DE112014001418T5 - Expandable blood pump for cardiac support - Google Patents

Abstract

A pump for introducing a flow rate has two inlets. The pump has a first structure for deployment within the vasculature and a second operable structure for directing fluid flow within the vascular system, the second structure having a larger diameter than the first structure. A centrifugal conveying element is configured to induce fluid flow by rotation about an axis of rotation, the flow being in a direction generally transverse to the axis of rotation of the conveying element.

Description

BACKGROUND

The present disclosure relates to blood pumps for cardiac assistance. More particularly, the present disclosure relates to expandable blood pumps and methods for their deployment and use for circulatory support. Many heart problems lead to the need for temporary cardiac support. These scenarios can range from unforeseen assistance in high risk cardiac surgery to immediate full support following a myocardial infarction. Acute pumps for temporary cardiac assist deviate from implantable pumps because the period of use may be brief in days or weeks, as opposed to long term in months or years. Situations requiring temporary cardiac assist can benefit greatly from the rapid deployment of a blood pump in a range of anatomical positions.

The blood pump of the present disclosure finds application in various aspects of the heart and vascular system. The cardiovascular system of the body is a closed circulatory system that consists of two types of circulation, the pulmonary circulation and the systemic circulation. In the pulmonary circulation, blood flows from the right part of the heart through the pulmonary artery trunk, which branches into pulmonary arteries that carry blood flow to the lungs. In the lungs, blood flows through lung capillaries, where carbon dioxide is removed from the blood and supplied with oxygen. The oxygenated blood then flows to the left part of the heart, where it is pumped through the aorta to the body's flow. The pumping of oxygen-enriched blood through the body is known as systemic circulation. In the systemic circulation, the left side of the heart pumps blood through the aorta and into the arterial system, which transports the blood through the body into capillaries and cells of the body. When oxygen-enriched blood flows through the body, the body cells remove the oxygen from the blood and replace it with carbon dioxide. The blood then enters the venous system to begin its return to the heart and lungs. The venous system contains small veins that converge into veins. In the upper part of the body, the blood flows from the veins into the superior vena cava, while in the lower part of the body, the blood flows from the veins into the inferior vena cava. The blood flows from the superior vena cava and the inferior vena cava into the right atrium of the right heart, where it again enters the cycle of the pulmonary circulation.

Because blood flows from the right part of the heart and into the lungs, while the blood flowing from the left part of the heart is circulated through the body, the left heart generates a much higher pressure than the right heart. The pressure generated by the right heart would not be sufficient to move blood through the tissues of the body while the pressure created by the left heart is applied to the blood circulating through the lungs, which would damage fragile pulmonary alveolar tissue in the lungs , In general, the right heart produces systolic pressures of 15-30 mm Hg and diastolic pressures of 3-12 mm Hg.

There is a need in the art for blood pumps that can enhance aspects of this type of therapy. More particularly, there is a need in the art for improved expanded blood pumps for cardiac assist and further for cardiac support for the left part of the heart, the right part of the heart, or both.

SUMMARY

The disclosure relates to a pumping system for introducing flow within a vascular system and methods of using the pumping system to initiate such flow. The system includes a cannula having a portion that is adjustable between an operable structure and a deployment structure, and a delivery element disposed in the adjustable portion. The system includes at least one end with an expanding member intended to engage a blood vessel. The system is configured to move blood from at least one end and through a side wall of the cannula.

BRIEF DESCRIPTION OF THE DRAWINGS

While the description concludes with claims particularly pertinent to the subject matter considered to form and distinctly claim the various embodiments of the present disclosure, it is believed that the embodiments will be understood from the following description taken in conjunction with the accompanying drawings better understood, in which:

1 FIG. 13 is a perspective view of an expandable blood pump according to an embodiment of the present disclosure. FIG.

2 FIG. 10 is a schematic representation of an expanding blood pump according to one embodiment of the present disclosure. FIG.

3 is a perspective view of a conveying element according to an embodiment of the present disclosure.

4A FIG. 13 is a perspective view of a conveyor element according to another embodiment of the present disclosure. FIG.

4B is a side view of the conveying element of 4A ,

5A is a perspective view of a conveying element according to another embodiment of the present disclosure.

5B is a side view of the conveying element of 5A ,

5C is a perspective view of the conveyor element.

5D is a side view of the conveying element, which represents a possible flow direction.

5E is another perspective view of the conveyor element, which represents a possible direction of rotation.

6 FIG. 12 is a perspective view of a cannula according to an embodiment of the present disclosure. FIG.

7A is a schematic side view of an embodiment of the cannula of 6 in an expanded structure.

7B is a schematic side view of an embodiment of the cannula of 6 in an expanded structure.

7C is a schematic side view of an embodiment of the cannula of 6 in a collapsed structure.

7D is a perspective view of an embodiment of the cannula with support elements, which are formed from a wire mesh.

7E is a perspective view of an embodiment of the cannula with support members forming a tubular enclosure.

7F is a side view of an embodiment of the cannula with tubular enclosure.

8A Fig. 3 are schematic side views of one embodiment of the cannula in an expanded structure.

8B is a schematic side view of an embodiment of the cannula of 8A ,

8C is a schematic side view of an embodiment of the cannula of 8A in a collapsed structure.

9A FIG. 12 is a perspective view of a cannula according to still another embodiment of the present disclosure having different diameters in the direction of its axial length. FIG.

9B is a perspective view of a cannula with radial beam rectifiers.

9C is a perspective view of a cannula with concentric beam rectifiers.

10A FIG. 11 is a side view of a cannula according to yet another embodiment of the present disclosure having a terminal fixation feature. FIG.

10B is a perspective view of the cannula of 10A ,

11A Figure 11 is a schematic side view of an opening in a wall between any combination of ventricle (s) and blood vessel (s).

11B is a schematic side view of an embodiment of the cannula of 10A in the opening of 11A is attached.

11C is a schematic side view of an embodiment of the cannula of 10A in the opening of 11A is fixed, wherein the opening also has an intermediate device which is fixed to the wall opening.

12 FIG. 11 is a perspective view of a catheter guiding system according to an embodiment of the present disclosure. FIG.

13 FIG. 13 is a perspective view of a catheter guide system according to another embodiment of the present disclosure. FIG.

14 FIG. 4 includes a side view and exploded side views of a power transmission system of a pump according to one embodiment of the present disclosure. FIG.

15 FIG. 12 is a perspective view of a power transmission system of a pump according to another embodiment of the present disclosure. FIG.

16 FIG. 12 is a perspective view of a power transmission system of a pump according to still another embodiment of the present disclosure. FIG.

17 FIG. 12 is a perspective view of a power transmission system of a pump according to still another embodiment of the present disclosure. FIG.

18 FIG. 13 is a perspective view of an expandable blood pump according to an embodiment of the present disclosure. FIG.

19 is a side view of in 18 shown, expandable blood pump.

20 FIG. 13 is a perspective view of an expandable blood pump according to an embodiment of the present disclosure, with certain parts shown in transparent. FIG.

21 FIG. 12 is a perspective view of a conveyor element according to an embodiment of the present disclosure. FIG.

21A - 21D Figures are side views of the conveying elements of the present invention.

22 is the perspective view of a conveying element according to another embodiment of the present disclosure.

23 is a view of the conveyor element of 22 in section, which is guided along the line AA.

24 FIG. 10 is an exploded perspective view of an expandable blood pump according to one embodiment of the present disclosure. FIG.

25 is a side view of in 24 shown, expandable blood pump

26 FIG. 13 is a perspective view of certain components of an expandable blood pump according to one embodiment of the present disclosure. FIG.

27 is a side view of the specific components of a 26 shown, expandable blood pump.

28 FIG. 13 is a perspective view of certain components of an expandable blood pump according to one embodiment of the present disclosure. FIG.

29 is a side view of the specific components of a 28 shown, expandable blood pump.

30 FIG. 13 is a perspective view of an expandable blood pump according to an embodiment of the present disclosure, with certain parts shown in transparent. FIG.

31 FIG. 10 is an exploded perspective view of an expandable pump according to one embodiment of the present disclosure. FIG.

32 is a side view of in 31 shown, expandable pump.

33 FIG. 13 is a perspective view of certain components of an expandable blood pump according to one embodiment of the present disclosure. FIG.

34 is a side view of the specific components of a 33 shown, expandable blood pump.

35 FIG. 12 is a perspective view of a conveyor element according to an embodiment of the present disclosure. FIG.

35A is a view of the conveyor element of 35 in section, which is taken along the line BB.

35B - 35F FIG. 12 illustrates cross-sectional views of other conveying elements of the present invention. FIG.

36 FIG. 10 is a flowchart of a method for deployment and use of an expandable blood pump according to one embodiment of the present disclosure. FIG.

37 FIG. 5 is a flowchart of another method for deployment and use of an expandable blood pump according to an embodiment of the present disclosure. FIG.

38 FIG. 10 is a schematic representation of an expandable blood pump and control system and console according to one embodiment of the present disclosure. FIG.

DETAILED DESCRIPTION

The present disclosure relates to a novel and advantageous cardiac assistive blood pump, including, but not limited to, acute cardiac assist and temporary cardiac assist. In particular, the present invention relates Disclosure of novel and beneficial blood pumps and methods of their deployment and use to quickly provide temporary circulatory support. The systems of the present disclosure may be used in the left part of the heart, right part of the heart, or both. Exemplary uses of the various embodiments of expandable blood pumps provided herein may range from unforeseen assistance in high risk cardiac surgery to immediate full support following myocardial infarction. Expandable blood pumps and methods of their deployment and use for circulatory support are described in US Application No. 13/590 488 to Evans et al., Filed Aug. 21, 2012, entitled "Expandable Blood Pumps and Methods for their Deployment and Use" and US Application No. 13/590 564, filed August 21, 2012, entitled "Expandable Vascular Pumps", both of which are incorporated herein by reference in their entirety.

In general, a pump with cannula and delivery element in a collapsed deployment structure may, for example, be inserted into a large blood vessel and delivered to the heart. Once the pump is located at or near the desired location, for example in a desired portion and chamber of the heart, the clinician or operating physician may utilize catheter controls to expand the cannula of the pump. With the expanded cannula and a generated conduit, the clinician or surgeon may subsequently expand the delivery element of the pump within the cannula, wherein alternately expansion of cannula and delivery element may occur simultaneously.

Rotation of the delivery member creates a flow of blood within the cannula between the inlet and outlet or outlets of the cannula. The cannula may also cause separation between any surrounding tissue and the rotating conveyor element. The cannula may also be adapted for engagement with structure or tissue in the heart, such as blood vessels including vena cava, such as the superior vena cava, inferior vena cava, or other vessels, or combinations thereof. The conveying element can be driven by a power transmission system and controlled by a control and / or power unit. The clinician or operating physician may enter therapeutic system parameters into the control unit that drives the pump at desired speeds for desired periods of time. The collapsed deployment structure may permit rapid deployment in multiple anatomical locations and removal, while the expanded, operable structure may allow for appropriate therapy.

The present disclosure in one embodiment relates to expandable blood pumps and methods of their deployment and use for circulatory support. The blood pump may include a cannula consisting of an adjustable support member and an elastic tissue cover allowing for a reduced or minimally collapsed size deployment structure and an operable structure of increased or maximum size.

