Catheter of heart pump shaped for anatomic fit

Abstract

To provide a heart pump assembly, also referred to as a catheter assembly, having a desired anatomical shape.SOLUTION: The catheter assembly can include a catheter and a cannula 303 having a bend between a proximal portion and a distal portion. A resting shape of the catheter and the cannula can be selected to allow the distal cannula portion to be positioned at a desired angle relative to an anatomical plane (e.g., a plane of an aortic arch). In some embodiments, a packaging tray 314 can be designed to set the catheter assembly in a desired resting shape. For example, the proximal cannula portion 308 can be positioned at a first angle relative to the catheter, and the proximal cannula portion can be positioned at a second angle out of the plane of the packaging tray via one or more inserts.SELECTED DRAWING: Figure 3

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Utility Patent Application No. 15 / 168,852, filed May 31, 2016, the contents of which are incorporated by reference herein in their entirety. [Background technology]

[0002] background A mechanical circulatory support device, also commonly referred to as a heart pump assembly or catheter assembly, can be introduced into the heart and configured to support or replace the natural heart pump function by periodic or continuous blood pumping. The heart pump assembly can include a pump, a cannula, and a catheter. When placed on the left side of the heart, the heart pump assembly draws blood from the left ventricle and pushes the blood into the aorta; when placed on the right side of the heart, the pump draws blood from the inferior vena cava and pushes the blood into the pulmonary artery. The heart pump assembly is introduced surgically or percutaneously during a cardiac procedure. In one approach, a pump assembly for the left heart is inserted into the femoral artery by a catheter insertion procedure.

[0003] During a catheterization procedure in preparation for insertion of the pump into the left heart, an introducer is inserted through an arteriotomy into the femoral artery to gain access to the artery and create an insertion pathway. A placement guidewire can be advanced along the insertion pathway into the artery. After the guidewire is inserted into the artery, the pump assembly can be advanced along the guidewire into the patient. Alternatively, the pump assembly can be inserted directly into the artery without a guidewire. The pump can be inserted through the femoral artery, into the ascending aorta, through the aortic valve, and into the left ventricle using standard catheterization procedures. Once positioned in the left heart, the pump assembly draws blood from the left ventricle through an inlet area near its tip and pushes the blood out of the cannula and into the ascending aorta.

[0004] The pump assembly can be advanced into the blood vessel, either over a guidewire or directly, as described above, and advanced to a desired axial location relative to the heart. To position the pump assembly in a desired rotational orientation, the user can apply a torque to the catheter, causing a twist / twist of the catheter and a rotation of the distal portion of the catheter and / or cannula.

[0005] Before being inserted into a patient, the catheter of the pump has an original 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 uncontrolled manner and the catheter bounces back. The original shape of the catheter (i.e., the rest or unstressed shape of the catheter when no external force is applied) can be affected during manufacturing and / or insertion. For example, sterilization is part of the manufacturing process and can include the alternating or cyclic application and removal of heat and moisture (referred to herein as thermal cycling). Because the catheter is sensitive to thermal cycling, once thermal cycling is completed, the catheter will set in a new rest shape. The above-mentioned rest shape after thermal cycling can be determined by features of the pump itself and / or features that hold the catheter in a particular shape, such as its packaging tray. However, the resulting rest shape of the catheter may not match the patient's anatomy. Only a limited amount of torque can be applied to the catheter, which can make it difficult to position the cannula in the patient at the desired axial position and rotational orientation. Summary of the Invention

[0006] overview Described herein are systems, methods and devices for providing a cardiac pump catheter assembly having a shape that facilitates placement of the pump assembly in a patient. The catheter assembly can include a catheter and a cannula coupled thereto. The plane of the cannula can be angularly offset from the plane of the catheter. In some embodiments, this angular offset is achieved by twisting the catheter and using heat or other methods to set the shape of the catheter. In other embodiments, the angular offset is achieved without twisting the catheter. For example, this can be achieved by rotating the cannula relative to the catheter prior to coupling the catheter and cannula, preforming the backbone of the catheter, and / or rotating the connection of the catheter to the handle and / or cannula. In addition to or instead of changing the rotation angle between the catheter and cannula, the cannula can also be translated into and / or out of the plane of the catheter before defining the shape. The translation of the cannula into the plane of the catheter can be measured by the bend angle between the proximal portion of the cannula and the axis of the 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 the plane of the fixed proximal portion of the catheter.

[0007] Rotation and / or translation of the cannula moves the pump inlet towards the free space of the ventricle (e.g., the left ventricle). For example, this can facilitate navigation and placement of the pump assembly in the left ventricle and can reduce the occurrence of aspiration events and low flow alarms. The catheter can be shaped and the cannula can be placed in the left ventricle at an angle towards the apex of the ventricle and oriented so that the pump inlet is located in the free space of the ventricle, thereby reducing the occurrence of aspiration of the heart wall and / or sucking in of biomaterial. The rotation angle of the cannula can result in a predetermined placement of the catheter and cannula in a desired position. For example, the rotation angle can be selected to be approximately equal to the angle between the plane of the aortic arch and the predetermined cannula placement plane. In such a case, rotation of the cannula relative to the catheter also urges the distal portion of the pump assembly away from the chordae tendineae that actuate the mitral valve. This can reduce the risk of the pump assembly getting stuck in it, which can also make extraction of the pump more difficult.

[0008] In embodiments where the rotation angle is achieved by twisting / twisting the catheter, a heat treatment can set the shape of the catheter. This heat treatment can be performed during sterilization of the catheter, where temperature, pressure and / or moisture can be applied periodically to set the shape of the catheter (e.g., by setting the shape of the metal or polymer spine of the catheter). This shape setting occurs when the material is softened and / or annealed at high temperature and then hardened at a lower temperature. In one example, a rotation angle and / or translation is imparted to the catheter spine during sterilization that biases the catheter into a desired orientation to form the catheter assembly in the anatomically correct position.

[0009] The new baseline stress-free shape of the catheter that is consequently formed by molding the catheter spine during sterilization or by any of the other methods described herein reduces the need to torque the catheter during insertion and placement of the pump assembly into the patient's vasculature (e.g., through the aorta and along the aortic arch). The improved catheter assembly may be useful for the IMPELLA® 5.0 pump, IMPELLA® 2.5 pump, IMPELLA CP® pump assemblies that are adapted for use in the left ventricle, or may be useful for any other cardiac pump.

[0010] Additionally, the relative position of the cannula and catheter can be selected to optimally fit the anatomy of a particular patient or patient population. This improved fit can also help reduce delivery times.

[0011] The unstressed catheter and the cannula rotated or translated away from the proximal portion of the catheter may be provided in a tray (e.g., a packaging tray). Alternatively, the unstressed catheter and the cannula rotated or translated away from the proximal portion of the catheter may be manufactured or provided without a tray. The tray may be configured to apply and maintain a twist to the catheter prior to thermal cycling (e.g., sterilization) of the catheter assembly. For example, as described above, a first portion of the tray may fix a first position on the catheter and a second portion of the tray may fix a second position on the cannula such that the cannula is rotated and the distal portion of the cannula is at an angle to the plane of the tray. The tray may include structure that allows the cannula to be located in a plane different from the plane of the catheter and packaging tray. After the catheter assembly is heat treated in a desired position, e.g., a position initially maintained by the two tray portions, when the catheter assembly is removed from the tray and during insertion into the patient, the catheter retains its twisted / twisted shape in an unstressed resting state and the cannula retains its shape and angular position.

[0012] Also disclosed herein are methods of manufacturing a catheter assembly having the above configuration. According to one method, the catheter proximal portion is held stationary and the cannula is rotated and / or translated until the cannula is in a desired position relative to the catheter. The cannula is then held stationary and thermal cycling is performed. After completion of the thermal cycling process, the shape of the catheter is set. In this configuration, the catheter is no longer under stress once the shape is set. In another method, the cannula, the catheter, or both, are rotated relative to each other 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 embodiments, a handle coupled to the catheter assembly is rotated relative to the catheter assembly or one or more components of the catheter assembly to define the shape of the assembly.

[0013] In one aspect, the catheter assembly includes a catheter including a catheter proximal section, a longitudinal axis, a catheter distal section, and a catheter transition section between the catheter proximal section and the catheter distal section, where the longitudinal axis forms a curve. The catheter assembly further includes a cannula coupled to the catheter distal section, the cannula having a cannula proximal section, a cannula distal section, and a cannula transition section including a curve between the cannula proximal section and the cannula distal section. When the cannula is inserted into the heart, the cannula distal section lies in a first plane and the curve of the longitudinal axis of the catheter section lies in a second plane, the first plane being different from and angularly offset relative to the second plane.

[0014] In certain embodiments, the angular offset of the first plane relative to the second plane is approximately substantially equal to the angle between the plane of the aortic arch defined by the ascending portion of the aorta and the descending portion of the aorta and the plane defined by the ascending portion of the aorta and the apex of the left ventricle.

