Intravascularly delivered blood pumps and related devices, systems, and methods

Abstract

Intravascularly delivered blood pumps and related devices, systems, and methods are disclosed herein. A method of intravascularly delivering a blood pump according to aspects of the present technology may include, for example, advancing an elongate delivery dilator through a patient's vasculature so that a first portion of the elongate delivery dilator is externally accessible near the subclavian artery and a second portion of the elongate delivery dilator is externally accessible near the femoral artery. The method may further include attaching the second portion of the elongate delivery dilator to a drive line, the opposite end of which is connected to a balloon; and then retracting the first portion of the elongate delivery dilator to move the drive line and balloon through the patient's vasculature to a target site with the balloon positioned within the aorta. TIFF2022532767000002.tif158128

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Patent Application No. 62 / 849,646, filed May 17, 2019, entitled PERCUTANEOUS BLOOD PUMP AND ASSOCIATED DEVICES, SYSTEMS, AND METHODS, the entire disclosure of which is incorporated herein by reference.

[0002] Technical Field The present technology relates to systems, devices, and methods for treating heart failure, and in particular to methods for endovascularly implanting circulatory support systems, and related systems and methods. [Background technology]

[0003] background The prevalence of heart failure is increasing worldwide, resulting in a costly burden for healthcare providers. Despite medical advances, the prognosis for patients with heart failure remains poor, especially for those with advanced stages of heart failure. This is due in part to limited treatment options for such patients. For example, heart transplantation remains limited by the supply of donor organs, and the use of left ventricular assist devices (LVADs) remains at approximately 5,000 implants per year; this is due, among other factors, to the requirement of major surgical intervention and cardiopulmonary bypass. In addition, the high cost of LVADs has hindered the widespread adoption of these devices. For example, some countries have decided not to fund the use of LVADs for long-term mechanical support of heart failure patients. While biventricular pacemakers are widely used to treat patients with early class III heart failure, the use of left ventricular assist devices is restricted to those with advanced class IV heart failure, leaving a group of heart failure patients with limited or no treatment options. Summary of the Invention

[0004] [Brief description of the drawings]

[0005] Many aspects of the present technology can be better understood with reference to the following drawings. The components in the drawings are not necessarily to scale, emphasis instead being placed upon clearly illustrating the principles of the present disclosure.

[0006] [Figure 1] 1 illustrates an intravascular circulatory support system implanted within a patient's vasculature and constructed in accordance with aspects of the present technology; [Figure 2A]

[0023] Figures 2A-2G illustrate various stages of a procedure for endovascularly implanting the circulatory support system depicted in Figure 1 in accordance with aspects of the present technology. Figures 2H and 2I are flow charts for a procedure for endovascularly removing and / or replacing one or more implanted components of the circulatory support system depicted in Figure 1 in accordance with aspects of the present technology. [Figure 2B] See legend to Figure 2A. [Figure 2C] See legend to Figure 2A. [Figure 2D] See legend to Figure 2A. [Figure 2E] See legend to Figure 2A. [Figure 2F] See legend to Figure 2A. [Figure 2G] See legend to Figure 2A. [Figure 2H] See legend to Figure 2A. [Figure 2I] See legend to Figure 2A. [Figure 3A] 3A-3C are side and cross-sectional views, respectively, of an extendable member and drive line configured in accordance with aspects of the present technology. [Figure 3B] See legend to Figure 3A. [Figure 3C] See legend to Figure 3A. [Figure 4A]Figures 4A and 4B are enlarged isometric and cross-sectional views, respectively, illustrating features of the drive line shown in Figures 3A-3C in accordance with aspects of the present technique, and Figure 4C is an enlarged side view of a kink-resistant element of the drive line shown in Figures 4A and 4B in accordance with aspects of the present technique. [Figure 4B] See legend to Figure 4A. [Figure 4C] See legend to Figure 4A. [Figure 5A] 5A-5C are partial cutaway side views of an elongate delivery dilator constructed in accordance with aspects of the present technology. [Figure 5B] See legend to Figure 5A. [Figure 5C] See legend to Figure 5A. [Figure 6] 6A and 6B are isometric views of a funnel assembly for reducing a cross-sectional dimension of an extendable member in accordance with aspects of the present technology. [Figure 7] 7A is a side view of a collapsing tube for reducing a cross-sectional dimension of an expandable member in accordance with aspects of the present technology, and FIGs. 7B and 7C are enlarged side views of proximal and distal portions, respectively, of the collapsing tube of FIG. 7A configured in accordance with aspects of the present technology. [Figure 8A] 8A and 8B are side perspective and partial cross-sectional views, respectively, of an arterial interface device for establishing hemostasis configured in accordance with aspects of the present technology. [Figure 8B] See legend to Figure 8A. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0007] Detailed Description The present technology provides circulatory support systems and devices, and methods for endovascularly implanting, retrieving, and replacing the same. In some embodiments, an endovascular delivery procedure begins by accessing both the subclavian artery (e.g., via the axillary artery) and the femoral artery of a patient, and advancing a guidewire through the patient's vasculature so that the guidewire extends between the subclavian artery and the femoral artery. The method continues by advancing an elongated delivery dilator over the guidewire so that the elongated delivery dilator extends between the subclavian artery and the femoral artery, with a first portion of the elongated delivery dilator externally accessible near the subclavian artery and a second portion of the elongated delivery dilator externally accessible near the femoral artery. The method further includes releasably attaching a second portion of the elongated delivery dilator to a first end region of a drive line; the drive line has a second end region connected to a de-inflated intra-aortic balloon. Pulling a first portion of the elongate delivery dilator near the subclavian artery moves the elongate delivery dilator, drive line, and balloon through the patient's vasculature in a counter-direction to blood flow until the balloon is positioned at a target site within the patient's descending aorta. Circulatory support systems delivered using the intravascular delivery systems and techniques described herein are designed to provide long-term support for patients suffering from heart failure.

[0008] Specific details of some embodiments of the present technology are described below with reference to Figures 1-8B. Although many of the embodiments of the present invention are described below with reference to the delivery and use of an intravascular ventricular assist device ("iVAD") that positions a balloon pump in the aorta to provide counterpulsation to help blood circulate through the body, other applications and other embodiments are within the scope of the present technology in addition to those described herein. For example, the delivery devices, systems, and methods described herein may be used to implant other devices in the aorta and / or at other target sites in the patient's vasculature. In addition, some other embodiments of the present technology may have different configurations, components, or procedures than those described herein, and features of the embodiments shown herein may be combined with each other. Thus, one skilled in the art will understand that the present technology may have other embodiments with additional elements or without some of the features shown and described below with reference to Figures 1-8B.

[0009] The terminology used in the following description is intended to be interpreted in its broadest possible manner, even when used in connection with the detailed description of certain specific embodiments of the present technology.Certain terms may be emphasized below; however, terms intended to be interpreted in a limited manner are clearly and specifically defined as such in this detailed description section.In addition, the present technology may also include other embodiments that fall within the scope of the embodiment but are not described in detail with respect to Figures 1-8B.

[0010] Throughout this specification, a reference to "one embodiment" or "an embodiment" means that a particular feature, structure, or characteristic described with respect to that embodiment is included in at least one embodiment of the present technology. Thus, the appearances of the phrases "in one embodiment" or "in an embodiment" in various places throughout this specification do not necessarily refer to the same embodiment. Furthermore, particular features or characteristics may be combined in any suitable manner in one or more embodiments.

[0011] Throughout this specification, references to "practitioner" refer to medical professionals performing a procedure and / or portions thereof, including physicians, physician assistants, nurse practitioners, and the like. "Practitioner" may also refer to automated devices for performing medical procedures, such as robotic arms. Additionally, while a certain procedure is described as being performed by "a" practitioner, further reference to "the" practitioner does not necessarily indicate that the same practitioner is performing each of the described steps of the procedure. In fact, steps of the procedure may be performed by multiple different practitioners. Thus, the use of "a" and "the" before the practitioner does not limit the scope of who is performing the described steps.

[0012] Throughout this specification, references to relative terms such as "generally," "approximately," and "about" are used herein to mean the stated value plus or minus 10%.

[0013] The headings provided herein are for convenience only and do not interpret the scope or meaning of the claimed technology.

[0014] Heart Failure and the Circulatory Support System Heart failure occurs when the heart cannot maintain blood flow to meet the body's needs. This occurs when the heart cannot pump adequately during contraction or cannot fill adequately during relaxation. Heart failure is a prevalent, costly, and potentially fatal condition. For example, heart failure currently affects approximately 6.5 million people in the United States and is expected to increase by 46% by 2030. The stage / severity of heart failure can be defined using the New York Heart Association (NYHA) class, with NYHA class I representing early disease and NYHA class IV representing later disease. Current treatment options for heart failure vary depending on the stage of heart failure and include drug therapy, cardiac resynchronization therapy (CRT), long-term mechanical circulatory support (e.g., left ventricular assist devices or "LVADs"), and heart transplantation, among many other options. Drug therapy and CRT are typically used in relatively early cases (e.g., patients with NYHA class II or early NYHA class III heart failure). However, these treatments typically only slow the progression of heart failure, meaning that patients who initially respond to medical treatment or CRT typically experience disease progression and require more advanced therapeutic intervention.

[0015] The prognosis for patients with heart failure remains poor: 1-year mortality is about 15.0% for patients with NYHA class III and about 28.0% for patients with NYHA class IV. This is at least in part due to the limited number of treatment options available for patients with late NYHA class III / early NYHA class IV heart failure. For example, heart transplantation offers the best chance of long-term survival in patients with late NYHA class IV, but this option is limited by a shortage of donor organs (e.g., approximately 2000 cases per year in the United States, 200 cases per year in Canada, and less than 100 cases per year in Japan). Thus, many patients with NYHA class III and class IV must rely on other treatments. For example, some patients undergo LVAD therapy as a bridge to heart transplantation or as a stand-alone treatment. However, LVAD therapy has several inherent drawbacks that limit its widespread use. Current LVAD therapies are expensive (e.g., over $100,000), typically require a major surgical procedure for implantation (typically a sternotomy or thoracotomy), typically require the use of cardiopulmonary bypass during the implantation procedure, and typically require blood products (e.g., approximately 10-12 units of blood products). LVAD therapies that are implanted through less invasive means (e.g., endovascularly) are used only for short-term circulatory support. In addition, postoperative care of patients receiving LVADs can be difficult and expensive, and can be highly anxiety-inducing, as the device must not lose or lose power for longer than a few minutes. LVAD therapy is also associated with several serious adverse events, including device failure, thrombosis, thromboembolism, stroke, infection, and bleeding. For at least these reasons, LVAD therapy is typically reserved for patients with end-stage disease (e.g., late NYHA class IV) who have limited options. This leaves a significant proportion of patients with heart failure too advanced for CRT but not severe enough to justify LVAD therapy / heart transplant (e.g., late NYHA class III / early NYHA class IV patients) without effective treatment options.Currently, approximately 1.6 million patients in the United States and 3.9 million patients in Europe have late Class III / early Class IV heart failure, representing a large patient population with limited treatment options.

[0016] Another treatment option for heart failure is counterpulsation therapy using an intra-aortic balloon pump (IABP). Counterpulsation therapy is achieved by rapidly inflating a balloon positioned within the patient's aorta just after aortic valve closure (dicrotic notch) and then rapidly de-inflating the balloon just before the onset of systole. Rapid inflation of the balloon increases diastolic aortic pressure by 25-70%, increasing end organ and coronary perfusion. Rapid de-inflation of the balloon reduces native ventricular ejection pressure, reducing afterload and external work of the left ventricle. Counterpulsation therapy has been shown to be effective when the patient's systolic aortic pressure is approximately 40-80 mmHg, native heart rate is approximately 70-110 bpm, and the counterpulsation volume (i.e., balloon volume) is approximately equal to the native left ventricular stroke volume.

[0017] Counterpulsation therapy is an attractive treatment option because the use of an IABP is much simpler than the implantation and use of an LVAD and has fewer associated adverse events. For example, physicians can implant an IABP without directly cannulating the heart. However, conventional counterpulsation systems implanted through minimally invasive procedures can only be used for short periods of time. This is for several reasons. For example, issues with arterial access (e.g., femoral artery), IABP durability, and biocompatibility can limit the use of IABP to short periods of time, less than about 14 days. Longer periods of IABP support (>14 days) can lead to increased frequency of vascular complications, infections, and bleeding. Furthermore, in its current form, the catheter-mounted IABP, which is advanced retrogradely from the femoral artery into the descending aorta, requires the patient to remain supine for the duration of the treatment. Thus, the patient cannot be made ambulatory (or discharged from the hospital). These limitations have prevented the IABP from being used as a long-term treatment for heart failure and instead it is used in short-term settings, such as patients awaiting transplant or undergoing coronary artery bypass surgery.

[0018] Some newer devices provide chronic counterpulsation but require invasive surgical implantation procedures. These devices have been developed and introduced into the clinic after the hemodynamic and metabolic benefits of counterpulsation therapy were demonstrated (e.g., Symphony by Abiomed, CardioVAD by LVAD Technologies, and C-Pulse by Sunshine Medical). The Symphony counterpulsation device showed hemodynamic efficacy in in vivo animal studies, but clinical trials in Canada were terminated. CardioVAD and C-Pulse devices reported increased cardiac output and end-organ perfusion, as well as a significant reduction in NYHA functional class, indicating clinical improvement. However, CardioVAD and C-Pulse have not yet achieved clinical acceptance due to the need for full thoracotomy or sternotomy for device implantation. Thus, previous cardiac surgery limits the use of these devices. Furthermore, placement of either device may complicate further treatments, such as LVAD or heart transplantation. Nevertheless, these clinical trials demonstrated hemodynamic and clinical benefits of chronic counterpulsation therapy in heart failure patients. The assignee / applicant of the present invention (NuPulseCV, Inc.) has developed a counterpulsation therapy system with lower device and hospitalization costs and lower adverse event burden than LVAD therapy; it was the first chronic circulatory support device approved by the U.S. Food and Drug Administration (FDA) for a feasibility study in NYHA class III and IV heart failure patients without the requirement of transplant listing (i.e., an all-comers study). Devices have been successfully implanted in over 50 patients in the U.S. for up to 361 days, with n=15 discharged. The devices showed improvement in NYHA functional class, and also statistically significant improvement over baseline heart failure values ​​in cardiac index (39%), cardiac output index (35%), and ejection fraction (48%).Although these systems are less invasive than current LVAD therapies, they still require a surgeon, an operating room, administration of general anesthesia, and approximately four hours. Thus, there is a large unmet clinical need for long-term mechanical circulatory support devices for patients with NYHA class III and IV heart failure that are less invasive, less expensive, non-restrictive, and / or have a lower adverse event burden.

