DE102013008158A1 - Distal bearing carrier - Google Patents

Abstract

In various embodiments, a catheter pump is disclosed herein. The catheter pump may include an elongated catheter body having a distal portion including an expandable cannula having an inlet and an outlet. The expandable cannula may have a deployment profile and an operational profile that is larger than the deployment profile. An impeller assembly may include an impeller shaft and an impeller body may include one or more blades. The impeller blades may draw blood into the cannula when rotated. Further, an expandable support may include a mounting portion disposed on the impeller shaft distal to the impeller body and a cannula-contacting portion for reducing a change in the tip gap due to bending of the cannula. The cannula-contacting portion may be located distal to the attachment portion.

Description

CONCLUSION BY REFERENCE TO ANY PRIORITY NOTIFICATION

All applications for which a foreign or domestic priority claim is set forth in the application data sheet as filed with the present application, including U.S. Application No. 61 / 646,755, filed May 14, 2012, entitled Distal Bearing Support, are hereby incorporated by reference Reference under 37 CFR § 1.57 included.

GENERAL PRIOR ART

Field of the invention

This application relates to pumps for the mechanical circulatory support of a heart. In particular, this application relates to support structures for an impeller assembly that may be used in a catheter pump.

Description of the Prior Art

Heart disease is a serious health problem with a high mortality rate. Doctors are increasingly using mechanical circulatory support systems to treat heart failure. The treatment of acute heart failure requires a device that can quickly provide help to the patient. Doctors want treatment options that can be used quickly and minimally invasively.

Intra-aortic balloon pumps (IABP) are currently the most common type of circulatory support device for the treatment of acute heart failure. IABPs are commonly used to treat heart failure in order to stabilize a patient after cardiogenic shock, during treatment of acute myocardial infarction (MI) or congestive heart failure, or to assist a patient during a high-risk percutaneous coronary intervention (PCI). Circulatory support systems may be used alone or in conjunction with pharmacological treatment.

In a conventional approach, an IABP is positioned in the aorta and actuated by counterpulsation to provide partial support to the circulatory system. In recent years, in an attempt to increase the level of potential support (i.e., higher flow), minimally invasive rotary blood pumps have been developed. A rotary blood pump is typically inserted into the body and connected to the cardiovascular system, for example, the left ventricle and the ascending aorta, to assist the pumping function of the heart. Other known applications pump venous blood from the right ventricle to the pulmonary artery to support the right side of the heart. One goal of acute circulatory support devices is to reduce the load on the heart muscle for a period of time to stabilize the patient prior to heart transplantation or for ongoing support.

There is a need for improved mechanical circulatory support devices for the treatment of acute heart failure. Fixed-chamber ventricular assist devices designed to provide near-complete cardiac output are either too large for percutaneous advancement (eg, through the femoral artery without an incision) or provide insufficient flow.

There is a need for a pump with improved performance and clinical results. There is a need for a pump that can provide increased flow rates with reduced risk of hemolysis and thrombosis. There is a need for a pump that is minimally invasive and can provide adequate flow rates for various indications while reducing the risk of serious adverse events. In one aspect, there is a need for a heart pump that can be minimally invasively placed, for example, by a 15 Fr or 12 Fr cut. In one aspect, there is a need for a heart pump that can provide an average flow rate of 4 l / min or more during operation, for example 62 mmHg pressure altitude. While the flow rate of a rotary pump can be increased by spinning the impeller faster, higher rotational speeds are known to increase the risk of hemolysis, which can lead to undesirable results and in some cases death. Accordingly, in one aspect, there is a need for a pump that can provide sufficient flow while minimizing the likelihood of hemolysis at high rotational speeds. These and other problems are overcome by the inventions described herein.

Further, there is a need to provide an operative device of the pump capable of pumping blood at high flow rates while reducing the risk of hemolysis on the operative device. For example, if an impeller assembly is provided to the operative device, the high speed of the impeller may cause hemolysis when blood bypasses the high speed impeller. Accordingly, there is a need to reduce the risk of hemolysis at the surgical device of the pump, especially when moving components are placed on the operative device.

SUMMARY OF THE INVENTION

There is an urgent need for a pumping device that can be inserted percutaneously and can also provide full cardiac output to the left, right or left and right sides of the heart, if necessary.

In one embodiment, a catheter pump is disclosed. The catheter pump may include an elongated catheter body having a distal portion including an expandable cannula having an inlet and an outlet. The expandable cannula may have a deployment profile and an operational profile that is larger than the deployment profile. An impeller assembly may include an impeller shaft, and an impeller body may include one or more blades. The impeller blades, when rotated, can draw blood into the cannula. Further, an expandable support may include a mounting portion disposed on the impeller shaft distal from the impeller body and configured to maintain a position of the impeller relative to a cannula wall. In some embodiments, a motor may be disposed at a proximal end of the elongate catheter body such that the motor remains away from the impeller when used outside the patient. A reclosable member may be located distally of the impeller in some embodiments. Further, the reclosable member may be coupled to a bearing coupled to the impeller, thereby allowing the impeller to rotate in the bearing structure while the reclosable member is held stationary distally of, but in alignment with, the impeller.

In another embodiment, a catheter pump is disclosed. The catheter pump may include an elongated catheter body having a distal portion including an expandable cannula having an inlet and an outlet. The expandable cannula may have a deployment profile and an operational profile that is larger than the deployment profile. An impeller may include a tubular body and at least one blade disposed about the tubular body for drawing blood into the cannula when the impeller is rotated. A reclosable element may be located distally of the tubular body in a guidewire passageway. The resealable element may be coupled to the tubular body in a manner that allows the tubular body to rotate while not re-rotating the reclosable element.

