Patent Description:
The present disclosure generally relates to the technical field of medical devices and, more specifically, to a pump head, a pump including the pump head, and an extracorporeal membrane oxygenation ("ECMO") device including the pump. The pump including the pump head may be used in an artificial heart.

Extracorporeal membrane oxygenation ("ECMO") is an important technology for providing life support to seriously ill patients who have severe cardiopulmonary function failure. An ECMO device primarily includes a pump for an artificial heart, an oxygenator, oxygen supply tubings (or conduits), and blood circulation tubings (or conduits).

A pump head of a dynamic pump is used along with the dynamic pump for extracorporeal blood circulation or blood circulation assistance in a heart surgery. Various issues have been observed in pump heads of conventional technologies in clinical applications. The issues associated with the pump heads of conventional technologies may include, for example, an inclination to form blood clot (or emblolus), destruction of blood cells, complex precharge exhaust processes, high blood flow resistance, etc. In conventional technologies, Chinese Patent Application No. <CIT> discloses a blood flow guiding device including a centrifugal maglev artificial heart pump, which resolves the issue of blood flow hysteresis to a certain degree. But the solution provided by this patent document attempts to reduce or eliminate the blood flow hysteresis and blood clotting (or embolism) primarily from the perspective of flow guiding. The solution provided in this patent document still cannot solve the issues related to destruction of the blood cells in the blood, damage to the blood, and blood clot formation.

Further relevant prior art is for instance disclosed in documents <CIT>, <CIT>, <CIT>, <CIT> and <CIT>.

A pump head according to the present invention comprises the technical features as defined in independent claim <NUM>. A pump according to the present invention comprises the technical features as defined in independent claim <NUM>. An ECMO device according to the present invention comprises the technical features as defined in independent claim <NUM>.

One objective of the present disclosure is to provide a concept for mitigating or addressing disadvantages and issues of conventional technical solutions.

Another objective of the present disclosure is to provide a novel pump head for a pump that may be used in an artificial heart, a pump having the pump head, and an ECMO device including the pump having the pump head.

According to a first aspect of the present disclosure, the above and other objectives are realized based on the pump head that may be used in an artificial heart. The pump head includes a volute casing with a blood inlet and a blood outlet.

In some embodiments, a shaft may be disposed at a center location inside the volute casing. In some embodiments, the shaft may be fixed to the volute casing (e.g., non-rotatable). For example, the shaft may be fixed to a lower portion of the volute casing and may extend inside the volute casing along a central axis of the volute casing. In some embodiments, a magnetic structure may be sleeve-fit onto the shaft. In some embodiments, a conical impeller having an open structure may be mounted to an exterior surface of the magnetic structure. When the magnetic structure rotates, the magnetic structure may drive the conical impeller to rotate.

In some embodiments, a first gap may exist between the shaft and the magnetic structure. When the magnetic structure drives the conical impeller to rotate, a portion of the blood may flow from a bottom of the volute casing upwardly through the first gap toward a top of the volute casing. At least partially due to the buoyant force generated by the upward blood flow, the conical impeller (along with the magnetic structure to which the conical impeller is coupled) may suspend in the blood.

In some embodiments, a plurality of vanes may be disposed at an exterior surface of the conical impeller. The plurality of vanes may include a plurality of alternately disposed first vanes and second vanes that may be spaced apart from one another. According to the invention as claimed, top portions of the first vanes are be connected through a first bowl-shaped structure having a downward opening.

An end of the shaft includes a second bowl-shaped structure having an upward opening. A spherical structure is disposed (e.g., embedded) between the first bowl-shaped structure and the second bowl-shaped structure. When the magnetic structure drives the conical impeller to rotate, a second gap exists between the spherical structure and the first bowl-shaped structure and the second bowl-shaped structure. During an operation of the pump, the second gap is filled with blood.

In some embodiments, the first vanes and the second vanes may be configured to tilt toward a same side at a predetermined angle. In some embodiments, heights of the first vanes may be greater than heights of the second vanes.

In some embodiments, the magnetic structure may include a mounting shaft having a hollow body. An annular wheel structure may be disposed at a bottom portion of the mounting shaft. A diameter of the annular wheel structure may be substantially the same as a diameter of an opening at a bottom portion of the conical impeller.

In some embodiments, a plurality of mounting grooves may be provided at a surface of the annular wheel structure. The mounting grooves may be spaced apart from one another. In some embodiments, magnetic elements may be mounted in the mounting grooves.

In some embodiments, an outer diameter of the mounting shaft may be substantially the same as a diameter of an opening provided at a top portion of the conical impeller.

In some embodiments, the spherical structure may be a ceramic ball bearing.

In some embodiments, the blood inlet may be configured to be perpendicular to a cross-sectional plane of the volute casing. The blood outlet may be tangent to the cross-sectional plane of the volute casing at the periphery of the volute casing.