In another embodiment, the cannula may vary in diameter along its axial length, which reduces or minimizes interference between expanded cannula and tissue openings. In addition, a change in cannula diameter may allow for a leading narrow portion of the cannula, which may improve handiness and allow for increased reach in the anatomy. Still further, a change in the cannula diameter may permit the position of the pump to be determined with respect to a vessel opening or other port through which it passes.

The cannula may contain multiple openings which may assist in preventing zero blood flow if tissue collapses at the inlet end of the cannula. The cannula, in some embodiments, may be configured such that an outlet expels the flow rate generally perpendicular to the axis of rotation of the pump. The blood pump may be operated by a fluid system including catheter support and return channels that cause a mechanical generator to rotate. The mechanical generator may be mechanically or magnetically coupled to a delivery element of the blood pump.

The present disclosure, in another embodiment, relates to a pump for initiating movement of a fluid relative to the pump. The pump may include an elongate cannula having at least one portion that is adjustable between an operable structure having a first diameter and a deployment structure having a substantially smaller diameter.

The pump may further include a delivery element disposed in the adjustable portion of the cannula and rotatable therein about a rotor axis. The conveying element may comprise a rigid or semi-rigid mast or a flexible supporting element that supports an elastic tissue, wherein the mast or support element with respect to the cannula between an operable Structure and a deployment structure are separately positionable, wherein the operable structure extends at least in a part of the tissue at a first radial distance from the rotor axis and the deployment structure collapses the part of the fabric into a second radial position of substantially shorter distance from the rotor axis.

In some embodiments, the cannula may include a helical support member with the helical support member spirally moving about the rotor axis. The helical support member may be adjustable from the operable structure to the deployment structure by twisting the helical support member. Alternatively or additionally, the helical support member may be adjustable from the operable structure into the deployment structure by positioning a proximal and distal end of the helical support member farther apart. The cannula may further include a cover supported by the helical member.

The cover may in some cases have a plurality of inlet openings and / or an outlet opening that allow the blood flow to leave the pump substantially perpendicular to the rotor axis. In some embodiments, the cannula may also include a second portion that is adjustable between an operable structure having a second diameter and a deployment structure having a substantially smaller diameter than the second diameter. In particular embodiments, the cannula may have a terminal fixation neck between the first cannula portion and the second cannula portion.

In other embodiments, the cannula may have an expandable member at one end, or may have an expandable member at both ends. The expandable member is designed to increase its size so that it can engage the anatomical structure. In some embodiments, the expandable member is configured to engage blood vessels. For example, the expandable member may be configured to engage blood vessels such as the aorta, vena cava, superior vena cava, inferior vena cava, other vessels, or combinations thereof. In other embodiments, the expandable member may engage with other or additional structures in the body or in the heart such as one or more valves in the heart. The expandable member may engage the tissue structure such that blood flow is reduced between, through, or around the expandable member and the tissue structure with which the expandable member is engaged is substantially reduced, substantially prevented or prevented ,

In some embodiments, the expandable element is configured to be positioned between a deployment structure that has substantially collapsed for reduced or minimum size and an operable structure in which the expandable element is partially or fully expanded in size. In some embodiments, the expandable element may be expanded by being inflated with a fluid such as air, saline, or other physiologically acceptable fluid, or combinations thereof. In other embodiments, the expandable member may be maintained in a constrained configuration when in the deployment structure, such as by being enclosed by a retention member such as a sleeve. When the sheath or other retaining member is disengaged from the expandable member, the expandable member expands to a size greater than the size of the expandable member when in its deployment structure. In still other embodiments, the expandable member may be mechanically held in a deployment structure, such as by gears that engage slots in the expandable member, wherein the gears are driven by a drive mechanism. In these embodiments, the drive mechanism may be utilized to expand or contract the expandable member to a desired extent.

In further embodiments, the conveyor element may comprise two or more dimensionally stable or semi-rigid masts or flexible support elements that support the elastic fabric, wherein the support elements are in the operable structure substantially perpendicular to the rotor axis and in the deployment structure substantially parallel to the rotor axis. A distal catheter portion may hold a first one of the support members and a proximal catheter portion may hold a second one of the support members, wherein at least one of the distal and proximal catheter portions is rotatable with respect to the other to radially offset the support members.

In other embodiments, a first end of the rigid or semi-rigid mast or flexible support member may be operatively connected to a first catheter portion of the conveyor member, and a second end of the rigid or semi-rigid flexible support member may be operatively connected to a second catheter portion, wherein at least one of the first and second second catheter sections with respect to the other is axially positionable so that when the catheter sections are positioned to each other, the support member is pressed into the operable structure, and when the catheter sections are moved away from each other, the support member is pressed into the deployment structure. Additionally, at least one of the first and second catheter sections may be rotatable with respect to the other to radially offset the first and second ends of the support elements.

The pump may include a drive shaft to control a rotational movement of the conveyor element. The drive shaft may include a proximal portion having a first gear at its distal end and a distal portion having a second gear at its proximal end, wherein rotation of the proximal portion is transmitted to the distal portion by having the first and second gears disposed adjacent are. In a further embodiment, a power transfer system of the pump for driving rotational movement of the impeller may comprise a mechanical generator for continuously transferring fluid movement into rotary motion of the generator about the rotor axis, and a first cavity for driving fluid into the mechanical generator and a pump second cavity, which transfers liquid away from the mechanical generator. The mechanical generator can be operatively connected to the conveyor element, whereby a rotational movement of the generator about the rotor axis is transferred into a rotary movement of the conveyor element about the rotor axis.

In a further embodiment, the power transmission system may further comprise one or more first magnets arranged and operatively connected to or near a mechanical generator and thereby rotatable about the rotor axis, and a magnet housing operatively connected to the conveyor element and the mechanical one Locator is disposed adjacent, wherein the housing has one or more second magnets, which are arranged around the rotor axis, interact with the first magnet to cause a rotational movement of the second magnet around the rotor axis magnetically.

The present disclosure, in yet another embodiment, relates to a method of deploying a pump for cardiac assist. The method may generally include providing a pump such as described above, inserting a catheter with the pump operatively connected at or near its distal end, into a blood vessel with cannula and delivery element in its deployment structures, guiding the pump to a desired one Include placement and adjustment of cannula and delivery element from their deployment structures into their operable structures.

The methods may also include adjusting the rigid or semi-rigid mast or flexible support member and flexible fabric to produce a desired angle of the blade. The conveyor element may be driven at a desired speed via a power transmission system. Additional methods may include returning the cannula and delivery member into their deployment structures and removing the catheter and pump from the blood vessel.

While numerous embodiments are disclosed, other embodiments of the present disclosure will become apparent to those skilled in the art from the following detailed description, which illustrates and describes illustrative embodiments of the disclosure. As will be appreciated, the various embodiments of the present disclosure are capable of modifications in various obvious aspects, all without departing from the spirit and scope of the present disclosure. Thus, the drawings and detailed description are to be considered as illustrative and not restrictive.

1 illustrates an embodiment of an expandable blood pump 100 according to the present disclosure. With additional reference to 2 can be an expandable blood pump 100 generally a catheter 102 with a pump 104 included, which is arranged at the inserted end of the catheter or in the vicinity, and a control and / or drive unit 106 which is operatively connected to or with an outer end of the catheter. The pump 104 can be a conveyor element 108 , a cannula 110 and a leadership system 112 include.

The catheter 102 may include a power transfer system which the pump 104 and the control and / or drive unit 106 operable connects. Several of these components such as conveying element 108 , Cannula 110 , Leadership system 112 and power transmission systems may include various embodiments that are within the blood pump 100 may be interchangeable or interchangeable to produce a variety of different embodiments of blood pumps, as will be understood from the following description.

FUNDING ELEMENT

In general, the various embodiments of conveyor elements of the present disclosure may include one or more blades that are made of a thin, flexible web or sheet material. In some embodiments, the blades hang on or between one or more generally moveable, resilient, rigid, or semi-rigid support members or masts. In other embodiments, the vanes are made of a material that does not utilize a support member or mast, such as where the bucket is a collapsible, collapsible, expandable or inflatable section of polymer, fabric, nitinol or other memory metal or other biologically suitable material or composite or the combination of these is. In some embodiments of conveyor elements disclosed herein, the conveyor element may be activated between a collapsed deployment structure and an expanded operable structure by altering the position of the moveable, rigid or semi-rigid support elements, thereby stretching the flexible tissue to a desired position and creating a blade surface , In other embodiments of conveyor elements disclosed herein, the conveyor element may be activated between a collapsed deployment structure and an expanded operable structure by altering the position of the vanes by inflating the conveyor element or retaining the vanes, or allowing them to deploy or expand to expand its operable structure of increased or maximum size. Thus, the conveyor element may allow a collapsed deconvolution structure of reduced or minimal size and an expanded, operable structure of increased or maximum size.

In some embodiments, the impeller may be activated between a collapsed deployment structure and an expanded operable structure separate from activation of the cannula (discussed in more detail below) between a collapsed deployment structure and an expanded, operable structure. Alternatively, an extension of cannula and delivery element may occur substantially simultaneously. In various embodiments disclosed herein, the geometry and scales of the blades may reduce hemolysis, thereby improving the results of the method as a result of improved therapy. Furthermore, the delivery member may be within the cannula at any axial distance from the distal tip.

In an in 3 illustrated embodiment, a conveyor element 300 from one or more blades 302 consist, each blade is an elastic tissue 304 that is attached between rigid or semi-rigid, free-standing support elements 302 attached to the catheter 308 are attached. The support elements 306 can be between positions substantially parallel and perpendicular to the axis of rotation 310 the pump turned or adjusted. With the support elements 306 in a position substantially parallel to the axis of rotation 310 the pump, can the elastic tissue 304 be withdrawn with these into a collapsed developmental structure. If the support elements 306 in a position substantially perpendicular to the axis of rotation 310 the pump are adjusted, as it is in 3 is shown, the elastic tissue 304 be extended with these into an expanded, operable structure.

The catheter 308 can be a catheter layer with a proximal section 312 and a distal section 314 include, which can be rotated relative to each other. Every scoop 302 can be a support element 306 at the proximal section 312 is arranged, and a support member on the distal section 314 exhibit. In this way, the angle of the elastic tissue, allowing the elastic tissue 304 is located in an expanded, operable structure, and thus the blade surface by rotation of the proximal section 312 and distal section 314 of the catheter 308 be generated or modified relative to each other. In a further embodiment, the in 4A and 4B is illustrated, a conveying element 400 an elastic fabric 402 contained on or between a generally semi-hard, but elastic support member 404 and optionally on the catheter 406 is attached. The generally semi-hard, but elastic support element 404 may be, but is not limited to, a medium rigidity wire in some embodiments, and may be at both ends 408 . 410 on the catheter 406 be attached. In one embodiment, the catheter 406 a sliding section 412 and a rotary section 414 which can be rotated relative to the sliding portion, wherein the support element 404 at both ends 408 . 410 may be attached to the sliding portion of the catheter. Part of the support element 404 Also, in general, can be at a fixed location 416 along the rotation section 414 be held axially.

For example, in one embodiment, the flexible support member 404 through the rotary section 414 run, as is in 4A is shown, so that a part of the support element generally at a fixed location 416 is held axially along the rotary section. In a further embodiment, the support element 404 in two Sections are shared, with each section one on the sliding section 414 attached end and one on the rotary section 414 at the fixed point 416 having fixed end. However, other suitable elements are contemplated within the spirit and scope of the present disclosure to allow the proximal end and distal end of the flexible support member to be considered 404 can move relative to each other in the axial direction. Where a retaining wire is used for one or more flexible support members, the retaining wire may be round or flat. Alternatively, the support members may be formed of a truncated tube, hollow wire, or similar structure.

