Patent Description:
A blood pump assembly is introduced in the circulatory system to deliver blood between locations in the circulatory system or heart. For example, when the blood pump assembly is deployed in the arterial system the blood pump assembly pulls blood from the left ventricle of the heart and expels the blood into the aorta. In another example, when the blood pump is deployed in the venous system, the blood pump pulls blood from the inferior vena cava, or pulls blood from the right atrium of the heart or the superior vena cava, and expels the blood into the pulmonary artery. Blood pump assemblies are introduced surgically or percutaneously during a cardiac procedure. In one approach when accessing the venous system or right heart, pump assemblies are inserted by a catheterization procedure through the femoral vein using an access sheath (introducer) and a guidewire.

During a catheterization procedure, an introducer is inserted into the femoral vein through an veinotomy to create an insertion path. The insertion path is used to advance a placement guidewire into the artery. For example, the insertion path is used to advance a placement guidewire through the right heart and into the pulmonary artery. Once the guidewire has been inserted into the artery (for example, the pulmonary artery), the pump assembly is backloaded onto the proximal end of the guidewire and pushed into the patient along the guidewire. The pump assembly may include a pump head including an impeller, a cannula, and a catheter.

The pump assembly is commonly loaded by a process called backloading, which involves inserting the proximal end of the guidewire into the distal end of the cannula and then advancing the cannula distally over the guidewire until the pump head is placed in a specified location. Backloading the pump assembly allows the guidewire to remain in position within the patient during the course of a procedure. However, commonly used cannulas of the pump assembly have a tortuous shape, and in some situations the cannula stiffness may prevent the cannula from advancing distally over the guidewire without displacing the guidewire or without extending the length of the procedure. For example, for systems delivering blood from the inferior vena cava to an opening in the pulmonary artery, commonly used cannulas have a fixed stiffness and a 3D shape having two "S" turns. This can make backloading and insertion of the cannula and pump assembly into a patient particularly difficult. The force required to bend a cannula, e.g., during insertion, can be measured as the force in Newtons required to obtain a <NUM> deflection of a cannula sample during a <NUM>-point bend rigidity test. Particular prior art is for instance disclosed in <CIT>, <CIT>, <CIT>, <CIT> and <CIT>.

According to the invention, a percutaneous pump system comprising the features of claim <NUM> is provided. A cannula supporting a percutaneous pump includes a proximal section with a first flexural modulus. The cannula also includes one or more distal sections with a flexural modulus different than the first flexural modulus. The flexural moduli are configured to allow efficient positioning of the cannula in a desired location without displacing the guidewire.

The systems, methods, and devices described herein provide an improved cannula that is configured to facilitate backloading of the pump assembly into the venous system of a patient over a guidewire. The cannula disclosed herein can be inserted into the system of a patient through an arteriotomy, or by veinotomy, or other procedures. The cannula has a stiffness that varies along its length to facilitate backloading of the cannula to a desired location within the heart (e.g., a patient's right heart) without displacing a guidewire. In particular, the cannula is flexible enough at its distal end to follow the guidewire without unnecessary displacement of the guidewire, but stiff enough at its proximal end to guide the cannula into place during backloading. To achieve this variable stiffness, the proximal section of the cannula may be made of a material or combination of materials which is stiffer than a material or combination of materials of the distal section of the guidewire. The lower stiffness of the distal section helps the cannula follow the path of the guidewire, and the higher stiffness of the proximal section increases the force required to buckle the cannula. In addition to facilitating initial delivery, the higher stiffness of the proximal section makes the cannula easier to guide once it has been inserted inside the patient, thereby reducing the amount of force required to exert on the proximal end during insertion. Reducing the amount of force required by varying the stiffness of the proximal section of the cannula also reduces the probability of kinking or buckling of the cannula during insertion. Varying the cannula stiffness also contributes to reducing the delivery time by improving adaptability and conformance to the anatomy of a particular patient, or improving conformance to a wider variation of patient anatomies. The improved cannula is particularly helpful for cannulas having complex or tortuous geometries, such as the cannulas used with the IMPELLA RP® pump or any other pump adapted for use in the right heart (e.g., between the inferior vena cava and the pulmonary artery).

The improved cannula disclosed herein can provide a number of additional advantages. For example, varying the stiffness of the cannula such that different portions of the cannula have different stiffnesses allows the cannula to be better suited for the anatomy of a particular patient, and this better fit helps reduce the delivery time. Furthermore, the variable stiffness cannula can improve manufacturability and can better accommodate larger tolerances for parts or processes.

In one aspect, a system for the insertion of a percutaneous pump comprises a cannula having a proximal inlet, a proximal section, a first distal section, and a distal outlet. The system also comprises a percutaneous pump coupled to the proximal inlet, and a transition zone between the proximal section and the first distal section. The proximal section has a first flexural modulus and the first distal section has a second flexural modulus which is smaller than the first flexural modulus.

In certain implementations, the transition zone is a fused transition zone. In some implementations the fused transition zone may have a length of up to <NUM> centimeters. Material properties may gradually change over the length of the transition zone.

In certain implementations, the fused transition zone is a thermally fused transition zone.

According to the invention as claimed, the first flexural modulus is configured to increase a buckling force of the cannula and the second flexural modulus is configured to match, (e.g., approximate) a flexural modulus of a guidewire on which the cannula is backloaded. In some implementations not according to the invention as claimed, the second flexural modulus may be configured to be less or significantly less than a flexural modulus of the guidewire on which the cannula is backloaded.