Compared with the conventional technologies, the volute pump head configured for use in an artificial heart according to the present disclosure can be used along with a dynamic pump of the artificial heart. To address the deficiencies and disadvantages of the conventional technologies, the systems and devices of the present disclosure can provide a reasonable extracorporeal blood circulation environment. The technical solutions provided by the present disclosure can be used in portable emergency rescue devices such as ECMO devices. The volume of the pump head of the present disclosure is small, which can effectively reduce the precharge amount. The disclosed pump head includes a conical impeller having an open structure, which makes it easier to exhaust gas bubbles from the blood. The heights and the tilting design of the first vanes and the second vanes may be configured to be advantageous for thorough flushing and for effectively reducing blood clot formation and destruction of blood cells. The design of the conical impeller and the shaft disposed inside the volute casing can effectively reduce heat generation, reduce the blood clot formation, and avoid destruction of the blood cells.

According to a second aspect of the present disclosure, the present disclosure also provides a pump, which may be used for an artificial heart. The pump may include the volute pump head configured for use in the artificial heart according to any of the technical solutions disclosed herein.

Compared with the conventional technologies, the advantages of the pump provided by the present disclosure are similar to the advantages of the volute pump head configured for use in the artificial heart as disclosed herein, which are not repeated.

According to a third aspect of the present disclosure, the present disclosure also provides an ECMO device. The ECMO device includes the pump configured for the artificial heart according to any of the technical solutions disclosed herein.

Compared with the conventional technologies, the advantages of the ECMO device provided by the present disclosure are similar to the advantages of the volute pump head configured for use in the artificial heart as provided herein, which are not repeated.

It should be understood that the above brief descriptions and the following detailed descriptions are illustrative descriptions and explanations, which should not be construed as limiting the scope of the present disclosure.

With reference to the accompanying drawings, the objectives, functions, and advantages of the present disclosure will be explained through the following descriptions of various embodiments of the present disclosure. In the drawings:.

The objectives and functions of the present disclosure, as well as the methods for achieving these objectives and functions, will be explained in detail with reference to illustrative embodiments shown in the drawings. The present disclosure is not limited by the illustrative embodiments disclosed herein. The objectives and the functions of the present disclosure may be realized through other different manners. The descriptions are intended to assist a person having ordinary skills in the art in achieving comprehensive understanding of the specific implementations of the technical solutions provided by the present disclosure.

In order to solve issues related to the pump head configured for use in an artificial heart in the conventional technologies, such as the inclination to form blood clots, destruction of the blood cells, complex precharge exhaust processes, high blood flow resistance, etc., the present disclosure provides the following technical solutions. The technical solutions are described and explained with reference to the illustrative embodiments shown in the accompanying drawings.

<FIG> schematically illustrates a perspective view of an overall structure of a pump head <NUM>, which may be configured for use in an artificial heart. According to an embodiment, the pump head <NUM> may be a part of a centrifugal blood pump. The pump head <NUM> may include a volute casing <NUM>. Thus, the pump head <NUM> may be referred to as a volute pump head. The volute casing <NUM> may include a blood inlet <NUM> configured to receive a flow of a blood, and a blood outlet <NUM> configured to allow the blood to flow out of the volute casing <NUM>. It is understood that the volute casing is used as an example. In other embodiments, the casing <NUM> may not be a volute casing. In an emergency surgery, the blood of a human body flows into the inner space of the volute casing <NUM> through the blood inlet <NUM>, and flows out of the volute casing <NUM> through the blood outlet <NUM>. The blood flowing out from the pump head <NUM> may be directed into an oxygenator (an example of which is shown in <FIG>), where blood oxygenation is performed. The oxygenated blood flowing out of the oxygenator may flow into the human body (e.g., a heart of the human body).

According to some embodiments of the present disclosure, the blood inlet <NUM> may be perpendicular to a cross-sectional plane of the volute casing <NUM>. The blood inlet <NUM> may be disposed at an upper portion of the volute casing <NUM>. The blood outlet <NUM> may be disposed at a lower portion of the volute casing <NUM>. The blood outlet <NUM> may be disposed at a circumferential portion along a direction tangent to the crosse-sectional plane of the volute casing <NUM>. That is, the blood outlet <NUM> may be tangent to the cross-sectional plane of the volute casing <NUM> at the periphery of the volute casing <NUM>. As shown in <FIG>, in some embodiments, the blood inlet <NUM> and the blood outlet <NUM> may be perpendicular to one another. The cross-sectional plane of the volute casing <NUM> refers to a plane in which a cross section of the volute casing <NUM> is located. In some embodiments, the blood inlet <NUM> is disposed at a center location of the volute casing <NUM>. For example, an extension of the blood inlet <NUM> may pass through a center of the cross section of the volute casing <NUM>. In some embodiments, the cross-sectional plane of the volute casing <NUM> may have a circular shape or a near circular shape. In some embodiments, the cross-sectional plane of the volute casing <NUM> may have other suitable shapes, such as an oval shape. Each of the blood inlet <NUM> and the blood outlet <NUM> may be in a form of a tube. The blood inlet <NUM> may be a tube protruding from the upper portion of the volute casing <NUM>. The blood outlet <NUM> may be a tube extending tangent to a circumferential portion of the lower portion of the volute casing <NUM>.

