Insertion catheter for a circulatory assist catheter

Abstract

An insertion catheter for a circulatory support catheter having a circulatory support device carried by an elongate flexible catheter shaft. The insertion catheter comprises a tubular body having a distal portion configured to axially movably receive the circulatory support device. The diameter of the distal portion is larger than the diameter of the intermediate portion of the tubular body. The insertion catheter may be inserted into an introducer sheath for delivery of the MCS device. The distal end of the insertion catheter may be located distal to the distal end of the introducer sheath and distal to the arterial bifurcation. The distal portion of the insertion catheter including the MCS device may be located distal to the bifurcation, and the distal end of the MCS device is slightly offset from the distal end of the tubular body.

Description

Technical Field

[0001] (Incorporation by reference to the application serving as the basis for priority) This application is an international application filed on May 24, 2022, entitled INSERTION CATHETER FOR A CIRCULATORY SUPPORT CATHETER, claiming priority based on U.S. Provisional Patent Application No. 63 / 345182, the entire content of which is hereby incorporated by reference in its entirety for all purposes and forms part of this specification.

[0002] The present disclosure generally relates to mechanical cardiovascular support systems used in the medical field to assist in the movement of blood. In particular, the present disclosure relates to improved insertion catheters, introducer sheaths, and various components thereof for the optimized delivery of mechanical circulatory support devices to the heart.

Background Art

[0003] (Description of related technologies) Mechanical circulatory support systems can be used to assist in the pumping of 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 remains difficult to manage despite advances in treatment options. CS is caused by a severe impairment of myocardial function that results in a decrease in cardiac output, end-organ hypoperfusion, and hypoxia. Clinically, this presents as hypotension that is resistant to volume resuscitation and is characterized by end-organ hypoperfusion that requires immediate pharmacological or mechanical intervention. Acute myocardial infarction (MI) accounts for more than about 80% of CS patients.

[0004] As a further example, percutaneous coronary intervention (PCI) is a non-surgical procedure for revascularizing stenotic coronary arteries. PCI includes various techniques such as, for example, balloon angioplasty, stent implantation, rotational ablation, and lithotripsy. PCI is considered high-risk if the patient has a related co-morbidity (e.g., frailty or advanced age), the PCT itself is very complex (e.g., bifurcation or total occlusion), or the hemodynamic state is difficult (e.g., ventricular dysfunction).

Summary of the Invention

Problems to be Solved by the Invention

[0005] For the percutaneous insertion of a patient's body as an acute therapy for CS and for temporary support during PCI, small catheter-based intracardiac blood pumps have been developed. However, existing solutions for the pump have various performance defects such as, for example, insufficient blood flow, the need for continuous motor purge within the pump, undesirable high hemolysis, and insufficient detection of hemodynamic parameters. Therefore, there remains a need for a mechanical circulatory support system having mechanisms to overcome these and other drawbacks, as well as improved methods for introducing such systems into the body.

Means for Solving the Problems

[0006] Each of the embodiments disclosed herein has several aspects, and no single one of those aspects is the sole factor for the desirable attributes of the present disclosure. Without limiting the scope of the present disclosure, some of its more prominent features are briefly described herein. After considering this discussion, and particularly after reading the section entitled "Mode for Carrying Out the Invention," one will understand how the features of the embodiments described herein provide advantages over existing systems, devices, and methods for circulatory support systems.

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

[0008] In some embodiments, disclosed herein is an insertion catheter for a circulatory support catheter having a circulatory support device carried by an elongate flexible catheter shaft, the insertion catheter comprising a tubular body having a proximal end, a distal end, a longitudinal axis extending between the proximal end and the distal end, a proximal portion adjacent the proximal end, a distal portion adjacent the distal end, and an intermediate portion between the proximal portion and the distal portion, the distal portion of the tubular body being configured to axially movably receive the circulatory support device and having a diameter larger than the diameter of the intermediate portion.

[0009] In the above-described insertion catheter or in other embodiments described herein, one or more of the following mechanisms may also be provided. In some embodiments, the insertion catheter further comprises a hub having a proximal end and a distal end, and the distal end of the hub is in fluid connection with the proximal end of the tubular body. In some embodiments, the tubular body further comprises a proximal transition section between the proximal portion and the intermediate portion, and a distal transition section between the distal portion and the intermediate portion. In some embodiments, the distal portion and the distal transition section are configured to receive a circulatory support device, and the intermediate portion, the proximal transition section, the proximal portion, and the hub are configured to receive an elongate flexible catheter shaft. In some embodiments, the distal portion, the intermediate portion, and the proximal portion are concentric about the longitudinal axis. In some embodiments, the intermediate portion has an outer diameter that is smaller than the outer diameter of the proximal portion and the outer diameter of the distal portion. In some embodiments, the distal portion has an inner diameter that is larger than the inner diameter of the intermediate portion and the proximal portion. In some embodiments, the tubular body is configured such that the proximal portion remains outside the patient's body when the insertion catheter is in use. In some embodiments, the tubular body is configured such that when the insertion catheter is in use, the middle portion passes from outside the patient's body through an arteriotomy of the femoral artery, through the femoral artery, through a branch of the femoral artery that joins the femoral artery, and extends into the aorta. In some embodiments, the tubular body is configured such that the distal portion is positioned within the patient's aorta when the insertion catheter is in use. In some embodiments, the distal end of the tubular body is configured to extend beyond the distal end of the introducer sheath when the insertion catheter is fully docked with the introducer sheath during use. In some embodiments, the tubular body of the insertion catheter has sufficient collapse resistance to maintain patency when passing through one or more hemostatic valves of the introducer sheath. In some embodiments, the distal end of the hub comprises one or more mechanisms for preventing rotation and / or axial movement of the insertion catheter when docked with the introducer sheath. In some embodiments, the insertion catheter comprises a tube having a valve in fluid communication with the inner lumen of the tubular body of the insertion catheter configured to be flushed with saline. In some embodiments, the insertion catheter comprises a hemostatic valve.In some embodiments, the insertion catheter comprises a plug disposed at the proximal end of a hub configured to connect to a sterile shield sleeve. In some embodiments, the elongated flexible catheter shaft includes a visual marker spaced proximally from the circulatory support device such that the visibility of the visual marker on the proximal side of the hub indicates that the circulatory support device is positioned within the tubular body of the insertion catheter. In some embodiments, the circulatory support device comprises a tubular housing, a motor, an impeller configured to be rotated by the motor, a first guide wire port on the distal end of the tubular housing, a second guide wire port on the sidewall of the tubular housing distal to the impeller, and a third guide wire port proximal to the impeller, and the distal end of the tubular body of the insertion catheter is removably connected to a guide wire aid configured to facilitate the entry of a guide wire through the first guide wire port. In some embodiments, the tubular body of the insertion catheter is configured to receive the circulatory support device using a removable guide wire guide tube, and the removable guide wire guide tube enters the first guide wire port on the distal end of the tubular housing, exits the tubular housing through the second guide wire port on the sidewall of the tubular housing distal to the impeller, re-enters the tubular housing through the third guide wire port proximal to the impeller, and extends proximally within the catheter shaft. In some embodiments, the hub comprises one or more mechanisms for preventing axial and optionally rotational movement of the circulatory support catheter. In some embodiments, the hub of the insertion catheter comprises a locking mechanism, the locking mechanism comprising a recess configured to receive a locking pad configured to removably lock to the circulatory support catheter. In some embodiments, the hub of the insertion catheter comprises a housing surrounding at least a portion of the locking mechanism, the housing comprising opposing first inner surface walls spaced further apart than opposing second inner surface walls, at least a portion of the locking mechanism comprising a radially outwardly extending tab, and the housing is configured to rotate to compress the tab inwardly to prevent axial movement of the circulatory support catheter.In some embodiments, the inward compression of the tab of the locking mechanism compresses the locking pad against the circulation support catheter. In some embodiments, the locking pad is configured to be removably locked to the catheter shaft of the circulation support catheter. In some embodiments, the tubular body of the insertion catheter has a length in the range of about 275 mm to about 675 mm and an inner diameter in the range of about 1.5 mm to about 6 mm. In some embodiments, the distal portion of the tubular body has a length in the range of about 75 mm to about 140 mm and an inner diameter in the range of about 3.5 mm to about 6 mm, the proximal portion of the tubular body has a length in the range of about 100 mm to about 165 mm and an inner diameter in the range of about 2.0 mm to about 4.5 mm, and the intermediate portion of the tubular body has a length in the range of about 150 mm to about 250 mm and an inner diameter in the range of about 1.5 mm to about 4.5 mm. In some embodiments, the tubular portion includes braided wire. In some embodiments, the distal end of the tubular body comprises a PET band configured to hold the ends of the braided wire. In some embodiments, the distal end of the tubular body includes a radiopaque marker. In some embodiments, the proximal portion of the tubular body is configured to transmit longitudinal forces without twisting. In some embodiments, the proximal portion of the tubular body is stiffer than the intermediate and distal portions. In some embodiments, the proximal portion of the tubular body includes reinforced double braided wire. In some embodiments, at least the distal portion of the tubular body is coated with a hydrophilic coating configured to reduce friction on its outer surface.

[0010] In some embodiments, as used herein, a circulatory support catheter includes a circulatory support device carried by an elongate flexible catheter shaft, the circulatory support device including a tubular housing, a motor, and an impeller configured to be rotated by the motor; and an insertion catheter including a tubular body having a proximal end, a distal end, a longitudinal axis extending between the proximal and distal ends, a proximal portion adjacent the proximal end, a distal portion adjacent the distal end, and an intermediate portion between the proximal and distal portions, wherein the distal portion of the tubular body is configured to axially movably receive the circulatory support device and has a diameter greater than the diameter of the intermediate portion. A mechanical circulatory support system is disclosed.

[0011] In the above-described system or other embodiments described herein, one or more of the following features may also be provided. In some embodiments, the impeller is configured to be rotated by a motor via a shaft. In some embodiments, the impeller is configured to be rotated by a motor via magnetic coupling. In some embodiments, the system does not require purging. In some embodiments, the insertion catheter further includes a hub having a proximal end and a distal end, and the distal end of the hub is in fluid connection with the proximal end of the tubular body. In some embodiments, the tubular body further includes a proximal transition section between the proximal portion and the intermediate portion and a distal transition section between the distal portion and the intermediate portion. In some embodiments, the distal portion and the distal transition section are configured to receive a circulatory support device, and the intermediate portion, the proximal transition section, the proximal portion, and the hub are configured to receive an elongate flexible catheter shaft. In some embodiments, the distal portion, the intermediate portion, and the proximal portion are concentric about a longitudinal axis. In some embodiments, the intermediate portion includes an outer diameter that is smaller than the outer diameter of the proximal portion and the outer diameter of the distal portion. In some embodiments, the distal portion includes an inner diameter that is larger than the inner diameter of the intermediate portion and the proximal portion. In some embodiments, the tubular body is configured such that when the insertion catheter is in use, the proximal portion remains outside the patient's body. In some embodiments, the tubular body is configured such that when the insertion catheter is in use, the middle portion passes from outside the patient's body through an arteriotomy of the femoral artery, through the femoral artery, through a branch of the femoral artery that joins the femoral artery, and extends into the aorta. In some embodiments, the tubular body is configured such that when the insertion catheter is in use, the distal portion is positioned within the patient's aorta. In some embodiments, the distal end of the tubular body is configured to extend beyond the distal end of the introducer sheath when the insertion catheter is fully docked with the introducer sheath during use. In some embodiments, the distal end of the hub includes one or more mechanisms for preventing rotation and / or axial movement of the insertion catheter when docked with the introducer sheath.In some embodiments, the insertion catheter comprises a tube having a valve in fluid communication with the inner lumen of the tubular body of the insertion catheter configured to be flushed with saline. In some embodiments, the insertion catheter comprises a hemostatic valve. In some embodiments, the insertion catheter comprises a plug disposed at the proximal end of a hub configured to connect to a sterile shield sleeve. In some embodiments, the elongated flexible catheter shaft includes a visual marker spaced proximally from the circulatory support device such that the visibility of the visual marker on the proximal side of the hub indicates that the circulatory support device is positioned within the tubular body of the insertion catheter. In some embodiments, the circulatory support device comprises a tubular housing, a motor, an impeller configured to be rotated by the motor, a first guide wire port on the distal end of the tubular housing, a second guide wire port on the side wall of the tubular housing distal to the impeller, and a third guide wire port proximal to the impeller, and the distal end of the tubular body of the insertion catheter is removably connected to a guide wire assist configured to facilitate the entry of a guide wire through the first guide wire port. In some embodiments, the tubular body of the insertion catheter is configured to receive the circulatory support device using a removable guide wire guide tube, and the removable guide wire guide tube enters the first guide wire port on the distal end of the tubular housing, exits the tubular housing through the second guide wire port on the side wall of the tubular housing distal to the impeller, re-enters the tubular housing through the third guide wire port proximal to the impeller, and extends proximally within the catheter shaft. In some embodiments, the hub comprises one or more mechanisms for preventing axial and optionally rotational movement of the circulatory support catheter. In some embodiments, the hub of the insertion catheter comprises a locking mechanism, the locking mechanism comprising a recess configured to receive a locking pad configured to removably lock to the circulatory support catheter.In some embodiments, the hub of the insertion catheter comprises a housing that surrounds at least a portion of the locking mechanism, the housing comprising opposing first inner surface walls that are spaced farther apart than opposing second inner surface walls, at least a portion of the locking mechanism comprising radially outwardly extending tabs, and the housing being configured to rotate to compress the tabs inwardly to prevent axial movement of the circulation support catheter. In some embodiments, the inward compression of the tabs of the locking mechanism compresses the locking pads against the circulation support catheter. In some embodiments, the locking pads are configured to be removably locked to the catheter shaft of the circulation support catheter. In some embodiments, the tubular body of the insertion catheter has a length in the range of about 275 mm to about 675 mm and an inner diameter in the range of about 1.5 mm to about 6 mm. In some embodiments, the distal portion of the tubular body has a length in the range of about 75 mm to about 140 mm and an inner diameter in the range of about 3.5 mm to about 6 mm, the proximal portion of the tubular body has a length in the range of about 100 mm to about 165 mm and an inner diameter in the range of about 2.0 mm to about 4.5 mm, and the intermediate portion of the tubular body has a length in the range of about 150 mm to about 250 mm and an inner diameter in the range of about 1.5 mm to about 4.5 mm. In some embodiments, the tubular portion includes braided wire. In some embodiments, the distal end of the tubular body comprises a PET band configured to hold the ends of the braided wire. In some embodiments, the distal end of the tubular body includes a radiopaque marker. In some embodiments, the proximal portion of the tubular body is configured to transmit longitudinal forces without twisting. In some embodiments, the proximal portion of the tubular body is stiffer than the intermediate and distal portions. In some embodiments, the proximal portion of the tubular body includes reinforced double braided wire. In some embodiments, at least the distal portion of the tubular body is coated with a hydrophilic coating configured to reduce friction on its outer surface.

[0012] In one embodiment, a method of using an insertion catheter with a circulatory support catheter having a circulatory support device carried by an elongate flexible catheter shaft, the method comprising inserting a distal end of the insertion catheter through a proximal end of an introducer sheath advanced into a patient's artery, and advancing the insertion catheter through the introducer sheath and any hemostatic valve of the introducer sheath until the distal end of the insertion catheter extends beyond the distal end of the introducer sheath, wherein the insertion catheter comprises a tubular body having a distal portion adjacent to a distal end configured to axially movably receive the circulatory support device, and wherein the insertion catheter is configured to protect the circulatory support device as the insertion catheter advances through the introducer sheath and any hemostatic valve of the introducer sheath, is disclosed.

[0013] In the above method or other embodiments described herein, one or more of the following features may also be provided. In some embodiments, the insertion catheter further comprises a hub fluidly connected to the proximal end of the tubular body, the hub configured to lock with the introducer sheath and prevent axial and / or rotational movement of the insertion catheter relative to the introducer sheath when the insertion catheter has advanced completely through the introducer sheath. In some embodiments, the tubular body further comprises a proximal portion adjacent its proximal end and an intermediate portion between the proximal portion and the distal portion. In some embodiments, the tubular body further comprises a proximal transition section between the proximal portion and the intermediate portion and a distal transition section between the distal portion and the intermediate portion. In some embodiments, the distal portion and the distal transition section are configured to receive a circulatory support device, and the intermediate portion, the proximal transition section, the proximal portion, and the hub are configured to receive an elongate flexible catheter shaft. In some embodiments, the tubular body is configured such that the proximal portion remains outside the patient's body when the insertion catheter has advanced completely through the introducer sheath. In some embodiments, the tubular body is configured such that the distal portion is positioned within the patient's aorta when the insertion catheter has advanced completely through the introducer sheath. In some embodiments, the tubular body is configured such that the intermediate portion extends from outside the patient's body, through an arteriotomy of the femoral artery, through the femoral artery, through a bifurcation of the femoral artery where it joins the aorta, and into the aorta when the insertion catheter has advanced completely through the introducer sheath. In some embodiments, the method further comprises advancing a circulatory support catheter through the insertion catheter until its target treatment position is reached within the patient. In some embodiments, the hub of the insertion catheter comprises a locking mechanism, and the method further comprises locking the axial position of the circulatory support catheter relative to the insertion catheter. In some embodiments, the locking mechanism comprises a recess configured to receive a locking pad configured to removably lock with the circulatory support catheter.In some embodiments, the hub of the insertion catheter comprises a housing that surrounds at least a portion of the locking mechanism, the housing comprising opposing first inner surface walls that are spaced further apart than opposing second inner surface walls, at least a portion of the locking mechanism comprising radially outwardly extending tabs, and the housing being configured to rotate to compress the tabs inwardly to prevent axial movement of the circulation support catheter. In some embodiments, the inward compression of the tabs of the locking mechanism compresses the locking pads against the circulation support catheter. In some embodiments, the locking pads are configured to be removably locked to the catheter shaft of the circulation support catheter. In some embodiments, the method further comprises rotating the housing of the hub to removably lock the axial position of the circulation support catheter relative to the insertion catheter.

[0014] Described herein are methods and apparatus related to a peel-away catheter configured to slidably receive at least a portion of an MCS system, the peel-away catheter comprising a catheter shaft configured to be divisible and / or separable into a plurality of elongated shaft portions. The proximal portion of the catheter shaft may be configured to mate with an insertion tool for the MSC system. In some examples, a medical delivery system may comprise a peel-away catheter that includes an introducer sheath, an insertion tool, and a catheter shaft having a portion disposed within the introducer sheath while the proximal portion of the catheter shaft is engaged with the insertion tool. The medical delivery system may comprise a spacer configured to axially displace the insertion tool away from the introducer sheath while the catheter shaft is engaged with the insertion tool.

[0015] This specification describes methods and apparatus related to a peel-away catheter configured to slidably receive at least a portion of an MCS system and be used independently of an insertion tool. For example, the MCS system can be slidably disposed through the peel-away catheter for navigation to a target location without using a separate insertion tool. In some examples, the peel-away catheter can include a catheter shaft extending distally from a catheter hub. The catheter hub may or may not be a peel-away hub. In some examples, the catheter hub is not a peel-away hub. For example, the catheter shaft can be peeled away from and / or removed from around the MCS system after the catheter shaft has been separated, disengaged, and / or disconnected from the catheter hub.

[0016] Also described herein is a medical delivery system comprising an insertion tool having an insertion tool hub and an insertion tool shaft extending distally from the insertion tool hub, and a peel-away catheter comprising a catheter shaft configured to be separable into a plurality of elongated shaft portions, the catheter shaft comprising a proximal portion configured to mate with a distal portion of the insertion tool shaft.

[0017] Also described herein is a medical delivery system, wherein the proximal portion of the catheter shaft comprises an insertion tool mating portion configured to be disposed on and have an interference fit with an outer surface of the distal portion of the insertion tool shaft.

[0018] Also described herein is a medical delivery system, wherein the insertion tool mating portion includes a flare configuration.

[0019] Also described herein is a medical delivery system, wherein the peel-away catheter further comprises first and second operator engagement handles coupled to respective portions of the proximal portion of the catheter shaft for an operator to engage to separate the catheter shaft into a plurality of elongated shaft portions.

[0020] Also described herein is a medical delivery system in which a peel-away catheter and an insertion tool are configured to slidably receive respective portions of a mechanical circulatory support (MCS) system.

[0021] Also described herein is a medical delivery system in which corresponding portions of a mechanical circulatory support (MCS) system are configured to be disposed through respective delivery lumens of an insertion tool and a peel-away catheter, and a distal tip of the mechanical circulatory support (MCS) system is configured to be disposed distal to a catheter shaft.

[0022] Also described herein is a medical delivery system further comprising a support sleeve having a slit and configured to be disposed around a portion of a shaft of a mechanical circulatory support (MCS) system, wherein a corresponding portion of a delivery lumen of the catheter shaft is configured to slidably receive the support sleeve and the portion of the shaft of the mechanical circulatory support (MCS) system.

[0023] Also described herein is a medical delivery system further comprising an introducer sheath having an introducer sheath shaft extending distally from an introducer sheath hub, wherein at least a portion of the catheter shaft is configured to be slidably disposed within the introducer sheath shaft and the introducer sheath hub while a proximal portion of the catheter shaft is engaged with a distal portion of an insertion tool shaft.

[0024] Also described herein is a medical delivery system further comprising a spacer configured to engage spacer engagement features of an introducer sheath hub and an insertion tool hub to axially space and align the introducer sheath hub and the insertion tool hub.

[0025] Also described herein is a medical delivery system, wherein the spacer comprises a distal portion configured to engage a spacer engagement feature of an introducer sheath hub, a proximal portion configured to engage a spacer engagement feature of an insertion tool hub, an inner portion extending between and perpendicular to the distal and proximal portions, and the distal and proximal portions each comprise a recessed edge configured to fit into a respective groove of the spacer engagement feature of the introducer sheath hub or the insertion tool hub.

[0026] Also described herein is a medical delivery system comprising an introducer sheath including an introducer sheath shaft extending distally from an introducer sheath hub, and a peel-away catheter including a catheter shaft extending distally from a catheter hub, wherein the introducer sheath and the peel-away catheter are configured to slidably receive a mechanical circulatory support (MCS) system. The system can include a spacer configured to engage the introducer sheath hub and the catheter hub to axially space the introducer sheath hub from the catheter hub.

[0027] Also described herein is a medical delivery system comprising a first elongated member having at least a portion configured to be slidably disposed within a first elongated member lumen extending along a first longitudinal portion of a shaft wall of a catheter shaft while the peel-away catheter is in a non-peeled configuration. The peel-away catheter includes a second elongated member having at least a portion configured to be slidably disposed within a second elongated member lumen extending along a second longitudinal portion of the shaft wall of the catheter shaft while the peel-away catheter is in a non-peeled configuration. The first and second elongated portions are configured to be laterally pulled through corresponding shaft wall portions between the first and second elongated member lumens and an outer surface of the shaft wall to cut the shaft wall into the first and second elongated shaft wall portions.

[0028] Also described herein is a medical delivery system in which the first elongated portion is disposed opposite about the circumference of the catheter shaft relative to the second elongated portion.

[0029] Also described herein is a medical delivery system comprising a first proximal shaft tab coupled to a proximal portion of the first elongated shaft wall portion and a second proximal shaft tab coupled to a proximal portion of the second longitudinal shaft wall portion, the first and second proximal shaft tabs being configured to be laterally pulled to tear corresponding shaft wall portions between the first and second elongated member lumens and an inner surface of the shaft wall to separate the shaft wall into the first and second elongated shaft wall portions.

[0030] Also described herein is a medical delivery system in which the first and second proximal shaft tabs are disposed in opposing positions about the circumference of the catheter shaft.

[0031] Also described herein is a medical delivery system comprising a first elongate member including a first elongate portion, a second elongate member including a second elongate portion, and first and second elongate wall portions. While the catheter shaft is in a non-peeled configuration, the first elongate portion may be between a first edge of the second elongate shaft wall portion and a second edge of the first elongate shaft wall portion, and the second elongate portion may be between a first edge of the first elongate shaft wall portion and a second edge of the second elongate shaft wall portion, and the first elongate portion and the second elongate portion are configured to be laterally pulled to separate the first elongate portion and the second elongate portion from the first elongate shaft wall portion and the second elongate shaft wall portion.

[0032] Also described herein is a medical delivery system in which the first elongate portion is disposed opposite around the circumference of the catheter shaft relative to the second elongate portion, and the first elongate shaft wall portion is disposed opposite around the circumference of the catheter shaft relative to the second elongate shaft wall portion.

[0033] Also described herein is a medical delivery system comprising a peel-away catheter having an elongate member including an elongate portion, the shaft wall of the catheter shaft including a first interlocking portion including a first plurality of mating portions along a longitudinal portion of the catheter shaft, and a second interlocking portion including a second plurality of mating portions along a longitudinal portion of the catheter shaft and configured to mate with the first interlocking portion. The peel-away catheter can include an elongate member including an elongate portion, and corresponding portions of the elongate portion are configured to be slidably disposed within respective elongate member lumen portions of the first and second plurality of mating portions of the first and second interlocking portions.

[0034] Also described herein is a medical delivery system in which the mating edges of the first and second interlocking portions have a rectangular wave shape.

[0035] Also described herein is a medical delivery system configured such that an elongated portion is drawn out from an elongated member lumen portion, allowing the first and second interlocking portions to separate.

[0036] Also described herein is a medical delivery system comprising an elongated member configured to hold together the edges of the shaft wall of a catheter shaft and maintain the catheter shaft in an unpeeled configuration.

[0037] Also described herein is a medical delivery system including a first edge portion of the shaft wall that includes a plurality of first openings at respective positions along the longitudinal portion of the first edge portion, and a second edge portion of the shaft wall that includes a plurality of second openings at respective positions along the longitudinal portion of the second edge portion. The elongated member can include an elongated portion, and the corresponding portions of the elongated portion are configured to be alternately disposed through the plurality of first and second openings to hold the first and second edge portions together.

[0038] Also described herein is a medical delivery system configured such that an elongated portion is pulled out from a plurality of first and second openings, allowing the first and second edge portions to separate.

[0039] Also described herein is a medical delivery system configured such that the catheter shaft is in a rolled configuration while the catheter shaft is in an unpeeled configuration.

