CN114225214A

CN114225214A - Catheter pump housing structure and catheter pump device

Info

Publication number: CN114225214A
Application number: CN202210028923.2A
Authority: CN
Inventors: 唐智荣; 赵贤忠; 薛志宽
Original assignee: Fengkaili Medical Instrument Shanghai Co ltd
Current assignee: Fengkaili Medical Instrument Shanghai Co ltd
Priority date: 2022-01-11
Filing date: 2022-01-11
Publication date: 2022-03-25
Also published as: WO2023134695A1

Abstract

The embodiment of the application discloses catheter pump shell structure and catheter pump device, wherein, catheter pump shell structure includes: a supporting seat; the transmission assembly comprises a rotating shaft arranged on the supporting seat and an impeller suspended at the far end of the rotating shaft; the pump shell comprises a pressure relief part and a pressure bearing part, wherein the pressure relief part is formed by encircling a plurality of elastic bent strips, the pressure bearing part is butted with the pressure relief part and is integrally formed, the near end of the pressure bearing part is connected with the supporting seat, the pressure bearing part is encircled by an elastic net structure to encircle the impeller, and the far end of the pressure relief part and the near end of the pressure bearing part are respectively provided with a blood suction inlet and a blood outflow port; and the elastic covering layer is covered on the net port of the pressure bearing part so as to seal and form a first cavity communicated with the blood suction port and the blood outflow port. This catheter pump casing structural design is ingenious, can make the clearance of predetermineeing between pump casing and the impeller ensure at controllable within range, avoids the emergence of mechanical hemolysis and mechanical failure, simultaneously, can discharge the insoluble particle and the heat that the catheter pump device produced at the work operation in-process.

Description

Catheter pump housing structure and catheter pump device

Technical Field

The embodiment of the application belongs to the technical field of heart auxiliary devices, and particularly relates to a catheter pump shell structure and a catheter pump device.

Background

Implantable catheter pumps are increasingly used in the treatment of patients with severe heart problems. A catheter pump is a heart assist device that can pump blood from the heart into a blood vessel to provide hemodynamic support. When the catheter pump is deployed on the left side of the heart, the catheter pump pumps blood from the left ventricle of the heart into the aorta; when the catheter pump is deployed on the right side of the heart, the catheter pump pumps blood from the inferior vena cava, bypassing the right atrium and right ventricle, and pumping blood into the pulmonary artery.

The existing catheter pump generally comprises a pump shell, an impeller, a catheter or a sheath tube and a flexible driving shaft, wherein the impeller, the catheter or the sheath tube are arranged in the pump shell, the flexible driving shaft is arranged in the catheter or the sheath tube and is connected with the impeller, and the near end of the flexible driving shaft is connected with a driving motor so as to drive the impeller to rotate through the driving motor to realize a blood pumping function. In the catheter pumps of the above type, the distal end and the proximal end of the impeller are generally mounted in the pump housing through bearing elements, the bearing elements play a role in supporting and assisting in rotation, and then, in the process that the drive motor drives the impeller to rotate through the flexible drive shaft, insoluble particles generated by rotation of the bearing elements at the distal end of the impeller cannot be discharged and recovered, so that a large amount of insoluble particles enter a human body, and harm is caused to the human body.

In addition, in the existing catheter pump, in order to obtain larger pump blood flow, both the pump shell and the impeller can be compressed and expanded, before the pump shell and the impeller enter a human body, the pump shell and the impeller are simultaneously compressed into a compressed state by external force, and enter a specified position of the human body in the compressed state through percutaneous surgery, and then the pump shell and the impeller are restored into the expanded state. In the process of intervention into a human body and operation in the human body, the outer wall of the pump shell is very easy to contact and collide with the wall of the human body vessel, so that the pump shell generates radial and axial deformation, a preset gap between the inner wall of the pump shell and the outer wall of the impeller is changed, even the outer wall of the impeller contacts with the deformed inner wall of the pump shell, and the impeller is scratched, rubbed, stuck and other bad conditions can occur, so that the human body has bad consequences such as mechanical hemolysis, thrombus and the like, and more serious patients can cause the operation failure of the whole catheter pump, thereby bringing great inconvenience to the operation.

