A cardiac pump catheter molded for anatomical 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 content of which is incorporated herein by reference in its entirety.

Background Art

[0002] Background Mechanical circulatory support devices, commonly referred to as either heart pump assemblies or catheter assemblies, can be introduced into the heart and are configured to assist or replace the native heart pump function by periodic or continuous blood pumping. A heart pump assembly can include a pump, cannulas, and catheters. When a heart pump assembly is disposed on the left side of the heart, it draws blood from the left ventricle and pumps that blood into the aorta; when the pump is disposed on the right side of the heart, it draws blood from the inferior vena cava and pumps that blood into the pulmonary artery. Heart pump assemblies are introduced surgically or percutaneously during heart procedures. In one approach, a pump assembly for the left heart is inserted into the femoral artery by a catheterization procedure.

[0003] During a catheterization procedure for inserting a pump into the left heart, an introducer is inserted from an arteriotomy into the femoral artery to gain access to the artery and form an insertion path. A placement guide wire can be advanced into the artery along the insertion path. After the guide wire is inserted into the artery, the pump assembly can be advanced along the guide wire into the patient. Alternatively, the pump assembly can be inserted directly into the artery without a guide wire. The pump can be inserted from the femoral artery, through the ascending aorta, through the aortic valve, and into the left ventricle by a standard catheterization procedure. When placed in the left heart, the pump assembly draws blood from the left ventricle through an inlet region near the tip and pumps that blood from the cannula into the ascending aorta.

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

[0005] Before insertion into a patient, the pump catheter has its original shape, and the amount of torque that can be safely applied to the catheter before the applied torque is released in an uncontrollable manner and the catheter springs back is limited. The catheter's original shape (i.e., the catheter's resting or stress-free shape when no external force is applied) may be affected during manufacturing and / or insertion. For example, sterilization is part of the manufacturing process and may involve the alternating or periodic application and removal of heat and moisture (referred herein to as thermal cycling). Because the catheter is sensitive to thermal cycling, once thermal cycling is complete, the catheter solidifies into a new resting shape. The aforementioned resting shape after thermal cycling may be determined by the characteristics of the pump itself and / or the characteristics that hold the catheter in a particular shape, such as its packaging tray. However, the resulting resting shape of the catheter may not conform to the patient's anatomical structure. Because only a limited amount of torque can be applied to the catheter, it may be difficult to position the cannula in the desired axial position and rotational orientation within the patient. [Overview of the project]

[0006] overview This specification describes systems, methods, and apparatus for providing a cardiac pump catheter assembly having a shape that facilitates the placement of the pump assembly within a patient. The catheter assembly may include a catheter and a cannula coupled thereto. The plane of the cannula may be angularly offset with respect to the plane of the catheter. In some embodiments, this angular offset is achieved by twisting the catheter and solidifying the shape of the catheter using heat or other methods. In other embodiments, the angular offset is achieved without twisting the catheter. For example, this may be achieved by rotating the cannula relative to the catheter before coupling the catheter and cannula, by pre-shaping the catheter backbone, and / or by rotating the handle and / or the catheter connection to the cannula. In addition to, or instead of, changing the angle of rotation between the catheter and the cannula, the cannula may also be translated in and / or out of the plane of the catheter and then shaped. The translation of the cannula in the plane of the catheter can be measured by the bending angle between the axis of the proximal portion of the cannula and the axis of the fixed proximal portion of the catheter. The translation of the cannula out of the catheter's plane can be measured by the angular offset between the plane of 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 toward the free space of the ventricle (e.g., the left ventricle). For example, this can facilitate the navigation and placement of the pump assembly in the left ventricle and reduce the occurrence of aspiration events and low blood flow alarms. The catheter can be molded so that the cannula is positioned at an angle toward the apex of the ventricle in the left ventricle, and the pump inlet is oriented so that it is located in the free space of the ventricle, thereby reducing the occurrence of aspiration of the heart wall and / or aspiration of biomaterials. The rotation angle of the cannula can result in a predetermined placement of the catheter and cannula to 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 a given cannula placement plane. In such cases, the rotation of the cannula relative to the catheter also biases 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 may also make the pump removal more difficult.

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

[0009] The novel baseline stress-free shape of the catheter, resulting from shaping the catheter spine during sterilization or by any other method described herein, reduces the need to apply torque to the catheter during insertion and positioning of the pump assembly into the patient's blood vessels (e.g., through the aorta and along the aortic arch). The improved catheter assembly may be useful for IMPELLA® 5.0 pumps, IMPELLA® 2.5 pumps, IMPELLA CP® pump assemblies adapted for use in the left ventricle, or for any other cardiac pump.

[0010] Furthermore, the relative position of the cannula and catheter can be selected to best suit the anatomical structure of a particular patient or patient group. This improved fit can also help reduce delivery time.

[0011] A stress-free catheter and a cannula rotated or translated away from the proximal portion of the catheter may be supplied in a tray (e.g., a packaging tray). Alternatively, a stress-free catheter and a cannula rotated or translated away from the proximal portion of the catheter may be manufactured or supplied without a tray. The tray may be configured to impart a twist to the catheter and maintain it therein before the 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 rotates and the distal portion of the cannula is at a certain angle to the plane of the tray. The tray may include a structure that allows the cannula to be positioned in a plane different from the plane of the catheter and the packaging tray. After the catheter assembly has been heat-treated in the desired position, e.g., the 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 / torsed shape in a stress-free, stationary state, and the cannula retains its shape and angular position.

[0012] Also disclosed herein are methods for manufacturing a catheter assembly having the above configuration. In one method, the proximal portion of the catheter is held in a fixed position, and the cannula is rotated and / or translated until the cannula is in a desired position relative to the catheter. Then, the cannula is held in a fixed position, and thermal cycling is performed. After the completion of the thermal cycling process, the shape of the catheter is fixed. In this configuration, once the shape is fixed, the catheter is no longer subjected to stress. In another method, the cannula, the catheter, or both are rotated relative to each other to achieve a specific 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 determine the shape of the assembly.

[0013] In one aspect, the catheter assembly includes a catheter comprising a proximal portion, a longitudinal axis, a distal portion, and a catheter transition portion between the proximal and distal portions, the longitudinal axis forming a curve. The catheter assembly further includes a cannula coupled to the distal portion, the cannula having a proximal portion, a distal portion, and a cannula transition portion with a curve between the proximal and distal portions. When the cannula is inserted into the heart, the 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 the second plane and angularly offset with respect to the second plane.

[0014] In certain embodiments, the angular offset of the first plane with respect to the second plane is substantially equal to the angle between the plane of the aortic arch defined by the ascending and descending portions 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 such that the catheter assembly has a predetermined anatomical shape when in a stationary state.

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

[0017] In certain embodiments, the angular offset is approximately 64° to 125°.

[0018] In certain embodiments, the angular offset is approximately 92°.

[0019] In certain embodiments, the angular offset is such that the distal portion of the catheter points towards 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 distal portion of the catheter.