In certain implementations, the distal outlet is configured to be inserted in a ventricle of a heart. In some implementations, the distal outlet is configured to be inserted through the right heart into the pulmonary artery.

In certain implementations, the proximal section of the cannula includes a proximal inner wall made of a first material and a proximal outer wall made of a second material, wherein a flexural modulus of the second material is greater than a flexural modulus of the first material.

In certain implementations, the first flexural modulus is greater than <NUM>,<NUM> psi (<NUM> psi = <NUM> kPa), and the second flexural modulus is lower than <NUM>,<NUM> psi. In some implementations, the first flexural modulus is between <NUM>,<NUM> psi and <NUM>,<NUM> psi, and the second flexural modulus is between <NUM>,<NUM> psi and <NUM>,<NUM> psi. In some implementations, the first flexural modulus is between <NUM>,<NUM> psi and <NUM>,<NUM> psi, and the second flexural modulus is between <NUM>,<NUM> psi and <NUM>,<NUM> psi.

In certain implementations, the first distal section of the cannula includes a first distal inner wall made of a first material and a first distal outer wall made of a second material, wherein a flexural modulus of the second material is greater than a flexural modulus of the first material.

In certain implementations, the cannula includes an inner wall and an outer wall and a reinforced coil located between the inner wall and an outer wall. In some implementations, the reinforced coil has a constant pitch length.

In certain implementations, a length of the proximal section is between about <NUM>%-<NUM>% of a length of the cannula.

In certain implementations, the cannula includes distal sections between the first distal section and a distal end. In some implementations, a second distal section between the first distal section and a distal end. In certain implementations, there is a second fused transition between the first distal section and a second distal section. In some implementations, there is a second thermofused transition between the first distal section and a second distal section.

In certain implementations, a length of the second distal section is between about <NUM>-<NUM>% of a length of the cannula.

In certain implementations, a first material of the proximal section is a thermoplastic polyurethane. In some implementations, a first material of the proximal section is a TT1065™ polyurethane. In certain implementations, a second material of the distal section is a thermoplastic polyurethane. In some implementations, a second material of the distal section is a TT1055™ polyurethane.

In another aspect, a cannula is used for inserting a percutaneous pump, the cannula comprising a proximal inlet coupled to the percutaneous pump, a proximal section with a first flexural modulus, and a first distal section thermally fused to the proximal section, the first distal section having a second flexural modulus which is smaller than the first flexural modulus.

In certain implementations, the first flexural modulus is configured to increase a buckling force of the cannula and the second flexural modulus is configured to match a flexural modulus of a guidewire on which the cannula is backloaded.

In certain implementations, the transition zone is a fused transition zone.

In certain implementations, the first flexural modulus is configured to increase a buckling force of the cannula and the second flexural modulus is configured to match, (e.g., approximate) a flexural modulus of a guidewire on which the cannula is backloaded.

In certain implementations, the distal outlet is configured to be inserted in a ventricle of a heart. In some implementations, the distal outlet is configured to be inserted in a right ventricle of the heart.

In another aspect, a method (not claimed) for percutaneously inserting a cannula into a ventricle of a heart comprises inserting a distal section of a cannula over a guidewire into the ventricle, and pushing a proximal section of the cannula over the guidewire into the ventricle, where a flexural modulus of the proximal section of the cannula is greater than a flexural modulus of the distal section of the modulus. In some implementations, the ventricle is the right ventricle of the heart.

To provide an overall understanding of the systems, methods, and devices described herein, certain illustrative embodiments will be described. Although the embodiments and features described herein are specifically described for use in connection with a percutaneous blood pump system for the right heart, it will be understood that all the components and other features outlined below may be combined with one another in any suitable manner and may be adapted and applied to blood pump systems for the left heart, left ventricle, or other types of cardiac therapy and cardiac assist devices, including balloon pumps, cardiac assist devices implanted using a surgical incision, and the like. Examples of specific implementations and applications are provided primarily for illustrative purposes.

The systems, methods, and devices described herein provide an improved cannula that is configured to facilitate backloading of the cannula into the arterial system of a patient over a guidewire. In particular, the cannula is flexible enough in its distal region to follow the guidewire without unnecessary displacement of the guidewire, but stiff enough at its proximal end to guide the cannula into place during backloading. To achieve this variable stiffness, the proximal section of the cannula may be made of a material or combination of materials which is stiffer than a material or combination of materials of the distal section of the guidewire. The lower stiffness of the distal section helps the cannula follow the path of the guidewire, and the higher stiffness of the proximal section increases the force required to buckle the cannula. In addition to facilitating initial delivery, the higher stiffness of the proximal section makes the cannula easier to guide once it has been inserted inside the patient, thereby reducing the amount of force physicians have to exert on the proximal end during insertion. Reducing the amount of force required also reduces the probability of kinking or buckling of the cannula during insertion. Varying the cannula stiffness also contributes to reducing the delivery time by improving conformance to the anatomy of a particular patient, or improving conformance to a wider range of patient anatomies. The improved cannula is particularly helpful for cannulas having complex or tortuous geometries, such as the cannulas used with the IMPELLA RP® pump or any other pump adapted for use in the right heart (e.g., between the inferior vena cava and the pulmonary artery). Furthermore, the method of manufacturing the improved cannula allows for greater tolerances than manufacturing methods for existing cannulas.

