal portion. In some embodiments, the angle defined by the bend may be at least 135 degrees and less than 180 degrees.

[0020] In some embodiments, the closed loop may be defined by a continuous curve. The closed loop may include one or more substantially straight segments. The closed loop may include a first point farthest from the midpoint, the radius of curvature of which may be smaller than the radius of curvature at a second point closer to the midpoint than the first point. The radius of curvature of the first point farthest from the proximal end may be smaller than the radius of curvature at the second point closer to the proximal end than the first point.

[0021] In some embodiments, the distal extension may include a lumen extending through at least a portion of the atraumatic distal extension. The lumen may be configured to receive a guidewire. The distal extension may not contain a lumen configured to receive a guidewire.

[0022] A system may be provided in various aspects. The system may include a pump section. The pump section may include a proximal end and a distal end. The pump section may be configured to allow blood to flow from a blood inlet through a cannula to a blood outlet. The system may include embodiments of a distal extension as disclosed herein, operatively coupled to the distal end of the pump section.

[0023] In some embodiments, the system may include a motor section. The motor section may be operatively coupled to the pump section via a drive shaft. In some embodiments, the system may also include a conduit. The conduit is operatively coupled to a proximal end of the pump section. The motor section may be coupled to a proximal end of the pump section. The conduit may be coupled to a proximal end of the motor section. The conduit may be positioned between the pump section and the motor section.

[0024] In various aspects, a method for inserting a blood pump can be provided. This method may include introducing a system that includes a blood pump into a blood vessel, the blood pump having an embodiment of a distal extension, as disclosed herein, disposed at a distal end of the blood pump. This method may include advancing the system through the blood vessel without using a guidewire, and allowing the distal extension to interact with at least one valve until the blood pump is positioned at the desired location.

[0025] In various aspects, a distal extension for a blood pump can be provided. The distal extension for the blood pump may include a tubular body. The tubular body may extend from a proximal end to a distal end. The tubular body may define a helical structure about an axis, wherein the helical structure completes n turns from the proximal end point to the distal end point of the tubular body, where n is at least 0.25.

[0026] In some embodiments, the tubular body may be coiled clockwise around the axis from the proximal end to the distal end to form the helical structure. The tubular body may also be coiled counterclockwise around the axis from the proximal end to the distal end to form the helical structure.

[0027] In some embodiments, the protrusions may extend from the surface of the tubular body to form the helical structure. In some embodiments, n is at least 1. In some embodiments, n may not exceed 3. In some embodiments, n does not exceed 1.

[0028] In some embodiments, the pitch of the helical structure may be at least three times the diameter or thickness of the tubular body. In some embodiments, the pitch of the helical structure may not exceed 10 times the diameter or thickness of the tubular body. The distal extension may not contain a lumen configured to receive the guidewire.

[0029] A system may be provided in various aspects. The system may include a pump section. The pump section may include a proximal end and a distal end. The pump section may be configured to allow blood to flow from a blood inlet through a cannula to a blood outlet. The system may include embodiments of a distal extension as disclosed herein, operatively coupled to the distal end of the pump section.

[0030] In some embodiments, the system may further include a motor section. The motor section may be operatively coupled to the pump section via a drive shaft. The system may also include a conduit operatively coupled to a proximal end of the pump section. The motor section may be coupled to the proximal end of the pump section. The conduit may be coupled to the proximal end of the motor section. The conduit may be positioned between the pump section and the motor section.

[0031] In various aspects, a method for inserting a blood pump can be provided. The method may include introducing a guiding catheter into a blood vessel. The method may include introducing a blood pump into a blood vessel having a distal extension with a helical structure as disclosed herein, located at a distal end. The method may include advancing the blood pump through the blood vessel without using a guidewire. The method may include rotating the blood pump to engage the helical structure with the guiding catheter. The method may include rotating the blood pump to interact the helical structure with one or more leaflets of the aortic valve. The method may include removing the guiding catheter. Attached Figure Description

[0032] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments of the invention and, together with the general description of the invention given above and the detailed description of the embodiments given below, serve to explain the principles of the invention.

[0033] Figure 1A This is a diagram of a blood pump with a distal extension.

[0034] Figure 1B This is a top view illustration of the distal extension.