[0021] In certain embodiments, the catheter assembly further includes a catheter handle, which is connected to the proximal portion of the catheter and rotated to adjust the position of the distal portion of the catheter.

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

[0023] In another aspect, the 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 cannula proximal portion, a cannula distal portion, and a cannula transition portion including a bend between the cannula proximal portion and the cannula distal portion. When the cannula is inserted into a patient's heart, the cannula distal portion is located within a first plane that is different from and angularly offset with respect to a second plane in which the patient's aortic arch is located.

[0024] In certain embodiments, the angular offset is approximately substantially equal to or greater than the angle between a plane defined by the ascending and descending portions of the aorta and a 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 stationary state. In certain embodiments, when the catheter assembly is inserted into a patient's aorta, the angular offset biases the cannula distal portion toward the apex of the left ventricle.

[0026] In certain embodiments, the angular offset is between about 64° and 125°.

[0027] In certain embodiments, the angular offset is about 92°.

[0028] In certain embodiments, the angular offset is an angular offset such that the distal catheter portion faces the apex.

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

[0030] In certain embodiments, the catheter assembly further includes a catheter handle, which is connected to the proximal portion of the catheter and rotated to adjust the position of the distal portion of the catheter.

[0031] In certain embodiments, the catheter assembly further includes a maneuvering mechanism connected to the proximal portion of the catheter and configured to adjust the position of the distal portion of the catheter 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 for shaping a catheter assembly to a desired anatomical form includes the step of shaping the longitudinal axis of the catheter into a curve located in a second plane. The catheter includes a proximal portion, a longitudinal axis, a distal portion, and a catheter transition portion between the proximal and distal portions. The method further includes the step of rotating the cannula relative to the catheter such that the first plane is angularly offset with respect to the second plane. The cannula includes a longitudinal axis, a proximal portion, a distal portion, and a curved portion between the proximal and distal portions, with the distal portion located in the first plane. The method further includes the step of connecting the proximal portion to the distal portion of the catheter.

[0034] In certain embodiments, the angular offset of the first plane with respect to the second plane is substantially equal to the angle between the plane of the aortic arch defined by the ascending and descending portions 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 the step of rotating the cannula relative to the catheter before connecting the proximal portion of the cannula to the distal portion of the catheter.

[0036] In a particular embodiment, the method further includes the step of rotating the cannula relative to the catheter after connecting the proximal portion of the cannula to the distal portion of the catheter.

[0037] In certain embodiments, the method further includes the step of engaging the catheter with a first insert before the rotation step, thereby preventing the catheter from moving relative to a second plane.

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

[0039] In certain embodiments, the method further includes, after the rotation step, a step of thermal cycling the catheter assembly so that the static shape of the catheter assembly solidifies after the completion of thermal cycling.

[0040] In yet another aspect, a system for configuring a catheter assembly into a certain anatomical shape includes a catheter and a catheter-coupled cannula, the cannula having a proximal portion, a distal portion, and a cannula transition portion including a curved portion between the proximal and distal portions. 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. The catheter is twisted by a certain angle between the first and second inserts such that the distal portion of the cannula rotates out of the plane of the packaging tray by a first angle.

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

[0042] In certain embodiments, the first angle is approximately 60° to 140°.

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

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

[0045] In certain embodiments, the first angle is approximately 92°.

[0046] In yet another aspect, a method for shaping a catheter assembly into a desired anatomical form includes the step of placing the catheter assembly inside a packaging tray. The packaging tray contains the catheter assembly, which includes a catheter and a cannula connected to the catheter, the cannula having a curved portion between its proximal and distal portions. The method further includes the step of engaging the catheter with a first insert, thereby preventing the catheter from moving relative to the packaging tray. The method further includes the steps of rotating the cannula by a certain angle relative to the packaging tray, and engaging the catheter with a second insert, thereby preventing the cannula from moving relative to the packaging tray. The method further includes the step of thermal cycling the catheter assembly so that the static shape of the catheter assembly solidifies after the completion of thermal cycling.