Disclosure of Invention

The embodiment of the application aims at solving at least one technical problem existing in the prior art. Therefore, the embodiment of the application provides a catheter pump shell structure and a catheter pump device, the structure is ingenious, a preset gap between the pump shell and the impeller can be ensured within a controllable range, the structural stability of the pump shell and the impeller in the process of intervening in a human body and running in the human body is ensured, the occurrence of mechanical hemolysis and mechanical faults is avoided, and meanwhile, insoluble particles and heat generated in the working and running process of the catheter pump device can be discharged.

In a first aspect, an embodiment of the present application provides a catheter pump housing structure, including:

a supporting seat;

the transmission assembly comprises a rotating shaft arranged on the supporting seat and an impeller suspended at the far end of the rotating shaft;

the pump shell comprises a pressure relief part and a pressure bearing part, wherein the pressure relief part is formed by encircling a plurality of elastic bent strips, the pressure bearing part is butted with the pressure relief part and is integrally formed, the near end of the pressure bearing part is connected with the supporting seat, the pressure bearing part is encircled by an elastic net structure so as to encircle the impeller, and the far end of the pressure relief part and the near end of the pressure bearing part are respectively provided with a blood suction inlet and a blood outflow port;

the elastic covering layer covers the net port of the pressure bearing part so as to form a first cavity communicated with the blood suction port and the blood outflow port in a sealing way;

wherein the pump casing and the impeller are each configured as a structure that is self-expandable after compression.

According to the structure of the pump housing of the catheter of the first aspect of the application, at least the following advantages are achieved:

the utility model provides a catheter pump shell structure, through setting the pump case into integrated into one piece's pressure relief portion and pressure-bearing portion, intervene the corresponding ventricle of human body or the in-process in the blood vessel through percutaneous operation when whole catheter pump shell structure, if the distal end of pump case and vascular wall contact collision, the pressure relief portion that is in the pump case distal end can preferentially receive the exogenic action of vascular wall, because pressure relief portion is enclosed by many elastic bending strip, elastic bending strip that constitutes pressure relief portion receives this exogenic action and appears elastic deformation promptly, make whole pressure relief portion realize buffering and the release to this external force, avoid this external force to transmit to the pressure-bearing portion and lead to the pressure-bearing portion to appear by a wide margin deformation, prevent that the clearance between impeller and the pressure-bearing portion that is in the pressure-bearing portion inside from reducing, reduce mechanical hemolysis and the impeller because of contacting with the pressure-bearing portion inner wall and block the probability on the pressure-bearing portion. In addition, because the pressure-bearing part that docks with the release portion is enclosed by elasticity network structure, the pressure-bearing part has certain hardness, can bear great radial and axial bending moment of torsion, when whole catheter pump shell structure is when human ventricle or blood vessel work operation, if the outer wall of pressure-bearing part collides with human ventricle or vascular wall contact, the pressure-bearing part can not make pressure-bearing part produce deformation basically because of its stronger intensity and anti bending capacity, the effort of ventricular wall or vascular wall to guarantee that the clearance between pressure-bearing part and the impeller maintains in predetermined within range, further reduce the probability that mechanical hemolysis takes place, simultaneously, also guaranteed the stability that the impeller does the rotation action. The utility model provides a catheter pump shell structure, through setting the pump case into integrated into one piece's pressure relief portion and pressure-bearing portion, with the help of the structural feature of pressure relief portion and pressure-bearing portion, whole pump case and impeller can expand by oneself after the compression have not only been kept, make the catheter pump device can acquire bigger flow, and can ensure that the clearance of predetermineeing between pump case and the impeller ensures at controllable within range, satisfy the casing support requirement of hanging the impeller of locating the rotation axis distal end, and simultaneously, guarantee that pump case and impeller are interveneing the human body and at human in-process structural stability, avoid the emergence of mechanical hemolysis and mechanical fault.

According to some embodiments of the present application, the elastic bending strips are formed by connecting a plurality of sections of connecting sections in an "S" shape or a "W" shape in sequence, and two adjacent elastic bending strips do not intersect.

According to some embodiments of the application, the mesh opening is diamond shaped.

According to some embodiments of this application, hold the splenium include with the radial pressure portion that the release portion docked and connect in the axial pressure portion that supports the seat, radial pressure portion is formed the cage form by many first elasticity muscle envelopes, axial pressure portion by many second elasticity muscle envelopes form the cage form and with radial pressure portion docks, the thickness of second elasticity muscle is greater than the thickness of first elasticity muscle.

