CN217938904U - Intervention blood pump - Google Patents

Abstract

The utility model provides an intervention formula blood pump, it includes: a blood pump main body and a flow guide assembly; the blood pump main body is connected with the far end of the flow guide assembly; the flow guide assembly comprises a flow passage membrane and a framework, the framework is connected with the flow passage membrane, the flow guide assembly has an expansion state and a contraction state, and when the flow guide assembly is in the expansion state, the framework supports the flow passage membrane so that the flow guide assembly is in a cylindrical shape; the far end of the blood pump main body is provided with a flow channel inlet, the near end of the flow guide assembly is provided with a flow channel outlet, and the blood pump main body and the flow guide assembly jointly form a blood flow channel; the blood pump main part includes the basket membrane, the distal end of runner membrane with the basket membrane is connected. So dispose, the skeleton can strut the runner membrane and provide certain holding power, can guarantee that the blood passageway that the runner membrane formed is stable in striding valve position, reduces the blood destruction because of the shake causes. Meanwhile, the framework is arranged, so that the radial deformation of the runner membrane is effectively prevented.

Description

Interventional blood pump

Technical Field

The utility model relates to the technical field of medical equipment, in particular to intervention formula blood pump.

Background

The percutaneous interventional blood pump is mainly used for emergency treatment of cardiogenic shock and auxiliary circulation during high-risk PCI operation. The blood pump arranged on the aortic valve can provide flow support of up to 4L/min, so that the blood pumping function of the heart is replaced, the life of a patient with cardiogenic shock can be saved, or the heart state is stabilized during the operation of a patient with high-risk PCI, the occurrence of arrhythmia is reduced, the operation risk is reduced, and the success rate of the high-risk PCI operation is ensured.

The percutaneous intervention type blood pump products on the current foreign markets have certain risks in the technology. Firstly, after the percutaneous intervention type blood pump completes ventricular intervention, the blood pump needs to pump blood in a heart chamber from the heart chamber to an aorta during operation, so that a blood passage needs to be established at the outlet of the blood pump, for example, a blood passage is formed by utilizing a runner membrane. When the blood pump is operated, blood passes through the paravalvular membrane from the ventricle to the aorta. However, the defect of this solution is that the flow passage membrane needs to be folded into the sheath tube for implantation, and in order to ensure the gripping performance, the material of the flow passage membrane needs to be selected from a softer elastic material, so that in the actual operation process, blood flowing through the flow passage membrane at a high speed may vibrate in the aorta through the flow passage membrane, which causes unstable operation of the blood pump in vivo and damage to blood, resulting in failed operation.

In addition, in the running process of the blood pump, because the paddles rotate at a high speed to pump blood, the blood flows through the flow channel membrane stage in a spiral mode and flows forwards, and due to the characteristics of fluid, the blood can impact the flow channel membrane at a certain speed to further cause the flow channel membrane to shake, so that hemodynamic disorder can be caused, and the risk of hemolysis and thrombosis is increased. Meanwhile, the shaking may cause fatigue damage to the extremely thin flow passage membrane, which may cause partial or complete stretching, deformation or even tearing of the flow passage membrane, resulting in damage to the blood passage, failure of the blood to be pumped from the ventricle into the aorta, and risk of surgical failure of the patient.

SUMMERY OF THE UTILITY MODEL

An object of the utility model is to provide an intervention formula blood pump to solve the regional easy vibrations that produce of blood route of current intervention formula blood pump, the problem of being impaired easily.

In order to solve the technical problem, the utility model provides an intervention formula blood pump, it includes: a blood pump main body and a flow guide assembly;

the blood pump main body is connected with the far end of the flow guide assembly; the flow guide assembly comprises a flow passage membrane and a framework, the framework is connected with the flow passage membrane, the flow guide assembly has an expansion state and a contraction state, and when the flow guide assembly is in the expansion state, the framework supports the flow passage membrane so that the flow guide assembly is in a cylindrical shape; the far end of the blood pump main body is provided with a flow channel inlet, the near end of the flow guide assembly is provided with a flow channel outlet, and the blood pump main body and the flow guide assembly jointly form a blood flow channel; the blood pump main body comprises a net basket membrane, and the far end of the runner membrane is connected with the net basket membrane.

Optionally, the flow channel film is coated outside the framework.

Optionally, the runner outlet is radially arranged on the runner membrane, the framework includes at least two supporting members, at least two supporting members are arranged around the runner membrane at intervals in the circumferential direction, and the supporting members avoid the runner outlet.