In yet another embodiment, an apparatus for generating movement of a fluid relative to the device is disclosed. The device may include a motor. An elongate catheter body may be coupled to the motor. The catheter body may include an expandable distal portion having an inlet and an outlet and a support structure disposed about a lumen. The expandable distal portion may include a deployment profile and an operational profile that is larger than the deployment profile. The device may include an impeller comprising at least one impeller blade. The apparatus may further include an expandable wheel carrier which, at least when the expandable distal portion has the operating profile, has an arcuate outer surface in contact with the support structure. Operation of the motor may cause the impeller to rotate to draw blood into the lumen. In some embodiments, the motor may be disposed at a proximal end of the elongate catheter body such that the motor remains away from the impeller when used outside the patient. A reclosable member may be located distally of the impeller in some embodiments. Further, the reclosable member may be coupled to a bearing coupled to the impeller to allow the impeller to rotate in the bearing structure while the reclosable member is held stationary distally of, but in alignment with, the impeller.

BRIEF DESCRIPTION OF THE DRAWINGS

A more complete understanding of the subject matter of this application and the various advantages thereof may be realized by reference to the following detailed description, in which reference is made to the accompanying drawings, wherein:

1 an embodiment of a catheter pump configured for percutaneous application and operation illustrated;

2 a plan view of an embodiment of a catheter assembly suitable for use with the catheter pump of 1 is;

3A - 3C the relative position of an impeller blade and an inner surface of a Illustrate impeller housing in a non-deformed configuration;

4 the catheter assembly is similar to that of 2 pointing in position within the anatomy;

5A - 5B Show cross-sectional views of an embodiment of a distal bearing support;

6A and 6B Show cross-sectional views of another embodiment of a distal bearing support; and

7A and 7B Show cross-sectional views of yet another embodiment of a distal bearing support and also illustrate a guide wire guide device.

More detailed descriptions of various embodiments of cardiac pump components useful in the treatment of patients suffering from cardiac stress, including acute heart failure, are set forth below.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

This application relates to devices for generating movement of a fluid relative to the device. In particular, the disclosed embodiments generally relate to various configurations for supporting an impeller disposed on a distal portion of a percutaneous catheter pump. As discussed in greater detail below, such a support structure may be advantageous for minimizing the deviation of a high speed impeller toward or into a structure that forms an inner surface of a cannula within which the impeller rotates. For example, in the disclosed embodiments, the cannula may be flexible, and the impeller may be flexibly supported by a support member remote from a distal end of the impeller shaft. In addition, the disclosed support structure may be advantageous at high impeller speeds as well as when impeller and cannula are subject to hydraulic forces. The disclosed carriers may, in various embodiments, act to maintain separation between the cannula and the impeller under various conditions. This support structure is particularly demanding for embodiments in which either or both of the impeller and cannula are collapsed or compressed for insertion of the pump. Further, a resealable tip may be disposed near the distal end of the impeller. The reclosable member may be configured to close a guidewire guide tube when the guidewire guide tube and / or a guidewire is withdrawn from the pump.

I. CATHETER PUMP SYSTEM AND METHOD

1 - 4 show aspects of an embodiment of a catheter pump 10 which can provide high performance flow rates. Various additional aspects of the pump and associated components are similar to those in U.S. Patent No. 7,393,181 . 8,376,707 . 7,841,976 . 7,022,100 and 7,998,054 and US Publication No. 2011/0004046 . 2012/0178986 . 2012/0172655 . 2012/0178985 and 2012/0004495 the entire contents of which are incorporated by reference herein for all purposes. Furthermore, this application includes, by reference, the subject matter disclosed in each of the following co-pending applications in its entirety and for all purposes: US Patent Application No. 61 / 780,656, which corresponds to Attorney Docket No. THOR.084PR2 entitled "FLUID HANDLING SYSTEM ", Filed on 13 March 2013; U.S. Patent Application No. 13 / 801,833, which corresponds to Attorney Docket No. THOR.089A, entitled "SHEATH SYSTEM FOR CATHETER PUMP", filed March 13, 2013; U.S. Patent Application No. 13 / 802,570, which corresponds to Attorney Docket No. THOR.090A, entitled "IMPELLER FOR CATHETER PUMP", filed March 13, 2013; U.S. Patent Application No. 13/801528 corresponding to Attorney Docket No. THOR.092A entitled "CATHETER PUMP" filed on Mar. 13, 2013 and US Patent Application No. 13/802468 corresponding to Attorney Docket No. THOR.093A , entitled "MOTOR ASSEMBLY FOR CATHETER PUMP", filed March 13, 2013.

A. Catheter pump system

The pump 10 includes a motor, which is controlled by a controller 22 is driven. The controller 22 controls the operation of the engine 14 and an infusion system 26 , which has an infusate flow in the pump 10 provides. A catheter system 80 that with the engine 14 coupled, houses an impeller within a distal portion thereof. In various embodiments, the impeller is driven by the engine 14 turned when the pump 10 is in operation. For example, the engine can 14 be arranged outside the patient. In some embodiments, the engine is 14 from the controller 22 separated, z. B. to be placed closer to the patient. In other embodiments, the engine is 14 Part of the controller 22 , In still other embodiments, the motor is miniaturized to be insertable into the patient. Such embodiments allow the drive shaft to be much shorter, e.g. B. shorter than that Distance from the aortic valve to the aortic arch (about 5 cm or less). Some examples of miniaturized motor catheter pumps and associated components and methods are described in US Pat US 5,964,694 ; US 6,007,478 ; US 6,178,922 and US 6,176,848 which are all hereby incorporated by reference in their entirety for all purposes herein.

2 shows features that facilitate percutaneous delivery to small blood vessels and high performance, including up to and in some cases beyond normal cardiac output, in all phases of the cardiac cycle. In particular, the catheter system includes 80 a catheter body 84 and a jacket assembly 88 , An embodiment of a blood flow assembly 92 is with the distal end of the catheter body 84 coupled. At least a portion of the blood flow assembly 92 is expandable and collapsible. For example, the blood flow assembly 92 include an expandable and collapsible cannula. The cannula may be formed of a superelastic material, and in some embodiments may have different shape memory material properties. The blood flow assembly 92 may also include an expandable and collapsible impeller. The cannula and the impeller are discussed further below. In the collapsed state, the distal end of the catheter system 80 advanced to the heart, for example, by an artery. In the expanded state, the blood flow assembly is 92 able to pump or dispense blood at high flow rates. 2 - 4 illustrate the expanded state of an embodiment. The collapsed state can be achieved by advancing a distal end 94 an elongated body 96 the shell assembly 88 distally over the cannula of the blood flow assembly 92 to a pooling of the blood flow assembly 92 to be provided. This will create an outer profile over the entire catheter assembly 80 provided, which has a small diameter, for example, a catheter size of about 12.5 Fr.

