Cardiac pump tip and delivery system coupling for mechanical circulatory support systems

Abstract

A minimally invasive, small percutaneous mechanical circulatory support system delivers a pump transcatheterally to the heart, which actively reduces the burden on the left ventricular system by pumping blood from the left ventricle to the ascending aorta and then to the systemic circulation. The pump may include a tubular housing, a motor, an impeller configured to be rotated by the motor, and a distal tip of the pump. The tip may include a guidewire lumen having a curved and / or extended contour. The system may include an insertion tool having a tubular body and configured to receive the circulatory support device axially movable, and an introducer sheath configured to receive the insertion tool axially movable. A coupling allows for connection and disconnection between the insertion tool and the introducer sheath. The coupling may include a hexagonal portion for self-positioning and further for tactile feedback.

Description

Technical Field

[0001] (Reference to Priority Application) This application claims priority to U.S. Patent Application No. 18 / 324,106, filed May 25, 2023, entitled HEART PUMP TIPS AND DELIVERY SYSTEM COUPLINGS FOR MECHANICAL CIRCULATORY SUPPORT SYSTEMS.

[0002] This development generally relates to mechanical circulatory support systems, and more particularly to heart pumps and delivery systems for coupling components of mechanical circulatory support systems.

Background Art

[0003] (Description of Related Art) Mechanical circulatory support systems can be used to assist in pumping blood during various medical procedures and / or as a therapy for certain heart conditions. For example, cardiogenic shock (CS) is a common cause of death and, despite advances in treatment options, management remains challenging. CS is caused by severe impairment of myocardial function, resulting in reduced cardiac output, decreased perfusion of end organs, and hypoxia. Clinically, this presents as refractory hypotension to volume resuscitation with features of decreased perfusion of end organs that require immediate pharmacological or mechanical intervention. Acute myocardial infarction (MI) accounts for over about 80% of CS patients.

[0004] As a further example, percutaneous coronary intervention (PCI) is a non-surgical procedure for revascularizing stenosed coronary arteries. PCI includes various techniques such as, for example, balloon angioplasty, stent implantation, rotational ablation, and lithotripsy. PCI is considered high risk when the patient has associated co-morbidities (such as frailty or advanced age), when the PCI itself is very complex (such as bifurcations or total occlusions), or when hemodynamic status is difficult (such as ventricular dysfunction).

[0005] For percutaneous insertion into the patient's body, small catheter-based intracardiac blood pumps have been developed as acute therapy for CS and for temporary support during PCI. However, existing solutions for pumps have various performance deficiencies, such as insufficient blood flow, the need for continuous motor purging within the pump, undesirably high hemolysis, and inadequate sensing of hemodynamic parameters. Therefore, there remains a need for mechanical circulatory support systems with features that overcome these and other shortcomings. [Overview of the Initiative]

[0006] Each embodiment disclosed herein has multiple aspects, and not just one of them is responsible for the desirable features of this disclosure. Without limiting the scope of this disclosure, some of its more prominent features are summarized below. After reviewing this description, and especially after reading the section titled “Modes for Carrying Out the Invention,” the features of the embodiments described herein will be understood in how they offer advantages over existing systems, devices, and methods for circulating support systems.

[0007] The following disclosure describes some non-limiting examples of embodiments. For example, other embodiments of the disclosed systems and methods may or may not include the features described herein. Furthermore, the disclosed advantages and benefits may apply only to specific embodiments and should not be used to limit this disclosure.

[0008] A minimally invasive, small percutaneous mechanical circulatory support system delivers a pump transcatheterally to the heart, which actively reduces the burden on the left ventricular system by pumping blood from the left ventricle to the ascending aorta and then to the systemic circulation. The pump may include a tubular housing, a motor, an impeller configured to be rotated by the motor, and a distal tip of the pump. The tip may include a guidewire lumen having a curved and / or extended contour. The system may include an insertion tool having a tubular body and configured to receive the circulatory support device axially movable, and an introducer sheath configured to receive the insertion tool axially movable. A coupling allows for connection and disconnection between the insertion tool and the introducer sheath. The coupling may include a hexagonal portion for self-positioning and further for tactile feedback.

[0009] In one embodiment, the technology described herein relates to a mechanical circulatory support system, the mechanical circulatory support system comprising a circulatory support catheter, the circulatory support device being supported by an elongated flexible catheter shaft, the circulatory support device comprising a tubular housing, a motor, and an impeller configured to be rotated by the motor, the circulatory support catheter, the circulatory support catheter comprising a tubular insertion tool configured to receive the circulatory support device in an axially movable manner, the introducer sheath having a tubular body, the introducer sheath configured to receive the insertion tool in an axially movable manner, and a hexagonal coupling configured to connect the insertion tool and the introducer sheath.

[0010] In some embodiments, the technology described herein relates to a mechanical circulation assist system, wherein the hexagonal coupling includes a male mating portion configured to connect to an insertion tool and a female mating portion configured to connect to an introducer sheath.

[0011] In some embodiments, the technology described herein relates to a mechanical circulation assist system, wherein the male fitting portion includes a hexagonal distal portion.

[0012] In some embodiments, the technology described herein relates to a mechanical circulation assist system, wherein the hexagonal distal portion includes a truncated hexagonal pyramid.

[0013] In some embodiments, the technology described herein relates to a mechanical circulation assist system, wherein the hexagonal distal portion includes a recess extending circumferentially around the hexagonal distal portion, approximately midway along the longitudinal axis of the hexagonal distal portion.

[0014] In some embodiments, the technology described herein relates to a mechanical circulation assist system, wherein the hexagonal distal portion of the male mating part is configured to fit into the corresponding hexagonal receiving portion of the female mating part.

[0015] In some embodiments, the technology described herein relates to a mechanical circulation assist system, wherein the female mating portion includes a hexagonal receiving portion configured to self-align the male mating portion with respect to the female mating portion in response to a force applied along the axial direction.

[0016] In some embodiments, the techniques described herein relate to a mechanical circulation assistance system, wherein the hexagonal coupling is configured to provide tactile feedback when the insertion tool is coupled to the introducer sheath.

[0017] In another embodiment, the technology described herein relates to a mechanical circulatory support system, the mechanical circulatory support system comprising a circulatory support catheter, the circulatory support device being supported by an elongated flexible catheter shaft, the circulatory support catheter comprising a tubular housing, a motor, and an impeller configured to be rotated by the motor, the insertion tool having a tubular body and configured to receive the circulatory support device in an axially movable manner, and a coupling configured to connect the insertion tool and an introducer, the coupling configured to allow the introducer to be removed from and replaced by the insertion tool.

[0018] In some embodiments, the technology described herein relates to a mechanical circulation assist system, and the coupling includes a screw coupling.

[0019] In some embodiments, the technology described herein relates to a mechanical circulation assist system, and the coupling includes a bayonet coupling.

[0020] In some embodiments, the technology described herein relates to a mechanical circulation assist system, and the coupling includes a push-pull coupling.

[0021] In some embodiments, the technology described herein relates to a mechanical circulation assistance system, and the introducer includes a fixed-size introducer.

[0022] In some embodiments, the technology described herein relates to a mechanical circulation assistance system, and the introducer includes an expandable introducer.

[0023] In some embodiments, the technology described herein relates to a mechanical circulation assist system, and the coupling includes a hexagonal coupling.

[0024] In another aspect, the technology described herein relates to a mechanical circulatory assist system, the mechanical circulatory assist system including an elongated flexible catheter shaft having a proximal end and a distal end, and a circulatory assist device carried by the distal end of the catheter shaft, the circulatory assist device including a tubular housing including an inlet tube, a distal tip attached to the distal end of the inlet tube, a motor, and an impeller configured to be rotated by the motor, the distal tip having an outer diameter larger than the outer diameter of the inlet tube.

[0025] In some embodiments, the technology described herein relates to a mechanical circulatory assist system, the outer diameter of the distal tip being located at the proximal end of the distal tip, and the outer diameter of the inlet tube being located at the distal end of the inlet tube.

[0026] In another aspect, the technology described herein relates to a mechanical circulatory assist system, the mechanical circulatory assist system including an elongated flexible catheter shaft having a proximal end and a distal end, and a circulatory assist device carried by the distal end of the catheter shaft, the circulatory assist device including a tubular housing, a motor, and an impeller configured to be rotated by the motor, the tubular housing of the circulatory assist device including 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, the distal end of the inlet tube including a tip, the tip including a lumen extending through a tip having a flared distal opening.

[0027] In some embodiments, the technology described herein relates to a mechanical circulatory assist system, the length and inner diameter of the lumen defining a curvature similar to the radius of curvature of a guidewire configured to be received into the lumen.

[0028] In some embodiments, the technology described herein relates to a mechanical circulatory assist system, the lumen including a flared proximal opening.

[0029] In some embodiments, the technology described herein relates to a mechanical circulatory assist system, and the lumen extends through a proximal extension that projects proximally from the tip.

[0030] Various aspects and embodiments of mechanical circulatory support systems, devices, and methods are described herein. A mechanical circulatory support system, device, and method may have any one or more of the following features, namely, a mechanical circulatory support system comprising a circulatory support device, which is a circulatory support catheter supported by an elongated flexible catheter shaft, the circulatory support device comprising a tubular housing, a motor, an impeller configured to be rotated by the motor, and an annular polymer seal located around the shaft; an insertion tool having a tubular body, configured to receive the circulatory support device in an axially movable manner; and an introducer sheath having a tubular body, configured to receive the insertion tool in an axially movable manner; the introducer sheath comprising a hub on the proximal end of the introducer sheath, the hub having a lock for preventing axial movement of the insertion tool; the hub comprising one or more hemostatic valves; and sufficient crush resistance to maintain patency when the tubular body of the insertion tool passes through the hemostatic valves of the introducer sheath. The system includes: a catheter shaft with a visual marker positioned proximal to the circulatory support device such that the 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; a first guidewire port on the distal end of the tubular housing of the circulatory support device; a second guidewire port located on the side wall of the tubular housing of the circulatory support device and distal to the impeller; and a third guidewire port on the proximal side of the impeller; the tubular body of the insertion tool having a length in the range of approximately 85 mm to approximately 160 mm and an inner diameter in the range of approximately 4.5 mm to approximately 6.5 mm; the tubular housing of the circulatory support device being an inlet tube coupled to the motor housing and including an inlet tube having one or more distal pump inlets and one or more proximal pump outlets; and an impeller adjacent to one or more proximal pump outlets; the system not requiring purging; and the introducer sheath being a 16 French size (Fr) sheath.The circulatory support device is configured to provide a blood flow rate of approximately 4.0 liters / minute (l / min) for approximately 6 hours; the insertion tool includes a hemostatic valve; the insertion tool includes a locking mechanism, the locking mechanism includes a recess configured to receive a locking pad configured to lock detachably against the circulatory support catheter; the insertion tool includes a housing surrounding at least a portion of the locking mechanism, the housing includes an opposing first inner wall spaced further apart than an opposing second inner wall, the locking mechanism includes a tab extending radially outward, the housing is configured to prevent axial movement of the circulatory support catheter by rotating to compress the tab inward, and the inward compression of the tab of the locking mechanism compresses the locking pad against the circulatory support catheter; the impeller is configured to be rotated by a motor via a shaft; the circulatory support device includes an annular polymer seal around the shaft; the circulatory support device includes a seal around the shaft, the seal includes a distal radial shaft seal, and this distal radial shaft seal is directed toward the impeller Having a distal side surface configured to face distally, and a radial inner lip configured to contact the shaft and extend proximal from the distal side surface toward the motor; further including a proximal radial shaft seal, the proximal radial shaft seal having a proximal side surface configured to face proximal to the motor, and a radial inner lip configured to contact the shaft and extend distal from the proximal side surface toward the impeller; the impeller is configured to be rotated by the motor via a magnetic coupling; the introducer sheath includes a hub on the proximal end of the introducer sheath, the hub having features for preventing axial movement and optionally rotational movement of the insertion tool; the hub and a relief bend positioned between the hub and the tubular body of the introducer sheath are configured to receive the tubular body of the insertion tool in an axially movable manner; the insertion tool includes a tube having a valve that is in fluid communication with the inner lumen of the tubular body of the insertion tool and is configured for flushing with saline solution;The distal end of the tubular body of the insertion tool is detachably connected to a guidewire aid configured to facilitate the entry of a guidewire through a first guidewire port; a detachable guidewire guide tube is introduced into a first guidewire port on the distal end of the tubular housing, exits the tubular housing through a second guidewire port on the side wall of the tubular housing which is located distal to the impeller, is reintroduced into the tubular housing through a third guidewire port on the proximal side of the impeller, and further extends proximal into the catheter shaft; the tubular body of the insertion tool is configured to receive a circulatory support device by a detachable guidewire guide tube; the tubular body of the insertion tool and the guidewire guide tube are transparent; the insertion tool includes a plug configured to connect to a sterile shield sleeve and located at the proximal end of the insertion tool; the mechanical circulatory support system is an elongated flexible catheter having a proximal end and a distal end A circulatory support device comprising a catheter shaft and a circulatory support device supported by the distal end of the catheter shaft, 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 approximately 4.0 liters / minute (l / min) for approximately 6 hours without purging the system; further comprising an insertion tool having a tubular body and configured to receive the circulatory support device in an axially movable manner; further comprising an introducer sheath having a tubular body and configured to receive the insertion tool in an axially movable manner; further comprising a controller that does not include any purging components; the controller does not include a cassette or port for purging; the impeller comprises a blade having a proximal blade section having a corrugated blade curvature defined by one or more curved portions of the skeleton lines of the blade;The tubular housing of the circulation assist device includes an inlet pipe having a main body, the main body including a first mounting section at the first end of the main body configured to attach the inlet pipe to the head unit of the circulation assist device, and a second mounting section at the second end of the main body, the first mounting section configured to connect to the head unit in a form-locking and / or force-locking manner, the main body further includes a structural section including at least one reinforcing recess between the first mounting section and the second mounting section, the impeller includes a blade having at least one blade section having a corrugated blade curvature; the tubular housing of the circulation assist device includes an inlet pipe having an inlet and an outlet, the outlet and the blade section having a corrugated blade curvature overlap at least partially in the axial direction; the impeller includes blade elements having a contour with camber lines, the blade angle (β) of the blade elements along the axis of rotation in the direction in which the curvature of each camber line when unwound in a plane begins toward the outlet opening The curvature of each camber line increases towards a large inflection point, and the curvature of each camber line decreases after the inflection point, and in the region of the impeller having a blade height SH of blade elements defined such that 25% ≤ SH / SHMAX ≤ 100% of the maximum blade height SHMAX, the inflection point of each camber line is located within the region of the upstream edge of the outlet opening of the inlet tube of the tubular housing; the system further includes a tubular housing comprising an outlet opening configured to facilitate the outflow of blood, and a diffuser configured to be coupled to the tubular housing, wherein in the operating position, the diffuser is configured to guide the blood laterally relative to the outlet opening after the blood has passed through the outlet opening; the tubular housing comprises an inlet tube having a mesh section having a mesh structure formed from at least one mesh wire; the mesh section is bent at an obtuse angle at a bending point; the tubular housing comprises an inlet tube for transporting blood through the inlet tube, and a reduced diameter section located at the distal end of the inlet tube;The tubular housing includes a supply head portion having at least one inlet opening for receiving fluid flow into the supply line, and a contour portion positioned adjacent to the supply head portion and including an internal contour, wherein the internal contour includes a first inner diameter at a first position, a second inner diameter at a second position, and a third inner diameter at a third position, the first inner diameter being larger than the second inner diameter, the third inner diameter being larger than the second inner diameter, the first inner diameter including the maximum inner diameter of the contour portion, the second inner diameter including the minimum inner diameter of the contour portion, the internal contour including a rounded portion at the second position, and the contour portion including a first inner half at the first position. The tubular housing includes a diameter and a second inner radius at the second position, the second inner radius being up to one-fifth smaller than the first inner radius, and the second position being located between the third and first positions; the tubular housing includes a radiopaque marker at the distal end of the tubular housing; the tubular housing includes an inlet tube having a nosepiece at the distal end of the inlet tube, the nosepiece including a radiopaque marker; the insertion tool includes a hemostatic valve; the insertion tool includes a locking mechanism, the locking mechanism being detachably locked to the catheter shaft. The system includes a recess configured to receive a configured locking pad; the insertion tool includes a housing enclosing at least a portion of the locking mechanism, the housing including opposing first inner surface walls spaced further apart than opposing second inner surface walls, at least a portion of the locking mechanism including a tab extending radially outward, the housing being configured to prevent axial movement of the catheter shaft by compressing the tab inward upon rotation; the inward compression of the tab of the locking mechanism compresses the locking pad relative to the catheter shaft; the minimally invasive, small percutaneous mechanical circulatory support system is positioned across the aortic valve via a single femoral artery access point; the system may include a low-bulk axially rotating blood pump supported by the distal end of an 8-French size catheter; the system may be percutaneously inserted through the femoral artery and positioned across the vena cava valve into the left ventricle; the device actively reduces the burden on the left ventricular system by pumping blood from the left ventricle into the ascending aorta and further into the systemic circulation;The impeller is configured to be rotated by a motor via a shaft; the circulation assist device includes an annular polymer seal around the shaft; the circulation assist device includes a seal around the shaft, the seal including a distal radial shaft seal, the distal radial shaft seal having a distal side surface configured to face distally toward the impeller, and a radial inner lip configured to contact the shaft and to extend proximal from the distal side surface toward the motor; The present invention further includes a proximal radial shaft seal, the proximal radial shaft seal having a proximal side surface configured to face proximal toward the motor, and a radial inner lip configured to contact the shaft and to extend distally from the proximal side surface toward the impeller; the impeller is configured to be rotated by the motor via a magnetic coupling; the introducer sheath includes a hub on the proximal end of the introducer sheath, the hub having features for preventing axial movement and optionally rotational movement of the insertion tool; the hub and a relief bend positioned between the hub and the tubular body of the introducer sheath are configured to receive the tubular body of the insertion tool in an axially movable manner; the insertion tool includes a tube having a valve in fluid communication with the inner lumen of the tubular body of the insertion tool, which is configured for flushing with saline solution; the tubular body of the insertion tool The distal end of the insertion tool is detachably connected to a guidewire aid configured to facilitate the entry of a guidewire through a first guidewire port; a detachable guidewire guide tube is introduced into a first guidewire port on the distal end of the tubular housing, exits the tubular housing through a second guidewire port on the side wall of the tubular housing which is located distal to the impeller, is reintroduced into the tubular housing through a third guidewire port on the proximal side of the impeller, and further extends proximal into the catheter shaft; the tubular body of the insertion tool is configured to receive a circulatory support device by the detachable guidewire guide tube; the tubular body of the insertion tool and the guidewire guide tube are transparent; the insertion tool includes a plug configured to connect to a sterile shield sleeve and located at the proximal end of the insertion tool;A mechanical circulatory support system for high-risk coronary intervention comprises an elongated flexible catheter shaft having a proximal and distal end, and a circulatory support device supported by the distal end of the catheter shaft, wherein the circulatory support device includes a tubular housing and has a proximal and distal end, an impeller within the housing, and a detachable guidewire guide tube, the guidewire guide tube being introduced into a first guidewire port on the distal end of the housing, leading out of the housing through a second guidewire port on the side wall of the housing which is located distal to the impeller, being reintroduced into the tubular housing through a third guidewire port on the proximal side of the impeller, and further extending proximal into the catheter shaft; the system may include a motor configured to rotate the impeller within the housing; the motor may be positioned distal to the third guidewire port; the tubular housing may have an axial length in the range of 60 mm to 100 mm; and the system may have an impeller connected to the tubular housing. The system may include a blood outlet port through which blood passes, and a blood intake port positioned distally and spaced apart from the blood outlet port on the housing; the housing may include 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 intervention may include a circulatory support catheter, the circulatory support catheter including a circulatory support device supported by an elongated flexible catheter shaft, an insertion tool having a tubular body configured to receive the circulatory support device axially movably, and an access sheath having a tubular body (also referred to herein as an introducer sheath) configured to receive the insertion tool axially movably; the access sheath may include an access sheath hub having an insertion tool lock for engaging with the insertion tool; the access sheath hub may include a catheter shaft lock for locking the access sheath hub against the catheter shaft;A controller configured to drive the motor of the mechanical circulatory support system may be provided, wherein the controller does not include a purge component; the purge component may include a cassette or port; the system does not require purging; a controller configured to drive the motor of the mechanical circulatory support system may be provided, having a housing for mounting electronic components and a handle positioned on top of the housing; the controller may include a visual alarm element wrapped around the handle on top of the housing; the housing does not have to include two or more control elements; 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, wherein the cable management system is positioned on the second end opposite to the first end; the controller may include a rotating fixed mounting part on the rear of the housing; a minimally invasive, small percutaneous mechanical left ventricular support system The system may be provided, and this support system is optimized for the treatment of patients suffering from cardiogenic shock; the system may include a low-bulk (e.g., 18Fr-19Fr) ventricular assist device (VSD) and an axially rotating blood pump and elongated inlet tube supported by the distal end of a 9 French size catheter; the system may be positioned to span the vena cava valve into the left ventricle, and the VSD pumps blood from the left ventricle into the ascending aorta and then into the systemic circulation. This will actively reduce the burden on the left ventricular heart and provide a maximum flow rate of approximately 6 L / min at 60 mmHg; a flow rate of 0.6 L / min to 6 L / min may be provided; intravascular access may be obtained using an 8 Fr to 16 Fr (e.g., 8 Fr to 10.5 Fr) introducer sheath, which is expandable to accommodate an 18 to 19 French size VSD; access may be via percutaneous femoral puncture or axillary access via surgical incision;The introducer sheath may be part of an introducer kit that may further include a guidewire, dilator, insertion tool, and guidewire aid; the motor may be completely sealed by enclosure within the motor housing, and the seal may have a magnetic coupling that allows the motor to drive the impeller without the need to remove the shaft from the housing; the magnetic coupling may include a cylindrical drive magnet array located within the motor housing, concentrically positioned within a cylindrical drive magnet array located outside the motor housing, and mechanically coupled to the impeller; the impeller rotates relative to the motor housing around a pivot bearing; the magnetic coupling is flushed by a constant blood flow through flush holes on the proximal and distal ends of the magnetic coupling; the sealed motor may allow for the elimination of the purging process required for certain competing devices; movement of the device after placement may be hindered by an intravascular anchor that is supported by the catheter shaft and provides anchor retention within the aorta; the anchor may be located within the catheter shaft It may include a plurality of radially outwardly expandable supports supported by a shaft, the supports configured to contact the wall of the aorta and to anchor the shaft so as not to move, while allowing perfusion through the anchor supports; movement may be inhibited by a locking mechanism that engages the catheter shaft in a fixed position with respect to an introducer sheath held in the arterial incision by sutures, thereby still holding the catheter shaft in relation to the intravascular access route; an onboard sensor detects aortic movement To enable real-time measurement of various parameters of interest, such as pulse pressure, left ventricular pressure (including left ventricular end-diastolic pressure (LVEDP)), temperature, blood flow velocity, or other parameters depending on clinically required performance; sensors may be included on the distal end of the device, such as on the distal end of the inlet tube on the distal side of the blood drain port; additional sensors may be provided on the proximal end of an elongated body, such as proximal to the blood drain port; certain sensors may include at least a first MEMS pressure-temperature sensor for direct measurement of absolute left ventricular pressure;Sensors that enable extraction of important physiological parameters such as LVEDP; ultrasonic transducers may be provided for direct measurement of blood flow through the pump, or optionally for direct measurement of blood flow around the pump; the surface of the ultrasonic transducer may be curved for increased focus and high sensitivity; a second MEMS pressure-temperature sensor may be provided on the proximal end of the inlet tube to enable differential pressure measurement, such as direct measurement of absolute aortic pressure; laser Doppler, thermal impedance sensor, or electrical impedance sensor, etc. Flow rate can be assessed by using other forms of sensors; a flexible conductor may extend along the length of the inlet tube to connect the distal and proximal sensors to the integrated system; the flexible conductor may also be in the form of a flexible PCB and may extend axially in a spiral around the inlet tube between the proximal and distal sensors; a multi-conductor cable bundle extends proximal through an elongated flexible tubular body to a connector at the proximal manifold for detachable connection to an external electronic control unit; for cardiac shock The mechanical ventricular assist system may include an elongated flexible catheter shaft having a proximal and distal end, and a ventricular assist device supported by the distal end of the shaft, wherein the ventricular assist device includes a ventricular assist device housing, a motor fixed rotationally to a drive magnet array, an impeller fixed rotationally to the drive magnet array, and a sealed motor housing located inside the ventricular assist device housing and enclosing the motor and the drive magnet array; the system may include a removable guidewire guide tube; the guide tube is introduced into a first guidewire port on the distal end of the housing, exits the housing through a second guidewire port on the side wall of the housing which is located distal to the impeller, is reintroduced into the housing through a third guidewire port on the proximal side of the impeller, and further extends proximal into the catheter shaft; the system may include on the housing at least one inlet port and at least one outlet port separated by a flexible section of the housing;The distance between the inlet port and the outlet port may be at least about 60 mm and no more than 100 mm, preferably 70 mm; the system may include a first pressure sensor adjacent to the inlet port; the system may include a second pressure sensor on the proximal side of the outlet port; the system may include a visual mark on the catheter shaft within a range of about 50 mm to about 150 mm 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 adjacent to the inlet port; the system may include a guidewire aid detachably supported by a ventricular assist device; the guidewire aid may include a tubular body having a distally facing opening and an inner diameter that increases distally toward this opening; A guidewire aid may include a guidewire guide tube attached to a tubular body; the guidewire guide tube may include a dividing line for dividing the guide tube so that the guide tube can be separated from a guidewire extending through the tube; the flexible section of the housing may include a flexible slotted tube covered by an outer polymer sleeve; a mechanical ventricular assist system for high-risk coronary intervention may include a ventricular assist catheter, which may include a ventricular assist device supported by an elongated flexible catheter shaft; a sealed motor and impeller located inside the ventricular assist device and rotatably coupled together by magnetic bearings; an insertion tool having a tubular body and configured to receive the ventricular assist device in an axially movable manner; and an access sheath having a tubular body and configured to receive the insertion tool in an axially movable manner; the access sheath having a first lock for engaging with the insertion tool The access sheath hub may include a hub; the access sheath hub may include a second lock for engaging with the catheter shaft; a controller configured to drive a motor for a mechanical circulatory assistance system, wherein the controller does not include a purge component; the purge component may include a cassette or port; the system does not require purging; a controller may be provided configured to drive a motor for a mechanical circulatory assistance system having a housing for mounting electronic components and a handle positioned on top of the housing; the controller may include a visual alarm element wrapped around the handle on top of the housing; the housing does not have to include two or more control elements; 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, the cable management system being positioned on the second end opposite the first end; the controller may include a rotating fixed mounting section on the rear of the housing;A method for transcatheterally delivering a pump to the heart, the method comprising advancing the pump through a vascular structure, wherein the pump is advanced with a guidewire, the guidewire extending through a first section of the catheter shaft located distal to the pump, through the tubular housing of the pump, outside the pump's impeller and motor, and returning into a second section of the catheter shaft located proximal to the pump; starting the motor and / or rotating the impeller, then removing the guidewire from the pump and / or positioning the pump in the heart; and / or leaving the guidewire in the pump during use, thereby ensuring that the guidewire and / or the pump remain at least partially within the left ventricle. [Brief explanation of the drawing]