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

[0048] After considering this disclosure, those skilled in the art will likely envision variations and modifications. The disclosed features may be embodied in any combination and partial combination (including multiple dependent and partial combinations) with one or more other features described herein. These various features, including any of their components, may be combined with or integrated into other systems. Furthermore, certain features may be omitted or not embodied. [Invention 1001] A catheter comprising a proximal portion, a longitudinal axis, a distal portion, and a catheter transition portion between the proximal and distal portions, wherein the longitudinal axis forms a curve. A cannula connected to the distal portion of the catheter, having a proximal portion of the cannula, a distal portion of the cannula, and a cannula transition portion including a curved portion between the proximal and distal portions of the cannula. Includes, When the cannula is inserted into the heart, the distal portion of the cannula is located in a first plane, the curve of the longitudinal axis of the catheter portion is located in a second plane, the first plane is different from the second plane and is angularly offset with respect to the second plane. Catheter assembly. [Invention 1002] A catheter assembly according to the present invention 1001, wherein the angular offset of the first plane with respect to the second plane is substantially equal to the angle between the plane of the aortic arch defined by the ascending and descending portions of the aorta and the plane defined by the ascending portion of the aorta and the apex of the left ventricle. [Invention 1003] A catheter assembly according to any one of the invention 1001 to 1002, wherein an angular offset is selected such that the catheter assembly has a predetermined anatomical shape when in a stationary state. [Invention 1004] A catheter assembly according to any of the present invention 1001 to 1003, wherein when the catheter assembly is inserted into the aorta, the angular offset biases the distal portion of the cannula toward the apex of the left ventricle. [Invention 1005] A catheter assembly according to any of the present invention 1001 to 1004, wherein the angular offset is approximately 64° to 125°. [Invention 1006] A catheter assembly according to any of invention 1001 to 1005, wherein the angular offset is approximately 92°. [Invention 1007] A catheter assembly according to any of the present invention 1001 to 1006, wherein the angle offset is such that the distal portion of the catheter faces the apex of the heart. [Invention 1008] A catheter assembly according to any one of the present invention 1001 to 1007, further comprising a stylet inserted into the catheter to adjust the shape of the distal portion of the catheter. [Invention 1009] A catheter handle, connected to the proximal portion of the catheter and rotated to adjust the position of the distal portion of the catheter. A catheter assembly further comprising any of the invention 1001 to 1008. [Invention 1010] A control mechanism connected to the proximal portion of the catheter and configured to adjust the position of the distal portion of the catheter after insertion. A catheter assembly according to any of the present invention 1001 to 1009, further comprising: [Invention 1011] A catheter including a proximal portion, a distal portion, and a catheter transition portion between the proximal and distal portions, A cannula connected to the distal portion of the catheter, having a proximal portion of the cannula, a distal portion of the cannula, and a cannula transition portion including a curved portion between the proximal and distal portions of the cannula. Includes, When the cannula is inserted into the patient's heart, the distal portion of the cannula is located in a first plane that is different from the second plane in which the patient's aortic arch is located and is angularly offset with respect to the second plane. Catheter assembly. [Invention 1012] A catheter assembly according to the present invention 1011, wherein the angular offset is substantially equal to or greater than the angle between the plane of the aortic arch defined by the ascending and descending portions of the aorta and the plane defined by the ascending portion of the aorta and the apex of the left ventricle. [Invention 1013] A catheter assembly according to the present invention 1011 or 1012, wherein an angular offset is selected such that the catheter assembly has a predetermined anatomical shape when in a stationary state. [Invention 1014] A catheter assembly according to any of invention 1011 to 1013, wherein when the catheter assembly is inserted into the patient's aorta, the angular offset biases the distal portion of the cannula toward the apex of the left ventricle. [Invention 1015] A catheter assembly according to any of the invention 1011 to 1014, wherein the angular offset is approximately 64° to 125°. [Invention 1016] A catheter assembly according to any of invention 1011 to 1015, wherein the angle offset is approximately 92°. [Invention 1017] A catheter assembly according to any of invention 1011 to 1016, wherein the angle offset is such that the distal portion of the catheter faces the apex of the heart. [Invention 1018] A catheter assembly according to any of the present invention 1011 to 1017, further comprising a stylet inserted into the catheter to adjust the shape of the distal portion of the catheter. [Invention 1019] A catheter handle, connected to the proximal portion of the catheter and rotated to adjust the position of the distal portion of the catheter. A catheter assembly further comprising any of the invention items 1011 to 1018. [Invention 1020] A control mechanism connected to the proximal portion of the catheter and configured to adjust the position of the distal portion of the catheter after insertion. A catheter assembly further comprising any of the invention items 1011 to 1019. [Invention 1021] A catheter assembly according to any of invention 1011 to 1020, comprising an inner polyamide layer and an outer polyurethane layer. [Invention 1022] A step of shaping the longitudinal axis of a catheter into the form of a curve located in a second plane, wherein the catheter includes a proximal portion, a longitudinal axis, a distal portion, and a catheter transition portion between the proximal and distal portions; A step of rotating a cannula relative to a catheter such that a first plane is angularly offset with respect to a second plane, wherein the cannula includes a longitudinal axis, a proximal portion of the cannula, a distal portion of the cannula, and a curved portion between the proximal and distal portions of the cannula, the distal portion of the cannula being located within the first plane; and The process of connecting the proximal portion of the cannula to the distal portion of the catheter. A method for shaping a catheter assembly into a desired anatomical form, including [details omitted]. [Invention 1023] The method of the present invention 1022, wherein the angular offset of the first plane with respect to the second plane is substantially equal to the angle between the plane of the aortic arch defined by the ascending and descending portions of the aorta and the plane defined by the ascending portion of the aorta and the apex of the left ventricle. [Invention 1024] The method of the present invention 1022 or 1023, wherein the step of rotating the cannula relative to the catheter is performed before connecting the proximal portion of the cannula to the distal portion of the catheter. [Invention 1025] Any method 1022 to 1024 of the present invention, wherein the step of rotating the cannula relative to the catheter occurs after the proximal portion of the cannula is connected to the distal portion of the catheter. [Invention 1026] Any method of the present invention 1022 to 1025, further comprising the step of engaging the catheter with a first insert before the rotation step, thereby preventing the catheter from moving relative to a second plane. [Invention 1027] Any method of the present invention 1022 to 1026, further comprising the step of engaging the catheter with a second insert before the rotation step, thereby preventing the movement of the distal portion of the cannula relative to the first plane. [Invention 1028] Any method of the present invention 1022 to 1027, further comprising the step of thermal cycling the catheter assembly after the rotation step so that the static shape of the catheter assembly solidifies after the completion of thermal cycling. [Invention 1029] A catheter assembly comprising a catheter and a cannula coupled to the catheter, wherein the cannula has a proximal portion, a distal portion, and a cannula transition portion including a curved portion between the proximal and distal portions, A packaging tray that houses the catheter assembly and includes a first insert and a second insert, the first insert being connected to the cannula and the second insert being connected to the catheter. Includes, The catheter is twisted between the first insert and the second insert by a certain angle of torsion so that the distal portion of the cannula rotates outward from the plane of the packaging tray at a first angle. A system for structuring catheter assemblies into a specific anatomical shape. [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 position. [Invention 1031] A system according to the present invention 1029 or 1030, wherein the first angle is approximately 60° to 140°. [Invention 1032] A system according to any of the invention 1029-1031, wherein when the catheter assembly is inserted into the patient's aorta, the first angle biases the distal portion of the cannula away from the mitral valve of the heart. [Invention 1033] A system according to any of the invention 1029 to 1032, wherein the first angle is substantially equal to the angle between the plane of the aortic arch defined by the ascending and descending portions of the aorta and the plane defined by the ascending portion of the aorta and the apex of the left ventricle. [Invention 1034] A system according to any of the invention 1029 to 1033, wherein the first angle is approximately 92°. [Invention 1035] A step of placing a catheter assembly inside a packaging tray, wherein the packaging tray contains the catheter assembly, and the catheter assembly includes a catheter and a cannula connected to the catheter, and the cannula includes a curved portion between the proximal and distal portions of the cannula; A step of engaging the catheter with a first insert, thereby preventing the catheter from moving relative to the packaging tray; A step of rotating the cannula by a certain angle relative to the packaging tray; The steps of engaging the catheter with a second insert, thereby preventing the cannula from moving relative to the packaging tray; and A process of thermally cycling a catheter assembly so that the static shape of the catheter assembly solidifies after the completion of thermal cycling. A method for shaping a catheter assembly into a desired anatomical form, including [details omitted]. [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 a desired plane of the distal portion of the cannula, and the rotation angle is configured such that the plane of the distal portion of the cannula is at the angle between the plane of the aortic arch and the desired plane of the distal portion of the cannula. [Brief explanation of the drawing]

[0049] The aforementioned and other objectives and advantages will become clear when the following detailed explanation is considered in conjunction with the attached drawings. Throughout the drawings, similar part numbers refer to similar parts.