B. impeller and cannula features, insert and operation

Referring to 3A - 3C The operating device of the pump can be an impeller 300 include one or more leaves 303 having. The one or more leaves 303 can / can differ from an impeller hub 301 extend out. It may be desirable to increase the flow rate of the heart pump while ensuring that the impeller 300 can be effectively used within a subject. For example, an impeller may have one or more blades 303 which are configured to be inserted into a subject in a stowed or compressed configuration. If the impeller 300 is positioned at the desired location, eg. In a heart chamber of a subject, as in 4 shown, the leaf (s) can / can 303 of the impeller 300 expand itself into an inserted or extended configuration in which the leaf (s) 303 radially from a hub 301 from extending / extending.

As in 3A - 3B shown, the impeller can 300 within a cannula or housing 202 be positioned. A free end of the leaves 303 can through a nip G from the wall W of the housing 202 be separated. The housing 202 may also have a stowed or compressed configuration and a deployed or extended configuration. The housing 202 and the impeller 300 may be from the stowed configuration from within the shell assembly 88 extend into the extended configuration. In such implementations, the shell assembly 88 the leaf (s) 303 and the case 202 Keep compressed until the leaf (s) 303 and the case 202 from within a lumen of the shell assembly 88 be pushed out. After the sheet (s) 303 has been released from the shell assembly, the sheet (s) may / may 303 itself to a deployed configuration with the aid of strain energy due to deformation of the blade (s) 303 within the shell assembly 88 in the leaves 303 is stored. The expandable housing 202 It can also self-expand with the help of stored strain energy after it has been forced out of the shell.

In the stowed configuration, point the impeller 300 and the case 202 a diameter which is preferably small enough to be inserted percutaneously into the vascular system of a patient. Thus, it may be advantageous to the impeller 300 and the case 202 so to assemble into a stowed configuration that is small enough that the case 202 and the impeller 300 can fit into the veins or arteries of the patient. In some embodiments, the impeller may 300 therefore, in the stowed configuration, have a diameter that corresponds to a catheter size between about 8 Fr and about 21 Fr. In one implementation, the impeller may 300 have a diameter in the stowed state, which corresponds to a catheter size of about 9 Fr. In other embodiments, the impeller 300 in the stowed configuration have a diameter between about 12 Fr and about 21 Fr. For example, in one embodiment, the impeller 300 in the stowed configuration have a diameter corresponding to a catheter size of about 12-12.5 Fr.

If the impeller 300 However, positioned within a ventricle, it may be advantageous to the impeller 300 such that, in the expanded or deployed configuration, it has a diameter that is as large as possible. In general, an enlarged diameter of the impeller 300 advantageously increase the flow rate through the pump. In some implementations, the impeller may 300 have a diameter which in the deployed configuration corresponds to a catheter size greater than about 12 Fr. In other embodiments, the impeller 300 have a diameter which, in the deployed or expanded configuration, corresponds to a catheter size greater than about 21 Fr.

In various embodiments, it may be important to increase the flow rate of the heart pump while ensuring that operation of the pump will not harm the subject. For example, an increased flow rate of the cardiac pump may advantageously result in better outcomes for a patient by improving blood circulation within the patient. Furthermore, the pump should avoid damage to the subject. For example, if the pump exerts excessive shear stress on the blood and fluid flowing through the pump (eg, flowing through the cannula), then the impeller may damage the blood cells, e.g. As hemolysis cause. If the impeller damages a large number of blood cells, hemolysis can lead to negative results for the subject. As will be explained below, various cannula and / or impeller parameters may affect the flow rate of the pump as well as the conditions within the body of the subject.

When the pump 10 Once activated, it can effectively increase blood flow out of the heart and through the patient's vascular system. In various embodiments disclosed herein, the pump 10 be configured to have a maximum flow rate (eg, low mmHg) greater than 4 l / min, greater than 4.5 l / min, greater than 5 l / min, greater than 5.5 l / min, more than 6 l / min, more than 6.5 l / min, more than 7 l / min, more than 7.5 l / min, more than 8 l / min, more than 9 l / min or more than 10 l / min generated. In various embodiments, the pump may be configured to have an average flow rate greater than 2 l / min, greater than 2.5 l / min, greater than 3 l / min, greater than 3.5 l / min, greater than 4 l / min, more than 4.25 l / min, more than 4.5 l / min, more than 5 l / min, more than 5.5 l / min or more than 6 l / min produced.

C. Exemplary application for supporting the left ventricle

4 illustrates a use of the catheter pump 10 , A distal section of the pump 10 which is an impeller assembly 92 is placed in the left ventricle (LV) of the heart to pump blood from the LV into the aorta. The pump 10 can be used in this way to treat patients with a variety of diseases, including cardiogenic shock, myocardial infarction and other heart diseases, as well as to assist a patient during a procedure such as percutaneous coronary intervention. A convenient way of placing the distal portion of the pump 10 in the heart is through a percutaneous approach and deployment using the Seldinger technique or other procedures known to cardiologists. These approaches allow the pump 10 in emergency medicine, a catheter lab, and other non-surgical circumstances. Modifications may also allow the pump 10 the right side of the heart supports. Example modifications that might be used to support the right side include providing delivery features and / or forming a distal portion to be placed through at least one heart valve from the venous side, as in FIG US 6,544,216 ; US 7,070,555 and US 2012-0203056A1 which are all hereby incorporated by reference in their entirety for all purposes.

