CN217828629U - Intervention type blood pump and intervention type blood pump system - Google Patents

Abstract

The utility model provides an intervention formula blood pump and intervention formula blood pump system, intervention formula blood pump includes: a blood pump main body and a support part; the blood pump main body comprises a basket support, an impeller and a basket covering film; the impeller is rotatably arranged in the basket support around the axial direction of the basket support, and the basket covering film is coated outside the basket support; the supporting part is arranged around the circumferential direction of the basket support and is connected with the basket support, and the supporting part is switched between an expansion state and a contraction state along the radial direction of the basket support; the support part is in the contracted state under the restriction of the conveying device; the support portion is in the expanded state when unconstrained; when the stent is in the expanded state, the radial outer dimension of the support part along the basket stent is larger than that of the basket stent, and at least one part of the support part is positioned outside the basket tectorial membrane. Therefore, the risk of suspended shaking of the intervention type blood pump in the heart chamber is reduced.

Description

Interventional blood pump and interventional blood pump system

Technical Field

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

Background

Percutaneous interventional blood pumps are mainly used for emergency treatment of cardiogenic shock and auxiliary circulation during high-risk PCI surgery. The blood pump arranged on the aortic valve can provide flow support of up to 4L/min, so that the blood pump function of the heart is replaced, the life of a patient suffering from cardiogenic shock can be saved, or the heart state is stabilized during the operation of a patient suffering from 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 prior percutaneous interventional blood pump product has certain hidden trouble in the technology. After the percutaneous intervention type blood pump finishes ventricular intervention, the head end part of the blood pump is in a suspended state in a ventricle in an operation stage, and the change of blood flow in the ventricle caused by the rotation of the rotor impeller at the moment can cause the vibration of the blades and the basket in the operation process, damage is caused to blood cells, and hemolysis and thrombus are generated. In addition, at the stage of starting the operation of the blood pump, the flow passage membrane is flushed away by blood flow, and because the outer diameters of the rotor impeller and the basket are smaller than the inner diameter of the flow passage membrane, the rotor impeller and the basket easily slide out of the ventricle to the aorta, so that the blood pump cannot continue to pump blood from the ventricle.

SUMMERY OF THE UTILITY MODEL

An object of the utility model is to provide an intervention formula blood pump and intervention formula blood pump system to solve current intervention formula blood pump and accomplish that the ventricle intervenes the back does not have effective fixed, causes the problem of destruction and rotor impeller and the easy roll-off of basket to the blood cell.

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 support part;

the blood pump main body comprises a basket support, an impeller and a basket covering film; the impeller is rotatably arranged in the basket support in the axial direction of the basket support, and the basket film covers the basket support; the supporting part is arranged around the circumferential direction of the basket support and is connected with the basket support, and the supporting part is switched between an expansion state and a contraction state along the radial direction of the basket support;

the support part is in the contracted state under the limitation of the conveying device; the support portion is in the expanded state when unconstrained;

when the stent is in the expanded state, the radial outer dimension of the supporting part along the basket stent is larger than that of the basket stent, and at least one part of the supporting part is positioned outside the basket covering film.

Optionally, in the interventional blood pump, the basket support has opposite inflow and outflow ends along its own axial direction, and one end of the support part is connected to the inflow end of the basket support; when the supporting part is in the expansion state, at least one part of the supporting part expands towards the outer direction of the basket support and is positioned outside the basket covering film.

Optionally, in the interventional blood pump, the support portion includes a plurality of support wires circumferentially distributed around the basket support, one end of each support wire is connected to the inflow end of the basket support, the other end of each support wire is a free end, and when the support portion is in the expansion state, the free end extends and expands towards the outside of the blood pump main body.

Optionally, in the interventional blood pump, one end of the support wire connected to the basket support extends along an axial direction of the basket support, the support wire is recessed toward a proximal direction, and a normal direction of the recess faces toward an outside of the basket support.

Optionally, in the interventional blood pump, the support wires are integrally formed with the inflow end of the basket support; or the supporting wires are welded with the inflow end of the net basket support.

Optionally, the interventional blood pump includes an inflow end bearing portion axially connected to an inflow end of the basket support, and the support portion includes a plurality of support wires circumferentially distributed around the inflow end bearing portion; one end of the supporting wire is connected with the inflow end bearing part, the other end of the supporting wire is a free end, and when the supporting part is in the expansion state, the free end extends and expands towards the outer direction of the blood pump main body.

Optionally, the interventional blood pump includes a contact portion, one end of the contact portion is connected to the inflow end bearing portion, and the support wire is connected to the inflow end bearing portion through the contact portion.