[0031] The aforementioned and other features of this disclosure will become more fully apparent from the following description and the accompanying claims, in conjunction with the accompanying drawings. These drawings illustrate only a limited number of embodiments in accordance with this disclosure and should not be considered limiting its scope; the disclosure will be described more specifically and in detail through the use of the accompanying drawings. The following detailed description refers to the accompanying drawings, which form part of this specification. In the drawings, unless otherwise indicated in the context, similar symbols typically identify similar components. The exemplary embodiments described in the detailed description, drawings, and claims are not intended to be limiting. Other embodiments may be used, and other modifications may be made without departing from the spirit or scope of the subject matter presented herein. It will be readily apparent that aspects of this disclosure can be arranged, substituted, combined, and designed in a wide variety of different configurations, as generally described herein and illustrated in the drawings, all of which are expressly intended and form part of this disclosure.

[0032] [Figure 1]Figure 1 is a cross-sectional view of an embodiment of a mechanical circulatory support (MCS) device of the present disclosure, which is supported by a catheter and positioned across the aortic valve via femoral artery access. [Figure 2] Figure 2 schematically illustrates several embodiments of an MCS system inserted into the body via an access route from the femoral artery to the left ventricle. [Figure 3] Figure 3 is a side view of an embodiment of an MCS system that may incorporate various features described herein. [Figure 4] Figure 4 shows the system from Figure 3, with the introducer sheath removed, including the insertion tool and guidewire loading aid. [Figure 5] Figure 5 shows an introducer kit having a sheath and dilator that can be used with the various MCS systems and methods described herein. [Figure 6] Figure 6 shows an embodiment of a placement guide wire that may be used with the various MCS systems and methods described herein. [Figure 7] Figure 7 is a partial perspective view of the distal pump region of the MCS device. [Figure 8A] Figure 8A is a side view of the distal region of the MCS device, showing the guidewire guide tube that defines the guidewire path and guidewire bag loading aid at predetermined positions. [Figure 8B] Figure 8B is a magnified detail view of the distal region of the MCS device, showing the guidewire guide tube that defines the guidewire path and guidewire bag loading aid at predetermined positions. [Figure 9A] Figure 9A is a side view of the pump area of ​​the MCS device. [Figure 9B] Figure 9B is a cross-sectional view of the MCS device through the impeller region. [Figure 10A] Figure 10A is a front view of the MCS controller. [Figure 10B] Figure 10B is a rear perspective view of the MCS controller. [Figure 11]Figure 11 shows a block diagram of an electronic system that can be housed within the controllers shown in Figures 10A and 10B. [Figure 12] Figure 12 shows an exploded view of each component of the electronic system shown in Figure 11 within the controller. [Figure 13] Figure 13 shows a side perspective view of the MCS controller. [Figure 14A] Figure 14A shows a graph illustrating the pressure difference between aortic pressure and left ventricular pressure. [Figure 14B] Figure 14B shows a graph illustrating the applied current for a constant rotational speed of the motor shaft. [Figure 15] Figure 15 shows an exemplary user interface for displaying control parameters. [Figure 16A] Figure 16A shows an exemplary user interface in configuration mode. [Figure 16B] Figure 16B shows an exemplary user interface in an operating mode. [Figure 17A] Figure 17A shows an embodiment of the electronic control element. [Figure 17B] Figure 17B shows an embodiment of the electronic control element. [Figure 18A] Figure 18A is an example left ventricular (LV) pressure curve illustrating the process for determining left ventricular end-diastolic pressure (LVEDP). [Figure 18B] Figure 18B is an example left ventricular (LV) pressure curve illustrating the process for determining left ventricular end-diastolic pressure (LVEDP). [Figure 18C] Figure 18C is an exemplary left ventricular (LV) pressure curve illustrating the process for determining left ventricular end-diastolic pressure (LVEDP). [Figure 18D] Figure 18D is an example left ventricular (LV) pressure curve illustrating the process for determining left ventricular end-diastolic pressure (LVEDP). [Figure 19] Figure 19 is a side view of an alternative embodiment of the pump in the MCS system. [Figure 20A]Figure 20A is a side view of an impeller, showing an embodiment of the impeller in the MCS system. [Figure 20B] Figure 20B is a partial side view of an impeller blade, showing an embodiment of the impeller in the MCS system. [Figure 21A] Figure 21A shows an embodiment of the pump area of ​​the MCS system. [Figure 21B] Figure 21B shows an embodiment of the pump area of ​​the MCS system. [Figure 21C] Figure 21C shows an embodiment of the pump area of ​​the MCS system. [Figure 22] Figure 22 is a side view of an embodiment of the inlet pipe of the MCS system. [Figure 23] Figure 23 is a perspective view of an embodiment of the inlet pipe of the MCS system. [Figure 24] Figure 24 is a perspective view of an embodiment of the pump area of ​​the MCS system. [Figure 25] Figure 25 is a partial cross-sectional view of the contour section of the inlet pipe in the pump area of ​​Figure 24. [Figure 26A] Figure 26A is one of several diagrams illustrating an embodiment of an insertion tool that may be used with the various MCS systems described herein. [Figure 26B] Figure 26B is one of several diagrams illustrating an embodiment of an insertion tool that may be used with the various MCS systems described herein. [Figure 26C] Figure 26C is one of several diagrams illustrating an embodiment of an insertion tool that may be used with the various MCS systems described herein. [Figure 26D] Figure 26D is one of several diagrams illustrating an embodiment of an insertion tool that may be used with the various MCS systems described herein. [Figure 26E] Figure 26E is one of several diagrams illustrating an embodiment of an insertion tool that may be used with the various MCS systems described herein. [Figure 27]Figure 27 is a partial cross-sectional view, through the impeller and magnetic coupling region, of an embodiment of a pump that may be used with various MCS systems described herein. [Figure 28A] Figure 28A is a side view of an ultrasonic transducer that may be used with the various MCS systems described herein. [Figure 28B] Figure 28B is a perspective view of an ultrasonic transducer that may be used with the various MCS systems described herein. [Figure 29] Figure 29 is a side view of an introducer sheath and hub that may be used with the various MCS systems described herein. [Figure 30A] Figure 30A is one of various diagrams of another embodiment of an MCS device having two lip seals facing each other. [Figure 30B] Figure 30B is one of various diagrams of another embodiment of an MCS device having two lip seals facing each other. [Figure 30C] Figure 30C is one of various diagrams of another embodiment of an MCS device having two lip seals facing each other. [Figure 31A] Figure 31A shows the distal end of the pump, which has an enlarged outer diameter relative to the proximal tubular portion of the pump and protrudes from the distal end of the insertion tool. [Figure 31B] Figure 31B shows the distal end of the pump shown in Figure 31A, separated. [Figure 32A] Figure 32A shows alternative embodiments of the distal end of a pump having various shapes for various MCS systems. [Figure 32B] Figure 32B shows alternative embodiments of the distal end of a pump having various shapes for various MCS systems. [Figure 33A] Figure 33A shows a cross-sectional view of an alternative embodiment of the distal end of the pump shown in Figure 32A. [Figure 33B] Figure 33B shows a cross-sectional view of an alternative embodiment of the distal end of the pump shown in Figure 32B. [Figure 33C]Figure 33C shows one of several diagrams of another alternative embodiment of a pump tip having a guidewire lumen with a flared distal opening, a cylindrical proximal extension, and a sensor notch. [Figure 33D] Figure 33D shows one of various diagrams of another alternative embodiment of a pump tip having a guidewire lumen with a flared distal opening and a cylindrical proximal extension and sensor notch. [Figure 33E] Figure 33E shows one of several diagrams of another alternative embodiment of a pump tip having a guidewire lumen with a flared distal opening and a cylindrical proximal extension and sensor notch. [Figure 33F] Figure 33F shows one of several diagrams of another alternative embodiment of a pump tip having a guidewire lumen with a flared distal opening, a cylindrical proximal extension, and a sensor notch. [Figure 33G] Figure 33G shows one of several diagrams of another alternative embodiment of a pump tip having a guidewire lumen with a flared distal opening and a cylindrical proximal extension and sensor notch. [Figure 34A] Figure 34A shows a male mating connector for connecting the insertion tool to the introducer of various MCS systems. [Figure 34B] Figure 34B shows a female-type mating section for connecting the insertion tool to the introducer of various MCS systems. [Figure 35A] Figure 35A is one of a series of diagrams illustrating the self-alignment step of the male and female mating parts shown in Figures 34A and 34B. [Figure 35B] Figure 35B is one of a series of diagrams illustrating the self-alignment step of the male and female mating parts shown in Figures 34A and 34B. [Figure 36A] Figure 36A is one of the sequential diagrams showing the steps of engaging the male and female mating parts shown in Figures 34A and 34B. [Figure 36B] Figure 36B is one of a series of diagrams illustrating the steps of engaging the male and female mating parts shown in Figures 34A and 34B.

[0033] Although the drawings identified above illustrate embodiments of the present disclosure, other embodiments are also contemplated, as described in the detailed description. This disclosure presents exemplary embodiments by representative, not limiting, examples. A number of other modifications and embodiments that fall within the scope and spirit of the principles of the embodiments of this disclosure can be devised by those skilled in the art. [Modes for carrying out the invention]

[0034] The following detailed description pertains to a particular embodiment of the development. This description refers to drawings, where, for clarity, similar parts or steps may be designated by the same number throughout. References to “one embodiment,” “an embodiment,” or “in some embodiments” in this specification mean that certain features, structures, or characteristics described in relation to an embodiment are included in at least one embodiment of the present invention. Occurrences of the phrases “one embodiment,” “an embodiment,” or “in some embodiments” in various places in this specification do not necessarily all refer to the same embodiment, nor are separate or alternative embodiments necessarily mutually exclusive with other embodiments. Furthermore, various features that may be shown by some embodiments but not by others are described. Similarly, various requirements that may be required in some embodiments but not in others are described. Hereinafter, embodiments of the present invention are described in detail, and examples thereof are shown in the accompanying drawings. Wherever possible, the same reference numerals are used throughout the drawings to refer to the same or similar parts.

[0035] A minimally invasive, miniaturized percutaneous mechanical circulatory support system is described for transcatheter delivery of a pump to the heart for actively reducing the burden on the left ventricular system by pumping blood from the left ventricle to the ascending aorta and systemic circulation. Various embodiments of the mechanical circulatory support system are described, which may include various features described herein. For example, the pump may include a tubular housing, a motor, an impeller configured to be rotated by the motor, and a distal tip of the pump. The tip may include a guidewire lumen having a curved and / or extended contour. The system may include an insertion tool having a tubular body and configured to receive a circulatory support device axially movable, and an introducer sheath configured to receive the insertion tool axially movable. A coupling allows connection and disconnection between the insertion tool and the introducer sheath. The coupling may include a hexagonal portion for self-positioning and further for tactile feedback. These and other features are described in further detail with reference to the figures.

[0036] Figure 1 is a schematic diagram of the distal tip of an embodiment of a mechanical circulatory support (MCS) system 10, which has a pump 22 attached to the tip of a catheter 16 placed inside the heart. Figure 2 schematically shows an MCS system inserted into the body via an access route from the femoral artery to the left ventricle, according to several embodiments. Some features of the MCS system 10 are described with respect to Figures 1 and 2, and further details of various features are provided elsewhere in this specification.

[0037] Various embodiments of the MCS system 10 and their various features are described herein. In some embodiments, the MCS system 10 may include a temporary left ventricular assist device or pump (for example, generally for about 6 hours or less, or in some embodiments for about 3 hours or less, about 4 hours or less, about 7 hours or less, about 8 hours or less, about 9 hours or less, or about 10 hours or less), which is also referred to as an MCS pump or MCS device. The device may be used during high-risk percutaneous coronary intervention (PCI) performed in selective or emergency hemodynamically stable patients with severe coronary artery disease and / or reduced left ventricular ejection fraction, for example, when a cardiac team including a cardiac surgeon determines that high-risk PCI is an appropriate treatment option. The pump is positioned across the aortic valve via a single femoral artery access.

[0038] In some embodiments, the MCS system 10 may include a longer-lasting pump 22, for example, as a therapy for cardiogenic shock. The MCS system 10 may include a pump 22 having a first magnet rotated by a motor in a sealed motor housing. An impeller having a second magnet may partially surround the first magnet outside the motor housing. The rotation of the first magnet rotates the second magnet and the impeller via magnetic communication.

[0039] In some embodiments, the MCS system 10 may include an insertion tool having a tubular body and configured to receive a circulatory assist device in an axially movable manner. The introducer sheath having a tubular body may be configured to receive the insertion tool in an axially movable manner. The insertion tool may protect the circulatory assist device, for example, when it is inserted into the sheath.

[0040] In some embodiments, the MCS system 10 may include a low-bulk axially rotating blood pump mounted on a catheter 16, such as an 8-French size (Fr) catheter. When positioned, the MCS pump 22 may be driven by the MCS controller to provide partial left ventricular assistance at a maximum of approximately 4.0 liters / min, which can be set to approximately 60 mmHg. System purging is not required due to improved bearing design and motor sealing. The MCS system 10 or a part thereof may be visualized under fluoroscopy, eliminating the need for placement using sensors.

[0041] In some embodiments, the MCS system 10 may include an introducer sheath. The sheath may be expandable. The expandable sheath may, for example, allow an initial access size of 8Fr–10Fr to facilitate insertion and closure, and may also be expandable to allow introduction of 14Fr, 16Fr, and 18Fr pump devices, and further may return to a narrower diameter of approximately 8Fr catheter after the pump has passed. This feature may allow the pump 22 to pass through the vascular system while minimizing shear forces within the vessel, thereby advantageously reducing the risk of bleeding and healing complications. Arterial incision bulging or stretching may be performed using radial stretching with minimal shear that is less damaging to the vessel. Access may be achieved via transfemoral, transaxillary, transaortic, or transapical approaches. In some embodiments, the expandable sheath may allow an initial access size of 8Fr–16Fr (e.g., 8–10.5)Fr to facilitate insertion and closure, and may be expandable to allow the introduction of devices of at least approximately 14Fr, 16Fr, 18Fr, or 19Fr.

[0042] In some embodiments, the inlet tube 70 of the pump 22 extends across the aortic valve 91. The impeller may be located in the outflow section 68 (also referred to herein as the pump outlet) of the inlet tube 70, drawing blood from the left ventricle 93 through the inlet tube 70 and discharging blood from the outflow section 68 into the ascending aorta 95. The motor may be mounted directly proximal to the impeller in a sealed housing, thereby eliminating the need to purge or clean the motor before or during use. This configuration provides hemodynamic support during high-risk PCI with sufficient time and safety for complete revascularization via a minimally invasive approach (rather than open surgery).

[0043] In some embodiments, the MCS system 10 actively reduces the burden on the left ventricular system by pumping blood from the ventricles into the ascending aorta and systemic circulation. When positioned, the MCS device, driven by a complementary MCS controller, can provide partial left ventricular assistance at a rate of 0.4 l / min to a maximum of 4.0 l / min. The MCS system 10 can eliminate the need for motor cleaning and may improve flow rate performance up to a maximum of 4.0 l / min at 60 mmHg, resulting in acceptable and safe hemolysis based on an impeller optimized by computational fluid dynamics (CFD) to minimize shear stress. When positioned, the VSD, driven by a complementary ventricular assistance controller 1000, can provide partial left ventricular assistance at a rate of 0.4 l / min to a maximum of 6.0 l / min. In some embodiments, the VSD can be driven by a complementary ventricular assist controller 1000 to provide partial left ventricular assist from 0.6 l / min to a maximum of 6.0 l / min. Within the range of 0.6 l / min to a maximum of 6.0 l / min, for example, 10 equally spaced flow levels may be possible.

[0044] In some embodiments, the MCS system 10 may include an 18Fr-19Fr axially rotating blood pump and inlet tube assembly mounted on the catheter 16, such as a catheter of 10.5Fr or less. When positioned, the ventricular assist pump 22 can be driven by the ventricular assist controller 1000, which may provide partial left ventricular assist at a pressure difference of about 60 mmHg, at least about 4 liters / min or 5 liters / min, and up to about 6.0 liters / min. In some embodiments of the pump 22, due to the encapsulated motor and magnetic bearing design, system purging is not required.

[0045] Generally, the overall MCS system 10 may include a set of related subsystems and accessories, including one or more of the following: The MCS system 10 may include a pump, shaft, proximal hub, insertion tool, proximal cable, infection shield, guide wire guide tube, and / or guide wire aid. The pump 22 may be supplied in a sterile condition. The MCS shaft may include an electrical cable and a guide wire lumen for over-the-wire insertion. The proximal hub includes a guide wire outlet with a valve for maintaining hemostasis and connects the MCS shaft to the proximal cable that connects the pump 22 to the controller 1000. The proximal cable 28 may be 3.5 m (approximately 177 inches) long and may extend from the sterile field 5 to the non-sterile field 3 where the controller 1000 is located. The MCS insertion tool may be supplied pre-mounted on the MCS device to facilitate the insertion of the pump into the introducer sheath and to protect the inlet tube and valve from potential damage or interference when passing through the introducer sheath. A peel-away guidewire aid may be pre-mounted on the MCS device to facilitate the insertion of a guidewire, such as a 0.018-inch placement guidewire, into the pump 22 and into the MCS catheter shaft 16. Optionally, the MCS insertion tool may also be pre-mounted so that the guidewire guide tube can pass at least partially through the space between the MCS device and the MCS insertion tool. A 3m 0.018-inch placement guidewire with a soft, pre-formed coiled tip for non-traumatic wire placement into the left ventricle may be used. The guidewire may be supplied sterile. A 14Fr or 16Fr introducer sheath may be used at a usable length of 275mm to maintain access into the femoral artery and to provide hemostasis between the 0.035-inch guidewire and diagnostic catheter and the 0.018-inch placement guidewire and insertion tool. The introducer sheath housing may be designed to accommodate the MCS insertion tool. The introducer sheath is supplied sterile.The introducer dilator may be compatible with the introducer sheath and facilitate non-traumatic insertion of the introducer sheath into the femoral artery. The introducer dilator is supplied in a sterile condition. A controller 1000 may be used to drive and operate the pump 22, to observe its performance and status, and / or to provide error and status information. The powered controller 1000 may be designed to support continuous operation for at least about 12 hours and include a basic interface for presenting and adjusting the level of support provided to the patient. Furthermore, the controller 1000 may provide optical and audible alarm notifications if the system detects an error during operation. The controller 1000 may be supplied in a non-sterile condition and may be contained in a container designed for cleaning and reuse outside the sterile field 5. The container for the controller 1000 may include a socket into which an extension cable is plugged.

[0046] In some embodiments, the pump 22 of the present disclosure (which may also be called a ventricular assist device (VSD) or mechanical circulatory assist device) may be a temporary (generally not exceeding about 6 days) left ventricular assist device for enhancing cardiac output in patients with cardiogenic shock, such as those caused by acute ST-elevation myocardial infarction. The pump 22 may be positioned to pump blood from the left ventricle to the ascending aorta, typically via transvascular access, across the aortic valve.

[0047] Referring to Figure 3, the overall MCS system 10 in several embodiments is illustrated, and its subcomponents are described in more detail below. For reference, the “distal” and “proximal” directions are indicated by arrows in Figures 3, 4, and 8A. As used herein, “distal” and “proximal” have their general and conventional meanings and include, without limitation, the direction further away from the patient’s body entry point as measured along the delivery pathway and the direction not farther away from the patient’s body entry point as measured along the delivery pathway.

[0048] System 10 may include an introducer sheath 12 having a proximal introducer hub 14 having a central lumen for axially movably receiving an MCS shaft 16 (the MCS shaft may also be referred herein to as a catheter, catheter shaft, and / or shaft). The MCS shaft 16 may extend between the proximal hub 18 of System 10 and a distal end 20 from which a guidewire 24 extends. The guidewire 24 described herein or any other guidewire may have a variety of features, such as that described in U.S. Provisional Patent Application No. 63 / 224326, filed July 21, 2021, entitled GUIDEWIRE, the entirety of which is incorporated herein by reference for all purposes and forms part herein. The hub 18 may include an integrated microcontroller or memory storage device for device identification and execution time tracking, the microcontroller or memory storage device may be used to prevent overuse in order to avoid excessive wear or other technical malfunctions. A microcontroller or memory device can disable the device, for example, to prevent the use of a used device. The microcontroller or memory device can communicate with a controller that can display information about the device or messages about its use. A non-invasive cannula tip made of radiopaque material allows for visualization of the implantation / explantation under fluoroscopy.