II. STRUCTURES FOR SUPPORTING A DISTAL WAREHOUSE

When the operative device, including at least the expandable cannula and the impeller, is positioned within the patient, the operative device may be exposed to bending loads. When the operative device is placed in a heart chamber, the bending loads may be caused by movement of the beating heart or other external loads. The gap G between the blade (s) of the impeller and the inner wall of the expandable cannula can be very small, in the range of ten thousandths of an inch. Due to the small gap between the cannula and the impeller blades, the bending loads can cause the impeller to come into contact with the inner wall of the expandable cannula. If the impeller comes into contact with the cannula while rotating at high speed, the impeller and / or cannula may / may be damaged. In addition, blood cell damage from contact when the impeller hits the wall of the expandable cannula can result, for example, if the cells intervene between these components devices. Because the impeller rotates at high speed, undesirable closure of the gap between the blade and the cannula internal diameter, even for a short time, can lead to damage to a significant number of blood cells. Preventing damage to a large number of blood cells is advantageous, making the system less invasive by minimizing negative side effects of using the catheter pump system. Thus, while the small "nip" may advantageously enhance the performance of the pump, the pump systems disclosed herein are advantageously configured to minimize the risk of adverse events (eg, hemolysis and hemorrhage) that are generally undesirable in cardiac pumping systems ,

A. Exemplary Distal Bearing Carrier with Improved Bending Stiffness

One approach to controlling the tip gap is to improve the flexural rigidity of the operative device. For example, the impeller and / or the cannula housing may be configured such that movement of the impeller blade (s) relative to the inner wall of the cannula housing is reduced. In particular, an increased rigidity of the operative device may reduce the deflection of the impeller in the direction of the cannula housing and / or the deflection of the cannula housing in the direction of the impeller. In one approach, the pump system is configured such that the impeller does not move significantly relative to the cannula housing, even though both may move together within the heart chamber. In various embodiments, a distal bearing carrier may be close, e.g. B. attached, be arranged adjacent to a distal portion of the impeller shaft.

5A is a side cross-sectional view of an operative device 500 a catheter pump according to an embodiment having a support member in an expanded or relaxed configuration. 5B is a side cross-sectional view of the operative device 500 from 5A Illustrated with the support member as inserted within a cannula. For example, the operative device 500 a cannula housing 502 , an impeller 503 which is inside the cannula housing 502 is arranged, and an example of a distal bearing support 501 which improves the flexural rigidity of the operative device 500 is configured to include. In 5A is the cannula housing 502 shown in an expanded configuration in outline to a diameter of the expanded cannula housing 502 with a diameter of the distal bearing carrier 501 to compare in a relaxed state. So it should be understood that the configuration of 5A (which eg the distal bearing carrier 501 shows when it passes through the walls of the cannula housing 502 extends) only serves the purpose of illustration.

The impeller 503 can be an impeller hub 504 and one or more leaves 505 which differ from the hub 504 extend from, include. The hub 504 so on an impeller shaft 506 be attached to that hub 504 relative to the impeller shaft 506 is rotatably fixed, z. For example, the hub rotates 504 with the wave 506 , As explained herein, the space between the free end of the sheet (s) may be 505 and an inner wall of the cannula housing 502 define a peak gap G. When the operative device 500 Bending loads exposed, the free end of the / sheet / leaves 505 in contact with the inner wall of the cannula housing 502 reach. As explained above, blood which is between the free end of the leaf (s) 505 and the cannula housing 502 flows, be damaged if the sheet (s) 505 on the cannula housing 505 meets / meet, which can negatively affect patient results.

As in 5A shown, the distal bearing carrier 501 a fixing section 507 , which is attached to a distal portion of the impeller shaft 506 coupled, a support element 508 which is attached to the attachment section 507 coupled, and a nose element 509 (also referred to as a cap in some arrangements) which is distal from the attachment portion 507 is arranged to comprise. The nose element 509 can be inside the support element 508 be arranged and coupled with this. Preferably, attachment portion 507 , Nose element 509 and support element 508 configured to be non-rotatable on the impeller shaft 506 are attached. For example, at least one proximal section 510 of the attachment section 507 which is over a distal section 511 the impeller shaft 506 is arranged to have an inner diameter which is larger than an outer diameter of the impeller shaft. The impeller shaft 506 can therefore relative to the attachment portion 507 rotate, such that the attachment portion 507 not with the impeller shaft 506 rotates. The interface between the attachment section 507 and the impeller shaft 506 preferably has a relatively low friction to heat generation and a torque resistance, which on the distal end 511 the impeller shaft 506 works to minimize.

During assembly of the distal bearing carrier 501 can the attachment section 507 over the distal end 511 the impeller shaft 506 slide. As discussed above, the attachment portion 507 be cantilevered in the illustrated embodiment, e.g. Eg not rotationally fixed relative to the impeller shaft 506 , In some embodiments, a tool may be in the distal end 511 the impeller shaft 506 be introduced to the distal end 511 widen it to keep it as the proximal section 510 of the attachment section 507 to make, for. B. the sections of the attachment portion 507 extending proximally to the dilated distal end 511 around the impeller shaft 506 are located. The flared distal end 511 This can prevent the attachment section 507 moves distally and away from the impeller shaft 506 solves. In some embodiments, the attachment portion 507 be made of a polymer such as PEEK. Because the attachment section 507 relative to the impeller shaft 506 not fixed, can the impeller shaft 506 within the attachment section 507 rotate freely. In addition, in some aspects, an optional ring element 512 around the impeller shaft 506 around between the attachment section 507 and the impeller 503 be positioned. The ring element 512 can act as an interface between the impeller 503 and the attachment portion 507 and may in some implementations be formed of a ^Teflon® (PTFE) or other low friction material.

