Inlet guard for blood pump

Abstract

Apparatus and methods are described, including methods for manufacturing a blood pump, the methods comprising inserting an impeller (50) into a frame (34), the impeller (50) configured to pump blood of a subject, the frame (34) comprising a proximal portion, a central portion, and a frustoconical distal portion (40). A pump outlet tube (24) is secured on the proximal portion of the frame and on at least a portion of the central portion of the frame. One or more blood inlet openings (108) are formed in the sheet of material (144). After forming the blood inlet opening (108), the sheet of material (144) is rolled to form a frustoconical inlet shield (145). An inlet guard (145) is coupled to the pump outlet tube and secured to the distal portion (40) of the frame. Other applications are also described.

Description

Cross-references to related applications

[0001] This application claims priority to U.S. Provisional Application No. 63 / 615,377, entitled "Inlet guards for bloodpumps," filed December 28, 2023, by Tuval et al. (which is incorporated herein by reference); U.S. Provisional Application No. 63 / 566,681, entitled "Inlet guards for blood pumps," filed March 18, 2024, by Tuval et al. (which is incorporated herein by reference); and U.S. Provisional Application No. 63 / 692,734, entitled "Inlet guards for blood pumps," filed September 10, 2024, by Tuval et al. (which is incorporated herein by reference). Example Field

[0002] Some embodiments relate generally to medical devices, and more specifically to blood pumps, such as those used in ventricular assist devices. background

[0003] Ventricular assist devices (VADs) are mechanical circulatory support devices designed to assist and unload the heart chambers to maintain or increase cardiac output. These VADs are used in patients with heart failure and those at risk of cardiac deterioration during percutaneous coronary intervention. Most commonly, left ventricular assist devices (LVADs) are administered to defective hearts to assist left ventricular function. In some cases, right ventricular assist devices (LVADs) are used to assist right ventricular function. These VADs may be designed for permanent implantation or temporarily placed via a catheter. Overview

[0004] Some embodiments of this disclosure include a blood pump comprising an inlet guard. The inlet guard includes a body, typically truncated conical in shape and shaped to define one or more blood inlet openings configured to allow blood to pass through. The inlet guard also includes a plurality of proximal flaps extending proximally from the body. The blood pump further includes: a frame including a proximal portion, a central portion, and a distal portion; an inner lining lining at least a portion of the central portion of the frame; an impeller configured to pump blood proximally, the impeller being disposed within the frame; and a pump outlet pipe secured to the proximal portion of the frame and at least a portion of the central portion of the frame, and thermally welded to the inner lining. The inlet guard is distal to the impeller, wherein the proximal flaps of the inlet guard are disposed between the pump outlet pipe and the inner lining, wherein the pump outlet pipe and the inner lining are thermally welded to each other. To facilitate this connection of the inlet guard, the inlet guard is typically made of a material with a glass transition temperature higher than that of each of the liner and the pump outlet pipe. Generally, the frame defines the struts, and the proximal fins do not overlap with any of the frame struts.

[0005] In some embodiments, to manufacture a truncated conical inlet guard, a blood inlet opening is formed in a sheet of material, which is then rolled into a truncated conical shape. The inlet guard is connected to the pump outlet pipe, for example, via a proximal wing as described above, and is secured to the distal portion of the frame.

[0006] Other embodiments include an inflatable element, various embodiments of which are described herein. The device also includes a pump outlet tube, in some embodiments of which includes a lateral wall shaped to define one or more blood outlet openings and is configured to be inserted through the subject's aorta into the left ventricle of the subject's heart, such that the blood outlet openings are located within the aorta and a distal portion of the pump outlet tube is located within the left ventricle. The device also includes an impeller configured to pump the subject's blood proximally through the pump outlet tube, such that blood exits the pump outlet tube via the blood outlet openings. The device also includes a delivery tube configured to extend from outside the subject's body through the pump outlet tube to the distal portion, and a drive cable passing through the delivery tube and configured to rotate the impeller. The inflatable element surrounds the delivery tube proximally to the blood outlet openings. Advantageously, the inflatable element helps prevent damage to the aortic wall and / or centralizes the proximal portion of the pump outlet tube within the aorta.

[0007] Therefore, according to some embodiments, a method for manufacturing a blood pump is provided. The method includes inserting an impeller into a frame configured to pump blood from a subject, the impeller comprising a proximal portion, a central portion, and a truncated conical distal portion. The method further includes securing a pump outlet tube to at least a portion of the proximal portion of the frame and to the central portion of the frame. The method also includes forming one or more blood inlet openings in a sheet of material, and after forming the blood inlet openings, rolling the sheet of material to form a truncated conical inlet guard. The method further includes coupling the inlet guard to the pump outlet tube and securing the inlet guard to the distal portion of the frame.

[0008] In some embodiments, One or more tabs extend from the sheet of material. Rolled material sheets include those rolled by pulling tabs, and The method also includes removing tabs from the material sheet after rolling the material sheet.

[0009] In some embodiments, the pump outlet tube is configured to cross the subject's aortic valve, and the impeller is configured to pump blood from the left ventricle of the subject's heart into the subject's aorta through the pump outlet tube.

[0010] In some embodiments, the blood inlet opening is sized such that the inlet guard is configured to prevent the chordae tendineae, cardiac column, and papillary muscles of the subject's left ventricle from entering the frame.

[0011] In some embodiments, for each blood inlet opening, the span of the blood inlet opening in at least one direction is less than 1 mm.

[0012] In some embodiments, the area of ​​each blood inlet opening is 0.05 square millimeters to 5 square millimeters.

[0013] In some embodiments, forming a blood inlet opening includes forming a blood inlet opening such that the porosity of the inlet guard is at least 40%.

[0014] In some embodiments, each blood inlet opening is hexagonal.

[0015] In some embodiments, forming a blood inlet opening includes forming a blood inlet opening such that the distance between each pair of adjacent blood inlet openings is 0.01 mm to 0.1 mm.

[0016] In some embodiments, securing the entrance guard to the distal portion of the frame includes securing the entrance guard to the distal portion of the frame by attaching the entrance guard to the distal portion of the frame.

[0017] In some embodiments, the method further includes forming a plurality of proximal flaps in a sheet of material, and connecting the inlet guard to the pump outlet pipe includes connecting the inlet guard to the pump outlet pipe by connecting the proximal flaps to the pump outlet pipe.

[0018] In some embodiments, securing the inlet guard to the distal portion of the frame includes securing the inlet guard to the distal portion of the frame by at least partially securing the proximal flap to the central portion of the frame.

[0019] In some embodiments, the central portion of the frame includes a plurality of rod segments, and forming the proximal wing includes shaping the proximal wing such that when the proximal wing is at least partially fixed to the central portion of the frame, the proximal wing does not overlap with any rod segment.

[0020] In some embodiments, shaping the proximal flap includes shaping the proximal strip such that when the proximal flap is at least partially fixed to the central portion of the frame, the proximal flap engages between the segments while simultaneously abutting the segments.

[0021] In some embodiments, the method further includes: At least a portion of the central part of the frame is lined with an inner lining; and Connect the entrance guard to the liner.

[0022] In some embodiments, the method further includes forming a plurality of proximal winglets in a sheet of material.

[0023] Connecting the inlet guard to the pump outlet pipe includes connecting the inlet guard to the pump outlet pipe via a near-side flap, and Connecting the inlet guard to the liner includes connecting the inlet guard to the liner by connecting the proximal wing to the liner, such that the proximal wing is located between the pump outlet pipe and the liner.

[0024] In some embodiments, connecting the proximal flap to the pump outlet pipe and the liner includes connecting the proximal flap to the pump outlet pipe and the liner by thermally welding the pump outlet pipe to the liner while the proximal flap is located between the pump outlet pipe and the liner.

[0025] In some embodiments, the method further includes forming a plurality of wing openings in the proximal wing, and thermally welding the pump outlet pipe to the liner includes thermally welding the pump outlet pipe to the liner at least partially via the wing openings.

[0026] In some embodiments, the glass transition temperature of the material is higher than the respective glass transition temperatures of the liner and the pump outlet pipe, and the heat welding of the pump outlet pipe to the liner includes heat welding the pump outlet pipe to the liner at a heat welding temperature lower than the glass transition temperature of the material but higher than the glass transition temperatures of the liner and the pump outlet pipe.

[0027] In some embodiments, The lining is made of polyurethane. The pump outlet pipe is made of polyether block amide, and The material is polyetheretherketone.

[0028] In some embodiments, The lining and pump outlet pipe are made of the same or different types of polyurethane, and The material is polyetheretherketone.

[0029] In some embodiments, Inserting the impeller into the frame includes inserting the impeller into the frame while the impeller is mounted on an axial shaft configured to rotate. The method also includes attaching a support housing to the frame on the distal side of the frame, the support housing accommodating a radial support configured to radially stabilize the axial shaft during rotation of the axial shaft, and Securing the entrance guard to the distal portion of the frame includes securing the entrance guard to the distal portion of the frame by attaching the entrance guard to the support housing.

[0030] In some embodiments, the method further includes forming a plurality of distal flaps in a sheet of material, and coupling the inlet guard to the support housing includes coupling the inlet guard to the support housing by coupling the distal flaps to the support housing.

[0031] According to some embodiments, a device including a blood pump is also provided. The blood pump includes a frame comprising a proximal portion, a central portion, and a truncated conical distal portion. The blood pump also includes an impeller disposed within the frame, the impeller being configured to pump blood from a subject. The blood pump also includes a pump outlet tube fixed to at least a portion of the proximal portion of the frame and the central portion of the frame. The blood pump further includes a truncated conical inlet guard comprising a rolled sheet of material shaped to define one or more blood inlet openings, the truncated conical inlet guard being coupled to the pump outlet tube and fixed to the distal portion of the frame.

[0032] According to some embodiments, a device including a blood pump is also provided. The blood pump includes a frame comprising a proximal portion, a central portion, and a distal portion. The blood pump also includes a liner, an impeller, and a pump outlet tube. The liner is lined on at least a portion of the central portion of the frame. The impeller is configured to pump blood of a subject proximally, and is disposed within the frame. The pump outlet tube is fixed to at least a portion of the proximal portion of the frame and the central portion of the frame, and is thermally welded to the liner. The blood pump also includes an inlet guard located distal to the impeller. The inlet guard includes a body shaped to define one or more blood inlet openings configured to allow blood passage. The inlet guard includes a plurality of proximal flaps extending proximally from the body and disposed between the pump outlet tube and the liner, wherein the pump outlet tube and the liner are thermally welded to each other, and the inlet guard is made of a material with a glass transition temperature higher than the respective glass transition temperature of the liner and the pump outlet tube.

[0033] In some embodiments, the proximal fin is shaped to define a plurality of fin openings, and the pump outlet pipe and the liner are at least partially thermally welded to each other via the fin openings.

[0034] In some embodiments, The lining is made of polyurethane. The pump outlet pipe is made of polyether block amide, and The material is polyetheretherketone.

[0035] In some embodiments, The lining and pump outlet pipe are made of the same or different types of polyurethane, and The material is polyetheretherketone.

[0036] In some embodiments, the pump outlet tube is configured to cross the subject's aortic valve, and the impeller is configured to pump blood from the left ventricle of the subject's heart into the subject's aorta through the pump outlet tube.

[0037] In some embodiments, the blood inlet opening is sized such that the inlet guard is configured to prevent the chordae tendineae, cardiac column, and papillary muscles of the subject's left ventricle from entering the frame.

[0038] In some embodiments, for each blood inlet opening, the span of the blood inlet opening in at least one direction is less than 1 mm.

[0039] In some embodiments, the area of ​​each blood inlet opening is 0.05 square millimeters to 5 square millimeters.

[0040] In some embodiments, the porosity of the inlet guard is at least 40%.

[0041] In some embodiments, each blood inlet opening is hexagonal.

[0042] In some embodiments, the distance between each pair of adjacent blood inlet openings is 0.01 mm to 0.1 mm.

[0043] In some embodiments, the entrance guard is attached to the distal portion of the frame.

[0044] In some embodiments, the proximal wing is at least partially fixed to the central portion of the frame.

[0045] In some embodiments, the central portion of the frame includes multiple rod segments, and the proximal wing does not overlap with any rod segment.

[0046] In some embodiments, the proximal flaps fit between and adjacent to the links.

[0047] In some embodiments, the device further includes: An axial shaft, configured to rotate; Radial support members, configured to radially stabilize the axial shaft during rotation; and The support housing accommodates the radial support and is connected to the frame on the distal side of the frame. The impeller is mounted on an axial shaft, and The inlet protection component is connected to the support housing.

[0048] In some embodiments, the inlet guard includes a plurality of distal flaps connected to the support housing.

[0049] In some embodiments, The distal portion of the frame is truncated conical, and The main body of the entrance protection component is a truncated cone shape and is fixed to the far side of the frame.

[0050] In some embodiments, the inlet guard comprises rolled sheet material.

[0051] In some embodiments, the body of the entrance guard is flat and disposed within a frame.

[0052] In some embodiments, the device further includes an axial shaft configured to rotate. The impeller is mounted on an axial shaft, and The main body of the entrance protection component is perpendicular to the axial shaft.

[0053] According to some embodiments, a device including a blood pump is also provided. The blood pump includes a frame comprising a proximal portion, a central portion including a plurality of rod segments, and a distal portion. The blood pump also includes an impeller disposed within the frame, the impeller being configured to pump blood of a subject proximally. The blood pump also includes a pump outlet tube fixed to at least a portion of the proximal portion of the frame and the central portion of the frame. The blood pump also includes an inlet guard located distal to the impeller, the inlet guard including a body shaped to define one or more blood inlet openings configured to allow blood to pass through, and the inlet guard including a plurality of proximal flaps coupled to the pump outlet tube and at least partially fixed to the central portion of the frame without overlapping any rod segments.

[0054] In some embodiments, the proximal flaps fit between and adjacent to the links.

[0055] In some embodiments, the pump outlet tube is configured to cross the subject's aortic valve, and the impeller is configured to pump blood from the left ventricle of the subject's heart into the subject's aorta through the pump outlet tube.

[0056] In some embodiments, the blood inlet opening is sized such that the inlet guard is configured to prevent the chordae tendineae, cardiac column, and papillary muscles of the subject's left ventricle from entering the frame.

[0057] In some embodiments, for each blood inlet opening, the span of the blood inlet opening in at least one direction is less than 1 mm.

[0058] In some embodiments, the area of ​​each blood inlet opening is 0.05 square millimeters to 5 square millimeters.

[0059] In some embodiments, the porosity of the inlet guard is at least 40%.

[0060] In some embodiments, each blood inlet opening is hexagonal.

[0061] In some embodiments, the distance between each pair of adjacent blood inlet openings is 0.01 mm to 0.1 mm.

[0062] In some embodiments, the entrance guard is attached to the distal portion of the frame.

[0063] In some embodiments, the device further includes a liner that is laid on at least a portion of the central portion of the frame and attached to the entrance guard.

[0064] In some embodiments, the proximal flap is attached to the liner.

[0065] In some embodiments, the pump outlet pipe and the liner are thermally welded together, wherein a proximal wing is disposed between the pump outlet pipe and the liner.

[0066] In some embodiments, the proximal fin is shaped to define a plurality of fin openings, and the pump outlet pipe and the liner are at least partially thermally welded to each other via the fin openings.

[0067] In some embodiments, the glass transition temperature of the inlet guard is higher than the respective glass transition temperatures of the liner and the pump outlet pipe.

[0068] In some embodiments, The lining is made of polyurethane. The pump outlet pipe is made of polyether block amide, and The entrance guard is made of polyetheretherketone (PEEK).

[0069] In some embodiments, The lining and pump outlet pipe are made of the same or different types of polyurethane, and The entrance guard is made of polyetheretherketone (PEEK).

[0070] In some embodiments, the device further includes: An axial shaft, configured to rotate; Radial support members, configured to radially stabilize the axial shaft during rotation; and The support housing accommodates the radial support and is connected to the frame on the distal side of the frame. The impeller is mounted on an axial shaft, and The inlet protection component is connected to the support housing.

[0071] In some embodiments, the inlet guard includes a plurality of distal flaps connected to the support housing.

[0072] In some embodiments, The distal portion of the frame is truncated conical, and The main body of the entrance protection component is a truncated cone shape and is fixed to the far side of the frame.

[0073] In some embodiments, the inlet protection element comprises a rolled sheet of material.

[0074] In some embodiments, the body of the entrance guard is flat and disposed within a frame.

[0075] In some embodiments, the device further includes an axial shaft configured to rotate. The impeller is mounted on an axial shaft, and The main body of the entrance protection component is perpendicular to the axial shaft.

[0076] According to some embodiments, an apparatus is also provided, comprising: The blood pump includes: - Framework; - A liner having a flexural modulus between 0.1 GPa and 2 GPa, and lining at least a portion of the frame; - An impeller, configured to pump the subject's blood, is housed within a frame; and - A pump outlet pipe having a flexural modulus between 0.1 GPa and 0.8 GPa, the pump outlet pipe being fixed to at least a portion of the frame and heat-welded to the liner. -- The melting temperatures of the lining and the pump outlet pipe differ from each other by no more than 20°C.

[0077] In some embodiments, the liner and the pump outlet pipe are made of the same material, such that the melting temperatures are the same.

[0078] In some embodiments, the flexural modulus of the liner is between 0.1 GPa and 0.8 GPa.

[0079] In some embodiments, the flexural modulus of the liner is between 0.8 GPa and 2 GPa.

[0080] In some embodiments, the flexural modulus of the pump outlet pipe is between 0.1 GPa and 0.5 GPa.

[0081] In some embodiments, the liner is made of a first polymer and the pump outlet pipe is made of a second polymer, and the first polymer and the second polymer belong to the same category of polymers.

[0082] In some embodiments, the first polymer and the second polymer are identical to each other.

[0083] In some embodiments, the first polymer and the second polymer are different polymers from each other.

[0084] In some embodiments, both the first polymer and the second polymer are polyurethanes.

[0085] In some embodiments, the melting temperatures of the liner and the pump outlet pipe differ from each other by within 10°C.

[0086] In some embodiments, the melting temperatures of the liner and the pump outlet pipe differ from each other by within 5°C.

[0087] In some embodiments, the lining and the pump outlet pipe have the same melting temperature.

[0088] In some embodiments, the glass transition temperatures of the liner and the pump outlet pipe differ from each other by less than 20°C.

[0089] In some embodiments, the glass transition temperatures of the liner and the pump outlet pipe differ from each other by less than 10°C.

[0090] In some embodiments, the glass transition temperatures of the liner and the pump outlet pipe differ from each other by within 5°C.

[0091] In some embodiments, the glass transition temperatures of the liner and the pump outlet pipe are the same.

[0092] According to some embodiments, an apparatus is also provided, comprising: The blood pump includes: - Framework; - A liner made of a first polymer with a flexural modulus between 0.1 GPa and 2 GPa, and lining at least a portion of the frame; - An impeller, configured to pump the subject's blood, is housed within a frame; and - A pump outlet pipe, made of a second polymer with a flexural modulus between 0.1 GPa and 0.8 GPa, is fixed to at least a portion of the frame and heat-welded to the liner. -- The first and second polymers belong to a single category of polymers.