Optionally, in the interventional blood pump, one end of the support wire connected to the inflow end bearing portion extends in a radial direction of the basket support, the support wire is concave towards a proximal direction, a normal direction of the concave is towards an inside of the basket support, and an extending direction of the free end is towards the outflow end.

Optionally, in the interventional blood pump, the other end of the supporting wire has a buffer portion, and/or the other end of the supporting wire is coated with an anticoagulant drug.

Optionally, in the interventional blood pump, the support portion includes a sliding ring movable along an axial direction of the blood pump main body and a plurality of support wires distributed circumferentially around the sliding ring, one end of each support wire is connected to an inflow end of the basket support, and the other ends of the plurality of support wires are gathered to the sliding ring; when the supporting part is in the expansion state, the middle part of the supporting wire is raised and expanded towards the outer direction of the blood pump main body.

Optionally, the interventional blood pump includes a contact portion, one end of the contact portion is connected to the inflow end bearing portion, and the sliding ring is movably sleeved on the contact portion.

Optionally, in the interventional blood pump, the material of the support wires and/or the material of the basket support comprises a memory metal.

Optionally, the interventional blood pump comprises a contact part, the contact part is connected with the distal end of the basket support; the supporting part is arranged on the contact part and is connected with the net basket support through the contact part.

Optionally, in the interventional blood pump, the support portion includes a plurality of branches, one end of each branch is connected to the contact portion, the other end of each branch is a free end, and when the support portion is in the expansion state, the other end of each branch extends to the outside direction of the blood pump main body.

Optionally, in the interventional blood pump, a material of the support portion and/or a material of the contact portion includes a flexible polymer material.

Optionally, in the interventional blood pump, the material of the support part and/or the material of the contact part further comprises a developing material.

In order to solve the technical problem, the utility model also provides an interventional blood pump system, which comprises the interventional blood pump, a transmission assembly and a driving assembly; the interventional blood pump is connected with the driving assembly through the transmission assembly, and the driving assembly drives the impeller of the interventional blood pump to act through the transmission assembly.

To sum up, in the utility model provides an intervention formula blood pump and intervention formula blood pump system, the intervention formula blood pump includes: a blood pump main body and a support part; the blood pump main body comprises a basket support, an impeller and a basket film; the net basket covering film is coated outside the net basket bracket; the impeller is rotatably arranged in the basket support around the axial direction of the basket support, the supporting part is circumferentially arranged around the basket support and is connected with the basket support, and the supporting part is switched between an expansion state and a contraction state along the radial direction of the basket support; the support part is in the contracted state under the restriction of the conveying device; the support portion is in the expanded state when unconstrained; when the stent is in the expanded state, the radial outer dimension of the support part along the basket stent is larger than that of the basket stent, and at least one part of the support part is positioned outside the basket tectorial membrane.

So dispose, the supporting part is after interveneeing to predetermined position, convertible to the expansion state and realize fixing in the heart room, and the basket support is connected with the supporting part, therefore the basket support is also relatively fixed, has reduced the shake risk of intervention formula blood pump unsettled state in the heart room, has reduced the formation of hemolysis and thrombus. In addition, the basket support is also relatively fixed in the ventricle, so that the risk that the basket support and the impeller fall from the ventricle to the ascending aorta can be avoided, the reliability of the interventional blood pump during operation is improved, and serious faults such as stalling and failure are avoided.

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 inserted into a ventricle;

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

FIG. 4 is an axial cross-sectional schematic view of the interventional blood pump of FIG. 3;

fig. 5 is a schematic view of a support portion according to a first embodiment of the present invention;

fig. 6 is a schematic view of an interventional blood pump according to a second embodiment of the present invention;

fig. 7 is a schematic view of a supporting portion according to a second embodiment of the present invention;

fig. 8 is a schematic view of an interventional blood pump according to a third embodiment of the present invention;

fig. 9 is a schematic view of a supporting portion according to a third embodiment of the present invention;

fig. 10 is a schematic diagram of an interventional blood pump according to a fourth embodiment of the present invention.

In the drawings:

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

100-blood pump body; 110-basket support; 111-inflow end; 112-the outflow end; 113-covering a film on a net basket; 120-an impeller; 121-a paddle; 122-a rotating shaft; 131-an inflow end bearing portion; 1311-inflow end connection; 1312-inflow end bearing; 1312 a-plain bearing; 1312 b-sliding bearing bush; 132-an outflow end bearing portion; 1321-outflow end connector; 1322-an outflow end bearing; 1322 a-plain bearing; 1322 b-plain bearing sleeve; 14-a flow-channel membrane;

200-a support; 210-support wires; 211-a buffer; 220-a slip ring; 230-a branching body; 300-a contact portion;

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, but rather are provided for the purpose of facilitating and distinctly claiming 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", "an" and "the" are generally employed in a sense including "at least one", the terms "at least two" and "two or more" 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 imply that there is a number of technical features being indicated. 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 a manual or hand-operated application scenario, 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 of ordinary skill in the art. Moreover, directional terminology, such as above, below, up, down, 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 current intervention formula blood pump and accomplish the ventricle and intervene the back and do not have effective fixed, cause the problem of destruction and rotor impeller and the easy roll-off of basket to blood cell.