[0049] The pump 22 includes a tubular housing. The tubular housing of the pump 22 is used herein in a broad sense and may include any component of the pump 22 or components within the pump region of the system, such as the inlet tube, distal end member, motor housing, other connecting tubular structures, and / or the proximal rear end of the motor housing. The pump 22, for example, the tubular housing is supported by the distal region of the MCS shaft 16. The system 10 includes at least one central lumen for receiving a guidewire 24 in an axially movable manner. The proximal hub 18 additionally includes an infection shield 26. A proximal cable 28 typically extends between the proximal hub 18 and a connector 30 for a detachable connection to a control system outside the sterile field 5 and drives the pump 22.

[0050] Referring to Figure 4, the system 10 may further include an insertion tool 32 extending distally from the proximal hub 34, having an elongated tubular body 36 having a length in the range of approximately 85 mm to approximately 160 mm (e.g., approximately 114 mm) and an inner diameter in the range of approximately 4.5 mm to approximately 8.0 mm (e.g., approximately 5.55 mm), which can be adapted to complement the length of the hub 122 and the length of the bend relief 130 (see Figure 5) of the introducer sheath 112. The tubular body 36 includes a central lumen, which is adapted to receive the MCS shaft 16 and the pump 22 axially movably through the central lumen, and the tubular body 36 also includes sufficient collapse resistance to maintain patency when passing through the hemostatic valve of the introducer sheath. As shown in Figure 4, the pump 22 can be positioned inside the tubular body 36 to facilitate its passage through the hemostatic valve on the proximal end of the introducer hub 14. Since the marker 37 (Figure 7) is located on the MCS shaft 16 at a position spaced proximal to the distal tip 64, the clinician will know that the pump is located inside the tubular body 36 as long as the marker 37 is visible on the proximal side of the hub 34.

[0051] The hub 34 may also include a first engagement structure 39 for engaging with a complementary second engagement structure on the introducer sheath to lock the insertion tool within the introducer sheath. The hub 34 may be connected to the infection shield 26 via a connector 41 such as a knob or button connected by force fitting, screw fastening, or other means. The hub 34 may also include a locking mechanism for clamping onto the shaft 16 to prevent the shaft 16 from sliding proximal or distal through the insertion tool after the MCS device has been positioned at the desired location in the heart. The locking mechanism may be driven by twisting one or more parts (e.g., two parts) of the hub 34. Other driving means may also be possible. The hub 34 may additionally include a hemostatic valve for sealing around the shaft 16. In some embodiments, the hub 34 may accommodate a passage for a larger diameter MCS device, including a pump. In one commercial presentation of the system, the packaged MCS device is pre-positioned within the insertion tool, and the guidewire aid is pre-loaded within the MCS device and shaft 16, as shown in Figure 4. In some examples, the MCS device is configured to be pre-positioned within the tube 36 and to advance distally. In such configurations, the lumen of the hub 34 may be smaller than that of 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 retracted into the tube 36, and then the insertion tool may be withdrawn from the introducer together with the pump in the tube 36. Further details of the guidewire aid 38 are described with reference to, for example, Figures 8A and 8B.

[0052] Referring to Figures 5 and 6, the introducer kit 110 may include a guidewire 100, an introducer sheath 112, a dilator 114, and / or a guidewire aid 38, as described with reference to Figures 8A and 8B. The guidewire 100 and introducer sheath 112 may correspond to the guidewire 24 and introducer sheath 12 described above. The guidewire 100 (e.g., a 0.018-inch placement guidewire) may include an elongated flexible body 101 extending between a proximal end 102 and a distal end 104. The distal zone of the body 101 may be pre-formed into a J-shaped tip or pigtail, as shown in Figure 6, to provide a non-traumatic distal tip. The proximal zone 106 may be configured to facilitate penetration through the MCS device and may extend between the proximal end 102 and a transition 108. The proximal zone 106 may have an axial length in the range of approximately 100 mm to approximately 500 mm (for example, approximately 300 mm).

[0053] The introducer kit 110 may include an introducer sheath 112 and / or a dilator 114. The introducer sheath 112 may include an elongated tubular body 116 extending between a proximal end 118 and a distal end 120. The tubular body 116 terminates proximal to a proximal hub 122. Optionally, the tubular body 116 is expandable or detachable. The proximal hub 122 includes a proximal end port 124 that extends along the length of the tubular body 116 and communicates with a central lumen extending to the outside through a distal opening, and is configured to axially detachably receive the elongated dilator 114. The proximal hub 122 may further comprise a lateral port 126, at least one and optionally two or more attachment mechanisms such as an eye 128 to facilitate suturing to the patient, and at least one and optionally multiple hemostatic valves to provide sealing around various introduced components such as a standard 0.035-inch guidewire, a 5Fr or 6Fr diagnostic catheter, a 0.018-inch placement guidewire 100, a shaft 16, and an insertion tool 32. The proximal hub 122 may have a lock to prevent axial movement of the insertion tool 32 and / or dilator 114.

[0054] Figure 7 shows additional details relating to the distal pump region 60 of the MCS system, showing the device or pump 22 and the distal portion of the catheter shaft 62. The pump zone or pump region 60 extends between the bend relief 62 and the distal tip 64 at the distal end of the shaft 16. The pump 22 includes a tubular housing 61, which 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 one or more pump outlets 68, which may be part of the inlet tube 70 or part of other structures such as an intermediate structure that joins the proximal end of the inlet tube 70 to the motor housing 74. As further described herein, guidewire guide aids may extend in 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).

[0055] The pump inlet 66 includes one or more windows or openings that are in fluid communication with the pump outlet 68 (also referred to herein as the outflow section) via a flow path that extends axially through the inlet pipe 70. The pump inlet may be located around the transition between the inlet pipe and the proximal end of the distal tip 64, and in any case is generally within about 5 cm or 3 cm from the distal port 76.

[0056] In some embodiments, the distal tip 64 is radiopaque. For example, the distal tip may be made from a polymer containing a radioactive mitigating agent such as barium sulfate, bismuth, tungsten, or iodine. In some embodiments, the entire MCS device is radiopaque. The radiopaque marker in the polymer can be at a concentration of 5 percent to 30 percent, or greater or less than that range. In some examples, the relative content of the radiopaque marker in the polymer may be 6 percent or at least 6 percent. In some examples, the relative content of the radiopaque marker in the polymer may be 20 percent or at least 20 percent. Advantageously, a larger relative content, such as 20 percent or more, can improve the visibility of the distal tip 64 under fluoroscopy. Thus, the distal end of the device is very visible, easily identifiable, and has a contrast as large as that of the metallic component in fluoroscopic imaging. In some embodiments, a radiopaque marker is positioned on the inlet tube 70 between the pump outlet 68 and the guidewire port 78, thereby indicating the current position of the MCS device relative to the aortic valve 91. In addition, as shown in the figures, the distal tip 64 has the same or similar outer diameter as the tubular housing 61. In some embodiments, the distal tip 64 or a portion thereof may have a larger outer diameter than the tubular housing 61, as will be further described herein with respect to, for example, Figures 31A to 33B.

[0057] The inlet tube 70 may include a highly flexible slotted (e.g., laser-cut) metal (e.g., nitinol) tube having a polymer (e.g., polyurethane) tube layer to separate the flow paths. The inlet tube 70 may have an axial length in the range of about 60 mm to about 100 mm, and may be about 67.5 mm in a single mounting. The outer diameter of the inlet tube 70 may typically be in the range of about 4 mm to about 5.4 mm, and may be about 4.66 mm in a single mounting. The wall thickness of the inlet tube 70 may be in the range of about 0.05 mm to about 0.15 mm. The connection between the inlet tube 70 and the distal tip 76, and to the motor, may be fixed by laser welding, adhesive, screwing, or the use of other interferential fitting engagement structures, or by press-fitting.

[0058] The impeller 72 may be located within the flow path between the pump inlet 66 and the pump outlet 68. In the illustrated embodiment, the impeller 72 is located adjacent to the pump outlet 68. As will be further described below, the impeller 72 may be rotationally driven on its proximal side by a motor housed within the motor housing 74.

[0059] Figures 8A and 8B are side cross-sectional and detailed views, respectively, of the pump region, illustrating an embodiment of the guidewire aid 38. The MCS device can be configured in either a rapid replacement configuration or an over-the-wire configuration. A first guidewire port 76, such as a distally facing opening on the distal surface of the distal tip 64, may communicate with a second guidewire port 78, such as an opening extending through the side wall of the inlet tube 70 and located distal to the impeller 72, via the first guidewire lumen passing through the distal tip 64 and at least a portion of the flow path of the inlet tube 70. This allows for rapid replacement of the guidewire 100 extending proximal along the catheter from the second guidewire port 78.

[0060] The catheter may be provided in an over-the-wire configuration, in which case the guidewire extends proximal through an internal guidewire lumen over the length of the catheter shaft 16. However, in the over-the-wire embodiments shown in Figures 7, 8A, and 8B, the guidewire 100 is led out of the inlet tube 70 via a second guidewire port 78, extends proximal across the outside of the impeller and motor housing, and then re-enters the catheter shaft 16 via a third guidewire port 80, which may be an opening in the side wall of the catheter shaft 16, or an opening in the pump, motor housing, or a proximal component of the back end. The third guidewire port 80 may be located proximal to the motor, and in the illustrated embodiment, it is located on the bend relief 62. The third guidewire port 80 is a guidewire lumen that extends proximal over the length of the shaft 16 and is in communication with the guidewire lumen that is supported by or located within the proximal hub 18 and leads out from the proximal guidewire port (see Figure 4).

[0061] As shown in Figure 8A, the pump may be supplied assembled with a detachable guidewire aid 38. The guidewire aid 38 may have a guide tube 83 for the guidewire. The guide tube 83 may be axially extended cylindrical or have other closed cross-sectional shapes. The guide tube 83 may be made of a flexible, transparent material such as polyimide. The guide tube 83 may be fitted to peel along its longitudinal axis, for example, by having a slit line or tear line along its longitudinal axis. The inner surface of the guide tube 83 may be provided with a lubricating coating such as PTFE. The guide tube 83 may follow the intended path of the guidewire 100 by extending proximal through the tip 64 from the first guidewire port 76, then returning outside the inlet tube through the second guidewire port 78, and returning into the catheter shaft 16 through the third guidewire port 80. In the illustrated implementation, the guide tube 83 of the guidewire extends proximal within the catheter shaft 16 to its proximal end 81 and communicates with, or is located within, a guidewire lumen extending to the proximal hub 18. The proximal end 81 of the guide tube 83 may be located within approximately 5 mm or 10 mm of the distal end of the shaft 16, or it may extend into the guidewire lumen of the catheter shaft by at least approximately 10 mm or 20 mm, such as in the range of approximately 10 mm to approximately 50 mm. In some embodiments, the third port 80 may be located inside the proximal end of a tubular housing, such as a motor housing or backend, or it may be located inside any other component of the device at a position proximal to the impeller.

[0062] The guidewire aid 38 may have a funnel 92. The funnel 92 may be located at the distal end of the guide tube 83, for example, at the distal tip 64, and may be pre-positioned and provided at the distal end of the inlet tube. The funnel 92 may increase in width distally from a narrow proximal end communicating with the guide tube 83 to a wider distal opening located at the distal end of the funnel 92. The funnel 92 may be conical, frustoconical, pyramidal, segmented, or other shapes. The proximal end of the funnel 92 may be attached to the distal end of the guide wire in the guide tube 83. The proximal end 102 of the guide wire 100 (see Figure 6) may be inserted into the funnel 92, pass through the first (distal) guidewire port 76, and may be guided along the intended path by tracking the inside of the guide wire in the guide tube 83. Subsequently, the guide tube 83 of the guide wire may be removed by sliding the guide tube 83 distally from the distal tip 64, and further by peeling the guide tube 83 in the longitudinal direction while leaving the guide wire 100 in place.

[0063] The guide wire support 38 may have a pull tab 94. In some embodiments, the distal end of the guide tube 83 of the guide wire is attached to the pull tab 94 of the guide wire support 38. The pull tab 94 may be constructed to be graspable by a human hand, for example, by a lateral planar extension as shown. The guide wire support 38, for example, the pull tab 94, the guide tube 83, and / or the funnel 92 may be provided with a tear line 75, as clearly seen in Figure 8B. The tear line 75 may be an axially extending dividing line. The tear line 75 may include a weakened region, a slotted region, or a perforated straight region. The removal of the guide wire support 38 may be carried out by pulling the guide wire tube 83 and / or funnel 92 by grasping the pull tab 94 as they are separated or peeled off along the dividing line 75, as shown in the detailed insert 91 of Figure 8B, and further by removing them from the guide wire 100.

[0064] The guidewire aid 38 may include a proximal opening 90 configured to removably receive the distal tip 64 and / or support at the distal end of the inlet tube 70 defining the window of the pump inlet 66, allowing the distal tip 64 and / or support to slide in. The guide tube 83 of the guidewire, having a lumen passing through it, is positioned within the proximal opening 90 and aligned to pass through the guidewire port 76 of the distal tip 64. The proximal opening 90 may further be configured to removably receive the distal end of the tubular body 36 of the insertion tool 32, allowing it to slide in, as shown in Figure 4. The MCS system may be dimensioned such that an annular space defined between the outer surface of the MCS device, such as the inlet tube 70, the motor housing 74, or the bend relief 16 of the MCS catheter, and the inner surface of the tubular body 36 of the insertion tool 32, allows the guide tube 83 of the guidewire to removably receive inside when the MCS device, the guidewire aid 38, and the insertion tool 32 are assembled together.

[0065] In some embodiments, the lumen of the guide wire guide tube 83 communicates with the distal flared opening of the funnel 92, which has a larger cross-section distally. The guide wire aid 38 may be assembled and provided on the MCS pump with respect to the guide wire guide tube 83 that is pre-loaded, so as to follow the guide wire path, for example, through port 76 into the MCS pump, through part of the fluid path in the inlet tube 70 to the outside of the MCS pump through port 78, and along the outside of the MCS pump, and then back into the shaft 16 through port 80. This assists the user in guiding the proximal end of the guide wire through the guide wire path into the funnel 92 and then into the guide wire lumen of the MCS shaft 16. A pull tab 94 may be provided on the guide wire aid 38 to facilitate grasping and removing the guide wire aid, including the guide wire guide tube 83, after the guide wire has been loaded. The guide wire support 38 may have, for example, a funnel 92, a proximal opening 90, and a longitudinal slit or tear line 75 along the guide tube 83 of the guide wire, in order to facilitate the removal of the guide wire support 38 from the MCS pump 22 and the guide wire 100.

[0066] Each feature of the guidewire support 38 described herein may be used with a variety of different MCS systems and / or pump devices. The guidewire support 38 may be used with respect to a guidewire path that is routed in and out of the pump housing as described, or with respect to a guidewire path that is not routed out of the housing. The guidewire support 38 is described herein as being used with an MCS system configured for temporary operation for high-risk PCI procedures. 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 support 38 may be used with a variety of different devices. The guidewire support 38 may also be used with a pump having a magnetic drive, in which case the motor rotates a first magnet within a sealed motor housing that magnetically communicates with a second magnet on the impeller located outside the sealed housing to rotate the impeller. Thus, the guidewire support 38 is not limited to being used only with the specific pump embodiments described herein.

[0067] Figures 9A and 9B show a side view and a partial cross-sectional view, respectively, of the pump 22. As shown, the impeller 72 may be mounted on a short, rigid motor drive shaft 140. In the illustrated implementation, the drive shaft 140 extends distally into the proximal central lumen of the impeller 72, such as through a proximal extension 154 on the impeller hub 146, and may be fixed by press fitting, laser welding, adhesive, or other joining techniques. The impeller 72 may include radially outward-extending helical blades 181, in which case the helical blades 181 may be spaced from the inner surface of the tubular impeller housing 82 by a distance in the range of about 40 micrometers to about 120 micrometers at their maximum outer diameter. The impeller housing 82 may also be a proximal extension of the inlet pipe 70 on the proximal side surface of a slot 71 formed in the inlet pipe 70, thereby providing flexibility distal to the impeller. The tubular outer membrane 73 can enclose the inlet pipe 70 and seal the slot 71 while preserving the flexibility of the inlet pipe. The pump outlet 68 may be formed on the side wall of the impeller housing 82, for example, axially aligned with the proximal portion of the impeller 72 (for example, the proximal 25% to 50% portion of the impeller).

[0068] The impeller 72 may contain medical-grade titanium. This allows for CFD-optimized impeller design in which transient gradients increase efficiency while minimizing shear stress to reduce blood cell damage (hemolysis). This latter characteristic cannot be achieved with mold-based manufacturing methods. The surface roughness of the impeller 72 may be reduced by electropolishing to minimize the impact on hemolysis.

[0069] In some implementations, the impeller hub 146 expands radially outward in the proximal direction to form an impeller base 150 that can allow blood flow to flow out of the outlet 68. The proximal surface of the impeller base 150 may be fixed to an impeller back 152, which may be in the form of a radially outward-extending flange fixed to the motor shaft 140. For this purpose, the impeller back 152 may have a central opening for receiving the motor drive shaft 140 and may be integrally formed with or joined to a tubular sleeve / proximal extension 154 adapted to be joined to the motor drive shaft 140. In some implementations, the impeller back 152 is first attached to the motor drive shaft 140 and joined via the use of adhesive or the like. In the second step, the impeller 72 may be advanced along the shaft and the impeller base 150 may be joined to the impeller back 152 by laser welding or the like.

[0070] The distal opening of the impeller back 152 may have an increased diameter distally to facilitate the application of adhesive. The proximal end of the tubular sleeve / proximal extension 154 may have an inlet slope, which decreases in outer diameter proximal to facilitate the sleeve advancing proximal on the motor shaft and passing through the seal 156, as will be further described below.

[0071] The motor 148 may include a stator 158 having conductive windings surrounding a cavity that encloses a motor armature 160 which may include a plurality of magnets rotatably fixed to the motor drive shaft 140. The motor drive shaft 140 may extend from the motor 148 through a rotating bearing 162 and further through a seal 156, and then lead out from a sealed motor housing 164 (also referred to herein as motor housing 74). The seal 156 may include a seal holder 166 supporting an annular seal 167, such as a polymer seal ring. The seal ring includes a central opening for receiving a tubular sleeve / proximal extension 154 and is biased radially inward relative to the tubular sleeve / proximal extension 154 to maintain the seal ring in a sliding sealing contact state with the rotatable tubular sleeve / proximal extension 154. To minimize wear on the seal, the outer surface of the tubular sleeve / proximal extension 154 may be provided with a smooth surface, such as by electropolishing.

[0072] 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 Figures 30A to 30C.

[0073] The pump may include a sealed motor and be configured to operate without requiring flushing or purging for short-duration applications (typically about 6 hours or less) related to high-risk PCI. This provides the opportunity to directly bond the impeller 72 onto the motor drive shaft 140, as will be described in more detail below, thereby eliminating issues associated with magnetic coupling, such as additional rigidity length, space requirements, or pump efficiency. The four-pole motor design allows for a maximum of 4.0 lmin at 60 mmHg. -1 Flow rate performance of (liters / minute) and low-temperature variation are possible. The motor cable interface may have high tension.

[0074] Figures 10A and 10B show a front and rear view of an embodiment of the MCS controller, i.e., controller 1000. Controller 1000 may support the operation of one or more cardiac or circulatory support systems, such as left ventricular assist devices, ventricular support devices, or MCS devices, as described herein. Controller 1000 may include a further module for supplying power to the cardiac support system. Controller 1000 may house electronic circuits for sending and receiving operating signals to and from the cardiac support system. Controller 1000 may house one or more hardware processors for receiving and processing data, such as sensor data from the cardiac support system, as described below. In some embodiments, controller 1000 may have an integrated or self-contained design in which all or almost all of the components necessary for the operation of the controller are housed inside the controller. For example, any power supply components, such as transformers or AC / DC converters, may be housed inside the controller 1000. As shown in Figure 2, controller 1000 may be wired to the pump via electronic wires extending to the pump through the catheter shaft 62.

[0075] In some embodiments, the controller 1000 may include a communication system, or any other suitable system, to enable the controller 1000 to be adapted to new or modified uses after the controller has been built. For example, multiple modes of wired or wireless communication may be integrated into the controller 1000 to communicate with external technologies such as RF, Wi-Fi, 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 that enables patient data synchronization, telemedicine, patient monitoring, real-time data collection, error reporting, and / or sharing of maintenance records.

[0076] The controller 1000 may include a housing for modules such as supporting any cardiac support systems described herein. The housing may further include a handle 1002 to support portability. In contrast to some other controllers, such as Abiomed's Impella Controller, the controller 1000 may not include components necessary for purging. For example, the controller 1000 does not include a cassette for purging. The cassette typically delivers rinse fluid to the catheter. However, the cassette requires considerable space, making the housing larger and heavier. Based on the design improvements described herein, such as the bearing design and sealed motor described herein, the controller 1000 does not include a cassette. Furthermore, in some embodiments, the controller 1000 does not require a port for receiving a purge tube. Thus, the controller 1000 may be lighter and more compact, supporting portability.

[0077] The controller may also include a cable management support 1004. In some embodiments, the cable management support 1004 is located on one end or one side of the controller 1000. The controller 1000 may also include a mount 1006 that can support mounting the controller to a pole in a clinical environment. The mount 1006 may rotate around an axis to support horizontal or vertical clamping. The mount 1006 may be quickly locked into a desired orientation by quick fastening using a slipping clutch. In some examples, the mount 1006 is located spaced apart from the cable management support 1004. Furthermore, in some embodiments, the cable management support 1004 is located on the left end of the controller 1000, as shown in Figure 10A. A port 1107 (such as the one shown in Figure 13) can be located on the side opposite to the cable management support 1004. In some examples, the control element 1008 described below is positioned on the side opposite to the cable management support 1004, very close to the port 1107. This may allow the user to have an improved interaction with the active components of the controller 1000. Thus, the arrangement of all these elements within the controller 1000 as illustrated can improve the operating experience and enhance portability.

[0078] The controller 1000 may include a control element 1008. In some embodiments, the control element 1008 may provide haptic feedback. The control element 1008 may include a push-button rotary dial. The control element 1008 may allow the user to control one or more processes described herein by changing parameters on the controller 1000. The control element 1008 may also include a status indicator 1010, as shown in Figure 10A. In some embodiments, the controller 1000 may include a separate confirmation control element. Furthermore, in some embodiments, apart from the separate confirmation control element, all parameters can be changed using a single control element 1008. Grouping controls within a dedicated area can improve the user experience.

[0079] Figure 11 shows a block diagram of an electronic system 1100 that may be included in the controller 1000. In some embodiments, the electronic system 1100 may include one or more circuit boards in conjunction with one or more hardware processors for controlling the MCS device 1110. The electronic system 1100 may also be able to receive signals, process signals, and transmit signals. The electronic system 1100 may also be able to generate displays and / or alarms. The electronic system 1100 may include a control system 1102 and a display system 1104. In some embodiments, the display system 1104 may be integrated into the control system 1102 and not separated as shown in Figure 11. In some embodiments, it may be advantageous for the display system 1104 to be separated from the control system 1102. For example, in the event of a failure of the control system 1102, the display system 1104 may function as a backup.

[0080] The control system 1102 may include one or more hardware processors to control various aspects of the MCS device 1110. For example, the control system 1102 can control the motor of the MCS device 1110. The control system 1102 may also receive signals from the MCS device 1110 and process parameters. Parameters may include, for example, flow rate, motor current, ABP, LVP, LVEDP, etc. The control system 1102 may generate alarms and statuses for the electronic system 1100 and / or the MCS device 1110. In some embodiments, the control system 1102 may support multiple MCS devices 1110. The control system 1102 may transmit generated alarms or status indicators 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 to display the processed data on a display screen. The control system 1102 may also include memory for storing data.

[0081] The electronic system 1100 may also include a battery 1106 that can enable the electronic system to operate without being connected to an external power source. The power interface 1108 can charge the battery 1106 from an external power source. The control system 1102 can supply current to the motor of the MCS device 1110 by using the battery power supply.

[0082] 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 gates or transistor logic, discrete hardware components, or any combination thereof designed to perform the functions described herein.

