CN116806163A - Mechanical circulation support system with insertion tool - Google Patents

Abstract

A minimally invasive micro-percutaneous mechanical circulatory support system for delivering a pump through a catheter to the heart actively unloading the left ventricle by pumping blood from the left ventricle into the ascending aorta and systemic circulation. The pump may include a tubular housing, a motor, an impeller configured to be rotated by the motor. The impeller may be rotated by a motor via a shaft or via a magnetic drive, with an annular polymeric seal around the shaft. The system may have an insertion tool having a tubular body and configured to axially movably receive the circulatory support device, and an introducer sheath configured to axially movably receive the insertion tool.

Description

Mechanical circulation support system with insertion tool

Incorporation by reference of any priority application

Any and all applications identifying foreign or domestic priority claims in the application data sheets filed with the present application are hereby incorporated by reference in accordance with 37cfr 1.57. For example, the present application claims priority from U.S. provisional application No. 63/116616 entitled "mechanical left ventricular support System for cardiogenic shock (MECHANICAL LEFT VENTRICULAR SUPPORT SYSTEM FOR CARDIOGENIC SHOCK)" filed on 11, 20, 2020, U.S. provisional application No. 63/229436 entitled "seal for mechanical circulatory support device (SEAL FOR AMECHANICAL CIRCULATORY SUPPORT DEVICE)" filed on 8, 2021, and U.S. provisional application No. 63/116686 entitled "mechanical circulatory support System for high risk coronary interventions (MECHANICAL CIRCULATORY SUPPORT SYSTEM FOR HIGH RISK CORONARY INTERVENTIONS)" filed on 11, 20, 2020, each of which is incorporated herein by reference in its entirety for all purposes and forms a part of the present specification.

Background

Mechanical circulatory support systems may be used to assist in pumping blood and/or as a treatment for certain cardiac diseases during various medical procedures. For example, cardiogenic Shock (CS) is a common cause of death and management is challenging despite advances in treatment options. CS is caused by severe impairment of myocardial performance, which results in reduced cardiac output, hypoperfusion of the final organ and hypoxia. Clinically, this is manifested as refractory hypotension in volume resuscitation, characterized by hypoperfusion of the final organ requiring immediate pharmacological or mechanical intervention. Acute Myocardial Infarction (MI) accounts for more than about 80% of CS patients.

As another example, percutaneous Coronary Intervention (PCI) is a non-surgical procedure that reconstructs stenotic coronary vessels. PCI includes a variety of techniques, such as balloon angioplasty, stent implantation, rotational atherectomy, and lithotripsy. PCI is considered to be a high risk if the patient has associated complications (e.g., frailty or advanced age), the PCI itself is very complex (e.g., bifurcation or total occlusion), or the hemodynamic status is challenging (e.g., impaired ventricular function).

Miniature, catheter-based endocardial blood pumps have been developed for percutaneous insertion into the body of a patient as acute treatment for CS and for temporary assistance during PCI. However, existing solutions for pumps have various performance drawbacks, such as insufficient blood flow, the need for continuous motor purging within the pump, undesirable high hemolysis, and insufficient sensing of hemodynamic parameters. Thus, there remains a need for a mechanical circulatory support system having features that overcome these and other disadvantages.

Disclosure of Invention

The embodiments disclosed herein each have several aspects, no single one of which is solely responsible for the desirable attributes of the present disclosure. Without limiting the scope of this disclosure, its more prominent features will now be discussed briefly. After considering this discussion, and particularly after reading the section entitled "detailed description" one will understand how the features of the embodiments described herein provide advantages over existing systems, devices, and methods for loop support systems.

The following disclosure describes non-limiting examples of some embodiments. For example, other embodiments of the disclosed systems and methods may or may not include the features described herein. Furthermore, the advantages and benefits disclosed may only apply to certain embodiments and should not be used to limit the present disclosure.

Various aspects and embodiments of mechanical cycle support systems, devices, and methods are described herein. The mechanical cycle support systems, devices, and methods may have one or more of any of the following features: a mechanical circulatory support system includes a circulatory support catheter including a circulatory support device carried by an elongate flexible catheter shaft, the circulatory support device including a tubular housing, a motor, an impeller configured to be rotated by the motor via a shaft, and an annular polymer seal about the shaft, an insertion tool having a tubular body and configured to axially movably receive the circulatory support device, and an introducer sheath having a tubular body and configured to axially movably receive the insertion tool; the introducer sheath includes a hub on a proximal end of the introducer sheath, the hub having a lock for preventing axial movement of the insertion tool; the hub includes one or more hemostatic valves; the tubular body of the insertion tool has sufficient resistance to collapse to remain unobstructed when passing through the hemostasis valve of the introducer sheath; the catheter shaft includes a visual marker proximally spaced from the circulatory support device such that visibility of the visual marker on the proximal side of the introducer sheath indicates that the circulatory support device is within the tubular body of the insertion tool; the system further includes a first guidewire port on a distal end of the tubular housing of the circulatory support, a second guidewire port on a sidewall of the tubular housing of the circulatory support and distal to the impeller, and a third guidewire port on a proximal side of the impeller; the tubular body of the insertion tool has a length in the range of about 85mm to about 160mm and an inner diameter in the range of about 4.5mm to about 6.5 mm; the tubular housing of the circulatory support device includes an inlet tube coupled to a motor housing, the inlet tube having one or more distal pump inlets and one or more proximal pump outlets, and the impeller being adjacent to the one or more proximal pump outlets; the system does not require purging; the introducer sheath is a 16 french (Fr) sheath; the circulatory support device is configured to provide a blood flow rate of about 4.0 liters per minute (l/min) for about 6 hours; the insertion tool includes a hemostatic valve; the insertion tool includes a locking mechanism including a recess configured to receive a locking pad configured to releasably lock with the circulatory support catheter; the insertion tool includes a housing surrounding at least a portion of the locking mechanism, the housing including opposing first inner surface walls spaced farther apart than opposing second inner surface walls, wherein the at least a portion of the locking mechanism includes radially outwardly extending tabs, and wherein the housing is configured to rotate to compress the tabs inwardly to prevent axial movement of the circulation supporting catheter; inward compression of the tabs of the locking mechanism compresses the locking pad against the circulatory support tube; the impeller is configured to be rotated by the motor via a shaft; the circulatory support means comprises an annular polymeric seal around the shaft; the circulatory support device includes a seal surrounding the shaft, the seal including a distal radial shaft seal having a distal end configured to face distally toward the impeller and a radial inner lip configured to contact the shaft and extend from the distal end in a proximal direction toward the motor; the seal further includes a proximal radial shaft seal having a proximal side configured to face proximally toward the motor and a radially inner lip configured to contact the shaft and extend from the proximal side in a distal direction toward the impeller; the impeller is configured to be rotated by the motor via a magnetic coupling; the introducer sheath includes a hub on a proximal end of the introducer sheath, the hub having features for preventing axial and optionally rotational movement of the insertion tool; the hub and a release bend disposed between the hub and the tubular body of the introducer sheath are configured to axially movably receive the tubular body of the insertion tool; the insertion tool includes a tube having a valve, the tube in fluid communication with an inner lumen of the tubular body of the insertion tool configured for flushing with saline; the distal end of the tubular body of the insertion tool is detachably connected to a guidewire assist device configured to facilitate guidewire access through the first guidewire port; a removable guidewire guide tube enters the first guidewire port on the distal end of the tubular housing, exits the tubular housing via the second guidewire port on the sidewall of the tubular housing distal to the impeller, reenters the tubular housing via the third guidewire port on the proximal side of the impeller, and extends proximally into the catheter shaft; the tubular body of the insertion tool is configured to receive the circulatory support device and the removable guidewire guide tube; the tubular body of the insertion tool and the guidewire guide tube are transparent; the insertion tool includes a plug disposed at a proximal end of the insertion tool, the plug configured to be connected to a sterile shield sleeve; a mechanical circulatory support system comprising an elongate flexible catheter shaft having a proximal end and a distal end, a circulatory support carried by the distal end of the catheter shaft, the circulatory support comprising a tubular housing, a motor, and an impeller configured to be rotated by the motor, wherein the circulatory support is configured to provide a blood flow rate of up to about 4.0 liters per minute (l/min) for about 6 hours without purging the system; the system further includes an insertion tool having a tubular body and configured to axially movably receive the circulatory support device; the system further includes an introducer sheath having a tubular body and configured to axially movably receive the insertion tool; the system further includes a controller that does not include a purge component; the controller does not include a cartridge or port for purging; the impeller includes a blade having a proximal blade section with a wave-shaped blade curvature defined by one or more curved portions of a skeleton line of the blade; the tubular housing of the circulatory support device comprises an inlet tube having a main body, wherein the main body comprises a first attachment section at a first end of the main body configured to attach the inlet tube to a head unit of the circulatory support device and a second attachment section at a second end of the main body, wherein the first attachment section is configured to connect to the head unit in a form-locking and/or force-locking manner, wherein the main body further comprises a structural section comprising at least one stiffening recess between the first attachment section and the second attachment section; the impeller comprises a blade having at least one blade section with a wavy blade curvature; the tubular housing of the circulation support device comprises an inlet tube having an inlet and an outlet, and wherein the outlet and the vane section having the undulating vane curvature at least partially axially overlap; the impeller comprises a blade element having a profile with camber lines, wherein the curvature of each of the camber lines increases along the rotation axis in a direction from the pump entry section towards the outlet opening to an inflection point where the blade angle (β) of the blade element is at a maximum, and wherein the curvature of each of the camber lines decreases after the inflection point, and wherein in a region of the impeller radially positioned relative to the rotation axis of the impeller and having the blade element blade height SH defined relative to a maximum blade height SHMAX such that 25% SH/SHMAX is less than or equal to 100%, the inflection point of each of the camber lines is located in a region of an upstream edge of an outlet opening of an inlet tube of the tubular housing; the system further includes a tubular housing including an outlet opening configured to facilitate blood outflow and a diffuser configured to be coupled with the tubular housing, wherein in an operational position, the diffuser is configured to direct blood transverse to the outlet opening after the blood has passed through the outlet opening; the tubular housing includes an inlet tube having a mesh section with a mesh structure formed of at least one mesh wire; the web section is bent at an obtuse angle at a bending point; the tubular housing includes an inlet tube for delivering blood therethrough; and a reduced diameter section at a distal end of the inlet tube; the tubular housing comprises a feed head portion comprising at least one inlet opening for receiving a fluid flow into a feed line and a profile portion disposed adjacent the feed head portion and comprising an inner surface profile, wherein the inner surface profile comprises a first inner diameter at a first location, a second inner diameter at a second location, and a third inner diameter at a third location, wherein the first inner diameter is greater than the second inner diameter, wherein the third inner diameter is greater than the second inner diameter, wherein the first inner diameter comprises a maximum inner diameter of the profile portion, and the second inner diameter comprises a minimum inner diameter of the profile portion, wherein the inner surface profile comprises a rounded portion at the second location, wherein the profile portion comprises a first inner radius at the first location and a second inner radius at the second location, wherein the second inner radius is at most one fifth less than the first inner radius, and wherein the second location is located between the first location and the third location; the tubular housing includes a radiopaque marker at a distal end of the tubular housing; the tubular housing comprising an inlet tube having a nose piece at a distal end of the inlet tube, the nose piece comprising a radiopaque marker; the insertion tool includes a hemostatic valve; the insertion tool includes a locking mechanism including a recess configured to receive a locking pad configured to releasably lock with the catheter shaft; the insertion tool includes a housing surrounding at least a portion of the locking mechanism, the housing including opposing first inner surface walls spaced farther apart than opposing second inner surface walls, wherein the at least a portion of the locking mechanism includes radially outwardly extending tabs, and wherein the housing is configured to rotate to compress the tabs inwardly to prevent axial movement of the catheter shaft; inward compression of the tabs of the locking mechanism compresses the locking pad against the catheter shaft; a minimally invasive, mechanical circulatory support system for placement through an aortic valve via a single femoral artery access point; the system may include a low-profile axially rotating blood pump carried by a distal end of an octafrench catheter; the system may be percutaneously inserted through the femoral artery and positioned through the aortic valve into the left ventricle; the device actively unloading the left ventricle by pumping blood from the left ventricle into the ascending aorta and the systemic circulation; the impeller is configured to be rotated by the motor via a shaft; the circulatory support means comprises an annular polymeric seal around the shaft; the circulatory support device includes a seal surrounding the shaft, the seal including a distal radial shaft seal having a distal end configured to face distally toward the impeller and a radial inner lip configured to contact the shaft and extend from the distal end in a proximal direction toward the motor; the seal further includes a proximal radial shaft seal having a proximal side configured to face proximally toward the motor and a radially inner lip configured to contact the shaft and extend from the proximal side in a distal direction toward the impeller; the impeller is configured to be rotated by the motor via a magnetic coupling; the introducer sheath includes a hub on a proximal end of the introducer sheath, the hub having features for preventing axial and optionally rotational movement of the insertion tool; the hub and a release bend disposed between the hub and the tubular body of the introducer sheath are configured to axially movably receive the tubular body of the insertion tool; the insertion tool includes a tube having a valve, the tube in fluid communication with an inner lumen of the tubular body of the insertion tool configured for flushing with saline; the distal end of the tubular body of the insertion tool is detachably connected to a guidewire assist device configured to facilitate guidewire access through a first guidewire port; a removable guidewire guide tube enters the first guidewire port on the distal end of the tubular housing, exits the tubular housing via a second guidewire port on a sidewall of the tubular housing distal of the impeller, reenters the tubular housing via a third guidewire port on a proximal side of the impeller, and extends proximally into the catheter shaft; the tubular body of the insertion tool is configured to receive the circulatory support device and the removable guidewire guide tube; the tubular body of the insertion tool and the guidewire guide tube are transparent; the insertion tool includes a plug disposed at a proximal end of the insertion tool, the plug configured to be connected to a sterile shield sleeve; a mechanical circulatory support system for high risk coronary interventions comprising an elongate flexible catheter shaft having a proximal end and a distal end, a circulatory support carried by the distal end of the shaft, the circulatory support comprising a tubular housing having a proximal end and a distal end, an impeller within the housing, a removable guidewire guide tube entering a first guidewire port on the distal end of the housing, exiting the housing via a second guidewire port on a sidewall of the housing distal to the impeller, re-entering the housing via a third guidewire port on the proximal side of the impeller, and extending proximally into the catheter shaft; the system may include a motor within the housing and configured to rotate the impeller; the motor may be positioned distal to the third guidewire port; the tubular housing may have an axial length in the range of 60mm to 100 mm; the system may include a blood exit port on the tubular housing in communication with the impeller, and a blood entry port on the housing distally spaced from the blood exit port; the housing may comprise a flexible slotted tube covered by an outer polymer sleeve; the system may include a sealed motor housing inside the tubular housing; a mechanical circulatory support system for high-risk coronary interventions, comprising a circulatory support catheter comprising a circulatory support device carried by an elongate flexible catheter shaft, an insertion tool having a tubular body and configured to axially movably receive the circulatory support device, and an access sheath (also referred to herein as an introducer sheath) having a tubular body and configured to axially movably receive the insertion tool; the access sheath may include an access sheath hub having an insertion tool lock for engaging the insertion tool; the access sheath hub may include a catheter shaft lock for locking the access sheath hub to the catheter shaft; a controller configured to drive a motor of the mechanical cycle support system may be provided, wherein the controller does not include a purge component; the purge component may comprise a cartridge or port; the system does not require purging; a controller configured to drive a motor of a mechanical circulation support system may be provided, the controller having a housing for mounting electronic components and a handle disposed on a top portion of the housing; the controller may include a visual alert element encircling the handle on the top portion of the housing; the housing may not include more than one control element; the control element may be a rotary dial; the control element may be positioned on the first end of the housing; the controller may include a cable management system positioned on a second end opposite the first end; the controller may include a rotationally fixed attachment on a rear side of the housing; a minimally invasive percutaneous mechanical left ventricular support system may be provided that is optimized for treating patients experiencing cardiogenic shock; the system may include a low-profile (e.g., 18Fr to 19 Fr) Ventricular Support Device (VSD) comprising an axially rotating blood pump carried by a distal end of a nine-french catheter and an elongate inlet tube; the system can be positioned across the VSD through the aortic valve into the left ventricle where it actively unloads the left ventricle by pumping blood from the left ventricle into the ascending aorta and systemic circulation, and can provide a flow rate of up to about 6L/min at 60 mmHg; a flow rate of between 0.6L/min and 6L/min may be provided; an intravascular access may be achieved using an 8 to 16Fr (e.g., 8 to 10.5 Fr) introducer sheath that is expandable to accommodate 18 to 19 french VSDs; the access may be via percutaneous transfemoral puncture, or via surgically incised armpit access; the introducer sheath may be part of an introducer set that may also include a guidewire, a dilator, an insertion tool, and a guidewire assist; the motor may be completely sealed by being enclosed within a motor housing with a magnetic coupling to allow the motor to drive the impeller without requiring a shaft to exit the housing; the magnetic coupling may include a cylindrical drive magnet array positioned within the motor housing, concentrically positioned within a cylindrical driven magnet array located outside the motor housing, and mechanically coupled to the impeller; the impeller rotates relative to the motor housing about a pivot jewel bearing; the magnetic coupling is flushed with a constant blood flow through flush holes on the proximal and distal ends of the magnetic coupling; the sealed motor can eliminate the purge process required for some competing devices; migration of the device after placement may be inhibited by an intravascular anchor carried by the catheter shaft, the intravascular anchor providing anchoring in the aorta; the anchor may include a plurality of radially outwardly expandable struts carried by the catheter shaft, the plurality of radially outwardly expandable struts configured to contact the aortic wall and anchor the shaft against migration while allowing infusion through the anchor struts; migration may be inhibited by a locking mechanism that engages the catheter shaft with an introducer sheath in a fixed position, the introducer sheath being held to the arteriotomy with a suture, thereby holding the catheter shaft stationary relative to the intravascular access path; the on-board sensor may enable real-time actual measurement of any of a variety of parameters of interest, such as aortic pressure, left ventricular pressure (including left ventricular end diastolic pressure or "LVEDP"), temperature, blood flow velocity, etc., depending on the desired clinical performance; the sensor may be included on a distal end of the device, such as a distal end of an inlet tube on a distal side of the blood outflow port; an additional sensor may be provided on the proximal end of the elongate body, e.g. proximal to the blood outflow port; the particular sensor may include at least a first MEMS pressure and temperature sensor for directly measuring absolute left ventricular pressure; a sensor capable of extracting a vital physiological parameter (such as LVEDP); an ultrasound transducer may be provided for directly measuring blood flow through the pump or alternatively around the pump; the ultrasound transducer surface may be curved and configured for increased focusing and high sensitivity; a second MEMS pressure and temperature sensor may be provided on the proximal end of the inlet tube, so as to be able to directly measure absolute aortic pressure and allow differential pressure measurement; other forms of sensors may be used to evaluate flow rate, such as laser doppler, thermal or electrical impedance sensors; a flexible electrical conductor may extend along the length of the inlet tube for connecting the distal sensor and the proximal sensor into an integrated system; the flexible conductor may be in the form of a flexible PCB that may extend axially helically around the inlet tube between the proximal sensor and the distal sensor; a multi-conductor cable bundle extends proximally through the elongate flexible tubular body to a connector at the proximal manifold for releasable connection to an external electronic control unit; a mechanical ventricular support system for cardiogenic shock may include an elongated flexible catheter shaft having proximal and distal ends, a ventricular support device carried by the distal end of the shaft, the ventricular support device including a ventricular support device housing, a motor rotationally fixed relative to a driving magnet array, an impeller rotationally fixed relative to a driven magnet array, and a sealed motor housing inside the ventricular support device housing and surrounding the motor and the driving magnet array; the system may include a removable guidewire guide tube; the guide tube may enter a first guidewire port on a distal end of the housing, exit the housing via a second guidewire port on a sidewall of the housing distal to the impeller, reenter the housing via a third guidewire port on a proximal side of the impeller, and extend proximally into the catheter shaft; the system may include at least one inlet port and at least one outlet port on the housing separated by a flexible section of the housing; the distance between the inlet port and the outlet port may be at least about 60mm and no longer than 100mm, preferably 70mm; the system may include a first pressure sensor proximate the inlet port; the system may include a second pressure sensor on a proximal side of the outlet port; the system may include a visual marker on the catheter shaft in the range of about 50mm to about 150mm from the distal end of the catheter shaft (or the start of the pump); the motor may be positioned distal to the third guidewire port; the system may include an ultrasonic transducer proximate the inlet port; the system may include a guidewire assist device removably carried by the ventricular support device; the guidewire assist device may include a tubular body having a distally facing opening and an inner diameter that increases in a distal direction toward the opening; the guidewire assist device may include a guidewire guide tube attached to the body; the guidewire guide tube may include a split line for splitting the guide tube such that the guide tube may be peeled away from a guidewire extending through the tube; the flexible section of the housing may comprise a flexible slotted tube covered by an outer polymer sleeve; a mechanical ventricular support system for high-risk coronary interventions may include a ventricular support catheter including a ventricular support device carried by an elongate flexible catheter shaft, a sealing motor and an impeller inside the ventricular support device and rotationally coupled together by a magnetic bearing, an insertion tool having a tubular body and configured to axially movably receive the ventricular support device, and an access sheath having a tubular body and configured to axially movably receive the insertion tool; the access sheath may include an access sheath hub having a first lock for engaging the insertion tool; the access sheath hub may include a second lock for engaging the catheter shaft; a controller configured to drive a motor of a mechanical circulation support system, wherein the controller does not include a purge component; the purge component may comprise a cartridge or port; the system does not require purging; a controller configured to drive a motor of a mechanical circulation support system may be provided, the controller having a housing for mounting electronic components and a handle disposed on a top portion of the housing; the controller may include a visual alert element encircling the handle on the top portion of the housing; the housing may not include more than one control element; the control element may be a rotary dial; the control element may be positioned on the first end of the housing; the controller may include a cable management system positioned on a second end opposite the first end; the controller may include a rotationally fixed attachment on a rear side of the housing; a method of delivering a pump to a heart via a catheter, the method comprising: advancing the pump through a vasculature, wherein the pump is advanced such that a guidewire extends through a first section of a catheter shaft distal to the pump, through a tubular housing of the pump, outside an impeller and motor of the pump, and back into a second section of the catheter shaft proximal to the pump; activating the motor and/or rotating the impeller before removing the guidewire from the pump and/or before placing the pump in the heart; and/or retaining the guidewire in the pump during use of the pump such that the guidewire and/or the pump is at least partially retained in the left ventricle.