[0040] Also described herein is a medical delivery system in which the shaft wall of the catheter shaft includes a first overlapping wall portion and a second overlapping wall portion, and during the time when the catheter shaft is in a rolled configuration, the first overlapping wall portion is configured to be on and in contact with the second overlapping wall portion along the longitudinal portion of the shaft wall.

[0041] Also, a medical delivery system is described herein, and the peel-away catheter includes a proximal shaft tab coupled to a proximal portion of the shaft wall of the catheter shaft, and the proximal shaft tab is coupled at a position circumferentially spaced from the first and second overlapping wall portions.

[0042] Also, a medical delivery system is described herein where the proximal shaft tab is oriented to face around the catheter shaft with respect to the first and second overlapping wall portions.

[0043] Also, described herein is a medical delivery system where at least one of the outer diameter of the catheter shaft and the diameter of the shaft delivery lumen of the catheter shaft is configured to fit the diameter of the corresponding portion of the MCS system through which it is disposed.

[0044] Also, described herein is a medical delivery system where the spacer is configured to engage the spacer engagement features of the introducer sheath hub and the catheter hub to axially separate and align the introducer sheath hub and the catheter hub.

[0045] Also, described herein is a medical delivery system where the spacer includes a distal portion configured to engage the spacer engagement feature of the introducer sheath hub, a proximal portion configured to engage the spacer engagement feature of the catheter hub, an inner portion extending between the distal portion and the proximal portion and perpendicular between the distal portion and the proximal portion, and the distal portion and the proximal portion each include a recessed edge configured to fit into a respective groove of the spacer engagement feature of the introducer sheath hub or the catheter hub.

[0046] Also, described herein is a medical delivery system where the catheter hub is not a peel-away hub.

[0047] The foregoing and other features of the present disclosure will become more fully apparent from the following description and the accompanying claims, taken in conjunction with the accompanying drawings. It is to be understood that the drawings illustrate only some embodiments of the present disclosure and are not to be considered as limiting its scope, and the present disclosure will be described in additional detail and with specificity through the use of the accompanying drawings. In the following detailed description, reference is made to the accompanying drawings, which form a part hereof. In the drawings, like symbols typically identify like components, unless the context dictates otherwise. The exemplary embodiments described in the detailed description, drawings, and claims are not intended to be limiting. Other embodiments may be utilized and other changes may be made without departing from the spirit or scope of the subject matter presented herein. Aspects of the present disclosure can be arranged, substituted, combined, and designed in a variety of different configurations, as generally described herein and illustrated in the drawings, all of which are explicitly contemplated and will be readily understood to be part of the present disclosure.

Brief Description of the Drawings

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[0049] The above-identified drawings described in embodiments of the present disclosure contemplate other embodiments as well, as described in the detailed description. The present disclosure presents, by way of illustration and not limitation, exemplary embodiments. Numerous other modifications and embodiments can be devised by those skilled in the art that fall within the scope and spirit of the principles of the embodiments of the present disclosure.

[0050] The following detailed description is directed to specific embodiments of the development. In this specification, reference is made to the drawings, in which like parts or steps may be designated by like numerals throughout for clarity. References herein to "one embodiment," "an embodiment," or "in some embodiments" mean that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment of the present invention. Appearances of the phrases "in one embodiment," "in an embodiment," or "in some embodiments" in various places in this specification are not necessarily all referring to the same embodiment, nor do separate or alternative embodiments necessarily exclude other embodiments. Further, various features are described that may be shown by some embodiments and not by other embodiments. Similarly, various requirements are described that may be requirements for some embodiments but not for other embodiments. Here, embodiments of the present invention are referred to in detail, and examples thereof are illustrated in the accompanying drawings. As far as possible, the same reference numbers are used throughout the drawings to refer to the same or similar parts.

[0051] FIG. 1 is a schematic view of the distal end of one embodiment of a mechanical circulatory support (MCS) system 10 having a pump 22 attached to the tip of a catheter 16 disposed within the heart. FIG. 2 schematically illustrates an MCS system inserted into the body via an access path from the femoral artery to the cerebral artery to the left ventricle, according to some embodiments. Some features of the MCS system 10 are described with respect to FIGS. 1 and 2, along with further details of various features provided elsewhere in this specification.

[0052] Various embodiments of the MCS system 10 are described herein with various features. In some embodiments, the MCS system 10 may include a temporary (e.g., generally about 6 hours or less, or in some embodiments 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) left ventricular support device or pump, also referred to as an MCS pump, an MCS device, or a circulatory support device. The device may be used, for example, during high-risk percutaneous coronary intervention (PCI) performed in a selectively or emergently hemodynamically stable patient with severe coronary artery disease and / or a reduced left ventricular ejection fraction when a cardiac team, including a cardiothoracic surgeon, determines that high-risk PCI is an appropriate treatment option. The pump may be positioned across the aortic valve via a single femoral artery access.

[0053] In some embodiments, the MCS system 10 may include a long-term 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 within a sealed motor housing. An impeller having a second magnet may partially surround the first magnet outside the motor housing. Rotation of the first magnet rotates the second magnet and the impeller via magnetic communication.

[0054] In some embodiments, the MCS system 10 may include an insertion tool having a tubular body configured to axially movably receive a circulatory support device (also referred to herein as an MCS pump or an MCS device) and its catheter 16 (also referred to herein as a catheter shaft, a pump shaft, or an MCS shaft). An introducer sheath having a tubular body (also referred to herein as an access sheath and / or an expandable sheath) may be configured to axially movably receive the insertion tool. The insertion tool may protect the circulatory support device, for example, during insertion into and through either the introducer sheath and its hemostatic valve.

[0055] In some embodiments, the MCS system 10 may include an axial rotation blood pump with a low profile mounted on a catheter 16, such as an 8 French (Fr) catheter. When in a predetermined position, the MCS pump 22 can be driven by the MCS controller 1000 to provide partial left ventricular support of up to about 4.0 liters per minute, which can be about 60 mmHg. Due to improved bearing design and seal motors, system priming is not required. The MCS system 10 or a portion thereof may be visualized by fluoroscopy, eliminating the need for sensor-based placement.

[0056] In some embodiments, the MCS system 10 may include an introducer sheath. The sheath may be expandable. An expandable sheath may allow, for example, an initial access size of 8Fr to 10Fr for easy insertion and closure, be expandable to allow introduction of 14Fr, 16Fr, and 18Fr pump devices, and return to a smaller diameter around the 8Fr catheter 16 and insertion tool when the pump 22 passes through. This mechanism allows passage of the pump 22 through the vasculature while minimizing shear forces within the blood vessel and advantageously reducing the risk of bleeding and healing complications. The arterial incision expansion or dilation may be performed using a radial expansion with minimal shear forces that are not harmful to the blood vessel. Access may be achieved via a transfemoral, transaxillary, transbrachial, or transapical approach. In some embodiments, the expandable sheath may allow an initial access size of 8Fr to 16Fr (e.g., 8 - 10.5) Fr to facilitate insertion and closure, be expandable, and allow introduction of at least about 14Fr, 16Fr, 18, or 19Fr devices.

[0057] In some embodiments, the inlet tube 70 of the pump 22 extends across the atmospheric valve 91. The impeller may be located in the outflow section 68 of the inlet tube 70 (also referred to herein as the pump outlet), draw blood from the left ventricle 93 through the inlet tube 70, and discharge it from the outflow section 68 into the ascending aorta 95. The motor may be attached in direct proximity to the impeller within a sealed housing, 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).

[0058] In some embodiments, the MCS system 10 actively unloads the left ventricle by pumping blood from the ventricle into the ascending aorta and the systemic circulation. When in a predetermined position, the MCS device 22 can be driven by a complementary MCS controller 1000 to provide partial left ventricular support from 0.4 l / min to a maximum of 4.0 l / min. The MCS system 10 can increase the flow performance up to a maximum of 4.0 l / min at 60 mmHg with acceptably safe hemolysis by a computational fluid dynamics (CFD)-optimized impeller that eliminates the need for motor washing and minimizes shear stress. When in a predetermined position, the MCS device 22 can be driven by a complementary MCS controller 1000 to provide partial left ventricular support from 0.4 l / min to a maximum of 6.0 l / min. In some embodiments, the MCS device 22 can be driven by a complementary MCS controller 1000 to provide partial left ventricular support from 0.6 l / min to a maximum of 6.0 l / min. The range from 0.6 l / min to a maximum of 6.0 l / min can allow, for example, 10 equidistant flow levels.

[0059] In some embodiments, the MCS system 10 may include an axially rotating blood pump of 18Fr to 19Fr and an inlet tube assembly attached on the catheter 16, such as an MCS device 22 with a catheter of 10.5Fr or less. When in a predetermined position, the MCS pump 22 can be driven by a complementary MCS controller 1000 that can provide partial left ventricular support of at least about 4.0 or 5.0 and up to about 6.0 liters per minute with a pressure difference of about 60 mmHg. In some embodiments of the pump 22, no system purge is required due to the enclosed motor and magnetic bearing design.

[0060] Generally, the entire MCS system 10 can include a series of related subsystems and accessories including one or more of the following. The MCS system 10 can include a pump, a shaft, a proximal hub, an insertion tool (or an insertion catheter described later in this specification), an introducer sheath, a proximal cable, an infection shield, a guidewire guide tube and / or a guidewire aid. The pump 22 may be provided sterilized. The MCS shaft can include an electrical cable and a guidewire lumen for over-the-wire insertion. The proximal hub can include a guidewire exit having a valve for maintaining hemostasis and connecting the MCS shaft to the proximal cable, and the proximal cable connects the pump 22 to the controller 1000. The proximal cable 28 may be 3.5 m (about 177 inches) in length and may extend from the sterile field 5 where the controller 1000 is located to the non-sterile field 3. The insertion tool facilitates the insertion of the pump and the catheter shaft into the introducer sheath and protects the inlet tube and valve from potential damage or interference when passing through the introducer sheath, and can be pre-attached to the MCS device and its catheter shaft or otherwise pre-connected and provided. The peel-away guidewire aid may be pre-attached to the MCS device to facilitate the insertion of a guidewire, such as a 0.018-inch positioning guidewire, into the pump 22 and into the MCS catheter shaft 16. Optionally, the insertion tool may also be pre-attached such that the guidewire guide tube can at least partially pass through the space between the MCS device and the insertion tool. A 3 m 0.018-inch positioning guidewire may be used and has a soft coiled preformed tip for non-invasive wire placement into the left ventricle. The guidewire may be provided sterilized. A 14Fr or 16Fr introducer sheath may be used with a usable length of 275 mm to maintain access to the femoral artery and provide hemostasis for a 0.035-inch guidewire, a diagnostic catheter, a 0.018-inch positioning guidewire, and the insertion tool. The housing of the introducer sheath may be designed to accommodate the insertion tool with the MCS device and its shaft mounted therein.The introducer sheath can be provided sterile. The introducer dilator is compatible with the introducer sheath and can facilitate non-traumatic insertion of the introducer sheath into the femoral artery. The introducer dilator can be provided sterile. The controller 1000 can be used to drive and operate the pump 22, observe its performance and status, and / or provide error and status information. The electric controller 1000 may be designed to support continuous operation for at least about 12 hours and may include a basic interface for indicating and adjusting the level of support provided to the patient. Further, the controller 1000 can provide optical and audible alarm notifications if the system detects an error during operation. The controller 1000 may be provided non-sterile and may be included within a housing designed for cleaning and reuse outside the sterile field 5. The controller 1000 enclosure may include a socket into which an extension cable is plugged.

[0061] In some embodiments, the pump 22 of the present disclosure (which may also be referred to as a ventricular support device (VSD) or a mechanical circulatory support device) may be a temporary (generally about 6 days or less) left ventricular support device for enhancing cardiac output in patients with cardiogenic shock, such as caused by acute ST elevation myocardial infarction. The pump 22 can typically be positioned across the aortic valve via a transvascular access to pump blood from the left ventricle into the ascending aorta.

[0062] Referring to FIG. 3, an MCS system 10 according to some embodiments is shown in its entirety, and its sub-components are described in more detail below. For reference, the distal and proximal directions are indicated by the arrows in FIGS. 3, 4, and 8A. As used herein, "distal" and "proximal" have their ordinary and customary meanings and include, but are not limited to, a direction further away from the entry point of the patient's body along the delivery path and a direction closer to the entry point of the patient's body along the delivery path.

[0063] The system 10 may include an introducer sheath 12 having a proximal introducer hub 14 with a central lumen for axially movably receiving an MCS shaft 16 (the MCS shaft may also be referred to as a catheter, catheter shaft, or shaft herein). The MCS shaft 16 may extend between a proximal hub 18 and the distal end 20 of the system 10, from which a guide wire 24 extends. The proximal hub 18 may be provided with an integrated microcontroller or memory storage device for device identification and run-time tracking to prevent overuse to avoid excessive wear or other technical malfunctions. The microcontroller or memory device may be able to disable the device, for example, to prevent use of a used device. They may be able to communicate with a controller 1000, which may be able to display information about the device or messages regarding its use. A non-traumatic cannula tip having a radiopaque material enables visualization of placement / implantation under fluoroscopy.

[0064] The pump 22 may comprise a tubular housing. The tubular housing of the pump 22 may include any component of the pump 22 or components within the pump region of the system, such as an inlet tube, distal end, motor housing, other connecting tubular structures, and / or the proximal end of the motor housing, as widely used herein. The pump 22, for example the tubular housing, is carried by the distal region of the MCS shaft 16. The system 10 comprises at least one central lumen for axially movably receiving the guide wire 24. An infection shield 26 may be additionally provided on the proximal hub 18. The proximal cable 28 may extend between the proximal hub 18 and a connector 30 for releasable connection to the controller 1000, typically outside the sterile field 3, and be able to drive the pump 22.

[0065] Referring to FIG. 4, the system 10 may further include an insertion tool 32 having an elongate tubular body 36 having a length in the range of about 85 mm to about 160 mm (e.g., about 114 mm), which is the length of the hub 122 and the bend relief 130 of the introducer sheath 112 (see FIG. 5), and may be adapted to span an inner diameter in the range of about 4.5 mm to about 8.0 mm (e.g., about 5.55 mm) extending distally from the proximal hub 34. The tubular body 36, in some embodiments, includes a central lumen adapted to axially movably receive the MCS shaft 16 and the pump 22 therethrough, and sufficient crush resistance to maintain patency when passing through the hemostatic valve of the introducer sheath. As shown in FIG. 4, the tubular body 36 can generally be configured as a straight, straight tube. Also as shown, the distal end of the tubular body 36 can taper distally such that its inner and outer diameters narrow in the distal direction. The pump 22 can be positioned within the tubular body 36 to facilitate passage of the pump 22 through the hemostatic valve on the proximal end of the introducer hub 14 and / or through the entire length of the introducer sheath 112. A marker 37 (FIG. 7) can be provided on the MCS shaft 16 spaced proximally from the distal tip 64 such that a clinician can see that the pump is within the tubular body 36 as long as the marker 37 is visible proximal to the hub 34.

[0066] The hub 34 of the insertion tool 32 may be provided with a first engagement structure 39 for engaging with a complementary second engagement structure on an introducer sheath (e.g., the insertion sheaths 14 and / or 112) to lock the insertion tool within the introducer sheath. For example, the first engagement structure 39 may be disposed at the distal end of the hub 34 such that when the insertion tool 32 is inserted into the introducer sheath, it engages with a complementary second engagement structure on the proximal end of the introducer sheath. As shown, such a first engagement structure may have an elliptical or oval cross-sectional shape, although other configurations are possible, and preferably, it can prevent relative rotational movement between the insertion tool and the introducer sheath when the insertion tool is docked (e.g., fully inserted) with the introducer sheath. The hub 34 may be connected to the infection shield 26 via a connection 41 such as a knob or button that connects via a press fit, screw, or other means. The hub 34 may also be provided with a locking mechanism for clamping onto the shaft 16 to prevent the shaft 16 from sliding proximally or distally through the insertion tool when the MCS device is positioned at the desired location in the heart (e.g., to prevent axial movement of the catheter shaft 16 and the MCS device 22). Additionally or alternatively, the locking mechanism of the insertion tool 32 may be configured to prevent the shaft 16 from rotating relative to the insertion tool. The locking mechanism may be actuated by screwing one or more parts (e.g., two parts) of the hub 34. Other actuation means may also be possible. The hub 34 may additionally be provided with 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 that includes a pump. In one commercial offering of the system, as shown in FIG. 4, the packaged MCS device is pre-positioned within the insertion tool and the guide wire aid is pre-loaded within the MCS device and the shaft 16. In some examples, the MCS device is pre-disposed within the tube 36 and configured to advance distally. In such a configuration, the lumen of the hub 34 may be smaller than the MCS device and the shaft 16 alone may be configured to pass through the hub 34.When removing the pump from the body, the MCS device may be retracted into the tube 36, and then the insertion tool may be withdrawn from the introducer sheath using the pump within the tube 36. Further details of the guide wire assist 38 are discussed, for example, with reference to FIGS. 8A and 8B.

[0067] Referring to FIGS. 5 and 6, the introducer kit 110 may include a guide wire 100, an introducer sheath 112, a dilator 114, and / or a guide wire assist 38, as discussed with reference to FIGS. 8A and 8B. The guide wire 100 and the introducer sheath 112 may correspond to the guide wire 24 and the introducer sheath 12 described above. The guide wire 100 (e.g., a 0.018-inch profile guide wire) may include an elongate flexible body 101 extending between a proximal end 102 and a distal end 104. The distal zone of the body 101 may be preformed into a J-tip or pigtail to provide a non-traumatic distal tip, as shown in FIG. 6. The proximal zone 106 may be configured to facilitate threading through the MCS device and may extend between the proximal end 102 and the transition 108. The proximal zone 106 may have an axial length within the range of about 100 mm to about 500 mm (e.g., about 300 mm).

[0068] The introducer kit 110 may include an introducer sheath 112 and / or an expander 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 may terminate proximally at a proximal hub 122. Optionally, the tubular body 116 may be expandable (e.g., to accommodate the passage of the MCS device 22 therethrough) or may be peelable. The proximal hub 122 includes a proximal end port 124 that extends throughout the length of the tubular body 116 and communicates with a central lumen that exits out through a distal opening configured to axially removably receive the elongated expander 114. The proximal hub 122 further includes at least one and optionally two or more attachment features such as a side port 126 and an eye 128 to facilitate suturing to the patient, and at least one and optionally a plurality of hemostatic valves to provide a seal around various introduced components such as a standard 0.035-inch guide wire, a 5 Fr or 6 Fr diagnostic catheter, a 0.018-inch placement guide wire 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 the expander 114. Further, the proximal hub 122 (e.g., the proximal end of the hub) may include a secondary engagement structure for engaging a first engagement structure 39 of the insertion tool 32.

[0069] Figure 7 shows additional details of the distal pump region 60 of the MCS system showing the device or pump 22 and the distal portion of the catheter shaft 16. The pump zone or region 60 extends between the bend relief 62 and the distal tip 64 at the distal end of the shaft 16. The pump 22 can include a tubular housing 61 that can include an inlet tube 70, a distal tip 64, and / or a motor housing 74. The tubular housing 61 can include one or more pump inlets 66 and / or outlets 68 that can be part of a portion of the inlet tube 70 or other structures such as an intermediate structure coupling the proximal end of the inlet tube 70 to the motor housing 74. As further described herein, the guide wire guide aid can extend inside and outside various components of the system such as the tubular housing 61 of the pump 22 and / or the catheter shaft 16 (e.g., bend relief 62).

[0070] The pump inlet 66 comprises one or more windows or openings in fluid communication with the pump outlet 68 (also referred to herein as the outflow section) by a flow path extending axially through the inlet tube 70. The pump inlet may be positioned near the transition between the inlet tube and the proximal end of the distal tip 64, and in any case is generally about 5 cm or less, or 3 cm or less, from the distal port 76.

[0071] In some embodiments, the distal tip 64 is radiopaque. For example, the distal tip may be made of a polymer containing a radiopaque agent such as barium sulfate, bismuth, tungsten, iodine. In some embodiments, the entire MCS device is radiopaque. In some embodiments, a radiopaque marker is positioned on the inlet tube 70 between the pump outlet 68 and the guide wire port 78 to indicate the current position of the MCS device relative to the aortic valve 91.

[0072] The inlet tube 70 may comprise a very flexible slotted (e.g., laser cut) metal (e.g., nitinol) tube having a polymeric (e.g., polyurethane) tubular layer for separating the flow paths. The inlet tube 70 may have an axial length in the range of about 60 mm to about 100 mm, and in one embodiment may be about 67.5 mm. The outer diameter of the inlet tube 70 may typically be in the range of about 4 mm to about 5.4 mm, and in one embodiment may be about 4.66 mm. 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 the connection to the motor, may be fixed, such as through the use of laser welding, adhesives, screw-in or other interference fit structures, or may be through press fitting.

[0073] The impeller 72 may be positioned within the flow path between the pump inlet 66 and the pump outlet 68. In the illustrated embodiment, the impeller 72 is positioned adjacent to the pump outlet 68. As further discussed below, the impeller 72 can be rotationally driven by a motor contained within the motor housing 74 on the proximal side of the impeller 72.

[0074] Figures 8A and 8B are a side cross-sectional view and a detailed view of the pump region showing an embodiment of the guide wire assist 38. The MCS device can be provided in either a rapid exchange or wire configuration. A first guide wire port 76, such as an opening facing distally on the distal surface of the distal tip 64, extends through the side wall of the inlet tube 70 via a first guide wire lumen passing through the distal tip 64 and at least a portion of the flow path within the inlet tube 70 and can communicate with a second guide wire port 78, such as an opening distal to the impeller 72. This can be used for rapid exchange where the guide wire 100 extends proximally along the catheter from the second guide wire port 78.

[0075] The catheter can be provided over a wire configuration in which a guide wire extends proximally through a guide wire lumen therein over the length of the catheter shaft 16. However, in the wire embodiments of FIGS. 7, 8A, and 8B, the guide wire 100 exits the inlet tube 70 through a second guide wire port 78, extends proximally across the outside of the impeller and motor housing, and re-enters the catheter shaft 16 through a third guide wire port 80 that can be an opening in the sidewall of the catheter shaft 16 or in a proximal component of the pump, motor housing, or backend. The third guide wire port 80 may be located proximally of the motor and, in the illustrated embodiment, is located on the bend relief 62. The third guide wire port 80 extends proximally over the length of the shaft 16 and communicates with a guide wire lumen that is carried by or located within the proximal hub 18 and exits at a proximal guide wire port (see FIG. 4).

[0076] As shown in FIG. 8A, the pump can be provided assembled with a removable guide wire assist 38. The guide wire assist 38 can have a guide wire guide tube 83. The guide tube 83 can be cylindrical or have another closed cross-sectional shape that extends axially. The guide tube 83 can be a flexible transparent material such as polyimide. The guide tube 83 can be adapted to be peeled longitudinally, such as having a longitudinal slit or tear line. A lubricating coating such as PTFE can be provided on the inner surface of the guide tube 83. The guide tube 83 can follow the intended path of the guide wire 100 from the first guide wire port 76, proximally through the tip 64, posteriorly outside the inlet tube through the second guide wire port 78, and back into the catheter shaft 16 through the third guide wire port 80. In the illustrated implementation, the guide wire guide tube 83 extends proximally within the catheter shaft 16 proximal to the proximal end 81 of the guide tube 83 and communicates with or extends into the guide wire lumen that extends to the proximal hub 18. The proximal end 81 of the guide tube 83 can be positioned within about 5 mm or 10 mm of the distal end of the shaft 16, or can extend at least about 10 mm or 20 mm into the catheter shaft guide wire lumen, such as within the range of about 10 mm to about 50 mm. In some embodiments, the third port 80 can be located within the proximal end of a tubular housing such as a motor housing or backend, or within any other component of the device at a position proximal to the impeller.

[0077] The guide wire aid 38 may have a funnel 92. The funnel 92 may be located at the distal end of the guide tube 83 and may be provided pre-positioned at the distal end of the inlet tube, for example, the distal tip 64. The funnel 92 may increase in width in the distal direction from a narrow proximal end that communicates with the guide tube 83 to a wider distal opening at the distal end of the funnel 92. The funnel 92 may be conical, frustoconical, pyramidal, segmented, or of other shapes. The proximal end of the funnel 92 may be attached to the distal end of the guide wire guide tube 83. The proximal end 102 (see FIG. 6) of the guide wire 100 may be inserted into the funnel 92, pass through the first (distal) guide wire port 76, and be guided along the intended path by tracking inside the guide wire guide tube 83. Next, the guide wire guide tube 83 may be removed by sliding the guide tube 83 distally from the distal tip 64, peeling it longitudinally, and leaving the guide wire 100 in place.

[0078] The guide wire aid 38 may have a pull tab 94. In some embodiments, the distal end of the guide wire guide tube 83 is attached to the pull tab 94 of the guide wire aid 38. The pull tab 94 may be a structure that can be grasped by a human hand, for example, having a lateral planar extension as shown. The guide wire aid 38, for example, the pull tab 94, the guide tube 83, and / or the funnel 92 may be provided with a tearable line 75, as can be seen more clearly in FIG. 8B. The tearable line 75 may be an axially extending dividing line. The tearable line 75 may include a weakened region, a slot, or a perforated straight region. Removal of the guide wire aid 38 can be accomplished, for example, by grasping the pull tab 94 and pulling out the guide wire tube 83 and / or the funnel 92 and removing it from the guide wire 100 while dividing or peeling along the dividing line 75 as shown in the detailed insertion portion 91 of FIG. 8B.

[0079] The guidewire assist 38 may include a proximal opening 90 configured to slide over and removably receive on the distal tip 64 and / or struts at the distal end of the inlet tube 70 that defines the window of the pump inlet 66. A guidewire guide tube 83 having a lumen therethrough is positioned within the proximal opening 90 and aligned to pass through the guidewire port 76 of the distal tip 64. The proximal opening 90 may be further configured to slidably receive and removably receive the distal end of the tubular body 36 of the insertion tool 32, as shown in FIG. 4. The MCS system has an annular space defined between an outer surface of an MCS device such as the inlet tube 70, the motor housing 74, or the MCS catheter bend relief 16, and an inner surface of the tubular body 36 of the insertion tool 32, such that when the MCS device, the guidewire assist 38, and the insertion tool 32 are assembled together, the guidewire guide tube 83 can be removably received therein.

