Patent Description:
During a catheterization procedure which prepares for insertion of the pump into the left heart, an introducer is inserted into the femoral artery through an arteriotomy to gain access to the artery and create an insertion path. A placement guidewire can be advanced into the artery along the insertion path. After the guidewire has been inserted into the artery, the pump assembly can be advanced over the guidewire and into the patient. Alternatively, the pump assembly can be inserted directly into the artery without a guidewire. The pump can be inserted via a standard catheterization procedure through the femoral artery, into the ascending aorta, across the aortic valve and into the left ventricle. When deployed in the left heart, the pump assembly pulls blood from the left ventricle through an inlet area near the tip and expels blood from the cannula into the ascending aorta.

The pump assembly can be advanced over the guidewire or directly into the vessel, as described above, and advanced to a desired axial position relative to the heart. To position the pump assembly in a desired rotational orientation, a user can apply torque to the catheter, resulting in torsion/twisting of the catheter and rotation of a distal portion of the catheter and/or of the cannula.

Prior to being inserted into a patient, a catheter of the pump has an inherent shape and there is a limited amount of torque that can be safely applied to the catheter before the applied torque is released in an uncontrollable manner such that the catheter recoils. The inherent shape of the catheter (i.e. the resting or unstressed shape of the catheter, when no external forces are imposed thereon) can be affected during manufacturing and/or insertion. For example, sterilization is part of the manufacturing process and can include applying and removing heat and humidity in an alternating or cyclical fashion (referred to herein as thermocycling). Because the catheter is sensitive to thermocycling, once the thermocycling is complete, the catheter sets in a new resting shape. The above-mentioned resting shape after thermocycling can be determined by features of the pump itself and/or features that hold the catheter in a specific shape such as its packaging tray. However, the resulting resting shape of the catheter may not match the patient's anatomy. Because a limited amount of torque can be applied to the catheter, it can be difficult to position the cannula in a desired axial location and rotational orientation in a patient.

<CIT> describes an intravascular rotary blood pump having one or more pressure sensors for measuring pressures within the patient's vascular system which are significant for operating the blood pump and/or for assessing the state of health of the patient's heart. <CIT> describes an intravascular rotary blood pump having one or more pressure sensors for measuring pressures within the patient's vascular system which are significant for operating the blood pump and/or for assessing the state of health of the patient's heart.

The present invention is defined by a catheter assembly according to claim <NUM>. Further advantageous features are provided in the dependent claims.

Systems, methods, and devices are described herein for providing a catheter assembly of a heart pump having a shape that facilitates positioning of the pump assembly within a patient. The catheter assembly includes a catheter and a cannula coupled thereto. The plane of the cannula is at an angular offset relative to the plane of the catheter. In some implementations, this angular offset is achieved by applying torsion to the catheter and setting the shape of the catheter using heat or other methods. In other implementations, the angular offset is achieved without applying torsion to the catheter. For example, this may be achieved by rotating the cannula relative to the catheter before coupling the catheter and cannula, pre shaping a backbone of the catheter, and/or by rotating the catheter's connection to the handle and/or the cannula. In addition or alternative to changing the rotation angle between the catheter and the cannula, the cannula may be translated within the plane of the catheter and/or out of the plane of the catheter and then the shape can be set. Translation of the cannula in the plane of the catheter can be measured by a bend angle between the proximal portion of the cannula and an axis of a fixed proximal portion of the catheter. Translation of the cannula out of the plane of the catheter can be measured by the angular offset between the proximal position of the cannula and a plane of the fixed proximal portion of the catheter.

Rotation and/or translation of the cannula shifts the inlet of the pump toward free space of a ventricle (e.g., the left ventricle). For example, this can facilitate navigation and positioning the pump assembly in the left ventricle and can reduce the occurrence of suction events and low blood flow alarms. The catheter can be shaped and the cannula can be oriented such that the cannula can be positioned in the left ventricle of the heart angled towards the apex of the ventricle and with the inlet of the pump located in the ventricle's free space, thereby reducing the occurrence of suctioning of the heart wall and/or biomaterial ingestion. The rotation angle of the cannula can result in a predetermined placement of the catheter and the cannula in a desired location. For example, the rotation angle can be selected to be about equal to an angle between a plane of the aortic arch and a predetermined cannula placement plane. In such a case, rotation of the cannula with respect to the catheter also biases a distal portion of the pump assembly away from chordae which actuate the mitral valve. This can reduce the chance of the pump assembly being caught therein which could make extracting the pump more difficult.

In implementations in which the rotation angle is achieved by torsioning/twisting the catheter, thermal treatment can set the shape of the catheter. This thermal treatment can occur during sterilization of the catheter during which temperature, pressure, and/or humidity can be cycled to set the shape of the catheter (e.g., by setting the shape of a metal or polymer spine of the catheter). This shape setting occurs as the material is relaxed and/or annealed at a high temperature and then set at a lower temperature. In one example, to form the catheter assembly in an anatomically correct position, the catheter spine is imparted with a rotation angle and/or translation during sterilization which biases the catheter in a desired orientation.

The resulting new, baseline unstressed shape of the catheter, formed by shaping a catheter spine during sterilization or by any of the other methods described herein, reduces the need to apply torque to the catheter during insertion and positioning of the pump assembly within the vessels of the patient (e.g., through the aorta and along the aortic arch). The improved catheter assembly may be helpful for the IMPELLA® <NUM> pump, IMPELLA® <NUM> pump, IMPELLA CP® pump assemblies which are adapted for use in the left ventricle, or may be helpful for any other heart pumps.

Furthermore, the relative position of the cannula and the catheter can be selected to best fit the anatomy of a particular patient or category of patients. This improved fit can also help reduce delivery time.

An unstressed catheter and a cannula rotated or translated away from a proximal portion of the catheter may be presented in a tray (e.g., a packaging tray). Alternatively, an unstressed catheter and a cannula rotated or translated away from a proximal portion of the catheter may be manufactured or presented without a tray. A tray may be configured to apply and maintain torsion in the catheter prior to thermocycling (e.g., sterilization) of the catheter assembly. For example, a first portion of the tray may immobilize a first location on the catheter and a second portion of the tray may immobilize a second location on the cannula such that the cannula is rotated and the distal portion of the cannula is at an angle relative to the plane of the tray, as described above. The tray may include a structure which allows the cannula to lie in a plane which is different from the plane of the catheter and the packaging tray. After the catheter assembly is thermally treated in the desired position, for example a position initially maintained by the two tray portions, the catheter retains its torsion/twisted shape in an unstressed, resting state, and the cannula retains its shape and angular position when the catheter assembly is removed from the tray and during insertion into a patient.