[0015] In certain embodiments, the angular offset is selected so that the catheter assembly has a predetermined anatomical shape when in a rest state.

[0016] In certain embodiments, the angular offset urges the cannula distal portion toward the apex of the left ventricle when the catheter assembly is inserted into the aorta.

[0017] In a particular embodiment, the angular offset is between about 64° and 125°.

[0018] In a particular embodiment, the angular offset is about 92°.

[0019] In certain embodiments, the angular offset is such that the catheter distal portion is directed toward the apex of the heart.

[0020] In certain embodiments, the catheter assembly further includes a stylet inserted into the catheter to adjust the shape of the catheter distal section.

[0021] In certain embodiments, the catheter assembly further includes a catheter handle connected to the catheter proximal section and turned to adjust the placement of the catheter distal section.

[0022] In certain embodiments, the catheter assembly further includes a steering mechanism connected to the catheter proximal portion and configured to adjust the placement of the catheter distal portion after insertion.

[0023] In another aspect, a catheter assembly includes a catheter including a catheter proximal section, a catheter distal section, and a catheter transition section between the catheter proximal section and the catheter distal section. The catheter assembly further includes a cannula coupled to the catheter distal section, the cannula having a cannula proximal section, a cannula distal section, and a cannula transition section including a curve between the cannula proximal section and the cannula distal section. When the cannula is inserted into the patient's heart, the cannula distal section lies in a first plane that is different from and angularly offset relative to a second plane in which the patient's aortic arch lies.

[0024] In certain embodiments, the angular offset is approximately substantially equal to or greater than the angle between the plane of the aortic arch defined by the ascending portion of the aorta and the descending portion of the aorta and the plane defined by the ascending portion of the aorta and the apex of the left ventricle.

[0025] In certain embodiments, the angular offset is selected such that the catheter assembly has a predetermined anatomical shape when in a resting state, hi certain embodiments, the angular offset biases the cannula distal portion toward the apex of the left ventricle when the catheter assembly is inserted into the aorta of a patient.

[0026] In a particular embodiment, the angular offset is between about 64° and 125°.

[0027] In a particular embodiment, the angular offset is about 92°.

[0028] In certain embodiments, the angular offset is such that the catheter distal portion is directed toward the apex of the heart.

[0029] In certain embodiments, the catheter assembly further includes a stylet inserted into the catheter to adjust the shape of the catheter distal section.

[0030] In certain embodiments, the catheter assembly further includes a catheter handle connected to the catheter proximal section and turned to adjust the placement of the catheter distal section.

[0031] In certain embodiments, the catheter assembly further includes a steering mechanism connected to the catheter proximal portion and configured to adjust the placement of the catheter distal portion after insertion.

[0032] In certain embodiments, the catheter assembly further includes an inner polyamide layer and an outer polyurethane layer.

[0033] In yet another aspect, a method of forming a catheter assembly into a desired anatomical shape includes forming a longitudinal axis of the catheter into a curve that lies in a second plane. The catheter includes a catheter proximal section, a longitudinal axis, a catheter distal section, and a catheter transition section between the catheter proximal section and the catheter distal section. The method further includes rotating the cannula relative to the catheter such that the first plane is angularly offset from the second plane. The cannula includes a longitudinal axis, a cannula proximal section, a cannula distal section, and a curve between the cannula proximal section and the cannula distal section, the cannula distal section lies in the first plane. The method further includes connecting the cannula proximal section to the catheter distal section.

[0034] In certain embodiments, the angular offset of the first plane relative to the second plane is approximately substantially equal to the angle between the plane of the aortic arch defined by the ascending portion of the aorta and the descending portion of the aorta and the plane defined by the ascending portion of the aorta and the apex of the left ventricle.

[0035] In certain embodiments, the method further includes rotating the cannula relative to the catheter prior to connecting the cannula proximal portion to the catheter distal portion.

[0036] In certain embodiments, the method further includes rotating the cannula relative to the catheter after connecting the cannula proximal portion to the catheter distal portion.

[0037] In certain embodiments, the method further includes the step of engaging the catheter with a first insert prior to the rotating step, thereby preventing movement of the catheter relative to the second plane.

[0038] In certain embodiments, the method further includes the step of engaging the catheter with a second insert prior to the rotating step, thereby preventing movement of the cannula distal portion relative to the first plane.

[0039] In certain embodiments, the method further comprises, after the rotating step, thermal cycling the catheter assembly such that the rest shape of the catheter assembly is solidified after completion of the thermal cycling.

[0040] In yet another aspect, 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 cannula proximal portion, a cannula distal portion, and a cannula transition portion including a curve between the cannula proximal portion and the cannula distal portion. The system further includes a packaging tray housing the catheter assembly and including 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 twisted through a twist angle such that the cannula distal portion is rotated out of the plane of the packaging tray at a first angle.

[0041] In certain embodiments, the first angle is approximately equal to the angle between the plane of the aortic arch and the predetermined cannula placement location.

[0042] In certain embodiments, the first angle is between about 60° and 140°.

[0043] In certain embodiments, the first angle urges the cannula distal portion away from the mitral valve of the heart when the catheter assembly is inserted into the aorta of a patient.

[0044] In certain embodiments, the first angle is approximately equal to the angle between the plane of the aortic arch defined by the ascending portion of the aorta and the descending portion of the aorta and the plane defined by the ascending portion of the aorta and the apex of the left ventricle.

[0045] In a particular embodiment, the first angle is about 92°.

[0046] In yet another aspect, a method of forming a catheter assembly into a desired anatomical shape includes placing the catheter assembly inside a packaging tray. The packaging tray houses the catheter assembly, the catheter assembly including a catheter and a cannula connected to the catheter, the cannula including a curve between a proximal portion and a distal portion of the cannula. 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 through a rotational 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 thermal cycling the catheter assembly such that a rest shape of the catheter assembly is solidified after completion of the thermal cycling.

[0047] In certain embodiments, the rotation angle is approximately equal to the angle between the plane of the aortic arch and the desired plane of the cannula distal portion, and the rotation angle is configured such that the plane of the cannula distal portion lies at an angle between the plane of the aortic arch and the desired plane of the cannula distal portion.