[0080] In some embodiments, the lumen of the guidewire guide tube 83 communicates with the distal flare opening of a funnel 92 that is larger in cross-section in the distal direction. The guidewire aid 38 is along the guidewire path, for example, into the MCS pump through port 76, through a portion of the fluid path in the inlet tube 70, out of the MCS pump through port 78, along the outside of the MCS pump, and back into the shaft 16 through port 80, and can be assembled and provided on the MCS pump together with the pre-loaded guidewire guide tube 83. This helps the user guide the proximal end of the guidewire through the guidewire path into the funnel 92 and into the guidewire lumen of the MCS shaft 16. A pull tab 94 can be provided on the guidewire aid 38 to facilitate gripping and removal of the guidewire aid including the guidewire guide tube 83 after the guidewire is loaded. The guidewire aid 38 can have a longitudinal slit or tear line 75, for example, along the funnel 92, the proximal opening 90, and the guidewire guide tube 83, to facilitate removal of the guidewire aid 38 from the MCS pump 22 and the guidewire 100. Further, the guidewire aid 38 and the guidewire guide tube 83 can be removed from the MCS device when loaded within the tubular body 36 of the insertion tool 32, such as after the guidewire is inserted.

[0081] The mechanism of the guidewire assist 38 described herein can be used with a variety of different MCS systems and / or pump devices. The guidewire assist 38 can be used in a guidewire path that enters and exits, or does not exit, the pump housing, as described. The guidewire assist 38 is described herein as being used in an MCS system configured for temporary operation for high-risk PCI procedures. The system can include a rotating impeller having a radial shaft seal and a motor that rotates the impeller via a shaft extending through the seal. The guidewire assist 38 can be used with a variety of different devices. The guidewire assist 38 may also be used with a pump having magnetic drive, where the motor rotates a first magnet within a sealed motor housing that magnetically communicates with a second magnet of the impeller outside the sealed housing to rotate the impeller. Thus, the guidewire assist 38 is not limited to use only with the specific pump embodiments described herein.

[0082] Figures 9A and 9B respectively show a side view and a partial cross-sectional view of the pump 22. As shown, the impeller 72 may be attached to a short rigid motor-driven shaft 140. In the illustrated implementation, the drive shaft 140 extends distally into a proximally facing central lumen within 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 helical blades 181 that extend radially outwardly, which may be spaced from the inner surface of the tubular impeller housing 82 within the range of about 40 μm to about 120 μm at its maximum outer diameter. The impeller housing 82 may be a proximal extension of the inlet tube 70 on the proximal side of a slot 71 formed within the inlet tube 70 to provide flexibility distally of the impeller. The outer tubular membrane 73 may enclose the inlet tube 70 and seal the slot 71 while retaining the flexibility of the inlet tube. The pump outlet 68 may be formed within the side wall of the impeller housing 82 that is axially aligned with, for example, the proximal portion (e.g., the proximal 25% to 50% portion) of the impeller 72.

[0083] The impeller 72 may include medical-grade titanium. This enables a CFD-optimized impeller design with unsteady gradients that minimize shear stress to reduce damage (hemolysis) to blood cells and increase efficiency, a feature not achievable with molding-based production methods. Electropolishing of the surface of the impeller 72 may reduce surface roughness and minimize its impact on hemolysis.

[0084] In some embodiments, the impeller hub 146 flares radially outward in the proximal direction to form an impeller base 150, which can direct blood flow from the outlet 68. The proximal surface of the impeller base 150 may be fixed to an impeller rear portion 152, which may be in the form of a radially extending flange fixed to the motor shaft 140. For this purpose, the impeller rear portion 152 may include 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 rear portion 152 is first attached to the motor drive shaft 140 and joined, such as through the use of an adhesive. In a second step, the impeller 72 may be advanced over the shaft, and the impeller base 150 may be coupled to the impeller rear portion 152, such as by laser welding.

[0085] The distal opening within the opening of the impeller rear portion 152 may increase in diameter in the distal direction to facilitate the application of an adhesive. The proximal end of the tubular sleeve / proximal extension 154 may decrease in outer diameter in the proximal direction to form an inlet ramp for facilitating advancing the sleeve proximally over the motor shaft and through a seal 156, as further discussed below.

[0086] The motor 148 may include a stator 158 having a conductive winding that surrounds a cavity that surrounds a motor armature 160 that may include a plurality of magnets fixed in the rotational direction with respect to the motor drive shaft 140. The motor drive shaft 140 may extend from the motor 148 through a rotary bearing 162 and also through a seal 156 and then out of the sealed motor housing 164 (also referred to herein as motor housing 74). The seal 156 may include a seal holder 166 that supports an annular seal 167 such as a polymer seal ring. The seal ring includes a central opening for receiving the tubular sleeve / proximal extension 154 and is biased radially inwardly with respect to the tubular sleeve / proximal extension 154 to maintain the seal ring in sliding sealing contact with the rotatable tubular sleeve / proximal extension 154. A smooth surface such as electropolishing may be provided on the outer surface of the tubular sleeve / proximal extension 154 to minimize seal wear.

[0087] The pump may include a hermetic motor for applications with short usage times for high-risk PCI (typically about 6 hours or less) and may be configured to be used without cleaning or purging. This provides an opportunity to directly bond the impeller 72 onto the motor drive shaft 140 and eliminates problems associated with magnetic coupling such as additional rigid lengths, space requirements, or pump efficiency, as discussed in more detail below. The 4-pole motor design enables flow performance up to 4.0 l / min (liters per minute) at 60 mmHg with low temperature variations. The motor cable interface may be provided with high tensile strength. -1 (liter / minute). The rotor bearing system 2700 of a pump, which can be used in various MCS systems described herein, is shown as an exemplary embodiment in the form of a pump for cardiovascular support and may have radial and axial motor mounts.

[0088] FIG. 10 is a partial cross-sectional view through the impeller and magnetic coupling region of one embodiment of a rotor bearing system 2700 of a pump that can be used in various MCS systems described herein. The rotor bearing system 2700 may have radial and axial motor mounts, shown as an exemplary embodiment in the form of a pump for cardiovascular support and for non-contact torque transmission.

[0089] The rotor bearing system 2700 may have a housing 2780. The housing 2780 may be a motor housing that encloses a motor, a drive shaft, and / or drive magnets and may be sealed from the surrounding environment. Within the housing 2780, a first cylindrical permanent magnet 2730 is placed on a shaft 2706 driven by a motor (not shown), and the permanent magnet 2730 is attached to rotate about a first axis 2705.

[0090] The housing 2780 may have a first cylindrical portion having a first outer diameter 2731 (e.g., in the range of 5 mm to 7 mm, preferably 6 mm) that radially encompasses the motor, a second cylindrical portion having a second outer diameter 2732 that is smaller (e.g., 0.3 mm to 1 mm, preferably 0.5 mm) than the first outer diameter, and a third cylindrical portion having a third outer diameter 2733 that is smaller (e.g., 1.7 mm to 2.3 mm, preferably 2.0 mm) than the second outer diameter.

[0091] The second outer diameter 2732 may fit snugly with the inlet tube housing 2722, and the second outer diameter and the inlet tube housing 2722 are sized such that the outer diameter of the inlet tube housing is in the same plane as the first outer diameter 2731 (e.g., the thickness of the inlet tube housing 2722 may be equal to half the difference between the first outer diameter and the second outer diameter). The third outer diameter 2733 of the housing 2780 may be, for example, in the range of 3.2 mm to 3.8 mm, preferably 3.5 mm.

[0092] The rotor bearing system 2700 may further include a rotor 2770 for conveying a liquid, and the rotor 2770 includes a second permanent magnet 2740 in the form of a hollow cylinder attached to rotate about the first axis 2705. The second permanent magnet 2740 in the form of a hollow cylinder is disposed in a component 2772 of the rotor 2770 in the form of a hollow cylinder. The second permanent magnet 2740 in the form of a hollow cylinder optionally includes a back iron 2750 on its exterior.

[0093] 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 (e.g., in the range of 3 mm to 4.2 mm). The second permanent magnet 2740 may have an outer diameter of 5.3 mm (e.g., within the range of 5 mm to 5.3 mm), a magnet height of 0.6 mm (e.g., within the range of 0.5 mm to 0.6 mm), and a length of 3.2 mm (e.g., within the range of 3 mm to 4.2 mm). The staggerer 2715 may be 1 mm (e.g., within the range of 0.1 mm to 1.2 mm). The rotor 2770 may have an outer diameter of 5.3 mm (e.g., less than the second outer diameter 2732 by a range of 0.1 to 0.4, preferably 0.2 mm) and a length of 15 mm.

[0094] The rotor 2770 can be arranged as an impeller that converts mechanical power transmitted by a coupling (e.g., a magnetic coupling) into hydraulic power to carry blood flow against blood pressure. The rotor 2770 may further include a tapered or conical part 2771 that fits into the part 2772 in the form of a hollow cylinder. The outer periphery of the base surface of the conical part 2771 may be connected to a ring-shaped opening on the axial end of the part 2772 in the form of a hollow cylinder.

[0095] The first permanent magnet 2730 and the second permanent magnet 2740 may at least partially overlap axially in the axial region indicated by the reference symbol 2716. In this case, the first permanent magnet 2730 is arranged axially shifted 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 the axial staggerer 2715 is drawn between these two vertical lines.

[0096] Due to the axial staggerer 2715, the second permanent magnet 2740 may be subjected to a force directed to the right in FIG. 10, and as a result, the ball 2717 disposed within the rotor 2770 is pressed onto the cone 2718 disposed within the housing 2780, and as a result, in this case, the first bearing 2720 and the third bearing 2790 that form a combination of axial and radial bearings 2719 are brought into contact and held. Alternatively, the balls may be disposed within the housing 2780 and the cones may be disposed within the rotor. When used as intended, the balls 2717 rotate within the cones 2718 and as a result, can absorb both radial and axial forces. The combined axial and radial bearing 2719 is, in this case, a solid body bearing. The balls 2717 are disposed within the conical portion 2771. The axial and radial bearing functions are achieved by the combination of the two elements, the balls 2717 and the cones 2718. The balls 2717 can have a diameter in the range of, for example, 0.5 mm to 0.9 mm, preferably 0.7 mm, and the cones 2718 can have a diameter of 1 mm, a height of 0.8 mm, and a cone angle in the range of 70° to 90°, preferably 80°. The axial bearing function of the combined bearing 2719 has the function of the first bearing and is designed for the relative axial positioning of the rotor 2770 and the housing 2780 and / or the shaft 2706 with respect to each other and is designed to absorb the axial force generated by the arrangement of the first permanent magnet 2730 and the second permanent magnet 2740. Further, the axial forces on the rotor bearing system 2700 can be adjusted so as to optimize the setting of the applied force.

[0097] The region of the housing 2780 with the first permanent magnet 2730 may be in the form of a hollow cylinder of the rotor 2770 and may be at least partially surrounded radially by the part 2772. Next, a channel 2774 in the form of a hollow cylinder may be formed between the housing 2780 and the part 2772 of the rotor 2770 through which liquid can flow. The bare or perforated 2702 may be disposed 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 part 2772 in the form of a hollow cylinder of the rotor 2770 and may be in fluid communication with the channel 2774. In use, when the rotor 2770 rotates, the liquid may be discharged centrifugally from the bar 2702 and the liquid may be drawn into the channel 2774 to replace the discharged liquid in a continuous flow. The flow arrow 2711 in this case indicates the direction of the liquid flow through the gap 2774. The flow arrow 2712 indicates the direction of the liquid flow transferred by the rotor vane 2773.

[0098] A second bearing 2710, which can be arranged as a radial, hydrodynamic, and blood lubricated plain bearing, can be arranged on the edge portion of the conical portion 2771 of the rotor 2770 facing away from the housing 2780. The second bearing 2710 can be designed to absorb radial forces and align with the rotational axis 2705 of the shaft 2706 or the first permanent magnet 2730 to position the rotational axis of the second permanent magnet 2740. In this case, the second bearing 2710 may be disposed between the rotor 2770 and the insert 2721, which can be fixed, particularly clamped or pushed, onto the ring-shaped edge portion on the second housing 2722, which is then fixed onto the housing 2780. The second housing 2722 in this case may form the outer skin of the rotor bearing system 2700 and the second housing 2722, which may also be referred to as the impeller housing, has a plurality of outlet windows 2723. The insert 2721 is preferably a bearing housing or a star that can be firmly attached (e.g., by adhesion, welding, or friction fitting) to the second housing 2722. The bearing star 2721 may have an outer diameter of 6 mm (e.g., within the range of 5 mm to 7 mm) and a length of 3 mm (e.g., within 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).

[0099] As another method, the insert 2721 and the second housing 2722 may be manufactured as a single part having a consistent inner diameter. In this arrangement, the extended inlet cannula can be connected to the combined insert and second housing 2722, for example, by laser welding.

[0100] The bearing 2710 may have a diameter of 1 mm (e.g., within the range of 0.75 mm to 1.5 mm) and a length of 1 mm (e.g., within the range of 0.75 mm to 2 mm).

[0101] 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 FIG. 10 acts on the rotor 2770 in the motor direction, i.e., from left to right in the exemplary embodiment of FIG. 10. This force is opposed by the hydraulic pressure applied to the rotor 2770 during operation, i.e., the hydraulic pressure applied from right to left in the exemplary embodiment of FIG. 10, which is in the opposite direction of the liquid flow 2711 generated by the rotating rotor vane 2773.

[0102] In this case, the axial force resulting from the combination of the first permanent magnet 2730 and the second permanent magnet 2740 may be optimized to be greater than the maximum expected hydraulic pressure, thereby ensuring that the rotor 2770 is always held in the defined axial position and not becoming too large compared to the maximum expected hydraulic pressure, thereby making it possible that the combination of the axial and radial bearings 2719 is not overloaded unnecessarily. Thus, friction and wear are minimized, and the torque transmitted to the rotor is reduced. This axial force can be optimized by adjusting the dimensions (e.g., length, thickness, outer diameter) of both permanent magnets 2730, 2740, and the axial displacement or stagger distance 2715, and, if a Halbach configuration is implemented, the segment angle α.

[0103] The optimization tests were conducted by the applicant using a Halbach magnet configuration with a pump device having a segment angle a of 45° and an outer diameter of 6.2 mm. Due to the 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 lengths of each magnet and the stagger 2715 were modified to study and optimize the effects on the axial force and torque. The sum of the magnet length and the stagger was limited to 4.2 mm due to the length constraint of the rigid section of the pump and can cross the tortuous vascular path during intravascular delivery to the heart. The conclusion of the study found that the optimized design has a magnet length of 3.2 mm (the length of both permanent magnets 2730, 2740), and an axial displacement of 1.0 mm or stagger 2715 generated to obtain the best results. The stagger 2715 in the range of 0.5 mm to 1 mm may be the basis of an alternative embodiment but was found not to be optimal. These results may represent an optimized coupling configuration for the tested device. The forces applied to the impeller and coupling are a function of the overall diameter of the device, the length of the inlet tube, the impeller design, the maximum impeller speed or blood flow rate, and other characteristics or dimensions that affect the hydraulic pressure, bearing friction laser, and eddy current laser. Therefore, the results may be different for devices with different dimensions or mechanisms compared to those tested.

[0104] For the purposes of this study, the maximum fluid load was assumed to be 1.2 mNm, the frictional losses in the bearing were assumed to be 0.2 mNm, and the eddy current losses were assumed to be 0.1 mNm for a total load torque of 1.5 mNm during normal operation. Using a safety factor of 3, the maximum load torque was set to 4.5 mNm. The friction and wear behavior can also be optimized by increasing the cone angle of the cone 2718, and sufficient radial load capacity must be ensured.

[0105] Figures 11A - 11C respectively show a front view, a rear perspective view, and a front perspective view of an embodiment of the MCS controller or controller 1000. The controller 1000 can support the operation of one or more cardiac or circulatory support systems, such as a left ventricular support device, a ventricular assist device, or an MCS device, as described herein. The controller 1000 may include one or more modules for providing power to the cardiac support system. The controller 1000 may house electronic circuitry for transmitting and receiving operation signals to and from the cardiac support system. The controller 1000 may house one or more hardware processors for receiving and processing data, such as sensor data, from the cardiac support system. In some embodiments, the controller 1000 may have an integrated or built - in design in which all or substantially all of the components necessary for the operation of the controller are housed within the controller. For example, any power components, such as a transformer or an AC / DC converter, may be housed within the controller 1000. As shown in FIG. 2, the controller 1000 may be wired to the pump 22 via an electronic wire that extends through the catheter shaft 16 to the pump 22.

[0106] 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 changed uses after the construction of the controller. For example, multiple modes of wired or wireless communication may be integrated within the controller 1000 to communicate with external technologies such as, for example, RF, Wifi®, and / or Bluetooth®. In some embodiments, the controller 1000 may have an RFID reader. In some embodiments, the controller 1000 may have a system or component that enables synchronization of patient data, telemedicine, patient monitoring, real - time data collection, error reporting, and / or sharing of maintenance records.

[0107] The controller 1000 may include a housing for these modules that supports any of the heart support systems described herein. The housing may further include a handle 1002 for supporting portability. In contrast to some other controllers, such as the Abiomed Impella controller, the controller 1000 may not include the components necessary for priming. For example, the controller 1000 does not include a cassette for priming. The cassette typically delivers a rinse solution to the catheter. However, the cassette requires a significant amount of area and makes the housing larger and heavier. Due to design improvements described herein, such as the bearing design and the sealed motor discussed herein, the controller 1000 does not include a cassette. Further, in some embodiments, the controller 1000 does not require a port for receiving a priming tube. Thus, the controller 1000 can be lightweight and compact to support portability.

[0108] The controller may also include a cable management support 1004. In some embodiments, the cable management support 1004 is positioned on one end or side of the controller 1000. The controller 1000 may also include a mount 1006 that can support attachment of the controller to a pole in a clinical environment. The mount 1006 can rotate about an axis and support a horizontal or vertical clamp. The mount 1006 may be rapidly locked in a desired orientation by quick fastening with a slip clutch. In some examples, the mount 1006 is positioned away from the cable management support 1004. Further, in some embodiments, the cable management support 1004 is positioned on the left end of the controller 1000 as shown in FIG. 11B. A port 1107 (as shown in FIG. 11C) may be positioned on a side opposite to the cable management support 1004. In some examples, the control element 1008 discussed below is positioned on a side opposite to the cable management support 1004 and proximate to the port 1107. This may enable 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 shown can improve the operating experience and portability.

[0109] The controller 1000 may include a control element 1008. In some embodiments, the control element 1008 can provide tactile feedback. The control element 1008 may include a push button rotary dial. The control element 1008 may enable a user to change parameters on the controller 1000 and control one or more of the processes described herein. The control element 1008 may also include a status indicator 1010 as shown in FIG. 11A. In some embodiments, the controller 1000 may include a separate confirmation control element. Further, in some embodiments, all parameters except the separate confirmation control element can be modified using a single control element 1008. Grouping of controls in dedicated areas can improve the user experience.

[0110] In some embodiments, the controller 1000 may include an alarm feedback system that can provide feedback to the operator regarding the operation of the MCS system. In some embodiments, the alarm feedback system can be in the form of an LED 1302 as shown. The LED 1302 may be positioned to be visible to the operator using the controller. As shown, the LED 1302 is positioned around the handle 1002. Thus, it can be viewed from a 360° position around the controller. The LED 1302 may be in the form of a ring (oval, oblong, circular, or any other suitable shape) that wraps around the handle 1002. Such an LED 1302 can be visualized from any direction as long as the top of the controller is visible. The control system can generate different colors or patterns for the LED 1302 to provide various alarms or states of the controller 1000 and / or the MCS device.

[0111] The controller 1000 further includes a port 1107 that can receive a cable connected to the MCS device 22. The port 1107 can support multiple versions of the MCS device. The controller 1000 can also include an RFID reader 1304 on the side surface of the controller 1000. The RFID reader 1304 can read the salesperson's badge and operate the device according to a specific demo mode. The controller 1000 can include an inclined glass cover 1306 as shown in FIG. 11C to improve readability for the user.

[0112] Figure 12 shows a side view of an expandable introducer sheath 2912. The expandable introducer sheath 2912 can be used with any of the MCS system or pump embodiments described herein. The expandable introducer sheath 2912 may have a hub 2922 and related components similar to the introducer sheath 112 described in connection with FIG. 5, and vice versa. Further, the elongate tubular body of the introducer sheath 2912 may be expandable from a first reduced inner cross-sectional area to a second enlarged inner cross-sectional area to allow passage of a device having an outer diameter (OD) greater than the first reduced cross-sectional area. The introducer sheath can be biased to return, or substantially return, to the first reduced cross-sectional area after expansion in response to passage of a sheath expansion device (e.g., an MCS device described herein) therethrough. The expandable introducer sheath 2912 may include an expandable support structure 2932, such as a tubular framework of a plurality of zigzag segments of a shape memory material such as nitinol, which allows for radial expansion in the presence of an expansion device passing therethrough, but will return to the first reduced cross-sectional area after removal and / or passage of the device. The expandable support structure 2932 may be encapsulated within a tubular flexible membrane 2930 capable of accommodating radial expansion and contraction. As further shown, the expandable introducer sheath 2912 includes a distal end 2920, a proximal end 2940, a side port 2926, a suture eyelet / eye 2928, a proximal hub 2922, and a proximal end port 2942 similar to the distal end 120, proximal end 118, side port 126, suture eyelet / eye 128, proximal hub 122, and proximal end port 124 of the introducer sheath 112 described herein. The expandable introducer sheath 2912 may also include a locking cap 2924 having one or more mechanisms at its proximal end that can engage / latch with an insertion tool and / or an insertion catheter (e.g., insertion tool 32, insertion tool 2632, insertion catheter 2832, and / or any of the insertion tools or catheters) such as a connector 2639 and / or an expander (e.g., expander 114) as described herein.

[0113] Figures 13A - 13E are various views of an embodiment of the insertion tool 2632. Figure 13A is a side view of the insertion tool 2632, Figure 13B is a longitudinal cross - sectional view of the insertion tool 2632 taken along line A - A of Figure 13A, Figures 13C and 13D are cross - sectional views taken along lines B - B and C - C shown in Figures 13A and 13B, and Figure 13E is an exploded view of the insertion tool 2632. The insertion tool 2632 may have the same or similar mechanisms and / or functions as the insertion tool 32 of Figure 4, and vice versa. Thus, the insertion tool 2632 can be used with the pump 22, or any other pump described herein, etc.

[0114] The insertion tool 2632 may have a generally elongated tubular configuration defining a longitudinal axis 2650. As shown in Figure 13A, the insertion tool 2632 may include a tubular body 2636 which may be a cylindrical tube at the distal end. The insertion tool 2632 may include a hub 2634 at the proximal end. The hub 2634 may include a connector 2639 (also referred to herein as a first engagement structure), a first housing section 2638, a second housing section 2640, a cap 2637, and / or a plug 2635. The connector 2639 may include a tube 2644 having a valve 2645 (shown in Figure 13E). As further shown in the cross - sectional view of Figure 13B, 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 further described below.

[0115] The tubular body 2636 at the distal end of the insertion tool 2632 may have a distal end and a proximal end, with a lumen extending therebetween. The tubular body 2636 may be cylindrical. The tubular body 2636 may be made of a polymer, plastic, other suitable material, or a combination thereof. The tubular body 2636 may be made of a transparent polymer such as nylon, Grilamid®, Pebax®, which may facilitate visual confirmation of the passage of the guide wire 100 through the guide wire guide tube 83 contained within the tubular body 2636. The tubular body 2636 may be expandable. The distal end of the tubular body 2636 may include a taper, e.g., a conical portion with a decreasing diameter in the distal direction, to facilitate insertion of the insertion tool 2632 (such as insertion into the introducer sheath described herein). The distal end of the tubular body 2636, such as a tapered distal end, may removably fit within the proximal opening 90 of the guide wire aid 38. The tapered end may be a material such as 55D Pebax® molded into 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 (e.g., rotatable between an open position and a locked position where the second housing section can be switched back and forth by rotating the second housing section 90 degrees relative to the first housing section) at its proximal end to the distal end of the second housing section 2640. The second housing section 2640 may be connected at its proximal end to the distal end of the cap 2637. The distal end of the plug 2635 may connect through the proximal end of the cap 2637.

[0116] The latching mechanism 2641 may have a longitudinally extending lumen through its body that is configured to receive a latching pad 2642. The latching pad 2642 may be an elastomeric material having a soft durometer such as a thermoplastic elastomer, soft Pebax®, or silicone. When inserted within the recess 2651, the latching pad 2642 may have an inner surface that substantially conforms to the inner surface of the longitudinally extending lumen of the latching mechanism 2641. As shown in FIG. 13B, the latching mechanism 2641 may be disposed within a hub 2634 that includes a connector 2639, a first housing section 2638, a second housing section 2640, and a cap 2637, such that all share a common longitudinal axis 2650 and the lumen of the latching mechanism 2641 is concentric with the lumen of the tubular body 2636, at least in an unlatched configuration. The latching mechanism 2641 may be connected to the proximal end of the connector 2639 at its distal end and may be connected to the distal end of the plug 2635 at its proximal end. The plug 2635 may have a longitudinally extending lumen through its body from its distal end to its proximal end.

[0117] When connected, the plug 2635, the locking mechanism 2641, the connector 2639, and the tubular body 2636 can create a fluid-sealed path extending along the longitudinal axis 2650 of the insertion tool 2632. The path may be fluid-sealed with the pump and the catheter shaft inserted therein. The valve 2649 and / or one or more sealing elements 2643 such as O-rings can help create 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 the valve 2649. The valve 2649 may have a conical flap with a decreasing width in the distal direction. When the pump or the catheter shaft is inserted through the valve 2649, the conical sidewalls can expand to allow the components to pass through, but can be compressed around the components to form a seal. The connection between the proximal end of the locking mechanism 2641 and the distal end of the plug 2635 may include one of the sealing elements 2643. The proximal end of the plug 2635 may include one of the sealing elements 2643 for fluid connection to other components of the circulation support system, such as the distal connector of the sterilization sleeve 26, which may have a fitting mechanism that locks to the plug 2635, such as by rotating a protrusion on the plug into a slot of the fitting feature. The sealing element 2643 may be an O-ring or other rounded sealing element that can engage to seal with the component passing through it.