According to some embodiments of the present application, the impeller includes a hub coaxially connected to the rotating shaft and a plurality of elastic blades circumferentially provided to the hub.

According to some embodiments of the application, the blood sucking device further comprises a pigtail connected to the far end of the pressure relief part and a guide wire used for penetrating the pigtail, wherein the far end of the guide wire can extend out of the far end of the pigtail, and the near end of the guide wire can extend out of the blood sucking hole.

According to some embodiments of the present application, further comprising a delivery tube for sleeving the support seat and the pump casing and compressing the pump casing and the impeller into a contracted state.

In a second aspect, embodiments of the present application provide a catheter pump device, including:

the above-described catheter pump housing construction; the supporting seat is a supporting sleeve, and a perfusion cavity is arranged at the far end of the supporting sleeve;

the transmission assembly further comprises a bearing sleeve and a transmission bearing which are arranged in the support sleeve, the rotating shaft is mounted in the bearing sleeve through the transmission bearing, an outer-layer flow channel communicated with the perfusion cavity is formed in the outer wall of the bearing sleeve, and an inner-layer flow channel communicated with the perfusion cavity is formed in a gap between an inner ring and an outer ring of the transmission bearing;

the far end of the multi-cavity sheath tube is connected with the near end of the support sleeve, and an inflow channel communicated with the outer layer runner and an outflow channel communicated with the inner layer runner are arranged on the multi-cavity sheath tube.

The catheter pump device according to the embodiment of the second aspect of the application has at least the following advantages:

the catheter pump device of the embodiment of the application arranges the bearing sleeve in the supporting sleeve and arranges the outer layer flow passage on the outer wall of the bearing sleeve, meanwhile, by arranging the multi-cavity sheath tube with the inflow channel and the outflow channel, when the whole catheter pump device is operated, an operating doctor can pour liquid into the inflow channel, make liquid flow into in the filling cavity that is in support cover distal end behind the inflow passageway, outer runner, benefit from the inlayer runner that the clearance between inner circle and the outer lane of drive bearing formed and fill the chamber and the outflow passageway intercommunication in the multi-chamber sheath respectively, the liquid that fills the intracavity can continue to flow through inlayer runner and outflow passageway, flow out from the export of outflow passageway at last, liquid passes through foretell flow pattern, the insoluble particle who produces when can effectually doing synchronous high-speed rotary motion with rotation axis and drive bearing discharges, avoid insoluble particle to get into in the human blood and produce the danger to the human body. Meanwhile, in the circulating flow process of the liquid along the flow path, the liquid can be continuously subjected to heat exchange with the rotating shaft and the transmission bearing, so that heat generated by the rotating shaft and the transmission bearing in the high-speed rotating process is timely discharged, the rotating shaft and the transmission bearing are prevented from being structurally damaged due to overheating, the rotating operation function of the impeller arranged at the far end of the rotating shaft in a suspending mode is guaranteed, and the normal and stable blood pumping function of the whole catheter pump device is further guaranteed.

According to some embodiments of the present application, the outer layer flow passage, the inflow channel and the outflow channel are all annular.

According to some embodiments of the application, the installation cavity has still been seted up at the middle part of multi-chamber sheath pipe, the driving piece is connected through the transmission hank silk to the near-end of rotation axis, the transmission hank silk is worn to locate in the installation cavity.

According to some embodiments of the application, the blood pressure-bearing part further comprises a flexible tube, the flexible tube is arranged on the outer wall of the pressure-bearing part and covers the blood outflow port, at least one outflow window is arranged on the outer wall of the flexible tube, a cavity of the flexible tube forms a circulation cavity communicated with the blood outflow port and the outflow window, and the flexible tube is configured into an elastic hose structure with an expandable and contractible outer wall.

According to some embodiments of the application, the flexible pipe is including the sharp interface section, fillet section, circular arc changeover portion, middle straightway and the derivation section of level and smooth connection in proper order, the circular arc changeover portion with middle straightway is tangent, the outflow window sets up in derive the section, the distal end of flexible pipe passes through the outer wall of bearing portion is connected to sharp interface section, with the cladding the blood flow export, the near-end of flexible pipe passes through derive the section and connect the outer wall of multi-chamber sheath pipe, the internal diameter of fillet section with the internal diameter of fillet changeover portion all increases along distal end to near-end gradually, the internal diameter of fillet section is greater than the internal diameter of sharp interface section, the internal diameter of fillet section is greater than the internal diameter of fillet section.