Also disclosed herein are methods of manufacturing a catheter assembly having the configurations described above. According to one method, the proximal catheter portion is held fixed, and the cannula is rotated and/or translated until the cannula is in the desired location relative to the catheter. The cannula is then held fixed and thermocycling is performed. After completion of the thermocycling process, the shape of the catheter is set. In this configuration the catheter is no longer under stress when in the set shape. In another method, the cannula, the catheter, or both are rotated relative to one another to achieve a particular desired angle between the distal portion of the cannula and a reference plane (e.g., the plane of the aortic arch). In some implementations, a handle coupled to the catheter assembly is rotated relative to the catheter assembly or one or more components of the catheter assembly and the shape of the assembly is set.

In one aspect, a catheter assembly includes a catheter including a proximal catheter portion, a longitudinal axis, a distal catheter portion, and a catheter transition portion between the proximal catheter portion and the distal catheter portion, wherein the longitudinal axis forms a curve. The catheter assembly further includes a cannula coupled to the distal catheter portion, the cannula having a proximal cannula portion, a distal cannula portion, and a cannula transition portion comprising a bend between the proximal cannula portion and the distal cannula portion. When the cannula is inserted in a heart, the distal cannula portion lies within a first plane, and the curve of the longitudinal axis of the catheter portion lies in a second plane, where the first plane is different from, and at an angular offset relative to the second plane.

In certain implementations, the angular offset of the first plane relative to the second plane is about substantially equal to an angle between a plane of an aortic arch defined by an ascending portion of an aorta and a descending portion of the aorta and a plane defined by the ascending portion of the aorta and an apex of a left ventricle of a heart.

In certain implementations, the angular offset is selected such that the catheter assembly has a predetermined anatomical shape when in the resting state.

In certain implementations, the angular offset biases the distal cannula portion toward the apex of the left ventricle of the heart when the catheter assembly is inserted through the aorta.

In certain implementations, the angular offset is between about <NUM>° and <NUM>°.

In certain implementations, the angular offset is about <NUM>°.

In certain implementations, the angular offset is such that the distal catheter portion is pointed toward an apex of the heart.

In certain implementations, the catheter assembly further includes a stylet inserted into the catheter to adjust a shape of the distal catheter portion.

In certain implementations, the catheter assembly further includes a catheter handle connected to the proximal catheter portion and rotated to adjust a position of the distal catheter portion.

In certain implementations, the catheter assembly further includes a steering mechanism connected to the proximal catheter portion and configured to adjust a position of the distal catheter portion after insertion.

In another example not being part of the invention, a catheter assembly includes a catheter including a proximal catheter portion, a distal catheter portion, and a catheter transition portion between the proximal catheter portion and the distal catheter portion. The catheter assembly further includes a cannula coupled to the distal catheter portion, the cannula having a proximal cannula portion, a distal cannula portion, and a cannula transition portion comprising a bend between the proximal cannula portion and the distal cannula portion. When the cannula is inserted in a heart of a patient, the distal cannula portion lies within a first plane that is different from, and at an angular offset relative to, a second plane in which an aortic arch of the patient lies.

In certain implementations, the angular offset is about substantially equal to or greater than an angle between a plane of an aortic arch defined by an ascending portion of an aorta and a descending portion of the aorta and a plane defined by defined by the ascending portion of the aorta and an apex of a left ventricle of the heart.

In certain implementations, the angular offset is selected such that the catheter assembly has a predetermined anatomical shape when in a resting state. In certain implementations, the angular offset biases the distal cannula portion toward the apex of a left ventricle of a heart when the catheter assembly is inserted through the aorta of the patient.

In certain implementations, the catheter assembly further includes an inner polyamide layer and an outer polyurethane layer.

In yet another example not being part of the invention, a method for setting a catheter assembly in a desired anatomical shape includes forming a longitudinal axis of a catheter into a curve which lies within a second plane. The catheter includes a proximal catheter portion, a longitudinal axis, a distal catheter portion, and a catheter transition portion between the proximal catheter portion and the distal catheter portion. The method further includes rotating a cannula relative to the catheter such that the first plane is at an angular offset relative to the second plane. The cannula includes a longitudinal axis, a proximal cannula portion, a distal cannula portion, and a bend between the proximal cannula portion and the distal cannula portion, wherein the distal cannula portion lies within a first plane. The method further includes connecting the proximal cannula portion to the distal catheter portion.

In certain implementations, the method further includes rotating the cannula relative to the catheter is before the connecting the proximal cannula portion to the distal catheter portion.

In certain implementations, the method further includes rotating the cannula relative to the catheter is after the connecting the proximal cannula portion to the distal catheter portion.

In certain implementations, the method further includes, before the rotating, engaging the catheter with a first insert, thereby preventing movement of the catheter relative to the second plane.

In certain implementations, the method further includes before the rotating, engaging the catheter with a second insert, thereby preventing movement of the distal cannula portion relative to the first plane.

In certain implementations, the method further includes, after the rotating, thermocycling the catheter assembly such that a resting shape of the catheter assembly is set after completion of the thermocycling.

In yet another example not being part of the invention, a system for configuring a catheter assembly into an anatomical shape includes a catheter assembly including a catheter and a cannula coupled to the catheter, the cannula having a proximal cannula portion, a distal cannula portion, and a cannula transition portion comprising a bend between the proximal cannula portion and the distal cannula portion. The system further includes a packaging tray that houses the catheter assembly and includes a first insert and a second insert, the first insert being coupled to the cannula and the second insert being coupled to the catheter. Between the first insert and the second insert the catheter is torsioned by a torsion angle such that the distal cannula portion is rotated at a first angle out of a plane of the packaging tray.

In certain implementations, the first angle is about equal to an angle between a plane of an aortic arch and a predetermined cannula placement location.

In certain implementations, the first angle is between about <NUM>° and <NUM>°.

In certain implementations, the first angle biases the distal cannula portion away from a mitral valve of a heart when the catheter assembly is inserted through the aorta of a patient.

In certain implementations, the first angle is about equal to the angle between a plane of an aortic arch defined by an ascending portion of an aorta and a descending portion of the aorta and a plane defined by the ascending portion of the aorta and an apex of a left ventricle of a heart.

In certain implementations, the first angle is about <NUM>°.

In yet another example not being part of the invention, a method for setting a catheter assembly in a desired anatomical shape includes positioning a catheter assembly inside a packaging tray. The packaging tray houses the catheter assembly, and the catheter assembly includes a catheter and a cannula connected to the catheter, the cannula including a bend between a proximal cannula portion and a distal cannula portion. The method further includes engaging the catheter with a first insert, thereby preventing movement of the catheter relative to the packaging tray. The method further includes rotating the cannula by a rotation angle relative to the packaging tray and engaging the catheter with a second insert, thereby preventing movement of the cannula relative to the packaging tray. The method further includes thermocycling the catheter assembly such that a resting shape of the catheter assembly is set after completion of the thermocycling.

