Intravascular blood pumps and methods of manufacture and use

Abstract

To provide a catheter blood pump realizing additional improvements in the field of ventricular support devices and blood pumps for treating compromised cardiac blood flow.SOLUTION: A catheter blood pump includes an expandable pump portion 1600 extending distally from an elongate shaft 1610. The pump portion 1600 includes an expandable impeller housing including an expandable blood conduit that defines a blood lumen between an inflow and an outflow. The pump portion includes one or more expandable impellers 1606, 1616 disposed at least partially within the blood lumen.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] Incorporation by Reference

[0001] This application claims priority to U.S. Provisional Patent Application No. 62 / 873,722, filed July 12, 2019, U.S. Provisional Patent Application No. 62 / 873,736, filed July 12, 2019, and U.S. Provisional Patent Application No. 62 / 881,176, filed July 31, 2019, all of which are incorporated herein by reference for all purposes.

[0002]

[0002] This application is related to WO2018 / 226991, WO2019 / 094963, WO2019 / 152875, and WO2020 / 028537, the disclosures of which are incorporated herein by reference for all purposes.

[0003]

[0003] All publications and patent applications mentioned in this specification are incorporated by reference herein to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference. [Background technology]

[0004]

[0004] Patients with cardiac disease may have a significantly reduced ability to carry blood through the heart and vasculature, which may pose significant risks during corrective procedures such as balloon angioplasty and stent delivery. There is a need for techniques to improve cardiac outflow volume or stability in these patients, particularly during corrective procedures.

[0005]

[0005] Intra-aortic balloon pumps (IABPs) are commonly used to support circulatory function, such as in treating patients with heart failure. The use of IABPs is common in treating patients with heart failure, such as supporting patients during high-risk percutaneous coronary intervention (HRPCI), stabilizing a patient's blood flow after cardiogenic shock, treating patients suffering from acute myocardial infarction (AMI), or treating decompensated heart failure. Such circulatory support can be utilized alone or in conjunction with pharmacological therapy.

[0006]

[0006] An IABP is typically placed in the aorta and functions by being inflated and deflated in a counter-pulsatile fashion relative to cardiac contraction, one of its functions being to provide additional support to the circulatory system. Summary of the Invention [Problem to be solved by the invention]

[0007]

[0007] More recently, minimally invasive rotary blood pumps have been developed that can be inserted into the body and connected to the cardiac system, such as to pump arterial blood from the left ventricle into the aorta to enhance the natural pumping capacity of the left side of a patient's heart. Another known method is to pump venous blood from the right ventricle to the pulmonary artery to enhance the natural pumping capacity of the right side of a patient's heart. The overall purpose is to reduce the workload of a patient's cardiac muscle and stabilize the patient, such as during a medical procedure that may place additional stress on the heart, to stabilize the patient before a heart transplant, or to provide continuous support to the patient.

[0008]

[0008] The smallest rotary blood pumps currently available can be inserted percutaneously into a patient's vasculature through an access sheath or through a vascular access graft to avoid the need for surgical intervention. The term for this type of device is a percutaneously inserted ventricular assist device.

[0009]

[0009] Additional improvements need to be achieved in the field of ventricular assist devices and similar blood pumps for treating reduced cardiac blood flow. [Means for solving the problem]

[0010]

[0010] One aspect of the present disclosure is a catheter blood pump having an expandable pump portion extending distally from an elongate shaft, the pump portion having an expandable impeller housing having an expandable blood conduit defining a blood lumen between an inlet and an outlet, one or more expandable impellers each positioned at least partially within the blood lumen, a sensor wire affixed to the expandable impeller housing and extending from a proximal end of the expandable impeller housing to a distal end of the expandable impeller housing, and a sensor coupled to the sensor wire and positioned distal to the distal end of the expandable blood conduit.

[0011] In this aspect, the sensor wire may be secured to the expandable impeller housing so as to be positioned radially outward of the expandable blood conduit.

[0012] In this embodiment, the sensor wire can be secured relative to the expandable impeller housing so that it does not float within the sensor wire lumen.

[0012]

[0013] In this aspect, a sensor wire may be disposed within the sensor wire lumen, and the sensor wire may be sized relative to the sensor wire lumen so as to float within the sensor wire lumen. The sensor wire lumen may be defined by an inner surface of an elongated hollow shaft, and the elongated hollow shaft may be secured to the expandable impeller housing. The elongated hollow shaft has a circular cross-sectional configuration. The catheter blood pump may further include an overlay disposed around the elongated hollow shaft, the overlay being arranged to secure the elongated hollow shaft to the expandable impeller housing. The overlay may include one or more types of material different from the material of the elongated hollow shaft. The overlay material may have at least one property different from a component of the expandable impeller housing radially within and adjacent to the elongated hollow shaft. The radially inner component may have a higher or lower stiffness than the overlay. The radially inner component may include a membrane of the expandable impeller housing.

[0013]

[0014] In this embodiment, the sensor wire lumen may be defined by one or more polymeric materials.

[0015] In this aspect, the sensor wire lumen can have a radially outer surface defined by the overlay.

[0014]

[0016] In this aspect, the sensor wire lumen can have a radially inner surface defined by an overlay or by a component of the expandable impeller housing, such as a membrane.

[0015]

[0017] In this aspect, the sensor wire lumen may be at least partially defined by a protrusion that protrudes radially outward from the generally circular cross-sectional profile of the expandable impeller housing.

[0016]

[0018] In this aspect, the sensor wire may extend in a helical configuration around at least a portion of the expandable impeller housing, optionally along the entire length of the expandable impeller housing.

[0017]

[0019] In this aspect, the sensor wire may extend in a linear configuration along at least a portion of the expandable impeller housing, optionally along the entire length of the expandable impeller housing.

[0018]

[0020] In this aspect, the sensor wire can extend in a helical configuration around a portion of the expandable impeller housing and in a linear configuration along at least a portion of the expandable impeller housing.

[0019]

[0021] In this embodiment, a sensor wire can extend proximally from the expandable impeller housing and can be in communication with a proximal region of the blood pump that is arranged to remain external to the patient when the impeller is operated. In this embodiment, the sensor wire can be an optical fiber.

[0020]

[0022] In this aspect, the sensor may be affixed to an expandable distal strut at the pump inflow, the distal strut extending distally to the distal end of the expandable blood conduit.

[0023] In this aspect, the sensor may be affixed to the radially outer surface of the expandable distal strut.

[0021]

[0024] In this embodiment, the sensor wire may be further anchored to the distal strut proximal to the sensor, and the sensor wire may be linearly aligned with the distal strut.

[0025] In this embodiment, the sensor wire lumen may be anchored to the distal strut proximal to the sensor, with the sensor wire disposed within the sensor wire lumen.

[0022]

[0026] In this embodiment, the sensor wire can be anchored to the proximal expandable strut, which extends proximally from the proximal end of the blood conduit. The sensor wire can follow the shape of the proximal strut.

[0023]

[0027] This embodiment may further comprise a sensor wire lumen in which the sensor wire is disposed, the sensor wire lumen may be anchored to the proximal expandable strut, and optionally the sensor wire lumen follows the shape of the proximal strut.

[0024]

[0028] In this embodiment, the expandable impeller housing can have one or more scaffold sections.

[0029] In this aspect, the expandable impeller housing can have greater stiffness in the proximal and distal impeller sections than in a central section between the distal and proximal impeller sections. The blood pump can further include a distal impeller within the distal impeller section and a proximal impeller within the proximal impeller section.

[0025]

[0030] In this embodiment, the sensor may be affixed such that the pressure sensitive area is optionally between 1 and 89 degrees relative to the longitudinal axis, for example between 5 and 85 degrees, 10 and 80 degrees.

[0026]

[0031] In this embodiment, the sensor wire may be secured to the expandable impeller housing, but may still move to some extent relative to the expandable impeller housing even when fixed relative to the expandable impeller housing.

[0027]

[0032] In this aspect, the sensor wire lumen may be connected to a source of inflation fluid such that the sensor wire lumen is inflatable, and the inflatable sensor wire lumen may have a closed distal end.

[0028]

[0033] One aspect of the present disclosure is a method of manufacturing a pump portion of an intravascular blood pump, the method including: creating a tubular substrate layer that directly or indirectly defines at least a portion of the blood lumen of the pump portion; disposing an elongated hollow shaft over and extending along at least a portion of the tubular substrate layer; and optionally applying an overlay over the elongated shaft along the entire length of the elongated shaft.

[0029]

[0034] In this embodiment, creating the tubular substrate layer includes depositing a softened polymeric material onto a mandrel and allowing the softened polymeric material to cool.

[0035] In this aspect, positioning the elongate hollow shaft over and extending along at least a portion of the tubular substrate layer includes positioning the elongate hollow shaft to have one or more linear sections, optionally wherein the elongate hollow shaft further has one or more helical sections.

[0030]

[0036] In this aspect, applying the overlay may include applying a softened thermoplastic material over the elongate hollow shaft.

[0037] This aspect may further include disposing the sensor wires radially outward of the substrate, optionally in a radial overlay.

[0031]

[0038] This embodiment can include removing the elongate hollow shaft after applying the overlay to create the sensor wire lumen.

[0039] This aspect may further include removing the elongate hollow shaft before radially disposing the sensor wire within the overlay.

[0032]

[0040] In this aspect, disposing the sensor wire can include disposing the sensor wire within an elongate hollow shaft.

[0041] This aspect can further include affixing a sensor to the pump portion, the sensor being coupled to a sensor wire. Attaching the sensor can include affixing the sensor to a strut, such as one or both of a proximal strut or a distal strut, extending axially from the end of the blood conduit.

[0033]

[0042] This embodiment may further include anchoring the sensor wire lumen to one or both of the proximal or distal struts, the struts extending axially from the blood conduit.

[0034]

[0043] This embodiment may further include affixing a second sensor to the blood pump, the second sensor being located at or near the outflow of the pump portion.

[0044] This embodiment can further include affixing a tubular substrate layer to any one or more of the expandable scaffolds or expandable members herein, either of which can provide radial support for the blood conduit.

[0035]

[0045] One aspect of the present disclosure is a catheter blood pump, the catheter blood pump comprising an expandable pump portion extending distally from an elongate shaft, the pump portion having an expandable impeller housing having an expandable blood conduit defining a blood lumen between an inlet and an outlet, and a fluid pathway in fluid communication with the expandable impeller housing extending proximally from the expandable impeller housing. an expandable portion positioned and configured to provide radial support to the blood conduit when the expandable portion is inflated, and one or more expandable impellers each positioned at least partially within a blood lumen adapted to move blood through the blood conduit.

[0036]

[0046] This embodiment can further include a fluid source spaced proximally from the expandable housing, such that the fluid source remains outside the body when the expandable housing is at the target location, and the fluid source is in fluid communication with the fluid pathway. The fluid source herein can be adapted to deliver fluid therefrom manually or automatically, or both.

[0037]

[0047] In this aspect, the blood conduit may be adapted and configured such that expansion of the expandable portion at least partially expands the blood conduit.

[0048] In this aspect, the expandable portion may be configured and positioned relative to the blood conduit such that, when expanded, the expandable portion provides greater radial support to the blood conduit at the location of the one or more impellers compared to areas of the blood conduit adjacent the one or more impellers.

[0038]

[0049] In this aspect, the expandable impeller housing can include two or more inflatable portions that, when inflated, can be configured and positioned relative to the blood conduit to provide greater radial support to the blood conduit at the location of the one or more impellers than the two or more inflatable portions, relative to regions of the blood conduit adjacent to the one or more impellers, The adjacent regions can be central regions of the expandable impeller housing, optionally between the impeller regions.

[0039]

[0050] In this aspect, the expandable portion can have an annular configuration in at least one section of the expandable portion. The expandable portion can have two or more axially spaced annular sections.

[0040]

[0051] One aspect of the present disclosure is a method of deploying a pump portion of a catheter blood pump within a subject's body, the method including: exposing an expandable impeller housing from within a delivery device, the expandable impeller housing having an expandable blood conduit and an inflatable portion positioned along at least a portion of the expandable blood conduit; exposing the impeller from within the delivery device such that the impeller is at least partially within the conduit and optionally at least partially expanding the impeller; delivering fluid from a fluid source positioned outside the subject's body along an inflation path into the inflatable portion; inflating the inflatable portion; and radially supporting the blood conduit using the inflated inflatable portion. [Brief explanation of the drawings]

[0041] [Figure 1]

[0052] 1 is a side view of an exemplary expandable pump portion having an expandable impeller housing, a blood conduit, and multiple impellers. FIG. [Figure 2]

[0053] FIG. 1 is a side view illustrating an exemplary expandable pump portion having an expandable impeller housing, a blood conduit, multiple impellers, and multiple expandable support members. [Figure 3A]

[0054] 1 illustrates an exemplary expandable pump portion having a blood conduit, multiple impellers, and multiple expandable members. [Figure 3B] 1 illustrates an exemplary expandable pump portion having a blood conduit, multiple impellers, and multiple expandable members. [Figure 3C] 1 illustrates an exemplary expandable pump portion having a blood conduit, multiple impellers, and multiple expandable members. [Figure 3D] 1 illustrates an exemplary expandable pump portion having a blood conduit, multiple impellers, and multiple expandable members. [Figure 4]

[0055] 1A-1C illustrate exemplary target locations of a blood conduit, multiple expandable members, and an expandable pump portion having multiple impellers. [Figure 5]

[0056] 1A and 1B show an exemplary pump portion having an expandable impeller housing, a blood conduit, and multiple impellers. [Figure 6A]

[0057] FIG. 1 illustrates at least a portion of an exemplary catheter blood pump having a pump section in which at least two different impellers can be rotated at different speeds. [Figure 6B]

[0058] FIG. 1 illustrates at least a portion of an exemplary catheter blood pump having a pump section in which at least two different impellers can be rotated at different speeds. [Figure 6C]

[0059] FIG. 6C illustrates at least a portion of an exemplary catheter blood pump having a pump portion with at least two impellers having different pitches. [Figure 7]

[0060] 1 illustrates at least a portion of an exemplary catheter blood pump having a pump portion. [Figure 8]

[0061] 10A-10C illustrate an example expandable pump section having multiple expandable impellers with one or more bends formed therein between adjacent impellers. [Figure 9]

[0062] 1 illustrates an exemplary expandable pump portion with multiple impellers and blood conduits. [Figure 10A]

[0063] 1A-1C illustrate an exemplary sequence of steps that may be performed to deploy an exemplary pump portion of a catheter blood pump. [Figure 10B] 1A-1C illustrate an exemplary sequence of steps that may be performed to deploy an exemplary pump portion of a catheter blood pump. [Figure 10C] 1A-1C illustrate an exemplary sequence of steps that may be performed to deploy an exemplary pump portion of a catheter blood pump. [Figure 10D] 1A-1C illustrate an exemplary sequence of steps that may be performed to deploy an exemplary pump portion of a catheter blood pump. [Figure 10E] 1A-1C illustrate an exemplary sequence of steps that may be performed to deploy an exemplary pump portion of a catheter blood pump. [Figure 10F] 1A-1C illustrate an exemplary sequence of steps that may be performed to deploy an exemplary pump portion of a catheter blood pump. [Figure 11]

[0064] FIG. 10 is a side view of an exemplary pump portion having a sensor wire. [Figure 12]

[0065] FIG. 10 is a cross-sectional view of an exemplary expandable impeller housing with a sensor wire secured to the expandable impeller housing. [Figure 13]

[0066] FIG. 10 is a cross-sectional view illustrating an exemplary expandable impeller housing having a sensor wire disposed within the sensor wire lumen. [Figure 14]

[0067] FIG. 10 is a cross-sectional view illustrating an exemplary expandable impeller housing having a sensor wire disposed within the sensor wire lumen. [Figure 15]

[0068] FIG. 10 is a cross-sectional view illustrating an exemplary expandable impeller housing having a sensor wire disposed within the sensor wire lumen. [Figure 16]

[0069] FIG. 10 is a side view of an exemplary pump portion having a sensor wire carried by and outside the expandable impeller housing, the pump portion having a sensor coupled to the sensor wire. [Figure 17]

[0070] 1A-1C illustrate exemplary steps in an exemplary method of manufacturing a pump portion. [Figure 18A]

[0071] 10A-10C illustrate an exemplary expandable pump portion with the expandable portion in a non-inflated configuration. [Figure 18B]

[0072] 1A-1C illustrate an exemplary expandable portion in an expanded state or configuration. [Figure 19A]

[0073] 10A-10C illustrate example method steps in manufacturing an example inflatable portion. [Figure 19B] 10A-10C illustrate example method steps in manufacturing an example inflatable portion. [Figure 20]

[0074] FIG. 10 is a side view of an exemplary pump section having one or more inflatable sections that provide radial support for an expandable impeller housing. [Figure 21]

[0075] FIG. 1 is a perspective view of an exemplary pump portion having one or more expandable portions that provide radial support to a blood conduit. [Figure 22A]

[0076] FIG. 1 is a perspective view of an exemplary pump portion having one or more expandable portions that provide radial support to a blood conduit. [Figure 22B]

[0077] FIG. 10 is a side view of an exemplary pump portion having one or more expandable portions that provide radial support to a blood conduit. [Figure 22C]

[0078] 1 is an end view of an exemplary pump portion having one or more expandable portions that provide radial support to a blood conduit. FIG. [Figure 23]

[0079] FIG. 1 illustrates an exemplary catheter blood pump. [Figure 24]

[0080] 1A-1C illustrate an exemplary collapsed delivery configuration of the pump portion of an exemplary catheter blood pump. [Figure 25A]

[0081] FIG. 10 is a perspective view showing a pump portion in an expanded state having one or more inflatable portions. [Figure 25B]

[0082] FIG. 25B shows the proximal region of the pump portion of FIG. 25A. [Figure 25C]

[0083] FIG. 25B shows the distal region of the pump portion of FIG. 25A. DETAILED DESCRIPTION OF THE INVENTION

[0042]

[0084] The present disclosure relates to medical devices, systems, and methods of use and manufacture. The medical devices herein can have a pump portion (which may also be referred to herein as an working portion) adapted to be placed within a physiological vessel, the pump portion having one or more components configured to act on a fluid. For example, the pump portion herein can have one or more rotating members that, when rotated, promote the movement of a fluid, such as blood, through a blood lumen defined by an impeller housing.