The following description refers to the accompanying drawings.

Referring to fig. 1, an interventional blood pump system is shown comprising: aninterventional blood pump 10, atransmission assembly 20 and adrive assembly 30; theinterventional blood pump 10 is connected with the drivingassembly 30 through thetransmission assembly 20, and the drivingassembly 30 drives the impeller of theinterventional blood pump 10 to act through thetransmission assembly 20. Referring to fig. 4, in an exemplary embodiment, theinterventional blood pump 10 has an impeller 120, thetransmission assembly 20 includes aninner sheath 21 and aflexible shaft 22 rotatably disposed in theinner sheath 21, a distal end of theflexible shaft 22 is connected to the impeller 120, and a proximal end of theflexible shaft 22 is connected to the drivingassembly 30. Therefore, the drivingassembly 30 can drive the impeller 120 to rotate through theflexible shaft 22. Alternatively, in some embodiments, driveassembly 30 may be integrated into a handle. Optionally, the interventional blood pump system may also include acontrol 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, theinterventional blood pump 10 in a compressed state is introduced through the femoral artery via the delivery device, a portion of the distal end of theinterventional blood pump 10 passes through theaortic valve 02 and into theleft ventricle 03 via the descending aorta and the ascendingaorta 01, after the delivery device is removed, theinterventional blood pump 10 is expanded from the compressed state to the deployed state, and the impeller within theinterventional blood pump 10 is actuated (e.g., rotated) by thedistal drive assembly 30 to pump blood from theleft ventricle 03 to the ascendingaorta 01.

Based on the background technology, the inventor finds that the existinginterventional blood pump 10 is mainly fixed by being clamped on theaortic valve 02, the fixing effect is not good, on one hand, the blood pump shakes greatly, blood cells are easy to damage, and on the other hand, the blood pump is easy to slip to the ascendingaorta 01.

Based on the research, the utility model provides an interventionformula blood pump 10 to there is not effective fixed after solving current intervention formula blood pump and accomplishing the ventricle and intervene, causes the problem of destruction and the easy roll-off of rotor wheel and basket to the blood cell. The present invention provides aninterventional blood pump 10, which is described below with reference to several embodiments.

[ EXAMPLES one ]

Referring to fig. 3 to 5, in one embodiment, aninterventional blood pump 10 is provided, which includes: ablood pump body 100 and asupport 200; the blood pumpmain body 100 comprises abasket support 110, an impeller 120 and abasket covering film 113; the impeller 120 is rotatably arranged in thebasket support 110 around the axial direction of thebasket support 110, and thebasket covering film 113 is covered outside thebasket support 110; the supportingportion 200 is circumferentially disposed around thebasket support 110 and connected to thebasket support 110, and the supportingportion 200 is switched between an expanded state and a contracted state in a radial direction of thebasket support 110; thesupport 200 is in the retracted state under the restriction of the conveying means; thesupport 200 is in the expanded state when unconstrained; wherein, in the expanded state, a radial outer dimension of thesupport portion 200 along thebasket support 110 is greater than a radial outer dimension of thebasket support 110, and at least a portion of thesupport portion 200 is located outside thebasket membrane 113. Note that, the radially outer dimension of thesupport portion 200 herein refers to the outer width of thesupport portion 200 in the radial direction. If the outer peripheral profile of thesupport portion 200 is circular, the radially outer dimension thereof is the maximum diameter of the circle. If thesupport portion 200 is composed of a plurality of support members (such as support wires or branches hereinafter), the radially outer dimension thereof is the maximum diameter of the circumscribed circle of the plurality of support members. The definition of the radially outer dimension of thebasket support 110 and the radially outer dimension of theflow passage membrane 14 may be understood hereinafter with reference to the definition of the radially outer dimension of thesupport portion 200 described above.