[0083] Figure 12 is an exploded view of an embodiment of a controller 1000 having physical components corresponding to the features of the block schematic diagram of the electronic system 1100 in Figure 11. As shown in Figure 12, the controller 1000 may include a control system 1102 and a display system 1104, including a circuit board located within the housing. The battery 1106 may be located within the lower section of the housing. The power interface 1108 may be located in the corner of the housing.

[0084] Figure 13 is a front perspective view of the controller 1000. In some embodiments, the controller 1000 may include an alarm feedback system, which may provide feedback to the operator regarding the operation of the MCS system. In some embodiments, the alarm feedback system may take the form of an LED 1302, as shown. The LED 1302 may be positioned so that it can be seen by the operator using the controller. As shown, the LED 1302 is positioned around the handle 1002, so that it can be seen from a 360° position around the controller. The LED 1302 may also take the form of a ring (elliptical, oblong, circular, or any other suitable shape) enclosing the handle 1002. Such an LED 1302 may be visible from any direction, as long as the top of the controller is visible. The control system 1102 may provide various alarms or statuses regarding the controller 1000 and / or the MCS device 1110 by generating various colors or patterns for the LED 1302.

[0085] The controller 1000 further includes a port 1107 that can accept a cable connected to the MCS device. The port 1107 can support multiple versions of the MCS device. The controller 1000 may also include an RFID reader 1304 on its side. The RFID reader 1304 can read salesperson badges and operate the device according to specific demo modes. The controller 1000 may include a glass cover 1306 that can be tilted as shown in Figure 13 to improve user readability.

[0086] Figure 14A shows a graph illustrating the pressure difference between aortic pressure and left ventricular pressure, which may be a typical pressure difference. In some examples, the MCS device 1110 can be positioned between two different pressure levels (left ventricle and aortic arch). Therefore, the MCS device 1110 may operate in relation to the pressure difference shown in Figure 14A. Thus, the motor of the MCS device 1110 may operate according to the pressure in some examples, and against the pressure in other examples. Therefore, it has been observed that the current supplied to the motor needs to vary based on the pressure difference in order to keep the motor speed, for example, the rotational speed of the motor shaft, constant or nearly stable.

[0087] Figure 14B shows the applied current for a constant motor speed. The current curve in Figure 14B behaves similarly to the pressure difference curve in Figure 14B. In some embodiments, the control system 1102 can control the motor to operate at a constant speed by varying the motor current. By using the fluctuations in the motor current, the control system 1102 can investigate the differential pressure, and consequently, the patient's physiology, operating conditions, and the state of the machine.

[0088] Figure 15 shows an exemplary user interface that can display flow parameters and motor current. The user interface can also display the parameters as a graph plotted over time. The user interface may be displayed on the controller 1000, for example, on a display.

[0089] Figure 16A shows an exemplary user interface in configuration mode, in which parameters such as flow rate settings can be changed using control element 1008. Control element 1008 may directly include a visual feedback system on and / or adjacent to the knob. Figure 16B shows an exemplary user interface in operation mode. Comparing Figures 16A and 16B, certain text on the user interface can be highlighted or emphasized depending on the mode. In configuration mode, the set flow rate is magnified. In operation mode, the flow rate is magnified. This improves readability for the user, especially when the user interface contains several parameters.

[0090] In some embodiments, depending on the type of MCS device 1110 connected to the controller, only some user interfaces may be available. For example, some of the devices described above may not include any sensors and may not support all of the user interfaces described above. These sensorless devices may be less expensive and smaller.

[0091] Figure 17 shows embodiments of the electronic control element 1702 and the visual indicator 1704. The electronic control element 1702 may include a display on the surface of the dial. Furthermore, the visual indicator 1704 may indicate the motor status or other operating conditions as the dial is rotated.

[0092] Figures 18A–18D are exemplary left ventricular (LV) pressure curves illustrating the process for determining left ventricular end-diastolic pressure (LVEDP). The control system 1102 can document status and operating parameters, which may be transmitted to the EMR system via network communication. The control system 1102 can measure left ventricular end-diastolic pressure (LVEDP). Figures 18A–18D illustrate a series of steps for determining the LVDEP from the measured LV pressure curve. Figure 18A shows an exemplary LV pressure curve measured at a sampling rate of 100 MHz. The control system 1102 can determine the LVDEP by processing the measured LV pressure curve. For example, the control system 1102 can identify the largest positive slope in the LV curve, as shown in Figure 18B. This allows for the identification of the pulse value. The start of the pulse can be identified using other techniques. After the pulse has been identified, the control system 1102 can find the maximum and minimum values ​​in the LV curve between two positive steep slopes, as shown in Figure 18B. This can also yield systolic and diastolic values. In some examples, the control system 1102 can identify the left minimum of the second gradient, as shown in Figure 18D. This value can represent the LVEDP determination.

[0093] As described above, for example with respect to Figure 14B, by controlling or synchronizing the motor current with respect to the heart and measuring the motor current, the control system 1102 can investigate differential pressure by measuring the current, and thereby investigate the patient's physiological processes, operating state, and machine state. Physiological processes may include the timing of the pump's impact with the heart wall. In some examples, the motor current is kept constant while measuring changes in RPM. In some examples, a separate flow sensor or pressure sensor is not required to investigate physiological processes. A motor design including a motor controller such as controller 1000 can enable high-resolution current measurement. In some examples, the motor controller is sensorless, and for example, the motor controller may not include a Hall sensor. In some examples, the control system 1102 may operate the motor in a pulsating mode to improve cardiac recovery.

[0094] Figure 19 shows a schematic side view of another embodiment of the pump 1900 for pumping blood 1905. The pump 1900 is designed and shaped for use in fluid channels such as blood vessels. The pump 1900 or its features may be used with any other pumps or features described herein, such as the pump 22, and vice versa. For example, the features of the pump 1900 may be used with the pump 22 described above. In some embodiments, the pump 22 includes the motor, shaft, and / or seal arrangement of the pump 1900, as will be further described.

[0095] The pump 1900 may have an impeller 1910, a drive unit 1915 having a shaft 1920, a shaft housing 1925, and / or a sealing device 1930. The impeller 1910 may be designed to pump a fluid 1905. The drive unit 1915 having a shaft 1920 may be designed to drive the impeller 1910. The shaft housing 1925 may be designed to house the shaft 1920 and / or the drive unit 1915, and is hereinafter also referred to as the “housing”. The sealing device 1930 may include at least one casing or housing sealing element 1935 and / or one impeller sealing element 1940, which is housed between the drive unit 1915 and the impeller 1910 and is designed to prevent the fluid 1905 from entering the drive unit 1915 and / or the shaft housing 1925 during the operation of the pump 1900.

[0096] According to this embodiment, the impeller 1910 may have an exemplary tapered base body which can rotate around a longitudinal axis during the operation of the impeller 1910. Radially around the longitudinal axis, the base body according to this embodiment has two blades to generate fluid flow or fluid suction in the fluid 1905 when the impeller 1910 rotates. For this purpose, the blades may be arranged helically around the outer wall of the base body according to this embodiment. The rotating body of the impeller 1910 is produced by rotating one or more so-called “B spindles”. According to some embodiments, the impeller 1910 may have different shapes, for example, a cylindrical base body and / or different numbers of blades or blades. According to this embodiment, the drive unit 1915, also referred to hereafter as the “drive”, has a motor 1945, for example, in the form of an electric motor. According to this embodiment, the motor 1945 is coupled to a shaft 1920. According to this embodiment, the shaft 1920 is linear. The shaft housing 1925 is correspondingly tubular according to this embodiment and houses at least the shaft 1920, or according to this embodiment, completely houses the entire drive unit 1915 together with the motor 1945. According to some embodiments, the motor 1945 is located outside 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 and elastic material. In other words, the housing sealing element 1935 and / or the impeller sealing element 1940 do not have a liquid or semi-liquid material.

[0097] According to this embodiment, the housing sealing element 1935 may be mounted to the inner surface of the shaft housing 1925 and / or arranged around the shaft 1920. According to this embodiment, the housing sealing element 1935 may be formed as a sealing ring, such as a rotating shaft seal. According to this embodiment, the housing sealing element 1935 may be mounted to the inlet opening 1947 of the shaft housing 1925 facing the impeller 1910. According to one embodiment, the housing sealing element 1935 may be directly fixed to the inlet opening 1947.

[0098] An additional or alternative impeller sealing element 1940 may be mounted to the impeller 1910 and / or positioned in contact with the shaft 1920 and / or the shaft housing 1925 according to this embodiment. According to this embodiment, the impeller sealing element 1940 may be designed as an additional sealing ring, here as a shaft seal. The shaft seal may also be described as a "V-ring". According to this embodiment, the V-ring may have a V-shaped or plate-shaped flexible sealing lip extending spaced apart from the annular base of the shaft seal. According to this embodiment, the sealing lip is mounted to the impeller 1910.

[0099] The impeller sealing element 1940 may also be pre-loaded toward the shaft 1920 while installed, according to this embodiment. Pretension may be introduced by deformation of the impeller sealing element 1940. According to some embodiments, the pump 1900 may have a spring element that causes pre-loading.

[0100] Furthermore, according to this embodiment, the impeller sealing element 1940 may have at least one gap sealing element 1950, which may be configured to fluid-seal the gap 1952 between the shaft housing 1925 and the impeller 1910 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 outer diameter of the gap sealing element 1950 may be larger than the outer diameter of the impeller sealing element 1940. According to this embodiment, the impeller sealing element 1940 may be coaxially positioned with respect to the additional sealing ring at the passage opening of the additional sealing ring.

[0101] The free end of the shaft 1920 may be fixed within the impeller 1910 according to this embodiment. According to some embodiments, the free end of the shaft 1920 and the impeller 1910 may be connected by a magnetic coupling without contact, thereby enabling the driving force of the motor 1945 to be transmitted magnetically to the impeller 1910.

[0102] The pump 1900 may also have a bearing device 1955 for radial and / or axial bearings of the shaft 1920 within the shaft housing 1925, according to this embodiment. For this purpose, the bearing device 1955 according to this embodiment may have two bearing elements at two ends inside the shaft housing 1925, where the shaft 1920 is mounted, for example, in the center. According to this embodiment, the housing sealing element 1935 may be located outside the space enclosed by the two bearing elements.

[0103] The pump 1900 presented herein may be used and configured as a blood pump for a cardiac assist system. According to one embodiment, the pump 1900 is designed as a ventricular assist device (VAD) pump for short-term implantation, having contact radial and / or axial seals.

[0104] If the pump 1900 is to be used as a temporary / short-term VAD pump, it is important that it can be implanted very quickly. According to this embodiment, the simplest possible system may be used for this purpose. Only one or more sealing elements 1935, 1940, 1950 may be present, and a liquid medium or partial liquid medium such as a washing medium or barrier medium may be dispensed, or external forced washing may be possible for sealing or to prevent blood from entering the motor.

[0105] 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 Figures 30A to 30C.

[0106] According to this embodiment, the pump 1900 presented herein may have an electrically driven unit in the form of an electric motor 1945, a rotating shaft 1920, an impeller 1910, a bearing device 1955, a shaft housing 1925, and / or at least one sealing element 1935, 1940, 1950, which may be rigidly connected to the housing 1925 in the form of a housing sealing element 1935 and have a sealing function with respect to the rotating shaft 1920 and / or the impeller 1910. Additionally or alternatively, the pump 1900 may have sealing elements in the form of an impeller sealing element 1940 and / or a gap sealing element 1950 that axially seal the housing 1925 with respect to the rotating impeller 1910. According to this embodiment, the impeller 1910 may consist of, for example, a hub and a core having at least two or more blades. During the operation of the pump 1900, the fluid 1905 may be supplied axially to the impeller 1910 (suction) and discharged radially / diagonally through an opening in the impeller housing of the impeller 1910, which is not shown herein. According to this embodiment, the impeller 1910 may be rigidly connected to the drive shaft 1920 of a motor 1945 that provides the required driving force. According to this embodiment, the shaft 1920 may be supported by at least one radial bearing and / or at least one axial bearing. Optionally, the bearings may also be implemented in combination with radial-axial bearings. According to one possible embodiment, the housing 1925 may have at least one sealing element 1935 relative to the impeller 1910. According to another embodiment, this at least one sealing element 1940, 1950 may be mounted relative to the impeller 1910. The seal may be of a contact design; that is, according to one embodiment, the sealing elements 1925, 1940 are always in contact with the shaft 1920 and the housing 1925. Furthermore, at least one (additional) sealing element 1940 that seals the shaft 1920 to the housing 1925 may be optionally / alternatively provided.This may be designed according to the embodiment such that the sealing element 1940 is pre-loaded toward the shaft 1920. According to one embodiment, this may be achieved using a spring, or according to another embodiment, by shaping the elastic sealing element 1940. One possible design of the housing sealing element 1935 is a rotary shaft seal. An axial shaft sealing ring is an alternative / optional possible design of the sealing element 1940.

[0107] According to one embodiment, the VAD pump 1900 may have a maximum outer diameter of less than 5 millimeters, and in another embodiment, it may have an outer diameter of less than 8 millimeters. According to one embodiment, the pump 1900 may be designed for short-term use of less than 24 hours, in another embodiment for use of less than 10 days, in another embodiment for use of less than 28 days, and in another embodiment for use of six months or less.

[0108] Figure 20A shows a side view of an alternative embodiment of the pump 2062 having an impeller 2068. The impeller 2068 is rotatably mounted inside an impeller housing, which may be the proximal end of the inlet pipe or a separate housing for the impeller 2068. The impeller 2068 may face the outlet opening 2066. The impeller 2068 may be provided for axial suction of blood through the outlet opening 2066, as well as for radial and / or diagonal discharge of such blood. The pump 2062 may include a rotating shaft 2032. The pump 2062 may rotate around the rotating shaft 2032. A motor in a sealed motor housing 2064 may rotate the impeller 2068.

[0109] The impeller 2068 may include at least one helically wound blade 2070. The blade 2070 may ensure efficient and gentle transport of blood. As shown in Figure 20A, the blade 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 acts as the upstream inlet opening of the impeller 2068, and discharged through the outlet opening 2066.

[0110] The skeleton wire 2004, which may be the camber wire of the blade 2070, may have a bend in the upstream starting region of the outlet opening 2066. The blade 2070 may extend from the upstream end of the pump rotor 2068 along its entire length or at least along the main portion of the hub 2000. In the embodiment of Figure 20A, the hub 2000 may have a diameter that increases in the direction of flow, such that the shape of the hub 2000 thickens along the direction of flow. This shape of the hub may facilitate radial and / or diagonal discharge of blood.

[0111] The blade 2070 may include a blade section 2002 having a corrugated blade curvature (e.g., a wave blade curvature) defined by a plurality of curved portions of the skeleton line 2004 of the blade 2070. As described herein, the corrugated curvature of the blade 2070 may refer to a change in the curvature of the blade section 2002 associated with a change in at least one sign, such as positive or negative concave / convex. At least one section of the blade 2070 and / or the entire blade section 2002, or a portion of the blade section 2002, may be located radially inward of the outlet opening 2066. The blade section 2002 may be located at least partially in the region of the edge 2006 facing the flow of the outlet opening 2066. The blade section 2002 may represent one or more transitions between a convex curvature and a concave curvature. The outlet opening 2066 of the tubular housing of the circulation assist device may at least partially overlap the blade section 2002 of the impeller 2068 having a wave-blade curvature.

[0112] In certain embodiments, the impeller 2068 may include two blades 2070 wound in the same direction around a hub 2000. Each blade 2070 may have a blade section 2002. In some embodiments, the impeller 2068 may include three or more blade elements 2070, such as three, four, five, six, or more. Pump 2062, or any other pump described herein, may have additional features or modifications, such as those described in International Publication No. 2019 / 229223, filed on 30 May 2019, entitled “AXIAL-FLOW PUMP FOR A VENTRICULAR ASSIST DEVICE AND METHOD FOR PRODUCING AN AXIAL-FLOW PUMP FOR A VENTRICULAR ASSIST DEVICE”, and / or “AXIAL-FLOW PUMP FOR A VENTRICULAR ASSIST DEVICE AND METHOD FOR PRODUCING AN AXIAL-FLOW PUMP FOR A VENTRICULAR ASSIST This may include, for example, the information contained in U.S. Patent Application No. 17 / 057252 (Publication No. 2021 / 330958) filed on 18 June 2021, entitled “DEVICE”, the disclosures of which are incorporated herein by reference in whole for all purposes and form part of this Spec.

[0113] Figure 20B shows a schematic diagram of an exemplary unwinding of the skeleton line 2004 of the blade element 2010 in Figure 20A. Two pairs of blade angles α1, β1 and α2, β2 are shown as examples, each representing the tangent slope of the tangent line 2030 that represents the curvature of the skeleton line 2004. Each tangent line 2030 is drawn into the cylindrical coordinate system by the z-axis parallel to the rotation axis 2032 of the pump rotor and by the φ-axis perpendicular to the z-axis. The φ-axis represents the circumferential direction of the pump rotor.

[0114] The tangential gradient initially increases in the direction of flow, as indicated by the vertical arrow, and then decreases again. According to this design example, the tangential gradient initially increases continuously from the blade tip edge 2034 to the blade trailing edge 2036 of the blade element 2010, and then decreases again upon reaching the bend point 2031 of the skeleton line 2004. Point 2038 indicates the location of flow discharge through the outlet opening of the pump housing, or more precisely, the start of axial flow discharge. The objective here is to ensure that the bend point 2031 and the start point of flow discharge 2038 are in close proximity.

[0115] As already described, according to one design example, the pump rotor may be realized by at least two blade elements 2010. The conveying medium is delivered axially to or drawn in by the pump rotor and discharged radially and / or diagonally through one or more outlet openings 2066 in the pump housing. The blade element 2010 is configured such that the angle α between the tangent 2030 formed by the blade surface or skeleton line 2004 and the rotation axis 2032 or 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 in the opposite range. The angle β changes to increase in the flow direction from the start of the pump rotor, i.e., from the blade tip 2034, at least in the region of the maximum diameter of the pump rotor, i.e., in the section within the region of the blade tip of the blade element 2010. The angle β takes its maximum value, particularly in the flow discharge initiation region 2038 or its vicinity, at least in the region of the maximum diameter of the pump rotor, i.e., in the section within the region of the blade tip of the blade element 2010.

[0116] In some embodiments, the impeller 2068 includes blade elements 2010 having a contour with skeleton lines 2004, the curvature of each skeleton line 2004 increasing along the axis of rotation 2032 in the direction toward the inflection point 2031 where the blade angle β of the blade element 2010 is maximum, starting from the pump intake section toward the outlet opening 2066, and the curvature of each skeleton line 2004 decreases after the inflection point 2031. Furthermore, in some cases, the region of the impeller 2068 located radially with respect to the axis of rotation 2032 has a blade height SH of the blade element 2010 defined with respect to the maximum blade height SHMAX such that 25% ≤ SH / SHMAX ≤ 100%, and the inflection point 2031 of each skeleton line 2004 is located in the region of the upstream edge of the outlet opening 2066 of the inlet pipe of the tubular housing. Blade element 2010 may have other features or modifications, such as those described in International Publication No. 2019 / 229223, filed on 30 May 2019, entitled “AXIAL-FLOW PUMP FOR A VENTRICULAR ASSIST DEVICE AND METHOD FOR PRODUCING AN AXIAL-FLOW PUMP FOR A VENTRICULAR ASSIST DEVICE,” and / or those described in U.S. Patent Application No. 17 / 057252 (U.S. Patent Application Publication No. 2021 / 330958), filed on 18 June 2021, entitled “AXIAL-FLOW PUMP FOR A VENTRICULAR ASSIST DEVICE AND METHOD FOR PRODUCING AN AXIAL-FLOW PUMP FOR A VENTRICULAR ASSIST DEVICE,” the disclosures of each document being incorporated herein by reference in whole for all purposes and forming part of this Specified.

[0117] Figures 21A-C show embodiments of a pump region 2160 having a tubular housing including an impeller housing 2115. The pump region 2160 may also include a pump 2117 having an alternative embodiment of the impeller housing 2115. In some embodiments, the impeller housing 2115 may include a diffuser, as will be further described. The pump region 2160 or its features may be used with any MCS system or pump described herein. The pump region 2160 may be positioned in a minimally invasive manner through a transfemoral or transaortic catheter in the aorta and / or at least partially in the ventricle. As described herein, the pump region 2160 may include a blood pump 2117 for a cardiac assist system. The maximum outer diameter of the pump region 2160 shown in Figure 21 may be less than 10 millimeters (e.g., 7 mm or less, 5 mm or less). The pump 2117 may have an axial design including an impeller 2168 that generates axial flow. The shaft design of pump 2117 may facilitate the pump region 2160 having a maximum outer diameter of less than 10 mm.

[0118] When the pump device 2160 is operating, blood flows through the inlet tube 2105 and is discharged through the outlet opening 2180 within the periphery of the impeller housing 2115 of the pump 2117, so as to be supplied to the aorta (for example, from the left ventricle, across the aortic valve, into the aorta). This is made possible by the embodiment of Figure 21A, in which the impeller 2168 is completely enclosed within a first section by the impeller housing 2115, which is in the form of a cylindrical / tubular impeller housing, and the impeller 2168 is interrupted within a second section by the outlet opening 2180 of the impeller housing 2115, and is implemented in such an embodiment of Figure 21A. The transition between these two sections is characterized by the beginning 2125 of the outlet opening 2180.

[0119] As shown in Figures 21B-C, some embodiments of the MCS system may further include a diffuser 2130 configured to be coupled to the tubular housing. The outlet opening 2180 may be configured to facilitate the outflow of blood from the tubular housing of the pump region 2160 (e.g., from the inlet pipe 2105 and / or from the impeller housing 2115). The diffuser 2130 may be configured to guide the blood laterally toward the outlet opening 2180 after the blood has passed through the outlet opening 2180.

[0120] As shown in Figure 21B, according to some embodiments, the diffuser 2130 may be circumferentially arranged around the impeller housing 2115. In the operating position 2132, the lateral surface of the diffuser 2130 may have a cross-sectional area that increases in the direction of blood flow 2133 (see arrow). In some embodiments, the diffuser 2130 itself may also have a cross-sectional area that increases in the direction of blood flow 2133. In this case, the diffuser 2130 may have a frustoconical shape within the operating position 2132. The diffuser 2130 may have a support structure having at least one support column 2134 and / or a flexible jacket 2135. As shown in the embodiment of Figure 21B, the diffuser 2130 has a plurality of support columns 2134.

[0121] The diffuser 2130 may be configured to be transitionable from a stationary position 2137 (shown in Figure 21C) to an operational position 2132 (shown in Figure 21B) and / or from the operational position 2132 to a stationary position 2137, and the diffuser 2130 may be configured to be foldable from the stationary position 2137 to the operational position 2132. The diffuser 2130 may produce an improved flow path, lower pressure loss, and increased pump efficiency.

[0122] The diffuser 2130 may be permanently or detachably connected to the impeller housing 2115. In some cases, the diffuser 2130 is configured to be flexible, crimpable, foldable, and / or deployable. This configuration may offer the advantage of being able to closely adhere to the impeller housing 2115 in a folded or crimped state, thereby enabling minimally invasive implantation. The diffuser 2130 may consist of a support structure having several supports 2134 made of a shape memory material (e.g., nitinol) and a flexible jacket 2135. The flexible jacket 2135 may be completely or at least partially closed in the circumferential direction, may be made of silicone and / or PU, and / or may be permanently or detachably connected to the support structure. Together with the support structure in the deployed state shown in Figure 21B, the lateral surface can provide a blood flow path to reduce blood loss as it flows out of the outlet opening 2180. The diffuser 2130 may have a lateral surface that encloses an increasing cross-sectional area, i.e., a diverging cross-sectional area, in the main flow direction 2133, i.e., in the axial direction of the rotation axis of the impeller 2168, when deployed. Thus, the downstream discharge surface 2136 of the diffuser 2130 may be larger than the connection surface of the diffuser 2130 having the impeller housing 2115, and which is located on the opposite side of the discharge surface 2136. In this case, the diffuser 2130 or at least its lateral surface may be configured in the form of a frustocone. The diffuser 2130 may include other shapes and / or configurations, such as a funnel shape, dome shape, umbrella shape, inverted bell shape, bell shape, bowl shape, and / or may have a convex, concave, stepped, or angular emission surface.