[0043]

[0085] Any disclosure of the present specification relating to an aspect of a system, a device, or a method of use or manufacture may be incorporated into any other appropriate disclosure of the present specification. For example, a diagram illustrating only one aspect of a device or method may be included in other embodiments even if not specifically mentioned in the description of one or any part of the present disclosure. Therefore, it should be understood that the present specification includes combinations of different parts of the present disclosure unless otherwise specified.

[0044]

[0086] FIG. 1 is a side view illustrating the distal portion of an exemplary catheter blood pump having an expandable pump portion 1600. The pump portion 1600 has a proximal impeller 1606 and a distal impeller 1616, both of which are operably connected to a drive mechanism 1612. In FIG. 1, the pump portion 1600 is shown in an expanded configuration and is adapted to collapse into a delivery configuration so that it can be delivered with a low profile. The impellers may be attached to the drive mechanism 1612. The drive mechanism 1612 (e.g., a drive cable) is operably connected to an external motor (not shown) and extends through an elongated shaft 1610. The phrases "pump portion" and "working portion" (or derivatives thereof) may be used interchangeably herein unless otherwise indicated. For example, without limitation, any working portion of the working portions herein is understood to be a pump portion.

[0045]

[0087] The pump portion 1600 includes an expandable support member 1602, which in this embodiment has a proximal end 1620 that extends proximally beyond the proximal end of the proximal impeller 1606 and a distal end 1608 that extends distally beyond the distal end of the distal impeller 1616. An expandable member 1602 is disposed radially outward of the impeller along the axial length of the impeller. The expandable member 1602 may be constructed in a manner similar to, and made from materials similar to, many types of expandable structures known in the medical arts so as to be collapsible and expandable. Examples of these approaches or methods are provided herein. Examples of suitable materials include, but are not limited to, polyurethane and polyurethane elastomers.

[0046]

[0088] The pump portion 1600 further includes an expandable blood conduit 1604, which is coupled to the expandable member 1602, has a length L, and extends axially between the impellers. Herein, the blood conduit may simply be referred to as a conduit. The conduit 1604 forms and provides a fluid lumen between the two impellers. During use, blood travels through the lumen defined by the conduit 1604. The conduits herein may be impermeable, or may be semi-permeable or even porous, so long as they are capable of defining a lumen. Also, unless otherwise specified, the conduits herein are flexible. The conduits herein extend completely (i.e., 360 degrees) around at least a portion of the pump portion. Within the pump portion 1600, the conduit extends completely around the expandable member 1602, but does not extend to the proximal or distal ends 1602, 1608 of the expandable member 1602. The structure of the expandable member creates at least one inlet aperture to allow inflow "I" and at least one outlet aperture to allow outflow "O." The conduit 1604 improves the dynamics of impeller pumping compared to a similar pump section 1600 without the conduit.

[0047]

[0089] The expandable support member 1602 can have a variety of configurations and can be made from a variety of materials. For example, the expandable member 1602 can be formed like an expandable stent or stent-like device, or like any other example provided herein. For example, but not limited to, the expandable member 1602 can be formed like a 24-end mesh. The expandable member 1602 may have an open braided configuration, such as a woven braid. However, more or fewer braided wires may be used. Exemplary materials for the expandable member include nitinol, cobalt alloys, and polymers. However, other materials may be used. The expandable member 1602 has an expanded configuration as shown, where the outermost dimension of the expandable member (measured perpendicular to the longitudinal axis of the working portion) is greater at least in the region where the expandable member is disposed radially outward of the impellers than the outermost dimension of a central region 1622 of the expandable member that extends axially between the impellers. The drive cable 1612 is coaxial with the longitudinal axis in this embodiment. In use, the central region may be positioned to span a valve, such as the aortic valve. In some embodiments, the expandable member 1602 is adapted and constructed to expand to an outermost dimension of 12-24F (4.0-8.0 mm) where the impellers are axially located within the expandable member, and to an outermost dimension of 10-20F (3.3-6.7 mm) in the central region 1622 between the impellers. The smaller outer dimension in the central region can reduce forces acting on the valve, thereby reducing or minimizing damage to the valve. The larger dimension of the expandable member in the impeller region can help stabilize the working portion axially during use. The expandable member 1602 has a general dumbbell configuration. The expandable member 1602 has an outer configuration that tapers from the impeller region to the central region 1622 and also tapers at the distal and proximal ends of the expandable member 1602.

[0048]

[0090] The expandable member 1602 has a proximal end 1620 coupled to a shaft 1610 and a distal end 1608 coupled to a distal tip 1624. An impeller and drive cable 1612 rotates within the expandable member and conduit assembly. The drive cable 1612 is axially stabilized relative to the distal tip 1624 but is free to rotate relative to the distal tip 1624.

[0049]

[0091] In some embodiments, the expandable member 1602 can be collapsed by pulling tension across the expandable member. This can include a linear movement that stretches the expandable member 1602 axially (e.g., but not limited to, moving 5-20 mm) until the expandable member 1602 assumes a collapsed configuration with the collapsed outer dimensions. The expandable member 1602 can also be collapsed by pushing an outer shaft, such as a sheath, over the expandable member / conduit assembly, thereby collapsing the expandable member and conduit into a collapsed delivery configuration.

[0050]

[0092] Impellers 1606 and 1616 are also adapted and constructed to stretch or radially compress one or more blades to a reduced outermost dimension (measured perpendicular to the longitudinal axis of the working portion). For example, without limitation, any of the impellers herein can have one or more blades made from a plastic compound with spring properties, such as any of the impellers described in U.S. Pat. No. 7,393,181. The disclosure of U.S. Pat. No. 7,393,181 is incorporated herein by reference and may be incorporated into embodiments herein unless otherwise indicated by this disclosure. Alternatively, for example, one or more foldable impellers can comprise a superelastic wire frame with a polymer or other material acting as webbing that intersects the wire frame, such as a wire frame as described in U.S. Pat. No. 6,533,716, the disclosure of which is incorporated herein by reference.

[0051]

[0093] The inflow and / or outflow configuration of the pump section 1600 may be predominantly axial in nature.

[0094] Exemplary sheathing and unsheathing techniques and concepts for folding and expanding medical devices are known, such as those described and shown in U.S. Pat. No. 7,841,976 or U.S. Pat. No. 8,052,749, the disclosures of which are incorporated herein by reference.

[0052]

[0095] 2 is a side view illustrating a deployed configuration (shown outside the body) of a distal portion of an exemplary embodiment of a catheter blood pump. The exemplary blood pump 1100 has an expandable pump portion 1104 and an elongated portion 1106 extending proximally from the pump portion 1104. The elongated portion 1106 may extend to a more proximal region of the system, not shown for simplicity, which may include, for example, a motor that rotates one or more impellers. The pump portion 1104 has a first expandable member 1108 and a second expandable member 1110 that are axially spaced apart along the longitudinal axis LA of the pump portion 1104. Axially spaced apart in this context means that the entire first expandable member is axially spaced apart from the entire second expandable member along the longitudinal axis LA of the pump portion 1104. A first end 1122 of the first expansible member 1108 is axially spaced from a first end 1124 of the second expansible member 1110 .

[0053]

[0096] The first expandable member 1108 and the second expandable member 1110 each generally have a plurality of elongated segments arranged relative to one another to define a plurality of apertures 1130. Only one aperture of the plurality of apertures 1130 in the second expandable member 1110 is labeled with a reference numeral. The expandable members can have a wide variety of configurations and can be constructed in a wide variety of ways, such as, but not limited to, any of the configurations or constructions in U.S. Pat. No. 7,841,976 or as described in U.S. Pat. No. 6,533,733, or as self-expanding metallic endoprosthetic materials. No. 16 tubing, etc. For example, and without limitation, one or both of the expansible members can have a braided configuration or can be formed at least in part by laser cutting a tubular element.

[0054]

[0097] The pump portion 1104 further includes an expandable blood conduit 1112 coupled to the first and second expandable support members 1108 and 1110 and extending axially between the first and second expandable members in the deployed configuration. A central region 1113 of the conduit 1112 spans an axial distance 1132, where the pump portion does not include the first and second expandable members 1108 and 1110. The central region 1113 may be considered to be axially between the expandable members. The distal end 1126 of the conduit 1112 does not extend distally as far as the distal end 1125 of the second expandable member 1110, and the proximal end 1128 of the conduit does not extend proximally as far as the proximal end 1121 of the first expandable member 1108.

[0055]

[0098] When the disclosure herein refers to a conduit coupled to an expandable member, the term coupled in this context does not require that the conduit be directly attached to the expandable member such that the conduit physically contacts the expandable member. However, even if not directly attached, the term coupled in this context means that the conduit and the expandable member are joined together such that the conduit will also begin to transition to a different configuration and / or size as the expandable member expands or collapses. Thus, coupled in this context means that the conduit will move when the expandable member to which it is coupled transitions between its expanded and collapsed configurations. In some descriptions, a conduit may be described as including one or more expandable support members.

[0056]

[0099] Any of the conduits herein may be deformable to some extent, allowing the conduit to collapse for delivery to a target location. For example, the conduit 1112 has an elongate member 1120 that may be made of one or more materials that allow a central region 1113 of the conduit to deform radially inward (toward the LA) to some extent when the working portion 1104 is deployed toward the configuration shown in FIG. 2 , e.g., in response to forces from the valve tissue (e.g., leaflets) or replacement valve during use. In some embodiments, the conduit may be stretched rigidly between the expandable members. Alternatively, the conduit may be designed with slack to improve compliance. This may be desirable when the working portion is positioned across a fragile structure, such as the aortic valve, allowing the valve to compress the conduit in a manner that minimizes point stresses within the valve. In some embodiments, the conduit may have a membrane attached to the proximal and distal expandable members. Exemplary materials that may be used for any of the conduits herein include, but are not limited to, polyurethane rubber, silicone rubber, acrylic rubber, expanded polytetrafluoroethylene, polyethylene, polyethylene terephthalate, including any combination thereof.

[0057]

[0100] Any of the conduits herein can have a thickness of 127 to 508 μm (5 to 20 thousandths of an inch (thou)), for example, from 25.4 μm (1 thou) to 381 μm (15 thou), from 38.1 μm (1.5 thou) to 381 μm (15 thou), from 38.1 μm (1.5 thou) to 254 μm (10 thou), or from 50.8 μm (2 thou) to 254 μm (10 thou).

[0058]

[0101] Any of the conduits herein, or at least a portion of a conduit, may be impermeable to blood. In Figure 2, pump portion 1104 has a lumen that extends from distal end 1126 of conduit 1112 to proximal end 1128 of conduit 1112. This lumen The lumen is defined by the conduit 1112 in the central region 1113, but may be considered to be defined by both the conduit and a portion of the expandable member in the region axially adjacent to the central region 1113. However, in this embodiment, it is the material of the conduit that causes the lumen to exist, and the material of the conduit also prevents blood from passing through the conduit.

[0059]

[0102] Any of the conduits herein secured to one or more expandable members, unless otherwise indicated, may be secured such that the conduit is disposed radially outward of the one or more expandable members, or radially inward of the one or more expandable members, or both, and the expandable members may be filled with the conduit material.

[0060]

[0103] In some embodiments including multiple expandable support members, the proximal and distal expandable members provide radial support and help maintain the conduit in an open configuration to create a blood lumen, while also creating an operating environment for the impellers, as described below. In the deployed configuration, each of the expandable members is maintained in a spaced-apart relationship with respect to its respective impeller, allowing the impellers to rotate within the expandable member without contacting the expandable member. The pump section 1104 has a first impeller 1116 and a second impeller 1118, with the first impeller 1116 radially disposed within the first expandable member 1108 and the second impeller 1118 radially disposed within the second expandable member 1110. In this embodiment, the two impellers, although separate and distinct, are operably connected to a common drive feature (e.g., drive cable 1117) such that the two impellers rotate in unison when the drive feature is actuated. In this deployed configuration, impellers 1116 and 1118 are axially spaced apart along longitudinal axis LA just as expansible members 1108 and 1110 are axially spaced apart.

[0061]

[0104] Impellers 1116 and 1118 also reside axially within the ends of expandable members 1108 and 1110, respectively (in addition to being radially within expandable members 1108 and 1110). Impellers herein may be considered to reside axially within the expandable members even if the expandable members have struts (e.g., struts that are tapered in side view) that extend from a central region of the expandable member toward the longitudinal axis of the working portion. In FIG. 2, second expandable member 1110 extends from a first end 1124 (proximal end) to a second end 1125 (distal end).

[0062]

[0105] In Figure 2, a distal portion of impeller 1118 extends distally beyond a distal end 1126 of conduit 1112, and a proximal portion of impeller 1116 extends proximally beyond a proximal portion 1128 of conduit 1112. In this illustration, a portion of each impeller resides axially within the conduit in this deployment configuration.

[0063]

[0106] In the exemplary embodiment shown in FIG. 2 , the impellers 1116 and 1118 are operably connected to a common drive feature 1117; in this embodiment, each of the impellers is coupled to a drive mechanism 1117 that extends through the shaft 1119 and the working portion 1104. The drive feature 1117 may be, for example, an elongated drive cable that, when rotated, also rotates the impellers. In this example, as shown, the drive mechanism 1117 extends to the distal tip 1114 and is axially fixed relative to the distal tip 1114, but the drive mechanism 1117 is also adapted to rotate relative to the distal tip 1114 upon actuation. Thus, in this embodiment, when the drive mechanism 1117 rotates, the impellers and drive mechanism 1117 rotate in unison. Any number of known mechanisms may be used to rotate the drive features, such as mechanisms that use a motor (e.g., an external motor).

[0064]

[0107] The expandable member and conduit are not connected to the impeller and drive mechanism in a manner that allows for rotational movement. In this embodiment, the proximal end 1121 of the proximal expandable member 1108 The proximal expandable member 1108 is coupled to a shaft 1119, which may be the shaft of the elongated portion 1106 (e.g., an outer catheter shaft). A distal end 1122 of the proximal expandable member 1108 is coupled to a central tubular member 1133, through which the drive mechanism 1117 extends. The central tubular member 1133 extends distally from the proximal expandable member 1108 within the conduit 1112 and is coupled to the proximal end 1124 of the distal expandable member 1110. Thus, the drive mechanism 1117 rotates within and relative to the central tubular member 1133. The central tubular member 1133 extends axially from the proximal expandable member 1108 to the distal expandable member 1110. A distal end 1125 of the distal expandable member 1110 is coupled to the distal end 1114 as shown. The drive mechanism 1117 is adapted to rotate relative to the tip 1114 but is axially fixed relative to the tip 1114 .

[0065]

[0108] The working portion 1104 is adapted and configured to collapse to a smaller profile than its deployed configuration (shown in FIG. 2). This allows the working portion 1104 to be delivered using a lower profile delivery device (smaller French size) than would be necessary if the working portion 1104 were not collapsible. Even if not specifically described herein, any expandable member and impeller may be adapted and configured to be collapsible to some degree to a smaller delivery configuration.

[0066]

[0109] The working portion herein can be collapsed into a collapsed delivery configuration using conventional techniques, such as those using an outer sheath that is movable relative to the working portion (e.g., by axially moving one or both of the sheath and the working portion). For example, but not limited to, any of the systems, devices, or methods shown in the following references can be used to facilitate collapsing the working portion herein: U.S. Patent No. 7,841,976 or U.S. Patent No. 8,052,749, the disclosures of which are incorporated herein by reference.