[0035] Figures 2A to 2F This is a side view illustration of various embodiments of the distal extension.

[0036] Figure 3 This is a diagram of a blood pump located inside the heart.

[0037] Figure 4A This is a diagram of the distal extension of the spiral.

[0038] Figure 4B This is a front view illustration of the distal extension of the spiral.

[0039] Figures 5 to 6 These are illustrations of various implementation schemes for the distal extension of the spiral.

[0040] Figure 7 This is a diagram of the distal spiral extension of the connecting guide tube.

[0041] It should be understood that the accompanying drawings are not necessarily drawn to scale and present slightly simplified representations of various features illustrating the basic principles of the invention. Specific design features of the operational sequence disclosed herein, including, for example, the specific dimensions, orientations, positions, and shapes of the various illustrated components, will be determined in part by the particular intended application and usage environment. Some features of the illustrated embodiments have been enlarged or modified relative to other features for visualization and clear understanding. Specifically, thin features may be thickened, for example, for clarity or for illustration. Detailed Implementation

[0042] The following description and accompanying drawings illustrate only the principles of the invention. Therefore, it should be understood that those skilled in the art will be able to design various arrangements that, while not explicitly described or shown herein, embody the principles of the invention and are included within its scope. Furthermore, all examples set forth herein are explicitly intended for illustrative purposes only to assist the reader in understanding the principles of the invention and the concepts proposed by the inventors to advance the prior art, and should be understood as not being limited to such specifically set forth examples and conditions. Additionally, unless otherwise specified (e.g., “otherwise” or “or alternatively”), the term “or” as used herein means non-exclusive or. Moreover, the various embodiments described herein are not necessarily mutually exclusive, as some embodiments may be combined with one or more other embodiments to form new embodiments.

[0043] Many of the innovative teachings of this application will be described with particular reference to the presently preferred exemplary embodiments. However, it should be understood that such embodiments provide only a few examples of the many advantageous uses of the innovative teachings herein. In general, the statements made in the specification of this application do not necessarily limit any of the various claimed inventions. Furthermore, some statements may apply to some inventive features but not others. Those skilled in the art and those who have acquired knowledge through the teachings herein will recognize that the invention is also applicable to a variety of other technical fields or embodiments.

[0044] refer to Figure 1AA system incorporating a blood pump (10) may be provided. The blood pump may include a pump section (20). The pump section may have a proximal end (28) and a distal end (29). The pump section may be configured to allow blood to flow from a blood inlet (22) through a cannula (24) to a blood outlet (26).

[0045] In some implementation schemes, in accordance with various aspects of this disclosure, Figure 1A The illustrated blood pump (10) is suitable for left ventricular support. In such embodiments, the blood pump (10) can be inserted percutaneously. For example, when used for left ventricular support, the blood pump (10) can be inserted into the aorta via a catheter insertion procedure through the femoral or axillary artery, across the aortic valve, and into the left ventricle. Once positioned in this manner, the blood pump (10) can deliver blood from the blood inlet (22) located inside the left ventricle through a cannula (24) to the blood outlet (26) located inside the ascending aorta.

[0046] In other embodiments, in accordance with various aspects of this disclosure, Figure 1A The blood pump (10) shown may be adapted for right ventricular support. In such embodiments, the blood pump (10) may also be inserted percutaneously. For example, when used for right ventricular support, the blood pump (10) may be inserted via a catheter insertion procedure through the femoral vein into the inferior vena cava, through the right atrium, across the tricuspid valve, into the right ventricle, across the pulmonary valve, and into the pulmonary artery. Once positioned in this manner, the blood pump (10) can deliver blood from a blood inlet (22) located inside the inferior vena cava through a cannula (24) to a blood outlet (26) located inside the pulmonary artery. In some embodiments, the blood pump (10) may be inserted via the internal jugular (IJ) vein. For example, in such embodiments, the blood pump (10) may be inserted via a catheter insertion procedure through the IJ vein into the superior vena cava, through the right atrium, across the pulmonary valve, and into the pulmonary artery. Once positioned in this manner, the blood pump (10) can deliver blood from a blood inlet (24) located inside the superior vena cava through a cannula (24) to a blood outlet (26) located inside the pulmonary artery.