In certain implementations, the rotation angle is about equal to an angle between a plane of an aortic arch and a desired plane for the distal cannula portion, and the rotation angle is configured such that a plane of the distal cannula portion is at the angle between the plane of the aortic arch and the desired plane for the distal cannula portion.

Variations and modifications will occur to those of skill in the art after reviewing this disclosure. The disclosed features may be implemented, in any combination and subcombination (including multiple dependent combinations and subcombinations), with one or more other features described herein. The various features described or illustrated above, including any components thereof, may be combined or integrated in other systems. Moreover, certain features may be omitted or not implemented.

Systems, methods, and devices are described herein for providing a catheter assembly of a heart pump having a shape that facilitates positioning of the pump assembly within a patient.

The catheter assembly can include a catheter and a cannula coupled thereto. The plane of the cannula can be at an angular offset relative to the plane of the catheter. In some implementations, this angular offset is achieved by applying torsion to the catheter and setting the shape of the catheter using heat or other methods. In other implementations, the angular offset is achieved without applying torsion to the catheter. For example, this may be achieved by rotating the cannula relative to the catheter before coupling the catheter and cannula, preshaping a backbone of the catheter, and/or by rotating the catheter's connection to the handle and/or the cannula. In addition or alternative to changing the rotation angle between the catheter and the cannula, the cannula may be translated within the plane of the catheter and/or out of the plane of the catheter and then the shape can be set. Translation of the cannula in the plane of the catheter can be measured by a bend angle between the proximal portion of the cannula and an axis of a fixed proximal portion of the catheter. Translation of the cannula out of the plane of the catheter can be measured by the angular offset between the proximal portion of the cannula and a plane of the fixed proximal portion of the catheter.

<FIG> shows an illustrative representation of a prior art packaged pump assembly <NUM>. The packaged pump assembly <NUM> includes a tray <NUM>, a tray portion <NUM>, a flexible atraumatic protrusion, also referred to as pigtail <NUM>, a pump inlet <NUM>, a distal cannula portion <NUM>, a proximal cannula portion <NUM>, a catheter <NUM>, and a catheter end unit <NUM>. The pigtail <NUM> extends from the inlet <NUM> which is adjacent to or located on the distal cannula portion <NUM>. The distal cannula portion <NUM> is angled from the proximal cannula portion <NUM> by an angle α. For example, the distal cannula portion <NUM> is angled from the proximal cannula portion <NUM> by an angle α of about <NUM>°. The proximal portion <NUM> is connected to the catheter <NUM>, and the proximal portion <NUM> is aligned with a direction of the catheter <NUM> such that there is no torsion between the proximal portion <NUM> and the catheter <NUM>. The proximal portion of the cannula <NUM> is located at a distance <NUM> from a principal edge of the tray, which is identical to a distance <NUM> between a portion of the catheter inside groove <NUM> and the principal edge of the tray. The proximal portion <NUM>, the distal portion <NUM>, and the catheter <NUM> lie in the plane of the upper surface of the tray portion <NUM>, which is parallel to the main plane of the packaging tray <NUM>. The catheter <NUM> is also connected to the catheter end unit <NUM>, which may include a repositioning unit, a plug, an infusion filter, a pressure reservoir and a check valve. The pigtail <NUM>, the distal portion <NUM>, and the proximal portion <NUM> are located within the tray portion <NUM> which is recessed relative to the rest of the tray <NUM>. In the configuration shown in <FIG> there is no torque applied to any of proximal portion <NUM>, distal portion <NUM>, or catheter <NUM>. The catheter <NUM> can be made of a polyamide inner layer and a polyurethane outer layer and when the tray <NUM> is sterilized, the tray <NUM>, the proximal portion <NUM>, the distal portion <NUM>, and the catheter <NUM> undergo thermocycling which affect the catheter materials. The catheter materials relax when the temperature increases and set when the temperature cools. The shape or spine of the catheter <NUM> provided by the tray <NUM> is set by the end of the sterilization process such that when the catheter <NUM> is removed from the tray <NUM> (e.g., for use in a procedure), the catheter <NUM> substantially retains its shape with the distal end of the catheter <NUM> aligned with the proximal portion <NUM> of the cannula.

As discussed above, when a catheter (e.g., catheter <NUM> in <FIG>) has set in this shape, in some cases it may be necessary to apply torque during placement, but there is a limit on the amount of torque which can be safely applied to the catheter before the catheter recoils. Applying too little force on the catheter makes positioning the pump assembly in the desired location difficult. However, applying too much force on the catheter can result in the applied force being released in an uncontrollable manner and/or can move the pump to an improper position resulting in low flow or suction. Accordingly, a steerable catheter (not shown) may be used to steer the catheter shaft and position the distal cannula portion in the anatomy. Such a steerable catheter may include a steering mechanism in a handle outside a patient's body, which allows for repositioning by steering. However, while a steerable catheter helps direct the cannula in the desired direction upon insertion, it may not allow for repositioning after the initial insertion. Procedures requiring frequent repositioning are again limited by the amount of torque which can be safely applied to the catheter before the applied torque is released in an uncontrollable manner and the catheter recoils. Furthermore, while the steerable catheter helps position the cannula in the desired location, it is limited by the existing shape of the cannula (such as the position of the distal cannula portion <NUM> relative to the catheter <NUM>).

<FIG> shows a top-down view of a conventional pump assembly (e.g., the prior art pump assembly <NUM> in <FIG>) in contact with the chordae <NUM> of the mitral valve <NUM> during a cadaver study. As discussed above in relation to <FIG>, the location of the catheter spine in the patient is affected by the way that the pump assembly is held in its packaging tray. And for a conventional tray configuration (e.g., the tray configuration of <FIG>), the inlet of the pump is biased to sit in or near the mitral valve and its structures when implanted into a patient (as shown in <FIG>). The pigtail and inlet portion of a conventional pump assembly <NUM> are tangled with the chordae <NUM> of the mitral valve <NUM>. This tangling can compromise the position of the inlet of the conventional pump assembly <NUM>, such as by obstructing the inflow leading to low blood flow and decreased circulatory support for the patient.

<FIG> shows a first illustrative embodiment of a packaged pump assembly <NUM>, the pump assembly <NUM> having a particular shape that facilitates positioning the pump in a patient. The packaged pump assembly <NUM> includes a tray <NUM>, a first tray portion <NUM>, a second tray portion <NUM>, an inlet <NUM>, a distal cannula portion <NUM>, a proximal cannula portion <NUM>, a catheter transition portion <NUM>, a proximal catheter portion <NUM>, a catheter end unit <NUM>, and a pigtail <NUM>. The pigtail <NUM> extends from the inlet <NUM>, located on the distal cannula portion <NUM>. The distal cannula portion <NUM> is angled from the proximal cannula portion <NUM> (by angle α, shown in <FIG>). In this example, the distal cannula portion <NUM> is angled from the proximal cannula portion <NUM> by an angle α which is substantially <NUM>°. In some implementations, the distal cannula portion <NUM> is angled from the proximal portion <NUM> by an angle α which may be <NUM>°, <NUM>°, <NUM>°, <NUM>° or <NUM>°.