Drawings

The foregoing and other features of the present disclosure will become more fully apparent from the following description and appended claims, taken in conjunction with the accompanying drawings. Understanding that these drawings depict only several embodiments in accordance with the disclosure and are not therefore to be considered limiting of its scope, the disclosure will be described with additional specificity and detail through use of the accompanying drawings. In the following detailed description, reference is made to the accompanying drawings, which form a part hereof. In the drawings, like reference numerals generally identify like components unless context dictates otherwise. The illustrative embodiments described in the detailed description, drawings, and claims are not meant to be limiting. Other embodiments may be utilized and other changes may be made without departing from the spirit or scope of the subject matter presented herein. It will be readily understood that the aspects of the present disclosure, as generally described herein, and illustrated in the figures, may be arranged, substituted, combined, and designed in a wide variety of different configurations, all of which are explicitly contemplated and form part of this disclosure.

Fig. 1 is a cross-sectional perspective view of an embodiment of a Mechanical Circulatory Support (MCS) device of the present disclosure carried by a catheter and positioned through an aortic valve via a femoral artery access.

Fig. 2 schematically illustrates an MCS system inserted into the body via a pathway from the femoral artery to the left ventricle, according to some embodiments.

Fig. 3 is a side elevation view of an embodiment of an MCS system that may incorporate various features described herein.

Fig. 4 is the system of fig. 3 with the introducer sheath removed and including an insertion tool and a guidewire loading aid.

Fig. 5 illustrates an introducer set with a sheath and dilator that may be used with the various MCS systems and methods described herein.

Fig. 6 illustrates an embodiment of a placement guidewire that may be used with the various MCS systems and methods described herein.

Fig. 7 is a partial perspective view of a distal pump region of the MCS device.

Fig. 8A and 8B are side elevation and close-up detail views, respectively, of a distal region of an MCS device, showing a guidewire guide tube defining a guidewire path and a guidewire post-loading aid in place.

Fig. 9A and 9B are side views of the pump region and a cross-sectional view through the impeller region of the MCS device, respectively.

Fig. 10A is a front elevation view of an MCS controller.

Fig. 10B is a rear perspective view of the MCS controller.

Fig. 11 shows a block diagram of an electronic system that may be housed within the controller of fig. 10A and 10B.

Fig. 12 shows an exploded view of the components of the electronic system of fig. 11 inside the controller.

Fig. 13 shows a side perspective view of the MCS controller.

Fig. 14A shows a graph showing the pressure difference between the aortic pressure and the left ventricular pressure.

Fig. 14B shows a graph of the current applied for a constant rotational speed of the motor shaft.

FIG. 15 illustrates an exemplary user interface for displaying control parameters.

Fig. 16A illustrates an exemplary user interface in a configuration mode.

Fig. 16B illustrates an exemplary user interface in an operational mode.

Fig. 17A and 17B show an embodiment of an electronic control unit.

Fig. 18A-18D are exemplary Left Ventricular (LV) pressure curves illustrating a procedure for determining Left Ventricular End Diastolic Pressure (LVEDP).

Fig. 19 is a side view of an alternative embodiment of a pump of the MCS system.

20A-20B are side views of an impeller and partial side views of impeller blades, respectively, showing an embodiment of an impeller of an MCS system.

Figures 21A-21C illustrate embodiments of pump areas of an MCS system.

Fig. 22 is a side view of an embodiment of an inlet tube of the MCS system.

Fig. 23 is a perspective view of an embodiment of an inlet tube of the MCS system.

Fig. 24 is a perspective view of an embodiment of a pump area of the MCS system.

Fig. 25 is a partial cross-sectional view of a profile section of an inlet tube of the pump region of fig. 24.

Fig. 26A-26E are various views of an embodiment of an insertion tool that may be used with the various MCS systems described herein.

Fig. 27 is a partial cross-sectional view through an impeller and magnetic coupling region of an embodiment of a pump that may be used with the various MCS systems described herein.

Fig. 28A and 28B are side and perspective views, respectively, of an ultrasound transducer that may be used with the various MCS systems described herein.

Fig. 29 is a side elevation view of an introducer sheath and hub that may be used with the various MCS systems described herein.

Fig. 30A-30C are various views of another embodiment of an MCS device having two lip seals facing each other.

While the presently disclosed embodiments set forth the identified figures above, other embodiments are also contemplated, as noted in the detailed description. The present disclosure presents illustrative embodiments by way of representation and not limitation. Numerous other modifications and embodiments can be devised by those skilled in the art which fall within the scope and spirit of the principles of the presently disclosed embodiments.

Detailed Description

The following detailed description is directed to certain specific embodiments of the improvements. In this specification, reference is made to the drawings wherein like parts or steps may be designated with like reference numerals throughout for clarity. Reference in the specification to "one embodiment," "an embodiment," or "in some embodiments" means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment of the invention. The appearances of the phrases "in one embodiment," "in an embodiment," or "in some embodiments" in various places throughout this specification are not necessarily all referring to the same embodiment, nor are separate or alternative embodiments necessarily mutually exclusive of other embodiments. Furthermore, various features are described which may be exhibited by some embodiments and not by others. Similarly, various requirements are described which may be requirements for some embodiments but may not be requirements for other embodiments. Reference will now be made in detail to embodiments of the present invention, examples of which are illustrated in the accompanying drawings. Wherever possible, the same reference numbers will be used throughout the drawings to refer to the same or like parts.

Fig. 1 is a schematic diagram of a distal end of an embodiment of a Mechanical Circulatory Support (MCS) system 10 having a pump 22 mounted on the tip of a catheter 16 placed in the heart. Fig. 2 schematically illustrates an MCS system inserted into the body via a pathway from the femoral artery to the left ventricle, according to some embodiments. Some features of MCS system 10 will be described with respect to fig. 1 and 2, with further details of the various features provided elsewhere herein.

Various embodiments of MCS system 10 having various features are described herein. In some embodiments, MCS system 10 may include a temporary (e.g., typically no more than about 6 hours, or in some embodiments no more than about 3 hours, no more than about 4 hours, no more than about 7 hours, no more than about 8 hours, no more than about 9 hours, or no more than about 10 hours) left ventricular support device or pump, also referred to as an MCS pump or MCS device. The device may be used during high risk Percutaneous Coronary Intervention (PCI) on selective or emergency, hemodynamic stable patients suffering from severe coronary artery disease and/or reduced left ventricular ejection fraction, for example when a cardiac team including cardiac surgeons has determined that high risk PCI is a suitable treatment option. The pump is placed through the aortic valve via a single femoral artery access.

In some embodiments, MCS system 10 may include a long-term pump 22, for example, as a treatment for cardiogenic shock. The MSC system 10 may include a pump 22 having a first magnet rotated by a motor within a sealed motor housing. An impeller having a second magnet may partially surround the first magnet outside the motor housing. Rotation of the first magnet causes rotation of the second magnet and the impeller via magnetic communication.

In some embodiments, MCS system 10 may include an insertion tool having a tubular body and configured to axially movably receive a circulatory support device. An introducer sheath having a tubular body may be configured to axially movably receive an insertion tool. The insertion tool may protect the circulatory support device (e.g., during insertion of the sheath).

In some embodiments, MCS system 10 may include a low profile axial rotary blood pump mounted on catheter 16 (e.g., an 8 french (Fr) catheter). When in place, MCS pump 22 may be driven by an MCS controller to provide a portion of left ventricular support of up to about 4.0 liters/min, which may be at about 60mm Hg. Because of the improved bearing design and sealed motor, no system purge is required. MCS system 10 or portions thereof may be visualized by fluoroscopy, eliminating the need to use sensor placement.

In some embodiments, MCS system 10 may include an introducer sheath. The sheath may be expandable. The expandable sheath may allow an initial access size of, for example, 8 to 10Fr to facilitate insertion and closure, be expandable to allow the introduction of a 14Fr, 16Fr and 18Fr pump device, and return to the narrower diameter of the catheter surrounding 8Fr once the pump passes. This feature may allow the pump 22 to pass through the vasculature while minimizing shear forces within the vessel, advantageously reducing the risk of bleeding and healing complications. The expansion or stretching of the arteriotomy can be accomplished with radial stretching with minimal shear, which is less detrimental to the vessel. The access may be via a transfemoral, transaxillary, transarterial, or transapical approach. In some embodiments, the expandable sheath may allow an initial access size of 8 to 16Fr (e.g., 8 to 10.5 Fr) to facilitate insertion and closure, and may be expandable to allow introduction of a device of at least about 14Fr, 16Fr, 18 or 19 Fr.

In some embodiments, the inlet tube 70 of the pump 22 extends through the aortic valve 91. The impeller may be located at the outflow section 68 of the inlet tube 70 (also referred to herein as a pump outlet), drawing blood from the left ventricle 93 through the inlet tube 70 and expelling it out of the outflow section 68 into the ascending aorta 95. The motor may be mounted directly proximal to the impeller in the sealed housing, eliminating the need to purge or flush the motor prior to or during use. This configuration provides hemodynamic support during high risk PCI with sufficient time and safety for complete vascular reconstruction via minimally invasive approaches (rather than open surgery).

In some embodiments, MCS system 10 actively unloads the left ventricle by pumping blood from the ventricle into the ascending aorta and systemic circulation. When in place, the MCS device may be driven by a supplemental MCS controller to provide a partial left ventricular support of between 0.4l/min and 4.0 l/min. MCS system 10 may eliminate the need for motor flushing, providing increased flow performance up to 4.0l/min at 60mmHg and acceptable safe hemolysis due to Computational Fluid Dynamics (CFD) optimized impellers that minimize shear stress. When in place, VSD may be driven by supplemental ventricular support controller 1000 to provide a portion of left ventricular support between 0.4l/min and 6.0 l/min. In some embodiments, VSD may be driven by supplemental ventricular support controller 1000 to provide a portion of left ventricular support between 0.6l/min and 6.0 l/min. For example, a range between 0.6l/min and 6.0l/min may allow 10 equidistant flow levels.

In some embodiments, MCS system 10 may include an 18 to 19Fr axially rotating blood pump and an inlet tube assembly mounted on catheter 16 (e.g., a catheter no greater than 10.5 Fr). When in place, ventricular support pump 22 may be driven by ventricular support controller 1000, which may provide partial left ventricular support of at least about 4 or 5 and up to about 6.0 liters/min at a pressure differential of about 60mm Hg. In some embodiments of the pump 22, no system purge is required due to the packaged motor and magnetic bearing design.

In general, the overall MCS system 10 may include a series of related subsystems and accessories, including one or more of the following: MCS system 10 may include pumps, shafts, proximal hubs, insertion tools, proximal threads, infection shields, guidewire guides, and/or guidewire aids. The pump 22 may be provided sterile. The MCS shaft may contain cables and guidewire lumens for over-the-wire insertion. The proximal hub contains a guidewire outlet with a valve to maintain hemostasis and connect the MCS shaft to a proximal cable that connects the pump 22 to the controller 1000. The proximal cable 28 may be 3.5m (about 177 inches) in length and extends from the sterile zone 5 to the non-sterile zone 3 where the controller 1000 is located. MCS insertion tools pre-installed on the MCS device may be provided to facilitate insertion of the pump into the introducer sheath and to protect the inlet tube and valve from potential damage or interference while passing through the introducer sheath. The peel wire assist device may be pre-installed on the MCS device to facilitate insertion of a guidewire (e.g., a 0.018 "placement guidewire) into the pump 22 and MCS catheter shaft 16, and optionally, the MCS insertion tool may also be pre-installed so that the guidewire guide catheter may pass at least partially through the space between the MCS device and the MCS insertion tool. A 3m, 0.018 "placement guidewire may be used with a soft coiled pre-shaped tip for atraumatic placement of the wire into the left ventricle. The guidewire may be provided sterile. A 14Fr or 16Fr introducer sheath having an available length of 275mm may be used to maintain access to the femoral artery and provide hemostasis for 0.035 "guidewires, diagnostic catheters, 0.018" placement guidewires, and insertion tools. The housing of the introducer sheath may be designed to house an MCS insertion tool. The introducer sheath is provided sterile. The introducer dilator may be compatible with the introducer sheath to facilitate atraumatic insertion of the introducer sheath into the femoral artery. The introducer dilator is provided sterile. A controller 1000 may be used that drives and operates the pump 22, observes its performance and condition, and/or provides error and status information. The power controller 1000 may be designed to support continuous operation for at least about 12 hours and include a basic interface to indicate and adjust the level of support provided to the patient. Further, in the event that the system detects an error during operation, the controller 1000 may provide optical and audible alert notifications. The controller 1000 may be provided non-sterile and housed in a housing designed for cleaning and reuse outside of the sterile field 5. The controller 1000 housing may contain a socket into which the extension cable is inserted.

In some embodiments, pump 22 of the present disclosure, which may also be referred to as a Ventricular Support Device (VSD) or mechanical circulatory support device, may be a temporary (typically no more than about 6 days) left ventricular support device for enhancing cardiac output in patients suffering from cardiogenic shock, e.g., caused by acute ST elevation myocardial infarction. The pump 22 may be placed through the aortic valve, typically via a transvascular access, to pump blood from the left ventricle to the ascending aorta.

Referring to fig. 3, an overall MCS system 10 is shown, according to some embodiments, the subcomponents of which are described in more detail below. For reference, the "distal" and "proximal" directions are indicated by arrows in fig. 3, 4, and 8A. As used herein, "distal" and "proximal" have their usual and customary meanings and include, but are not limited to, a direction measured along the delivery path farther from the entry point of the patient's body, and a direction measured along the delivery path nearer to the entry point of the patient's body, respectively.

The system 10 may include an introducer sheath 12 having a proximal introducer hub 14 with a central lumen for axially movably receiving a MCS shaft 16 (MCS shaft may also be referred to herein as a catheter, catheter shaft, and/or shaft). MCS shaft 16 may extend between proximal hub 18 and distal end 20 of system 10 with guidewire 24 extending therefrom. The GUIDEWIRE 24, or any other GUIDEWIRE described herein, may have various features, such as those described in U.S. provisional application No. 63/224326, entitled "GUIDEWIRE (guidwire)" and filed at 7/21 of 2021, the entire contents of which are incorporated herein by reference for all purposes and form a part of this specification. The hub 18 may be provided with an integrated microcontroller or memory storage device for device identification and tracking run-time, which may be used to prevent excessive use to avoid excessive wear or other technical failures. The microcontroller or memory device may disable the device, for example, to prevent a used device. They may communicate with a controller, which may display information about the device or messages about its use. Atraumatic cannula tips with radiopaque material allow the implant/explant to be visualized under fluoroscopy.

The pump 22 comprises a tubular housing. The tubular housing of the pump 22 is used broadly herein and may include any component of the pump 22 or component in the pump region of the system, such as an inlet tube, distal end piece, motor housing, other connecting tubular structure, and/or proximal rear end of the motor housing. A pump 22, such as a tubular housing, is carried by the distal region of the MCS shaft 16. The system 10 is provided with at least one central lumen for axially movably receiving the guidewire 24. The proximal hub 18 is additionally provided with an infection shield 26. A proximal cable 28 extends between the proximal hub 18 and the connector 30 for releasable connection to a control system, typically external to the sterile field 3, to drive the pump 22.

Referring to fig. 4, the system 10 may additionally include an insertion tool 32 having an elongate tubular body 36 with a length in the range of about 85mm to about 160mm (e.g., about 114 mm), which may be adapted to span the length of the hub 122 and the bend release 130 of the introducer sheath 112 (see fig. 5), and an inner diameter in the range of about 4.5mm to about 8.0mm (e.g., about 5.55 mm), extending distally from the proximal hub 34. The tubular body 36 includes a central lumen adapted to axially movably receive the MCS shaft 16 and the pump 22 therethrough, and sufficient resistance to collapse to remain unobstructed when passing through the hemostasis valve of the introducer sheath. As shown in fig. 4, the pump 22 may be positioned within the tubular body 36 such that the pump 22 passes through the hemostatic valve(s) on the proximal end of the introducer hub 14. Indicia 37 (fig. 7) is disposed on MCS shaft 16 proximally spaced from distal tip 64 such that the clinician knows that the pump is within tubular body 36 as long as indicia 37 is visible on the proximal side of hub 34.

The hub 34 may be provided with a first engagement structure 39 for engaging a complementary second engagement structure on the introducer sheath to lock the insertion tool into the introducer sheath. Hub 34 may be connected to infection shield 26 via a connection 41, such as a knob or button connected via a force fit, screw, or other means. Hub 34 may also be provided with a locking mechanism for clamping onto shaft 16 to prevent shaft 16 from sliding proximally or distally through the insertion tool once the MCS device has been positioned at the desired location in the heart. The locking mechanism may be actuated by twisting one or more portions (e.g., two portions) of the hub 34. Other actuation means are also possible. The hub 34 may additionally be provided with a hemostatic valve to seal around the shaft 16. In some embodiments, hub 34 may accommodate passage of a larger diameter MCS device including a pump. In one commercial illustration of the system, as shown in fig. 4, the packaged MCS device is pre-positioned within the insertion tool, and the guidewire assist device is pre-loaded within the MCS device and shaft 16. In some examples, the MCS device is configured to be pre-positioned in tube 36 and advanced distally. In such a configuration, the lumen in the hub 34 may be smaller than the MCS device, and only the shaft 16 may be configured to pass through the hub 34. When the pump is removed from the body, the MCS device may be pulled into the tube 36, and then the insertion tool may be pulled out of the introducer with the pump in the tube 36. For example, further details of the guidewire assist device 38 are discussed with reference to fig. 8A and 8B.

Referring to fig. 5 and 6, the introducer set 110 may include a guidewire 100, an introducer sheath 112, a dilator 114, and/or a guidewire assist 38 (as discussed with reference to fig. 8A and 8B). The guidewire 100 and introducer sheath 112 may correspond to the guidewire 24 and introducer sheath 12 discussed above. The guidewire 100 (e.g., a 0.018 "placement guidewire) may include an elongate flexible body 101 extending between a proximal end 102 and a distal end 104. The distal region of the body 101 may be preformed into a J-tip or pigtail, as shown in fig. 6, to provide an atraumatic distal tip. Proximal region 106 may be configured to facilitate passage through MCS device and may extend between proximal end 102 and transition 108. The proximal region 106 may have an axial length in the range of about 100mm to about 500mm (e.g., about 300 mm).

The introducer set 110 may include an introducer sheath 112 and/or a dilator 114. The introducer sheath 112 may include an elongate tubular body 116 extending between a proximal end 118 and a distal end 120. The tubular body 116 terminates proximally in a proximal hub 122. Optionally, the tubular body 116 is expandable or peelable. The proximal hub 122 includes a proximal port 124 in communication with a central lumen extending the entire length of the tubular body 116 and extending through the distal opening configured for axially removably receiving the elongate dilator 114. The proximal hub 122 may additionally be provided with a side port 126, at least one and optionally two or more attachment features (such as an eye 128) to facilitate suturing to a patient, and at least one and optionally a plurality of hemostatic valves for providing a seal around various introduction components (such as standard 0.035 "guidewire, 5Fr or 6Fr diagnostic catheter, 0.018" placement guidewire 100, shaft 16 and insertion tool 32). The proximal hub 122 may have a lock for preventing axial movement of the insertion tool 32 and/or the dilator 114.

Fig. 7 shows additional detail of distal pump region 60 of the MCS system, showing distal portions of device or pump 22 and catheter shaft 62. A pump region or zone 60 extends between a curved relief 62 at the distal end of the shaft 16 and a distal tip 64. Pump 22 includes a tubular housing 61 that may include an inlet tube 70, a distal tip 64, and/or a motor housing 74. The tubular housing 61 may include one or more pump inlets 66 and/or outlets 68, which may be part of an inlet tube 70 or part of other structure such as an intermediate structure connecting the proximal end of the inlet tube 70 to the motor housing 74. As further described herein, the guidewire guidance aid may extend into and out of various components of the system, such as the tubular housing 61 of the pump 22 and/or the catheter shaft 16 (e.g., the bend relief 62).

The pump inlet 66 includes one or more windows or openings that are in fluid communication with a pump outlet 68 (also referred to herein as an outflow section) through a flow path that extends axially through an inlet tube 70. The pump inlet may be generally located at the transition between the inlet tube and the proximal end of the distal tip 64, and in any event is typically in the range of about 5cm or 3cm or less from the distal port 76.