Optionally, the support member extends from the proximal end to the distal end of the flow passage membrane, and the axial extension length of the support member is not more than 1/3 of the axial length of the flow passage membrane.

Optionally, the interventional blood pump includes an inner sheath, and the inner sheath penetrates through the flow guide assembly and is connected to the blood pump main body; the runner membrane comprises a main body section and a necking section positioned at the proximal end of the main body section, wherein the large-diameter end of the necking section is connected with the main body section, and the small-diameter end of the necking section is connected with the inner sheath tube;

the supporting piece extends from the small-diameter end of the reducing section along the axial direction, crosses the flow passage outlet, expands outwards and is connected with the main body section; or; the support member extends distally from the small diameter end of the throat section along the sidewalls of the throat section and the main body section.

Optionally, the runner membrane includes a main body section, and the framework includes a main body support section for supporting the main body section; the main body supporting section comprises a grid section and/or a spiral section, the grid section and the spiral section are circumferentially distributed around the flow channel membrane, and the spiral section is spirally distributed around the flow channel membrane.

Optionally, the blood pump body comprises an impeller, and the spiral direction of the spiral section is the same as the rotation direction of the impeller.

Optionally, the main body support section comprises at least two spiral sections, and the spiral directions of the at least two spiral sections are opposite and intersect.

Optionally, the proximal end of the body support section is connected to the distal end of the support.

Optionally, the blood pump main body comprises a basket, and the framework is connected with the basket.

To sum up, the utility model provides an intervention formula blood pump includes: a blood pump main body and a flow guide assembly; the blood pump main body is connected with the far end of the flow guide assembly; the flow guide assembly comprises a flow passage membrane and a framework, the framework is connected with the flow passage membrane, the flow guide assembly has an expansion state and a contraction state, and when the flow guide assembly is in the expansion state, the framework supports the flow passage membrane so that the flow guide assembly is in a cylindrical shape; the far end of the blood pump main body is provided with a flow channel inlet, the near end of the flow guide assembly is provided with a flow channel outlet, and the blood pump main body and the flow guide assembly jointly form a blood flow channel; the blood pump main part includes the basket membrane, the distal end of runner membrane with the basket membrane is connected.

So dispose, the skeleton can strut the runner membrane and provide certain holding power for blood is when leading the flow assembly, even have the impact to the runner membrane, the support of skeleton can guarantee that the blood passageway that the runner membrane formed is stable in striding valve position, reduces because shake and the blood destruction that causes. Meanwhile, the framework is arranged, so that the radial deformation of the runner membrane is effectively prevented, and the tearing damage caused by the thinning of the wall surface of the runner membrane due to the extension is prevented. The setting of skeleton also is favorable to the pressure of water conservancy diversion subassembly to be held in addition, and the existence of skeleton makes the runner membrane can not compressed to one side when pressing and holding, but equipartition in the pipe to can fold smoothly to the pipe in, and the skeleton can strut the runner membrane and provide certain support after the expansion, when guaranteeing to realize folding, the runner membrane has sufficient support strength.

Drawings

Those skilled in the art will appreciate that the drawings are provided for a better understanding of the invention and do not constitute any limitation on the scope of the invention. Wherein:

fig. 1 is a schematic view of an interventional blood pump system to which the present invention relates;

fig. 2 is a schematic illustration of an interventional blood pump according to the present invention being introduced into a ventricle;

fig. 3 is a schematic view of an interventional blood pump according to the present invention;

fig. 4 is a cross-sectional view of an interventional blood pump according to the present invention along the axial direction;

fig. 5 is a perspective view of an interventional blood pump according to a first embodiment of the present invention along an axial direction;

fig. 6 is a perspective view of a deflector assembly according to a first embodiment of the present invention;

fig. 7 is a perspective view of the connection of the diversion assembly and the basket support according to the first embodiment of the present invention;

fig. 8 is a schematic view of a diversion assembly according to a second embodiment of the present invention;

fig. 9 is a perspective view of a diversion assembly according to a third embodiment of the present invention;

fig. 10 is a perspective view of a diversion assembly according to a fourth embodiment of the present invention;

fig. 11 is a perspective view of a flow guide assembly according to a fifth embodiment of the present invention;

fig. 12 is a schematic view of a flow guide assembly according to a sixth embodiment of the present invention.