As shown in <FIG> and <FIG>, a shaft <NUM>, a magnetic structure <NUM>, and an impeller <NUM> having an open structure <NUM> may be disposed inside the volute casing <NUM>. In some embodiments, as shown in <FIG>, the open structure <NUM> may have a cone shape. It is understood that the shape of the open structure <NUM> is not limited to the cone shape. The open structure <NUM> may have any suitable shape other than a cone shape. For discussion purposes, the impeller <NUM> may be referred to as a conical impeller <NUM>. It is understood that the pump head <NUM> may be made of any suitable materials that can provide a long service life suitable for use in an artificial heart.

The volute casing <NUM> may include a lower volute casing <NUM> and an upper volute casing <NUM>. In some embodiments, as shown in <FIG>, the shaft <NUM> may be a fixed shaft that is fixedly disposed at the lower volute casing <NUM>. The shaft <NUM> may be disposed at a center location of the lower volute casing <NUM> and may be perpendicular to the center location of the lower volute casing <NUM>. The shaft <NUM> may extend from the lower volute casing <NUM> toward the upper volute casing <NUM>. For illustrative purposes, the shaft <NUM> is shown as having a cylindrical shape. It is understood that the shaft <NUM> may have any other suitable shapes, such as a rectangular prism shape. The magnetic structure <NUM> may have a hollow body. For illustrative purposes, the hollow body is shown as having a cylindrical shape. It is understood that the hollow body may have any suitable shape, such as a rectangular prism shape. The hollow body of the magnetic structure <NUM> may define a channel, through which the magnetic structure <NUM> may be sleeve-fit onto the exterior surface of the shaft <NUM>. The conical impeller <NUM> and the magnetic structure <NUM> may be disposed between the lower volute casing <NUM> having the shaft <NUM> and the upper volute casing <NUM>. The conical impeller <NUM> may be closer to the upper volute casing <NUM>, and the magnetic structure <NUM> may be closer to the lower volute casing <NUM>. The conical impeller <NUM> having an open structure <NUM> may be mounted (e.g., sleeve-fit) to an exterior surface of the body of the magnetic structure <NUM>. The open structure <NUM> may be a cone-shaped structure including a cone-shaped surface <NUM>, an upper opening <NUM>, and a lower opening <NUM>. A diameter of the lower opening <NUM> is larger than a diameter of the upper opening <NUM>, as shown in <FIG>. When the magnetic structure <NUM> rotates, the magnetic structure <NUM> may drive the conical impeller <NUM> mounted on the magnetic structure <NUM> to rotate. It should be noted that the rotation of the magnetic structure <NUM> may be driven by a suitable driving mechanism <NUM>, as shown in <FIG>. For example, the driving mechanism <NUM> may include a driving magnetic structure <NUM> having the same magnetism as the magnetic structure <NUM>. The driving mechanism <NUM> may also include an electric motor <NUM>. The driving magnetic structure <NUM> may be mounted on a rotating shaft of the electric motor <NUM>. The driving mechanism <NUM> may be disposed adjacent the bottom of the lower volute casing <NUM> of the volute pump head <NUM>. The electric motor <NUM> may drive the driving magnetic structure <NUM> to rotate. A magnetic field may exist between the driving magnetic structure <NUM> and the magnetic structure <NUM> disposed inside the volute casing <NUM>. When the driving magnetic structure <NUM> rotates, the magnetic force may cause the magnetic structure <NUM> to rotate. The driving magnetic structure <NUM> mounted to the electric motor <NUM> may be a permanent magnet or an electromagnetic magnet. According to the embodiments of the present disclosure, a first gap may exist between the shaft <NUM> and the magnetic structure <NUM>. When the magnetic structure <NUM> drives the conical impeller <NUM> to rotate, a portion of the blood may flow upwardly (e.g., in a direction from the lower volute casing <NUM> to the upper volute casing <NUM>) through the first gap. The upward flow of the portion of the blood may exert an upward buoyant force on the conical impeller <NUM>, which may lift the conical impeller <NUM> and the magnetic structure <NUM>, to which the conical impeller <NUM> is mounted. Thus, the impeller <NUM> and the magnetic structure <NUM> may suspend in the blood. Because the conical impeller <NUM> suspends in the blood, the friction between the conical impeller <NUM> and other components of the pump head <NUM> (e.g., the casing <NUM>) may be minimized or negligible, which may reduce the probability of blood clot formation when the blood flows through the impeller <NUM>, and reducing the destruction of the blood cells.