In some embodiments, distal tip 64 is radiopaque. For example, the distal tip may be made of a polymer containing a radiopaque agent such as barium sulfate, bismuth, tungsten, iodine. In some embodiments, the MCS device as a whole is radio-opaque. In some embodiments, a radiopaque marker is positioned on the inlet tube 70 between the pump outlet 68 and the guidewire port 78 to indicate the current position of the MCS device relative to the aortic valve 91.

The inlet tube 70 may comprise a highly flexible slotted (e.g., laser cut) metal (e.g., nitinol) tube having a polymeric (e.g., polyurethane) tubular layer to isolate the flow path. The inlet tube 70 may have an axial length in the range of about 60mm to about 100mm, and in one embodiment may be about 67.5mm. The outer diameter of the inlet tube 70 may generally be in the range of about 4mm to about 5.4mm, and in one embodiment may be about 4.66mm. The wall thickness of the inlet tube 70 may be in the range of about 0.05mm to about 0.15 mm. The connection between the inlet tube 70 and the distal tip 76, and the connection to the motor, may be secured, for example, by using laser welding, adhesive, threads, or other interference fit engagement structures, or may be secured via a press fit.

The impeller 72 may be positioned in the flow path between the pump inlet 66 and the pump outlet 68. In the illustrated embodiment, the impeller 72 is positioned adjacent the pump outlet 68. As discussed further below, the impeller 72 may be rotationally driven on a proximal side of the impeller 72 by a motor contained within a motor housing 74.

Fig. 8A and 8B are side cross-sectional and detail views, respectively, of the pump region showing an embodiment of the guidewire assist device 38. MCS means may be provided either in a fast switching or in a monolithic switching configuration. The first guidewire port 76 (e.g., a distally facing opening on the distal side of the distal tip 64) may be in communication with the second guidewire port 78 (e.g., an opening extending through the sidewall of the inlet tube 70 and distal to the impeller 72) via a first guidewire lumen through at least a portion of the flow path in the distal tip 64 and the inlet tube 70. This may be used for rapid exchange, where the guidewire 100 extends proximally along the catheter from the second guidewire port 78.

The catheter may be provided in a unitary exchange configuration in which the guidewire extends proximally through the guidewire lumen thereof over the entire length of the catheter shaft 16. However, in the overall exchange embodiment of fig. 7, 8A and 8B, the guidewire 100 exits the inlet tube 70 via a second guidewire port 78, extends proximally through the exterior of the impeller and motor housing, and reenters the catheter shaft 16 via a third guidewire port 80, which may be an opening in the sidewall of the catheter shaft 16 or an opening in the sidewall of the proximal component of the pump, motor housing, or back end. The third guidewire port 80 may be located proximal to the motor and, in the illustrated embodiment, on the bend relief 62. The third guidewire port 80 communicates with a guidewire lumen that extends proximally over the entire length of the shaft 16 and exits at a proximal guidewire port carried by or within the proximal hub 18 (see fig. 4).

As shown in fig. 8A, the pump may be assembled with a removable guidewire assist device 38. The guidewire assist device 38 can have a guidewire guide tube 83. The guide tube 83 may be axially extending cylindrical or other closed cross-sectional shape. The guide tube 83 may be a flexible transparent material such as polyimide. The guide tube 83 may be adapted for longitudinal peeling, for example with a longitudinal slit or tear line. The inner surface of the guide tube 83 may be provided with a lubricating coating, such as PTFE. The guide tube 83 may track the intended path of the guidewire 100, proximally from the first guidewire port 76, through the tip 64 and back out of the inlet tube via the second guidewire port 78, and back into the catheter shaft 16 via the third guidewire port 80. In the illustrated embodiment, the guidewire guide tube 83 extends proximally within the catheter shaft 16 to the proximal end 81 of the guide tube 83, communicating with or within a guidewire lumen extending to the proximal hub 18. The proximal end 81 of the guide tube 83 may be positioned within about 5mm or 10mm of the distal end of the shaft 16, or may extend at least about 10mm or 20mm, such as in the range of about 10mm to about 50mm, into the catheter shaft guidewire lumen. In some embodiments, the third port 80 may be located within the proximal end of a tubular housing (e.g., a motor housing or a rear end), or in any other component of the device at a location proximal to the impeller.

The guidewire assist device 38 can have a funnel 92. Funnel 92 may be located at the distal end of guide tube 83 and is configured to be pre-positioned at the distal end of the inlet tube, such as at distal tip 64. The width of the funnel 92 may increase in the distal direction from a narrow proximal end in communication with the guide tube 83 to a wider distal opening at the distal end of the funnel 92. Funnel 92 may be conical, frustoconical, pyramidal, segmented, or other shape. The proximal end of the funnel 92 may be attached to the distal end of the guidewire guide tube 83. A proximal end 102 (see fig. 6) of the guidewire 100 can be inserted into the funnel 92, passed through the first (distal) guidewire port 76 and guided along a desired path by tracking inside the guidewire guide tube 83. The guidewire guide tube 83 can then be removed by sliding the guide tube 83 distally out of the distal tip 64 and longitudinally peeling it apart, thereby retaining the guidewire 100 in place.

The guidewire assist device 38 can have a pull tab 94. In some embodiments, the distal end of the guidewire guide tube 83 is attached to a pull tab 94 of the guidewire assist device 38. The pull tab 94 may be a structure capable of being grasped by a human hand, for example having a lateral planar extension as shown. The guidewire aid 38, such as the pull tab 94, the guide tube 83 and/or the funnel 92, may be provided with a tearable line 75, as more clearly seen in fig. 8B. The tearable line 75 may be an axially extending split line. The tearable line 75 may comprise a weakened portion, a groove or a perforated linear region. Removal of the guidewire assist 38 can be accomplished, for example, by grasping the pull tab 94 and pulling out the guidewire tube 83 and/or funnel 92 and removing the guidewire tube and/or funnel from the guidewire 100 as the guidewire tube and/or funnel is severed or peeled along the parting line 75, such as shown in detail illustration 91 of fig. 8B.

The guidewire assist device 38 can include a proximal opening 90 configured to slide over and removably receive a distal tip 64 and/or post at the distal end of the inlet tube 70, which defines a window of the pump inlet 66. A guidewire guide tube 83 having a lumen therethrough is positioned within the proximal opening 90 and aligned to pass through the guidewire port 76 of the distal tip 64. As shown in fig. 4, the proximal opening 90 may be further configured to slide over and removably receive the distal end of the tubular body 36 of the insertion tool 32. The MCS system may be sized such that when the MCS device, the guidewire assist device 38 and the insertion tool 32 are assembled together, an annular space defined between an outer surface of the MCS device (e.g., the inlet tube 70, the motor housing 74 or the MCS catheter bend release 16) and an inner surface of the tubular body 36 of the insertion tool 32 may removably receive the guidewire guide tube 83 therein.

In some embodiments, the lumen of the guidewire guide tube 83 communicates with a distal flared opening of a funnel 92 that increases in cross-section in the distal direction. Guidewire assist 38 can be configured to be assembled on a MCS pump with guidewire guide tube 83 preloaded along the guidewire path, such as into the MCS pump through port 76, preloaded out of the MCS pump through port 78 through a portion of the fluid path within inlet tube 70, along the exterior of the MCS pump and back into shaft 16 through port 80. This assists the user in guiding the proximal end of the guidewire through the guidewire path into the funnel 92 and into the guidewire lumen of the MCS shaft 16. A pull tab 94 may be provided on the guidewire assist device 38 to facilitate grasping and removal of the guidewire assist device, including the guidewire guide tube 83, after loading the guidewire. Guidewire assist 38 may have a longitudinal slit or tear line 75 (e.g., along funnel 92, proximal opening 90, and guidewire guide tube 83) to facilitate removal of guidewire assist 38 from MCS pump 22 and guidewire 100.

The features of the guidewire assist device 38 described herein may be used with a variety of different MCS systems and/or pump devices. The guidewire assist device 38 can be used to enter and exit the guidewire path of the pump housing (as described), or not exit the guidewire path of the housing. Guidewire assist device 38 is described herein as being used with an MCS system configured for temporary operation of high risk PCI surgery. The system may include a rotating impeller having a radial shaft seal and a motor that rotates the impeller via a shaft extending through the seal. The guidewire assist device 38 can be used with a variety of different devices. The guidewire assist 38 can also be used with a pump having a magnetic drive, wherein the motor rotates a first magnet within the sealed motor housing that is in magnetic communication with a second magnet of the impeller external to the sealed housing to rotate the impeller. Thus, the guidewire assist device 38 is not limited to use with only the specific pump embodiments described herein.

Fig. 9A and 9B depict side and partial cross-sectional views, respectively, of the pump 22. As shown, the impeller 72 may be attached to a short rigid motor drive shaft 140. In the illustrated embodiment, the drive shaft 140 extends distally into a proximally facing central lumen in the impeller 72, such as by a proximal extension 154 on the impeller hub 146, where it may be secured by press-fitting, laser welding, adhesive, or other bonding technique. The impeller 72 may include radially outwardly extending helical blades 181 which may be spaced apart from the inner surface of the tubular impeller housing 82 at their maximum outer diameter in the range of about 40 μm to about 120 μm. The impeller housing 82 may be a proximal extension of the inlet tube 70, on the proximal side of the slot 71 formed in the inlet tube 70, to provide flexibility distally of the impeller. The tubular outer membrane 73 may surround the inlet tube 70 and seal the groove 71 while maintaining the flexibility of the inlet tube. The pump outlet 68 may be formed in a sidewall of the impeller housing 82, for example, axially aligned with a proximal portion of the impeller 72 (e.g., a proximal 25% to 50% portion of the impeller).

Impeller 72 may comprise medical grade titanium. This enables CFD optimized impeller designs with minimized shear stress for reduced damage to blood cells (hemolysis) and non-constant slope of increased efficiency. The latter feature cannot be achieved with a mold-based production method. Electropolishing of the surface of impeller 72 may reduce surface roughness to minimize the effect on hemolysis.

In some embodiments, the impeller hub 146 flares radially outward in a proximal direction to form an impeller base 150 that can direct blood out of the outlet 68. The proximal surface of the impeller base 150 may be secured to an impeller back 152, which may be in the form of a radially outwardly extending flange secured to the motor shaft 140. To this end, the impeller back 152 may be provided with a central aperture to receive the motor drive shaft 140, and may be integrally formed with or coupled to a tubular sleeve/proximal extension 154 adapted to be coupled to the motor drive shaft 140. In some embodiments, the impeller back 152 is first attached to the motor drive shaft 140 and bonded, for example, by using an adhesive. In a second step, the impeller 72 may be advanced over the shaft and the impeller base 150 bonded to the impeller back 152, such as by laser welding.

The diameter of the distal opening in the aperture in the impeller back 152 may increase in the distal direction to facilitate application of the adhesive. The outer diameter of the proximal end of the tubular sleeve/proximal extension 154 may decrease in the proximal direction to form an inlet ramp for facilitating proximal advancement of the sleeve over the motor shaft and through the seal 156, discussed further below.

The motor 148 may include a stator 158 having electrically conductive windings surrounding a cavity that encloses a motor armature 160, which may include a plurality of magnets rotationally fixed relative to the motor drive shaft 140. The motor drive shaft 140 may extend from the motor 148 through the swivel bearing 162 and also through the seal 156 prior to exiting the sealed motor housing 164 (also referred to herein as the motor housing 74). The seal 156 may include a seal retainer 166 that supports an annular seal 167, such as a polymeric seal ring. The seal ring includes a central aperture for receiving the tubular sleeve/proximal extension 154 and is biased radially inward against the tubular sleeve/proximal extension 154 to maintain the seal ring in sliding sealing contact with the rotatable tubular sleeve/proximal extension 154. The outer surface of the tubular sleeve/proximal extension 154 may be provided with a smooth surface, for example by electropolishing, to minimize wear on the seal.

In some embodiments, the pump 22 may include a seal and/or one or more features of a seal, as described herein with respect to fig. 30A-30C.

In short use time (typically no more than about 6 hours) applications of high risk PCI, the pump may include a sealed motor and be configured to be used without flushing or purging. This provides the opportunity to directly couple the impeller 72 to the motor drive shaft 140, as discussed in further detail below, eliminating problems sometimes associated with magnetic couplings, such as additional rigid length, space requirements, or pump efficiency. The four-pole motor design allows flow performance up to 4.0lmin-1 (liters/min) at 60mmHg and low temperature variation. The motor cable interface may be provided with a high tensile strength.

Fig. 10A and 10B illustrate front and rear views of an embodiment of an MCS controller or controller 1000. The controller 1000 may support the operation of one or more cardiac or circulatory support systems, such as a left ventricular support device, a ventricular assist device, or an MCS device as described herein. The controller 1000 may include one or more modules to provide power to the heart support system. The controller 1000 may house electronic circuitry to send and receive operating signals to the heart support system. The controller 1000 may house one or more hardware processors as described below to receive and process data, such as sensor data, from the heart support system. In some embodiments, the controller 1000 may have an integrated or stand-alone design, with all or nearly all of the components required for operation of the controller housed within the controller. For example, any power supply component (such as a transformer or an AC/DC converter) may be housed within the controller 1000. As shown in fig. 2, the controller 1000 may be wired to the pump via an electronic wire extending through the catheter shaft 62 to the pump.

In some embodiments, the controller 1000 may include a communication system or any other suitable system to allow the controller 1000 to be adapted for new or modified uses after the controller is constructed. For example, various wired or wireless communication modes may be integrated within the controller 1000 to communicate with external technologies (e.g., RF, wifi, and/or bluetooth). In some embodiments, the controller 1000 may have an RFID reader. In some embodiments, the controller 1000 may have a system or component capable of synchronizing patient data, telemedicine, patient monitoring, real-time data collection, error reporting, and/or sharing maintenance records.

The controller 1000 may include a housing for these modules that support any of the cardiac support systems described herein. The housing may further include a handle 1002 to support portability. In contrast to some other controllers (e.g., the Abiomed impeller controller), the controller 1000 may not include the components required for purging. For example, the controller 1000 does not include a cassette for purging. The cassette typically delivers irrigation fluid to the catheter. However, the cartridge requires a considerable footprint and makes the housing larger and heavier. Due to the design improvements described herein, such as the bearing design and seal motor described herein, the controller 1000 does not include a cartridge. Further, in some embodiments, the controller 1000 does not require a port for receiving a purge tube. Thus, the controller 1000 may be light and compact to support portability.

The controller may also include a cable management support device 1004. In some embodiments, the cable management support 1004 is positioned on one end or side of the controller 1000. The controller 1000 may also include a mount 1006 that may support a lever for mounting the controller into a clinical environment. The mount 1006 may be rotated about an axis to support horizontal or vertical clamping. The mount 1006 can be quickly locked into a desired orientation by quick tightening with a slip clutch. In some cases, the mount 1006 is located remotely from the cable management support device 1004. Further, in some embodiments, the cable management support 1004 is positioned on the left end of the controller 1000, as shown in fig. 10A. The port 1107 (e.g., as shown in fig. 13) may be positioned on the opposite side of the cable management support device 1004. In some cases, a control element 1008, discussed below, is positioned on the opposite side of the cable management support device 1004 and in close proximity to the port 1107. This may enable a user to have improved interaction with active components of the controller 1000. Thus, the arrangement of all of these elements in the controller 1000 as shown may improve the operating experience and improve portability.

The controller 1000 may include a control element 1008. In some embodiments, control element 1008 may provide haptic feedback. The control element 1008 may include a push button rotary dial. Control element 1008 may enable a user to change parameters on controller 1000 to control one or more processes described herein. The control element 1008 may also include a status indicator 1010 as shown in fig. 10A. In some embodiments, the controller 1000 may include a separate validation control element. Furthermore, in some embodiments, a single control element 1008 may be used to modify all parameters, except for a separate validation control element. Grouping of controls in dedicated areas may improve the user experience.

Fig. 11 shows a block diagram of an electronic system 1100 that may be included in the controller 1000. In some embodiments, electronic system 1100 may include one or more circuit boards in combination with one or more hardware processors for controlling MCS device 1110. Electronic system 1100 may also receive signals, process signals, and transmit signals. The electronic system 1100 may further generate a display and/or an alert. Electronic system 1100 may include control system 1102 and display system 1104. In some embodiments, the display system 1104 may be integrated into the control system 1102 and not separate as shown in fig. 11. In some embodiments, it may be advantageous for the display system 1104 to be separate from the control system 1102. For example, in the event of a failure of the control system 1102, the display system 1104 may be used as a backup.

Control system 1102 may include one or more hardware processors to control various aspects of MCS device 1110. For example, control system 1102 may control the motor of MCS device 1110. Control system 1102 may also receive signals and process parameters from MCS device 1110. Parameters may include, for example, flow rate, motor current, ABP, LVP, LVEDP, etc. Control system 1102 may generate alarms and status of electronic system 1100 and/or MCS device 1110. In some embodiments, control system 1102 may support multiple MCS devices 1110. The control system 1102 may send the generated alert or status indicator to the display system 1104. The display system 1104 may include one or more hardware processors to receive processed data from the control system 1102 and render the processed data for display on a display screen. The control system 1102 may also include a memory for storing data.

The electronic system 1100 may also include a battery 1106 that may enable its electronic system to operate without being connected to an external power source. The power interface 1108 may charge the battery 1106 from an external power source. Control system 1102 may use battery power to supply current to the motor of MCS device 1110.

The one or more hardware processors may include microcontrollers, digital signal processors, application Specific Integrated Circuits (ASICs), field Programmable Gate Arrays (FPGAs) or other programmable logic devices, discrete gate or transistor logic, discrete hardware components, or any combination thereof designed to perform the functions described herein.

Fig. 12 is an exploded view of an embodiment of a controller 1000 having physical components corresponding to the features of the block diagram schematic of the electronic system 1100 of fig. 11. As shown in fig. 12, the controller 1000 may include a control system 1102 and a display system 1104 that include a circuit board disposed within a housing. The battery 1106 may be located within a bottom section of the housing. The power interface 1108 may be located within a corner of the housing.

Fig. 13 is a front perspective view of the controller 1000. In some embodiments, the controller 1000 may include an alarm feedback system that may provide feedback to an operator regarding the operation of the MCS system. In some embodiments, the alarm feedback system may be in the form of an LED 1302 as shown. The LED 1302 may be positioned so that it is visible to an operator using the controller. As shown, LED 1302 is positioned around handle 1002. Thus, it can be seen from a 360 ° position around the controller. The LEDs 1302 may be in the form of a ring (oval, oblong, circular, or any other suitable shape) that surrounds the handle 1002. Such LEDs 1302 may be visualized from any direction as long as the top of the controller is visible. Control system 1102 may generate different colors or patterns for LEDs 1302 to provide various alarms or status of controller 1000 and/or MCS device 1110.

The controller 1000 further includes a port 1107 that may receive a cable connected to the MCS device. Port 1107 may support multiple versions of MCS devices. The controller 1000 may also include an RFID reader 1304 on one side of the controller 1000. The RFID reader 1304 may read the badge of the sales representative and operate the device according to a particular demonstration mode. The controller 1000 may include a glass cover 1306 that is tilted as shown in fig. 13 to improve user readability.

Fig. 14A shows a graph of the pressure differential between the aortic pressure and the left ventricular pressure, which may be typical pressure differential. In some cases, MCS device 1110 may be positioned between two different pressure levels (left ventricle and aortic arch). Thus, MCS device 1110 may operate against the differential pressure shown in fig. 14A. Thus, the motor of MCS device 1110 may operate with pressure in some cases and may operate against pressure in other cases. Thus, it is observed that in order to keep the speed of the motor (e.g., the rotational speed of the motor shaft) constant or approximately steady, the current supplied to the motor will need to be changed based on the pressure differential.

Fig. 14B shows the current applied for a constant motor speed. The current profile of fig. 14B follows a similar behavior as the differential pressure profile of fig. 14B. In some embodiments, the control system 1102 may control the motor to run at a constant speed by varying the motor current. The control system 1102 may use the change in motor current to detect differential pressure and, thus, physiological, operating, and machine conditions of the patient.

FIG. 15 illustrates an exemplary user interface that may display flow rate parameters and motor current. The user interface may also display the parameters as a graph drawn over time. The user interface may be displayed on the controller 1000, for example, on a display.

Fig. 16A illustrates an exemplary user interface in a configuration mode, wherein control element 1008 may be used to modify a parameter, such as setting a flow rate. The control element 1008 may include a visual feedback system directly on and/or adjacent to the knob. FIG. 16B illustrates an exemplary user interface during an operational mode. Comparing fig. 16A and 16B, certain text on the user interface may be highlighted or emphasized depending on the mode. In the configuration mode, the set flow rate is increased. In the operating mode, the flow rate increases. This improves the readability of the user, in particular when the user interface comprises several parameters.

In some embodiments, only some user interfaces are available depending on the type of MCS device 1110 connected to the controller. For example, some of the devices discussed above may not include any sensors and may not support all of the user interfaces discussed above. These sensorless devices can be lower cost and smaller.

Fig. 17 shows an embodiment of an electronic control 1702 and a visual indicator 1704. The electronic control 1702 may include a display on a face of the dial. Further, the visual indicator 1704 may indicate the state of the motor or other operating condition as the dial is rotated.