[0118] The fluid sealing path along the longitudinal axis 2650 of the insertion tool 2632 can be configured to axially receive a circulation support device or pump, such as any of the devices or pumps described herein. For example, the lumen 2620 of the tubular body 2636 may be configured to axially receive the pump 22 and optionally the guide wire guide tube 83, and the longitudinally extending lumen within the hub 2634 may be sized to slidably receive the shaft 16 (e.g., an 8 French shaft) of the MCS device. When the pump 22 is contained within the lumen of the tubular body 2636, the shaft 16 is contained within the longitudinally extending lumen of the hub 2634, the locking mechanism is in the unlocked state (as shown in FIG. 13C), and the pump 22 can be advanced distally from the tubular body 2636, e.g., into the tubular body 116 of the introducer sheath 112, prior to advancing into the patient's vasculature from the introducer sheath by advancing the shaft 16 distally. The tubular body 2636 of the insertion tool 2632 has a circulation support device, such as the pump 22, therein and can be configured to be received by an introducer sheath (e.g., the introducer sheath 112 and / or 2912) as described herein. Thus, the tubular body 2636 of the insertion tool 2632 can have sufficient collapse resistance to maintain patency when passing through the hemostatic valve of the introducer sheath.

[0119] Insertion tool 2632 may be configured to removably lock with a circulation support device when inserted within insertion tool 2632. In some embodiments, insertion tool 2632 may be removably locked with the MSC shaft 16 (also referred to as a catheter or catheter shaft) of the circulation support device. When insertion tool 2632 is locked with the circulation support device, axial (e.g., longitudinal / proximal / distal) movement and / or rotational movement of the circulation support device may be prevented. Insertion tool 2632 may be locked to the circulation support device by engagement of a locking pad 2642 with at least a portion of the circulation support device. To engage locking pad 2642 with at least a portion of a circulation support device such as shaft 16, locking pad 2642 may be compressed by a locking mechanism 2641.

[0120] The locking mechanism 2641 can compress the locking pad 2642 by the interaction between one or more locking tabs 2646 of the locking mechanism 2641 and the inner surface or surface of the second housing section 2640. The locking tab 2646 may extend radially outward from the opposing side wall 2647 of the locking mechanism. The locking tab 2646 may be offset along the longitudinal axis 2650. The second housing section 2640, together with the cap 2643, may be configured to rotate with respect to the first housing section 2638, the locking tab 2646, and the plug 2635 (the axis of rotation is along the longitudinal axis 2650 of the insertion tool 2632). When configured in this way, 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 locking tabs 2646, compress the locking tabs 2646 inwardly, and result in a radially inward compression of the locking pad 2642. As shown in FIG. 13C, when the second housing section 2640 rotates counterclockwise by 90 degrees (as oriented in FIG. 13C, or rotates clockwise with respect to the first housing section 2638), the inner surface side wall 2640B of the second housing section 2640 contacts the locking tabs 2646 (shown as having a curved outer surface in this embodiment), pushes them inwardly, and can compress the locking mechanism 2641 inwardly with respect to the locking pad 2642. When the locking tabs 2646 are longitudinally offset, the inward compression of the locking tabs 2646, and thus, for example, the locking pad 2642 with respect to the shaft 16, may slightly bend the shaft 16 within the region of the locking pad 2642 and hold the shaft 16 in place. Alternatively, or additionally, the shaft 16 may be compressed by the locking pad 2642 and hold / lock the shaft 16 in place.

[0121] As shown in FIG. 13C, the second housing section 2640 may include two opposing first side walls 2640A that may be rounded as shown, and are connected by two opposing second side walls 2640B that may be straight. A first distance, e.g., a first diameter, between the two opposing first side walls 2640A may be greater than a second distance, e.g., a second diameter, between the two opposing second side walls 2640B. In the unlocked state, as shown in FIG. 13C, the two opposing first side walls 2640A may be adjacent to respective locking tabs 2646. When rotated to the locked position, the two opposing second side walls 2640B may contact and compress respective locking tabs 2646 as described, due to the shorter distance between the second side walls 2640B. Each locking tab 2646 may be formed from a rounded outer collar 2646A that is contacted by a respective second side wall 2640B, for gentle compression and to reduce the risk of the tab breaking. As the second housing section 2640 is rotated counterclockwise further away (i.e., counterclockwise with respect to the first housing section 2638) as oriented, each locking tab 2646 may form a radially outer edge 2646B that is contacted by a respective second side wall 2640B. The edge 2646B may be straight as shown, or otherwise may conform to the contour of the inner surface of the second side wall 2640B. For example, with the two opposing straight surfaces of the edge 2646B and the second side wall 2640B in contact, the second housing section 2640 may be stationary in the rotational direction without requiring an external force by the user. Movement into engagement of the edge 2646B with the inner surface of the second side wall 2640B may generate a snap-like tactile feedback.

[0122] To unlock the circulation support device from the insertion tool 2632, the second housing section 2640 may be rotated in the opposite direction (clockwise as oriented in FIG. 13C or counterclockwise relative to the first housing section 2638). The first housing section 2638 and the second housing section 2640 may include a mechanism that can hold the insertion tool 2632 in the unlocked position until the user of the system selects to lock the circulation support device in place relative to the insertion tool 2632. In some embodiments, the interaction between the locking tab 2646 and the second housing section 2640 may hold the insertion tool 2632 in the unlocked position until the user of the system selects to lock the circulation support device relative to the insertion tool 2632. Similarly, the first housing section 2638 and the second housing section 2640 may be provided with a mechanism that can hold the insertion tool 2632 in the locked position as described until the user of the system selects to unlock the circulation support device relative to the insertion tool 2632. In some embodiments, the interaction between the locking tab 2646 and the second housing section 2640 may hold the insertion tool 2632 in the locked position until the user of the system selects to unlock the circulation support device relative to the insertion tool 2632.

[0123] The connector 2639 of the insertion tool 2632 can be configured to engage with the introducer sheath (e.g., releasably lock / unlock with the introducer sheath) as described herein. For example, the outer surface of the distal end of the connector 2639 can be provided with mating bumps or flexible tabs of the lock cap 2924 within the proximal end port 2942 of the introducer sheath hub and / or an inner circumferential groove for engaging components such as the lock of the introducer sheath. The engagement between the distal end of the connector 2639 and the locking cap 2924 can generate a snap-like tactile feedback. The connector 2639 can prevent rotation of the insertion tool connector 2639 relative to the introducer hub 2922 and, when connected, engage with the introducer sheath locking cap 2924 in a manner that prevents rotation of the first housing section 2638 relative to the introducer hub. For example, the distal end of the connector 2639 and the proximal end port 2942 of the introducer sheath may have an elliptical, oval, square, polygonal, or non-circular cross-sectional shape. Further, the cross-sectional shape of the connector 2639 can taper to a smaller cross-sectional area in the distal direction to facilitate insertion into the lock cap 2924 of the introducer sheath. Locking the insertion tool 2632 to the introducer sheath can 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.

[0124] FIG. 13D shows a portion of the connection between the connector 2639 and the distal end of the locking mechanism 2641, and the proximal ends of the connector 2639 and the elongated tubular body 2636. In some embodiments, a tube 2644 that may be in fluid connection with the longitudinal lumen of the insertion tool 2632 is also shown. The locking mechanism 2641 may include a radially outwardly extending protrusion that is received within a corresponding groove or recess of the connector 2639. This engagement may rotationally stabilize the locking mechanism 2641 relative to the connector 2639. An adhesive may be added to bond the protrusion and the groove to securely connect the connector 2639 and the locking mechanism 2641. The adhesive may also be added to bond the locking mechanism 2641 to the first housing section 2638 to securely connect them. The connector 2639 may have an inward flange that has the same size and shares a longitudinal lumen within the hub 2634 and a lumen with the shaft 2650, which may provide a stop when inserting the tubular body 2636 into the connector 2639 during manufacture, protect the valve 2649, and hold the opening to the tube 2644 in place.

[0125] FIG. 13E is an exploded view of the insertion tool 2632 according to FIGS. 13A - 13D and some embodiments. As shown, the tube 2644 in fluid communication with the longitudinal lumen of the insertion tool 2632 can have a valve 2645, such as a stopcock, at its opposite edge portion. The valve 2645 can be adjusted to prevent or allow the flow of fluid through the valve 2645.

[0126] The insertion tool 2632 may have a length in the range of about 85 mm to about 200 mm (e.g., about 192 mm). In some embodiments, the longitudinal lumen of the insertion tool 2632 may include a diameter in the range of about 4.5 mm to about 8.0 mm (e.g., about 5.55 mm). The insertion tool 2632 may be sized and configured such that when the pump 22 is fully within the tubular body 2636, the marking 37 (see FIG. 7) is visible proximal to the insertion tool hub 2634. The insertion tool 2632 may include a hemostatic valve (e.g., hemostatic valve 2645) for sealing around a circulatory support system that passes through it (e.g., seals around the MCS shaft 16). When provided, the hemostatic valve may accommodate a passageway for a larger diameter MCS device that includes the pump. In commercially available embodiments of the circulatory support system, as described herein, the packaged MCS device is pre-positioned within the insertion tool 2632 and the guide wire assist is pre-loaded within the MCS device and shaft 16.

[0127] Figures 14A-14E are various views of an embodiment of an insertion catheter 2832 that can be used with the various MCS systems and devices described herein. Figure 14A is a perspective view, Figure 14B is a side view, Figure 14C is a top view, Figure 14D is a bottom view, and Figure 14E is an exploded perspective view of the insertion catheter 2832. The insertion catheter 2832 can have the same or similar mechanisms and / or functions as the insertion tools described herein, such as insertion tools 32 and 2632. For example, at least some of the mechanisms of the insertion catheter 2832 that can be the same or similar to the features of the insertion tool 2632 are numbered with the same last two digits, but begin with "28" instead of 26. For example, as shown in Figures 14A-14E, the insertion catheter 2832 can have a generally elongated tubular configuration having a proximal end and a distal end, a longitudinal axis 2850 extending therebetween, a tubular body 2836 aligned with the longitudinal axis 2850, and a hub 2834 connected to the tubular body 2836. The hub 2834 can include mechanisms that are the same or similar to the hub 2634, including having a lock mechanism 2841 with a recess 2851, a locking tab 2846, and a locking pad 2842, which is the same or similar to the lock mechanism 2641 having a recess 2651, a locking tab 2646, and a locking pad 2642, and / or can have the same or similar functions. The hub 2834 can include a connector 2839, a first housing section 2838, a second housing section 2840, a cap 2837, a plug 2835, a hemostatic valve 2849, and / or one or more sealing elements 2843. The connector 2839 can include a tube 2844 having a valve 2845. The insertion catheter 2832 can also include other features that are the same or similar to the insertion tool 2632, although the tubular body 2836 can be configured differently than the tubular body 2636, as discussed with respect to Figures 15A-15C. Further, using a different tubular body 2836, the insertion catheter 2832 can include an adapting 2861 shown in Figure 14E configured to fluidly connect and seal the tubular body 2836 to the hub 2834 (e.g., to the connector 2839 of the hub 2834).

[0128] Figures 15A to 15C are various views of the tubular body 2836 of the insertion catheter 2832. Figure 15A is a side view of the tubular body 2836, Figure 15B is a longitudinal cross-sectional view of the tubular body 2836 taken along line D-D of Figure 15A, and Figure 15C is an enlarged view of detail E of Figure 15B. The tubular body 2836 may include one or more features that advantageously increase the operability and / or use cases of the insertion catheter 2832, as further described below.

[0129] The tubular body 2836 may have a proximal end 2851 and a distal end 2857, with a longitudinal axis 2850 extending therebetween, and may have a proximal portion 2852 adjacent to the proximal end 2851, a distal portion 2856 adjacent to the distal end 2857, and an intermediate portion 2854 between the proximal portion 2852 and the distal portion 2856. Unlike the tubular bodies of other insertion tools described herein, the distal portion, intermediate portion, and proximal portion can each have different inner diameters and / or outer diameters, and thus the tubular body 2836 may also include a proximal transition section 2853 between the proximal portion 2852 and the intermediate portion 2854, and a distal transition section 2855 between the intermediate portion 2854 and the distal portion 2856. All portions and sections of the tubular body 2836 may be concentric about the longitudinal axis 2850, as shown. Further, all portions and sections of the tubular body 2836 can together form a common lumen 2820.

[0130] The tubular body 2836 can be configured to extend beyond the distal end of an introducer sheath (e.g., any of the introducer sheaths described herein) when the insertion catheter 2832 is in use. Thus, the tubular body 2836 of the insertion catheter 2832 can have a length in the range of about 275 mm to about 675 mm, an inner diameter in the range of about 1.5 mm to about 6 mm, and an outer diameter in the range of about 2 mm to about 7 mm. The distal portion 2856 and the distal transition section 2855 can be configured to receive (e.g., axially movably receive) at least a portion of the circulatory support device 22 and optionally a guide wire guide tube 83 connected thereto (e.g., where the guide wire guide tube is at least partially positioned external to the circulatory support device). For this reason, the distal portion 2856 can have a length in the range of about 75 mm to about 140 mm, or a length configured to include up to 100% of the MCS device, or a length configured to accommodate only the tapered portion of the distal tip 64 protruding from the distal end 2857, and an inner diameter in the range of about 3.5 mm to about 6 mm, or an inner diameter in the range from a first inner diameter configured to slidably receive the catheter shaft 16 of the MCS device 22 to a second inner diameter configured to slidably receive the MCS device 22. The distal transition section 2855 has a length in the range of about 5 mm to about 55 mm, as well as an inner and outer diameter that vary along its length and can satisfy the inner and outer diameters of the distal and intermediate portions. The intermediate portion 2854 and the proximal portion 2852 can be configured to receive (e.g., axially movably receive) the elongated flexible catheter shaft 16 extending proximally from the circulatory support device 22. Thus, the intermediate portion 2854 can have a length in the range of about 150 mm to about 250 mm and an inner diameter in the range of about 1.5 mm to about 4.5 mm. The proximal portion 2852 can have a length in the range of about 100 mm to about 165 mm and an inner diameter in the range of about 2.0 mm to about 6 mm. The proximal transition section 2853 has a length in the range of about 1 mm to about 20 mm and an inner and outer diameter that vary along its length and can satisfy the inner and outer diameters of the intermediate and proximal portions at its edge portions.Overall and as shown, the distal portion 2856 can have an inner diameter that is larger than the inner diameter of the intermediate portion 2854 and the inner diameter of the proximal portion 2852. Further, the intermediate portion 2854 can have an outer diameter that is smaller than the outer diameter of the proximal portion 2852 and the outer diameter of the distal portion 2856. In some embodiments, the outer diameter of the proximal portion 2852 may be the same as or similar to the outer diameter of the intermediate portion 2854, such that the proximal transition section 2853 may not be necessary.

[0131] The tubular body 2836 can be a composite having a liner and a jacket material such as Pebax 72D having a propeller. Unlike the tubular bodies of other insertion tools described herein, the tubular body 2836 can vary in stiffness and / or its ability to resist torsion along its length. As shown in the cross-section of FIG. 15B, the proximal portion 2852 can be configured to have a greater stiffness than the portion of the tubular body 2836 distal to the proximal portion so as to transmit longitudinal forces without twisting. To achieve such greater stiffness, the proximal portion 2852 can have a greater wall thickness, a greater diameter (e.g., a greater outer diameter), and / or a reinforced wall structure than other portions of the tubular body 2836. For example, the proximal portion 2852 and optionally the proximal transition section 2853 can include a reinforced double braided wire such as 10 PPI, 0.002 inch × 0.005 inch SS 304V wire. Conversely, other portions and / or sections of the tubular body 2836, such as the distal portion 2856 and optionally the distal transition section 2855, can include a braided wire (e.g., a single braided wire) such as 38 PPI, 0.002 inch × 0.005 inch SS 304V wire.

[0132] Similar to the insertion tool 2632, the distal end 2857 of the tubular body 2836 can have a taper, such as a conical portion with a decreasing diameter in the distal direction, to facilitate the insertion of the insertion catheter 2832 (such as insertion into an introducer sheath as described herein). The distal end of the tubular body 2836, such as a tapered distal end, can be removably fitted within the proximal opening 90 of the guide wire assist 38. Further, the tubular body 2836 can include a band 2858 adjacent to its distal end 2857. The band 2858 can be a PET band configured to hold the ends of the braided wires of the distal portion 2856. In an alternative embodiment, the band 2858 can be a radiopaque marker.

[0133] To facilitate the insertion of the insertion catheter 2836 (such as insertion into an introducer sheath as described herein), at least the distal portion 2856 of the tubular body 2836 can have a hydrophilic coating to reduce friction on its outer surface. In some embodiments, the distal portion or the entire tubular body 2836 can be coated with a hydrophilic coating to reduce external surface friction. Further in relation to insertion, the tubular body 2836 of the insertion catheter 2832 can be configured to have sufficient folding resistance to maintain patency when passing through one or more hemostatic valves of the introducer sheath.

[0134] Figures 16A - 16D are various views of the MCS device 22 and its catheter shaft 16, separate from the insertion catheter 2832. Figure 16A shows a perspective view of the MCS device 22 and its catheter shaft 16 at an upper separation from the bottom insertion catheter 2832. Figure 16B shows a perspective view of the MCS device 22 and its catheter shaft 16 loaded within the insertion catheter 2832. Figures 16C and 16D show side views corresponding to Figures 16A and 16B. In particular, the side view of Figure 16C shows how the tubular body of the insertion catheter 2832 is adapted to receive the variable outer diameter of the MCS device 22 and its catheter shaft 16. Specifically, referring to Figures 15A - 15C, Figure 16C shows how the distal portion 2856 and the distal transition section 2855 of the insertion catheter 2832 are configured to receive the enlarged diameter of the MCS device 22, while the proximal portion / section of the distal portion 2856 needs to be large enough to fit over the catheter shaft 16 through it. In such a configuration, the MCS device 22 and its catheter shaft 16 may be positioned within the insertion catheter 2832 by advancing the insertion catheter 2832 distally over the catheter shaft 16 until the MCS device 22 is contained within the distal portion 2856. For example, no further distal movement is achieved until the proximal end of the MCS device 22 physically abuts the inner surface of the distal transition section 2855. Such an interaction between the inner surface of the distal transition section 2855 and the proximal end of the MCS device due to the variable diameter (e.g., enlarged distal diameter) of the tubular body 2836 also enables the longitudinal force applied to the insertion catheter 2832 to be transmitted rearwardly to the MCS device 22, thereby facilitating the loading of the insertion catheter 2832 having the MCS device 22 within the introducer sheath as described herein.

[0135] In some embodiments of the circulatory support system, the MCS device may be pre-positioned and packaged within the insertion catheter 2832, as shown in FIGS. 16B and 16D. When fully positioned within the insertion catheter 2832, the distal end of the MCS device 22 may extend beyond the distal end of the insertion catheter 2832, as shown. In some embodiments, the guidewire assist 38 may be pre-loaded into the MCS device and shaft 16 as described herein using the distal end 2857 of the insertion catheter 2832 received by the proximal opening 90 of the guidewire assist 38.

[0136] FIGS. 17A-17C are various views of the MCS device 22 and its catheter shaft 16 disposed within the insertion catheter 2832 and partially within the introducer sheath 2912 (which can be exchanged for any of the other introducer sheaths described herein). FIG. 17A shows a perspective view of such an assembly, FIG. 17B shows a side view, and FIG. 17C shows a perspective cross-sectional view. The shown introducer sheath 2912 is configured to be expandable, and as seen in FIGS. 17A-17C, the tubular body of the introducer sheath expands to conform to the enlarged diameter of the MCS device 22 inside the insertion catheter 2832 and is folded outside the insertion catheter 2832 to have a smaller diameter. Also shown are potential configurations of the first and second engagement structures of the insertion catheter 2832 and the introducer sheath 2912 for locking the insertion catheter 2832 and the introducer sheath 2912 with the introducer sheath 2912 (e.g., within it). As shown, the first engagement structure at the distal end of the hub of the insertion catheter 2832 may fit into a complementary second engagement structure at the proximal end of the hub of the introducer sheath 2912 and may have a cross-sectional shape configured to prevent rotation. For example, the cross-sectional shape may have a non-circular shape such as an ellipse, triangle, square, hexagon, octagon, or a shape having a ridge or other radial asymmetry that prevents rotation of the first engagement structure within the second engagement structure.

[0137] Figure 18 shows the MCS device 22 and its catheter shaft 16 disposed within an insertion catheter 2832 (upper) not inserted within an introducer sheath 2912 (interchangeable with any of the other introducer sheaths described herein), a partially inserted insertion catheter 2832 (central portion), and a fully inserted insertion catheter 2832 (lower). The partially inserted configuration shown centrally may correspond to the partially inserted configurations shown in FIGS. 17A - 17C. As described herein, the MCS device 22 and its catheter shaft 16 may be pre-packaged within the insertion catheter 2832. The upper image shows this pre-packaged assembly after a guide wire has been loaded through the MCS device 22 and its catheter shaft 16. After performing an arteriotomy to gain access to the femoral artery and obtaining the distal end of the introducer sheath 2912 advanced through the arteriotomy, the distal end of the insertion catheter 2832 having the MCS device 22 and the inner located catheter shaft 16 may be inserted through the proximal end of the introducer sheath. Next, the insertion catheter 2832 having the MCS device 22 and the inner located catheter shaft 16 may be advanced distally through the introducer sheath 2912 and through any hemostatic valve through which it may be further advanced until the insertion catheter 2832 is locked / docked within the introducer sheath 2912 as described herein (corresponding to the bottom image).

[0138] The insertion catheter 2832 can be configured such that when the insertion catheter 2832 is fully docked with the introducer sheath 2912, the distal end of the tubular body 2836 of the insertion catheter 2832 extends beyond the distal end of the introducer sheath 2912. Such a configuration advantageously eliminates the need to individually push the MCS device through any portion of the lumen of the introducer sheath 2912, thereby minimizing the amount of pushing force required to advance the MCS device 22. Instead, the MCS device advances completely through the lumen of the introducer sheath 2912 while being positioned within the insertion catheter 2832.

[0139] Also shown is a mechanism of the insertion catheter 2832 that can improve the safety and reliability of the procedure. For example, to maintain the arteriotomy at the smallest possible diameter, the insertion catheter 2832 can be configured such that its proximal portion 2852 (which may have an enlarged diameter relative to the intermediate portion 2854) remains outside the body when the insertion catheter 2832 is fully docked with the introducer sheath 2912. As another example, to minimize the occlusion of the internal lumen of the artery through which the device passes during use of the system to reduce the risk of ischemia (e.g., lower limb ischemia), the insertion catheter 2832 can be configured such that its intermediate portion 2854 (which may have a reduced diameter relative to the proximal and distal portions) extends from outside the body. Through an arteriotomy in the femoral artery, through the femoral artery, through a branch of the femoral artery to connect to the molar, and when the insertion catheter 2832 is fully docked with the introducer sheath 2912, it enters the aorta (see the dotted lines indicating "arteriotomy" and "branch" in FIG. 18). Further, the insertion catheter 2832 can be configured such that its distal portion 2856 (which may have the maximum diameter of the tubular body of the insertion catheter) is positioned within a large cavity having an internal lumen larger than the femoral artery and can adapt to the size of the distal portion without risk of ischemia. From this position, the MCS device 22 can be moved from the insertion catheter 2832 to its desired position within the body (e.g., across the aortic valve), and the insertion catheter 2832 can lock the catheter shaft 16 in place as described herein to prevent its axial and / or rotational movement, and the introducer sheath can lock the insertion catheter 2832 in place as described herein to prevent its axial and / or rotational movement and can be fixed, for example, sutured, to the patient's body, thus fixing the catheter shaft 16 relative to the patient. When the procedure is completed, removal of the MCS device 22 and its catheter shaft 16 may be the reverse of insertion, but the MCS device 22 is first pulled proximally until it is placed within the insertion catheter 2832, and then the insertion catheter 2832 and the MCS device 22 and its catheter shaft 16 can be removed from the body.

[0140] Figures 19A, 19B, and 20 illustrate the use of a peel-away catheter configured to slidably receive at least a portion of an MCS system to facilitate delivery of the MCS system. The peel-away catheter can comprise a catheter shaft configured to be divisible and / or separable into a plurality of elongated shaft portions. In some examples, a medical delivery system can comprise a peel-away catheter including a catheter shaft having a portion disposed within an introducer sheath while a proximal portion of the introducer sheath, an insertion tool, and the catheter shaft are engaged with the insertion tool. The medical delivery system can comprise a spacer configured to axially separate the insertion tool from the introducer sheath.

[0141] FIG. 19A is a side view of a delivery assembly 1900 comprising a peel-away catheter 1902 configured to facilitate delivery of the MCS system 10 to a target location. FIG. 19B is a side view of the peel-away catheter 1902. In some examples, the peel-away catheter 1902 can be configured to slidably receive at least a portion of the MCS system 10, such as at least a portion of the shaft 16 and pump 22 of the MCS system. The peel-away catheter 1902 can improve the pushability of the MCS system 10 and / or reduce or prevent damage to the MCS system 10, while the MCS system 10 is navigated through a tortuous vascular pathway. As described herein, at least a portion of the peel-away catheter 1902 can be received by an introducer sheath that includes an expandable introducer sheath. The peel-away catheter 1902 can protect the MCS system 10 while at least a portion of the MCS system 10 advances through the introducer sheath. The peel-away catheter 1902 can be removed through the introducer sheath from around the MCS system 10, including around the MCS device shaft 16 and / or pump 22, such as after deployment of the MCS system 10.