[0123] Figure 21C shows the diffuser 2130 in the stationary position 2137. In the stationary position 2137, the diffuser 2130 may be configured to be in close contact with the impeller housing 2115, thereby enabling minimally invasive implantation.

[0124] Pump 2117, diffuser 2130, other pumps or diffusers described herein, or their features are described in International Publication No. 2019 / 229214, filed on 30 May 2019, entitled “PUMP HOUSING DEVICE, METHOD FOR PRODUCING A PUMP HOUSING DEVICE, AND PUMP HAVING A PUMP HOUSING DEVICE”, and / or “PUMP HOUSING DEVICE, METHOD FOR PRODUCING A PUMP HOUSING DEVICE, AND PUMP HAVING A PUMP HOUSING DEVICE”. Additional features or modifications may be present, such as those described in U.S. Patent Application No. 17 / 057548 (Publication No. 2021 / 290932), filed on 19 May 2021, entitled “DEVICE”, and the disclosures of each document are incorporated herein by reference in whole for all purposes and form part of this Spec.

[0125] Figure 22 is a side view of an alternative embodiment of the inlet pipe 2201 of the MCS system. The inlet pipe 2201 may have a main body 2225. The inlet pipe 2201 may include a first connection section 2221 (which may also be referred to herein as a first mounting section) at a first end (e.g., distal end) of the inlet pipe main body, which can connect / mount the inlet pipe 2201 to a distal end and / or to the head unit of the circulatory assist device. In some embodiments, the first connection section 2221 may be configured to connect to the distal end and / or the head unit in a form-locking manner and / or force-locking manner. The inlet pipe 2201 may also include a second connection section 2222 (which may also be referred to herein as a second mounting section) at a second end (e.g., proximal end) of the inlet pipe main body. The second connection section 2222 may connect the inlet pipe 2201 to the pump outlet. In some cases, the second connection section 2222 may connect the inlet pipe 2201 to the impeller housing. In some embodiments, the second connection section 2222 may connect the inlet pipe 2201 to the motor housing. The main body 2225 of the inlet pipe 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.

[0126] In some embodiments, the structural section 2223 may include one or more reinforcing recesses that can vary the stiffness of the inlet pipe 2201. The reinforcing recesses may extend over a portion of the structural section 2223 or over the entire structural section 2223. The reinforcing recesses may be arranged in a helical circumferential manner. The reinforcing recesses may also be in the form of slots.

[0127] Figure 22 further includes geometric reference numerals to show exemplary dimensions of the inlet pipe 2201. In the first connection section 2221, the inlet pipe 2201 may have an inner diameter of 6.5 mm (or 4.5 mm to 8.5 mm) indicated by reference numeral 2205. The outer diameter indicated within this region by reference numeral 2210 may be 7 mm (or 5 mm to 9 mm). The angle of the bend indicated by reference numeral 2215 may be 26 degrees (or 16 degrees to 36 degrees). Reference numeral 2220 may be 15 mm (or 10 mm to 20 mm) in length, representing the region of the inlet pipe 2201 including the first connection section 2221 and the pump inlet 2224, as well as the region 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. An adjacent bend in the structural section 2223, which may be inclined with respect to the longitudinal axis of the inlet pipe 2201, may have a length of 14 millimeters, as indicated by reference numeral 2225. The adjacent portion of the inlet pipe 2201, indicated by reference numeral 2230, includes the structural section 2223 and the remainder of the second connecting section 2222. Inlet tube 2201, or any other inlet tube described herein, may have additional features or modifications, such as those described in International Publication No. 2019 / 229210, filed May 30, 2019, entitled “LINE DEVICE FOR CONDUCTING A BLOOD FLOW FOR A HEART SUPPORT SYSTEM, AND PRODUCTION AND ASSEMBLY METHOD,” and / or those described in U.S. Patent Application No. 17 / 057355 (U.S. Patent Application Publication No. 2021 / 268264), filed May 18, 2021, entitled “LINE DEVICE FOR CONDUCTING A BLOOD FLOW FOR A HEART SUPPORT SYSTEM, AND PRODUCTION AND ASSEMBLY METHOD,” the disclosures of each document being incorporated herein by reference in whole for all purposes and forming part of this Specified.

[0128] Figure 23 is a perspective view of an alternative embodiment of the inlet 2301 of the MCS system. The inlet tube 2301 may be used with any pump or MCS system described herein. The inlet tube 2301 may be in the form of a mesh or braided suction hose. The inlet tube 2301 has a main body 2305. The main body 2305 may have a first connecting section 2310 at a first end for connecting the inlet tube 2301 to a distal end, and a second connecting 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 out or formed within the first connecting section 2310. The inlet opening 2340 may be implemented as a multi-part window. The pump inlet 2330 may include three rectangular inlet openings 2340, which are rounded in the form of arcs in the direction of the braided section 2320.

[0129] The main body 2305 may have a braided section (also called a mesh section) 2320 between the connecting sections 2310, 2315. The braided section 2320 has a braided structure (also called a mesh structure) 2335 formed from at least one braided wire (also called a mesh wire) 2325. The main body 2305 has a pump inlet 2330 located in the first connecting section 2310 for introducing blood flow into the base / main body 2305. The inlet tube 2301 is shaped / configured to be connectable to adjacent components of the circulatory support system. The braided structure 2335 may be shaped as a diamond grid. For this purpose, at least one braided wire 2325 may be braided as a grid and have multiple diamond meshes forming the braided structure 2335. The braided flow channel may be a braided section 2320. The braided section 2320 may be formed from a shape memory material. The inlet tube 2301 may be formed entirely from nitinol. By using nitinol, the inlet tube 2301 can be suitable not only for short-term use but also for a service life of more than 10 years. Because nitinol can combine the advantages of biocompatibility and shape memory properties, it is possible to implement complex structures in a small installation space, such as the braided section 2320 shown in Figure 23.

[0130] The braided section 2320 may be perforated at the locations of the connecting sections 2310 and 2315. For this purpose, the connecting sections 2310 and 2315 may have fastening elements for being inserted into one section of the braided wire 2325. Additionally or alternatively, the braided section 2320 may be glued or soldered to the connecting sections 2310 and 2315.

[0131] The braided section 2320 may extend over at least half of the inlet tube 2301 to adjust the stiffness of the inlet tube 2301. The inlet tube 2301 may be shaped to allow transfemoral surgery (accessed via the groin). Thus, the inlet tube 2301 may be sufficiently flexible to be pushed through the aortic arch, and may also be stiff enough to be pushed axially through the vessel without twisting. The relevant requirements regarding the flexibility and stiffness of the inlet tube 2301 may be set by the shaping of the braided section 2320. The design of the braided structure may determine the ratio of flexibility to stiffness. Variables influencing the ratio of flexibility to stiffness include the number of wire tracks of at least one braided wire 2325, the stiffness and material thickness of at least one braided wire 2325, and the braiding pattern of the braided structure 2335.

[0132] The more wire tracks a braided wire 2325 has, the more rigid the braided structure 2335 may be. The braided wire 2325 may contain, for example, 12 to 24 wire tracks. The larger the wire diameter of the braided wire 2325, the stiffer the braided structure 2335 may be. The wire diameter may be, for example, 0.1 mm to 0.3 mm. In addition, the material properties of the braided wire 2325 are important; that is, the larger the elastic modulus of the braided wire 2325, the stiffer the braided structure 2335 may be. The braided wire 2325 may have an elasticity of, for example, 74 Gpa to 83 GPa. The type of braiding of the braided structure 2335 is also important; that is, the denser the mesh braiding, the stiffer it may be.

[0133] In the embodiment shown in Figure 23, the inlet tube 2301 may be bent in the direction of the first connecting section 2310, and the bend is shaped, for example, as an obtuse angle with respect to the longitudinal axis of the inlet tube 2301. The braided section 2320 may be bent at an obtuse angle at the bending point. The bend may be achieved by heat treatment of the nitinol braided section 2320. Based on the shape memory properties of nitinol, the inlet tube 2301 can be formed with a curved shape of the braided section 2320 that corresponds to human anatomical structure, so that the inlet opening of the pump inlet 2330 of the first connecting section 2310 can be positioned in the center of the heart chamber. Inlet tube 2301, or any other inlet tube described herein, may have additional features or modifications, such as those described in International Publication No. 2019 / 229211, filed on 30 May 2019, entitled “LINE DEVICE FOR CONDUCTING A BLOOD FLOW FOR A HEART SUPPORT SYSTEM, HEART SUPPORT SYSTEM, AND METHOD FOR PRODUCING A LINE DEVICE,” and / or those described in U.S. Patent Application No. 17 / 057411 (U.S. Patent Application Publication No. 2021 / 290937), filed on 1 June 2021, entitled “LINE DEVICE FOR CONDUCTING A BLOOD FLOW FOR A HEART SUPPORT SYSTEM, HEART SUPPORT SYSTEM, AND METHOD FOR PRODUCING A LINE DEVICE,” the entire contents of each document are incorporated herein by reference in whole for all purposes and form part of this Specified.

[0134] Figure 24 is a perspective view of an alternative embodiment of the pump region 2460 of the MCS system. The pump region 2460 or its features may be used with any pump region or MCS system described herein. The pump region 2460 has an inlet tube 2401. The elongated axial design of the pump region 2460 shown in Figure 24, which has essentially a constant outer diameter, allows for transfemoral or transaortic implantation of the pump region 2460 for placement in a blood vessel, for example, in the aorta, via a catheter.

[0135] Depending on the shape of the aortic valve position, the inlet tube 2401 has, for example, a longitudinal axis inclination or curvature, and thus has a slightly curved shape. In addition to the inlet tube 2401, the pump region 2460 includes the pump unit 2486. The pump region 2460 may also include the distal tip 2485, the housing section 2488, and / or the anchoring frame 2487. The inlet tube 2401 may be positioned between the distal tip 2485 and the pump unit 2486. The pump unit 2486 is connected to the housing section 2488, to which the anchoring frame 2487 is attached, at an end spaced apart from the inlet tube 2401.

[0136] The inlet pipe 2401 may be designed to guide fluid flow from the pump region 2460 to the pump unit 2486. The inlet pipe 2401 may include a pump inlet 2430 and a contour section 2435. The pump inlet 2430 may have at least one inlet opening 2440 for introducing fluid flow into the inlet pipe 2401. At least one inlet edge of the inlet opening 2440 of the pump inlet 2430 may be rounded. The inlet opening 2440 may be designed, for example, as a window-shaped inlet opening cut or formed inside the pump inlet 2430. The contour section 2435 may have an internal contour. The contour section 2435 is positioned adjacent to the pump inlet 2430. Viewed in the flow direction, the inner diameter of the contour section 2435 at the first position is larger than the inner diameter at the second position. Therefore, in some embodiments, the inlet tube 2401 may have a reduced diameter section at its distal end. The inner contour has a rounded shape at the second position to reduce the inner diameter. The length of the contour section 2435 may correspond to the radius of the inlet tube 2401 within the tolerance range. The tolerance range may be a deviation of up to 20% from the radius of the inlet tube.

[0137] In Figure 24, the pump inlet 2430 and contour section 2435 are shown by example. In particular, the contour section 2435 may be a smaller or larger portion of the inlet canal 2401 than shown in Figure 24. At implantation, the pump inlet 2430 and contour section 2435 are located within the left ventricle. Another section of the inlet canal 2401 is led through the aortic valve, and the section of the pump region 2460 having the pump unit 2486 is located within a section of the aorta at implantation. The pump outlet 2445 within the region of the pump unit 2486 guides the fluid flow carried through the inlet canal 2401 into the aorta. Reference numeral 2450 indicates, for example, the location of a cardiac valve, such as the aortic valve, through which the inlet canal 2401 is advanced to position the pump region 2460.

[0138] Circulatory support systems that are limited in terms of installation space and can be implanted in a minimally invasive manner, such as the circulatory support system having a pump region 2460 as shown herein, have relatively small power consumption at a particular pump efficiency. Efficiency is limited by friction within the pump of the pump unit 2486. Pressure loss or friction in the inlet pipe 2401 when the fluid flow is directed from the inlet opening 2440 of the pump inlet 2430 in the heart chamber to the pump unit 2486 can be influenced by the shape of the inlet pipe 2401. For this purpose, the inlet edge of the inlet opening 2440 may be rounded to reduce pressure loss. This alone cannot prevent flow separation. Flow separation may be suppressed, thereby reducing pressure loss by an inlet inner contour formed according to the approach presented herein in the form of a contour section 2435.

[0139] Figure 25 is a partial cross-sectional view of the contour section 2435 of the inlet pipe 2401. Exemplary dimensional relationships of the contour section 2435 and the inner contour 2555 are shown. Half of the axial cross-section of the contour section 2435 is shown. The inner diameter 2560 of the contour section 2435 is larger at the first position 2565 compared to the inner diameter 2560 at the second position 2570. To reduce the inner diameter 2560 at the second position 2570, the inner contour 2555 may have a rounding 2575 in the form of an axially arc-shaped inner wall profile. The first position 2565 may indicate a point on the contour section 2435 along its longitudinal axis, and the second position 2570 may indicate a further point on the contour section 2435 along its longitudinal axis. The second position 2570 may be downstream of the first position 2565. In the exemplary embodiments shown herein, the longitudinal axis corresponds to the axis of rotation 2580 of the contour section 2435.

[0140] The first position 2565 may be located within the contour section 2435 between the pump inlet and the second position 2570. With respect to the flow direction of the fluid flow introduced through the pump inlet and directed towards the pump unit through the inlet pipe and therefore through the contour section 2435, the first position 2565 is located upstream of the second position 2570. In addition, in the embodiment of Figure 25, the inner diameter of the contour section 2435 at the third position 2585 is larger than the inner diameter at the second position 2570. The third position 2585 is downstream of both the first position 2565 and the second position 2570.

[0141] The inner radius of the contour section 2435 at the second position 2570 may be up to one-fifth smaller than the inner radius at the first position 2565. In Figure 25, this is indicated by the reference numeral 2590, which represents one-fifth of the inner radius. Correspondingly, the rounding 2575 of the inner contour 2555 is designed as a convex bulge in an area of ​​at most one-fifth of the inner radius, as additionally illustrated by the reference numeral 2590.

[0142] In some embodiments, the inner contour 2555 may be designed to be rotationally symmetric. A portion of the contour section 2435 located opposite to a portion of the inner contour 2555 shown in Figure 25, relative to the axis of rotation 2580, has a corresponding rotation of the symmetric inner contour 2555. The formation of the contour section 2435 and the inner contour 2555 shown in Figure 25 makes it possible to reduce or suppress flow divergence of the fluid flow in the inlet pipe that otherwise forms downstream of the inlet edge. In this case, the outer diameter 2595 of the contour section 2435 remains constant, and advantageously, there is no increase in the installation space of the inlet line. Pressure loss of the fluid flow can be reduced by the embodiment of the contour section 2435 shown in Figure 25, which has the inner contour 2555. The inlet flow of the fluid flow, and therefore the flow behavior, is directed only locally by the contour section 2435.

[0143] In some embodiments, the contour section 2435 may have a length equivalent to up to twice the inner diameter of the inlet pipe. Based on the shape of the contour section 2435, the pressure loss of the fluid flow is smaller further downstream compared to the inlet pipe with a constant inner diameter and no inner contour, because there is less turbulence downstream due to the suppression or reduction of separation. The inner contour 2555 is shaped so that flow separation is greatly suppressed over a length of up to four times the radius of the inlet pipe. The local outer diameter 2595 of the inlet pipe is limited by a predetermined wall thickness. To reduce flow separation, the inlet edge adjacent to the inlet opening of the pump inlet is rounded convexly. The optimization of the shape of the inner contour 2555, such as the shape shown in Figure 25, is optionally rotationally symmetric, or alternatively, independent of the angle of rotation.

[0144] In the embodiment shown in Figure 25, the optimization of the contour profile of the inner contour 2555 may be such that, regardless of the described entrance edge curvature, it forms two concave sections and one convex section with a constant wall thickness, as shown in Figure 25 with reference to the first position 2565, the second position 2570, the third position 2585 and the roundness 2575. For this purpose, the inner wall contour is optionally shaped such that a local inner wall radius of up to 4 / 5 is achieved with a constant wall thickness of the contour section 2435, based on the inner wall radius.

[0145] In some embodiments, the pump region 2460 includes a tubular housing having a supply head portion (e.g., at the pump inlet 2430) having at least one inlet opening (e.g., inlet opening 2440) for receiving fluid flow into a supply line (e.g., inlet pipe 2401). The tubular housing may also include a contour portion (e.g., contour section 2435) located adjacent to the supply head portion (e.g., pump inlet 2430) having an internal contour (e.g., surface contour 2555). The internal contour may include a first inner diameter at a first position 2565, a second inner diameter at a second position 2570, and a third inner diameter at a third position 2585. The first inner diameter may be larger than the second inner diameter, and the third inner diameter may be larger than the second inner diameter. The first inner diameter may include the maximum inner diameter of the contour portion (e.g., contour section 2435), and the second inner diameter may include the minimum inner diameter of the contour portion (e.g., contour section 2435). The inner contour (e.g., surface contour 2555) may include a rounded portion at the second position 2570. The contour portion (e.g., contour section 2435) may include a first inner radius at the first position 2565 and a second inner radius at the second position 2570, the second inner radius being up to one-fifth smaller than the first inner radius, and the second position 2570 being located between the third position 2585 and the first position 2565.

[0146] The inlet pipe 2401 or any other inlet pipe described herein is described in International Publication No. 2020 / 016438, filed on 19 July 2019, entitled “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,” and / or “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 Additional features or modifications may be included, such as those described in U.S. Patent Application No. 17 / 261335 (Publication No. 2021 / 339005), filed on 19 July 2021, entitled “SYSTEM”, and the entire contents of each document are incorporated herein by reference for all purposes and form part of this Specified.

[0147] Any embodiment of the MCS system and pump described herein may include an insertion tool. Various exemplary embodiments of insertion may be used and are described herein.

[0148] Figures 26A to E are various diagrams of embodiments of the insertion tool 2632. Figure 26A is a side view of the insertion tool 2632; Figure 26B is a longitudinal cross-sectional view of the insertion tool 2632 cut along line AA in Figure 26A; Figures 26C and 26D are cross-sectional views cut along lines BB and CC shown in Figures 26A and 26B, respectively; and Figure 26E is an exploded view of the insertion tool 2632. The insertion tool 2632 may have the same or similar features and / or functions as the insertion tool 32 in Figure 4, and vice versa. Thus, the insertion tool 2632 may be used with the pump 22 or any other pumps described herein.

[0149] The insertion tool 2632 may have an overall elongated tubular configuration defining a longitudinal axis 2650. As shown in Figure 26A, the insertion tool 2632 may include a tubular body 2636 at its distal end, which may be a cylindrical tube. The insertion tool 2632 may include a hub 2634 at its proximal end. The hub 2634 may include a connector 2639 (also referred herein to as the 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 tube 2644 having a valve 2645 (shown in Figure 26E). As further shown in the cross-sectional view of Figure 26B, the insertion tool 2632 may also include a locking mechanism 2641, a locking pad 2642, a hemostatic valve 2649, and / or one or more sealing elements 2643. The locking mechanism 2641 may include a locking tab 2646, as will be further described below.

[0150] The tubular body 2636 located at the distal end of the insertion tool 2632 may have a distal end, a proximal end, and a lumen extending between the distal and proximal ends. The tubular body 2636 may be cylindrical. The tubular body 2636 may be made from a polymer, plastic, other suitable material, or a combination thereof. The tubular body 2636 may be made from a transparent polymer such as nylon, Grilamid®, or Pebax®, which may facilitate visual confirmation of the passage of the guide wire 100 through the guide tube 83 of the guide wire 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 with a decreasing diameter distally, to facilitate the insertion of the insertion tool 2632 (e.g., insertion into the introducer sheath as described herein). The distal end of the tubular body 2636, such as a tapered distal end, may be detachably fitted into the proximal opening 90 of the guidewire aid 38. The tapered end may be made of a material such as 55DPebax® molded onto the tubular body. 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 at its proximal end to the distal end of the second housing section 2640 (for example, rotatably, so as to be switchable between an open position and a locked position 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 plug 2635 may be connected through the proximal end of cap 2637.

[0151] The locking mechanism 2641 may have a lumen extending longitudinally through its body, and the recess 2651 is configured to receive a locking pad 2642. The locking pad 2642 may be an elastomer material having a soft durometer, such as a thermoplastic elastomer, soft Pebax®, or silicone. When inserted into the recess 2651, the locking pad 2642 may have an inner surface substantially matching the inner surface of the longitudinally extending lumen of the locking mechanism 2641. As shown in Figure 26B, the locking mechanism 2641 may be located within a hub 2634 including a connector 2639, a first housing section 2638, a second housing section 2640, and a cap 2637, such that they all share a common longitudinal axis 2650 and the lumen of the locking mechanism 2641 is concentric with respect to 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, or at its proximal end to the distal end of the plug 2635. The plug 2635 may have a lumen that extends longitudinally through its body from its distal end to its proximal end.

[0152] When connected, the plug 2635, the locking mechanism 2641, the connector 2639, and the tubular body 2636 may form a fluid-sealed path extending along the longitudinal axis 2650 of the insertion tool 2632. The path may be fluid-sealed by the pump and by the catheter shaft inserted inside. A valve 2649 and / or one or more sealing elements 2643, such as an O-ring, may assist in the formation of the fluid-sealed 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 distally. When the pump or catheter shaft is inserted through the valve 2649, the conical sidewall may remain compressed around the component, although it may expand to allow the component to pass through the interior, thereby forming 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 be fluidly connected to other components of a circulating support system, such as the distal connector of a sterile sleeve 26, by including one of the sealing elements 2643, which may have a mating mechanism that locks to the plug 2635 by rotating a protrusion on the plug into a slot of the mating mechanism. The sealing element 2643 may be an O-ring, or another rounded sealing element that can seally engage with components passing through it.

[0153] A fluid-sealed path along the longitudinal axis 2650 of the insertion tool 2632 may be configured to axially movably receive a circulatory assist device or pump, such as any device or pump described herein. For example, the lumen 2620 of the tubular body 2636 may be configured to axially movably receive a pump 22 and optionally a guide tube 83 for a guide wire, and the longitudinally extending lumen within the hub 2634 may be sized to slidably receive a shaft 16 (e.g., an 8-French shaft) of the MCS device. When the pump 22 is housed in the lumen of the tubular body 2636, the shaft 16 is housed in a longitudinally extending lumen within the hub 2634, and the locking mechanism is in the unlocked state (as shown in Figure 26C), and the pump 22 may be advanced distally from the tubular body 2636 into, for example, the tubular body 116 of the introducer sheath, and then advanced distally from the introducer sheath 112 into the patient's vascular system by advancing the shaft 16 distally. The tubular body 2636 of the insertion tool 2632 has a circulatory support device such as the pump 22 inside and may be configured to be received by an introducer sheath (e.g., introducer sheath 112) as described herein. Thus, the tubular body 2636 of the insertion tool 2632 may have sufficient collapse resistance to maintain patency when it passes through the hemostatic valve of the introducer sheath.

[0154] The insertion tool 2632 may be configured to lock detachably against the circulatory support device when inserted into the insertion tool 2632. In some embodiments, the insertion tool 2632 may lock detachably against the MCS shaft 16 (also called a catheter or catheter shaft) of the circulatory support device. When the insertion tool 2632 is locked against the circulatory support device, axial movement (e.g., longitudinal / proximal / distal) of the circulatory support device may be prevented. The insertion tool 2632 may be locked against the circulatory support device by a locking pad 2642 engaging with at least a portion of the circulatory support device. To engage the locking pad 2642 with at least a portion of the circulatory support device, such as the shaft 16, the locking pad 2642 may be compressed by a locking mechanism 2641.