The proximal cannula portion <NUM> and the distal cannula portion <NUM> are fixed relative to the tray <NUM> by the first tray portion <NUM>. A midpoint of the cannula between its proximal portion <NUM> and its distal portion <NUM> is at a distance <NUM> from a principal edge of the tray <NUM>. The proximal cannula portion <NUM> is connected to a catheter transition portion <NUM>, and the catheter transition portion <NUM> is torsioned between the proximal cannula portion <NUM> and the second tray portion <NUM> where the catheter <NUM> is fixed relative to the tray <NUM>. The catheter <NUM> may be fixed relative to the tray <NUM> at a location at a distance <NUM> from a principal edge of the tray. This distance <NUM> may be smaller than the distance <NUM> between the cannula and the principal edge of the tray. Alternatively, the distance <NUM> may be greater than the distance <NUM> between the cannula and the principal edge of the tray. The midpoint of the cannula is at a distance <NUM> from the point where the catheter is fixed. The distance <NUM> may be equal to <NUM>% of a principal length of the tray. In another example, the distance <NUM> may be equal to <NUM>%, <NUM>%, <NUM>% or <NUM>% of the principal length of the tray. Alternatively, a distance between the point where the cannula <NUM> is fixed relative to the tray <NUM> and a coupling between the cannula <NUM> and the proximal portion <NUM> of the cannula is selected to be between <NUM>-<NUM>% of a length of the catheter (e.g., <NUM>%, <NUM>%, <NUM>%, <NUM>%, <NUM>%, <NUM>%). The proximal portion <NUM> and the distal portion <NUM> of the cannula are in one plane which is at an angular offset from the plane of the packaging tray <NUM>. In another example, the distance <NUM> may be greater than either the distance <NUM> and <NUM>.

The angular offset θ2 between the plane of the cannula and the plane of the tray defines the shape of the catheter transition portion <NUM>, as shown in <FIG>. The translation and/or rotation of the cannula also results in the distal portion of the cannula <NUM> being rotated in the plane of the packaging tray, and rotated out of the plane of the packaging tray (corresponding to a plane of the aortic arch), as shown in <FIG> and <FIG>. The proximal catheter portion <NUM> is also connected to the catheter end unit <NUM>, which may include a repositioning unit, a plug, an infusion filter, a pressure reservoir and a check valve.

The proximal and transition portions of the catheter <NUM>, <NUM> can be have a polyamide inner layer and a polyurethane outer layer. In addition, the catheter of any of the embodiments described in <FIG> and <FIG> may be braided to increase the amount of torque which can safely be applied once the pump assembly is in place.

When the tray <NUM> is sterilized, the tray <NUM>, the proximal portion <NUM>, the distal cannula portion <NUM>, the proximal cannula portion <NUM> and the catheter transition portion <NUM> undergo thermocycling with changes in temperature and humidity which affect the catheter materials. For example, the temperature may vary between <NUM> and <NUM> above a transition temperature such that the material is soft and elastic. The catheter materials relax when the temperature increases and set when the temperature cools. The shape or spine of the catheter is set by the end of the sterilization process such that when the catheter is no longer in the tray <NUM> (e.g., when the catheter is in use in a procedure), the catheter substantially retains its shape. For example, the proximal cannula portion <NUM> being at an angle relative to a plane of the proximal catheter portion <NUM>, and the distal cannula portion <NUM> being in a plane angled from the plane of an aortic arch. In one example, the shape or spine of the catheter transition portion <NUM> is set by the end of the sterilization process, such that when the catheter transition portion <NUM> is no longer in the tray <NUM> (e.g., when the catheter is in use in a procedure) the catheter substantially retains its shape, the proximal cannula portion <NUM> is at an angle relative to a plane of the proximal catheter portion <NUM>, and the distal cannula portion <NUM> is in a plane which is at an angular offset from the plane of an aortic arch.

In certain embodiments, the proximal cannula portion <NUM> is in a first plane, and the proximal catheter portion <NUM> is in a second plane which is not parallel to the first plane. An angular offset between the first plane and the second plane is determined based on a desired placement for the cannula and catheter assembly. For example, as described in relation to <FIG> above and <FIG>, <FIG> and <FIG> below, a desired anatomical position may be a position which both rotates and translates an inlet of a pump away from a mitral valve of a heart and toward the apex of a left ventricle. In one example, an angle θ2 between a first plane of the proximal cannula portion <NUM> and a second plane of the proximal catheter portion <NUM> is <NUM>°. In one example, an angular offset between a plane of the distal cannula portion <NUM> and a plane of the aortic arch (e.g., the plane of the packaging tray in the exemplary embodiment of <FIG>) is between <NUM>° and <NUM>°. Preferably, an angular offset between a plane of the distal cannula portion <NUM> and a plane of the aortic arch is between <NUM>° and <NUM>°. Preferably, an angular offset between a plane of the distal cannula portion <NUM> and a plane of the aortic arch is about <NUM>°.

As discussed above, when a catheter (e.g., catheter <NUM> in <FIG>) has set, for example as a result of thermocycling, it can be difficult to insert a pump assembly into a patient because of the limited amount of torque which can be safely applied to the catheter before the applied torque is released in an uncontrollable manner and the catheter recoils. A packaging tray <NUM> is one way to allow rotating the distal cannula portion <NUM> relative to the proximal catheter portion <NUM>, thereby torsioning the catheter transition portion <NUM> before the pump assembly <NUM> is positioned in the packaging tray <NUM>. This provides a better anatomical fit of the pump assembly <NUM> relative to a patient. Configuring the shape of the catheter transition portion <NUM> in this way also contributes to a reduction in the delivery time because it reduces the risk of the cannula <NUM> being stuck in the chordae. Alternatively rotation of the distal cannula portion <NUM> can be carried out even in the absence of a packaging tray, or following the removal of the pump assembly from a packaging tray.

<FIG> shows a top-down view of a first illustrative embodiment of a pump assembly at a distance from the chordae <NUM> of the mitral valve <NUM>. during a cadaver study. As shown, the pigtail and inlet portion of a first illustrative embodiment of a pump assembly <NUM> are positioned along the side <NUM> of the mitral valve <NUM>, but free from the chordae <NUM> of the mitral valve <NUM> such that the inlet portion will not be obstructed. This can in turn reduce the risk of suction and/or low blood flow through the pump due to improper pump positioning.