Fig. 18A-18D are exemplary Left Ventricular (LV) pressure curves illustrating a procedure for determining Left Ventricular End Diastolic Pressure (LVEDP). The control system 1102 may record status and operating parameters, which may be communicated to the EMR system via network communications. The control system 1102 may measure the Left Ventricular End Diastolic Pressure (LVEDP). Fig. 18A to 18D show a series of steps for determining LVDEP from a measured LV pressure curve. Fig. 18A shows an exemplary LV pressure curve measured at a 100MHz sampling rate. The control system 1102 may process the measured LV pressure curve to determine LVDEP. For example, the control system 1102 may identify the maximum positive gradient in the LV curve, as shown in fig. 18B. This can identify the pulse value. Other techniques may be used to identify the beginning of a pulse. Once the pulse is identified, the control system 1102 may find the maximum and minimum between 2 steep positive slopes in the LV curve, as shown in fig. 18B. This may also produce a systolic value and a diastolic value. In some cases, the control system 1102 may identify a minimum to the left of the second slope, as shown in fig. 18D. This value may represent a LVEDP determination.

As described above, for example, with respect to fig. 14B, controlling or synchronizing the motor current with the heart and measuring the motor current may enable the control system 1102 to detect differential pressure, and thus physiological processes, operating conditions, and machine conditions of the patient by measuring the current. The physiological process may include when the pump hits the wall of the heart. In some cases, the motor current remains constant while measuring the change in RPM. In some cases, a separate flow or pressure sensor is not required to detect the physiological process. Motor designs that include a motor controller (e.g., controller 1000) may enable high resolution current measurement. In some cases, the motor controller is sensorless, e.g., the motor controller may not include a hall sensor. In some cases, the control system 1102 may operate the motor in a pulsatile mode to improve heart recovery.

Fig. 19 shows a schematic side view of another embodiment of a pump 1900 for pumping blood 1905. Pump 1900 is designed and shaped for use in a fluid pathway such as a blood vessel. Pump 1900 or features thereof may be used with any other pump or feature described herein (e.g., pump 22), and vice versa. For example, features of pump 1900 may be used with pump 22 described above. In some embodiments, pump 22 includes a motor, shaft, and/or sealing device of pump 1900, as further described.

Pump 1900 may have an impeller 1910, a drive 1915 with a shaft 1920, a shaft housing 1925, and/or a seal 1930. Impeller 1910 may be designed to pump fluid 1905. A drive 1915 having a shaft 1920 may be configured to drive the impeller 1910. Shaft housing 1925 may be designed to house shaft 1920 and/or drive 1915, and may also be referred to hereinafter as a "housing". The sealing device 1930 may include at least one shell or housing sealing element 1935 and/or one impeller sealing element 1940 that is housed between the drive device 1915 and the impeller 1910 and is designed to prevent the fluid 1905 from entering the drive device 1915 and/or the shaft housing 1925 during operation of the pump 1900.

According to this embodiment, the impeller 1910 may have an exemplary conical base that may rotate about a longitudinal axis during operation of the impeller 1910. Radially about the longitudinal axis, the base according to this embodiment has two blades to create a fluid flow or fluid suction in the fluid 1905 when the impeller 1910 rotates. For this purpose, according to this embodiment, the blades may be spirally wound around the outer wall of the base body. The rotating body of the impeller 1910 is created by the rotation of one or more so-called "B-spindles". According to some embodiments, the impeller 1910 may have a differently shaped (e.g., cylindrical) base and/or a different number of blades or vanes. According to this embodiment, the drive means/unit 1915 (which will hereinafter also be referred to as "drive") has a motor 1945 (e.g. in the form of an electric motor). According to this embodiment, motor 1945 is coupled to shaft 1920. According to this embodiment, shaft 1920 is straight. According to this embodiment, shaft housing 1925 is correspondingly tubular and houses at least shaft 1920, or according to this embodiment, entirely drive unit 1915 with motor 1945. According to some embodiments, the motor 1945 is disposed outside of the shaft housing 1925. According to this embodiment, the housing sealing element 1935 and/or the impeller sealing element 1940 are made of a strong yet resilient material. In other words, the housing sealing element 1935 and/or the impeller sealing element 140 do not have a liquid or semi-liquid material.

According to this embodiment, housing sealing element 1935 may be attached to the inside of shaft housing 1925 and/or disposed about shaft 1920. According to this embodiment, the housing sealing element 1935 may be formed as a sealing ring (of the rotary shaft seal according to this embodiment). According to this embodiment, a housing sealing element 1935 may be attached to an inlet opening 1947 of the shaft housing 1925 facing the impeller 1910. According to one embodiment, the housing sealing element 1935 may be directly secured to the inlet opening 1947.

According to this embodiment, additional or alternative impeller sealing elements 1940 may be attached to impeller 1910 and/or disposed about shaft 1920 and/or contacting shaft housing 1925. According to this embodiment, the impeller sealing element 1940 may be designed as an additional sealing ring, here an axial shaft seal. The axial shaft seal may also be described as a "V-ring". According to this embodiment, this V-ring may have a V-shaped or plate-shaped flexible sealing lip extending away from the annular base of the axial shaft seal. According to this embodiment, the sealing lip is attached to the impeller 1910.

According to this embodiment, impeller sealing element 1940 may also be preloaded towards shaft 1920 in the installed state. The pretension may be caused by deformation of the impeller sealing element 1940. According to some embodiments, pump 1900 may have spring elements that cause the preload.

Further, according to this embodiment, the impeller sealing element 1940 may have at least one gap sealing element 1950, which may be arranged to fluidly seal the gap 1952 between the shaft housing 1925 and the impeller 1910, so as to prevent the fluid 1905 from entering the gap 1952. According to this embodiment, the gap sealing element 1950 may be designed as an additional sealing ring. According to this embodiment, the clearance seal element 1950 may have an outer diameter greater than the outer diameter of the impeller seal element 1940. According to this embodiment, the impeller sealing element 1940 may be arranged coaxially in the passage opening of the additional sealing ring with respect to the additional sealing ring.

According to this embodiment, the free end of shaft 1920 may be fixed in impeller 1910. According to some embodiments, the free end of shaft 1920 and impeller 1910 may be connected without contact by means of a magnetic coupling, whereby the driving force of motor 1945 may be magnetically transferred to impeller 1910.

According to this embodiment, pump 1900 may also have bearing arrangement 1955 for radial and/or axial bearings of shaft 1920 in shaft housing 1925. To this end, bearing apparatus 1955 according to this embodiment may have two bearing elements at opposite ends of the interior of shaft housing 1925 in which shaft 1920 is mounted (e.g., centrally). According to this embodiment, the housing sealing element 1935 may be arranged outside the space defined by the two bearing elements.

The pump 1900 presented herein may be used and configured as a blood pump for a heart support system. According to one embodiment, pump 1900 is designed as a Ventricular Assist Device (VAD) pump for short term implantation with contact radial and/or axial seals.

If pump 1900 is used as a VAD pump for temporary/short use, it is important that it can be implanted very quickly. According to this embodiment, a system as simple as possible can be used for this purpose. Only one or more sealing elements 1935, 1940, 1950 may be present and liquid or a portion of the liquid medium (e.g., a flushing medium or barrier medium) may be dispensed or an external forced flush may be used to seal or prevent blood from entering the motor.

In some embodiments, the pump 1900 may include a seal and/or one or more features of a seal, as described herein with respect to fig. 30A-30C.

According to this embodiment, the pump 1900 proposed herein may have an electric drive in the form of an electric motor 1945, a rotary shaft 1920, an impeller 1910, a bearing device 1955, a shaft housing 1925 and/or at least one sealing element 1935, 1940, 1950, which according to an embodiment may be firmly connected to the housing 1925 in the form of a housing sealing element 1935 and have a sealing function with respect to the rotary shaft 1920 and/or the impeller 1910. Additionally or alternatively, the pump 1900 may have sealing elements in the form of impeller sealing elements 1940 and/or gap sealing elements 1950 that seal the housing 1925 against the rotating impeller 1910 in an axial direction. According to this embodiment, the impeller 1910 may be composed of a core having, for example, a hub and at least two or more blades. During operation of the pump 1900, the fluid 1905 may be axially fed to the impeller 1910 (suction) and radially/diagonally discharged through openings in the impeller housing of the impeller 1910, not shown herein. According to this embodiment, the impeller 1910 may be firmly connected to the drive shaft 1920 of the motor 1945, which provides the required drive power. According to this embodiment, shaft 1920 may be supported by at least one radial bearing and/or at least one axial bearing. Alternatively, the bearing may also be implemented in combination with a radial-axial bearing. According to one possible embodiment, the housing 1925 may have at least one sealing element 1935 to the impeller 1910. According to another embodiment, the at least one sealing element 1940, 1950 may be attached to the impeller 1910. The seals may be of a contact design, i.e., according to one embodiment, sealing elements 1925, 1940 are always in contact with shaft 1920 and housing 1925. Further, at least one (further) sealing element 1940 may optionally/alternatively be arranged, which seals shaft 1920 against housing 1925. This may be designed in such a way that sealing element 1940 is preloaded towards shaft 1920 according to an embodiment. This may be achieved with a spring according to one embodiment or, according to another embodiment, by shaping the resilient sealing element 1940. One possible design of the housing seal element 1935 is a rotary shaft seal. An axial shaft seal ring is a possible design of alternative/optional sealing element 1940.

According to one embodiment, the VAD pump 1900 may have a maximum outside diameter of less than five millimeters, and in another embodiment, it may have an outside diameter of less than eight millimeters. According to one embodiment, pump 1900 may be designed for short-term use of less than 24 hours, in another embodiment for use of less than ten days, in another embodiment for use of less than 28 days, and in another embodiment for use of less than or equal to six months.

Fig. 20A shows a side view of an alternative embodiment of a pump 2062 having an embodiment of an impeller 2068. The impeller 2068 is rotatably mounted within an impeller housing, which may be the proximal end of the inlet tube or a separate housing for the impeller 2068. The impeller 2068 may face the outlet opening 2066. The impeller 2068 may provide axial suction as well as radial and/or diagonal discharge of blood via the outlet opening 2066. The pump 2062 may include an axis of rotation 2032. The pump 2062 may rotate about the axis of rotation 2032. The motor sealing the interior of the motor housing 2064 may rotate the impeller 2068.

The impeller 2068 may include at least one helically wound blade 2070. The blades 2070 may ensure efficient and gentle delivery of blood. As shown in fig. 20A, the blades 2070 may be helically wound around the hub 2000 of the pump 2062. The hub may form the inner core of the impeller 2068. The flow direction of the blood flow path is indicated by three arrows. Blood is drawn in by the pump inlet, which serves as an inlet opening upstream of the impeller 2068, and exits from the outlet opening 2066.

The skeleton line 2004 of the blade 2070, which may be arcuate, may have an inflection point in the region beginning upstream of the outlet opening 2066. The blades 2070 may extend from the upstream end of the pump rotor 2068 throughout the length of the hub 2000 or at least over a substantial portion thereof. In the embodiment of fig. 20A, the hub 2000 may have a diameter that increases in the flow direction such that the shape of the hub 2000 becomes thicker along the flow direction. Such a shape of the hub may facilitate radial and/or diagonal drainage of blood.

The blade 2070 may include a blade section 2002 having a wave-shaped blade curvature (e.g., a wave-shaped blade curvature) defined by a plurality of curved portions of the skeleton line 2004 of the blade 2070. As discussed herein, the wave curvature of the blade 2070 may refer to a change in curvature of the bucket section 2002 associated with at least one sign change (e.g., positive or negative concavity/convexity). At least one section of the blade 2070 and/or the entire vane section 2002 or a portion of the vane section 2002 may be located radially inward of the outlet opening 2066. The vane section 2002 may be at least partially in the region of the flow-facing edge 2006 of the outlet opening 166. The vane segment 2002 may represent one or more transitions between convex and concave curvatures. The outlet opening 2066 of the tubular housing of the circulation support device may at least partially overlap the vane section 2002 of the impeller 2068 having a contoured vane curvature.

In certain embodiments, the impeller 2068 may include two blades 2070 wound around the hub 2000 in the same direction. Each blade 2070 may have a bucket section 2002. In some embodiments, impeller 2068 may include more than two blade elements 2070, such as three, four, five, six, or more. The pump 2062 or other pumps described herein may have additional features or modifications such as those described in PCT publication No. WO 2019/229223 entitled "AXIAL flow pump for ventricular assist device and method for producing an AXIAL flow pump for ventricular assist device (AXIAL-FLOW PUMP FOR AVENTRICULAR ASSIST DEVICE AND METHOD FOR PRODUCING AN AXIAL-FLOW PUMP FOR A VENTRICULAR ASSIST DEVICE)" filed on day 5, month 18, 2021, and/or in U.S. patent application No. 17/057252 entitled "AXIAL flow pump for ventricular assist device and method for producing an AXIAL flow pump for ventricular assist device (AXIAL-FLOW PUMP FOR A VENTRICULAR ASSIST DEVICE AND METHOD FOR PRODUCING AN AXIAL-FLOW PUMP FOR AVENTRICULAR ASSIST DEVICE)", the disclosure of each of which is incorporated herein by reference in its entirety for all purposes and forms a part of the present specification.

Fig. 20B shows an exemplary deployment schematic of the skeleton line 2004 of the vane element 2010 of fig. 20A. As an example, two pairs of blade angles α are plotted ₁ 、β ₁ And alpha ₂ 、β ₂ Each of which represents the tangential slope of a tangent 2030 representing the curvature of the skeleton line 2004. Each tangent 2030 is drawn into a cylindrical coordinate system with the z-axis parallel to the axis of rotation 2032 of the pump rotor and the Φ -axis perpendicular to the z-axis. The Φ -axis represents the circumferential direction of the pump rotor.

The tangential slope initially increases in the flow direction, as indicated by the vertical arrow, and then decreases again. According to this design example, the tangential slope initially increases continuously from the blade leading edge 2034 to the blade trailing edge 2036 of the blade element 2010 and decreases again when reaching the inflection point 2031 of the skeleton line 2004. The point 2038 marks the location of the flow discharge via the outlet opening of the pump housing, more precisely the beginning of the flow discharge in the axial direction. The purpose here is to ensure that the inflection point 2031 is in close proximity to the point 2038 where the flow discharge starts.

As already described, according to a design example, the pump rotor may be implemented with at least two vane elements 2010. The transport medium is axially delivered to or sucked in by the pump rotor and discharged radially and/or diagonally through one or more outlet openings 2066 in the pump housing. The vane element 2010 is configured such that an angle α between a tangent 2030 formed by the vane surface or the skeleton line 2004 and the rotation axis 2032 or the z-axis varies in the axial direction. The angle β between the circumferential direction or Φ axis and the blade surface or skeleton line 2004 varies to an opposite extent. The angle β changes such that it increases in the flow direction from the beginning of the pump rotor (i.e. from the vane leading edge 2034), at least in the region of the maximum diameter of the pump rotor (i.e. in the section in the region of the vane tips of the vane element 2010). In particular, the angle β assumes its maximum value in the region of the beginning 2038 of the flow discharge or in close proximity thereto, at least in the region of the maximum diameter of the pump rotor (i.e. in a section in the region of the blade tips of the blade elements 2010).

In some embodiments, the impeller 2068 includes a vane element 2010 having a profile with skeleton lines 2004, and when deployed into a plane, the curvature of each skeleton line 2004 increases along the rotational axis 2032 in a direction from the pump entry section toward the outlet opening 2066 to an inflection point 2031 where the vane angle β of the vane element 2010 is at a maximum, and the curvature of each skeleton line 2004 decreases after the inflection point 2031. Furthermore, in some cases, the region of the impeller 2068 that is radially positioned relative to the rotational axis 2032 of the impeller 2068 has a blade height SH of the blade element 2010 defined relative to a maximum blade height SHMAX such that 25% SH/SHMAX 100% or less, with the inflection point 2031 of each skeleton line 2004 being located in the region of the upstream edge of the outlet opening 2066 of the inlet tube of the tubular housing. The vane element 2010 may have other features or modifications such as those described in PCT publication No. WO 2019/229223 entitled "AXIAL flow pump for ventricular assist device and method for producing an AXIAL flow pump for ventricular assist device (AXIAL-FLOW PUMP FOR A VENTRICULAR ASSIST DEVICE AND METHOD FOR PRODUCING AN AXIAL-FLOW PUMP FOR A VENTRICULAR ASSIST DEVICE)" filed on 5-30, and/or in U.S. patent application No. 17/057252 entitled "AXIAL flow pump for ventricular assist device and method for producing an AXIAL flow pump for ventricular assist device (AXIAL-FLOW PUMP FOR A VENTRICULAR ASSIST DEVICE AND METHOD FOR PRODUCING AN AXIAL-FLOW PUMP FOR AVENTRICULAR ASSIST DEVICE)" filed on 18, 2021, the disclosures of each of which are incorporated herein by reference in their entirety for all purposes and form a part of the present specification.

Fig. 21A-C illustrate an embodiment of a pump region 2160 having a tubular housing including an impeller housing 2115. The pump region 2160 may include an alternative embodiment pump 2117 having an impeller housing 2115. In some embodiments, the impeller housing 2115 may include a diffuser, as further described. Pump region 2160 or features thereof may be used with any MCS system or pump described herein. The pump region 2160 may be minimally invasively disposed in the aorta and/or at least partially disposed in the ventricle by trans-femoral or trans-aortic catheters. As described herein, the pump region 2160 may include a blood pump 2117 for a cardiac support system. The maximum outer diameter of the pump region 2160 shown in fig. 21 may be less than ten millimeters (e.g., less than or equal to 7mm, less than or equal to 5 mm). Pump 2117 may have an axial design that includes an impeller 2168 against which axial flow occurs. The axial design of pump 2117 may facilitate pump area 2160 having a maximum outside diameter of less than 10 mm.

During operation of the pump device 2160, blood flows through the inlet tube 2105 and is discharged through the outlet opening 2180 in the circumference of the impeller housing 2115 of the pump 2117 for feeding into the aorta (e.g., from the left ventricle, through the aortic valve, and to the aorta). This can be achieved by the embodiment of fig. 21A, wherein the impeller 2168 is completely surrounded in a first section by the impeller housing 2115 in the form of a cylindrical/tubular impeller housing, and is interrupted in a second section by an outlet opening 2180 in the impeller housing 2115. The transition between these two sections is characterized by the start 2125 of the outlet opening 2180.

As shown in fig. 21B-C, some embodiments of the MCS system may further include a diffuser 2130 configured to be coupled with the tubular housing. The outlet opening 2180 may be configured to facilitate blood flow out of the tubular housing of the pump region 2160 (e.g., from the inlet tube 2105 and/or from the impeller housing 2115). The diffuser 2130 may be configured to direct blood laterally to the outlet opening 2180 after the blood has passed through the outlet opening 2180.

As shown in fig. 21B and according to some embodiments, the diffuser 2130 may be disposed circumferentially around the impeller housing 2115. In the operational position 2132, a side surface of the diffuser 2130 may have a cross-sectional area that increases in the direction of flow 2133 of blood (see arrows). In some embodiments, the diffuser 2130 itself may also have a cross-sectional area that increases in the direction of flow 2133 of the blood. In this case, the diffuser 2130 may have a frustoconical shape in the operational position 2132. The diffuser 2130 may have a support structure with at least one strut 2134 and/or a flexible sheath 2135. As shown in the embodiment of fig. 21B, the diffuser 2130 has a plurality of struts 2134.

The diffuser 2130 may be formed to be transferable from the rest position 2137 (shown in fig. 21C) to the operational position 2132 (shown in fig. 21B) and/or from the operational position 2132 to the rest position 2137, wherein the diffuser 2130 is formed such that it is foldable from the rest position 2137 to the operational position 2132. The diffuser 2130 may result in improved flow paths and lower pressure losses as well as an increase in pump efficiency.

The diffuser 2130 may be permanently or removably attached to the impeller housing 2115. In some cases, the diffuser 2130 is configured to be flexible, crimpable, collapsible, and/or expandable. This configuration may provide the following advantages: in the collapsed or rolled state, it may nest snugly to the impeller housing 2115 and thus allow for minimally invasive implantation. The diffuser 2130 may be configured with a support structure having a number of struts 2134 made of a shape memory material (e.g., nitinol) and a flexible sheath 2135. The flexible sheath 2135 may be fully or at least partially closed in the circumferential direction and may be made of silicone and/or PU and/or may be permanently or removably connected to a support structure. Together with the support structure shown in the unfolded state in fig. 21B, the side surfaces may be used for the flow path of blood in order to reduce losses when blood flows out of the outlet opening(s) 2180. The diffuser 2130 may have a side surface that, in the expanded state, surrounds an increasing (i.e., diverging) cross-sectional area in the main flow direction 2133 (i.e., in the direction of the axis of rotation of the impeller 2168). The downstream discharge surface 2136 of the diffuser 2130 may be larger than the connection surface of the diffuser 2130 with the impeller housing 2115 disposed opposite the discharge surface 2136. In this case, the diffuser 2130 or at least a side surface thereof may be configured in the form of a truncated cone. The diffuser 2130 may include other shapes and/or configurations in the operational position 2132, such as a funnel shape, a dome shape, an umbrella shape, an inverted bell shape, a bowl shape, and/or it may have a convex, concave, stepped, or angled discharge surface.

Fig. 21C shows the diffuser 2130 in the resting position 2137. In the rest position 2137, the diffuser 2130 may be configured to nest tightly to the impeller housing 2115 and may therefore be minimally invasive to implant.