In an exemplary embodiment, thebasket support 110 is a hollow tube, the material of thebasket support 110 includes a memory metal such as nitinol, and thebasket support 110 is manufactured by cutting the tube by laser engraving, heat setting, sand blasting, and polishing. Thebasket support 110 is in an expanded state when unrestrained, and a cavity formed inside the basket support is used for forming a liquid passage for the impeller 120 to rotate, and preferably, thebasket covering film 113 is covered outside thebasket support 110 through a process such as thermal shrinkage. Optionally, the hollow structure of thebasket support 110 is a diamond shape, on one hand, the hollow structure can ensure the gripping performance and also provide enough support strength to ensure that thebasket support 110 is not flattened to rub against the impeller 120 in the blood pumping process, and on the other hand, the hollow structure also provides enough connection area for thebasket covering membrane 113 to ensure the quality and performance of the membrane surface after membrane covering.

Optionally, the impeller 120 is used to pump blood along the axial direction of thebasket support 110 by rotating. In the example shown in fig. 3 and 4, the impeller 120 rotates to drive blood flow from the left to the right in the figure. Thus, the opposite ends of thebasket support 110 in its axial direction define an inflow end 111 (left end in fig. 3 and 4) and an outflow end 112 (right end in fig. 3 and 4) according to the direction of blood flow.

Further, theinterventional blood pump 10 comprises an inflowend bearing portion 131 axially connected to theinflow end 111 of thebasket support 110, and an outflowend bearing portion 132 axially connected to theoutflow end 112 of thebasket support 110. In one example, the inflowend bearing portion 131 includes aninflow end connector 1311 and aninflow end bearing 1312. Theinflow end connector 1311 may be a plurality of circumferentially distributed rods of the same material as thebasket support 110, and may be welded to theinflow end 111 of thebasket support 110 or may be integrally formed with thebasket support 110 extending distally. Preferably, when theinterventional blood pump 10 is not under the external force of the delivery device and is in the deployed state, the rods of theinflow end connector 1311 enclose to form a truncated cone shape, which gradually shrinks towards the distal end. Theinflow end bearing 1312 includes a slidingbearing 1312a made of a wear-resistant polymer material and a slidingbearing sleeve 1312b made of a metal material, the slidingbearing sleeve 1312b is sleeved outside the slidingbearing 1312a, and the slidingbearing 1312a is internally provided with a bearing hole coaxially arranged with thebasket support 110 for the rotating shaft to rotatably penetrate through. Thesleeve bearing 1312b is connected to theinflow end connector 1311 by welding or bonding, and is configured such that the inflowend bearing portion 131 is coaxially fixed with respect to thebasket support 110. The outflowend bearing part 132 includes anoutflow end connector 1321 and anoutflow end bearing 1322.

The outflow-end connector 1321 has a structure similar to that of the inflow-end connector 1311, and more preferably, a rod member having a double-layered structure, forming a double-layered truncated cone structure, to improve radial stability, so that the impeller 120 is not pressed to be deformed by an external force during the pressing and expanding stages. Theoutflow end bearing 1322 includes aslide bearing 1322a made of an abrasion-resistant polymer material and aslide bearing sleeve 1322b made of a polymer material. Theoutflow end bearing 1322 is similar in construction to theinflow end bearing 1312. The slidingbearing bush 1322b made of high molecular material can be conveniently connected with theinner sheath 21 in thetransmission assembly 20 by bonding, thermal shrinkage or hot melting. Theslide bearing bush 1322b is connected to theoutflow end connector 1321 by heat shrinkage or adhesion, so that the outflowend bearing portion 132 is coaxially fixed with respect to thebasket support 110.

Referring to fig. 4, the impeller 120 includes ablade 121 and arotating shaft 122, theblade 121 is preferably made of an elastic material, and therotating shaft 122 is fixedly connected to theblade 121 along an axial direction of theblade 121. The distal end of therotating shaft 122 rotatably penetrates into theinflow end bearing 1312, and the proximal end of therotating shaft 122 rotatably penetrates into theoutflow end bearing 1322. So configured, the impeller 120 can rotate around the axis of thebasket support 110 at high speed, with the axis of rotation being located at the center of thebasket support 110.

Furthermore, theinterventional blood pump 10 further includes aflow passage membrane 14, a distal end of theflow passage membrane 14 is connected with thebasket covering membrane 113 through a thermal shrinkage or thermal fusion mode, a proximal end of theflow passage membrane 14 is connected with theinner sheath 21, and a passage for pumping blood from the blood pumpmain body 100 is formed inside theflow passage membrane 14, so that the blood is pumped from theleft ventricle 03 to the ascendingaorta 01 through theaortic valve 02.