[0142] Referring to FIG. 19A, the delivery assembly 1900 may include an insertion tool 1950 and a peel-away catheter 1902. The peel-away catheter 1902 may include a catheter shaft 1904 having a sheath delivery lumen 1918 that extends through the catheter shaft 1904. The proximal portion 1906 of the catheter shaft 1904 may be configured to mate with the insertion tool 1950. In some examples, the proximal portion 1906 of the catheter shaft 1904 may be configured to mate with a portion of the insertion tool 1950 having a tubular configuration. For example, the insertion tool 1950 may include an insertion tool shaft 1952 and an insertion tool hub 1956, and the insertion tool shaft 1952 may extend distally from the insertion tool hub 1956. The proximal portion 1906 of the catheter shaft 1904 may be mated with the distal portion 1954 of the insertion tool shaft 1952. The insertion tool 1950 may include an insertion tool delivery lumen 1958 that extends therethrough. For example, the proximal portion 1906 of the catheter shaft 1904 may be mated with the distal portion 1954 of the insertion tool shaft 1952 such that the sheath delivery lumen 1918 may be aligned with the insertion tool delivery lumen 1958. The MCS system 10 may be pre-loaded onto the insertion tool 1950 and the peel-away catheter 1902 for advancement to the target location.

[0143] In some examples, the support sleeve 1930 may be positioned around at least a portion of the shaft of the MCS system 10 to facilitate advancement of the MCS system 10 to the target location, provide column strength enhancement, and / or protect the MCS system 10. In some examples, the support sleeve 1930 may be disposed around a portion of the shaft 16 of the MCS system 10. The support sleeve 1930 may include a slit 1932 that facilitates removal of the support sleeve 1930 from around the MCS system 10. In some examples, a portion of the support sleeve 1930 may be received within the insertion tool delivery lumen 1958. Another portion of the support sleeve 1930 may be received within the sheath delivery lumen 1918. For example, the proximal end 1934 of the support sleeve 1930 may be within the insertion tool delivery lumen 1958. The distal end 1936 of the support sleeve 1930 may be configured to be received within the sheath delivery lumen 1918.

[0144] Referring to FIG. 19B, a side view of the peel-away catheter 1902 is shown. The catheter shaft 1904 can be removable / peelable / separable so that the catheter shaft 1904 can be removed from around the MCS system 10. In some examples, the catheter shaft 1904 can be configured to split and / or separate along at least one longitudinal portion extending along the entire length of the catheter shaft 1904 to enable removal of the catheter shaft 1904 from around the MCS system 10. The longitudinal portion can extend along a dimension including along a straight path parallel or substantially parallel to the longitudinal axis of the catheter shaft 1904. The catheter shaft 1904 can be configured to split and / or separate along one or more longitudinal portions to enable removal of the catheter shaft 1904. In some examples, the catheter shaft 1904 can be split and / or separated along one longitudinal portion such that the catheter shaft 1904 can be removed from around the MCS device by sliding the MCS system 10, such as the shaft 16 and / or the pump 22 of the MCS system 10, through a slit formed by an adjacent portion of the catheter shaft 1904 for separation and / or splitting. As another method, the catheter shaft 1904 can be split and / or separated along two or more longitudinal portions. For example, the catheter shaft 1904 can be split and / or separated into two or more pieces after the catheter shaft 1904 is split and / or separated along each of the plurality of longitudinal portions. The catheter shaft 1904 can be split and / or separated into various numbers of elongated shaft portions, including two, three, or four pieces. In some examples, the catheter shaft 1904 can include two longitudinal portions 1916 along which the catheter shaft 1904 can be split and / or separated. One longitudinal portion 1916 is shown in FIG. 19B. The other longitudinal portion 1916 can be on a portion of the catheter shaft 1904 not shown in FIG. 19B. For example, the two longitudinal portions 1916 can be on oppositely oriented portions of the catheter shaft 1904.Alternatively, the two longitudinal portions 1916 can be respective portions of the catheter shaft 1904 that are not oppositely oriented.

[0145] In some examples, the longitudinal portions can have the same or similar material as adjacent portions of the catheter shaft 1904. For example, the material of the catheter shaft 1904 can facilitate separation and / or splitting along the longitudinal portions. In some examples, the catheter shaft 1904 can include a material configured to propagate a break from an initial proximal slit to enable separation into a plurality of elongated shaft portions of the catheter shaft 1904. Alternatively, the longitudinal portions can include weakened portions to facilitate separation and / or splitting of the catheter shaft 1904 along the longitudinal portions.

[0146] Referring again to FIG. 19B, the peel-away catheter 1902 can include first and second operator engagement handles 1920, 1922. The first and second operator engagement handles 1920, 1922 can be coupled to respective portions of the catheter shaft 1904, such as the proximal portion 1906, and include at least a portion that extends laterally from the catheter shaft 1904. The first operator engagement handle 1920 can be coupled to the first elongated shaft portion 1904A. The second operator engagement handle 1922 can be coupled to the second elongated shaft portion 1904B. An operator can engage the first and second operator engagement handles 1920, 1922 to pull the catheter shaft 1904 apart along each longitudinal portion 1916. For example, the operator can pull the first and second operator engagement handles 1920, 1922 away from each other to split and / or pull apart the catheter shaft 1904 into the first and second elongated shaft portions 1904A, 1904B, respectively.

[0147] As described herein, the proximal portion 1906 of the catheter shaft 1904 can be fitted with the distal portion 1954 of the insertion tool shaft 1952. In some examples, the proximal portion 1906 can have an insertion tool fitting portion 1908 configured to fit with the distal portion 1954 of the insertion tool shaft 1952. The insertion tool fitting portion 1908 can have a lateral cross-sectional size (e.g., a cross-section perpendicular to the longitudinal axis of the catheter shaft 1904) that is larger than that of a more distal portion of the catheter shaft 1904. For example, the outer diameter and / or inner diameter of the insertion tool fitting portion 1908 can be made larger than the outer diameter and / or inner diameter of a more distal portion of the catheter shaft 1904. The insertion tool fitting portion 1908 can provide an interference fit with the distal portion 1954 of the insertion tool shaft 1952 to provide a hemostatic connection therebetween. For example, the diameter of a portion of the delivery lumen 1918 extending through the insertion tool fitting portion 1908 can be sized to be disposed on the outer surface of the distal portion 1954 of the insertion tool shaft 1952 and have an interference fit, thereby providing a hemostatic connection. In some examples, the insertion tool fitting portion 1908 can have an inner and / or outer lateral cross-sectional size that increases along the longitudinal direction extending to the proximal end 1912 of the catheter shaft 1904 so as to provide a flare configuration. The flare configuration can facilitate an interference fit with the insertion tool shaft 1952 and / or the provision of a hemostatic connection.

[0148] In some alternative examples, the proximal portion of the catheter shaft can be inserted into the distal portion of the insertion tool shaft and configured to have an interference fit, e.g., such that the sidewall of the distal portion of the insertion tool shaft is on the outer surface of the proximal portion of the catheter shaft. In some alternative examples, the interference fit between the proximal portion of the catheter shaft and the distal portion of the insertion tool shaft can include a releasable butt joint, such as a radially releasable joint, so that the proximal portion of the catheter shaft can be removed from the distal portion of the insertion tool shaft.

[0149] The length and / or cross-sectional size of the catheter shaft 1904 can be selected based at least in part on the size of the MCS system 10 slidably received within the delivery lumen 1918. The length and / or inner diameter of the catheter shaft 1904 (e.g., the cross-sectional size of the delivery lumen 1918) can be configured to accommodate the MCS system 10 and / or the support sleeve 1930. In some examples, the distal tip 64 of the MCS system 10 can be aligned with the distal end 1914 of the catheter shaft 1904. For example, at least a portion of the distal tip 64, such as at least a portion of the distal portion of the nose cone of the MCS system 10, can be disposed distally of the catheter shaft 1904 while the MCS system 10 is pre-loaded within the catheter shaft 1904. In some examples, the proximal end of the distal tip 64 can be aligned with the distal end 1914 of the catheter shaft 1904 such that the distal tip 64 is distal to the catheter shaft 1904. For example, the distal portion of the nose cone of the MCS system 10 can be disposed distally of the catheter shaft 1904 while the MCS system 10 is pre-loaded within the catheter shaft 1904.

[0150] In some examples, at least a portion of the outer surface 1924 of the catheter shaft 1904 may include a hydrophilic coating. In some examples, the hydrophilic coating can facilitate navigation of the catheter shaft 1904, including through the introducer sheath. In some examples, the catheter shaft 1904 may include one or more markers 1926 that are radiopaque to facilitate visualization of the position of the catheter shaft 1904. In some examples, the marker 1926 may be on and / or coupled to the outer surface 1924 of the catheter shaft 1904. For example, the catheter shaft 1904 may include a plurality of radiopaque markers disposed at respective positions along the longitudinal dimension of the catheter shaft 1904 to facilitate visualization of the advancement of the catheter shaft 1904 through the introducer sheath. In some examples, one or more of the markers 1926 may be on the distal portion 1910, including at or near the distal end 1914 of the catheter shaft 1904.

[0151] FIG. 20 is a side view of a delivery system 2000 having a pre-loaded MCS system 10 therethrough. The delivery system 2000 may include a spacer 2002, a peel-away catheter 1902 described with reference to FIGS. 19A and 19B, an insertion tool 2020, and an introducer sheath 2030. The peel-away catheter 1902 can be fitted with the insertion tool 2020. The insertion tool 2020 may include an insertion tool shaft 2022 extending distally from an insertion tool hub 2024. For example, an insertion tool fitting portion 1908 of the catheter shaft 1904 can be fitted with the insertion tool shaft 2022. The fitting between the peel-away catheter 1902 and the insertion tool shaft 2022 may be the same as or similar to the fitting between the peel-away catheter 1902 and the insertion tool shaft 1952 described with reference to FIGS. 19A and 19B. A portion of the catheter shaft 1904 of the peel-away catheter 1902 including the distal portion 1910 can be disposed through a delivery lumen 2036 (not shown) of the introducer sheath 2030. The introducer sheath 2030 may include an introducer sheath shaft 2032 extending distally from an introducer sheath hub 2034. A portion of the catheter shaft 1904 can be disposed through at least a portion of the delivery lumen 2036 extending through the introducer sheath shaft 2032 and the introducer sheath hub 2034.

[0152] The spacer 2002 may comprise at least a portion configured to be positioned between the introducer sheath hub 2034 and the insertion tool hub 2024 while the insertion tool mating portion 1908 of the catheter shaft 1904 is mated with the insertion tool shaft 2022, so as to axially separate the introducer sheath hub 2034 from the insertion tool hub 2024. The spacer 2002 may be configured to maintain a fixed distance between the introducer sheath hub 2034 and the insertion tool hub 2024, for example, such that the introducer sheath hub 2034 is distal along the longitudinal axis of the introducer sheath hub 2034 and / or the insertion tool hub 2024 and is aligned with the insertion tool hub 2024. During the navigation of the catheter shaft 1904 and the introducer sheath 2030 carrying the MCS system 10, the spacing and / or alignment can be maintained. The spacer 2002 can be removed after the introducer sheath 2030 has advanced to the target position so as to allow the advancement of the catheter shaft 1904, the insertion tool 2020, and / or the MCS system 10. In some alternative examples, after the introducer sheath 2030 has been navigated to the target position, such as while carrying an expander extending therethrough, the peel-away catheter 1902 coupled to the insertion tool 2020 can advance within the introducer sheath 2030. For example, the expander can be withdrawn, and the peel-away catheter 1902 pre-loaded with the MCS system 10 therethrough can advance at least partially through the introducer sheath 2030. The spacer 2002 can engage the introducer sheath hub 2034 and the insertion tool hub 2024 to maintain the axial spacing and / or alignment therebetween. The spacer 2002 can be removed to facilitate the peeling and / or removal of the peel-away catheter 1902, such as after the MCS system 10 has been deployed from the peel-away catheter 1902.

[0153] The spacer 2002 may comprise a distal portion 2006 configured to engage an introducer sheath hub 2034 and a proximal portion 2008 configured to engage an insertion tool hub 2024. The inner portion 2004 may extend between and be connectable to the proximal portion 2008 and the distal portion 2006. The distal portion 2006 may comprise a first hub engagement feature 2010 configured to engage the introducer sheath hub 2034, including a corresponding spacer engagement feature 2038 of the introducer sheath hub 2034. The proximal portion 2008 may comprise a second hub engagement feature 2012 configured to engage the insertion tool hub 2024, including a corresponding spacer engagement feature 2026 of the insertion tool hub 2024. In some examples, the spacer engagement feature 2038 may be on the proximal portion 2040 of the introducer sheath hub 2034. In some examples, the spacer engagement feature 2026 may be on the distal portion 2028 of the insertion tool hub 2024.

[0154] In some examples, each of the spacer engagement features 2038, 2026 of the introducer sheath hub 2034 and the insertion tool hub 2024 may comprise at least partially circumferentially extending grooves and / or recesses that include the entire perimeter of a portion of each hub. The first and second hub engagement features 2010, 2012 may include at least a portion configured to fit and / or couple with the grooves and / or recesses by and / or being received within the respective grooves and / or recesses. In some examples, at least a portion of the distal portion 2006 and the proximal portion 2008 may be oriented at an angle, including being perpendicular or substantially perpendicular to the inner portion 2004. In some examples, while the spacer 2002 is engaged with the insertion tool hub 2024 and the introducer sheath hub 2034, at least a portion of the inner portion 2004 may be oriented along a direction parallel or substantially parallel to the longitudinal axis of the insertion tool hub 2024 and / or the introducer sheath hub 2034. At least a portion of each of the distal portion 2006 and the proximal portion 2008 may be received within the respective grooves and / or recesses of the introducer sheath hub 2034 or the insertion tool hub 2024. The first hub engagement feature 2010 may comprise an edge of the distal portion 2006 received within the groove and / or recess of the introducer sheath hub 2034. The second hub engagement feature 2012 may include an edge of the proximal portion 2008 received within the groove and / or recess of the insertion tool hub 2024. The edges of the distal portion 2006 and the proximal portion 2008 may be configured to have complementary shapes and / or sizes of the respective grooves and / or recesses. For example, the edges of the distal portion 2006 and / or the proximal portion 2008 received within the grooves and / or recesses of the introducer sheath hub 2034 and / or the insertion tool hub 2024 may have a concave curvature configured to fit with a groove and / or recess extending along a path having a convex shape. Alternatively, or in combination, the spacer engagement features may have any number of other different configurations, including slots, depressions, and the like.

[0155] Of course, the peel-away catheter described herein can be used in combination with one or more of the other insertion tools and / or introducer sheaths described herein.

[0156] Figures 21A-28 show various examples of peel-away catheters (e.g., shafts, jackets, or sheaths) that can be used to deliver the MCS system described herein independent of the insertion tool.

[0157] Figure 21A is an exploded perspective view of an example of a peel-away catheter 3100 and an MCS system 10 pre-loaded through the peel-away catheter 3100. Figure 21B is a perspective view of a catheter shaft 3120 of the peel-away catheter 3100 that is peeled away from and / or removed from around the MCS system 10, including around the shaft 16 of the MCS system 10. The peel-away catheter 3100 can include a first elongate member 3150 and a second elongate member 3160 that each include portions configured to be received within respective elongate member lumens 3170, 3180 of the catheter shaft 3120. As described in further detail herein, an operator can pull on the elongate members 3150, 3160 to facilitate splitting and / or separating the catheter shaft 3120 into a plurality of elongate shaft portions. Figure 21A shows the catheter shaft 3120 in an unpeeled configuration. Figure 21B shows the use of the first and second elongate members 3150, 3160 to split and / or separate the catheter shaft 3120 into first and second elongate shaft portions 3120a, 3120b to facilitate peeling away and / or removing the catheter shaft 3120 from around the MCS system 10.

[0158] The first elongate member 3150 may include a first elongate portion 3152. A first proximal elongate member tab 3158 may be coupled to a proximal portion of the first elongate portion 3152, including the proximal end 3154 of the first elongate portion 3152. The second elongate member 3160 may comprise a second elongate portion 3162. A second proximal elongate member tab 3168 may be coupled to a proximal portion of the second elongate portion 3162, including the proximal end 3164 of the second elongate portion 3162. The catheter shaft 3120 may include a first elongate member lumen 3170 that extends along a first longitudinal portion of the shaft wall 3134 of the catheter shaft 3120. The catheter shaft 3120 may include a second elongate member lumen 3180 that extends along a second longitudinal portion of the shaft wall 3134. For example, corresponding portions of the shaft wall 3134 may define the first and second elongate member lumens 3170, 3180. At least a portion of the first elongate portion 3152 may be configured to be received within the first elongate member lumen 3170. At least a portion of the second elongate portion 3162 may be configured to be received within the second elongate member lumen 3180. The first and second proximal elongate member tabs 3158, 3168 are disposed external to the catheter shaft 3120 to facilitate operation by an operator (e.g., grasping the first and second proximal elongate member tabs 3158, 3168 and pulling on the first and second elongate members 3150, 3160). For example, the first and second proximal elongate member tabs 3158, 3168 and / or a portion of the first and / or second elongate portions 3152, 3162 may be disposed external to the catheter shaft 3120, including the proximal side of the sheath shaft 3120 (as shown in FIG. 21A). In some examples, a respective portion of each of the first and second elongate portions 3152, 3162 may be disposed through respective openings at the proximal ends 3172, 3182 of the first and second elongate member lumens 3170, 3180 such that the first and second proximal elongate member tabs 3158, 3168 are disposed external to the catheter shaft 3120. For example, the proximal ends 3172, 3182 of the first and second elongate member lumens 3170, 3180 may be at the proximal end 3128 of the catheter shaft 3120.

[0159] The distal end 3156 of the first elongated portion 3152 is coupled to the catheter shaft 3120, and the distal end 3166 of the second elongated portion 3162 is coupled to the catheter shaft 3120. The first and second elongated portions 3152, 3162 can be tensioned and pulled laterally from the longitudinal axis of the catheter shaft 3120 to divide and / or separate the catheter shaft 3120 into a first elongated shaft portion 3120a and a second elongated shaft portion 3120b, as shown, for example, in FIG. 21B. For example, the shaft wall 3134 can be divided and / or separated into a first elongated shaft wall portion 3134a and a second elongated shaft wall portion 3134b. In some examples, the distal end 3156 of the first elongated portion 3152 can be coupled to the catheter shaft 3120 at a first location on the distal portion 3126 of the catheter shaft 3120, including a first location of the distal portion of the shaft wall 3134. For example, the distal end 3156 of the first elongated portion 3152 can be coupled to a first location of the distal portion of the shaft wall 3134 that defines the distal end 3174 of the first elongated member lumen 3170. In some examples, the distal end 3166 of the second elongated portion 3162 can be coupled to the catheter shaft 3120 at a second location on the distal portion 3126 of the catheter shaft 3120, including a second location of the distal portion of the shaft wall 3134. In some embodiments, the distal end 3166 of the second elongated portion 3162 can be coupled to a second location of the distal portion of the shaft wall 3134 that defines the distal end 3184 of the second elongated member lumen 3180. The distal ends 3174, 3184 of the first and second elongated member lumens 3170, 3180 can each be at or proximal to the distal end 3130 of the catheter shaft 3120. For example, the distal ends 3174, 3184 of the first and second elongated member lumens 3170, 3180 can each be at or proximal to the distal end of the shaft wall 3134.

[0160] In some examples, the first elongated portion 3152 and / or the second elongated portion 3162 may be coupled to or may include respective markers 3190, 3192 that are radiopaque markers. In some examples, markers 3190, 3192 may each include at least a portion disposed at or near the distal ends 3174, 3184 of respective elongated member lumens 3170, 3180. For example, the distal ends 3156, 3166 of the elongated portions 3152, 3162 may each be coupled to markers 3190, 3192 and / or a portion of the shaft wall 3134.

[0161] The peel-away catheter 3100 may include a first proximal shaft tab 3140 coupled to a first proximal portion of the catheter shaft 3120. Additionally or optionally, the peel-away catheter 3100 may include a second proximal shaft tab 3142 coupled to a second proximal portion of the catheter shaft 3120. For example, the first proximal shaft tab 3140 may be coupled to a proximal portion of the first elongated shaft wall portion 3134a. The second proximal shaft tab 3142 may be coupled to a proximal portion of the second elongated shaft wall portion 3134b. The first and second proximal shaft tabs 3140, 3142 may be configured to be pulled laterally away from the longitudinal axis of the catheter shaft 3120 to separate the catheter shaft 3120 into first and second elongated shaft portions 3120a, 3120b, such as first and second elongated shaft wall portions 3134a, 3134b.

[0162] The first and second proximal shaft tabs 3140, 3142, and the first and second elongated members 3150, 3160 may be disposed at respective positions around the catheter shaft 3120. In some examples, for example, as shown in FIG. 2lA, the first and second proximal shaft tabs 3140, 3142 may be disposed at opposing positions around the catheter shaft 3120. In some examples, the first and second elongated members 3150, 3160 may be disposed at opposing positions around the catheter shaft 3120.

[0163] The catheter shaft 3120 can extend distally from the catheter hub 3102. The catheter hub 3102 can include a hub delivery lumen 3104 that extends therethrough, such as from a proximal end 3106 to a distal end 3108. A portion of the MCS system 10, such as the shaft 16 of the MCS system 10, can be slidably disposed through the hub delivery lumen 3104. The catheter hub 3102 may or may not be a peel-away hub.

[0164] In some examples, the catheter hub 3102 is not a peel-away hub. For example, while in an unpeeled configuration, the catheter shaft 3120 can extend distally from the catheter hub 3102. The catheter hub 3102 can be coupled and / or engaged to the catheter shaft 3120. For example, the distal end 3108 of the catheter hub 3102 can be coupled and / or engaged to the proximal end 3128 of the catheter shaft 3120. The distal end 3108 of the catheter hub 3102 and / or the proximal end 3128 of the catheter shaft 3120 can include any number of engagement features configured to enable a connection between the catheter hub 3102 and the catheter shaft 3120. In some examples, after the peel-away catheter 3100 carrying the MCS system 10 has been advanced to the target location, the catheter hub 3102 can be separated, disengaged, and / or detached from the catheter shaft 3120 such that the catheter shaft 3120 can be removed from around the MCS system 10.

[0165] Referring to FIG. 21B, the operator can engage the first and second elongate member tabs 3158, 3168 to pull the first and second elongate members 3150, 3160, which include the first and second elongate portions 3152, 3162, laterally away from the longitudinal axis of the catheter shaft 3120 such that the first and second elongate portions 3152, 3162 can cut through corresponding portions of the shaft wall 3134 between the respective elongate member lumens 3170, 3180 and the outer surface of the shaft wall 3134. The operator can engage the first and second proximal shaft tabs 3140, 3142 to pull them laterally away from the longitudinal axis of the catheter shaft 3120 to tear a portion of the shaft wall 3134 between the respective elongate member lumens 3170, 3180 and the inner surface of the shaft wall 3134. In some examples, the inner surface of the shaft wall 3134 can include at least a portion that defines a shaft delivery lumen 3122 that extends through the catheter shaft 3120. Corresponding portions of the MCS system 10 can be slidably disposed through the shaft delivery lumen 3122.

[0166] Cutting the corresponding portions of the shaft wall 3134 between each of the elongated member lumens 3170, 3180 and the outer surface of the shaft wall 3134, and tearing the corresponding portions of the shaft wall 3134 between the first and second elongated member lumens 3170, 3180 and the inner surface of the shaft wall 3134 can enable or facilitate the separation of the shaft wall 3134 into the first and second elongated shaft wall portions 3134a, 3134b. In some examples, the thickness of the portion of the shaft wall 3134 along or defining the first and second elongated member lumens 3170, 3180 (e.g., the distance between the outer surface of the shaft 3120 and the shaft delivery lumen 3122) may be less than the thickness of other portions of the shaft wall 3134 to facilitate cutting and / or fracturing of the shaft wall 3134. For example, the thickness of the shaft wall 3134 in the longitudinal portion along which the first and second elongated member lumens 3170, 3180 extend may be less than the thickness of other wall portions or adjacent wall portions, including those at the vertical positions around the circumference of the catheter shaft 3120.

[0167] In some examples, dividing the catheter shaft 3120 into separate elongated shaft portions 3120a, 3120b can be performed progressively. For example, a first longitudinal portion of the catheter shaft 3120 can be peeled and / or divided. After the first longitudinal portion is divided, the remaining non-peeled portion of the catheter shaft 3120 can be translated proximally along the MCS system 10 to divide an additional longitudinal portion of the catheter shaft 3120. Additional longitudinal portions can be divided until the entire catheter shaft 3120 is removed.

[0168] FIG. 22A is an exploded perspective view of an example of a peel-away catheter 3200 and an MCS system 10 pre-loaded through the peel-away catheter 3200. FIG. 22B is a more detailed view of the proximal portion of the catheter shaft. FIG. 22C is a perspective view of a catheter shaft 3220 of the peel-away catheter 3200 that is peeled away from and / or removed from around the MCS system 10, including around the shaft 16 of the MCS system 10. The peel-away catheter 3200 can comprise a first elongate member 3250 and a second elongate member 3260 that each extend along a longitudinal portion of the catheter shaft 3220. As described in more detail herein, an operator can pull on the elongate members 3250, 3260 to facilitate splitting and / or separating the catheter shaft 3220 into a plurality of elongate shaft portions. FIGS. 22A and 22B show the catheter shaft 3220 in a non-peeled configuration. FIG. 22C shows separating the first and second elongate members 3250, 3260 from the remaining portion of the catheter shaft 3220 to split and / or separate the catheter shaft 3220, for example, forming first and second elongate shaft portions 3220a, 3220b separated from the first and second elongate members 3250, 3260.

[0169] The first elongated member 3250 may include a first elongated portion 3252. A first proximal elongated member tab 3258 may be connected to a proximal portion of the first elongated portion 3252, including the proximal end 3254 of the first elongated portion 3252. The second elongated member 3260 may comprise a second elongated portion 3262. A second proximal elongated member tab 3268 may be connected to a proximal portion of the second elongated portion 3262, including the proximal end 3264 of the second elongated portion 3262. At least a portion of each of the first and second elongated portions 3252, 3262 may extend along all or substantially all of the longitudinal dimension, such as the length of the catheter shaft 3220. In some examples, each of the first elongated portion 3252 and the second elongated portion 3262 may form a wall portion of the catheter shaft 3220. For example, the catheter shaft 3220 may include a first elongated shaft wall portion 3234a and a second elongated shaft wall portion 3234b. The first and second elongated portions 3252, 3262 may be positioned between the respective ends of the first and second elongated shaft wall portions 3234a, 3234b. For example, the second elongated portion 3262 may be positioned between a first edge 3236 of the first elongated shaft wall portion 3234a and a second edge 3242 of the second elongated shaft wall portion 3234b, and may be, for example, sandwiched. The first elongated portion 3252 may be positioned between a second edge 3238 of the first elongated shaft wall portion 3234a and a first edge 3240 of the second elongated shaft wall portion 3234b, and may be, for example, sandwiched. In some examples, the first and second elongated portions 3252, 3262 may be in opposed positions around the circumference of the catheter shaft 3220. In some examples, the first and second elongated portions 3252, 3262 and the first and second elongated shaft wall portions 3234a, 3234b together may form the sidewall of the catheter shaft 3220. In some examples, the inner surfaces of the first and second elongated portions 3252, 3262, as well as the inner surfaces of the first and second elongated shaft wall portions 3234a, 3234b, may together define a shaft delivery lumen 3222 configured to slidably receive the MCS system 10.The first and second elongated portions 3252, 3262 may extend from the proximal end 3228 to the distal end 3230 of the catheter shaft 3220, including from the proximal end to the distal end of the elongated shaft wall portions 3434a, 3434b.