[0093] In some embodiments, the flexural modulus of the liner is between 0.1 GPa and 0.8 GPa.

[0094] In some embodiments, the flexural modulus of the liner is between 0.8 GPa and 2 GPa.

[0095] In some embodiments, the flexural modulus of the pump outlet pipe is between 0.1 GPa and 0.5 GPa.

[0096] In some embodiments, the first polymer and the second polymer are identical to each other.

[0097] In some embodiments, the first polymer and the second polymer are different polymers from each other.

[0098] In some embodiments, both the first polymer and the second polymer are polyurethanes.

[0099] In some embodiments, the melting temperatures of the liner and the pump outlet pipe differ from each other by within 20°C.

[0100] In some embodiments, the melting temperatures of the liner and the pump outlet pipe differ from each other by within 10°C.

[0101] In some embodiments, the melting temperatures of the liner and the pump outlet pipe differ from each other by within 5°C.

[0102] In some embodiments, the lining and the pump outlet pipe have the same melting temperature.

[0103] In some embodiments, the glass transition temperatures of the liner and the pump outlet pipe differ from each other by less than 20°C.

[0104] In some embodiments, the glass transition temperatures of the liner and the pump outlet pipe differ from each other by less than 10°C.

[0105] In some embodiments, the glass transition temperatures of the liner and the pump outlet pipe differ from each other by within 5°C.

[0106] In some embodiments, the glass transition temperatures of the liner and the pump outlet pipe are the same.

[0107] This disclosure will be more fully understood from the following detailed description of embodiments thereof, taken in conjunction with the accompanying drawings, in which: Brief description of the attached diagram

[0108] Figure 1A This is a schematic diagram of a ventricular assist system according to some embodiments; Figure 1B The deployment of a ventricular assist device in the left ventricle of a subject is illustrated schematically according to some embodiments; Figure 1C and Figure 1D This is a schematic diagram of the pump head portion of a ventricular assist device according to some embodiments; Figure 2 This is a schematic diagram of a frame accommodating the impeller of a ventricular assist device according to some embodiments; Figure 3A and Figure 3B This is a schematic diagram of the impeller of a ventricular assist device according to some embodiments; Figure 4 This is a schematic diagram of an impeller disposed within a frame of a ventricular assist device according to some embodiments; Figure 5A and Figure 5B This is a schematic diagram of the impeller and frame of a ventricular assist device according to some embodiments, respectively in its non-radial constraint state and radial constraint state; Figure 5C This is an enlarged schematic diagram of the proximal end of the frame of a ventricular assist device according to some embodiments; Figure 5D , Figure 5E and Figure 5F This is a schematic diagram of a connecting element according to some embodiments; Figure 6A , Figure 6B and Figure 6C This is a schematic diagram of a ventricular assist device according to some embodiments, the ventricular assist device including an inner liner located on the inner side of a frame housing the impeller of the ventricular assist device; Figure 7A , Figure 7B , Figure 7C and Figure 7D This is a schematic diagram of a pump outlet tube that defines a blood inlet opening at its distal end according to some embodiments; Figure 8A This is a schematic diagram of a material sheet according to some embodiments; Figure 8B It is based on some embodiments of the invention. Figure 8A A schematic diagram of a truncated conical inlet guard formed from sheet material; Figure 8C This is a schematic diagram of a material sheet according to some embodiments; Figure 8D This is a schematic diagram of a truncated conical inlet guard fixed to the distal portion of a frame according to some embodiments; Figure 9A This is a schematic diagram of an expandable element surrounding a delivery tube according to some embodiments; Figure 9B This is a schematic diagram of the pump head portion of a ventricular assist device according to some embodiments; Figure 10A , Figure 10B , Figure 10C and Figure 10D This is a schematic diagram of the pump head portion of a ventricular assist device according to some embodiments; Figure 10E This is a schematic diagram of a pump outlet tube that defines a blood flow chamber at its proximal end according to some embodiments; Figure 10F This is a schematic diagram of a fillable element disposed at the proximal end of the pump outlet pipe according to some embodiments; Figure 10G This is a schematic diagram of a fillable element disposed near the pump outlet pipe according to some embodiments; Figure 10H This is a schematic diagram of the pump head portion of a ventricular assist device according to some embodiments; Figure 10I and Figure 10J These are schematic diagrams of tilted and front perspective views of a fillable element according to some embodiments; Figure 10K , Figure 10L , Figure 10M and Figure 10N This is a schematic diagram of the pump head portion of a ventricular assist device according to some embodiments. Figure 10OA schematic front view of the proximal end of the pump head portion of a ventricular assist device according to some embodiments is shown; Figure 10P This is a schematic diagram of the pump head portion of a ventricular assist device according to some embodiments; Figure 11A , Figure 11B , Figure 11C and Figure 11D This is a schematic diagram of a portion of a ventricular assist device according to some embodiments; Figure 11E These are schematic diagrams of an entrance protection element according to some embodiments; and Figure 11F This is a schematic diagram of an entrance protection element disposed within a frame, according to some embodiments. Detailed description

[0109] First refer to Figure 1A This is a schematic diagram of a ventricular assist system 12 according to some embodiments, which includes a ventricular assist device 20 configured to assist the left ventricular function of a subject 43. Also referenced is... Figure 1B This schematically illustrates the deployment of device 20 within the left ventricle 22 of subject 43 according to some embodiments. See also: Figure 1C This is a schematic diagram of the pump head portion 27 of the device 20 according to some embodiments. Given that the scope of this disclosure includes the use of the devices and methods described herein in anatomical locations other than the left ventricle and aorta, the ventricular assist device 20 and / or portions thereof are sometimes referred to herein (in the specification and claims) as a blood pump.

[0110] The ventricular assist device 20 includes a pump outlet tube 24 shaped to define one or more blood outlet openings 109. Typically, a proximal segment 106 of the pump outlet tube defines the blood outlet openings 109 such that the blood outlet openings are located near the proximal end 28 of the pump outlet tube 24. The pump outlet tube is configured for insertion into the left ventricle 22 through the aorta 30 of the subject 43, such that the blood outlet openings 109 are located within the aorta by means of the pump outlet tube passing through the aortic valve 26 of the subject, and a distal segment 102 of the pump outlet tube (which includes the distal end 32 of the pump outlet tube) is located within the left ventricle. The pump outlet tube 24 (which may also be referred to as a "blood pump tube") is typically an elongated tube, with its axial length generally much larger than its diameter.

[0111] The ventricular assist device also includes an impeller 50, which in some embodiments is disposed within the distal segment 102. The impeller 50 is configured to pump the subject's blood proximally through a pump outlet tube, such that the blood exits the pump outlet tube via a blood outlet opening 109. Thus, during operation of the impeller 50, blood flows from the pump outlet tube into the ascending aorta.

[0112] The ventricular assist device also includes a delivery tube 142 configured to extend from outside the subject's body through a pump outlet tube to a distal section of the pump outlet tube. The device also includes a drive cable 130 passing through the delivery tube and operatively coupled to an impeller 50. System 12 also includes a motor unit 23 comprising a motor 15 configured to rotate the impeller via the drive cable 130.

[0113] The pump outlet pipe typically defines one or more blood inlet openings 108 at its distal end, through which blood flows from the left ventricle into the pump outlet pipe during impeller operation. For example... Figure 1C As shown, for some applications, the pump outlet pipe defines a single axially oriented blood inlet opening. Alternatively, the pump outlet pipe defines multiple lateral blood inlet openings, for example, as... Figure 1B As shown.

[0114] For some applications, ventricular assist devices (VADs) are used to assist left ventricular function in a subject during percutaneous coronary intervention (PCI). In this case, the VAD is typically used for a period of up to 6 hours (e.g., up to 10 hours), during which there is a risk of hemodynamic instability (e.g., during or immediately after PCI). Alternatively or additionally, VADs are used to assist left ventricular function in patients with cardiogenic shock for an even longer period (e.g., 2-20 days, or 4-14 days, for example). Cardiogenic shock can include any low cardiac output state (e.g., acute myocardial infarction, myocarditis, cardiomyopathy, postpartum, etc.). For some applications, VADs are used to assist left ventricular function in a subject for an even longer period (e.g., several weeks or months), for example, in bridgeto-recovery treatment. For some such applications, the VAD is permanently or semi-permanently implanted, and the impeller of the VAD is percutaneously powered, for example, using an external antenna magnetically connected to the impeller.

[0115] like Figure 1B As shown, Figure 1BThe steps for deploying a ventricular assist device in the left ventricle are illustrated. Typically, the distal end of the ventricular assist device, including a pump outlet tube 24, a distal end element 107, and other components described in detail below, is guided into the left ventricle and inserted into the left ventricle via a guidewire 10 (e.g., a standard 0.018-inch guidewire) passing through the distal end element 107. Typically, the guidewire 10 includes a soft, non-invasive distal end. In some embodiments, the distal end element is straightened using an end straightening element described in Figures 23A-23C of Tuval WO 21 / 205346 (which is incorporated herein by reference) before the guidewire is passed through the device.

[0116] During insertion of the distal end of the device into the left ventricle, a delivery catheter 143 is positioned on the distal end of the device such that the delivery catheter 143 retains the pump outlet tube 24 in a radially constrained configuration. In some embodiments, the delivery catheter is positioned within a standard sheath, such as a 10Fr sheath. Once the distal end of the device is positioned in the left ventricle (and the sheath (if used) is withdrawn), the pump outlet tube, along with other components of the device, is removed from the delivery catheter within the left ventricle by retracting the delivery catheter from the device. (Throughout this document, advancing the device without advancing the delivery catheter is also referred to as retracting the delivery catheter.) Retracting the delivery catheter typically leaves the self-expanding components of the distal end of the device, such as the pump outlet tube, in a non-radially constrained configuration, as described in further detail below. Subsequently, the delivery catheter is typically retracted back into the descending aorta, and the guidewire 10 is withdrawn from the subject's body.

[0117] Typically, the distal end element 107 is located at the apex of the left ventricle, for example, as described in Figures 17B-17D of Tuval WO 24 / 057252 (which is incorporated herein by reference).

[0118] In some embodiments, after the pump outlet tube is removed from the delivery conduit, the distal end element is positioned and the guidewire is withdrawn from the distal end element. The distal end of the device has greater flexibility when not radially constrained compared to when radially constrained, and this flexibility facilitates the positioning of the distal end element.

[0119] In some embodiments, the distal distal element is positioned at the apex by pushing it toward the apex while simultaneously withdrawing the guidewire from it. On the other hand, if the guidewire is withdrawn before pushing the distal distal element toward the apex, it may be difficult to position the distal distal element correctly. Similarly, if the guidewire is withdrawn after pushing the distal distal element toward the apex, the withdrawal may cause the distal distal element to change shape, which could also lead to incorrect positioning.

[0120] After the guide wire is removed from the device, the driven magnet unit 310 (shown for example in Figures 18A-18B) and drive cable 130 are connected to the motor unit 23, and the device is activated.

[0121] In some applications, to remove the left ventricular device from the subject's body at the end of treatment, the delivery catheter is advanced over the distal end of the device, which causes the self-expanding component of the distal end of the device (e.g., the pump outlet tube) to have a radially constrained configuration. Alternatively or additionally, the distal end of the device is retracted into the delivery catheter, which also causes the self-expanding component of the distal end of the device to have a radially constrained configuration.

[0122] In some embodiments, the distal end of the device is reinserted into a delivery catheter within the subject's descending aorta. The advantage of performing reinsertion in the descending aorta (rather than, for example, the left ventricle, ascending aorta, or aortic arch) is that the descending aorta is straight. Furthermore, in some cases, the device may release thrombi or fragments when reinserted. In the descending aorta, the risk of thrombi or fragments reaching the brain is lower.

[0123] For some applications (not shown), the ventricular assist device and / or delivery catheter 143 includes an ultrasound transducer at its distal end, and the ventricular assist device is advanced toward the ventricle of the subject under ultrasound guidance.

[0124] System 12 also includes a console 21, which includes a computer processor 25 configured to drive the impeller to rotate. For example, the computer processor can control a motor 15 via cable 224, which, as described above, drives the impeller to rotate via drive cable 130. For some applications, the computer processor is configured to detect or estimate physiological parameters of a subject (such as left ventricular pressure, natural cardiac output, cardiac afterload, rate of change of left ventricular pressure, etc.) and control the rotation of the impeller accordingly. Typically, depending on the memory technology used, the operations performed by the computer processor described herein translate the physical state of a memory into different magnetic polarities, charges, etc., which is a real physical artifact communicating with the computer processor. The computer processor 25 is typically a hardware device programmed with computer program instructions to produce a dedicated computer. For example, when programmed to perform the techniques described herein, the computer processor 25 typically acts as a dedicated ventricular assist computer processor and / or a dedicated blood pump computer processor.

[0125] For some applications, cleaning system 17 (in) Figure 1A (As shown in the figure) Drive fluid (e.g., glucose solution) passes through multiple parts of the ventricular assist device 20, for example, to cool parts of the device, clean and / or lubricate the junction between the rotating parts and the fixed support, and / or to flush away debris from parts of the device.

[0126] Typically, console 21 also includes a display 228, embodiments of which will be described below with reference to FIG14.

[0127] Typically, along the distal section 102 of the pump outlet tube 24, a frame 34 is at least partially disposed within the pump outlet tube and surrounding the impeller 50, with a distal end element 107 disposed distally relative to the frame 34. The frame is typically made of a shape memory alloy (e.g., nitinol). For some applications, the shape memory alloy of the frame is shaped such that at least a portion of the frame (and therefore the distal section 102 of the tube 24) presents a generally circular, elliptical, or polygonal cross-sectional shape when no force is applied to the distal section 102 of the tube 24. By presenting its generally circular, elliptical, or polygonal cross-sectional shape, the frame is configured to hold the distal section of the pump outlet tube in an open state. Typically, during operation of the ventricular assist device, the distal section of the pump outlet tube is configured to be placed within the subject's body such that the distal section of the pump outlet tube is at least partially disposed within the left ventricle.

[0128] For some applications, along the proximal segment 106 of the pump outlet tube 24, the frame is not disposed within the pump outlet tube, so the pump outlet tube is not supported by the frame 34 in the open position. The pump outlet tube 24 is typically made of a blood-impermeable collapsible material, making it collapsible. For example, the pump outlet tube 24 may comprise polyurethane, polyester, and / or silicone. Alternatively or additionally, the pump outlet tube may be made of polyethylene terephthalate (PET) and / or polyether block amide (e.g., PEBAX®). For some applications (not shown), the pump outlet tube is reinforced with a reinforcing structure (e.g., a braided reinforcement structure such as braided nitinol tubing). Typically, the proximal segment of the pump outlet tube is configured to be positioned such that it is at least partially disposed within the ascending aorta of the subject. For some applications, the proximal segment of the pump outlet tube passes through the aortic valve of the subject, entering the ascending aorta from the left ventricle of the subject, such as... Figure 1B As shown.

[0129] As described above, the pump outlet tube typically defines one or more blood inlet openings 108 at its distal end, through which blood flows from the left ventricle into the pump outlet tube during impeller operation. For some applications, a proximal section of the pump outlet tube defines one or more blood outlet openings 109, through which blood flows from the pump outlet tube into the ascending aorta during impeller operation. Typically, the pump outlet tube defines multiple blood outlet openings 109, for example, between two and eight blood outlet openings (e.g., between two and four blood outlet openings). During impeller operation, the pressure of the blood flow through the pump outlet tube typically keeps the proximal section of the tube open. For some applications, such as in the event of impeller failure, the proximal section of the pump outlet tube is configured to collapse inward in response to pressure outside the proximal section of the pump outlet tube exceeding the pressure inside the proximal section of the pump outlet tube. In this way, the proximal section of the pump outlet tube acts as a safety valve, thereby preventing retrograde blood flow from the aorta into the left ventricle.

[0130] Refer again Figure 1C For some applications, frame 34 is shaped such that it defines a proximal conical (or "truncated cone") portion 36, a central cylindrical portion 38, and a distal conical portion 40. Typically, the proximal conical portion is oriented proximal, i.e., oriented such that the narrow end of the cone is proximal to the wide end of the cone. Further, typically, the distal conical portion is oriented distally, i.e., oriented such that the narrow end of the cone is distal to the wide end of the cone.

[0131] For some applications, within at least a portion of frame 34 (e.g., all or part of the central cylindrical portion of the frame), for example... Figure 1D The liner 39 shown is laid on the frame. Depending on the application, the liner 39 partially or completely overlaps with the lined portion of the pump outlet pipe 24 on the frame, as shown in the reference below. Figures 6A-6B As described in further detail. For other applications, such as Figure 1C As shown, the pump head portion does not include the liner 39.

[0132] In some embodiments, the pump outlet tube 24 includes a tapered proximal portion 42 and a cylindrical central portion 44, the cylindrical central portion 44 typically spanning a proximal section 106 and a distal section 102. The proximal tapered portion is typically oriented proximal, i.e., oriented such that the narrow end of the cone is proximal relative to the wide end of the cone. Typically, a blood outlet opening 109 is defined by the pump outlet tube 24 such that the opening extends at least partially along the proximal tapered portion of the tube 24. For some such applications, the blood outlet opening is teardrop-shaped, such as... Figure 1CAs shown. Typically, the teardrop-shaped property of the blood outlet opening, combined with an opening that extends at least partially along the proximal conical portion of the tube 24, allows blood to flow out of the blood outlet opening at its location along a flow line substantially parallel to the longitudinal axis of the tube 24.

[0133] For some applications (not shown), the diameter of the pump outlet pipe 24 varies along the length of its central portion, giving the central portion a truncated conical shape. For example, the central portion of the pump outlet pipe may widen from its proximal end to its distal end, or it may narrow from its proximal end to its distal end. For some applications, the central portion of the pump outlet pipe has a diameter between 5 mm and 7 mm at its proximal end, and between 8 mm and 12 mm at its distal end.

[0134] In some embodiments, a drive cable 130 is coupled to an axial shaft 92, which passes through an impeller 50 and is configured to rotate the impeller. In some such embodiments, the distal end element 107 includes an axial shaft receiving tube 126 and a distal end portion 120. The axial shaft receiving tube 126 is configured to receive the distal portion of the axial shaft 92 during axial forward and backward movement of the axial shaft and / or during delivery of the ventricular assist device. (Typically, during delivery of the ventricular assist device, the frame is held in a radially constrained configuration, which typically results in the axial shaft being positioned differently relative to the frame relative to its position during operation of the ventricular assist device.) Typically, the distal end portion 120 is configured to have a curved shape when deployed into the left ventricle of a subject, e.g., as... Figure 1C As shown. For some applications, the curvature of the distal end portion is configured to provide a non-invasive end to the ventricular assist device 20. Alternatively or additionally, the distal end portion is configured to separate the blood inlet opening 108 of the ventricular assist device from the wall of the left ventricle.