According to some embodiments of the application, the shape of the flexible tube is configured to satisfy the following condition:

the diameter of the straight line interface section is D1;

the diameter of the middle straight line segment is D2;

the axial length of the pump casing which allows radial expansion deformation is L1;

the sum of the axial lengths of the straight line interface section, the fillet section and the circular arc transition section is L2;

an included angle between a connecting line between the middle point of the main boundary of the straight line interface section and the middle point of the main boundary of the middle straight line section and the central axis of the pump shell is alpha;

the radius of the circle where the fillet section is located is R1, and the radius of the circle where the circular arc transition section is located is R2;

wherein the content of the first and second substances,

the value range of the alpha is 0-10 degrees;

the value range of the R1 is 0-L1/tan (alpha/2);

the value range of R2 is 0 to (D2-D1)/(2 tan (alpha/2) sin (alpha));

the value of L2 is (D2-D1)/(2 star (α)).

α is 5 °;

the R1 is L1/tan (alpha/2);

the R2 ═ (D2-D1)/(2 × (α/2) × sin (α)).

Drawings

In order to more clearly illustrate the technical solutions of the embodiments of the present application, the drawings needed to be used in the embodiments of the present application will be briefly described below, and it is obvious that the drawings described below are only some embodiments of the present application, and it is obvious for those skilled in the art to obtain other drawings based on these drawings without creative efforts.

FIG. 1 is a schematic structural view of a catheter pump housing structure and catheter pump device according to some embodiments of the present application;

FIG. 2 is a schematic structural view of a pump casing according to some embodiments of the present application;

FIG. 3 is another schematic illustration of a pump casing according to some embodiments of the present application;

FIG. 4 is a partial schematic structural view of a catheter pump housing structure according to some embodiments of the present application;

FIG. 5 is an enlarged view of a portion of FIG. 4 at A;

FIG. 6 is another structural schematic of the catheter pump housing structure and catheter pump device of some embodiments of the present application;

FIG. 7 is a schematic structural view of a catheter pump device according to some embodiments of the present application;

FIG. 8 is a schematic structural view of a catheter pump device according to some embodiments of the present application after insertion into a patient;

FIG. 9 is another schematic structural view of a catheter pump device according to some embodiments of the present application;

FIG. 10 is a graph of a blood streamline simulation within a flexible tube according to some embodiments of the present application;

FIG. 11 is another simulated view of a blood flow line within a flexible tube according to some embodiments of the present application.

In the drawings: a support base 100; a perfusion chamber 110; a transmission assembly 200; a rotating shaft 210; an impeller 220; a hub 221; a flexible blade 222; a drive bearing 230; the inner layer flow path 231; a bearing housing 240; an outer layer flow channel 241; a drive strand 250; a pump housing 300; a pressure relief portion 310; an elastic bending strip 311; a pressure receiving portion 320; a network port 321; a radial bearing portion 322; an axial bearing portion 323; a first cavity 330; a blood suction port 340; a blood flow outlet 350; an elastic cover layer 400; a multi-lumen sheath 500; an inflow channel 510; an outflow channel 520; a flexible tube 600; an egress window 610; a flow-through chamber 620; a pigtail 700; a guidewire 800; delivery tube 900; a blood vessel 10; a heart chamber 20; a heart valve 30.

Detailed Description

Features and exemplary embodiments of various aspects of the present application will be described in detail below. In the following detailed description, numerous specific details are set forth in order to provide a thorough understanding of the present application. It will be apparent, however, to one skilled in the art that the embodiments of the present application may be practiced without some of these specific details. The following description of the embodiments is merely intended to provide a better understanding of the present application by illustrating examples thereof.

In the description of the present application, it should be understood that the orientation or positional relationship referred to in the description of the orientation, such as the upper, lower, front, rear, left, right, etc., is based on the orientation or positional relationship shown in the drawings, and is only for convenience of describing the embodiments of the present application and simplifying the description, but does not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and thus, should not be construed as limiting the embodiments of the present application.