As in 5A - 5B shown, the support element 508 over a distal section 513 of the attachment section 507 be arranged. The distal section 513 of the attachment section 507 may have a necked or stepped region for receiving the support element 508 include. A mechanical connection can be made between the support element 508 and another rotationally fixed portion of the distal bearing support 501 , z. B. between a proximal portion of the support element 508 and the attachment portion 507 be provided. For example, the attachment portion 507 one or more barbs (not shown) around the perimeter of the attachment portion 507 are positioned around. In some implementations, the barbs are positioned around the circumference every 120 degrees. The barbs can be inserted into corresponding slots in the support element 508 engage the support element 508 at the attachment portion 507 to secure. The barbs could alternatively in one embodiment on the support element 508 formed and configured to be in the mounting portion 507 extend and intervene in this. In some arrangements, instead of or in addition to the mechanical connection, an adhesive bond between the attachment portion 507 and the support element 508 provided. In a further embodiment, the support element 508 and the attachment section 507 Portions of a unitary body that can be formed from a cylindrical exit tube. In some embodiments, the support member may be formed of nitinol.

The nose element 509 can be distal to the attachment section 507 and within the proximal portion 514 of the support element 508 be positioned. Like the attachment section 507 can also be the nose element 509 additionally or alternatively barbs (not shown) around the circumference of the nose element 509 around (e.g., offset 120 degrees) to fit into the corresponding slots in the support member 508 intervene. The nose element 509 may be configured to control blood flow through the cannula housing 502 in the area of the distal bearing carrier 501 , z. B. distal to the impeller 503 , compensates.

So the attachment section 507 around the impeller shaft 506 be fixed (axially clamped by the flared portion 511 , but otherwise rotationally decoupled from the impeller shaft 506 ), the support element 508 can over the barbs to the attachment section 507 pair and the nose element 509 Can have additional barbs on the support element 508 couple. In some embodiments, a single continuous member is provided which functions as the nose portion 509 and the attachment section 507 combined. For example, these components may be formed as a unitary component to which the support member may be coupled.

The support element 508 can a stiffer structure, for. A skeletal, cage-like or other flexible structure extending distally from or out of the nose member 509 and / or attachment section 507 extends. For example, the support element 508 one or more wings 516 or fingers which are biased to extend radially outward. As in 5A shown, the support element 508 have a size and shape such that the radial distance from one or more of the wings 516 or finger to a projection of the longitudinal axis of the impeller shaft 506 in its natural, relaxed condition greater than the radial distance from the cannula wall to a projection of the longitudinal axis of the impeller shaft 506 is when the cannula is 502 in an operating configuration (eg extended). If the wings 516 or fingers inside the cannula 502 are positioned when the cannula 502 is in an expanded state (eg as in 5B ), fingers or wings 516 a radially outwardly directed force against the inner wall of the cannula housing 502 exercise. This radially outward force can reduce the bending stiffness of the cannula housing 502 increase. By increasing the bending stiffness of the cannula housing 502 can the revealed distal bearing bracket 501 reduce the risk of hemolysis during operation of the pump.

As in 5A - 5B shown, the wings can 516 an elongated element, e.g. An elongate arcuate member or a connecting arch, which extends from the proximal portion 514 of the support element 508 extends out. The wings 516 may in some arrangements have a concave section 522 that is between the proximal section 514 of the support element 508 and a free end of the wings is arranged, for. Near the proximal section 514 , include. The concave section 522 can be inward toward the interior of the cannula 502 be bent. Furthermore, the wings can 516 a convex section 521 in contact with a supporting region 520 of the cannula housing 502 exhibit. The convex section 521 may in some embodiments outward toward the wall of the cannula 502 be bent. It should be understood that, due to the radially outward bias of the wings 516 , the convex section 521 the wing 516 a radially outwardly directed force against the cannula housing 502 at the support region 520 can produce where the convex section 521 Contact to the cannula housing 502 Has.

Various embodiments of the cannula housing 502 may comprise a web of metallic material coated with an elastic film. In some cases, the radially outward force passing through the convex portions 521 against the cannula housing 502 is applied, deform or otherwise damage the metallic fabric and / or the elastic coating film. To prevent deformation of the cannula housing 502 and / or damage to the elastic film, in some embodiments, the metallic tissue may be attached to the support region 520 the cannula wall, which in contact with the convex portions 521 stands, made denser than at other locations of the cannula housing 502 , The additional metallic material at the support region 520 near the convex sections 521 can provide extra support for the case 502 and provide the elastic film to prevent unwanted deformation of the housing 502 and / or the film.

In the illustrated embodiment, the support member unfolds 508 in a flower shape, z. B. can the fingers 516 form the shape of petals and / or a non-planar connecting arc or isomorphic form. The exemplary embodiment has four wings 516 on. Every wing 516 can be through a pair of proximal struts 523 and a pair of distal struts 524 be formed or defined. As in 5B For example, any proximal strut may be shown 523 with the proximal section 514 of the support element 508 be coupled or trained. The proximal struts 523 can wrap around the attachment section 507 and / or the nose element 509 be spaced. The distal ends of the proximal struts 523 may be at proximal ends of the distal struts 524 pair as in 5A - 5B shown. The distal ends of the distal struts 524 can couple to each other. As in 5B For example, the convex section can be shown 521 the wing 516 between the proximal and distal ends of the distal struts 524 be arranged.

As in 5B shown, can have a distal end 515 from each of the exemplary wings 516 extend generally parallel to the cannula housing and curves slightly inwardly toward the impeller axis at its tip to prevent the edges from entering the cannula housing 502 incise. Furthermore, the outer curved surfaces of the wings 516 or fingers are not stiff on the inner surface of the cannula housing 502 be fixed, but instead, a relative movement between the two may be possible. This relative movement allows for easier expansion and consolidation of the operative device of the catheter pump system. From the description herein, it will be understood that the stowed and deployed configuration of the support member 508 depending on the application, and can be modified in various examples based on the design of the impeller and the cannula housing.

B. Exemplary Distal Bearing Carrier with Improved Maneuverability

While the distal bearing carrier of 5A - 5B Advantageously, the operative device of the catheter pump system can stiffen, the support member extends distally beyond the distal end of the impeller shaft (and / or the impeller). Because the rigid support member extends beyond the distal end of the impeller and / or the impeller shaft (eg, axially displaced from the distal end of the impeller shaft), a length of the catheter pump extending from a proximal portion of the impeller to the distal End of the support member having a relatively high bending stiffness, because this section includes the relatively stiff impeller in addition to the support member. This length may be referred to as the "stiff length". A long, stiff length can be disadvantageous because it can interfere with maneuverability as the catheter pump (operating device) is pushed through the arched aortic arch. Thus, it may be desirable to reduce the length of the "stiff length" portion of the catheter pump while still maintaining high flexural stiffness when operative Device in or near a ventricle, z. B. the left ventricle, is positioned.