[0050] [Figure 1] An exemplary prior art pump assembly is shown. [Figure 2] A top-down partial diagram of the prior art pump assembly located next to the mitral valve is shown. [Figure 3] A first exemplary embodiment of a pump assembly having a stationary shape that provides a closer anatomical fit than prior art pump assemblies is shown. [Figure 4] A top-down partial view of the first exemplary pump assembly, located next to the mitral valve, is shown. [Figure 5] A front view of a first exemplary embodiment of a pump assembly positioned next to a prior art pump assembly and a mitral valve is shown. [Figure 6] An isometric view of a first exemplary embodiment of a pump assembly located in a first portion of a packaging tray, configured to hold the cannula outside the plane of the packaging tray. [Figure 7] Figure 6 shows the first part of the packaging tray and a front view of the pump assembly. [Figure 8] Figure 6 shows a plan view of the first part of the packaging tray and the pump assembly. [Figure 9] Figure 6 shows the first part of the packaging tray and a side view of the pump assembly. [Figure 10] An isometric view of a second exemplary embodiment of the pump assembly, located in the first part of the packaging tray and held in place by a cover, is shown. [Figure 11] This shows the second part of the packaging tray, which is configured to hold the proximal portion of the catheter in a fixed position. [Figure 12] A third exemplary embodiment of the pump assembly is shown, in which the cannula is rotated approximately 90° relative to the catheter compared to the pump assembly in Figure 1. [Figure 13] A fourth exemplary embodiment of the pump assembly is shown, in which the cannula is rotated approximately 180° relative to the catheter compared to the pump assembly in Figure 1. [Figure 14] A fifth exemplary embodiment of the pump assembly is shown, in which the cannula is rotated approximately 270° relative to the catheter compared to the pump assembly in Figure 1. [Figure 15] A sixth exemplary embodiment of a pump assembly is shown, having a proximal and distal cannula portion held at a specific angle, and a catheter transition portion fixed in a curved shape that mimics the angle of the aortic arch. [Figure 16] A front view of a first exemplary embodiment of a pump assembly positioned within the left ventricle and aortic arch of a patient is shown. [Figure 17] Figure 16 shows a top-down view of the pump assembly. [Figure 18] An eighth exemplary embodiment of a pump assembly having a pre-formed backbone that affects the resting shape of the catheter is shown. [Figure 19] A ninth exemplary embodiment of a pump assembly having a first substantially straight catheter portion and a second curved catheter portion is shown. [Figure 20] A tenth exemplary embodiment of a pump assembly having a stylet inserted into a catheter, configured to adjust the resting shape of the catheter, is shown. [Figure 21] This illustrates an exemplary process for constructing the static shape of a pump assembly. [Modes for carrying out the invention]

[0051] Detailed explanation This specification describes systems, methods, and apparatus for providing a cardiac pump catheter assembly having a shape that facilitates the placement of the pump assembly within a patient. The catheter assembly may include a catheter and a cannula coupled thereto. The plane of the cannula may be angularly offset with respect to the plane of the catheter. In some embodiments, this angular offset is achieved by twisting the catheter and solidifying the shape of the catheter using heat or other methods. In other embodiments, the angular offset is achieved without twisting the catheter. For example, this may be achieved by rotating the cannula relative to the catheter before coupling the catheter and cannula, by pre-shaping the catheter backbone, and / or by rotating the handle and / or the catheter connection to the cannula. In addition to, or instead of, changing the angle of rotation between the catheter and the cannula, the cannula may also be translated in and / or out of the plane of the catheter and then shaped. The translation of the cannula in the plane of the catheter can be measured by the bending angle between the axis of the proximal portion of the cannula and the axis of the fixed proximal portion of the catheter. The translation of the cannula out of the catheter's plane can be measured by the angular offset between the plane of 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 toward the free space of the ventricle (e.g., the left ventricle). For example, this can facilitate the navigation and placement of the pump assembly in the left ventricle and reduce the occurrence of aspiration events and low blood flow alarms. The catheter can be molded so that the cannula is positioned at an angle toward the apex of the ventricle in the left ventricle, and the pump inlet is oriented so that it is located in the free space of the ventricle, thereby reducing the occurrence of aspiration of the heart wall and / or aspiration of biomaterials. The rotation angle of the cannula can result in a predetermined placement of the catheter and cannula to 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 a given cannula placement plane. In such cases, the rotation of the cannula relative to the catheter also biases 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 may also make the pump removal more difficult.

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

[0054] The novel baseline stress-free shape of the catheter, resulting from shaping the catheter spine during sterilization or by any other method described herein, reduces the need to apply torque to the catheter during insertion and positioning of the pump assembly into the patient's blood vessels (e.g., through the aorta and along the aortic arch). The improved catheter assembly may be useful for IMPELLA® 5.0 pumps, IMPELLA® 2.5 pumps, IMPELLA CP® pump assemblies adapted for use in the left ventricle, or for any other cardiac pump.

[0055] Furthermore, the relative position of the cannula and catheter can be selected to best suit the anatomical structure of a particular patient or patient group. This improved fit can also help reduce delivery time.

[0056] A stress-free catheter and a cannula rotated or translated away from the proximal portion of the catheter may be supplied in a tray (e.g., a packaging tray). Alternatively, a stress-free catheter and a cannula rotated or translated away from the proximal portion of the catheter may be manufactured or supplied without a tray. The tray may be configured to impart a twist to the catheter and maintain it therein before the 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 rotates and the distal portion of the cannula is at a certain angle to the plane of the tray. The tray may include a structure that allows the cannula to be positioned in a plane different from the plane of the catheter and the packaging tray. After the catheter assembly has been heat-treated in the desired position, e.g., the 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 / torsed shape in a stress-free, stationary state, and the cannula retains its shape and angular position.

[0057] Also disclosed herein are methods for manufacturing a catheter assembly having the above configuration. In one method, the proximal portion of the catheter is held in a fixed position, and the cannula is rotated and / or translated until the cannula is in a desired position relative to the catheter. Then, the cannula is held in a fixed position, and thermal cycling is performed. After the completion of the thermal cycling process, the shape of the catheter is fixed. In this configuration, once the shape is fixed, the catheter is no longer subjected to stress. In another method, the cannula, the catheter, or both are rotated relative to each other to achieve a specific 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 determine the shape of the assembly.

[0058] Figure 1 shows an exemplary diagram of a prior art packaged pump assembly 100. The packaged pump assembly 100 includes a tray 114, a tray portion 116, a flexible non-traumatic projection (also called a pigtail 102), a pump inlet 104, a distal cannula portion 106, a proximal cannula portion 108, a catheter 110, and a catheter end unit 112. The pigtail 102 extends from the inlet 104, which is adjacent to or located on the distal cannula portion 106. The distal cannula portion 106 is bent at an angle α from the proximal cannula portion 108. For example, the distal cannula portion 106 is bent at an angle α of approximately 35° from the proximal cannula portion 108. The proximal portion 108 is connected to the catheter 110, and the proximal portion 108 is aligned with the direction of the catheter 110, with no twisting between the proximal portion 108 and the catheter 110. The proximal portion 108 of the cannula is located at a distance 134 from the main edge of the tray, which is the same distance 132 between the portion of the catheter's internal groove 130 and the main edge of the tray. The proximal portion 106, distal portion 108, and catheter 110 are located on the upper surface plane of the tray portion 116, which is parallel to the main plane of the packaging tray 114. The catheter 110 is also connected to a catheter end unit 112, which may include a repositioning unit, plug, infusion filter, pressure reservoir, and check valve. The pigtail 102, distal portion 106, and proximal portion 108 are located within the tray portion 116, which is recessed relative to the rest of the tray 114. In the configuration shown in Figure 1, no torque is applied to the proximal portion 108, the distal portion 106, or the catheter 110. The catheter 110 may 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 rises and hardens when the temperature falls.The shape or spine of the catheter 110 provided by the tray 114 is solidified by the end of the sterilization process, and when the catheter 110 is removed from the tray 114 (for example, for use in a procedure), the catheter 110 substantially retains its shape such that the end of the catheter 110 aligns with the proximal portion 108 of the cannula.