<FIG> shows a front view of a conventional pump assembly and a first illustrative embodiment of a pump assembly positioned across an aortic valve and in the left ventricle. <FIG> shows the aorta <NUM>, the mitral valve <NUM>, the chordae502, a conventional pump assembly <NUM> and an illustrative embodiment of a pump assembly <NUM>. The pump assemblies <NUM> and <NUM> are advanced through the aorta <NUM> across the aortic valve. When the conventional pump assembly <NUM> is used, the chordae <NUM> of the mitral valve interfere with the distal cannula portion <NUM>, as shown also in <FIG>. In contrast, when the first illustrative embodiment of a pump assembly <NUM> is positioned therein, the distal cannula portion is shifted away from the chordae <NUM> of the mitral valve and instead passes through the aortic valve and into the left ventricle.

The angle between the descending aorta. direction and the location of the ideal pump placement (e.g., biased away from the mitral valve) was determined using software such as Mimics®. This angle is the desired angle at which the distal portion of the cannula (and the pump) should be positioned relative to a plane of the aortic arch to obtain an assembly shape which provides an anatomical fit. By way of example, the distal portion of the cannula can be angled in a similar way relative to a packaging tray to achieve this shape and provide a closer anatomical fit. The anatomically optimum rotation angle of the distal cannula portion relative to the plane of the aortic arch (as shown in <FIG>) may depend on patient size and anatomy. Aortic arches differ in size and shape and the size of the ventricle varies based on size and age. In one study, the average rotation angle of the distal cannula portion (and the associated catheter transition portion torsion angle) varied between <NUM>° and <NUM>° respectively, with a preferred angle of <NUM>°. In certain implementations, the rotation angle is <NUM>°, <NUM>°, <NUM>°, <NUM>°, <NUM>°, <NUM>°, <NUM>°, <NUM>°, <NUM>°, <NUM>°, <NUM>°, <NUM>°, or any other suitable angle. In some cases the rotation angle may also be greater than <NUM>° (e.g., <NUM>°) or less than <NUM>° (e.g., <NUM>°).

<FIG> show various views of a first portion <NUM> of a packaging tray which holds a first illustrative pump assembly. The cannula <NUM> includes a pigtail <NUM>, an inlet <NUM>, a distal portion <NUM>, and a proximal portion <NUM>. An angle θ1 between the proximal portion <NUM> and an axis of the proximal portion of a catheter is shown at least in <FIG>. A dihedral angle θ2 between the proximal portion <NUM> and the plane in which a connected catheter is positioned (e.g., the principal plane of a packaging tray) is shown at least in <FIG>. The first portion of the packaging tray can include a bottom <NUM> and a protrusion <NUM>. The bottom <NUM> may be added to an existing packaging tray as an insert, e.g., placed within the recess <NUM> of the tray <NUM> shown in <FIG>. Alternatively, the bottom <NUM> may be integral to a packaging tray (e.g., tray <NUM> shown in <FIG>). The protrusion <NUM> is centrally located on the bottom <NUM> and supports both the distal portion <NUM> and the proximal portion <NUM> of the cannula. Alternatively, the protrusion <NUM> may support one of the proximal portion <NUM> or the distal portion <NUM>. The top of the protrusion <NUM> follows the shape of the proximal portion <NUM> and the distal portion <NUM> of the cannula. The length of the protrusion <NUM> may vary between <NUM>% and <NUM>% of the length of the bottom <NUM>. The height of the protrusion <NUM> may vary, and may be configured such that the pigtail <NUM> is not in contact with the bottom <NUM>. Alternatively, a shape of the protrusion <NUM> may be adapted to accommodate a different cannula geometry.

<FIG> shows a front view of the first portion <NUM> of a packaging tray. The cannula includes a pigtail <NUM>, an inlet <NUM>, a distal portion <NUM> and a proximal portion <NUM>. The first portion of the packaging tray also includes a recess or ridge <NUM> which can hold the cannula in a fixed position such as via a press-fit. In any of the embodiments described herein, the ridge may hold a portion or an entire length of the cannula. For example, the ridge may contact over <NUM>%, <NUM>%, <NUM>%, <NUM>%, <NUM>%, <NUM>%, <NUM>%, <NUM>%, <NUM>% of the cannula. In another example, the ridge may be replaced by a groove, such as a 3D printed groove, or a thermoformed cavity configured to grip the cannula.

<FIG> shows an isometric view of a first portion <NUM> of a packaging tray (not shown) which holds a second illustrative embodiment of a pump assembly. The first portion <NUM> includes a bottom <NUM>, a protrusion <NUM>, a ridge <NUM>, and a cover <NUM> with a protrusion <NUM>, a protrusion <NUM>, and a protrusion <NUM>. The bottom <NUM>, the ridge <NUM>, and the protrusion <NUM> may be similar to the corresponding components shown in <FIG>. The cover <NUM> provides additional support to keep a cannula in place relative to a packaging tray. A portion of the cannula is clamped between the ridge <NUM> and the protrusion <NUM> of the cover <NUM>. The ridge <NUM> may be a press-fit ridge. In addition, protrusions <NUM> and <NUM> may lock with protrusions located on a packaging tray to ensure that there is no movement relative to the packaging tray. Ensuring that the catheter transition portion (not shown) sets in a shape that provides a better anatomical fit can improve ease of use and reduce the time required to deliver and position the pump in the heart and/or can reduce suction and/or low flow events due to improper positioning. An additional means of fixing the cannula <NUM> relative to the bottom <NUM> provides redundancy and guarantees that the catheter transition portion will set in the desired anatomical position, despite twisting the body of the cannula relative to the catheter.

<FIG> shows a second portion <NUM> of a packaging tray in a first illustrative embodiment of a pump assembly configured to hold a cannula therein. The second portion of the packaging tray includes a hinge <NUM>, grip pads <NUM>, a protrusion <NUM>, a protrusion <NUM>, a protrusion <NUM>, and a protrusion <NUM>. Before a catheter transition portion is torqued and the cannula is fixed in place relative to a packaging tray (e.g., as discussed in relation to <FIG>), a proximal portion of the catheter (e.g., proximal portion <NUM> in <FIG>) must also be fixed in place relative to the packaging tray. The second portion <NUM> may be integral to the packaging tray, or may be an insert which can be connected to an existing packaging tray. In one example, the second portion is located at a fixed distance from the coupling between the cannula and the catheter. For example, the second portion <NUM> is located away from the coupling between the cannula and the catheter by a distance equal to <NUM>% of the catheter length. In another example the distance between the coupling and the second portion may be <NUM>%, <NUM>%, <NUM>% or <NUM>% of the catheter length.