In the drawings:

01-ascending aorta; 02-aortic valve; 03-left ventricle; 10-an interventional blood pump; 20-a transmission assembly; 21-inner sheath; 22-a flexible shaft; 30-a drive assembly; 40-a control component;

11-a blood pump body; 111-pigtail catheter; 112-a basket; 113-an impeller; 114-a basket membrane; 115-a front bearing housing; 116-a rear bearing housing; 12-a flow directing assembly; 121-a flow channel membrane; 1211-a flow channel outlet; 1212-a body section; 1213-a necking section; 122-a backbone; 1221-a support; 1222-a helical segment.

Detailed Description

To make the objects, advantages and features of the present invention clearer, the present invention will be described in further detail with reference to the accompanying drawings and specific embodiments. It is to be noted that the drawings are in simplified form and are not to scale, and are merely intended to facilitate and clarify the explanation of the embodiments of the present invention. Further, the structures illustrated in the drawings are intended to be part of actual structures. In particular, the drawings are intended to show different emphasis, sometimes in different proportions.

As used in this application, the singular forms "a," "an," and "the" include plural referents, the term "or" is generally employed in a sense including "and/or," the terms "a number of" are generally employed in a sense including "at least one," the terms "at least two" are generally employed in a sense including "two or more," and moreover, the terms "first," "second," and "third" are used for descriptive purposes only and are not to be construed as indicating or implying relative importance or to imply that the number of technical features indicated are present. Thus, a feature defined as "first," "second," or "third" may explicitly or implicitly include one or at least two of that feature, "one end" and "the other end" and "proximal end" and "distal end" generally refer to the corresponding two parts, including not only the endpoints. The terms "proximal" and "distal" are defined herein with respect to an interventional blood pump system having a drive assembly configured to mechanically and/or electrically couple an interventional blood pump to the proximal end. The term "proximal" refers to a location of an element that is closer to the drive assembly, and the term "distal" refers to a location of an element that is closer to the interventional blood pump and thus further from the drive assembly. Alternatively, in manual or hand-operated application scenarios, the terms "proximal" and "distal" are defined herein with respect to an operator, such as a surgeon or clinician. The term "proximal" refers to a position of an element closer to an operator, and the term "distal" refers to a position of an element closer to an interventional blood pump and thus further away from the operator. Furthermore, as used in the present application, the terms "mounted," "connected," and "disposed" on another element should be construed broadly, and generally only mean that there is a connection, coupling, fit, or drive relationship between the two elements, and that the connection, coupling, fit, or drive between the two elements can be direct or indirect through intervening elements, and should not be construed as indicating or implying any spatial relationship between the two elements, i.e., an element can be located in any orientation within, outside, above, below, or to one side of another element unless the content clearly dictates otherwise. The specific meaning of the above terms in the present invention can be understood according to specific situations by those skilled in the art. Moreover, directional terminology, such as upper, lower, upward, downward, left, right, etc., is used with respect to the exemplary embodiments as they are shown in the figures, with the upward or upward direction being toward the top of the corresponding figure and the downward or downward direction being toward the bottom of the corresponding figure.

An object of the utility model is to provide an intervention formula blood pump to solve the regional easy vibrations that produce of blood route of current intervention formula blood pump, the problem of being impaired easily.

The following description refers to the accompanying drawings.

Referring to fig. 1, an interventional blood pump system is shown comprising: an interventional blood pump 10, a transmission assembly 20 and a drive assembly 30; the interventional blood pump 10 is connected with the driving assembly 30 through the transmission assembly 20, and the driving assembly 30 drives the impeller of the interventional blood pump 10 to move through the transmission assembly 20. Referring to fig. 4, in an exemplary embodiment, the interventional blood pump 10 has an impeller 120, the transmission assembly 20 includes an inner sheath 21 and a flexible shaft 22 rotatably disposed in the inner sheath 21, a distal end of the flexible shaft 22 is connected to the impeller 120, and a proximal end of the flexible shaft 22 is connected to the driving assembly 30. Therefore, the driving assembly 30 can drive the impeller 120 to rotate through the flexible shaft 22. Alternatively, in some embodiments, drive assembly 30 may be integrated into a handle. Optionally, the interventional blood pump system may further comprise a control assembly 40 for monitoring and controlling other components of the interventional blood pump system. The individual components of such an interventional blood pump system are well understood by those skilled in the art and will not be described in detail here.