[0059] As described above, once the catheter (e.g., catheter 100 in Figure 1) solidifies into this shape, it may be necessary 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 springs back. If the force applied to the catheter is too small, it becomes difficult to position the pump assembly to the desired location. However, if the force applied to the catheter is too large, it may result in the applied force being released in an uncontrollable manner and / or moving the pump to the wrong position, resulting in low flow rate or suction. Therefore, a maneuverable catheter (not shown) may be used to maneuver the catheter shaft and position the distal portion of the cannula into an anatomical structure. Such a maneuverable catheter may include a maneuvering mechanism in a handle outside the patient's body, which allows for repositioning by maneuver. However, while a maneuverable catheter helps to orient the cannula in the desired direction during insertion, it cannot allow for repositioning after initial insertion. Procedures requiring frequent repositioning also limit the amount of torque that can be safely applied to the catheter before the applied torque is released in an uncontrollable manner and the catheter springs back. Furthermore, while a maneuverable catheter helps position the cannula in the desired location, it is limited by the existing shape of the cannula (for example, the position of the distal portion 106 of the cannula relative to the catheter 110).

[0060] Figure 2 shows a top-down view of a conventional pump assembly (e.g., the prior art pump assembly 100 in Figure 1) in contact with the chordae tendineae 202 of the mitral valve 204 during cadaver dissection. As mentioned above in relation to Figure 1, the position of the catheter spine in the patient is influenced by how the pump assembly is held in its packaging tray. Also, in the case of conventional tray configurations (e.g., the tray configuration in Figure 1), the pump inlet tends to be located in or near the mitral valve and its structure when implanted in the patient (as shown in Figure 2). The pigtail and inlet portions of the conventional pump assembly 201 are entangled with the chordae tendineae 202 of the mitral valve 204. This entanglement can lead to a flaw in the placement of the inlet of the conventional pump assembly 201, for example by obstructing inflow, potentially resulting in low blood flow and reduced circulatory support to the patient.

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

[0062] The proximal portion 308 and distal portion 306 of the cannula are fixed to the tray 314 by a first tray portion 317. The midpoint of the cannula between its proximal portion 308 and distal portion 306 is located at a distance 334 from the main edge of the tray 314. The proximal portion 308 of the cannula is connected to a catheter transition portion 309, which is twisted between the proximal portion 308 of the cannula and a second tray portion 319 to which the catheter 303 is fixed to the tray 314. The catheter 303 can be fixed to the tray 314 at a distance 332 from the main edge of the tray. This distance 332 may be smaller than the distance 334 between the cannula and the main edge of the tray. Alternatively, the distance 332 may be larger than the distance 334 between the cannula and the main edge of the tray. The midpoint of the cannula is located at a distance 336 from the point to which the catheter is fixed. Distance 336 may be equal to 20% of the main length of the tray. In another example, distance 336 may be equal to 30%, 40%, 50%, or 60% of the main length of the tray. Alternatively, the distance between the point where the cannula 303 is fixed to the tray 314 and the junction between the cannula 303 and the 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. The proximal portion 306 and distal portion 308 of the cannula are in one plane that is angularly offset from the plane of the packaging tray 314. In another example, distance 336 may be greater than either distance 334 or 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 portion 309, as shown in Figure 9. Furthermore, translation and / or rotation of the cannula results in the distal portion 308 of the cannula rotating in the plane of the packaging tray and out of the plane of the packaging tray (corresponding to the plane of the aortic arch), as shown in Figures 8 and 9. The proximal portion of the catheter 311 is also connected to a catheter end unit 312, which may include a repositioning unit, plug, infusion filter, pressure reservoir, and check valve.

[0064] The proximal and transitional portions 309, 311 of the catheter may have a polyamide inner layer and a polyurethane outer layer. In addition, any of the catheters in the embodiments shown in Figures 3 and 12-14 may be braided to increase the amount of torque that can be safely applied after the pump assembly has been positioned.

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

[0066] In certain embodiments, the proximal portion of the cannula 308 is in a first plane, and the proximal portion of the catheter 311 is in a second plane that is not parallel to the first plane. The angular offset between the first and second planes is determined based on the desired arrangement of the cannula and catheter assembly. For example, as described with respect to Figure 2 above and Figures 4-5, 16 and 21 below, the desired anatomical position may be one in which the pump inlet is rotated and translated away from the mitral valve of the heart and directed toward the apex of the left ventricle. In one example, the angle θ2 between the first plane of the proximal portion of the cannula 308 and the second plane of the proximal portion of the catheter 311 is 40°. In one example, the angular offset between the plane of the distal portion of the cannula 306 and the plane of the aortic arch (for example, the plane of the packaging tray in the exemplary embodiment of Figure 3) is 70° to 120°. Preferably, the angular offset between the plane of the distal portion 306 of the cannula and the plane of the aortic arch is 80° to 110°. Preferably, the angular offset between the plane of the distal portion 306 of the cannula and the plane of the aortic arch is approximately 92°.

[0067] As described above, if the catheter (for example, catheter 100 in Figure 1) solidifies, for example as a result of thermal cycling, it may become difficult to insert the pump assembly into the patient because the amount of torque that can be safely applied to the catheter before the applied torque is released in an uncontrollable manner and the catheter bounces back is limited. The packaging tray 314 is one way to rotate the distal portion 306 of the cannula relative to the proximal portion 311 of the catheter, thereby allowing the catheter transition portion 309 to twist 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. Also, shaping the catheter transition portion 309 in this way reduces the risk of the cannula 303 becoming immobile in the chordae tendineae, thus contributing to a reduction in delivery time. Alternatively, the rotation of the distal portion 306 of the cannula can be performed in the absence of the packaging tray, or after the pump assembly has been removed from the packaging tray.

[0068] Figure 4 shows a top-down view of a first exemplary embodiment of a pump assembly located at a distance from the chordae tendineae 402 of the mitral valve 404 during cadaver dissection. As shown, the pigtail and inlet portions 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, and the inlet portion is not blocked. This, on the other hand, can reduce the risk of aspiration and / or low blood flow through the pump due to incorrect pump placement.