In the description of the embodiments of the present application, the meaning of a plurality of means is one or more, the meaning of a plurality of means is two or more, and more than, less than, more than, etc. are understood as excluding the present number, and more than, less than, etc. are understood as including the present number. If the first and second are described for the purpose of distinguishing technical features, they are not to be understood as indicating or implying relative importance or implicitly indicating the number of technical features indicated or implicitly indicating the precedence of the technical features indicated.

In the description of the embodiments of the present application, unless otherwise explicitly limited, terms such as setting, installing, connecting and the like should be understood in a broad sense, and those skilled in the art can reasonably determine the specific meanings of the terms in the present application in combination with the specific contents of the technical solutions.

It should be noted that the embodiments and features of the embodiments in the present application may be combined with each other without conflict. The embodiments will be described in detail below with reference to the accompanying drawings.

In addition, it should be noted that, in the description of the embodiments of the present application, "in vivo" means in a tissue organ of a patient and "in vitro" means outside the tissue organ of the patient, unless otherwise specifically defined. Meanwhile, in the embodiments of the present application, "distal" refers to a direction away from the physician, and "proximal" refers to a direction closer to the physician.

It should be noted that in a normal human heart, during a beating cycle, when the heart contracts, the aortic valve located between the left ventricle and the aorta opens, and blood in the left ventricle flows into the aorta under systolic pressure, so that the aorta is transfused into the tissue and organs of the human body; at the same time, the pulmonary valve between the right ventricle and the pulmonary artery is opened, and the blood in the right ventricle flows into the pulmonary artery, so that the pulmonary artery transfuses blood into the pulmonary vein and branch organs of the human body. When the heart relaxes, the aortic valve is closed, and the blood in the aorta is prevented from flowing back to the left ventricle; at the same time, the pulmonary valve closes, preventing blood in the pulmonary artery from flowing back into the right ventricle. The aorta of the human body is sequentially divided into ascending aorta, aortic arch and descending aorta along the blood flowing direction, and the ascending aorta, the aortic arch and the descending aorta are sequentially communicated.

The causes of coronary heart disease or other cardiovascular diseases mainly show that blood cannot flow to cardiac muscle or brain in time, resulting in hypoxia necrosis of organ tissues. The utility model provides a catheter pump shell structure and catheter pump device can provide stable blood circulation for patient's heart and support, alleviate heart burden when improving coronary artery and distal organ perfusion volume, are favorable to patient's sign stability and postoperative rehabilitation in the art.

Referring to fig. 1, 2, 3 and 4, the embodiment of the present application discloses a catheter pump housing structure including a support base 100, a transmission assembly 200, a pump housing 300 and an elastic cover 400.

Wherein the pump casing 300 and the impeller 220 are each configured as a self-expandable structure after compression.

The transmission assembly 200 includes a rotating shaft 210 disposed on the support base 100 and an impeller 220 suspended at a distal end of the rotating shaft 210.

The pump casing 300 includes a pressure relief portion 310 defined by a plurality of elastic bending strips 311 and a pressure receiving portion 320 integrally connected to the pressure relief portion 310, wherein a proximal end of the pressure receiving portion 320 is connected to the support base 100, the pressure receiving portion 320 is defined by an elastic net structure to surround the impeller 220, and a distal end of the pressure relief portion 310 and a proximal end of the pressure receiving portion 320 are respectively provided with a blood suction port 340 and a blood outflow port 350.

The elastic covering layer 400 covers the mesh opening 321 of the pressure receiving portion 320 to form a first chamber 330 in communication with the blood suction opening 340 and the blood outflow opening 350 in a sealed manner. That is, the first cavity 330 is enclosed by the pressure-bearing portion 320 covered with the elastic covering layer 400.

It should be noted that, the supporting seat 100 is preferably a tubular shape with two substantially sealed ends, and the supporting seat 100 is a rigid structural body, which can be made of stainless steel, PEEK, POM, etc. with mechanical strength and high density, so as to ensure that the supporting seat 100 does not deform unacceptably under certain pressure and bending force, so as to bear and support the bearing portion 320 of the pump casing 300, and further provide a mounting carrier for the whole pump casing 300.