1. Exemplary distal bearing carrier for improved maneuverability of the operative device

6A is a side cross-sectional view of an operative device 600 a catheter pump according to another embodiment having a support member in an expanded or relaxed configuration. 6B is a side cross-sectional view of the operative device 600 from 6A illustrated with the support member as arranged in a cannula. Unless otherwise stated, the reference numbers of 6A - 6B refer to similar components as those in above 5A - 5B stated, relative to 5A - 5B increased by 100. For example, the operative device 600 a cannula housing 602 , an impeller 603 which is inside the cannula housing 602 is arranged, and another example of a distal bearing support 601 which is used to improve the flexural rigidity and maneuverability of the operative device 600 is configured to include. The impeller 603 can be an impeller hub 604 which is on a wheel shaft 606 is attached, and one or more leaves 605 that are different from the hub 604 extend from, include. As in 5A illustrated above 6A the distal bearing carrier 601 in a relaxed state just for purposes of illustration.

As in 5A - 5B can the distal bearing carrier 601 a nose element 609 or a cap configured to equalize blood flow. In addition, the distal bearing carrier 601 a support element 608 include several wings 616 which extend radially outward with a radially outward bias when in the cannula housing 602 are positioned. As in 5A - 5B can the wings 616 a concave section 622 and a convex section 621 in contact with the tissue of the cannula housing 602 at a supporting region 620 stands, include. Furthermore, the wings can 616 an arcuate member having a pair of separate proximal struts 623 and a pair of distal struts 624 which couple at their distal ends.

However, unlike the distal bearing carrier 501 in 5A - 5B the distal bearing carrier 601 from 6A - 6B provide a shortened rigid length while increasing flexural rigidity when the pump is positioned within a heart chamber. As in 6A - 6B illustrates overlaps at least a proximal portion 614 of the support element 608 axially the impeller shaft 606 in contrast to the axial displacement from the distal end 511 the impeller shaft 506 as in the embodiment of 5A , In other words, in the embodiment of 5A is an axial gap or distance between the furthest distal aspect of the impeller shaft 506 (eg the distal end 511 ) and the most proximal aspect of the support element 508 provided, whereas in the embodiment of 6A no axial gap between the most distal aspect 611 the impeller shaft 606 and the most proximal aspect of the support element 608 is provided. The length of the rigid portions (eg, the "stiff length") can thereby be compared to the embodiment of FIG 5A - 5B be shortened. Actually, because of the support element 608 from 6A - 6B to a lesser degree distal over the distal end 611 the impeller shaft 606 also extends as the support element 508 from 5A - 5B , the rigidity of the operative device 600 in the embodiment of 6A - 6B be lower. The operative device 600 from 6 can therefore be more easily maneuvered over the aortic arch during insertion.

For example, in 6A a fixing section 607 (eg, an interface material) over the impeller shaft 606 be positioned, for. B. around it, around the shaft 606 to couple stiff. In some embodiments, the attachment portion 607 comprise a PEEK heat shrink material overlaying the impeller shaft 606 be upset and deal with the wave 606 can turn. For example, the heat shrink material may be prior to forming the impeller 603 be applied, for. B. by casting. The nose element 609 can on the impeller shaft 606 be shaped. In some embodiments, the distal end 611 the impeller shaft 606 Eingreifmerkmale 632 for increasing the fixation of the nose element 609 on the shaft 606 include. The intervention characteristics 632 may include circumferential recesses or holes, e.g. B. formed by laser drilling. When the nose element 609 over the distal end 611 can be molded, parts of the nose element 609 flow back into the circumferential holes to the fixation of the nose element 609 at the distal end 611 the impeller shaft 606 to support.

The proximal section 614 of the support element 608 can over the attachment section 607 be attached to the support element 608 on the impeller 603 to fix. In some embodiments, a nitinol support element 608 be cooled to the proximal end 614 of the support element 608 stretch, so that the proximal end 614 over the attachment section 607 can be pressed. When the support element 608 returns to room temperature, the nitinol can return to its original size. The proximal The End 614 of the support element 608 may include one or more slots circumferentially on the proximal end 614 of the support element 608 are spaced. Each of the one or more slots may extend from the most proximal side of the support member 608 extend distally and terminate at a wider hole region. The slots may be through the thickness of the proximal end portion 614 of the support element 608 be educated. In some embodiments, the slots extend through the entire thickness of the proximal end portion 614 of the support element 608 however, in other embodiments, the slots may extend only partially through the thickness. The slots can be used around the proximal end 614 of the support element 608 expand or widen when the support element 608 over the nose element 609 is pressed to a coupling to the attachment portion 607 make. This expansion or expansion can advantageously fixing the support element 608 above the nose element 609 support. The attachment section 607 (dealing with the impeller shaft 606 turns) can be within the proximal end 614 of the support element 608 rotate freely. As above, the support element 608 provide improved flexural stiffness. In addition, the support element 608 As discussed herein, improved maneuverability of the operative device 600 deploy by the stiff length of the operative device 600 is reduced.

2. Exemplary Maneuverable Distal Carrier with Lockable Guidewire Lumen

Although the in 6A - 6B illustrated distal bearing carrier 601 can provide improved flexural rigidity and reduced rigid length, there may be some potential problems with the embodiment of FIG 6A - 6B give. For example, the shaped nose element 609 from 6A - 6B be susceptible to damage during operation of the pump, and the nose element 609 can operate under different operating or environmental conditions from the impeller shaft 606 abort. In addition, the support element can 608 in the embodiment of 6A - 6B axially displace in the distal direction, causing the support element 608 against the nose element 609 can be pressed when the support element 608 moves distally. When the support element 608 against the nose element 609 pushes, could the nose element 609 break, or the resulting distally directed force could be turning the impeller shaft 606 slow down or stop.