Referring to fig. 4 and 5, in the first embodiment, one end of the supportingportion 200 is connected to the inflow end of thebasket support 110; when the supportingpart 200 is in the expanded state, at least a portion of the supportingpart 200 is expanded in an outer direction of thebasket support 110. In an exemplary embodiment, thesupport portion 200 includes a plurality ofsupport wires 210 circumferentially distributed around thebasket support 110, one end of eachsupport wire 210 is connected to theinflow end 111 of thebasket support 110, the other end of eachsupport wire 210 is a free end, and when thesupport portion 200 is in the expanded state, the other end of eachsupport wire 210 extends and expands towards the outside of theblood pump body 100 and is located outside thebasket cover 113. One end of thesupport portion 200 may be connected to the inflow end of thebasket support 110, and may be directly connected or indirectly connected.

In the example shown in fig. 4 and 5, thesupport wire 210 is curved arcuately toward the outside while facing in the proximal direction. Preferably, one end of thesupport wire 210 connected with thebasket support 110 extends along the axial direction of the basket support, thesupport wire 210 is concave towards the proximal direction, and the normal direction of the concave is towards the outer part of thebasket support 110. Thesupport wire 210 is curved to be concave in a proximal direction to facilitate loading of thesupport wire 210 into the sheath of the delivery device. It is understood that, in other embodiments, the concave portion of the supportingfilament 210 may be not only disposed in a curved shape, but also disposed in a multi-segment zigzag shape, which is not limited in the present embodiment. Further, theinterventional blood pump 10 may be gradually loaded into the sheath of the delivery device from the proximal end to the distal end. The sheath of the delivery device can restrict the expansion of thesupport portion 200, so that thesupport portion 200 is converted to the contracted state, and thesupport wire 210 is straightened and received in the sheath. It should be noted that the present embodiment does not specifically limit the conveying device, and those skilled in the art can select and use the conveying device according to the prior art.

Optionally, thesupport wires 210 are integrally formed with theinflow end 111 of thebasket support 110, and extend distally from theinflow end 111 of thebasket support 110, for example, by carving and heat-setting; alternatively, thesupport wires 210 are welded to theinflow end 111 of thebasket support 110. The shape design of the supportingwires 210 of the supportingportion 200 can refer to the structure of a human ventricle, so that each supportingwire 210 of the supportingportion 200 is unfolded outwards after the delivery device is withdrawn and is in contact with the ventricle wall at a proper position, and the relative fixation of the ventricle wall and the supportingwires 210 is realized, thereby achieving the purpose of fixing thebasket support 110 in the ventricle. Meanwhile, after the supportingportion 200 is expanded, the radial outer dimension of the supportingportion 200 is larger than the radial outer dimension of thebasket support 110 and theflow passage membrane 14 after being flushed, so that even if the supportingwires 210 of the supportingportion 200 are not completely fixed on the ventricular wall, thebasket support 110 and the impeller 120 therein will not fall out of the ventricle due to blood impact.

Preferably, the other end of the supporting wire 210 (i.e., the end far from the end connected to the basket support 110) has abuffer portion 211, and/or the other end of the supportingwire 210 is coated with an anticoagulant. Thebuffer 211 may be, for example, a blunt tip, a spheroid, a flexible ball, or the like, and thebuffer 211 may be, for example, made of a biocompatible material that is configured to prevent damage to the ventricular wall when in contact with the ventricular wall. The anticoagulant drugs are gradually released into the blood at the stage of the expansion of thebasket support 110 and the operation of the blood pump, so that the risk of generating thrombus can be reduced. Preferably, an anticoagulant may be coated on the outer surface of thebuffer portion 211.

Optionally, the material of the supportingwire 210 includes a memory metal, such as nitinol, which may be the same as or different from the material of thebasket support 110, and this embodiment is not limited thereto.

Optionally, theinterventional blood pump 10 further comprises acontact part 300, and thecontact part 300 is connected with the distal end of theblood pump body 100. In an alternative example, thecontact portion 300 is a flexible tubular member, the proximal end of which is connected to theinflow end connector 1311, such as by heat shrinking or gluing, outside of a number of rods connected to theinflow end connector 1311. Thecontact portion 300 may be made of a polymer material having flexibility such as PEBAX. The distal end of thecontact portion 300 is curled when not restrained by an external force. Thecontact 300 is used to determine the location of the prototype implant during the implantation phase.

In the squeezing and folding stage before operation, the sheath of the conveying device can be pushed from the proximal end to the distal end of theinterventional blood pump 10, so that thesupport wire 210 is bent and flattened, and thecontact part 300 is straightened and collected in the sheath, thereby completing the loading.

The present embodiment provides an interventional blood pump system comprising aninterventional blood pump 10 as described above, and thus has the beneficial effects brought about by aninterventional blood pump 10 as described above. Other component structures of interventional blood pump systems are referred to in the art and will not be further developed herein.