[0155] The locking mechanism 2641 may compress the locking pad 2642 through the interaction between one or more locking tabs 2646 of the locking mechanism 2641 and the inner surface or inner surface of the second housing section 2640. The locking tabs 2646 may extend radially outward from the opposing side walls 2647 of the locking mechanism. The locking tabs 2646 may be offset along the longitudinal axis 2650. The second housing section 2640 may be configured to rotate together with the cap 2637 relative to the first housing section 2638, relative to the locking tabs 2646, and relative to the plug 2635 (with its axis of rotation along the longitudinal axis 2650 of the insertion tool 2632). With this configuration, when the second housing section 2640 rotates, one or more inner surfaces or side walls 2640B of the second housing section 2640 may contact one or more of the lock tabs 2646, compressing the lock tabs 2646 inward and resulting in radial inward compression of the lock pad 2642. As shown in Figure 26C, when the second housing section 2640 rotates 90 degrees counterclockwise (in the orientation of Figure 26C, or clockwise relative to the first housing section 2638), the inner side walls 2640B of the second housing section 2640 may contact the lock tabs 2646 (shown in this embodiment as having a curved outer surface), pushing them inward and thereby compressing the lock mechanism 2641 inward relative to the lock pad 2642. If the lock tab 2646 is offset longitudinally, for example, the inward compression of the lock tab 2646, and thus the lock pad 2642, relative to the shaft 16 may cause the shaft 16 to bend slightly in the area of ​​the lock pad 2642, thereby holding the shaft 16 in place. Alternatively or additionally, the shaft 16 may be compressed by the lock pad 2642, which may also hold / lock the shaft 16 in place.

[0156] As shown in Figure 26C, the second housing section 2640 may include two opposing first side walls 2640A, which may be rounded as shown, or connected by two opposing second side walls 2640B that may be straight. For example, the first distance between the two opposing first side walls 2640A, forming a first diameter, may be greater than the second distance between the two opposing second side walls 2640B, forming a second diameter. In the unlocked position, as shown in Figure 26C, the two opposing first side walls 2640A may each be adjacent to their corresponding lock tabs 2646. When rotated to the locked position, the two opposing second side walls 2640B may, due to the short distance between them, contact and compress their corresponding lock tabs 2646, as described. Each locking tab 2646 may include a rounded outer corner 2646A that is contacted by the corresponding second side wall 2640B for gradual compression and to reduce the risk of breaking the tab. When the second housing section 2640 is further rotated counterclockwise (i.e., clockwise relative to the first housing section 2638) as oriented, each locking tab 2646 may include a radially outer edge 2646B that is contacted by the corresponding second side wall 2640B. The edges 2646B may be linear as shown, or in other embodiments, they may coincide with the inner contour of the second side wall 2640B. For example, when the two opposing linear surfaces of the edges 2646B and the second side wall 2640B are in contact, the second housing section 2640 may rotate to rest without requiring external force from the user. A snap-like tactile feedback may be generated by the movement of the edge portion 2646B to engage with the inner surface of the second side wall 2640B.

[0157] To unlock the circulatory assist device from the insertion tool 2632, the second housing section 2640 may be rotated in the opposite direction (clockwise as oriented in Figure 26C, or counterclockwise relative to the first housing section 2638). The first housing section 2638 and the second housing section 2640 may include features that allow the insertion tool 2632 to be kept in the unlocked position until the user of the system chooses to lock the circulatory assist device in place relative to the insertion tool 2632. In some embodiments, interaction between the flexible tab 2648 and the second housing section 2640 may allow the insertion tool 2632 to be kept in the unlocked position until the user of the system chooses to lock the circulatory assist device relative to the insertion tool 2632. Similarly, the first housing section 2638 and the second housing section 2640 may include features that allow the insertion tool 2632 to be kept in the locked position, as described, until the user of the system chooses to unlock the circulatory assist device relative to the insertion tool 2632. In some embodiments, the interaction between the lock tab 2646 and the second housing section 2640 may keep the insertion tool 2632 in the locked position until the user of the system chooses to unlock the circulation assist device relative to the insertion tool 2632.

[0158] The connector 2639 of the insertion tool 2632 may be configured to engage with (e.g., to lock / unlock removably) the introducer sheath as described herein. For example, the outer surface of the distal end of the connector 2639 may include an inner circumferential groove that can be used to engage with components such as a mating ridge or flexible tab of the lock cap 2924 in the proximal end port 2942 of the introducer sheath hub, and / or a lock of the introducer sheath. The engagement of the distal end of the connector 2639 with the lock cap 2924 may produce a snapping tactile feedback. The connector 2639 may mate with the introducer sheath lock cap 2924 in such a manner that it prevents rotation of the first housing section 2638 with respect to the introducer hub when connected, by preventing rotation of the insertion tool connector 2639 with respect to the introducer hub 2922. For example, the distal end of connector 2639 and the proximal end port 2942 of the introducer sheath may be elliptical, square, or non-circular in shape. Alternative embodiments of connector 2639 are illustrated in Figures 34A to 36B and will be described with reference to these figures. This may facilitate handling by allowing the user to hold 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.

[0159] Figure 26D shows part of the connection between the connector 2639 and the distal end of the locking mechanism 2641, and part of the connection between the connector 2639 and the proximal end of the elongated tubular body 2636. Also shown in some embodiments is a tube 2644 that can be fluidly connected to the longitudinal lumen of the insertion tool 2632. The locking mechanism 2641 may include a radially outward-extending projection that is received in a corresponding groove or recess of the connector 2639. This engagement may rotationally stabilize the locking mechanism 2641 relative to the connector 2639. Adhesive may be added to bond the projection and the groove in order to firmly connect the connector 2639 and the locking mechanism 2641. Adhesive may also be added to firmly connect them by bonding the locking mechanism 2641 to the first housing section 2638. The connector 2639 may have an inner flange having a lumen of the same size and sharing an axis 2650 with a longitudinally extending lumen within the hub 2634, the inner flange being able to provide a locking portion when the tubular body 2636 is inserted into the connector 2639 during manufacturing, thereby protecting the valve 2649 and keeping the opening to the pipe 2644 open.

[0160] Figure 26E shows an exploded view of the insertion tool 2632 according to Figures 26A-D and some embodiments. As shown, the tube 2644 may be fluidly connected to the longitudinal lumen of the insertion tool 2632 and may have a valve 2645, such as a stopcock, at its opposite end. The valve 2645 may be adjusted to prevent or allow fluid flow through the valve 2645.

[0161] The insertion tool 2632 may have a length in the range of approximately 85 mm to approximately 200 mm (e.g., approximately 192 mm). In some embodiments, the longitudinal lumen of the insertion tool 2632 may include a diameter in the range of approximately 4.5 mm to approximately 8.0 mm (e.g., approximately 5.55 mm). The insertion tool 2632 may be sized and configured such that the marker 37 (see Figure 7) is located proximal to the insertion tool hub 2634 when the pump 22 is fully inside the tubular body 2636. The insertion tool 2632 may include a hemostatic valve (e.g., hemostatic valve 2645) to seal around the circulatory support system passing through it (e.g., it may seal around the MCS shaft 16). If provided, the hemostatic valve may accommodate a passage of a larger diameter MCS device, including the pump. In a commercial embodiment of the circulatory support system, the packaged MCS device is pre-positioned inside the insertion tool 2632, and the guidewire aid is pre-loaded inside the MCS device and shaft 16, as described herein.

[0162] Figure 27 is a partial cross-sectional view, through the impeller and magnetic coupling region, of an embodiment of a rotor bearing system 2700 for a pump that may be used with various MCS systems described herein. The rotor bearing system 2700 may have non-contact torque transmission and radial and axial motor mounts, as shown in exemplary embodiments in the form of a pump for cardiovascular assistance.

[0163] The rotor bearing system 2700 has a housing 2780. The housing 2780 may be a motor housing that encapsulates a motor, a drive shaft, and / or a drive magnet, and this motor housing may be sealed to protect it from the surrounding environment. Inside the housing 2780, a first cylindrical permanent magnet 2730 is seated on a shaft 2706 driven by a motor (not shown), and the permanent magnet 2730 is mounted to rotate around a first shaft 2705.

[0164] The housing 2780 may have a first cylindrical portion having a first outer diameter 2731 (for example, in the range of 5 mm to 7 mm, preferably 6 mm) that radially encloses the motor; a second cylindrical portion having a second outer diameter 2732 smaller than the first outer diameter (for example, smaller by 0.3 mm to 1 mm, preferably 0.5 mm); and a third cylindrical portion having a third outer diameter 2733 smaller than the second outer diameter (for example, smaller by 1.7 mm to 2.3 mm, preferably 2.0 mm).

[0165] The second outer diameter 2732 may be securely fitted to the inlet pipe housing 2722, in which case the second outer diameter and the inlet pipe housing 2722 are sized such that the outer diameter of the inlet pipe housing is coplanar with respect to the first outer diameter 2731 (for example, the thickness of the inlet pipe 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 in the range of, for example, 3.2 mm to 3.8 mm, and preferably 3.5 mm.

[0166] The rotor bearing system 2700 may further include a rotor 2770 for conveying liquid, in which case the rotor 2770 includes a second permanent magnet 2740 in the form of a hollow cylinder, which is also mounted to rotate around a first shaft 2705. The second permanent magnet 2740 in the form of a hollow cylinder is located within a hollow cylinder portion 2772 of the rotor 2770. The second permanent magnet 2740 in the form of a hollow cylinder optionally includes a back iron 2750 on its outer surface.

[0167] In some embodiments, the first permanent magnet 2730 may have an outer diameter of 3 mm, a magnet height of 1 mm, and a length of 3.2 mm (for example, in the range of 3 mm to 4.2 mm). The second permanent magnet 2740 may have an outer diameter of 5.3 mm (for example, in the range of 5 mm to 5.3 mm), a magnet height of 0.6 mm (for example, in the range of 0.5 mm to 0.6 mm), and a length of 3.2 mm (for example, in the range of 3 mm to 4.2 mm). The stagger 2715 may be 1 mm (for example, in the range of 0.1 mm to 1.2 mm). The rotor 2770 may have an outer diameter of 5.3 mm (for example, 0.1 to 0.4 mm smaller than the second outer diameter 2732, preferably by 0.2 mm) and a length of 15 mm.

[0168] The rotor 2770 may be positioned as an impeller that transmits blood flow to blood pressure by converting mechanical force transmitted by a coupling (e.g., a magnetic coupling) into hydraulic pressure. The rotor 2770 may further include a tapered or conical portion 2771 that fits into portion 2772 in the form of a hollow cylinder. The outer circumference of the base surface of the conical portion 2771 may be connected to a ring-shaped opening on the axial end of portion 2772 in the form of a hollow cylinder.

[0169] The first permanent magnet 2730 and the second permanent magnet 2740 may overlap at least partially in the axial direction within the axial region marked by reference symbol 2716. In this case, the first permanent magnet 2730 is axially staggered with respect to the second permanent magnet 2740. The centers of the first permanent magnet 2730 and the second permanent magnet 2740 are marked by vertical lines, and an axial stagger 2715 is drawn between these two vertical lines.

[0170] The axial stagger 2715 may subject the second permanent magnet 2740 to a force directed to the right in Figure 27, as a result of the ball 2717 located in the rotor 2770 being pushed onto the cone 2718 located in the housing 2780, thereby causing the first bearing 2720 and the third bearing 2790, which in this case form a combined axial and radial bearing 2719, to be in contact and held. Alternatively, the ball may be located in the housing 2780, and the cone may be located in the rotor. When used as intended, the ball 2717 rotates within the cone 2718, thereby absorbing both radial and axial forces. The combined axial and radial bearing 2719 in this case is a solid body bearing. The ball 2717 is located within the conical portion 2771. The axial and radial bearing functions are achieved by a combination of two elements, namely the combination of balls 2717 and cones 2718. Balls 2717 may have a diameter of, for example, 0.5 mm to 0.9 mm, preferably 0.7 mm, and cones 2718 may have a diameter of 1 mm, a height of 0.8 mm, and a conical angle of, preferably 80°, in the range of 70° to 90°. The axial bearing function of the combined bearing 2719 has the function of a first bearing and is designed for the relative axial positioning of the rotor 2770 and the housing 2780 and / or shaft 2706 relative to each other, absorbing the axial forces arising from the arrangement of the first permanent magnets 2730 and the second permanent magnets 2740. Furthermore, the axial forces on the rotor bearing system 2700 may be adjusted so that the applied force setting can be optimized.

[0171] The area of ​​the housing 2780 containing the first permanent magnet 2730 may be radially surrounded, at least partially, by a portion 2772 of the rotor 2770 in the form of a hollow cylinder. A channel 2774, also in the form of a hollow cylinder, may be formed between the housing 2780 and the portion 2772 of the rotor 2770, through which a liquid can flow. The bore or perforation 2702 may be located within the rotor 2770, preferably within the conical portion 2771 of the rotor 2770, or within the transition of the conical portion 2771 to the hollow cylinder portion 2772 of the rotor 2770, and the bore or perforation 2702 may be in fluid communication with the channel 2774. When the rotor 2770 rotates during use, the liquid may be centrifugally discharged from the perforation 2702, and the liquid may be drawn into the channel 2774, replacing the discharged liquid in a continuous flow. In this case, flow arrow 2711 indicates the direction of liquid flow through gap 2774. Flow arrow 2712 indicates the direction of liquid flow moved by rotor blade 2773.

[0172] A second bearing 2710, which can be configured as a radial bearing, a hydrodynamic bearing, and a blood-lubricated plain bearing, may be positioned on the end of the conical portion 2771 of the rotor 2770, facing away from the housing 2780. The second bearing 2710 may be designed to absorb radial forces and may also be designed to position the rotation axis of the second permanent magnet 2740 in alignment with the shaft 2706 or the rotation axis 2705 of the first permanent magnet 2730. In this case, the second bearing 2710 may be positioned between the rotor 2770 and the insert 2721, which can be fixed in a ring-shaped end on the second housing 2722, particularly by clamping or press-fitting, and the second housing 2722 is fixed on the housing 2780. In this case, the second housing 2722 may form the outer skin of the rotor bearing system 2700, and the second housing 2722, which may also be called the impeller housing, has a plurality of outlet windows 2723. The insert 2721 is preferably a bearing housing or bearing star that can be firmly attached to the second housing 2722 (e.g., by bonding, welding, or friction fitting). The bearing star 2721 may have an outer diameter of 6 mm (e.g., in the range of 5 mm to 7 mm) and a length of 3 mm (e.g., in the range of 2 mm to 5 mm). The second housing 2722 may have an outer diameter of 6 mm (e.g., in the range of 5 mm to 7 mm), a length of 18 mm (e.g., in the range of 15 mm to 21 mm), and a wall thickness of 0.25 mm (e.g., in the range of 0.15 mm to 0.5 mm).

[0173] Alternatively, the insert 2721 and the second housing 2722 may be manufactured as a single piece that may have a consistent inner diameter. In this arrangement, the expansion inlet cannula may be connected to the combined insert and second housing 2722, for example, by laser welding.

[0174] The bearing 2710 may have a diameter of 1 mm (for example, in the range of 0.75 mm to 1.5 mm) and a length of 1 mm (for example, in the range of 0.75 mm to 2 mm).

[0175] Due to the axial stagger 2715 determined by the design between the first permanent magnet 2730 and the second permanent magnet 2740, the defined axial force in the exemplary embodiment of Figure 27 acts on the rotor 2770 in the direction of the motor, i.e., from left to right in the exemplary embodiment of Figure 27. This force is opposed by the hydraulic pressure pushed onto the rotor 2770 during operation, i.e., from right to left in the exemplary embodiment of Figure 27, which is in the opposite direction to the fluid flow 2711 generated by the rotating rotor blades 2773.

[0176] In this case, the axial force resulting from the coupling of the first permanent magnet 2730 and the second permanent magnet 2740 may be optimized to be greater than the maximum expected oil pressure, thereby ensuring that the rotor 2770 is always held in a specified axial position without exceeding the expected maximum oil pressure, and preventing the combined axial and radial bearings 2719 from being unnecessarily overloaded, thereby minimizing friction and wear and reducing the torque transmitted to the rotor. This axial force may be optimized by adjusting the dimensions of both permanent magnets 2730 and 2740 (e.g., length, thickness, outer diameter), the axial displacement or stagger distance 2715, and the segment angle α if a Halbach configuration is implemented.

[0177] Optimization studies were conducted by the applicant using a Halbach magnet configuration with a pump device having a segment angle α of 45° and an outer diameter of 6.2 mm. Due to diameter constraints of the device, the inner and outer diameters of the first permanent magnet were selected to be 1.0 mm and 3.0 mm, respectively. The inner and outer diameters of the second permanent magnet were selected to be 4.1 mm and 5.3 mm, respectively. The length of each magnet and stagger 2715 was modified and optimized to study its effect on axial force and torque. The sum of the magnet length and stagger was limited to 4.2 mm due to constraints on the length of the rigid section of the pump, so that it could traverse the meandering vascular pathway during intravascular delivery to the heart. In conclusion, the study found that the optimized design had a magnet length of 3.2 mm (length of both permanent magnets 2730 and 2740) and an axial displacement of 1.0 mm or stagger 2715, which produced the best results. Stagger 2715 in the range of 0.5 mm to 1 mm may be the basis for alternative embodiments, but proved to be suboptimal. These results may represent the optimized coupling configuration for the tested apparatus. Since the forces applied to the impeller and coupling are a function of the overall apparatus diameter, inlet pipe length, impeller design, maximum impeller speed or blood flow velocity, and other characteristics or dimensions that affect oil pressure and bearing friction losses and eddy current losses, the results may differ for apparatuses with different dimensions or characteristics than those tested.

[0178] For the purposes of this study, the maximum fluid load was assumed to be 1.2 mNm, the bearing friction loss was assumed to be 0.2 mNm, and the eddy current loss was assumed to be 0.1 mNm for a total load torque of 1.5 mNm under normal operation. Using a safety factor of 3, a maximum load torque of 4.5 mNm was fabricated. Friction and wear behavior can also be optimized by increasing the cone angle of cone 2718, in which case sufficient radial load capacity must be ensured.

[0179] Figures 28A-B show embodiments of the ultrasonic transducer 2860 that may be incorporated into embodiments of the circulatory support system described herein. For example, the ultrasonic transducer 2860 or its features may be incorporated into embodiments of the MCS system and pump described herein for long-term use, such as for the treatment of cardiogenic shock, and / or in embodiments having a magnetic drive with a sealed motor housing, and / or in other embodiments.

[0180] The ultrasonic transducer 2860 may be located distal to the blood intake port (also referred herein as the pump inlet and / or inlet opening). The ultrasonic transducer 2860 may include a positioning tab 2862 configured to bond to a positioning channel of the nosepiece (also referred herein as the distal tip) 64. A guidewire lumen (also referred herein as the guidewire port) 76 may extend through the ultrasonic transducer 2860. The ultrasonic transducer 2860 may include an acoustic backing 2866 having a proximal concave surface 2868 and a distal end surface 2870. The guidewire lumen 76 may extend through the acoustic backing 2866. The proximal concave surface 2868 may comprise at least one, preferably two or more, piezoelectric elements 2872 directed from the concave surface 2868 to convergence at a focal length 2874 in the range of about 6 mm to about 14 mm, preferably about 10 mm. The piezoelectric element 2872 on the concave surface 2868 can direct the ultrasonic waves 2878 towards a focal region 2880 located at a focal length 2874. The concave surface 2868 and the piezoelectric element 2872 may be covered by an acoustic impedance matching layer 2876.

[0181] The distal end 2870 of the ultrasonic transducer 2860 may be provided with a plurality of electrodes 2882 for connecting the conductor to the piezoelectric element 2872. In addition, positioning structures such as tabs or recesses, such as a positioning tab 2862, may be provided in adjacent structures such as the nosepiece 64 or the MCS / VSD inlet tube 70 to ensure proper rotational orientation of the ultrasonic transducer 2860 by engaging complementary tabs or recesses, such as the positioning channels described above. Thus, the focal region 2880 of the directional ultrasound 2878 is located in a blood flow path adjacent to or downstream of a blood intake port in the blood flow channel, thereby providing blood flow velocity data by evaluating the Doppler shift of the reflected ultrasound detected by the ultrasonic transducer 2860.

[0182] Other embodiments or features relating to ultrasonic flow sensors, and also methods for measuring flow by ultrasound, are described in International Publication No. 2020 / 064707, filed on 24 September 2019, entitled “METHOD AND SYSTEM FOR DETERMINING A FLOW SPEED OF A FLUID FLOWING THROUGH AN IMPLANTED, VASCULAR ASSISTANCE SYSTEM”, U.S. Patent Application No. 17 / 274354 (U.S. Patent Application Publication No. 2022 / 126086), filed on 8 March 2021, entitled “METHOD AND SYSTEM FOR DETERMINING A FLOW SPEED OF A FLUID FLOWING THROUGH AN IMPLANTED, VASCULAR ASSISTANCE SYSTEM AND The MCS system or pump may be incorporated into such a system or pump as described in International Publication No. 2019 / 234166, filed on June 6, 2019, entitled “IMPLANTABLE, VASCULAR ASSISTANCE SYSTEM”, and / or in U.S. Patent Application No. 15 / 734523 (U.S. Patent Application Publication No. 2022 / 039669), filed on December 2, 2020, entitled “SYSTEMS AND METHODS FOR DETERMINING A FLOW SPEED OF A FLUID FLOWING THROUGH A CARDIAC ASSIST DEVICE”, and the entire contents of each document are incorporated herein by reference in whole for all purposes and form part of this specification.

[0183] Figure 29 shows a side view of the expandable introducer sheath 2912. The expandable introducer sheath 2912 may be used in conjunction with any embodiment of the MCS system or pump described herein. The expandable introducer sheath 2912 may have a hub 2922 and associated components similar to those of the introducer sheath 112 described in connection with Figure 5, and vice versa. Furthermore, the elongated tubular body of the introducer sheath 2912 is expandable from a first reduced inner cross-sectional area to a second enlarged inner cross-sectional area, thereby allowing, for example, the passage of a device having an outer diameter (OD) larger than the first reduced cross-sectional area. The introducer sheath may be biased to return to the first reduced cross-sectional area, or to approximately return to such a cross-sectional area, after expansion in response to the passage of a sheath expansion device (e.g., the MCS and / or VSD device described herein) through it. The expandable introducer sheath 2912 may include an expandable support structure 2932, such as a tubular framework consisting of multiple zigzag sections of a shape memory material such as nitinol, which allows for radial expansion in the presence of an expansion device passing through it, but returns to a first reduced cross-sectional area after the device is removed. The expandable support structure 2932 may be enclosed within a tubular flexible membrane 2930 capable of accommodating radial expansion and contraction. Furthermore, as shown in the figure, the expandable introducer sheath 2912 may include a distal end 2920, a proximal end 2940, a lateral port 2926, a suture hole / eye 128, a proximal hub 122, and a proximal port 2942, similar to the introducer sheath 112 described herein, which includes a distal end 120, a proximal end 118, a lateral port 126, a suture hole / eye 128, a proximal hub 122, and a proximal port 124. The expandable introducer sheath 2912 may also include a locking cap 2924 at its proximal end having one or more features that can engage / lock with an insertion tool (e.g., insertion tool 32 and / or insertion tool 2632) such as the connector 2639 and / or dilator (e.g., dilator 114) as described herein.

[0184] Another embodiment of an MCS device having a sealed rotating shaft is shown in Figures 30A to 30C. Figure 30A is a partial cross-sectional view of a device having two opposing lip seals, a front disk, a central disk, and a back disk contained within a seal housing; Figure 30B is an isometric, exploded, partially cut view thereof; and Figure 30C is a cross-sectional view of the seal components separated as a subassembly. The MCS devices of Figures 30A to 30C, or any modifications or embodiments thereof, may be included in any MCS device described herein, and may also include any features for an MCS device 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 or features of Figures 30A to 30C, in particular their sealing features. Alternatively or additionally, any embodiment of a pump described herein may include other sealing features, such as those described in U.S. Provisional Patent Application No. 63 / 229436, filed on 4 August 2021, entitled “SEAL FOR A MECHANICAL CIRCULATORY SUPPORT DEVICE,” the entirety of which is incorporated herein by reference for all purposes and forms part of this specification.