[0047] The blood pump may include a motor section (30). The motor section may be operatively coupled to a pump section via a drive shaft (32). The drive shaft may be operatively coupled to an impeller (34). The impeller may be disposed within the pump section and may be configured to allow blood to flow through the pump section when the impeller rotates. In some embodiments, at least a portion of the drive shaft (32) may be flexible.

[0048] The blood pump may include a catheter (40) operatively coupled to the proximal end of the pump segment. In some embodiments (such as...) Figure 1AIn the embodiments shown, the catheter is indirectly connected to the pump segment. More specifically, in some embodiments, the motor segment may be connected to the proximal end of the pump segment, and the catheter may be connected to the proximal end (38) of the motor segment. In some embodiments (not shown), the catheter may be positioned between the pump segment and the motor segment. In such embodiments (not shown), the motor segment may be located outside the patient's body. In some embodiments (not shown), the catheter (40) may include one or more lumens. For example, the catheter (40) may include a lumen through which a flushing fluid can travel to the motor segment (30). In some embodiments, the catheter (40) may include a pre-formed bend configured to abut against a predetermined portion of the patient's anatomy when the blood pump (10) is in the desired position.

[0049] The distal extension (100) can be operatively coupled to the distal end (29) of the pump section (20). In some embodiments, this can be a direct coupling, such as... Figure 1A As shown. In some embodiments, this can be an indirect connection; that is, one or more additional elements (not shown) may be present between the distal extension and the distal end of the pump section.

[0050] The distal extension for the blood pump may include a tubular body (110) extending from a proximal end (112) to a distal end (114). The distal end may be coupled to a midpoint (116) on the tubular body between the proximal and distal ends to form a closed loop (120) at the distal end (103) of the non-invasive distal extension (101). As will be understood, the midpoint (116) may be placed at any suitable location between the proximal end (112) and the distal end (114).

[0051] The closed loop can be formed in any suitable manner. For example, in some embodiments, the distal end surface (118) of the tubular body (110) may be coupled to the outer surface (119) of the tubular body at a midpoint (116). For example, in other embodiments, the tubular body (110) may be configured as a single piece forming the closed loop (120).

[0052] A closed loop (120) can define an extension through a hole (122). (See reference) Figure 1B The closed loop may have a central plane (124) parallel to the central axis (198) of the tubular body (110) at the proximal end (112). The central axis (126) of the hole (122) may extend through the closed loop in a direction perpendicular to the central plane of the closed loop.

[0053] In some embodiments, the stiffness of the distal extension may be constant. In some embodiments, the distal extension may have a proximal portion (102) having a stiffness greater than that of the distal portion (104). In other embodiments, the distal portion (104) may have a stiffness greater than that of the proximal portion (102). In some embodiments, the proximal portion (102) may have a stiffness greater than that of the tubular body (110) forming the closed loop (120).

[0054] As will be understood, the distal extension may be made of any suitable material. For example, in some embodiments, the distal extension may be made of a polymeric material. In other embodiments, different portions of the distal extension may be made of different materials. For example, in one embodiment, a portion of the tubular body (110) may be made of a polymeric material having a first stiffness, and a second portion of the tubular body (110) may be made of a polymeric material having a second stiffness greater than or less than the first stiffness. As will be understood, the tubular body (110) may be made of any suitable number of materials and / or portions.

[0055] refer to Figures 2A to 2F The tubular body (110) may include a bend (130). The bend may define an angle (131) between the central axis (132) of a first substantially straight segment (133) of the tubular body proximal to the bend and the central axis (134) of a second substantially straight segment (135) of the tubular body distal to the bend. In some embodiments, the angle is defined on the same side of the tubular body on which a closed loop is formed. In some embodiments, the angle may be at least 100 degrees. In some embodiments, the angle may be at least 110 degrees. In some embodiments, the angle (131) may be at least 120 degrees. In some embodiments, the angle may be at least 130 degrees. In some embodiments, the angle is at least 135 degrees. In some embodiments, the angle may be less than 180 degrees. In some embodiments, the angle may be less than 170 degrees. In some embodiments, the bend (130) may be configured such that when the blood pump (10) is in the desired position, a portion of the tubular body (110) will abut against or near a predetermined portion of the patient's heart. For example, the bend (130) may be configured such that when the blood pump (10) is in the desired position, at least a portion of the closed loop (120) abuts against a predetermined portion of the patient's heart. In other examples, the bend (130) may be positioned such that a portion of the closed loop (120) is positioned at or near the apex of the left ventricle during operation of the blood pump (10).