According to the embodiments of the present disclosure, a plurality of vanes may be disposed at an exterior surface of the conical impeller <NUM>. The vanes may include a plurality of first vanes <NUM> and second vanes <NUM> that are alternately arranged and spaced apart from one another. In the following descriptions, an example configuration having three first vanes and three second vanes is used to explain the disclosed technical solution. To better illustrate this embodiment, the first vanes are labelled as number <NUM> first vane 303a, number <NUM> first vane 303b, and number <NUM> first vane 303c. Similarly, the second vanes are labelled as number <NUM> second vane 304a, number <NUM> second vane 304b, and number <NUM> second vane 304c in <FIG> and <FIG>.

The first vanes and the second vanes may be alternately disposed on an exterior conical surface <NUM> of the conical impeller <NUM>, and may be spaced apart from one another. A height (or heights) of the first vanes may be greater than a height (or heights) of the second vanes. The first vanes and the second vanes may be tilted toward a same side at a predetermined angle. For example, the three first vanes and the three second vanes may be tilted toward a same direction at an angle of about <NUM> degrees. Top portions of the first vanes may be connected together through a connecting structure <NUM>. In some embodiments, the connecting structure <NUM> may have a bowl-shaped structure with a downward opening. For discussion purposes, in the following descriptions, the connecting structure <NUM> may be referred to as a first bowl-shaped structure <NUM>. That is, the top portions of the number <NUM> first vane 303a, the number <NUM> first vane 303b, and the number <NUM> first vane 303c may be connected together through the first bowl-shaped structure <NUM> having a downward opening. The structural configurations of the first vanes and the second vanes are advantageous for thorough flushing, reducing blood clot formation, and reducing destruction of blood cells. By adopting a conical impeller having an open structure, as described herein, it is easier to exhaust air bubbles from the blood. The conical impeller with an open structure also effectively reduces heat generation, reduces blood clot formation, and reduces destruction of blood cells.

In some embodiments, the distances between a neighboring first vane and a neighboring second vane may be the same or may be different. For example, a first distance between the number <NUM> first vane 303a and the number <NUM> second vane 304a may be the same or different from a second distance between the number <NUM> first vane 303a and the number <NUM> second vane 304c.

In some embodiments of the present disclosure, the magnetic structure <NUM> may include a mounting shaft <NUM> having a hollow body. For illustrative purposes, the mounting shaft <NUM> is shown as having a cylindrical shape. It is understood that the mounting shaft <NUM> may have any other suitable shape, such as a rectangular prism shape. The mounting shaft <NUM> with the hollow body may sleeve-fit onto the shaft <NUM>. An annular wheel structure <NUM> may be disposed or formed at a bottom portion of the mounting shaft <NUM>. An outer diameter of the mounting shaft <NUM> may be the same as a diameter of the upper opening <NUM> at a top portion of the cone-shaped structure <NUM> of the conical impeller <NUM>. The conical impeller <NUM> may be sleeve-fit onto the exterior surface of the mounting shaft <NUM> through the upper opening <NUM>. A diameter of the annular wheel structure <NUM> may be the same as a diameter of the lower opening <NUM> at a bottom portion of the conical impeller <NUM>. A plurality of mounting grooves <NUM> may be provided at a surface of the annular wheel structure <NUM> and may be spaced apart from one another. Magnetic elements <NUM> may be mounted within the mounting grooves <NUM>, as shown in <FIG>. The magnetic elements <NUM> may be any structure having or capable of generating a magnetism, such as permanent magnets, etc. The mounting grooves <NUM> may have any suitable cross-sectional shape, such as square, rectangle, circle, oval, etc. Correspondingly, the magnetic elements <NUM> may have a suitable shape that matches with the cross-sectional shape of the mounting grooves <NUM>. The pump head <NUM> may be made of any suitable materials. For example, the pump head <NUM> may be made of a metal, a plastic, a carbon fiber, or a combination thereof. The mounting grooves <NUM> may be depressions in the surface of the annular wheel structure <NUM>, or may be through holes penetrating the surfaces of the annular wheel structure <NUM>. In some embodiments, the mounting grooves <NUM> may be provided at an upper surface (the surface facing the conical impeller <NUM>) of the annular wheel structure <NUM>, at a lower surface (the surface facing the lower volute casing <NUM>) of the annular wheel structure <NUM>, or at both upper surface and lower surface. In some embodiments, instead of having magnetic elements <NUM> disposed in the mounting grooves <NUM>, the entire structure of the annular wheel structure <NUM> may be formed by a plurality of segments, some of the segments may be magnetic elements, as shown in <FIG>.