<FIG> shows an illustrative embodiment of a blood pump assembly <NUM>. The skilled artisan will understand that the embodiment of <FIG> is illustrative and not intended to limit the scope of the subject matter described herein. The blood pump assembly <NUM> includes a pump <NUM>, a pump housing <NUM>, a proximal end <NUM>, a distal end <NUM>, a cannula <NUM>, an impeller (not shown), a catheter <NUM>, an inlet area <NUM>, an outlet area <NUM>, and sensor <NUM>. The catheter <NUM> is connected to the inlet area <NUM> of the cannula <NUM>. The inlet area <NUM> is located near the proximal end <NUM> of the cannula, and the outlet area <NUM> is located toward the distal end <NUM> of the cannula <NUM>. The inlet area <NUM> includes a pump housing <NUM> with a peripheral wall <NUM> located radially outward from, and extending about, a rotation axis of the impeller blades (not shown). The impeller (not shown) is rotatably coupled to the pump <NUM> at the inlet area <NUM> adjacent to the sensor <NUM> on the wall <NUM> of the pump housing <NUM>. The pump housing <NUM> may be composed of a metal in accordance with implementations.

The embodiments described in <FIG> can be applied to a blood pump assembly as shown in <FIG>, or can be applied to any other blood pump assembly configuration, such as a blood pump assembly including an external motor located at a proximal end of a drive shaft, the external motor controlling blades located at a distal end of the driveshaft.

The cannula <NUM> has a shape which conforms to the anatomy of the right heart of a patient. In this exemplary embodiment, the cannula has a proximal end <NUM> arranged to be located near the patient's inferior vena cava, and a distal end <NUM> arranged to be located near the pulmonary artery. The cannula <NUM> includes a first segment S1 extending from the inflow area to a point B between the inlet area <NUM> and the outlet area <NUM>. The cannula <NUM> also includes a second segment S2 extending from a point C, which is an inflection between the inlet area <NUM> and the outlet area <NUM>, to the outlet area <NUM>. In some implementations, B and C may be at the same location along the cannula <NUM>. The first segment S1 of the cannula is curved, for example forming an 'S' shape in a first plane. In some implementations, the segment S1 can have curvatures between about <NUM>° and <NUM>° (e.g., <NUM>°, <NUM>°, <NUM>°, <NUM>°, <NUM>°, <NUM>°, <NUM>°, <NUM>°, <NUM>°, <NUM>°, <NUM>°, <NUM>°, <NUM>°, or <NUM>°). The second segment S2 of the cannula is curved, for example forming an 'S' shape in a second plane. In some implementations, segment S2 can have curvatures between about <NUM>° and <NUM>° (e.g., <NUM>°, <NUM>°, <NUM>°, <NUM>°, <NUM>°, <NUM>°, <NUM>°, <NUM>°, <NUM>°, <NUM>°, <NUM>°, <NUM>°, <NUM>°, or <NUM>°). The second plane can be different from the first plane. In some implementations, the second plane is parallel or identical to the first plane. In certain implementations, the second plane is oblique or perpendicular to the first plane.

<FIG> shows a lateral cross-section of a conventional cannula <NUM> labeled as prior art. The skilled artisan will understand that the embodiment of <FIG> is illustrative and not intended to limit the scope of the subject matter described herein. The conventional cannula includes a main section <NUM>, a coil wire <NUM>, and a bore through which the blood circulates, referred to as the lumen <NUM>, through which passes a guidewire <NUM>. The coil wire <NUM> is located within a wall of the main section <NUM>. The coil wire <NUM> comprises a wire of circular cross section, such as a round wire. In the embodiment of <FIG>, and in any other embodiment described herein in <FIG>, the coil wire <NUM> or its equivalent is positioned over a first inner layer, and covered and sealed by a second layer, e.g. a lamination layer. The materials of the first inner layer and second outer layer, located respectively below and above the coil wire <NUM> may be different materials or may be made of the same material. For example, the coil wire <NUM> is located between an inner layer (e.g., a thermoplastic polyurethane such as Dermopan) and an outer layer (e.g., a thermoplastic polyurethane such as TT1065). The main section <NUM> is made of a single material, for example dispensed 55D polyurethane. The main section <NUM> has a constant outer diameter and a constant inner diameter, and the coil wire <NUM> has a constant pitch <NUM>, made of the single material. As a result, the main section <NUM> has a constant flexural modulus.

As discussed above, when a cannula (e.g., cannula <NUM> in <FIG>) is too stiff, backloading and insertion of a pump assembly (e.g., pump assembly <NUM> in <FIG>) into a patient may be undesirably difficult. Accordingly, some physicians may use a cannula with a coil wire which has a variable pitch length to modify the stiffness of the cannula and to position the cannula without displacing the guidewire <NUM> out of the pulmonary valve. However, when the coil wire pitch length is varied, the kink resistance of the cannula may be compromised because the coil wire pitch length affects the minimum bend radius of the cannula. Furthermore, for particular pumps, such as the IMPELLA RP® pump which is used in combination with a curved cannula (e.g., cannula <NUM> in <FIG>), decreasing kink resistance by varying the coil wire pitch length may result in damage to the patient's artery because varying the coil wire pitch length affects the spring constant of the cannula and makes the cannula harder to control.