[0019] The present technology provides long-term or chronic counterpulsation therapy for heart failure patients that can be implanted using minimally invasive endovascular procedures. For example, the present technology includes an endovascular ventricular assist device that provides partial circulatory support, can be implanted minimally invasively without entering the chest, and generally does not require cardiopulmonary bypass or blood product administration. In particular, the present technology includes an endovascular IABP delivery technique to further reduce the invasiveness of implantation and allow cardiologists and other physicians dedicated to the procedure to implant the device in a catheter lab using standard minimally invasive techniques rather than extensive surgery. The endovascular implantation procedure does not require general anesthesia and can be completed in about 2 hours or less. The endovascular implantation procedure and associated devices and systems of the present invention are expected to further reduce the cost of surgery and hospitalization, as well as adverse events, compared to current IABP implantation procedures and devices. Furthermore, the devices and systems described herein are designed to provide patients with long-term or chronic therapy (e.g., for more than about 6 months).

[0020] Selected Aspects of Chronic Intravascular Circulatory Support System FIG. 1 illustrates a circulatory support and / or intravascular ventricular assist system 100 ("system 100") configured in accordance with an optional aspect of the present technology. System 100 may include an expandable member 110 implantable within the aorta of a patient suffering from heart failure. System 100 may further include a first drive line 120 (also referred to as an "internal drive line"), an arterial interface device or stopper device 130, a second drive line 140, a skin interface device 190, a drive unit 150, and a sensor 160. System 100, when implanted, may provide counterpulsation therapy to a patient suffering from heart failure.

[0021] The expandable member 110 may be a balloon or other element that changes size and / or shape in response to being filled with a gas or liquid. For example, in some embodiments, the expandable member 110 is a balloon composed of a biocompatible, non-thrombogenic elastomeric material (e.g., Biospan®-S). The expandable member 110 may also be made of other suitable materials. The expandable member 110 may be transitioned between at least a first generally de-inflated state and a second generally inflated state. The expandable member 110 has a first volume when in the first (e.g., de-inflated) state and a second volume when in the second (e.g., inflated) state that is greater than the first volume. Thus, the expandable member 110 may provide counterpulsation therapy by repeatedly transitioning between the first and second states. To transition the expandable member 110 between the first and second states, the drive unit 150 may direct a fluid (gas or liquid, e.g., air) into the interior volume of the expandable member 110 via the first drive line 120 and the second drive line 140, as described in more detail below. The expandable member 110 may also be sized and / or shaped to reduce and / or prevent the expandable member 110 from blocking arteries branching off the aorta, such as the renal arteries. Additional details of the expandable member 110 are described below with respect to FIGS. 3A-3C. In some embodiments, the expandable member 110 may also have certain features generally similar to those described in U.S. Pat. Nos. 8,066,628, 8,323,174, and 8,326,421, the disclosures of which are incorporated herein by reference in their entirety. In some embodiments, the expandable member 110 includes an expandable end effector separate from or in addition to a balloon.

[0022] The first drive line 120 is an elongated structure having a lumen extending therethrough for delivering inflation gas to the expandable member 110. The first drive line 120 can be positioned at least partially within the patient's vasculature (e.g., between the aorta and the axillary or subclavian arteries). After the system 100 is implanted, the first drive line 120 can have a first end portion (e.g., a distal end portion) coupled to the expandable member 110 and positioned within the patient's vasculature (e.g., within the descending aorta) and a second end portion (e.g., a proximal end portion) coupled to the second drive line 140 and positioned externally within the patient's vasculature. The first drive line 120 can exit the patient's vasculature at an arteriotomy, such as in the axillary artery, subclavian artery, or another suitable blood vessel.

[0023] The second drive line 140 may also be an elongated structure having a lumen extending therethrough. The second drive line 140 may be positioned at least partially subcutaneously but external to the patient's vasculature. After the system 100 is implanted, the second drive line has a first end portion (e.g., a distal end portion) coupled to the first drive line 120 and a second end portion (e.g., a proximal end portion) coupled to the skin interface device 190. The first drive line 120 and the second drive line 140 may be made of the same or different materials and may have the same or different dimensions (e.g., length, outer diameter, inner diameter, etc.). In some embodiments, the second drive line 140 may include absorbing features to reduce longitudinal strain that may be transferred to the first drive line 120 when the patient moves. For example, in some embodiments, the absorbent feature is a curved region (e.g., an "S" shape or other serpentine curve) that can compress in response to a longitudinal force, thereby reducing and / or preventing the longitudinal force from being transmitted to the intravascular portion of the system 100 (e.g., the first drive line 120 and / or the expandable member 110).

[0024] The first drive line 120 may be coupled to the second drive line 140 using any suitable technique. In some embodiments, the first drive line 120 is at least partially inserted into the second drive line 140 (or vice versa) and secured thereto using a compression ring. In some embodiments, the first drive line 120 is sewn, glued, stitched, or otherwise secured to the second drive line 140. In some embodiments, the first drive line 120 is attached to the second drive line 140 via a combination of the techniques described above and / or via other suitable attachment techniques. Regardless of the connection mechanism, when the first drive line 120 is coupled to the second drive line 140, the lumen of the first drive line 120 is fluidly connected to the lumen of the second drive line 140 such that gas flowing through the lumen of the second drive line 140 also flows through the lumen of the first drive line 120. Although described as first and second drive lines, in some embodiments the first drive line 120 and the second drive line 140 may be a single integral component.

[0025] As discussed above, the first drive line 120 may be coupled to the extendable member 110 to deliver inflation gas thereto. For example, a first end portion of the first drive line 120 may be connected to the extendable member 110 such that a lumen extending through the first drive line 120 is in fluid communication with the interior of the extendable member 110. Thus, gas flowing through the lumen of the first drive line 120 toward the extendable member 110 may enter the extendable member 110, which transitions the extendable member 110 from a first state to a second state (e.g., inflates the extendable member 110). The first drive line 120 may also receive gas from the extendable member 110 as the extendable member 110 transitions between the second state and the first state (e.g., as the extendable member 110 de-inflates). Additional details of the first drive line 120 are shown with respect to FIGS. 4A and 4B.

[0026] The arterial interface device or stopper device 130 provides long-term (e.g., greater than about 3 months, greater than about 6 months, greater than about 12 months, etc.) hemostasis to the arteriotomy (e.g., at the subclavian or axillary artery) where the first drive line 120 exits the vasculature. The stopper device 130 may include multiple anchoring elements that can be used to securely fix the stopper device 130 in a desired orientation or position. Additional details of the stopper device 130 are described in more detail with respect to Figures 8A and 8B. In some embodiments, the stopper device 130 may include certain features generally similar to those described in U.S. Patent No. 7,892,162, the disclosure of which is incorporated herein by reference in its entirety. For example, the stopper device 130 may include a sewing ring (e.g., a patch of polyester velour that is sutured to the artery to provide mechanical support), a graft (e.g., a polyester fabric defining a lumen and sutured to the sewing ring and the artery to provide arterial access), and a stopper element (e.g., a silicone plug having a lumen for receiving the first drive line 120 that is inserted into the lumen of the graft to provide hemostasis).

[0027] The skin interface device 190 is a percutaneous device that allows an external drive unit 150 to drive the actuation of the implanted extensible member 110. For example, in some embodiments, the skin interface device 190 provides a stable and / or reliable exit site for the second drive line 140, allowing the second drive line 140 to be directly connected to the drive unit 150. In other embodiments, the second drive line 140 may be coupled to an interior-facing portion of the skin interface device 190, and the drive unit 150 may be coupled (e.g., via a hose, conduit, or other tube 192) to an exterior-facing portion of the skin interface device 190. In such embodiments, the skin interface device 190 may direct gas received from the drive unit 150 (e.g., via tube 192) to the second drive line 140 for delivery to the extensible member 110. In some embodiments, the skin interface device 190 may be generally similar to the skin interface device described in US Pat. No. 10,137,230, the entire disclosure of which is incorporated herein by reference.

[0028] The drive unit 150 may generate a flow of gas into and out of the extendable member 110 via the first drive line 120 and the second drive line 140. For example, the drive unit 150 may generate a positive pressure to accelerate gas into the extendable member 110 via the first drive line 120 and the second drive line 140, thereby inflating the extendable member 110. The drive unit 150 may also induce a negative pressure to pull gas out of the extendable member 110 via the first drive line 120 and the second drive line 140, thereby de-inflating the extendable member 110. The drive unit 150 may induce the flow of gas into and out of the extendable member 110 through a number of different mechanisms. For example, the drive unit 150 may utilize a bellows, blower, compressor, accelerator, or other similar features to drive the flow of gas into and out of the extendable member 110. In some embodiments, the drive unit 150 may control the volume of air forced into the extensible member 110 to avoid over-inflating the extensible member 110. For example, in an embodiment utilizing a bellows to generate the airflow, the volume of the airflow generated by the bellows (e.g., the volume of the bellows) may be matched to the internal volume of the extensible member 110. In some embodiments, the drive unit 150 uses ambient air (e.g., "room air") from the environment surrounding the drive unit 150 to drive the operation of the system 100. Without being bound by theory, the use of ambient air is expected to reduce the size, weight, and / or cost of the drive unit 150 compared to drive units that rely on an internal supply of gas or fluid (e.g., a helium tank). For example, in some embodiments, the drive unit 150 is about 2.2 kg or less. Thus, in some embodiments, the drive unit is portable / ambulatory. In other embodiments, the drive unit 150 is operatively coupled to or otherwise includes a source of gas or fluid (not shown), such as a helium tank. The drive line may be disconnected near the skin interface device 190 when the system 100 is not in use during operational conditions.

[0029] The sensor 160 may sense one or more physiological parameters related to the patient's intrinsic cardiac rhythm to synchronize operation of the system 100 with the cardiac cycle. In particular, the sensed one or more physiological parameters may be used to automatically synchronize operation of the drive unit 150 with the patient's intrinsic heartbeat so that the expandable member 110 is inflated and deflated at the appropriate times during the cardiac cycle. In some embodiments, the sensor 160 may sense one or more physiological parameters in real time. As illustrated in FIG. 1, the sensor 160 may be coupled to the skin interface device 190 via a subcutaneous wire 162. The skin interface device 190 may relay measurements received from the sensor to the drive unit 150 via a wired or wireless connection. In other embodiments, the sensor 160 may be wirelessly connected to the drive unit 150 and may transmit the sensed measurements directly to the drive unit 150 without the skin interface device 190. The sensor 160 may be an implanted sensor, an external sensor, or both an implanted sensor and an external sensor. For example, in some embodiments, sensor 160 is an implantable bipolar electrode that is positioned in or near the heart or other suitable tissue to determine, for example, when the left ventricle is contracting or relaxing.

[0030] System 100 provides chronic support of cardiac function and blood flow while still allowing the patient to remain ambulatory. Typical ventricular assist devices require femoral access for drive lines and / or connection to a large, fixed external control unit, thus confining the patient to a bed in a supine position for the duration of the treatment. In contrast, system 100 allows the patient to move about relatively unhindered. Furthermore, the level of treatment provided by system 100 is adjustable to match the needs of the patient. For example, the ratio of volume displacement and support provided by expandable member 110 (e.g., 1:1, 1:2, 1:3 support) can be adjusted to vary the support provided. Without being bound by theory, gradually reducing volume displacement over time may provide a controlled cardiac load, which may be beneficial for cardiac recovery in some cases. Additionally, unlike conventional circulatory support systems, system 100 can be turned off, such as to assess the patient's ability to handle the demands of the heart without support prior to removal of system 100, or for another suitable reason. For example, in some embodiments, expandable member 110 is designed to remain within the aorta in a de-inflated condition for a relatively long period of time (e.g., 23 hours per day). This is in contrast to conventional devices, which often must be removed if turned off for more than about 15 minutes, as reactivation can flush out emboli that formed while in a non-operating state.

[0031] An alternative method for endovascular implantation of a chronic circulatory support system. The present technology provides endovascular implantation devices, systems, and methods. Figures 2A-2G illustrate various stages of an endovascular implantation procedure according to select embodiments of the present technology. Although the implantation procedure is described with respect to implantation of the system 100 of Figure 1, the same implantation method may also be used for implantation of other endovascular ventricular assist devices and / or other types of endovascular devices.

[0032] The endovascular implantation procedure of the present technology involves establishing access to the patient's vascular system at two different locations. For example, FIG. 2A illustrates a first introducer sheath 270 inserted into a first vessel and a second introducer sheath 275 inserted into a second vessel. In the illustrated embodiment, the first vessel is the femoral artery FA and the second vessel is the axillary artery AA and / or the subclavian artery, although other vessels may be accessed and used. As will be understood by those skilled in the art, the subclavian artery is continuous with the axillary artery, with the transition between the two arteries typically defined at the lateral edge of the first rib. Thus, although the endovascular implantation procedure is described below using the axillary artery AA as the second vessel, the procedure may be performed in the same manner using the subclavian artery as the second vessel. Additionally, although the illustrated embodiment shows the first introducer sheath 270 inserted into the right femoral artery, the first introducer sheath 270 may alternatively be inserted into the left femoral artery. Similarly, although the illustrated embodiment shows the second introducer sheath 275 inserted into the left axillary artery, the second introducer sheath 275 may alternatively be inserted into the right axillary artery. A medical practitioner may select an appropriate vessel based on, for example, the patient's anatomy, medical history, and other factors. The first introducer sheath 270 provides hemostatic and controlled access to the first vessel, and the second introducer sheath 275 provides hemostatic and controlled access to the second vessel. For example, in some embodiments, the first introducer sheath 270 includes a first hemostatic valve, and the second introducer sheath 275 includes a second hemostatic valve.