[0135] like Figure 1BAs shown in the enlarged portion, for some applications, the pump outlet pipe 24 extends to the end of the distal tapered portion 40 of the frame, and the pump outlet pipe defines a plurality of lateral blood inlet openings 108, as described in further detail below. For some such applications, the pump outlet pipe defines a distal tapered (or “truncated cone”) portion 47, which is oriented distally, i.e., oriented such that the narrow end of the cone is distal relative to the wide end of the cone. For some such applications (not shown), the pump outlet pipe defines two to four lateral blood inlet openings (e.g., four lateral blood inlet openings). Typically, for such applications, each blood inlet opening defines an area greater than 20 square millimeters (e.g., greater than 30 square millimeters) and / or less than 60 square millimeters (e.g., less than 50 square millimeters), such as 20 square millimeters–60 square millimeters, or 30 square millimeters–50 square millimeters. Alternatively or additionally, the outlet tube may define a greater number of smaller lateral blood inlet openings, for example, more than 10 blood inlet openings, more than 100 blood inlet openings, more than 200 blood inlet openings, or more than 300 blood inlet openings, for example, 50-100 blood inlet openings, 100-300 blood inlet openings, or 300-500 blood inlet openings. For some such applications, each blood inlet opening defines an area greater than 0.05 mm² (e.g., greater than 0.1 mm²) and / or less than 3 mm² (e.g., less than 1 mm²), for example, an area of ​​0.05 mm²-3 mm² or 0.1 mm²-1 mm². Alternatively, each blood inlet opening defines an area greater than 0.1 mm² (e.g., greater than 0.3 mm²) and / or less than 5 mm² (e.g., less than 1 mm²), for example, an area of ​​0.1 mm²-5 mm² or 0.3 mm²-1 mm². In the following, references are made, for example... Figures 7A-7D To describe such an application in further detail.

[0136] As described above, in some embodiments, the blood inlet opening 108 is defined by the distal tapered portion 47 of the pump outlet tube. Therefore, even blood inlet openings described as "lateral blood inlets" need not be oriented entirely laterally relative to the longitudinal axis of the pump outlet tube. Rather, in some embodiments, these blood inlet openings are obliquely positioned relative to the longitudinal axis of the pump outlet tube. In contrast, in some embodiments, blood outlet openings are described as "laterally facing blood outlet openings" because in such embodiments, the blood outlet openings are laterally positioned relative to the longitudinal axis of the pump outlet tube due to being defined by the central cylindrical portion of the pump outlet tube. (In other embodiments, the blood outlet openings are obliquely positioned relative to the longitudinal axis of the pump outlet tube due to being at least partially defined by the proximal tapered portion of the pump outlet tube.) In some embodiments, proximal to the proximal conical portion 42, the pump outlet tube defines a tubular connection portion 45, via which the pump outlet tube is connected to the delivery tube 142 (e.g., via adhesive). In some such embodiments, the pump outlet tube is manufactured from a single continuous tube, wherein corresponding portions of the tube are molded to define the tubular connection portion 45, the proximal conical portion 42, the distal conical portion 47, and the cylindrical central portion 44. Typically, in this case, the blood inlet opening and the blood outlet opening are cut from the tube (e.g., laser-cut). In some embodiments, the tubular connection portion is cut (e.g., in a tapered manner) before being adhered to the delivery tube 142 of the ventricular assist device to reduce the thickness of the layer of pump outlet tube connected to the delivery tube 142 and / or to prevent the formation of folds in the tubular connection portion of the pump outlet tube.

[0137] In some embodiments, (a) the blood outlet opening 109 is defined by a portion of the wall of the blood outlet tube that extends at least partially into the proximal tapered portion of the pump outlet tube, and / or (b) the blood outlet opening 109 is laterally oriented due to being defined by the central cylindrical portion of the pump outlet tube 24. The scope of this disclosure includes combining other features of the pump outlet tube and / or other portions of the ventricular assist device with any configuration of the blood outlet opening described and / or shown in this application.

[0138] It should be noted that the above description of the pump outlet pipe 24 and the blood outlet opening 109 also applies to other embodiments described herein. Furthermore, the scope of this disclosure includes... Figure 1C The pump outlet pipe shown defines a single axially oriented blood inlet opening 108 or, as... Figure 1B The pump outlet pipe, which defines multiple lateral blood inlet openings 108 as shown, is appropriately modified to be combined with other features of the ventricular assist device described herein.

[0139] In some embodiments, pressure sensor 216 measures blood pressure in the left ventricle of a subject, for example, as described in Tuval WO 24 / 057252 (which is incorporated herein by reference).

[0140] Now for reference Figure 1D This is a schematic diagram of the pump head portion of a ventricular assist device according to some embodiments.

[0141] In some embodiments, the pump outlet tube 24 does not define a tubular connecting portion. Instead, initially, the proximal portion of the tube forming the proximal tapered section is shaped into a cylinder (which is generally continuous with the cylindrical shape of the central portion). Strips are cut (e.g., laser-cut) from this proximal portion of the tube, leaving other strips 29 still attached to and extending proximally from the central cylindrical portion of the tube. The proximal ends of the strips 29 are then adhered to the delivery tube 142 of the ventricular assist device in such a way that they define the proximal tapered portion of the pump outlet tube, which defines the blood outlet opening 109. In other words, the blood outlet opening 109 is formed between the strips 29 by adhering the strips to the delivery tube 142 of the ventricular assist device.

[0142] For some applications, by using the latter method to form the proximal tapered portion of the pump outlet tube and the blood outlet opening, the thickness of the layer of the pump outlet tube connected to the delivery tube 142 is less than the thickness of the tubular connection portion formed by the former method. For some applications, this reduces the sharpness of the diameter change at the junction between the proximal end of the delivery tube 142 and the region where the delivery tube is located.

[0143] Now for reference Figure 2 , Figure 2 This is a schematic diagram of a frame 34 housing the impeller of a ventricular assist device 20 according to some applications of the present invention. The frame 34 is typically made of a shape memory alloy such as nitinol, and the shape memory alloy is shaped such that the central portion 38 of the frame (and therefore the tube 24) has a generally circular, elliptical, or polygonal cross-sectional shape when no force is applied to the pump outlet tube 24. By presenting its generally circular, elliptical, or polygonal cross-sectional shape, the frame is configured to keep the distal portion of the tube in an open state. (Since the central portion 38 of the frame typically has a circular cross-section, the central portion of the frame is also referred to herein as the “cylindrical portion” of the frame.) Typically, the frame is a stent-like frame because it includes rod segments 37 that sequentially define the cells. In some embodiments, the frame is laser-cut from metal or alloy tubing. Typically, the frame is covered by a pump outlet pipe 24 and / or by a liner 39, as described below. Figures 6A-6B Description. As described below, for some applications, the impeller 50 undergoes axial back-and-forth movement relative to the frame 34. Typically, during the movement of the impeller relative to the frame, the portion of the impeller that defines the maximum span of the impeller is positioned within the central cylindrical portion 38 of the frame 34. In some cases, if the cell size of the central cylindrical portion 38 of the frame 34 is too large, the pump outlet pipe 24 and / or the liner 39 ( Figure 1DThe tube 24 (and / or liner) is stretched between the edges of the cells, causing the pump outlet tube 24 and / or liner 39 to not define a circular cross-section. For some applications, if this occurs in an area defined by the portion of the impeller that defines the maximum span of the impeller, this results in a substantially non-constant clearance between the edge of the impeller blades and the tube 24 (and / or liner) at that location during the impeller's rotation cycle. For some applications, this may lead to increased hemolysis compared to a substantially constant clearance between the edge of the impeller blades and the tube 24 (and / or liner) at that location during the impeller's rotation cycle.

[0144] refer to Figure 2 At least in part, taking into account the problems described in the previous paragraph, within the central cylindrical portion 38 of the frame 34, the frame defines a large number of relatively small cells. Typically, when the frame is configured with its non-radial constraint, the maximum cell width CW (i.e., the distance from the inner edge of the support at the central joint on one side of the cell to the inner edge of the support at the central joint on the other side of the cell, as measured around the circumference of the cylindrical portion 38) of each cell within the cylindrical portion of the frame is less than 2 mm, for example, between 1.4 mm and 1.6 mm, or between 1.6 mm and 1.8 mm. Due to the relatively small size of the cells, the liner 39 defines a substantially circular cross-section within the cylindrical portion of the frame.

[0145] Still referencing Figure 2 And starting from the distal end of the frame (which is on the right side of the figure), the frame typically defines the following portion: (a) a connecting portion 31, through which the frame is connected to the distal support housing 118H of the ventricular assist device (e.g. Figure 5A As shown, (b) the distal tapered portion 40, (c) the central cylindrical portion 38, (d) the proximal tapered portion 36, and (e) the proximal segment joint 33. As shown, when the frame transitions from the proximal end of the frame toward the center of the frame (e.g., when the frame transitions from the proximal segment joint 33 through the proximal tapered portion 36 to the central cylindrical portion 38), the frame segments 37 pass through joints 35, where two segments branch off from a single segment in a Y-shape.

[0146] During the assembly of the ventricular assist device, the impeller is typically inserted into the frame 34 via the open proximal end of the frame. In some embodiments, prior to impeller insertion, the pump outlet pipe 24 ( Figure 1CThe impeller is fixed to the frame, including at the distal end of the frame. In such an embodiment, the impeller cannot be inserted via the distal end of the frame because the distal end of the frame is covered by the pump outlet pipe 24. Therefore, the proximal rod segment joint 33 remains open so that the impeller is placed within the frame via the proximal end of the frame. After the impeller is inserted via the proximal end of the frame, the proximal rod segment joint closes. For some applications, the proximal rod segment joint surrounds the proximal support housing 116H ( Figure 5A The outer closure (as shown below) is as follows (refer to the following). Figures 5A-5B Further detailed description. Typically, the fixing element 117 (e.g., Figure 5A The ring shown in the diagram holds the rod segment joint in its closed configuration around the outside of the near-side support housing 116H.

[0147] In other embodiments, the pump outlet pipe does not extend to the distal end of the frame 34, or the distal portion of the pump outlet pipe is secured to the distal portion of the frame only after the impeller has been inserted into the frame. In some such embodiments, the impeller is inserted into the frame via the distal end of the frame.

[0148] In some embodiments, before or after the impeller is inserted, the distal connection portion 31 is connected to the distal support housing 118H, for example, via a snap-fit ​​mechanism. Figure 5A (As shown in the image).

[0149] Typically, when frame 34 is configured in its non-radial constraint configuration, the total length of frame 34 is greater than 25 mm (e.g., greater than 30 mm) and / or less than 50 mm (e.g., less than 45 mm), for example, 25 mm–50 mm or 30 mm–45 mm. Typically, when frame 34 is configured in its radial constraint configuration (within delivery conduit 143), the length of frame is increased by 2 mm to 5 mm. Typically, when frame 34 is configured in its non-radial constraint configuration, the length of the central cylindrical portion of frame 34 is greater than 12 mm (e.g., greater than 15 mm) and / or less than 28 mm (e.g., less than 24 mm), for example, 12 mm–28 mm or 15 mm–24 mm. For some applications, the ratio of the length of the central cylindrical portion of the frame to the total length of the frame is greater than 1:3 and / or less than 3:4, for example, between 1:3 and 3:4.

[0150] Now for reference Figures 3A-3B , Figures 3A-3BThis is a schematic diagram of an impeller 50 according to some embodiments. Typically, the impeller includes at least one external helical elongated element 52 wound around a central axial spring 54, such that the helical structure defined by the helical elongated element is coaxial with the central axial spring. Typically, the impeller includes two or more helical elongated elements (e.g., three helical elongated elements, such as...). Figures 3A-3B (As shown). For some applications, the helical elongated element and the central axial spring are made of shape memory material (e.g., a shape memory alloy such as nitinol). Typically, each helical elongated element and the central axial spring is supported by a membrane 56 of material (e.g., an elastomer, such as polyurethane, and / or silicone) between them. For some applications, the membrane of the material includes nitinol sheets embedded therein, for example, to reinforce the membrane of the material.

[0151] Each helical elongated element, together with a membrane extending from the helical elongated element to the spring, defines the blades of the corresponding impeller, wherein the helical elongated element defines the outer edge of the blade, and the axial spring defines the axis of the impeller. Typically, the membrane of material extends along the spring and covers the spring.

[0152] Typically, the proximal ends of the spring 54 and the helical elongated element 52 extend from the proximal bushing (i.e., sleeve support) 64 of the impeller, such that the proximal ends of the spring 54 and the helical elongated element 52 are positioned at similar radial distances from the longitudinal axis of the impeller. Similarly, typically, the distal ends of the spring 54 and the helical elongated element 52 extend from the distal bushing 58 of the impeller, such that the distal ends of the spring 54 and the helical elongated element 52 are positioned at similar radial distances from the longitudinal axis of the impeller. The helical elongated element typically rises gradually from the proximal bushing before reaching its maximum span, and then gradually descends towards the distal bushing. Typically, the helical elongated element is symmetrical along its length, such that the rising portion of its length is symmetrical with respect to the falling portion of its length. Typically, the impeller defines a cavity 62 through which it passes, which typically extends through and is defined by the impeller's spring 54, as well as the proximal bushing 64 and the distal bushing 58.

[0153] Now for reference Figure 4 , Figure 4 This is a schematic diagram of an impeller 50 disposed within a frame 34 of a ventricular assist device 20 according to some embodiments. For some applications, a liner 39 is laid on the frame within at least a portion of the frame 34 (e.g., all or part along the central cylindrical portion 38 of the frame). Depending on the application, the liner partially or completely overlaps with the pump outlet pipe 24 on the liner-lined portion of the frame, as referenced below. Figures 6A-6B As described in further detail.

[0154] like Figure 4 As shown, a gap G typically exists between the outer edge of the impeller 50 and the liner 39, even at the point where the impeller span is at its maximum. For some applications, it is desirable that the gap between the outer edge of the impeller blades and the liner 39 be relatively small so that the impeller can effectively pump blood from the subject's left ventricle into the subject's aorta. (Note that since the gap between the outer edge of the impeller 50 and the liner 39 is relatively small even at the point where the impeller span is at its maximum, and because of the shape of the impeller, the impeller functions as an axial flow impeller, in which the impeller pumps blood axially from the distal end to the proximal end of the pump outlet pipe 24.) It is also desirable to maintain the gap between the outer edge of the impeller blades and the inner surface of the frame 34 throughout the rotation of the impeller within the frame 34, for example, to reduce the risk of hemolysis.

[0155] For some applications, when both impeller 50 and frame 34 are configured in a non-radial constraint configuration and before the impeller is operated, at the position where the impeller span is at its maximum, the gap G between the outer edge of the impeller and the liner 39 is greater than 0.05 mm (e.g., greater than 0.1 mm) and / or less than 1 mm (e.g., less than 0.4 mm), for example, 0.05 mm-1 mm or 0.1 mm-0.4 mm.

[0156] Typically, the axial shaft 92 passes through the impeller 50's axis via the impeller's cavity 62. For some applications, the axial shaft is rigid, such as a rigid tube. For other applications, the axial shaft is made of a shape memory material (e.g., a shape memory alloy, such as nitinol). Typically, this material has some elasticity, such that even if the axial shaft becomes bent (e.g., during delivery of the pump head to the left ventricle), the axial shaft retains its straight shape once deployed within the subject's body.

[0157] A proximal bushing 64 is disposed on the axial shaft 92, and a distal bushing 58 is disposed on the axial shaft distal to the proximal bushing. For some applications, the proximal bushing 64 of the impeller is coupled to the shaft such that the axial position of the proximal bushing relative to the shaft is fixed, and the distal bushing 58 of the impeller is slidable relative to the shaft (i.e., slidable along the shaft). For example, the proximal bushing can be coupled, for instance, via a snap-fit ​​mechanism to a connecting element 65 disposed on the axial shaft (in... Figure 4 (As shown in the figure). Alternatively, the distal bushing 58 of the impeller is coupled to the shaft such that the axial position of the distal bushing relative to the shaft is fixed, and the proximal bushing 64 of the impeller is slidable relative to the shaft.

[0158] The axial shaft itself is supported by a proximal radial support 116 and a distal radial support 118. Figure 5ARadial stability is achieved. Furthermore, the axial shaft radially stabilizes the impeller relative to the inner surface of the frame 34 by passing through the cavity 62 defined by the impeller, thereby maintaining a relatively small gap (e.g., the gap as described above) between the outer edge of the impeller blades and the inner surface of the frame 34 during impeller rotation.

[0159] Refer again Figures 3A-3B For some applications, the impeller includes a plurality of elongated elements 67 extending radially from the central axial spring 54 to the outer helical elongated element 52. For some applications, as shown, the impeller includes a single integrated anti-overextension element 72 defining the plurality of elongated elements 67. For some applications, the anti-overextension element 72 defines a ring 73 and a plurality of elongated elements 67 extending radially from the ring. For some applications, the ring 73 of element 72 is positioned around (and coupled to) the spring, for example, by being positioned around a tube 70, which is typically located at the longitudinal center of the spring. The ends of the respective elongated elements 67 are then coupled to the respective helical elongated elements 52.

[0160] For some applications, the elongated element 67 holds the helical elongated element 52 (which defines the outer edge of the impeller blades) within a given distance relative to the central axial spring. In this way, the elongated element is configured to prevent the outer edge of the impeller from being forced radially outward due to the forces applied to the impeller during impeller rotation. The elongated element is thus configured to maintain a gap between the outer edge of the impeller blades and the inner surface of the frame 34 during impeller rotation.

[0161] The elongated element 67 is typically flexible, but substantially non-stretchable along the axis defined by the elongated element. Typically, each of the elongated elements 67 is configured not to resist compression. More precisely, each elongated element 67 is configured to apply a tensile force to the helical elongated element 52, preventing radial outward movement of the helical elongated element 52 such that (in the absence of elongated element 67) the gap between the helical elongated element 52 and the central axial spring 54 will be greater than the length of the elongated element 67. When a force causing radial outward movement of the helical elongated element 52 (in the absence of elongated element 67) is applied to the impeller, this anti-impeller over-expansion element is configured to prevent radial expansion of the impeller. Typically, a corresponding elongated element 67 is disposed within each impeller blade and is configured to prevent radial expansion of the impeller blade. For some applications, element 72 is made of polyester and / or another polymer or a fiber-containing natural material and / or nitinol (or a similar shape memory alloy).

[0162] Typically, impeller 50 is inserted into the left ventricle via a conduit, while impeller 50 is in a radially constrained configuration. In this configuration, both the helical elongated element 52 and the central axial spring 54 are axially elongated and radially constrained. Typically, the membrane 56 of a material (e.g., silicone and / or polyurethane) changes shape to correspond to the shape changes of the helical elongated element and the axially supporting spring (both of which support the membrane of the material). Using a spring to support the inner edge of the membrane typically allows the membrane to change shape without breaking or collapsing because the spring provides a large surface area bound by the inner edge of the membrane. For some applications, using a spring to support the inner edge of the membrane reduces the diameter of the impeller that might be radially constrained compared to, for example, using a rigid shaft to support the inner edge, because the diameter of the spring itself can be reduced by axially elongating the spring.