<FIG> shows a lateral cross-section of a first illustrative embodiment of a cannula <NUM>, having a similar general structure as the cannula <NUM> (<FIG>) but including a variable stiffness along its length. The skilled artisan will understand that the embodiment of <FIG> is illustrative and not intended to limit the scope of the subject matter described herein. The cannula <NUM> has a variable stiffness along its length. The stiffness of the cannula <NUM> may vary along its length due to the use of different materials, the use of a variable diameter or coil pitch, and/or a combination of the use of different materials and a variable diameter or coil pitch. The cannula <NUM> includes a proximal section <NUM>, which is near the impeller, a first distal section <NUM>, which is near the pump head, a transition region <NUM>, a coil wire <NUM> wound around the cannula, a lumen <NUM>, and a guidewire <NUM>. The guidewire <NUM> passes through the lumen <NUM>. Instead of a single main section <NUM> as in the conventional cannula <NUM>, the cannula <NUM> includes two sections, the proximal section <NUM> and the first distal section <NUM>. The proximal section <NUM> is used to push the cannula onto the guidewire <NUM>. The first distal section <NUM> follows the guidewire <NUM> to enter the patient and is coupled to the proximal section <NUM> by the transition region <NUM>. In some embodiments, the transition region spans between <NUM>-<NUM>% of the cannula length and has a flexibility modulus that varies from its proximal to distal ends, thereby joining the proximal and distal regions of the cannula with a variable flexural modulus. The coil wire <NUM> is located within a wall <NUM> of the proximal section <NUM> and the first distal section <NUM>.

The proximal section <NUM> is made of a first material. The first material may have a flexural modulus between about <NUM>,<NUM> psi psi (<NUM> psi = <NUM> kPa) and <NUM>,<NUM> psi, preferably between <NUM>,<NUM> psi and <NUM>,<NUM> psi. The first material may have a first flexural modulus between <NUM>,<NUM> psi and <NUM>,<NUM> psi. For example, the proximal section <NUM> may be made of TT1065™ TPU (thermoplastic polyurethane), a thermoplastic, a polymer, or any other material that becomes pliable above a specific temperature and solidifies upon cooling. For example, the proximal section <NUM> may be constructed of preferred thermoplastics (e.g., polyurethanes) exhibiting solvent resistance and biostability over a wide range of hardnesses and can be configured to have varied hardness levels. The proximal section <NUM> has a constant diameter, the coil wire <NUM> has a constant pitch <NUM>, and the proximal section <NUM> has a first flexural modulus.

The first distal section <NUM> is made of a second material, for example a material with a flexural modulus between about <NUM>,<NUM> psi psi (<NUM> psi = <NUM> kPa) and <NUM>,<NUM> psi, preferably between <NUM>,<NUM> psi and <NUM>,<NUM> psi. The second material may have a second flexural modulus between <NUM>,<NUM> psi and <NUM>,<NUM> psi. For example, the first distal section <NUM> may be made of TT1055™ TPU. The first distal section <NUM> has a constant diameter, the coil wire <NUM> has a constant pitch <NUM>, and the first distal section <NUM> has a second flexural modulus. The second flexural modulus is smaller than the first flexural modulus of the proximal section <NUM>. In some implementations, no coil wire is included in the cannula <NUM> (and thereby reducing the tendency of the cannula to buckle).

The lower stiffness of the first distal section <NUM> helps the cannula <NUM> follow the path of the guidewire <NUM>. Simultaneously, the higher stiffness of the proximal section <NUM> improves delivery of the cannula <NUM> by increasing the buckling force of the cannula <NUM>. The higher stiffness of the proximal section <NUM> also makes it easier to convert force applied on the cannula <NUM> into movement of the cannula inside the patient, thereby reducing the amount of force required to exert on the proximal end during insertion. The higher stiffness of the proximal section also reduces the probability that the cannula <NUM> will kink or buckle during insertion.

To further reduce the probability of kinking or buckling during insertion, the stiffness of the cannula can be varied along its length, for example over three different sections, as shown in <FIG> shows a lateral cross-section of a second illustrative embodiment of a cannula <NUM>. The skilled artisan will understand that the embodiment of <FIG> is illustrative and not intended to limit the scope of the subject matter described herein. The cannula <NUM> has a variable stiffness along its length. The stiffness of the cannula <NUM> may vary along its length due to the use of different materials, the use of a variable diameter or coil pitch, and/or a combination of the use of different materials and a variable diameter or coil pitch. The cannula <NUM> includes a proximal section <NUM>, a first transition region <NUM>, a first distal section <NUM>, a second transition region <NUM>, a second distal section <NUM>, a coil wire <NUM> wound around the cannula, a lumen <NUM>, and a guidewire <NUM>. The guidewire <NUM> passes through the lumen <NUM>.