The sliding section 412 of the catheter 406 can be axial along the rotation section 414 between axial positions to the fixed point 416 moved backwards and forwards. With the sliding section 412 which is in a position generally relatively away from the fixed point 416 can be moved, parts of the support element 404 closer to the axis of rotation 418 pulled the pump, which causes the elastic tissue 402 With this in a collapsed development structure is withdrawn.

When the sliding section 412 in a position generally relative to the fixed location 416 is shifted, parts of the support element 404 from the axis of rotation 418 The pump will be pushed away, thereby causing the elastic tissue 402 with this expanded into an expanded, operable structure, as it is in 4A is shown. With the elastic tissue 402 in an expanded, operable structure, the angle of the elastic web and thus the blade surface can be determined by rotation of the pivot portion 414 of the catheter with respect to the sliding section 412 be generated or modified as it is in 4B is shown.

In yet another, in 5A and 5B illustrated embodiment, a conveying element 500 one or more blades 502 each comprising an elastic fabric 504 contained on or between a generally semi-hard, but elastic support member 506 and optionally the catheter 508 is attached. The generally semi-hard, but elastic support element 504 may be, but is not limited to, a medium rigidity wire in some embodiments, and may be at both ends 510 . 512 with the catheter 508 be attached.

In one embodiment, the catheter 508 a catheter layer having a proximal (alternatively distal) portion 514 and a distal (alternatively proximal) section 516 contain, with a portion or both along the axis of rotation 518 the pump are axially positionable, and either a portion or both are rotatable about the axis of rotation of the pump, so that the distal portion and the proximal portion can be positioned and rotated in the axial direction relative to each other.

The support element 506 can be on one end 510 with the distal section 514 and at one end 512 with the proximal section 516 be attached, wherein the ends can be positioned by the distal and proximal portions in the axial direction and rotated relative to each other. However, within the spirit and scope of the present disclosure, other suitable elements are contemplated, which are the distal end 510 and proximal end 512 the elastic support element 506 allow to move in the axial direction and / or rotationally relative to each other.

As in 5C . 5D and 5E As shown, the geometry of the impeller may be a blade angle (θ ₁ ) at the inlet that will be sharper (more perpendicular and less parallel to the axis of rotation) and a blade angle (θ ₂ ) at the outlet that is flatter (more parallel to the axis of rotation) will be marked. The transition between the two angles may occur in stages to improve flow performance and reduce turbulence and other losses.

For example, the blade angle (θ) may be between the axis direction (or axis of rotation) 518 and a tangential line 519 to the blade 502 be measured as it is in 5B is shown in the the tangential line 519 at the radially outer part of the tissue 504 or along the elastic support member 506 is defined. Furthermore, the inlet or proximal blade angle θ _{1 may be} relatively larger to the proximal or inlet portion 516 of the conveyor element 500 That is, with the blade edge or tangential line along the elastic support member 506 or the outer part of the fabric 504 more or less perpendicular to the axis direction 518 is aligned. Conversely, the outlet or distal blade angle (θ ₂ ) may be toward the distal or outlet portion 514 towards (i.e., the bucket edge or tangent along the elastic support member) may be relatively smaller (θ ₂ <θ ₁ ) 506 or the outer part of the fabric 504 more or less parallel to or along the axis direction 518 is aligned.

Where the angle of the blade transition gradually changes, the value of the blade angle (θ) may be substantially consistent with a substantially continuous derivative (eg, the first) between the distal end 514 and proximal end 516 of the axial element or catheter 508 be constant. In addition, the bucket angle may vary from approximately perpendicular or slightly less than perpendicular to the proximal end 516 towards (ie, θ ₁ ≤ 90 °) to approximately parallel or slightly larger than parallel to the distal end 514 out (θ ₂ ≥ 0 °). Alternatively, the blade angle (θ) may be between upper and lower limits, or both, for example, θ ≥ 10 °, θ ≥ 20 °, or θ ≥ 30 °; and / or θ ≤ 80 °, θ ≤ 70 ° or θ ≤ 60 °.

The relationship between proximal section 516 and distal section 514 of the catheter 508 can also be reversed so that θ ₁ > θ ₂ . Accordingly, in some embodiments, the flow direction F (arrow 520 ) in each direction along the conveyor element 500 from the end 514 to the end 516 towards or from the end 516 to the end 514 progress without loss of commonality.

In further embodiments, the blade angle (θ) may be along the conveyor element 500 may be substantially constant such that θ ₁ ≈ θ ₂ , or the blade angle (θ) may substantially monotonically decrease or increase between θ ₁ and θ ₂ , where θ ₁ ≠ θ ₂ . Where the blade angle changes, the change as a function of the axial position z may be linear. For example, the blade angle may be defined as: θ (z) = θ ₁ + mz, [1] wherein the inclination m = (θ ₁ - θ ₂ ) / Δz and Δz = z ₂ - z _{1 is} the axial distance between the first blade angle θ ₁ and the second blade angle θ ₂ . In a logarithmic profile, the blade angle can vary as: θ (z) = θ ₁ + Δθ × log [1 + (b-1) (z-z ₁ ) / Δz] [2] where Δθ = θ ₂ -θ ₁ and b is the base of the logarithm so that θ (z ₁ ) = θ ₁ + θ ₂ × log (1), which is θ ₁ , and so that θ (z ₂ ) = θ ₁ + Δθ × log (b), which is θ ₂ . Alternatively, the change may be sinusoidal: θ (z) = θ ₁ + Δθ × sin [(z - z ₁ ) π / nΔz] [3] where n specifies the periodic character, for example n = 2. The blade angle θ can also vary exponentially or assume a different functional form. The blade angle θ may also have local minimum values and maximum values between θ ₁ and θ ₂ .

Each or both of the distal and / or proximal sections 514 . 516 of the catheter 508 can along the axis of rotation 518 the pump between axial positions towards each other or moved away from each other or axially adjusted. With the distal and proximal sections 514 . 516 , which are generally displaced relative to each other in a position away from each other, parts of the support member 506 closer to the axis of rotation 518 pulled the pump, which causes the elastic tissue 504 withdrawn with these in a sunken deployment structure.

If the distal section 514 and the proximal section 516 can be adjusted in a position generally relative to each other, parts of the support element 506 from the axis of rotation 518 The pump will be pushed away, thereby causing the elastic tissue 504 into an expanded, operable structure, as in 5A is shown is expanded. With the elastic tissue 504 In expanded, operable structure, the angle of the elastic tissue and thus the blade surface can be created or by rotation of one or both of the distal and / or proximal portions 514 . 516 of the catheter 410 relative to each other, as in 5B is shown to be modified.

The rotation of the conveyor element 500 in or along a working direction R (arrow 522 ) may be a mechanism to allow the conveyor element 500 unfolds and expands by using flow, pressure, preload, centrifugal force, or a combination of these, to the tissues 504 in a radially outer position with respect to the axis of rotation 518 that is, in an operable position outside the catheter 508 located blades 502 to spread. The rotation in the opposite direction can cause the collapse of the mechanism, with the blades 502 closer to the catheter 508 are positioned and tissue 504 in a more radial position inwards with respect to the axis 518 pile.

In general, the working direction of the rotation of a relatively higher pressure surface of the blade (or pair of blades) 522 to a relatively lower pressure surface of the blade (or pair of blades) 502 be there like it is in 5E is shown. In some embodiments, the tissue may 504 also flex under load to create a substantially concave pressure surface along one side of the blade 502 (eg 502A ) and a substantially convex suction surface along the opposite side of the blade 502 (eg 502B ) to create. Alternatively, the working direction or curvature (or both) may be based on flow conditions and that of the impeller 500 supplied power or torque can be reversed.

The various embodiments of cannulas described above may be made of any suitable materials. For example, the various embodiments of cannulas described above may be made from a Polymer, an elastic tissue, a metal or a metal alloy, a shape memory material or combinations of materials, but not limited to be made. The material of the tissues 504 may also be a woven gauze attached to the support elements 506 attached, such as nitinol or fabric fabric. Openings may be left in the gauze for improved flow dynamics whereby the gauze may be coated. If a coating is used, it may be made of silicone or polyurethane (PU).

The support elements or masts 506 may also be formed of a straight or bent wire, wire mesh or hose, for example laser cut tubing or laser cut tubing. One of tissue 504 and support elements 506 or both may also be formed of or include additional cover material, for example, (foamed) polytetrafluoroethylene (ePTFE or PTFE), low density polyethylene (HDPE or PEHD), polyethylene terephthalate (PET or PETE), or a polyimide or silicone material. Where laser cutting or laser cut tubing is described, laser cutting and other forms of pattern cutting can be employed by, for example, cutting a molding tube or sheet of material such as nitinol or other memory metal or other biologically suitable metal alloy, polymer or composite.

NEEDLE

In general, the various embodiments of cannulas of the present disclosure may include a plurality of support members or ribs and may be activated between a collapsed deployment structure and an expanded, operable structure by altering the relative position of the ribs. In some embodiments, as noted above, the cannula may be activated between a collapsed deployment structure and an expanded operable structure separated from activation of the delivery element between a collapsed deployment structure and an expanded, operable structure.

In an expanded, operable structure, a conduit can be created within which the delivery element of the pump can be expanded and operated. Operation of the delivery member may cause blood flow within the cannula between the inlet and outlet of the cannula, which is typically provided at the proximal end and distal end of the cannula, respectively. In some embodiments, the cannula may also cause separation between any surrounding tissue and the delivery element.

In one embodiment, in 6 and schematically in 7A . 7B and 7C can be shown, the cannula 600 a thin, elastic film or gauze cover 602 contained by one or more or between one or more, substantially dimensionally stable or semi-rigid support elements 604 is held in a spiral arrangement containing a variety of ribs 606 produce. In an extended, operable structure, the ribs can 606 , as in 6 shown, stretched and / or the cover 602 support to a line 608 in which the conveying element (eg conveying element 500 as in 6 although any of the above described conveying elements are suitable) can be extended to its operable structure. In some embodiments, the substantially dimensionally stable or semi-rigid support elements 604 be biased in a spiral arrangement in the expanded, operable structure.

The cannula 600 can be of an open or operational structure, as in 7A and 7B shown in a like in 7C shown, collapsed unfolding or deployment structure are adjusted. In one embodiment, the catheter 610 turn on again 6 a catheter layer having a distal portion 612 and a proximal section 614 containing one or both sections along the axis of rotation 616 the pump are axially positionable, so that the distal and proximal portions can be positioned axially relative to each other.

The cannula 600 , or more specifically, in some embodiments, the support elements 604 can be on one end 618 with the distal section 612 and at one end 620 with the proximal section 614 be attached, thereby allowing the ends of the cannula 600 , or the support elements 604 , are also positioned axially relative to each other by distal and proximal portions. So can the cannula 600 in one embodiment, from an open structure to a collapsed deployment structure, by causing the support elements 604 generally offset relative to each other, are axially displaced, thereby causing portions of the support members to be closer to the axis of rotation 616 the pump will be pulled, and will cause the elastic gauze cover 602 to be withdrawn.