The second portion <NUM> may be a butterfly clip with a hinge <NUM> which can be closed such that gripping pads <NUM> are located below and above the catheter. The gripping pads <NUM> may be coated with a slip-resistant or high-friction coefficient material to resist torque applied to the catheter. Outer protrusions <NUM> and <NUM> fit within one another and secure the second portion <NUM> in the clamped position. Similarly, inner protrusions <NUM> and <NUM> mate to secure the second portion <NUM> in the clamped position. In any of the embodiments described herein, the inserts or integral portions of the tray may be replaced by a fitted groove or trough within the tray. For example, a groove may be 3D printed to fit the catheter and hold it in the desired position.

As discussed above, ensuring that a catheter sets in a shape that provides a better anatomical fit contributes to a reduction in the delivery time. In one example, this can be achieved by ensuring that the catheter transition portion sets in a shape that provides a better anatomical fit. The combination of the gripping pads <NUM> and both sets of protrusions <NUM>, <NUM> and <NUM>, <NUM> fixes the catheter relative to the packaging tray and guarantees that the catheter transition portion will set in the desired anatomical position, despite the torque or stress applied on the catheter transition portion from rotating the cannula relative to the catheter.

<FIG> shows a third illustrative embodiment of a pump assembly. The pump assembly includes a tray portion <NUM>, a pigtail <NUM>, a distal cannula portion <NUM>, a proximal cannula portion <NUM>, and a catheter transition portion <NUM>. This third illustrative embodiment is similar to the embodiment shown in <FIG>, except that the cannula is rotated <NUM>° relative to the catheter such that the catheter transition portion <NUM> is torsioned by <NUM>°. The first and second portions of the packaging tray which hold the cannula and the catheter in place, respectively, are omitted for clarity. Rotating the cannula <NUM>° relative to the catheter provides a different anatomical fit for the catheter transition portion, which may be beneficial for certain patient anatomies. The <NUM>° rotation also shifts the pigtail away from the tray and may prevent damage to the pigtail in the packaging.

<FIG> shows a fourth illustrative embodiment of a pump assembly. The pump assembly includes a tray portion <NUM>, a pigtail <NUM>, a distal cannula portion <NUM>, a proximal cannula portion <NUM>, and a catheter transition portion <NUM>. This fourth illustrative embodiment is similar to the embodiment shown in <FIG>, except that the cannula is rotated <NUM>° relative to its conventional positioning (e.g., the position of the prior art cannula shown in <FIG>). In this exemplary embodiment, the distal cannula portion <NUM> is in the same plane as the plane of the catheter <NUM>, which is parallel to the plane of the packaging tray portion <NUM>). However, the catheter transition portion <NUM> is torsioned by <NUM>° relative to the proximal catheter portion (not shown) within the plane of the packaging tray portion <NUM>. The first and second portions of the packaging tray which hold the cannula and the catheter in place, respectively, are omitted for clarity.

<FIG> shows a fifth illustrative embodiment of a pump assembly. The pump assembly includes a tray portion <NUM>, a pigtail <NUM>, a distal cannula portion <NUM>, a proximal cannula portion <NUM>, and a catheter transition portion <NUM>. This third illustrative embodiment is similar to the embodiment shown in <FIG>, except that the distal cannula portion <NUM> is rotated <NUM>° relative to the catheter proximal portion (not shown) and the catheter transition portion is torsioned by <NUM>° relative to the catheter proximal portion (not shown). The first and second portions of the packaging tray which hold the cannula and the catheter in place, respectively, are omitted for clarity.

<FIG> shows a sixth illustrative embodiment of a pump assembly. The pump assembly includes a packaging tray <NUM>, a tray portion <NUM>, a pigtail <NUM>, a distal cannula portion <NUM>, a proximal cannula portion <NUM>, a first catheter portion <NUM>, a second catheter portion <NUM>, a second tray portion <NUM> with multiple elements, and a catheter end unit <NUM>. The pigtail <NUM> extends from the distal cannula portion <NUM>. The distal cannula portion <NUM> is angled from the proximal cannula portion <NUM>. For example, the distal cannula portion <NUM> is angled from the proximal cannula portion <NUM> by an angle α of <NUM>°. In some implementations, the distal cannula portion <NUM> is angled from the proximal portion <NUM> by an angle α between <NUM>° and <NUM>°.

The proximal cannula portion <NUM> and the distal cannula portion <NUM> are fixed relative to the tray <NUM> by a first tray portion (not shown) in the recessed tray portion <NUM>. The proximal cannula portion <NUM> is connected to a catheter transition portion <NUM>, and the catheter transition portion <NUM> is torsioned between the proximal cannula portion <NUM> and the second tray portion <NUM> where the catheter is fixed to the tray <NUM>. As in the embodiments shown in <FIG> and <FIG>, the proximal cannula portion <NUM> may be angled from the plane of the packaging tray <NUM> by an angle θ2 (e.g., shown in <FIG>). The angle θ2 between the proximal portion of the cannula <NUM> and the plane of the tray, the angle θ1 (e.g., shown in <FIG>) and the catheter torsion angle define the shape of the catheter transition portion <NUM>. In addition, the position of the multiple elements of the second tray portion <NUM> may be configured to achieve a "packaged-in-place" configuration such that the majority of the length of the catheter forms a straight line and the curvature of the catheter transition portion <NUM> in the plane of the packaging tray simulates the curve of the aortic arch.

The proximal catheter portion <NUM> is also connected to the catheter end unit <NUM>, which may include a repositioning unit, a plug, an infusion filter, a pressure reservoir and a check valve. The catheter end unit <NUM> may also be rotated relative to the proximal portion of the catheter <NUM> to reduce the torque applied on the proximal catheter portion in the tray prior to sterilization.

<FIG> shows a seventh illustrative embodiment of a pump assembly <NUM> located in a heart <NUM>, and <FIG> shows a top down view of the pump assembly <NUM>. The pump assembly <NUM> includes a pigtail <NUM>, a distal cannula portion <NUM>, a proximal cannula portion <NUM>, a bend <NUM> between the distal cannula portion <NUM> and the proximal cannula portion <NUM>, proximal catheter portion <NUM> and distal catheter portion <NUM>. The heart <NUM> includes a ventricle apex <NUM>, aorta <NUM>, and the aortic arch <NUM>. The pigtail <NUM> extends from the distal cannula portion <NUM> and is located near the ventricle apex <NUM>. The catheter portion <NUM> follows the aorta <NUM> and the aortic arch <NUM>. The catheter portion <NUM> located after the aortic arch is connected to the proximal cannula portion <NUM>. The bend in the cannula <NUM> is located between the proximal cannula portion <NUM> and the distal cannula portion <NUM>. An angular offset γ shown in <FIG> is the angular offset between a first plane containing the distal cannula portion <NUM>, and a second plane containing the catheter (catheter portions <NUM> and <NUM>) with the apex of angular offset γ being the bend in the cannula <NUM>. When the distal cannula portion <NUM> is inserted in the heart <NUM> via the aorta <NUM> and aortic arch <NUM>, with the distal cannula portion <NUM> in the first plane, the curve of the longitudinal axis of the catheter portion (encompassing the proximal catheter portion <NUM> and the distal catheter portion <NUM>) lies in the second plane. The proximal cannula portion <NUM> also lies within the second plane.