According to some embodiments of the present disclosure, as shown in <FIG>, an end portion <NUM> of the shaft <NUM> may be depressed inwardly to form a second bowl-shaped structure <NUM> having an upward opening. A spherical structure <NUM> may be embedded or disposed between the first bowl-shaped structure <NUM> and the second bowl-shaped structure <NUM>. That is, the spherical structure <NUM> may be disposed within a space formed by the first bowl-shaped structure <NUM> and the second bowl-shaped structure <NUM>. A second gap may exist between the spherical structure <NUM> and the first bowl-shaped structure <NUM>, and between the spherical structure <NUM> and the second bowl-shaped structure <NUM>. When the magnetic structure <NUM> drives the conical impeller <NUM> to rotate, a portion of the blood may flow upwardly through the first gap, and a portion of the blood may fill in the second gap, which may cause the spherical structure <NUM> to suspend in the blood. Thus, the spherical structure <NUM> may not touch the shaft <NUM>. This configuration reduces the friction between the spherical structure <NUM> and the end portion <NUM> of the shaft <NUM>. Accordingly, the blood that is in touch with the spherical structure <NUM> may reduce the temperature of the spherical structure <NUM>. In the meantime, this configuration may reduce the damage to the blood. Furthermore, the conical impeller <NUM> may be lifted, such that when rotating, the conical impeller <NUM> may suspend in the blood. Due to the suspension of the conical impeller <NUM> in the blood, and because the conical impeller <NUM> may not rub against the spherical structure <NUM>, the temperature of the spherical structure <NUM> may be reduced. The reduction in the temperature of the spherical structure <NUM> may reduce the blood clot formation and the damage to the blood.

In some embodiments, the spherical structure <NUM> may be a ceramic ball. The ceramic ball <NUM> may function as a rotating bearing at the upper portion of the conical impeller <NUM>, which renders the rotation of the conical impeller <NUM> smooth, thereby improving the efficiency of the blood flow. In the present disclosure, after the various components disposed inside the volute casing <NUM> are assembled, the shaft <NUM> may be inserted into a central channel (or bore) <NUM> of the mounting shaft <NUM> of the magnetic structure <NUM>, such that the mounting shaft <NUM> may sleeve-fit onto the shaft <NUM>. A diameter of the central channel <NUM> may be larger than a diameter of the shaft <NUM>. Thus, a gap may exist between the magnetic structure <NUM> (e.g., the inner surface of the mounting shaft <NUM>) and the shaft <NUM>. The conical impeller <NUM> may be sleeve-fit onto the mounting shaft <NUM> to cover the magnetic structure <NUM>. The spherical structure <NUM> disposed at the end portion <NUM> of shaft <NUM> may be embedded in a depressed groove formed between and by the first bowl-shaped structure <NUM> having a downward opening and the second bowl-shaped structure <NUM> having an upward opening. An exterior edge of the mounting shaft <NUM> may be flush with an edge <NUM> of the upper opening <NUM> at the top portion of the conical impeller <NUM>. An exterior edge of the annular wheel structure <NUM> may be flush with an edge <NUM> of a bottom portion of the conical impeller <NUM>. That is, the mounting shaft <NUM> may extend into the upper opening <NUM> of the conical impeller <NUM>, and may be coupled with the edge <NUM> of the upper opening <NUM>. The edge <NUM> of the conical impeller <NUM> may be coupled with the exterior edge of the annular wheel structure <NUM>.

As shown in <FIG> and <FIG>, when the electric motor <NUM> drives the driving magnetic structure <NUM> located at the bottom of the volute casing <NUM> to rotate, the driving magnetic structure <NUM> may cause the magnetic structure <NUM> to rotate through the magnetic field between the driving magnetic structure <NUM> and the magnetic structure <NUM>, thereby causing the conical impeller <NUM> mounted on the magnetic structure <NUM> to rotate. The centrifugal force generated by the rotation of the conical impeller <NUM> may cause the blood to flow into the chamber of the volute casing <NUM> through the blood inlet <NUM>. The blood may flow out of the chamber of the volute casing <NUM> through the blood outlet <NUM> due to the centrifugal force generated by the rotation of the conical impeller <NUM>. Thus, a pump <NUM> (shown in <FIG>) including the pump head <NUM> may be referred to as a centrifugal blood pump.

During an operation, the blood may fill the chamber of the volute casing <NUM>. A major portion of the blood may undergo a centrifugal movement due to the rotation of the conical impeller <NUM>, and may flow out of the chamber of the volute casing <NUM> through the blood outlet <NUM>. A small portion of the blood may flow to the bottom portion of the volute casing <NUM>, and may move upwardly through the first gap between the shaft <NUM> and the magnetic structure <NUM>. The conical impeller <NUM> may be lifted upwardly away from the spherical structure <NUM> (which may be a ceramic ball) through the centrifugal force and a mechanical force. The mechanical force may be generated by the spherical structure <NUM> that is disposed at the end portion <NUM> of the shaft <NUM>. The mechanical force causes the conical impeller <NUM> to suspend in the blood, thereby reducing the load and the friction on the spherical structure <NUM>. In the present disclosure, the spherical structure <NUM> may not rub against the first bowl-shaped structure <NUM> having a downward opening included in the conical impeller <NUM>. As a result, the temperature of the spherical structure <NUM> can be reduced. The reduction in temperature can significantly reduce the formation of blood clots and the damage to the blood.