[0056] In some embodiments, the diameter or thickness (140) of the tubular body at the first point of the closed loop may be equal to the diameter or thickness (141) of the tubular body at the second point of the closed loop (see example). Figure 2A In some embodiments, the diameter or thickness (142) of the tubular body at the proximal end may differ from the diameter or thickness (140) of the tubular body in the closed loop (see, for example...). Figure 2B In some embodiments, the diameter or thickness (140) of the tubular body at the first point of the closed loop may differ from the diameter or thickness (141) of the tubular body at the second point of the closed loop (see example). Figure 2C In some implementations, the tubular body may have a constant thickness or diameter along the entire closed loop.

[0057] In some embodiments, the diameter or thickness (140) of the tubular body at a first point of the closed loop may increase or decrease along the length of the tubular body (110) to the diameter or thickness (141) of the tubular body at a second point of the closed loop. For example, the diameter or thickness (140) may increase or decrease continuously to the diameter or thickness (141) of the tubular body at the second point of the closed loop. In other embodiments, the diameter or thickness (140) of the tubular body in the closed loop may increase or decrease along the length of the tubular body to the diameter or thickness (142) of the tubular body at the proximal end. As will be understood, although certain geometries are described herein, the diameter or thickness may be increased or decreased using any suitable geometry. For example, the diameter or thickness may increase or decrease in a stepwise manner. In some embodiments, the diameter or thickness may increase or decrease in one or more segments. For example, the diameter or thickness may increase or decrease along one or both of the straight segments (133, 135). Alternatively, in other embodiments, the diameter or thickness may increase or decrease along at least a portion of the length of the tubular body forming the closed loop.

[0058] As will be further understood, the diameter or thickness can be increased or decreased by any suitable combination of any suitable geometry. While diameter or thickness is used, it is not required that the tubular body have a circular cross-sectional measurement. For example, in some embodiments, the tubular body may be elliptical in shape, and therefore the diameter may refer to the maximum cross-sectional measurement. As will be understood, although the tubular body is shown as having a circular cross-sectional geometry, the tubular body may have any suitable cross-sectional geometry.

[0059] The hole can be configured to have any suitable shape or design. In some embodiments, the hole can be circular (see example...). Figures 2A to 2B In some implementations, the hole may be non-circular (see example...). Figures 2C to 2FIn some implementations, the central axis (150) of the hole is centered within the closed loop (see example...). Figure 2B In some implementations, the central axis (150) of the hole is offset from the center within the closed loop (see, for example...). Figure 2C The central axis (150) of the hole does not pass through the center point (152) of the closed loop.

[0060] In some implementations, the closed loop can be circular (see example...). Figures 2A to 2C In some implementations, the closed loop may be non-circular (see example...). Figures 2A to 2C ).

[0061] In some implementations, the closed loop may be defined by a continuous curve (160) (see example...) Figure 2A and Figure 2D In some implementations, the closed loop may have one or more basic straight segments (133, 135) (see example...). Figure 2E In some embodiments, where the distal extension includes a bend (130), the midpoint (116) may be located proximal to the bend (see, for example...). Figures 2E to 2F In some embodiments, where the distal extension includes a bend, the midpoint (116) may be located distal to the bend (see example...). Figure 2A ).

[0062] In some implementations, a distal extension having a "sharper" or "sharper" distal end portion may be advantageous. (Reference) Figure 2E In some implementations, the closed loop may include a first point (170) that is furthest from the midpoint (116), the radius of curvature of which is smaller than the radius of curvature of a second point (172) that is closer to the midpoint than the first point.

[0063] In some implementations, a distal extension having a "flatter" or "less sharp" distal end portion may be advantageous. (Reference) Figure 2F In some implementations, the closed loop may include a first point (170) furthest from the proximal end, the radius of curvature of which is smaller than the radius of curvature of a second point (172) closer to the proximal end than the first point.

[0064] The distal extension may include a lumen (180) extending through at least a portion of the atraumatic distal extension. The lumen may be configured to receive a guidewire. In some embodiments, the distal extension may not contain any lumen. In some embodiments, the distal extension may not contain a lumen configured to receive a guidewire.