The PUMP 2117, diffuser 2130, other PUMPs described herein or the diffuser or features thereof may have additional features or modifications such as those described in PCT publication No. WO 2019/229214 entitled "PUMP HOUSING DEVICE, METHOD for producing a PUMP HOUSING DEVICE, AND PUMP with PUMP HOUSING DEVICE (METHOD FOR PRODUCING A PUMP HOUSING DEVICE, AND PUMP HAVING A PUMP HOUSING DEVICE)" filed on 5/30 th 2019, AND/or in U.S. patent application No. 17/057548 entitled "PUMP HOUSING DEVICE, METHOD for producing a PUMP HOUSING DEVICE, AND PUMP with PUMP HOUSING DEVICE (METHOD FOR PRODUCING A PUMP HOUSING DEVICE, AND PUMP HAVING A PUMP HOUSING DEVICE)", the disclosure of each of which is incorporated herein by reference in its entirety for all purposes AND forms a part of this specification.

Fig. 22 is a side view of an alternative embodiment of an inlet tube 2201 of an MCS system. The inlet tube 2201 may have a body 2225. The inlet tube 2201 may include a first connection section 2221 (which may also be referred to herein as a first attachment section) at a first end (e.g., distal end) of the inlet tube body, which may connect/attach the inlet tube 2201 to a distal tip and/or head unit of the circulatory support device. In some embodiments, the first connection section 2221 may be configured to connect to the distal tip and/or the head unit in a form-locking and/or force-locking manner. The inlet tube 2201 may also include a second connection section 2222 (which may also be referred to herein as a second attachment section) at a second end (e.g., proximal end) of the inlet tube body. The second connection section 2222 may connect the inlet tube 2201 to a pump outlet. In some cases, the second connection section 2222 may connect the inlet tube 2201 to the impeller housing. In some embodiments, the second connection section 2222 may connect the inlet tube 2201 to the motor housing. The body 2225 of the inlet tube 2201 may also include a structural section 2223 extending between the second connection section 2222 and the first connection section 2221. In some embodiments, the structural section 2223 may extend between the pump inlet 2224 and the second connection section 2222.

In some embodiments, the structural section 2223 may include one or more stiffening recesses that may alter the rigidity of the inlet tube 2201. The reinforcement recess may extend over a portion of the structural section 2223 or over the entire structural section 2223. The reinforcement recesses may be arranged in a spiral circumferential manner. The stiffening recess may be in the form of a groove.

Fig. 22 further includes geometric reference numerals for illustrating exemplary dimensions of the access tube 2201. At the first connection section 2221, the inlet tube 2201 may have an inner diameter of 6.5 millimeters (or between 4.5 and 8.5 millimeters) as shown by indicia 2205. The outer diameter shown by the mark 2210 in this area may be 7 millimeters (or between 5mm and 9 mm). The bend angle indicated by reference 2215 may be 26 degrees (or between 16 degrees and 36 degrees). The mark 2220 may be a length of 15 millimeters (or between 10 millimeters and 20 millimeters) of the area of the inlet tube 2201 including the first connection section 2221 and the pump inlet 2224 and the area of the structural section 2223 having the recess closest to the pump inlet 2224. In some embodiments, the first connection section 2221 is part of the pump inlet 2224. The adjacent curved portion of the structural section 2223, which may be inclined relative to the longitudinal axis of the inlet tube 2201, may have a length of 14 millimeters, as indicated by reference 2225. The adjacent portion of the inlet tube 2201, shown by reference 2230, includes the remaining portion of the structural section 2223 and the second connection section 2222. The inlet tube 2201 or any other inlet tube described herein may have additional features or modifications such as those described in PCT publication No. WO 2019/229210, entitled "line set up for directing blood flow of a cardiac support SYSTEM AND method of production AND assembly (LINE DEVICE FOR CONDUCTING A BLOOD FLOW FOR A HEART SUPPORT SYSTEM, AND PRODUCTION AND ASSEMBLY METHOD)" filed on day 5, month 30 of 2019, AND/or in U.S. patent application No. 17/057355, entitled "line set up for directing blood flow of a cardiac support SYSTEM AND method of production AND assembly (LINE DEVICE FOR CONDUCTING A BLOOD FLOW FOR A HEART SUPPORT SYSTEM, AND PRODUCTION AND ASSEMBLY METHOD)" filed on day 18 of 2021, the disclosure of each of which is incorporated herein by reference in its entirety for all purposes AND forms a part of this specification.

Fig. 23 is a perspective view of an alternative embodiment of an inlet 2301 of the MCS system. The inlet tube 2301 may be used with any of the pumps or MCS systems described herein. The inlet tube 2301 may be in the form of a mesh or braided suction hose. The inlet tube 2301 has a body 2305. The body 2305 may have a first connection section 2310 at a first end for connecting the inlet tube 2301 to a distal tip and a second connection section 2315 at a second end for connecting the inlet tube 2301 to a pump outlet. The pump inlet 2330 may have at least one inlet opening 2340 cut or formed in the first connection section 2310. The inlet opening 2340 may be implemented as a multipart window. Pump inlet 2330 may include three rectangular inlet openings 2340 that are rounded in the form of circular arcs in the direction of braiding section 2320.

Body 2305 may have a braided section (which may also be referred to as a mesh section) 2320 between connection sections 2310 and 2315. Braiding section 2320 has a braiding structure (which may also be referred to as a mesh structure) 2335 formed from at least one braiding wire (which may also be referred to as a mesh wire) 2325. The body 2305 has a pump inlet 2330 disposed in the first connection section 2310 for introducing blood flow into the base/body 2305. The inlet tube 2301 is shaped/configured to be connectable to adjacent components of a circulatory support system. Woven structure 2335 may be shaped as a diamond grid. For this purpose, at least one braided wire 2325 may be braided as a mesh and have a plurality of diamond shaped meshes forming a braided structure 2335. Braided flow channel may be braided section 2320. Braided section 2320 may be formed of a shape memory material. The inlet tube 2301 may be formed entirely of nitinol. By using nitinol, the inlet tube 2301 may be suitable for not only short term use, but also for a service life of more than 10 years. Nitinol may combine the advantages of biocompatibility and shape memory properties, which allows for complex structures in a small installation space, as in the braided section 2320 shown in fig. 23.

Braiding section 2320 may be perforated at connection sections 2310 and 2315. For this purpose, connection sections 2310 and 2315 may have fastening elements for screwing into sections of braided wire 2325. Additionally or alternatively, braided section 2320 may be glued or welded to connection sections 2310 and 2315.

Braided section 2320 may extend over at least half of inlet tube 2301 in order to adjust the rigidity of inlet tube 2301. The inlet tube 2301 may be shaped to enable transfemoral surgery (via inguinal access). The inlet tube 2301 may thus be flexible enough to be pushed through the aortic arch, and also rigid so that it may be pushed through the blood vessel in an axial direction without kinking. The relative requirements of flexibility and rigidity of the inlet tube 2301 may be set by means of the shaping of the braided section 2320. The design of the woven structure may determine the ratio of flexibility to rigidity. Variables that affect the ratio of flexibility to stiffness include the number of wire tracks of the at least one braided wire 2325, the stiffness and material thickness of the at least one braided wire 2325, and the braid pattern of the braided structure 2335.

The greater the number of wire tracks of the at least one braided wire 2325, the greater the rigidity of braided structure 2335 may be. Braided wire 2325 may include, for example, 12 to 24 wire tracks. The larger the wire diameter of braided wire 2325, the stiffer braided structure 2335 may be. For example, the wire diameter may be between 0.1 mm and 0.3 mm. In addition, the material properties of braided wire 2325 are important: the higher the modulus of elasticity of braided wire 2325, the more rigid braided structure 2335 may be. Braided wire 2325 may have an elasticity of between 74GPa and 83GPa, for example. The braid type of braided structure 2335 is also important: the tighter the braid is engaged, the harder it can be.

In the embodiment shown in fig. 23, the inlet tube 2301 may be curved in the direction of the first connection section 2310, e.g. shaped as an obtuse angle with respect to the longitudinal axis of the inlet tube 2301. Braided section 2320 may be bent at an obtuse angle at a bending point. Bending may be achieved by heat treatment of nitinol braided section 2320. Due to the shape memory properties of nitinol, the inlet tube 2301 may be formed with a curved shape corresponding to the braided section 2320 of the human anatomy in order to enable the inlet opening of the pump inlet 2330 of the first connection section 2310 to be positioned in the center of the ventricle. The inlet tube 2301 or any other inlet tube described herein may have additional features or modifications such as those described in PCT publication No. WO 2019/229211 entitled "line set for directing blood flow of a cardiac SUPPORT SYSTEM, AND method for producing a line set (LINE DEVICE FOR CONDUCTING A BLOOD FLOW FOR A HEART SUPPORT SYSTEM, HEART SUPPORT SYSTEM, AND METHOD FOR PRODUCING A LINE DEVICE)" filed on 5-30-2019, AND/or in U.S. patent application No. 17/057411 entitled "line set for directing blood flow of a cardiac SUPPORT SYSTEM, AND method for producing a line set (LINE DEVICE FOR CONDUCTING A BLOOD FLOW FOR A HEART SUPPORT SYSTEM, HEART SUPPORT SYSTEM, AND METHOD FOR PRODUCING A LINE DEVICE)", each of which is incorporated herein by reference in its entirety for all purposes AND forms a part of the present specification.

Fig. 24 is a perspective view of an alternative embodiment of a pump area 2460 of the MCS system. Pump area 2460 or a feature thereof may be used with any of the pump areas or MCS systems described herein. Pump region 2460 has inlet tube 2401. The elongate axial design of the pump region 2460 shown in fig. 24 has a substantially constant outer diameter such that the pump region 2460 can be implanted trans-femoral or trans-aortic for placement in a blood vessel (e.g., the aorta) by means of a catheter.

Depending on the shape of the aortic valve location, the inlet tube 2401 has an inclination or curvature, e.g., longitudinal axis, and thus has a slightly curved shape. In addition to the inlet tube 2401, the pump region 2460 includes a pump unit 2486. The pump region 2460 can also include a distal tip 2485, a housing section 2488, and/or an anchor frame 2487. The inlet tube 2401 may be disposed between the distal tip 2485 and the pump unit 2486. The pump unit 2486 is connected to a housing section 2488 at an end remote from the inlet pipe 2401, to which an anchor frame 2487 is attached.

The inlet tube 2401 may be designed to direct fluid flow to the pump unit 2486 of the pump region 2460. The inlet tube 2401 may include a pump inlet 2430 and a profile section 2435. The pump inlet 2430 can have at least one inlet opening 2440 for introducing a fluid flow into the inlet tube 2401. At least one inlet edge of the inlet opening 2440 of the pump inlet 2430 can be rounded. The inlet opening 2440 can be designed as a window-shaped inlet opening, for example, cut into the pump inlet 2430 or formed within the pump inlet. The profile section 2435 can have an inner surface profile. The profile section 2435 is disposed adjacent to the pump inlet 2430. In the flow direction, the inner diameter of the profile section 2435 at the first location is greater than the inner diameter at the second location. Thus, in some embodiments, the inlet tube 2401 may have a reduced diameter section at the distal end of the inlet tube 2401. The inner surface profile has a rounded shape to reduce the inner diameter at the second location. The length of the profile section 2435 can correspond to the radius of the inlet tube 2401 within a tolerance range. The tolerance range may be a maximum twenty percent deviation from the radius of the inlet pipe.

In fig. 24, the pump inlet 2430 and the profile section 2435 are shown as labeled by way of example. In particular, the profile section 2435 may be part of a smaller or larger inlet tube 2401 than shown in fig. 24. When implanted, the pump inlet 2430 and the contour section 2435 are disposed in the left ventricle. The other section of the inlet tube 2401 is guided through the aortic valve and the section of the pump region 2460 with the pump unit 2486 is arranged in the section of the aorta when implanted. Pump outlet 2445 in the region of pump unit 2486 directs fluid flow delivered through inlet tube 2401 into the aorta. The marker 2450 shows, by way of example, the position of a heart valve (e.g., an aortic valve) through which the inlet tube 2401 passes in order to position the pump region 2460.

A circulatory support system that is limited in terms of installation space, such as the circulatory support system shown here by way of example with a pump region 2460 (which can be implanted in a minimally invasive manner), has relatively low power at a certain pump efficiency. Efficiency is limited by friction in the pump of pump unit 2486. When fluid flow is directed from the inlet opening 2440 of the pump inlet 2430 in the ventricle to the pump unit 2486, pressure loss or friction in the inlet tube 2401 may be affected by the shape of the inlet tube 2401. For this purpose, the inlet edge of the inlet opening 2440 may be rounded in order to reduce pressure losses. This alone may not prevent flow separation. By the inlet inner surface profile being formed in the form of profile section 2435 according to the method presented here, flow separation can be suppressed and thus pressure losses can be reduced.

Fig. 25 is a partial cross-sectional view of the contour section 2435 of the inlet tube 2401. An exemplary dimensional relationship of the contour section 2435 and the interior surface contour 2555 is shown. An axial section of half of the profile section 2435 is shown. The inner diameter 2560 of the profile section 2435 at the first location 2565 can be greater than the inner diameter 2560 at the second location 2570. The inner surface profile 2555 can have a radius 2575 in the form of an axially arcuate inner wall profile to reduce the inner diameter 2560 at the second location 2570. The first location 2565 may mark a point of the profile section 2435 along a longitudinal axis of the profile section 2435 and the second location 2570 may mark another point of the profile section 2435 along the longitudinal axis. Second location 2570 may be downstream of first location 2565. In the exemplary embodiment shown here, the longitudinal axis corresponds to the rotational axis 2580 of the profile section 2435.

The first location 2565 may be disposed in the profile section 2435 between the pump inlet and the second location 2570. With respect to the flow direction of the fluid flow introduced through the pump inlet, said fluid flow is guided through the inlet pipe in the direction of the pump unit and thus through the profile section 2435, the first location 2565 is arranged upstream of the second location 2570. Additionally, in the embodiment of fig. 25, the inner diameter of the profile section 2435 at the third location 2585 is greater than the inner diameter at the second location 2570. Third location 2585 is downstream of first location 2565 and second location 2570.

The inner radius of the contour section 2435 at the second location 2570 can be at most one fifth smaller than the inner radius at the first location 2565. In fig. 25, this is shown by the mark 2590 marking one fifth of the inner radius. Accordingly, the rounding 2575 of the inner surface contour 2555 is designed as a convex bulge in the region of one fifth of the inner radius at most, which is additionally indicated by the reference 2590.

In some embodiments, the inner surface profile 2555 can be designed to be rotationally symmetrical. Thus, the profile section 2435 has a symmetrical rotation of the inner surface profile 2555 relative to the portion of the rotation axis 2580 opposite the portion of the inner surface profile 2555 shown in fig. 25. By forming the contour section 2435 and the inner surface contour 2555 shown in fig. 25, flow separation of the fluid flow in the inlet tube, which would otherwise be formed downstream of the inlet edge, can be reduced or suppressed. In this case, the outer diameter 2595 of the profile section 2435 remains constant and advantageously does not increase the installation space of the inlet line. The pressure loss of the fluid flow can be reduced by means of the embodiment of the profile section 2435 shown in fig. 25 with the inner surface profile 2555. The flow behavior of the inlet flow and thus of the fluid flow is only locally guided through the contour section 2435.

In some embodiments, the profile section 2435 can have a length corresponding to a maximum of twice the inlet tube inner diameter. Due to the shape of the profile section 2435, the pressure loss of the fluid flow is lower further downstream than in an inlet pipe with a constant inner diameter without an inner surface profile, as the suppression or reduction of separation causes less turbulence downstream. The inner surface profile 2555 is shaped in such a way that flow separation is largely inhibited over a length of up to four times the inlet tube radius. The local outer diameter 2595 of the inlet tube is limited by the prescribed wall thickness. Near the inlet opening of the pump inlet, the inlet edge is convexly rounded in order to reduce flow separation. Optimization of the shape of the inner surface profile 2555, such as the shape shown in fig. 25, is optionally rotationally symmetrical, or alternatively, independent of the rotation angle.

In the embodiment of fig. 25, optimization of the profile of the inner surface profile 2555 can form two concave sections and one convex section with constant wall thickness, regardless of the inlet edge rounding described, as shown in fig. 25 with reference to first, second, third and rounding 2565, 2570, 2585, 2575. For this purpose, the inner wall contour is optionally shaped in such a way that, with a constant wall thickness of the contour section 2435, an inner wall radius of up to four fifths based on the inner wall radius is locally achieved.

In some embodiments, the pump region 2460 includes a tubular housing having a feed head portion (e.g., at the pump inlet 2430) with at least one intake opening (e.g., inlet opening 2440) for receiving a fluid flow into a feed line (e.g., inlet pipe 2401). The tubular housing may also include a contoured portion (e.g., contoured section 2435) having an inner surface contour (e.g., surface contour 2555) disposed adjacent to the feed head portion (e.g., pump inlet 2430). The inner surface profile may include a first inner diameter at a first location 2565, a second inner diameter at a second location 2570, and a third inner diameter at a third location 2585. The first inner diameter may be greater than the second inner diameter, and the third inner diameter may be greater than the second inner diameter. The first inner diameter may include a maximum inner diameter of the profile portion (e.g., profile section 2435) and the second inner diameter may include a minimum inner diameter of the profile portion (e.g., profile section 2435). The inner surface profile (e.g., surface profile 2555) can include a rounded portion at a second location 2570. The contoured portion (e.g., contoured section 2435) may include a first inner radius at a first location 2565 and a second inner radius at a second location 2570, wherein the second inner radius is at most one fifth smaller than the first inner radius, and wherein the second location 2570 is located between the third location 2585 and the first location 2565.

The inlet tube 2401 or any other inlet tube described herein may have additional features or modifications such as those described in PCT publication No. WO 2020/016438 entitled "feed line for pump unit of heart assist system, heart assist system and method for producing feed line for pump unit of heart assist system (FEED LINE FOR A PUMP UNIT OF A CARDIAC ASSISTANCE SYSTEM, CARDIAC ASSISTANCE SYSTEM AND METHOD FOR PRODUCING A FEED LINE FOR A PUMP UNIT OF A CARDIAC ASSISTANCE SYSTEM)" filed on day 7, month 19 of 2019, and/or in U.S. patent application No. 17/261335 entitled "feed line for pump unit of heart assist system, heart assist system and method for producing feed line for pump unit of heart assist system (FEED LINE FOR A PUMP UNIT OF A CARDIAC ASSISTANCE SYSTEM, CARDIAC ASSISTANCE SYSTEM AND METHOD FOR PRODUCING A FEED LINE FOR A PUMP UNIT OF A CARDIAC ASSISTANCE SYSTEM)", each of which is incorporated herein by reference in its entirety for all purposes and forms a part of this specification.

Any of the embodiments of MCS systems and pumps described herein may include an insertion tool. Various exemplary embodiments of insertion tools may be used and are described herein.

Fig. 26A-E are various views of an embodiment of an insertion tool 2632. Fig. 26A is a side view of insertion tool 2632, fig. 26B is a longitudinal cross-sectional view of insertion tool 2632 taken along line A-A in fig. 26A, fig. 26C and 26D are cross-sectional views taken along lines B-B and C-C shown in fig. 26A and 26B, respectively, and fig. 26E is an exploded view of insertion tool 2632. Insertion tool 2632 may have the same or similar features and/or functions as insertion tool 32 of fig. 4, and vice versa. Accordingly, insertion tool 2632 may be used with pump 22 or any other pump described herein, and the like.

Insertion tool 2632 may have a generally elongated tubular configuration defining a longitudinal axis 2650. As shown in fig. 26A, insertion tool 2632 may include a tubular body 2636 at a distal end, which may be a cylindrical tube. Insertion tool 2632 may include a hub 2634 at a proximal end. The hub 2634 may include a connector 2639 (also referred to herein as a first engagement structure), a first housing section 2638, a second housing section 2640, a cap 2637, and/or a plug 2635. The connector 2639 may include a conduit 2644 (shown in fig. 26E) having a valve 2645. As further shown in the cross-sectional view of fig. 26B, insertion tool 2632 may further include a locking mechanism 2641, a locking pad 2642, a hemostasis valve 2649, and/or one or more sealing elements 2643. The locking mechanism 2641 may include a locking tab 2646, as described further below.

The tubular body 2636 at the distal end of the insertion tool 2632 can have distal and proximal ends and a lumen extending therebetween. The tubular body 2636 may be cylindrical. The tubular body 2636 mayMade of a polymer, plastic, other suitable material, or a combination thereof. The tubular body 2636 may be made of a transparent polymer such as nylon,Which may facilitate visual confirmation of the passage of the guidewire 100 through the guidewire guide tube 83 contained within the tubular body 2636. The tubular body 2636 may be expandable. The distal end of the tubular body 2636 may include a taper, such as a conical portion that decreases in diameter in a distal direction, to facilitate insertion of the insertion tool 2632 (e.g., into an introducer sheath as described herein). The distal end, e.g., tapered distal end, of the tubular body 2636 may be removably fitted into the proximal opening 90 of the guidewire assist device 38. The tapered end may be e.g. 55D +.>Is a material of (3). The tubular body 2636 may be connected at its proximal end to the distal end of the connector 2639. The connector 2639 may be connected at its proximal end to the distal end of the first housing section 2638. The first housing section 2638 may be connected to a distal end of the second housing section 2640 at a proximal end thereof (e.g., rotatably, rotatable between an open position and a locked position that may be switched back and forth by rotating the second housing section 90 degrees relative to the first housing section). The second housing section 2640 may be connected at its proximal end to the distal end of the cap 2637. The distal end of the plug 2635 may be connected by the proximal end of the cap 2637.