[0067]

[0110] Figures 3A-3E show an exemplary working portion similar in some respects to the working portion shown in Figure 2. Working portion 340 is similar to working portion 1104 in that it has two expandable members that are axially spaced apart from one another when the working portion is expanded, and a conduit extending between the two expandable members. Figure 3A is a perspective view, Figure 3B is a side cross-sectional view, and Figures 3C and 3D are enlarged side cross-sectional views of the cross-section of the view of Figure 3B.

[0068]

[0111] The working portion 340 has a proximal impeller 341 and a distal impeller 342, which are coupled and operably connected to a drive cable, which defines a lumen therein. The lumen can be sized to accommodate a guidewire that can be used to deliver the working portion to a desired location. The drive cable, in this embodiment, has a first section 362 (e.g., a coiled material), a second section 348 (e.g., a tubular member) that couples the proximal impeller 341, a third section 360 (e.g., a coiled material), and a fourth section 365 (e.g., a tubular member) that couples the distal impeller 342. All of these drive cable sections have the same inner diameter, resulting in a constant lumen diameter. These drive cable sections can be secured to one another using known attachment techniques. The distal end of the fourth section 365 extends to a distal region of the working portion, thereby allowing the working portion to be advanced, for example, over a guidewire, to position the working portion. In this embodiment, the second and fourth sections may have a higher stiffness than the first and third sections. For example, the second and fourth sections may be tubular, and the first and third sections may be of rolled material to reduce stiffness.

[0069]

[0112] Working portion 340 has proximal and distal expandable members 343 and 344, each extending radially outward from one of the impellers. The expandable members have distal and proximal ends that may extend axially beyond the distal and proximal ends of the impellers, as can be seen in FIGS. 3B-3D . A conduit 356 is coupled to the two expandable members, the conduit 356 having proximal and distal ends 353 and 352. Each of the two expandable members has a plurality of proximal and distal struts. The proximal struts in proximal expandable member 343 extend to and are secured to shaft section 345, which is coupled to bearing 361, through which a drive cable extends and is configured and dimensioned to rotate. The distal struts of the proximal expandable member 343 extend to and are anchored to a proximal region (in this case, the proximal end) of the central tubular member 346, with the central tubular member 346 axially disposed between the expandable members. The proximal end of the central tubular member 346 is coupled to a bearing 349, as shown in FIG. 3C, through which a drive cable extends and rotates. The proximal struts of the distal expandable member 344 extend to and are anchored to a distal region (in this case, the distal end) of the central tubular member 346. Furthermore, a bearing 350 is coupled to the distal region of the central tubular member 346, as shown in FIG. 3D. The drive cable extends through and rotates relative to the bearing 350. The distal struts of the distal expandable member extend to and are fixed to shaft section 347 (see FIG. 3A), which may be considered part of the distal end. Shaft section 347 is coupled to bearing 351 (see FIG. 3D), through which the drive cable extends and rotates relative to bearing 351. The distal tip further includes bearing 366 (see FIG. 3D), which may be a thrust bearing. Although not explicitly included in this description, working portion 340 may be similar or equivalent to working portion 1104 in some respects.In this embodiment, conduit 356 extends at least as far as the end of the impeller, as opposed to working portion 1104. Either embodiment can be modified to extend the conduit to the positions described in other embodiments. In some embodiments, section 360 can be a tubular section instead of being coiled.

[0070]

[0113] In alternative embodiments, at least a portion of any of the impellers herein extends outside the fluid lumen. For example, only a portion of the impeller may extend proximally or distally beyond the end of the fluid lumen. In some embodiments, the portion of the impeller that extends outside the fluid lumen is the proximal portion of the impeller and has a proximal end (see, e.g., the proximal impeller in FIG. 2). In some embodiments, the portion of the impeller that extends outside the fluid lumen is the distal portion of the impeller and has a distal end (see, e.g., the distal impeller in FIG. 2). When the disclosure herein refers to an impeller extending outside (i.e., beyond) the fluid lumen, this is intended to refer to the relative axial positions of the components as most easily seen in a side or top view, such as in FIG. 2.

[0071]

[0114] However, a second impeller at another end of the fluid lumen may not extend beyond the fluid lumen. For example, an exemplary alternative design may have a proximal impeller (similar to the proximal impeller of FIG. 2) that extends proximally beyond the proximal end of the fluid lumen, and the fluid lumen does not extend distally beyond the distal end of the distal impeller (as in FIG. 3). Alternatively, the distal end of the distal impeller may extend distally beyond the distal end of the fluid lumen, but the proximal end of the proximal impeller does not extend proximally beyond the proximal end of the fluid lumen. In any of the pump sections herein, none of the impellers may extend beyond the end of the fluid lumen.

[0072]

[0115] Although specific example locations may be shown herein, the fluid pump may be usable in a wide variety of locations within the body. Some example locations for placement include near the aortic or pulmonary valve, such as spanning the valve and being located on one or both sides of the valve, and in the case of the aortic valve, optionally including a portion located within the ascending aorta. In some other embodiments, for example, the pump may be located further downstream in use, such as in the descending aorta.

[0073]

[0116] FIG. 4 shows an example placement of the working portion 1104 from the system 100 of FIG. 2. One difference shown in FIG. 4 is that the conduit extends at least as far as the end of the impeller as in FIGS. 3A-3D. FIG. 4 shows the working portion 1104 in a deployed configuration, positioned in place to span the aortic valve. The working portion 1104 can be delivered, as shown, for example, but not limited to, via femoral artery access (a known access procedure). Although not shown for simplicity, the system 100 can further include an outer sheath or shaft within which the working portion 1104 is positioned during delivery to a location near the aortic valve. The sheath or shaft can be moved proximally (toward the ascending aorta "AA" and away from the left ventricle "LV"), thereby allowing the working portion 1104 to deploy and expand. For example, the sheath can be retracted to allow the second expandable member 1110 to expand, and continued proximally to allow the first expandable member 1108 to expand.

[0074]

[0117] In this embodiment, the second expandable member 1110 is expanded and positioned in a deployed configuration such that the distal end 1125 is within the left ventricle "LV," distal to the aortic valve leaflets "LV," and distal to the annulus. Furthermore, the proximal end 1124 is positioned distal to the leaflets "VL." However, in some embodiments, the proximal end 1124 may extend axially slightly within the leaflets VL. This embodiment is an example of a method in which at least half of the second expandable member 1110 resides within the left ventricle when measured along its length (measured along the longitudinal axis). Furthermore, as shown, this is also an example of a method in which the entire second expandable member 1110 resides within the left ventricle. This is also an example of a method in which at least half of the second impeller 1118 is positioned within the left ventricle, and even an embodiment in which the entire second impeller 1118 is positioned within the left ventricle.

[0075]

[0118] Continued retraction of the outer shaft or sheath (and / or distal movement of the working end 1104 relative to the outer sheath or shaft) continues to release the conduit 1112 until the central region 113 is released and deployed. The expansion of the expandable members 1108 and 1110 causes the conduit 1112 to assume a more open configuration, as shown in FIG. 4. Thus, in this embodiment, the conduit 1112 does not have the same self-expanding properties as the expandable members, but deployment of the working end causes the conduit to assume a more open, deployed configuration. At least a portion of the central region 1113 of the conduit 1112 is located at the coaptation region with the aortic valve. In FIG. 3, there is a short length of the central region 1113 that extends distally beyond the leaflets VL, but at least a portion of the central region 1113 resides axially within the leaflets.

[0076]

[0119] Continued retraction of the outer shaft or sheath (and / or distal movement of the working end 1104 relative to the outer sheath or shaft) deploys the first expandable member 1108. In this embodiment, the first expandable member 1108 is expanded and placed in a deployed configuration (as shown) so that the proximal end 1121 resides within the ascending aorta AA, proximal to the leaflet "LV." Furthermore, although the distal end 1122 is positioned proximal to the leaflet VL, in some approaches the distal end 1122 may extend axially slightly within the leaflet VL. This embodiment is an example of a method in which at least half of the first expandable member 1110 resides within the ascending aorta when measured along its length (measured along the longitudinal axis). Furthermore, as shown, this is also an example of a method in which the entirety of the first expandable member 1110 resides within the AA. This is also an example of a method in which at least half of the first impeller 1116 is disposed within the AA, and even an embodiment in which the entirety of the first impeller 1116 is disposed within the AA.

[0077]

[0120] At any time during or after deployment of the working portion 1104, the position of the working portion can be accessed by any technique, such as under fluoroscopy. The position of the working portion can be adjusted at any time during or after deployment. For example, the working portion 1104 can be moved axially (distally or proximally) after the second expandable member 1110 is released but before the first expandable member 1108 is released, thereby repositioning the working portion. In addition, the working portion can be repositioned, for example, after the entire working portion has been released from the sheath and reached a desired final position.

[0078]

[0121] It should be understood that the positions of the components shown in FIG. 4 (relative to the anatomy) are to be considered as exemplary final positions for the various components of the working portion 1104, even if repositioning occurs after initial deployment.

[0079]

[0122] One or more of the expandable members herein may be configured to and may be expanded in a variety of ways, such as by self-expanding, by mechanical actuation (e.g., by one or more axial forces exerted on the expandable member, by using a separate balloon radially disposed within the expandable member that expands to push the expandable member radially outward, etc.), or a combination thereof.

[0080]

[0123] As used herein, expansion generally refers to a reconfiguration to a larger profile having a larger outermost radial dimension (relative to the longitudinal axis), regardless of the specific manner in which one or more components are expanded. For example, a stent that self-expands and / or is subjected to an outward radial force may "expand," as the term is used herein. A device that unfolds or unfolds may assume a larger profile and may be considered to expand, as the term is used herein.

[0081]

[0124] The impellers may similarly be adapted and configured to expand in a variety of ways depending on their configuration. For example, when one or more impellers are released from the sheath, they may automatically return to or toward another larger-profile configuration due to the materials and / or configuration of the impeller's design (see, e.g., U.S. Pat. No. 6,533,716 or U.S. Pat. No. 7,393,181, both of which are incorporated herein by reference). Thus, in some embodiments, retracting the outer restraint allows both the expansible member and impellers to naturally return to their larger-profile deployed configurations without any other actuation.

[0082]

[0125] As shown in the embodiment of Figure 4, the working portion has first and second impellers spaced apart on either side of the aortic valve, with each of the first and second impellers disposed within a separate expandable member. This contrasts with some designs in which the working portion has a single elongated expandable member. Unlike a single generally tubular expandable member that extends across the entire valve, the working portion 1104 provides a gap between the expandable members 1108 and 1110. The expandable basket has a conduit 1112 extending therethrough. The conduit has greater flexibility and deformability than the expandable basket, thereby allowing for greater deformation of the working portion at the location of the leaflets, such as occurs when the expandable member extends across the aortic valve leaflets. This can reduce damage to the leaflets after the working portion is deployed in the subject.

[0083]

[0126] Additionally, forces exerted by the leaflets on the central region of a single expandable member can translate axially to other regions of the expandable member, potentially causing undesired deformation of the expandable member at the location of one or more impellers. This can cause the outer expandable member to contact the impeller, thereby undesirably interfering with the rotation of the impeller. A design with separate expandable members around each impeller, and particularly one in which each expandable member and impeller is supported at both ends (i.e., distal and proximal), allows for a high level of precision in the placement of the impellers relative to the expandable member. Two separate expandable members may be able to maintain their deployed configuration more reliably than a single expandable member.

[0084]

[0127] As discussed above, it may be desirable to be able to reconfigure the working portion so that it can be delivered through a 9F sheath and achieve sufficient flow rates in use that are not possible with some current products during deployment and / or testing. For example, some products may be too large to be reconfigured to a sufficiently small delivery profile, while some compact designs may not be able to achieve the desired high flow rates. An illustrative advantage of the examples of Figures 1, 2, 3A-3D, and 4 is that, for example, the first and second impellers can work together to achieve the desired flow rate, and by having two axially spaced impellers, the entire working portion can be reconfigured to a smaller delivery profile than designs that use a single impeller to achieve the desired flow rate. Thus, these embodiments use multiple smaller, axially spaced, reconfigurable impellers to achieve both the desired small delivery profile and the desired high flow rate.

[0085]

[0128] Thus, embodiments herein can achieve a small delivery profile while maintaining a sufficiently high flow rate, while creating a more deformable and flexible central region of the working portion, exemplary benefits of which are described above (e.g., cooperative contact with vulnerable valve leaflets).

[0086]

[0129] Figure 5 shows an operating portion similar to that shown in Figure 1. Operating portion 265 has a proximal impeller 266 and a distal impeller 267, both coupled to a drive shaft 278 that extends into a distal bearing housing 272. A similar proximal bearing housing is present at the proximal end of the operating portion. The operating portion further has an expandable member, generally designated 270, and a conduit 268 secured to the expandable member and extending along substantially the entire length of the expandable member. Expandable member 270 has distal struts 271 secured to strut supports 273 that are secured to distal tips 273. Expandable member 270 further has proximal struts secured to the proximal strut supports. 1 are incorporated by reference in this embodiment for all purposes, even if not explicitly stated. The expandable member 265 further includes a helical tension member 269 disposed along the periphery of the expandable member, the helical tension member 269 having a helical configuration when the expansion member is in the expanded configuration as shown. The helical tension member 269 is positioned and adapted to induce a rotation wrap when folded. The working portion 265 can be folded from the expanded configuration shown, while simultaneously rotating one or both impellers at a relatively low speed to facilitate spiral folding of the impellers through interaction with the expandable members. The helical tension member 269 (or helically configured expandable member cells) acts as the tension member of the assembly; when the expandable basket is pulled in tension along its length for folding (e.g., by stretching to a significant length, such as approximately twice its length), the tension member 269 is pulled into linear alignment, thereby rotating / twisting the desired segment of the expandable member during folding, which in turn causes the expandable member and blades to fold while the impeller blades curl radially inward. An exemplary configuration of such a tension member, when in its helical configuration, has a curved shape approximately equal to the maximum length of the expandable member when folded. In an alternative embodiment, only a portion (or portions) of the expandable member surrounding the foldable impeller is rotated when folded.

[0087]

[0130] There are alternative approaches for constructing working portions that rotate the expandable member (and thus cause the impeller blades to roll and fold) upon collapse upon extension. Any expandable member, even a dual-impeller design, can be constructed with such structures. For example, when using an expandable member having multiple "cells" (e.g., a laser-cut elongated member) in the same sense as the term is commonly understood, the expandable member can have multiple specific cells that together define a specific configuration, such as a helical configuration, where the cells defining this configuration have different physical properties than other cells within the expandable member. In some embodiments, the expandable member can have a braided (i.e., braided) configuration, where the twisted region can comprise the entire group of wires or a significant portion (e.g., more than half) of the braided wires. Such a twisted braided configuration can be achieved, for example, by twisting the wires during the braiding process, particularly over the length of the largest diameter portion of the braided configuration, while pulling on the mandrel over which the wires are braided. This configuration may be completed during a second operation in the building process, such as mechanically twisting the reticulated configuration before heat setting the wrapped profile on the shaped mandrel.

[0088]

[0131] Any of the conduits herein may function, be configured, and be made of materials that create a fluid lumen therein between a first end (e.g., distal end) and a second end (e.g., proximal end). Fluid flows into the inflow region, through the fluid lumen, and out through the outflow region. Flow into the inflow region may be designated herein by an "I," and flow out at the outflow region may be designated by an "O." Any of the conduits herein may be impermeable. Any of the conduits herein may alternatively be semi-permeable. Any of the conduits herein may be porous but still define a fluid lumen therethrough. In some embodiments, the conduit is a membrane or other relatively thin layered member. Unless otherwise indicated, any of the conduits herein may be secured to the expandable member, such that the conduit may reside radially inside and / or outside the expandable member when secured. For example, the conduit may extend radially within the expandable member such that an inner surface of the conduit resides radially within the expandable member when secured to the expandable member.

[0089]

[0132] Any of the expandable members herein can be constructed of a variety of materials and in a variety of ways. For example, the expandable member can have a mesh configuration or can be formed by laser machining. The material can be deformable, such as Nitinol. The material can be deformable, such as Nitinol. The expandable member can be self-expanding or adapted to at least partially actively expand.

[0090]

[0133] In some embodiments, the expandable member is adapted to self-expand when released from within a containing tubular member, such as a delivery catheter, guide catheter, or access sheath. In some alternative embodiments, the expandable member is adapted to expand by active expansion, such as actuation of a pull rod to move at least one of the distal and proximal ends of the expandable member toward each other. In alternative embodiments, the deployed configuration may be influenced by the configuration of one or more expandable structures. In some embodiments, one or more expandable members may be deployed, at least in part, by the influence of blood flowing through the conduit. Any combination of the above expansion mechanisms may be used.