[0170] Figure 22B shows the proximal portion 3224 of the catheter shaft 3220 in further detail. In some examples, the transverse cross-section of the first elongated portion 3252 and / or the second elongated portion 3262 may have end portions with a greater width than the cross-section of the inner portion extending between the end portions. The transverse cross-section may be taken along a plane perpendicular or substantially perpendicular to the longitudinal axis of the catheter shaft 3220. For example, the transverse cross-section of the first elongated portion 3252 may include a shape having a first edge portion 3272, a second edge portion 3274, and an inner portion 3270 between the first edge portion 3272 and the second edge portion 3274. The first end portion 3272 may be disposed further away from the longitudinal axis of the catheter shaft 3220, and the second end portion 3274 may be disposed closer to the longitudinal axis. In some examples, the first end portion 3272 and the second end portion 3274 may be oriented in opposite directions. The width, such as the dimension extending along the plane of the cross-section of the first end portion 3272 and the second end portion 3274, may be greater than the width of the inner portion 3270. In some examples, the transverse cross-section of the second elongated portion 3262 may include a first end portion 3282, a second end portion 3284, and an inner portion 3280 between the first end portion 3282 and the second end portion 3284. The first end portion 3282 may be disposed closer to the longitudinal axis of the catheter shaft 3220, and the second end portion 3284 may be disposed further away from the longitudinal axis. In some examples, the first end portion 3282 and the second end portion 3284 may be oriented in opposite directions. The width of the first end portion 3282 and the second end portion 3284 may be greater than the width of the inner portion 3280. In some examples, the portions of the first and second end portions 3272, 3274, 3282, 3284 of the transverse cross-sections of the first and second elongated portions 3252, 3262 are disposed on and / or in contact with portions of the respective inner and outer surfaces of the adjacent elongated shaft wall portions 3434a, 3434b, for example, to facilitate fixing the elongated portions 3252, 3262 to the first and second elongated shaft wall portions 3234a, 3234b. In some examples, the transverse cross-section of the first elongated portion 3252 and / or the second elongated portion 3262 can take the shape of an "l-beam".

[0171] In some examples, one or both of the first and second elongated portions 3252, 3262 may each include one or more markers including radiopaque markers to facilitate visualization of the position of the catheter shaft 3220. For example, one or both of the first elongated portion 3252 and the second elongated portion 3262 may each include one or more radiopaque markers coupled to and / or embedded within a portion thereof, including distal portions such as distal ends 3256, 3266.

[0172] Referring to FIG. 22C, the operator can engage the first and second proximal elongated member tabs 3258, 3268 to laterally pull away the first and second elongated members 3250, 3260, such as the first and second elongated portions 3252, 3262, from the longitudinal axis of the catheter shaft 3220. Pulling the first and second elongated portions 3252, 3262 laterally can separate the first and second elongated portions 3252, 3262 from the first and second elongated shaft wall portions 3234a, 3234b, facilitating removal of the catheter shaft 3220 from around the MCS system 10. For example, the first elongated portion 3252 can be separated from a first edge 3236 of the first elongated shaft wall portion 3234a and a second edge 3242 of the second elongated shaft wall portion 3234b. The second elongated portion 3262 can be separated from a second edge 3238 of the first elongated shaft wall portion 3234a and a first edge 3240 of the second elongated shaft wall portion 3234b.

[0173] In some examples, removing the catheter shaft 3220 from around the MCS system 10 can be performed incrementally. For example, a first longitudinal portion of the catheter shaft 3220 can be peeled and / or dissected. After the first longitudinal portion is dissected, the remaining non-peeled portion of the catheter shaft 3220 can be translated proximally along the MCS system 10 to dissect an additional longitudinal portion of the catheter shaft 3220. Additional longitudinal portions can be dissected until the entire catheter shaft 3220 is removed.

[0174] Figures 21A-22C illustrate separating the catheter shafts 3120, 3220 into two elongated shaft portions, but it will be understood that the catheter shafts 3120, 3220 can be separated into more than two elongated shaft portions. For example, a peel-away catheter can include an elongated member configured to allow the catheter shaft to separate into more than two elongated shaft portions.

[0175] FIG. 23A is an exploded perspective view of an example of a peel-away catheter 3300 pre-loaded through the MCS system 10, and the peel-away catheter 3300 includes a catheter shaft 3320 having a first interlocking portion 3340a and a second interlocking portion 3340b along its longitudinal portion. FIG. 23B is a perspective view of the catheter shaft 3320 of the peel-away catheter 3300 peeled away from and / or removed from around the MCS system 10, including around the shaft 16 of the MCS system 10. The shaft wall 3334 of the catheter shaft 3320 may include a pair of interlocking portions, such as first and second interlocking portions 3340a, 3340b, that extend along its longitudinal portion. In some examples, the inner surface of the shaft wall 3334 may define a shaft delivery lumen 3322 that extends through the catheter shaft 3320. FIG. 23A shows the catheter shaft 3320 in a non-peeled configuration, such as while the first interlocking portion 3340a and the second interlocking portion 3340b are fitted together and / or engaged. FIG. 23B shows the first and second interlocking portions 3340a, 3340b that are unlocked and / or separated, such as by peeling and / or removing the catheter shaft 3320 from around the MCS system 10.

[0176] The first and second interlocking portions 3340a, 3340b may extend along all or part of a longitudinal dimension such as the length of the catheter shaft 3320, e.g., from the proximal end 3328 to the distal end 3330 of the catheter shaft 3320. For example, the first and second interlocking portions 3340a, 3340b may extend along all of a longitudinal dimension such as the length of the shaft wall 3334. The first and second interlocking portions 3340a, 3340b may include a plurality of corresponding mating portions 3342a, 3342b configured to fit and / or engage with each other to form an interlock. For example, the shapes of the edge 3344a of the first interlocking portion 3340a and the edge 3344b of the second interlocking portion 3340b may be complementary to each other and configured to form a fit and / or engagement between the interlocking portions 3340a, 3340b. In some examples, the mating edges 3344a, 3344b of the first interlocking portion 3340a and the second interlocking portion 3340b may each have a wavy shape. In some examples, each of the mating portions 3342a of the first interlocking portion 3340a may include a peak of a wavy shape including a rectangular wave shape, and the corresponding mating portion 3342b of the second interlocking portion 3340b may include a valley of a wavy shape including a rectangular wave shape. The first interlocking portion 3340a and the second interlocking portion 3340b can have straight or substantially straight edges, although it will be understood that any number of other shapes including arcuate edges are applicable. For example, the first and second interlocking portions may include corresponding concave and convex portions configured to fit and / or engage together to form an interlock.

[0177] The peel-away catheter 3300 may comprise an elongate member 3350 having an elongate portion 3352 and a proximal elongate member tab 3358 associated with being coupled to the proximal end 3354 of the elongate portion 3352. Referring to FIG. 23A, while the peel-away catheter 3300 is in a non-peeled configuration, at least a portion of the elongate portion 3352 can be slidably received through respective lumen portions that extend through respective mating portions 3342a, 3342b of first and second interlocking portions 3340a, 3340b, respectively. In some examples, the first and second interlocking portions 3340a, 3340b of the catheter shaft 3320, such as the shaft wall 3334, can include corresponding elongate member lumen portions 3346a, 3346b (e.g., extending through longitudinal portions of the first and second interlocking portions 3340a, 3340b) for slidably receiving respective portions of the elongate portion 3352. For example, respective portions of the shaft wall 3334 can define corresponding elongate member lumen portions 3346a, 3346b that extend at least partially through the longitudinal dimension of each mating portion 3342a, 3342b. In some examples, the first and second elongate member lumen portions 3346a, 3346b can conform to the contour and / or profile of the inner and / or outer surface of the shaft wall 3334. Each mating portion 3342a, 3342b can comprise a corresponding elongate member lumen portion 3346a, 3346b that extends at least partially therethrough. For example, the elongate member lumen portion of the most distal mating portion may or may not extend through the entire longitudinal dimension of the mating portion.

[0178] Referring to FIG. 23A, the elongated portion 3352 is slidably disposed through the elongated member lumen portions 3346a, 3346b of the first and second interlocking portions 3340a, 3340b to maintain the catheter shaft 3320 in a non-detached configuration. While the catheter shaft 3320 is in a non-detached configuration, the elongated member 3350 including the elongated portion 3352 can be in a tensioned state to maintain the interlocking portions 3340a, 3340b in a mated (e.g., interlocked) state. In some examples, the distal end 3356 of the elongated portion 3352 is coupled to a portion of the shaft wall 3334 that defines a portion including the distal end of a radiopaque marker (not shown) that includes at least a portion disposed in the most distal elongated member lumen portion and / or the most distal elongated member lumen portion. The distal end of the most distal elongated member lumen portion may be proximal or distal to the distal end 3330 of the catheter shaft 3320. The most distal elongated member lumen portion is shown as being on the first interlocking portion 3340a of FIG. 23A. The proximal end 3354 of the elongated portion 3352 can be disposed outside the catheter shaft 3320, including proximal to the proximal end 3328 of the catheter shaft 3320, to facilitate manipulation of the elongated member 3350. For example, the distal end of the most distal elongated member lumen portion may be the proximal end or the distal end of the shaft wall 3334. The proximal end 3354 of the elongated portion 3352 can be disposed outside the shaft wall 3334, including proximal to the proximal end of the shaft wall 3334.

[0179] Referring to FIG. 23B, the elongated member 3350 can be translated proximally to remove it from the marker to which it is connected such that the distal end 3356 of the elongated portion 3352 can be pulled out of the shaft wall 3334 and / or through the elongated member lumen portions 3346a, 3346b of the catheter shaft 3320. The operator can engage the proximal elongated member tab 3358 to pull on the elongated portion 3352 and translate the elongated portion 3352 proximally through the elongated member lumen portions 3346a, 3346b. FIG. 23B shows the distal end 3356 of the elongated portion 3352 being pulled out through the elongated member lumen portion 3346a of the first interlocking portion 3340a. After the elongated portion 3352 has been removed from the catheter shaft 3320, the interlocking portions 3340a, 3340b can be unlocked and / or separated so that the catheter shaft 3320 can be removed from around the MCS system 10. For example, the mating edges 3344a, 3344b of the first and second interlocking portions 3340a, 3340b can be separated to allow the MCS system 10 including the shaft 16 to pass between the mating edges 3344a, 3344b.

[0180] Of course, while one elongated member has been described with reference to FIGS. 23A and 23B, multiple elongated members can be used to maintain the corresponding pairs of multiple pairs of interlocking portions in an interlocked state. For example, the catheter shaft can be divided and / or separated into multiple elongated shaft portions.

[0181] FIG. 24A is an exploded perspective view of an example of a peel-away catheter 3400 and an MCS system 10 pre-loaded through the peel-away catheter 3400. FIG. 24B is a perspective view of a catheter shaft 3420 of the peel-away catheter 3400 that is peeled away from and / or removed from around the MCS system 10, including around the shaft 16 of the MCS system 10. The peel-away catheter 3400 may include a catheter shaft 3420 and an elongate member 3450 configured to secure together the edges of the shaft wall 3434 of the catheter shaft 3420. FIG. 24A shows the catheter shaft 3420 in a non-peeled configuration, such as while the edges of the shaft wall 3434 are secured together by the elongate member 3450. FIG. 24B shows the elongate member 3450 removed from the catheter shaft 3420 and the catheter shaft 3420 peeled away from and / or removed from around the MCS system 10.

[0182] The elongate member 3450 may include an elongate portion 3452 and a proximal elongate member tab 3458 coupled to the proximal end 3454 of the elongate portion 3452. The shaft wall 3434 may have a first edge portion 3434a having a plurality of first openings 3460 at respective positions along a longitudinal portion of the first edge portion 3434a. The shaft wall 3434 may have a second edge portion 3434b having a plurality of second openings 3462 at respective positions along a longitudinal portion of the second edge portion 3434b. For example, the plurality of first and second openings 3460, 3462 may extend through the thickness of the shaft wall 3434. In some examples, the inner surface of the shaft wall 3434 may define a shaft delivery lumen 3422 that extends through the catheter shaft 3420.

[0183] The elongated portion 3452 can be configured to be disposed through a plurality of openings 3460, 3462. In some embodiments, as shown in FIG. 24A, the elongated portion 3452 can extend alternately through the openings 3460, 3462. For example, the elongated portion 3452 can be configured to be alternately disposed (e.g., penetrate) between an opening 3460 on the first edge portion 3434a and an opening 3462 on the second edge portion 3434b such that the elongated portion 3452 can secure the first and second edge portions 3434a, 3434b together. For example, the elongated member 3450 can be joined by stitching, stitching and / or lacing the first and second edge portions 3434a, 3434b together. The distal end 3456 of the elongated portion 3452 can be coupled to the distal portion 3426 of the catheter shaft 3420. For example, the distal end 3456 of the elongated portion 3452 can be coupled to a portion of the shaft wall 3434 that includes at least a portion of the most distal one of the openings 3460, 3462 of the first or second edge portions 3434a, 3434b. In some examples, tension can be maintained within the elongated portion 3452 disposed (e.g., extending) through the plurality of first and second openings 3460, 3462 to facilitate maintaining the first edge 3436a of the first edge portion 3434a adjacent to and in contact with the second edge 3436b of the second edge portion 3434b. In some examples, maintaining the tension of the elongated portion 3452 can include fixing and / or connecting one or more portions of the elongated portion 3452, including a portion of the shaft wall 3434 that defines one or more of the plurality of first and second openings 3460, 3462, to respective portions of the shaft wall 3434. The proximal elongated member tab 3458 can be disposed externally, including proximally of the proximal end 3428 of the catheter shaft 3420, to facilitate operation by an operator. For example, the proximal elongated member tab 3458 can be disposed externally, including proximally of the proximal end of the shaft wall 3434.

[0184] Referring to FIG. 24B, the operator can engage the proximal elongate member tab 3458 to pull the elongate portion 3452 and translate the elongate portion 3452 proximally through the first and second openings 3460, 3462. The elongate portion 3452 can be removed from the shaft wall 3434 to facilitate splitting and / or separating of the shaft wall 3434 along the first and second edges 3436a, 3436b. For example, the operator can pull the proximal elongate member tab 3458 to disconnect and / or cut the distal end 3456 of the elongate portion 3452 from the shaft wall 3434 and / or make any other connections of the elongate portion 3452 to any other part of the shaft wall 3434 to enable proximal translation of the elongate portion 3452. After the elongate portion 3452 is removed from the catheter shaft 3420, the first and second edges 3436a, 3436b can be split and / or separated to enable removal or separation of the shaft 3420 from around the MCS system 10 including the shaft 16. FIG. 24B shows the distal end 3456 of the elongate portion 3452 being drawn through the first opening 3460 of the first edge portion 3434a.

[0185] Of course, although one elongate member has been described with reference to FIGS. 24A and 24B, multiple elongate members can be used to maintain corresponding pairs of multiple interlocking portions in an interlocked state. For example, the catheter shaft can be split and / or separated into multiple elongate shaft portions.

[0186] FIG. 25A is an exploded perspective view of an example of a peel-away catheter 3500 and an MCS system 10 pre-loaded through the peel-away catheter 3500. The peel-away catheter 3500 includes a catheter shaft 3520 having a rolled configuration while in a non-peeled configuration. FIG. 25B is a perspective view of the catheter shaft 3520 of the peel-away catheter 3500 that is peeled away from and / or removed from around the MCS system 10, including around the shaft 16 of the MCS system 10. For example, the shaft wall 3534 of the catheter shaft 3520 can include a first overlapping wall portion 3534a configured to be over and / or in contact with a second overlapping wall portion 3534b along a longitudinal portion of the shaft wall 3534. In some examples, a portion of the inner surface of the shaft wall 3534 can define a shaft delivery lumen 3522 that extends through the catheter shaft 3520. FIG. 25A shows the catheter shaft 3520 in a non-peeled configuration, such as while the catheter shaft 3520 is in a rolled configuration. FIG. 25B shows the catheter shaft 3520 in a deployed configuration, such as peeling away and / or removing the catheter shaft 3520 from around the MCS system 10.

[0187] Referring to FIG. 25A, while in the non-peeled configuration, the catheter shaft 3520 can take a wound configuration. The first overlapping wall portion 3534a may be on and / or in contact with the second overlapping wall portion 3534b along the entire longitudinal dimension such as the length of the shaft wall 3534. For example, the first longitudinal edge 3536 of the shaft wall 3534 may be on and / or in contact with the outer surface portion of the second overlapping wall portion 3534b. The second longitudinal edge 3538 of the shaft wall 3534 is on and / or may be in contact with the inner surface of the first overlapping wall portion 3534a. In some examples, the degree of overlap of the shaft wall 3534 can be less than 100% around the catheter shaft 3520. In some examples, the degree of overlap of the shaft wall 3534 can be about 20% to about 80% around the catheter shaft 3520, including from about 40% to about 60%. The degree of overlap of the shaft wall 3534 can be selected to facilitate maintaining the catheter shaft 3520 around the MCS system 10 while the catheter shaft 3520 is in the roll configuration, while allowing the catheter shaft 3520 to be removed from around the MCS system 10 without damaging the MCS system 10 and / or the patient, or without substantially damaging them.

[0188] The peel-away catheter 3500 can include a proximal shaft tab 3540 coupled to the proximal portion 3524 of the catheter shaft 3520, including the proximal end 3528 of the catheter shaft 3520. In some examples, the proximal shaft tab can be coupled to a proximal portion including the proximal end of the shaft wall 3534. In some examples, the proximal shaft tab 3540 can be coupled at a position circumferentially spaced from the first and second overlapping wall portions 3534a, 3534b. In some examples, the proximal shaft tab 3540 can be oriented oppositely around the circumference of the catheter shaft 3520 with respect to the first and second overlapping wall portions 3534a, 3534b.

[0189] Referring to FIG. 25B, the operator can engage the proximal shaft tab 3540 to peel and / or remove the catheter shaft 3520 from around the MCS system 10. For example, the proximal shaft tab 3540 can be pulled laterally away from the longitudinal axis of the catheter shaft 3520 to peel and / or remove the catheter shaft 3520 from around the MCS system 10.

[0190] In some alternative examples, the catheter shaft may not comprise overlapping portions while the catheter shaft is in a rolled configuration. In some examples, the shaft walls of the catheter shaft may include edges configured to be adjacent to each other while the catheter shaft is in a non-peeled configuration. For example, the shaft wall can take a "C" shape.

[0191] Figures 26 and 27 are side cross-sectional views of examples of peel-away catheters 3600, 3700 having a pre-loaded MCS system 10 therethrough. The peel-away catheters 3600, 3700 may each comprise shafts 3620, 3720 having an outer diameter that varies along the longitudinal dimension and an outer diameter that is the same or similar along the longitudinal dimension, respectively. Referring to FIG. 26, the catheter shaft 3620 may include a proximal portion 3624 having an outer diameter that is smaller than the outer diameter of the distal portion 3626 of the catheter shaft 3620. The outer diameter of the distal portion 3626 may be larger than the outer diameter of the proximal portion 3624 to accommodate the pump 22 of the MCS system 10 having a larger diameter than the shaft 16 proximal to the pump 22. For example, the outer profile, contour, and / or shape of the catheter shaft 3620 may correspond to, conform to, and / or match the contour of a portion of the MCS system 10 pre-loaded through the catheter shaft 3620. Referring to FIG. 27, the catheter shaft 3720 may include an outer diameter that is the same or substantially the same along the entire length or substantially the entire length of the catheter shaft 3720. As shown in FIGS. 26 and 27, the catheter shafts 3620, 3720 may each comprise shaft delivery lumens 3622, 3722 extending therethrough. In some examples, the respective diameters of the shaft delivery lumens 3622, 3722 may correspond to, conform to, and / or match the diameter of a portion of the MCS system 10 pre-loaded through the catheter shafts 3620, 3720. For example, the respective diameters of the shaft delivery lumens 3622, 3722 may be smaller in the proximal portions 3624, 3724 than in the distal portions 3626, 3726 of the catheter shafts 3620, 3720. The diameters of the shaft delivery lumens 3622, 3722 extending through the distal portions 3626, 3726 may be configured to accommodate the pump 22 of the MCS system 10. Alternatively, the diameter of the shaft delivery lumen may remain the same or similar along the entire length or substantially the entire length of the catheter shafts 3620, 3720.

[0192] The peel-away catheters 3600, 3700 may include first proximal shaft tabs 3650, 3750 respectively coupled to proximal portions 3624, 3724 of catheter shafts 3620, 3720. The peel-away catheters 3600, 3700 may include second proximal shaft tabs 3652, 3752 respectively coupled to proximal portions 3624, 3724 of catheter shafts 3620, 3720. For example, each of the first proximal shaft tabs 3650, 3750 may be coupled to the proximal portion of a respective first elongated shaft portion 3620a, 3720a. The second proximal shaft tabs 3652, 3752 may be coupled to the proximal portion of a respective second elongated shaft portion 3620b, 3720b. By pulling the first and second proximal shaft tabs 3650, 3652 laterally away from the longitudinal axis of the catheter shaft 3620, the catheter shaft 3620 can be separated into the first and second elongated shaft portions 3620a, 3620b. By pulling the first and second proximal shaft tabs 3750, 3752 laterally away from the longitudinal axis of the catheter shaft 3720, the catheter shaft 3720 can be separated into the first and second elongated shaft portions 3720a, 3720b.

[0193] The catheter shafts 3620, 3720 may each include a first weakened longitudinal portion 3636, 3736 and a second weakened longitudinal portion 3638 (not shown), 3738 (not shown). The first weakened longitudinal portions 3636, 3736 and the second weakened longitudinal portions 3638, 3738 may extend along at least a portion of the longitudinal dimension of the catheter shafts 3620, 3720, including the entire length or substantially the entire length of the catheter shafts 3620, 3720. In some examples, the first weakened longitudinal portions 3636, 3736 and the second weakened longitudinal portions 3638, 3738 may extend from the proximal ends 3628, 3728 to the distal ends 3630, 3730 of the catheter shafts 3620, 3720. For example, the shaft walls 3634, 3734 of each catheter shaft 3620, 3720 may include the first weakened longitudinal portions 3636, 3736 and the second weakened longitudinal portions 3638, 3738 along their entire length or substantially their entire length. In some embodiments, the first weakened longitudinal portions 3636, 3736 and / or the second weakened longitudinal portions 3638, 3738 may include depressions and / or perforations formed in the shaft walls 3634, 3734. In some examples, at least a portion of the inner surface of the shaft walls 3634, 3734 may define shaft delivery lumens 3622, 3722 configured to slidably receive the MCS system 10. In some examples, the first weakened longitudinal portions 3636, 3736 and the second weakened longitudinal portions 3638, 3738 may be oriented opposite each other around the circumference of the respective catheter shafts 3620, 3720. The operator can pull the first and second proximal shaft tabs 3650, 3652 laterally away from the longitudinal axis of the catheter shaft 3620 and separate the shaft wall 3634 into the first and second elongated shaft wall portions 3634a, 3634b. The operator can pull the first and second proximal shaft tabs 3750, 3752 laterally away from the longitudinal axis of the catheter shaft 3720 and separate the shaft wall 3734 into the first and second elongated shaft wall portions 3734a, 3734b.

[0194] Figures 26 and 27 illustrate separating catheter shafts 3620 and 3720 into two elongated shaft portions, but it will be understood that catheter shafts 3620 and 3720 can be separated into more elongated shaft portions. For example, catheter shafts 3620 and 3720 can include several weakened longitudinal portions configured to allow the catheter shafts 3620 and 3720 to separate into a desired number of elongated shaft portions.

[0195] In some examples, catheter shafts 3120, 3220, 3320, 3420, 3520, 3620, 3720 described with reference to FIGS. 21A-27 can have longitudinal dimensions such as a length configured to receive the MCS system 10. For example, while the MCS system 10 is pre-loaded, a distal tip portion 64 such as the nose cone portion of the MCS system 10 is disposed distal to the distal ends 3130, 3230, 3330, 3430, 3530, 3630, 3730 of catheter shafts 3120, 3220, 3320, 3420, 3520, 3620, 3720 via distal openings 3132, 3232, 3332, 3432, 3532, 3632, 3732.

[0196] In some examples, the catheter shafts 3120, 3220, 3320, 3420, 3520 described with reference to FIGS. 21A - 25B may include the outer diameter and / or diameter of a portion of the MCS system 10 disposed therethrough, and are configured to correspond, conform, and / or match the outer diameter and / or diameter of the shaft delivery lumens 3122, 3222, 3322, 3422, 3522, 3622, 3722. For example, the outer diameter and / or diameter of the shaft delivery lumens 3122, 3222, 3322, 3422, 3522 in the proximal portions 3124, 3224, 3324, 3424, 3524 may be smaller than the outer diameter and / or diameter of the distal portions 3126, 3226, 3326, 3426, 3526. For example, the distal portions 3126, 3226, 3326, 3426, 3526 may be sized to accommodate the pump 22 of the MCS system 100. Alternatively, one or both of the outer diameter and / or diameter of the shaft delivery lumens 3122, 3222, 3322, 3422, 3522 may be the same or similar along the entire length or substantially the entire length of the catheter shafts 3120, 3220, 3320, 3420, 3520.