Referring to fig. 2, in use, the interventional blood pump 10 in a compressed state is introduced through the femoral artery via the delivery device, a portion of the distal end of the interventional blood pump 10 passes through the aortic valve 02 and into the left ventricle 03 via the descending aorta and the ascending aorta 01, after the delivery device is removed, the interventional blood pump 10 is expanded from the compressed state to the deployed state, and the impeller within the interventional blood pump 10 is actuated (e.g., rotated) by the distal drive assembly 30 to pump blood from the left ventricle 03 to the ascending aorta 01.

Referring to fig. 3 and 4, the interventional blood pump 10 includes a blood pump body 11 and a flow guide assembly 12; the blood pump body 11 is connected with the far end of the diversion component 12. In one example, the blood pump body 11 includes a pigtail conduit 111, a basket 112, an impeller 113, a basket membrane 114, a front bearing sleeve 115, and a rear bearing sleeve 116. The pigtail catheter 111 is used for assisting the interventional blood pump 10 to be fixed in the left ventricle 03, ensuring that the part contacted with the ventricular wall is smooth and preventing the inner wall of the ventricle from being damaged. The basket 112 is made of a shape memory metal such as nitinol, which is capable of being compressed, folded, and unfolded to expand, and in an unfolded state, to form a space for the impeller 113 to rotate. The front bearing housing 115 and the rear bearing housing 116 are respectively connected with the basket 112, the distal end of the impeller 113 is movably inserted into the front bearing housing 115, and the proximal end is movably inserted into the rear bearing housing 116. The mesh basket covering film 114 can be coated on the outer wall of the framework body of the mesh basket 112 through a heat shrinkage process, a dip coating process or the like. Further, the flow guiding assembly 12 includes a flow passage film 121, the flow passage film 121 is cylindrical, and a distal end of the flow passage film 121 is connected to the basket film 114, for example, the connection may be achieved by thermal shrinkage fixing or high polymer thermal fusion welding. The flow path membrane 121 further has a flow path outlet 1211 opened in the radial direction. In operation of the interventional blood pump 10, the blood pump body 11 is mainly located in the left ventricle 03, the flow guiding element 12 spans the valve (referred to as the aortic valve 02), the fluid passage outlet 1211 is relatively close to the proximal end of the fluid passage membrane 121 and is located in the region of the ascending aorta 01, and after being pumped into the fluid passage membrane 121 by the impeller 113, blood flows out of the fluid passage outlet 1211 and enters the ascending aorta 01.

In one embodiment, referring to fig. 3, 4 and 6, the inner sheath 21 extends through the flow-guiding assembly 12 and is connected to the blood pump body 11, and in particular, the inner sheath 21 may be connected to the rear bearing sleeve 116 and to the basket 112. The flow conduit membrane 121 comprises a main body section 1212 and a necked-down section 1213 at a proximal end of the main body section 1212. It will be appreciated that the tapered section 1213 has a large diameter end and a small diameter end, and the large diameter end of the tapered section 1213 is connected to the main body section 1212, and the small diameter end of the tapered section 1213 is connected to the inner sheath 21. The connection between the small diameter end of the reduced section 1213 and the inner sheath 21 can be achieved by thermal shrinkage or high-molecular thermal fusion welding.

Optionally, the flow channel film 121 is made of a high molecular material, such as polyurethane TPU, silica gel, nylon PA, polyethylene PE, polyether block polyamide PEBAX, or polyethylene terephthalate PET, and in order to reduce the folding resistance during the interventional operation, the wall thickness of the flow channel film 121 is preferably 0.01mm to 0.1 mm. The inventors found that the thinner wall thickness causes the blood to be impacted and shaken when flowing through the area of the flow channel membrane 121, which affects the flow of the blood, and that shaking for a long time increases the risk of the flow channel membrane 121 breaking. And thicker wall thickness can affect fold loading.

On the other hand, before actual intervention, the distal end of the interventional blood pump 10 needs to be folded through the sheath tube, and at this stage, the flow channel membrane 121 may be axially elongated under the action of axial thrust because the wall thickness is thin, so that a certain accumulation phenomenon is generated at the distal end close to the basket 112 by the flow channel membrane 121 along with the pushing of the sheath tube, and the difficulty in folding the basket 112 is increased.