[0033] To establish access to the target vessel (e.g., the axillary artery AA and / or the femoral artery FA), the practitioner may optionally first detect the target vessel using one or more imaging techniques (e.g., ultrasound, fluoroscopy). Following detection of the target vessel, the practitioner may create a micropuncture (e.g., needle puncture) in the target vessel using any suitable technique, such as the standard or modified Sedinger technique. With the needle inserted in the target vessel, the practitioner may insert a guidewire through the needle and into the target vessel. The practitioner may remove the needle while leaving at least a portion of the guidewire in the vessel. In some embodiments, the vessel may then be closed using a conventional Perclose device to minimize bleeding. In some embodiments, the practitioner may use multiple Perclose devices. The practitioner may also place a sheath (e.g., an 8 Fr sheath) or other dilator (e.g., a side arm) over the guidewire to re-establish access to the vessel (e.g., if the vessel was previously closed with the guidewire still in place). In some embodiments, the arteriotomy is progressively dilated using progressive dilators / sheaths (e.g., 10 Fr, 12 Fr, etc.). Once the targeted dilation is achieved, an introducer sheath may be inserted into the target vessel. In some embodiments, the introducer sheath is inserted into the vessel to further dilate the vessel toward the targeted dilation (e.g., inserted before the targeted dilation is achieved). Once the introducer sheath is in the vessel, the practitioner may then access other target vessels (e.g., the axillary artery AA or femoral artery FA) using the same or a similar process.

[0034] The introducer sheath may be selected based on the target vessel. For example, in some embodiments, the introducer sheath is a peel-away sheath having a length of about 10 cm or more. In other embodiments, the introducer sheath is a non-peel-away sheath or other "longer" sheath having a length of about 30 cm or more. For example, in patients with extremely tortuous subclavian arteries, using a non-peel-away sheath at the axillary artery AA may simplify the process of establishing access to the axillary artery AA. In some embodiments, the introducer sheath may be expandable within the artery, such as a SoloPath™ sheath.

[0035] Returning to the illustrated embodiment, the first introducer sheath 270 at the femoral artery FA may have a diameter of about 12 Fr to about 20 Fr (e.g., about 16 Fr, about 18 Fr, etc.). The femoral artery FA can typically accommodate a larger diameter sheath, such as a 16 Fr sheath, than certain other locations in the patient's vasculature, including the axillary artery AA. Using a larger diameter sheath makes it easier to insert selected components, such as the system 100, into the patient's vasculature. The second introducer sheath 275 may have a diameter of about 8 Fr to about 16 Fr (e.g., about 12.5 Fr, about 14 Fr, etc.).

[0036] Once access to the femoral artery FA and the axillary artery AA is established, the guidewire GW may be advanced through the patient's vasculature such that the guidewire GW extends between the femoral artery FA and the axillary artery AA as illustrated in FIG. 2A. In particular, the guidewire GW may be exteriorized through a first introducer sheath 270 in the femoral artery FA and through a second introducer sheath 275 in the axillary artery AA, thereby establishing a "rail" between the first introducer sheath 270 and the second introducer sheath 275 in a technique referred to as "flossing" the patient. The guidewire GW may be any suitable guidewire long enough to extend between the first introducer sheath 270 and the second introducer sheath 275. For example, in some embodiments, the guidewire GW has a length of greater than about 200 cm (e.g., about 220 cm, about 240 cm, about 260 cm, etc.). The guidewire GW may have any suitable diameter (e.g., about 0.035 inches). In some embodiments, the guidewire GW is an exchange length angled wire (e.g., Glidewire).

[0037] In some embodiments, the practitioner establishes a rail by inserting the guidewire GW through the second introducer sheath 275 and into the axillary artery AA. The practitioner then inserts a catheter (e.g., a 5 Fr MP-1 catheter, JR4 catheter, etc.) through the first introducer sheath 270 and into the femoral artery. The practitioner may guide the catheter toward the axillary artery AA to capture the guidewire GW. The catheter may then be used to guide the guidewire GW from the axillary artery AA into the distal aorta and to the femoral artery FA (e.g., using a LAO 20° projection). The guidewire GW may then be exteriorized through the second introducer sheath 275 at the femoral artery FA. If the guidewire GW does not penetrate the hemostasis valve on the first introducer sheath 270, the practitioner may insert a clamp into the hemostasis valve and may once again attempt to advance the guidewire GW through the first introducer sheath 270. If the guidewire GW still does not penetrate the hemostasis valve, the guidewire may be clamped onto the sheath and the guidewire may be pulled while maintaining hemostasis using another suitable technique (e.g., manual compression above / above the access site). In such an embodiment, once the GW is exteriorized at the femoral artery arteriotomy, a new introducer sheath may be advanced over the guidewire. Although the above technique describes inserting the guidewire GW through the second introducer sheath 275 and advancing it towards the first introducer sheath 270, in other embodiments, the guidewire may alternatively be inserted through the first introducer sheath 270 and advanced towards the second introducer sheath 275 using a similar technique.

[0038] After the rail is established, an elongate delivery dilator 280 (also referred to as a "delivery tube," "delivery shaft," "delivery sheath," "delivery catheter," or "interceptor dilator") may be advanced over the guidewire GW to extend between the first introducer sheath 270 at the femoral artery FA and the second introducer sheath 275 at the axillary artery AA, as illustrated in FIG. 2B. For example, a medical practitioner may insert the elongate delivery dilator 280 into the patient's axillary artery AA via the second introducer sheath 275, advance the elongate delivery dilator 280 through a portion of the patient's vasculature, and exteriorize the elongate delivery dilator 280 through the first introducer sheath 270. As will be described in more detail with respect to FIG. 5A, the elongate delivery dilator 280 may have an inwardly beveled or pointed end region to aid in guiding the elongate delivery dilator 280 in a retrograde direction into the first introducer sheath 270 and penetrating the hemostatic valve therein. In some embodiments, a reverse operation is used to advance the elongate delivery dilator 280 (i.e., the elongate delivery dilator 280 is inserted through the first introducer sheath 270 and advanced toward the second introducer sheath 275). After advancing the elongate delivery dilator 280 through the patient's vasculature, a first portion 282 (e.g., a proximal end portion) of the elongate delivery dilator 280 becomes externally accessible near the axillary artery AA, and a second portion 284 (e.g., a distal end portion) of the elongate delivery dilator 280 becomes externally accessible near the femoral artery FA. For example, Figure 2C shows a close-up view of the elongate delivery dilator 280 exiting the femoral artery FA via the first introducer sheath 270. Additional details of the elongate delivery dilator 280 are detailed with respect to Figures 5A-5C. Once the elongate delivery dilator 280 is positioned as shown in Figure 2B, the guidewire GW may be removed.

[0039] An exteriorized distal end portion 284 of the elongate delivery dilator 280 may be releasably connected to the first drive line 120. More specifically, the distal end portion 284 may be releasably connected to a first end region 222 of the first drive line 120, which also includes a second end region 224 connected to the expandable member 110. The elongate delivery dilator 280 may be securely secured to the first drive line 120 using a connector or other attachment mechanism. For example, as described in further detail with respect to FIGS. 4A-5C, the first end region 222 of the first drive line 120 may have a threaded female connection element, and the distal end portion 284 of the elongate delivery dilator 280 may have a threaded male connection element sized and shaped to interface with the threaded female connection element. 5B and 5C, the distal end portion 284 of the elongate thin delivery dilator 280 may have a removable portion that covers the threaded male connection element until it is ready to connect to the drive line 120. Thus, in some embodiments, after the distal end portion 284 of the elongate thin delivery dilator 280 is exteriorized through the first introducer sheath 270 to expose the threaded male connection element, the medical practitioner removes the removable portion of the elongate thin delivery dilator 280. The medical practitioner then connects the elongate thin delivery dilator 280 to the first drive line 120 by threading the threaded male connection element into the threaded female connection element on the first drive line 120.

[0040] Pulling on the proximal end portion 282 of the elongate delivery dilator 280 moves the first drive line 120 and the expandable member 110 through the first introducer sheath 270 and into the patient's vasculature. For example, once the elongate delivery dilator 280 is connected to the first drive line 120, a medical practitioner may pull the elongate delivery dilator 280 at the exteriorized proximal end portion 282 proximate the axillary artery AA. Because the elongate delivery dilator 280 is connected to the first drive line 120 at its distal end portion 284, the first drive line 120 and the expandable member 110 are pulled through the first introducer sheath 270 and into the femoral artery FA as the elongate delivery dilator 280 is withdrawn from the axillary artery AA through the second introducer sheath 275, as shown in FIG. 2D. The practitioner may continue to pull the elongate delivery dilator 280 out of the axillary artery AA, which moves the expandable member 110 through the patient's vasculature in a direction opposite to the blood flow. The practitioner may continue to pull the elongate delivery dilator 280 until the first drive line 120 is exteriorized near the axillary artery AA and / or until the expandable member 110 is in a desired position (e.g., in the descending thoracic aorta). The positioning of the expandable member 110 can be confirmed via CT bony landmarks and / or angiograms, such as with a 5F Omni™ Flush catheter or pigtail catheter inserted through the first introducer sheath 270. For example, in some embodiments, the practitioner may want to confirm that the expandable member 110 is positioned above the renal arteries and therefore does not block the renal arteries.

[0041] In some embodiments, the first drive line 120 is long enough (e.g., about 200 cm or more) to extend between and through both the first introducer sheath 270 and the second introducer sheath 275 simultaneously. This ensures that a portion of the first drive line 120 remains outside the patient's body while the expandable member 110 is implanted. Thus, even if the first drive line 120 is accidentally detached from the elongate delivery dilator 280 during the implantation procedure, a portion of the first drive line 120 at the first introducer sheath 270 and / or the second introducer sheath 275 will still be outside the patient's body, preventing the first drive line 120 and the expandable member 110 from being lost inside the patient's body.

[0042] In some embodiments, the expandable member 110 is deflated before being pulled through the first introducer sheath 270 and into the femoral artery FA. For example, a medical practitioner may attach a Y-connector to the proximal end portion 282 of the elongate delivery dilator 280. Because the lumen of the elongate delivery dilator 280 is in fluid communication with the interior of the expandable member 110 (via the first drive line 120), the medical practitioner may remove air from the expandable member 110 using a syringe or other pump element. The medical practitioner may then close the Y-connector (e.g., using a stopcock) to maintain negative pressure within the expandable member 110, the first drive line 120, and the elongate delivery dilator 280. Without wishing to be bound by theory, deflating the expandable member 110 is expected to reduce and / or minimize the profile of the expandable member 110, making it easier to pull through the first introducer sheath 270 and into the patient's vasculature.

[0043] In some embodiments, the expandable member 110 is folded, twisted, or otherwise placed in a reduced cross-sectional delivery state prior to or during pulling into the femoral artery FA through the first introducer sheath 270. For example, the expandable member 110 may be pulled through a funnel assembly or other collapsing tube to reduce one or more dimensions of the expandable member 110. Exemplary funnel assemblies and collapsing tubes are described in more detail below with respect to FIGS. 6A-7C. In some embodiments, the expandable member 110 may be manually folded or twisted in addition to or in lieu of using a funnel assembly or other collapsing tube. Reducing the dimensions (e.g., cross-sectional dimensions, outer diameter, etc.) of the expandable member 110 is expected to make it easier to pull the expandable member 110 through the first introducer sheath 270 and into the patient's vasculature. In some embodiments, the folding and / or twisting steps may be performed in combination with the degassing procedure described above. In other embodiments, the folding and / or twisting steps are performed in place of the degassing procedure described above. In some embodiments, the folding procedure is performed immediately prior to pulling the extendable member 110 into the vasculature. In other embodiments, the extendable member 110 may be preloaded into the funnel assembly / folding tube. However, in some embodiments, no folding device is used and the extendable member 110 is loaded / pulled directly into and through the first introducer sheath 270.

[0044] If the expandable member 110 does not require repositioning or does not move easily after it is inside the patient's vasculature, the practitioner may remove the stopcock from the Y-connector and insert a wire (e.g., a 0.035 inch Supra Core wire - not shown) through the elongate delivery dilator 280 and first drive line 120 and into the expandable member 110. The wire may provide a rail for movement. The practitioner may also insert a dilator sheath (e.g., a 12 Fr Check-Flo® sheath) over the wire and into the expandable member 110 to provide a reinforcing rail for movement. Additionally or alternatively, the practitioner may advance a second wire (e.g., a stiff wire with an angle for sliding) outside of but alongside the elongate delivery dilator 280 and / or first drive line 120 to act as a "buddy wire." This second wire may be inserted through the same (e.g., original) incision in the axillary artery AA, or a new micropuncture or arteriotomy may be made. Another option to facilitate moving the expandable member 110 within the patient's vasculature is for the medical practitioner to insert a snare or other feature into the femoral artery FA via the first introducer sheath 270. The snare or other feature may releasably grab the expandable member 110. The expandable member 110 may then be both pushed and pulled toward the desired position within the patient's vasculature.