Instead of a single main section <NUM> as in the conventional cannula <NUM>, the cannula <NUM> of <FIG> includes three sections, the proximal section <NUM>, the first distal section <NUM> and the second distal section <NUM>. As shown, the first distal section is fit between the proximal section and the second distal section. The stiffness in the proximal, first distal and second distal sections will preferably vary. The proximal section <NUM> can be used by physicians to push the cannula onto the guidewire <NUM>, the first distal section <NUM> retains its shape but follows the guidewire inside the patient, and the second distal section <NUM> follows the guidewire <NUM> to enter the patient. The proximal section <NUM> and the first distal section <NUM> are coupled by the first transition region <NUM>, which may be a thermofused transition region, a heat shrink sleeve or a lap joint. The first distal section <NUM> and the second distal section <NUM> are coupled by the second transition region <NUM>, which may be a thermofused transition. As referred to herein "thermofused" means connected as a result of a thermic reaction between materials. For example, a first distal section <NUM> made of plastic may be thermofused with a second distal section <NUM> made of plastic. A transition refers to the region connecting two elements, such as the region where a plastic of the first distal section fused with a plastic of the second distal section by a thermic reaction.

In the embodiment shown in <FIG>, the coil wire <NUM> is located within the wall of the proximal section <NUM>, the first distal section <NUM>, and the second distal section <NUM>. In some implementations, no coil wire is included. The proximal section <NUM> can be made of a first material. For example, the first material may be TT1065™ polyurethane. The proximal section <NUM> may have a constant diameter, the coil wire <NUM> may have a constant pitch <NUM>, and the proximal section <NUM> may have a first flexural modulus. The first distal section <NUM> is made of a second material. For example, the second material may be TT1055™ polyurethane. The first distal section <NUM> has a constant diameter, the coil wire <NUM> has a constant pitch <NUM>, and the first distal section <NUM> has a second flexural modulus. The second flexural modulus is smaller than the first flexural modulus of the proximal section <NUM>. The second distal section <NUM> is made of a third material. For example, the third material may be TT1055™ polyurethane. The second distal section <NUM> has a constant diameter, the coil wire <NUM> has a constant pitch <NUM>, and the second distal section <NUM> has a third flexural modulus. The third flexural modulus is smaller than the first flexural modulus of the proximal section <NUM> and the second flexural modulus of the first distal section <NUM>. In some implementations transitions <NUM> and <NUM> may be any other type of transition, such as transition using adhesives or fasteners, a transition created by interference fits, or as a result of welding or overmolding.

Alternatively, at any transition described in <FIG>, for example transition region <NUM> between the first distal section <NUM> and the second distal section <NUM> in <FIG>, two sections may be connected by using a solvent material or an adhesive material. Alternatively, a heat shrink sleeve may be positioned over the transition region to seal both sections together. A lap joint may be used to connect both sections. A transition region may use a vertical transition such as transition region <NUM> as shown in <FIG>, or a transition with a tapered or angled cross-section, to reduce the potential for kinks to develop at the transition region.

In the embodiment of <FIG>, the presence of three sections instead of two sections further improves the cannula with respect to the embodiment in <FIG>. For example, three sections may be used to conform to the anatomy of a particular patient, or to conform to different types of patient anatomies. As noted above, varying the cannula stiffness can facilitate delivery. The lower stiffness of the second distal section <NUM> helps the cannula <NUM> follow the path of the guidewire <NUM>. The stiffness of the first distal section <NUM> enables the first distal section to also follow the path of the guidewire and simultaneously to better transmit force applied on the proximal section <NUM>. As noted above, the higher stiffness of the proximal section <NUM> improves delivery of the cannula <NUM>.

<FIG> shows a lateral cross-section of a third illustrative embodiment of a cannula <NUM> having a cannula with multiple sections that provide varying stiffness along the length of the cannula. The skilled artisan will understand that the embodiment of <FIG> is illustrative and not intended to limit the scope of the subject matter described herein. The cannula <NUM> has a variable stiffness along its length. The stiffness of the cannula <NUM> may vary along its length due to the use of different materials, the use of a variable diameter or coil pitch, and/or a combination of the use of different materials and a variable diameter or coil pitch. The cannula <NUM> includes a proximal section <NUM>, a transition <NUM>, a first distal section <NUM>, a coil wire <NUM>, a lumen <NUM>, and a guidewire <NUM>. The guidewire <NUM> passes through the lumen <NUM>. Instead of a single main section <NUM> as in the conventional cannula <NUM>, the cannula <NUM> includes two sections, the proximal section <NUM> and the first distal section <NUM>. The proximal section <NUM> can be used by physicians to push the cannula onto the guidewire <NUM>. The first distal section <NUM> follows the guidewire <NUM> to enter the patient, and is coupled to the proximal section <NUM> by the transition <NUM>. The coil wire <NUM> is located within the wall of the proximal section and the first distal section. The proximal section <NUM> is made of a first material. For example, the first material may be TT1065™ polyurethane. The first distal section <NUM> is made of a second material. For example, the second material may be TT1055™ polyurethane. The proximal section <NUM> and the first distal section <NUM> have constant diameters. The coil wire <NUM> has a variable pitch which increases along a longitudinal axis of the cannula, with coil wire pitch <NUM> being smaller than coil wire pitch <NUM> and greater than coil wire pitch <NUM>, the smaller pitch resulting in higher rigidity. In some implementations, the coil wire pitch may be constant for proximal section <NUM>, and the coil wire pitch may be constant for first distal section <NUM> but smaller than the coil wire pitch for proximal section <NUM>. The proximal section <NUM> has a first flexural modulus, and the first distal section <NUM> has a second flexural modulus. The second flexural modulus is smaller than the first flexural modulus of the proximal section <NUM>. The stiffness of the cannula (and its deliverability) are improved by using a coil wire <NUM> with a decreasing pitch, and by selecting materials with differing flexural moduli for the proximal section <NUM> and the first distal section <NUM>. The combination of these features varies the cannula's stiffness, thereby facilitating delivery.