In conclusion, after the supportingportion 200 is inserted into the predetermined portion, the supporting portion can be switched to the expanded state to be fixed in the ventricle, and thebasket support 110 is connected with the supportingportion 200, so that thebasket support 110 is relatively fixed, the shaking risk of the insertiontype blood pump 10 in the suspended state in the ventricle is reduced, and the hemolysis and the formation of thrombus are reduced. In addition, since thebasket support 110 is also relatively fixed in the ventricle, the risk that thebasket support 110 and the impeller 120 fall from the ventricle to the ascendingaorta 01 can be avoided, the reliability of theinterventional blood pump 10 during operation is improved, and serious faults such as stalling and failure are avoided.

[ example two ]

Referring to fig. 6 and 7, the interventional blood pump and interventional blood pump system according to the second embodiment of the present invention are substantially the same as the interventional blood pump and interventional blood pump system according to the first embodiment, and the description of the same parts is omitted, and only different points will be described below.

In the second embodiment, the structure of the supportingportion 200 and the connection manner with thebasket support 110 are different from the first embodiment. Specifically, in the second embodiment, the supportingportion 200 includes a plurality of supportingwires 210 circumferentially distributed around the inflowend bearing portion 131; one end of thesupport wire 210 is connected to the inflowend bearing portion 131, the other end of thesupport wire 210 is a free end, and when thesupport portion 200 is in the expanded state, the other end of thesupport wire 210 extends and expands in the direction outside the blood pumpmain body 100.

In one example, one end of thesupport wire 210 is connected to the slidingbearing sleeve 1312b of the inflowend bearing portion 131 by welding, which can ensure the connection strength between the two. In the example shown in fig. 6 and 7, the other end of thesupport wire 210 is curved outwardly while being curved in an arc shape toward the proximal direction.

Preferably, one end of thesupport wire 210 connected to the inflowend bearing portion 131 extends along a radial direction of thebasket support 110, thesupport wire 210 is concave towards a proximal direction, a normal direction of the concave is towards an inner portion of thebasket support 110, and an extending direction of the free end is towards theoutflow end 112. Thesupport wire 210 is curved to be concave in the proximal direction to facilitate loading of thesupport wire 210 into the sheath of the delivery device. In addition, the shape of the supportingwires 210, which is concave and faces the inside of thebasket support 110 in the normal direction, combines the elasticity of the supportingwires 210, so that the interventional blood pump can be released first and then enter the ventricle, and then the supportingwires 210 can expand to play a role in fixing after entering the ventricle.

Further, the proximal end of thetubular contact portion 300 is sleeved outside thesupport wire 210 and the inflowend bearing portion 131, and is connected by heat shrinkage or bonding. With such a configuration, the supportingportion 200 is an independent structure, which is convenient for processing, and does not need to be formed with thebasket support 110, thereby reducing the process difficulty and the processing cost. In the pre-operative crimping stage, a section of the inner sheath is sleeved in from the distal end of thecontact portion 300 to the free end beyond thesupport portion 200, thesupport wire 210 is crimped therein, the outer sheath is pushed from the proximal end of theinterventional blood pump 10 to the distal end, and after at least the position beyond thesupport portion 200, the inner sheath sleeved on thecontact portion 300 and thesupport portion 200 is removed, so as to realize the integral crimping of theinterventional blood pump 10. It will be appreciated that during the withdrawal phase, the supportingfilaments 210 may be folded back distally by pushing them distally from the proximal end of theinterventional blood pump 10 directly with the sheath so that the supportingfilaments 210 are received into the sheath.

In another example, thesupport wire 210 may not be directly connected to the inflowend bearing portion 131, but indirectly connected to the inflowend bearing portion 131 through thecontact portion 300. Specifically, the supportingwire 210 may be connected to thecontact portion 300 by heat shrinking or bonding, for example, bonding to the inner wall of the tubular proximal end of thecontact portion 300, and then thecontact portion 300 is sleeved on the inflowend bearing portion 131 and connected by heat shrinking or bonding.

[ EXAMPLE III ]

Referring to fig. 8 and 9, an interventional blood pump and an interventional blood pump system according to a third embodiment of the present invention are substantially the same as the interventional blood pump and the interventional blood pump system according to the first embodiment, and the description of the same parts is omitted, and only different points will be described below.

In the third embodiment, the structure of the supportingportion 200 is different from the first embodiment. Specifically, in the third embodiment, thesupport portion 200 includes a slidingring 220 movable along the axial direction of the blood pumpmain body 100 and a plurality ofsupport wires 210 circumferentially distributed around the slidingring 220, one end of eachsupport wire 210 is connected to theinflow end 111 of thebasket support 110, and the other ends of the plurality ofsupport wires 210 are collected to the slidingring 220; when thesupport portion 200 is in the expanded state, the middle portion of thesupport wire 210 is raised and expanded toward the outside of the blood pumpmain body 100.