[0045] With the expandable member 110 within the patient's vasculature, the procedure continues by moving (e.g., pulling) the first drive line 120, with the expandable member 110 attached thereto, through the patient's vasculature until the expandable member 110 is positioned at the target site. For example, as shown in FIG. 2E, the target site for the expandable member 110 may be within the descending thoracic aorta, at which point the first end region 222 of the first drive line 120 is also exteriorized near the axillary artery AA. In some embodiments, the first drive line 120 may exit through a second introducer sheath 275. For example, if the first drive line 120 has an outer diameter smaller than the diameter of the second introducer sheath 275 (e.g., if the first drive line 120 is a 12.5 Fr drive line and the second introducer sheath 275 is a 14 Fr sheath), the first drive line 120 will exit the axillary artery AA through the second introducer sheath 275. However, if the first drive line 120 has a diameter larger than the diameter of the second introducer sheath 275 (e.g., if the first drive line 120 is a 12.6 Fr drive line and the second introducer sheath 275 is a 12.5 Fr sheath), the second introducer sheath 275 will be withdrawn from the axillary artery AA along with the first drive line 120, as shown in FIG. 2E. In some embodiments, the outer diameter of the drive line may be tapered or otherwise beveled such that the first end region 222 has a smaller outer diameter than the second end region 224. In such an embodiment, the first end region 222 may fit through the second introducer sheath 275, while the second end region 224 cannot fit through the second introducer sheath 275. Once the first drive line 120 exits the patient's vasculature at the axillary artery AA, the elongate delivery dilator 280 may be disconnected from the first drive line 120 (e.g., by unscrewing the male connecting element from the female connecting element). Similarly, the second introducer sheath 275 may be removed, regardless of whether it remains within the axillary artery AA when the first drive line 120 is withdrawn from the axillary artery AA.

[0046] The medical practitioner may insert an arterial interface device (e.g., stopper device 130) onto the first drive line 120 to re-establish hemostasis in the axillary artery AA, as shown in FIG. 2F. At least a portion of the stopper device 130 may extend into the axillary artery AA to provide hemostasis. The medical practitioner may use a variety of suitable anchoring techniques or mechanisms to secure the stopper device 130 in place for long-term or permanent implantation. For example, the stopper device 130 may include an anchoring mechanism that provides stability near the arteriotomy site. As described below with respect to FIGS. 8A and 8B, the anchoring mechanism may be an expandable member, a biocompatible glue, a suture, other suitable elements, or a combination thereof. In some embodiments, the stopper device 130 is an implantable stopper and is positioned subcutaneously. Thus, the stopper device 130 may remain in the patient to provide hemostasis in the axillary artery AA for the duration of the treatment.

[0047] In other embodiments, the practitioner may use other suitable techniques to re-establish hemostasis in the axillary artery AA. For example, the practitioner may insert an angled guidewire into the femoral artery and advance a catheter (e.g., JR4 catheter, RDC catheter, etc.) over the guidewire and into the femoral artery FA. The catheter may be advanced through the patient's vasculature to the second introducer sheath 275 and exchanged for a wire (e.g., a 0.018 inch V18 wire). An appropriately sized (e.g., based on CT or ultrasound) subclavian balloon (e.g., a 0.035 inch balloon) may be advanced over the wire. The second introducer sheath 275 may then be removed while the subclavian balloon is inflated to prevent blood flow. To provide hemostasis, a Perclose ProGlide® suture may be tightened over the first drive line 120 exiting the axillary artery AA and manual compression may be maintained. If hemostasis is not achieved initially, the subclavian balloon may be inflated in the axillary artery AA and held with manual compression (e.g., for 10 minutes). If hemostasis is still not achieved, the practitioner may re-advance the second introducer sheath 275 into the axillary artery AA, verify the position of the second introducer sheath 275 within the arteriotomy by contrast injection, inject biocompatible glue (e.g., Floseal®), and confirm hemostasis after manual compression.

[0048] The practitioner may also remove the first introducer sheath 270 from the femoral artery FA using a suitable vascular closure device and / or technique. For example, in some embodiments, the practitioner may remove the first introducer sheath 270 and achieve hemostasis using a MANTA® vascular system closure device or other similar device. If hemostasis is not initially achieved in the femoral artery FA, ​​the practitioner may optionally apply manual compression or use a balloon, stent, or other device to achieve hemostasis.

[0049] 2G, the medical practitioner may implant the second drive line 140 within the patient. For example, the medical practitioner may create a subcutaneous tunnel from the abdomen to the pectoral muscle and advance the second drive line 140 through the tunnel from the abdomen to the pectoral muscle such that a first end region 242 of the second drive line 140 remains adjacent the abdomen and a second end region 244 of the second drive line is adjacent the stopper device 130.

[0050] As previously mentioned, the first drive line 120 has a relatively long length to span and extend through the femoral and axillary artery arteriotomy during the implantation procedure. Thus, a portion of the first drive line 120 may need to be removed to allow connection to the second drive line 140 and / or to fit within the patient. Thus, the medical practitioner may remove (e.g., cut, detach, remove, etc.) the excess length of the first end region 222 of the first drive line 120 extending out of the stopper device 130, thereby forming a "new" proximal end portion 223. The medical practitioner may then securely fasten the proximal end portion 223 of the first drive line 120 to the second end region 244 of the second drive line 140 to form a pneumatic seal therebetween (e.g., seal up to 500 mmHg to prevent gas leakage), as shown in FIG. 2G. In some embodiments, the second end region 244 of the second drive line 140 has an inner diameter that is approximately equal to or slightly larger than the outer diameter of the proximal end portion 223 of the first drive line 120. For example, the second end region 244 of the second drive line 140 may have an inner diameter that is expandable to about 5 mm, and the proximal end portion 223 of the first drive line 120 may have an outer diameter of about 4.2 mm. Thus, the second end region 244 of the second drive line 140 may be placed "over" at least a portion of the proximal end portion 223 of the first drive line 120. The second drive line 140 may then be securely fastened to the first drive line 120 using a compression ring or sutures, or the like, to provide a pneumatic seal between the first drive line 120 and the second drive line 140. Thus, in some embodiments, the second drive line 140 may be referred to as an "overtube." Without wishing to be bound by theory, it is expected that the relatively large inner diameter of the second drive line 140 will allow for faster shuttle of fluid (e.g., gas such as air) in and out of the extensible member 110 and will make it easier to connect the second drive line 140 to the skin interface device 190.

[0051] Optionally, a first end region 242 of the second drive line 140 may then be trimmed to a suitable length and connected to the skin interface device 190 using barbs, mating threads, and / or other suitable connection features. In some embodiments, the second drive line 140 may further include an anchoring feature (not shown) for securely fastening the second drive line 140 to tissue. For example, the second drive line 140 may include one or more wings or appendages 245 with a number of holes (not shown) for suturing the second drive line 140 to patient tissue. Thus, in some embodiments, the medical practitioner may anchor the second drive line 140 to tissue once the second drive line 140 is in the desired position. The medical practitioner may then connect the drive unit 150 to the skin interface device 190 to drive the actuation of the expandable member 110.

[0052] The endovascular implantation procedure described above with reference to Figures 2A-2G is expected to provide multiple benefits. For example, the endovascular approach to implanting an intra-aortic blood pump is less invasive than surgical methods. The endovascular procedure does not require a sternotomy or thoracotomy, nor does it require the use of cardiopulmonary bypass or blood products. Rather, the procedure described herein can, at least in some embodiments, be completed by a cardiologist using local anesthesia in a cardiac catheterization lab. This is expected to reduce the complexity, time, and cost associated with open chest surgical approaches to implanting circulatory support systems. The procedure of the present invention is also expected to reduce hospital stays and reduce re-admissions and / or reoperations due to post-operative complications. In addition, the endovascular procedure of the present invention does not prevent patients from receiving LVADs and / or other cardiac support systems in the event of disease progression. This is in contrast to systems implanted via sternotomy or thoracotomy; such procedures may disrupt the chest cavity and prevent further major surgery.

[0053] Moreover, the above-described endovascular implantation technique also provides at least some advantages over other endovascular implantation techniques for LVADs. For example, the above-described technique allows for implantation of the system 100 in an orientation that allows for long-term use of the system 100 and does not require the patient to remain in a supine position during treatment. This is due, at least in part, to the orientation of the drive line 120 extending in a cranial (rather than caudal) direction from the expandable member 110 when implanted according to the above-described endovascular implantation technique.

[0054] For at least the aforementioned reasons, the endovascular procedure of the present invention allows circulatory support to be used earlier in disease progression and in a larger class of patients than conventional procedures. For example, conventional circulatory support therapy (e.g., LVAD) is limited to advanced heart failure cases due to the complexity and risks associated with implanting a circulatory support system. However, the procedure of the present invention expands the class of patients who may receive a circulatory support system by reducing the complexity, time, and cost, and increasing safety of implanting a circulatory support system endovascularly (rather than surgically). For example, the present technology may expand the availability of circulatory support therapy to all patients with NYHA class III or class IV heart failure, not just the most advanced patients.

[0055] As will be understood by those skilled in the art, various steps described above may be omitted and / or performed in an alternative order without departing from the scope of the present technology. Similarly, various steps and procedures described above may be performed with components other than those expressly identified or described.

[0056] Selective Methods for Removing and / or Replacing Chronic Circulatory Support Systems - Patent application An implanted circulatory support system, such as the iVAS system 100 described above with reference to Figures 1-2G, or components thereof, may require removal or replacement for clinical and / or device-related reasons, such as myocardial recovery or device expiration. Accordingly, the present technology also provides methods for removing an implanted circulatory support system (e.g., system 100) and / or portions thereof (e.g., expandable member 110). For example, the extraction and / or replacement procedures described herein can remove the expandable member 110 from a location superior or cranial to the implanted expandable member 110 (e.g., through the subclavian or axillary arteries, as described below with reference to Figure 2H), or from a location caudal to the implanted expandable member 110 (e.g., through the femoral artery, as described below with reference to Figure 2I).

[0057] FIG. 2H is a flow chart illustrating an extraction and / or replacement procedure 201 for removing an expandable member 110 through the subclavian or axillary artery according to aspects of the present technology. The extraction procedure 201 is described with reference to the endovascular ventricular assist system 100 of FIG. 1 and various features of the associated delivery system illustrated in FIGS. 2A-2G, but the extraction procedure 201 may be used to extract and / or replace other endovascular implants or may use features of other delivery systems. The extraction procedure 201 may begin by inserting a guidewire (e.g., similar to the guidewire GW shown in FIG. 2A) into the patient's vasculature at the subclavian or axillary artery AA (block 202). For example, a medical practitioner may insert the wire through a port in the stopper device 130 (e.g., through the second side port 839, further described above with respect to FIG. 8A) and into the patient's axillary artery AA. When the wire is inserted into the patient's vasculature, it remains outside of the first drive line 120 (e.g., to the side of the first drive line 120). The procedure 201 may continue with retracting the portion of the first drive line 120 that is outside of the patient's vasculature to move the expandable member 110 in a cranial direction through the patient's vasculature (block 204) and ultimately through the arteriotomy in the axillary artery AA (block 206). In some embodiments, the expandable member 110 may be withdrawn through the stopper device 130 while the stopper device 130 remains inserted into the axillary artery AA. In other embodiments, the stopper device 130 may be withdrawn along with the expandable member 110. In either case, the wire remains within the patient's vasculature after the first drive line 120 and the expandable member 110 are withdrawn. In embodiments in which the stopper device 130 is also withdrawn, the medical practitioner may re-establish temporary or permanent hemostasis at the arteriotomy using over-the-wire arteriotomy closure techniques known to those skilled in the arteriotomy (block 208).

[0058] The practitioner may optionally implant a second (e.g., new or replacement) expandable member (e.g., a balloon or other expandable member similar to the expandable member 110 described above) after the expandable member 110 has been removed (block 207). If the practitioner desires to implant a replacement expandable member, the practitioner may establish access, including wire access, to the femoral artery using the endovascular implantation technique described above with respect to FIGS. 2A-2D. In embodiments in which the stopper device 130 is withdrawn from the axillary artery AA during removal of the expandable member 110, the practitioner may insert a new introducer sheath (e.g., similar to the second introducer sheath 275) into the axillary artery AA. The replacement expandable member may then be implanted using the endovascular implantation technique described above with respect to FIGS. 2A-2G. In embodiments in which the stopper device 130 remains inserted in the axillary artery AA after removal of the expandable member 110, the practitioner may remove the stopper device 130 from the axillary artery AA and insert a new introducer sheath (e.g., similar to the second introducer sheath 275) into the axillary artery AA. A replacement expandable member may then be implanted using the endovascular implantation technique described above with respect to FIGS. 2A-2G. In other embodiments, the stopper device 130 may provide access to the axillary artery AA instead of the second introducer sheath 275, eliminating the need for the second introducer sheath 275. A replacement expandable member may then be implanted using the endovascular implantation technique described above with respect to FIGS. 2A-2G, except with the stopper device 130 instead of the second introducer sheath 275.

[0059] FIG. 2I is a flow chart illustrating an extraction and / or replacement procedure 210 for removing the expandable member 110 through the femoral artery in accordance with aspects of the present technology. The extraction procedure 210 is described with reference to the endovascular ventricular assist system 100 of FIG. 1 and various features of the associated delivery system illustrated in FIGS. 2A-2G, however, the extraction procedure 210 may be used to remove and / or replace other endovascular implants or may use features of other delivery systems. The procedure 210 may begin by establishing access to an artery caudal to the expandable member 110, such as the femoral artery FA (block 211). For example, a medical practitioner may insert a removal sheath into the femoral artery FA using techniques similar to those described above with respect to inserting a first introducer sheath 270 into the patient's femoral artery FA. In some embodiments, the removal sheath may be the same as or at least generally similar to the first introducer sheath 270. The medical practitioner may disconnect the first drive line 120 from the second drive line 140 to provide access to the interior lumen of the first drive line 120 (block 212). The medical practitioner may also optionally remove the stopper device 130. However, in some embodiments, the medical practitioner leaves the stopper device 130 in the axillary artery AA throughout the entire extraction procedure 201.