[0197] The peel-away catheters 3200, 3300, 3400, 3500, 3600, 3700 described with reference to FIGS. 22A-27 may each include a catheter hub 3202, 3302, 3402, 3502, 3602, 3702. The catheter shafts 3220, 3320, 3420, 3520, 3620, 3720 described with reference to FIGS. 22A-27 may extend distally from the corresponding catheter hubs 3202, 3302, 3402, 3502, 3602, 3702. The catheter hubs 3202, 3302, 3402, 3502, 3602, 3702 may have one or more features of the catheter hub 3102 described with reference to FIGS. 21A and 21B. For example, the catheter hubs 3202, 3302, 3402, 3502, 3602, 3702 may include hub delivery lumens 3204, 3304, 3404, 3504, 3604, 3704 that extend therethrough, such as from a proximal end 3206, 3306, 3406, 3506, 3606, 3706 to a distal end 3208, 3308, 3408, 3508, 3608, 3708. In some examples, the catheter hubs 3202, 3302, 3402, 3502, 3602, 3702 are not peel-away hubs. For example, after the peel-away catheters 3200, 3300, 3400, 3500, 3600, 3700 carrying the MCS system 10 are advanced to the target location, the catheter hubs 3202, 3302, 3402, 3502, 3602, 3702 may be separated from the catheter shafts 3220, 3320, 3420, 3520, 3620, 3720, such that the catheter shafts 3220, 3320, 3420, 3520, 3620, 3720 may be removed from around the MCS system 10. Alternatively, the catheter hubs 3202, 3302, 3402, 3502, 3602, 3702 may be peelable and may be removed together with or separately from the catheter shafts 3220, 3320, 3420, 3520, 3620, 3720.

[0198] FIG. 28 is a side view of a delivery system 3800 having a pre-loaded MCS system 10 therethrough. The delivery system 3800 can include a peel-away catheter 3820 comprising a catheter shaft 3822 extending distally from a catheter hub 3830, and an introducer sheath 3840 comprising an introducer sheath shaft 3842 extending distally from an introducer sheath hub 3844. The MCS system 10 can be pre-loaded through the peel-away catheter 3820. A portion of the catheter shaft 3822 carrying the MCS system 10 can be disposed through the introducer sheath 3840, such as through a delivery lumen of the introducer sheath 3840. The introducer sheath 3840 can have one or more mechanisms of the introducer sheaths described herein. In some examples, the introducer sheath 3840 can be an expandable introducer sheath. The delivery system 3800 can include a spacer 3802 configured to axially separate the catheter hub 3830 from the introducer sheath hub 3844. In some examples, the position of the MCS system 10 can be fixed relative to the peel-away catheter 3820. For example, the catheter hub 3830 can include a friction engagement member configured to engage a portion of the MCS system 10, such as a portion of the shaft 16, disposed through a hub delivery lumen to fix the translational position of the MCS system 10.

[0199] The spacer 3802 may include one or more features of the spacer 2002 described with reference to FIG. 20. For example, the spacer 3802 may include at least a portion configured to be positioned between the introducer sheath hub 3844 and the peel-away catheter hub 3830 to axially separate the introducer sheath hub 3844 from the catheter hub 3830. The spacer 3802 may be configured to maintain a fixed distance between the introducer sheath hub 3844 and the catheter hub 3830 such that, for example, the introducer sheath hub 3844 is distal to and aligned with the catheter hub 3830 along the longitudinal axis of the introducer sheath hub 3844 and / or the catheter hub 3830. In some examples, after being moved to a target position, such as while the introducer sheath 3840 carries an expander extending therethrough, the peel-away catheter 3820 can be advanced into the introducer sheath 3840. For example, the expander can be withdrawn, and the peel-away catheter 3820 having the pre-loaded MCS system 10 therethrough can be advanced at least partially through the introducer sheath 3840. The catheter hub 3830 may include engagement features configured to engage a portion of the MCS system 10 extending through the catheter hub 3830 to maintain the axial and / or rotational position of the MCS system 10. In some examples, the spacer 3802 may be configured to maintain the spacing and / or alignment between the introducer sheath hub 3844 and the catheter hub 3830 after the peel-away catheter 3820 is desirably positioned. For example, the spacing and / or alignment can be maintained while the MCS system 10 is deployed from the peel-away catheter 3820. The spacer 3802 may be removable to facilitate peeling and / or removal of the peel shaft 3822, such as after the MCS system 10 is deployed from the peel-away catheter 3820.In some examples, the catheter hub 3830 can re-engage with the MCS system 10 after removal of the catheter shaft 3822, such that re-engaging the spacer 3802 with the introducer sheath hub 3844 and the catheter hub 3830 can facilitate fixing the position of the MCS system 10 relative to the introducer sheath 3840.

[0200] The spacer 3802 can include a distal portion 3806 configured to engage the introducer sheath hub 3844 and a proximal portion 3808 configured to engage the catheter hub 3830. The inner portion 3804 can extend between and couple the proximal portion 3808 and the distal portion 3806. The distal portion 3806 can include a first hub engagement feature 3810 configured to engage the introducer sheath hub 3844, including a corresponding spacer engagement feature 3848 of the introducer sheath hub 3844. The proximal portion 3808 can include a second hub engagement feature 3812 configured to engage the catheter hub 3830, including a corresponding spacer engagement feature 3834 of the catheter hub 3830. In some examples, the spacer engagement feature 3848 can be on the proximal portion 3846 of the introducer sheath hub 3844. In some examples, the spacer engagement feature 3834 can be on the distal portion 3832 of the catheter hub 3830.

[0201] In some examples, each of the spacer engagement features 3848 of the introducer sheath hub 3844 and the catheter hub 3830 can include a groove and / or recess that at least partially extends circumferentially around a portion of each hub. The first and second hub engagement features 3810, 3812 can include at least a portion configured to fit and / or couple with the groove and / or recess by and / or being received within the respective groove and / or recess. In some examples, at least a portion of the distal portion 3806 and the proximal portion 3808 can be oriented at an angle, including being perpendicular or substantially perpendicular to the inner portion 3804. In some examples, while the spacer 3802 engages the catheter hub 3830 and the introducer sheath hub 3844, at least a portion of the inner portion 3804 can be oriented along a direction parallel or substantially parallel to the longitudinal axis of the catheter hub 3830 and / or the introducer sheath hub 3844. At least a portion of each of the distal portion 3806 and the proximal portion 3808 can be received within the respective groove and / or recess of the introducer sheath hub 3844 or the catheter hub 3830. The first hub engagement feature 3810 can comprise an edge of the distal portion 3806 received within the groove and / or recess of the introducer sheath hub 3844. The second hub engagement feature 3812 can include an edge of the proximal portion 3808 received within the groove and / or recess of the catheter hub 3830. The edges of the distal portion 3806 and the proximal portion 3808 can be configured to have complementary shapes and / or sizes of the respective groove and / or recess. For example, the edges of the distal portion 3806 and / or the proximal portion 3808 received within the groove and / or recess of the introducer sheath hub 3844 and / or the catheter hub 3830 can have a concave curvature configured to fit with a groove and / or recess extending along a convex-shaped path. Alternatively, or in combination, the spacer engagement features can have any number of other different configurations, including slots, depressions, etc.

[0202] In some examples, the catheter shaft 3822 may include one or more mechanisms of the catheter shaft 3620 described with reference to FIG. 26. For example, the first proximal shaft tab 3826 and the second proximal shaft tab 3828 may be coupled to respective portions of the proximal portion 3824 of the catheter shaft 3822. The operator can pull the first proximal shaft tab 3826 and the second proximal shaft tab 3828 laterally away from the longitudinal axis of the catheter shaft 3822 to separate the catheter shaft 3822 into first and second elongated shaft portions.

[0203] In some examples, the medical delivery system may comprise one or more other catheter shafts described herein. For example, the catheter shafts 3120, 3220, 3320, 3420, 3520, 3620, 3720 described with reference to FIGS. 21A - 27 may be applicable. In some examples, the catheter shafts 3120, 3220, 3320, 3420, 3520, 3620, 3720 may each be coupled to a catheter hub having one or more mechanisms of the catheter hub 3830 that includes spacer engagement features.

[0204] Of course, one or more of the catheter shafts 3120, 3220, 3320, 3420, 3520, 3620, 3720 described herein may include one or more markers coupled to and / or formed therein that include radiopaque markers to facilitate visualization of the position of the catheter shaft. In some examples, the markers may be on and / or coupled to the outer surface of the catheter shafts 3120, 3220, 3320, 3420, 3520, 3620, 3720. For example, the catheter shafts 3120, 3220, 3320, 3420, 3520, 3620, 3720 may include a plurality of radiopaque markers disposed at respective positions along the longitudinal dimension to facilitate visualization of advancement through the introducer sheath of the catheter shafts 3120, 3220, 3320, 3420, 3520, 3620, 3720. In some examples, one or more of the markers include those that are at or proximate to the distal ends 3130, 3230, 3330, 3430, 3530, 3630, 3730 and may be on the distal portions 3126, 3226, 3326, 3426, 3526, 3626, 3726 of the catheter shafts 3120, 3220, 3320, 3420, 3520, 3620, 3520, 3620, 3720. In some examples, one or more of the elongate members described herein, including one or more of the elongate portions of the elongate member, can include one or more markers such as radiopaque markers, coupled to and / or formed therein. In some examples, one or more of the distal end and / or the elongate portions such as the distal end thereof may include one or more radiopaque markers coupled to and / or formed therein. Markers that include radiopaque markers can provide a visual indication to the operator regarding the position of the catheter shaft, including the position of the distal portion of the catheter shaft. For example, the markers can reduce or prevent over-insertion of the catheter shaft such that the distal end of the catheter shaft is not positioned distally of the distal end of the introducer sheath during advancement of the catheter shaft and / or the MCS system.

[0205] In some alternative examples, a peel-away catheter may comprise a catheter shaft that can be partially peeled away. For example, the proximal portion of the catheter shaft may remain around the MCS system after the more distal portion of the catheter shaft has been peeled away from and / or removed from around the MCS system. For example, the more distal portion of the catheter shaft may include one or more mechanisms of the catheter shafts described herein. In some examples, a peel-away catheter may comprise a non-peelable catheter hub and a catheter shaft having a non-peelable proximal portion. As described herein, the peel-away catheter can be inserted into an introducer sheath for delivery of the MCS system. In some examples, the proximal portion of the catheter shaft may be separated and / or disengaged from the distal detachable portion of the catheter shaft. The portion of the catheter shaft that has not been peeled away and / or removed may be sized to remain within the introducer sheath hub of the introducer sheath, such that the non-peeled portion has a length shorter than the length of the introducer sheath hub. In some alternative examples, the catheter shaft may comprise a distal portion configured to house a pump of the detachable MCS system and a non-detachable proximal portion. For example, the portion of the catheter shaft proximal to the portion configured to house the pump may remain around the MCS system. In some examples, the portion of the catheter shaft that is not peeled may be received within the introducer sheath.

[0206] Figures 29A and 29B are a perspective view and a cross-sectional view, respectively, illustrating the MCS device 22 located distally within the enlarged portion of the insertion catheter 2832 and distally of the branch inserted within the introducer sheath 2912 prior to further deploying and advancing the MCS device 22 further distally within the large vessel. FIG. 29B is a truncated schematic view of the system showing the various relative positions of the various components. As shown in FIGS. 29A and 29B, in this embodiment, the enlarged portion of the insertion catheter 2832 that includes the MCS device 22 may not be located entirely distally of the distal end 2913 of the introducer sheath 2912, as will be further described.

[0207] As shown, the introducer sheath 2912 is relatively long compared to other embodiments described herein and can thus extend into the aorta beyond the branch. Further, the tubular body 2836 may be relatively shorter than that illustrated in FIG. 18. Making the introducer sheath 2912 longer and the tubular body 2836 shorter allows the enlarged portion of the insertion catheter to be completely contained within the introducer sheath 2912, except for a small distal portion 2860 that extends distally from the distal end of the introducer sheath 2912. In some embodiments, prior to the insertion catheter 2832 being fully inserted within the introducer sheath 2912 and the MCS device 22 advancing into the aorta, the MCS device 22 may be completely contained within the introducer sheath 2912 and not extend distally therefrom. As shown, the distal end 2860 of the tubular body 2836 of the insertion catheter 2832 may be proximal to the distal end 25 of the distal portion 23 of the MCS device 22. The distal end 25 of the MCS device 22 may extend distally beyond the distal end 2860 of the introducer sheath 2912 by 0.5 cm or less, 1 cm or less, 1.5 cm or less, 2 cm or less, 3 cm or less, or about 1 cm.

[0208] The distal end 2860 of the tubular body 2836 of the insertion catheter 2832 may be positioned distal to the distal end 2913 of the introducer sheath 2912, as shown. In some embodiments, the distal end 2860 may be the same as, or proximal to, the distal end 2913. The distal end 2860 of the tubular body 2836 may be offset distally or proximally from the distal end 2913 of the introducer sheath 2912 by 0.5 cm or less, 1 cm or less, 2 cm or less, 3 cm or less, 4 cm or less, 5 cm or less, or 10 cm or less. When the insertion catheter 2832 is fully docked with the introducer sheath 2912, the tubular body 2836 may not be visible or may not be exposed since the tubular body 2836 can be housed within the introducer sheath 2912.

[0209] Various advantages result from the configurations described in FIGS. 29A and 29B. For example, such a configuration with a relatively short tubular body 2836 may be easy to handle since less of the tubular body 2836 needs to be advanced into the body. The shorter tubular body 2836 can increase rigidity and thus increase responsiveness to pushing forces. Additionally, the shorter length of the tubular body 2836 reduces the risk of internal trauma damage as it advances through the body and aorta.

[0210] Further, when removing the tubular body 2836 and the insertion catheter 2832 from the introducer sheath 2912 at the end of the procedure, there is no need to proximally retract the enlarged portion of the insertion catheter 2832 into the introducer sheath 2912 as in other embodiments such as that shown in FIG. 18. Instead, the enlarged portion of the insertion catheter 2832 is already within the introducer sheath 2912, which eliminates the additional force required to open the introducer sheath 2912 and proximally retract the enlarged portion of the insertion catheter 2832 inwardly. This reduces the risk that the introducer sheath 2912 will buckle or cause other difficulties for the puller.

[0211] If the insertion catheter 2832 remains inside the introducer sheath 2912 as previously described and illustrated in FIG. 29B, the introducer sheath 2912 may have a larger diameter than other embodiments described herein, such as the embodiment illustrated in FIG. 18, and the MCS device 22 extends completely through the introducer sheath 2912. Such a configuration with a larger diameter does not increase the risk of shielding because, as shown in FIG. 29A, the distal end 23 is located distally of the branch.

[0212] Various modifications to the implementations described in this disclosure will be readily apparent to those skilled in the art, and the general principles defined herein may be applied to other implementations without departing from the spirit or scope of this disclosure. Accordingly, this disclosure is not intended to be limited to the embodiments shown herein, but rather to be consistent with the broadest scope that does not conflict with the claims, principles, and novel features disclosed herein. The term "example" is used herein to mean "serving as an example, instance, or illustration." Any implementation described herein as "exemplary" need not necessarily be construed as preferred or advantageous over other implementations, unless otherwise specified. The term "about" can refer to values within ±1%, ±2%, ±3%, ±4%, ±5%, ±10%, ±15%, or other ranges, depending on the context and as understood by those skilled in the art.

[0213] Exemplary embodiments The following are some non-limiting exemplary embodiments of the subject matter described herein.

[0214] Example 1: An insertion catheter for a circulatory support catheter having a circulatory support device carried by an elongated flexible catheter shaft, the insertion catheter comprising a tubular body having a proximal end, a distal end, a longitudinal axis extending between the proximal end and the distal end, a proximal portion adjacent to the proximal end, a distal portion adjacent to the distal end, and an intermediate portion between the proximal portion and the distal portion, the distal portion of the tubular body being configured to axially movably receive the circulatory support device, the diameter of the distal portion being larger than the diameter of the intermediate portion.

[0215] Example 2: The insertion catheter of any example herein, particularly Example 1, further comprising a hub having a proximal end and a distal end, the distal end of the hub being in fluid connection with the proximal end of the tubular body.

[0216] Example 3: The insertion catheter of any example herein, the tubular body further comprising a proximal transition section between the proximal portion and the intermediate portion and a distal transition section between the distal portion and the intermediate portion.

[0217] Example 4: The insertion catheter of any example herein, particularly Example 3, wherein the distal portion and the distal transition section are configured to receive the circulatory support device, and the intermediate portion, the proximal transition section, the proximal portion, and the hub are configured to receive an elongated flexible catheter shaft.

[0218] Example 5: The insertion catheter of any example herein, wherein the distal portion, the intermediate portion, and the proximal portion are concentric about the longitudinal axis.

[0219] Example 6: The insertion catheter of any example herein, wherein the intermediate portion has an outer diameter smaller than the outer diameter of the proximal portion and the outer diameter of the distal portion.

[0220] Example 7: The insertion catheter of any example herein, wherein the distal portion has an inner diameter larger than the inner diameter of the intermediate portion and the proximal portion.

[0221] Example 8: The insertion catheter of any embodiment herein, wherein the tubular body is configured such that the proximal portion remains outside the patient's body when the insertion catheter is in use.

[0222] Example 9: The insertion catheter of any embodiment herein, wherein the tubular body is configured such that when the insertion catheter is in use, the intermediate portion extends from outside the patient's body, through an arteriotomy of the femoral artery, through the femoral artery, through a branch of the femoral artery that joins the aorta, and into the aorta.

[0223] Example 10: The insertion catheter of any embodiment herein, wherein the tubular body is configured such that the distal portion is positioned within the patient's aorta when the insertion catheter is in use.

[0224] Example 11: The insertion catheter of any embodiment herein, particularly the insertion catheter of Embodiments 2 to 10, wherein the distal end of the tubular body is configured to extend beyond the distal end of the introducer sheath when the insertion catheter is fully docked with the introducer sheath during use.

[0225] Example 12: The insertion catheter of any embodiment herein, particularly the insertion catheter of Embodiment 11, wherein the tubular body of the insertion catheter has sufficient folding resistance to maintain patency when passing through one or more hemostatic valves of the introducer sheath.

[0226] Example 13: The insertion catheter of any embodiment herein, particularly the insertion catheter of Embodiment 11, wherein the distal end of the hub includes one or more mechanisms for preventing rotation and / or axial movement of the insertion catheter when docked with the introducer sheath.

[0227] Example 14: The insertion catheter of any embodiment herein, comprising a tube having a valve in fluid communication with the inner lumen of the tubular body of the insertion catheter configured to be flushed with saline.

[0228] Example 15: The insertion catheter of any example herein, wherein the insertion catheter includes a hemostatic valve.

[0229] Example 16: The insertion catheter of any example herein, wherein the insertion catheter comprises a plug disposed at the proximal end of a hub configured to connect to a sterile shield sleeve.

[0230] Example 17: The insertion catheter of any example herein, wherein the elongated flexible catheter shaft includes a visual marker proximal to the circulatory support device such that the visibility of the visual marker on the proximal side of the hub indicates that the circulatory support device is positioned within the tubular body of the insertion catheter.

[0231] Example 18: The circulatory support device includes a tubular housing, a motor, an impeller configured to be rotated by the motor, a first guide wire port on the distal end of the tubular housing, a second guide wire port on the side wall of the tubular housing distal to the impeller, and a third guide wire port proximal to the impeller. The distal end of the tubular body of the insertion catheter is removably connected to a guide wire assist configured to facilitate the entry of a guide wire through the first guide wire port.

[0232] Example 19: The tubular body of the insertion catheter is configured to receive the circulatory support device with a removable guide wire guide tube. The removable guide wire guide tube enters the first guide wire port on the distal end of the tubular housing, exits the tubular housing through the second guide wire port on the side wall of the tubular housing distal to the impeller, re-enters the tubular housing through the third guide wire port proximal to the impeller, and extends proximally within the catheter shaft. For any example herein, particularly the insertion catheter of Example 18.

[0233] Example 20: The insertion catheter of any example herein, particularly Examples 2 to 19, wherein the hub comprises one or more mechanisms for preventing axial and optionally rotational movement of the circulation support catheter.

[0234] Example 21: The insertion catheter of any example herein, particularly Examples 2 to 20, wherein the hub of the insertion catheter comprises a locking mechanism, and the locking mechanism comprises a recess configured to receive a locking pad configured to removably lock with the circulation support catheter.

[0235] Example 22: The insertion catheter of any example herein, particularly Example 21, wherein the hub of the insertion catheter comprises a housing surrounding at least a portion of the locking mechanism, the housing comprises opposing first inner surface walls spaced farther apart than opposing second inner surface walls, at least a portion of the locking mechanism comprises a tab extending radially outwardly, and the housing is configured to rotate to compress the tab inwardly to prevent axial movement of the circulation support catheter.

[0236] Example 23: The insertion catheter of any example herein, particularly Example 22, wherein the inward compression of the tab of the locking mechanism compresses the locking pad against the circulation support catheter.

[0237] Example 24: The insertion catheter of any example herein, particularly Examples 21 to 23, wherein the locking pad is configured to be removably locked with the catheter shaft of the circulation support catheter.

[0238] Example 25: The insertion catheter of any example herein, wherein the tubular body of the insertion catheter has a length in the range of about 275 mm to about 675 mm and an inner diameter in the range of about 1.5 mm to about 6 mm.

[0239] Example 26: An insertion catheter of any example herein, wherein the distal portion of the tubular body has a length in the range of about 75 mm to about 140 mm and an inner diameter in the range of about 3.5 mm to about 6 mm, the proximal portion of the tubular body has a length in the range of about 100 mm to about 165 mm and an inner diameter in the range of about 2.0 mm to about 4.5 mm, and the intermediate portion of the tubular body has a length in the range of about 150 mm to about 250 mm and an inner diameter in the range of about 1.5 mm to about 4.5 mm.

[0240] Example 27: An insertion catheter of any example herein, wherein the tubular portion includes a braided wire.

[0241] Example 28: An insertion catheter of any example herein, particularly Example 27, wherein the distal end of the tubular body includes a PET band configured to hold the edge portion of the braided wire.

[0242] Example 29: An insertion catheter of any example herein, wherein the distal end of the tubular body includes a radiopaque marker.

[0243] Example 30: An insertion catheter of any example herein, wherein the proximal portion of the tubular body is configured to transmit longitudinal force without twisting.

[0244] Example 31: An insertion catheter of any example herein, wherein the proximal portion of the tubular body is harder than the intermediate and distal portions.

[0245] Example 32: An insertion catheter of any example herein, wherein the proximal portion of the tubular body includes a reinforced double braided wire.

[0246] Example 33: An insertion catheter of any example herein, wherein at least the distal portion of the tubular body is coated with a hydrophilic coating configured to reduce friction on its outer surface.

[0247] Example 34: A circulatory support catheter, comprising a circulatory support device carried by an elongated flexible catheter shaft, the circulatory support device including a tubular housing, a motor, and an impeller configured to be rotated by the motor; and an insertion catheter including a tubular body, the tubular body having a proximal end, a distal end, a longitudinal axis extending between the proximal end and the distal end, a proximal portion adjacent to the proximal end, a distal portion adjacent to the distal end, and an intermediate portion between the proximal portion and the distal portion, wherein the distal portion of the tubular body is configured to axially movably receive the circulatory support device, and the diameter of the distal portion is larger than the diameter of the intermediate portion. A mechanical circulatory support system.

[0248] Example 35: The insertion catheter according to any example herein, particularly Example 34, wherein the impeller is configured to be rotated by a motor via a shaft.

[0249] Example 36: The insertion catheter according to any example herein, particularly Example 34, wherein the impeller is configured to be rotated by a motor via magnetic coupling.

[0250] Example 37: The insertion catheter according to any example herein, particularly Examples 34 - 36, wherein the system does not require purging.

[0251] Example 38: The insertion catheter according to any example herein, particularly Examples 34 - 37, further comprising a hub having a proximal end and a distal end, wherein the distal end of the hub is in fluid connection with the proximal end of the tubular body.

[0252] Example 39: The insertion catheter according to any example herein, particularly Examples 34 - 38, wherein the tubular body further comprises a proximal transition section between the proximal portion and the intermediate portion and a distal transition section between the distal portion and the intermediate portion.

[0253] Example 40: An insertion catheter according to any example herein, particularly Examples 34-39, wherein the distal portion and the distal transition section are configured to receive a circulatory support device, and the intermediate portion, the proximal transition section, the proximal portion, and the hub are configured to receive an elongate flexible catheter shaft.

[0254] Example 41: An insertion catheter according to any example herein, particularly Examples 34-40, wherein the distal portion, the intermediate portion, and the proximal portion are concentric about the longitudinal axis.

[0255] Example 42: An insertion catheter according to any example herein, particularly Examples 34-41, wherein the intermediate portion includes an outer diameter that is smaller than the outer diameter of the proximal portion and the outer diameter of the distal portion.

[0256] Example 43: An insertion catheter according to any example herein, particularly Examples 34-42, wherein the distal portion includes an inner diameter that is larger than the inner diameter of the intermediate portion and the proximal portion.

[0257] Example 44: An insertion catheter according to any example herein, particularly Examples 34-43, wherein the tubular body is configured such that the proximal portion remains outside the patient's body when the insertion catheter is in use.

[0258] Example 45: An insertion catheter according to any example herein, particularly Examples 34-44, wherein the tubular body is configured such that when the insertion catheter is in use, the intermediate portion extends from outside the patient's body through an arteriotomy of the femoral artery, through the femoral artery, through a branch of the femoral artery where it joins the aorta, and into the aorta.

[0259] Example 46: An insertion catheter according to any example herein, particularly Examples 34-45, wherein the tubular body is configured such that the distal portion is positioned within the patient's aorta when the insertion catheter is in use.

[0260] Example 47: The insertion catheter of any example herein, particularly the insertion catheters of Examples 34 - 46, wherein the distal end of the tubular body is configured to extend beyond the distal end of the introducer sheath when the insertion catheter is fully docked with the introducer sheath during use.

[0261] Example 48: The insertion catheter of any example herein, particularly the insertion catheter of Example 47, wherein the distal end of the hub includes one or more mechanisms for preventing rotation and / or axial movement of the insertion catheter when docked with the introducer sheath.