Thesupport wires 210 may be formed of a material that is welded to theinflow end 111 of thebasket support 110 after being formed separately, or may be formed integrally with theinflow end 111 of thebasket support 110 and extended distally from thebasket support 110, similar to the forming process of the embodiment. Unlike the first embodiment, when the supportingportion 200 is in the expanded state, the other ends of the supportingwires 210 are not expanded outward but are connected to the slidingring 220 in a converging manner. And when the supportingpart 200 is not restrained by the conveying device, the middle part of the supportingwire 210 is raised, so that the supportingpart 200 forms an outward bulge. During the pre-operative crimping stage, the sheath is used to push distally from the proximal end of theinterventional blood pump 10, flattening the ridges of thesupport wire 210, as will be appreciated, as the slidingring 220 moves distally.

Compared with the supportingparts 200 of the first and second embodiments, the structure of the supportingpart 200 of the third embodiment is changed from point contact to surface contact, so that the possibility of puncture injury to the ventricular wall is reduced. And the process of the device entering the conveying device is smoother.

Further, one end of thecontact portion 300 is connected to the inflowend bearing portion 131, and the slidingring 220 is movably sleeved on thecontact portion 300. Preferably, the inner diameter of the slidingring 220 is adapted to the outer diameter of thecontact portion 300, and during the squeezing and folding stage, the slidingring 220 moves distally along thecontact portion 300 when the sheath flattens the ridges of thesupport wire 210.

Alternatively, the material of the slidingring 220 includes a developing material, and when thesupport portion 200 is in the contracted state under the restriction of the conveying device, the slidingring 220 is located flush with a predetermined position (e.g., a head end) of thecontact portion 300. So configured, during implantation, the operator can clearly determine the location of the prototype implantation by observing the location of theslip ring 220. Thecontact portion 300 can be processed without using a specific developing material, thereby reducing the cost.

[ EXAMPLE IV ]

Referring to fig. 10, an interventional blood pump and an interventional blood pump system according to a fourth embodiment of the present invention are substantially the same as the interventional blood pump and the interventional blood pump system according to the first embodiment, and the description of the same parts is omitted, and only different points are described below.

In the fourth embodiment, the structure of thecontact portion 300, the structure of thesupport portion 200 and the connection manner of thebasket support 110 are different from those of the first embodiment. Specifically, in the fourth embodiment, thecontact portion 300 is a straight tube, and the distal end thereof is connected to thesupport portion 200 without being curled. Thesupport portion 200 is disposed on thecontact portion 300, and is connected to thebasket support 110 through thecontact portion 300.

In an example, thesupport portion 200 includes a plurality ofbranches 230, one end of eachbranch 230 is connected to thecontact portion 300, the other end of eachbranch 230 is a free end, and when thesupport portion 230 is in the expanded state, the other end of eachbranch 230 extends toward the outside of the blood pumpmain body 100. Preferably, thebranch body 230 is curved arcuately toward the outside and also toward the proximal direction. Preferably, the arc of thebranch 230 is concave in the proximal direction to facilitate thebranch 230 to be loaded into the sheath of the delivery device.

Optionally, the material of the supportingportion 200 and/or the material of thecontact portion 300 includes a flexible polymer material. In one embodiment, thebranches 230 are made of a polymer material such as PEBAX, which is softer than the material of thebasket support 110, so that the supportingportion 200 formed by thebranches 230 is softer than the supportingportion 200 made of the memory metal in the previous embodiment, thereby reducing the risk of puncture injury to the inner wall of the ventricle.

Further, the material of the supportingportion 200 and/or the material of thecontact portion 300 may further include a developing material, for example, the supportingportion 200 and thecontact portion 300 may be mixed with a polymer material and processed to be developed in a whole body, so as to facilitate the doctor to monitor the position of theinterventional blood pump 10 in the ventricle.

To sum up, in the utility model provides an intervention formula blood pump and intervention formula blood pump system, the intervention formula blood pump includes: a blood pump main body and a support part; the blood pump main body comprises a basket support, an impeller and a basket covering film; the impeller is rotatably arranged in the basket support in the axial direction of the basket support, and the basket film covers the basket support; the supporting part is arranged around the circumference of the net basket support and is connected with the net basket support, and the supporting part is switched between an expansion state and a contraction state along the radial direction of the net basket support; the support part is in the contracted state under the limitation of the conveying device; the support portion is in the expanded state when unconstrained; when the stent is in the expanded state, the radial outer dimension of the support part along the basket stent is larger than that of the basket stent, and at least one part of the support part is positioned outside the basket tectorial membrane. So dispose, the supporting part is after interveneeing to predetermined position, convertible to the expansion state and realize fixing in the heart room, and the basket support is connected with the supporting part, therefore the basket support is also relatively fixed, has reduced the shake risk of intervention formula blood pump unsettled state in the heart room, has reduced the formation of hemolysis and thrombus. In addition, the basket support is also relatively fixed in the ventricle, so that the risk that the basket support and the impeller fall from the ventricle to the ascending aorta can be avoided, the reliability of the interventional blood pump during operation is improved, and serious faults such as stalling and failure are avoided.