[0060] The medical practitioner may advance a wire (e.g., similar to the guidewire GW shown in FIG. 2A) through the first drive line 120 and into the interior volume of the expandable member 110 (Block 213). In some embodiments, the wire may include a snare element that is advanced to the distal end region of the expandable member 110 (e.g., into the nipple 316, which will be described in more detail with respect to FIG. 3B). The snare element may be a ball, hook, or "J" shape, etc., at the distal end portion of the wire. With the snare element within the expandable member 110 and the wire extending from the snare element and out of the first drive line 120, an elongated removal sheath (which may be the same as or generally similar to the elongated delivery dilator 280) may be coupled to the first drive line 120 outside the patient's axillary artery (Block 214). The elongated removal sheath may be coupled either directly or indirectly to the first drive line 120. For example, in some embodiments, an attachment device may be inserted into first drive line 120 over a wire with a snare element prior to connecting the elongated removal sheath to first drive line 120. The attachment device may have a securing mechanism (e.g., barbs) to secure it to first drive line 120 and a locking mechanism (e.g., screw clasp, threads, mating surfaces, etc.) to secure it to the elongated removal sheath. In embodiments in which the stopper device 130 is removed, the elongated removal sheath may also be positioned within a second sheath (e.g., generally similar to second introducer sheath 275) prior to being advanced over the wire and coupled to first drive line 120.

[0061] The practitioner may advance the capture mechanism through the removal sheath in the femoral artery and toward the expandable member 110 in the aorta (Block 215). In some embodiments, the capture mechanism may be a catheter having one or more capture elements (e.g., hooks, snare, graspers, etc.) sized and / or shaped to interact with the snare elements. The capture elements may optionally include one or more locking mechanisms for locking the capture elements once they engage the snare elements. Once the capture mechanism is in proximity to the expandable member 110 in the aorta, the practitioner may grasp the expandable member 110 with the one or more capture elements (e.g., by engaging a snare element positioned within the expandable member 110) (Block 216). The expandable member 110 may then be pulled toward the removal sheath in the femoral artery by pulling the catheter and / or pushed toward the sheath in the femoral artery FA by pushing the elongated removal sheath (Block 217). As the expandable member 110 moves towards the removal sheath, the elongated removal sheath is pulled into the patient's vasculature at the arteriotomy in the axillary artery. In the embodiment in which the stopper device 130 has been removed and the elongated removal sheath is positioned within the second sheath, the second sheath may be advanced along with the elongated removal sheath until it enters the axillary artery AA and provides hemostasis. If hemostasis is not achieved initially, the medical practitioner may apply manual compression or insert a balloon to achieve hemostasis.

[0062] The medical practitioner may remove the expandable member 110 and first drive line 120 from the patient's vasculature by pulling / pushing them through the removal sheath (block 218). In some embodiments, the expandable member 110 may not fit through the removal sheath, and the removal sheath is withdrawn from the femoral artery during removal of the expandable member 110. In such cases, the medical practitioner may close the arteriotomy using standard techniques (e.g., using a MANTA® device) and / or apply manual compression to the arteriotomy to minimize bleeding.

[0063] The expandable member 110 and first drive line 120 are withdrawn from the removal sheath as a single unit while the elongate delivery dilator is also advanced through the removal sheath to extend between the patient's axillary artery and the patient's femoral artery, thus maintaining a pathway from the axillary artery to the femoral artery. The first drive line 120 may optionally be disconnected from the elongate removal sheath, and the wire with the snare feature may be removed from the elongate delivery dilator (block 219). A second wire (e.g., a 0.035" wire, Amplatz stiff wire, J-wire, etc.) may optionally be passed through the elongated removal sheath from the femoral artery to the axillary artery. As a result, the ends of the wire and elongated delivery dilator are outside the axillary and femoral arteries, allowing access to and control of the axillary and femoral artery arteriotomy. In embodiments where the removal sheath has been exteriorized during removal of the expandable member 110 at the femoral artery arteriotomy, a second removal sheath (which may also be the same as or generally similar to the first introducer sheath 270) may be pushed over the elongated removal sheath to achieve hemostasis at the femoral artery arteriotomy.

[0064] In some embodiments, the practitioner may implant a second (e.g., new or replacement) expandable member after the expandable member 110 has been removed (Block 219). To do so, the old drive line and expandable member may be detached from the elongated removal sheath as described above, and a replacement drive line and expandable member (e.g., similar to the first drive line 120 and expandable member 110 described above) may be attached thereto. The replacement expandable member may then be pulled into the vasculature by retracting the elongated removal sheath adjacent the axillary artery AA in a manner similar to the endovascular implantation procedure described above with respect to Figures 2C-2G. In other embodiments, the practitioner may simply remove the elongated removal sheath and close the axillary artery arteriotomy and femoral artery arteriotomy using standard over-the-wire closure techniques (Block 221).

[0065] These endovascular extraction and replacement procedures and systems allow for the removal and / or replacement of balloon pumps and / or other endovascular devices using an endovascular approach, thus avoiding major surgery. That is, removal of conventional circulatory support systems requires a second sternotomy procedure, which is associated with a significantly increased risk of adverse events and mortality. In contrast, the present technology provides a minimally invasive endovascular procedure for the removal and / or replacement of implanted devices.

[0066] Selected components of intravascular delivery systems and intravascular circulatory support systems 3A-8B illustrate additional details of select components of the endovascular delivery system described above with respect to system 100 of FIG. 1 and FIG. 2A-2G. The components of system 100 (i.e., an intra-aortic ventricular assist device) described herein may be delivered via the endovascular delivery and / or replacement procedures described in FIG. 2A-2I, or may be delivered using other suitable implantation procedures. The components of the delivery system described herein may be used to deliver and / or remove system 100 to support blood flow, and / or may be used to endovascularly deliver and / or remove other devices from a patient's vasculature.

[0067] FIG. 3A is a side view of an extendable member 110 and a first drive line 120 configured in accordance with aspects of the present technology. FIG. 3B is an enlarged side view of the extendable member 110 of FIG. 3A, and FIG. 3C is an enlarged side view of a connection between the extendable member 110 and a first drive line 120 configured in accordance with aspects of the present technology. FIGS. 3A-3C illustrate the extendable member 110 in an expanded state (also referred to as a "first state" or "extended state") in which the extendable member 110 is at least partially filled with a fluid (e.g., a gas such as air). As shown in FIG. 3A, the extendable member 110 is coupled to a second end region 224 of the first drive line 120, and a lumen (described below with reference to FIGS. 4A-4B) extending through the first drive line 120 is in fluid communication with an interior space 317 of the extendable member 110. Thus, the first drive line 120 may deliver gas (eg, air) into and out of the expandable member 110 to drive the expansion and de-expansion (stretching and compressing) of the expandable member 110 .

[0068] 3B, the extensible member 110 may have a first (e.g., proximal) end portion 312 and a second (e.g., distal) end portion 314. The first end portion 312 may be connected to the first drive line 120, as described in more detail with respect to FIG. 3C. The first end portion 312 may include an inwardly tapered or tapered neck 313 such that the cross-sectional diameter of the extensible member 110 decreases in a distal to proximal direction at the tapered neck 313. In some embodiments, the first end portion 312 may have a greater material thickness relative to other portions of the extensible member 110. Without wishing to be bound by theory, it is expected that the thicker material reduces kinking and stretching at the interface of the extensible member 110 and the first drive line 120.

[0069] The second end portion 314 may also include an inwardly tapered or tapered neck 315 such that the cross-sectional diameter of the expandable member 110 decreases in a proximal to distal direction at the beveled neck 315. The beveled neck 315 is designed to fit into narrow sections of the aorta to avoid occlusion of branching vessels such as the renal arteries, thereby reducing the risk of renal ischemia when the expandable member 110 is implanted within a patient's aorta. The beveled neck 313 at the first end portion 312 and the beveled neck 315 at the distal end portion may also facilitate folding or twisting the expandable member 110 to reduce its size for implantation and / or extraction. The second end portion 314 may also optionally include a papilla or other engagement feature 316. In some embodiments, the papilla 316 is expected to facilitate snaring the expandable member 110 during an endovascular extraction procedure. For example, as described above, a snare or other capturing feature may wrap around the nipple 316 to grip the expandable member 110. In some embodiments, the nipple 316 may be sized and shaped to receive the end of the bulbous feature of the wire, and a snare or other engagement mechanism may grip around the bulbous feature in the nipple 316 to better engage the expandable member 110 for retrieval.

[0070] The expandable member 110 may transition between a de-inflated / non-distensible state (not shown) and an inflated / distensible state. For example, in some embodiments, the expandable member 110 is a balloon or other elastic structure. A balloon transitions from a de-inflated state to an inflated state when the interior of the balloon is filled with a gas or fluid. A balloon transitions from an inflated state to a de-inflated state when the gas or fluid is withdrawn from the interior of the balloon. The expandable member 110 may also be another suitable structure capable of transitioning between a non-distensible state and a distensible state. The expandable member 110 may be composed of any suitable biocompatible material. For example, the expandable member 110 may be composed of a biocompatible elastomer, such as polyurethane (e.g., BioSpan® S). Without wishing to be bound by theory, it is expected that when the expandable member 110 is in a de-inflated state, the expandable member 110 will remain generally flat without folds or depressions. Unlike conventional intra-aortic balloon pumps, this allows the expandable member 110 to remain implanted within the patient even when the system 100 is turned off. Thus, in some embodiments, the expandable member 110 is designed to remain within the patient even when the system is turned off. The expandable member 110 may remain within the patient when the system 100 is turned off for an extended period of time, such as more than an hour.

[0071] The expandable member 110 may be made in a variety of different sizes and / or shapes, depending, for example, on the patient's anatomy and / or clinical needs. In some embodiments, the expandable member 110 may have a displacement volume of about 20 ml to about 60 ml. For example, in some embodiments, the displacement volume is about 50 ml. As used herein, displacement volume refers to the volume difference between an inflated state and a de-inflated state. Thus, the displacement volume is generally similar to, but not necessarily identical to, the volume of the expandable member in the inflated state. The expandable member 110 may have a length of about 15 cm to about 30 cm. For example, in some embodiments, the expandable member 110 has a length of more than about 19 cm, such as about 20 cm or about 25 cm. Thus, in some embodiments, the expandable member 110 is longer than a conventional intra-aortic balloon pump. Notably, the beveled neck 315 at the second end portion 314 allows the expandable member 110 to have a relatively large length while maintaining a low risk of blocking the renal arteries. As will be understood by one of ordinary skill in the art, the expandable member 110 may have dimensions other than those expressly set forth herein to accommodate different patient anatomies, such as for use in the pediatric population.

[0072] 3C, a first end portion 312 of the expandable member 110 is coupled to a second end region 224 of the first drive line 120. The first end portion 312 may include an engagement region 311 extending proximally from an angled neck 313. The engagement region 311 may fit over a portion of the first drive line 120 (i.e., a portion of the first drive line 120 may be at least partially inserted into the engagement region 311). The engagement region 311 may be securely fastened to the first drive line 120 using an attachment feature 318. The attachment feature 318 may be a compression ring or other suitable element that provides an airtight connection / pneumatic seal between the engagement region 311 and the first drive line 120, thereby preventing gas delivered to the interior space 317 of the expandable member 110 via the first drive line 120 from leaking out of the expandable member 110 into the external environment (e.g., into the patient's vasculature when the expandable member 110 is implanted).

[0073] 4A-4C illustrate various features of a first drive line 120 configured in accordance with aspects of the present technology. FIGS. 4A and 4B are perspective and cross-sectional views, respectively, of the first drive line 120, and FIG. 4C is a side view of a kink-resistant element 427 of the first drive line 120. As shown in FIGS. 4A and 4B, the first drive line 120 may have a generally tubular wall 425 defining a lumen 421 extending therethrough. The generally tubular wall 425 may be gas impermeable to prevent gas from leaking out of the lumen 421 into the patient's vasculature. In some embodiments, the generally tubular wall 425 may include multiple layers. For example, in the illustrated embodiment, the generally tubular wall 425 includes an inner membrane 426 and an outer membrane 428 concentrically enclosing the inner membrane 426. A coil or other helically wound kink-resistant element 427 (shown alone in FIG. 4C ) may be disposed between and / or partially within the inner membrane 426 and the outer membrane 428. The inner membrane 426 and the outer membrane 428 may be at least partially composed of a flexible material. Additionally, the outer membrane 428 may be composed of an anti-thrombogenic material, such as elastin-s, to reduce and / or prevent clot formation thereon when the first drive line 120 is implanted within the vasculature of a patient. The coil 427 may be composed of Nitinol or another suitable kink-resistant material. In some embodiments, the coil 427 may have a pitch P of less than about 1 mm (e.g., about 0.5 mm). Without being bound by theory, incorporating coil 427 within tubular wall 425 provides several advantages, including: (1) providing additional stability to generally tubular wall 425; (2) reducing the thickness of generally tubular wall 425 required to achieve the desired stability; and (3) reducing and / or preventing kinking or collapsing of first drive line 120. In some embodiments, coil 427 extends only along a portion of first drive line 120, which divides the first drive line into a "reinforced" section and a "non-reinforced" section. In other embodiments, coil 427 extends along the entire length or approximately the entire length of first drive line 120.

[0074] The first end region 222 of the first drive line 120 may also include a connecting element 429 for connecting the first drive line 120 to the elongate delivery dilator 280 (FIGS. 5A-5C). Thus, the connecting element 429 may also be referred to as an elongate delivery dilator connecting element 429. The connecting element 429 may be a threaded female connecting element sized and shaped to receive a corresponding threaded male connecting element on the elongate delivery dilator 280. In other embodiments, the connecting element 429 may be a threaded male connecting element sized and shaped to receive a corresponding threaded female connecting element on the elongate delivery dilator 280. In still other embodiments, the connecting element 429 is another suitable fastening mechanism for securely fastening the first drive line 120 to the elongate delivery dilator 280. In some embodiments, the connecting element 429 includes an aperture 429a or other feature that allows air to flow through and / or around the connecting element 429 and into the lumen 421. Thus, when the first drive line 120 is connected to the elongate delivery dilator 280 via the connecting element 429, gas can flow through the elongate delivery dilator 280 and enter the lumen 421 via the aperture 429a, and vice versa.