Additionally or alternatively, one of the distal and proximal portions may be 612 . 614 or both around the axis of rotation 616 the pump be rotatable so that the distal and proximal portions can be rotated relative to each other. In this regard, the ends of the cannula 600 or the support elements 604 additionally or alternatively by the distal and proximal sections 612 . 614 be positioned rotatable relative to each other. Thus, in one embodiment, the cannula 600 be adjusted into a collapsed deployment structure by additionally or alternatively causing the ends of the helical support elements 604 be rotated relative to each other, reducing the size of the line 608 decreases and held in between gauze cover 602 coincides.

However, any other suitable elements are contemplated within the spirit and scope of the present disclosure to allow the distal and proximal ends of the support members to be considered 604 move axially and / or rotatable relative to each other. In a further embodiment, the cannula 600 and / or catheters 610 Contain a pull cord that can be pulled to remove any loose material from the retracted gauze cover 602 collect and hold them relatively closer to the catheter body.

The support elements 604 and ribs 606 or both may consist of a wire enclosure or braid or a laser-cut shape memory tube, as shown in FIG 7B and 7E is shown to be formed. It can also be a combination design of straight support elements 604 or ribs 606 essentially in the longitudinal or axial direction, at the proximal end 614 and distal end 612 the cannula 600 supported, and a braided pattern or gauze pattern of support elements 604 or ribs 606 essentially over the circumference or spirally in the middle, between the ends 614 and 612 ,

The pattern may also be reversed, with a circumferential or spirally braided pattern or gauze pattern of support members 604 or ribs 606 at the ends and a substantially straight or axial or longitudinal pattern of support members 604 or ribs 606 between. Where the rib pattern 606 from a laser cut tubular support member 604 is formed, the geometry can also be provided without or substantially without projections, for example, without sharp projections, on a shell or similar element, which is above the cannula 600 may be provided or via the cannula 600 in the collapsed structure or unfolding structure.

7F is a side view of the cannula 600 in an embodiment with a tubular enclosure. In this embodiment, the cannula includes 600 a support structure consisting of substantially straight or axially aligned ribs 606 is formed, extending from the proximal end or area 614 to the distal end or area 612 extend, with at least one transversely stiffened structure 607 in an intermediate or middle area 613 , between the ends 612 and 614 ,

The support structures 606 and 607 the cannula 600 may be formed, for example, by laser cutting from a memory metal such as a Nitinol tube, or by using another suitable material as described herein. For example, the structure of 7F , similar to the embodiment of FIG 7E , with a cross-bracing structure 607 formed in a sinusoidal, sawtooth or stent-like pattern for additional hoop strength in the central region 613 is trained. Alternatively, the transverse stiffener 607 be formed of one or more ribs in the circumference or spirally, as described above.

support ribs 606 are at the catheter 610 at one end, for example the first end 620 of the proximal region 614 fixed or fixed. The opposite end (eg the second end 618 of the distal area 612 ) slips into the axial dimension with respect to the catheter 610 and the proximal end 620 , If the case 622 from the collapsed cannula 600 is deported, the support elements 606 and 607 be biased to expand into its operative form, with the longitudinal ribs 606 radially and axially from the first end 620 in the proximal area 614 substantially axially from the proximal region 614 through the middle area 613 and in the distal area 612 as well as axially and radially from the distal region 612 to the second end 618 extend. The transverse stiffening structure 607 Expands essentially over the circumference and radially out to the middle area 613 the cannula 600 as described above.

The gauze cover 602 may, as described above, be formed of ePTFE or polyurethane or other suitable cloth material or silicone. When the cannula shell 622 is withdrawn to the cannula 622 by sliding in the proximal direction, becomes the second (free) end 618 typically to the first (fixed) end 610 slide or reposition, which cannula 600 and gauze 602 expanded in the radial direction for deployment and operation. The support elements 606 and 607 deform from the deployment state to the operating state by gauze or cover 602 be extended to a flow for the conveyor element 500 to build. If the case 622 slides back in a distal direction become supporting elements 606 and 607 as well as gauze 602 through the shell 622 covered by herself deform for removal from the operating state back to the deployment state.

The conveying element 500 may be formed with blades formed of memory metal such as nitinol, or may be a memory metal such as nitinol wires 501 which are coated with a gauze or fabric material to blades as described above 502 to form, with the blades 502 and wires 501 on the drive shaft 630 at the proximal end 532 of shovels 502 and conveying element 500 are fixed. The distal end 531 of conveying element 500 and shovels 502 slips in the axial dimension with respect to the proximal end 532 ,

If the cannula 600 expands, the support elements become 607 and 606 biased into its operative form, and the distal (free) end 531 of the conveyor element 500 slides or shifts axially to the proximal (fixed) end 532 out. On the drive shaft 630 can be in the distal area 612 an attack 632 be provided to overflow the free end 531 of the conveyor element 531 , for example, between the free end 531 and the distal end 618 the cannula 606 , to prevent. Suitable coating materials for conveying element 500 and shovels 502 (eg tissue 504 above) and for the cannula 600 (eg cover material 602 ) include silicone, polyurethane, biologically suitable fabric materials, wire mesh and cut sheet metal, and combinations thereof, for example, with a material selected for use as a structural form and another selected for use as a coating or fabric.

The drive shaft 630 may consist of a flexible wire wrap in at least part of the proximal region 614 be formed, for example, until the drive shaft 630 the conveying element 500 at the proximal end 532 reached. The drive shaft 630 can be made of a substantially straight or semi-hard wire in the middle area 630 and distal area 612 , for example, from the proximal end 632 to the distal end 531 , Attack 632 and distal end 618 the cannula 600 be educated. In the proximal area 614 becomes the drive shaft 633 through the catheter 610 at the end 620 supported. In the distal area 612 can the drive shaft 630 through a short section of the catheter at the distal end 618 the cannula 600 be supported where the distal end 618 through the structural elements 606 and 607 is held.

In contrast to other designs, the longitudinal support elements include 606 parts 606A extending radially and axially in the proximal region 614 and distal area 612 extend, and parts 606B which are essentially axial in the middle section 613 , between the proximal and distal areas 614 and 612 , extend. Furthermore, the drive shaft can 632 from the first (proximal) end 620 the cannula 600 at the catheter 610 through the proximal area 614 , middle range 613 with conveyor element 500 and distal area 612 with stop 632 to the second (distal) end 618 extend. So can the cannula 600 axially and radially on the catheter 610 at the proximal end 620 via radial and axial load bearing parts 606A the support elements 606 in the proximal region 614 be determined.

In the distal area 612 may be the distal end 618 however, along the drive shaft 630 Sliding to freedom of movement in the axial direction with respect to the proximal end 620 as described above, while axial / radial parts 606A the longitudinal support elements 606 the distal end 618 the cannula 600 in the radial sense of direction about the drive shaft 603 establish. Alternatively, the distal end may be 618 the cannula 600 with respect to the drive shaft 630 be set radially, with an axial freedom of movement is provided by the fact that the drive shaft axially within the catheter 610 slides.

This avoids the axially folded deployment structures of some solid-solid designs while providing a radial support to the distal end 618 the cannula 600 in the radial direction sense by avoiding structural problems caused by fixed-free designs. In this axially slipping structure of the cannula 600 at the distal end 618 is a shell 622 for pushing over the full axial length of the cannula 600 and back in both the proximal (opening) and distal (coincident) directions, without binding.

Alternatively, the proximal end 620 the cannula 600 be designed to be relative to the catheter 610 and the (fixed) distal end 618 to slide axially, leaving the cannula 600 unfolded or collapsed by a distal and proximal, axial movement of the drive shaft 630 concerning the catheter 610 and the (eg axially immovable) shell 622 , where the drive shaft 630 at the cannula 630 at the distal end 618 axially fixed as described above. In this embodiment could be an axial movement of the drive shaft 630 also be used to the conveying element in combination with the cannula 600 merge and unfold, the conveying element 500 would collapse and get in the cannula 600 would unfold, and the cannula 600 collapse and unfold when the proximal end 620 in the (eg axially fixed) shell 622 retracted or extended from this.

One of cannula 600 and catheters 610 or both can also be provided with fixing elements to the pumping system 100 with respect to an anatomical element, for example a vessel wall, heart valve or an anatomical feature of the heart. For example, in various embodiments, a screw or other mechanical retention pin or fastener may be used 652 at the top of the pumping system 100 For example, on the catheter portion of the distal end or tip 618 the cannula 600 , be provided to cannula 600 and pumping system 100 secure to a heart wall.

Alternatively, one or more hooks or prong-type mechanical retention pins may be used 652 be designed, for example, to be combined with the cannula 600 to deploy to attach to a trabeculae or similar trabecular formation within a chamber of the heart or a similar feature of the heart wall. One or more retaining pins 652 may also be provided as a guidewire anchor to secure or anchor the guidewire as described below, the pumping system 100 is positioned by running over the guidewire and into the desired anchoring point.

In other embodiments, outside the cannula 600 one or more balloons or other expansion elements 654 be provided to the pump 100 to attach to a vascular feature such as a heart valve or aortic wall. The balloon elements 654 may be due to the action of a biasing element as described above or by pressurization of a fluid, such as by the pump 100 or via an additional channel or cavity, for example, connected to a fluid drive system described below.

The balloon elements 654 can be in any combination of the proximal, middle and distal areas 614 . 613 and 612 the cannula 600 be provided. The balloon elements 654 can also be along the catheter 610 or the shell 622 be provided to the catheter 610 to attach to an aortic wall or other vessel structure.

In another embodiment, in 8A . 8B and 8C is shown schematically, the cannula 800 a thin, resilient sheet or gauze cover, which may be formed by or between one or more substantially rigid or semi-rigid support members 804 are attached in a linear, axial arrangement containing a plurality of ribs 806 which are generally aligned parallel to the catheter body. In an expanded, operable structure, the ribs can 806 , as in 8A and 8B shown, stretched and / or support the cover to a line 808 to produce, in which the conveyor element is expanded into its operable structure. In some embodiments, the substantially dimensionally stable or semi-rigid support elements 804 be biased in a linear, axial arrangement in the expanded, operable structure.

Similar to the embodiments of 6 and 7 can the cannula 800 into a collapsed developmental structure, as in 8C is illustrated, to be adjusted. In one embodiment, the catheter 810 as discussed above, include a catheter layer having a distal portion and a proximal portion, wherein the one or both portions are along the axis of rotation 812 the pump are axially positionable, so that the distal and proximal portions can be positioned axially relative to each other. The cannula 800 , or more specifically, in some embodiments, the support members 804 , can at one end 814 with the distal section and at one end 816 be attached to the proximal portion, thereby allowing the ends of the cannula or the support elements 804 also be positioned axially relative to each other through the distal and proximal portions.

Thus, in one embodiment, the cannula 800 be displaced into a collapsed deployment structure by causing the support elements 804 generally axially displaced relative to each other, thereby causing portions of the support members to be closer to the axis of rotation 812 the pump will be pulled, and will cause the elastic gauze cover 802 being pulled back with these. Conversely, the cannula can 800 be opened in an expanded or operable structure by causing the support elements 804 generally axially displaced relative to each other, thereby causing portions of the support members from the axis of rotation 812 The pump will be positioned away, and causes the elastic gauze cover 802 is expanded or unfolded with these. This can be achieved by, for example, the proximal end 816 and distal end 814 the cannula 800 be relatively positioned or the corresponding proximal and distal parts of the catheter 810 be positioned relatively axially.