Based on the above research, please refer to fig. 5 to 12, an embodiment of the present invention provides a flow guiding assembly 12, which includes a flow passage membrane 121 and a framework 122, wherein the framework 122 is connected to the flow passage membrane 121, the flow guiding assembly 12 has an expanded state and a contracted state, and when the flow guiding assembly 12 is in the expanded state, the framework 122 supports the flow passage membrane 121 so that the flow guiding assembly 12 is in a cylindrical shape; the cylindrical shape is not limited to a cylindrical shape, but the frame 122 may be configured to stretch the flow guide assembly 12 and the blood pump body 11 to form a passage by spreading the flow guide membrane 121, and the specific shape of the cross section is not limited. The distal end of the blood pump main body 11 is provided with a flow channel inlet, the proximal end of the flow guide assembly 12 is provided with a flow channel outlet 1211, and the blood pump main body 11 and the flow guide assembly 12 together form a blood flow channel.

With such a configuration, the frame 122 can prop open the flow channel membrane 121 and provide a certain supporting force, so that when blood flows through the flow guide assembly 12, even if there is an impact on the flow channel membrane 121, the support of the frame 122 can ensure that the blood passage formed by the flow channel membrane 121 is stabilized at the valve crossing position, and thus blood damage caused by shaking is reduced. Meanwhile, the framework 122 also effectively prevents the radial deformation of the runner membrane 121, and prevents the runner membrane 121 from being torn and damaged due to wall thinning caused by extension. In addition, the framework 122 is also beneficial to the pressing and holding of the flow guide assembly 12, the existence of the framework 122 during the pressing and holding process enables the flow passage membrane 121 not to be compressed to one side, but is uniformly distributed in the sheath tube and can be smoothly folded into the sheath tube, the framework 122 can prop open the flow passage membrane 121 and provide certain support after the expansion, and the flow passage membrane 121 has enough support strength while the folding is ensured.

Furthermore, due to the provision of the skeleton 122, the deformation of the flow passage membrane 121 during the folding of the distal end of the interventional blood pump 10 will be alleviated. Specifically, in the folding stage, the runner film 121 will be limited by the framework 122 and compressed more uniformly in the axial direction, so that axial elongation and accumulation are avoided, and the folding difficulty is reduced.

Alternatively, the frame 122 may be connected to the basket 112, for example, by heat welding, and this configuration may provide another form of connection between the runner film 121 and the basket film 114. Preferably, the basket 112 and the frame 122 are metal members made of memory metal such as nitinol, and are manufactured by cutting a tube by laser engraving, and then performing heat setting, sand blasting, and polishing. Without the frame 122, the flow channel film 121 and the basket film 114 must be made of the same material and connected by laser welding or heat fusion, as shown in fig. 3, the flow channel film 121 is heat shrunk on the basket film 114, which will increase the radial thickness of the part, thereby increasing the difficulty of the sheath tube compressing the basket 112. Referring to fig. 7, since the frame 122 is connected to the basket 112, such as by thermal melting or laser welding, the flow guiding assembly 12 is connected to the blood pump body 11 in a metal connection manner, which has higher connection strength and is less likely to fall off compared to the connection of the polymer material between the flow passage membrane 121 and the basket membrane 114. In addition, the connection manner allows the basket film 114 and the flow passage film 121 to be made of different materials according to different functions, for example, on the premise that the basket film 114 is made of polyurethane, the flow passage film 121 can be made of a polymer material, such as PE, which has better toughness and strength and can be processed to be thinner. Therefore, the compliance during folding can be further improved, and the difficulty of interventional operation is reduced.

Optionally, the runner film 121 is coated outside the framework 122. In one embodiment, the frame 122 is a metal frame, preferably formed from a memory material such as nitinol. The runner film 121 may be covered outside the frame 122 by heat melting or sewing. That is, the frame 122 is fixedly connected to the inner wall of the flow passage membrane 121. In another embodiment, the skeleton 122 may also be wrapped inside the runner film 121 by using a thermal welding method of a polymer material.

Referring to fig. 5 to 7, in an embodiment, the framework 122 includes at least two supporting members 1221, the at least two supporting members 1221 are spaced around the circumference of the runner membrane 121, and the supporting members 1221 are disposed away from the runner outlet 1211. In one embodiment, the supporting member 1221 extends in the axial direction according to the outer contour shape of the flow passage membrane 121 in the expanded state, and the cross-sectional shape of the supporting member 1221 is preferably a circle, and the diameter of the cross-sectional shape is between 0.05mm and 0.3mm, although in other embodiments, the cross-sectional shape of the supporting member 1221 may be a square, a diamond, or the like, which is not limited by the present invention. The number of the supporting members 1221 may be set according to the maximum working flow of the interventional blood pump 10, and preferably, the framework 122 includes 4 to 6 supporting members 1221, and 4 to 6 supporting members 1221, which are preferably uniformly distributed around the circumference of the flow passage membrane 121, and are reasonably arranged according to the size and position of the flow passage outlet 1211, so as to prevent the supporting members 1221 from directly passing through the flow passage outlet 1211 to damage the flowing blood. It will be appreciated that the probability of the flutter of the flow passage membrane 121 increases when the maximum working flow of the interventional blood pump 10 is large, and accordingly, the number of the supporting members 1221 may be increased to 6 to 8, but should not exceed 10 at most, to prevent the excessive supporting members 1221 from having a large negative effect on the folding performance.