[0075] First drive line 120 may have an outer diameter of less than about 6 mm. For example, in some embodiments, the outer diameter is about 4.2 mm. In other embodiments, the outer diameter is less than about 4.2 mm. Notably, the outer diameter of first drive line 120 may be selected to fit through first introducer sheath 270 and / or second introducer sheath 275 during an intravascular implantation procedure described herein. For example, in some embodiments, first drive line 120 has an outer diameter of 4.2 mm (e.g., 12.6 Fr), first introducer sheath 270 is a 16 Fr sheath, and second introducer sheath 275 is a 14 Fr sheath. In such embodiments, first drive line 120 fits through both first introducer sheath 270 and second introducer sheath 275. The outer diameter may also be small enough to fit within a variety of different patient anatomies (e.g., a larger drive line may be implanted only in patients whose axillary artery diameter is above a certain threshold). First drive line 120 may have an inner diameter (i.e., the diameter of lumen 421, as defined by intima 426) of about 2 mm to 5 mm. For example, in some embodiments, the inner diameter is about 3.3 mm. In other embodiments, the inner diameter is less than 3.3 mm.

[0076] The first drive line 120 has a relatively long length. For example, the first drive line 120 may be greater than about 200 cm (e.g., about 300 cm). As discussed above, having a relatively long length ensures that a portion of the first drive line 120 remains outside the patient's body during the implantation procedure. Once the first drive line 120 is disconnected from the elongate delivery dilator 280 during the implantation procedure, the portion of the first drive line 120 that remains outside the patient's body may be used to retrieve the first drive line 120 and the expandable member 110 from the patient's vasculature. Due to its relatively long length, the first drive line 120 is typically cut before securely fastening the first drive line 120 to the second drive line 140. For example, a portion of the first end region 222 may be removed, thereby removing the portion of the first drive line 120 having the connecting element 429, but since the first drive line 120 is in position prior to cutting the first drive line 120, the connecting element 429 is no longer needed.

[0077] In embodiments where only a portion of first drive line 120 is reinforced, the reinforced portion may have a first outer diameter that is greater than a second outer diameter of the non-reinforced portion. For example, the reinforced portion may have an outer diameter of about 4.2 mm, and the non-reinforced portion may have an outer diameter of about 4 mm. In such embodiments, the reinforced portion may have a length greater than about 30 cm, and the non-reinforced portion may have a length greater than about 10 cm. In some embodiments, the reinforced portion includes second end region 224, and the non-reinforced portion includes first end region 222. The transition between the first and second outer diameters may be tapered or otherwise gradual.

[0078] 5A-5C are side partial cross-sectional views of various features of an elongate delivery dilator 280 configured in accordance with aspects of the present technology. As shown in FIG. 5A, the elongate delivery dilator 280 forms a generally tubular conduit, shaft, pipe, or the like having a lumen 592 extending therethrough. The lumen 592 is sized to allow the elongate delivery dilator 280 to be advanced over a wire (e.g., a 0.035 inch wire). As previously described, the elongate delivery dilator 280 may include a first portion 282 (e.g., a proximal end portion) and a second portion 284 (e.g., a distal end portion). In some embodiments, the proximal end portion 282 may include a valve or port 853 (e.g., a check valve, a luer lock, a sealable silicone port, or the like) to provide controlled access to the lumen 592. For example, as described above with respect to FIG. 3D, a syringe, Y-connector, or three-way stopcock, or the like, may be attached to the first drive line 120 at the valve 853 to degas the expandable member 110 prior to drawing into the patient's vasculature. In embodiments including a port 583, the port 583 remains outside the patient's body (e.g., at the axillary artery access site) throughout the implantation procedure. The distal end portion 284 of the elongate delivery dilator 280 may be designed to penetrate a hemostatic valve in an introducer sheath (e.g., the first introducer sheath 270) when inserted into the introducer sheath in a retrograde direction. For example, in the illustrated embodiment, the distal end portion 284 is at least partially pointed and / or angled inwardly to aid in penetrating the hemostatic valve.

[0079] A distal-most segment of the distal end portion 284 may include a removable portion 585 (e.g., a removable distal tip). The removable portion 585 may be securely secured to the elongate delivery dilator 280 at an attachment interface 586, which will be described in more detail below with reference to FIGS. 5B and 5C. During an endovascular implantation procedure described herein, the removable portion 585 is removed from the elongate delivery dilator 280 after the distal end portion 284 is exteriorized in the first introducer sheath 270 (e.g., near the femoral artery). The first drive line 120 is then connected to the elongate delivery dilator 280 at the attachment interface 586.

[0080] 5B and 5C illustrate additional features of the elongate delivery dilator 280 near the attachment interface 586. More specifically, FIG. 5B illustrates the removable portion 585 connected to the elongate delivery dilator 280 at the attachment interface 586, and FIG. 5B illustrates the removable portion spaced apart (e.g., disconnected) from the elongate delivery dilator 280 at the attachment interface 586. Referring together to FIGS. 5B and 5C, the elongate delivery dilator 280 includes a first connecting element 587a and a second connecting element 587b near the attachment interface 586. The first connecting element 587a and the second connecting element 587b engage to releasably securely fasten the removable portion 585 to the elongate delivery dilator 280. In the illustrated embodiment, the first connecting element 587a is a threaded female connecting element and the second connecting element 587b is a threaded male connecting element. In operation, the removable portion 585 may be releasably secured to the elongate delivery dilator 280 by threading the threaded male connecting element into the threaded female connecting element. The removable portion 585 may be removed from the elongate delivery dilator 280 by unscrewing the threaded female connecting element from the threaded male connecting element. In other embodiments, the first connecting element 587a is a threaded male connecting element and the second connecting element 587b is a threaded female connecting element. In either case, the first connecting element 587a and the second connecting element 587b may include an aperture 591 extending therethrough to allow the elongate delivery dilator 280 to be advanced over a wire.

[0081] The first connecting element 587a and the second connecting element 587b may be composed of a generally inflexible material (e.g., stainless steel). Because the first connecting element 587a and the second connecting element 587b are composed of a generally inflexible material, the elongate delivery dilator 280 may not bend or flex at the attachment interface 586. Thus, despite stiffness at the attachment interface 586, the first connecting element 587a and the second connecting element 587b may have a relatively short combined length when connected to allow the elongate delivery dilator 280 to take a path through various curves in the patient's vasculature. For example, the first connecting element 587a and the second connecting element 587b may have a combined length of less than about 2 cm and / or less than about 1 cm.

[0082] The second connecting element 587b may also be used to connect the first drive line 120 to the elongate delivery dilator 280 (once the removable portion 585 is removed) by engaging the elongate delivery dilator connecting element 429 on the first drive line 120. Thus, the second connecting element 587b may also be referred to as a drive line connecting element 587b. In embodiments where the elongate delivery dilator connecting element 429 on the first drive line 120 is a threaded male connecting element, the second connecting element 587b is a threaded female connecting element. Similarly, in embodiments where the elongate delivery dilator connecting element 429 is a threaded female connecting element, the second connecting element 587b is a threaded male connecting element. To place the elongate delivery dilator 280 in fluid connection with the lumen 421 of the first drive line 120, an aperture 591 on the second connecting element 587b aligns with an aperture 429a on the elongate delivery dilator connecting element 429. This allows gas to be drawn from the expandable member 110 through the first drive line 120 and the elongate delivery dilator 280, such as during the degassing procedure described above.

[0083] 5A-5C together, the elongate delivery dilator 280 may include an outer membrane 588. The outer membrane 588 may be gas impermeable and composed of any suitable material that is biocompatible and / or anti-thrombogenic. For example, in some embodiments, the outer membrane 588 is composed of elastin-S. In some embodiments, the elongate delivery dilator 280 also includes one or more stiffening wires 589. In some embodiments, the stiffening wires 589 are generally similar to the coils 427 in the first drive line 120. For example, the stiffening wires 589 may be one or more helically wound Nitinol coils that are generally kink resistant. Although shown only near the attachment interface 586, the stiffening wires 589 may extend along the entire length or a substantial length of the elongate delivery dilator 280. However, in other embodiments, the stiffening wires 589 are located only near the attachment interface 586 to provide additional stability at the attachment interface 586.

[0084] The elongate delivery dilator 280 may have an outer diameter of less than about 6 mm (excluding those embodiments in which the port 583 is included). For example, in some embodiments, the outer diameter is about 4.2 mm. In other embodiments, the outer diameter is less than about 4.2 mm. Notably, the outer diameter of the elongate delivery dilator 280 may be selected to fit through the first introducer sheath 270 and / or the second introducer sheath 275 during the implantation procedure described herein. For example, in some embodiments, the elongate delivery dilator 280 has an outer diameter of 4.2 mm (e.g., 12.6 Fr), the first introducer sheath 270 is a 16 Fr sheath, and the second introducer sheath 275 is a 14 Fr sheath. Thus, the elongate delivery dilator 280 fits through both the first introducer sheath 270 and the second introducer sheath 275. The outer diameter may also be small enough to allow the elongate delivery dilator 280 to fit into and through a variety of different patient anatomies. In some embodiments, the elongate delivery dilator 280 has an outer diameter that is the same and / or approximately the same as the outer diameter of the first drive line 120. The elongate delivery dilator 280 also has a relatively long length. For example, the elongate delivery dilator 280 may have a length of more than about 200 cm (e.g., about 300 cm). As discussed above, having a relatively long length ensures that the elongate delivery dilator 280 can extend between the first introducer sheath 270 and the second introducer sheath 275.

[0085] 6A and 6B are isometric views of a funnel assembly 600 configured in accordance with aspects of the present technology. Specifically, FIG. 6A is an isometric view of the funnel assembly 600 coupled to a sheath 670, and FIG. 6B is a partially exploded view of the funnel assembly 600 and the sheath 670. Referring to both FIGS. 6A and 6B, the funnel assembly 600 includes a body portion 601 and a cap 605. An opening 602 provides access to the interior of the body portion 601; the body portion 601 is generally conical and has a number of vanes (not shown) or other folding features. The body portion 601 also has a relatively long and narrow distal end section 603. In some embodiments, the distal end section 603 is sized and shaped to interface with a sheath, such as the sheath 670 (which may be generally similar to the first introducer sheath 270 described above). For example, the distal end section 603 may fit within or otherwise pass through a hemostasis valve within the sheath 670.

[0086] The funnel assembly 600 may be used to automatically fold, twist, or otherwise reduce the size of an extendable member (e.g., extendable member 110) to fit the extendable member into and through the sheath 670. In operation, the extendable member may be pulled through the body portion 601 of the funnel assembly 600 and into the distal end section 603. Vanes or other folding features may automatically fold, twist, or otherwise reduce the size of the extendable member as it is pulled through the body portion 601. The folded or twisted extendable member may then be pulled through the sheath 670. While in the illustrated embodiment the funnel assembly 600 is directly coupled to the sheath 670, in other embodiments the funnel assembly 600 may be spaced from the sheath 670 and / or the extendable member may be loaded into the body portion 601 prior to inserting the funnel assembly 600 into the sheath 670. In some embodiments, lubrication (e.g., Viperslide®, Rotaglide™, etc.) may be added to the inside of body portion 601 to make it easier to pull the expandable member through body portion 601. Once the expandable member is inside body portion 601, a cap 605 may be connected to opening 602 of body portion 601 to reduce or minimize blood loss.

[0087] 7A-7C illustrate a collapsing tube 700 configured in accordance with aspects of the present technology. Specifically, FIG. 7A is a side view of the collapsing tube 700, FIG. 7B is a close-up view of a first end portion of the collapsing tube 700, and FIG. 7B is a close-up view of a second end portion of the collapsing tube 700. Referring first to FIG. 7A, the collapsing tube 700 may be a generally elongated tube or shaft having a first (e.g., proximal or inlet) end portion 702 and a second (e.g., distal or outlet) end portion 704. Referring to FIG. 7B, the first end portion 702 includes an opening 703. The opening 703 is at least partially rounded or otherwise flared to prevent and / or reduce damage to an extendable member being drawn into the collapsing tube 700 through the opening 703. 7C, the second end portion 704 tapers to transition from a first outer diameter D1 to a second outer diameter D2. The tapered second end portion 704 makes it easier to insert the collapsing tube 700 through a hemostasis valve in an introducer sheath, such as the first introducer sheath 270 described above. The tapered second end portion 704 may be inserted into the introducer sheath before loading the expandable member into the collapsing tube 700 or with the expandable member preloaded into the collapsing tube 700. The inner diameter of the collapsing tube 700 may remain substantially the same even though the outer diameter is reduced.

[0088] The collapsing tube 700 may be used to fold, twist, or otherwise reduce the size of an expandable member (e.g., expandable member 110) to fit through an introducer sheath (e.g., first introducer sheath 270). In operation, an expandable member may be loaded into the collapsing tube 700 by pulling the expandable member through the opening 703. In some embodiments, the expandable member may be manually twisted or otherwise collapsed before being pulled into the collapsing tube 700. With the expandable member in the collapsing tube 700, the second end portion 704 of the collapsing tube 700 is inserted into the introducer sheath. The expandable member is then pulled out of the second end portion 704 of the collapsing tube 700, through the introducer sheath, and into the patient's vasculature. In some embodiments, lubrication (e.g., Viperslide®, Rotaglide™, etc.) may be added to the inside of the collapsing tube 700 to make it easier to pull the expandable member through the collapsing tube 700. Once the expandable member is inside the collapsing tube 700, a cap or other plug (not shown) may be inserted into the opening 703 to reduce or minimize blood loss when the collapsing tube 700 is inserted into the introducer sheath.