Further, if a Seldinger insertion technique is used to advance the operative device to the heart, a guidewire and guidewire guide tube may be used. For example, the guidewire guide tube may be disposed through a central lumen of the catheter pump. The clinician may insert a guidewire through the guidewire guide tube and advance the guidewire toward the heart. After advancing the operative device over the guidewire and into the heart, the guidewire and guidewire guide may be removed from the catheter pump. If the guide wire guide tube and / or the guide wire through a distal portion of the nose element 609 is withdrawn, the distal portion may not adequately occlude the lumen through the impeller shaft. Accordingly, there is a need for an improved distal bearing carrier that provides a reclosable nose element and an improved support element.

7A is a side cross-sectional view of an operative device 700 a catheter pump according to another embodiment with a support member in a expanded or relaxed state or configuration. 7B is a side cross-sectional view of the operative device 700 from 7A shown with the support member as disposed in the cannula. Unless otherwise stated, the reference numbers of 7A - 7B refer to similar components, such as those referred to in above 5A - 5B and 6A - 6B was referenced, relative to 6A - 6B increased by 100. For example, the operative device 700 a cannula housing 702 , an impeller 703 which is inside the cannula housing 702 is arranged, and another example of a distal bearing support 701 which improves the flexural rigidity and maneuverability of the operative device 700 is configured to include. The impeller 703 can be an impeller hub 704 which is on a wheel shaft 706 is attached, and one or more leaves 705 that are different from the hub 704 extend from, include. As 5A illustrated above 7A the distal bearing carrier 701 in a relaxed state just for purposes of illustration.

In addition, the distal bearing carrier 701 as in 5A - 5B and 6A - 6B a nose element 709 or a cap configured to equalize blood flow. The distal bearing carrier 701 can also have a fixing section 707 that attaches to the impeller shaft 706 is configured, and a support element 708 , which is coupled to the attachment portion include. The support element 708 can have several wings 716 which extend radially outward with a radially outward bias when in the cannula housing 702 are positioned. The wings 716 can have a concave section 722 and a convex section 721 which is connected to the tissue of the cannula housing 702 at a supporting region 720 is in contact. Furthermore, the wings can 716 an arcuate member having a pair of separate proximal struts 723 and a pair of distal struts 724 which are coupled at their distal ends include. In addition, a guide wire guide tube 750 through the impeller shaft 706 run. As discussed above, a guidewire may be advanced through the guidewire guide tube and into the anatomy of the patient. As in 6A - 6B overlaps a proximal section 714 of the support element 708 a distal end 711 the impeller shaft, reducing the stiff length of the operative device 700 can be shortened.

The support element 708 may initially be loose over the distal section 711 the impeller shaft 706 be attached. A spacer or a disc 756 (eg, formed from Nitinol) may be at or near the proximal end portion 714 of the support element 708 be formed to a distal movement of the support element 708 to prevent in the axial direction. For example, the disc can 756 in some embodiments, to the proximal end 714 of the support element 708 be welded. The attachment section 707 may in such embodiments within the support element 708 to the impeller shaft 706 glued or otherwise secured to it, that the attachment section 707 with the wave 706 rotates. In other embodiments, the impeller shaft 706 be free to move relative to the attachment section 707 to turn. An optional expansion section at the distal end 711 the impeller shaft 706 can be designed (as in 5A ), to prevent the attachment section 707 in the distal direction relative to the shaft 706 shifts. The distal end 711 the impeller shaft, which may include a flared portion, may be formed in a recess of an enlarged distal portion of the attachment portion 707 (eg an interface element). As shown, a proximal portion of the attachment portion 707 a bushing portion which is near the proximal portion 714 of the support element 708 around the impeller shaft 706 is arranged include. The flared portion of the distal end 711 the impeller shaft 706 may have a diameter which is larger than the bushing portion.

A resealable element 754 , or a septum, may be within a stepped region or recess near the distal end 760 of the attachment section 707 be introduced, for. B. in an enlarged portion which is located distal to the enlarged portion, in which the distal end 711 the impeller shaft 706 is arranged. The resealable element 754 can be used to close the opening formed when the guidewire and / or guidewire guide 750 (eg made of stainless steel) is / are removed. For example, the attachment portion 707 against the resealable element 754 Press to open the resealable item 754 radially compressing or forcing the resealable element 754 is biased to reseal the lumen when the guide wire guide 750 and / or the guidewire is / are removed. In some embodiments, the reclosable element rotates 754 possibly not relative to the impeller shaft 706 and / or the attachment portion 707 , In other embodiments, the reclosable element rotates 754 possibly with the attachment section 707 , The resealable element 754 For example, a self-healing polymer and / or a high-hardness polymer or any other polymer may be used to reclose the guidewire guide 750 is suitable. As in 7A - 7B shown, the resealable element 754 distal to the impeller shaft 706 in the stepped region or recess of a distal portion of the attachment portion 707 (eg an interface element). In addition, the flared portion at the distal end 711 be arranged in or near the recess, which the resealable element 754 includes.

The nose element 709 can be within the distal end 760 of the attachment section 707 be installed. Barb inside the nose element 709 can engage in slots located in the attachment section 707 are located. Because the nose element 709 to the attachment section 707 couples, and because the attachment section 707 to the impeller shaft 706 Couples, both the nose element can 709 as well as the attachment section 707 with the wheel 703 rotate. The support element 708 can remain so rotationally fixed that the support element 708 not with the wheel 703 rotates.

In the implementation of 7A - 7B Therefore, the rigid length can be shortened while also providing a reclosable element (a "septum") to prevent fluid from entering the openings formed when the guidewire guide tube is withdrawn after a guidewire is inserted with the Seldinger tube. Technique was used. In addition, the disc prevents 756 , which at the proximal end of the support element 708 coupled, the distal axial displacement of the support element 708 , By securing the support element 708 in the distal direction, the distal bearing carrier can 701 Advantageously, damage to the nose element 709 and / or pinching the impeller 703 due to a displacement of the support element 708 avoid.