[0048] Variations and modifications will occur to those skilled in the art after considering this disclosure. The disclosed features may be embodied in any combination and subcombination (including multiple subcombinations and subcombinations) with one or more other features described herein. The various features may be combined or integrated into other systems, including any of their components. Moreover, certain features may be omitted or not embodied. [The present invention 1001] a catheter including a proximal catheter section, a longitudinal axis, a distal catheter section, and a catheter transition section between the proximal catheter section and the distal catheter section, the longitudinal axis defining a curve; a cannula coupled to the catheter distal portion, the cannula having a proximal cannula portion, a distal cannula portion, and a cannula transition portion including a curve between the proximal cannula portion and the distal cannula portion; Including, when the cannula is inserted into the heart, the cannula distal portion lies in a first plane and the curve of the longitudinal axis of the catheter portion lies in a second plane, the first plane being distinct from and angularly offset relative to the second plane; Catheter assembly. [The present invention 1002] A catheter assembly of the present invention 1001, wherein the angular offset of the first plane relative to the second plane is approximately substantially equal to the angle between the plane of the aortic arch defined by the ascending portion of the aorta and the descending portion of the aorta and the plane defined by the ascending portion of the aorta and the apex of the left ventricle. [The present invention 1003] The catheter assembly of any of the present inventions 1001 to 1002, wherein the angular offset is selected so that the catheter assembly has a predetermined anatomical shape when in a resting state. [The present invention 1004] The catheter assembly of any of the present inventions 1001 to 1003, wherein when the catheter assembly is inserted into the aorta, the angular offset urges the cannula distal portion toward the apex of the left ventricle. [The present invention 1005] Any of the catheter assemblies of the present inventions 1001 to 1004, wherein the angular offset is approximately 64° to 125°. [The present invention 1006] Any of the catheter assemblies of the present invention 1001 to 1005, wherein the angular offset is approximately 92°. [The present invention 1007] The catheter assembly of any one of claims 1001 to 1006, wherein the angular offset is such that the distal portion of the catheter faces the apex of the heart. [The present invention 1008] The catheter assembly of any of claims 1001 to 1007, further comprising a stylet inserted into the catheter to adjust the shape of the catheter distal portion. [The present invention 1009] a catheter handle that is connected to the proximal catheter section and that is turned to adjust the placement of the distal catheter section; The catheter assembly of any one of the present inventions 1001 to 1008, further comprising: [The present invention 1010] a steering mechanism connected to the proximal catheter portion and configured to adjust the placement of the distal catheter portion after insertion. The catheter assembly of any one of the present inventions 1001 to 1009, further comprising: [The present invention 1011] a catheter including a proximal catheter section, a distal catheter section, and a catheter transition section between the proximal catheter section and the distal catheter section; a cannula coupled to the catheter distal portion, the cannula having a proximal cannula portion, a distal cannula portion, and a cannula transition portion including a curve between the proximal cannula portion and the distal cannula portion; Including, when the cannula is inserted into the patient's heart, the cannula distal portion lies in a first plane that is distinct from and angularly offset relative to a second plane in which the patient's aortic arch lies. Catheter assembly. [The present invention 1012] A catheter assembly of the present invention 1011, wherein the angular offset is approximately substantially equal to or greater than the angle between the plane of the aortic arch defined by the ascending portion of the aorta and the descending portion of the aorta and the plane defined by the ascending portion of the aorta and the apex of the left ventricle. [The present invention 1013] A catheter assembly of the present invention 1011 or 1012, wherein the angular offset is selected such that the catheter assembly has a predetermined anatomical shape when in a rest state. [The present invention 1014] The catheter assembly of any of claims 1011 to 1013, wherein the angular offset urges the cannula distal portion toward the apex of the left ventricle when the catheter assembly is inserted into the patient's aorta. [The present invention 1015] A catheter assembly of any of the present inventions 1011 to 1014, wherein the angular offset is approximately 64° to 125°. [The present invention 1016] A catheter assembly of any of the present inventions 1011 to 1015, wherein the angular offset is approximately 92°. [The present invention 1017] A catheter assembly according to any one of claims 1011 to 1016, wherein the angular offset is such that the distal portion of the catheter faces the apex of the heart. [The present invention 1018] The catheter assembly of any of claims 1011 to 1017, further comprising a stylet inserted into the catheter for adjusting the shape of the catheter distal portion. [The present invention 1019] a catheter handle that is connected to the proximal catheter section and that is turned to adjust the placement of the distal catheter section; The catheter assembly of any of the present inventions 1011 to 1018, further comprising: [The present invention 1020] a steering mechanism connected to the proximal catheter portion and configured to adjust the placement of the distal catheter portion after insertion. The catheter assembly of any of the present inventions 1011 to 1019, further comprising: [The present invention 1021] A catheter assembly according to any one of claims 1011 to 1020, comprising an inner polyamide layer and an outer polyurethane layer. [The present invention 1022] forming a longitudinal axis of a catheter into a curve that lies in a second plane, the catheter including a proximal catheter section, a longitudinal axis, a distal catheter section, and a catheter transition section between the proximal catheter section and the distal catheter section; rotating the cannula relative to the catheter such that a first plane is angularly offset from the second plane, the cannula including a longitudinal axis, a proximal cannula portion, a distal cannula portion, and a curve between the proximal and distal cannula portions, the distal cannula portion lying in the first plane; and connecting the cannula proximal portion to the catheter distal portion. A method of forming a catheter assembly into a desired anatomical shape, comprising: [The present invention 1023] The method of the present invention 1022, wherein the angular offset of the first plane relative to the second plane is approximately substantially equal to the angle between the plane of the aortic arch defined by the ascending portion of the aorta and the descending portion of the aorta and the plane defined by the ascending portion of the aorta and the apex of the left ventricle. [The present invention 1024] The method of any one of claims 1022 to 1023, wherein the step of rotating the cannula relative to the catheter is prior to connecting the cannula proximal portion to the catheter distal portion. [The present invention 1025] Any of the methods of inventions 1022 to 1024, wherein the step of rotating the cannula relative to the catheter occurs after the cannula proximal portion is connected to the catheter distal portion. [The present invention 1026] Any of the methods of claims 1022 to 1025, further comprising the step of engaging the catheter with a first insert prior to the rotating step, thereby preventing movement of the catheter relative to the second plane. [The present invention 1027] Any of the methods of claims 1022-1026, further comprising the step of engaging the catheter with a second insert prior to the rotating step, thereby preventing movement of the cannula distal portion relative to the first plane. [The present invention 1028] Any of the methods of claims 1022 to 1027, further comprising, after the rotating step, a step of thermal cycling the catheter assembly such that the rest shape of the catheter assembly is solidified after completion of the thermal cycling. [The present invention 1029] 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 including a curve between the proximal cannula portion and the distal cannula portion; a packaging tray housing the catheter assembly and including a first insert and a second insert, the first insert being coupled to the cannula and the second insert being coupled to the catheter; Including, the catheter is twisted between the first insert and the second insert through a twist angle such that the cannula distal portion is rotated out of the plane of the packaging tray at a first angle. A system for configuring a catheter assembly into an anatomical shape. [The present invention 1030] The system of the present invention 1029, wherein the first angle is approximately equal to the angle between the plane of the aortic arch and a predetermined cannula placement location. [The present invention 1031] The system of the present invention 1029 or 1030, wherein the first angle is between about 60° and 140°. [The present invention 1032] The system of any of claims 1029 to 1031, wherein the first angle urges the cannula distal portion away from the mitral valve of the heart when the catheter assembly is inserted into the patient's aorta. [The present invention 1033] Any of the systems of claims 1029 to 1032, wherein the first angle is approximately equal to the angle between the plane of the aortic arch defined by the ascending portion of the aorta and the descending portion of the aorta and the plane defined by the ascending portion of the aorta and the apex of the left ventricle. [The present invention 1034] Any of the systems of claims 1029 to 1033, wherein the first angle is approximately 92°. [The present invention 1035] placing a catheter assembly inside a packaging tray, the packaging tray housing the catheter assembly, the catheter assembly including a catheter and a cannula connected to the catheter, the cannula including a curve between a proximal cannula portion and a distal cannula portion; engaging the catheter with a first insert, thereby preventing movement of the catheter relative to the packaging tray; rotating the cannula through a rotational angle relative to the packaging tray; engaging the catheter with a second insert, thereby preventing movement of the cannula relative to the packaging tray; and thermal cycling the catheter assembly such that the rest shape of the catheter assembly is solidified after completion of the thermal cycling. A method of forming a catheter assembly into a desired anatomical shape, comprising: [The present invention 1036] The method of the present invention 1035, wherein the rotation angle is approximately equal to the angle between the plane of the aortic arch and the desired plane of the cannula distal portion, and the rotation angle is configured such that the plane of the cannula distal portion is at an angle between the plane of the aortic arch and the desired plane of the cannula distal portion. [Brief description of the drawings]

[0049] The above and other objects and advantages will become apparent from the following detailed description considered in conjunction with the accompanying drawings, in which like reference numerals refer to like parts throughout.

[0050] [Figure 1] 1 illustrates an exemplary prior art pump assembly. [Diagram 2] 1 shows a top-down partial view of a prior art pump assembly positioned next to the mitral valve. [Diagram 3] 1 illustrates a first exemplary embodiment of a pump assembly having a resting shape that provides a closer anatomical fit than prior art pump assemblies. [Figure 4] 1 shows a top-down, partial view of a first exemplary pump assembly positioned next to the mitral valve. [Diagram 5] 1A-1D show a partial front view of a first exemplary embodiment of a prior art pump assembly and a pump assembly positioned next to the mitral valve. [Figure 6] 1 shows an isometric view of a first exemplary embodiment of a pump assembly in a first portion of a packaging tray configured to hold a cannula out of the plane of the packaging tray. [Figure 7] 7 shows a front view of the first portion of the packaging tray and pump assembly of FIG. 6. [Figure 8] 7 shows a plan view of a first portion of the packaging tray and pump assembly of FIG. 6. [Figure 9] FIG. 7 shows a side view of the first portion of the packaging tray and pump assembly of FIG. 6. [Figure 10] 1 illustrates an isometric view of a second exemplary embodiment of a pump assembly in a first portion of a packaging tray and held in place by a cover. [Figure 11] 13 shows a second portion of a packaging tray configured to hold a proximal portion of a catheter in a fixed position. [Figure 12] 2 illustrates a third exemplary embodiment of a pump assembly in which the cannula is rotated approximately 90 degrees relative to the catheter as compared to the pump assembly of FIG. 1. [Figure 13] 2 illustrates a fourth exemplary embodiment of a pump assembly in which the cannula is rotated approximately 180 degrees relative to the catheter as compared to the pump assembly of FIG. 1. [Figure 14] 11 illustrates a fifth exemplary embodiment of a pump assembly in which the cannula is rotated approximately 270° relative to the catheter as compared to the pump assembly of FIG. [Figure 15] A sixth exemplary embodiment of a pump assembly is shown having a proximal cannula portion and a distal cannula portion held at a specific angle and having a catheter transition portion set into a curved shape that mimics the angle of the aortic arch. [Figure 16] 1 illustrates a front view of a first exemplary embodiment of a pump assembly positioned within a patient's left ventricle and aortic arch. [Figure 17] FIG. 17 illustrates a top down view of the pump assembly shown in FIG. [Figure 18] 13 illustrates an eighth exemplary embodiment of a pump assembly having a preformed backbone that influences the resting shape of the catheter. [Figure 19] 13 illustrates a ninth exemplary embodiment of a pump assembly having a first substantially straight catheter portion and a second curved catheter portion. [Figure 20] 10 illustrates a tenth exemplary embodiment of a pump assembly having a stylet inserted into the catheter configured to adjust the resting shape of the catheter. [Figure 21] 1 illustrates an exemplary process for configuring the static geometry of a pump assembly. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0051] Detailed Description Described herein are systems, methods and devices for providing a cardiac pump catheter assembly having a shape that facilitates placement of the pump assembly in a patient. The catheter assembly can include a catheter and a cannula coupled thereto. The plane of the cannula can be angularly offset from the plane of the catheter. In some embodiments, this angular offset is achieved by twisting the catheter and using heat or other methods to set the shape of the catheter. In other embodiments, the angular offset is achieved without twisting the catheter. For example, this can be achieved by rotating the cannula relative to the catheter prior to coupling the catheter and cannula, preforming the backbone of the catheter, and / or rotating the connection of the catheter to the handle and / or cannula. In addition to or instead of changing the rotation angle between the catheter and cannula, the cannula can also be translated into and / or out of the plane of the catheter before defining the shape. The translation of the cannula into the plane of the catheter can be measured by the bend angle between the proximal portion of the cannula and the axis of the 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 the plane of the fixed proximal portion of the catheter.