[0069] Figure 5 shows a front view of a conventional pump assembly and a first exemplary embodiment of the pump assembly, positioned in the left ventricle across the aortic valve. Figure 5 shows exemplary embodiments of the aorta 501, mitral valve 504, chordae tendineae 502, conventional pump assembly 503, and pump assembly 505. 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 interfere with the distal portion of the cannula 506, as also shown in Figure 2. In contrast, when the first exemplary embodiment of the pump assembly 505 is positioned therein, the distal portion of the cannula separates 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 position (e.g., biased away from the mitral valve) is determined using software such as Mimics®. This angle is the desired angle at which the distal portion of the cannula (and pump) should be positioned relative to the plane of the aortic arch in order to obtain an assembly shape that provides anatomical fit. As an example, the distal portion of the cannula can also be angled relative to the packaging tray to achieve this shape and provide a closer anatomical fit. The anatomically optimal rotation angle of the distal portion of the cannula relative to the plane of the aortic arch (shown in Figure 17) may depend on the patient's physique and anatomical structure. The aortic arch varies in size and shape, and the size of the ventricles varies based on physique and age. In one study, the mean rotation angle of the distal portion of the cannula (and associated catheter transition torsion angle) varied between 125° and 65°, respectively, with a preferred angle of 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] Figures 6–9 show various views of the first portion 600 of a packaging tray that holds a first exemplary pump assembly. The cannula 603 includes a pigtail 602, an inlet 604, a distal portion 606, and a proximal portion 608. The angle θ1 between the proximal portion 608 and the axis of the proximal portion of the catheter is shown in at least Figure 8. The dihedral angle θ2 between the proximal portion 608 and the plane on which the connected catheter is positioned (e.g., the main plane of the packaging tray) is shown in at least Figure 9. The first portion of the packaging tray may include a base 620 and a projection 621. The base 620 may be added to an existing packaging tray as an insert placed in a recess 116 of the tray 114 shown in Figure 1, for example. Alternatively, the base 620 may be integrated with the packaging tray (e.g., the tray 514 shown in Figure 5). The projection 621 is located in the center of the base 620 and supports both the distal portion 606 and the proximal portion 608 of the cannula. Alternatively, the projection 621 may support either the proximal portion 608 or the distal portion 606. The top of the projection 621 follows the shape of the proximal and distal portions 606 of the cannula. The length of the projection 621 may vary between 25% and 75% of the length of the base 620. The height of the projection 621 may vary and may be configured so that the pigtail 602 does not come into contact with the base 620. Alternatively, the shape of the projection 621 may be adapted to accommodate different cannula shapes.

[0072] Figure 7 shows a front view of the first portion 600 of the 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 portion 622 that can hold the cannula in place, for example, by press fitting. In any embodiment described herein, the ridge portion may hold a portion or the entire length of the cannula. For example, the ridge portion may contact 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, or 90% of the cannula. In another example, the ridge portion may be replaced with a groove, for example, a 3D-printed groove, or a thermoformed cavity configured to grip the cannula.

[0073] Figure 10 shows an isometric view of a first portion 1000 of a packaging tray (not shown) holding a second exemplary embodiment of the pump assembly. The first portion 1000 includes a base 1020, a projection 1021, a ridge 1022, and a cover 1017, the cover having projections 1022, 1024, and 1023. The base 1020, ridge 1022, and projection 1021 may be analogous to the corresponding components shown in Figures 7-9. The cover 1017 provides further support for maintaining the cannula in a fixed position relative to the packaging tray. A portion of the cannula is compressed between the ridge 1022 and the projection 1019 of the cover 1017. The ridge 1022 may be a press-fit ridge. In addition, projections 1023 and 1024 may lock with projections positioned on the packaging tray to ensure no movement relative to the packaging tray. Ensuring that the catheter transition portion (not shown) solidifies into a shape that provides a better anatomical fit improves ease of use, reduces the time required to pump the device to the heart and position it, and reduces aspiration and / or low-flow events due to mispositioning. Further means of securing the cannula 1025 to the base 1020 provide redundancy and ensure that the catheter transition portion solidifies in the desired anatomical position despite twisting the cannula body relative to the catheter.

[0074] Figure 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, protrusions 1137, 1134, 1136, and 1138. The proximal portion of the catheter (e.g., the proximal portion 511 in Figure 5) must also be fixed in place relative to the packaging tray before the catheter transfer portion receives torque and the cannula is fixed in place relative to the packaging tray (e.g., as described with respect to Figure 10). The second portion 1100 may be integrated 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 joint 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 be closed so that the grip pad 1132 is positioned above and below the catheter. The grip pad 1132 may be coated with an anti-slip or high-friction material to resist the torque applied to the catheter. The outward projections 1136 and 1134 interlock with each other to secure the second portion 1100 in a crimped position. Similarly, the inward projections 1137 and 1138 interlock to secure the second portion 1100 in a crimped position. In any embodiment described herein, the tray insert or integral portion may be replaced by a groove or trough that fits into the tray. For example, a groove for fitting the catheter and holding the catheter in a desired position may be 3D printed.

[0076] As described above, ensuring that the catheter solidifies into a shape that provides a better anatomical fit contributes to reducing delivery time. In one example, this can be achieved by ensuring that the catheter transition portion solidifies into a shape that provides a better anatomical fit. The combination of the grip pad 1132 and the projections 1136, 1134 and 1137, 1138 of both sets secures the catheter to the packaging tray and ensures that the catheter transition portion solidifies into the desired anatomical position despite the torque or stress applied to the catheter transition portion from rotating the cannula relative to the catheter.

[0077] Figure 12 shows a third exemplary embodiment of the pump assembly. The pump assembly includes a tray portion 1216, a pigtail 1202, a distal cannula portion 1206, a proximal cannula portion 1208, and a catheter transition portion 1210. This third exemplary embodiment is similar to the embodiment shown in Figure 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 are omitted for clarity. Rotating the cannula 90° relative to the catheter provides different anatomical fits for the catheter transition portion, which may be beneficial for specific patient anatomical structures. The 90° rotation also allows the pigtail to be separated from the tray, preventing damage to the pigtail during packaging.

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

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

[0080] Figure 15 shows a sixth exemplary embodiment of the pump assembly. The pump assembly includes a packaging tray 1514, a tray portion 1516, a pigtail 1502, a distal cannula portion 1506, a proximal cannula 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 distal cannula portion 1506. The distal cannula portion 1506 is bent at a certain angle from the proximal cannula portion 1508. For example, the distal cannula portion 1506 is bent at an angle α of 35° from the proximal cannula portion 1508. In some embodiments, the distal cannula portion 1506 is bent at an angle α of 25° to 45° from the proximal portion 1508.

[0081] The proximal and distal portions of the cannula 1508 and 1506 are secured to the tray 1514 by a first tray portion (not shown) in a recessed tray portion 1516. The proximal portion of the cannula 1508 is connected to a catheter transition portion 1509, which is twisted between the proximal portion of the cannula 1508 and a second tray portion 1511, to which the catheter is secured to the tray 1514. As in the embodiments shown in Figures 5 and 12-14, the proximal portion of the cannula 1508 may be angled by an angle θ2 (e.g., shown in Figure 9) from the plane of the packaging tray 1514. The angle θ2, angle θ1 (e.g., shown in Figure 8), and catheter twist angle between the proximal portion of the cannula 1508 and the plane of the tray define the shape of the catheter transition portion 1509. In addition, the positions of multiple elements of the second tray portion 1511 may be configured to achieve a "positional packaging" configuration such that the majority of the catheter length 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 proximal portion of the catheter 1513 is also connected to a catheter end unit 1512, which may include a repositioning unit, plug, injection filter, pressure reservoir, and check valve. Rotating the catheter end unit 1512 relative to the proximal portion 1513 of the catheter may reduce the torque applied to the proximal portion of the catheter in the tray before sterilization.