As with the above embodiments, any other suitable elements are contemplated within the spirit and scope of the present disclosure to allow the distal end to be contemplated 814 and the proximal end 816 the support elements 804 move axially relative to each other. In a further embodiment, the cannula 800 and / or the catheter 810 Contain a pull cord that can be pulled to remove any loose material from the retracted gauze cover 804 collect and hold the gauze cover relatively closer to the catheter body. In any of these embodiments, collapse of the cannula may occur 800 also cause the delivery element to collapse into the deployment position, with expansion or deployment of the cannula 800 may also allow the conveyor element to expand out of the collapsed deployment position and open outwardly into an operable or deployed position.

In some embodiments, the cannula, as shown in FIG 6 to 8C is shown to have a generally constant diameter in the axial direction along the catheter body. However, the cannula can 900 in other embodiments, such as in 9A shown having a diameter extending axially along the catheter body 102 changes. In these embodiments, the cannula 900 two or more axial sections 904 . 906 of substantially constant diameters and one or more transition sections 908 from one section of constant diameter to another section of constant but different diameter.

A conveying element, such as that described above, may be provided in any suitable axial section. As shown, a conveyor element (eg, the one shown in FIG 9A shown conveyor element 500 although any of the above described conveying elements are suitable) in a proximal axial section 906 relatively larger diameter than a distal axial section 904 be provided. In such an embodiment, the transition from a relatively larger diameter conduit to a relatively smaller diameter conduit may also provide throughput through the distal, axial portion 904 and out of the cannula 900 to increase out.

According to some embodiments, the operation of a delivery element within the various embodiments of cannulas described herein may facilitate the passage of a fluid, e.g. Blood, into an inlet opening at one end of the cannula, through the cannula and out of an outlet opening at an opposite end of the cannula. Generally, the liquid flow may be substantially axial to the axis of rotation of the conveying element. However, in some embodiments, a cannula 900 additionally or alternatively an inlet 911 or outlet openings 909 Contain the fluid flow in or out of the cannula 900 out, substantially perpendicular to the axis of rotation of the conveying element, allow. In still other embodiments, a cannula may have multiple inlets 911 For example, in the inlet section or proximal axial section 906 the cannula 900 , and / or multiple outlets 909 For example, in the outlet section or distal axial section 904 the cannula 900 , which may help to prevent blockages of inflow and / or outflow of fluid to and from the pump.

The cannula 900 and other devices described herein may also include beam rectifiers, for example in 9B and 9C shown beam rectifier 916 , use. The beam rectifier 916 may consist of one or more elastic membranes extending radially from the catheter 910 to the cannula 900 ( 9B ) or along the axis 118 of the flow path 920 between the catheter 910 and the cannula 900 ( 9C ) or a combination thereof. The beam rectifier 916 thus divide the flow path 920 between catheters 910 and cannula 916 into a number of radially or concentrically divided channels. Alternatively, the beam rectifier 916 have a rectangular, square, triangular or hexagonal channel structure or another embodiment. Beam rectifier 910 can also be used in combination with additional inlet and outlet holes, openings or connections 909 and 111 as described above. Beam rectifier 916 direct a swirling and other, non-axial flow, which is in rotation or in scope through the channel 920 moves in an axial flow, which is essentially along the axis 918 through the different channels that run along the flow path 920 are trained, move. The beam rectifier 116 can be along or above the proximal (inlet) end 914 from cannula 900 and catheters 910 , along or above the distal (outlet) end 912 the cannula 900 and the catheter 910 , or at both ends 914 and 902 be arranged.

In still other embodiments, the cannula 1000 as it is in 10A and 10B is shown, one or more features 1002 to fix the connection. More specifically, the cannula 1000 as it is in cross section in 11A is shown at the one opening 1102 in the wall 1103 is present, for example, but not limited to, between any combination of ventricle (s) and blood vessel (s), designed to be placed in the opening, expanded as described in various ways above, and essentially with respect to the opening through the one or more features 1002 for connection fixing, as shown in cross section in 11B is illustrated, remains attached.

In a specific embodiment, one end of the cannula 1000 such as the distal end 1004 but not limited to a section of line 1006 of the conveying element, a neck portion 1008 and a terminal fixing portion 1010 include. As described above with respect to the various cannula embodiments, the cannula may 1000 that the line section 1006 of the conveyor element, neck section 1008 and a terminal fixing portion 1010 includes, between a collapsed deployment structure and an expanded, operable structure.

As it is in 10A and 10B is shown, the neck portion 1008 be configured in the expanded, operable structure to expand to a diameter that is smaller than the extended diameter of the conveyor element line section 1006 and the terminal fixing section 1010 , whereby a generally clock-glass-like shape is formed, with a bag 1012 formed between the conduit section of the conveying element and the fixing section of the terminal at the neck section.

As it is in 11B Illustrated is the cannula 1000 be expanded at one position so that the at the neck portion 1008 trained bag 1012 upon expansion of the cannula generally with the wall opening 1102 can curse. The relatively larger diameter of the pipe section 1006 the conveying element and the fixing section 1010 The connection can be designed so that it can not easily pass through the wall opening 1102 when the cannula is in the expanded, operable structure, thus causing the cannula 1000 essentially with respect to the opening through the bag 1012 remains attached. In additional embodiments, as shown in FIG 11C shown is an intervening device 1104 , such as a port or similar device, at the wall opening 1102 be fixed, for example, to improve only the opening strength and / or the opening geometry.

The elastic sheeting or gauze cover of the various embodiments of the cannulas described above may be made of any suitable materials, such as, but not limited to, a polymer, a metal or metal alloy, a shape memory material, or combinations of such materials. In further embodiments, the cannulas described above may be provided without elastic foil or gauze covers, thereby leaving the support elements free. Alternatively, another cover or structural support materials may be provided which include, but are not limited to, PTFE or ePTFE, HDPE or PEHD, PET or PETE, PU, polyimide, silicone materials, and combinations thereof.

The pump and delivery member mechanisms as well as the corresponding cannula and corresponding flow path and channel structures may also be fixed in an anatomical site by catheter support through the vessel wall or heart valve 1103 resting cannula, by a guiding feature that rests against the internal or external anatomical structure of a heart, vein, artery or blood vessel through a coil anchor, or by inflating a balloon, for example between the cannula and a vessel wall, heart valve or other anatomical structure 1103 as described above. With respect to again 1 For example, in one embodiment, the various embodiments of the conveying elements and cannulas described in the present disclosure may be adjusted to expand and contract the conveying elements and / or cannulas between an expanded, operable structure and a collapsed deployment structure, by forming a plurality of concentric layers Cases of the catheter, as described in more detail below, is used. Generally, however, in various embodiments, the plurality of concentric layers may include a drive shaft layer slidable along the axial direction of the catheter for adjusting the delivery member and a cannula sheath slidable along the axial direction of the catheter for adjusting the cannula. In alternative or additional embodiments, the drive shaft layer and / or the cannula shell may be rotatable about the axis of rotation to allow, for example, a change in blade angle of the conveyor element and / or collapse of a spiral support member, elastic support member, elastic gauze or elastic gauze supporting the support element cover as described above.

GUIDE

In general, the various embodiments of pumps disclosed herein may include a guide system for directing the catheter and pump into and through the vessel assembly to the desired anatomical position, for example, at the heart. Suitable guidance systems according to a in 12 illustrated embodiment of the present disclosure, an opening or a passage 1202 through, or along, the central axis 1204 of the catheter 1206 included, allowing catheter and pump 1208 over a guide wire 1210 be used and move along this, as will be understood by those skilled in the art.

In another, in 13 In the illustrated embodiment, a guiding system for directing the catheter and pump into and through the vessel assembly to the desired anatomical position may include a steerable catheter tip 1302 include. More specifically, the catheter 1304 a generally flexible section 1306 at its distal end or in the vicinity. The flexible section 1306 may have an adjustable curvature that allows the flexible portion of the catheter to be adjusted to target the catheter in the desired direction of travel. In one embodiment, the flexible portion 1306 have a bias to curvature in a given direction or, in some embodiments, may have a bias for no curvature.

The flexible section 1306 may include a cable anchored thereto to control the curvature of the flexible portion, the cable passing through the catheter to an external control system. In a specific embodiment, the cable is at or near the top 1308 of the flexible section 1306 anchored, which can allow easy control. The cable can be used to the flexible section 1306 for example, by manipulating or pulling the cable on the external control system to effect a desired curvature of the flexible section. Accordingly, when the cable is manipulated or released in another direction, the flexible portion may 1306 return to its normal biased position.

In each of these examples, placement aids such as radiopaque (radiopaque) markers could be included near the pump or at other locations that support placement via fluoroscopy or other imaging technique. Alternatively, such placement aids, tags, or tags could be included in one or more of a pump, cannula, catheter, delivery member, or other component.

POWER TRANSMISSION

In general, the various embodiments of pumps disclosed herein may include a power transfer system in the catheter for driving the delivery member. For example, the transmission system may be controlled by a control and / or power unit operably connected to or external to an external end of the catheter. The power transmission system may generally provide for the transfer of power from the external control and / or power unit to mechanical power required by the pump or the conveyor.

In one embodiment, the transmission system, as in 14 illustrated, a drive shaft included, which connects the conveying element by a coupling directly to a drive motor of the control and / or power unit. In one embodiment, the catheter 1402 as briefly described above, contain a plurality of concentric layers. In such an embodiment, these layers may be a cable in the order from the very inside to the outside 1404 , a rotatable layer 1408 the drive shaft, a drive shaft layer 1410 relating to the rotatable layer 1408 axially positionable, and in some embodiments may be rotatable therewith, and an axially positionable cannula shell 1412 include, but not limited to.

The cable 1404 For example, it may be used to control the guiding system, such as a steerable catheter tip as described above; however, in other embodiments, the cable may 1404 be omitted by leaving a passage for a guidewire along which the catheter can move. The inner catheter sheath 1406 can the cable 1404 surround. The rotatable drive shaft layer 1408 can cause the rotational movement for the conveying element and transmit the rotational movement to this.

The drive shaft layer 1410 relating to the rotatable layer 1408 can be axially positioned, as described above, can be used to retract and deploy any of the embodiments of the conveyor element of the present disclosure. The cannula shell 1412 can with respect to the inner catheter sheath 1406 be axially positionable and utilized to retract and deploy any of the embodiments of the cannula of the present disclosure as described above.

The outer shell 1406 For example, an embedded braid or other structural element to increase torque transmission, or a coil to improve kink resistance, or both.

In one or more embodiments, the drive shaft layers 1408 . 1410 longitudinal but resilient, allowing the drive shaft to have flexibility as it is steered through the vessel assembly but retains the ability to impart rotational motion. The drive shaft and drive shaft layers 1408 . 1410 can as solid wire or mehrdrähtiger coil structure (or thread or fiber) be executed.

The hollow center of a catheter element, for example the inner catheter sheath 1406 or drive shaft layer 1408 or 1410 , could allow passage of a guidewire. There could also be a short, solid section for attaching the pump.

One of the drive shaft layers 1408 . 1410 or both may be lubricated with a lubricant, such as, but not limited to, physiological saline. The construction may also utilize low friction coatings such as Teflon between relatively moving or rotating layers or elements, for example sheath layers, guidewires, cables and corrugated layers. The dimensionally stable section can also be supported by mechanical bearings such as ball bearings, hydrodynamic bearings or plain bearings. The rotatable drive shaft layer 1408 or both drive shaft layers 1408 . 1410 can, as described so, be used to control the pump by a rotary motion is delivered or transmitted to the conveyor element.