Referring to fig. 8, in one embodiment, the supporting member 1221 extends from the proximal end to the distal end of the flow passage membrane 121, and the axial extension length of the supporting member 1221 is not more than 1/3 of the axial length of the flow passage membrane 121. If the support 1221 extends over the entire axial length of the flow conduit membrane 121, as in the previous exemplary embodiments shown in fig. 5 to 7, it may cause the valve of the interventional blood pump 10 to be unable to open and close normally in the operation stage, and after the interventional blood pump 10 is removed after the operation is finished, there may be a risk of incomplete valve closing, so in this embodiment, the axial length of the support 1221 may be configured to be shorter, and the position is configured at the proximal end portion of the flow conduit membrane 121, and only the proximal end portion of the flow conduit membrane 121 is supported, so that the stability of the passage of the flow conduit membrane 121 during the operation of the interventional blood pump 10 may be ensured, and damage to the valve may also be reduced. Preferably, the length of the support 1221 is no more than one third of the total axial length of the Runner Membrane 121, and the support 1221 can be visualized to determine whether the Runner Outlet 1211 is currently located above the valve, so as to ensure that the support 1221 is located in the ascending aorta 01.

In one embodiment, as shown in fig. 8, the supporting member 1221 extends from the small diameter end of the reduced section 1213 to the distal end along the reduced section 1213 and the side wall of the main body section 1212, i.e. the shape of the supporting member 1221 extends according to the outer contour shape of the flow passage membrane 121 in the expanded state, and it is always kept in contact with the flow passage membrane 121.

In another embodiment, as shown in FIG. 9, the struts 1221 extend axially from the reduced diameter end of the converging section 1213 beyond the flow passage outlet 1211 and then expand outwardly and connect to the main section 1212. In this embodiment, the supporting member 1221 is substantially umbrella-shaped, and the proximal portion of the supporting member 1221 is attached to the inner sheath 21, for example, by thermal shrinkage and high polymer thermal welding, so that the small diameter end of the necking section 1213, the proximal portion of the supporting member 1221 and the inner sheath 21 are connected together. The support 1221 is held in an axially linear, distally extending configuration until it passes over the flow passage outlet 1211 and is folded outwardly, expanded, and into abutting engagement with the inner wall of the main body segment 1212. It should be noted that, here, the supporting member 1221 extends along the axial direction, and the supporting member 1221 may be attached to the inner sheath 21 to extend, or may be suspended between the inner sheath 21 and the main body segment 1212. In some embodiments, the supporting member 1221 and the inner wall of the main body segment 1212 may also be connected by sewing, heat shrinking, polymer heat welding, or the like. In other embodiments, the support 1221 can also abut against the inner wall of the main body segment 1212, and the support 1221 expands to expand the main body segment 1212 after the sheath is withdrawn according to the memory effect of the memory metal. Since the supporting member 1221 of the present embodiment is attached to the inner sheath 21 when passing through the region of the flow channel outlet 1211, and does not block the blood from flowing through the flow channel outlet 1211, the framework 122 of the present embodiment is particularly suitable for the case where the flow channel outlet 1211 cannot be bypassed when more supporting members 1221 are required. In addition, since most of the supporting member 1221 is attached to the inner sheath 21, only a small portion of the distal end is expanded outside the region, and the folding force required is correspondingly small, thereby facilitating folding and loading into the outer sheath.