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

[0084] As shown in the figure, the distal portion of the cannula 1614 is positioned to face the ventricular apex 1606. For reference, Figure 17 shows an exemplary arrangement of cannula 1650 and cannula 1660 in an alternative cannula configuration having an angular offset γ between the plane containing the catheter (catheter portions 1608 and 1609) and the plane containing the distal portion 1614 of cannula 1660. As shown in Figures 16 and 17, the distal portion 1614 of cannula 1660 and the catheter portion 1608 are in different planes, and the angular offset γ between the plane of the aortic arch 1604 and the planes of the proximal portion 1610 and distal portion 1614 of cannula 1660 biases cannula 1660 toward the ventricular apex 1601. The rotation of the distal portion 1614 of the cannula relative to the catheter portion 1608 biases the distal portion 1614 away from the chordae tendineae that actuate the mitral valve, thereby reducing the risk of the pump assembly 1601 becoming immobile after being pumped through the aortic valve into the left ventricle. This rotation can also reduce the occurrence of aspiration of the cardiac wall and / or biomaterial by the pump assembly 1601.

[0085] Figure 18 shows an eighth exemplary embodiment of a pump assembly. The pump assembly includes a pigtail 1802, a distal cannula portion 1806, a proximal cannula portion 1808, a catheter portion 1810, a catheter end unit 1812, and a backbone 1820. The pigtail 1802 extends from the distal cannula portion 1806. The backbone 1820 may be a pre-formed internal or external backbone. For example, the backbone may be made of nitinol or a similar shape memory material. The backbone 1820 extends along the entire length of the catheter portion 1810 and may provide stability and shape memory for the catheter portion 1810. By pre-forming the catheter backbone 1820 to impart a rotation angle to the distal cannula portion 1806, it may be possible to achieve the rotation angle with only relatively small changes to the existing manufacturing process. For example, in some embodiments, pre-forming the backbone requires fewer changes to the manufacturing process than rotating the catheter during sterilization.

[0086] Figure 19 shows 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 distal cannula portion 1906, a proximal cannula portion 1908, a distal catheter portion 1909, a proximal catheter portion 1910, and a catheter end unit 1912 (details not shown). The exemplary plane 1920 is the plane in which the curve of the longitudinal axis of the catheter portion (encompassing the proximal catheter portion 1909 and the distal catheter portion 1910) is located in a stationary state. The proximal cannula portion 1908 is also located in the exemplary plane 1920 in a stationary state. The pigtail 1902 extends from the distal cannula portion 1906 and is angled by an angle β from the plane of the exemplary plane 1920. The proximal catheter portion 1910 may be kept substantially straight, and the distal catheter portion 1909 may be molded for anatomical fit. For example, the distal portion of the catheter 1909 may be formed into a plane 1920 that may be the plane of the patient's aortic arch. The forming of the distal portion of the catheter 1909 may be carried out in combination with the use of a packaging tray (e.g., packaging tray 314 in Figure 3) or without the use of a packaging tray. The forming of the distal portion of the catheter 1909 may be carried out as an integrated step in the manufacturing process or as an additional step performed on an already manufactured pump assembly. For example, the distal portion of the catheter 1909 may be formed on the aortic arch in a manner similar to that used to form the JL4 catheter. To pre-form the catheter, the catheter may be annealed at a temperature of 50°C to 80°C, preferably 60°C. As a result of forming the distal portion of the catheter 1909, the distal portion of the cannula 1902 may be positioned outside the reference plane 1920. For example, as described with respect to Figures 16 and 17, the distal portion of the cannula 1902 may be positioned at an angle to the plane of the aortic arch such that the distal portion of the cannula points the pigtail 1902 toward the apex of the ventricle.Pre-shaping the distal portion of the catheter 1909 on the aortic arch positions the distal portion of the cannula 1902 outside the reference plane 1920, thereby biasing the distal portion of the cannula 1902 away from the chordae tendineae that actuate the mitral valve, and thus facilitating the insertion of the pump assembly 1901 by reducing the risk of the pump assembly 1901 becoming immobile after being pumped through the aortic valve into the left ventricle.

[0087] Figure 20 shows a tenth exemplary embodiment of the pump assembly. The pump assembly includes a pigtail 2002, a distal cannula portion 2006, a proximal cannula portion 2008, a catheter portion 2010, a catheter end unit 2012, and at least one stylet 2020. The pigtail 2002 extends from the distal cannula portion 2006. At least one stylet 2020 is a reshaping wire inserted into the catheter portion 2010 and may be used to adjust the catheter portion 2010 to obtain an anatomical fit to a particular anatomical structure. For example, the stylet 2020 may 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 a certain angle from the plane of the aortic arch in which the catheter portion 2010 is located. Such angles are shown, for example, in the exemplary embodiments of Figures 16 and 17. Various types of stylet 2020 may be used in this exemplary embodiment. For example, the stylet 2020 may be made of metal or polymer. This exemplary embodiment using the stylet 2020 may be used in place of, or in combination with, the pre-formed backbone of the exemplary embodiment shown in Figure 18. Multiple stylets 2020 of various shapes may be used sequentially until the distal portion of the cannula 2006 is positioned in the desired location.

[0088] Figure 21 shows an exemplary method 2100 for configuring a stationary shape of a pump assembly, for example, one of the exemplary embodiments shown in Figures 5–15. Method 2100 can be embodied to configure a catheter that is part of a pump assembly (for example, pump assembly 100 shown in Figure 1) which includes, but is not limited to, a pump assembly described in any of the embodiments described in Figures 5–15. The catheter and cannula may have a resulting stationary shape that conforms to the anatomical structure of the patient's left ventricle and aortic arch.

[0089] In step 2102, the pump assembly is placed in the tray package. The pump assembly may include a cannula having a proximal and distal portion, and a catheter having a proximal portion and a cannula transition portion, which may be distal to the proximal portion. In step 2104, the proximal portion of the catheter is held in place in the packaging tray. The proximal portion of the catheter may be held in place by an integral part of the packaging tray or by 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 the desired position. Alternatively, an insert such as a butterfly clip or any other suitable clip or gripping element that can withstand torque may be used.

[0090] In step 2106, the pump assembly is rotated with the proximal catheter fixed, causing it to twist the catheter transition portion. The pump assembly is rotated with the proximal catheter fixed until the catheter transition portion reaches the desired shape and desired twist angle. The twist angle of the catheter transition portion may be approximately equal to or greater than the angle between the axis of the descending aorta and a given cannula placement position. 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 for the selection of a twist angle to suit the anatomical structure of a particular patient or patient group. As described above in relation to θ1 and θ2, the cannula may be translated parallel to the axis of the proximal portion of the catheter and to the plane of the packaging tray.