[0163] As described above, for some applications, the proximal bushing 64 of the impeller 50 is coupled to the axial shaft 92 such that the axial position of the proximal bushing relative to the shaft is fixed, while the distal bushing 58 of the impeller is slidable relative to the shaft. For example, the proximal bushing can be coupled, for example, via a snap-fit ​​mechanism, to a connecting element 65 disposed on the axial shaft (in... Figure 4 (As shown in the diagram). In some applications, when the impeller is radially constrained for insertion into the ventricle or removal from the subject's body, the impeller is axially elongated by sliding the distal bushing distally along the axial shaft. Alternatively (not shown), the distal bushing 58 of the impeller is coupled to the shaft such that the axial position of the distal bushing relative to the shaft is fixed, and the proximal bushing 64 of the impeller is slidable relative to the shaft. In some applications, when the impeller is radially constrained for insertion into the ventricle or removal from the subject's body, the impeller is axially elongated by sliding the proximal bushing proximally along the axial shaft. (As shown in the diagram). Figures 3A-3B As shown, after being released into the subject's body, the impeller exhibits its non-radial constraint configuration (where the impeller is typically set to a non-radial constraint configuration during impeller operation).

[0164] Now for reference Figure 5A and Figure 5B , Figure 5A and Figure 5B This is a schematic diagram of the impeller 50 and frame 34 of a ventricular assist device 20 according to some embodiments, in their non-radial restraint and radial restraint states, respectively. During catheter insertion into the subject's body, the impeller and frame are typically configured in a radial restraint state, while during impeller operation within the subject's left ventricle, the impeller and frame are configured in a non-radial restraint state. Also referenced... Figure 5C , Figure 5C This is an enlarged schematic diagram of the proximal end of the frame of a ventricular assist device according to some embodiments.

[0165] like Figure 5B As shown, the frame and impeller are typically held in a radially constrained configuration by the delivery duct 143. Typically, in a radially constrained configuration of the impeller, the impeller has a total length greater than 15 mm (e.g., greater than 20 mm) and / or less than 30 mm (e.g., less than 25 mm), for example, 15 mm–30 mm or 20 mm–25 mm. More typically, in a non-radially constrained configuration of the impeller, the impeller has a length greater than 10 mm (e.g., greater than 12 mm) and / or less than 20 mm (e.g., less than 18 mm), for example, 10 mm–20 mm or 12 mm–18 mm. Typically, when the frame 34 is configured in its non-radially constrained configuration, the frame 34 has a total length greater than 25 mm (e.g., greater than 30 mm) and / or less than 50 mm (e.g., less than 45 mm), for example, 25 mm–50 mm or 30 mm–45 mm. Typically, when the frame is configured with its radial constraint (within the delivery conduit 143), the length of the frame increases by between 2 mm and 5 mm.

[0166] For some applications, when the impeller is configured in its non-radial constraint configuration and before operation, at the position of maximum impeller diameter, the outer diameter of the impeller is greater than 7 mm (e.g., greater than 8 mm) and / or less than 11 mm (e.g., less than 10 mm), for example, 7 mm–11 mm, or 8 mm–10 mm. For some applications, when the frame 34 is configured in its non-radial constraint configuration, the inner diameter of the frame 34 (measured from the inner side of the liner 39 on one side of the frame to the inner side of the liner on the opposite side of the frame) is greater than 7.5 mm (e.g., greater than 8.5 mm) and / or less than 10.5 mm (e.g., less than 9.5 mm), for example, 7.5 mm–10.5 mm, or 8.5 mm–9.5 mm. For some applications, when the frame is configured in its non-radial constraint configuration, the outer diameter of the frame 34 is greater than 8 mm (e.g., greater than 9 mm) and / or less than 12 mm (e.g., less than 11 mm), for example, 8 mm–12 mm, or 9 mm–11 mm.

[0167] For some applications, when the impeller is configured in its radially constrained configuration, for example during delivery of a ventricular assist device via delivery catheter 143, at the position where the impeller's outer diameter is at its maximum, the impeller's outer diameter is greater than 1.5 mm (e.g., greater than 2 mm) and / or less than 3 mm (e.g., less than 2.5 mm), such as 1.5 mm–3 mm or 2 mm–2.5 mm. For some applications, at the position where the impeller's outer diameter is at its maximum, the ratio between the impeller's outer diameter in (a) the non-radially constrained configuration and (b) the radially constrained configuration is greater than 3:1, such as greater than 7:2 or greater than 4:1.

[0168] For some applications, when the frame is configured in its radially constrained configuration, for example during delivery of a ventricular assist device via delivery catheter 143, the outer diameter of the frame is greater than 2 mm (e.g., greater than 2.5 mm) and / or less than 4 mm (e.g., less than 3.5 mm), such as 2 mm–4 mm or 2.5 mm–3.5 mm. For some applications, the ratio of the outer diameter of the frame in (a) the non-radially constrained configuration of the frame to (b) the radially constrained configuration of the frame is greater than 5:2, such as greater than 3:1.

[0169] As described above, typically, the axial shaft 92 passes through the impeller cavity 62 along the axis of the impeller 50. Typically, the proximal bushing 64 of the impeller is connected to the shaft via a connecting element 65, such that the axial position of the proximal bushing relative to the shaft is fixed, and the distal bushing 58 of the impeller is slidable relative to the shaft. Alternatively, the distal bushing 58 of the impeller is connected to the shaft, such that the axial position of the distal bushing relative to the shaft is fixed, and the proximal bushing 64 of the impeller is slidable relative to the shaft.

[0170] The axial shaft itself is radially stabilized via a proximal radial support 116 and a distal radial support 118. Typically, the proximal support housing 116H is configured to surround and house the proximal support, and the distal support housing 118H is configured to surround and house the distal support. For some such applications, the radial supports and support housings are made of corresponding, different materials. For example, the radial support may be made of a first material with relatively high hardness, such as ceramic (e.g., zirconium oxide), and the support housing may be made of a second material that can be molded into the desired shape, such as a metal or alloy (e.g., stainless steel, cobalt-chromium, and / or nitinol).

[0171] For some applications, the axial shaft 92 is made of metal or alloy, such as stainless steel. For some such applications, the area of ​​the axial shaft that contacts either the proximal support 116 or the distal support 118 during operation of the ventricular assist device is covered with a ceramic sleeve 240 (e.g., a zirconia sleeve). In this way, the radial interface between the axial shaft and the proximal and distal supports is a ceramic-ceramic interface. As described further in detail herein, in some embodiments, the impeller and the axial shaft are configured to undergo axial reciprocating motion during operation of the ventricular assist device. Therefore, for some applications, the axial shaft is covered with a ceramic sleeve along a length greater than 5 mm, for example, greater than 7 mm, at locations along the axial shaft corresponding to each of the proximal and distal supports. In this way, the ceramic sleeve remains in contact with the radial supports during the axial reciprocating motion of the axial shaft.

[0172] For some applications, each section of the axial shaft covered by a ceramic sleeve is shaped (e.g., via milling, molding, or different forming processes) to define one or more grooves or notches 95, such as Figure 5C The cross-sectional view is shown. Alternatively or additionally (not shown), the inner surface of the ceramic sleeve is shaped to define one or more grooves or notches. For some such applications, in order to bond the sleeve to the axial shaft, adhesive is injected into the grooves or notches, and then the adhesive diffuses from the grooves or notches through the interface between the axial shaft and the sleeve.

[0173] For some applications, the proximal support housing 116H and the distal support housing 118H perform additional functions. Referring first to the proximal support housing, as described above, for some applications, the proximal segment joint 33 of the frame 34 closes around the outer side of the proximal support housing. For some applications, the outer surface of the proximal support housing defines a groove shaped to receive the proximal segment joint. For example, as shown, the proximal segment joint has a widened head, and the groove defined by the outer surface of the proximal support housing is shaped to conform to the widened head of the proximal segment joint. Typically, a retaining element 117 (which typically includes a ring) holds the segment joint in its closed configuration around the outer side of the proximal support housing 116H.

[0174] For some applications, an additional portion of the ventricular assist device is coupled to the proximal support housing. For example, in some applications, a drive cable 130 extends from outside the subject's body to an axial shaft 92 and is coupled to the axial shaft such that the axial shaft rotates with the drive cable. Typically, the drive cable rotates within a first outer tube 140, which serves as a drive cable support tube and extends from outside the subject's body to the proximal support housing. For some applications, the first outer tube is disposed within a second outer tube 142 (also referred to herein as a "delivery tube"), which also extends from outside the subject's body to the proximal support housing. For some applications, the first outer tube 140 and / or the second outer tube 142 are coupled to the proximal support housing (e.g., using adhesive). For example, the first outer tube 140 may be coupled to the inner surface of the proximal support housing, and the second outer tube 142 may be coupled to the outer surface of the proximal support housing. Typically, the cleaning fluid passes between the first outer tube 140 and the second outer tube 142, for example as shown in Figure 15B of Tuval WO 24 / 057252 (which is incorporated herein by reference).

[0175] Referring now to the distal support housing 118H, for some applications, the distal connecting portion 31 of the frame 34 is connected to the outer surface of the distal support housing 118H, for example, via a snap-fit ​​mechanism. For example, the outer surface of the proximal portion 119 of the distal support housing may include a snap-fit ​​mechanism to which the distal connecting portion 31 of the frame 34 is connected. For some applications, the distal support 118 is disposed within the proximal portion 119 of the distal support housing, such as... Figure 5A As shown. As described above, for some applications, the pump outlet tube 24 extends to the distal end of the frame 34 and defines a lateral blood inlet opening 108. For some such applications, a connecting portion 41 (e.g., a tubular connecting portion) extends distally from the pump outlet tube and is coupled to the distal support housing to anchor the distal end of the pump outlet tube. For some applications, the intermediate portion 123 of the distal support housing defines a ridged or threaded outer surface to which the connecting portion 41 of the pump outlet tube is coupled (e.g., via adhesive). For some applications, the outer surface is ridged to enhance the connection between the distal support housing and the connecting portion 41 of the pump outlet tube. For some applications, the outer surface is threaded to enhance the connection between the distal support housing and the connection portion 41 of the pump outlet pipe, and to facilitate the application of adhesive between the outer surface and the connection portion 41 of the pump outlet pipe. For some applications, the distal portion 121 of the distal support housing is configured to reinforce the area to which the distal end of the shaft 92 of the distal end element 107 moves (e.g., the axial shaft receiving tube 126 or a portion thereof). Typically, the distal end element 107 is coupled to the outer surface of the distal portion 121 of the distal support housing (e.g., via adhesive). For some applications, at least a portion of the outer surface of the distal portion 121 of the distal support housing is ridged and / or threaded to enhance the connection between the distal end element 107 and the distal support housing.

[0176] As described above, the axial shaft 92 is radially stabilized via the proximal radial support 116 and the distal radial support 118. Furthermore, the axial shaft, by passing through the cavity 62 defined by the impeller, radially stabilizes the impeller relative to the inner surface of the frame 34 and the liner 39, such that, as described above, even the relatively small gap (e.g., the gap described above) between the outer edge of the impeller blades and the liner 39 is maintained during impeller rotation. Typically, the impeller itself is not directly housed within any radial or thrust support. Instead, supports 116 and 118 act as radial supports relative to the axial shaft.

[0177] In some embodiments, the pump head portion 27 (and more generally, the ventricular assist device 20) does not include any thrust support configured to be disposed within the subject's body and configured to resist the thrust generated by the rotation of the impeller. For some applications, one or more thrust supports are disposed outside the subject's body (e.g., in situations such as...). Figure 1A The motor unit 23 shown is used to resist the thrust generated by the rotation of the impeller, and the resistance is provided only by one or more thrust supports located outside the subject's body. For some applications, mechanical and / or magnetic elements are configured to hold the impeller within a given axial position range. For example, a magnet located at the proximal end of the drive cable (e.g., outside the subject's body) can be configured to apply axial movement to the impeller and / or hold the impeller within a given axial position range.

[0178] In an alternative embodiment, the axial shaft 92 is omitted, and instead the impeller is connected to the distal portion of the drive cable 130; for example, the drive cable may pass through the impeller cavity 62. In other words, the distal portion of the drive cable can serve as the axial shaft. Therefore, it should be understood that throughout this specification, the distal portion of the drive cable (which may also be referred to as the "axial shaft") can replace the axial shaft 92.

[0179] Typically, the space between delivery catheter 143 and delivery tube 142 serves as an aortic pressure sensing channel. During operation of the left ventricular assist device, the distal end of the delivery catheter is typically positioned in the descending aorta of the subject, exposing the channel to aortic blood flow and aortic blood pressure.

[0180] Now for reference Figure 5D , Figure 5E and Figure 5F These figures are schematic diagrams of the connecting element 65 according to some embodiments. As described above, for some applications, the proximal bushing 64 of the impeller 50 is coupled to the axial shaft 92 such that the axial position of the proximal bushing relative to the shaft is fixed, while the distal bushing 58 of the impeller is slidable relative to the shaft. For some applications, the proximal bushing is coupled to the axial shaft via the connecting element 65, for example, via a snap-fit ​​mechanism. Typically, the connecting element includes a first region (or “part”) 66 disposed around the axial shaft 92 and a second region (or “part”) 71 which may also be disposed around the axial shaft.

[0181] The connecting element is connected to the proximal bushing 64 at the second region 71. As described above, this connection can be achieved via a snap-fit ​​mechanism. For example, the second region 71 can be shaped to define one or more protrusions 19, the proximal bushing 64 can be shaped to define one or more recesses 18, and the proximal bushing can be connected to the second region 71 by engaging the protrusions 19 into the recesses 18. Alternatively, the proximal bushing can be shaped to define the protrusions 19, the second region 71 can be shaped to define the recesses 18, and the proximal bushing can be connected to the second region 71 by engaging the protrusions into the recesses.

[0182] The connecting element is coupled to the axial shaft 92 at a first region 66. For example, in some applications, the first region of the connecting element is welded to the shaft. In other applications, the connecting element (or at least the first region 66) is made of a shape memory material (e.g., a shape memory alloy, such as nitinol or cobalt-chromium alloy). For example, the connecting element may include a tube of shape memory material cut to define a first region and a second region. In some such applications, at least the first region of the connecting element (or the entire connecting element) is shaped to have an inner diameter smaller than the outer diameter of the axial shaft (e.g., between 0.01 mm and 0.1 mm smaller). For example, the axial shaft may have an outer diameter of 0.9 mm, and the inner diameter of the first region of the connecting element may be between 0.85 mm and 0.89 mm (e.g., 0.87 mm). Thus, after the first region is positioned around the axial shaft, the first region becomes radially contracted around the axial shaft and is therefore positioned in place relative to the axial shaft. For some applications, it is ideal to attach the connecting element to the axial shaft in this way rather than by welding, because the connecting element and / or axial shaft will be weakened by the heat during welding.

[0183] For some applications, the first region of the connecting element is shaped to define one or more slits 75, for example, by including a tube defining the slits 75. The slits 75 facilitate radial expansion of the first region, allowing the first region to be positioned about an axial shaft. As described above, after being positioned about the axial shaft, the first region can contract radially about the axial shaft.

[0184] The slit 75 may include various features to facilitate the expansion of the first region 66. For example, in some embodiments, one or more slits 75 are open-ended slits 75o, each having an open end. The open-ended slits 75o may include one or more proximal open slits 75op (opening at the proximal end of the first region 66) and / or one or more distal open slits 75od (opening at the distal end of the first region). Optionally, the length L0 of each open-ended slit may be 5%-40% of the length L1 of the connecting element. As an alternative or supplement to the open-ended slits 75o, one or more slits 75 may be closed-ended slits 75c, each without any open end. In some embodiments, such as Figures 5D-5F As shown, the closed end slit 75c and the open end slit 75o alternate around the circumference of the first region 66.

[0185] During the manufacture of the blood pump, a first region 66 is positioned around an axial shaft 92 such that, as described above, the first region becomes radially contracted around the axial shaft. Typically, in addition to the first region 66, a second region 71 is positioned around the axial shaft.

[0186] After the connecting element is attached to the axial shaft, the impeller is attached to the axial shaft via a second region of the connecting element connected to the proximal bushing 64. As described above, this connection can be performed by a snap-fit ​​mechanism; for example, the protrusion 19 can snap into the recess 18. Thus, when the axial shaft rotates, the impeller blades rotate, thereby pumping the subject's blood.

[0187] In an alternative embodiment, the second region 71 is coupled to the distal bushing 58 (e.g., via a snap-fit ​​mechanism, as described), such that the distal bushing is fixed in place relative to the axial shaft, and the proximal bushing 64 is slidable along the axial shaft.

[0188] Now for reference Figure 6A and Figure 6B , Figure 6A and Figure 6B This is a schematic diagram of a ventricular assist device 20 according to some embodiments, which includes a liner 39 that is lined inside a frame 34 that houses an impeller 50.

[0189] For some applications, the liner 39 is laid inside the frame 34 (e.g., by bonding to the frame) to provide a smooth inner surface (e.g., a smooth inner surface having a substantially circular cross-sectional shape) through which blood is pumped by the impeller. Generally, by providing a smooth surface, the cover material reduces hemolysis caused by impeller-pumped blood compared to blood being pumped between the impeller and the rod section of the frame 34. For some applications, the liner 39 comprises polyurethane, polyester, and / or silicone. Alternatively or additionally, the liner comprises polyethylene terephthalate (PET) and / or polyether block amide (e.g., PEBAX®).

[0190] Typically, the liner is disposed on the inner surface of at least a portion of the central cylindrical portion 38 of the frame 34. For some applications, the pump outlet pipe 24 also covers the central cylindrical portion 38 of the frame 34, for example, around the outer side of the frame, such that the pump outlet pipe 24 and the liner 39 overlap for at least 50% of the liner's length, for example, over the entire length of the cylindrical portion of the frame 34, such as... Figure 6A As shown. For some applications, there is only partial overlap between the pump outlet pipe 24 and the liner 39, for example, as... Figure 6B As shown. For example, the pump outlet pipe 24 may overlap the liner 39 by less than 50% (e.g., less than 25%) of the liner length. In some such applications, during insertion of the ventricular assist device 20 into the subject's body, the impeller is advanced distally within the frame 34 such that the impeller is not positioned within the overlapping area between the pump outlet pipe and the liner, thus eliminating a longitudinal position where the impeller, pump outlet pipe 24, frame 34, and liner 39 all overlap each other. Figure 6A and Figure 6B As shown, for some applications, a single axially oriented blood inlet opening 108 is defined at the distal end of the pump outlet pipe and / or liner. Alternatively, the liner is disposed on the inner surface of at least a portion of the central cylindrical portion 38 of the frame 34, and the pump outlet pipe extends to the distal end of the frame and defines a plurality of lateral blood inlet openings 108. Such applications are referred to below for example... Figures 7A-7D Further detailed description.

[0191] Typically, in the overlapping area between the liner 39 and the pump outlet pipe 24, the liner is shaped to form a smooth surface (e.g., to reduce hemolysis, as described above), and the pump outlet pipe 24 is shaped to conform to the shape of the rod segment of the frame 34 (e.g., as described above). Figure 6A (As shown in the cross-section). Furthermore, the lining typically has a basically circular cross-section (e.g., due to the relatively small cell width within the central cylindrical portion of the frame, as referenced above). Figure 2(as described above). For some applications, in the overlapping area between the liner 39 and the pump outlet pipe 24, the pump outlet pipe and the liner are joined together, for example, via vacuum, via adhesive and / or using a thermal welding process, which typically involves the thermoforming of the pump outlet pipe, as described below.