[0262] Example 49: The insertion catheter of any example herein, particularly the insertion catheters of Examples 34 - 48, including a tube having a valve in fluid communication with the inner lumen of the tubular body of the insertion catheter configured to be flushed with saline.

[0263] Example 50: The insertion catheter of any example herein, particularly the insertion catheters of Examples 34 - 49, wherein the insertion catheter includes a hemostatic valve.

[0264] Example 51: The insertion catheter of any example herein, particularly the insertion catheters of Examples 34 - 50, comprising a plug disposed at the proximal end of the hub configured to connect to a sterile shield sleeve.

[0265] Example 52: The insertion catheter of any example herein, particularly the insertion catheters of Examples 34 - 51, wherein the elongated flexible catheter shaft includes a visual marker proximal to and spaced from a circulation support device such that the visibility of the visual marker on the proximal side of the hub indicates that the circulation support device is positioned within the tubular body of the insertion catheter.

[0266] Example 53: A circulation support device includes a tubular housing, a motor, an impeller configured to be rotated by the motor, a first guide wire port on the distal end of the tubular housing, a second guide wire port on the side wall of the tubular housing distal to the impeller, and a third guide wire port proximal to the impeller. The distal end of the tubular body of the insertion catheter is removably connected to a guide wire aid configured to facilitate the entry of a guide wire through the first guide wire port. The insertion catheter of any example herein, particularly Examples 34 - 52.

[0267] Example 54: The tubular body of the insertion catheter is configured to receive the circulation support device with a removable guide wire guide tube. The removable guide wire guide tube enters the first guide wire port on the distal end of the tubular housing, exits the tubular housing through the second guide wire port on the side wall of the tubular housing distal to the impeller, re - enters the tubular housing through the third guide wire port proximal to the impeller, and extends proximally within the catheter shaft. The insertion catheter of any example herein, particularly Example 53.

[0268] Example 55: The hub includes one or more mechanisms for preventing axial and optionally rotational movement of the circulation support catheter. The insertion catheter of any example herein, particularly Examples 38 - 54.

[0269] Example 56: The hub of the insertion catheter includes a locking mechanism. The locking mechanism includes a recess configured to receive a locking pad configured to removably lock with the circulation support catheter. The insertion catheter of any example herein, particularly Examples 38 - 55.

[0270] Example 57: The hub of the insertion catheter comprises a housing that surrounds at least a portion of the locking mechanism, the housing comprises opposing first inner surface walls that are spaced farther apart than opposing second inner surface walls, at least a portion of the locking mechanism comprises tabs that extend radially outwardly, and the housing is configured to rotate so as to compress the tabs inwardly to prevent axial movement of the circulation support catheter. The insertion catheter of any example herein, particularly Example 56.

[0271] Example 58: The inward compression of the tabs of the locking mechanism compresses the locking pads against the circulation support catheter. The insertion catheter of any example herein, particularly Example 57.

[0272] Example 59: The locking pads are configured to be removably locked to the catheter shaft of the circulation support catheter. The insertion catheter of any example herein, particularly Examples 56 - 58.

[0273] Example 60: The tubular body of the insertion catheter has a length in the range of about 275 mm to about 675 mm and an inner diameter in the range of about 1.5 mm to about 6 mm. The insertion catheter of any example herein, particularly Examples 34 - 59.

[0274] Example 61: The distal portion of the tubular body has a length in the range of about 75 mm to about 140 mm and an inner diameter in the range of about 3.5 mm to about 6 mm, the proximal portion of the tubular body has a length in the range of about 100 mm to about 165 mm and an inner diameter in the range of about 2.0 mm to about 4.5 mm, and the intermediate portion of the tubular body has a length in the range of about 150 mm to about 250 mm and an inner diameter in the range of about 1.5 mm to about 4.5 mm. The insertion catheter of any example herein, particularly Examples 34 - 60.

[0275] Example 62: The tubular portion includes braided wires. The insertion catheter of any example herein, particularly Examples 34 - 61.

[0276] Example 63: An insertion catheter according to any example herein, particularly Examples 34 to 62, comprising a PET band configured such that the distal end of the tubular body holds the edge portion of the braided wire.

[0277] Example 64: An insertion catheter according to any example herein, particularly Examples 34 to 63, wherein the distal end of the tubular body includes a radiopaque marker.

[0278] Example 65: An insertion catheter according to any example herein, particularly Examples 34 to 64, wherein the proximal portion of the tubular body is configured to transmit longitudinal forces without twisting.

[0279] Example 66: An insertion catheter according to any example herein, particularly Examples 34 to 65, wherein the proximal portion of the tubular body is stiffer than the intermediate and distal portions.

[0280] Example 67: An insertion catheter according to any example herein, particularly Examples 34 to 66, wherein the proximal portion of the tubular body includes a reinforced double braided wire.

[0281] Example 68: An insertion catheter according to any example herein, particularly Examples 34 to 67, wherein at least the distal portion of the tubular body is coated with a hydrophilic coating configured to reduce friction on its outer surface.

[0282] Example 69: A method of using an insertion catheter with a circulatory support catheter having a circulatory support device carried by an elongated flexible catheter shaft, the method comprising inserting a distal end of the insertion catheter through a proximal end of an introducer sheath advanced into a patient's artery, and advancing the insertion catheter through the introducer sheath and any hemostatic valve of the introducer sheath until the distal end of the insertion catheter extends beyond the distal end of the introducer sheath, wherein the insertion catheter comprises a tubular body having a distal portion adjacent to a distal end configured to axially movably receive the circulatory support device, and the insertion catheter is configured to protect the circulatory support device as it advances through the introducer sheath and any hemostatic valve of the introducer sheath.

[0283] Example 70: The method of using an insertion catheter according to any embodiment herein, particularly Example 69, wherein the insertion catheter further comprises a hub fluidly connected to a proximal end of the tubular body, the hub being configured to lock with the introducer sheath when the insertion catheter has advanced completely through the introducer sheath and to prevent axial and / or rotational movement of the insertion catheter relative to the introducer sheath.

[0284] Example 71: The method of using an insertion catheter according to any embodiment herein, particularly Examples 69-70, wherein the tubular body further comprises a proximal portion adjacent to its proximal end and an intermediate portion between the proximal portion and the distal portion.

[0285] Example 72: The method of using an insertion catheter according to any embodiment herein, particularly Example 71, wherein the tubular body further comprises a proximal transition section between the proximal portion and the intermediate portion and a distal transition section between the distal portion and the intermediate portion.

[0286] Example 73: A method of using an insertion catheter of any example herein, particularly Example 72, wherein the distal portion and the distal transition section are configured to receive a circulatory support device, and the intermediate portion, the proximal transition section, the proximal portion, and the hub are configured to receive an elongate flexible catheter shaft.

[0287] Example 74: A method of using an insertion catheter of any example herein, particularly Examples 71 - 73, wherein the tubular body is configured such that the proximal portion remains outside the patient's body when the insertion catheter has advanced completely through the introducer sheath.

[0288] Example 75: A method of using an insertion catheter of any example herein, particularly Examples 69 - 74, wherein the tubular body is configured such that the distal portion is positioned within the patient's aorta when the insertion catheter has advanced completely through the introducer sheath.

[0289] Example 76: A method of using an insertion catheter of any example herein, particularly Examples 71 - 75, wherein the tubular body is configured such that when the insertion catheter advances completely through the introducer sheath, the middle portion extends from outside the patient's body, through an arteriotomy of the femoral artery, through the femoral artery, through a branch of the femoral artery that joins the aorta, and into the aorta.

[0290] Example 77: A method of using an insertion catheter of any example herein, particularly Examples 69 - 76, further comprising advancing a circulatory support catheter through the insertion catheter until a target treatment location within the patient's body is reached.

[0291] Example 78: A method of using an insertion catheter of any example herein, particularly Example 77, wherein the hub of the insertion catheter comprises a locking mechanism, and the method further comprises locking the axial position of the circulatory support catheter relative to the insertion catheter.

[0292] Example 79: A method of using an introducer catheter of any of the examples herein, particularly Example 78, the locking mechanism being configured to receive a locking pad configured to removably lock to a circulation support catheter, the method comprising a recess.

[0293] Example 80: A method of using an introducer catheter of any of the examples herein, particularly Examples 78 - 79, wherein the hub of the introducer catheter comprises a housing surrounding at least a portion of the locking mechanism, the housing comprising opposing first inner surface walls spaced further apart than opposing second inner surface walls, at least a portion of the locking mechanism comprising tabs extending radially outwardly, the housing being configured to rotate to compress the tabs inwardly to prevent axial movement of the circulation support catheter.

[0294] Example 81: A method of using an introducer catheter of any of the examples herein, particularly Example 80, wherein the inward compression of the tabs of the locking mechanism compresses the locking pad against the circulation support catheter.

[0295] Example 82: A method of using an introducer catheter of any of the examples herein, particularly Examples 79 - 81, wherein the locking pad is configured to be removably locked to the catheter shaft of the circulation support catheter.

[0296] Example 83: A method of using an introducer catheter of any of the examples herein, particularly Examples 79 - 82, further comprising the step of rotating the housing of the hub to removably lock the axial position of the circulation support catheter relative to the introducer catheter.

[0297] Example 84: A medical delivery system comprising an insertion tool comprising an insertion tool hub and an insertion tool shaft extending distally from the insertion tool hub, and a peel - away catheter comprising a catheter shaft configured to be separable into a plurality of elongated shaft portions, the catheter shaft comprising a proximal portion configured to mate with the distal portion of the insertion tool shaft.

[0298] Example 85: A system according to any example herein, particularly the system described in Example 84, comprising an insertion tool fitting portion configured such that a proximal portion of the catheter shaft is disposed on and has an interference fit with an outer surface of a distal portion of the insertion tool shaft.

[0299] Example 86: A system according to any example herein, particularly the system described in Example 85, wherein the insertion tool fitting portion includes a flare configuration.

[0300] Example 87: A system according to any example herein, particularly the systems of Examples 84 - 86, further comprising first and second operator engagement handles coupled to respective portions of a proximal portion of the catheter shaft for engagement by an operator to separate the peel - away catheter into a plurality of elongated shaft portions.

[0301] Example 88: A system according to any example herein, particularly the systems of Examples 84 - 86, wherein the peel - away catheter and the insertion tool are configured to slidably receive respective portions of a mechanical circulatory support (MCS) system.

[0302] Example 89: A system according to any example herein, particularly the system of Example 88, wherein corresponding portions of the mechanical circulatory support (MCS) system are disposed through respective delivery lumens of the insertion tool and configured to peel the catheter, and a distal tip of the mechanical circulatory support (MCS) system is configured to be disposed distally of the catheter shaft.

[0303] Example 90: A system according to any example herein, particularly the system of Example 88, further comprising a support sleeve having a slit and configured to be disposed around a portion of a shaft of the mechanical circulatory support (MCS) system, and a corresponding portion of the delivery lumen of the catheter shaft is configured to slidably receive the support sleeve and the portion of the shaft of the mechanical circulatory support (MCS) system.

[0304] Example 91: A system according to any example herein, particularly the system of Examples 84 - 86, further comprising an introducer sheath having an introducer sheath shaft extending distally from an introducer sheath hub, wherein at least a portion of the catheter shaft is configured to be slidably disposed within the introducer sheath shaft and the introducer sheath hub while a proximal portion of the catheter shaft is engaged with a distal portion of the insertion tool shaft.

[0305] Example 92: A system according to any example herein, particularly the system of Example 91, further comprising a spacer configured to engage spacer engagement features of the introducer sheath hub and the insertion tool hub to axially space and align the introducer sheath hub and the insertion tool hub.

[0306] Example 93: A system according to any example herein, particularly the system of Example 92, wherein the spacer comprises a distal portion configured to engage a spacer engagement feature of the introducer sheath hub, a proximal portion configured to engage a spacer engagement feature of the insertion tool hub, and an inner portion extending between and perpendicular to the distal and proximal portions, wherein the distal and proximal portions each comprise a recessed edge configured to engage a respective groove of the spacer engagement feature of the introducer sheath hub or the insertion tool hub.

[0307] Example 94: A medical delivery system comprising an introducer sheath including an introducer sheath shaft extending distally from an introducer sheath hub, and a peel - away catheter including a catheter shaft extending distally from a catheter hub, wherein the introducer sheath and the peel - away catheter are configured to slidably receive a mechanical circulatory support (MCS) system. The system may include a spacer configured to engage the introducer sheath hub and the catheter hub to axially space the introducer sheath hub from the catheter hub.

[0308] Example 95: Any example herein, particularly the system of Example 94, comprising a first elongated member including at least a portion configured to be slidably disposed within a first elongated member lumen extending along a first longitudinal portion of the shaft wall of a catheter shaft while the peel-away catheter is in a non-peeled configuration. The peel-away catheter includes a second elongated member including at least a portion configured to be slidably disposed within a second elongated member lumen extending along a second longitudinal portion of the shaft wall of the catheter shaft while the peel-away catheter is in a non-peeled configuration. The first and second elongated portions are configured to be pulled laterally to cut through corresponding shaft wall portions between the first and second elongated member lumens and the outer surface of the shaft wall to separate the shaft wall into first and second elongated shaft wall portions.

[0309] Example 96: Any example herein, particularly the system of Example 95, wherein the first elongated portion is disposed opposite about the circumference of the catheter shaft relative to the second elongated portion.

[0310] Example 97: Any example herein, particularly the system of Example 94 or 95, wherein the peel-away catheter comprises a first proximal shaft tab coupled to a proximal portion of the first elongated shaft wall portion and a second proximal shaft tab coupled to a proximal portion of the second longitudinal shaft wall portion, and the first and second proximal shaft tabs are configured to be pulled laterally to tear through corresponding shaft wall portions between the first and second elongated member lumens and the inner surface of the shaft wall to separate the shaft wall into first and second elongated shaft wall portions.

[0311] Example 98: Any example herein, particularly the system of Example 97, wherein the first and second proximal shaft tabs are disposed at positions opposite about the circumference of the catheter shaft.

[0312] Example 99: A peel-away catheter, comprising a first elongate member including a first elongate portion, a second elongate member including a second elongate portion, and first and second elongate wall portions, of any example herein, particularly the system of Example 94. While the catheter shaft is in a non-peeled configuration, the first elongate portion may be between a first edge of the second elongate shaft wall portion and a second edge of the first elongate shaft wall portion, and the second elongate portion may be between a first edge of the first elongate shaft wall portion and a second edge of the second elongate shaft wall portion, and the first elongate portion and the second elongate portion are configured to be pulled laterally to separate the first elongate portion and the second elongate portion from the first elongate shaft wall portion and the second elongate shaft wall portion.

[0313] Example 100: A system of any example herein, particularly the system of Example 99, wherein the first elongate portion is disposed opposite around the catheter shaft relative to the second elongate portion, and the first elongate shaft wall portion is disposed opposite around the catheter shaft relative to the second elongate shaft wall portion.

[0314] Example 101: A peel-away catheter includes an elongate member including an elongate portion, and a shaft wall of the catheter shaft includes a first interlocking portion including a first plurality of mating portions along a longitudinal portion of the catheter shaft, and a second interlocking portion including a second plurality of mating portions along a longitudinal portion of the catheter shaft and configured to mate with the first interlocking portion, of any example herein, particularly the system of Example 94. The peel-away catheter can include an elongate member including an elongate portion, and corresponding portions of the elongate portion are configured to be slidably disposed within respective elongate member lumen portions of the first and second plurality of mating portions of the first and second interlocking portions.

[0315] Example 102: A system of any example herein, particularly the system described in Example 101, wherein the mating edges of the first and second interlocking portions have a rectangular wave shape.

[0316] Example 103: The system of any example herein, particularly the system of Example 101 or 102, wherein the elongated portion is configured to be pulled out from the lumen portion of the elongated member to allow the first and second interlocking portions to separate.

[0317] Example 104: The system of any example herein, particularly the system of Example 94, wherein the peel-away catheter includes an elongated member configured to hold the edges of the shaft wall of the catheter shaft together to maintain the catheter shaft in a non-peeled configuration.

[0318] Example 105: The system of any example herein, particularly the system described in Example 104, wherein the shaft wall comprises a first edge portion having a plurality of first openings at respective positions along the longitudinal portion of the first edge portion, and a second edge portion having a plurality of second openings at respective positions along the longitudinal portion of the second edge portion. The elongated member can include an elongated portion, and the corresponding portions of the elongated portion are configured to be alternately arranged through the plurality of first and second openings to hold the first edge portion and the second edge portion together.

[0319] Example 106: The system of any example herein, particularly the system of Example 104 or 105, wherein the elongated portion is configured to be pulled out from the plurality of first and second openings to allow the first and second edge portions to separate.

[0320] Example 107: The system of any example herein, particularly the system of Example 94, wherein the catheter shaft is configured to be in a roll configuration while the catheter shaft is in a non-peeled configuration.

[0321] Example 108: The shaft wall of the catheter shaft includes a first overlapping wall portion and a second overlapping wall portion, and while the catheter shaft is in a rolled configuration, the first overlapping wall portion is configured to be on and in contact with the second overlapping wall portion along a longitudinal portion of the shaft wall. Any example of the present specification, particularly the system of Example 107.

[0322] Example 109: The peel-away catheter includes a proximal shaft tab coupled to a proximal portion of the shaft wall of the catheter shaft, and the proximal shaft tab is coupled at a position circumferentially spaced from the first and second overlapping wall portions. Any example of the present specification, particularly the system of Example 107 or 108.

[0323] Example 110: The proximal shaft tab is oriented to face around the circumference of the catheter shaft with respect to the first and second overlapping wall portions. Any example of the present specification, particularly the system of Example 109.

[0324] Example 111: At least one of the outer diameter of the catheter shaft and the diameter of the shaft delivery lumen of the catheter shaft is configured to fit that of the corresponding portion of the MCS system through which it is disposed. Any example of the present specification, particularly the system of Examples 94 - 110.

[0325] Example 112: The spacer is configured to engage with the spacer engagement features of the introducer sheath hub and the catheter hub to axially space and align the introducer sheath hub and the catheter hub. Any example of the present specification, particularly the system of Examples 94 - 111.

[0326] Example 113: A system according to any example herein, particularly the system of Example 112, wherein the spacer comprises a distal portion configured to engage a spacer engagement feature of an introducer sheath hub, a proximal portion configured to engage a spacer engagement feature of a catheter hub, an inner portion extending between and perpendicular to the distal and proximal portions, and wherein the distal and proximal portions each include a recessed edge configured to fit into a respective groove of the spacer engagement feature of the introducer sheath hub or catheter hub.

[0327] Example 114: A system according to any example herein, particularly the systems of Examples 94 - 113, wherein the catheter hub is not a peel - away hub.

[0328] Specific features described in the context of separate implementations herein may also be implemented in combination within a single implementation. Conversely, various features described in the context of a single implementation may also be implemented separately or in any suitable sub - combination in multiple implementations. Further, even if a mechanism is described above as functioning in a particular combination and was initially claimed as such, one or more mechanisms from the claimed combination may in some cases be excluded from that combination, and the claimed combination may be directed to a sub - combination or variation of a sub - combination.

[0329] Similarly, although operations are depicted in the drawings in a particular order, this should not be understood as requiring that such operations be performed in the particular order shown, or in a sequential order, or that all of the illustrated operations be performed, in order to achieve a desirable result. Further, other embodiments are included within the following claims. In some cases, the acts recited in the claims may be performed in a different order and still achieve a desirable result.

[0330] One of ordinary skill in the art will understand that the terms used herein are generally intended as “open” terms (e.g., the term “comprising” should be construed to mean “including but not limited to,” the term “including” should be construed to mean “including but not limited to,” etc.). If a specific number of recited elements in a claim is intended, such intent will be expressly recited in the claims, and one of ordinary skill in the art will further understand that if no such recitation exists, no such intent exists. For example, by way of illustration, the following appended claims may contain the use of introductory phrases “at least one” and “one or more” to introduce a listing of elements in the claims. However, the use of such phrases should not be construed to mean that the introduction of a claim element by indefinite articles “a” or “an” limits any particular claim containing such introduced listing of claim elements to embodiments containing only one such listing, as the same claims will apply to embodiments containing more than one such introduced element, whether introduced by the introductory phrases “one or more” or “at least one,” or by the use of definite articles to identify the elements in the claim (e.g., “a” and / or “an” should typically be construed to mean “at least one” or “one or more”).

[0331] Furthermore, even if a specific number of the recited claims introduced is explicitly recited, one of ordinary skill in the art will recognize that such a recitation should typically be construed to mean at least the recited number (e.g., a bare recitation of two recitations, typically at least two recitations, or two or more recitations without other modifiers). Further, in conventions similar to at least one of A, B, and C, generally, such a structure is intended in the sense that one of ordinary skill in the art would understand conventionally (e.g., a system having at least one of A, B, and C includes, but is not limited to, a system having A alone, B alone, C alone, A and B together, A and C together, B and C together, and / or A, B, and C together). In the case of a convention analogous to "at least one of A, B, or C", generally, such a structure is intended in the sense that one of ordinary skill in the art would understand conventionally (e.g., a system having at least one of A, B, or C includes, but is not limited to, a system having A alone, B alone, C alone, A and B together, A and C together, B and C together, and / or A, B, and C together). It will be further understood by one of ordinary skill in the art that any auxiliary words and / or phrases presenting two or more alternative terms in any of the description, claims, or drawings should be understood to contemplate the possibility of including one of the terms, any of the terms, or both terms. For example, the phrase "A or B" would be understood to include the possibilities of "A" or "B" or "A and B".

[0332] If an exemplary embodiment includes an "and / or" link between a first feature and a second feature, this should be read such that an embodiment according to one embodiment has both the first feature and the second feature, and an embodiment according to a further embodiment has only the first feature or only the second feature.

Claims

1. An insertion catheter for a circulatory support catheter having a circulatory support device carried by an elongate flexible catheter shaft, the insertion catheter comprising: a tubular body having a proximal end, a distal end, a longitudinal axis extending between the proximal end and the distal end, a proximal portion adjacent to the proximal end, a distal portion adjacent to the distal end, and an intermediate portion between the proximal portion and the distal portion; wherein: the distal portion of the tubular body is configured to axially movably receive the circulatory support device; the insertion catheter, wherein the diameter of the distal portion is larger than the diameter of the intermediate portion.

2. The insertion catheter according to claim 1, further comprising a hub having a proximal end and a distal end, the distal end of the hub being in fluid connection with the proximal end of the tubular body.

3. The tubular body further comprises a proximal transition section between the proximal portion and the intermediate portion and a distal transition section between the distal portion and the intermediate portion, the distal portion and the distal transition section being configured to receive the circulatory support device, and the intermediate portion, the proximal transition section, the proximal portion, and the hub being configured to receive the elongate flexible catheter shaft. The insertion catheter according to claim 1.

4. The insertion catheter according to claim 1, wherein the intermediate portion has an outer diameter smaller than the outer diameter of the proximal portion and the outer diameter of the distal portion.

5. The insertion catheter according to claim 1, wherein the distal portion has an inner diameter larger than the inner diameter of the intermediate portion and the proximal portion.

6. The insertion catheter according to claim 1, wherein the distal end of the tubular body is configured to extend beyond the distal end of the introducer sheath when the insertion catheter is fully docked with the introducer sheath during use.

7. The insertion catheter according to claim 6, wherein the distal end of the hub comprises one or more mechanisms for preventing rotation and / or axial movement of the insertion catheter when docked with the introducer sheath.

8. The insertion catheter according to claim 1, wherein the circulatory support device comprises a tubular housing, a motor, and an impeller configured to be rotated by the motor.

9. The insertion catheter according to claim 1, wherein the proximal portion of the tubular body is harder than the intermediate portion and the distal portion.

10. A mechanical circulatory support system, A circulatory support catheter comprising a circulatory support device carried by an elongate flexible catheter shaft, the circulatory support device comprising a tubular housing, a motor, and an impeller configured to be rotated by the motor, a circulatory support catheter, An insertion catheter comprising a proximal end, a distal end, a longitudinal axis extending between the proximal end and the distal end, a proximal portion adjacent to the proximal end, a distal portion adjacent to the distal end, and a tubular body having an intermediate portion between the proximal portion and the distal portion, Comprising, The distal portion of the tubular body is configured to axially movably receive the circulatory support device, The system wherein the diameter of the distal portion is larger than the diameter of the intermediate portion.

11. The system according to claim 10, wherein the impeller is configured to be rotated by the motor via a shaft or a magnetic coupling.

12. The system according to claim 10, wherein the system does not require purging.

13. The system according to claim 10, wherein the intermediate portion includes an outer diameter smaller than the outer diameter of the proximal portion and the outer diameter of the distal portion.

14. The system according to claim 10, wherein the distal portion includes an inner diameter larger than the inner diameters of the intermediate portion and the proximal portion.

15. The system according to claim 10, wherein the insertion catheter comprises a hemostatic valve.

16. A method of using an insertion catheter together with a circulatory support catheter having a circulatory support device carried by an elongate flexible catheter shaft, Inserting a distal end of the insertion catheter through a proximal end of an introducer sheath advanced into an artery of a patient; Advancing the insertion catheter through the introducer sheath until the distal end of the insertion catheter extends beyond the distal end of the introducer sheath; Including, The insertion catheter comprises a tubular body having a distal portion adjacent to the distal end configured to axially movably receive the circulatory support device, A method of using an insertion catheter configured to protect the circulatory support device as the insertion catheter advances through the introducer sheath. **Claim 17** The method of claim 16, wherein the insertion catheter further comprises a hub fluidly connected to the proximal end of the tubular body, the hub configured to lock with the introducer sheath when the insertion catheter has advanced completely through the introducer sheath and to prevent axial and / or rotational movement of the insertion catheter relative to the introducer sheath. **Claim 18** The method of claim 16, wherein the tubular body is configured such that when the insertion catheter has advanced completely through the introducer sheath, the proximal portion remains outside the patient's body. **Claim 19** The method of claim 16, wherein the tubular body is configured such that when the insertion catheter has advanced completely through the introducer sheath, the distal portion is positioned within the patient's aorta. **Claim 20** The method of claim 16, wherein the tubular body is configured such that when the insertion catheter has advanced completely through the introducer sheath, the intermediate portion extends from outside the patient's body, through an arteriotomy of the femoral artery, through the femoral artery, through a branch of the femoral artery that joins the aorta, and into the aorta.

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