In another, in 15 In the illustrated embodiment, the transmission system may include a drive shaft member configured generally as described above, except that at one or more locations along the drive shaft there is an array of gears 1502 can be used to relatively sharper bends or angles in the drive shaft between a distal portion 1504 the drive shaft and a proximal portion 1506 allow the drive shaft while maintaining a torque along the drive shaft. In some embodiments, the drive shaft sections 1504 . 1505 with gears 1502 be brought into contact with each other at their adjacent ends or via a tension member such as a cable or a sheath, but not limited to, keep contact with each other. The angle between the drive shaft sections 1504 . 1506 can be adjustable.

In another, in 16 , illustrated embodiment, the transmission system, a liquid-operated or hydrostatic transmission system 1602 in combination with a magnetic coupling device 1604 include. In general, an external system may direct a liquid to a mechanical generator which causes a rotational movement of the mechanical generator, which is transmitted via a magnetic coupling to the conveyor element. In a specific embodiment, the hydrostatic transmission system 1602 a catheter body or an outer shell 1606 and an inner shell 1608 which is concentrically disposed within the outer shell, the distal ends thereof with a mechanical generator 1610 operatively connected.

The inner shell 1608 may provide an inlet channel or cavity through which fluid from the external system to the mechanical generator 1610 is discharged while the outer shell 1606 may provide an exhaust passage or cavity through which fluid is returned from the mechanical generator to the external system; Of course, in other embodiments, the outer shell may provide the inlet channel while the inner shell may provide the outlet channel. The mechanical generator 1610 For example, the axial movement of the liquid passing therethrough may be in rotational motion of the generator about the central axis 1612 of the catheter.

At a distal end of the generator 1610 , or in the vicinity thereof, the generator may have a proximal end of the magnetic coupling means 1604 include one or more magnets 1614 contains. The magnets 1614 can also move between them around the middle axis by the rotation of the generator 1612 of the catheter rotating, causing the distal end of the mechanical generator 1610 a changing magnetic field is generated.

At the distal end of the hydrostatic transmission system 1602 , or in the vicinity thereof, may be the distal end of the magnetic coupling device 1604 be positioned, which is a housing 1616 which also has one or more magnets 1618 that contains the magnets 1614 the proximal end of the magnetic coupling device cooperate to a rotational movement of the housing 1616 to effect. This is more specific due to the rotational movement of the magnets 1614 the proximal end of the magnetic coupling device 1604 generated alternating magnetic field with the magnets 1618 in the case 1616 together, which causes their rotational movement.

A conveying element 1620 Like any of the various embodiments of conveyor elements described herein, it may be operable with the distal end of the magnetic coupling device 1604 or housing 1616 be connected and therefore rotate with it. An advantage of such a fluid powered or hydrostatic transmission system 1602 in combination with a magnetic coupling device 1604 is the interchangeability of the conveying element, because the indirect connection caused by the magnetic Coupling device is provided between the transmission system and the conveying element, relatively easy connecting causes each other to exchange between embodiments of the conveying element.

In another, in 17 schematically illustrated embodiment, the transmission system can easily be a liquid-operated or hydrostatic transmission system 1702 that drives an operably connected conveyor element. In general, an external system may direct a liquid to a mechanical generator, causing a rotational movement of the mechanical generator that is transmitted substantially directly to the impeller. In a specific embodiment, the hydrostatic transmission system 1702 a catheter body or an outer shell 1704 and an inner shell 1706 , which is concentrically disposed within the outer shell, with their distal ends with a mechanical generator 1708 operatively connected.

The inner shell 1706 may cause an inlet channel or cavity through which liquid from the external system to the mechanical generator 1708 is discharged while the outer shell 1704 may cause an exhaust passage or cavity through which fluid is returned from the mechanical generator to the external system; Of course, in other embodiments, the outer shell may effect the inlet channel while the inner shell may effect the outlet channel. The mechanical generator 1708 For example, the axial movement of the liquid passing therethrough may be in a rotational movement of the generator about the central axis 1710 of the catheter. The mechanical generator 1708 can be directly connected to the conveyor element, such as any of the various embodiments of conveyor elements described herein; however, it is recognized that any suitable elements for indirect or operable connection of the mechanical generator 1708 and conveyor element, such as, but not limited to, a transmission system, are within the spirit and scope of the present disclosure.

With regard to the various liquid-operated or hydrostatic transmission systems described above, a fluid-operated or hydrostatic transmission system may be externally connected, for example, with a hydraulic connector or compressible hose containing the fluid-operated or hydrostatic transmission system to an external control unit to couple the liquid, as will be understood by those skilled in the art. The external control unit may or may not be a component of the control and / or power unit described herein.

In yet another embodiment, the transmission system may be electrically powered. More specifically, like any of the various embodiments of delivery elements described herein, the delivery element may be operatively connected to or near the end of the pump of the catheter. An electrical system may be operated by the control and / or power unit operably connected to or with an external end of the catheter and may regulate the energy for use in controlling the motor and rotating the impeller, as will be recognized by those skilled in the art ,

The electrical system or a portion thereof may be located at or near the motor or may be located at any other suitable location, including the control and / or power unit operatively connected to or to an external end of the catheter but not limited to it. The electrical system and the control and / or power unit may be operatively connected by electrical plugs or electrical conductors.

18 and 19 illustrate an alternative embodiment of the expandable blood pump of the present disclosure. The expandable blood pump of 18 and 19 is particularly suitable for use with the right part of the heart, in that the blood pump has a proximal inlet 1802 and a distal inlet 1804 having. The cannula 1902 has a lateral cannula outside 1806 with at least one lateral opening 1904 that works like one or more outlets. In operation, the blood enters the expandable blood pump at the proximal inlet 1802 at the proximal end 1901 , at the distal inlet 1804 at the distal end 1903 or both and leaves the expandable blood pump through the outlet of the at least one lateral opening 1904 , Thus, cover or cannula 1902 allowing the blood stream to leave the expandable blood pump in a direction that is transverse, generally transverse, or substantially perpendicular to the axis of the conveyor element. The blood flow through the at least one lateral opening 1904 increases the pressure of the blood in the right heart, which causes the blood to flow from the right heart to move to the lungs and enter the cycle of the pulmonary circulation.

In other embodiments, the expandable blood pump may be a proximal expandable member 1906 at the proximal inlet 1802 , a distal expandable element 1908 at the distal inlet 1804 or both. each expandable element 1906 . 1908 may be designed to increase in outer size, as well as in diameter or some of the circumference or the entire circumference, so that it can engage with an anatomical structure. In some embodiments, the expandable elements 1906 . 1908 be designed to engage with blood vessels. For example, the expandable elements 1906 . 1908 be designed to engage blood vessels such as the aorta, vena cava, superior vena cava, inferior vena cava, other vessels, or combinations thereof. In other embodiments, the expandable member may engage with other or additional structures in the body or in the heart, such as one or more valves in the heart. The expandable member may engage the tissue structure such that the blood flow is reduced substantially between, around or around the outside of the expandable member and the tissue structure with which the outside of the expandable member is engaged. is substantially prevented or prevented.

In some embodiments, the expandable elements are 1906 . 1908 designed to be positioned between a deployment structure, generally collapsed for reduced or minimal size, and an operable structure in which the expandable element is partially or fully expanded in size. In some embodiments, the expandable member may be expanded by being inflated with fluid such as air, saline, another physiologically acceptable fluid, or combinations thereof. Where inflation is utilized, inflation may be accomplished by a local pump, by a separate conduit operatively connected to an external control unit, or a combination. The expandable elements 1906 . 1908 For example, they may be operatively connected by a channel so that inflation of one will result in inflation of the two, or may be separately inflatable and adjustable. In other embodiments, the expandable member may be expanded by other mechanisms, such as mechanical, including by using biased members. In other embodiments, the expandable member may be maintained in a constrained configuration when in deployment structure, such as by being retained by a retention member such as a sleeve. When the sheath or other retaining member is disengaged from the expandable member, the expandable member expands to a size greater than the size of the expandable member when in its deployment structure. In still other embodiments, the expandable member may be mechanically retained in a deployment structure, such as by gears that engage in slots in the expandable member, the gears being driven by a drive mechanism. In these embodiments, the drive mechanism may be used to expand or contract the expandable member to any desired extent.

In some embodiments, the expandable elements 1906 . 1908 be provided with an opening which acts as an inlet to the pump. Consequently, the proximal expandable element 1906 with a proximal expandable element opening 1808 , the distal expandable element 1908 with a distal expandable element opening 1810 or both expandable elements 1906 . 1908 be provided with an opening. In some embodiments, the size of one or both of the openings 1808 . 1810 be determined. In some embodiments, the size of one or both of the openings 1808 . 1810 be selectively adjustable to monitor or control blood flow through one or both of the openings 1808 . 1810 to support. Thus, in use, one or both of the openings 1808 . 1810 can be expanded, one or both of the openings are contracted, one opening unchanged, while the other is either expanded or contracted, or one opening can be extended while the other is contracted. This selective control over orifice size enhances the ability of the expandable blood pump of the present disclosure to properly control the blood flow, to obtain a desired blood flow through the superior vena cava, and a potentially different blood flow through the inferior vena cava. In further embodiments, one of the expandable elements 1906 . 1908 or both each comprise two or more extensibly attached or arranged expandable elements or one or more fixed elements operatively attached to one or more expandable elements. For example, in one embodiment, an expandable element 1906 (or an expandable element 1908 or both) two or more concentric expandable elements formed as rings or pads; in such an embodiment, an inner ring may be expandable to a fixed structure, while an outer ring may be expandable into an adjustable structure, or vice versa; or both may be expandable to a fixed structure, or both may be expandable into an adjustable structure. In other embodiments, an expandable element 1906 . 1908 in a slightly different way be designed such as in a U-shaped or other staggered or irregular arrangement. In other embodiments, an expandable element could 1906 . 1908 as a foam-like, polymeric or other elastic segment provided in a C-shape with an expansible member disposed in the open part of the C to contact one of the ends of the C or both when expanded , For the expandable element 1906 . 1908 Any other desired arrangement can be used.

In one embodiment, the proximal expandable element 1906 be positioned and shaped to engage the inferior vena cava. In another embodiment, the distal expandable member 1908 be positioned and shaped to engage the superior vena cava. In a further embodiment, the proximal expandable member 1906 be positioned and configured to engage the inferior vena cava and the distal expandable member 1908 may be positioned and configured to engage the superior vena cava. When the proximal expandable element 1906 is engaged with the inferior vena cava and the distal expandable member 1908 With the superior vena cava engaged, the expandable blood pump may be arranged to control all or substantially all of the blood flow into the right part of the heart.

In other embodiments, an expandable ring may be formed on one or more expandable elements 1906 . 1908 or outside thereof to assist in preventing blood flow on the outside of the expandable blood pump. The ring may include a membrane secured to the ring. The ring may be attached to one or more of the expandable elements 1906 . 1908 , the cannula, other parts of the expandable blood pump, or combinations of these. In a deployment structure, the ring (and membrane) may be constrained near or on the expandable blood pump. In the operable structure, the ring would expand and conform to the surrounding tissue to effect a partial or complete seal, thus assisting in directing the blood through the pump.