Modifications of catheter pumps that include a catheter assembly with a distal wheel carrier may be used to support the right side. For example, a catheter body containing the impeller and the distal bearing support may be configured to have an inserted shape that corresponds to the shape of the vasculature traversed between a peripheral vascular access point and the right ventricle. From the description herein, it will be understood that the catheter assembly may be modified based on the corresponding anatomy to suit the desired vascular approach. For example, the catheter assembly may be shaped to the heart in the introductory state for insertion through the subclavian artery. The catheter pump may be configured to support the right side for insertion through a smaller opening and at a lower average flow rate. In various embodiments, the catheter assembly is scaled up for a higher flow rate for sick patients and / or larger patients.

Although the inventions herein have been described with reference to particular embodiments, it is to be understood that the embodiments are merely illustrative of the principles and applications of the present inventions. It is therefore to be understood that numerous modifications may be made to the illustrative embodiments and that other arrangements may be practiced without departing from the spirit and scope of the present invention as defined by the appended claims. Thus, it is intended that the present application cover the modifications and variations of these embodiments and their equivalents.

QUOTES INCLUDE IN THE DESCRIPTION

This list of the documents listed by the applicant has been generated automatically and is included solely for the better information of the reader. The list is not part of the German patent or utility model application. The DPMA assumes no liability for any errors or omissions.

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Claims (22)

A catheter pump comprising: an elongated catheter body having a distal portion including an expandable cannula having an inlet and an outlet, the expandable cannula having a delivery profile and an operating profile that is larger than the delivery profile; an impeller assembly including an impeller shaft and an impeller body including one or more blades, the impeller blades drawing blood into the cannula when rotated; an expandable support having a mounting portion disposed on the impeller shaft distal to the impeller body and configured to maintain a position of the impeller relative to a cannula wall. The catheter pump of claim 1, wherein the expandable support comprises an elongated member having a convex portion in contact with an inner wall of the expandable cannula. The catheter pump of claim 2, wherein the expandable cannula comprises a tissue, wherein the tissue at a support region of the cannula which is in contact with the convex portion is denser than in another region of the cannula. The catheter pump of claim 2, wherein the elongated member has a proximal end coupled to the attachment portion, a free distal end, and a concave portion disposed between the proximal end and the free distal end. The catheter pump of claim 2, wherein the elongated member has first and second proximal struts circumferentially spaced from each other and first and second distal struts coupled to one another at distal ends thereof, the proximal ends of the distal struts being connected to the distal ends coupled to the proximal struts. The catheter pump of claim 5, wherein the convex portion is disposed between the proximal and distal ends of the distal struts. The catheter pump of claim 1, wherein the attachment portion comprises a cylindrical member disposed on the impeller shaft in a manner that allows the impeller shaft to rotate therein. The catheter pump of claim 7, wherein a portion of the expandable support in contact with the cannula has a proximal body disposed over and secured to an outer surface of the cylindrical member. The catheter pump of claim 8, wherein the impeller shaft has an enlarged diameter at the distal end thereof and the cylindrical member has a diameter less than the increased diameter at the proximal end thereof. The catheter pump of claim 9, wherein the cylindrical member has an enlarged distal portion having an inner diameter greater than the enlarged diameter at the distal end of the impeller shaft. The catheter pump of claim 10, further comprising a reclosable septum disposed in the enlarged distal portion of the cylindrical member. The catheter pump of claim 10, further comprising a cap coupled to the distal end of the cylindrical member, the cap having a rounded distal portion having an opening for passing a guidewire through the impeller assembly. The catheter pump of claim 7, further comprising a spacer disposed between the impeller body and a proximal end of the expandable carrier. A catheter pump comprising: an elongate catheter body having a distal portion including an expandable cannula having an inlet and an outlet, the expandable cannula having a delivery profile and an operating profile greater than the delivery profile; an impeller having a tubular body and at least one blade disposed about the tubular body for drawing blood into the cannula when the impeller is rotated; a reclosable member disposed distally of the tubular body in a guidewire passage, the reclosable member being coupled to the tubular body in a manner that allows the tubular body to rotate while the reclosable member is not rotated , The catheter pump of claim 14, wherein the tubular body has a hypotube and the reclosable member is disposed in an interior recess of a distal portion of an interface member, wherein a proximal Section of the interface element has a sleeve which is arranged around the hypotube. The catheter pump of claim 15, wherein the hypotube has at the distal end a flared portion of increased diameter greater than the diameter of the sleeve. The catheter pump of claim 15, wherein the recess is formed in an enlarged portion of the interface extending distally of the sleeve and having an inner periphery greater than the diameter of the sleeve, wherein the flared portion of the hypotube is disposed in the recess , The catheter pump of claim 17, wherein the enlarged portion of the recess is a first enlarged portion, and further comprising a second enlarged portion distal to the first enlarged portion, and wherein the reclosable member is disposed in the second enlarged portion. Apparatus for generating movement of a fluid relative to the apparatus, comprising: an engine; an elongated catheter body coupled to the motor, the catheter body having an expandable distal portion with an inlet and an outlet and a support structure disposed about a lumen, the expandable distal portion having a deployment profile and an operating profile is greater than the provisioning profile; an impeller having at least one impeller blade; an expandable wheel carrier having an arcuate outer surface in contact with the support structure, at least when the expandable distal portion has the operating profile; wherein operation of the motor causes the impeller to rotate to draw blood into the lumen. The apparatus of claim 19, wherein the motor is disposed at a proximal end of the elongated catheter body such that the motor remains away from the impeller when used outside the patient. The device of claim 19, further comprising a reclosable member disposed distally of the impeller. The apparatus of claim 21, wherein the reclosable member is coupled to a bearing coupled to the impeller, thereby allowing the impeller to rotate in the bearing structure while the reclosable member is held stationary distally of, but in alignment with, the impeller becomes.

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