As shown, the distal cannula portion <NUM> is placed such that it points towards the ventricle apex <NUM>. For reference, <FIG> shows an exemplary placement of a cannula <NUM>, and a cannula <NUM> in an alternate cannula placement with the angular offset γ between the plane containing the catheter (catheter portions <NUM> and <NUM>) and the plane containing the distal cannula portion <NUM> of the cannula <NUM>. As shown in <FIG> and <FIG>, the distal portion of the cannula <NUM> of the cannula <NUM> and the catheter portion <NUM> are in different planes and the angular offset γ between the plane of the aortic arch <NUM> and the plane of the proximal cannula portion <NUM> of the cannula <NUM> and the distal cannula portion <NUM> of the cannula <NUM> biases the cannula <NUM> toward the ventricle apex <NUM>. The rotation of the distal cannula portion <NUM> relative to the catheter portion <NUM> biases the distal cannula portion <NUM> away from the chordae which actuate the mitral valve, thereby reducing the chance of the pump assembly <NUM> being stuck following delivery to the left ventricle through the aortic valve. This rotation can also reduce the occurrence of suctioning of the heart wall and/or biomaterial ingestion by the pump assembly <NUM>.

<FIG> shows an eighth illustrative embodiment of a pump assembly. The pump assembly includes a pigtail <NUM>, a distal cannula portion <NUM>, a proximal cannula portion <NUM>, a catheter portion <NUM>, a catheter end unit <NUM>, and a backbone <NUM>. The pigtail <NUM> extends from the distal cannula portion <NUM>. The backbone <NUM> may be a pre-shaped, internal or external backbone. For example, the backbone may be made of Nitinol, or a similar shapememory material. The backbone <NUM> may run through the entire length of the catheter portion <NUM> and provide stability and shape memory for the catheter portion <NUM>. Imparting a rotation angle on the distal cannula portion <NUM> by pre-shaping the catheter backbone <NUM> can allow the rotation angle to be achieved with relatively minor modifications to existing manufacturing processes. For example, in some embodiments, preforming the backbone requires fewer changes to the manufacturing process than rotating the catheter during sterilization.

<FIG> shows a ninth illustrative embodiment of a pump assembly. The pump assembly <NUM> is shown in an illustrative plane <NUM>, and includes a pigtail <NUM>, a distal cannula portion <NUM>, a proximal cannula portion <NUM>, a distal catheter portion <NUM>, a proximal catheter portion <NUM>, and a catheter end unit <NUM> (details not shown). The illustrative plane <NUM> is the plane in which the curve of the longitudinal axis of the catheter portion (encompassing the proximal catheter portion <NUM> and the distal catheter portion <NUM>) lies in a resting state. The proximal cannula portion <NUM> also lies in the illustrative plane <NUM> in the resting state. The pigtail <NUM> extends from the distal cannula portion <NUM> and is angled out of the plane of illustrative plane <NUM> by angle β. The proximal catheter portion <NUM> may be kept substantially straight, and the distal catheter portion <NUM> may be shaped for an anatomical fit. For example, the distal catheter portion <NUM> may be shaped in the plane <NUM>, which may be a plane of the aortic arch in a patient. Shaping of the distal catheter portion <NUM> may be done in combination with using a packaging tray (e.g., packaging tray <NUM> from <FIG>), or without using a packaging tray. The shaping of the distal catheter portion <NUM> may be done as an integral step of the manufacturing process, or may be an additional step performed on an already manufactured pump assembly. For example, the distal catheter portion <NUM> may be shaped over the aortic arch in a manner similar to that use to shape a JL4 catheter. To pre-shape the catheter, the catheter may be annealed at a temperature between <NUM> and <NUM>, preferably at <NUM>. As a result of the shaping of the distal catheter portion <NUM>, the distal cannula portion <NUM> may be positioned out of reference plane <NUM>. For example, as described in relation to <FIG> and <FIG>, the distal cannula portion <NUM> may be positioned at an angle relative to the plane of the aortic arch such that the distal cannula portion points the pigtail <NUM> towards the apex of a ventricle. Positioning the distal cannula portion <NUM> out of the reference plane <NUM> by preshaping the distal catheter portion <NUM> over the aortic arch can facilitate insertion of the pump assembly <NUM>, by biasing the distal cannula portion <NUM> away from the chordae which actuate the mitral valve, thereby reducing the chance of the pump assembly <NUM> being stuck following delivery to the left ventricle through the aortic valve.

<FIG> shows a tenth illustrative embodiment of a pump assembly. The pump assembly includes a pigtail <NUM>, a distal cannula portion <NUM>, a proximal cannula portion <NUM>, a catheter portion <NUM>, a catheter end unit <NUM>, and at least one stylet <NUM>. The pigtail <NUM> extends from the distal cannula portion <NUM>. The at least one stylet <NUM> is a geometry altering wire inserted into the catheter portion <NUM>, and may be used to adjust the catheter portion <NUM> to obtain an anatomical fit for a specific anatomy. For example, stylet <NUM> may be used to adjust the shape of a distal portion of the catheter portion <NUM> such that the distal portion of the cannula <NUM> is biased at an angle from the plane of the aortic arch in which the catheter portion <NUM> is located. Such an angle is shown for example, in the exemplary embodiments of <FIG> and <FIG>. Different types of stylets <NUM> may be used in this exemplary embodiment. For example, the stylet <NUM> may be made of a metal or a polymer. This exemplary embodiment with the stylet <NUM> may be used instead of, or in combination with the pre-shaped backbone of the exemplary embodiment shown in <FIG>. Multiple stylets <NUM> with different shapes may be used in succession until the distal cannula portion <NUM> is located in the desired position.

<FIG> shows an illustrative method <NUM> for configuring a resting shape of a pump assembly, such as one of the illustrative embodiments shown in <FIG>. The method <NUM> may be implemented to configure a catheter which is part of a pump assembly (e.g., pump assembly <NUM> shown in <FIG>) including but not limited to the pump assemblies described in any of the aforementioned implementations in <FIG>. The catheter and cannula may have a resulting resting shape which matches the anatomy of the left ventricle and aortic arch of a patient.

In step <NUM>, the pump assembly is positioned in the tray packaging. The pump assembly may include a cannula with a proximal portion and a distal portion, and a catheter with a proximal portion and a cannula transition portion, which may be distal relative to the proximal portion. In step <NUM>, the proximal catheter portion is held fixed relative to the packaging tray. The proximal catheter portion may be held fixed with an integral portion of the packaging tray, or an insert added to the packaging tray. For example, a trough or groove may be 3D printed or formed within the tray to hold the catheter in the desired position. Alternatively, an insert may be used such as a butterfly clip or any other suitable clip or gripping element capable of resisting torque.