[0192] For some applications, the liner 39 and the pump outlet pipe 24 are made of different materials (e.g., different classes of polymers). For example, the liner may be made of polyurethane, while the pump outlet pipe may be made of polyether block amide (e.g., PEBAX®). Alternatively, for example, the liner and the pump outlet pipe may be made of different types of polymers of the same class, such as different types of polyurethane. Alternatively, the liner 39 and the pump outlet pipe 24 may be made of the same material. For example, both the liner and the pump outlet pipe may be made of the same type of polyurethane (i.e., the same polyurethane polymer) or polyether block amide (e.g., PEBAX®).

[0193] In some embodiments, regardless of whether the liner and the pump outlet pipe are made of the same material (e.g., the same polyurethane polymer) or different materials (e.g., different polyurethane polymers or different classes of polymers), the flexural modulus of the liner is greater than 0.1 GPa and / or less than 2 GPa, for example, between 0.1 GPa and 2 GPa, and the flexural modulus of the pump outlet pipe is greater than 0.1 GPa and / or less than 0.8 GPa (e.g., less than 0.5 GPa), for example, between 0.1 GPa and 0.8 GPa, or between 0.1 GPa and 0.5 GPa.

[0194] Typically, the pump outlet tubing has a flexural modulus greater than 0.1 GPa and / or less than 0.8 GPa (e.g., less than 0.5 GPa), for example, between 0.1 GPa and 0.8 GPa, or between 0.1 GPa and 0.5 GPa. Therefore, the pump outlet tubing is typically configured to be sufficiently flexible such that the edges defined by the pump outlet tubing (e.g., the edges of the blood outlet opening 109) will not damage the subject's tissues (e.g., the aortic wall).

[0195] As described above, the liner typically has a flexural modulus greater than 0.1 GPa and / or less than 2 GPa, for example, between 0.1 GPa and 2 GPa. For some applications, the liner has a flexural modulus greater than 0.8 GPa (e.g., greater than 1 GPa) and / or less than 2 GPa (e.g., less than 1.5 GPa), for example, between 0.8 GPa and 2 GPa, or between 1 GPa and 1.5 GPa. For some applications, by having a flexural modulus greater than 0.8 GPa (e.g., greater than 1 GPa), the liner is configured to open the configuration support frame 34 when the ventricular assist device is in the deployed state. For some applications, by having a flexural modulus greater than 0.8 GPa (e.g., greater than 1 GPa), the liner is able to perform the function of its padding frame (and optionally, to open the configuration support frame) while having a relatively small thickness, for example, less than 0.3 mm, making it easier for the pump head portion of the device to be accommodated in its radial constraint configuration. Alternatively, the liner may have a flexural modulus greater than 0.1 GPa and / or less than 0.8 GPa (e.g., less than 0.5 GPa), for example, between 0.1 GPa and 0.8 GPa, or between 0.1 GPa and 0.5 GPa.

[0196] For some applications, the liner and pump outlet pipe are made of the same material (e.g., one type of polyurethane), and both the liner and pump outlet pipe have a flexural modulus greater than 0.1 GPa and / or less than 0.8 GPa (e.g., less than 0.5 GPa), for example, between 0.1 GPa and 0.8 GPa, or between 0.1 GPa and 0.5 GPa. Alternatively, the liner and pump outlet pipe may be made of different types of polymers of the same class (e.g., different types of polyurethane). For some such applications, (a) the lining has a flexural modulus greater than 0.8 GPa (e.g., greater than 1 GPa) and / or less than 2 GPa (e.g., less than 1.5 GPa), for example between 0.8 GPa and 2 GPa, or between 1 GPa and 1.5 GPa, and (b) the pump outlet pipe has a flexural modulus greater than 0.1 GPa and / or less than 0.8 GPa (e.g., less than 0.5 GPa), for example between 0.1 GPa and 0.8 GPa, or between 0.1 GPa and 0.5 GPa.

[0197] Typically, the melting temperatures of the liner and the pump outlet pipe differ from each other by within 20°C, for example, within 10°C or within 5°C. Specifically, in embodiments where the liner and the pump outlet pipe are made of the same class of polymers (e.g., polymers of the same class but different types, or polymers of the same type), the melting temperatures of the liner and the pump outlet pipe differ from each other by within 20°C, for example, within 10°C or within 5°C. Similar melting temperatures facilitate the thermal welding of the liner to the pump outlet pipe, as described below.

[0198] More typically, the glass transition temperatures of the liner and the pump outlet pipe differ from each other by within 20°C, for example, within 10°C or within 5°C. In particular, in embodiments where the liner and the pump outlet pipe are made of the same class of polymers (e.g., polymers of the same class but different types, or polymers of the same type), the glass transition temperatures of the liner and the pump outlet pipe differ from each other by within 20°C, for example, within 10°C or within 5°C. Similar melting temperatures facilitate the thermal welding of the liner to the pump outlet pipe, as described below.

[0199] Typically, the pump outlet pipe is secured to the cylindrical portion 38 of the frame 34 by joining or otherwise connecting it to the cylindrical portion of the frame and / or the liner 39.

[0200] For some applications, the liner is bonded directly to the inner surface of the frame before the pump outlet pipe is bonded to the outside of the frame. Note that by bonding the liner directly to the inner surface of the frame (rather than simply bonding the liner to the pump outlet pipe, thereby sandwiching the frame between the liner and the pump outlet pipe), any discontinuities in the surface provided by the liner, such as bubbles, wrinkles, and other smoothness issues, are generally avoided.

[0201] For example, in some embodiments, a liner shaped like a tube is placed on a mandrel having the desired diameter. The mandrel is then heated to a temperature above the glass transition temperature of the liner but below its melting temperature. The heat causes the liner to shrink around the mandrel, thus achieving the desired diameter. Subsequently, a frame (typically the central cylindrical portion of the frame) is placed on top of the liner, and pressure is applied to the frame while the assembly of the mandrel, liner, and frame is heated in an oven. The heat and pressure bond the frame to the liner.

[0202] For some applications, techniques similar to those described above, used to enhance the bond between the helical elongated elements of the elastomeric membrane and the impeller, are used to enhance the bond between the inner surfaces of the liner and the frame. For example, in some applications, the frame is initially treated to enhance the bond between the inner surfaces of the liner and the frame. For some applications, the frame treatment includes applying plasma treatment to the frame (e.g., to the inner surface of the frame), immersing the frame in a coupling agent having at least two functional groups (e.g., a silane solution) configured to bond with the frame and the material used to manufacture the liner, respectively, immersing the frame in a solution containing the material used to manufacture the liner (e.g., a polyurethane solution), and / or spraying such a solution onto the inner surface of the frame. For some applications, the liner is made of an elastomeric material (e.g., polyurethane), and the coupling agent is a silane solution, such as a solution of n-(2-aminoethyl)-3-aminopropyltrimethoxysilane, wherein the silane contains a first functional group (e.g., (OH)) configured to bond with the framework (which is typically made of an alloy, such as nitinol), and the silane contains a second functional group (e.g., (NH2)) configured to bond with the elastomeric material.

[0203] After the liner has been attached to the frame, a portion of the pump outlet pipe 24 is positioned around the outside of the frame and subjected to heat and pressure. Typically, at this stage, the components are heated to a heat-welding temperature higher than the glass transition temperature of at least one of the pump outlet pipe 24 and the liner 39, such that the pump outlet pipe 24 is heat-welded to the liner. Typically, the heat-welding temperature is chosen such that it is high enough to soften at least one of the liner and the pump outlet pipe for welding to the other, but not high enough to melt either of these components.

[0204] As described above, in some embodiments where the liner and pump outlet pipe are made of the same class of polymers (e.g., polymers of the same class but different types, or polymers of the same type), the respective melting temperatures of the liner and pump outlet pipe differ from each other by within 20°C, for example, within 10°C, or within 5°C. In some embodiments where the liner and pump outlet pipe are made of the same class of polymers (e.g., polymers of the same class but different types, or polymers of the same type), the respective glass transition temperatures of the liner and pump outlet pipe differ from each other by within 20°C, for example, within 10°C, or within 5°C. Advantageously, similar melting temperatures and / or glass transition temperatures facilitate the selection of a hot-welding temperature that is high enough to soften both the liner and pump outlet pipe to become weldable to each other, but not high enough to melt either of these components.

[0205] In some embodiments, during the thermal welding process, a mandrel is used to heat the frame from the inside. Typically, when the frame is heated, the outer tube (which is usually made of silicone) applies pressure to the pump outlet pipe 24, causing the pump outlet pipe 24 to be pushed radially inward to conform to the shape of the frame's rod segment, such as... Figure 6A The cross-section is shown. For some applications, the mandrel is shorter than the liner, leaving a margin on the outside of the mandrel at each end of the liner. Therefore, the liner acts as a shield to protect the pump outlet pipe from overheating and damage. In other words, the margin prevents the mandrel from direct contact with the frame and / or the pump outlet pipe. In other embodiments, the heat welding process is performed in an oven.

[0206] For some applications, after thermal welding, the combination of the frame, liner, and the portion of the pump outlet pipe 24 arranged around the frame is shaped to the desired shape and size using shaping techniques known in the art.

[0207] Now for reference Figure 6C , Figure 6C This is a schematic diagram of a liner according to some embodiments, the liner including an extension 39e extending proximally beyond a cylindrical portion 38 of a frame 34. In some applications, the liner extension 39e is not attached to the inner surface of the frame 34; instead, the material including the extension oscillates freely in the blood flow generated by the impeller. In some cases, the liner extension increases the efficiency of the impeller pumping blood, for example, by correcting for the nonlinear flow path of the blood generated by the impeller pumping.

[0208] Now for reference Figures 7A-7D , Figures 7A-7D This is a schematic diagram of a pump outlet tube 24 or a portion thereof according to some embodiments, configured to define a lateral blood inlet opening 108 at its distal end. For some applications, the pump outlet tube extends substantially to the distal end of the distal tapered portion 40 of the frame 34. For such applications, the pump outlet tube typically defines a distal tapered portion 46, which is distally oriented, i.e., oriented such that the narrow end of the tapered portion is distal relative to the wide end of the tapered portion. Typically, the pump outlet tube includes a connecting portion 41 (e.g., a tubular connecting portion, as shown) extending distally from the pump outlet tube. As described above, the connecting portion is coupled to the distal support housing to anchor the distal end of the pump outlet tube.

[0209] For some applications (not shown), the pump outlet tube defines two to four lateral blood inlet openings. Typically, for such applications, each blood inlet opening defines an area greater than 20 mm² (e.g., greater than 30 mm²) and / or less than 60 mm² (e.g., less than 50 mm²), such as 20-60 mm² or 30-50 mm². Alternatively or additionally, the outlet tube defines a greater number of smaller blood inlet openings 108, such as more than 10 blood inlet openings, more than 100 blood inlet openings, more than 200 blood inlet openings, or more than 300 blood inlet openings, such as 50-100 blood inlet openings, 100-300 blood inlet openings, or 300-500 blood inlet openings. For some applications, the blood inlet openings are sized to (a) allow blood to flow from the subject's left ventricle into the tube, and (b) prevent structures from the subject's left ventricle from entering the frame. Typically, for such applications, the distal tapered portion 46 of the pump outlet pipe 24 is configured to reduce the risk of structures from the left ventricle (e.g., chordae tendineae, cardiac columns, and / or papillary muscles) entering the frame 34 and potentially being damaged by the impeller and / or axial shaft and / or causing damage to the left ventricular assist device. Therefore, for some applications, the blood inlet opening is shaped such that the width (or span) of the opening is less than 1 mm in at least one direction, for example, 0.1 mm–1 mm or 0.2 mm–0.6 mm. By defining such a small width (or span), typically, structures from the left ventricle (e.g., chordae tendineae, cardiac columns, and / or papillary muscles) are prevented from entering the frame 34. For some such applications, each blood inlet opening defines an area greater than 0.05 mm² (e.g., greater than 0.1 mm²) and / or less than 3 mm² (e.g., less than 1 mm²), for example, an area of ​​0.05 mm²–3 mm² or 0.1 mm²–1 mm². Alternatively, each blood inlet opening may be defined as having an area greater than 0.1 square millimeters (e.g., greater than 0.3 square millimeters) and / or less than 5 square millimeters (e.g., less than 1 square millimeter), such as an area of ​​0.1 square millimeters to 5 square millimeters or 0.3 square millimeters to 1 square millimeter.

[0210] Typically, the portion of the pump outlet tube that defines the blood inlet opening has a porosity greater than 40%, for example, greater than 50%, greater than 60%, or greater than 70% (where porosity is defined as the percentage of the area of ​​that portion that is porous for blood flow). Therefore, on the one hand, the blood inlet opening is relatively small (to prevent left ventricular structures from entering the frame), but on the other hand, the porosity of the portion of the pump outlet tube that defines the blood inlet opening is relatively high to allow sufficient blood to flow into the pump outlet tube.

[0211] For some applications, each blood inlet opening has a circular or polygonal shape. For other applications, each blood inlet opening has a hexagonal shape, such as... Figures 7A-7D As shown. Typically, using openings with a hexagonal shape allows the portion of the pump outlet tube defining the blood inlet opening to have a relatively high porosity (e.g., as described above), while providing sufficient material between the blood inlet openings to prevent tearing and / or stretching of the material. Figure 7B As shown, for some applications, the width W of the gap between adjacent hexagonal (or other polygonal) holes is greater than 0.01 mm (e.g., greater than 0.02 mm) and / or less than 0.2 mm (e.g., less than 0.15 mm), such as 0.01 mm–0.2 mm or 0.02 mm–0.15 mm. For some applications, the distance D between opposite sides of each hexagon (or other type of polygon) is greater than 0.1 mm (e.g., greater than 0.2 mm) and / or less than 0.8 mm (e.g., less than 0.6 mm), such as 0.1 mm–0.8 mm or 0.2 mm–0.6 mm. Figure 7B As shown, typically, each polygon encloses a circle (such that any structure that cannot pass through such a circle cannot pass through the polygon). Typically, the diameter of the circle enclosed by the polygon is equal to the distance D, for example, greater than 0.1 mm (e.g., greater than 0.2 mm) and / or less than 0.8 mm (e.g., less than 0.6 mm), such as 0.1 mm–0.8 mm, or 0.2 mm–0.6 mm.

[0212] The scope of this disclosure includes lateral blood inlet openings having uniform size and / or shape (e.g., circular, rectangular, polygonal, and / or hexagonal lateral blood inlet openings). Similarly, the scope of this disclosure includes a distal tapered portion 46 of a pump outlet pipe defining a lateral blood inlet opening, the lateral blood inlet opening being arranged such that the distal tapered portion has uniform porosity, wherein the porosity is substantially consistent across different regions of the distal tapered portion.

[0213] The scope of this disclosure also includes lateral blood inlet openings of non-uniform size and / or shape (e.g., circular, rectangular, polygonal, and / or hexagonal lateral blood inlet openings) arranged in any configuration along the distal tapered portion 46 of the pump outlet pipe. Similarly, the scope of this disclosure includes the distal tapered portion 46 of the pump outlet pipe defining a lateral blood inlet opening, the lateral blood inlet opening being arranged such that the distal tapered portion has non-uniform porosity, the porosity varying between different regions of the distal tapered portion. For some applications, the shape and / or size of the lateral blood inlet opening, and / or the porosity of the distal tapered portion, are varied to result in varying hemodynamics at different regions of the distal tapered portion. Alternatively or additionally, the shape and / or size of the lateral blood inlet opening, and / or the porosity of the distal tapered portion, are varied to result in a variation in the shape of the distal tapered portion along its length.

[0214] For some applications, the thickness of the polymer material forming the pump outlet tube 24 along the distal tapered portion 46 is greater than the thickness in other regions of the pump outlet tube (e.g., within the central cylindrical portion and / or proximal tapered portion). For some such applications, the pump outlet tube 24 is manufactured in this way to prevent tearing within the distal tapered portion 46, which defines the blood inlet opening 108, and may (in some cases) have a greater risk of tearing than other portions of the pump outlet tube.

[0215] Now for reference Figure 7D , Figure 7D This is an enlarged schematic diagram of the junction between the distal end of the pump outlet pipe 24 and the distal end element 107. Typically, the pump outlet pipe includes a connecting portion 41 (e.g., a tubular connecting portion, as shown) extending distally from the pump outlet pipe. As described above, the connecting portion is connected to the distal support housing 118H to anchor the distal end of the pump outlet pipe. Also as described above, the pump outlet pipe is typically connected to the outer side of the central cylindrical portion of the frame. For some applications, the distal tapered portion 46 of the pump outlet pipe itself is not coupled to the distal tapered portion 40 of the frame. Instead, the distal tapered portion 46 of the pump outlet pipe is held in place relative to the distal tapered portion 40 of the frame because the connecting portion 41 is connected to the distal support housing 118H, and the pump outlet pipe is connected to the outer side of the central cylindrical portion of the frame. Alternatively, the distal tapered portion 46 of the pump outlet pipe is directly connected to the distal tapered portion 40 of the frame (e.g., via heat shrink).

[0216] As described above, for some applications, the connecting portion 41 is coupled to the outer surface of portion 123 of the distal support housing 118H. For some applications, the connecting portion 41 defines an opening 111 (e.g., toward the distal end of the connecting portion), such as... Figure 7D As shown. For some applications, the adhesive is applied between the outer surfaces of the connecting portion 41 and the portion 123 of the distal support housing 118H via holes. For some applications, the outer surface of the portion 123 of the distal support housing 118H is threaded. Typically, the threaded outer surface allows the adhesive to spread gradually and uniformly between the connecting portion 41 and the outer surface of the portion 123 of the distal support housing 118H. Furthermore, the connecting portion is typically transparent, making the diffusion of the adhesive visible through the connecting portion. Therefore, for some applications, the application of the adhesive is terminated once the adhesive has sufficiently diffused between the connecting portion 41 and the outer surface of the portion 123 of the distal support housing 118H (e.g., once the outer surface of the portion 123 is covered with adhesive).

[0217] Now for reference Figure 8A and Figure 8B , Figure 8A This is a schematic diagram of sheet 144 of a material (such as polyether block amide, polyether ether ketone, or another polymer) according to some embodiments. Figure 8B This is a schematic diagram of a truncated conical inlet guard 145 formed from sheet 144 according to some embodiments.

[0218] In some embodiments, sheet 144 is provided for forming inlet guard 145, inlet guard 145 providing a distal portion 46 of the pump outlet pipe. Figure 7D The blood inlet opening 108 may have any of the properties described above for the distal portion 46 of the pump outlet pipe, and is formed, for example, in a sheet 144 via laser cutting. The sheet 144 is then rolled to form a truncated conical inlet guard. Thus, this method of forming the inlet guard utilizes the fact that it is easier to form a hole in a flat material piece than in a three-dimensional structure.