[0052] Rotation and / or translation of the cannula moves the pump inlet towards the free space of the ventricle (e.g., the left ventricle). For example, this can facilitate navigation and placement of the pump assembly in the left ventricle and can reduce the occurrence of aspiration events and low flow alarms. The catheter can be shaped and the cannula can be placed in the left ventricle at an angle towards the apex of the ventricle and oriented so that the pump inlet is located in the free space of the ventricle, thereby reducing the occurrence of aspiration of the heart wall and / or sucking in of biomaterial. The rotation angle of the cannula can result in a predetermined placement of the catheter and cannula in a desired position. For example, the rotation angle can be selected to be approximately equal to the angle between the plane of the aortic arch and the predetermined cannula placement plane. In such a case, rotation of the cannula relative to the catheter also urges the distal portion of the pump assembly away from the chordae tendineae that actuate the mitral valve. This can reduce the risk of the pump assembly getting stuck in it, which can also make extraction of the pump more difficult.

[0053] In embodiments where the rotation angle is achieved by twisting / twisting the catheter, a heat treatment can set the shape of the catheter. This heat treatment can be performed during sterilization of the catheter, where temperature, pressure and / or moisture can be applied periodically to set the shape of the catheter (e.g., by setting the shape of the metal or polymer spine of the catheter). This shape setting occurs when the material is softened and / or annealed at high temperature and then hardened at a lower temperature. In one example, a rotation angle and / or translation is imparted to the catheter spine during sterilization that biases the catheter into a desired orientation to form the catheter assembly in the anatomically correct position.

[0054] The new baseline stress-free shape of the catheter that is consequently formed by molding the catheter spine during sterilization or by any of the other methods described herein reduces the need to torque the catheter during insertion and placement of the pump assembly into the patient's vasculature (e.g., through the aorta and along the aortic arch). The improved catheter assembly may be useful for the IMPELLA® 5.0 pump, IMPELLA® 2.5 pump, IMPELLA CP® pump assemblies that are adapted for use in the left ventricle, or may be useful for any other cardiac pump.

[0055] Additionally, the relative position of the cannula and catheter can be selected to optimally fit the anatomy of a particular patient or patient population. This improved fit can also help reduce delivery times.

[0056] The unstressed catheter and the cannula rotated or translated away from the proximal portion of the catheter may be provided in a tray (e.g., a packaging tray). Alternatively, the unstressed catheter and the cannula rotated or translated away from the proximal portion of the catheter may be manufactured or provided without a tray. The tray may be configured to apply and maintain a twist to the catheter prior to thermal cycling (e.g., sterilization) of the catheter assembly. For example, as described above, a first portion of the tray may fix a first position on the catheter and a second portion of the tray may fix a second position on the cannula such that the cannula is rotated and the distal portion of the cannula is at an angle to the plane of the tray. The tray may include structure that allows the cannula to be located in a plane different from the plane of the catheter and packaging tray. After the catheter assembly is heat treated in a desired position, e.g., a position initially maintained by the two tray portions, when the catheter assembly is removed from the tray and during insertion into the patient, the catheter retains its twisted / twisted shape in an unstressed resting state and the cannula retains its shape and angular position.

[0057] Also disclosed herein are methods of manufacturing a catheter assembly having the above configuration. According to one method, the catheter proximal portion is held stationary and the cannula is rotated and / or translated until the cannula is in a desired position relative to the catheter. The cannula is then held stationary and thermal cycling is performed. After completion of the thermal cycling process, the shape of the catheter is set. In this configuration, the catheter is no longer under stress once the shape is set. In another method, the cannula, the catheter, or both, are rotated relative to each other 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 embodiments, a handle coupled to the catheter assembly is rotated relative to the catheter assembly or one or more components of the catheter assembly to define the shape of the assembly.

[0058] 1 shows an exemplary diagram of a prior art packaged pump assembly 100. Packaged pump assembly 100 includes a tray 114, a tray portion 116, a flexible atraumatic protrusion (also referred to as pigtail 102), a pump inlet 104, a cannula distal portion 106, a cannula proximal portion 108, a catheter 110, and a catheter end unit 112. Pigtail 102 extends from inlet 104 adjacent to or located at cannula distal portion 106. Cannula distal portion 106 is bent at angle α from cannula proximal portion 108. For example, cannula distal portion 106 is bent at angle α of about 35° from cannula proximal portion 108. The proximal portion 108 is connected to the catheter 110 and is aligned with the catheter 110 so that there is no twist between the proximal portion 108 and the catheter 110. The proximal portion 108 of the cannula is at a distance 134 from the major edge of the tray, which is the same as the distance 132 between the portion of the catheter internal groove 130 and the major edge of the tray. The proximal portion 106, the distal portion 108 and the catheter 110 lie in the plane of the top surface of the tray portion 116, which is parallel to the major plane of the packaging tray 114. The catheter 110 is also connected to a catheter end unit 112, which may include a repositioning unit, plugs, infusion filters, pressure reservoirs and check valves. The pigtail 102, the distal portion 106 and the proximal portion 108 lie in the tray portion 116, which is recessed relative to the remainder of the tray 114. 1, no torque is applied to either the proximal portion 108, the distal portion 106, or the catheter 110. The catheter 110 can be made of a polyamide inner layer and a polyurethane outer layer, and when the tray 114 is sterilized, the tray 114, the proximal portion 108, the distal portion 106, and the catheter 110 undergo thermal cycling that affects the catheter material. The catheter material softens when the temperature increases and hardens when the temperature decreases.The shape or spine of the catheter 110 provided by the tray 114 is solidified by the end of the sterilization process, so that when the catheter 110 is removed from the tray 114 (e.g., for use in a procedure), the catheter 110 substantially retains its shape with the end of the catheter 110 aligned with the proximal portion 108 of the cannula.

[0059] As noted above, once the catheter (e.g., catheter 100 of FIG. 1) has set in this shape, it may be necessary in some cases to apply torque during placement, but there is a limit to the amount of torque that can be safely applied to the catheter before it bounces back. Applying too little force to the catheter makes it difficult to place the pump assembly in the desired location. However, applying too much force to the catheter may result in the applied force being released in an uncontrolled manner and / or may move the pump to an incorrect location resulting in low flow rate or suction. Thus, a steerable catheter (not shown) may be used to steer the catheter shaft to place the cannula distal portion in the anatomy. Such a steerable catheter may include a steering mechanism in the handle outside the patient's body, which allows for repositioning by steering. However, while steerable catheters assist in pointing the cannula in a desired direction during insertion, they do not allow for repositioning after initial insertion. Procedures requiring frequent repositioning are also limited in the amount of torque that can be safely applied to the catheter before the applied torque is released in an uncontrolled manner causing the catheter to bounce back. Additionally, while a steerable catheter aids in placing the cannula at a desired location, it is limited by the existing shape of the cannula (eg, the location of the cannula distal portion 106 relative to the catheter 110).

[0060] FIG. 2 shows a top-down view of a conventional pump assembly (e.g., prior art pump assembly 100 of FIG. 1) in contact with chordae tendineae 202 of mitral valve 204 during cadaver dissection. As discussed above in connection with FIG. 1, the position of the catheter spine in the patient is affected by the way in which the pump assembly is held in its packaging tray. Also, with a conventional tray configuration (e.g., tray configuration of FIG. 1), the inlet of the pump tends to be located in or near the mitral valve and its structures when implanted in the patient (as shown in FIG. 2). The pigtail and inlet portion of the conventional pump assembly 201 are entangled with the chordae tendineae 202 of the mitral valve 204. This entanglement can cause a defect in the placement of the inlet of the conventional pump assembly 201, for example, by obstructing inflow, resulting in low blood flow and reduced circulatory support to the patient.