In step <NUM>, the pump assembly is rotated while the proximal catheter portion is held fixed, which torsions the catheter transition portion. The pump assembly is rotated while the proximal catheter portion is held fixed, until the catheter transition portion has reached the desired shape and desired torsion angle. The torsion angle of the catheter transition portion may be about equal to or greater than an angle between an axis of a descending aorta and a predetermined cannula placement location. The torsion angle may vary between <NUM>° and <NUM>° (e.g., <NUM>°, <NUM>°, <NUM>°, <NUM>°, <NUM>°, <NUM>°, <NUM>°, <NUM>°, <NUM>°, <NUM>°, <NUM>°, <NUM>°, or any other suitable angle).

The preferred torsion angle may be <NUM>°. In some implementations, the torsion angle may be greater than <NUM>° (e.g., <NUM>°) or less than <NUM>° (e.g., <NUM>°). The packaging tray may be adjustable to allow the torsion angle to be chosen to suit the anatomy of a particular patient or category of patients. As described above in relation to θ1 and θ2, the cannula may also be translated relative to the axis of the proximal catheter portion, and relative to the plane of the packaging tray.

In step <NUM>, the now-rotated and translated proximal cannula portion is fixed relative to the packaging tray. The proximal cannula portion may be held fixed with an integral portion of the packaging tray, or an insert added to the packaging tray, and the distal cannula portion is held fixed relative to the packaging tray with an integral portion of the packaging tray or an added insert. Fixing both the cannula and the proximal catheter portions relative to the packaging tray as described in steps <NUM> and <NUM> ensures that the catheter transition portion will retain the desired torsion during thermocycling. In an alternative embodiment, any of the inserts may be replaced by a trough or groove formed within the tray to hold the catheter in the desired position.

For example, the groove may be 3D printed or may be the result of a heat molding process.

In step <NUM>, thermocycling is applied to the tray packaging containing the pump assembly. Once thermocycling is complete the pump assembly will be set in the desired shape. For example, the temperature may vary between <NUM> and <NUM> above a transition temperature such that the material is soft and elastic. Depending on the material, the temperature used during thermocycling may vary between -<NUM> and <NUM>° C (e.g., -<NUM>, - <NUM>, -<NUM>, -<NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, or any other suitable temperature)The preferred temperature range may be -<NUM> and <NUM> (e.g., -<NUM>, -<NUM>, - <NUM>, -<NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>). The catheter materials relax when the temperature increases and set when the temperature cools. The shape or spine of the catheter, and in particular the shape of the catheter transition portion is set by the end of the sterilization process, such that when the catheter transition portion is no longer in the tray (e.g., when the catheter is in use in a procedure) the catheter transition portion substantially retains its shape.

Use of the packaging tray allows the catheter transition portion to be torsioned such that the cannula is rotated and translated into a position that is a better anatomical fit and can thereby reduce the time for delivery into a patient. Torsioning the catheter transition portion also contributes to a reduction in the delivery time because it reduces the likelihood of the cannula being stuck in the chordae during insertion.

Variations and modifications will occur to those of skill in the art after reviewing this disclosure. For example, in some implementations, any of the embodiments described in <FIG> and <FIG> may be combined. For example, the first portion of the packaging tray of <FIG> and the second portion of the packaging tray of <FIG> may be confined with different pump assembly packaging configurations described with respect to <FIG>. In another example, features described with respect to <FIG> may be combined with any of the embodiments described in <FIG> and <FIG>, with or without a packaging tray. The disclosed features may be implemented, in any combination and subcombination (including multiple dependent combinations and subcombinations), with one or more other features described herein. The various features described or illustrated above, including any components thereof, may be combined or integrated in other systems. Moreover, certain features may be omitted or not implemented.

It is important to note that the constructions and arrangements of apparatuses or the components thereof as shown in the various exemplary implementations are illustrative only. Although only a few implementations have been described in detail in this disclosure, those skilled in the art who review this disclosure will readily appreciate that many modifications are possible (e.g., variations in sizes, dimensions, structures, shapes and proportions of the various elements, values of parameters, mounting arrangements, use of materials, colors, orientations, etc.) without materially departing from the novel teachings and advantages of the subject matter disclosed. For example, elements shown as integrally formed may be constructed of multiple parts or elements, the position of elements may be reversed or otherwise varied, and the nature or number of discrete elements or positions may be altered or varied. The order or sequence of any process or method steps may be varied or re-sequenced according to alternative implementations. Other substitutions, modifications, changes and omissions may also be made in the design, operating conditions and arrangement of the various exemplary implementations without departing from the scope of the present disclosure.

For the purpose of this disclosure, the termed "coupled" means the joining of two members directly or indirectly to one another. Such joining may be stationary or moveable in nature. Such joining may be achieved with the two members or the two members and any additional intermediate members being integrally formed as a single unitary body with one another or within the two members of the two members and any additional intermediate members being attached to one another. Such joining may be permanent in nature or may be removable or releasable in nature.

" As used herein in the specification and in the claims, "or" should be understood to have the same meaning as "and/or" as defined above. Only terms clearly indicated to the contrary, such as "only one of" or "exactly one of" will refer to the inclusion of exactly one element of a number or list of elements. In general, the term "or" as used herein shall only be interpreted as indicating exclusive alternatives (i.e. "one or the other but not both") when preceded by terms of exclusivity, such as "either," "one of" "only one of," or "exactly one of.

The claims should not be read as limited to the described order or elements unless stated to that effect. It should be understood that various changes in form and detail may be made by one of ordinary skill in the art.

Claim 1:
A catheter assembly comprising:
a catheter including a proximal catheter portion (<NUM>), a longitudinal axis, a distal catheter portion (<NUM>), and a catheter transition portion between the proximal catheter portion (<NUM>) and the distal catheter portion (<NUM>), wherein the longitudinal axis forms a curve, the curve of the longitudinal axis encompassing the proximal catheter portion (<NUM>) and the distal catheter portion (<NUM>); and
a cannula coupled to the distal catheter portion (<NUM>), the cannula having a proximal cannula portion (<NUM>), a distal cannula portion (<NUM>), and a cannula transition portion comprising a bend (<NUM>) between the proximal cannula portion (<NUM>) and the distal cannula portion (<NUM>);
wherein the cannula is configured such that, when the cannula is inserted in a heart, the distal cannula portion (<NUM>) points towards the ventricle apex (<NUM>), the cannula lies within a first plane, and the curve of the longitudinal axis of the catheter and the proximal cannula portion (<NUM>) lies in a second plane, wherein the first plane is different from, and at an angular offset relative to the second plane.