The locking mechanism 2641 may have a longitudinally extending lumen through its body with a recess 2651 configured to receive the locking pad 2642. The locking pad 2642 may be an elastomeric material having a hardness such as thermoplastic elastomer, softOr silicone. When inserted into recess 2651, locking pad 2642 may have an inner surface that substantially coincides with an inner surface of the longitudinally extending lumen of locking mechanism 2641. As shown in fig. 26B, a locking mechanism 2641 may be provided including a connector 2639, a first housingThe segments 2638, the second housing segment 2640, and the hub 2634 of the cap 2637 are within such that they all share a common longitudinal axis 2650, and the lumen of the locking mechanism 2641 is concentric with the lumen of the tubular body 2636, at least in the unlocked configuration. The locking mechanism 2641 may be connected at its distal end to the proximal end of the connector 2639 and may be connected at its proximal end to the distal end of the plug 2635. The plug 2635 may have a longitudinally extending lumen through its body from its distal end to its proximal end.

When connected, the plug 2635, locking mechanism 2641, connector 2639, and tubular body 2636 can create a fluid-tight path extending along the longitudinal axis 2650 of the insertion tool 2632. The path may be fluid tight with the pump and catheter shaft inserted therein. The valve 2649 and/or one or more sealing elements 2643, such as O-rings, may help create a fluid-tight path. For example, the connection between the proximal end of the connector 2639 and the distal end of the locking mechanism 2641 may include a valve 2649. The valve 2649 may have a conical flap that decreases in width in the distal direction. When a pump or catheter shaft is inserted through valve 2649, the conical sidewall may expand to allow the component to pass therethrough, but remain compressed around the component to create a seal. The connection between the proximal end of the locking mechanism 2641 and the distal end of the plug 2635 may include one of the sealing elements 2643. The proximal end of the plug 2635 may include one of the sealing elements 2643 to fluidly connect to other components of the circulatory support system (e.g., the distal connector of the sterile sleeve 26) which may have mating features that lock to the plug 2635, for example, by rotating a protrusion on the plug into a groove in the mating features. The sealing element 2643 may be an O-ring or other rounded sealing element that may sealingly engage the component passing therethrough.

The fluid-tight path along the longitudinal axis 2650 of the insertion tool 2632 may be configured to axially movably receive a circulatory support device or pump, such as any of the devices or pumps described herein. For example, lumen 2620 of tubular body 2636 may be configured to axially movably receive pump 22 and optional guidewire guide tube 83, and the longitudinally extending lumen in hub 2634 may be sized to slidably receive shaft 16 (e.g., an 8 french shaft) of the MCS device. When the pump 22 is contained within the lumen of the tubular body 2636, the shaft 16 is contained within the longitudinally extending lumen in the hub 2634, and the locking mechanism is in an unlocked state (as shown in fig. 26C), the pump 22 can be advanced distally out of the tubular body 2636, for example into the tubular body 116 of the introducer sheath 112, and then advanced from the introducer sheath into the vasculature of the patient by advancing the shaft 16 in a distal direction. The tubular body 2636 of the insertion tool 2632 (having a circulatory support device such as the pump 22 therein) may be configured to be received by an introducer sheath (e.g., the introducer sheath 112) as described herein. Thus, the tubular body 2636 of the insertion tool 2632 can have sufficient resistance to collapse to remain unobstructed when passing through the hemostasis valve of the introducer sheath.

Insertion tool 2632 may be configured to releasably lock with the circulatory support device when the circulatory support device is inserted into insertion tool 2632. In some embodiments, the insertion tool 2632 may be releasably lockable with the MSC shaft 16 (also referred to as a catheter or catheter shaft) of the circulatory support device. When insertion tool 2632 is locked with the circulatory support device, axial (e.g., longitudinal/proximal/distal) movement of the circulatory support device may be prevented. Insertion tool 2632 may be locked to the circulatory support by engagement of locking pad 2642 with at least a portion of the circulatory support. To engage the locking pad 2642 with at least a portion of the circulatory support (e.g., the shaft 16), the locking pad 2642 may be compressed by the locking mechanism 2641.

The locking mechanism 2641 may compress the locking pad 2642 by interaction between one or more locking tabs 2646 of the locking mechanism 2641 and one or more inner surfaces of the second housing section 2640. The locking tabs 2646 may extend radially outward from opposing sidewalls 2647 of the locking mechanism. The locking tab 2646 may be offset along the longitudinal axis 2650. The second housing section 2640, along with the cap 2643, may be configured to rotate relative to the first housing section 2638, the locking tab 2646, and the plug 2635 (with the axis of rotation along the longitudinal axis 2650 of the insertion tool 2632). Configured in this manner, as the second housing section 2640 rotates, one or more inner surfaces or sidewalls 2640B of the second housing section 2640 may contact one or more of the locking tabs 2646, thereby compressing the locking tabs 2646 inwardly, thereby causing the locking pads 2642 to compress radially inwardly. As shown in fig. 26C, if the second housing section 2640 is rotated 90 degrees counterclockwise (oriented as in fig. 26C, or clockwise relative to the first housing section 2638), the inner surface sidewalls 2640B of the second housing section 2640 may contact the locking tabs 2646 (shown in this embodiment as having curved outer surfaces) and force them inward, compressing the locking mechanism 2641 inward against the locking pads 2642. With the locking tabs 2646 longitudinally offset, inward compression of the locking tabs 2646, and thus the locking pads 2642, against, for example, the shaft 16 may cause the shaft 16 to flex slightly in the region of the locking pads 2642, thereby holding the shaft 16 in place. Alternatively or additionally, the shaft 16 may be compressed by the locking pad 2642 and hold/lock the shaft 16 in place.

As shown in fig. 26C, the second housing section 2640 may include two opposing first sidewalls 2640A, which may be rounded as shown, connected by two opposing second sidewalls 2640B, which may be straight. A first distance (e.g., a first diameter) between two opposing first sidewalls 2640A may be greater than a second distance (e.g., a second diameter) between two opposing second sidewalls 2640B. In the unlocked state, as shown in fig. 26C, two opposing first sidewalls 2640A may be adjacent to respective locking tabs 2646. When rotated to the locked position, due to the short distance between the second sidewalls 2640B, two opposing second sidewalls 2640B may contact and compress the respective locking tabs 2646, as described above. The locking tabs 2646 may each include rounded outer corners 2646A contacted by respective second sidewalls 2640B for gradual compression and reducing the risk of breaking the tabs. As the second housing section 2640 is rotated further counterclockwise in orientation (i.e., clockwise relative to the first housing section 2638), the locking tabs 2646 may each include a radially outer edge 2646B contacted by the respective second sidewall 2640B. The edge 2646B may be straight as shown or otherwise match the contour of the inner surface of the second sidewall 2640B. In the case of two opposing straight surfaces (e.g., of edge 2646B and second sidewall 2640B) in contact, second housing section 2640 may be rotationally stationary without requiring external force from a user. Movement into engagement of the edge 2646B with the inner surface of the second sidewall 2640B may create a snap-like tactile feedback.

To unlock the circulatory support from the insertion tool 2632, the second housing section 2640 may be rotated in the opposite direction (e.g., a clockwise orientation in fig. 26C, or a counter-clockwise orientation relative to the first housing section 2638). The first housing section 2638 and the second housing section 2640 may include features that may hold the insertion tool 2632 in an unlocked position until a user of the system selects to lock the circulation support device in place relative to the insertion tool 2632. In some embodiments, the interaction between the flexible tabs 2649 and the second housing section 2640 may hold the insertion tool 2632 in the unlocked position until a user of the system selects to lock the circulatory support device relative to the insertion tool 2632. Likewise, the first and second housing sections 2638, 2640 may include features that may hold the insertion tool 2632 in a locked position, as described, until a user of the system selects to unlock the circulation support device relative to the insertion tool 2632. In some embodiments, the interaction between the locking tab 2646 and the second housing section 2640 may hold the insertion tool 2632 in the locked position until a user of the system selects to unlock the cyclic support device relative to the insertion tool 2632.

The connector 2639 of the insertion tool 2632 may be configured to engage (e.g., releasably lock/unlock) with an introducer sheath as described herein. For example, the outer surface of the distal end of the connector 2639 may include an inward circumferential groove that may be used to engage features such as mating bumps or flexible tabs in the locking cap 2924 in the proximal port 2942 of the introducer sheath hub and/or a lock of the introducer sheath. Engagement of the distal end of the connector 2639 with the locking cap 2924 may produce a snap-like tactile feedback. The connector 2639 may mate with the introducer sheath locking cap 2924 in a manner that prevents rotation of the insertion tool connector 2639 relative to the introducer hub 2922, thereby preventing rotation of the first housing section 2638 relative to the introducer hub when connected. For example, the distal end of the connector 2639 and the proximal port 2942 of the introducer sheath may be oval or square or non-circular in shape. This may facilitate handling by allowing a user to grasp the introducer hub 2922 and/or the first housing section 2638 with one hand while rotating the second housing section 2640 with the other hand.

Fig. 26D shows a portion of the connection between the connector 2639 and the distal end of the locking mechanism 2641 and the connector 2639 and the proximal end of the elongate tubular body 2636. Also shown is a conduit 2644, which in some embodiments may be fluidly connected to a longitudinal lumen of insertion tool 2632. The locking mechanism 2641 may include radially outwardly extending protrusions that are received into corresponding grooves or recesses of the connector 2639. This engagement may rotationally stabilize the locking mechanism 2641 relative to the connector 2639. An adhesive may be added to adhere the protrusions and grooves to firmly connect the connector 2639 and the locking mechanism 2641. An adhesive may be added to adhere the locking mechanism 2641 to the first housing section 2638, thereby also firmly connecting them. The connector 2639 may have an inward flange with a lumen that is the same size as the longitudinally extending lumen in the hub 2634 and shares the axis 2650, which may provide a stop when the tubular body 2636 is inserted into the connector 2639 during manufacture, which may protect the valve 2649 and keep the opening to the tube 2644 open.

Fig. 26E illustrates an exploded view of an insertion tool 2632 according to fig. 26A-D and some embodiments. As shown, tube 2644 may be fluidly connected to a longitudinal lumen of insertion tool 2632 and may have a valve 2645 (e.g., a stopcock) at an opposite end thereof. Valve 2645 may be adjusted to prevent or allow fluid flow through valve 2645.

Insertion tool 2632 may have a length in the range of about 85mm to about 200mm (e.g., about 192 mm). In some embodiments, the longitudinal lumen of insertion tool 2632 may include a diameter in the range of about 4.5mm to about 8.0mm (e.g., about 5.55 mm). The insertion tool 2632 may be sized and configured such that when the pump 22 is fully within the tubular body 2636, the indicia 37 (see fig. 7) are exposed proximally of the insertion tool hub 2634. Insertion tool 2632 may include a hemostasis valve (e.g., hemostasis valve 2645) to seal around the circulatory support system therethrough (e.g., to seal around MCS shaft 16). The hemostatic valve, if provided, may accommodate passage of a larger diameter MCS device including a pump. In a commercial embodiment of the circulatory support system, the packaged MCS device is pre-positioned within the insertion tool 2632 and the guidewire assist device is pre-loaded within the MCS device and the shaft 16, as described herein.

Fig. 27 is a partial cross-sectional view through an impeller and magnetic coupling region of an embodiment of a rotor bearing system 2700 of a pump that may be used with the various MCS systems described herein. Rotor bearing system 2700 may have non-contact torque transfer and radial and axial motor mounts, shown as exemplary embodiments in the form of pumps for cardiovascular support.

Rotor bearing system 2700 has housing 2780. Housing 2780 may be a motor housing that encloses a motor, a drive shaft, and/or a drive magnet, which may be hermetically sealed from the surrounding environment. Within the housing 2780, a first cylindrical permanent magnet 2730 is disposed on a shaft 2706 that is driven by a motor (not shown), and the permanent magnet 2730 is mounted for rotation about a first axis 2705.

The housing 2780 may have: radially surrounding a first cylindrical portion of the motor having a first outer diameter 2731 (e.g., in the range of 5 to 7mm, preferably 6 mm); a second cylindrical portion having a second outer diameter 2732 that is smaller than the first outer diameter (e.g., in the range of 0.3 to 1mm, preferably 0.5mm, smaller than the first outer diameter); and a third cylindrical portion having a third outer diameter 2733 (e.g., 1.7 to 2.3mm, preferably 2.0mm, less than the second outer diameter) that is less than the second outer diameter.

The second outer diameter 2732 may be securely mated with the inlet tube housing 2722, where the second outer diameter and the inlet tube housing 2722 are sized such that the outer diameter of the inlet tube housing is flush with the first outer diameter 2731 (e.g., the thickness of the inlet tube housing 2722 may be equal to the difference between the first outer diameter and the second outer diameter divided by 2). The third outer diameter 2733 of the housing 2780 may be, for example, in the range of 3.2 to 3.8mm, preferably 3.5mm.

The rotor bearing system 2700 may further include a rotor 2770 for transporting liquid, wherein the rotor 2770 includes a second permanent magnet 2740 in the form of a hollow cylinder that is also mounted for rotation about the first axis 2705. A second permanent magnet 2740 in the form of a hollow cylinder is disposed in a member 2772 of the rotor 2770 in the form of a hollow cylinder. The second permanent magnet 2740 in the form of a hollow cylinder optionally includes a back iron 2750 on its exterior.

In some embodiments, the first permanent magnet 2730 may have an outer diameter of 3mm, a magnet height of 1mm, and a length of 3.2mm (e.g., in the range of 3 to 4.2 mm). The second permanent magnet 2740 may have an outer diameter of 5.3mm (e.g., in the range of 5mm to 5.3 mm), a magnet height of 0.6mm (e.g., in the range of 0.5mm to 0.6 mm), and a length of 3.2mm (e.g., in the range of 3mm to 4.2 mm). The interlace 2715 may be 1mm (e.g., in the range of 0.1 to 1.2 mm). The rotor 2770 may have an outer diameter of 5.3mm (e.g., in the range of 0.1 to 0.4mm, preferably 0.2mm, less than the second outer diameter 2732) and a length of 15 mm.

The rotor 2770 may be arranged as an impeller that converts mechanical power transmitted through a coupling (e.g., a magnetic coupling) into hydraulic power to resist blood pressure from delivering blood flow. The rotor 2770 may further include a tapered or conical member 2771 that mates with the member 2772 in the form of a hollow cylinder. The outer circumference of the base surface of the conical member 2771 may be connected with an annular opening on the axial end of the member 2772 in the form of a hollow cylinder.

The first permanent magnet 2730 and the second permanent magnet 2740 may at least partially axially overlap in an axial region marked by reference numeral 2716. In this case, the first permanent magnets 2730 are axially staggered with respect to the second permanent magnets 2740. The centers of the first and second permanent magnets 2730, 2740 are marked by vertical lines, with an axial stagger 2715 drawn between the two vertical lines.

Due to the axial stagger 2715, the second permanent magnet 2740 may experience a force to the right in fig. 27 such that the balls 2717 disposed in the rotor 2770 are pushed onto the cones 2718 disposed in the housing 2780 such that the first bearing 2720 and the third bearing 2790, which in this case form a combined axial and radial bearing 2719, remain in contact. Alternatively, the balls may be disposed in the housing 2780 and the cone disposed in the rotor. When used as intended, the ball 2717 rotates in the cone 2718 so that both radial and axial forces can be absorbed. In this case, the combined axial and radial bearing 2719 is a solid body bearing. The ball 2717 is disposed in the conical member 2771. The axial bearing function and the radial bearing function are achieved by a combination of two element balls 2717 and a cone 2718. For example, the ball 2717 may have a diameter in the range of 0.5mm to 0.9mm, preferably 0.7mm, and the cone 2718 may have a diameter of 1mm, a height of 0.8mm, and a cone angle in the range of 70 ° to 90 °, preferably 80 °. The axial bearing function of the combination bearing 2719 has the function of a first bearing and is designed for axial positioning of the rotor 2770 and the housing 2780 and/or the shaft 2706 relative to each other and absorbs axial forces generated by the arrangement of the first permanent magnets 2730 and the second permanent magnets 2740. Further, the axial force on rotor bearing system 2700 may be adjusted such that the applied force setting may be optimized.

The region of the housing 2780 including the first permanent magnet 2730 may be at least partially radially surrounded by the member 2772 of the rotor 2770 in the form of a hollow cylinder. A passage 2774 in the form of a hollow cylinder may then be formed between the housing 2780 and the member 2772 of the rotor 2770 through which liquid may flow. The bore or perforation 2702 may be disposed in the rotor 2770, preferably in a conical member 2771 of the rotor 2770, or in a transition of the conical member 2771 to a member 2772 of the rotor 2770 in the form of a hollow cylinder, and may be in fluid communication with the channel 2774. In use, as rotor 2770 rotates, liquid may be centrifugally drained from bore 2702 and liquid may be pulled into channel 2774 to replace the drained liquid in a continuous flow. In this case, flow arrow 2711 indicates the direction of flow of liquid through gap 2774. Flow arrow 2712 indicates the direction of flow of liquid conveyed by rotor blades 2773.

The second bearing 2710, which may be arranged as a radial, hydrodynamic and bloodlubricated sliding bearing, may be arranged on the end of the conical member 2771 of the rotor 2770 facing away from the housing 2780. The second bearing 2710 may be designed to absorb radial forces and position the axis of rotation of the second permanent magnet 2740 in alignment with the axis of rotation 2705 of the shaft 2706 or the first permanent magnet 2730. In this case, the second bearing 2710 may be arranged between the rotor 2770 and the insert 2721, which may be fastened (in particular clamped or pressed in) in an annular end on the second housing 2722, which in turn is fastened to the housing 2780. In this case, the second housing 2722 may form an outer skin of the rotor bearing system 2700, wherein the second housing 2722, which may also be referred to as an impeller housing, has a plurality of outlet windows 2723. The insert 2721 is preferably a bearing housing or star that can be securely attached (e.g., glued, welded, or friction fit) to the second housing 2722. The bearing star 2721 may have an outer diameter of 6mm (e.g., in the range of 5mm to 7 mm) and a length of 3mm (e.g., in the range of 2mm to 5 mm). The second housing 2722 may have an outer diameter of 6mm (e.g., in the range of 5mm to 7 mm), a length of 18mm (e.g., in the range of 15mm to 21 mm), and a wall thickness of 0.25mm (e.g., in the range of 0.15mm to 0.5 mm).

Alternatively, the insert 2721 and the second housing 2722 may be manufactured as a single piece, which may have a uniform inner diameter. In this arrangement, the extended inlet sleeve may be connected to the combined insert and second housing 2722, for example, by laser welding.

The bearing 2710 may have a diameter of 1mm (e.g., in the range of 0.75 to 1.5 mm) and a length of 1mm (e.g., in the range of 0.75 to 2 mm).

Due to the axial stagger 2715 determined by the design between the first permanent magnet 2730 and the second permanent magnet 2740, the axial force defined in the exemplary embodiment of fig. 27 acts on the rotor 2770 in the direction of the motor (i.e., left to right in the exemplary embodiment of fig. 27). This force is opposite to the hydraulic force exerted on the rotor 2770 during operation, that is, from right to left in the exemplary embodiment of fig. 27, which is opposite to the direction of the liquid flow 2711 generated by the rotating rotor blades 2773.

In the present case, the axial force resulting from the coupling of the first and second permanent magnets 2730, 2740 may be optimized to be greater than the maximum expected hydraulic force, which ensures that the rotor 2770 remains in a defined axial position at all times, without being much greater than the maximum expected hydraulic force, which may allow the combined axial and radial bearing 2719 to be not unnecessarily overloaded, thereby minimizing friction and wear and reducing torque transferred to the rotor. If a Halbach (Halbach) configuration is implemented, this axial force may be optimized by adjusting the dimensions (e.g., length, thickness, outer diameter) and axial displacement or stagger distance 2715 of the two permanent magnets 2730, 2740, as well as the segment angle α.

The applicant has conducted an optimization study using Halbach magnet configuration, wherein the segment angle α is 45 ° and the pump device has an outer diameter of 6.2mm. The inner and outer diameters of the first permanent magnet were chosen to be 1.0mm and 3.0mm, respectively, due to the diameter constraints of the device. The inner and outer diameters of the second permanent magnet were selected to be 4.1mm and 5.3mm, respectively. The length of each magnet and interlace 2715 was modified to study the effect on axial force and torque and to optimize. Due to the constraint on the length of the rigid section of the pump, the sum of the magnet length and staggering is limited to 4.2mm, so it can traverse a tortuous vascular path during endovascular delivery to the heart. The study found that the optimal design had a magnet length of 3.2mm (the length of the two permanent magnets 2730, 2740) and an axial displacement or staggering 2715 of 1.0mm, yielding the best results. An interlace 2715 in the range of 0.5 to 1mm may be the basis for alternative embodiments, but is found to be suboptimal. These results may represent an optimized coupling configuration of the device under test. Because the force applied to the impeller and coupling is a function of the overall device diameter, inlet tube length, impeller design, maximum impeller speed or blood flow rate, and other characteristics or dimensions that affect hydraulic pressure, bearing friction losses, and eddy current losses, the results of devices having different dimensions or characteristics may be different than the devices tested.

For the purposes of this study, the maximum fluid load was assumed to be 1.2mNm, the friction loss of the bearing was assumed to be 0.2mNm, and the eddy current loss was assumed to be 0.1mNm, with a total load torque of 1.5mNm during normal operation. A safety factor of 3 was used such that the maximum load torque was 4.5mNm. Friction and wear behavior can also be optimized by increasing the cone angle of the cone 2718, where sufficient radial load capacity must be ensured.