The volume of the volute pump head <NUM> configured for an artificial heart according to the present disclosure is small. The centrifugal force generated by the rotation of the conical impeller <NUM> may cause a major portion of the blood flow to enter the chamber of the volute casing <NUM> through the blood inlet <NUM> and exit the chamber through the blood outlet <NUM>. A small portion of the blood may flow along an additional path inside the chamber, as described above. The small portion of the blood may protect the internal components by lifting the conical impeller <NUM> and the spherical structure <NUM>, thereby reducing the blood clot formation, reducing heat generation by the components disposed inside the volute casing <NUM>, and functioning as a lubrication to the components.

The volute pump head <NUM> configured for use in an artificial heart according to the present disclosure can be used along with a dynamic pump for the artificial heart. To address the deficiencies and disadvantages of the conventional technologies, the systems and devices of the present disclosure can provide a reasonable extracorporeal blood circulation environment. The technical solutions provided by the present disclosure can be used in portable emergency rescue devices such as ECMO devices. The volume of the pump head of the present disclosure is small, which can effectively reduce the precharge amount. The disclosed pump head includes a conical impeller having an open, cone-shaped structure, which makes it easier to exhaust gas bubbles from the blood. The heights and the tilting design of the first vanes and the second vanes are configured to be advantageous for thorough flushing and for effectively reducing blood clot formation and destruction of blood cells. The design of the conical impeller and the shaft disposed inside the volute casing can effectively reduce heat generation, reduce the blood clot formation, and avoid destruction of the blood cells.

According to a second aspect of the present disclosure, as shown in <FIG>, the present disclosure also provides the pump <NUM>, which may be configured for an artificial heart (also referred to as an artificial heart pump <NUM>, a dynamic pump <NUM>, or a centrifugal blood pump <NUM>). The pump <NUM> for the artificial heart may include the volute pump head <NUM> according to any of the above embodiments or technical solutions described herein.

As shown in <FIG>, the pump <NUM> may include the driving magnetic structure <NUM> provided adjacent a lower portion of the volute pump head <NUM>. For example, the driving magnetic structure <NUM> may be spaced apart from the lower volute casing <NUM> with a gap. The driving magnetic structure <NUM> may be fixedly mounted to the electric motor <NUM>. When the electric motor <NUM> rotates, the driving magnetic structure <NUM> mounted on the electric motor <NUM> may be driven to rotate. The magnetic structure <NUM> may generate a magnetic field, which in turn may apply a magnetic force on the magnetic structure <NUM> disposed inside the volute casing <NUM> of the pump head <NUM>. The magnetic force may drive the magnetic structure <NUM> to rotate. The driving mechanism <NUM> may include driving devices other than the electric motor <NUM>, which is not limited by the present disclosure.

<FIG> illustrate an exploded view of the volute pump head <NUM>, according to another embodiment of the present disclosure. This embodiment includes structures and elements similar to those shown in <FIG>. The descriptions of the similar or the same structures and elements and their functions may refer to the above descriptions. As shown in <FIG>, the shaft <NUM> included in the embodiment shown in <FIG> is replaced by a rotating shaft <NUM>. Although not shown in <FIG>, the rotating shaft <NUM> may be directly coupled with a rotating shaft of the electric motor <NUM> of the driving mechanism <NUM> shown in <FIG>, and the driving magnetic structure <NUM> may be eliminated. The rotating shaft <NUM> may include a plurality of magnetic elements <NUM> distributed along the exterior surface of the shaft <NUM>. Correspondingly, the mounting shaft <NUM> of the magnetic structure <NUM> may include a plurality of magnetic elements <NUM> distributed along the inner surface and/or the outer surface of the mounting shaft <NUM>. In the magnetic structure <NUM>, the annular wheel structure <NUM> may be eliminated. When the magnetic structure <NUM> is sleeve-fit onto the rotating shaft <NUM> with a gap between the mounting shaft <NUM> and the rotating shaft <NUM>, the magnetic elements <NUM> on the mounting shaft <NUM> may correspond to the magnetic elements <NUM> on the rotating shaft <NUM>. When the rotating shaft <NUM> is driven by the electric motor of the driving mechanism <NUM> to rotate, the magnetic force between the magnetic elements <NUM> and the magnetic elements <NUM> mounted on the mounting structure <NUM> may cause the magnetic structure <NUM> to rotate. When the volute pump head <NUM> is in the embodiment shown in <FIG>, the pump <NUM> may include the volute pump head <NUM> as shown in <FIG> and the driving mechanism <NUM> including the electric motor <NUM> but not including the driving magnetic structure <NUM>.