The at least one lateral opening 1904 is in 18 and 19 represented as a series of holes. In other embodiments, any number of side openings 1904 to be available. In still other embodiments, the side openings 1904 be of any desired shape and size. In other embodiments, the cannula 1902 be made of a porous or gauze material with a large number of pores or openings. In still other embodiments, the cannula is 1902 absent, while in other embodiments, a cannula 1902 or may not have, supporting ribs the proximal inlet 1802 and distal inlet 1804 connect.

As in 18 and 19 can be seen, the expandable blood pump, many of the above-discussed components such as drive shaft 1910 , Catheter 1912 , etc. included. A support element 1812 may be arranged so that the axis of rotation of the conveyor element generally in the center of the expandable elements 1906 . 1908 is attached. The support element 1812 may be formed of spokes such as nitinol or other polymeric or other suitable material. In one embodiment, the support element 1812 made of a series of flexible segments or strands, so if the axis 1814 is moved in one direction, a segment or a strand on the other side is brought into tension, and a segment or strand in the direction of force of the axis 1814 in compression or both can be brought to the position of the axis 1814 maintain. It can be any desired arrangement of the support element 1812 be used with any suitable number or shape of segments or strands.

The length of the cannula 1902 can be axially adjustable, as above with respect to 4 . 5 and 6 is described. In further embodiments, the cannula 1902 extendible, overlapping portions which slide over each other to allow an axial adjustment of the length of the expandable blood pump. In other embodiments, the cannula 1902 be made of a material which is sufficiently elastic to stretch and contract so as to allow axial displacement of the length of the expandable blood pump.

In some embodiments, according to 19 the length L _{D of} the distal expandable element 1908 , according to 19 the length L _{P of} the proximal expansible element 1906 or both, in addition to or instead of having the length of the expandable blood pump that is axially adjustable, be sufficient to provide at least partial deployment in the opposite vena cava of the right heart, such that the distal expandable member 1908 at least partially disposed within the superior vena cava, the proximal expandable member 1906 at least partially disposed within the inferior vena cava or both. In some embodiments, the length L _{D of} the distal expandable Elements 1908 , the length L _{P of} the proximal expansible element 1906 or both are adjustable in the axial direction by one or more paths described above with respect to radial expansion. An axial extension of one of the expandable elements 1906 . 1908 or both, it allows the extent of use of one of the expandable elements 1906 . 1908 or to calibrate both into the opposite vena cava or to a desired extent to accommodate hearts of different sizes. In still further embodiments, the expandable blood pump of the present disclosure may be provided in varying lengths such that an expandable blood pump of suitable or desired size or length may be selected for use with an existing right heart size of a given patient.

In some embodiments, the expandable heart pump of the present disclosure has two inlets facing each other on opposite sides of the cannula 1902 are arranged. In other embodiments, the expandable heart pump of the present disclosure may include an inlet where an end of the cannula 1902 is completed. In other embodiments, additional inlets may be provided, such as via conduits or tubes connected to the expandable heart pump. Wherever leads or tubes are used, these can be any suitable angle with the cannula 1902 have if a cannula 1902 is used. In other embodiments, the cannula 1902 Branches or other passages that act as inlets. In other embodiments, holes or pores in the cannula 1902 how inlets are effective. In further embodiments, a distal end of the expandable heart pump may act like an inlet, and the proximal end of the expandable heart pump acts as an outlet, or vice versa.

20 FIG. 12 shows a perspective view of the expandable blood pump of the present disclosure, wherein the cannula. FIG 1902 is shown transparently, and with other components in 18 . 19 and 20 are represented by the same reference numbers are used. 20 and 21 make the conveyor element 2002 that is, at least one rotor blade 2004 even though in 20 and 21 four rotor blades 2004 are shown. Every rotor blade 2004 may be flat or curved or otherwise shaped as needed such that the vanes, viewed from a cross-sectional perspective looking at a plane perpendicular to the axis of rotation 1814 is to form a spiral or other arrangement. As can be seen, forms the conveying element 2002 in the execution of 20 and 21 a blood circulation pump. The conveying element 2002 can be of any desired design with any desired number of blades 2004 be shaped. As it is in 20 and 21 Shown is the profile of the blades 2004 of the conveyor element 2002 be curved so that the edges of the blades 2004 in the middle area 2006 further from the axis of rotation 1814 of the conveyor element 2002 extend as the edges of the blades 2004 to the areas 2008 of the conveyor element 2002 , As the blade edges move farther from the axis of rotation 1814 in the middle area 2006 extend as to the areas 2008 This may assist in the blood flow from the proximal end 1901 and distal end 1903 the expandable blood pump through the at least one lateral opening 1904 in the cannula 1902 to improve.

The conveying element can have any other suitable profile. In one embodiment, the profile is generally planar or horizontal as shown in FIG 3 is shown. In another embodiment, the central area of the blades is closer to the axis of rotation than are the end areas. Still other embodiments of the profile are as shown in FIG 21 Abis 21D is shown. Any suitable blade profile is within the scope of the present invention. In the 21B illustrated embodiment includes a plurality of smaller blades, which may be staggered about the axis of rotation of the conveying element.

Generally, when used as right heart pumps, which include centrifugal pumps for use in the right heart, the pump will produce a bloodstream that is generally transverse to the axis of rotation of the delivery member (including, in some embodiments, a side of a cannula or cover) rather than a blood stream would generally be in the axial direction, as can be seen from the use of the conveying elements in 4 to 7 or otherwise.

The centrifugal conveying elements of the present invention may use any suitable number of blades, from one to two or more. That certain examples of the present invention use four blades should not be construed as limiting. In some embodiments, the conveyor element will have multiple blades, some or all of which are not the same length and / or not in the length of the cannula, which blades may be staggered about the axis of rotation or arranged in any other desired arrangement ,

22 and 23 show a further embodiment of the conveying element 2002 for use with the expandable blood pump of the present disclosure. The conveying element 2202 has a middle area 2206 that is different from the axis of rotation 1814 of the conveyor element 2202 extends further than the edges of the blades 2204 to the end areas 2208 of the conveyor element 2202 , The conveying element 2202 also includes a rotor core area 2210 that is different from the axis of rotation 1814 according to 23 extends to the outside. The runner core area 2210 It helps prevent blood from getting near the axis of rotation 1814 accumulates, pools, clogs or clots.

The conveying element 2202 can be positioned while in a collapsed orientation. In some embodiments, the rotor core area becomes 2210 extended by employing fluid (such as air, physiological saline, or other physiologically acceptable fluid) therein, while in other embodiments, the rotor core region 2210 is mechanically expanded, which includes allowing biasing elements in an expanded state.

The conveyor elements 2002 of the present invention can be made of any suitable materials as described above. For example, in some embodiments, the conveyor elements 2002 made of a material that does not use a support element or mast, such as where the blade 2004 is a collapsible, foldable, expandable or inflatable section of polymer, fabric, nitinol or other memory metal or other biologically suitable material or composite or combinations thereof. In other embodiments of conveying elements disclosed herein 2002 can the conveying element 2002 between a collapsed deployment structure and an expanded, operable structure by changing the position of the blades 2004 , By blowing the conveyor element or be activated by the blades 2004 be held back or expanded into their operable structure.

24 to 29 provide other views of an expandable blood pump of the present invention with a detail showing types and various arrangements of components. 29 further shows a clearance gap 2902 of the proximal conveying element and a distance gap 2904 a distal conveyor element. As shown, the gap gap 2902 of the proximal conveying element and the spacing gap 2904 of the distal conveying element to be rather small and approximately equal. In other embodiments, clearance gap 2902 of the proximal conveying element and spacing gap 2904 of the distal conveyor element have any desired length; and they can generally be the same or different, for example, such that either the space gap 2902 of the proximal conveying element is greater than the distance gap 2904 of the distal conveyor element or the gap gap 2902 of the proximal conveying element is smaller than the distance gap 2904 a distal conveying element. When the conveying element is arranged so that it is axially adjustable, so that the distance gaps 2902 and 2904 However, they can not be adjusted immediately, allowing the delivery element to be located closer to the inferior vena cava than to the superior vena cava or, if required, closer to the superior vena cava than to the inferior vena cava. If the conveyor element is axially adjustable, this allows relative adjustments between the pump inlets. Where the adjustable blood pump of the invention is used as a right heart pump, when the delivery element is axially adjustable, this allows adjustments between the superior vena cava, the inferior vena cava, both, and relative adjustments between the two.

30 Figure 5 illustrates another embodiment of the expandable heart pump of the present invention in which the delivery element has more than one segment. The conveying element 3001 the in 30 shown expandable blood pump has Förderelementsegmente, the proximal conveyor element segment 3002 and the distal conveyor element segment 3004 , on. The various segments may be of equal or different lengths, and may be the same diameter or different diameters. They can have the same or a different number of blades and can be made of the same or different materials. They may also be similar or different as above with respect to 29 described, and the gap between them can be adjusted if necessary. Furthermore, they can each separate drive shafts 3010 and 3011 so that they can be independently controlled as needed. All of these parameters can be adjusted as needed so that the desired blood flow and desired relative sizes of blood flow from the inlets can be calibrated and selected. Any suitable number of conveyor element segments may be used. In one embodiment, three conveyor element segments are each used with their own drive shafts. In an embodiment where three conveyor element segments are used, the middle conveyor element segment is rotated at a higher speed than either or both of the other Conveyor segments to produce a larger blood flow in a lateral direction from the axis of rotation.

31 to 35 provide other views of an expandable heart pump of the present invention with a detail in which types and various arrangements of components are shown.

The shape and orientation of one or more of the blades can be adjusted. As in 35 In one embodiment, the blades may have a slight curve. 35B to 35F As can be seen, any desired arrangement can be used with any number of blades and any number of conveyor element segments.

The various embodiments of conveyor elements of the present disclosure may include one or more blades made of a thin, resilient web or sheet material. In some embodiments, the blades are suspended by or between one or more generally moveable, resilient, rigid, or semi-rigid support members or masts. In other embodiments, the vanes are made of a material that does not utilize a support member or mast, such as where the bucket is a collapsible, collapsible, expandable or inflatable section of polymer, fabric, a web of wires, nitinol or other memory metal or other biologically suitable Material or a composite material or a combination of these is. In some embodiments of conveyor elements disclosed herein, the conveyor element may be activated between a collapsed deployment structure and an expanded operable structure by altering the position of the moveable, rigid or semi-rigid support members, thereby stretching the flexible tissue to a desired position and creating a blade surface , In other embodiments of conveyor elements disclosed herein, the conveyor element may be activated between a collapsed deployment structure and an expanded operable structure by altering the position of the vanes by inflating the conveyor element, by restraining the vanes, or allowing them to deploy or expand to expand its operable structure of increased or maximum size, or by changing the relative proximal and distal positions of the pump (and length therebetween). Thus, the conveyor element may allow a collapsed deconvolution structure of reduced or minimal size and an expanded, operable structure of increased or maximum size.

As noted, the cannula may be retained by support members or ribs as described above with reference to Figs 6 and 7 is exactly described. Leadership as related to above 12 and 13 is described. Power transmission as above in conjunction with 14 . 15 . 16 and 17 is described. In some embodiments of the present invention, the expandable blood pump may be provided within a sheath, as described above in connection with FIG 14 is described.