[0065] A method for inserting a blood pump can be provided in various aspects. (Reference) Figure 3The method may include introducing a system into a blood vessel (such as the aorta (2)), which may include a blood pump (10) as disclosed herein. The blood pump may have an embodiment having a distal extension (100) as disclosed herein at a distal end of the blood pump.

[0066] The method may include advancing the system through the blood vessel without using a guidewire and allowing the distal extension (100) to interact with at least one valve (4) until the blood pump (10) is positioned in the desired location (such as the left ventricle (3) of the heart (1)).

[0067] In some respects, a distal spiral extension can be provided. (See reference) Figure 4A The distal extension (100) for the blood pump may include a tubular body (401) extending from a proximal end (402) to a distal end (403), wherein the tubular body defines a helical structure (400) about an axis (410). The tubular body may include a radiopaque portion (408), which may be, for example, at or near the distal end (403). The helical ends may be used, for example, to interact with leaflets on a valve (such as the aortic valve) or with other medical devices. The helical shape allows the blood pump to be mounted on a guiding catheter without the use of a guidewire. Reference Figure 4B From the proximal end (404) to the distal end (405) of the tubular body, the helical structure (400) can be configured to complete n turns (406) around the axis (410), where n is at least 0.25. Figure 4B In this context, n is approximately 0.75, but as will be understood, there is no practical limitation on the number of turns. In some implementations, n can be ≥0.25, ≥0.5, ≥0.75, ≥1, or ≥2. In some implementations, n can be ≤20, ≤10, ≤9, ≤8, ≤7, ≤6, ≤5, ≤4, ≤3, ≤2, or ≤1.

[0068] refer to Figure 5 The pitch (407) of the helix can be any suitable distance. For various distal extensions, the pitch p can be greater than the diameter or thickness (142) of the tubular body. The pitch can be less than three times the diameter or thickness (142) of the tubular body. The pitch can be at least three times the diameter or thickness (142) of the tubular body. The pitch can not exceed 10 times the diameter or thickness (142) of the tubular body. In some aspects, the pitch can be ≥1.25 times, ≥1.5 times, ≥1.75 times, ≥2 times, ≥2.5 times, ≥3 times, or ≥5 times the diameter or thickness (142) of the tubular body. In some aspects, the pitch can be ≤20 times, ≤10 times, ≤9 times, ≤8 times, ≤7 times, ≤6 times, or ≤5 times the diameter or thickness (142) of the tubular body.

[0069] The tubular body can be coiled clockwise or counterclockwise around the axis from the proximal end to the distal end to form a helical structure. Figure 4A and Figure 5 In the middle, the tubular body is curled clockwise. (Reference) Figure 6 As can be seen, the tubular body can also be rolled up counterclockwise.

[0070] In some implementations, the protrusions can extend from the surface of the tubular body to form a spiral structure.

[0071] A method for inserting a blood pump can be provided in various ways. This method may include introducing a guiding catheter into a blood vessel. Such catheters are well known in the art. The path of the guiding catheter may be above the aortic arch and into the left ventricle.

[0072] The method may include introducing a blood pump into a blood vessel, the blood pump having a distal extension (100) having a helical structure (400) disposed at a distal end as disclosed herein.

[0073] This method may include advancing a blood pump through a blood vessel without using a guidewire. The method may include rotating the blood pump to engage a helical structure with a guiding catheter. An example of this can be seen in… Figure 7 The diagram shows a guide tube (710) passing through the helical structure (400). In practice, by rotating the blood pump in the appropriate direction (712), the distal end (403) of the helical structure (400) can engage the guide tube, and as the blood pump continues to rotate, the helical structure is wound around the guide tube at least partially.

[0074] The method may include rotating the blood pump to cause the helical structure to interact with one or more leaflets of the aortic valve. In the same manner, the distal end of the helical structure is used to engage the guiding catheter, and the distal end and the helical structure may also interact with the leaflets of the valve, which may help to facilitate insertion and provide some control over the positioning of the leaflets.

[0075] This method may include removing the guiding catheter. For example, once the blood pump is properly placed in the blood vessel, the guiding catheter can be removed.