[0219] like Figure 8A As shown, the sheet 144 is typically shaped like a segment of a torus, comprising a longer, arcuate proximal end 152, a shorter, arcuate distal end 154, and opposing lateral edges 156. For rolling the sheet, as indicated by the rolling indicator 158, one lateral edge 156 is joined (e.g., bonded) to a surface of the sheet near the opposing lateral edge. See below for reference. Figure 8C Further described, one or more tabs extending from the sheet can facilitate this rolling. After the inlet guard is formed, the inlet guard is coupled to the pump outlet pipe, for example, coupled to the cylindrical portion 44 ( Figure 1C The distal end of ).

[0220] In some embodiments, a plurality of proximal flaps 146 are formed in a sheet of material, for example, by cutting a slit 150 in the proximal end of the sheet to define the flaps 146. Thus, the inlet guard includes a truncated conical body 145m and proximal flaps 146, the truncated conical body 145m being shaped to define a blood inlet opening. The inlet guard is coupled to the pump outlet pipe by coupling the proximal flaps 146 to the pump outlet pipe. Advantageously, the flaps 146 help prevent folds or creases in the inlet guard.

[0221] In some embodiments, the inlet guard is also connected to the liner 39 ( Figure 7A For example, as described below. Figure 8D As shown, the proximal wing 146 can be connected to the liner, such that the proximal wing is sandwiched between the liner and the pump outlet pipe.

[0222] As a specific example, in some applications, the liner and the pump outlet pipe are heat-welded to each other, for example, as referenced above. Figures 6A-6B The proximal wing is located between the liner and the pump outlet pipe. In some such embodiments, to protect the inlet guard from degradation during the heat welding process, the heat welding temperature (the temperature to which the liner and pump outlet pipe are heated) is lower than the glass transition temperature of the inlet guard, but higher than the glass transition temperature of at least one of the liner and the pump outlet pipe (and in some embodiments, higher than the glass transition temperatures of both the liner and the pump outlet pipe). Furthermore, as mentioned above, the heat welding temperature is generally lower than the respective melting points of the liner and the pump outlet pipe, such that the pump outlet pipe is bonded to the liner without deformation of either the liner or the pump outlet pipe.

[0223] In some embodiments, the inlet guard is made of the same material as the liner and / or pump outlet pipe, such as polyurethane (e.g., Pellethane®) or polyetheretherketone. In other embodiments, the inlet guard is made of a different material. In some such embodiments, the material used to manufacture the inlet guard has a glass transition temperature higher than the respective glass transition temperatures of the liner and the pump outlet pipe. The hot-welding temperature is lower than the glass transition temperature of the material, but higher than the respective glass transition temperatures of the liner and the pump outlet pipe.

[0224] For example, in some applications, the liner is made of polyurethane (e.g., Pellethane®), the pump outlet pipe is made of polyether block amide (e.g., PEBAX®), and the inlet guard is made of polyetheretherketone (PEEK). The heat-welding temperature is below the glass transition temperature of PEEK but above the respective glass transition temperatures of the polyurethane and the polyether block amide. Alternatively, the liner and pump outlet pipe may be made of the same or different types of polyurethane, and the inlet guard may be made of PEEK or polyether block amide (e.g., PEBAX®). The heat-welding temperature is below the glass transition temperature of PEEK or polyether block amide (e.g., PEBAX®) but above the glass transition temperature of the polyurethane.

[0225] In addition to being connected to the pump outlet pipe, the inlet guard is fixed to the distal portion of the frame. For example, in some embodiments, the inlet guard uses, for example, the method described above. Figure 6A The combination of heat and pressure used to connect the pump outlet pipe to the frame is used to connect (e.g., to) the distal portion of the frame. Alternatively or additionally, such as Figure 8D As shown, the inlet guard is secured to the distal portion 40 of the frame by at least partially securing the proximal flap 146 to the central portion 38 of the frame. For example, the proximal flap may be clamped between the liner 39 and the pump outlet pipe 24 on the central portion of the frame. Alternatively or additionally, the inlet guard is secured to the distal portion of the frame by coupling the inlet guard to the distal support housing 118H and / or the connecting portion 31 of the frame. For example, in some embodiments, a plurality of distal flaps 148 are formed in the sheet 144, and the inlet guard is coupled to the support housing and / or the connecting portion 31 by coupling the distal flaps 148 to the support housing and / or the connecting portion 31.

[0226] Now for reference Figure 8C , Figure 8C This is a schematic diagram of sheet 144 according to some embodiments. Also refer to... Figure 8D , Figure 8D This is a schematic diagram of a truncated conical inlet guard 145 according to some embodiments, which is described above with reference to... Figures 8A-8B The sheet 144 is formed and fixed to the distal portion 40 of the frame 34.

[0227] In some embodiments, the proximal flap 146 is shaped such that when the proximal flap is at least partially fixed to the central portion 38 of the frame, the proximal flap does not overlap with any of the frame segments 37. Therefore, advantageously, the proximal flap does not excessively interfere with the connection between the pump outlet pipe and the frame, and does not excessively increase the diameter of the pump head. For example, the proximal flap may be shaped such that when the proximal flap is at least partially fixed to the central portion of the frame, the proximal flap engages with and abuts the segments 37 simultaneously. Therefore, advantageously, although it does not overlap with the segments, the proximal flap provides a large surface area for connecting the inlet guard to the pump outlet pipe.

[0228] Alternatively or additionally, the proximal fin 146 is shaped to define a plurality of fin openings 161, and the pump outlet pipe and the liner are at least partially thermally welded to each other via the fin openings 161. In other words, when the pump outlet pipe is heated during the thermal welding process, the pump outlet pipe passes through the fin openings 161 and is bonded to the liner. Typically, the pump outlet pipe is also bonded to the liner between the proximal fins.

[0229] In some embodiments, at least some of the fin openings 161 (such as those in the distal portion of the proximal fin) are sized and shaped to resemble the blood inlet opening 108. One advantage of such an embodiment is its ease of manufacture. Another advantage is that the uncovered portion of the fin does not impair the function of the inlet guard even if the pump outlet pipe does not completely cover the proximal fin.

[0230] In some embodiments, one or more tabs 155 extend from the sheet 144, for example, from the lateral edge 156 of the sheet (e.g. Figure 8C (As shown). Sheet 144 is rolled by pulling tabs 155. After rolling, the tabs are removed (e.g., cut) from the sheet.

[0231] Note the reference above. Figures 8A-8D The described embodiments are even applicable to cases where the inlet guard is made of tubing rather than sheet material. Examples of such embodiments include clamping the proximal wing during thermal welding, the wing opening, the higher glass transition temperature of the inlet guard, shaping the proximal wing to avoid overlap with the frame segment, and connecting the inlet guard (e.g., via the distal wing) to the distal support housing.

[0232] Furthermore, these embodiments are even applicable to situations where the main body of the entrance guard is flat and set within a frame, as shown in the following references. Figures 11E-11F Further description.

[0233] Now for reference Figure 9A , Figure 9A This is a schematic diagram of an expandable element 314 surrounding the delivery tube 142 according to some embodiments. Also refer to... Figure 9B, Figure 9B This is a schematic diagram of the pump head portion 27 according to some embodiments.

[0234] In some embodiments, such as Figures 9A-9B As shown (and as Figures 10A-10B , Figures 10F-10H and Figures 10K-10P As shown below, an expandable element 314 surrounds the delivery tube 142. In some such embodiments, the expandable element 314 includes an expandable support or an expandable braided element. Alternatively, the expandable element 314 includes an inflatable element 316 (e.g., a balloon 114). For some applications, the inflatable element 316 is inflated using a pumped fluid (e.g., air or saline) from the ventricular assist device. For example, in some embodiments, such as... Figure 9B As shown, the wall of the delivery tube is shaped to define one or more openings 320, and a fillable element 316 surrounds the openings 320 such that fluid flowing into the fillable element from the delivery tube through the openings fills the fillable element. Typically, the filling fluid includes a cleaning fluid located distal to the openings 320 and cleaning the interface between the axial shaft and any fixed supports (including radial supports and / or thrust supports) that do not rotate with the axial shaft. Alternatively or additionally, the filling fluid is from a separate dedicated supply source.

[0235] Typically, the expandable element 314 is located proximal to the blood outlet opening 109, wherein the length of the delivery tube between the expandable element 314 and the blood outlet opening is less than 30 mm.

[0236] In some embodiments, such as Figure 9A As shown, the expandable element 314 is located entirely near the pump outlet pipe. For example, in some embodiments, the expandable element 314 is disposed between the delivery pipe 142 and the pump outlet pipe 24 (e.g., Figure 9A Slightly near the junction between (as shown). For example, in some embodiments, the expandable element 314 is located on the tubular connection portion 45 or strip 29 (as shown). Figure 1D Slightly proximal to the side.

[0237] In other embodiments, such as Figure 9B As shown, the expandable element 314 is at least partially disposed within the pump outlet pipe 24 when expanded, for example, it is completely disposed within the pump outlet pipe 24. In some such embodiments, the pump outlet pipe does not include the tapered proximal portion and is not directly connected to the delivery pipe 142.

[0238] The expandable element 314 is configured to protect the aortic wall from damage, for example, by preventing the sometimes sharp edges of the blood outlet opening 109 from contacting the aortic wall. Alternatively or additionally, the expandable element 314 is configured to center a portion of the ventricular assist device (e.g., the portion of the delivery tube 142 near the pump outlet tube) within the aorta. The expandable element 314 is configured to perform these functions by adjoining the aortic wall.

[0239] Alternatively or additionally, the expandable element 314 may be shaped to guide blood through the blood outlet opening 109, such as Figure 9B The blood flow arrow 318 is shown in the diagram. For example, in some embodiments, the distal end of the expandable element has a width that decreases as it moves distally; for example, the distal end is a truncated cone shape, such that blood is guided at an angle from the distal end of the expandable element through the blood outlet opening. Alternatively or additionally, the expandable element has angled and / or curved surfaces configured to guide blood flow in this manner. For some applications, by guiding blood flow in this way, the overall pumping efficiency of the device is increased compared to a device that does not include an expandable element.

[0240] Note that the expandable element 314 can be combined with any embodiment of the pump outlet pipe 24 described in Figures 33A-33C of WO 24 / 057252 of Tuval (which is incorporated herein by reference).

[0241] In some applications, ventricular assist devices including the expandable element 314 are selected for long-term treatment, such as for the treatment of cardiogenic shock, due to the protection provided by the expandable element. On the other hand, for short-term treatment, such as percutaneous coronary intervention, devices without the expandable element 314 are selected (e.g., such as...). Figure 1D As shown), it is assumed that the chance of damage to the aortic wall is small over a shorter period of time. Alternatively or additionally, other factors should be considered when deciding whether to select a device that includes the expandable element 314.

[0242] Now for reference Figure 10A , Figure 10B , Figure 10C and Figure 10D These figures are schematic diagrams of the pump head portion 27 according to some embodiments.

[0243] Figure 10A Similar to Figure 9B ,because Figure 10A An expandable element 314 is shown, which includes an inflatable element 316 (e.g., balloon 114) that surrounds the delivery tube 142 and is at least partially (e.g., completely) disposed within the pump outlet tube 24, proximal to the blood outlet opening. Furthermore, in Figure 10A In, such as in Figure 9B Similar to the previous example, the expandable element acts as a blood flow guide by directing blood from the proximal end of the pump outlet tube through the blood outlet opening (as indicated by blood flow arrow 318). However, Figure 10A and Figure 9B The difference lies in the shape of the scalable element; specifically, in Figure 10A In this case, the expandable components are more spherical.

[0244] In some embodiments, regardless of the shape of the expandable element, it is coupled to a lateral wall of the pump outlet tube, which is shaped to define a blood outlet opening 109 within 0.5 mm to 5 mm (e.g., 1 mm to 3 mm). In other words, in some embodiments, the axial distance D3 between the furthest portion of the lateral wall coupled to the expandable element and the nearest portion of the edge of each blood outlet opening is between 0.5 mm and 5 mm (e.g., between 1 mm and 3 mm). Advantageously, this range is small enough that any blood directed away from the expandable element can quickly exit the blood outlet opening, but large enough that the expandable element does not push the edge of the blood outlet opening (which is sometimes sharp) into the wall of the aorta.

[0245] refer to Figure 10B For some applications, the expandable element 314 is a porous expandable element, such as an expandable cage or support 172, which surrounds the delivery tube 142 within and / or immediately adjacent to the pump outlet tube, allowing blood to be pumped through the porous expandable element. For example, in some embodiments, the porous expandable element is located at the proximal end of the pump outlet tube, and the proximal end of the pump outlet tube is coupled to the delivery tube 142 via the porous expandable element. For some such applications, the pump outlet tube does not define a blood outlet opening 109. Figure 10A Instead, as indicated by blood flow arrow 174, blood flows out of the pump outlet tube only through a porous expandable element. For some applications, the porous expandable element comprises a structure made of shape memory alloys, such as laser-cut shape memory alloys and / or braided shape memory alloys.

[0246] refer to Figure 10C For some applications, the proximal portion 178 of the pump outlet tube 24 defining the blood outlet opening 109 is folded inward toward the distal end of the pump outlet tube. Typically, as shown, the proximal portion 178 is folded inward such that the blood outlet opening guides blood proximally (generally parallel to the axis of the outer tube 142) rather than radially outward (away from the axis of the outer tube 142), as indicated by blood flow arrow 362. For some applications, the proximal portion 178 is folded inward such that the blood outlet tube forms a protective layer between the blood flowing out of the blood outlet opening and the aortic wall of the subject.

[0247] refer to Figure 10D For some applications, the blood outlet opening 109 is defined by the substantially proximal surface 190 of the pump outlet tube, rather than by a lateral surface of the pump outlet tube. Typically, for such applications, blood flow from the pump outlet tube is axially guided, as indicated by blood flow arrow 364.

[0248] Now for reference Figure 10E The figure is a schematic diagram of a pump outlet tube 24 according to some embodiments, which defines a blood flow chamber 366 at its proximal end. For some applications, the blood flow chamber is defined by an intima 368 disposed within the proximal end of the pump outlet tube and defining a hole 370 through the intima. As indicated by blood flow arrow 372, blood flows into the blood flow chamber through the hole 370. Subsequently, as indicated by blood flow arrow 374, blood flows out of the blood flow chamber and into the subject's aorta via a blood outlet opening 109 (generally as described above). Typically, due to blood flow through the blood flow chamber, the blood flow chamber fills to center a portion of the left ventricular assist device (e.g., a delivery tube, particularly the portion of the delivery tube near the pump outlet tube 24) within the aorta by contact with the aortic wall. Typically, the intima is shaped to guide blood out of the blood outlet opening.

[0249] In some applications, the inner lining 368 is a continuation of the pump outlet tube 24, and the inner lining is covered by an outer lining that defines the blood outlet opening and forms the outer surface of the blood flow chamber 366. In such applications, the proximal end of the blood outlet tube is shaped to guide blood out of the blood outlet opening.

[0250] Typically, the combination of the proximal end of the blood outlet tube and an additional membrane (whether intima or adventitia) is configured to define a blood flow chamber 366, which generally functions as described above. Generally, the scope of this disclosure includes any structure providing a blood flow chamber disposed at the proximal end of the pump outlet tube, the blood flow chamber defining (a) an orifice 370 through which blood is pumped into the blood flow chamber, and (b) a blood outlet opening 109 configured to be disposed within the aorta, through which blood flows from the blood flow chamber and into the aorta.

[0251] Now for reference Figure 10F The figure is a schematic diagram of an inflatable element 316 (such as a balloon 114) disposed at the proximal end of the pump outlet pipe 24 according to some embodiments.

[0252] Figure 10F Refer to the above Figure 10A The aforementioned features are similar to Figure 9B However, they differ in the shape of the refillable element 316. Specifically, in Figure 10F In the pump outlet pipe 24, the refillable element 316 includes two parts: a distal refillable element portion 316d, which is connected to the inside of the lateral wall of the pump outlet pipe 24 (therefore, it typically seals the proximal end of the pump outlet pipe); and a proximal refillable element portion 316p, which is wider than the pump outlet pipe and is located proximal to the pump outlet pipe.

[0253] Generally, it is desirable to avoid contact between the aortic wall and the lateral wall portion 24p of the pump outlet tubing, where the pump outlet tubing is connected to the inflatable element. The proximal inflatable element portion 316p is configured to protect the aortic wall from such contact. Furthermore, the proximal inflatable element portion 316p is typically configured to center the delivery tubing 142 within the aorta.

[0254] Typically, the distal refillable element portion 316d is at least partially cylindrical to facilitate connection to the pump outlet tube. For example, in some embodiments, the proximal portion 316dp of the distal refillable element portion 316d is cylindrical. Alternatively or additionally, the distal refillable element portion is shaped to guide blood through the blood outlet opening 109, as indicated by the blood flow arrow 318. For example, in some embodiments, the distal portion 316dd of the distal refillable element portion 316d has a width that decreases as it moves distally; for example, the distal portion 316dd is a truncated cone shape, such that the distal portion 316dd guides blood.

[0255] Now for reference Figure 10G The figure is a schematic diagram of an inflatable element 316 (such as a balloon 114) disposed near the pump outlet pipe 24 according to some embodiments.

[0256] Figure 10G Similar to Figure 9A However, the difference lies in... Figure 10G In this configuration, the distal portion 316a of the refillable element is turned inward and outward and connected to the delivery tube 142 at the junction 317. Therefore, advantageously, the connection between the pump outlet tube and the delivery tube does not interfere with the connection between the refillable element and the delivery tube.

[0257] In some embodiments, such as Figure 10G As shown, the pump outlet pipe includes a tubular connection portion 45, through which the pump outlet pipe is connected to the delivery pipe 142. The distal portion 316a of the refillable element is connected to the delivery pipe proximal to the tubular connection portion, for example at a distance of less than 20 mm, such as less than 10 mm, from the tubular connection portion.

[0258] Now for reference Figure 10H The figure is a schematic diagram of the pump head portion 27 according to some embodiments. Figure 10H Refer to the above Figure 10AThe aforementioned features are similar to Figure 9B .

[0259] In some embodiments, to form the blood outlet opening 109, portions of the lateral wall of the pump outlet tube 24 are cut. In some such embodiments, instead of removing these portions (i.e., instead of cutting closed curves in the lateral wall to completely separate these portions from the rest of the wall), flaps 170 are cut in the lateral wall (i.e., open curves are cut in the lateral wall to define flaps 170). The flaps 170 are then folded inwards and coupled to the inflatable element, as indicated by the fold indicator 169.

[0260] As referenced above Figure 9A The edges of the blood outlet opening are sometimes sharp, and there is a risk that these edges may come into contact with the aortic wall. The inflatable element 316 can mitigate this risk by adjaculating against the aortic wall, thus maintaining a distance between the edges and the aortic wall. However, some risks remain, namely that in certain situations, the inflatable element may push the edges into the aortic wall. One way to mitigate this risk is to maintain a distance between the inflatable element and the edges, as described above. Figure 10A As described above. Alternatively or additionally, the wing 170 is constructed, for example, using a reference... Figure 10H The described technique eliminates portions of the edge adjacent to the fillable element to mitigate this risk.

[0261] Now for reference Figures 10I-10J These figures are schematic diagrams of oblique and front perspective views of the fillable element 316 according to some embodiments.