[0091]

[0134] The blood pump and fluid movement devices, systems, and methods herein may be used in and placed in a variety of locations within the body, and although specific examples may be presented herein, it should be understood that the working portions may be placed in regions within the body different from those specifically described herein.

[0092]

[0135] In any of the embodiments herein in which the medical device has multiple impellers, the device may be adapted to rotate the impellers at various speeds. FIG. 6A shows a medical device having a gear set 1340 coupled to both the inner drive member 1338 and the outer drive member 1336, which are operably connected to the distal impeller 1334 and the proximal impeller 1332, respectively. The drive further includes a motor 1342 that drives the rotation of the inner drive member 1338. The inner drive member 1338 extends through the outer drive member 1336. Operation of the motor 1342 causes the two impellers to rotate at various speeds via underdrive and overdrive ratios. The gear set 1340 may be adapted to drive either the proximal or distal impeller more quickly than the other. Any of the devices herein can have any of the gear sets herein for driving the impeller at various speeds.

[0093]

[0136] Figure 6B shows a portion of an alternative embodiment of a dual impeller device (1350) that is also adapted to rotate different impellers at different speeds. A gear set 1356 is coupled to both the inner drive member 1351 and the outer drive member 1353, which are coupled to the distal impeller 1352 and the proximal impeller 1354, respectively. The device further has a motor as in Figure 6A. Figures 6A and 6B show how the gear sets can be adapted to drive the proximal impeller at a slower or faster speed than the distal impeller.

[0094]

[0137] 7 shows an alternative exemplary embodiment of a fluid pump 1370 capable of rotating the first and second impellers at various speeds. A first motor 1382 drives a cable 1376 coupled to the distal impeller 1372, and a second motor 1384 drives (via a gear set 1380) an outer drive member 1378 coupled to the proximal impeller 1374. The drive cable 1376 extends through the outer drive member 1378. The motors can be controlled and operated independently, thus allowing for separate control of the speeds of the two impellers. This system setup can be used with any of the systems herein having multiple impellers.

[0095]

[0138] In some embodiments, a common drive cable or drive shaft can initiate rotation of two (or more) impellers, but the blade pitch (angle of rotational curvature) of the two impellers can be different, with the distal or proximal impeller having a steeper or less steeper angle than the other impeller. This allows for a more efficient and efficient rotation of the impellers than with a gear set. A similar effect can be produced. Figure 6C shows a portion of a medical device (1360) having a common drive cable 1366 coupled to a proximal impeller 1364 and a distal impeller 1362, and further coupled to a motor (not shown). The proximal impeller herein can have a higher or lower pitch than the distal impeller herein. Any of the working portions (or distal portions) herein that include multiple impellers can be modified to have first and second impellers with different pitches.

[0096]

[0139] In any of the embodiments herein, the pump portion can have a compliant or semi-flexible (collectively referred to as flexible) exterior structure. In various embodiments, the flexible portion is pliable. The flexible portion only partially deforms under pressure. For example, the central portion of the pump can be formed with a flexible outer structure so that it deforms in response to valve forces. In this way, the external force of the pump against the valve leaflets is reduced. This can help prevent damage to the valve at the location where the working portion traverses the valve.

[0097]

[0140] FIG. 8 illustrates an exemplary embodiment of a pump section having first, second, and third axially spaced impellers 152, each disposed within an expandable member 154. A conduit 155 may extend across the length of the pump section as described in various embodiments herein to help create and define a fluid lumen. However, in alternative embodiments, the first, second, and third impellers may be disposed within a single expandable member, as shown in FIG. 1. In FIG. 8, the fluid lumen extends from the distal end to the proximal end, with features of the distal and proximal ends described elsewhere herein. The embodiment of FIG. 8 may have any other suitable features described herein, including methods of use.

[0098]

[0141] The embodiment of Figure 8 is also an example of an outer housing having at least one bend formed in the outer housing between the distal end of the proximal impeller and the proximal end of the distal impeller, where the distal region of the housing distal to the bend is not axially aligned with the proximal region of the housing proximal to the bend along the axis. In this embodiment, there are two bends 150 and 151 formed in the housing, each between two adjacent impellers.

[0099]

[0142] In use, the curved portion formed in the housing can be positioned to span a valve, such as the aortic valve shown in Figure 8. In this positioning method, the middle and distal-most impellers are positioned in the left ventricle, and the proximal-most impeller is positioned in the ascending aorta. Curve 151 is positioned just downstream of the aortic valve.

[0100]

[0143] A curve, such as curve 151 or 152, may be incorporated into any of the embodiments or designs herein. The curve may be at a pre-formed angle or may be adjustable in situ.

[0101]

[0144] In any of the embodiments herein, unless otherwise indicated, the outer housing can have a substantially uniform diameter throughout its length.

[0102]

[0145] In Figure 8, a pump is placed through the axillary artery, which is an exemplary method of accessing the aortic valve, allowing the patient to ambulate and become active relatively undisturbed. However, it will be appreciated from the description herein that the pump may be introduced into position above and traverse the aortic arch in a variety of ways, including a femoral approach.

[0103]

[0146] One aspect of the present disclosure is an intravascular blood pump having a distal impeller axially spaced from a proximal impeller. In one embodiment, the distal and proximal impellers are separated from each other. For example, the distal and proximal impellers may be connected only by being individually attached to a common drive shaft. This differs from impellers having multiple blade rows. The phrase "distal impeller" as used herein does not necessarily mean the most distal impeller of the pump, but may generally refer to an impeller located distal to the proximal impeller, even if there are additional impellers located distal to the distal impeller. Similarly, the phrase "proximal impeller" as used herein does not necessarily mean the most proximal impeller of the pump, but may generally refer to an impeller located proximal to the proximal impeller, even if there are additional impellers located proximal to the proximal impeller. Axial spacing (or any derivative thereof) refers to spacing across the length of the pump segment, such as along the longitudinal axis of the pump segment, even if curvatures exist within the pump segment. In various embodiments, the proximal and distal impellers are each disposed within a respective housing and configured to maintain a precise and consistent tip clearance, with the span between the impellers having a relatively flexible (or fully flexible) fluid lumen. For example, each impeller may be disposed within a respective housing having an outer wall with a relatively high stiffness to resist radial collapse. The section between the impellers may have a relatively high stiffness, and in some embodiments, this section is maintained open primarily by fluid pressure therein.

[0104]

[0147] Although not required in the embodiments herein, there may be advantages to minimizing the axial spacing between the proximal and distal impellers. For example, the pump portion may be delivered to a target location through a portion of the anatomy with a relatively sharp bend, such as the aorta, and even into the aortic valve. For example, the pump portion may be delivered to the aortic valve via femoral artery access. It may be advantageous to have a system that can bend relatively easily to facilitate delivery of the system through bends in the anatomy. Some designs, in which multiple impellers are very close to each other, allow the system to have a relatively high stiffness throughout the span of the multiple impellers. By spacing the impellers axially, and optionally providing regions of relatively high flexibility between the impellers, portions of the system can be made more flexible, easier to bend, and therefore more easily and safely advanced through bends. An additional exemplary advantage is that this axial spacing allows for a relatively high flexibility region between the impellers, which may be located, for example, at the location of a valve (e.g., the aortic valve). Furthermore, there are other potential advantages and functional differences between various embodiments herein and a typical multi-stage pump. A typical multi-stage pump has functionally closely spaced blade rows (sometimes referred to as impellers) such that the blade rows function together as synchronized stages. It will be recognized that flow separation may occur as it passes through the distal impeller. In various embodiments described herein, the distal and proximal impellers may be sufficiently separated such that flow separation from the distal impeller is significantly reduced (i.e., increased recombination) and localized turbulence dissipates before the flow enters the proximal impeller.

[0105]

[0148] Any of the embodiments including a distal impeller and a proximal impeller, or At any point herein, the axial spacing between the distal end of the proximal impeller and the proximal end of the distal impeller may be 1.5 cm to 25 cm, inclusive, along the longitudinal axis of the pump section or along the longitudinal axis of the housing section containing the fluid lumen. This distance may be measured when the pump section containing any impeller is in an expanded configuration. This exemplary range may provide exemplary flexibility benefits described herein when the pump section is delivered through the aorta, for example, through curved portions of the anatomy, such as the aortic valve. FIG. 9 (shown in an expanded configuration outside of a patient) illustrates the axial spacing between impellers, Lc, which in some embodiments may be 1.5 cm to 25 cm as described herein. In embodiments where there may be more than one impeller, any two adjacent impellers (i.e., impellers without any other rotating impellers between them) may be axially separated by any of the axial spacing distances described herein.

[0106]

[0149] While some embodiments have the distal end of the proximal impeller spaced axially from the proximal end of the distal impeller along the axis by 1.5 cm to 25 cm, the disclosure herein also includes any subrange of axial spacing within this general range of 1.5 cm to 25 cm. That is, the disclosure includes all ranges within that range, including any lower limit equal to or greater than 1.5 cm, and all subranges, including any upper limit equal to or less than 25 cm. Illustrative subranges are shown in the following examples: In some embodiments, the distal end of the proximal impeller is spaced axially from the proximal end of the distal impeller along the axis by 1.5 cm to 20 cm, 1.5 cm to 15 cm, 1.5 cm to 10 cm, 1.5 cm to 7.5 cm, 1.5 cm to 6 cm, 1.5 cm to 4.5 cm, or 1.5 cm to 3 cm. In some embodiments, the axial spacing is 2 cm to 20 cm, 2 cm to 15 cm, 2 cm to 12 cm, 2 cm to 10 cm, 2 cm to 7.5 cm, 2 cm to 6 cm, 2 cm to 4.5 cm, or 2 cm to 3 cm. In some embodiments, the axial spacing is 2.5 cm to 15 cm, 2.5 cm to 12.5 cm, 2.5 cm to 10 cm, 2.5 cm to 7.5 cm, or 2.5 cm to 5 cm (e.g., 3 cm). In some embodiments, the axial spacing is 3 cm to 20 cm, 3 cm to 15 cm, 3 cm to 10 cm, 3 cm to 7.5 cm, 3 cm to 6 cm, or 3 cm to 4.5 cm. In some embodiments, the axial spacing is 4 cm to 20 cm, 4 cm to 15 cm, 4 cm to 10 cm, 4 cm to 7.5 cm, 4 cm to 6 cm, or 4 cm to 4.5 cm. In some embodiments, the axial spacing is 5 cm to 20 cm, 5 cm to 15 cm, 5 cm to 10 cm, 5 cm to 7.5 cm, or 5 cm to 6 cm. In some embodiments, the axial spacing is 6 cm to 20 cm, 6 cm to 15 cm, 6 cm to 10 cm, or 6 cm to 7.5 cm. In some embodiments, the axial spacing is 7 cm to 20 cm, 7 cm to 15 cm, or 7 cm to 10 cm. In some embodiments, the axial spacing is 8 cm to 20 cm, 8 cm to 15 cm, or 8 cm to 10 cm.In some embodiments, the axial spacing is between 9 cm and 20 cm, between 9 cm and 15 cm, or between 9 cm and 10 cm. In various embodiments, the fluid lumens between the impellers are relatively unsupported.

[0107]

[0150] In any of the embodiments herein, one or more impellers may have a length measured axially between the distal end of the impeller and the proximal end of the impeller (referred to as "L" in FIG. 9, respectively). SD " and "L SP "), which is 0.5 cm to 10 cm, or any subrange thereof. The following examples provide illustrative subranges. In some embodiments, the impeller axial length is 0.5 cm to 7.5 cm, 0.5 cm to 5 cm, 0.5 cm to 4 cm, 0.5 cm to 3 cm, 0.5 cm to 2 cm, or 0.5 cm to 1.5 cm. In some embodiments, the impeller axial length is 0.8 cm to 7.5 cm, 0.8 cm to 5 cm, 0.8 cm to 4 cm, or 0.5 cm to 1.5 cm. cm, 0.8 cm to 3 cm, 0.8 cm to 2 cm, or 0.8 cm to 1.5 cm. In some embodiments, the axial length of the impeller is 1 cm to 7.5 cm, 1 cm to 5 cm, 1 cm to 4 cm, 1 cm to 3 cm, 1 cm to 2 cm, or 1 cm to 1.5 cm. In some embodiments, the axial length of the impeller is 1.2 cm to 7.5 cm, 1.2 cm to 5 cm, 1.2 cm to 4 cm, 1.2 cm to 3 cm, 1.2 cm to 2 cm, or 1.2 cm to 1.5 cm. In some embodiments, the axial length of the impeller is 1.5 cm to 7.5 cm, 1.5 cm to 5 cm, 1.5 cm to 4 cm, 1.5 cm to 3 cm, or 1.5 cm to 2 cm. In some embodiments, the axial length of the impeller is 2 cm to 7.5 cm, 2 cm to 5 cm, 2 cm to 4 cm, or 2 cm to 3 cm. In some embodiments, the axial length of the impeller is between 3 cm and 7.5 cm, between 3 cm and 5 cm, or between 3 cm and 4 cm. In some embodiments, the axial length of the impeller is between 4 cm and 7.5 cm, or between 4 cm and 5 cm.

[0108]

[0151] In any of the embodiments herein, the fluid lumen can have a length from the distal end to the proximal end, shown as length Lp in Figure 9. In some embodiments, the length Lp of the fluid lumen is between 4 cm and 40 cm, or any subrange therein. For example, in some embodiments, the length Lp can be between 4 cm and 30 cm, between 4 cm and 20 cm, between 4 cm and 18 cm, between 4 cm and 16 cm, between 4 cm and 14 cm, between 4 cm and 12 cm, between 4 cm and 10 cm, between 4 cm and 8 cm, or between 4 cm and 6 cm.

[0109]

[0152] In any of the embodiments herein, the housing can have a deployed diameter, shown in FIG. 9 as dimension Dp, at least at the location of the impellers (and optionally at locations between the impellers). In some embodiments, Dp can be 0.3 cm to 1.5 cm, or any subrange therein. For example, Dp can be 0.4 cm to 1.4 cm, 0.4 cm to 1.2 cm, 0.4 cm to 1.0 cm, 0.4 cm to 0.8 cm, or 0.4 cm to 0.6 cm. In some embodiments, Dp can be 0.5 cm to 1.4 cm, 0.5 cm to 1.2 cm, 0.5 cm to 1.0 cm, 0.5 cm to 0.8 cm, or 0.5 cm to 0.6 cm. In some embodiments, Dp can be 0.6 cm to 1.4 cm, 0.6 cm to 1.2 cm, 0.6 cm to 1.0 cm, or 0.6 cm to 0.8 cm. In some embodiments, Dp may be 0.7 cm to 1.4 cm, 0.7 cm to 1.2 cm, 0.7 cm to 1.0 cm, or 0.7 cm to 0.8 cm.

[0110]

[0153] In any of the embodiments herein, the impeller can have a deployed diameter, shown as dimension Di in Figure 9. In some embodiments, Di can be between 1 mm and 30 mm, or any subrange therein. For example, in some embodiments, Di can be between 1 mm and 15 mm, between 2 mm and 12 mm, between 2.5 mm and 10 mm, or between 3 mm and 8 mm.

[0111]

[0154] In any of the embodiments herein, a tip clearance exists between the outer diameter of the impeller and the inner diameter of the fluid lumen. In some embodiments, the tip clearance may be between 0.01 mm and 1 mm, such as between 0.05 mm and 0.8 mm, or such as between 0.1 mm and 0.5 mm.

[0112]

[0155] In any of the embodiments herein having multiple impellers, the axial spacing between the impellers (along the length of the pump section, even if there are curvatures within the pump section) may be between 2 mm and 100 mm, or between 5 mm and 100 mm. Any combination of upper and lower limits may be used, including 0.00 mm (for example, 10 mm to 80 mm, 15 mm to 70 mm, 20 mm to 50 mm, 2 mm to 45 mm, etc.).

[0113]

[0156] A blood pump, such as any of the intravascular pumps herein, can benefit from having one or more fluid paths through which fluid can flow through the device. For example, but not by way of limitation, a blood pump can benefit from having one or more fluid paths through which fluid can flow to perform any of the following exemplary functions: cooling rotating components (e.g., drive cables) to prevent overheating; flushing small particles that may seize rotating components (e.g., drive cables) to prevent damage from small particles; lubricating rotating components (e.g., one or more bearings); and preventing blood from entering the pump (e.g., near or at the distal end of the pump). Fluid delivery through one or more fluid paths can accomplish any number of these functions. For example, the disclosure of WO2020 / 073047A1 is incorporated by reference in its entirety for all purposes.

[0114]

[0157] The following disclosure provides exemplary method steps that may be performed when using any of the blood pumps described herein, or portions thereof. It should be understood that not all steps need be performed, and these steps are intended to be exemplary procedures. Furthermore, it is contemplated that the order of one or more steps may be varied as appropriate in some instances.