[0076] Various modifications can be made to the systems, methods, apparatus, mechanisms, techniques, and portions thereof described herein with reference to the various accompanying drawings, and such modifications are considered to be within the scope of the invention. For example, while a specific order of steps or arrangement of functional elements is presented in the various embodiments described herein, various other orders / arrangements of steps or functional elements may be utilized in the context of various embodiments. Furthermore, while modifications to embodiments may be discussed individually, multiple modifications, compound modifications, etc., may be used simultaneously or sequentially in various embodiments.

[0077] Although various embodiments incorporating the teachings of this invention have been shown and described in detail herein, those skilled in the art can readily devise many other variations of embodiments that still incorporate these teachings. Therefore, while the foregoing is directed to various embodiments of the invention, other and additional embodiments of the invention can be devised without departing from the essential scope of the invention. Accordingly, the appropriate scope of the invention will be determined by the claims.

Claims

1. A distal extension (100) for a blood pump, comprising: A tubular body (110) extends from a proximal end (112) to a distal end (114), the distal end being connected to a midpoint (116) on the tubular body between the proximal end and the distal end, thereby forming a closed loop (120) at the distal end of the non-invasive distal extension, the closed loop defining an opening (122) extending through the closed loop, the closed loop having a central plane (124) parallel to the central axis (118) of the tubular body at the proximal end. The tubular body includes a bend (130) that defines an angle (131) between the central axis (132) of a first substantially straight section (133) of the tubular body near the bend and the central axis (134) of a second substantially straight section (135) of the tubular body far from the bend.

2. The distal extension according to claim 1, wherein, The central axis (126) of the hole extends through the closed loop in a direction perpendicular to the central plane of the closed loop (120).

3. The distal extension according to claim 2, wherein, The hole (122) is circular.

4. The distal extension according to claim 2, wherein, The hole (122) is non-circular.

5. The distal extension according to any one of claims 2 to 4, wherein, The central axis (150) of the hole (122) is eccentric within the closed loop (120).

6. The distal extension according to any one of claims 2 to 4, wherein, The central axis (150) of the hole (122) is centered within the closed loop (120).

7. The distal extension according to any one of claims 2 to 6, wherein, The diameter or thickness (142) of the tubular body (110) at the proximal end (112) is different from the diameter or thickness (140) of the tubular body in the closed loop (120).

8. The distal extension according to any one of claims 2 to 6, wherein, The diameter or thickness (140) of the tubular body (110) at the first point of the closed loop (120) is equal to the diameter or thickness (141) of the tubular body at the second point of the closed loop.

9. The distal extension according to any one of claims 2 to 6, wherein, The diameter or thickness (140) of the tubular body (110) at the first point of the closed loop is different from the diameter or thickness (141) of the tubular body at the second point of the closed loop.

10. The distal extension according to any one of claims 2 to 6, wherein, The tubular body has a constant thickness or diameter along the entire closed loop.

11. The distal extension according to any one of claims 1 to 10, wherein, The distal end surface (118) of the tubular body is connected to the outer surface (119) of the tubular body at the midpoint (116).

12. The distal extension according to any one of claims 1 to 11, wherein, The midpoint (116) is located near the bend (130).

13. The distal extension according to any one of claims 1 to 12, wherein, The midpoint (116) is located on the far side of the bend (130).

14. The distal extension according to any one of claims 1 to 13, wherein, The distal extension has a proximal portion (102) with a stiffness greater than that of the distal portion (104).

15. The distal extension according to any one of claims 1 to 14, wherein, The angle (131) defined by the curved portion (130) is at least 135 degrees and less than 180 degrees.

16. The distal extension according to any one of claims 1 to 15, wherein, The closed loop (120) is defined by the continuous curve (160).

17. The distal extension according to any one of claims 1 to 15, wherein, The closed loop (120) includes one or more basic straight segments (133, 135).

18. The distal extension according to any one of claims 1 to 15, wherein, The closed loop (120) includes a first point (170) that is furthest from the midpoint (116), and the radius of curvature of the first point is smaller than the radius of curvature of a second point (172) that is closer to the midpoint than the first point.

19. The distal extension according to any one of claims 1 to 15, wherein, The radius of curvature of the first point (170) furthest from the proximal end is smaller than the radius of curvature of the second point (172) which is closer to the proximal end than the first point.