Fig. 28A-B illustrate aspects of an ultrasound transducer 2860 that may be incorporated into embodiments of the circulatory support systems described herein. For example, ultrasound transducer 2860 or features thereof may be incorporated into embodiments of MCS systems and pumps described herein for long term use, e.g., for treatment of cardiogenic shock, and/or in embodiments having a magnetic drive with a sealed motor housing, and/or in other embodiments.

Ultrasound transducer 2860 may be disposed distal to a blood access port (also referred to herein as a pump inlet and/or inlet opening). The ultrasonic transducer 2860 may include a locating tab 2862 configured to couple with a locating channel of a nose piece (also referred to herein as a distal tip) 64. A guidewire lumen (also referred to herein as a guidewire port) 76 may extend through the ultrasound transducer 2860. The ultrasonic transducer 2860 may include an acoustic backing 2866 having a proximal concave surface 2868 and a distal surface 2870. The guidewire lumen 76 may extend through the acoustic backing 2866. The proximal concave surface 2868 may be provided with at least one and preferably two or more piezoelectric elements 2872 focused for converging at a focal length 2874 in the range of about 6mm to about 14mm and preferably about 10mm from the concave surface 2868. The piezoelectric element 2872 on the concave surface 2878 may direct the ultrasonic waves 2878 to a focal region 2880 positioned at a focal length 2874. Concave surface 2876 and piezoelectric element 2872 may be covered by acoustic impedance matching layer 2876.

The distal end 2870 of the ultrasonic transducer 2870 may be provided with a plurality of electrodes 2872 to connect conductors to the piezoelectric element 2872. In addition, a locating feature such as a tab or recess, for example locating tab 2862, may be provided to ensure proper rotational orientation of the ultrasound transducer 2860 by engaging a complementary tab or recess (e.g., the locating channel described above) in an adjacent feature (e.g., nose 64 or MCS/VSD inlet tube 70). The focal region 2880 of the directional ultrasound 2878 is thus positioned in the blood flow path within the blood flow path near or downstream of the blood inlet port to provide blood flow velocity data by evaluating the Doppler shift of the reflected ultrasound waves detected by the ultrasound transducer 2860.

Other embodiments or features of ultrasonic flow sensors and METHODs FOR measuring flow by ultrasound may be incorporated into MCS systems or pumps, such as PCT publication No. WO 2020/064707, titled "METHOD and system FOR determining flow rate of fluid through an implanted vascular assist system (METHOD AND SYSTEM FOR DETERMINING A FLOW SPEED OF A FLUID FLOWING THROUGH AN IMPLANTED, VASCULAR ASSISTANCE SYSTEM)" filed on day 2019, day 3, day 8 of 2021, U.S. application No. 17/274354, filed on day 6, 2019, entitled "METHOD and METHOD FOR determining flow rate of fluid through an implanted vascular assist system (SYSTEMS AND METHOD FOR 78)" filed on day 6, and/or PCT publication No. WO 2019/234166, titled "METHOD and METHOD FOR determining flow rate of fluid through a heart assist device (385628 METHOD FOR 78), filed on day 12, each of which is incorporated herein by reference in its entirety.

Fig. 29 illustrates a side elevation view of an expandable introducer sheath 2912. The expandable introducer sheath 2912 may be used with any of the embodiments of MCS systems or pumps described herein. The expandable introducer sheath 2912 may have a hub 2922 and associated components similar to the introducer sheath 112 described in connection with fig. 5, and vice versa. Further, the elongate tubular body of the introducer sheath 2912 can expand from a first reduced internal cross-sectional area to a second increased internal cross-sectional area, such as to allow passage of a device having an Outer Diameter (OD) that is greater than the first reduced cross-sectional area. After expansion in response to passage of a sheath expansion device (e.g., MCS and/or VSD device as described herein), the introducer sheath may be biased to return or approximately return to the first reduced cross-sectional area. The expandable introducer sheath 2912 may include an expandable support structure 2932, e.g., a tubular frame of a plurality of zig-zag segments of a shape memory material (such as nitinol), which allows radial expansion in the presence of an expansion device therethrough, but will return to a first reduced cross-sectional area after removal of the device. The expandable support structure 2932 may be enclosed within a tubular flexible membrane 2930 that can accommodate radial expansion and contraction. As further shown, the expandable introducer sheath 2912 may include a distal end 2920, a proximal end 2940, a side port 2926, suture eyelet (s)/eye 2928, a proximal hub 2922, and a proximal port 2942, similar to the distal end 120, proximal end 118, side port 126, suture eyelet (s)/eye 128, proximal hub 122, and proximal port 124 of the introducer sheath 112 described herein. The expandable introducer sheath 2912 may also include a locking cap 2924 at its proximal end having one or more features that may be engaged/locked with an insertion tool (e.g., insertion tool 32 and/or insertion tool 2632), such as a connector 2639 and/or a dilator (e.g., dilator 114), as described herein.

Another embodiment of an MCS device with a sealed rotating shaft is shown in fig. 30A-30C. Fig. 30A is a partial cross-sectional view of the device with two lip seals facing each other, a front disc, a middle disc and a rear disc housed in a seal housing, fig. 30B is an isometric exploded partial cross-sectional view thereof, and fig. 30C is a cross-sectional view of the seal member shown separated as a subassembly. The MCS devices of fig. 30A-30C, or variations or embodiments thereof, may be included in any of the MCS systems described herein, and may include any of the features of the MCS devices described herein, and vice versa. Thus, for example, pump 22, MCS system 10, motor housing 74, pump 1900, pump 2062, and/or pump area 2160, etc. may include the MCS devices of fig. 30A-30C or features thereof, particularly sealing features thereof. Alternatively or additionally, any of the pump embodiments described herein may include other sealing features, such as those described in U.S. provisional application No.63/229436 entitled SEAL FOR mechanical circulatory support device (SEAL FOR A MECHANICAL CIRCULATORY SUPPORT DEVICE), filed on 8/4 of 2021, the entire contents of which are incorporated herein by reference FOR all purposes and form a part of this specification.

As shown in fig. 30A-30C, the device includes a distal annular radial or rotary shaft seal 3266 having a radially inward contact lip 3267 forming a seal cavity 3176 a. The contact lip 3267 and the sealing cavity 3176a of the distal seal 3266 face proximally. The distal seal 3266 thus has an "open side" facing proximally toward the motor, and a "flat side" facing distally toward the impeller and blood. The distal seal 3266 is thus oriented "rearward" from the conventional orientation. In some embodiments, the "open side" may be the side of the seal 3266 formed in part by the upper and/or lower flanges or lips of the seal 3266. The cavity may be formed by the open side of the seal 3266. The cavity may be formed between an end wall of the seal 3266 and one or more flanges or lips of the seal 3266. The cavity may have a spring and/or grease located therein. Further details of the end walls, lips, etc. are described herein.

The device further includes a proximal annular radial or rotary shaft seal 3270 having a radially inward contact lip 3271 forming a seal cavity 3176 b. The contact lip 3271 and the seal cavity 3176b of the proximal annular seal 3270 face distally. The proximal seal 3270 thus has an "open side" facing distally toward the motor (as described above), and a "flat side" facing proximally toward the impeller and blood. Thus, the seal assembly includes a proximal annular seal 3270 and a distal annular seal 3266 having their contact lips 3267, 3271 and seal cavities 3176a, 3176b facing each other.

Lips 3267, 3271 contact shaft 3140. Lips 3267, 3271 may extend along axis 3140. All or a portion of one or more radially inward surfaces of lips 3267, 3271 may contact shaft 3140. Lips 3267, 3271 may be flat and/or have non-flat features, as described in further detail herein, for example, with respect to fig. 30C.

Seals 3266, 3270 may include radially outer lips 3263, 3264. Lips 3263, 3264 may contact the radially inward surface of the housing or other component of the sealed compartment. Lips 3263, 3264 may extend along the housing or other component. Lips 3263, 3264 may seal the space between seals 3266, 3270 and the housing or other component. The radially outer surfaces of lips 3263, 3264 may be flat, non-flat, or a combination thereof.

Lips 3263, 3264 may extend from respective end walls 3262, 3259. Lip 3263 extends distally from end wall 3262. Lip 3264 extends proximally from end wall 3259. End walls 3262, 3259 may refer to "flat" sides as described herein. Radially inner lips 3267, 3271 may extend from end walls 3262, 3259 as described. The outer lips 3263, 3264 may extend perpendicular to the end walls 3262, 3259 in the absence of external forces and/or when installed in a sealed compartment. The outer lips 3263, 3264 may have the same or similar features as the inner lips 3267, 3271, such as a leading edge, groove or recess, etc.

In some embodiments, intermediate elastomeric disk 3260 can be positioned between proximal annular seal 3270 and distal annular seal 3266. Distal elastomeric disk 3255 can be positioned distal to distal annular seal 3266. Proximal elastomeric disk 3275 may be positioned proximal to proximal annular seal 3270.

Optionally, a seal housing made from front seal container 3240 and optional seal container cap 3278 (see fig. 30B and 30C) may contain seal components in the subassembly. The subassembly may be inserted onto the drive shaft 3140 and into the motor housing 3164. Alternatively, the sealing member may be assembled in the motor housing by inserting the members separately and sequentially into cavities in the motor housing on the drive shaft 3140. The sealing member may then be covered with a rear (proximal) sealing cap 3278, which may be attached (e.g., welded, friction fit, form fit, glued) to the motor housing.

Both distal elastomeric disk 3255 and intermediate elastomeric disk 3260 can be made from an elastomeric biocompatible material, such as PTFE, elastomeric polyurethane, or a composite material (e.g., PTFE and polyimide). As shown in fig. 30B, one or more of the discs 3255, 3260 may have an Inner Diameter (ID) 3256, 3261 that is less than the Outer Diameter (OD) of the drive shaft 3140, which may optionally include an inner diameter contacting impeller back extension 3154. For example, IDs 3256, 3261 can be in the range of 80% to 95% (e.g., about 87%) of OD 3141. In one embodiment, ID 3256, 3261 is 0.52mm +/-0.02mm, and OD 3141 is 0.60mm +/-0.01mm. This dimensional difference creates a high interference between the elastomeric disks 3255, 3260 and the drive shaft to maintain the seal. For example, the ideal interference may be in the range of.070 mm to.080 mm. Both elastomeric disks 3255, 3260 can have a thickness in the range of 80 μm to 140 μm (e.g., about 100 μm).

Characteristics of the elastomeric discs 3255, 3260, such as high interference, material hardness (e.g., in the range of 70 to 85 shore hardness), and thickness, may allow the discs to deform upon insertion onto a drive shaft. For example, the disc may be compressed outwardly so that the disc ID may be stretched, or the plane of the disc may be curved, particularly in the area near the ID. The deformation of the disc may provide contact pressure with the drive shaft 3140 even as the disc material wears over time. Furthermore, the high interference provides an amount of material that may wear before the contact pressure is reduced to zero, which may extend the functional duration of the disc 3255, 3260 acting as a blood barrier. Furthermore, the high interference can compensate for small tolerances of the eccentricity of the drive shaft within the disc.

The characteristics of the discs 3255, 3260 may allow them to act as a fluid barrier for at least a portion of the expected duration of MCS device use while minimizing friction or torque transmission reduction. In addition, distal elastomeric disk 3255 can serve as a first barrier to blood for at least a portion of the duration of use. If blood seeks to pass the more distal barrier, the intermediate elastomeric disk 3260 can serve as an additional barrier to blood. Moreover, disk 3260 can act as a divider between distal annular seal cavity 3176a and proximal annular seal cavity 3176b, helping to keep grease contained in these cavities aside each annular seal, which in turn extends the functional duration of the annular seals. Optionally, the grease or lubricant dispensed in the distal seal chamber 3176a may be the same as or different from the grease or lubricant dispensed in the proximal seal chamber 3176 b. In some embodiments, proximal disc 3276 may have the same or similar features as distal disc 3255 and intermediate disc 3260.

In addition to their relative positions and orientations, the distal seal 3266 and the proximal seal 3270 may have similar characteristics to each other or to other seals 3156 disclosed in connection with other embodiments. For example, both the distal seal and the proximal seal may have seal retainers 3265, 3274, annular seals with contact lips 3267, 3271, seal cavities 3176a, 3176b defined in part by the seal retainers and the annular seals, and/or garter springs 3269, 3273 retained in the respective seal cavities 3176a, 3176 b. Seals 3266, 3270 may have the same inner diameter and lip size. Alternatively, the seals 3266, 3270 may have primarily different outer diameters so they are easily distinguished from one another during manufacture.

Instead of garter springs 3269, 3273, the seal may comprise a different component (e.g., an O-ring) that applies a radially inward force or a separate component that does not have a force applied, wherein the characteristics of an elastomeric annular seal with contact lips self-applies a radially inward contact force.

The distal annular seal 3266 and the proximal annular seal 3270 may be made of biocompatible elastomeric materials, such as PTFE, elastomeric polyurethane, or composite materials (e.g., PTFE and polyimide), which may optionally have one or more additives to enhance durability. The grease may be contained in one or both seal cavities 3176a, 3176b, and optionally a third grease reservoir is maintained between the proximal seal and the proximal disc 3275, and may be the same grease or a different grease. In one embodiment, the first grease is deposited in the distal seal cavity, which may have a higher viscosity and grease consistency (e.g., NLGL 4 grade or higher) than the third grease deposited in the proximal seal cavity (e.g., NLGL 2 grade) or the second grease held in a third grease reservoir held between the proximal seal and the proximal disc. In another embodiment, grease is deposited in the distal seal lumen (e.g., NLGL 4 grade or higher), and oil is deposited in the proximal seal lumen.

Alternatively, the distal seal 3266 may have a leading edge 3231 on its distal face, which is the surface of the distal seal that contacts a rotating component such as the drive shaft 3140, except for a contact lip 3267. The leading edge 3231 is part of a distal annular seal 3266 having an inner diameter that is smaller than an inner diameter of a portion of the contact lip 3267 proximal to the leading edge 3231. The leading edge 3231 can be part of a distal annular seal 3266 having an inner diameter that is less than an outer diameter of a motor drive shaft 3140 with which the inner diameter mates. For example, the ID of the leading edge may be in the range of 75% to 95% (e.g., 80% to 90%, about 87%) of OD 3141. In one embodiment, the ID is 0.52mm and the OD 3141 is 0.60mm. By forming a flush connection with the rotational shaft 3140 on the distal face of the seal, the leading edge may serve to reduce the occurrence of blood being actively sucked under the contact lip 3267, which may help to increase the life of the seal. Distal annular seal 3266 can be made with a groove between leading edge 3231 and contact lip 3267 as shown. The leading edge 3231 may be formed in part by adjacent grooves or recesses formed in the inner surface of the lip 3267. Alternatively, the leading edge 3231 may have a smooth transition to the contact lip 3267.

The orientation of proximal seal 3270, wherein contact lip 3271 and seal cavity 3176b are directed distally, may facilitate the overall sealing function in a variety of ways: for example, grease is retained in the cavities 3176b and 3176a between the distal seal 3266 and the proximal seal 3270, which coats the contact surfaces between the contact lips 3267, 3271 and the drive shaft 3140 to reduce wear, minimize torque transmission reduction or heat formation, and block blood ingress; higher pressure on the distal side of the seal 3270 relative to the proximal side (e.g., due to compressed grease held in the seal cavity 3176b or where blood seeks to cross a more distal blood barrier) may support the contact pressure of the contact lip 3271. The axial length of a portion of the contact lip 3271 of the contact shaft may be in the range of 0.3 to 0.8mm (e.g., about 0.5 mm).

Alternatively, as shown in fig. 30A, the device may have a proximal disc 3275 positioned proximal to the proximal seal 3270. The proximal disc may serve as another barrier to prevent blood from entering the drive shaft bearing 3162 or the motor compartment. Furthermore, the proximal disc may help to account for small tolerances in the eccentricity of the drive shaft. Proximal disc 3275 may be made of a biocompatible elastomeric material (such as PTFE or elastomeric polyurethane or compound) and has a generally disc shape with a central bore having an inner diameter 3276 through which drive shaft 3140 passes and contacts. ID 3276 may be in the range of 80% to 97% (e.g., about 93%) of OD 3141. In one embodiment, the ID is 0.56mm and the OD 3141 is 0.6mm, which may be greater than the ID of the distal disc 3255 or intermediate disc 3260 to have less impact on torque transmission loss. Alternatively, the proximal disc 3275 may have a greater thickness (as shown in fig. 30A) than the distal disc 3255 or intermediate disc 3260, which, together with the elastomeric properties of the discs, may provide axial compression of the sealing member when the proximal disc is compressed between the front sealing container 3240 and the rim on the motor housing 3164. For example, the thickness of the proximal disc, the intermediate disc and the distal disc may be in the range of 0.10mm to 0.15 mm. Due to the size of the stack of sealing members in the axial direction and the space within the housing that compresses the stack, the proximal disc 3275 may be axially compressed. In some embodiments, proximal disc 3275 may be non-flat, e.g., spherical, such as a Belleville washer shape to provide compression.

Fig. 30B and 30C illustrate the device of fig. 30A, but with a relatively thin proximal disc 3275, and the addition of a sealed container cap 3278. In this embodiment, all sealing components are contained within the sealed container, for example as a subassembly. The sealed container may include a front sealed container 3240 and a sealed container cap 3278, both of which may be made of a metal such as stainless steel or titanium, and securely connected, for example, with a friction fit, form fit, threaded, or welded.

The front sealing container 3240 is for receiving sealing components with or without a sealing container cap 3278 and is convenient to manufacture. The front seal container has a flat rigid distal surface 3241 that provides a surface for mechanically pressing the seal member into the motor housing 3164 while protecting the softer, more frangible seal member. The flat rigid surface 3241 also ensures that the axial gap 3174 between the surface 3241 and the impeller is consistent so that blood in the axial gap is expelled and the back surface of the rotating impeller does not inadvertently contact the sealing member. The surface 3241 has a central bore 3242 with an inner diameter that is greater than the outer diameter of the drive shaft 3140. For example, the bore 3242 may have a diameter in the range of 0.080mm to 0.150mm (e.g., about 0.100 mm) that is greater than the outer diameter of the rotating member passing through the bore, which may be used as a physical filter to prevent particles from escaping the container as a risk management measure. For example, when the drive shaft has a diameter of 0.60mm, the aperture 3242 may be in the range of 0.68mm to 0.75mm (e.g., about 0.70 mm). In other words, the radial clearance between the drive shaft and the container 3240 can be in the range of 0.040mm to 0.075mm (e.g., about 0.050 mm). The front seal container has a cylindrical sidewall with an inner surface 3248 for constraining the seal member to ensure that there is no lateral movement that could compromise the integrity or life of the seal. Proximal chamfer 3244 facilitates insertion into the motor housing during manufacture. The distal chamfer 3243 facilitates insertion of the inlet tube 3070 or alternatively the impeller housing 3082 over the front sealed container 3240. Further, the front sealing container 3240 can have a recessed outer surface 3245 for insertion into the motor housing 3164. An embodiment of a heart pump with sealing element 3156 as shown in fig. 30A may have a motor housing no greater than 25.5mm in length. Where additional length is added to the motor housing by the seal subassembly and optional wiring module connected to the proximal end of the motor housing, the length of the motor housing may extend to no more than 33mm.

Methods of making the sealing subassembly may include, but are not limited to: the seal members are inserted into the front seal container in the sequence and orientation described herein, optionally dispensing grease in the seal cavity sequentially or simultaneously, releasing bubbles using a centrifuge or vacuum chamber, and closing the seal container with seal container cap 3278. The seal subassembly may be inserted onto the drive shaft 3140, optionally into the motor housing, and connected to the motor housing (e.g., by laser welding the intersection of the slot 3246, which may include the front seal container 3240, and the slot 3247 of the motor housing). The impeller may be connected to the drive shaft (e.g., with the arrangements described herein with respect to other embodiments and figures). The impeller housing 3082 or inlet tube 3070 with integrated impeller housing may be connected to the motor housing and/or the front seal container 3240. The device may be enclosed in an airtight package wherein air is evacuated to prevent drying of the grease dispensed in the seal.