[0115]

[0158] Prior to use, the blood pump may be prepared for use by priming the lumen (including any tubular spaces) or pump assembly with a sterile solution (e.g., heparinized saline) to remove any air bubbles from any fluid lines. The catheter, including any number of purge lines, may then be connected to the console. Alternatively, the catheter may be connected to the console and / or a separate pump that is used to prime the catheter to remove air bubbles.

[0116]

[0159] After priming the catheter, access to the patient's vasculature can be achieved using an appropriately sized introducer sheath (for example, but not limited to, via femoral access). Then, using standard valve crossing techniques, the diagnostic pigtail catheter can be advanced over, for example, a 0.9 mm (0.035") guidewire until the pigtail catheter is firmly positioned at the target site (e.g., the left ventricle). The guidewire can then be removed, and a second wire 320 (e.g., a 0.457 mm (0.018") wire) can be inserted through the pigtail catheter. The pigtail catheter can then be removed (see FIG. 10A), and the blood pump 321 (including the catheter, catheter sheath, and pump portion within the sheath; see FIG. 10B) can be advanced over a second wire toward the target location (e.g., the left ventricle "LV"), such as across the aortic valve "AV," using, for example, one or more radiopaque markers to position the blood pump.

[0117]

[0160] Once proper placement is confirmed, the catheter sheath 322 (see FIG. 10C) can be retracted, first exposing the distal region of the pump portion. In FIG. 10C, the distal region of the expandable housing has been released from the sheath 322 and is allowed to expand, as is the distal impeller 324. The proximal end of the housing 323 and the proximal impeller 325 have not yet been released from the sheath 322. Continuing to retract the sheath 322 past the proximal end of the housing 323 allows the housing 323 and the proximal impeller 325 to expand (see FIG. 10D). The inlet region (indicated by the arrow even though the impeller is not yet rotating) is also shown. The pump section includes an inlet portion (indicated with an arrowhead, although the impeller is not yet rotating) and a distal impeller in the left ventricle. The outflow portion (indicated with an arrowhead, although the impeller is not yet rotating) and a proximal impeller in the ascending aorta (AA). A region of the outer housing between the two impellers, which may have greater flexibility than the housing region surrounding the impellers, extends to straddle the aortic valve (AV), as described in more detail herein. In the exemplary operating position shown, the inlet portion of the pump section is distal to the aortic valve in the left ventricle, and the outlet of the pump section is proximal to the aortic valve in the ascending aorta ("AA").

[0118]

[0161] A second wire (e.g., a 0.018" guidewire) may then be moved prior to operation of the pump assembly (see FIG. 10E). If desired or necessary, the pump portion may be reoriented (actively or passively) at one or more locations described herein, as shown in FIG. 10F. If necessary, the pump portion may be repositioned to achieve the intended placement, for example, with the first impeller on one side of the heart valve and the second impeller on the other side of the heart valve. It should be understood that in FIG. 10F, the pump portion does not interfere with or interact with the mitral valve in any way.

[0119]

[0162] Any number of purge lines may then be attached to a proximal portion of the blood pump, which is located external to the patient. For example, fluid inlet and outlet lines may be attached to one or more fluid ports on the proximal portion of the blood pump. A purge process may then be initiated to move fluid through at least one fluid path into the blood pump. One or more verification steps may be performed to verify that purging is occurring as intended before turning on the pump. The pump assembly may then be operated, thereby rotating one or more impellers. Any one of flow rate, pressure, and motor operation may be monitored at any time.

[0120]

[0163] Any text that may appear in any figure is understood to be descriptive but exemplary and does not require that any particular component be included in an embodiment.

[0121]

[0164] The present disclosure further includes catheter blood pumps having one or more sensors thereon or therein, methods of manufacture, and uses thereof. By way of example only, any blood pump herein may have one or more sensors configured to sense pressure. Sensors configured to sense blood pressure may be included on an intravascular blood pump for a variety of purposes, such as, but not limited to, estimating flow and detecting the position of the blood pump. Additionally, for example, one or more sensors may be axially spaced apart (e.g., one sensor near the inlet and one sensor near the outlet) and used to determine pressure differentials across pump sections.

[0122]

[0165] FIG. 11 illustrates an exemplary catheter blood pump 450 having an expandable and collapsible pump portion 451 (shown in an expanded or deployed state) disposed distally relative to an elongate body 455, the pump portion having an expandable impeller housing 461 with a blood conduit defining a blood lumen between an inflow "I" and an outflow "O." The pump portion has one or more impellers, any of which may be at least partially axially disposed within the fluid lumen (for clarity, impellers are not shown in FIG. 11 ). The expandable impeller housing 461 has a sensor wire housing 460 extending at least partially along the length of the expandable impeller housing. The pump portion 451 may further include a sensor wire (e.g., optical fiber) affixed to a sensor, and the sensor wire housing 460 may extend through the expandable impeller housing. The sensor wire is disposed within the sensor wire housing 460, and the sensor wire may be sized to float within the sensor wire lumen defined by the sensor wire housing 460. The sensor wire housing generally defines a sensor wire lumen within which a sensor wire may be disposed. However, this disclosure may use the phrases sensor wire lumen (i.e., terms) and sensor wire housing interchangeably, although a lumen is generally considered to be a space within a structural housing. The expandable impeller housing herein may also be referred to herein as an expandable housing.

[0123]

[0166] In the embodiment of FIG. 11, the sensor wire housing 460 (which defines the lumen therein) has a helical configuration (in other words, a spiral form) along at least a portion of the expandable housing 461, and the sensor wire housing 460 can have a helical configuration along at least 50% of the length of the expandable housing, such as 55%, 60%, 65%, 70%, 75%, 80%, 85%, 90%, 95%, or 100% of the length of the expandable housing.

[0124]

[0167] The sensor wire housing herein can have a linear configuration (in other words, a straight line form) along at least a portion of the expandable housing, such as at least 50% of the length of the expandable housing, such as 55%, 60%, 65%, 70%, 75%, 80%, 85%, 90%, 95%, or 100% of the length of the expandable housing.

[0125]

[0168] The sensor wire housing herein can have a helical configuration along a portion of its length and a linear or other configuration along another portion of its length. The sensor wire housing herein can have a helical configuration in one or more axially spaced apart discrete helical regions, and optionally a linear configuration in one or more axially spaced apart discrete linear regions. The sensor wire housing may have other non-linear and non-helical configurations.

[0126]

[0169] The sensor wire housing herein generally helps protect one or more sensor wires (e.g., optical fibers). Sensor wires (e.g., optical fibers) can be very brittle and can be prone to breakage, especially when the pump portion is advanced through curved vasculature and bends. The sensor wire housing herein can be sized relative to the sensor wire to allow it to float within the lumen, which can provide space for the wire to move slightly as the pump portion is advanced and / or used, thereby reducing the likelihood of sensor wire breakage.

[0127]

[0170] However, in some embodiments, the sensor wire may be fixed relative to the impeller housing so that it does not float in space. When described as fixed relative to the impeller housing, flexibility of the material may allow for some slight movement between the sensor wire and the impeller housing, but fixed in this context generally means not free-floating within the open lumen. While FIG. 12 provides an example cross-sectional view of an expandable housing 465 (details of the expandable housing 465 are not shown for clarity, but the expandable housing 465 may include any structure of any pump portion herein, such as a membrane, an expandable support member, and an impeller, and these example details may be found elsewhere herein), the sensor wire 466 is fixed (does not float) relative to the expandable housing 465 and is secured to the expandable housing 465 by an overlay (i.e., a covering) 467, which is attached to the expandable housing 465 by an overlay 467. The overlay 467 may be placed over the sensor wire 466 to secure the wire 466 to the housing 465. The overlay 467 and sensor wire 466 may have any configuration along the length of the expandable housing, such as a helical configuration, a partial helical configuration, a curved configuration, a partial curved configuration, a linear configuration, a partial linear configuration, or any combination thereof.

[0128]

[0171] FIG. 13 shows an example cross-sectional view of an example expandable impeller housing 470 (again, for clarity, details of the expandable impeller housing 470 are not shown, but the expandable housing 470 can include any structural portion of any pump portion herein, such as the membrane, expandable support member, and impeller, and these example details may be found elsewhere herein). In this embodiment, the pump portion has a sensor wire housing that defines a sensor wire lumen sized and configured for the sensor wire to float within the lumen along at least a portion of the expandable impeller housing. In any of the embodiments that have a sensor wire housing, the sensor wire can be secured to the expandable housing at one or more separate locations, e.g., at one or both of the proximal or distal ends of the sensor wire housing, where the sensor wire extends outside the sensor wire housing. In the embodiment of FIG. 13, the pump portion has a separate sensor wire housing that defines a sensor wire lumen 471. By way of example only, the sensor wire housing may be a hollow tubular element, such as a tube, extending along at least a portion of the expandable housing. The sensor wire housing herein, in the context of the sensor wire lumen, may be a wide variety of materials, such as elastomeric, semi-rigid, or rigid. In any of the embodiments herein, the sensor wire housing may not significantly increase the stiffness of the expandable impeller housing at the location of the sensor wire housing, although it may slightly increase stiffness.

[0129]

[0172] Any of the sensor wire housings herein that house a sensor wire may have a non-circular cross-sectional shape, such as a rectilinear configuration (e.g., triangular, rectangular, square), or a curved configuration (e.g., oval), or any other undefined irregular shape. In this exemplary embodiment, the sensor wire housing, which defines a lumen 471, is secured to the expandable housing 470 at least in part by an overlay 473, which in this embodiment is disposed around the radially outermost portion of the sensor wire housing and lumen 471. The overlay 473 functions, at least in part, to help secure the sensor wire housing to the expandable housing. In this exemplary embodiment, this may be a combination of the expandable membrane material of the housing 470 and the overlay 473, which together surround the sensor wire housing and help secure the sensor wire housing to the expandable housing 470. The membrane of the expandable impeller housing 470 is disposed radially within the sensor wire housing, and an overlay 473 is disposed around the sensor wire housing and lumen 471, including around the radially outermost portion of the sensor wire housing as shown. In any of the embodiments herein, the membrane of the expandable housing 470 may not directly contact the sensor wire housing, and thus there may be one or more layers of overlay material between the expandable housing 470 and the sensor wire housing.

[0130]

[0173] Any of the overlays herein may differ from the expandable housing membrane in one or more respects. For example, possible differences herein in this context include, for example, one or more of chemical structure, durometer, stiffness, and thickness. For example, in this context, an overlay is considered different from a conduit membrane if it is made of the same material as the membrane but has a different durometer. In addition, For example, in the present context, an overlay is considered different from an impeller housing membrane if the overlay is of the same material as the membrane but has a different thickness than the membrane.

[0131]

[0174] In any of the embodiments herein, the overlay can comprise a polymeric material, optionally a urethane, and optionally a polycarbonate-based (i.e., polycarbonate-based). In any of the embodiments herein, the membrane that at least partially defines the blood flow lumen can comprise a polymeric material, optionally a urethane, and optionally a polycarbonate-based. In any of the embodiments herein, the membrane can have the same chemical structure as the overlay.

[0132]

[0175] FIG. 14 illustrates an exemplary embodiment in which sensor wire lumen 478 is not defined by a separate structural sensor wire housing, such as in the embodiment of FIG. 13 . In the example of FIG. 14 , lumen 478 is defined by a combination of overlay 477 and expandable housing 475. By way of example only, the sensor wire lumen of FIG. 14 can be created by forming a pump section as shown in FIG. 13 (with or without sensor wire 472 positioned as shown) and then removing the sensor wire housing, now creating lumen 478 defined by overlay 477 and expandable housing 475. In some embodiments, the overlay can include one or more polymeric materials, and the wire lumen can be defined by one or more polymeric materials. Again, expandable housing 475 can include any structural portion of any expandable housing herein, such as a membrane, an expandable support member, and an impeller; these exemplary details can be found elsewhere herein. Sensor wire 476 is shown floating within lumen 478.

[0133]

[0176] 15 shows an exemplary cross-sectional view of an embodiment of an expandable housing 480 (again, for clarity, the impeller is not shown) having a sensor wire 482 floating within a lumen 481, where the lumen 481 has a non-circular cross-section. In this embodiment, the cross-section is a rectilinear structure (e.g., rectangular, square). This cross-section can be created by first placing a rectilinear structural element on the expandable housing 480, similar to the description of FIG. 14, and then attaching an overlay 483 thereon and then removing the rectilinear structural element. Furthermore, the lumen 481 can be defined by a structural member of the sensor wire housing that is secured with the overlay 483.

[0134]

[0177] 16 is a side view of a pump portion having an exemplary expandable impeller housing 480 with a sensor 482 coupled to the expandable housing 480 and a sensor wire lumen 484 (and sensor wire therein) extending in a linear configuration along the expandable housing. The sensor wire lumen 484 may be any of the wire lumens described herein. The expandable impeller housing 480 may be any of the expandable housings described herein, including any expandable housing having two or more impellers and any expandable housing having one or more expandable support members that help provide structural support for the expandable housing.

[0135]

[0178] In FIG. 16, a sensor 482 (which may be a pressure sensor) is affixed to a distal strut 486 of the expandable housing, the strut being near the inlet of the pump portion. Strut 486 may be any of the struts described herein or incorporated by reference in any reference. The sensor herein may be affixed directly or indirectly to one or more reinforcing elements (e.g., struts, or scaffold elements) of the expandable portion. In this embodiment, the sensor is affixed radially inward relative to a portion of the expandable housing that at least partially surrounds the impeller. Any of the sensors herein may be coupled to an element using this configuration.

[0136]

[0179] In this embodiment (and any embodiment herein), the sensor is affixed such that the pressure sensitive area of ​​the sensor is non-perpendicular to the longitudinal axis of the expandable housing, optionally between 1 and 89 degrees relative to the longitudinal axis, such as between 5 and 85 degrees, between 10 and 80 degrees, etc. The reference angle theta is shown in FIG.

[0137]

[0180] In any of the embodiments herein, a sensor wire extends along the expandable housing and is connected to a proximal region of the blood pump that is spaced apart to remain external to the patient when the impeller is in use. Sensing information from one or more sensors can be used to estimate flow and detect the position of the blood pump. Additionally, one or more sensors can be spaced apart axially (e.g., one sensor near the inlet and one near the outlet, not shown) and used to determine pressure differentials across the pump sections.

[0138]

[0181] The present disclosure further describes a method of fabricating a pump portion of an intravascular blood pump. The fabrication method can include creating a sensor wire lumen within the pump portion. An exemplary method is described in the context of FIGS. 11-17. The exemplary method can include creating a tubular substrate layer, disposing an elongate shaft having a hollow lumen over and extending along at least a portion of the tubular substrate layer, and depositing an overlay (e.g., 473, 467, 477, 483) over the elongate shaft and over the tubular substrate layer along substantially the entire length of the elongate shaft so that the overlay surrounds the elongate shaft.

[0139]

[0182] 17 shows exemplary steps in which a tubular substrate layer 491 is fabricated (e.g., by vapor deposition) onto a mandrel 490. The tubular substrate layer 491 can be a wide variety of materials, such as an elastomeric material, a semi-rigid material, or a rigid material. In some embodiments, the tubular substrate layer 491 comprises a polymeric material, including, for example, but not limited to, a polycarbonate-based urethane. Fabricating the tubular substrate layer can include spray-depositing a softened polymeric material onto a mandrel (e.g., 490) and hardening the polymeric material upon cooling.

[0140]

[0183] An elongate shaft 492 defining a lumen therein may then be disposed over the tubular substrate layer 491, optionally in a helical and / or linear configuration, optionally as one or more separate helical sections and / or one or more linear sections, and maintained in this configuration utilizing any of a variety of techniques, such as applying an adhesive (e.g., tape) to the axially outer end section of the tubular substrate layer.

[0141]

[0184] Material (e.g., 473, 467, 477, 483) can then be applied over and around the elongate shaft 492, such that the material overlies the elongate shaft. Depending on the material, the material may be allowed to harden upon cooling. For example, the material may be a material that softens when heated and hardens upon cooling, such as a thermoplastic. The overlay material may be any of the example materials described herein and may have any of the example properties described herein.

[0142]

[0185] In any of the embodiments described herein, the overlay may be applied only to regions of the elongate shaft (e.g., 473, 467, 477) so that the overlay has the same configuration as the elongate shaft along the tubular substrate layer. One exemplary method for doing this is to mask the areas where the overlay material is not to be applied. (e.g., masking all areas except for the helical or linear areas where the elongate shaft will be located.) However, in any of the embodiments herein, the overlay is applied over the entire tubular substrate (including the elongate shaft), thereby essentially creating an additional tubular layer of material.