[0061] 3 shows a first exemplary embodiment of a packaged pump assembly 300, which has a particular shape that facilitates placement of the pump on a patient. The packaged pump assembly 300 includes a tray 314, a first tray portion 317, a second tray portion 319, an inlet 304, a cannula distal portion 306, a cannula proximal portion 308, a catheter transition portion 309, a catheter proximal portion 311, a catheter end unit 312, and a pigtail 302. The pigtail 302 extends from the inlet 304 located at the cannula distal portion 306. The cannula distal portion 306 is angled from the cannula proximal portion 308 (by angle α shown in FIG. 1). In this example, the cannula distal portion 306 is angled from the cannula proximal portion 308 by angle α, which is substantially 35°. In some embodiments, cannula distal portion 306 is bent from proximal portion 308 by an angle α, which may be 25°, 30°, 35°, 40°, or 45°.

[0062] The cannula proximal portion 308 and the cannula distal portion 306 are fixed to the tray 314 by a first tray portion 317. The midpoint of the cannula between its proximal portion 308 and its distal portion 306 is a distance 334 from the major edge of the tray 314. The cannula proximal portion 308 is connected to a catheter transition portion 309 which twists between the cannula proximal portion 308 and a second tray portion 319 to which the catheter 303 is fixed to the tray 314. The catheter 303 may be fixed to the tray 314 at a distance 332 from the major edge of the tray. This distance 332 may be less than the distance 334 between the cannula and the major edge of the tray. Alternatively, the distance 332 may be greater than the distance 334 between the cannula and the major edge of the tray. The midpoint of the cannula is a distance 336 from the point at which the catheter is fixed. Distance 336 may be equal to 20% of the major length of the tray. In another example, distance 336 may be equal to 30%, 40%, 50%, or 60% of the major length of the tray. Alternatively, the distance between the point at which cannula 303 is fixed to tray 314 and the junction between cannula 303 and proximal portion 306 of the cannula is selected to be 10-60% (e.g., 10%, 20%, 30%, 40%, 50%, 60%) of the length of the catheter. Proximal portion 306 and distal portion 308 of the cannula lie in a plane that is angularly offset from the plane of packaging tray 314. In another example, distance 336 may be greater than either of distances 334 and 332.

[0063] The angular offset θ2 between the plane of the cannula and the plane of the tray defines the shape of the catheter transition section 309, as shown in Figure 9. Translation and / or rotation of the cannula also results in the distal portion 308 of the cannula rotating in and out of the plane of the packaging tray (which corresponds to the plane of the aortic arch), as shown in Figures 8 and 9. The catheter proximal section 311 is also connected to a catheter end unit 312, which may include a repositioning unit, plugs, an infusion filter, a pressure reservoir, and a check valve.

[0064] The proximal and transition sections 309, 311 of the catheter can have a polyamide inner layer and a polyurethane outer layer. Additionally, the catheter of any of the embodiments described in Figures 3 and 12-14 may be braided to increase the amount of torque that can be safely applied after the pump assembly is deployed.

[0065] When the tray 314 is sterilized, the tray 314, proximal section 306, cannula distal section 308, cannula proximal section 309 and catheter transition section 311 undergo thermal cycling, resulting in changes in temperature and humidity that affect the catheter material. For example, the temperature can range from 70° C. to 150° C. above the transition temperature, such that the material becomes soft and elastic. The catheter material softens as the temperature increases and hardens as the temperature decreases. The shape or spine of the catheter is solidified by the end of the sterilization process, such that the catheter substantially retains its shape when the catheter is no longer in the tray 314 (e.g., when the catheter is being used in a procedure). For example, the cannula proximal section 308 is at an angle to the plane of the catheter proximal section 311, and the cannula distal section 306 is at a plane angled from the plane of the aortic arch. In one example, the shape or spine of catheter transition portion 309 is set by the end of the sterilization process, so that when catheter transition portion 309 is no longer in tray 314 (e.g., when the catheter is being used in a procedure), the catheter substantially retains its shape, cannula proximal portion 308 is at an angle relative to the plane of catheter proximal portion 311, and cannula distal portion 306 is in a plane that is angularly offset from the plane of the aortic arch.

[0066] In certain embodiments, the cannula proximal portion 308 lies in a first plane and the catheter proximal portion 311 lies in a second plane that is not parallel to the first plane. The angular offset between the first and second planes is based on the desired placement of the cannula and catheter assembly. For example, as described with respect to FIG. 2 above and FIGS. 4-5, 16 and 21 below, the desired anatomical location may be a location that both rotates and translates the pump inlet away from the mitral valve of the heart and toward the apex of the left ventricle. In one example, the angle θ2 between the first plane of the cannula proximal portion 308 and the second plane of the catheter proximal portion 311 is 40°. In one example, the angular offset between the plane of the cannula distal portion 306 and the plane of the aortic arch (e.g., the plane of the packaging tray in the exemplary embodiment of FIG. 3) is 70° to 120°. Preferably, the angular offset between the plane of the cannula distal portion 306 and the plane of the aortic arch is between 80° and 110°. Preferably, the angular offset between the plane of the cannula distal portion 306 and the plane of the aortic arch is about 92°.

[0067] As mentioned above, if a catheter (e.g., catheter 100 of FIG. 1) freezes, for example as a result of thermal cycling, it can be difficult to insert the pump assembly into a patient due to a limited amount of torque that can be safely applied to the catheter before the torque is released in an uncontrolled manner and the catheter recoils. The packaging tray 314 is one way to rotate the cannula distal portion 306 relative to the catheter proximal portion 311, thereby allowing the catheter transition portion 309 to be twisted before the pump assembly 300 is placed in the packaging tray 314. This provides a better anatomical fit of the pump assembly 300 to the patient. Configuring the catheter transition portion 309 in this manner also contributes to faster delivery times, since it reduces the risk of the cannula 303 getting stuck in the chordae tendineae. Alternatively, the rotation of the cannula distal portion 306 can be performed in the absence of a packaging tray or after the pump assembly is removed from the packaging tray.

[0068] 4 shows a top-down view of a first exemplary embodiment of a pump assembly during cadaver dissection, away from the chordae tendineae 402 of the mitral valve 404. As shown, the pigtail and inlet portion of the first embodiment of the pump assembly 401 are positioned along the side 403 of the mitral valve 404, but away from the chordae tendineae 402 of the mitral valve 404, leaving the inlet portion unobstructed. This, in turn, can reduce the risk of aspiration and / or low blood flow through the pump due to incorrect pump placement.

[0069] 5 shows a front view of a conventional pump assembly and a first exemplary embodiment of a pump assembly disposed in the left ventricle across the aortic valve. FIG. 5 shows an aorta 501, a mitral valve 504, chordae tendineae 502, a conventional pump assembly 503, and an exemplary embodiment of a pump assembly 505. The pump assemblies 503 and 505 are advanced into the aorta 501 across the aortic valve. When the conventional pump assembly 503 is used, the chordae tendineae 502 of the mitral valve interferes with the cannula distal portion 506, as also shown in FIG. 2. In contrast, when the first exemplary embodiment of the pump assembly 505 is disposed therein, the cannula distal portion moves away from the chordae tendineae 502 of the mitral valve and instead passes through the aortic valve into the left ventricle.

[0070] The angle between the direction of the descending aorta and the ideal pump placement location (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 pump) should be placed relative to the plane of the aortic arch to obtain an assembly shape that provides an anatomical fit. As an example, the distal portion of the cannula can be angled relative to the packaging tray as well to achieve this shape and provide a closer anatomical fit. The anatomically optimal rotation angle of the cannula distal portion relative to the plane of the aortic arch (shown in Figure 17) may depend on the patient's size and anatomy. Aortic arches vary in size and shape, and ventricular sizes vary based on size and age. In one study, the mean rotation angle of the cannula distal portion (and associated catheter transition portion twist angle) varied between 125° and 65°, respectively, with the preferred angle being 92°. In certain embodiments, the rotation angle is 65°, 70°, 75°, 80°, 85°, 90°, 95°, 100°, 105°, 110°, 115°, 120°, or any other suitable angle. In some cases, the rotation angle may be greater than 125° (e.g., 180°) or less than 64° (e.g., 30°).