20. The distal extension according to any one of claims 1 to 19, wherein, The distal extension includes a lumen extending through at least a portion of the non-invasive distal extension, and wherein the lumen is configured to receive a guidewire.

21. The distal extension according to any one of claims 1 to 20, wherein, The distal extension does not contain a lumen configured to receive a guidewire.

22. The distal extension according to any one of claims 1 to 21, wherein, The closed loop (120) is circular.

23. The distal extension according to any one of claims 1 to 21, wherein, The closed loop (120) is non-circular.

24. A system (10) comprising: Pump section (20), the pump section having a proximal end (28) and a distal end (29), the pump section being configured to allow blood to flow from the blood inlet (22) through the cannula (24) to the blood outlet (26). and The distal extension (100) according to claim 1 is operatively coupled to the distal end (29) of the pump section.

25. The system of claim 24 further includes a motor section (30) operatively connected to the pump section via a drive shaft (32).

26. The system of claim 25 further includes a conduit (40) operatively connected to the proximal end of the pump section.

27. The system according to claim 26, wherein, The motor section is connected to the proximal end of the pump section, and the conduit is connected to the proximal end of the motor section.

28. The system according to claim 26 or 27, wherein, The conduit is disposed between the pump section and the motor section.

29. A distal extension (100) for a blood pump, comprising: A tubular body (110) extends from a proximal end (112) to a distal end (114). The distal end is connected to the midpoint (116) between the proximal end and the distal end on the tubular body, thereby forming a non-circular closed loop (120) at the distal end of the non-invasive distal extension, the non-circular closed loop defining an aperture (122) extending through the non-circular closed loop, the non-circular closed loop having a central plane (124) parallel to the central axis (118) of the tubular body at the proximal end.

30. The distal extension according to claim 29, wherein, The central axis (126) of the hole extends through the non-circular closed loop in a direction perpendicular to the central plane of the non-circular closed loop.

31. The distal extension according to claim 30, wherein, The hole (122) is circular.

32. The distal extension according to claim 30, wherein, The hole (122) is non-circular.

33. The distal extension according to any one of claims 30 to 32, wherein, The central axis (150) of the hole (122) is eccentric within the non-circular closed loop (120).

34. The distal extension according to any one of claims 30 to 32, wherein, The central axis of the hole (122) is centered within the non-circular closed loop (120).

35. The distal extension according to any one of claims 30 to 34, wherein, The diameter or thickness (142) of the tubular body at the proximal end is different from the diameter or thickness (140) of the tubular body (110) in the non-circular closed loop (120).

36. The distal extension according to any one of claims 30 to 34, wherein, The diameter or thickness (140) of the tubular body at the first point of the non-circular closed loop is equal to the diameter or thickness (141) of the tubular body at the second point of the non-circular closed loop.

37. The distal extension according to any one of claims 30 to 34, wherein, The diameter or thickness (140) of the tubular body at the first point of the non-circular closed loop is different from the diameter or thickness (141) of the tubular body at the second point of the non-circular closed loop.

38. The distal extension according to any one of claims 30 to 34, wherein, The tubular body has a constant thickness or diameter (140) along the entire non-circular closed loop.

39. The distal extension according to any one of claims 29 to 38, wherein, The distal end surface (118) of the tubular body (110) is connected to the outer surface (119) of the tubular body at the midpoint (116).

40. The distal extension according to any one of claims 29 to 39, wherein, The distal extension includes a bend (130), and the midpoint (116) is located near the bend.

41. The distal extension according to any one of claims 29 to 40, wherein, The distal extension has a proximal portion (102) with a stiffness greater than that of the distal portion (104).

42. The distal extension according to any one of claims 29 to 41, wherein, The non-circular closed loop (120) is defined by a continuous curve (160).

43. The distal extension according to any one of claims 29 to 41, wherein, The non-circular closed loop (120) includes one or more basic straight segments (133, 135).

44. The distal extension according to any one of claims 29 to 41, wherein, The non-circular closed loop (120) includes a first point (170) that is farthest from the midpoint (116), and the radius of curvature of the first point is smaller than the radius of curvature of a second point (172) that is closer to the midpoint than the first point.

45. The distal extension according to any one of claims 29 to 41, wherein, The radius of curvature of the first point (170) furthest from the proximal end is smaller than the radius of curvature of the second point (172) which is closer to the proximal end than the first point.