[0143]

[0186] If an elongate shaft (e.g., a tubular shaft) is to be left in place (e.g., as in FIG. 13 ), a sensor wire can be advanced into the wire lumen defined by the elongate shaft; in this case, the elongate shaft is considered a sensor wire housing as described herein. For example, the proximal end of an optical fiber can be loaded into the distal end of the lumen, thereby avoiding the need to advance a sensor through the lumen. To help facilitate placement of the sensor wire within the lumen, the sensor wire can be coupled to a stiffer guide element (i.e., a guiding element), which can be first fed into the end of the lumen, passed through the lumen, and out the other side, and then retracted from the other side, thereby pulling the sensor wire into the lumen. The guide element can then be disconnected from the sensor wire.

[0144]

[0187] If the elongate shaft is to be removed during the manufacturing process (e.g., FIG. 14), the elongate shaft can be removed before placing the sensor wire into the lumen. The sensor can be advanced into the lumen. The sensor may be advanced into the lumen utilizing the guide element concept described above.

[0145]

[0188] Any of the methods herein can include affixing a sensor to one or more stiffening elements of a pump portion, such as a strut (e.g., FIG. 16). The sensor can be directly (e.g., physically engaged) or indirectly attached to the one or more stiffening elements.

[0146]

[0189] Any of the methods herein may include affixing a second sensor to the pump portion at or adjacent to the outflow tract portion. For example, the second sensor may be affixed to a reinforcing element of the pump portion, such as a proximal strut, or to any portion of the elongate shaft extending proximally from the pump portion (e.g., 455 in FIG. 11 ). The second sensor may be coupled to a sensor wire that may or may not be within the second wire lumen. In any of the embodiments herein, the second sensor wire may be fixed to the pump portion, while the first (e.g., distal) sensor wire may be allowed to float within the lumen.

[0147]

[0190] The disclosure herein includes blood pumps that can have one or more expandable members that can facilitate one or more functions. An expandable member may also be referred to herein as an expandable portion. In some exemplary embodiments, the expandable member may be inflated to at least partially assist in expanding the expandable impeller housing. In some exemplary embodiments, the expandable member may be inflated to provide radial support along at least a portion of the expandable impeller housing, thereby assisting in maintaining tip clearance between the impeller blades and the blood lumen conduit. In some embodiments, the expandable portion may further function as a housing for structural components (i.e., not fluids). In some examples, the expandable portion may house a portion of a sensor system, such as a sensor wire (e.g., a sensor wire coupled to a sensor). Any of the expandable members herein may be adapted to provide two or more of these functions, or to provide other functions provided herein by the expandable member. Any of the expandable impeller housings herein may be adapted to provide the expandable impeller housing of the present invention. It may include or incorporate any of the expandable members described herein.

[0148]

[0191] FIG. 18A illustrates an exemplary region of a portion of a catheter blood pump 500 having an expandable impeller housing 502, which may be any of the expandable impeller housings described herein. The expandable impeller housing 502 has an expandable conduit defining a blood lumen. The expandable housing 502 has an expandable support member 570 secured to a membrane 512, which provides radial support for the membrane and defines the blood lumen. The membrane 512 may include one or more layers of material secured together. Although not shown, at least one impeller is disposed within the expandable impeller housing 502. Optional struts 506 are shown, as is a central drive mechanism 514. An elongated shaft 508 extends proximally from the expandable impeller housing. However, the distal direction may alternatively be to the right in FIG. 18A . In this embodiment, an inflation lumen 520, affixed to the struts 506 and having a configuration that conforms to (i.e., follows) the configuration of the struts 506, is fluidly connected to the inflatable portion 504 such that fluid (e.g., liquid, gas) can be advanced from an external fluid source and / or fluid pump (not shown) through the inflation lumen 520 and into the inflatable portion 504 to inflate the inflatable portion 504. Fluid delivery to any of the inflatable portions herein can be manually delivered and / or automatically controlled in any of the embodiments herein. FIG. 18A shows the inflatable portion in an uninflated configuration, and FIG. 18B shows the inflatable portion 504 in an inflated configuration that can be further inflated relative to the uninflated configuration. Upon inflation, internal fluid pressure increases relative to the uninflated configuration.

[0149]

[0192] In some embodiments, an expandable portion (e.g., expandable portion 504) may be disposed at one or both ends of the blood conduit of the expandable impeller housing, as shown, and one or more expandable portions may be disposed between the ends of the blood conduit. After expansion, the expandable member may provide radial support for the expandable impeller housing, thereby helping to maintain a tip gap between one or more blades and the blood conduit wall, particularly in the impeller region of the impeller housing. When expanded, the expandable member may increase stiffness and provide radial support to the expandable impeller housing. When expanded, the expandable member may assist in providing and / or maintaining circularity to the expandable impeller housing at the location of the expandable portion. The housing can have one or more expandable portions along its length, such as 1 to 50. Any number of expandable members 504 may be included along the length of the blood conduit as may be desired to provide additional radial support at one or more particular locations. For example, the expandable housing can have expandable members at one or both ends of one or more expandable support members that surround the impeller described elsewhere herein.

[0150]

[0193] Figures 18A and 18B show an example of an expandable member that does not form / define the entire inner surface of the blood conduit of the expandable impeller housing. In Figures 18A and 18B, the expandable member does not, in fact, form any of the inner surface of the blood conduit.

[0151]

[0194] Figures 18A and 18B show an example of an expandable member having an annular configuration and a straight configuration in side view, and an example of an expandable member positioned perpendicular to the longitudinal axis of the blood conduit, with the relative angle shown at the bottom of Figure 18B.

[0152]

[0195] 18A and 18B show an embodiment of an expandable member disposed at either the proximal or distal end of the blood conduit.

[0196] Additionally, expandable member 504 is an embodiment of an annular expandable member.

[0153]

[0197] FIG. 20 illustrates an expandable impeller housing 530 showing example locations of one or more expandable members. An optional expandable member 532' is disposed at the proximal end of the expandable support member. An optional expandable member 532''' is disposed at the distal end of the expandable support member. An optional expandable member 532'' is disposed between the ends of the conduit and between the ends of the expandable support member. FIG. 20 illustrates how one or more expandable portions can be included in the expandable impeller housing and positioned to provide radial support at one or more desired locations along the length of the conduit, such as in the impeller region to provide radial support.

[0154]

[0198] FIG. 20 further illustrates an optional fluid lumen 534 that extends axially, in this embodiment having a linear configuration, and that may fluidly connect one or more of the expandable members 532. In this example, the fluid lumen 534 extends along the length of the expandable member region of the blood conduit. The expandable impeller housing may further include a fluid lumen similar to the inflation lumen 520 of FIGS. 18A and 18B for connecting one or more expandable members to a fluid source (not shown) at a proximal region of the blood pump. The inflation lumen 534 may house a sensor component therein, such as a sensor wire, as shown in FIGS. 11-17 and described in more detail elsewhere herein. An optional sensor 536, which may be coupled to the sensor wire, may be coupled to the distal strut, as shown. Any other aspect of any expandable housing herein may be included in the expandable housing 530 and is expressly incorporated by reference in FIG. 20. The fluid lumen 534 may be a curved, linear, or helical configuration, or any combination thereof. The fluid lumen 534 can have one or more axially spaced sections having different configurations. For example, without limitation, the fluid lumen 534 can transition from a linear configuration to a helical configuration in a central region and then transition back to a linear configuration. The pump portion can further have any number of axially extending fluid lumens 534.

[0155]

[0199] If the expandable members are fluidly connected, they may be considered a single expandable portion even though some embodiments herein describe them as separate expandable members. For example, if expandable portions 532', 532", 532'" and lumen 534 are all fluidly connected, then all of expandable portions 532', 532", 532'" and lumen 534 may be considered a single expandable portion.

[0156]

[0200] 19A and 19B show an exemplary method of making an annular-shaped expandable member, such as expandable members 504 and 532′-532′″. Tubular member 504 can be equipped with two ends, one of which can have a junction tube 505 inserted into it, as shown in FIG. 19A. The other end of tube 504 is bent and wrapped around and over junction tube 505, and adhesive applied to the end of tube 504 secures the ends together. Side apertures can be made along the length of tube 504 at the sides, and separate inflation tubing 520 can be secured into the side apertures (e.g., with adhesive), thereby creating an inflation lumen for the expandable member. Inflation tube 520 can be fluidly connected to a fluid source at the proximal end of the blood pump (optionally using one or more connectors). The annular expandable portion can then be coupled to the expandable impeller housing.

[0157]

[0201] 21 shows an exemplary expandable housing 540 having a helical expandable member 542 that can optionally extend along the length of an expandable conduit 546. An optional distal impeller 548 and an optional proximal impeller 550 are shown. While an optional orthogonally oriented expandable member 544 is shown at the proximal end of the blood conduit, the expandable impeller housing can have any number of expandable members at various locations, as in the case shown in FIG. 20, and any of these expandable members can be in fluid communication, in which case the communicated expandable members are considered a single expandable member.

[0158]

[0202] FIG. 21 further illustrates an expandable impeller housing with a blood conduit that can be transitioned to an expanded configuration by expanding one or more expandable members. For example, a helical expandable member and / or one or more orthogonally oriented members can expand the blood conduit to a fully deployed configuration (e.g., cylindrical). As an alternative to FIG. 21, the expandable impeller housing can have only orthogonally oriented expandable members that expand the conduit to a fully expanded configuration. Alternatively, in an alternative embodiment, the expandable impeller housing from FIG. 20 may not have an expandable support member around each impeller. Thus, FIG. 21 further illustrates an exemplary expandable housing in which one or more expandable members can be used to expand the blood conduit and provide radial support to one or more regions of the expandable housing upon expansion.

[0159]

[0203] 20 and 21 show an expandable member disposed between the proximal and distal ends of a conduit.

[0204] 18A, 18B, 20, and 21 show an inflatable member disposed at a first end of an expandable support member having an impeller at least partially disposed therein.

[0160]

[0205] 20 and 21 show expandable members that are axially spaced apart from other expandable members.

[0206] FIG. 20 shows a blood pump having a first orthogonally oriented expandable member at the proximal end of the conduit, a second orthogonally oriented expandable member at the distal end of the conduit, a third orthogonally oriented expandable member at a first end of the first expandable member having an impeller at least partially disposed therein, and a fourth orthogonally oriented expandable member at a first end of the second expandable member having a second impeller at least partially disposed therein.

[0161]

[0207] FIG. 21 shows an expandable member having a helical configuration along at least a portion of its length.

[0208] FIG. 21 illustrates an example of an expandable member having a first region having a first configuration (e.g., annular, linear, perpendicular to the longitudinal axis) and a second region having a second configuration (e.g., spiral), where the second configuration is different from the first configuration.

[0162]

[0209] FIG. 20 is an illustration of an expandable housing comprising a plurality of expandable members each adapted to be expanded, any of which may be in fluid communication.

[0163]

[0210] FIG. 20 is an example of at least two expandable members that are fluidly connected to each other and to a first fluid source, such that the expandable members can be inflated using fluid disposed in the first fluid source (the fluid source is not shown, but may be any fluid reservoir).

[0164]

[0211] As an alternative to Figure 21, the spiral section and the orthogonally oriented section may be in fluid communication with a fluid source, but not with each other. The orthogonal and orthogonal sections would each have inflation lumens coupled to different regions. In this embodiment, or any other embodiment, the first and second inflation members may be fluidly connected to first and second fluid sources. This may allow for separate inflation, which may be beneficial, for example, if different fluid pressures / stiffnesses are desired in different regions of the impeller housing. For example, and without limitation, it may be desirable to have a right-angle annular inflatable member with higher stiffness than a helical inflatable member in the central region of the expandable housing.

[0165]

[0212] 18A-21 show examples of blood conduits having a deformable membrane that at least partially defines a lumen, where the membrane is secured (directly or indirectly) to any of the expandable members.

[0166]

[0213] 18A-21 show embodiments of expandable members that do not form any part of the inner surface of the blood conduit (eg, the membrane surface forms the conduit).

[0214] 18A-21 illustrate an embodiment of an expandable member that is disposed entirely radially outward of a flexible membrane that at least partially defines a blood lumen.

[0167]

[0215] 18A-21 show an example of a surface-less expandable member having a cylindrical configuration that extends along the entire length of the blood conduit.

[0216] 20 is an example where a sensor component may be disposed on the expandable member (e.g., 534), optionally where the sensor component floats within the expandable member such that upon expansion, the sensor component floats within the fluid. In various embodiments, the sensor component may be free to move within the lumen of the expandable member. The sensor component may be a sensor wire, optionally a fiber optic wire or a conductive wire.

[0168]

[0217] 20 and 21 are examples of expandable members having at least one non-orthogonally oriented section (e.g., axially linear, helical, or curved), optionally where a second component is present within the lumen.

[0169]

[0218] 20 is an example of an expandable member further having one or more orthogonally oriented portions fluidly connected to a non-orthogonally oriented section in which a sensor component is disposed, where the one or more orthogonally oriented portions do not have a sensor component extending in a orthogonal direction. The sensor component is disposed in at least one of the orthogonally oriented portions herein only where the orthogonally oriented portion is coupled (fluidly connected) to the non-orthogonally oriented portion.

[0170]

[0219] Any of the fluids herein may be, for example, a gas or a liquid. For example, one expandable member may be inflated with a gas and a second expandable member may be inflated with a fluid.

[0171]

[0220] In some alternative embodiments, the expandable member forms a portion of the fluid conduit (e.g., a bilayer region of the fluid conduit that is fluidly connected to the fluid source), but not the entire fluid conduit. For example, the expandable member can have a generally cylindrical configuration (in at least a portion of the expandable member), and an impeller can be at least partially disposed within the cylindrical configuration. In other embodiments, the expandable member has two generally cylindrical, axially spaced apart regions, each of which has an impeller at least partially disposed therein. In embodiments where the blood pump has at least two axially spaced apart, cylindrical expandable regions (which can form portions of the fluid conduit (which can be part of the same expandable member or different expandable members)), a central region of the pump portion can extend between the two cylindrical regions, and the central region may or may not have an expandable member. For example, a central region between two cylindrical regions can have an expandable member that is in at least one of a linear configuration, a curved configuration, or a helical configuration and can be in fluid communication with one or both of the cylindrical expandable regions. Alternatively, the central region can have no expandable member, but can have a fluid lumen that is in fluid communication with one or more expandable members axially spaced from the central region.

[0172]

[0221] In some embodiments, the expandable member forms a portion of the blood conduit (e.g., a bilayer region of the fluid conduit that is fluidly connected to the fluid source), and in another region of the pump portion, the expandable member is further partially disposed on the outer surface of the blood conduit. For example, in some embodiments, the pump portion has a cylindrical expandable section that forms a portion of the blood conduit (e.g., any impeller of the impellers herein is at least partially disposed within the cylindrical expandable section), and axially adjacent the cylindrical expandable section, the pump portion has a second region having a non-cylindrical expandable member that is one or more of overlying, embedded in, or within the blood conduit.

[0173]

[0222] In any of the embodiments herein, any of the expandable members (or at least a portion of the expandable member) may be sandwiched between two layers of material (e.g., an inner layer and an outer layer). For example, any of the expandable members of FIGS. 18A-21 may be sandwiched between outer and inner layers of material. Any of the inner layers in this context may form the inner surface of the blood conduit (or may be part of a composite of layers, with the innermost layer of the composite forming the inner blood conduit surface). Any of the outer layers in this context may help smooth the transition to the expandable member, thereby preventing the expandable member from getting caught, for example, on the distal region of a sheath or other device used in the resheathing / folding process. Any of the outer layers in this context may extend over a portion of the length of the blood conduit or over the entire length of the blood conduit. Any of the inner and outer layers (or composites of layers) in the present context can comprise a variety of flexible materials, such as any of the membrane materials of the materials herein.

[0174]

[0223] The disclosure herein further includes methods of deploying a blood pump having one or more expandable members. The following methods may include any of the deployment methods described herein. The pump portion may be advanced into a fluid delivery device, such as a sheath or other lumen, in a collapsed configuration. The method may include exposing an expandable impeller housing from within the delivery device, the expandable housing having a conduit and an expandable member. The method may include exposing an impeller from within the delivery device such that the impeller resides at least partially within the conduit, where the impeller may expand at least to some extent upon exposure. The method may further include delivering fluid from a fluid source, along an inflation path, and into the expandable member to inflate the expandable member. In various embodiments, any of the methods herein may include collapsing one or more expandable members. In various embodiments, a vacuum is applied to remove fluid (or, optionally, gas, in the case of a closed system) from the expandable member. In any of the embodiments herein, the expandable member is inflatable using purge fluid from a console purge system. In such cases, the purge fluid pressure can be reduced to allow the inflatable member to collapse. In the case of the particular expandable pump described herein, when the pump collapses by being contained within a sheath, purge fluid can be forced out of the inflatable member and into the waste line, thereby allowing the pump portion to collapse.