Any embodiment of the MCS system and its features described herein may include various additional features or modifications, such as those described in the following patents: PCT publication nos. WO 2020/089429, 2021, 4, 29, 17/290083, 2019, 5, 30, electronic module and arrangement FOR ventricular assist devices, and PCT publication nos. WO 2019/229221, 2020, 11, 19, and ELECTRONICS MODULE AND ARRANGEMENT FOR use in cardiac assist devices, device and method FOR determining cardiac output of cardiac assist systems, 2019/234152, 2026, 18, device and 7341, and method FOR use in cardiac assist systems, respectively, by 31, 2019, 10, 31, 29, and by means of "system and method FOR controlling cardiac assist systems (SYSTEM AND METHOD FOR CONTROLLING A CARDIAC ASSISTANCE SYSTEM)", 17/057039, 2019, 6, 30, and by means of "device and method FOR determining cardiac output of cardiac assist systems (DEVICE AND METHOD FOR DETERMINATION OF A CARDIAC OUTPUT FOR A CARDIAC ASSISTANCE SYSTEM)", by means of "electronic module and arrangement FOR ventricular assist devices", by means of 19, 2020, and by means of "method FOR use in cardiac assist devices", by means of "ELECTRONICS MODULE AND ARRANGEMENT FOR use in cardiac assist devices", by means of "system ASSIST DEVICE, AND METHOD FOR PRODUCING AVENTRICULAR ASSIST DEVICE", and by means of "device and method FOR determining cardiac assist systems", by means of "device and method FOR determining cardiac assist systems" (by means of us patent application No. WO 2019/234152, 2028, 35, 20115, 35) PCT publication No. 2020/0030706 entitled "apparatus and METHOD FOR monitoring health status of patient (DEVICE AND METHOD FOR MONITORING THE STATE OF HEALTH OF A PATIENT)", U.S. application No. 17/266056 entitled "apparatus and METHOD FOR monitoring health status of patient (DEVICE AND METHOD FOR MONITORING THE STATE OF HEALTH OF A PATIENT)", PCT publication No. WO 2020/064707 entitled "METHOD and system FOR determining flow rate of fluid through implanted vascular assist system (METHOD AND SYSTEM FOR DETERMINING A FLOW SPEED OF A FLUID FLOWING THROUGH AN IMPLANTED, VASCULAR ASSISTANCE SYSTEM)", published by 2021, 3, 8, entitled "METHOD and system FOR determining flow rate of fluid through implanted vascular assist system (METHOD AND SYSTEM FOR DETERMINING A FLOW SPEED OF A FLUID FLOWING THROUGH AN IMPLANTED, VASCULAR ASSISTANCE SYSTEM)", published by PCT publication No. WO 2019/2348 entitled "implantable ventricular assist system and METHOD FOR operating same (IMPLANTABLE VENTRICULAR ASSIST SYSTEM AND METHOD FOR OPERATING SAME)", published by PCT publication No. WO 2019/2348 entitled "implantable ventricular assist system and METHOD FOR operating same" (published by 2019, published by 2021, 3, 8, entitled "METHOD FOR determining flow rate of fluid through implanted vascular assist system" (published by METHOD AND SYSTEM, published by us patent application No. 17/274354), published by 2019, 9, 30, entitled "implantable ventricular assist system and METHOD FOR operating same" (published by us patent application No. 4342, 2019, etc.), PCT publication No. WO 2019/234149, titled "SENSOR head device FOR minimally invasive VENTRICULAR assist device and METHOD FOR producing such SENSOR head device (SENSOR HEAD DEVICE FOR A MINIMAL INVASIVE VENTRICULAR ASSIST DEVICE AND METHOD FOR PRODUCING SUCH A SENSOR HEAD DEVICE)", U.S. patent application Ser. No. 15/734036, titled "SENSOR head device FOR minimally invasive VENTRICULAR assist device and METHOD FOR producing such SENSOR head device (SENSOR HEAD DEVICE FOR A MINIMAL INVASIVE VENTRICULAR ASSIST DEVICE AND METHOD FOR PRODUCING SUCH A SENSOR HEAD DEVICE)", PCT publication No. WO 2019/234166 entitled "METHOD FOR determining the flow rate of a fluid through an implanted vascular assistance system and an implantable vascular assistance system (METHOD FOR DETERMINING A FLOW SPEED OF A FLUID FLOWING THROUGH AN IMPLANTED, VASCULAR ASSISTANCE SYSTEM AND IMPLANTABLE, VASCULAR ASSISTANCE SYSTEM)", filed 6/2019, PCT publication No. WO 2019/234167, filed on 12/2020, entitled "System and METHOD FOR determining flow Rate of fluid flowing through a Heart assist device (SYSTEMS AND METHODS FOR DETERMINING AFLOW SPEED OF A FLUID FLOW THROUGH A CARDIAC ASSIST DEVICE)", filed on 6/2019, entitled "DETERMINATION device and METHOD FOR determining viscosity of fluid (DETERMINATION APPLIANCE AND METHOD FOR DETERMINING A VISCOSITY OF A FLUID)", filed on 12/2020, U.S. patent application Ser. No. 15/734519, entitled "apparatus AND METHOD FOR determining viscosity of fluid" (DETERMINATION APPLIANCE AND METHOD FOR DETERMINING A VISCOSITY OF A FLUID), PCT publication No. WO 2019/234169, entitled "apparatus AND METHOD FOR analyzing viscosity of fluid (ANALYSIS APPARATUS AND METHOD FOR ANALYZING A VISCOSITY OF A FLUID) filed on 6 th 2019, U.S. patent application Ser. No. 15/734489, entitled" apparatus AND METHOD FOR analyzing viscosity of fluid (ANALYSIS APPARATUS AND METHOD FOR ANALYZING A VISCOSITY OF A FLUID) ", entitled" METHOD AND apparatus FOR detecting AND OPERATING wear status of VENTRICULAR assist device ", filed on 21 th 2019, entitled" METHOD AND DEVICE FOR DETECTING A WEAR CONDITION OF A VENTRICULAR ASSIST DEVICE AND FOR OPERATING SAME, AND PCT publication No. 2019/243582, AND/or "METHOD AND apparatus FOR detecting AND OPERATING wear status of VENTRICULAR assist device", filed on 27 th 2021, AND the entire disclosure of which is incorporated herein by reference in their entirety by reference to the patent application Ser. No. 15/734489, entitled "METHOD AND apparatus FOR detecting wear status of VENTRICULAR assist device", AND apparatus (METHOD 6736 FOR OPERATING SAME, AND "applied on the whole by reference to the patent application Ser. No. 20,9743).

Various modifications to the embodiments described in this disclosure will be readily apparent to those skilled in the art, and the generic principles defined herein may be applied to other embodiments without departing from the spirit or scope of the disclosure. Thus, the present disclosure is not intended to be limited to the embodiments shown herein but is to be accorded the widest scope consistent with the claims, the principles and novel features disclosed herein. The word "example" is used herein to mean "serving as an example, instance, or illustration. Any embodiment described herein as "exemplary" is not necessarily to be construed as preferred or advantageous over other embodiments, unless otherwise specified. Depending on the context and as one of ordinary skill in the art can appreciate, the word "about" may refer to a value within ±1%, ±2%, ±3%, ±4%, ±5%, ±10%, ±15% or other ranges.

Certain features that are described in this specification in the context of separate embodiments can also be implemented in combination in a single embodiment. Conversely, various features that are described in the context of a single embodiment can also be implemented in multiple embodiments separately or in any suitable subcombination. Furthermore, although features may be described above as acting in certain combinations and even initially claimed as such, one or more features from a claimed combination can in some cases be excised from the combination, and the claimed combination may be directed to a subcombination or variation of a subcombination.

Similarly, although operations are depicted in the drawings in a particular order, this should not be understood as requiring that such operations be performed in the particular order shown or in sequential order, or that all illustrated operations be performed, to achieve desirable results. In addition, other embodiments are within the scope of the following claims. In some cases, the actions recited in the claims can be performed in a different order and still achieve desirable results.

It will be understood by those within the art that, in general, terms used herein are generally intended to be "open" terms (e.g., the term "comprising" should be interpreted as "including but not limited to," the term "having" should be interpreted as "having at least," the term "comprising" should be interpreted as "including but not limited to," etc.). Those skilled in the art will also understand that if a specific number of an introduced claim recitation is intended, such an intent will be explicitly recited in the claim, and in the absence of such recitation no such intent is present. For example, as an aid to understanding, the following appended claims may contain usage of the introductory phrases "at least one" and "one or more" to introduce claim recitations. However, the use of such phrases should not be construed to imply that the introduction of a claim recitation by the indefinite articles "a" or "an" limits any particular claim containing such introduced claim recitation to embodiments containing only one such recitation, even when the same claim includes the introductory phrases "one or more" or "at least one" and indefinite articles such as "a" or "an" (e.g., "a" and/or "an" should typically be interpreted to mean "at least one" or "one or more"); the same holds true for the use of definite articles used to introduce claim recitations.

In addition, even if a specific number of an introduced claim recitation is explicitly recited, those skilled in the art will recognize that such recitation should typically be interpreted to mean at least the recited number (e.g., the bare recitation of "two recitations," without other modifiers, typically means at least two recitations, or two or more recitations). Furthermore, where a convention analogous to "at least one of A, B and C, etc." is used, such a construction in general is intended in the sense one having skill in the art would understand the convention (e.g., "a system having at least one of A, B and C" would include but not be limited to a system having only a, only B, only C, A and B together, a and C together, B and C together, and/or A, B and C together, etc.). Where a convention analogous to "at least one of A, B or C, etc." is used, such a construction in general is intended in the sense one having skill in the art would understand the convention (e.g., "a system having at least one of A, B or C" would include but not be limited to a system having only a, only B, only C, A and B together, a and C together, B and C together, and/or A, B and C together, etc.). Those skilled in the art will also appreciate that, in the description, claims, or drawings, virtually any disjunctive word and/or phrase presenting two or more alternative terms should be understood to contemplate the possibilities of including one of the terms, either of the terms, or both terms. For example, the phrase "a or B" should be understood to include the possibility of "a" or "B" or "a and B".

If an exemplary embodiment includes an "and/or" connection between a first feature and a second feature, this is interpreted in such a way that such embodiment has both the first feature and the second feature in accordance with one embodiment, and only the first feature or only the second feature in accordance with another embodiment.

Claims (64)

1. A mechanical circulation support system, comprising:

a circulatory support catheter comprising a circulatory support device carried by an elongate flexible catheter shaft, the circulatory support device comprising a tubular housing, a motor and an impeller configured to be rotated by the motor;

an insertion tool having a tubular body and configured to axially movably receive the circulatory support device; and

an introducer sheath having a tubular body and configured to axially movably receive the insertion tool.

2. The system of claim 1, wherein the impeller is configured to be rotated by the motor via a shaft.

3. The system of any one of the preceding claims, wherein the circulation support device comprises an annular polymer seal around the shaft.

4. The system of any of the preceding claims, wherein the circulatory support device comprises a seal surrounding the shaft, the seal comprising a distal radial shaft seal having a distal and a radially inner lip configured to face distally towards the impeller, the radially inner lip configured to contact the shaft and extend from the distal side in a proximal direction towards the motor.

5. The system of any of the preceding claims, further comprising a proximal radial shaft seal having a proximal side configured to face proximally toward the motor and a radially inner lip configured to contact the shaft and extend from the proximal side in a distal direction toward the impeller.

6. The system of any of the preceding claims, wherein the impeller is configured to be rotated by the motor via a magnetic coupling.

7. The system of any of the preceding claims, wherein the introducer sheath comprises a hub on a proximal end of the introducer sheath, the hub having features for preventing axial and optionally rotational movement of the insertion tool.

8. The system of any one of the preceding claims, the hub comprising one or more hemostasis valves.

9. The system of any of the preceding claims, wherein the tubular body of the insertion tool has sufficient resistance to collapse to remain unobstructed when passing through the one or more hemostatic valves of the introducer sheath.

10. The system of any of the preceding claims, wherein the hub and a release bend disposed between the hub and a tubular body of the introducer sheath are configured to axially movably receive the tubular body of the insertion tool.

11. The system of any one of the preceding claims, wherein the insertion tool comprises a tube having a valve, the tube being in fluid communication with an inner lumen of the tubular body of the insertion tool configured for flushing with saline.

12. The system of any of the preceding claims, the catheter shaft comprising a visual marker proximally spaced from the circulatory support device such that visibility of the visual marker on the proximal side of the introducer sheath indicates that the circulatory support device is located within the tubular body of the insertion tool.

13. The system of any of the preceding claims, further comprising a first guidewire port on a distal end of the tubular housing of the circulatory support device, a second guidewire port on a sidewall of the tubular housing of the circulatory support device and distal to the impeller, and a third guidewire port on a proximal side of the impeller.

14. The system of any one of the preceding claims, wherein a distal end of the tubular body of the insertion tool is detachably connected to a guidewire assist device configured to facilitate guidewire access through the first guidewire port.

15. The system of any of the preceding claims, wherein a removable guidewire guide tube enters the first guidewire port on the distal end of the tubular housing, exits the tubular housing via the second guidewire port on the sidewall of the tubular housing distal of the impeller, reenters the tubular housing via the third guidewire port on the proximal side of the impeller, and extends proximally into the catheter shaft.

16. The system of any of the preceding claims, wherein the tubular body of the insertion tool is configured to receive the circulatory support device and the removable guidewire guide tube.

17. The system of any of the preceding claims, wherein the tubular body of the insertion tool and the guidewire guide tube are transparent.

18. The system of any of the preceding claims, wherein the tubular body of the insertion tool has a length in the range of about 85mm to about 160mm and an inner diameter in the range of about 4.5mm to about 6.5 mm.

19. The system of any one of the preceding claims, the tubular housing of the circulatory support device comprising an inlet tube coupled with a motor housing, the inlet tube having one or more distal pump inlets and one or more proximal pump outlets, and the impeller being adjacent to the one or more proximal pump outlets.

20. The system of any of the preceding claims, wherein the system does not require purging.

21. The system of any of the preceding claims, wherein the introducer sheath is a 16 french (Fr) sheath.

22. The system of any one of the preceding claims, wherein the circulatory support is configured to provide a blood flow rate of about 4.0 liters per minute (l/min) for about 6 hours.

23. The system of any one of the preceding claims, wherein the insertion tool comprises a hemostatic valve.

24. The system of any one of the preceding claims, wherein the insertion tool comprises a plug disposed at a proximal end of the insertion tool, the plug configured to be connected to a sterile shield sleeve.

25. The system of any of the preceding claims, wherein the insertion tool comprises a locking mechanism comprising a recess configured to receive a locking pad configured to releasably lock with the circulatory support catheter.

26. The system of any of the preceding claims, wherein the insertion tool comprises a housing surrounding at least a portion of the locking mechanism, the housing comprising opposing first inner surface walls spaced farther apart than opposing second inner surface walls, wherein the at least a portion of the locking mechanism comprises a radially outwardly extending tab, and wherein the housing is configured to rotate to compress the tab inwardly to prevent axial movement of the circulation supporting catheter.

27. The system of any one of the preceding claims, wherein inward compression of the tabs of the locking mechanism compresses the locking pad against the circulatory support catheter.

28. A mechanical circulation support system, comprising:

an elongate flexible catheter shaft having a proximal end and a distal end;

a circulatory support carried by the distal end of the catheter shaft, the circulatory support comprising a tubular housing, a motor, and an impeller configured to be rotated by the motor;

wherein the circulatory support device is configured to provide a blood flow rate of up to about 4.0 liters per minute (l/min) for about 6 hours without purging the system.

29. The system of claim 28, wherein the impeller is configured to be rotated by the motor via a shaft.

30. The system of any one of claims 28-29, wherein the circulatory support comprises an annular polymeric seal around the shaft.

31. The system of any of claims 28-30, wherein the circulatory support device comprises a seal surrounding the shaft, the seal comprising a distal radial shaft seal having a distal and a radially inner lip configured to face distally toward the impeller, the radially inner lip configured to contact the shaft and extend from the distal side in a proximal direction toward the motor.

32. The system of any of claims 28-31, further comprising a proximal radial shaft seal having a proximal side configured to face proximally toward the motor and a radially inner lip configured to contact the shaft and extend from the proximal side in a distal direction toward the impeller.

33. The system of any of claims 28-32, wherein the impeller is configured to be rotated by the motor via a magnetic coupling.

34. The system of any one of claims 28-33, further comprising an insertion tool having a tubular body and configured to axially movably receive the circulatory support device.

35. The system of any of claims 28-34, further comprising an introducer sheath having a tubular body and configured to axially movably receive the insertion tool.

36. The system of any of claims 28-35, further comprising a controller that does not include a purge component.

37. The system of any one of claims 28-36, wherein the controller does not include a cartridge or port for purging.

38. The system of any of claims 28-37, the impeller comprising a blade having a proximal blade section with a wave-shaped blade curvature defined by one or more curved portions of a skeleton line of the blade.

39. The system of any one of claims 28-38, the tubular housing of the circulation support device comprising an inlet tube having a body, wherein the body comprises:

a first attachment section at a first end of the body, the first attachment section configured to attach the inlet tube to a head unit of the circulatory support device; and

a second attachment section at a second end of the body, wherein the first attachment section is configured to connect to the head unit in a form-locking and/or force-locking manner, wherein the body further comprises a structural section comprising at least one stiffening recess between the first attachment section and the second attachment section.

40. The system of any of claims 28-39, the impeller comprising a blade having at least one blade section with a contoured blade curvature.

41. The system of any of claims 28-40, wherein the tubular housing of the circulatory support device comprises an inlet tube having an inlet and an outlet, and wherein the outlet and the blade section having the undulating blade curvature at least partially axially overlap.

42. The system of any one of claims 28-41, the impeller comprising:

a vane element having a profiled surface with curves, wherein the curvature of each of the curves increases along the rotation axis in a direction from a pump entry section towards an outlet opening to an inflection point where a vane angle (β) of the vane element is at a maximum when deployed into a plane, and wherein the curvature of each of the curves decreases after the inflection point, and

wherein in a region of the impeller radially positioned relative to the rotational axis of the impeller and having a blade height SH of the blade element defined relative to a maximum blade height SHMAX such that 25% SH/SHMAX is 100%, the inflection point of each of the arcs is located in a region of an upstream edge of an outlet opening of an inlet pipe of the tubular housing.

43. The system of claim 28, further comprising:

a tubular housing including an outlet opening configured to facilitate blood outflow; and

a diffuser configured to be coupled with the tubular housing, wherein, in an operational position, the diffuser is configured to direct blood transverse to the outlet opening after the blood has passed through the outlet opening.

44. The system of any one of claims 28-43, the tubular housing comprising an inlet tube having a mesh section with a mesh structure formed from at least one mesh wire.

45. The system of any of claims 28-44, wherein the mesh section is bent at an obtuse angle at a bending point.

46. The system of any one of claims 28-45, the tubular housing comprising an inlet tube for delivering blood therethrough; and a reduced diameter section at a distal end of the inlet tube.

47. The system of any one of claims 28-46, the tubular housing comprising:

a feed head portion comprising at least one intake opening for receiving a fluid flow into a feed line; and

A profile portion disposed adjacent to the feed head portion and comprising an inner surface profile, wherein the inner surface profile comprises a first inner diameter at a first location, a second inner diameter at a second location, and a third inner diameter at a third location, wherein the first inner diameter is greater than the second inner diameter, wherein the third inner diameter is greater than the second inner diameter, wherein the first inner diameter comprises a maximum inner diameter of the profile portion and the second inner diameter comprises a minimum inner diameter of the profile portion, wherein the inner surface profile comprises a rounded portion at the second location, wherein the profile portion comprises a first inner radius at the first location and a second inner radius at the second location, wherein the second inner radius is at most one-fifth less than the first inner radius, and wherein the second location is located between the third location and the first location.

48. The system of any one of claims 28-47, the tubular housing comprising a radiopaque marker at a distal end of the tubular housing.

49. The system of any one of claims 28-48, the tubular housing comprising an inlet tube having a nose piece at a distal end of the inlet tube, the nose piece comprising a radiopaque marker.

50. The system of any one of claims 28-49, wherein the insertion tool comprises a hemostatic valve.

51. The system of any of claims 28-50, wherein the insertion tool comprises a locking mechanism comprising a recess configured to receive a locking pad configured to releasably lock with the catheter shaft.

52. The system of any of claims 28-51, wherein the insertion tool comprises a housing surrounding at least a portion of the locking mechanism, the housing comprising opposing first inner surface walls spaced farther apart than opposing second inner surface walls, wherein the at least a portion of the locking mechanism comprises a radially outwardly extending tab, and wherein the housing is configured to rotate to compress the tab inwardly to prevent axial movement of the catheter shaft.

53. The system of any of claims 28-52, wherein inward compression of the tab of the locking mechanism compresses the locking pad against the catheter shaft.

54. The system of any of claims 28-53, wherein the introducer sheath comprises a hub on a proximal end of the introducer sheath, the hub having features for preventing axial and optionally rotational movement of the insertion tool.

55. The system of any one of claims 28-54, the hub comprising one or more hemostatic valves.

56. The system of any of claims 28-55, wherein the tubular body of the insertion tool has sufficient resistance to collapse to remain unobstructed when passing through the one or more hemostatic valves of the introducer sheath.

57. The system of any of claims 28-56, wherein the hub and a release bend disposed between the hub and the tubular body of the introducer sheath are configured to axially movably receive the tubular body of the insertion tool.

58. The system of any one of claims 28-57, wherein the insertion tool comprises a tube having a valve, the tube in fluid communication with an inner lumen of the tubular body of the insertion tool configured for flushing with saline.

59. The system of any of claims 28-58, further comprising a first guidewire port on a distal end of the tubular housing of the circulatory support device, a second guidewire port on a sidewall of the tubular housing of the circulatory support device and distal to the impeller, and a third guidewire port on a proximal side of the impeller.

60. The system of any one of claims 28-59, wherein a distal end of the tubular body of the insertion tool is detachably connected to a guidewire assist device configured to facilitate guidewire access through the first guidewire port.

61. The system of any one of claims 28-60, wherein a removable guidewire guide tube enters the first guidewire port on the distal end of the tubular housing, exits the tubular housing via the second guidewire port on the sidewall of the tubular housing distal to the impeller, reenters the tubular housing via the third guidewire port on the proximal side of the impeller, and extends proximally into the catheter shaft.

62. The system of any one of claims 28-61, wherein the tubular body of the insertion tool is configured to receive the circulatory support device and the removable guidewire guide tube.

63. The system of any of claims 28-62, wherein the tubular body of the insertion tool and the guidewire guide tube are transparent.

64. The system of any one of claims 28-63, wherein the insertion tool comprises a plug disposed at a proximal end of the insertion tool, the plug configured to be connected to a sterile shield sleeve.