[0262] In some embodiments, the fillable element 316 is shaped to define one or more (e.g., three, four, or six to ten) recesses 440, the function of which is described with reference to the following figures. Typically, due to being shaped to define the recesses 440, the fillable element 316 includes protrusions 442, the number of which is the same as the number of recesses. The recesses 440 extend between the protrusions 442.

[0263] Now for reference Figure 10K-Figure 10M These figures are schematic diagrams of the pump head portion 27 according to some embodiments.

[0264] As a point of reference, it should be noted that an adhesive is typically required to attach the pump outlet tube 24 to the inflatable element 316. However, in some cases, the adhesive may cause the inflatable element to become less flexible and / or damage the aortic wall. Therefore, in some embodiments, the pump outlet tube is attached (e.g., thermally welded) to the delivery tube 142 instead of the inflatable element. In such embodiments, the pump outlet tube 24 includes a plurality of tabs 444 extending proximally from a proximal portion of the pump outlet tube, and these tabs attach to the delivery tube proximal to the inflatable element.

[0265] In some embodiments, such as Figure 10K-Figure 10M As shown, the tab 444 passes through the groove 440. Advantageously, the groove reduces the profile of the device so that the tab does not contact the aortic wall. Furthermore, the groove holds the tab in place, thereby reducing the risk of blood stagnation between the tab and the inflatable element. Typically, the tab is attached proximally to the delivery tube close to the inflatable element, further reducing the risk of blood stagnation.

[0266] In some embodiments, such as Figure 10K-Figure 10L As shown, the inflatable element 316 is offset proximally from the proximal portion of the pump outlet tube to define a plurality of blood outlet openings 109 between the tabs 444 and between the proximal portion of the pump outlet tube and the inflatable element. Blood exits the proximal portion of the pump outlet tube through these blood outlet openings. Advantageously, it is generally not necessary to cut individual blood outlet openings in the lateral walls of the pump outlet tube.

[0267] In other embodiments, such as Figure 10M As shown, the fillable element contacts (e.g., is coupled to) the proximal portion of the blood outlet tube, and blood exits through the blood outlet opening 109 in the lateral wall of the pump outlet tube.

[0268] Now for reference Figure 10N This figure is a schematic diagram of the pump head portion 27 according to some embodiments. Also refer to... Figure 10O The figure shows a schematic front view of the proximal end of the pump head portion 27 according to some embodiments.

[0269] Figure 10N-Figure 10O An alternative solution for reducing the risk of blood stagnation is illustrated. Specifically, the inflatable element 316 is disposed within the proximal portion of the pump outlet tube such that the tab 444 is substantially or entirely located proximal to the inflatable element. Typically, the tab is coupled to the delivery tube 142 at a distance of 0.5 mm to 6 mm (e.g., 1 mm–3 mm) from the inflatable element.

[0270] As indicated by blood flow arrow 318j, at least some blood exits the proximal portion of the pump outlet tube via groove 440. These blood jets help reduce the risk of blood stagnation between the pump outlet tube and the inflatable element or between the tab and the delivery tube.

[0271] In some embodiments, such as Figure 10N As shown, the side wall of the pump outlet pipe is shaped to define a blood outlet opening 309, and some blood exits the proximal portion of the pump outlet pipe through the blood outlet opening. In other embodiments, all blood exits via a groove 440.

[0272] Now for reference Figure 10P The figure is a schematic diagram of the pump head portion 27 according to some embodiments.

[0273] Figure 10P The embodiments shown are similar to Figure 10A The embodiments shown. For example, in Figure 10P In this configuration, the lateral wall of the pump outlet tube is shaped to define a blood outlet opening 109, and a fillable element 316 surrounds the delivery tube 142 and is at least partially (e.g., completely) disposed within the pump outlet tube proximal to the blood outlet opening. However, in Figure 10P In this configuration, multiple tabs 444 extend proximally from the proximal portion of the pump outlet tube and are coupled to the delivery tube proximal to the inflatable element (e.g., immediately adjacent to it). Thus, advantageously, even if some blood flows to the proximal side of the inflatable element 316 (instead of leaving the pump outlet tube via the blood outlet opening 109), the blood can still leave the pump outlet tube via the space between the tabs 444.

[0274] In some embodiments, such as Figure 10P As shown, the fillable element is not shaped to define any recesses. In other embodiments, the fillable element is shaped to define one or more recesses, and tabs pass through the recesses, for example, as... Figure 10M As shown.

[0275] Now for reference Figure 11A , Figure 11B , Figure 11C and Figure 11D These figures are schematic diagrams of portions of a ventricular assist device 20 according to some embodiments, the device including an inlet guard 400 disposed within a frame 34. The inlet guard 400 is shaped to define one or more openings 402, such as... Figure 11D As shown in the enlarged view, these holes 402 are arranged around the axial shaft and positioned within the frame 34 on the distal side of the impeller, allowing blood to flow through the holes 402 to the impeller. The inlet guard can be connected to the shaft segment of the frame 34 and the frame liner 39. Figure 4 ), the inner wall of the pump outlet pipe 24 and / or the housing 118H of the distal support component.

[0276] For some applications, the inlet guard 400 is flat and / or configured to be perpendicular to the axial shaft (i.e., perpendicular to the longitudinal axis of the frame). Therefore, advantageously, the inlet guard can occupy a relatively small space and / or provide a favorable flow direction for blood. Typically, the inlet guard is a tortuous surface.

[0277] For some applications, the ventricular assist device includes a thrust support in the pump head portion 27. Typically, for such applications, the impeller does not move distally to the cylindrical portion 38 of the frame 34 (during delivery of the device to the left ventricle or during device operation).

[0278] For some applications, the inlet guard is placed within the frame at or near the distal end of the central cylindrical portion of the frame (e.g., within 1 mm of the distal end of the cylindrical portion). This placement simplifies the assembly of the blood pump. For some applications, the distal support housing 118H extends into the distal tapered portion of the frame (e.g., to at least the end of the central cylindrical portion of the frame), and the inner edge of the inlet guard 400 is coupled to the distal support housing, such as... Figures 11A-11B As shown.

[0279] Typically, inlet guards are polymeric, meaning they are made of polymeric materials such as polyurethane (e.g., Pellethane®, polyethylene terephthalate (“PET”), ultra-high molecular weight polyethylene (“UHMWPE”), and / or polyether block amide (e.g., Pebax®)) shaped to define pores 402. For some applications, the thickness of the inlet guard is greater than 40 micrometers (e.g., greater than 50 micrometers) and / or less than 100 micrometers (e.g., less than 80 micrometers), for example, 40-100 micrometers or 50-80 micrometers. Therefore, the inlet guard can be configured to withstand pressure but be compressible.

[0280] Typically, for applications of the ventricular assist device 20 including an inlet guard 400 disposed within the frame 34, the pump outlet tube 24 does not extend to the distal end of the distal tapered portion 40 of the frame 34. Furthermore, the pump outlet tube 24 may have an open distal end instead of terminating at the distal tapered portion. (Therefore, the inlet guard simplifies the manufacture of the blood pump.) The distal end of the pump outlet tube may be located proximal to the distal end of the distal tapered portion of the frame. For example, the distal end of the pump outlet tube may be within 1 mm of the distal end of the central cylindrical portion of the frame 34; that is, the pump outlet tube may only extend to the end of or near the cylindrical portion of the frame 34. Thus, blood can flow into the frame 34 through the opening defined by the distal tapered portion of the frame.

[0281] For some applications, the opening 402 of the inlet guard 400 is sized to (a) allow blood to flow from the subject's left ventricle into the pump outlet tube 24, and (b) prevent structures from the subject's left ventricle from entering the pump outlet tube. Typically, for such applications, the inlet guard is configured to reduce the risk of structures from the left ventricle (e.g., chordae tendineae, cardiac columns, and / or papillary muscles) entering the pump outlet tube 24 and potentially being damaged by the impeller and / or axial shaft and / or causing damage to the ventricular assist device.

[0282] For some applications, the inlet guard 400 is defined as having more than 10 holes, more than 50 holes, more than 100 holes, more than 150 holes, or more than 200 holes, such as 50-100 holes, 100-150 holes, 150-200 holes, or 200-300 holes. For some applications, the holes are sized to (a) allow blood to flow from the subject's left ventricle into the tube, and (b) prevent structures from the subject's left ventricle from entering the frame. Typically, for such applications, the inlet guard is configured to reduce the risk of structures from the left ventricle (e.g., chordae tendineae, cardiac columns, and / or papillary muscles) entering the cylindrical portion of the frame 34 and potentially being damaged by the impeller and / or axial shaft and / or causing damage to the left ventricular assist device. Therefore, for some applications, the holes are shaped such that for each hole, the span in at least one direction is less than 1 mm, for example, 0.1 mm to 1 mm or 0.2 mm to 0.6 mm. By defining such a small width (or span), typically structures from the left ventricle (such as chordae tendineae, cardiac columns, and / or papillary muscles) are prevented from entering the cylindrical portion of frame 34.

[0283] For some applications, each hole is defined as having an area greater than 0.05 square millimeters (e.g., greater than 0.1 square millimeters or 0.3 square millimeters) and / or less than 5 square millimeters (e.g., less than 3 square millimeters or 1 square millimeter), such as 0.05 square millimeters to 5 square millimeters, 0.05 square millimeters to 3 square millimeters, 0.1 square millimeters to 1 square millimeter, 0.1 square millimeters to 5 square millimeters, or 0.3 square millimeters to 1 square millimeter.

[0284] Typically, the inlet guard has a porosity of at least 40%, for example greater than 50%, greater than 60%, or greater than 70% (where porosity is defined as the percentage of the area of ​​the portion that is porous for blood flow). Thus, on the one hand, the pores are relatively small (to prevent structures of the left ventricle from entering the frame), but on the other hand, the porosity of the portion defining the pores in the pump outlet tube is relatively high to allow sufficient blood to flow into the pump outlet tube.

[0285] For some applications, each hole has a circular or polygonal shape. For other applications, each hole has a hexagonal shape, such as... Figure 11D The most clearly illustrated example is shown below. Typically, using openings with a hexagonal shape allows the inlet guard to have a relatively high porosity (e.g., as described above), while providing sufficient material between the openings to prevent tearing and / or stretching of the material.

[0286] like Figure 11D As shown, for some applications, the width W2 of the gap between adjacent holes 402 (i.e., the distance between each pair of adjacent holes) is greater than 0.01 mm (e.g., greater than 0.02 mm) and / or less than 0.2 mm (e.g., less than 0.15 mm), for example, 0.01 mm - 0.2 mm, or 0.02 mm - 0.15 mm.

[0287] like Figure 11D As further shown, for some applications, the distance D2 between opposite sides of each hexagon (or other type of polygon) is greater than 0.1 mm (e.g., greater than 0.2 mm) and / or less than 0.8 mm (e.g., less than 0.6 mm), such as 0.1 mm–0.8 mm or 0.2 mm–0.6 mm. Typically, each polygon encloses a circle (such that any structure that cannot pass through such a circle cannot pass through the polygon). Typically, the diameter of the circle enclosed by the polygon is equal to the distance D2, such as greater than 0.1 mm (e.g., greater than 0.2 mm) and / or less than 0.8 mm (e.g., less than 0.6 mm), such as 0.1 mm–0.8 mm or 0.2 mm–0.6 mm.

[0288] For some applications, the frame is assembled with the internal inlet guard in the following manner. As mentioned above, during the assembly of the pump head section, the proximal end of the frame 34 is typically open. For some applications, the inlet guard is placed through the open proximal end of the frame while being supported on a rod (e.g., a mandrel). The inlet guard typically has an integral toroidal shape, wherein the edges of this shape define an inner and outer circle, such as... Figure 11D As shown. The inner circle defined by the inlet guard is typically connected to the distal support housing 118H, as... Figures 11A-11B As shown, the outer circle is connected to the rod segment of frame 34, pump outlet pipe 24, and / or liner 39. For some applications, the above-described connection between the inlet guard and other parts of the device is performed via stitching, via hooks, via adhesives, and / or via heat fusion.

[0289] As described above, in some embodiments, the inlet guard is coupled to the distal support housing, which may accommodate radial supports and / or thrust supports. In such embodiments, typically, the distal support housing is partially or entirely disposed within the frame 34. For example, at least 10%, 50%, or 80% of the length of the support housing may be disposed within the frame. Furthermore, even for applications where the blood pump does not include the inlet guard 400, the distal support housing may extend into the frame.

[0290] Now for reference Figure 11E This figure is a schematic diagram of an entrance guard 400 according to some embodiments. Also refer to... Figure 11F This figure is a schematic diagram of an inlet guard 400 disposed within a frame 34 according to some embodiments. (Note that some components of the pump head portion, such as the axial shaft 92 and the liner 39, are not included.) Figure 11F (As shown in the image.) Figures 11E-11F The embodiment of the entrance protection element 400 shown combines Figures 11A-11D Aspects of the embodiments and Figures 8A-8D Aspects of the embodiments. In particular, the body 400m of the inlet guard, shaped to define the opening 402 (which may alternatively be referred to as the blood inlet opening 108), is flat and disposed within the frame 34, for example, such that the body 400m is perpendicular to the axial shaft 92, as... Figures 11A-11D As shown. For example, the main body 400m can be a complex surface, including an inner circular edge 401i optionally connected to the distal support housing and an outer circular edge 401o optionally connected to the rod segment 37, pump outlet pipe 24, and / or liner 39. Furthermore, as... Figures 8A-8D As shown, the inlet guard includes a proximal flap 146, via which the inlet guard is coupled to the pump outlet pipe 24 and / or the liner of the frame. For example, the proximal flap can be sandwiched between the pump outlet pipe and the liner, for example, via the aforementioned thermal welding process. In some embodiments (not shown), the inlet guard 400 includes a distal flap 148 (e.g., as shown in the image). Figures 8A-8D As shown), the distal wing 148 extends from the inner edge 401i to the distal side and is connected to the distal support housing.

[0291] As a specific example, in some applications, the liner and the pump outlet pipe are heat-welded to each other, for example, as referenced above. Figures 6A-6BThe proximal wing is located between the liner and the pump outlet pipe. In some such embodiments, to protect the inlet guard 400 from degradation during the heat welding process, the heat welding temperature (the temperature to which the liner and pump outlet pipe are heated) is below the glass transition temperature of the inlet guard, but above the glass transition temperature of at least one of the liner and the pump outlet pipe (and in some embodiments, above the glass transition temperatures of both the liner and the pump outlet pipe). Furthermore, as mentioned above, the heat welding temperature is generally below the respective melting points of the liner and the pump outlet pipe, such that the pump outlet pipe is bonded to the liner without deformation of either the liner or the pump outlet pipe.

[0292] In some embodiments, the inlet guard 400 is made of the same material as the liner and / or the pump outlet pipe, such as polyurethane (e.g., Pellethane®) or polyetheretherketone. In other embodiments, the inlet guard 400 is made of a different material. In some such embodiments, the material used to manufacture the inlet guard has a glass transition temperature higher than the respective glass transition temperatures of the liner and the pump outlet pipe. The hot-welding temperature is lower than the glass transition temperature of the material, but higher than the respective glass transition temperatures of the liner and the pump outlet pipe.

[0293] For example, in some applications, the liner is made of polyurethane (e.g., Pellethane®), the pump outlet pipe is made of polyether block amide (e.g., PEBAX®), and the inlet guard 400 is made of polyetheretherketone (PEEK). The heat-welding temperature is below the glass transition temperature of PEEK but above the respective glass transition temperatures of the polyurethane and the polyether block amide. Alternatively, the liner and pump outlet pipe may be made of the same or different types of polyurethane, and the inlet guard 400 may be made of PEEK or polyether block amide (e.g., PEBAX®). The heat-welding temperature is below the glass transition temperature of PEEK or polyether block amide (e.g., PEBAX®) but above the glass transition temperature of the polyurethane.

[0294] For some applications, the inlet guard 400 is connected to the pump outlet pipe 24 and / or the frame liner by at least partially securing the proximal flap 146 to the central portion 38 of the frame. For example, the proximal flap may be clamped between the liner 39 and the pump outlet pipe 24 on the central portion of the frame.

[0295] In some embodiments, the proximal flap 146 is shaped such that when the proximal flap is at least partially fixed to the central portion 38 of the frame, the proximal flap does not overlap with any of the frame segments 37. Therefore, advantageously, the proximal flap does not excessively interfere with the connection between the pump outlet pipe and the frame, and does not excessively increase the diameter of the pump head. For example, the proximal flap may be shaped such that when the proximal flap is at least partially fixed to the central portion of the frame, the proximal flap engages with and abuts the segments 37 simultaneously. Therefore, advantageously, although it does not overlap with the segments, the proximal flap provides a large surface area for connecting the inlet guard to the pump outlet pipe.

[0296] Alternatively or additionally, the proximal fin 146 is shaped to define a plurality of fin openings 161, and the pump outlet pipe and the liner are at least partially thermally welded to each other via the fin openings 161. In other words, when the pump outlet pipe is heated during the thermal welding process, the pump outlet pipe passes through the fin openings 161 and is bonded to the liner. Typically, the pump outlet pipe is also bonded to the liner between the proximal fins.

[0297] Those skilled in the art will recognize that this disclosure is not limited to what has been specifically shown and described above. Rather, the scope of this disclosure includes both combinations and sub-combinations of the various features described above, as well as variations and modifications of this disclosure that would arise to those skilled in the art upon reading the foregoing description and are not found in the prior art.

Claims

1. A method for manufacturing a blood pump, the method comprising: An impeller is inserted into a frame configured to pump blood from a subject, the frame comprising a proximal portion, a central portion, and a truncated conical distal portion; The pump outlet pipe is secured to the proximal portion of the frame and to at least a portion of the central portion of the frame; One or more blood inlet openings are formed in the material sheet; After the blood inlet opening is formed, the material sheet is rolled to form a truncated conical inlet guard; Connect the inlet protective component to the pump outlet pipe; as well as Secure the entrance guard to the distal portion of the frame.

2. The method according to claim 1, in, One or more tabs extend from the sheet of material. The rolling of the material sheet includes rolling the material sheet by pulling the tabs, and The method further includes removing the tabs from the material sheet after rolling the material sheet.

3. The method according to claim 1, wherein, The pump outlet pipe is configured to traverse the aortic valve of the subject, and wherein the impeller is configured to pump blood from the left ventricle of the subject's heart into the subject's aorta through the pump outlet pipe.

4. The method according to claim 1, wherein, The blood inlet opening is sized such that the inlet guard is configured to prevent the chordae tendineae, cardiac column, and papillary muscles of the left ventricle of the subject's heart from entering the frame.

5. The method according to claim 1, wherein, For each of the blood inlet openings, the span of the blood inlet opening in at least one direction is less than 1 mm.

6. The method according to claim 1, wherein, The area of ​​each of the blood inlet openings is 0.05 square millimeters to 5 square millimeters.

7. The method according to claim 1, wherein, Forming the blood inlet opening includes forming the blood inlet opening such that the porosity of the inlet guard is at least 40%.

8. The method according to claim 1, wherein, Each of the blood inlet openings is hexagonal.

9. The method according to claim 1, wherein, Forming the blood inlet opening includes forming the blood inlet opening such that the distance between each pair of adjacent blood inlet openings is 0.01mm-0.1mm.