[0089] 8A and 8B illustrate additional aspects of a stopper device 130 (also referred to as an "arterial interface device") configured in accordance with aspects of the present technology. More specifically, FIG. 8A is a front view of the stopper device 130, and FIG. 8B is a cross-sectional view of the stopper device 130 along the axis shown in FIG. 8A. Referring together to FIGS. 8A and 8B, the stopper device 130 includes a shaft 831 defining a first lumen 842 extending therethrough. The first lumen 842 has a diameter at least slightly larger than an outer diameter of the first drive line 120 such that the first drive line 120 can be inserted into and extend through the shaft 831 and / or the stopper device 130 can be positioned and / or advanced over the first drive line 120. The stopper device 130 further includes a fastening mechanism 832 capable of securely fastening the stopper device 130 to the first drive line 120 and providing a hemostatic seal therebetween. In some embodiments, the fastening mechanism 832 is a compression ring, a Touhy Borst valve, or the like. In some embodiments, the stopper device 130 may optionally include a drive line receiving element 843 that is inserted into a lumen at the fastening mechanism 832, as shown in FIG. 8B. The drive line receiving element 843 may include a channel 844 that extends at least partially into the lumen 842. The first drive line 120 may be threaded into and through the channel 844 to secure the first drive line 120 to the stopper device 130.

[0090] Distal end portion 831a of shaft 831 may be tapered (e.g., inwardly tapered) to facilitate insertion of stopper device 130 into the arteriotomy (e.g., upon advancement over first drive line 120) to provide hemostasis to the arteriotomy. Thus, an outer diameter of distal end portion 831a decreases in a proximal-to-distal direction. Thus, in operation, further insertion of distal end portion 831a into the artery may progressively dilate the arteriotomy to achieve hemostasis. In some embodiments, distal end portion 831a also includes a marker (e.g., a radiopaque marker) to facilitate visualization of distal end portion 831a via one or more imaging techniques.

[0091] The stopper device 130 may also include one or more anchoring mechanisms for securely fixing the stopper device 130 in a desired orientation / position. For example, the stopper device 130 includes a first anchoring mechanism 833 (e.g., a distal anchoring mechanism). In the illustrated embodiment, the first anchoring mechanism 833 is a resilient and / or non-compliant expandable member (e.g., a balloon) that can be transitioned between a first de-inflated / unstretched state (not shown) and a second inflated / stretched state (shown). When the stopper device 130 is positioned within the human body, expanding the first anchoring mechanism 833 expands the expandable member and presses it against the surrounding tissue, thereby stabilizing the stopper device 130 near the arteriotomy. In some embodiments, the first anchoring mechanism 833 may include an adhesive element in addition to or instead of the expandable member. The first anchoring mechanism 833 may also take other suitable forms. For example, in some embodiments, the first anchoring mechanism 833 is a plurality of barbs (e.g., expandable nitinol barbs), hooks, tabs, suture holes, or other features that can be used to stabilize or otherwise secure the stopper device 130 in a desired position.

[0092] As illustrated in FIG. 8A, the stopper device 130 may include a first side port 836 that allows a user to selectively inflate the first anchoring mechanism 833. The first side port 836 may include a second lumen 837 in fluid communication with the interior of the first anchoring mechanism 833. A valve or other stopper 838 (e.g., a check valve, a luer lock, a sealable silicone port, etc.) may be included in the first side port to provide controlled access to the second lumen 837. To inflate the first anchoring mechanism 833 and anchor the stopper device 130, a gas or liquid (e.g., saline) may be injected into the first anchoring mechanism 833 via the first side port 836. For example, in some embodiments, a syringe may be used to inject saline through the first side port 836 and into the first anchoring mechanism. Once inflated, the valve 838 may be closed. In some embodiments, the first anchoring mechanism 833 may remain inflated for an extended period of time (e.g., greater than about one year) as long as the valve 838 remains closed.

[0093] The stopper device 130 may further include a second anchoring mechanism 834 configured for extravascular positioning and securement to tissue adjacent the arteriotomy. The second anchoring mechanism 834 may include one or more wings or other appendages 835 extending from the main stopper body proximally from the first anchoring mechanism 833. The one or more wings or other appendages 835 may include a number of holes 835a. The holes 835a may be used to suture the stopper device 130 to tissue to stabilize and / or otherwise secure the stopper device 130 in a desired orientation / position.

[0094] When the stopper device 130 is implanted on the first drive line 120 in the axillary artery, it may need to be bent or flexed (e.g., toward the patient's abdomen) before it can be securely secured to the patient's tissue. Thus, at least a portion of the shaft 831 is at least partially flexible. For example, the shaft 831 may include a bendable region 831b between the first anchoring mechanism 833 and the second anchoring mechanism 834. A medical practitioner may manipulate the stopper device 130 into a desired orientation / position by bending or flexing the stopper at the bendable region 831b. Once in the desired orientation / position, the stopper device 130 may be securely secured in place using the first anchoring mechanism 833 and the second anchoring mechanism 834.

[0095] As illustrated in FIG. 8A, the stopper device 130 may further include a second side port 839. The second side port 839 provides access to a third lumen 840; the third lumen 840 is in fluid communication with the first lumen 842 and allows a medical practitioner or other user to insert a wire into the patient's vasculature to facilitate device exchange, removal, or general control of the vasculature. For example, a medical practitioner may insert a wire through the second side port, through the third lumen 840, through the first lumen 842, and into the patient's vasculature. In such a case, the wire extends through the first lumen 842 (e.g., between the first drive line 120 and the wall defining the shaft 831) outside and alongside the first drive line 120. In other embodiments, the third lumen 840 may extend along the length of the shaft 831 to the distal end portion 831a to provide an isolated channel for the wire. The second side port 839 may include a locking mechanism 841 to block access to the third lumen 840 when not in use. The locking mechanism 841 may be any suitable locking mechanism, including a plug, a cap (e.g., a luer lock), an obturator, or the like. EXAMPLES

[0096] Several aspects of the present technology are described in the following examples. 1. 1. A method for implanting a circulatory support system within a patient's vascular system, the method comprising: accessing a first blood vessel of the patient; accessing a second blood vessel of the patient; advancing the guidewire through the patient's vascular system such that the guidewire extends between the first blood vessel and the second blood vessel; advancing an elongate delivery dilator over the guidewire such that the elongate delivery dilator extends between the first blood vessel and the second blood vessel, wherein a first portion of the elongate delivery dilator is externally accessible adjacent the first blood vessel and a second portion of the elongate delivery dilator is externally accessible adjacent the second blood vessel; releasably attaching the second portion of the elongate delivery dilator to a first end region of a drive line, the drive line further including a second end region attached to an expandable member; moving the second portion of the elongate delivery dilator, the drive line, and the expandable member through the patient's vascular system in a direction counter to blood flow while the first portion of the elongate delivery dilator is withdrawn from the patient until the expandable member is positioned within the patient's aorta; and removing the elongate delivery dilator from the first end region of the drive line after the first end region of the drive line exits the patient's vascular system near the first blood vessel, wherein after removal, the expandable member and at least a portion of the drive line remain within the patient's vascular system to support cardiac function. 2. The method of example 1, wherein the first blood vessel is the subclavian artery or the axillary artery. 3. The method of example 1 or 2, wherein the second blood vessel is a femoral artery. 4. the step of accessing a first blood vessel includes inserting a first introducer sheath into the first blood vessel, the first introducer sheath including a first hemostatic valve for providing controlled access to the first blood vessel; the step of accessing the second blood vessel includes inserting into the second blood vessel a second introducer sheath including a second hemostatic valve for providing controlled access to the second blood vessel; The method according to any one of Examples 1 to 3. 5. removing the first introducer sheath from the first blood vessel; and hemostatically sealing the first vessel about the drive line by advancing an arterial interface device over the drive line. The method of Example 4, further comprising: 6. removing the second introducer sheath from the second blood vessel; and hemostatically sealing said second blood vessel. The method of Example 4 or 5, further comprising: 7. 7. The method of any of Examples 1-6, further comprising removing a distal tip from the second portion of the elongate delivery dilator prior to releasably attaching the second portion of the elongate delivery dilator to the drive line, wherein removing the distal tip exposes a connecting element. 8. The method of any of Examples 1-7, further comprising folding, twisting, or otherwise reducing a cross-sectional dimension of the expandable member before moving the expandable member into the patient's vasculature. 9. The method of example 8, further comprising pulling the expandable member through a funnel or tube before the expandable member is pulled into the patient's vascular system, the funnel or tube automatically reducing the cross-sectional dimension of the expandable member. 10. The method of example 8, wherein the step of folding, twisting or otherwise reducing a cross-sectional dimension of the expandable member comprises reducing an outer diameter of the expandable member. 11. The method according to any one of the preceding claims, wherein the expandable member is a balloon. 12. the drive line is a first drive line; Following the step of removing the elongate delivery dilator from the first drive line, securing a first end region of the first drive line to a second drive line; tunneling the second drive line into a subcutaneous region of the patient; and securing the second drive line to a skin interface device. The method according to any one of Examples 1 to 10, further comprising: 13. 13. The method of example 12, further comprising removing a portion of the first end region of the first drive line prior to the step of securely fastening the first end region of the first drive line to the second drive line. 14. the step of securely fastening the first end region of the first drive line to the second drive line includes placing a first drive line lumen extending through the first drive line in fluid communication with a second drive line lumen of the second drive line; the first and second drive line lumens are also in fluid communication with the interior of the expandable member; The method described in Example 12. 15. 13. The method of example 12, further comprising the step of securing a portion of the second drive line to tissue of the patient. 16. 1. A method for implanting a circulatory support system within a patient's vascular system, the method comprising: accessing a subclavian artery of said patient; accessing a femoral artery of said patient; advancing the guidewire through the patient's vascular system such that the guidewire extends between the subclavian artery and the femoral artery; advancing an elongate delivery dilator over the guidewire such that the elongate delivery dilator extends between the subclavian artery and the femoral artery, wherein a first portion of the elongate delivery dilator is externally accessible adjacent the subclavian artery and a second portion of the elongate delivery dilator is externally accessible adjacent the femoral artery; releasably attaching the second portion of the elongate delivery dilator to a first end region of a drive line, the drive line further including a second end region attached to an end effector; pulling the second portion of the elongate delivery dilator, the drive line, and the end effector through the patient's vasculature in a direction counter to blood flow while the first portion of the elongate delivery dilator is withdrawn from the patient until the end effector is positioned within a target site within the patient's vasculature; and removing the elongate delivery dilator from the first end region of the drive line after the first end region of the drive line exits the patient's vasculature near the subclavian artery, wherein after removal, the end effector and at least a portion of the drive line remain within the patient's vasculature. 17. advancing an arterial interface device over a first end region of the drive line after the first end region of the drive line exits the patient's vasculature proximate the subclavian artery; and Establishing hemostasis in the subclavian artery with the arterial interface device. The method of example 16, further comprising: 18. The method of Example 17, further comprising anchoring the arterial interface device to tissue near the subclavian artery. 19. 20. The method of example 18, wherein the step of anchoring the arterial interface device comprises expanding an expandable anchoring element on the arterial interface device. 20. The method of any of Examples 16-19, further comprising removing a distal tip from the second portion of the elongate delivery dilator prior to releasably attaching the second portion of the elongate delivery dilator to the drive line, wherein removing the distal tip exposes the connecting element. twenty one. The method of any of Examples 16-20, further comprising folding, twisting, or otherwise reducing a cross-sectional dimension of the end effector before moving the end effector into the patient's vasculature. twenty two. below: an elongate delivery dilator having a first end portion, a second end portion, and a lumen extending between the first end portion and the second end portion, the elongate delivery dilator configured to advance over a guidewire positioned within a patient's vasculature and to extend through the patient's vasculature between a first blood vessel and a second blood vessel; an expandable member configured to be positioned within the patient's descending aorta to provide circulatory support to the patient's heart; and a drive line having a first end region connectable to the expandable member and a second end region connectable to the second end portion of the elongate delivery dilator; a pump assembly including: A system for intravascular implantation of a blood pump assembly within a patient, comprising: twenty three. The second end portion of the elongated delivery dilator a drive line connection element configured to releasably connect the elongate delivery dilator to a second end region of a drive line; a removable portion coupled to the drive line connection element; Including, Removing the removable portion from the elongate delivery dilator exposes the drive line connection element. The system of Example 22. twenty four. The system of Example 23, wherein the removable portion is configured to guide an elongate delivery dilator through the introducer sheath. twenty five. A system described in any of Examples 22 to 24, wherein a first end region of the drive line includes an elongate delivery dilator connection element configured to releasably engage a second end portion of the elongate delivery dilator. 26. The system of any one of Examples 22-25, wherein the drive line includes an inner membrane, an outer membrane, and a kink-resistant element disposed between the inner membrane and the outer membrane. 27. 27. The system of example 26, wherein the kink-resistant element is a helically wound nitinol coil. 28. The system of Example 26 or 27, wherein the outer membrane comprises a biocompatible and anti-thrombogenic material. 29. The system of any of Examples 22-28, wherein the drive line has a length of greater than about 200 cm. 30. The system of any of Examples 22-29, wherein the drive line has an outer diameter of about 4.2 mm or less. 31. The system described in any one of Examples 22 to 30, wherein the expandable member is a balloon. 32. The system of example 31, wherein the balloon has an internal volume of about 20 mL to 60 mL. 33. The system of example 31 or 32, wherein the balloon has a proximal end portion connectable to a drive line and a distal end portion spaced apart from the proximal end portion, at least a portion of the distal end portion tapering inwardly. 34. The system of example embodiment 33, wherein the proximal end portion has a greater material thickness than the distal end portion. 35. The system of any of Examples 22-34, wherein the expandable member comprises a biocompatible and anti-thrombogenic material. 36. The system of any of Examples 22-35, further comprising a funnel assembly configured to fold, twist, or otherwise reduce the dimension of the extensible member. 37. The system of any of Examples 22-36, further comprising a folding tube configured to fold, twist, or otherwise reduce dimensions about the expandable member. 38. The system described in any of Examples 22-37, further comprising an arterial interface device configured to provide a hemostatic seal in the first blood vessel. 39. an arterial interface device including a shaft defining a first lumen for receiving a portion of the drive line therethrough; a distal end portion of the shaft configured to be placed within a first blood vessel. The system described in Example 38. 40. The system of Example 39, wherein the distal end portion of the shaft is tapered. 41. The system of Example 38 or 39, wherein the arterial interface device comprises an expandable anchoring element coupled to the shaft near the distal end portion. 42. the drive line is a first drive line; a second drive line connectable to the first drive line and configured to extend subcutaneously between the first drive line and a skin interface device. A system described in any one of Examples 23 to 41. 43. the second drive line further includes one or more wings; and the one or more wings having one or more apertures; The system described in Example 42. 44. The second drive line an absorbing feature configured to reduce longitudinal strain in the first drive line when the second drive line is connected to the first drive line; The system of example 42 or 43, comprising: 45. The system of any of Examples 42-44, wherein the second drive line has an inner diameter equal to or greater than the outer diameter of the first drive line. 46. a first drive line having a distal segment including a first end region connectable to the expandable member and a proximal segment including a second end region connectable to the second drive line; at least a portion of the proximal segment is configured to be removed before the first drive line is connected to the second drive line. A system described in any one of Examples 42 to 45. 47. 1. A delivery system for intravascular implantation of a blood pump assembly within a patient, comprising: an elongated tubular element having a lumen extending therethrough and an end portion; a connecting element positioned at the end portion of the elongated tubular element and configured to releasably secure the elongated tubular element to a blood pump assembly drive line; and a removable portion extending longitudinally from the end portion of the elongated tubular element and releasably connected to the end portion of the elongated tubular element via the connecting element; Including, A delivery system, wherein the elongated tubular member and the removable portion are configured to advance together over a guidewire positioned within a patient's vascular system and extend through the patient's vascular system between a first blood vessel and a second blood vessel. 48. The delivery system of Example 47, wherein the removable portion tapers away from the elongated tubular element to guide the elongated tubular element through the introducer sheath. 49. the connecting element is a first connecting element, the removable portion having a second connecting element configured to releasably engage the first connecting element; The delivery system of Example 47 or 48. 50. The delivery system of Example 49, wherein the first connecting element and the second connecting element, when coupled together, have a combined length of less than about 2 cm. 51. A delivery system described in any of Examples 47 to 50, wherein the connecting element is a threaded connecting element. 52. A delivery system described in any of Examples 47 to 51, wherein the connecting element comprises an aperture in fluid communication with the lumen. 53. The delivery system of any of Examples 47-52, further comprising a kink-resistant element extending along at least a portion of the elongated tubular element. 54. 54. The delivery system of Example 53, wherein the kink-resistant element comprises at least one helically wound wire. 55. A delivery system as described in any of Examples 47-54, wherein the elongated tubular element has a length of greater than about 200 cm. 56. A delivery system as described in any of Examples 47 to 55, wherein the elongated tubular element has a length of about 300 cm. 57. A delivery system described in any of Examples 47-56, wherein the elongated tubular element has an outer diameter of about 4.2 mm or less. 58. 1. An arterial interface device for use with an implanted blood pump having a drive line extending through an opening in a blood vessel, comprising: a shaft having a proximal end portion, a distal end portion, and a lumen extending between the proximal end portion and the distal end portion, the distal end portion tapering distally and configured to be placed within the blood vessel, the lumen configured to receive a portion of the drive line; a fastening mechanism configured to securely fasten the drive line to the arterial interface device; an anchoring element near the distal end portion for securely anchoring the arterial interface device to tissue; Including, An arterial interface device configured to provide a hemostatic seal in the blood vessel. 59. the mooring element is a first mooring element, the first anchoring element includes a balloon configured to transition from a non-distensible state to a distensible state to secure the arterial interface device to tissue; 13. The arterial interface device, comprising: a first side port extending from a proximal end portion of the shaft and in fluid communication with the anchoring element, the first side port configured to deliver fluid to the balloon to place the balloon in an expanded state; a second side port extending from the proximal end portion of the shaft and in fluid communication with the lumen, the second side port configured to receive a guidewire advanceable within the blood vessel; one or more wings extending laterally outward from the shaft, the one or more wings having a plurality of holes configured to receive sutures that anchor the arterial interface device to adjacent tissue; A second mooring element comprising: The arterial interface device of Example 58, further comprising: 60. The arterial interface device of Example 58, wherein the anchoring element is an expandable member configured to transition from a non-extended state to an extended state to securely secure the arterial interface device to tissue. 61. The arterial interface device of Example 60, wherein the anchoring element is a balloon. 62. The arterial interface device of Example 60, wherein the anchoring element is one or more expandable barbs. 63. a side port in fluid communication with an interior of the expandable member, the side port configured to receive a fluid to expand the expandable member; 62. The arterial interface device of Example 60 or 61, further comprising: 64. The arterial interface device of any of Examples 58-63, wherein the anchoring element comprises an adhesive element. 65. the mooring element is a first mooring element, 13. The arterial interface device, comprising: one or more wings extending laterally outward from the shaft, the one or more wings having a plurality of holes configured to receive sutures that anchor the arterial interface device to adjacent tissue; a second mooring element comprising: The arterial interface device of any of Examples 58 to 64, further comprising: 66. The arterial interface device of any of Examples 58-65, wherein a portion of the shaft is at least partially flexible. 67. The arterial interface device of any of Examples 58-66, wherein the distal end portion comprises a marker that can be visualized through one or more imaging techniques. 68. a port in fluid communication with the lumen, the port configured to receive a guidewire that can be advanced into the blood vessel; The arterial interface device of any of Examples 58 to 67, further comprising: 69. 1. A method for removing an intravascular assist device implanted within a patient's vasculature, comprising the steps of: advancing a distal portion of the wire through a drive line positioned within the patient's vascular system and into an interior volume of an expandable member coupled to a first end portion of the drive line, the wire being advanced until a snare element on the distal portion is adjacent a distal end portion of the expandable member; attaching an elongate delivery dilator via an attachment mechanism to a second portion of the drive line that is external to the patient's vasculature; accessing a second blood vessel at an access site downstream from the expandable member; advancing the capture mechanism into the second blood vessel, through the patient's vasculature and toward the expandable member; grasping the extendable member with a capture mechanism by engaging a snare element positioned within the extendable member; pulling the expandable member towards the access site via the capture mechanism and / or pushing the expandable member towards the access sheath via the elongate delivery dilator; and Removing the expandable member from the patient's vasculature via the access site in the second blood vessel. 70. The method of Example 69, wherein the first blood vessel is the subclavian artery or the axillary artery. 71. The method of Example 69 or 70, wherein the second blood vessel is the femoral artery. 72. The step of accessing the second vessel includes inserting a sheath into the second vessel; The step of removing the expandable member from the patient's vasculature includes advancing the expandable member at least partially into the sheath and removing the sheath containing the expandable member from the second blood vessel. The method according to any one of Examples 69 to 71. 73. The step of accessing the second vessel includes inserting a sheath into the second vessel; The step of removing the expandable member from the patient's vasculature includes advancing the expandable member through a sheath, the sheath remaining within the second blood vessel following removal of the expandable member. The method according to any one of Examples 69 to 72. 74. The method of any of Examples 69-73, wherein the snare element comprises a ball or hook positioned at the distal end region of the wire. 75. The method of any of Examples 69-74, wherein after the step of removing the expandable member from the patient's vasculature, a distal portion of the elongate delivery dilator extends through the access site, an intermediate portion of the elongate delivery dilator extends through a portion of the patient's vasculature, and a proximal portion of the elongate delivery dilator extends out of the first blood vessel. 76. removing the drive line and the expandable member from a distal portion of the elongate delivery dilator; removably attaching a replacement drive line to a distal end portion of the elongate delivery dilator, the replacement drive line being securely fixed to the replacement expandable member; and pulling the replacement drive line and the replacement expandable member into the patient's vascular system by pulling a distal portion of the elongate delivery dilator toward the first blood vessel. The method of Example 75, further comprising:

[0097] conclusion The above detailed description of the aspects of the present technology is not intended to be exhaustive or to limit the present technology to the precise form disclosed above. Although specific aspects and examples of the present technology have been described above for illustrative purposes, various equivalent modifications are possible within the scope of the present technology, as will be recognized by those skilled in the art. For example, although steps are presented in a given order, steps may be performed in a different order in alternative embodiments. Various aspects described herein may also be combined to provide further embodiments.

[0098] Unless the context clearly requires otherwise, throughout the description and examples herein, words such as "comprise" and "comprising" should be construed in an inclusive sense, i.e., "including, but not limited to," rather than an exclusive or exhaustive sense. As used herein, "connected," "coupled," or variants thereof, refer to any connection or coupling, either direct or indirect, between two or more elements; the coupling or coupling between elements may be physical, logical, or a combination thereof. In addition, the words "herein," "above," "below," and words of similar import, when used in this application, refer to this application as a whole and not to any particular portions of this application. Where the context permits, words using the singular or plural form in the above detailed description may also include the respective plural or singular forms. As used herein, the phrase "and / or" as in "A and / or B" refers to A only, B only, and A and B. It will also be recognized that specific embodiments have been described herein for illustrative purposes, but that various modifications may be made without departing from the technology. Furthermore, while advantages associated with some embodiments of the technology have been described in the context of those embodiments, other embodiments may also exhibit such advantages, and not all embodiments need necessarily exhibit such advantages to fall within the scope of the technology. Thus, the present disclosure and related technology may encompass other embodiments not expressly shown or described herein.

[0099] Where a range of values ​​is provided, it is understood that each intermediate value between the upper and lower limits of that range, to the tenth of the unit of the lower limit unless the context clearly indicates otherwise, is also specifically disclosed. Each subrange between any stated or intermediate value within a stated range and any other stated or intermediate value within that stated range is also encompassed within the disclosure. The upper and lower limits of these subranges may be independently included or excluded within the range, and each range in which either or both of the upper and lower limits are included within the subrange or not is also encompassed within the disclosure, subject to the specifically excluded limit being within the stated range. Where a stated range includes one or both limits, ranges excluding either or both of those included limits are also included within the disclosure.

Claims

1. below: an elongate delivery dilator having a first end portion, a second end portion, and a lumen extending between the first end portion and the second end portion, the elongate delivery dilator configured to advance over a guidewire positioned within a patient's vasculature and to extend through the patient's vasculature between a first blood vessel and a second blood vessel; an expandable member configured to be positioned within the patient's descending aorta to provide circulatory support to the patient's heart; and a drive line having a first end region connectable to the expandable member and a second end region connectable to the second end portion of the elongate delivery dilator; a pump assembly including: A system for intravascular implantation of a blood pump assembly within a patient, comprising:

2. The second end portion of the elongated delivery dilator a drive line connection element configured to releasably connect the elongate delivery dilator to a second end region of a drive line; a removable portion coupled to the drive line connection element; Including, removing the removable portion from the elongate delivery dilator to expose the drive line connection element.

2. The system of claim 1.

3. 3. The system of claim 2, wherein the removable portion is configured to guide the elongate delivery dilator through the introducer sheath.

4. 10. The system of claim 1, wherein a first end region of the drive line includes an elongate delivery dilator connecting element configured to releasably engage a second end portion of the elongate delivery dilator.

5. 10. The system of claim 1, wherein the drive line comprises an inner membrane, an outer membrane, and a kink-resistant element disposed between the inner membrane and the outer membrane.

6. 6. The system of claim 5, wherein the kink-resistant element is a helically wound Nitinol coil.

7. 6. The system of claim 5, wherein the outer membrane comprises a biocompatible and anti-thrombogenic material.

8. 10. The system of claim 1, wherein the drive line has a length of greater than about 200 cm.

9. 10. The system of claim 1, wherein the drive line has an outer diameter of about 4.2 mm or less.

10. 10. The system of claim 1, wherein the expandable member is a balloon.

11. 11. The system of claim 10, wherein the balloon has an internal volume of about 20 mL to about 60 mL.

12. 11. The system of claim 10, wherein the balloon has a proximal end portion connectable to a drive line and a distal end portion spaced from the proximal end portion, at least a portion of the distal end portion tapering inwardly.

13. The system of claim 12 , wherein the proximal end portion has a greater material thickness than the distal end portion.

14. The system of claim 1 , wherein the expandable member comprises a biocompatible and anti-thrombogenic material.

15. 10. The system of claim 1, further comprising a funnel assembly configured to fold, twist or otherwise reduce a dimension about the extendible member.

16. 10. The system of claim 1, further comprising a folding tube configured to fold, twist or otherwise reduce dimensions about the expandable member.

17. 10. The system of claim 1, further comprising an arterial interface device configured to provide a hemostatic seal in the first blood vessel.

18. an arterial interface device including a shaft defining a first lumen for receiving a portion of the drive line therethrough; a distal end portion of the shaft configured to be placed within a first blood vessel.

20. The system of claim 17.

19. 20. The system of claim 18, wherein a distal end portion of the shaft is tapered.

20. 20. The system of claim 18, wherein the arterial interface device comprises an expandable anchoring element coupled to the shaft near the distal end portion.

21. the drive line is a first drive line; a second drive line connectable to the first drive line and configured to extend subcutaneously between the first drive line and a skin interface device.

2. The system of claim 1.

22. the second drive line further includes one or more wings; and the one or more wings having one or more apertures; 22. The system of claim 21.

23. The second drive line an absorbing feature configured to reduce longitudinal strain in the first drive line when the second drive line is connected to the first drive line; 22. The system of claim 21, comprising:

24. 22. The system of claim 21, wherein the second drive line has an inner diameter equal to or greater than an outer diameter of the first drive line.

25. a first drive line having a distal segment including a first end region connectable to the expandable member and a proximal segment including a second end region connectable to the second drive line; at least a portion of the proximal segment is configured to be removed before the first drive line is connected to the second drive line.

22. The system of claim 21.

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