[0175]

[0224] In various embodiments, the expandable member can be inflated with a purge fluid and configured as a lumen for the purge fluid. For example, the expandable member can extend from the proximal end of the pump to the distal bearing, thereby allowing the distal bearing to be purged. In this way, the expandable member can perform multiple functions, such as accommodating sensor wires, delivering purge fluid, and providing additional structural support for the shroud / blood conduit.

[0176]

[0225] In any of these methods, expanding the expandable member can at least assist in expanding the conduit, if not be a significant part of the conduit expansion process. For example, an expandable support member (scaffold) may or may not be included in the pump portion. In any of the methods herein, expanding the expandable member can provide increased radial support (increased stiffness) at the location of the expanded member, which can help maintain lumen circulability and can help maintain tip clearance between the impeller blades and the conduit wall.

[0177]

[0226] Any of the methods herein can include inflating a second inflatable member, which can be inflated with fluid from a second fluid source or from the first fluid source.

[0178]

[0227] As used herein, an expandable member refers to a component that is expandable even if portions thereof have different configurations.

[0228] Any of the methods herein can include expanding a tubular member containing a sensor component, such as a sensor wire (eg, an optical fiber), therein.

[0179]

[0229] Any of the expandable members herein may be deflated using one or more techniques. For example, any of the expandable members herein may be at least partially deflated by introducing a vacuum to at least partially remove fluid from the expandable member. Additionally or alternatively, any of the expandable members herein may be at least partially deflated by applying one or more forces to the expandable member to displace fluid therein toward a waste or fluid reservoir. For example, a shaft may be pushed distally over one or more expandable members, thereby applying a force to the expandable member to force fluid therefrom. Additionally or alternatively, a radially inward force may be applied to one or more expandable members, thereby force fluid therefrom. One or more forces may be applied to push fluid toward the proximal end of the blood pump toward a waste device or fluid source.

[0180]

[0230] Figures 22A-24 show an exemplary pump portion of an intravascular blood pump, and Figure 22C shows cross section AA shown in Figure 22B. The embodiment of Figures 20A-42 has similarities to the embodiment shown in Figure 21, as can be seen. The pump portion 4100 has an expandable impeller housing 4101 having an expandable and collapsible conduit through which blood is pumped by one or more impellers. The expandable housing 4101 has a conduit 4102, which in some embodiments may be a membrane having a relatively thin wall and which may have a cylindrical configuration, the inner surface of which defines a lumen through which blood is pumped. The expandable housing 4101 further has an inflatable member 4103 secured to the expandable conduit 4102. The expandable member 4103 is in fluid communication with the inflation passage 4104, and the inflation passage 4104 extends through the expandable housing 4101. 22A and 22B . A section of the inflatable pathway is secured to the proximal strut 4105. While this section of the inflatable pathway 4104 secured to the strut 4105 may also be inflatable, it is generally not considered to be part of the inflatable member 4103 that is secured to the expandable conduit and is inflated to promote expansion of the expandable conduit 4102.

[0181]

[0231] 22A and 22B, includes a conduit 4102 secured to an expandable member 4103. In this embodiment, the expandable member 4103 is positioned radially outward of the inner surface of the conduit 4102.

[0182]

[0232] The conduits may be made from a variety of materials, for example, the conduits herein may comprise one or more of polyurethane rubber, silicone rubber, acrylic rubber, expanded polytetrafluoroethylene, polyethylene, or polyethylene terephthalate, including any combination thereof.

[0183]

[0233] The expandable member 4103 may be the same material as the conduit or may be a different material. The expandable member 4103 may comprise one or more of polyurethane rubber, silicone rubber, acrylic rubber, expanded polytetrafluoroethylene, polyethylene, or polyethylene terephthalate, including any combination thereof.

[0184]

[0234] The expandable member 4103 is an example of an expandable member having a helical configuration along at least one section of its length. The expandable member 4103 is an example of an expandable member having a helical configuration along its entire length. The expandable member 4103 is an example of an expandable member that does not form the entire inner surface of a conduit. The expandable member 4103 is an example of an expandable member that does not form any portion of the inner surface of a conduit. The expandable member 4103 is an example of an expandable member that extends from the proximal end to the distal end of a conduit. The expandable member 4103 is an example of an expandable member that is disposed completely radially outside of a flexible conduit. The expandable member 4103 is an example of an expandable member that does not have a cylindrical configuration along the length of a conduit.

[0185]

[0235] The inflatable member 4103 is an embodiment of an inflatable lumen that is not parallel to the longitudinal axis of the pump portion over at least 50% of the length of the inflatable member, over at least 60% of the length of the inflatable member, over at least 70% of the length of the inflatable member, over at least 80% of the length of the inflatable member, and over at least 90% of the length of the inflatable member.

[0186]

[0236] The inflatable member 4103 is also an example of a lumen secured to an expandable conduit, where the lumen has a proximal end aligned with the proximal end of the expandable conduit, and where the lumen has a configuration along its length that is not simply axial between the proximal end of the lumen and the distal end of the lumen. In this embodiment, the distal end of the lumen extends to the distal end 4110 of the conduit, and the proximal end of the lumen is aligned (or at least substantially axially aligned) with the proximal end 4111 of the conduit.

[0187]

[0237] The inflation passage 4104 (which is in fluid communication with the expandable member) may be secured to the proximal strut 4105 using a variety of techniques, such as stitching and / or adhesives.

[0238] 23 conceptually illustrates an external inflation fluid source 4130 in fluid communication with the expandable member 4103 via an inflation pathway 4104. The inflation pathway 4104 extends proximally from the expandable conduit 4102, through the catheter 4120, and in fluid communication with the fluid source 4130. The inflation pathway 4104 internal to the catheter 4120 may be configured in one or more structural configurations. The inflation path 4104 may include a fluid lumen created by an element and thus need not be a single structural component extending from the distal end of the catheter to the proximal end of the catheter. A fluid source 4130 may be fluidly connected to the inflation path 4104 at a connection location 4121 where the two lumens can be attached to establish fluid communication. The fluid reservoir may have a pump adapted and configured to deliver inflation fluid from the fluid reservoir, through the inflation path, and into the inflatable member.

[0188]

[0239] The one or more impellers and the drive mechanism that causes the one or more impellers to rotate may be any of the impellers and drive mechanisms described herein.

[0189]

[0240] The helical expandable member may be manufactured separately and later adhered to the collapsible and expandable conduit. For example, the conduit may first be advanced over a mandrel. The helical expandable member may then be disposed around the conduit and secured to the conduit using, for example, an adhesive and / or heat securing process. The inflation path may be secured to the expandable member before or after the inflation path is secured to the collapsible and expandable conduit.

[0190]

[0241] The expandable member can be expanded to cause the expandable conduit to assume a deployed configuration, thereby creating a blood lumen. Any of the methods of use herein are expressly incorporated by reference herein for all purposes into the following exemplary methods of use. For example, pump portion 4100 can be positioned adjacent to the aortic valve, such as shown in FIG. 4. Methods of use and deployment of pump portion 4100 can incorporate by reference any of the methods of use and deployment herein.

[0191]

[0242] 24 shows the pump portion 4100 in a collapsed delivery configuration within the sheath 4140. After the pump portion 4100 has been advanced to the vicinity of the target location, the sheath 4140 may be retracted relative to the pump portion, thereby exposing the pump portion 4100 near the target location (e.g., the aortic valve). Fluid may then be advanced from the fluid reservoir 4130, through the fluid path 4104, and into the expandable member, thereby inflating the expandable member.

[0192]

[0243] Expansion of the expandable member increases fluid pressure within the expandable member, improving the expandable member's stiffness and expanding the expandable conduit to its fully deployed configuration, as shown in FIGS. 22A and 22B. Once the expandable conduit is reconfigured toward its fully deployed configuration, one or more impellers can be actuated to increase blood flow through the conduit. As shown in FIG. 22A, the expandable member axially stretches the pump section in which the impellers are located, thus providing radial support for the conduit at the locations of the impellers and between the impellers. This expandable member may also be incorporated into pump sections having a single impeller. The expandable member herein is positioned relative to the conduit such that delivering fluid to the expandable member provides radial support for the conduit and expands the conduit toward the deployed configuration, thereby enabling blood vessel pumping through the conduit. In some embodiments, the expandable member can be secured to the expandable conduit; in some embodiments, the expandable member need not be secured directly to the expandable conduit.

[0193]

[0244] 25A-25C show an exemplary embodiment of a pump portion 4160 of a catheter blood pump that may be considered similar in some respects to the embodiment shown in FIGS. 18A-24. The pump portion 4160 has one or more expandable members (which may also be referred to herein as expandable elements or expandable portions) and an expandable blood conduit. The plurality of inflatable members are positioned relative to the expandable conduit such that, upon inflation, the one or more inflatable members radially support the expandable conduit. The pump portion 4160 further includes two impellers (shown in phantom in FIGS. 25B and 25C ) disposed at least partially within the expandable blood conduit, the two impellers configured to pump blood upon rotation. The impellers have one or more blades. In alternative embodiments, the pump portion can have only one impeller or can have three or more impellers. The one or more inflatable members are fluidly connected to one or more fluid inflation paths extending proximally relative to the expandable housing toward one or more fluid sources (see FIG. 23 ).

[0194]

[0245] The pump portion 4160 is an example of a pump portion in which one or more expandable members are configured and positioned relative to the blood conduit such that, when expanded, the expandable portion provides greater radial support at the location of the impeller compared to non-impeller regions (which may also be referred to as regions axially adjacent to the impeller regions). For example, the one or more expandable members provide greater radial support to the expandable conduit 4162 at the impeller proximal region 4163 and the impeller distal region 4165 compared to a central region 4164 axially between the two impellers. This can help provide greater structural support in the region of the impeller, which can help maintain tip clearance between the edges of the impeller blades and the blood conduit. When the pump portion is disposed in such a location, reducing radial support in the central region 4164 can help maintain a degree of flexibility in the central region, thereby helping to provide greater flexibility when the valve leaflets contact the pump portion (as described in more detail herein and incorporated by reference into this section for all purposes) (see, e.g., FIGS. 10A-10F). Additionally, it may simply not be as important to provide as much radial support in the non-impeller regions as in the impeller regions, and thus the inflatable member may be configured and adapted to not provide as much support in one or more non-impeller regions when inflated.

[0195]

[0246] The pump portion 4160 has one or more expandable members that provide radial support for the expandable conduit 4162. An expandable member may have multiple sections, which are provided herein with different reference numbers. For example, an expandable member may be considered to be a combination of individually numbered expandable members, and thus, this combination of expandable members may itself be considered a single expandable member. For example, FIGS. 25A-25C show expandable members 4170, 4171, and 4172. However, 4170, 4171, and 4172 may be considered to be part of the same expandable member, in which case the figures refer to sections 4170, 4171, and 4172 of a single expandable member.

[0196]

[0247] In some examples, individual inflatable members may be considered any and all sections of a pump portion that are fluidly connected to a single fluid source. For example, sections 4170 and 4171 may be fluidly connected to a single fluid source and may be simultaneously inflated when delivering fluid from the fluid source. Also, section 4172 (not fluidly connected to 4170 and 4171) may be fluidly connected to a second fluid source. In this example, sections 4170 and 4171 may be considered sections of a first inflatable member, and section 4172 may be considered a second inflatable member. Accordingly, this disclosure is exemplary and not intended to limit the definition of inflatable member, and inflatable members herein may, in fact, comprise other structural elements that are described as separate inflatable members herein.

[0197]

[0248] In the exemplary embodiment of FIGS. 25A-25C, the spiral sections 4170, 4171, and 4172 provide radial support to the conduit 4162 when inflated as shown. The configuration and arrangement of the different sections 4170, 4171, and 4172 is somewhat similar to a multi-start thread, where the different sections 4170, 4171, and 4172 have a coiled configuration around the conduit with different thread locations such that the different sections are axially spaced apart around the conduit (even though they may physically contact adjacent sections of the inflatable member). These sections may be considered to be coiled and may be between other inflatable sections. These sections are arranged in a pattern along their length (e.g., 4170 / 4171 / 4172, repeated), but in this embodiment do not radially overlap each other.

[0198]

[0249] In other embodiments, there may be only a single impeller (e.g., a proximal impeller or a distal impeller). In such instances, there may be only a single region (e.g., region 4163 or region 4165) that provides greater radial support to the conduit compared to axially adjacent non-impeller regions.

[0199]

[0250] The pitch of all three sections 4170-4172 is smaller in the impeller regions 4163 and 4165 compared to the central non-impeller region 4164. As shown, these pitches increase progressively between the distal end of the proximal impeller and the center of the conduit, and decrease progressively distally as the helical section approaches the distal impeller. The pitch of any of sections 4170-4172 may be constant through at least a portion of the impeller regions 4163 and 4165.

[0200]

[0251] In alternative embodiments, each of the one or more impeller regions can have a generally cylindrically-shaped inflatable member surrounding all or substantially all of the impeller, with a non-cylindrical-shaped inflatable member extending axially from the one or more cylindrically-shaped inflatable members. For example, the pump portion can have one or more inflatable sections in the central region having a linear configuration, with one or more inflatable sections extending axially away from the cylindrically-shaped inflatable member of the impeller region. Alternatively, the pump portion can have one or more inflatable sections in the central region having a helical configuration, with one or more inflatable sections extending axially away from the cylindrically-shaped inflatable member of the impeller region. Alternatively, the pump portion can have one or more inflatable sections in the central region having a curved configuration (e.g., a serpentine configuration), with one or more inflatable sections extending axially away from the cylindrically-shaped inflatable member of the impeller region. The pump portion may have two or more inflatable sections in the central region that do not have the same general configuration as the inflatable sections of other central regions (e.g., one inflatable section may be linear, one inflatable section may be serpentine, one inflatable section may have a different curved configuration, etc.), and any of these sections may be considered part of the same inflatable member, further discussion of which is provided herein.

[0201]

[0252] 25A-25C show the pump portion when the one or more inflatable members are inflated (e.g., after deployment from a delivery device). The pump portion 4160 may be folded as described herein with reference to FIG. 24, which description is incorporated by reference herein for all purposes.

Claims

1. 1. A catheter blood pump comprising: an expandable pump portion extending distally from the elongate shaft, an expandable impeller housing having an expandable blood conduit defining a blood lumen between an inlet portion and an outlet portion; one or more expandable impellers each disposed at least partially within the blood lumen; a sensor wire secured to the expandable impeller housing and extending from a proximal end of the expandable impeller housing to a distal end of the expandable impeller housing; a sensor coupled to the sensor wire, the sensor positioned distal to the distal end of the expandable blood conduit; an expandable pump portion having A catheter blood pump comprising:

2. The catheter blood pump of claim 1 , wherein the sensor wire is secured to the expandable impeller housing so as to be positioned radially outward of the expandable blood conduit.

3. The catheter blood pump of claim 1 , wherein the sensor wire is disposed within a sensor wire lumen, the sensor wire being sized relative to the sensor wire lumen so that the sensor wire floats within the sensor wire lumen.

4. The catheter blood pump of claim 3 , wherein the sensor wire lumen is defined by an inner surface of an elongated hollow shaft, the elongated hollow shaft being fixedly attached to the expandable impeller housing.

5. The catheter blood pump of claim 4 , wherein the elongated hollow shaft has a circular cross-sectional configuration.

6. 5. The catheter blood pump of claim 4, further comprising an overlay disposed about the elongated hollow shaft, the overlay positioned to secure the elongated hollow shaft to the expandable impeller housing.

7. The catheter blood pump of claim 6 , wherein the overlay comprises one or more types of material that are different from the material of the elongate hollow shaft.

8. The catheter blood pump of claim 6 , wherein the overlay comprises a polymeric material, optionally a urethane, optionally a polycarbonate-based material.

9. 7. The catheter blood pump of claim 6, wherein an overlay material has at least one characteristic that is different from a component of the expandable impeller housing that is radially within and adjacent to the elongated hollow shaft.

10. The catheter blood pump of claim 9 , wherein the component has a higher stiffness than the overlay.

11. The catheter blood pump of claim 9 , wherein the component has a lower stiffness than the overlay.

12. 10. The catheter of claim 9, wherein the component includes a membrane of the expandable impeller housing. Tel blood pump.

13. 10. The catheter blood pump of claim 9, wherein the overlay is thicker than the component, the thickness being measured perpendicular to a longitudinal axis of the expandable impeller housing.

14. 10. The catheter blood pump of claim 9, wherein the overlay is thinner than the component, the thickness being measured perpendicular to a longitudinal axis of the expandable impeller housing.

15. The catheter blood pump of claim 9 , wherein the overlay has a different durometer than the component.

16. The catheter blood pump of claim 9 , wherein the overlay has the same chemical structure as the component.

17. The catheter blood pump of claim 9 , wherein the overlay has a different chemical structure than the component.

18. The catheter blood pump of claim 3 , wherein the sensor wire lumen is defined by one or more polymeric materials.

19. The catheter blood pump of claim 3 , wherein the sensor wire lumen has a radially outer surface defined by an overlay.