[0185] As shown in Figures 30A to 30C, the apparatus includes a distal annular radial or rotary shaft seal 3266 having a radially inward-facing contact lip 3267 that forms a seal cavity 3176a. The contact lip 3267 and seal cavity 3176a of the distal seal 3266 are oriented proximal. Thus, the distal seal 3266 has an "open side" that faces proximal toward the motor and a "flat side" that faces distal toward the impeller and blood. Thus, the distal seal 3266 is oriented "rearward" from the conventional orientation. In some embodiments, the "open side" may be a side of the seal 3266 that is partially formed by the upper flange and / or lower flange or by the lip of the seal 3266. The cavity may be formed by the open side of the seal 3266. The cavity may be formed between the end wall of the seal 3266 and one or more flanges or lips of the seal 3266. The cavity may contain a spring and / or grease located inside. Further details regarding the end walls, lips, etc., are described herein.

[0186] The device further includes a proximal annular radial or rotary shaft seal 3270 having a radially inward contact lip 3271 that forms a seal cavity 3176b. The contact lip 3271 and seal cavity 3176b of the proximal annular seal 3270 are distally oriented. Thus, the proximal seal 3270 has an "open side" (as described above) distally oriented toward the motor and a "flat side" proximal oriented toward the impeller and blood. Thus, the seal assembly includes the proximal annular seal 3270 and a distal annular seal 3266 having opposite orientations, whose contact lips 3267, 3271 and their seal cavities 3176a, 3176b are opposite each other.

[0187] Lips 3267 and 3271 are in contact with shaft 3140. Lips 3267 and 3271 may extend along shaft 3140. All or part of one or more radially inner surfaces of lips 3267 and 3271 may be in contact with shaft 3140. Lips 3267 and 3271 may be flat and / or have non-flat features, for example, as will be described in more detail herein with respect to Figure 30C.

[0188] The seals 3266, 3270 may include radially outward lips 3263, 3264. The lips 3263, 3264 may contact the radially inward surface of the housing or other components of the sealing compartment. The lips 3263, 3264 may extend along the housing or other components. The lips 3263, 3264 may seal the space between the seals 3266, 3270 and the housing or other components. The radially outward surfaces of the lips 3263, 3264 may be flat, non-flat, or a combination thereof.

[0189] Lips 3263 and 3264 may extend from their corresponding end walls 3262 and 3259, respectively. Lip 3263 extends distally from end wall 3262. Lip 3264 extends proximal to end wall 3259. End walls 3262 and 3259 may refer to the “flat” sides as described herein. Radially inner lips 3267 and 3271 may extend from end walls 3262 and 3259 as described. Outer lips 3263 and 3264 may extend perpendicularly to end walls 3262 and 3259, either when there is no external force and / or when installed within a seal compartment. Outer lips 3263 and 3264 may have the same or similar features as inner lips 3267 and 3271, such as a leading edge, groove or recess, etc.

[0190] In some embodiments, the central elastomer disc 3260 may be positioned between the proximal annular seal 3270 and the distal annular seal 3266. The distal elastomer disc 3255 may be positioned distal to the distal annular seal 3266. The proximal elastomer disc 3275 may be positioned proximal to the proximal annular seal 3270.

[0191] Optionally, a seal housing fabricated from a front seal container 3240 and an optional seal container cap 3278 (see Figures 30B and 30C) may house the seal components within a subassembly. The subassembly may be inserted onto the drive shaft 3140 and into the motor housing 3164. Alternatively, the seal components may be assembled within the motor housing by inserting each component separately and sequentially into the cavity of the motor housing onto the drive shaft 3140. The seal components may then be covered by a rear (proximal) seal cap 3278 that can be attached to the motor housing (e.g., by welding, friction fitting, morph fitting, or bonding).

[0192] Both the distal elastomer disc 3255 and the central elastomer disc 3260 may be made from an elastomer biocompatible material such as PTFE, elastic polyurethane, or a compound material such as PTFE and polyimide. As shown in Figure 30B, one or more of the discs 3255, 3260 may have an inner diameter (ID) 3256, 3261 smaller than the outer diameter (OD) of the drive shaft 3140, which may optionally include an impeller back extension 3154 with which the inner diameter contacts. For example, the IDs 3256, 3261 may be in the range of 80% to 95% (e.g., about 87%) of the OD 3141. In one configuration, the IDs 3256, 3261 are 0.52 mm ± 0.02 mm and the OD 3141 is 0.60 mm ± 0.01 mm. This dimensional difference causes high interference between the elastomer discs 3255, 3260 and the drive shaft in order to maintain a seal. For example, the ideal interference may be in the range of 0.070 mm to 0.080 mm. Both elastomer discs 3255 and 3260 may have a thickness in the range of 80 μm to 140 μm (e.g., about 100 μm).

[0193] The properties of the elastomer discs 3255, 3260, such as high interference, material durometer (e.g., in the range of 70 Shore to 85 Shore), and thickness, may allow the disc to deform when inserted onto the drive shaft. For example, the disc may be compressed outward so that the disc ID can be stretched, or the plane of the disc may be curved, particularly in the area close to the ID. The deformation of the disc may provide contact pressure against the drive shaft 3140, even if the disc material wears down over time. Furthermore, high interference may provide an amount of material that can be worn down before the contact pressure decreases to zero, which may extend the functional lifespan of the discs 3255, 3260 to act as a blood barrier. Additionally, high interference may compensate for small tolerances of eccentricity of the drive shaft within the disc.

[0194] The properties of discs 3255 and 3260 may allow them to act as fluid barriers for at least a portion of the intended duration of use of the MCS device, while minimizing friction or reducing torque transmission. Additionally, the distal elastomer disc 3255 may function as a primary barrier against blood for at least a portion of the duration of use. The central elastomer disc 3260 may function as an additional barrier against blood, if it is configured to pass through the more distal barrier. Disc 3260 may also act as a separator between the distal annular seal cavity 3176a and the proximal annular seal cavity 3176b, thereby helping to maintain the grease contained within those cavities adjacent to each annular seal, thereby extending the functional duration of the annular seals. Optionally, the grease or lubricant dispensed into the distal seal cavity 3176a may be the same as or different from the grease or lubricant dispensed into the proximal seal cavity 3176b. In some embodiments, the proximal disk 3275 may have the same or similar characteristics as the distal disk 3255 and the central disk 3260.

[0195] Apart from their relative position and orientation, the distal seal 3266 and the proximal seal 3270 may have similar properties with respect to each other and with respect to other seals 3156 disclosed in relation to other implementations. For example, both the distal and proximal seals may have annular seals with seal holders 3265, 3274, contact lips 3267, 3271, seal cavities 3176a, 3176b partially defined by the seal holders and the annular seals, and / or gutter springs 3269, 3273 held in the corresponding seal cavities 3176a, 3176b, respectively. The seals 3266, 3270 may have the same inner diameter and lip dimensions. Optionally, the seals 3266, 3270 may have mainly different outer diameters so that they are easily distinguishable from each other during manufacturing.

[0196] As an alternative to the garter springs 3269 and 3273, the seal may include a different component that applies a radially inward force, such as an O-ring, or it may not have a separate component that applies force, in which case the properties of the elastomer annular seal having a contact lip are such that it applies a radially inward contact force on its own.

[0197] The distal annular seal 3266 and the proximal annular seal 3270 may be made from a biocompatible elastomer material such as PTFE, elastic polyurethane, or a compound material such as PTFE and polyimide, and may optionally have one or more additives to enhance durability. Grease may be contained in one or both seal cavities 3176a, 3176b, or, more optionally, in a third grease reservoir held between the proximal seal and the proximal disk 3275, and the grease may be the same grease or a different grease. In one implementation, a first grease is deposited in the distal seal cavity, and this first grease may have a higher viscosity and higher grease consistency (e.g., NLGL class 4) compared to a third grease deposited in the proximal seal cavity (e.g., NLGL class 2) or a second grease held in the third grease reservoir held between the proximal seal and the proximal disk. In another implementation, grease is deposited in the distal seal cavity (e.g., NLGL class 4 or higher), and oil is deposited in the proximal seal cavity.

[0198] Optionally, the distal seal 3266 may have a tip edge 3231 on its distal surface, which, in addition to the contact lip 3267, is the surface of the distal seal that contacts a rotating member such as the drive shaft 3140. The tip edge 3231 is a portion of the distal annular seal 3266 having a smaller inner diameter compared to the inner diameter of a portion of the contact lip 3267 located proximal to the tip edge 3231. The tip edge 3231 may also be a portion of the distal annular seal 3266 having an inner diameter smaller than the outer diameter of the motor drive shaft 3140 with which it fits. For example, the ID of the tip edge may be in the range of 75% to 95% (e.g., 80% to 90%, approximately 87%) of the OD 3141. In one implementation, the ID is 0.52 mm and the OD 3141 is 0.60 mm. By providing a coplanar connection to the rotating shaft 3140 on the distal surface of the seal, the tip edge may function to reduce the occurrence of blood being actively drawn directly beneath the contact lip 3267, which may contribute to extending the life of the seal. The distal annular seal 3266 may be manufactured as shown, having a groove between the tip edge 3231 and the contact lip 3267. The tip edge 3231 may be partially formed by adjacent grooves or recesses formed on the inner surface of the lip 3267. Alternatively, the tip edge 3231 may have a smooth transition to the contact lip 3267.

[0199] When the contact lip 3271 and the seal cavity 3176b are oriented distally, the orientation of the proximal seal 3270 may facilitate the overall sealing function in various ways, for example, by ensuring that the lubricating grease covering the contact surface between the contact lip 3267, 3271 and the drive shaft 3140 is retained within the cavities 3176b, 3176a between the distal seal 3266 and the proximal seal 3270, thereby reducing wear, minimizing reductions in torque transmission or thermoformation, and further enabling resistance to blood intrusion, as well as allowing greater pressure on the distal side of the seal 3270 compared to the proximal side (for example, due to compressed grease retained within the seal cavity 3176b, or corresponding to blood passing through a more distal blood barrier) to support the contact pressure on the contact lip 3271. The axial length of the portion of the contact lip 3271 that is in contact with the shaft may be in the range of 0.3 mm to 0.8 mm (for example, about 0.5 mm).

[0200] Optionally, the device may have a proximal disk 3275 positioned proximal to the proximal seal 3270, as shown in Figure 30A. The proximal disk may function as another barrier to prevent blood from entering the drive shaft bearing 3162 or motor compartment. Furthermore, the proximal disk may help accommodate small tolerances in the eccentricity of the drive shaft. The proximal disk 3275 may be made from a biocompatible elastomer material such as PTFE or elastic polyurethane or compound, and may have an overall disk shape with a central hole having an inner diameter 3276 through which the drive shaft 3140 passes and makes contact. The ID 3276 may be in the range of 80% to 97% (e.g., about 93%) of the OD 3141. In one implementation, the ID is 0.56 mm and the OD 3141 is 0.6 mm, which may be larger compared to the ID of the distal disk 3255 or the central disk 3260, so as to have less impact with respect to torque transmission loss. Optionally, the proximal disk 3275 may be thicker than the distal disk 3255 or the central disk 3260, as shown in Figure 30A, which, along with the elastomer properties of the disk, may provide axial compression of the sealing components when the proximal disk is compressed between the front seal container 3240 and the edge on the motor housing 3164. For example, the thicknesses of the proximal disk, central disk, and distal disk may be in the range of 0.10 mm to 0.15 mm. The proximal disk 3275 may be compressed axially based on the dimensions of the stack of each sealing component in the axial direction, and based on the space in the housing that compresses the stack. In some embodiments, the proximal disk 3275 may be non-flat to provide compression, and may be spherical, for example, in the shape of a Belleville washer.

[0201] Figures 30B and 30C show the apparatus of Figure 30A, but with the addition of a relatively thin proximal disk 3275 and a seal container cap 3278. In this implementation, all sealing components are contained within the seal container, for example, as a subassembly. The seal container may include a front seal container 3240 and a seal container cap 3278, both of which may be made from a metal such as stainless steel or titanium and may be securely connected by, for example, friction fitting, morph fitting, screwing, or welding.

[0202] The front seal container 3240 functions to enclose the seal components with or without the seal container cap 3278 and also functions to facilitate manufacturing. The front seal container has a flat and rigid distal surface 3241 that provides a surface for mechanically pushing the seal components into the motor housing 3164 while protecting the softer and more fragile seal components. The flat and rigid surface 3241 also ensures that the axial gap 3174 between the surface 3241 and the impeller is consistent, as a result of blood being released in the axial gap and the back of the rotating impeller not inadvertently coming into contact with the seal components. The surface 3241 has a central hole 3242 with an inner diameter larger than the outer diameter of the drive shaft 3140. For example, the hole 3242 may have a diameter larger than the outer diameter of the rotating part passing through the hole, in the range of 0.080 mm to 0.150 mm (e.g., about 0.100 mm), thereby functioning as a physical filter to prevent particles from leaking out of the container as a risk management measure. For example, when the diameter of the drive shaft is 0.60 mm, the hole 3242 may be in the range of 0.68 mm to 0.75 mm (e.g., about 0.70 mm). In other words, the radial gap between the drive shaft and the container 3240 may be in the range of 0.040 mm to 0.075 mm (e.g., about 0.050 mm). The front-seal container has cylindrical side walls with inner surfaces 3248 that function to restrict the sealing components so as to ensure there is no lateral movement that could impair the integrity or lifespan of the seal. The proximal chamfer 3244 facilitates insertion into the motor housing during manufacturing. The distal chamfer 3243 facilitates the insertion of the inlet tube 3070, or alternatively, facilitates the insertion of the impeller housing 3082 above the front seal container 3240. Furthermore, the front seal container 3240 may have a recessed outer surface 3245 for insertion into the motor housing 3164. The embodiment of the cardiac pump having the seal element 3156 shown in Figure 30A may have a motor housing with a length of 25.5 mm or less.The length of the motor housing may be extended by 33 mm or less, due to the additional length added to the motor housing by the seal subassembly and by an optional wiring module connected to the proximal end of the motor housing.

[0203] Methods for manufacturing the seal subassembly may include, but are not limited to, inserting the seal components into the front seal container in the order and orientation described herein; dispensing grease into each seal cavity, optionally sequentially or simultaneously; removing air bubbles using a centrifuge or vacuum chamber; and closing the seal container with the seal container cap 3278. The seal subassembly may be inserted onto the drive shaft 3140 and optionally into the motor housing, and may be connected to the motor housing by laser welding, for example, the intersection which may include the rubbed 3246 of the front seal container 3240 and the rubbed 3247 of the motor housing. The impeller may be connected to the drive shaft in arrangements described herein, for example, with respect to other embodiments and figures. The impeller housing 3082 or inlet pipe 3070 having an integrated impeller housing may be connected to the motor housing and / or the front seal container 3240. The device may be packaged in an airtight package with the air removed to prevent the grease dispensed into each seal from drying out.

[0204] Figures 31A to 33G illustrate aspects and embodiments of the distal end 3350 of a pump that may be used with various MCS systems, such as those described herein. Figure 31B shows another view of the pump tip 3307 of the distal end 3350 of the pump shown in Figure 31A, separated from the rest of the system. Figures 32A and 32B illustrate alternative embodiments of the distal end of the pump that may be used with various MCS systems, such as those described herein. Figures 33A and 33B show cross-sectional views of alternative embodiments of the distal end of the pump and pump tip 3307 shown in Figures 32A and 32B, respectively. The pump tip 3307 may be used with any pump region of any MCS system described herein.

[0205] The distal end 3350 of the pump may include a guidewire port 3335, such as a distally facing opening on the distal surface of the pump tip 3307. The pump tip 3307 may have a non-traumatic outward curve 3331. The distal tip 3307 may be configured to connect to an inlet pipe 3345 beginning at a substantially midway connection point 3309 along the entire length of the pump tip 3307. The connection point 3309 may additionally correspond to the inlet pipe 3345 and the distal end of a tubular housing 3342. The tubular housing 3342 may include a tapered tip 3343. In other examples, the tip 3343 of the tubular housing 3342 may be substantially coplanar with the curve 3331 of the pump tip 3307 at the connection point 3309.

[0206] The pump tip 3307 may include a distal portion 3306, a recessed portion 3340, a middle portion 3321, and an inner proximal portion 3323. The distal portion 3306 may include a guidewire port 3335 at its distal end and may have a non-traumatic lateral curve 3331. The non-traumatic lateral curve 3331 of the distal portion 3306 may terminate at the recessed portion 3340 such that a recess 3340 is formed, having a diameter 3353 smaller than the diameter 3302 of the distal portion 3306. The diameter 3353 of the recessed portion 3340 may additionally be smaller than the diameter 3312 of the middle portion 3321 or the inner proximal portion 3323 of the pump tip 3307. The recess 3340 may include a ring or other shape having a diameter smaller than the maximum diameter 3302 of the distal portion 3306. In some examples, the diameter 3302 of the distal portion 3306 may be in the range of 3mm to 6mm, such as approximately 4.7mm or 5.2mm, and the diameter 3312 of the intermediate portion 3321 may be in the range of 3mm to 6mm, such as approximately 4.5mm. The section between the central portion 3321 and the recessed portion 3340 may be a sloping portion 3339. The sloping portion 3339 may increase in diameter towards the proximal end of the recessed portion 3340 and may terminate at the intermediate portion 3321. The sloping portion 3339 may form a 30-degree incline with respect to the longitudinal axis of the pump tip 3307. The central portion 3321 may have a diameter 3312 that is larger than the diameter 3353 of the distal end of the recessed portion 3340 and smaller than the maximum diameter 3302 of the distal portion 3306. The intermediate portion 3321 may have a substantially constant outer diameter, such as being substantially cylindrical. The intermediate portion 3321 may be connected to the inner proximal portion 3323 which has an outer curve 3333. The outer curve 3333 may be inclined, convex, or other shapes, terminating at the guide wire port 3337 at the proximal end. The outer curve 3333 may be a frustoconical shape, tapering in diameter towards the proximal end.

[0207] The length 3361 of the distal portion 3306 may be approximately equal to, less than, or greater than the combined length of the length 3355 of the intermediate portion 3321 (shown in Figure 31B, or 3355A / B shown in Figures 33A and B) and the length 3357 of the medial proximal portion 3323 (shown in Figure 31B, or 3357A / B shown in Figures 33A and B). Thus, the recessed portion 3340 may be located approximately midway along the entire axial length of the pump tip 3307. In some examples, the length 3361 may be in the range of about 3 mm to 7 mm, for example, about 5.5 mm; the length 3355 may be in the range of about 1 mm to 4 mm, for example, about 2.5 mm; the length 3357 may be in the range of about 1 mm to 4 mm, for example, about 2.5 mm; and the total length may be in the range of about 6 mm to 15 mm, for example, about 10.5 mm.

[0208] The interior 3351 of the pump tip 3307 may be configured to receive a guidewire, such as those described herein. The interior 3351 may be referred to herein as the guidewire lumen. The contour of the interior 3351 may be straight, tapered, or all or part of another shape. For example, the interior 3351 may be straight along the length of the pump tip 3307 to form a cylinder, or it may form a curve 3325 to form a funnel, trumpet, taper, or other flare at both the proximal guidewire port 3335 and / or the distal guidewire port 3337. The shape and / or internal dimensions of the interior 3351 of the pump tip 3307 may be configured to control the interaction between the guidewire and the pump tip 3307. For example, as shown in Figures 33A and 33B, the shape and / or internal dimensions of the pump tip 3307, including but not limited to the total length of the interior 3351, the inner diameter 3310 of the interior 3351 (such as that shown in Figure 33B), and / or the outlet diameters 3311A / B of the guidewire ports 3335 / 3337, may be adapted based on the radius of curvature of the guidewire to improve the sliding of the MCS device over the guidewire during delivery. The outlet diameters 3311A / B may be in the range of approximately 2mm to 4mm, such as a diameter of approximately 2.2mm. The inner diameter 3310 may be in the range of approximately 1mm to 2mm, such as approximately 1.5mm. For example, a shorter length of the pump tip 3307 may help to facilitate a reduction in frictional force between the guidewire and the guidewire lumen due to less contact with the shortened pump tip 3307. The ratio of the length to the minimum diameter of the interior 3351 may be selected based on one or more guidewire parameters, such as the radius of curvature of the guidewire. Additionally, the pump tip 3307 may be tapered at the guidewire ports 3335 and / or 3337 so that the ports have a larger outer diameter than if the interior 3352 were cylindrical. This allows for the removal of the guidewire even if the guidewire has one or more twists of up to 45 degrees in the transition zone of the flexible section.Advantageously, the tapered design of the guidewire allows it to be straightened during removal without generating significant frictional forces.

[0209] As shown in Figures 32A and 32B, the total length 3304A / B, the length 3313A / B of the distal portion 3306A / B, and the length 3315A / B of the proximal portion 3303 may be modified in different embodiments. Other lengths and / or dimensions, such as the length 3357A / B of the inner proximal portion 3323, and the combined length 3355A / B of the intermediate portion 3321 and recess 3340, which together constitute the length 3315A / B of the proximal portion 3303, may be additionally modified and / or remain in similar ratios. As described above, the selected length 3304A of the pump tip 3307 may help to facilitate the reduction of frictional force between the guidewire and the guidewire lumen due to less contact with the pump tip 3307. The ratio of the total length 3304A / B of the interior 3351 to the minimum diameter may be selected based on one or more guidewire parameters, such as the radius of curvature of the guidewire. In some examples, lengths 3313A and / or 3313B may range from approximately 3mm to 7mm, such as approximately 5.5mm; lengths 3315A / B may range from approximately 3mm to 7mm, such as approximately 5mm; and / or total length 3304A / B may range from approximately 6mm to 15mm, such as approximately 10.5mm. Various lengths and diameters may be selected to define a lumen contour or curvature similar to the radius of curvature of the guidewire.

[0210] As shown in Figures 32A and B, and 33A and B, the maximum diameter of the pump tip 3307 may include the maximum diameter 3308 of the distal portion 3306. The outer diameter 3308 of this distal tip may be between 4 mm and 6 mm, such as 4.7 mm or 5.1 mm. As shown in Figures 32A and 33A, the maximum diameter 3308 may be coplanar with respect to the inlet pipe 3346A. Alternatively, the maximum diameter 3308 may be larger than the diameter 3305B of the inlet pipe 3346B. The maximum diameter 3308 of the distal portion 3306 may be within the range between the inner and outer diameters of the insertion pipe 3301.

[0211] The maximum diameter 3308 of the pump tip 3307 may be smaller than the outer diameter of the insertion tube so as to interlock only with respect to the insertion tube at the tip of the insertion tool. If the maximum diameter 3308 is smaller than the inner diameter of the insertion tube 3301, there is a risk that pushing the pump tip 3307 in may expose the distal end of the insertion tube. If the maximum diameter 3308 is larger than the outer diameter of the insertion tube 3301, it increases the risk of the device becoming stuck in the insertion sheath valve when removing the device after the procedure.

[0212] Advantageously, the larger distal portion 3306 of the pump tip 3307 may help prevent the pump tip 3307 from advancing excessively proximal into the insertion tube 3301 of the insertion tool. For example, if the distal portion 3306 is coplanar with respect to the inlet tube (e.g., having a similar outer diameter to the inlet tube 3301), the exposed lip of the insertion tube may catch on the introducer handle when the device is advanced distally into the introducer. This could expose or create sharp corners, potentially causing damage to the blood vessel or introducer sheath. For example, if the pump tip 3307 is inserted slightly off-axis with respect to the longitudinal axis of the introducer, the pump tip 3307 may be pushed into the insertion tube, in which case the distal portion of the insertion tube is unsupported and could cause serious damage to the tip of the insertion tube. In a design with an enlarged distal portion 3306 of the pump tip 3307, it is possible to reduce the likelihood of the distal portion 3306 being pushed proximally into the insertion tube, thereby helping to prevent damage to the insertion tube due to the distal portion of the tube being unsupported. Additionally, when the outer diameter of the pump tip is similar in size to the outer diameter of the inlet tube of the insertion tube, only a small force (approximately 2.5 Newtons) is required to push the distal tip in, so there is a potential risk that the device may be pushed into the insertion tube during insertion. If this occurs, the distal end of the insertion tube 3343 may remain unprotected, and there may be a risk of damage to the distal end.