Referring to fig. 10, in an alternative embodiment, the supporting member 1221 extends from the distal end to the proximal end of the flow passage membrane 121, and the axial extension length of the supporting member 1221 is not more than 1/3 of the axial length of the flow passage membrane 121. The distal end of the support 1221 may be welded to the basket 112, and may extend proximally along the side wall of the main body segment 1212, or may be bent inwardly at a portion near the proximal end to conform to the inner sheath 21. It should be noted that in some embodiments, the framework 122 may only include the support 1221 located at the proximal portion of the runner membrane 121, or only include the support 1221 located at the distal portion of the runner membrane 121, while in other embodiments, the framework 122 may include both the support 1221 located at the proximal portion of the runner membrane 121 and the support 1221 located at the distal portion of the runner membrane 121, i.e., the framework 122 is divided into two portions, i.e., a proximal portion and a distal portion, as shown in fig. 10. The axial length of both parts of the frame 122 does not exceed 1/3 of the axial length of the casting membrane 121, and thus, the frame 122 is not provided in at least one third of the middle part of the casting membrane 121, which is intended to be a region through the valve, and the flexible casting membrane 121 can minimize the influence on the opening and closing of the valve compared with the more rigid frame 122. Not only improves the strength of the diversion component 12 in the operation process, but also reduces the damage to the valve.

Referring to fig. 11, in one embodiment, the skeleton 122 includes a main body supporting section for supporting the main body section 1212. Optionally, the main body support segment includes a grid segment arranged circumferentially around the flow path membrane 121 and/or a spiral segment 1222 arranged spirally around the flow path membrane 121. In some cases, to increase the stability of the flow passage membrane 121, a straight-line structure similar to the frame 122 shown in fig. 6 requires a larger number of supporting members 1221, which increases the difficulty of folding the flow guiding assembly 12 and affects the surgical procedure. And the main part supports the setting of section and then can be so that under the prerequisite that the skeleton silk quantity is as little as possible, for runner membrane 121 provides sufficient holding power, also can guarantee the realization that runner membrane 121 can be smooth folding when increasing stability. In some embodiments, the body support section comprises a mesh section, which may be formed of various mesh structures, such as diamond mesh, which may be cut from a metal tube. In other embodiments, the body support section includes a coil section 1222, and the coil section 1222 may include a plurality of wires helically coiled. Of course, in other embodiments, the spiral segments 1222 and the mesh segments may be co-located.

Alternatively, the main body support section and the support 1221 may be arranged at the same time, the support 1221 is mainly arranged at the proximal end portion of the flow channel membrane 121, the main body support section is mainly arranged at the portion of the main body section 1212 of the flow channel membrane 121, especially at the distal end of the flow channel outlet 1211, and the proximal end of the main body support section is connected to the distal end of the support 1221. The support 1221 is connected to the main body support section starting from the small diameter end of the constricted section 1213 and extending distally along the side wall of the flow passage membrane 121 beyond the area of the flow passage outlet 1211. It should be noted that the number of the grid segments or the spiral segments 1222 included in the main body supporting segment may be the same as the number of the supporting members 1221, or may be different from the number of the supporting members 1221. For example, depending on the flow rate, a portion of the axially symmetrical supports 1221 may be connected to the main body support section, and the remaining portion of the supports 1221 may extend only beyond the area of the flow path outlet 1211 and be left empty. Optionally, the pitch of the spiral section 1222 is 10mm to 50mm, the density of the pitch is related to the flow rate, and in the case of a large flow rate, the pitch of the spiral section 1222 should be correspondingly reduced to increase the strength of the flow channel membrane 121 and reduce the jitter; conversely, when the flow rate is small, the spiral section 1222 with a larger pitch can be used to reduce jitter. Correspondingly, the mesh size of the mesh segment can also be adapted according to the traffic.

Preferably, the spiral direction of the spiral section 1222 is the same as the rotation direction of the impeller 113. The spiral direction of the spiral section 1222 is the same as the rotation direction of the impeller 113, and the spiral direction of the pumped blood is the same as the spiral section 1222, so that the damage of the skeleton 122 to the blood can be reduced.

Referring to fig. 12, in one embodiment, the main body support segment includes at least two spiral segments 1222, and the spiral directions of the at least two spiral segments 1222 are opposite and intersect. So configured, the oppositely spiraled segments 1222 form a lattice structure, which is not too dense for easy gripping and expansion of the flow guide member 12, and preferably includes 2-3 lattice structures in the axial direction of the flow channel membrane 121. The spiral section 1222 that the grid structure compares the unidirectional spiral is more stable, and in addition, the connected mode of grid structure and runner membrane 121 can only realize being connected of skeleton 122 and runner membrane 121 through sewing up or laser welding the node position, has reduced the degree of difficulty of technology.