[0091] In step 2108, the proximal portion of the cannula, now rotated and translated, is secured to the packaging tray. The proximal portion of the cannula may be held in place by an integral part of the packaging tray or by an insert added to the packaging tray, while the distal portion of the cannula may be held in place by an integral part of the packaging tray or by an added insert. As described in steps 2104 and 2108, securing both the cannula and the proximal portion of the catheter to the packaging tray ensures that the catheter transition portion maintains the desired twist during thermal cycling. In an alternative embodiment, one 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 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 solidifies into the desired shape. For example, the temperature may be in the range of 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 may vary between -40°C and 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 may 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). Catheter material softens as the temperature rises and solidifies as the temperature falls. The shape of the catheter or spine, particularly the shape of the catheter transition portion, is solidified by the end of the sterilization process, and the catheter transition portion substantially retains its shape when it is no longer in the tray (for example, when the catheter is being used in a procedure).

[0093] The use of a packaging tray allows the catheter transition section to twist, enabling the cannula to rotate and translate to a position of better anatomical fit, thereby reducing delivery time to the patient. The twisting of the catheter transition section also contributes to reduced delivery time by reducing the risk of the cannula becoming immobile in the chordae tendineae during insertion.

[0094] After considering this disclosure, those skilled in the art will likely envision variations and modifications. For example, in some embodiments, any of the embodiments shown in Figures 3 and 6-20 may be combined. For instance, the first portion of the packaging tray in Figures 6-9 and the second portion of the packaging tray in Figure 10 may be enclosed in 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 embodiments shown in Figures 3 and 6-21, with or without the use of a packaging tray. The disclosed features may be embodied in any combination and partial combination (including multiple dependent and partial combinations) with one or more other features described herein. The various features described and illustrated above, including any of their components, may be combined with or integrated into other systems. Furthermore, certain features may be omitted or not embodied.

[0095] It is important to note that the structure and arrangement of the apparatus or its components as shown in the various exemplary embodiments are illustrative only. Although only a few embodiments are described in detail in this disclosure, a person skilled in the art who considers this disclosure will readily understand that numerous modifications are possible without substantially departing from the novel teachings and merits of the disclosed subject matter (e.g., changes in the size, dimensions, structure, shape and proportions of various elements, parameter values, mounting structures, material use, color, orientation, etc.). For example, elements shown as being formed as a single unit may consist 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 rearranged according to alternative embodiments. Furthermore, other substitutions, modifications, changes and omissions may be made in the design, operating conditions and arrangement of various exemplary embodiments without departing from the scope of this disclosure.

[0096] While various inventive embodiments are described and illustrated herein, those skilled in the art will readily conceive of a variety of other mechanisms and / or structures for performing a function and / or obtaining one or more of the results and / or benefits described herein, and each such change and / or modification will be considered within the scope of the inventive embodiments described herein. More generally, those skilled in the art will readily understand that, unless otherwise noted, any parameters, dimensions, materials and configurations described herein are intended to be illustrative, and that actual parameters, dimensions, materials and / or configurations will depend on the specific application (one or more) in which the inventive teachings are used. Those skilled in the art will be able to recognize or confirm many equivalents of the particular inventive embodiments described herein by means of very conventional experimentation. Thus, it will be understood that the embodiments are presented only as examples, and that within the scope of the claims and their equivalents, the inventive embodiments can be carried out in ways other than those specifically described and claimed. The inventive embodiments of this disclosure relate to each of the individual features, systems, articles, materials, kits and / or methods described herein. In addition, any combination of two or more such features, systems, articles, materials, kits, and / or methods is included in the inventive scope of this disclosure, provided that they are not contradictory.

[0097] In relation to this disclosure, the term “joining” means a direct or indirect joining of two members to one another. Such joinings may be static or movable. Such joinings may be achieved by two members or two members and any further intermediate members being formed integrally with each other as a single body, or by two members or two members and any further intermediate members being attached to each other. Such joinings may be permanent or removable or detachable.

[0098] As used herein and in the claims, the singular indefinite article should be understood to mean “at least one” unless it is explicitly indicated otherwise. As used herein and in the claims, “or” should be understood to have the same meaning as “and / or” as defined above. For example, when dividing items in a list, “or” or “and / or” must be interpreted as inclusive, that is, including the number of elements or at least one in the list, but also including more than one, and optionally including further items not in the list. Only terms that are explicitly indicated as not being inclusive, 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, as used herein, the term “or” should be interpreted as indicating an exclusive selection (i.e., “one or the other, but not both”) only when followed by a term indicating exclusivity, such as “either of ~,” “one of ~,” “only one of ~” or “exactly one of ~.”

[0099] In the claims and the above specification, all transitional phrases, such as “including,” “having,” “containing,” “accompanying,” “holding,” and “composed of,” should be understood to be non-restrictive, that is, “including, but not limited to.”

[0100] Unless otherwise stated, the claims should not be read as being limited to the order or elements described. It should be understood that various modifications in form and detail can be made by those skilled in the art without departing from the spirit and scope of the claims. All embodiments falling within the spirit and scope of the following claims and their equivalents are claimed.

[0101] Examples of modifications, substitutions, and alterations are verifiable by those skilled in the art and can be implemented without departing from the scope of the information disclosed herein. All references cited herein are incorporated by reference as a whole and constitute part of this application.

Claims

1. A catheter assembly comprising a catheter and a cannula coupled to the catheter, wherein the catheter comprises a proximal portion and a distal portion, and the cannula comprises a proximal portion, a distal portion, and a curved portion between the proximal and distal portions, A packaging tray comprising a first part and a second part, wherein the first part is configured to hold the proximal portion of the cannula in a fixed position relative to the packaging tray, and the second part is configured to hold the proximal portion of the catheter in a fixed position relative to the packaging tray. Includes, The catheter is twisted by a certain angle between the first and second parts such that the distal portion of the cannula rotates or translates outward from the plane of the packaging tray at a first angle, and the first and second parts are configured to maintain the twist of the catheter. A system for structuring catheter assemblies into a specific anatomical shape.

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

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

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

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

6. The system according to 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 the plane defined by the ascending portion of the aorta and the apex of the left ventricle.

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

8. The system according to claim 1, wherein the 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 according to claim 8, wherein the recess or groove is configured to hold the proximal portion of the cannula by press fitting.

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

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

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

13. A method for configuring a catheter assembly into a certain anatomical shape using the system described in Claim 1, wherein the system comprises: The process involves positioning the proximal portion of the catheter in the second part of the packaging tray such that the second part holds the proximal portion of the catheter in a fixed position relative to the packaging tray, A step of twisting the catheter by a certain twist angle such that the distal portion of the cannula rotates or moves parallel to the outside of the plane of the packaging tray at a first angle, A step of positioning the proximal portion of the cannula on the first part of the packaging tray such that the first part holds the proximal portion of the cannula in a fixed position relative to the packaging tray, When the catheter assembly is removed from the packaging tray, the catheter is given the step of retaining the twist. Methods that include...

Images