<FIG> shows a lateral cross-section of a fourth illustrative embodiment of a cannula <NUM>. The skilled artisan will understand that the embodiment of <FIG> is illustrative and not intended to limit the scope of the subject matter described herein. The cannula <NUM> has a variable stiffness along its length. The stiffness of the cannula <NUM> may vary along its length due to the use of different materials, the use of a variable diameter or coil pitch, and/or a combination of the use of different materials and a variable diameter or coil pitch. The cannula <NUM> includes a proximal section <NUM>, a first distal section <NUM>, a coil wire <NUM>, a lumen <NUM>, and a guidewire <NUM>. The cannula may include a coil wire <NUM>, similar to the coil wires described in relation to <FIG> and <FIG> that follow. The guidewire <NUM> passes through the lumen <NUM>. Instead of using a uniform material for the proximal section wall and using a uniform material for the first distal section wall, as in the conventional cannula <NUM>, for each section the cannula <NUM> includes an inner layer and an outer layer which are concentric and use different materials, a first material in the inner layer and a second material in the outer layer. The proximal section <NUM> is made of an inner layer <NUM> and an outer layer <NUM>. The first distal section <NUM> is made of an inner layer <NUM> and an outer layer <NUM>. The proximal section <NUM> has a first flexural modulus, and the first distal section <NUM> has a second flexural modulus. The second flexural modulus is smaller than the first flexural modulus of the proximal section <NUM>. The presence of an inner layer <NUM> and an outer layer <NUM> with different material properties, in combination with a proximal section <NUM> and the first distal section <NUM> having different flexural moduli further improves delivery of the cannula. The stiffness of the cannula can be modified by selecting material properties both in a longitudinal (proximal-distal) direction and in a radial (inner-outer) direction. For example, the flexural modulus for the first section is greater than <NUM>,<NUM> psi (<NUM> psi = <NUM> kPa), and the flexural modulus for the second section is smaller than <NUM>,<NUM> psi. In another example, the flexural modulus for the first section is equal to or greater than <NUM>,<NUM> psi, and the flexural modulus for the second section is equal to or lower than <NUM>,<NUM> psi. As noted above, varying the cannula stiffness can reduce the delivery time.

<FIG> shows a lateral cross-section of a fifth illustrative embodiment of a cannula <NUM>. The skilled artisan will understand that the embodiment of <FIG> is illustrative and not intended to limit the scope of the subject matter described herein. The cannula <NUM> includes a main section <NUM>, a coil wire <NUM>, and a bore through which the blood circulates, referred to as the lumen <NUM>, through which passes a guidewire <NUM>. The coil wire <NUM> is located within a wall of the main section <NUM>. In this fifth embodiment, the coil wire <NUM> comprises a wire of rectangular cross section, such as a wire ribbon. In the embodiment of <FIG>, and in any other embodiment described herein in <FIG> and <FIG>, the coil wire <NUM> or its equivalent is positioned over a first inner layer, and covered and sealed by a second layer, e.g. a lamination layer. The materials of the first inner layer and second outer layer, located respectively below and above the coil wire <NUM> may be different materials or may be made of the same material. For example, the coil wire <NUM> is located between an inner layer (e.g., a thermoplastic polyurethane such as Dermopan) and an outer layer (e.g., a thermoplastic polyurethane such as TT1065). The main section <NUM> is made of a single material, for example dispensed 55D polyurethane. The main section <NUM> has a constant outer diameter and a constant inner diameter, and the coil wire <NUM> has a constant pitch <NUM>, made of the single material. As a result, the main section <NUM> has a constant flexural modulus.

<FIG> shows a lateral cross-section of a sixth illustrative embodiment of a cannula <NUM> having a cannula with multiple sections that provide varying stiffness along the length of the cannula. The skilled artisan will understand that the embodiment of <FIG> is illustrative and not intended to limit the scope of the subject matter described herein. The cannula <NUM> has a variable stiffness along its length. The stiffness of the cannula <NUM> may vary along its length due to the use of different materials, the use of a variable diameter or coil pitch, and/or a combination of the use of different materials and a variable diameter or coil pitch. The cannula <NUM> includes a proximal section <NUM>, a first transition <NUM>, a first distal section <NUM>, a second transition <NUM>, a second distal section <NUM>, a coil wire <NUM>, a lumen <NUM>, and a guidewire <NUM>. The guidewire <NUM> passes through the lumen <NUM>. Instead of a single main section <NUM> as in the conventional cannula <NUM> shown in <FIG>, the cannula <NUM> includes three sections, the proximal section <NUM>, the first distal section <NUM>, and the second distal section <NUM>. The proximal section <NUM> can be used by physicians to push the cannula onto the guidewire <NUM>. The first distal section <NUM> and the second distal section <NUM> follows the guidewire <NUM> to enter the patient, where the first distal section <NUM> is coupled to the proximal section <NUM> by the first transition <NUM>. The coil wire <NUM> is located within the wall of the proximal section <NUM>, the first distal section <NUM> and the second distal section <NUM>. The coil wire <NUM> may comprise a round wire. The proximal section <NUM> is made of a first material. For example, the first material may be TT1065™ polyurethane. The first distal section <NUM> is made of a second material. For example, the second material may be TT1055™ polyurethane. The second distal section <NUM> is made of a third material. For example, the third material may be TT1065™ polyurethane. The proximal section <NUM>, the first distal section <NUM> and the second distal section <NUM> have constant diameters. The coil wire <NUM> has a variable pitch which increases along a longitudinal axis of the cannula, with coil wire pitch <NUM> being smaller than coil wire pitch <NUM> and greater than coil wire pitch <NUM>, the smaller pitch resulting in higher rigidity. In some implementations, the coil wire pitch may be constant for proximal section <NUM>, and the coil wire pitch may be constant for first distal section <NUM> but smaller than the coil wire pitch for proximal section <NUM>, and, further, the coil wire pitch may be constant for second distal section <NUM> but smaller than the coil wire pitch for proximal section <NUM>. The proximal section <NUM> has a first flexural modulus, the first distal section <NUM> has a second flexural modulus, and the second distal section <NUM> has a third flexural modulus. The second flexural modulus and the third flexural modulus are each smaller than the first flexural modulus of the proximal section <NUM>. The stiffness of the cannula (and its deliverability) are improved by using a coil wire <NUM> with a decreasing pitch, and by selecting materials with differing flexural moduli for the proximal section <NUM> and the first distal section <NUM>. The combination of these features varies the cannula's stiffness, thereby facilitating delivery. In certain embodiments, the coil wire <NUM> may comprise a wire ribbon. In certain embodiments, the coil wire pitches <NUM>-<NUM> may differ from each other, and in other embodiments, at least two of the pitches <NUM>-<NUM> may be the same.