In some embodiments of the present invention, when used in a right heart structure, the expandable blood pump may be a beam rectifier as discussed above with reference to FIG 9 described, which may take the form of a disc or a flat member whose plane is transverse to the axis of rotation of the expandable blood pump generally. The beam rectifier may be of any desired shape and oriented in any orientation. If the jet rectifier is used with a centrifugal pump, it may be provided as a flat ring, with the conveyor element being free to rotate within the central part of the ring.

In further embodiments, as described above, one or more balloons or other expansion elements 654 outside the cannula 600 be provided to the pump 100 to attach to a vascular feature such as a heart valve or aortic wall. balloon members 654 can expand through the action of a biasing element as described above or by pressurization with a liquid, such as by the pump 100 or via an additional channel or cavity, for example by connection to a fluid drive system described below.

A method of deploying and using an expandable blood pump according to various embodiments described herein will be described with reference to FIG 36 described. As in the step 3602 As shown, a catheter may be inserted with a pump at its distal end into a large blood vessel and guided to a desired location, such as the heart. The expandable blood pump may be inserted through a femoral artery, radial artery, clavicle artery, through the skin, or through any other passage or access. One or more expandable elements may be partially expanded to aid deployment. In other embodiments, an additional expandable element can be used to helping to move the expandable blood pump to the desired location. For further assistance in positioning, X-ray fluoroscopy, X-ray opaque (radiopaque) markers or other methods may be used.

Once positioned, the expandable elements can be expanded to press against the surrounding vessel or other tissue. This helps to reduce or eliminate blood flow past the outside of the expandable blood pump or to direct blood flow through the device into the inlets. Expanding the expandable elements may also assist in complete expansion of the device. The drive shaft rotates, whereby the conveying element is rotated. The rotation of the delivery member creates a pressure gradient between the inlets and the outlet by opening one or more heart valves, including the tricuspid valve and / or pulmonary valve, thereby creating a flow of blood, such as through the right heart. Pressure in the body can be measured by sensors, as further described herein. The flow through the inlets may be adjusted and the flow through each inlet may be adjusted relative to the flow through the other inlet as described herein, including by changing the pressure in the expandable element or by changing the inlet size in that the position of the conveyor element is changed relative to the two outlets by changing the diameter or arrangement of the conveyor element by changing the position of the conveyor element or by using a conveyor element with more than one segment and possibly the relative speeds of the conveyor Segments are changed.

If desired, additional tools or devices may be inserted through the catheter. Upon completion of therapy, or if it is desirable to remove or reposition the expandable blood pump, it may be reoriented into a partially or totally collapsed structure and then repositioned or removed.

As described in detail above, the pump may include a delivery member and a cannula, wherein the delivery member and cannula may be initially deployed in a collapsed deployment structure. The delivery member and cannula may be biased in the deployment structure or, alternatively, retracted into the deployment structure using a control unit operatively connected to or near the external end of the catheter. Once the pump is positioned at the desired location or in the vicinity, for example at the desired chamber of the heart, in step 3604 the clinician or operating physician use the control unit to control the cannula of the pump, as described above, into an expanded, operable structure, thereby creating a conduit to pump flow.

With the expanded cannula and a generated lead, the clinician or surgeon may step in 3606 Adjust the pump delivery element within the cannula into its expanded, operable structure. Although as separate steps 3604 . 3606 As shown, in some embodiments, the adjustment of the cannula and delivery member into their expanded, operable structures may be performed substantially simultaneously.

In step 3608 For example, the bucket angle may be adjusted as needed, as described in detail above for each of the various embodiments of the conveyor to produce the desired flow direction of the pump. In step 3610 For example, a power transfer system may be activated by, for example, using the control unit to cause rotation of the delivery member and generation of pump flow in the cannula between the inlet (inlets) and outlet (outlets) of the cannula. The clinician or operating physician may then enter therapeutic system parameters into the control unit to drive the conveyor at the desired speed. In general, the collapsed deployment structure may allow for rapid deployment and removal from various anatomical positions, while the expanded, operable structure may allow for adequate therapy.

Another method for deployment and use of an expandable blood pump according to the various embodiments described herein is with reference to FIG 37 described. As it is in the step 3702 As shown, a catheter with a pump may be inserted into a large blood vessel and guided to the desired location, such as the heart. The expandable blood pump may be inserted through a femoral artery, radial artery, or any other suitable passageway. The pump may include a delivery member and a cannula, wherein the delivery member and cannula may be initially deployed in a collapsed deployment structure. The delivery member and cannula may be biased in the deployment structure by means of a control unit operatively connected to the proximal end of the catheter or proximate thereto or, alternatively, retracted into the deployment structure.

Where the expandable blood pump is positioned within the right heart, it may be desirable to locate the proximal inlet of the expandable blood pump within the inferior vena cava and the distal inlet within the superior vena cava, as in step 3704 is shown.

In step 3706 the cannula is distended and in the crotch 3708 the conveying element. It should be clear that some or all of these steps may be performed simultaneously or in a different order. For example, the steps 3706 and 3708 be made simultaneously. step 3704 can be before or after one of the steps 3706 and 3708 or both.

In step 3710 For example, a power transfer system may be activated by, for example, using the control unit to effect rotation of the delivery member and creation of a flow within the cannula from the inlets through the side of the cannula or between inlet (inlets) and outlet (outlets) of the cannula , The clinician or operating physician may enter therapeutic system parameters into the control unit to drive the conveyor at the desired speed. In general, the collapsed deployment structure may permit rapid deployment into multiple anatomical locations and retrieval, while the expanded, operable structure may allow for adequate therapy.

In addition to those related to 36 and 37 In addition, as shown in one of the figures, additional process steps may be included to perform one or more of the other functions described herein 36 and 37 includes illustrated steps.

38 provides a control center 3801 for the expandable blood pump of the present invention. The control center 3801 can conduct one or more pumps. The controller function may include a microprocessor and microprocessor memory 3806 to control the expandable blood pumps, such as based on one or more predetermined algorithms, sensor feedback, and operator input. The control center 3801 can be customized to coordinate, communicate with and / or direct sensors and other medical equipment, controllers, and monitors. Sensors can be positioned in the bloodstream at various locations throughout the body to measure one or more of blood flow, blood pressure, temperature, oxygen content, and other parameters. At any desired anatomical location, any suitable sensor or sensors may be used. For example, in one embodiment, pressure can be measured using a Swan-Ganz catheter. The sensors can be wireless 3804 or they can be wired with a control unit 3805 be. The sensors may be operatively connected to the expandable blood pump, or they may be separate or a combination of these.

The control center 3801 has at least one catheter interface 3802 , The catheter interface 3802 can be mechanical. In other embodiments, the connection of the catheter interface may be magnetic, a liquid, or a combination of these and mechanical, as described in greater detail above. The pump may be operatively connected to one or more interfaces. It can be a drive 3803 be provided, which is a motor driver 3803 which is operatively connected to a drive shaft such as via a clutch.

The control center 3801 can be controlled by an internal or external processor, such as a program or other set of instructions. The control center 3801 can be adapted to be mounted on a pole, the patient, a bed frame or other. The program or instructions may be provided in a staged memory or storage device. The user interface 3807 can use one or more of audio signals, visual and other signals, and transmission methods. Audio transmission can be through an audio driver 3808 and one or more speakers 3809 be relieved.

The control center 3801 can be due to a power source of the building or the power grid of the building 3813 be powered. The control center 3801 can be a module for power control 3810 and it can be with an internal or external backup power supply 3811 be provided. The reserve power supply 3811 can be powered by battery, generator, something else or a combination. The power control module 3810 can control whether the control center 3801 through the power network of the building 3818 , the backup power supply 3811 , something else or a combination of these is powered.

There are many ways, such as the control center 3801 can be used during operation. In one embodiment, a pump is deployed. With the control center 3801 For example, a catheter of the expandable blood pump may be connected, with the console recognizing the pump and prompting an operator for an appropriate input to start the pump. In the same way, additional pumps can be started. The control center 3801 and / or the operator may configure various control parameters, such as conveyor speed, maximum torque, alarm thresholds, etc. Where more than one pump is used, the pumps may be operated independently, or the console may coordinate its operation based on, for example, predetermined algorithms, sensor feedback, and / or operator input. The console can be used to coordinate the operation of various medical equipment and equipment. In one embodiment, the console may effect a single control interface to adjust the speed of cardiovascular assistance, a bypass, and / or the catheter pump. This may help to switch a patient from supporting the blood pump to long-term support of another device.

The control center 3801 may involve numerous wired or wireless sensor data streams, such as in an algorithm. If the pump involves electrodes, the control center can 3801 to sample and pace based on the input it receives. The control center 3801 would be able to transfer patient and machine data to the database of the building. The control center 3801 would be a communication interface 3812 of the building.

The control center 3801 It is capable of operating multiple pumps, detecting and controlling pumps, providing and communicating with a console (which may be wireless) with a console, coordinating and / or controlling with other devices.

Although the various embodiments of the present disclosure have been described with reference to preferred embodiments, those skilled in the art will recognize that changes may be made in form and detail without departing from the spirit and scope of the present disclosure. In particular, various elements of the figures may be interchanged or combined to form different groupings and arrangements of features without loss of commonality. For example, the cannula, delivery member, rib, support member, catheter, gauze, shovel, mast, and other features as illustrated in various figures and described using various reference numerals in the specification, may each be replaced or combined in accordance with the various embodiments of the invention are adapted to different applications, functions and materials while remaining within the spirit and scope of the invention as encompassed by the following claims.

Claims (20)

A pump for introducing a flow within a vasculature, comprising: at least one inlet; and a delivery element configured to introduce fluid flow by rotation about an axis, wherein the liquid flow is transverse in a direction generally to the axis; wherein the delivery element has a first structure for deployment within the vasculature and a second structure for directing fluid flow within the vasculature, the second structure having a larger diameter than the first structure. Pump according to claim 1, comprising at least two inlets. A pump according to claim 1, comprising an expandable member at the at least one inlet. The pump of claim 3, wherein the expandable member includes a selectively adjustable orifice. Pump according to claim 3, wherein the conveying element has at least two segments. A pump according to claim 5, wherein each conveyor element segment is independently controllable. Pump according to claim 2, wherein the conveying element has an axially adjustable position. A pump according to claim 3, comprising an expandable member on each of the at least two inlets. A pump according to claim 8, wherein each expandable member has a selectively adjustable aperture. Pump according to claim 3, wherein the expandable member has a length which is axially adjustable. Pump according to claim 2, wherein the pump has an axially adjustable length. A pump according to claim 4, wherein the conveying element comprises an expandable core portion. A pump for introducing a flow within a vascular system, comprising: at least two inlets; a cannula; and a delivery element configured to introduce the fluid flow by rotation about an axis; wherein the delivery element has a first structure for deployment within the vasculature and a second structure for directing fluid flow within the vascular system, the second structure having a larger diameter than the first structure; and wherein the cannula has a first structure for deployment within the vasculature and a second structure for directing fluid flow within the vasculature, the second structure having a larger diameter than the first structure. The pump of claim 13, wherein the fluid flow is in a direction generally transverse to the axis. A pump according to claim 13, comprising an expansible member at each inlet. The pump of claim 15, wherein each expandable member has a selectively adjustable aperture. The pump of claim 15, comprising a catheter extending to a proximal end of the cannula, wherein the catheter is configured to position the cannula within the vasculature. The pump of claim 14, wherein the cannula includes a plurality of side ports. A pump according to claim 16, wherein the conveyor element comprises at least two segments. A pump according to claim 16, wherein the conveyor element comprises blades having a curved profile.

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