10. The method according to claim 1, wherein, Securing the entrance guard to the distal portion of the frame includes securing the entrance guard to the distal portion of the frame by attaching the entrance guard to the distal portion of the frame.

11. The method according to any one of claims 1-10, further comprising forming a plurality of proximal fins in the material sheet, wherein, Connecting the inlet guard to the pump outlet pipe includes connecting the inlet guard to the pump outlet pipe by connecting the proximal wing to the pump outlet pipe.

12. The method according to claim 11, wherein, Securing the entrance guard to the distal portion of the frame includes securing the entrance guard to the distal portion of the frame by at least partially securing the proximal flap to the central portion of the frame.

13. The method according to claim 12, wherein, The central portion of the frame includes a plurality of rod segments, and wherein forming the proximal wing includes shaping the proximal wing such that when the proximal wing is at least partially fixed to the central portion of the frame, the proximal wing does not overlap with any of the rod segments.

14. The method according to claim 13, wherein, Shaping the proximal wing includes shaping the proximal strip such that when the proximal wing is at least partially fixed to the central portion of the frame, the proximal wing engages between the rod segments and simultaneously abuts the rod segments.

15. The method according to any one of claims 1-10, further comprising: At least a portion of the central part of the frame is lined with an inner lining; and Connect the inlet guard to the liner.

16. The method of claim 15, further comprising forming a plurality of proximal fins in the material sheet, in, Connecting the inlet guard to the pump outlet pipe includes connecting the inlet guard to the pump outlet pipe by connecting the proximal wing to the pump outlet pipe, and Connecting the inlet guard to the liner includes connecting the inlet guard to the liner by connecting the proximal wing to the liner, such that the proximal wing is located between the pump outlet pipe and the liner.

17. The method according to claim 16, wherein, Connecting the proximal wing to the pump outlet pipe and the liner includes: while the proximal wing is located between the pump outlet pipe and the liner, connecting the proximal wing to the pump outlet pipe and the liner by heat-welding the pump outlet pipe to the liner.

18. The method of claim 17, further comprising forming a plurality of wing openings in the proximal wing, wherein, The heat welding of the pump outlet pipe to the liner includes at least partially heat welding the pump outlet pipe to the liner via the wing opening.

19. The method of claim 17, wherein, The glass transition temperature of the material is higher than the respective glass transition temperature of the liner and the pump outlet pipe, and wherein the heat welding of the pump outlet pipe to the liner comprises heat welding the pump outlet pipe to the liner at a heat welding temperature lower than the glass transition temperature of the material but higher than the glass transition temperature of the liner and the pump outlet pipe.

20. The method according to claim 19, in, The liner is made of polyurethane. The pump outlet pipe is made of polyether block amide, and The material in question is polyetheretherketone (PEEK).

21. The method according to claim 19, in, The liner and the pump outlet pipe are made of the same or different types of polyurethane, and The material in question is polyetheretherketone (PEEK).

22. The method according to any one of claims 1-10, in, Inserting the impeller into the frame includes inserting the impeller into the frame while the impeller is mounted on an axial shaft configured to rotate. The method further includes attaching a support housing to the frame on the distal side of the frame, the support housing accommodating a radial support configured to radially stabilize the axial shaft during rotation. The method of securing the entrance guard to the distal portion of the frame includes securing the entrance guard to the distal portion of the frame by connecting the entrance guard to the support housing.

23. The method of claim 22, further comprising forming a plurality of distal flaps in the material sheet, wherein, Connecting the inlet guard to the support housing includes connecting the inlet guard to the support housing by connecting the distal wing to the support housing.

24. An apparatus comprising: Blood pump, the blood pump comprising: - A frame, the frame comprising a proximal portion, a central portion and a truncated conical distal portion; - An impeller configured to pump blood from a subject, the impeller being disposed within the frame; - A pump outlet pipe, said pump outlet pipe being fixed to the proximal portion of the frame and to at least a portion of the central portion of the frame; and - A truncated conical inlet guard comprising a rolled sheet of material shaped to define one or more blood inlet openings, the truncated conical inlet guard being coupled to the pump outlet pipe and secured to the distal portion of the frame.

25. The device according to claim 24, wherein, The pump outlet pipe is configured to traverse the aortic valve of the subject, and wherein the impeller is configured to pump blood from the left ventricle of the subject's heart into the subject's aorta through the pump outlet pipe.

26. The device according to claim 24, wherein, The blood inlet opening is sized such that the inlet guard is configured to prevent the chordae tendineae, cardiac column, and papillary muscles of the left ventricle of the subject's heart from entering the frame.

27. The device according to claim 24, wherein, For each of the blood inlet openings, the span of the blood inlet opening in at least one direction is less than 1 mm.

28. The device according to claim 24, wherein, The area of ​​each of the blood inlet openings is 0.05 square millimeters to 5 square millimeters.

29. The device according to claim 24, wherein, The porosity of the inlet protection component is at least 40%.

30. The device according to claim 24, wherein, Each of the blood inlet openings is hexagonal.

31. The device according to claim 24, wherein, The distance between each pair of adjacent blood inlet openings is 0.01mm-0.1mm.

32. The device according to claim 24, wherein, The entrance guard is connected to the distal portion of the frame.

33. The device according to any one of claims 24-32, wherein, The inlet protection component includes multiple proximal fins, which are connected to the pump outlet pipe.

34. The device according to claim 33, wherein, The proximal wing is at least partially fixed to the central portion of the frame.

35. The device according to claim 34, wherein, The central portion of the frame includes a plurality of rod segments, wherein the proximal wing does not overlap with any of the rod segments.

36. The device according to claim 35, wherein, The proximal wing fits between the rod segments and is adjacent to the rod segments.

37. The device according to any one of claims 24-32, further comprising a liner that is laid over at least a portion of the central portion of the frame and connected to the inlet guard.

38. The device according to claim 37, wherein, The inlet protection component includes a plurality of proximal flaps connected to the pump outlet pipe and the liner, such that the proximal flaps are located between the pump outlet pipe and the liner.

39. The device according to claim 38, wherein, The pump outlet pipe and the liner are thermally welded together, wherein the proximal wing is disposed between the pump outlet pipe and the liner.

40. The device according to claim 39, wherein, The proximal wing is shaped to define a plurality of wing openings, and wherein the pump outlet pipe and the liner are at least partially thermally welded to each other via the wing openings.

41. The device according to claim 39, wherein, The glass transition temperature of the material is higher than that of the liner and the pump outlet pipe, respectively.

42. The device according to claim 41, in, The liner is made of polyurethane. The pump outlet pipe is made of polyether block amide, and The material in question is polyetheretherketone (PEEK).

43. The device according to claim 41, in, The liner and the pump outlet pipe are made of the same or different types of polyurethane, and The material in question is polyetheretherketone (PEEK).

44. The device according to any one of claims 24-32, further comprising: An axial shaft, the axial shaft being configured to rotate; A radial support member configured to radially stabilize the axial shaft as it rotates; and A support housing that accommodates the radial support and is coupled to the frame on the distal side of the frame. The impeller is mounted on the axial shaft, and The inlet protection component is connected to the support housing.

45. The device according to claim 44, wherein, The inlet protection component includes multiple distal flaps, which are connected to the support housing.

46. ​​An apparatus comprising: Blood pump, the blood pump comprising: - A frame, the frame comprising a proximal portion, a central portion and a distal portion; - Lining, which is laid on at least a portion of the central portion of the frame; - An impeller configured to pump blood from the subject proximally, the impeller being disposed within the frame; - A pump outlet pipe, the pump outlet pipe being fixed to at least a portion of the proximal portion of the frame and the central portion of the frame, and the pump outlet pipe being heat-welded to the liner; and - Inlet protection element, the inlet protection element: -- Located on the far side of the impeller, -- Includes a body shaped to define one or more blood inlet openings configured to allow blood to pass through. -- Includes multiple proximal flaps extending proximally from the body and disposed between the pump outlet pipe and the liner, wherein the pump outlet pipe and the liner are thermally welded together, and -- Made of a material whose glass transition temperature is higher than that of the liner and the pump outlet pipe, respectively.

47. The device according to claim 46, wherein, The proximal wing is shaped to define a plurality of wing openings, and wherein the pump outlet pipe and the liner are at least partially thermally welded to each other via the wing openings.

48. The device according to claim 46, in, The liner is made of polyurethane. The pump outlet pipe is made of polyether block amide, and The material in question is polyetheretherketone (PEEK).

49. The device according to claim 46, in, The liner and the pump outlet pipe are made of the same or different types of polyurethane, and The material in question is polyetheretherketone (PEEK).

50. The device according to claim 46, wherein, The pump outlet pipe is configured to traverse the aortic valve of the subject, and wherein the impeller is configured to pump blood from the left ventricle of the subject's heart into the subject's aorta through the pump outlet pipe.

51. The device according to claim 46, wherein, The blood inlet opening is sized such that the inlet guard is configured to prevent the chordae tendineae, cardiac column, and papillary muscles of the left ventricle of the subject's heart from entering the frame.

52. The device according to claim 46, wherein, For each of the blood inlet openings, the span of the blood inlet opening in at least one direction is less than 1 mm.

53. The device according to claim 46, wherein, The area of ​​each of the blood inlet openings is 0.05 square millimeters to 5 square millimeters.

54. The device according to claim 46, wherein, The porosity of the inlet protection component is at least 40%.

55. The device according to claim 46, wherein, Each of the blood inlet openings is hexagonal.

56. The device according to claim 46, wherein, The distance between each pair of adjacent blood inlet openings is 0.01mm-0.1mm.

57. The device according to claim 46, wherein, The entrance guard is connected to the distal portion of the frame.

58. The device according to any one of claims 46-57, wherein, The proximal wing is at least partially fixed to the central portion of the frame.

59. The device according to claim 58, wherein, The central portion of the frame includes a plurality of rod segments, wherein the proximal wing does not overlap with any of the rod segments.

60. The device according to claim 59, wherein, The proximal wing fits between the rod segments and is adjacent to the rod segments.

61. The device according to any one of claims 46-57, further comprising: An axial shaft, the axial shaft being configured to rotate; A radial support member configured to radially stabilize the axial shaft as it rotates; and A support housing that accommodates the radial support and is coupled to the frame on the distal side of the frame. The impeller is mounted on the axial shaft, and The inlet protection component is connected to the support housing.

62. The device according to claim 61, wherein, The inlet protection component includes multiple distal flaps, which are connected to the support housing.

63. The device according to any one of claims 46-57, in, The distal portion of the frame is truncated conical, and The main body of the entrance protection component is truncated conical and is fixed to the distal portion of the frame.

64. The device according to claim 63, wherein, The inlet protection component comprises rolled sheet material.

65. The device according to any one of claims 46-57, wherein, The main body of the entrance protection component is flat and is disposed within the frame.

66. The device of claim 65, further comprising an axial shaft configured to rotate. in, The impeller is mounted on the axial shaft, and The main body of the inlet protective component is perpendicular to the axial shaft.

67. An apparatus comprising: Blood pump, the blood pump comprising: - A frame, the frame comprising a proximal portion, a central portion comprising multiple pole segments, and a distal portion; - An impeller configured to pump blood from the subject proximally, the impeller being disposed within the frame; - A pump outlet pipe, said pump outlet pipe being fixed to the proximal portion of the frame and to at least a portion of the central portion of the frame; and - Inlet protection element, the inlet protection element: -- Located on the far side of the impeller, -- Includes a body shaped to define one or more blood inlet openings configured to allow blood to pass through, and -- Includes multiple proximal flaps, which are connected to the pump outlet pipe and are at least partially fixed to the central portion of the frame without overlapping any of the rod segments.

68. The device according to claim 67, wherein, The proximal wing fits between the rod segments and is adjacent to the rod segments.

69. The device according to claim 67, wherein, The pump outlet pipe is configured to traverse the aortic valve of the subject, and wherein the impeller is configured to pump blood from the left ventricle of the subject's heart into the subject's aorta through the pump outlet pipe.

70. The device according to claim 67, wherein, The blood inlet opening is sized such that the inlet guard is configured to prevent the chordae tendineae, cardiac column, and papillary muscles of the left ventricle of the subject's heart from entering the frame.

71. The device according to claim 67, wherein, For each of the blood inlet openings, the span of the blood inlet opening in at least one direction is less than 1 mm.

72. The device according to claim 67, wherein, The area of ​​each of the blood inlet openings is 0.05 square millimeters to 5 square millimeters.

73. The device according to claim 67, wherein, The porosity of the inlet protection component is at least 40%.

74. The device according to claim 67, wherein, Each of the blood inlet openings is hexagonal.

75. The device according to claim 67, wherein, The distance between each pair of adjacent blood inlet openings is 0.01mm-0.1mm.

76. The device according to claim 67, wherein, The entrance guard is connected to the distal portion of the frame.

77. The device according to any one of claims 67-76, further comprising a liner that is laid over at least a portion of the central portion of the frame and connected to the inlet guard.

78. The device according to claim 77, wherein, The proximal wing is attached to the liner.

79. The device according to claim 77, wherein, The pump outlet pipe and the liner are thermally welded together, wherein the proximal wing is disposed between the pump outlet pipe and the liner.

80. The device according to claim 79, wherein, The proximal wing is shaped to define a plurality of wing openings, and wherein the pump outlet pipe and the liner are at least partially thermally welded to each other via the wing openings.

81. The device according to claim 79, wherein, The glass transition temperature of the inlet guard is higher than that of the liner and the pump outlet pipe, respectively.

82. The device according to claim 81, in, The liner is made of polyurethane. The pump outlet pipe is made of polyether block amide, and The inlet protective component is made of polyetheretherketone.

83. The device according to claim 81, in, The liner and the pump outlet pipe are made of the same or different types of polyurethane, and The inlet protective component is made of polyetheretherketone.

84. The device according to any one of claims 67-76, further comprising: An axial shaft, the axial shaft being configured to rotate; A radial support member configured to radially stabilize the axial shaft as it rotates; and A support housing that accommodates the radial support and is coupled to the frame on the distal side of the frame. The impeller is mounted on the axial shaft, and The inlet protection component is connected to the support housing.

85. The device according to claim 84, wherein, The inlet protection component includes multiple distal flaps, which are connected to the support housing.

86. The device according to any one of claims 67-76, in, The distal portion of the frame is truncated conical, and The main body of the entrance protection component is truncated conical and is fixed to the distal portion of the frame.

87. The device according to claim 86, wherein, The inlet protection component comprises rolled sheet material.

88. The device according to any one of claims 67-76, wherein, The main body of the entrance protection component is flat and is disposed within the frame.

89. The device of claim 88, further comprising an axial shaft configured to rotate. in, The impeller is mounted on the axial shaft, and The main body of the inlet protective component is perpendicular to the axial shaft.

90. An apparatus comprising: Blood pump, the blood pump comprising: - Framework; - A liner having a flexural modulus between 0.1 GPa and 2 GPa, and lining at least a portion of the frame; - An impeller configured to pump blood from a subject, the impeller being disposed within the frame; and - A pump outlet pipe having a flexural modulus between 0.1 GPa and 0.8 GPa, the pump outlet pipe being fixed to at least a portion of the frame and thermally welded to the liner. -- The melting temperatures of the lining and the pump outlet pipe differ from each other by less than 20°C.

91. The device according to claim 90, wherein, The liner and the pump outlet pipe are made of the same material, so that their melting temperatures are the same.

92. The device according to claim 90, wherein, The flexural modulus of the lining is between 0.1 GPa and 0.8 GPa.

93. The device according to claim 90, wherein, The flexural modulus of the lining is between 0.8 GPa and 2 GPa.

94. The device according to claim 90, wherein, The flexural modulus of the pump outlet pipe is between 0.1 GPa and 0.5 GPa.

95. The device according to claim 90, wherein, The liner is made of a first polymer, and the pump outlet pipe is made of a second polymer, wherein the first polymer and the second polymer belong to a single category of polymers.

96. The device according to claim 95, wherein, The first polymer and the second polymer are identical to each other.

97. The device according to claim 95, wherein, The first polymer and the second polymer are different polymers from each other.

98. The device according to claim 95, wherein, Both the first polymer and the second polymer are polyurethanes.

99. The device according to claim 90, wherein, The melting temperatures of the lining and the pump outlet pipe differ from each other by less than 10°C.

100. The device according to claim 99, wherein, The melting temperatures of the lining and the pump outlet pipe differ from each other by less than 5°C.

101. The device according to claim 100, wherein, The lining and the pump outlet pipe have the same melting temperature.

102. The device according to claim 90, wherein, The glass transition temperatures of the liner and the pump outlet pipe differ from each other by less than 20°C.

103. The device according to claim 102, wherein, The glass transition temperatures of the liner and the pump outlet pipe differ from each other by less than 10°C.

104. The device according to claim 103, wherein, The glass transition temperatures of the liner and the pump outlet pipe differ from each other by less than 5°C.

105. The device according to claim 104, wherein, The glass transition temperatures of the liner and the pump outlet pipe are the same.

106. An apparatus comprising: Blood pump, the blood pump comprising: - Framework; - A liner made of a first polymer with a flexural modulus between 0.1 GPa and 2 GPa, and lining at least a portion of the frame; - An impeller configured to pump blood from a subject, the impeller being disposed within the frame; and - A pump outlet pipe, said pump outlet pipe being made of a second polymer with a flexural modulus between 0.1 GPa and 0.8 GPa, said pump outlet pipe being fixed to at least a portion of the frame and thermally welded to the liner. -- The first polymer and the second polymer belong to a single category of polymers.

107. The device according to claim 106, wherein, The flexural modulus of the lining is between 0.1 GPa and 0.8 GPa.

108. The device according to claim 106, wherein, The flexural modulus of the lining is between 0.8 GPa and 2 GPa.

109. The device according to claim 106, wherein, The flexural modulus of the pump outlet pipe is between 0.1 GPa and 0.5 GPa.

110. The device according to claim 106, wherein, The first polymer and the second polymer are identical to each other.

111. The device according to claim 106, wherein, The first polymer and the second polymer are different polymers from each other.

112. The device according to claim 106, wherein, Both the first polymer and the second polymer are polyurethanes.

113. The device according to claim 106, wherein, The melting temperatures of the lining and the pump outlet pipe differ from each other by no more than 20°C.

114. The device according to claim 113, wherein, The melting temperatures of the lining and the pump outlet pipe differ from each other by less than 10°C.

115. The device according to claim 114, wherein, The melting temperatures of the lining and the pump outlet pipe differ from each other by less than 5°C.

116. The device according to claim 115, wherein, The lining and the pump outlet pipe have the same melting temperature.

117. The device according to claim 106, wherein, The glass transition temperatures of the liner and the pump outlet pipe differ from each other by less than 20°C.

118. The device according to claim 117, wherein, The glass transition temperatures of the liner and the pump outlet pipe differ from each other by less than 10°C.

119. The device according to claim 118, wherein, The glass transition temperatures of the liner and the pump outlet pipe differ from each other by less than 5°C.

120. The device according to claim 119, wherein, The glass transition temperatures of the liner and the pump outlet pipe are the same.

Images