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

Claims (14)

1. An interventional blood pump, comprising: a blood pump main body and a support part;

the blood pump main body comprises a basket support, an impeller and a basket film; the impeller is rotatably arranged in the basket support around the axial direction of the basket support, and the basket covering film is coated outside the basket support; the supporting part is arranged around the circumferential direction of the basket support and is connected with the basket support, and the supporting part is switched between an expansion state and a contraction state along the radial direction of the basket support;

the support part is in the contracted state under the limitation of the conveying device; the support portion is in the expanded state when unconstrained;

when the stent is in the expanded state, the radial outer dimension of the supporting part along the basket stent is larger than that of the basket stent, and at least one part of the supporting part is positioned outside the basket covering film.

2. The interventional blood pump of claim 1, wherein the basket support has opposite inflow and outflow ends in its axial direction, one end of the support being connected to the inflow end of the basket support; when the supporting part is in the expansion state, at least one part of the supporting part expands towards the outer direction of the basket support and is positioned outside the basket covering film.

3. The interventional blood pump of claim 2, wherein the support portion comprises a plurality of support wires circumferentially distributed around the basket support, one end of the support wires is connected to the inflow end of the basket support, the other end of the support wires is a free end, and the free end extends and dilates in a direction outside the blood pump body when the support portion is in the dilated state.

4. The interventional blood pump of claim 3, wherein the ends of the support wires connected to the basket support extend in an axial direction of the basket support, the support wires are concave in a proximal direction, and a normal to the concave is directed outwardly of the basket support.

5. The interventional blood pump of claim 3, wherein the support wires are integrally formed with the inflow end of the basket support; or the supporting wires are welded with the inflow end of the net basket support.

6. The interventional blood pump of claim 2, comprising an inflow end bearing axially connected to an inflow end of the basket support, the support comprising a plurality of support wires circumferentially distributed about the inflow end bearing; one end of the supporting wire is connected with the inflow end bearing part, the other end of the supporting wire is a free end, and when the supporting part is in the expansion state, the free end extends and expands towards the outer direction of the blood pump main body.

7. The interventional blood pump of claim 6, comprising a contact portion having one end connected to the inflow end bearing portion, the support wire being connected to the inflow end bearing portion through the contact portion.

8. The interventional blood pump of claim 6, wherein the ends of the support wires connected to the inflow end bearing extend in a radial direction of the basket support, the support wires are concave in a proximal direction, the normal to the concave is toward the inside of the basket support, and the free ends extend toward the outflow end.

9. The interventional blood pump of claim 3 or 6, wherein the other end of the support wire has a buffer and/or the other end of the support wire is coated with an anticoagulant drug.

10. The interventional blood pump of claim 2, wherein the support portion comprises a sliding ring movable in an axial direction of the blood pump body and a plurality of support wires circumferentially distributed around the sliding ring, one end of the support wires is connected with the inflow end of the basket support, and the other end of the plurality of support wires is gathered to the sliding ring; when the supporting part is in the expansion state, the middle part of the supporting wire is raised and expands towards the external direction of the blood pump main body.

11. The interventional blood pump of claim 10, comprising a contact portion and an inflow end bearing portion axially connected to an inflow end of the basket support, wherein one end of the contact portion is connected to the inflow end bearing portion, and wherein the sliding ring is movably disposed around the contact portion.

12. The interventional blood pump of claim 1, comprising a contact connected to a distal end of the basket support; the supporting part is arranged on the contact part and is connected with the basket support through the contact part.

13. The interventional blood pump of claim 12, wherein the support portion comprises a plurality of branches, one end of the branches is connected to the contact portion, the other end of the branches is a free end, and the other end of the branches extends in an outside direction of the blood pump body when the support portion is in the distended state.

14. An interventional blood pump system comprising an interventional blood pump according to any one of claims 1 to 13, further comprising a transmission assembly and a drive assembly; the interventional blood pump is connected with the driving assembly through the transmission assembly, and the driving assembly drives the impeller of the interventional blood pump to act through the transmission assembly.

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