<FIG> is an exploded view of the volute pump head <NUM> according to another embodiment of the present disclosure. This embodiment includes structures and elements similar to those shown in <FIG>. The descriptions of the similar or the same structures and elements and their functions may refer to the above descriptions. As shown in <FIG>, instead of disposing magnetic elements <NUM> in grooves, the annular wheel structure <NUM> is formed by a plurality of magnetic segments <NUM> and a plurality of non-magnetic segments <NUM> that are alternately distributed and coupled together. The magnetic segments <NUM> may magnetically couple with the driving magnetic structure <NUM> shown in <FIG>. For example, the driving magnetic structure <NUM> may include a plurality of magnetic elements corresponding to the magnetic segments <NUM>. When the magnetic structure <NUM> is driven by the electric motor <NUM> to rotate, the rotation may cause the annular wheel structure <NUM> to rotate due to the magnetic force between the magnetic structure <NUM> and the magnetic segments <NUM>. The other structures and elements are the same as those described above in connection with <FIG> and <FIG>. When the volute pump head <NUM> is in the embodiment shown in <FIG>, the pump <NUM> may include the volute pump head <NUM> shown in <FIG> and the driving mechanism <NUM> (including the driving magnetic structure <NUM> and the electric motor <NUM>) shown in <FIG>.

<FIG> schematically illustrates a cross-sectional view of the volute pump head <NUM> configured for use in the artificial heart, according to another embodiment of the present disclosure. This embodiment includes structures and elements similar to those shown in <FIG>. In this embodiment, the end portion <NUM> may not have a bowl-shaped structure <NUM> shown in <FIG>. Instead, the end portion <NUM> of the shaft <NUM> may have a first flat surface <NUM>. A first magnetic element <NUM> may be disposed at the first flat surface <NUM>. Correspondingly, the conical impeller <NUM> may not have a bowl-shaped structure <NUM>. Instead, the conical impeller <NUM> may have an upper structure <NUM> with a second flat surface <NUM> facing the first flat surface <NUM> of the end portion <NUM> of the shaft <NUM>. A second magnetic element <NUM> may be disposed at the second flat surface <NUM> facing the first magnetic element <NUM>. The second magnetic element <NUM> may be magnetically coupled with the first magnetic element <NUM>. Although one magnetic element is shown as being disposed at each of the first and second flat surfaces, it is understood that in some embodiments, a plurality of magnetic elements may be disposed at each flat surface <NUM> or <NUM>. In some embodiments, the magnetic elements <NUM> and <NUM> may provide a repulsive magnetic force, which may push the upper structure <NUM> away from the end portion <NUM> to maintain a gap between the second flat surface <NUM> and the first flat surface <NUM>. Thus, during operation, the rotating conical impeller <NUM> may not contact the end portion <NUM> of the shaft <NUM>, thereby eliminating or reducing the friction between the conical impeller <NUM> and the shaft <NUM>. In some embodiments, the magnetic elements <NUM> and <NUM> may provide an attractive magnetic force. During operation, the upward flowing blood may push the conical impeller <NUM> away from the end portion <NUM> of the shaft <NUM>, and the attractive magnetic force between the magnetic elements <NUM> and <NUM> may pull the conical impeller <NUM> toward the end portion <NUM>. The magnetic elements <NUM> and <NUM> may be configured with a suitable attractive magnetic force such that the conical impeller <NUM> suspends in the blood during an operation, with a gap between the second flat surface <NUM> and the first flat surface <NUM>, thereby eliminating or reducing the friction between the conical impeller <NUM> and the shaft <NUM>.

<FIG> schematically illustrates a cross-sectional view of the volute pump head <NUM> configured for use in the artificial heart, according to another embodiment of the present disclosure. This embodiment includes structures and elements similar to those shown in <FIG>. In this embodiment, the end portion <NUM> may include a spherical structure <NUM> disposed a tip portion of the end portion <NUM>. The bowl-shaped structure <NUM> of the conical impeller <NUM> may have a curved surface corresponding to the spherical structure <NUM> of the end portion <NUM>. A gap may exist between the curved surface of the bowl-shaped structure <NUM> and the spherical structure <NUM>. A magnetic element <NUM> may be disposed at the curved surface of the bowl-shaped structure <NUM> or behind the curved surface of the bowl-shaped structure <NUM>. A corresponding magnetic element <NUM> may be disposed at the exterior surface of the spherical structure <NUM> of the end portion <NUM> of the shaft <NUM>, or behind the surface of the spherical structure <NUM>. The magnetic elements <NUM> and <NUM> may be magnetically coupled with one another. In some embodiments, the magnetic elements <NUM> and <NUM> may generate a repulsive magnetic force, which may push the conical impeller <NUM> away from the end portion <NUM>. Thus, during an operation, the conical impeller <NUM> may suspend in the blood with a gap between the bowl-shaped structure <NUM> and the spherical structure <NUM> of the end portion <NUM> of the shaft <NUM>. The gap may eliminate or reduce the friction between the conical impeller <NUM> and the shaft <NUM> during an operation.