[0071] 6-9 show various views of a first portion 600 of a packaging tray holding a first exemplary pump assembly. A cannula 603 includes a pigtail 602, an inlet 604, a distal portion 606, and a proximal portion 608. An angle θ1 between the proximal portion 608 and the axis of the proximal portion of the catheter is shown at least in FIG. 8. A dihedral angle θ2 between the proximal portion 608 and a plane in which the connected catheter is placed (e.g., the main plane of the packaging tray) is shown at least in FIG. 9. The first portion of the packaging tray can include a bottom 620 and a protrusion 621. The bottom 620 may be added to an existing packaging tray as an insert, for example, placed in the recess 116 of the tray 114 shown in FIG. 1. Alternatively, the bottom 620 may be integral with the packaging tray (e.g., the tray 514 shown in FIG. 5). The protrusion 621 is located in the center of the bottom 620 and supports both the distal portion 606 and the proximal portion 608 of the cannula. Alternatively, protrusion 621 may support either proximal portion 608 or distal portion 606. The top of protrusion 621 follows the shape of the proximal portion 608 and distal portion 606 of the cannula. The length of protrusion 621 may vary between 25% and 75% of the length of base 620. The height of protrusion 621 may vary and may be configured such that pigtail 602 does not contact base 620. Alternatively, the shape of protrusion 621 may be adapted to accommodate different cannula shapes.

[0072] 7 shows a front view of a first portion 600 of a packaging tray. The cannula includes a pigtail 602, an inlet 604, a distal portion 606, and a proximal portion 608. The first portion of the packaging tray also includes a recess or ridge 622 that can hold the cannula in place, for example, by a press fit. In any of the embodiments described herein, the ridge can hold a portion or the entire length of the cannula. For example, the ridge can contact 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90% of the cannula. In another example, the ridge can be replaced with a groove, for example a 3D printed groove, or a thermoformed cavity configured to grip the cannula.

[0073] FIG. 10 shows an isometric view of a first portion 1000 of a packaging tray (not shown) holding a second exemplary embodiment of a pump assembly. The first portion 1000 includes a base 1020, a protrusion 1021, a ridge 1022, and a cover 1017, the cover having protrusions 1022, 1024, and 1023. The base 1020, ridge 1022, and protrusion 1021 may be similar to the corresponding components shown in FIGS. 7-9. The cover 1017 provides additional support to keep the cannula in place relative to the packaging tray. A portion of the cannula is clamped between the ridge 1022 and the protrusion 1019 of the cover 1017. The ridge 1022 may be a press-fit ridge. Additionally, the protrusions 1023 and 1024 may lock with protrusions located on the packaging tray to ensure no movement occurs relative to the packaging tray. Ensuring that the catheter transition section (not shown) freezes in a shape that provides a better anatomical fit can improve ease of use, reduce the time required to deliver and position the pump to the heart, and reduce aspiration and / or low flow events due to misplacement. An additional means of securing the cannula 1025 relative to the base 1020 provides redundancy, ensuring that the catheter transition section freezes in the desired anatomical location despite twisting of the body of the cannula relative to the catheter.

[0074] FIG. 11 shows a second portion 1100 of a packaging tray in a first exemplary embodiment of a pump assembly configured to hold a cannula therein. The second portion of the packaging tray includes a hinge 1130, a grip pad 1132, a protrusion 1137, a protrusion 1134, a protrusion 1136, and a protrusion 1138. Before the catheter transition portion is torqued and the cannula is fixed in place relative to the packaging tray (e.g., as described with respect to FIG. 10), the proximal portion of the catheter (e.g., proximal portion 511 in FIG. 5) must also be fixed in place relative to the packaging tray. The second portion 1100 may be integral with the packaging tray or may be an insert that can be connected to an existing packaging tray. In one example, the second portion is located at a certain distance from the junction between the cannula and the catheter. For example, the second portion 1100 is located at a distance equal to 10% of the length of the catheter from the junction between the cannula and the catheter. In another example, the distance between the junction and the second portion may be 20%, 30%, 40% or 50% of the length of the catheter.

[0075] The second portion 1100 may be a butterfly clip with a hinge 1130 that can close so that grip pads 1132 are positioned above and below the catheter. The grip pads 1132 may be coated with a non-slip or high coefficient of friction material to resist torque applied to the catheter. Outer projections 1136 and 1134 mate to secure the second portion 1100 in a clamped position. Similarly, inner projections 1137 and 1138 mate to secure the second portion 1100 in a clamped position. In any of the embodiments described herein, the insert or integral portion of the tray may be replaced by a groove or trough that fits within the tray. For example, a groove may be 3D printed to accommodate the catheter and hold it in the desired position.

[0076] As noted above, ensuring that the catheter sets in a shape that provides a better anatomical fit contributes to reduced delivery times. In one example, this can be accomplished by ensuring that the catheter transition section sets in a shape that provides a better anatomical fit. The combination of grip pad 1132 and both sets of protrusions 1136, 1134 and 1137, 1138 secure the catheter to the packaging tray and ensure that the catheter transition section sets in the desired anatomical location despite torque or stresses applied to the catheter transition section from rotating the cannula relative to the catheter.

[0077] FIG. 12 shows a third exemplary embodiment of a pump assembly. The pump assembly includes a tray portion 1216, a pigtail 1202, a cannula distal portion 1206, a cannula proximal portion 1208, and a catheter transition portion 1210. This third exemplary embodiment is similar to the embodiment shown in FIG. 5, except that the cannula is rotated 90° relative to the catheter and the catheter transition portion 1210 is twisted 90°. The first and second portions of the packaging tray that hold the cannula and catheter in place, respectively, are omitted for clarity. Rotating the cannula 90° relative to the catheter provides a different anatomical fit for the catheter transition portion that may be beneficial for certain patient anatomy. The 90° rotation may also move the pigtail away from the tray, preventing damage to the pigtail during packaging.

[0078] FIG. 13 shows a fourth exemplary embodiment of a pump assembly. The pump assembly includes a tray portion 1316, a pigtail 1302, a cannula distal portion 1306, a cannula proximal portion 1308, and a catheter transition portion 1310. This fourth exemplary embodiment is similar to the embodiment shown in FIG. 5, except that the cannula is rotated 180° relative to its normal orientation (e.g., the orientation of the prior art cannula shown in FIG. 1). In this exemplary embodiment, the cannula distal portion 1306 is in the same plane as the plane of the catheter 1310, which is parallel to the plane of the packaging tray portion 1316. However, the catheter transition portion 1310 is twisted 180° relative to the catheter proximal portion (not shown) within the plane of the packaging tray portion 1316. The first and second portions of the packaging tray, respectively, that hold the cannula and catheter in place, have been omitted for clarity.

[0079] 14 shows a fifth exemplary embodiment of a pump assembly. The pump assembly includes a tray portion 1416, a pigtail 1402, a cannula distal portion 1406, a cannula proximal portion 1408, and a catheter transition portion 1410. This third exemplary embodiment is similar to that shown in FIG. 5, except that the cannula distal portion 1408 is rotated 270° relative to the catheter proximal portion (not shown), and the catheter transition portion is twisted 270° relative to the catheter proximal portion (not shown). The first and second portions of the packaging tray, which hold the cannula and catheter in place, respectively, have been omitted for clarity.

[0080] 15 shows a sixth exemplary embodiment of a pump assembly. The pump assembly includes a packaging tray 1514, a tray portion 1516, a pigtail 1502, a cannula distal portion 1506, a cannula proximal portion 1508, a first catheter portion 1509, a second catheter portion 1513, a second tray portion 1511 having multiple elements, and a catheter end unit 1512. The pigtail 1502 extends from the cannula distal portion 1506. The cannula distal portion 1506 is bent at an angle from the cannula proximal portion 1508. For example, the cannula distal portion 1506 is bent at an angle α of 35° from the cannula proximal portion 1508. In some embodiments, the cannula distal portion 1506 is bent at an angle α of 25° to 45° from the proximal portion 1508.

[0081] The cannula proximal portion 1508 and the cannula distal portion 1506 are secured to the tray 1514 by a first tray portion (not shown) in a recessed tray portion 1516. The cannula proximal portion 1508 is connected to a catheter transition portion 1509 which is twisted between the cannula proximal portion 1508 and a second tray portion 1511 where the catheter is secured to the tray 1514. As in the embodiment shown in Figures 5 and 12-14, the cannula proximal portion 1508 may be angled from the plane of the packaging tray 1514 by an angle θ2 (e.g., shown in Figure 9). The angle θ2 between the cannula proximal portion 1508 and the plane of the tray, the angle θ1 (e.g., shown in Figure 8), and the catheter twist angle define the shape of the catheter transition portion 1509. Additionally, the position of the elements of the second tray portion 1511 may be configured to achieve a "pack in place" configuration, such that the majority of the length of the catheter forms a straight line and the curve of the catheter transition portion 1509 in the plane of the packaging tray mimics the curve of the aortic arch.

[0082] The catheter proximal section 1513 is also connected to a catheter end unit 1512, which may include a repositioning unit, plugs, an infusion filter, a pressure reservoir, and a check valve. Also, the catheter end unit 1512 may be rotated relative to the proximal section 1513 of the catheter to reduce the torque applied to the proximal section of the catheter in the tray prior to sterilization.