20. 20. The catheter blood pump of claim 19, wherein the sensor wire lumen has a radially inner surface defined by the overlay.

21. 20. The catheter blood pump of claim 19, wherein the sensor wire lumen has a radially inner surface that includes a component of the expandable impeller housing.

22. 22. The catheter blood pump of claim 21, wherein the component is a membrane of the expandable impeller housing.

23. The catheter blood pump of claim 3 , wherein the sensor wire lumen is at least partially defined by a protrusion that protrudes radially outward relative to the generally circular cross-sectional profile of the expandable impeller housing.

24. 24. The blood pump of claim 23, wherein the protrusions have the same chemical structure as components of the expandable blood conduit.

25. 24. The blood pump of claim 23, wherein the protrusions have a different chemical structure than the membrane of the expandable blood conduit.

26. 24. The blood pump of claim 23, wherein the protrusion has at least one characteristic different from the membrane of the expandable blood conduit.

27. 2. The catheter blood pump of claim 1, wherein the sensor wire is fixed relative to the expandable impeller housing so that the sensor wire does not float within the sensor wire lumen.

28. an overlay disposed around the sensor wire; 28. The catheter blood pump of claim 27, wherein a is positioned to secure the sensor wire to the expandable impeller housing.

29. 30. The catheter blood pump of claim 28, wherein the overlay has at least one property that differs from a property of the membrane of the expandable impeller housing.

30. 30. The catheter blood pump of claim 29, wherein the overlay comprises a polymeric material, optionally a urethane, optionally polycarbonate-based.

31. 30. The catheter blood pump of claim 29, wherein the membrane has a higher stiffness than the overlay.

32. 30. The catheter blood pump of claim 29, wherein the membrane has a lower stiffness than the overlay.

33. 30. The catheter blood pump of claim 29, wherein the overlay is thicker than the membrane, the thickness being measured perpendicular to the longitudinal axis of the expandable impeller housing.

34. 30. The catheter blood pump of claim 29, wherein the overlay is thinner than the membrane, the thickness being measured perpendicular to a longitudinal axis of the expandable impeller housing.

35. 30. The catheter of claim 29, wherein the overlay has a different durometer than the membrane.

36. 30. The catheter blood pump of claim 29, wherein the overlay has the same chemical structure as the membrane.

37. 30. The catheter blood pump of claim 29, wherein the overlay has a different chemical structure than the membrane.

38. 38. The catheter blood pump of claim 1, wherein the sensor wire extends in a helical configuration around at least a portion of the expandable impeller housing.

39. 39. The catheter blood pump of claim 38, wherein the sensor wire extends in a helical configuration along the entire length of the expandable impeller housing.

40. 38. The catheter blood pump of claim 1, wherein the sensor wire extends in a linear configuration along at least a portion of the expandable impeller housing.

41. 38. The catheter blood pump of claim 1, wherein the sensor wire extends in a linear configuration along the entire length of the expandable impeller housing.

42. 38. The catheter blood pump of claim 1, wherein the sensor wire extends in a helical configuration around a portion of the expandable impeller housing and extends in a linear configuration along at least a portion of the expandable impeller housing.

43. The sensor wire extends proximally from the expandable impeller housing and communicates with a proximal region of the blood pump that is positioned to remain external to the patient during operation of the impeller.

43. A catheter blood pump according to any one of claims 1 to 42.

44. 44. The catheter blood pump of claim 1, wherein the sensor wire is an optical fiber.

45. 45. The catheter blood pump of claim 1, wherein the sensor is secured to an expandable distal strut at the pump inlet, the distal strut extending distally relative to a distal end of the expandable blood conduit.

46. 46. ​​The catheter blood pump of claim 45, wherein the sensor is affixed to a radially outer surface of the expandable distal strut.

47. 46. ​​The catheter blood pump of claim 45, wherein the sensor wire is further anchored to the distal strut proximal to the sensor.

48. 48. The catheter blood pump of claim 47, wherein the sensor wire is linearly aligned with the distal strut.

49. 49. The catheter blood pump of claim 45, wherein a sensor wire lumen is secured to the distal strut proximal to the sensor, and the sensor wire is disposed within the sensor wire lumen.

50. 50. The catheter blood pump of claim 45, wherein the sensor wire is anchored to a proximal expandable strut, the proximal strut extending proximally from the proximal end of the blood conduit.

51. 51. The catheter blood pump of claim 50, wherein the sensor wire follows the configuration of the proximal strut.

52. 52. The catheter blood pump of claim 50 or claim 51, further comprising a sensor wire lumen within which the sensor wire is disposed, the sensor wire lumen being anchored to the proximal expandable strut.

53. 53. The catheter blood pump of claim 52, wherein the sensor wire lumen follows the configuration of the proximal struts.

54. 54. The catheter blood pump of any one of claims 1 to 53, wherein the expandable impeller housing has one or more scaffold sections.

55. 55. The catheter blood pump of claim 54, wherein the expandable impeller housing has increased stiffness in the proximal and distal sections compared to a central section between the distal and proximal sections.

56. 56. The catheter blood pump of claim 54 or claim 55, further comprising a distal impeller in the distal section and a proximal impeller in the proximal section.

57. 57. The catheter blood pump of claim 1, wherein the sensor is fixed so that the pressure sensing area is not perpendicular to the longitudinal axis of the expandable housing.

58. 58. The catheter blood pump of claim 57, wherein the sensor is affixed such that the pressure sensing area is optionally between 1 degree and 89 degrees relative to the longitudinal axis, such as between 5 degrees and 85 degrees, between 10 degrees and 80 degrees, etc.

59. 59. The catheter blood pump of any one of claims 1 to 58, wherein the sensor wire is fixedly attached to the expandable impeller housing but is movable relative to the expandable impeller housing.

60. 60. The catheter blood pump of any one of claims 1, 2, and 27-59, wherein the sensor wire is secured to the expandable impeller housing and the sensor wire is surrounded by material along its length where it is secured to the expandable housing.

61. 1. A method of manufacturing a pump portion of an intravascular blood pump, comprising: fabricating a tubular substrate layer, said tubular substrate layer directly or indirectly defining at least a portion of a blood lumen of said pump section; disposing an elongated hollow shaft over and extending along at least a portion of the tubular substrate layer; applying an overlay onto the elongated hollow shaft along substantially the entire length of the elongated hollow shaft; A method comprising:

62. 62. The method of claim 61, wherein creating a tubular substrate layer comprises depositing a softened polymeric material onto a mandrel and allowing the softened polymeric material to cool.

63. 63. The method of claim 61 or claim 62, wherein the step of positioning the elongate hollow shaft over and extending along at least a portion of the tubular substrate layer includes a step of positioning the elongate hollow shaft to have one or more spiral sections, and optionally the elongate hollow shaft further has one or more linear sections.

64. 63. The method of claim 61 or claim 62, wherein the step of positioning an elongate hollow shaft over and extending along at least a portion of the tubular substrate layer includes a step of positioning the elongate shaft to have one or more linear sections, and optionally the elongate shaft further has one or more helical sections.

65. 65. The method of any one of claims 61 to 64, wherein applying an overlay comprises applying a softened thermoplastic material over the elongate hollow shaft.

66. 66. The method of any one of claims 61 to 65, further comprising the step of placing a sensor wire radially within the overlay.

67. 67. The method of claim 66, further comprising removing the elongate hollow shaft to create a sensor wire lumen.

68. 68. The method of claim 67, wherein the step of removing the elongated hollow shaft occurs before the step of radially disposing the sensor wire within the overlay.

69. 67. The method of claim 66, wherein placing the sensor wire comprises placing the sensor wire within the elongate hollow shaft.

70. 70. The method of any one of claims 61 to 69, further comprising the step of affixing a sensor to the pump portion, the sensor being coupled to the sensor wire.

71. 71. The method of claim 70, wherein anchoring the sensor comprises anchoring the sensor to a strut extending axially from an end of a blood conduit.

72. 72. The method of claim 71, wherein anchoring the sensor to a strut comprises anchoring the sensor to a distal strut.

73. 73. The method of any one of claims 61 to 72, further comprising the step of anchoring the sensor wire lumen to a proximal strut, the proximal strut extending proximally from a proximal end of the blood conduit.

74. 74. The method of any one of claims 61 to 73, further comprising the step of affixing a second sensor to the blood pump, the second sensor being positioned at or near the outflow of the pump portion.

75. 75. The method of any one of claims 61-74, further comprising affixing the tubular substrate layer to one or more expandable scaffold sections, each of the one or more expandable scaffold sections providing radial support for a blood conduit.

76. 27. The catheter blood pump of claim 3, wherein the sensor wire lumen is in fluid communication with a source of inflation fluid such that the sensor wire lumen is inflatable.

77. 77. The catheter blood pump of claim 76, wherein the sensor wire lumen has a closed distal end.

78. 1. A catheter blood pump comprising: an expandable pump portion extending distally from the elongate shaft, an expandable impeller housing having an expandable blood conduit defining a blood lumen between an inlet and an outlet, an expandable portion fluidly connected to a fluid path extending proximally from the expandable impeller housing, the expandable portion secured to the blood conduit and positioned to provide radial support for the blood conduit when the expandable portion is inflated; and one or more expandable impellers each disposed at least partially within the blood lumen and adapted to move blood through the blood conduit; an expandable pump portion having A catheter blood pump comprising:

79. 79. The catheter blood pump of claim 78, further comprising a fluid source spaced proximally from the expandable housing, the fluid source remaining outside the body when the expandable housing is at a target location, the fluid source being in fluid communication with the fluid pathway.

80. 80. The catheter blood pump of claim 79, wherein the fluid source is adapted to deliver fluid therefrom either manually or automatically, or both.

81. 79. The catheter blood pump of claim 78, wherein the blood conduit is adapted and configured such that inflation of the expandable portion at least partially enlarges the blood conduit.

82. 82. The catheter blood pump of any one of claims 78 to 81, wherein the inflatable portion has an annular configuration in at least one section of the inflatable portion.

83. 83. The catheter blood pump of any one of claims 78 to 82, wherein the inflatable portion does not form the entire inner surface of the blood lumen.

84. 84. The catheter blood pump of any one of claims 78 to 83, wherein the expandable portion has at least one section having an annular configuration and is oriented perpendicular to the longitudinal axis of the blood conduit.

85. 85. The catheter blood pump of claim 84, wherein the section is a first section and the expandable portion further comprises a second section axially spaced from the first section, the second section having an annular portion and oriented perpendicular to a longitudinal axis of the blood conduit.

86. 85. The catheter blood pump of claim 84, wherein the section is disposed within an impeller region of the expandable impeller housing, the impeller region being disposed at least partially around the impeller.

87. 87. The catheter blood pump of claim 86, wherein the section is located at one of a proximal end and a distal end of the impeller region.

88. 87. The catheter blood pump of claim 86, wherein the section is axially disposed between the proximal and distal ends of the impeller region.

89. 87. The catheter blood pump of claim 86, wherein the section is disposed at one of the proximal or distal end of the blood conduit.

90. 85. The catheter blood pump of claim 84, wherein the section is disposed at one of the distal end or the proximal end of the blood conduit.

91. 85. The catheter blood pump of claim 84, wherein the section is disposed between a distal end and a proximal end of the blood conduit.

92. 85. The catheter blood pump of claim 84, wherein the section is disposed at a first end of an expandable scaffold disposed around the impeller.

93. 93. The catheter blood pump of any one of claims 78 to 92, wherein the inflatable portion is a first inflatable portion and the expandable impeller housing further comprises a second inflatable portion fluidly connected to the fluid pathway or to another fluid pathway extending proximally from the expandable impeller housing.

94. 79. The catheter blood pump of claim 78, wherein the inflatable portion has a helical configuration along at least a portion of the expandable impeller housing.

95. the expandable portion has a constant pitch along the expandable impeller housing; 95. The catheter blood pump of claim 94.

96. 95. The catheter blood pump of claim 94, wherein the expandable portion has a variable pitch along the expandable impeller housing.

97. 97. The catheter blood pump of claim 96, wherein the expandable portion has a smaller pitch in the impeller region compared to regions adjacent the impeller region.

98. 98. The catheter blood pump of claim 97, wherein the impeller region is a first impeller and the expandable portion has a smaller pitch in a second impeller region compared to a region adjacent the first impeller region.

99. 99. The catheter blood pump of claim 98, wherein the adjacent region is a central region axially between the first impeller region and the second impeller region.

100. 97. The catheter blood pump of claim 96, wherein the expandable portion extends over a greater surface area of ​​the expandable impeller housing within the impeller region compared to areas axially adjacent the impeller region.

101. 101. The catheter blood pump of any one of claims 78 to 100, wherein the expandable portion is configured and positioned relative to the blood conduit such that, when expanded, the expandable portion provides greater radial support to the blood conduit at the location of one or more of the impellers compared to areas of the blood conduit adjacent one or more of the impellers.

102. 101. The catheter blood pump of any one of claims 78 to 100, wherein the expandable impeller housing comprises two or more inflatable portions configured and positioned relative to the blood conduit such that, when inflated, the two or more inflatable portions provide greater radial support to the blood conduit at the location of one or more of the impellers compared to areas of the blood conduit adjacent one or more of the impellers.

103. 103. The catheter blood pump of claim 101 or claim 102, wherein the adjacent region is a central region of the expandable impeller housing.

103. 79. The catheter blood pump of claim 78, wherein the expandable impeller housing comprises two or more expandable portions, the two or more expandable portions having a helical configuration and configured to be disposed between one another along at least a portion of the blood conduit.

104. 104. The catheter blood pump of claim 103, wherein the two or more expandable portions have a double-start thread configuration.

105. 104. The catheter blood pump of claim 103, wherein the two or more expandable portions have a triple-start thread configuration.

106. 106. The catheter blood pump of any one of claims 78 to 105, wherein the inflation path is anchored to a proximal strut extending proximally from the expandable impeller housing.

107. The expansion path includes a proximal spool extending proximally from the expandable impeller housing.

106. A catheter blood pump according to any one of claims 78 to 105, forming a slot.

108. 108. A catheter blood pump as described in any one of claims 78 to 107, wherein the blood conduit has a deformable membrane that at least partially defines the lumen, the membrane being secured (directly or indirectly) to any of the inflatable members.

109. 109. The catheter blood pump of any one of claims 78 to 108, wherein the inflatable portion is disposed entirely radially outward of a flexible membrane that at least partially defines the blood lumen.

108. 109. The catheter blood pump of any one of claims 78 to 108, wherein a sensor component is disposed in the expandable portion, and optionally the sensor component floats within the expandable portion.

109. 109. The catheter blood pump of claim 108, wherein the sensor component is a sensor wire.

110. 109. The catheter blood pump of claim 108, wherein the expandable portion has at least one non-orthogonally oriented section in which the sensor component is disposed.

111. 1. A method for deploying a pump portion of a catheter blood pump within the body of a subject, the method comprising: exposing an expandable impeller housing from within a delivery device, the expandable impeller housing having an expandable blood conduit and an inflatable portion secured to and positioned along at least a portion of the expandable blood conduit; exposing an impeller from within the delivery device, the impeller being at least partially within the blood conduit, and optionally at least partially expanding the impeller; delivering fluid from a fluid source disposed external to the body of the subject along an inflation path into the inflatable portion; inflating the inflatable portion; and radially supporting the blood conduit with the expanded expandable portion.

112. 112. The method of claim 111, wherein expanding the expandable portion at least partially expands the blood conduit toward a cylindrical configuration.

113. 113. The method of claim 111 or claim 112, wherein the step of radially supporting the blood conduit with the expanded expandable portion assists in maintaining tip clearance between the impeller blades and the blood conduit as the impeller rotates.

114. 114. The method of any one of claims 111 to 113, wherein delivering fluid along the inflation path comprises delivering fluid along the inflation path with a sensor wire positioned within the inflation path.

115. 115. The method of any one of claims 111 to 114, further comprising at least partially deflating the inflatable portion a period of time after the step of inflating the inflatable portion.

116. 116. The method of claim 115, wherein at least partially deflating the inflatable portion comprises introducing a vacuum to at least partially remove fluid from within the inflatable portion.

117. 117. The method of any one of claims 111 to 116, wherein the step of radially supporting the blood conduit further comprises the step of radially supporting the blood conduit more strongly at the location of the impeller compared to non-impeller regions.

118. 118. The method of claim 117, wherein providing stronger radial support to the blood conduit at the location of the impeller compared to the non-impeller region comprises providing stronger radial support to the blood conduit at the location of a second impeller region compared to the non-impeller region.

119. 118. The method of any one of claims 111 to 117, further comprising positioning the expandable impeller housing to span an aortic valve.

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