[0213] As described above, the MCS system may include an insertion tool that can be coupled to the introducer. For example, the MCS system may include an insertion tool 2632 having a tubular body 2636 configured such that its proximal end connects to the distal end of the connector 2639 of the insertion tool shown in Figure 26E. The connector 2639 may also be mated to the introducer sheath lock cap 2924 (Figure 29) 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 2922 when connected.

[0214] Figures 33C to 33G illustrate alternative embodiments of the pump tip 3307 that may be used with the MCS system described herein. Figure 33C shows a radial cross-sectional view, Figure 33D shows a side view, Figure 33E shows a perspective view, Figure 33F shows a detailed perspective view of the recessed portion 3340 (such as the one described herein with reference to Figure 31B), and Figure 33G shows an axial cross-sectional view. As shown, the pump tip 3307 may be configured to have one or more notches 3372, 3374 on the lateral surface and / or circumferential side surface of the pump tip 3307. The notches 3372, 3374 may be located in the proximal region of the pump tip 3307. The notches 3372 may be configured to receive one or more sensors, such as a pressure sensor and / or an ultrasonic sensor. One or more sensors may be located in a recess or cavity formed by the notch 3372 and may be mounted against one or more surfaces 3370 adjacent to the notch 3372. Surface 3370 may be a portion of the outer surface of the side wall of the pump tip 3307. The notch 3372 provides space for holding sensors, such as MEMS sensors for detecting pressure and / or temperature. The cutout 3374 provides space for a conductor. The space around the extension 3380 provides an area for mounting an ultrasonic transducer. The diameter of the distal portion 3306C of the pump tip 3307 may range from 4 mm to 8 mm, such as about 6 mm or about 6.5 mm. The interior 3351 may include a guidewire port 3335 and may have a flared distal opening and a cylindrical proximal opening. The interior 3352 may extend proximal into the extension 3380 projecting proximal from the pump tip 3307, as shown in the figure.

[0215] Figures 34A and 34B illustrate alternative embodiments of an insertion tool versus introducer connector, including a male mating portion 3400 and a female mating portion 3450, which may be used in place of connector 2639 (Figure 26E) in various MCS systems. Figures 35A and 35B are sequential diagrams illustrating the steps of self-aligning the mating portion 3400 and the female mating portion 3450. Figures 36A and 36B are sequential diagrams illustrating the steps of mating the male mating portion 3400 and the female mating portion 3450.

[0216] The male mating portion 3400 may include a hexagonal distal portion 3404 and a proximal portion 3402. The proximal portion 3402 may be configured to connect to an insertion tool such as the insertion tool 2632 shown in Figure 26E. The hexagonal distal portion 3404 may include an insertion tube connecting portion 3403, one or more walls 3410 configured to form a hexagonal or other polygonal shape with radial symmetry, such as a polygon with 3, 4, 5, 6, 7, or 8 side sides, and recessed portions 3408 that are radially recessed inward relative to adjacent walls 3410. The hexagonal distal portion 3404 of the male mating portion 3400 may have a maximum diameter smaller than the outer diameter of the proximal portion 3402. The proximal portion 3402 may include a lateral receiving region 3406 for receiving a tube such as the tube 2644 shown in Figure 26E. The lateral receiving region 3406 may be an opening with a diameter similar to that of the tube, or it may be an opening slightly larger than that of the tube.

[0217] The distal hexagonal portion 3404 may include one or more walls 3410, such as six walls, to form a hexagonal shape. One or more walls 3410 may be connected by one or more rounded edges 3416. The distal surface 3407 of the distal hexagonal portion 3404 may also include one or more rounded edges 3412. The main surfaces of one or more walls 3410 may be parallel to the longitudinal axis of the male mating portion 3400, and the rounded edges 3416 may extend parallel to the longitudinal axis. Thus, the distal hexagonal portion 3404 may form a hexagonal shape that extends longitudinally and has a recessed portion 3408.

[0218] Additionally or alternatively, the main surfaces of one or more walls 3410 may be inclined with respect to the longitudinal axis of the male mating portion 3400 (e.g., tapered or stepped) such that the minimum diameter of the hexagonal distal portion 3404 is located at the distal end 3407 and the maximum diameter of the hexagonal distal portion 3404 is located at the distal end 3414 of the lateral receiving region 3406. Thus, the hexagonal distal portion 3404 may form a truncated hexagonal pyramidal or conical shape with a recessed portion 3408. Advantageously, a slight conical shape may facilitate the removal of the male mating portion 3400 from the mold used to form the part, and may also facilitate the self-centering of the male mating portion 3400 with respect to the female mating portion 3450 described herein. Additionally, having a hexagonal shape facilitates alignment, making connection easier and allowing alignment of the male mating portion 3400 and the female mating portion 3450 in more ways than would be possible with an elliptical or other shape.

[0219] The insertion tube coupling portion 3403 of the male mating portion 3400 may include a coupling for permanent or temporary connection to the tubular body 2636. The insertion tube coupling portion 3403 may be located at the distal end 3407 of the male mating portion 3400. The coupling may be threaded, bayonet, snap-fit, or similar, or a combination thereof. Advantageously, the coupling may allow the tubular body 2636 to be detached so that tubular bodies of different dimensions or characteristics can be connected to its designated position. This may provide the user with multiple options for how the MCS device is delivered, for example, using a fixed or expandable introducer sheath. Advantageously, having the option to use a fixed or expandable sheath can assist in passing the introducer through tortuous anatomical structures, such as winding and calcified blood vessels, and can be switched as needed.

[0220] The recessed portion 3408 of the hexagonal distal portion 3404 may define a channel configured to receive one or more projections 3462 of one or more tabs 3458 of the female mating portion 3450. The depth of the channel may be based on the dimensions of one or more projections 3462 of the tabs 3458 of the female mating portion 3450 in order to maintain interpartinature and / or provide tactile feedback when one or more projections 3462 of the tabs 3458 are mated with the channel.

[0221] The distal end 3463 of the female mating portion 3450 may include one or more coupling portions 3464 configured to couple with the sheath. The coupling portion 3464 may include one or more tabs 3468 having projections 3466, such as lips, configured to latch onto one or more portions of the sheath. Each of the coupling portions 3464 may include two or more tabs 3468 on opposing sides of the diameter of the female mating portion 3450.

[0222] The female mating portion 3450 may include a hexagonal receiving portion 3451 configured to receive a hexagonal distal portion 3404 at its proximal end 3452. The hexagonal receiving portion 3451 may include one or more walls 3456 and one or more tabs 3458 having one or more projections 3462. The walls 3456 and tabs 3458 may form a hexagonal shape that is approximately the same as or slightly larger than the size and shape of the hexagonal distal portion 3404 in order to form the receiving portion 3451. The one or more walls 3456 and tabs 3458 may alternate such that all other sides of the hexagonal shape of the hexagonal receiving portion 3451 are tabs 3458 and all other sides of the hexagonal shape of 3451 are walls 3456. Other patterns are also possible. While hexagonal shapes are sometimes referred to, it should be noted that the wall 3456 and tab 3458 may be configured to form hexagonal or other polygonal shapes with radial symmetry, such as polygons with 3, 4, 5, 6, 7, or 8 sides.

[0223] The wall 3456 of the hexagonal receiving portion 3451 may be pentagonal in shape, such that the vertices of the pentagon are aligned with the proximal end 3452 of the hexagonal receiving portion 3451. The pentagonal shape may form an inclined proximal-facing wall 3470 at the intersection of the circular opening of the female mating portion 3450 and the hexagonal receiving portion 3451 at the proximal end. One or more tabs 3458 may additionally form an inclined proximal-facing wall 3470 at the intersection of the circular opening of the female mating portion 3450 and the hexagonal receiving portion 3451 at the proximal end. One or more tabs 3458 may be configured to bend substantially radially from the central axis of the female mating portion 3450. This bend may allow one or more tabs 3458 to be housed, enabling the hexagonal distal portion 3404 of the male mating portion 3400 to advance beyond one or more protrusions 3462 and snap into the recess 3408. One or more walls 3456 and / or tabs 3458 may also be similarly inclined and / or oriented to be substantially parallel to one or more walls 3410 of the male mating portion 3400 in conjunction with the female mating portion 3450, in order to facilitate mating of the male mating portion 3400 and the female mating portion 3450. Advantageously, the shape, inclination, and orientation of one or more components of the hexagonal receiving portion 3451 may act as guide cams to orient and align the male mating portion 3400 when it is received into the hexagonal receiving portion 3451. The radius on the distal end 3407 of the male mating portion 3400 and the guide cam 3456 on the female mating portion 3450 may be selected so as to interact with each other and reduce the number of planar surfaces that can come into contact with each other. Further considerations regarding the self-alignment of the mating portions will be explained with reference to Figures 35A and 35B.

[0224] Figures 35A and 35B illustrate the self-alignment of the male mating portion 3400 and the female mating portion 3450. As shown in inset 3520A of Figure 35A, the male mating portion 3512 may initially be oriented at a certain angle to the female mating portion 3510 such that point 3522 of the male mating portion 3512 is oriented at an angle φ1 with respect to point 3524 of the female mating portion 3510. When the user pushes the male mating portion further into the female mating portion, such as to the position shown in Figure 35B, the male mating portion and the female mating portion may begin to align until they are fully aligned. As shown in inset 3520B of Figure 35B, the male mating portion 3512 may be oriented at a certain angle relative to the female mating portion 3510 after the user pushes the male mating portion further into the female mating portion, such that point 3522 of the male mating portion 3512 is oriented at an angle φ2 relative to point 3524 of the female mating portion 3510, where φ2 is less than φ1. This self-alignment may be facilitated by the shape and orientation of the hexagonal receiving portion 3451 of the female mating portion 3450, as described herein.

[0225] Figures 36A and 36B show the male mating portion 3400 and the female mating portion 3450 in an un-matted state and a mated state, respectively. As shown in Figures 36A and 36B, the male mating portion 3400 can be coupled to the insertion tool 3608 and the tubular body 3606. The female mating portion 3450 can be coupled to the catheter 3602. Therefore, the mating of the male mating portion 3400 and the female mating portion 3450 allows the insertion tool 3608 to be coupled to the catheter 3602. As shown, the mating of the male mating portion 3400 and the female mating portion 3450 can be held or maintained, for example, by the channel 3408 of the male mating portion 3400 passing through the lip or projections 3462, 3612 of the female mating portion 3450. This makes it easier to verify the connection, and when properly mated, a click is felt in the right place, providing haptic feedback to the user.

[0226] Any embodiment of the MCS system described herein, and its features, are, for example, International Publication No. 2020 / 089429, filed on 31 October 2019, entitled “SYSTEM AND METHOD FOR CONTROLLING A CARDIAC ASSISTANCE SYSTEM”, U.S. Patent Application No. 17 / 290083 (U.S. Patent Application Publication No. 2021 / 393944), filed on 29 April 2021, entitled “SYSTEM AND METHOD FOR CONTROLLING A CARDIAC ASSISTANCE SYSTEM”, International Publication No. 2019 / 229221, filed on 30 May 2019, entitled “ELECTRONICS MODULE AND ARRANGEMENT FOR A VENTRICULAR ASSIST DEVICE, AND METHOD FOR PRODUCING A VENTRICULAR ASSIST DEVICE”, and “ELECTRONICS MODULE AND ARRANGEMENT FOR A VENTRICULAR ASSIST DEVICE,U.S. Patent Application No. 17 / 057039 (U.S. Patent Publication No. 2021 / 290929), filed November 19, 2020, entitled “AND METHOD FOR PRODUCING A VENTRICULAR ASSIST DEVICE”, International Publication No. 2019 / 234152, filed June 6, 2019, entitled “DEVICE AND METHOD FOR DETERMINATION OF A CARDIAC OUTPUT FOR A CARDIAC ASSISTANCE SYSTEM”, U.S. Patent Application No. 15 / 734841 (U.S. Patent Publication No. 2021 / 379359), filed June 18, 2021, entitled “DEVICE AND METHOD FOR DETERMINATION OF A CARDIAC OUTPUT FOR A CARDIAC ASSISTANCE SYSTEM”, “DEVICE AND METHOD FOR MONITORING THE STATE OF HEALTH International Publication No. 2020 / 030706, filed on August 7, 2019, titled “F of a Patient”, U.S. Patent Application No. 17 / 266056 (U.S. Patent Application Publication No. 2022 / 032036), filed on October 13, 2021, titled “DEVICE AND METHOD FOR MONITORING THE STATE OF HEALTH OF A PATIENT”, International Publication No. 2020 / 064707, filed on September 24, 2019, titled “METHOD AND SYSTEM FOR DETERMINING A FLOW SPEED OF A FLUID FLOWING THROUGH AN IMPLANTED,U.S. Patent Application No. 17 / 274354 (U.S. Patent Publication No. 2022 / 126086), filed on March 8, 2021, entitled “VASCULAR ASSISTANCE SYSTEM”, International Publication No. 2019 / 234148, filed on June 9, 2019, entitled “IMPLANTABLE VENTRICULAR ASSIST SYSTEM AND METHOD FOR OPERATING SAME”, U.S. Patent Application No. 15 / 734342 (U.S. Patent Publication No. 2021 / 346675), filed on July 30, 2021, entitled “IMPLANTABLE VENTRICULAR ASSIST SYSTEM AND METHOD FOR OPERATING SAME”, “SENSOR HEAD DEVICE FOR A MINIMAL INVASIVE VENTRICULAR ASSIST DEVICE AND METHOD FOR PRODUCING SUCH A SENSOR HEAD International Publication No. 2019 / 234149, filed on June 9, 2019, titled "SENSOR HEAD DEVICE FOR A MINIMAL INVASIVE VENTRICULAR ASSIST DEVICE AND METHOD FOR PRODUCING SUCH A SENSOR HEAD DEVICE," U.S. Patent Application No. 15 / 734036 (U.S. Patent Application Publication No. 2021 / 290087), filed on June 8, 2021, titled "METHOD FOR DETERMINING A FLOW SPEED OF A FLUID FLOWING THROUGH AN IMPLANTED, VASCULAR ASSISTANCE SYSTEM AND IMPLANTABLE,International Publication No. 2019 / 234166, filed on June 6, 2019, entitled “VASCULAR ASSISTANCE SYSTEM”, U.S. Patent Application No. 15 / 734523 (U.S. Patent Application Publication No. 2022 / 039669), filed on December 2, 2020, entitled “SYSTEMS AND METHODS FOR DETERMINING A FLOW SPEED OF A FLUID FLOWING THROUGH A CARDIAC ASSIST DEVICE”, International Publication No. 2019 / 234167, filed on June 6, 2019, entitled “DETERMINATION APPLIANCE AND METHOD FOR DETERMINING A VISCOSITY OF A FLUID”, “DETERMINATION APPLIANCE AND METHOD FOR DETERMINING A VISCOSITY OF A U.S. Patent Application No. 15 / 734519 (U.S. Patent Publication No. 2022 / 047173), filed on December 2, 2020, titled "FLUID"; International Publication No. 2019 / 234169, filed on June 6, 2019, titled "ANALYSIS APPARATUS AND METHOD FOR ANALYZING A VISCOSITY OF A FLUID"; U.S. Patent Application No. 15 / 734489 (U.S. Patent Publication No. 2022 / 050037), filed on December 2, 2020, titled "ANALYSIS APPARATUS AND METHOD FOR ANALYZING A VISCOSITY OF A FLUID"; "METHOD AND DEVICE FOR DETECTING A WEAR CONDITION OF A VENTRICULAR ASSIST DEVICE AND FOR OPERATING SAME, AND VENTRICULAR ASSIST International Publication No. 2019 / 243582, filed on June 21, 2019, entitled “Method and Device for Detecting a Wear Condition of a Ventricular Assist Device and for Operating Same,This document may include various additional features or modifications, such as those described in U.S. Patent Application No. 17 / 252498 (Publication No. 2021 / 346678), filed on 27 July 2021, entitled “AND VENTRICULAR ASSIST DEVICE,” each of which is incorporated herein by reference in whole for all purposes and forms part of this document.

[0227] Various modifications to the implementations described herein will be readily apparent to those skilled in the art, and the general principles defined herein can be applied to other implementations without departing from the spirit or scope of this disclosure. Therefore, this disclosure is not intended to be limited to the implementations shown herein, but should be given the broadest scope consistent with the claims, principles, and novel features disclosed herein. The term “Example” is used herein solely to mean “serving as an example, illustration, or demonstration.” Any implementation described herein as “Example” should not be construed as necessarily preferable or advantageous to other implementations unless otherwise stated. The term “About” may, depending on the context and as can be understood by those skilled in the art, refer to values ​​within ±1%, ±2%, ±3%, ±4%, ±5%, ±10%, ±15%, or other ranges.

[0228] In the context of separate implementations, certain features described herein may also be implemented in combination in a single implementation. Conversely, various features described in the context of a single implementation may also be implemented separately in multiple implementations or in any preferred subcombination. Furthermore, features may be described above as acting in a particular combination, and may initially be claimed as such, but one or more features from a claimed combination may, in some cases, be removed from that combination, and the claimed combination may cover subcombinations or variations thereof.

[0229] Similarly, while the actions are illustrated in a specific order in the drawings, this should not be understood as requiring that such actions be performed in a specific or sequential order shown, or that all illustrated actions be performed, in order to achieve the desired result. Additionally, other implementations are also within the scope of the following claims. In some cases, the actions enumerated in the claims may be performed in a different order, and the desired result may still be obtained.

[0230] In general, a person skilled in the art will understand that the terms used herein are generally intended to be "open" terms (for example, the term "including" should be interpreted as "including but not limited to," "having" as "at least having," "includes" as "includes but not limited to," and so on). A person skilled in the art will further understand that if a particular number is intended in the description of the introduced claims, such intention is explicitly stated in the claims, and if such statement is not present, such intention does not exist. For example, for the sake of understanding, the following appended claims may include the use of the introductory phrases "at least one" and "one or more" to introduce the description of the claims. However, the use of such phrases should not be interpreted as implying that the introduction of a claim description with the indefinite article "a" or "an" limits any particular claim containing such introduced claim description to embodiments containing only one such description, even if the same claim contains the introductory phrase "one or more" or "at least one," as well as an indefinite article such as "a" or "an" (for example, "a" and / or "an" should typically be interpreted as meaning "at least one" or "one or more"). The same applies to the use of the definite article used to introduce a claim description.

[0231] In addition, even if specific numbers are explicitly stated in the description of the claims introduced, a person skilled in the art will recognize that such a description should typically be interpreted as meaning at least the stated numbers (for example, the mere description of “two descriptions” without other modifiers usually means at least two descriptions, or more than two descriptions). Furthermore, in instances where a convention similar to “at least one of A, B, and C, etc.” is used, such interpretation is generally intended in the sense that a person skilled in the art will understand the convention (for example, “a system having at least one of A, B, and C” includes, but is not limited to, A alone, B alone, C alone, A and B together, A and C together, B and C together, and / or a system having A, B, and C together, etc.). In practice where a convention similar to "at least one of A, B, or C" is used, such interpretation is generally intended to be understood by a person skilled in the art (for example, "a system having at least one of A, B, or C" includes, but is not limited to, A alone, B alone, C alone, A and B together, A and C together, B and C together, and / or a system having A, B, and C together). A person skilled in the art will further understand that substantially any separate word and / or phrase presenting two or more alternative terms in a description, claim, or drawing should be understood as intending the possibility of including one of the terms, either of the terms, or both of the terms. For example, it will be understood that the phrase "A or B" includes the possibility of "A" or "B" or "A and B".

[0232] If an exemplary embodiment includes the conjunction "and / or" between the first and second features, it should be read that an embodiment according to one embodiment has both the first and second features, and according to a further embodiment, it has either the first feature only or the second feature only.

Claims

1. A mechanical circulation support system, A circulatory support catheter comprising a circulatory support device supported by an elongated flexible catheter shaft, wherein the circulatory support device comprises 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 receive the circulation assist device so as to be movable in the axial direction, An introducer sheath having a tubular body and configured to receive the insertion tool so as to be movable in the axial direction, A mechanical circulation assistance system comprising a polygonal coupling configured to connect the insertion tool and the introducer sheath.

2. The mechanical circulation assistance system according to claim 1, wherein the polygonal coupling includes a male mating portion configured to connect to the insertion tool and a female mating portion configured to connect to the introducer sheath.

3. The mechanical circulation assistance system according to claim 2, wherein the male fitting portion includes a polygonal distal portion.

4. The mechanical circulation assistance system according to claim 3, wherein the distal polygon portion includes a truncated polygonal pyramid.

5. The mechanical circulation assist system according to claim 3 or 4, wherein the distal polygonal portion includes a recessed portion extending circumferentially around the distal polygonal portion, approximately midway along the longitudinal axis of the distal polygonal portion.

6. The mechanical circulation assistance system according to any one of claims 3 to 5, wherein the polygonal distal portion of the male fitting portion is configured to fit into the corresponding polygonal receiving portion of the female fitting portion.

7. The mechanical circulation assistance system according to any one of claims 2 to 5, wherein the female fitting portion includes a polygonal receiving portion configured to self-align the male fitting portion with respect to the female fitting portion in response to a force applied along the axial direction.

8. The mechanical circulation assistance system according to any one of claims 1 to 7, wherein the polygonal coupling is configured to provide tactile feedback when the insertion tool is coupled to the introducer sheath.

9. A mechanical circulation support system, A circulatory support catheter comprising a circulatory support device supported by an elongated flexible catheter shaft, wherein the circulatory support device comprises 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 receive the circulation assist device so as to be movable in the axial direction, A mechanical circulation assistance system comprising a coupling configured to connect the insertion tool and an introducer, the coupling configured to allow the remove and replace of the introducer from the insertion tool.

10. The mechanical circulation assist system according to claim 9, wherein the coupling includes a screw coupling.

11. The mechanical circulation assistance system according to claim 9, wherein the coupling includes a bayonet coupling.

12. The mechanical circulation assistance system according to claim 9, wherein the coupling includes a push-pull coupling.

13. The mechanical circulation assistance system according to any one of claims 9 to 12, wherein the introducer includes a fixed-size introducer.

14. The mechanical circulation assistance system according to any one of claims 9 to 12, wherein the introducer includes an expandable introducer.

15. The mechanical circulation assistance system according to claim 9, wherein the coupling includes a polygonal coupling.

16. A mechanical circulation support system, A long, slender, flexible catheter shaft having a proximal end and a distal end, A mechanical circulatory support system comprising a circulatory support device supported by the distal end of the flexible catheter shaft, the circulatory support device comprising a tubular housing including an inlet tube, a distal tip attached to the distal end of the inlet tube, a motor, and an impeller configured to be rotated by the motor, wherein the distal tip has an outer diameter larger than the outer diameter of the inlet tube.

17. The mechanical circulation assist system according to claim 16, wherein the outer diameter of the distal tip is located at the proximal end of the distal tip, and the outer diameter of the inlet pipe is located at the distal end of the inlet pipe.

18. A mechanical circulation support system, A long, slender, flexible catheter shaft having a proximal end and a distal end, A circulatory support device supported by the distal end of the flexible catheter shaft, comprising a tubular housing, a motor, and an impeller configured to be rotated by the motor, A mechanical circulation assist system comprising a tubular housing of the circulation assist device, the tubular housing of which includes an inlet pipe coupled to a motor housing, the inlet pipe having one or more distal pump inlets and one or more proximal pump outlets, the distal end of the inlet pipe including a tip, the tip including a lumen extending through the tip having a flared distal opening.

19. The mechanical circulation assistance system according to claim 18, wherein the length and inner diameter of the lumen define a curvature similar to the radius of curvature of a guidewire configured to be received into the lumen.

20. The mechanical circulatory support system according to claim 18 or 19, wherein the lumen includes a flared proximal opening.

21. The mechanical circulatory assistance system according to any one of claims 18 to 20, wherein the lumen extends through a proximal extension projecting proximal from the tip.

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