In some embodiments, the magnetic elements <NUM> and <NUM> may be suitably configured to generate an attractive magnetic force, which may pull the conical impeller <NUM> toward the end portion <NUM>. During an operation, the upward flow of the blood may apply a force on the conical impeller <NUM> to push the conical impeller <NUM> upwardly, away from the end portion <NUM>. The attractive magnetic force may be suitably designed to counter a portion of the upward pushing force generated by the upward flow of the blood, thereby maintaining a suitable gap between the spherical structure <NUM> and the bowl-shaped structure <NUM> of the conical impeller <NUM>. The gap may eliminate or reduce the friction between the conical impeller <NUM> and the shaft <NUM> during an operation.

Although the configurations of the structures facing each other for the conical impeller <NUM> and the end portion <NUM> shown in <FIG> and <FIG> are each illustrated based on the embodiment shown in <FIG> and <FIG>, it is understood that the same configurations of the structures facing each other for the conical impeller <NUM> and the end portion <NUM> may be applicable to the embodiments shown in <FIG> and <FIG>.

Compared with the conventional technologies, the advantages provided by the pump for the artificial heart according to the present disclosure may be similar to the advantages provided by the pump head according to any of the technical solutions described herein, which are not repeated.

According to a third aspect of the present disclosure, the present disclosure also provides an ECMO device. The ECMO device may include a pump (or a dynamic pump, a centrifugal blood pump) according to any of the technical solutions described herein. <FIG> schematically illustrates an ECMO device <NUM> including the pump <NUM> that includes the disclosed volute pump head <NUM>, according to an embodiment of the present disclosure. As shown in <FIG>, the ECMO device <NUM> include the pump <NUM> and an oxygenator <NUM>. The pump <NUM> and the oxygenator <NUM> may be fluidly coupled with one another through one or more tubings (or conduits) <NUM>. The pump <NUM> and the oxygenator <NUM> may be fluidly coupled with the heart of a patient <NUM> through tubings (or conduits) <NUM>. The oxygenator <NUM> may be configured to exchange oxygen and carbon dioxide with the blood, functioning as an artificial lung. That is, carbon dioxide may be exchanged out of the blood and oxygen may be exchanged into the blood. As shown by the arrows (indicating the blood flowing direction) in <FIG>, the blood flowing out of the patient is pumped by the pump <NUM> to flow through the oxygenator <NUM>, in which the oxygen is exchanged into the blood, and carbon dioxide is exchanged out of the blood. The blood output from the oxygenator <NUM> continues to flow into the heart of the patient. The ECMO device <NUM> may also include a controller <NUM>. The controller <NUM> may include a suitable processor and/or a non-transitory computer-readable storage medium. The non-transitory computer-readable storage medium may be configured to store data, including computer-executable software or program codes or instructions. The processor may include any suitable data processing devices, such as a central processing unit ("CPU"). The controller <NUM> may be communicatively coupled with the pump <NUM> and the oxygenator <NUM>, and may control the operations of the pump <NUM> and the oxygenator <NUM>. For example, the controller <NUM> may control the rotating speed of the driving mechanism <NUM> to control the rotating speed of the conical impeller <NUM>, thereby controlling the gap between the conical impeller <NUM> and the end portion <NUM>, i.e., to control the suspension of the conical impeller <NUM> in order to minimize the friction and maximize the blood pumping efficiency.

Compared with the conventional technologies, the advantages of the ECMO device of the present disclosure may be similar to the advantages of the pump head configured for use in an artificial heart, which are not repeated.

Claim 1:
A pump head, comprising:
a casing: (<NUM>) including a blood inlet (<NUM>) configured to receive a flow of a blood and a blood outlet (<NUM>) configured to allow the blood to flow out of the casing;
a shaft (<NUM>) disposed in the casing;
a magnetic structure (<NUM>) mounted onto the shaft; and
an impeller (<NUM>) having an open structure (<NUM>) and mounted to an exterior surface of the magnetic structure through an opening provided at the open structure.
the impeller includes a plurality of vanes disposed at an exterior surface of the open structure, the plurality of vanes including a plurality of first vanes (<NUM>) and a plurality of second (<NUM>),
top portions of the first vanes are connected through a first bowl-shaped structure (<NUM>) having a downward opening,
the shaft includes a second bowl-shaped structure (<NUM>) having an upward opening at an end of the shaft,
a spherical structure (<NUM>) is disposed between the first bowl-shaped structure and the second bowl-shaped structure, and
when the magnetic structure drives the impeller to rotate, a gap exists between the spherical structure and the first bowl-shaped structure and the second bowl-shaped structure, the gap being filled with the blood.