<FIG> shows a lateral cross-section of a seventh illustrative embodiment of a cannula <NUM>. The skilled artisan will understand that the embodiment of <FIG> is illustrative and not intended to limit the scope of the subject matter described herein. The cannula <NUM> has a variable stiffness along its length. The stiffness of the cannula <NUM> may vary along its length due to the use of different materials, the use of a variable diameter or coil pitch, and/or a combination of the use of different materials and a variable diameter or coil pitch. The cannula <NUM> includes a proximal section <NUM>, a first distal section <NUM>, a coil wire <NUM>, a lumen <NUM>, and a guidewire <NUM>. The cannula may include a coil wire <NUM>, similar to the coil wires described in relation to <FIG>, that is the coil wire <NUM> may comprise a round wire or a wire ribbon. The guidewire <NUM> passes through the lumen <NUM>. Instead of using a uniform material for the proximal section wall and using a uniform material for the first distal section wall, as in the conventional cannula <NUM>, for each section the cannula <NUM> includes an inner layer and an outer layer which are concentric and use different materials, a first material in the inner layer and a second material in the outer layer. The proximal section <NUM> is made of an inner layer <NUM> and an outer layer <NUM>. The first distal section <NUM> is made of the same inner layer <NUM> and an outer layer <NUM>. Therefore in this embodiment, the inner layer <NUM> lines the inner surface of the proximal section <NUM> and the first distal section <NUM>. As the inner layer <NUM> of cannula <NUM> is the same for both the proximal section <NUM> and first distal section <NUM>, cannula <NUM> offers improved manufacturability. The proximal section <NUM> has a first flexural modulus, and the first distal section <NUM> has a second flexural modulus. The second flexural modulus is smaller than the first flexural modulus of the proximal section <NUM>. The presence of an inner layer <NUM> and an outer layer <NUM> with different material properties, in combination with a proximal section <NUM> and the first distal section <NUM> having different flexural moduli further improves delivery of the cannula. The stiffness of the cannula can be modified by selecting material properties both in a longitudinal (proximal-distal) direction and in a radial (inner-outer) direction. For example, the flexural modulus for the first section is greater than <NUM>,<NUM> psi (<NUM> psi = <NUM> kPa), and the flexural modulus for the second section is smaller than <NUM>,<NUM> psi. In another example, the flexural modulus for the first section is equal to or greater than <NUM>,<NUM> psi, and the flexural modulus for the second section is equal to or lower than <NUM>,<NUM> psi. As noted above, varying the cannula stiffness can reduce the delivery time.

<FIG> shows a table summarizing material properties of exemplary embodiments of the cannula shown in <FIG>. The skilled artisan will understand that the table of <FIG> is illustrative and not intended to limit the scope of the subject matter described herein. The table indicates combinations of materials used for an inner layer of a cannula, for example layer <NUM> in <FIG> and materials used for an outer layer of a cannula, for example layer <NUM> in <FIG>, along with the resulting cannula section stiffness, for example the stiffness of the proximal section <NUM> in <FIG>, measured as the force in Newtons required to obtain a <NUM> deflection during a <NUM>-point bend rigidity test for a cannula sample with a constant coil pitch length. As indicated in <FIG>, certain combinations of inner and outer materials require less force to obtain the <NUM> deflection than the conventional cannula section. For example, only <NUM> N are required for a TT1055™ inner layer and a TT1055™ outer layer as opposed to the <NUM> N required for a conventional cannula with inner and outer layers made of the same Dispensed 55D material. The flexural modulus for TT1055™ may be lower than <NUM>,<NUM> psi (<NUM> psi = <NUM> kPa), e.g., between <NUM>,<NUM> psi and <NUM>,<NUM> psi, and the flexural modulus for TT1065™ may be greater than <NUM>,<NUM> psi, e.g., between <NUM>,<NUM> psi and <NUM>,<NUM> psi. The flexural modulus for the second material (e.g., TT1055™) may be <NUM>,<NUM> psi and the flexural modulus for the first material (e.g., TT1065™) may be <NUM>,<NUM> psi.