46. ​​The distal extension according to any one of claims 29 to 45, wherein, The distal extension includes a lumen extending through at least a portion of the non-invasive distal extension, and wherein the lumen is configured to receive a guidewire.

47. The distal extension according to any one of claims 29 to 46, wherein, The distal extension does not contain a lumen configured to receive a guidewire.

48. A system (10) comprising: Pump section (20), the pump section having a proximal end (28) and a distal end (29), the pump section being configured to allow blood to flow from the blood inlet (22) through the cannula (24) to the blood outlet (26). and The distal extension (100) according to claim 32 is operatively coupled to the distal end (29) of the pump section.

49. The system of claim 48 further includes a motor section (30) operatively connected to the pump section via a drive shaft (32).

50. The system of claim 49 further includes a conduit (40) operatively connected to the proximal end of the pump section.

51. The system according to claim 50, wherein, The motor section is connected to the proximal end of the pump section, and the conduit is connected to the proximal end of the motor section.

52. The system according to claim 50 or 51, wherein, The conduit is disposed between the pump section and the motor section.

53. A method for inserting a blood pump, comprising: A blood pump is introduced into a blood vessel, the blood pump having a distal extension as described in claim 1 or 29 located at a distal end; as well as The blood pump is advanced through the blood vessel without the use of a guidewire, and the distal extension is allowed to interact with at least one valve until the blood pump is positioned as desired.

54. A distal extension (100) for a blood pump, comprising: A tubular body (401) extends from a proximal end (402) to a distal end (403) defining a helical structure about an axis (410), wherein the helical structure completes n turns from a proximal end point (404) to a distal end point (405) of the tubular body, where n is at least 0.

25.

55. The distal extension according to claim 54, wherein, The tubular body (110) is rolled clockwise around the axis from the proximal end to the distal end to form the helical structure.

56. The distal extension according to claim 54, wherein, The tubular body (110) is rolled counterclockwise around the axis from the proximal end to the distal end to form the helical structure.

57. The distal extension according to any one of claims 54 to 56, wherein, The spiral structure is formed by protrusions extending from the surface of the tubular body.

58. The distal extension according to any one of claims 54 to 57, wherein, n is at least 1.

59. The distal extension according to any one of claims 54 to 58, wherein, n does not exceed 3.

60. The distal extension according to any one of claims 54 to 47, wherein, n does not exceed 1.

61. The distal extension according to any one of claims 54 to 60, wherein, The pitch (407) of the spiral structure does not exceed three times the diameter or thickness (142) of the tubular body.

62. The distal extension according to any one of claims 54 to 60, wherein, The pitch (407) of the spiral structure is at least three times the diameter or thickness (142) of the tubular body.

63. The distal extension according to claim 62, wherein, The pitch (407) of the spiral structure does not exceed 10 times the diameter or thickness (142) of the tubular body.

64. The distal extension according to any one of claims 54 to 63, wherein, The distal extension does not contain a lumen configured to receive a guidewire.

65. A system (10) comprising: Pump section (20), the pump section having a proximal end (28) and a distal end (29), the pump section being configured to allow blood to flow from the blood inlet (22) through the cannula (24) to the blood outlet (26). and The distal extension (100) according to claim 54 is operatively coupled to the distal end (29) of the pump section.

66. The system of claim 65 further includes a motor section (30) operatively connected to the pump section via a drive shaft (32).

67. The system of claim 66 further includes a conduit (40) operatively coupled to the proximal end of the pump section.

68. The system according to claim 67, wherein, The motor section is connected to the proximal end of the pump section, and the conduit is connected to the proximal end of the motor section.

69. The system according to claim 67, wherein, The conduit is disposed between the pump section and the motor section.

70. A method of inserting a blood pump, comprising: The guiding catheter is introduced into the blood vessel; A blood pump is introduced into the blood vessel, the blood pump having a distal extension as described in claim 54 located at a distal end; and To advance the blood pump through the blood vessel without using a guidewire; and Rotate the blood pump to engage the helical structure with the guide tube.

71. The method of claim 70, further comprising rotating the blood pump to cause the helical structure to interact with one or more leaflets of the aortic valve.

72. The method of claim 70 or 71 further comprises removing the guide tube.

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