[0083] FIG 16 illustrates a seventh exemplary embodiment of a pump assembly 1601 positioned in a heart 1603, and FIG 17 illustrates a top down view of the pump assembly 1601. The pump assembly 1601 includes a pigtail 1616, a cannula distal portion 1614, a cannula proximal portion 1610, a curved portion 1612 between the cannula distal portion 1614 and the cannula proximal portion 1610, a catheter proximal portion 1608, and a catheter distal portion 1609. The heart 1603 includes a ventricular apex 1601, an aorta 1602, and an aortic arch 1604. The pigtail 1616 extends from the cannula distal portion 1614 and is positioned near the ventricular apex 1601. The catheter portion 1608 follows the aorta 1602 and the aortic arch 1604. The catheter portion 1609, located behind the aortic arch, connects to the cannula proximal portion 1610. A bend 1612 in the cannula is located between the cannula proximal portion 1610 and the cannula distal portion 1614. The angular offset γ shown in FIG. 17 is the angular offset between a first plane including the cannula distal portion 1614 and a second plane including the catheter (catheter portions 1608 and 1609), with the apex of the angular offset γ being the bend 1612 in the cannula. When the cannula distal portion 1614 is inserted into the heart 1603 via the aorta 1602 and the aortic arch 1604, the curve of the longitudinal axis of the catheter portions (including the catheter proximal portion 1608 and the catheter distal portion 1609) lies in the second plane, with the cannula distal portion 1604 in the first plane. The cannula proximal portion 1610 also lies in the second plane.

[0084] As shown, the cannula distal portion 1614 is positioned to point toward the ventricular apex 1606. For reference, FIG. 17 shows an example arrangement of the cannula 1650 and cannula 1660 in an alternative cannula arrangement having an angular offset γ between a plane containing the catheter (catheter portions 1608 and 1609) and a plane containing the cannula distal portion 1614 of the cannula 1660. As shown in FIGS. 16 and 17, the cannula distal portion 1614 and catheter portion 1608 of the cannula 1660 are in a different plane, and the angular offset γ between the plane of the aortic arch 1604 and the plane of the cannula proximal portion 1610 and the cannula distal portion 1614 of the cannula 1660 biases the cannula 1660 toward the ventricular apex 1601. Rotation of the cannula distal portion 1614 relative to the catheter portion 1608 urges the cannula distal portion 1614 away from the chordae tendineae that actuate the mitral valve, thereby reducing the risk of the pump assembly 1601 getting stuck after being pumped through the aortic valve and into the left ventricle. This rotation can also reduce the occurrence of heart wall suction and / or biomaterial aspirate by the pump assembly 1601.

[0085] 18 illustrates an eighth exemplary embodiment of a pump assembly. The pump assembly includes a pigtail 1802, a cannula distal portion 1806, a cannula proximal portion 1808, a catheter portion 1810, a catheter end unit 1812, and a backbone 1820. The pigtail 1802 extends from the cannula distal portion 1806. The backbone 1820 can be a preformed internal or external backbone. For example, the backbone may be made of Nitinol or a similar shape memory material. The backbone 1820 can extend the entire length of the catheter portion 1810 and provide stability and shape memory for the catheter portion 1810. Imparting a rotation angle to the cannula distal portion 1806 by preforming the catheter backbone 1820 can allow for the rotation angle to be achieved with relatively minor modifications to existing manufacturing processes. For example, in some embodiments, preforming the backbone requires fewer modifications to the manufacturing process than rotating the catheter during sterilization.

[0086] 19 illustrates a ninth exemplary embodiment of a pump assembly. The pump assembly 1901 is shown in an exemplary plane 1920 and includes a pigtail 1902, a cannula distal portion 1906, a cannula proximal portion 1908, a catheter distal portion 1909, a catheter proximal portion 1910, and a catheter end unit 1912 (details not shown). The exemplary plane 1920 is a plane in which the curve of the longitudinal axis of the catheter portions (including the catheter proximal portion 1909 and the catheter distal portion 1910) lies in a resting state. The cannula proximal portion 1908 also lies in the exemplary plane 1920 in a resting state. The pigtail 1902 extends from the cannula distal portion 1906 and is angled from the plane of the exemplary plane 1920 by an angle β. The catheter proximal portion 1910 can be maintained substantially straight, and the catheter distal portion 1909 can be shaped for an anatomical fit. For example, the catheter distal portion 1909 may be molded to a plane 1920, which may be the plane of the aortic arch of the patient. The molding of the catheter distal portion 1909 may be performed in combination with the use of a packaging tray (e.g., packaging tray 314 of FIG. 3) or may be performed without the use of a packaging tray. The molding of the catheter distal portion 1909 may be performed as an integrated step of the manufacturing process or may be an additional step performed on an already manufactured pump assembly. For example, the catheter distal portion 1909 may be molded on the aortic arch in a manner similar to that used to mold the JL4 catheter. To pre-form the catheter, the catheter may be annealed at a temperature between 50° C. and 80° C., preferably 60° C. As a result of molding the catheter distal portion 1909, the cannula distal portion 1902 may be disposed outside of the reference plane 1920. For example, as described with respect to Figures 16 and 17, the cannula distal portion 1902 may be positioned at an angle relative to the plane of the aortic arch such that the cannula distal portion points the pigtail 1902 toward the apex of the ventricle.Positioning the cannula distal portion 1902 out of the reference plane 1920 by preforming the catheter distal portion 1909 over the aortic arch can facilitate insertion of the pump assembly 1901 by biasing the cannula distal portion 1902 away from the chordae tendineae that actuate the mitral valve, thereby reducing the risk of the pump assembly 1901 becoming stuck after being delivered through the aortic valve and into the left ventricle.

[0087] 20 illustrates a tenth exemplary embodiment of a pump assembly. The pump assembly includes a pigtail 2002, a cannula distal portion 2006, a cannula proximal portion 2008, a catheter portion 2010, a catheter end unit 2012, and at least one stylet 2020. The pigtail 2002 extends from the cannula distal portion 2006. The at least one stylet 2020 is a shape-changing wire inserted into the catheter portion 2010 and can be used to adjust the catheter portion 2010 to obtain an anatomical fit to a particular anatomy. For example, the stylet 2020 can be used to adjust the shape of the distal portion of the catheter portion 2010 such that the distal portion of the cannula 2002 is biased at an angle from the plane of the aortic arch in which the catheter portion 2010 is located. Such an angle is shown, for example, in the exemplary embodiments of FIGS. 16 and 17. Various types of stylets 2020 may be used in this exemplary embodiment. For example, the stylet 2020 may be made of metal or polymer. This exemplary embodiment using a stylet 2020 may be used in place of or in combination with the preformed backbone of the exemplary embodiment shown in FIG. 18. Multiple stylets 2020 of various shapes may be used sequentially until the cannula distal portion 2006 is in the desired configuration.

[0088] Figure 21 illustrates an exemplary method 2100 for configuring a rest shape of a pump assembly, such as one of the exemplary embodiments shown in Figures 5-15. Method 2100 may be implemented to configure a catheter that is part of a pump assembly (e.g., pump assembly 100 shown in Figure 1), including but not limited to the pump assemblies described in any of the previous embodiments in Figures 5-15. The catheter and cannula may have a resulting rest shape that matches the anatomy of the patient's left ventricle and aortic arch.

[0089] In step 2102, a pump assembly is placed in the tray package. The pump assembly may include a cannula having a proximal portion and a distal portion, and a catheter having a proximal portion and a cannula transition portion that may be distal to the proximal portion. In step 2104, the catheter proximal portion is held fixed relative to the packaging tray. The catheter proximal portion may be held fixed by an integral part of the packaging tray or an insert added to the packaging tray. For example, a trough or groove may be 3D printed or formed in the tray to hold the catheter in a desired position. Alternatively, an insert such as a butterfly clip or any other suitable clip or gripping element capable of withstanding torque may be used.

[0090] In step 2106, the pump assembly is rotated while the catheter proximal section is fixed, which twists the catheter transition section. The pump assembly is rotated while the catheter proximal section is fixed until the catheter transition section reaches the desired shape and the desired twist angle. The twist angle of the catheter transition section may be approximately equal to the angle between the axis of the descending aorta and the predetermined cannula placement location, or it may be greater. The twist angle may vary between 125° and 64° (e.g., 65°, 70°, 75°, 80°, 85°, 90°, 95°, 100°, 105°, 110°, 115°, 120°, or any other suitable angle). A preferred twist angle may be 92°. In some embodiments, the twist angle may be greater than 125° (e.g., 180°) or less than 64° (e.g., 30°). The packaging tray may be adjustable to allow the twist angle to be selected to suit the anatomy of a particular patient or patient group. As described above in relation to θ1 and θ2, the cannula may be translated relative to the axis of the proximal catheter section and relative to the plane of the packaging tray.

[0091] At step 2108, the now turned and translated cannula proximal portion is secured to the packaging tray. The cannula proximal portion may be held fixed by an integral part of the packaging tray or an insert added to the packaging tray, and the cannula distal portion is held rigidly to the packaging tray by an integral part of the packaging tray or an insert added to the packaging tray. Securing both the cannula and the catheter proximal portion to the packaging tray as described in steps 2104 and 2108 ensures that the catheter transition portion retains the desired twist during thermal cycling. In an alternative embodiment, any of the inserts may be replaced by a trough or groove formed in 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 thermoforming process.