To sum up, the utility model provides an intervention formula blood pump includes: a blood pump main body and a flow guide assembly; the blood pump main body is connected with the far end of the flow guide assembly; the flow guide assembly comprises a flow passage membrane and a framework, the framework is connected with the flow passage membrane, the flow guide assembly has an expansion state and a contraction state, and when the flow guide assembly is in the expansion state, the framework supports the flow passage membrane so that the flow guide assembly is in a cylindrical shape; the far end of the blood pump main body is provided with a flow channel inlet, the near end of the flow guide assembly is provided with a flow channel outlet, and the blood pump main body and the flow guide assembly jointly form a blood flow channel; the blood pump main body comprises a net basket membrane, and the far end of the runner membrane is connected with the net basket membrane.

So the configuration, the skeleton can strut the runner membrane and provide certain holding power for even there is the impact to the runner membrane when blood flows through the guide subassembly, the blood passageway that the support of skeleton also can guarantee that the runner membrane forms is stable in striding valve position, reduces because shake and the blood destruction that causes. Meanwhile, the framework is arranged, so that the radial deformation of the runner membrane is effectively prevented, and the tearing damage caused by wall thinning caused by extension of the runner membrane is prevented. In addition, the framework is also favorable for pressing and holding the flow guide assembly, the flow channel membrane cannot be compressed to one side due to the existence of the framework in the pressing and holding process, but is uniformly distributed in the conduit and can be smoothly folded into the conduit, and the framework can be used for propping open the flow channel membrane and providing certain support after expansion, so that the flow channel membrane has enough support strength while the folding is ensured.

It should be noted that the above embodiments may be combined with each other. The above description is only for the purpose of describing the preferred embodiments of the present invention, and is not intended to limit the scope of the present invention, and any changes and modifications made by those skilled in the art according to the above disclosure are all within the scope of the appended claims.

Claims (10)

1. An interventional blood pump, comprising: a blood pump main body and a flow guide assembly;

the blood pump main body is connected with the far end of the flow guide assembly; the flow guide assembly comprises a flow passage membrane and a framework, the framework is connected with the flow passage membrane, the flow guide assembly has an expansion state and a contraction state, and when the flow guide assembly is in the expansion state, the framework supports the flow passage membrane so that the flow guide assembly is in a cylindrical shape; the far end of the blood pump main body is provided with a flow channel inlet, the near end of the flow guide assembly is provided with a flow channel outlet, and the blood pump main body and the flow guide assembly jointly form a blood flow channel; the blood pump main part includes the basket membrane, the distal end of runner membrane with the basket membrane is connected.

2. The interventional blood pump of claim 1, wherein the flow corridor membrane is coated outside the framework.

3. The interventional blood pump of claim 1, wherein the flow channel outlet is radially open on the flow channel membrane, the frame comprises at least two support members, the at least two support members are spaced around the circumference of the flow channel membrane, and the support members are offset from the flow channel outlet.

4. The interventional blood pump of claim 3, wherein the support extends from a proximal end to a distal end of the flow conduit membrane and an axial extent of the support is no more than 1/3 of an axial extent of the flow conduit membrane.

5. The interventional blood pump of claim 4, comprising an inner sheath extending through the flow directing assembly and connected to the blood pump body; the runner membrane comprises a main body section and a necking section positioned at the proximal end of the main body section, wherein the large-diameter end of the necking section is connected with the main body section, and the small-diameter end of the necking section is connected with the inner sheath tube;

the supporting piece extends from the small-diameter end of the reducing section along the axial direction, crosses the flow passage outlet, expands outwards and is connected with the main body section; alternatively, the support member extends distally from the small diameter end of the throat section along the sidewalls of the throat section and the body section.

6. The interventional blood pump of claim 4, wherein the flow conduit membrane comprises a main body section, the skeleton comprising a main body support section for supporting the main body section; the main body support section comprises a grid section and/or a spiral section, wherein the grid section is circumferentially distributed around the flow channel membrane, and the spiral section is spirally distributed around the flow channel membrane.

7. The interventional blood pump of claim 6, wherein the blood pump body comprises an impeller, the helical section having a helical direction that is the same as the direction of rotation of the impeller.

8. The interventional blood pump of claim 6, wherein the body support section comprises at least two of the helical sections having opposite helical directions and intersecting.

9. The interventional blood pump of claim 6, wherein a proximal end of the body support section is connected with a distal end of the support.

10. The interventional blood pump of claim 1, wherein the blood pump body comprises a basket, the skeleton being connected to the basket.

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