<FIG> shows a method <NUM> (not claimed) for inserting a cannula according to certain implementations. The skilled artisan will understand that the method of <FIG> is illustrative and not intended to limit the scope of the subject matter described herein. The method <NUM> may be implemented to insert a cannula which is part of a pump assembly (e.g., pump assembly <NUM> shown in <FIG>) onto a guidewire using a cannula, as disclosed or enabled by this disclosure, for example the cannulas described in any of the aforementioned implementations in <FIG>. The cannulas in the aforementioned implementations of <FIG> have a variable stiffness along its length. The stiffness of the cannulas may vary along their lengths due to the use of different materials, due to the use of a variable diameter or coil pitch, and/or due to a combination of the use of different materials and a variable diameter or coil pitch. The cannula may have a shape which matches the anatomy of a heart. For example, the cannula may have a shape which matches the right heart, e.g., the shape of the right ventricle.

In step <NUM>, the distal end of the cannula is inserted over a guidewire. The cannula includes a proximal section and a distal section which can include more than one distal section, such as first and second distal sections or more. The proximal section may be used to push the cannula onto the guidewire. The distal sections follow the guidewire to enter the patient and are coupled to the proximal section. The proximal section may be stiffer than the distal sections. A lower stiffness of a distal section helps the cannula follow the path of the guidewire. Simultaneously, the higher stiffness of the proximal section improves delivery of the cannula by increasing the buckling force of the cannula. The higher stiffness of the proximal section also makes easier transmitting force applied on the cannula into movement of the cannula inside the patient, thereby reducing the amount of force physicians have to exert on the proximal end during insertion. The variable stiffness of the cannula can reduce the delivery time from an average delivery time of between about <NUM> minutes and <NUM> minutes (depending on the patient and procedure) to an average of about <NUM> minutes to <NUM> minutes or less.

The method <NUM> further includes positioning a distal section of the cannula over the guidewire and applying pressure on the proximal section of the cannula to position the cannula in a desired location without displacing the guidewire (step <NUM>). The proximal section may be used to push the cannula to its desired location. The proximal section may be stiffer than the distal section. The higher stiffness of the proximal section also makes easier transmitting force applied on the cannula into movement of the cannula inside the patient, thereby reducing the amount of force required to exert on the proximal end during insertion. Simultaneously, a lower stiffness of the distal section (e.g., first distal section) offers a lower resistance as the cannula is pushed along the path of the guidewire. The variable stiffness of the cannula can reduce the delivery time from an average delivery time of between about <NUM> minutes and <NUM> minutes (depending on the patient and procedure) to an average of about <NUM> minutes to <NUM> minutes or less.

Variations and modifications will occur to those of skill in the art after reviewing this disclosure. For example, in some implementations, any of the alternative embodiments described in <FIG> may be combined. For example, the varying pitch coil structure of the cannula in <FIG> may be combined with the different guidewire materials described with respect to <FIG>. In another example, the different inner and outer layers of <FIG> may be combined with any of the proximal and distal material combinations shown in <FIG> and <FIG>. Further, while the cannula described in the aforementioned sections comprises various grades of polyurethane, it will be understood that other material choices are available. These include high-density polyethylene (HDPE) material, medium-density polyethylene (MDPE) material, low-density polyethylene (LDPE) material, polyether ether ketone (PEEK), polyether block amide (such as PEBAX) and polyester. The various features described or illustrated above, including any components thereof, may be combined or integrated in other systems. Moreover, certain features may be omitted or not implemented. For example, the internal structure of the cannulas described in the aforementioned embodiments may be adopted in a corkscrew shape cannula which could be made using a thermoform process, such as that described in <CIT>.

It is important to note that the constructions and arrangements of apparatuses or the components thereof as shown in the various exemplary implementations are illustrative only. It is, therefore, to be understood that the foregoing implementations are presented by way of example only and that, within the scope of the appended claims, implementations may be practiced otherwise than as specifically described.

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

" As used herein in the specification and in the claims, "or" should be understood to have the same meaning as "and/or" as defined above. Only terms clearly indicated to the contrary, such as "only one of" or "exactly one of" will refer to the inclusion of exactly one element of a number or list of elements.

It should be understood that various changes in form and detail may be made by one of ordinary skill in the art without departing from the scope of the appended claims.

Claim 1:
A percutaneous pump system, the system comprising:
a cannula (<NUM>) having a proximal inlet (<NUM>), a proximal section (<NUM>), a first distal section (<NUM>), and a distal outlet (<NUM>);
a percutaneous pump (<NUM>) configured to couple to the proximal inlet (<NUM>); and
a guidewire (<NUM>) on which the cannula (<NUM>) can be backloaded,
wherein the cannula (<NUM>) has a transition zone (<NUM>) between the proximal section (<NUM>) and the first distal section (<NUM>) and the proximal section (<NUM>) has a first flexural modulus and the first distal section (<NUM>) has a second flexural modulus which is smaller than the first flexural modulus,
characterized in that the first flexural modulus is configured to increase a buckling force of the cannula (<NUM>) and the second flexural modulus is configured to match a flexural modulus of the guidewire (<NUM>).