[0092] In step 2110, thermal cycling is applied to the tray package containing the pump assembly. Once thermal cycling is complete, the pump assembly hardens into the desired shape. For example, the temperature can range from 70°C to 150°C above the transition temperature at which the material becomes soft and elastic. Depending on the material, the temperature used during thermal cycling can vary between -40°C to 70°C (e.g., -40°C, -30°C, -20°C, -10°C, 0°C, 10°C, 20°C, 30°C, 40°C, 50°C, 60°C, 70°C or any other suitable temperature). A preferred temperature range can be -20°C to 50°C (e.g., -20°C, -15°C, -10°C, -5°C, 0°C, 5°C, 10°C, 15°C, 20°C, 25°C, 30°C, 35°C, 40°C, 45°C, 50°C). The catheter material softens as the temperature increases and hardens as the temperature decreases. The shape of the catheter or spine, particularly the shape of the catheter transition section, is solidified by the end of the sterilization process so that the catheter transition section substantially retains its shape when the catheter transition section is no longer in the tray (e.g., when the catheter is being used in a procedure).

[0093] The use of a packaging tray allows the catheter transition section to twist, allowing the cannula to rotate and translate to a position that is a better anatomical fit, thereby reducing delivery time to the patient. The twisting of the catheter transition section also contributes to reduced delivery time because it reduces the risk of the cannula getting stuck in the chordae tendineae during insertion.

[0094] Variations and modifications will occur to those skilled in the art after considering this disclosure. For example, in some embodiments, any of the aspects described in Figures 3 and 6-20 may be combined. For example, the first portion of the packaging tray of Figures 6-9 and the second portion of the packaging tray of Figure 10 may be enclosed in the various pump assembly packaging configurations described with respect to Figures 12-15. In another example, the features described with respect to Figures 16-21 may be combined with any of the aspects described with respect to Figures 3 and 6-21, with or without the use of a packaging tray. The disclosed features may be embodied in any combination and subcombination (including multiple subcombinations and subcombinations) with one or more other features described herein. The various features described and illustrated above, including any component parts thereof, may be combined or integrated into other systems. Moreover, certain features may be omitted or not embodied.

[0095] It is important to note that the construction and arrangement of the device or its components as shown in the various exemplary embodiments are exemplary only. Although only a few embodiments are described in detail in this disclosure, those skilled in the art who consider this disclosure will readily appreciate that numerous modifications (e.g., changes in size, dimensions, configuration, shape and proportions of various elements, parameter values, mounting configurations, material use, color, orientation, etc.) are possible without substantially departing from the novel teachings and advantages of the disclosed subject matter. For example, elements shown as integrally formed may be composed of multiple parts or elements, the arrangement of elements may be reversed or otherwise changed, and the nature or number of separate elements or arrangements may be changed. The order or sequence of any process or method steps may be changed or reordered according to alternative embodiments. Also, other substitutions, modifications, changes and omissions may be made in the design, operating conditions and arrangements of the various exemplary embodiments without departing from the scope of the present disclosure.

[0096] Although various inventive embodiments have been described and illustrated herein, those skilled in the art will readily envision a variety of other mechanisms and / or structures for performing the functions and / or obtaining the results and / or one or more of the advantages described herein, and each such change and / or modification is deemed to be within the scope of the inventive embodiments described herein. More generally, those skilled in the art will readily appreciate that, unless otherwise noted, any parameters, dimensions, materials, and configurations described herein are intended to be exemplary, and that the actual parameters, dimensions, materials, and / or configurations will depend on the specific application(s) for which the inventive teachings are used. Those skilled in the art will recognize, or be able to ascertain, using no more than routine experimentation, many equivalents to the specific inventive embodiments described herein. Thus, it will be understood that the embodiments are presented by way of example only, and that, within the scope of the claims and their equivalents, the inventive embodiments may be practiced otherwise than as specifically described and claimed. Inventive embodiments of the present disclosure relate to each individual feature, system, article, material, kit, and / or method described herein. In addition, any combination of two or more such features, systems, articles, materials, kits, and / or methods is within the inventive scope of the present disclosure, unless such features, systems, articles, materials, kits, and / or methods are inconsistent.

[0097] In the context of this disclosure, the term "coupled" refers to the direct or indirect joining of two members to each other. Such joining may be of a static or mobile nature. Such joining may be achieved by the two members or the two members and any further intermediate members being integrally formed with each other as one integral body, or by the two members or the two members and any further intermediate members being attached to each other. Such joining may be of a permanent nature or of a removable or releasable nature.

[0098] The singular indefinite article as used in the specification and claims should be understood to mean "at least one" unless expressly indicated otherwise. "Or" as used in the specification and claims should be understood to have the same meaning as "and / or" as defined above. For example, when separating items in a list, "or" or "and / or" should be interpreted as being inclusive, i.e., including at least one of the number of elements or list, but also including more than one, and optionally including additional items not in the list. Only terms that clearly indicate otherwise, such as "only one of" or "exactly one of," refer to the inclusion of the number of elements or exactly one element in the list. In general, the term "or" as used herein should be interpreted as indicating exclusive selection (i.e., "only one or the other, but not both") only when followed by a term indicating exclusivity, such as "any of," "one of," "only one of," or "exactly one of."

[0099] In the claims and the above specification, all transitional phrases, such as "comprising," "having," "containing," "with," "holding," "composed of," etc., should be understood to be open-ended, i.e., "including, but not limited to."

[0100] The claims should not be read as limited to the described order or elements unless so stated. It should be understood that various changes in form and detail may be made by those skilled in the art without departing from the spirit and scope of the claims. All embodiments that come within the spirit and scope of the following claims and equivalents thereto are claimed.

[0101] Examples of modifications, substitutions and variations are ascertainable by one skilled in the art and can be made without departing from the scope of the information disclosed herein. All references cited herein are incorporated by reference in their entirety and constitute a part of this application.

Claims

1. A catheter assembly including a catheter and a cannula coupled to the catheter, the catheter including a catheter proximal portion and a catheter distal portion, the cannula having a cannula proximal portion, a cannula distal portion, and a curved portion between the cannula proximal portion and the cannula distal portion; a packaging tray housing the catheter assembly and including a first portion and a second portion, the first portion configured to hold the cannula proximal portion in a fixed position relative to the packaging tray, and the second portion configured to hold the catheter proximal portion in a fixed position relative to the packaging tray; Including, the catheter is twisted through a twist angle between the first and second portions such that the cannula distal portion rotates or translates out of the plane of the packaging tray at a first angle, and the first and second portions are configured to maintain the twist of the catheter. A system for configuring a catheter assembly into an anatomical shape.

2. The system of claim 1, wherein the first angle is equal to the angle between the plane of the aortic arch and the predetermined cannula placement position.

3. The system of claim 1, wherein the first angle is between 60° and 140°.

4. The system of claim 1, wherein the first angle is 92°.

5. The system of claim 1, wherein when the catheter assembly is inserted into the patient's aorta, the first angle urges the cannula distal portion away from the mitral valve of the heart.

6. The system of claim 1, wherein the first angle is equal to the angle between the plane of the aortic arch defined by the ascending portion of the aorta and the descending portion of the aorta and a plane defined by the ascending portion of the aorta and the apex of the left ventricle.

7. The system of claim 1, wherein the first portion and the second portion are integral parts of a packaging tray.

8. The system of claim 1, wherein a first portion of the packaging tray includes a recess or groove configured to hold the proximal portion of the cannula in a fixed position.

9. The system of claim 8, wherein the recess or groove is configured to retain the cannula proximal portion by press fit.

10. The system of claim 1, wherein the second portion of the packaging tray includes a trough or groove configured to hold the catheter proximal portion in a fixed position.

11. The system of claim 1, wherein the second portion of the packaging tray includes a clip or gripping element configured to grip and hold the catheter proximal portion in a fixed position and to resist torque.

12. The system of claim 1, wherein the second portion of the packaging tray includes a plurality of elements configured to hold the catheter proximal portion in a fixed position such that the catheter proximal portion is held in a straight line within the plane of the packaging tray.

13. A method of configuring a catheter assembly into an anatomical shape using the system of claim 1, the system comprising: placing the catheter proximal portion on a second portion of the packaging tray such that the second portion holds the catheter proximal portion in a fixed position relative to the packaging tray; twisting the catheter through a twist angle such that a distal portion of the cannula is rotated or translated out of the plane of the packaging tray at a first angle; placing the cannula proximal portion on a first portion of the packaging tray such that the first portion holds the cannula proximal portion in a fixed position relative to the packaging tray; causing the catheter to retain the twist when the catheter assembly is removed from the packaging tray; A method comprising:

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