The proximal end of the rotating shaft 210 may be rotatably installed in the supporting base 100 through a rotating member such as a bearing, and the distal end of the rotating shaft 210 extends out of the supporting base 100 to facilitate the installation of the impeller 220, so that the pressure-bearing portion 320 of the pump housing 300 surrounds the impeller 220 to suspend the impeller 220 in the pump housing 300. It should be noted that the proximal end of the rotating shaft 210 can also be directly connected to the rotating driving member mounted on the supporting base 100; of course, the proximal end of the rotating shaft 210 may also be indirectly connected to a rotating driving member located outside the body through a transmission twisted wire, and the rotating driving member may be a motor, or the like, so that the rotating driving member directly or indirectly drives the rotating shaft 210 to rotate, and further drives the impeller 220 suspended in the pump housing 300 to rotate, thereby achieving the function of pumping blood.

Referring again to fig. 2 and 3, in the pump casing 300 of the embodiment of the present application, the plurality of elastic bending strips 311 constituting the pressure relief portion 310 and the elastic mesh structure constituting the pressure bearing portion 320 are made of an elastic memory material. In addition, the impeller 220 and the elastic covering layer 400 are also made of elastic memory material, preferably, memory plastic with higher strength or memory alloy, and are not limited in particular. With the above arrangement, the entire pump casing 300 and the impeller 220 within the pump casing 300 can be compressed into a compressed state, and at the same time, can be expanded into an initial state after being compressed.

It should be noted that, in the description of the present application, the forced compression of the pump casing 300 and the impeller 220 in the pump casing 300 means that a physician compresses the outer wall of the pump casing 300 through a delivery tube or other compression device, so that the pump casing 300 and the impeller 220 in the pump casing 300 are in the compression device, at this time, the pump casing 300 and the impeller 220 in the pump casing 300 are in a contracted state under the action of forced external force, and when the corresponding compression device is withdrawn and separated from the pump casing 300, the pump casing 300 and the impeller 220 in the pump casing 300 are expanded and restored to an initial maximum volume state under the action of self elastic force.

The pump casing 300 is subjected to the non-forced external force action, which means that the pressure relief portion 310 and the pressure bearing portion 320 of the formed pump casing 300 are subjected to the extrusion force of the blood vessel wall when the whole catheter pump casing structure is in contact with the blood vessel wall in the patient body and is in operation in the patient body. It will be appreciated that the external non-forced force to which the pump casing 300 is subjected may be much less than the artificially applied force to which it is subjected, and may be of insufficient magnitude to compress the pump casing 300 and the impeller 220 within the pump casing 300 into a contracted state as compared to the artificially applied force, and the external non-forced force may only cause radial or axial bending deformation of the pump casing 300.

Referring to fig. 2 and 3 again, in the pump housing 300 according to the embodiment of the present invention, the pressure relief portion 310 and the pressure receiving portion 320 abutting and integrally formed with the pressure relief portion 310 are substantially in a cage shape in the expanded state, and the center axes of the pressure relief portion 310 and the pressure receiving portion 320 are aligned to ensure the regularity of the pump housing 300. Meanwhile, in the embodiment of the present application, since the pressure relief portion 310 is surrounded by the plurality of elastic bending strips 311, a gap exists between two adjacent elastic bending strips 311, and the elastic covering layer 400 may also cover the gap formed between two adjacent elastic bending strips 311 on the outer periphery of the pressure relief portion 310, so as to seal the gap between two adjacent elastic bending strips 311 on the pressure relief portion 310.

Of course, referring to fig. 1 to 4 again, when the gap formed between two adjacent elastic bending strips 311 on the pressure relief portion 310 is not covered by the elastic covering layer 400 or is only partially covered by the elastic covering layer 400, the blood suction port 340 may be formed by the gap between two adjacent elastic bending strips 311 located at the distal end of the pressure relief portion 310; alternatively, one or more blood suction ports 340 may be separately provided at the distal end of the pressure relief portion 310; similarly, the blood outflow port 350 may be formed by one or more net ports 321 at the proximal end of the pressure-receiving portion 320, in which case the one or more net ports 321 serving as the blood outflow port 350 are not sealed by the elastic covering layer 400, ensuring smooth outflow of blood therefrom; alternatively, one or more blood flow outlets 350 may be separately provided at the proximal end of the pressure containing portion 320.

It should be noted that the entire pump casing 300 is substantially football-shaped in the unfolded state, that is, the distal end of the pressure relief portion 310 and the proximal end of the pressure bearing portion 320 are substantially tapered, and the blood suction port 340 and the blood outflow port 350 are respectively located at the tapered positions of the two ends of the pump casing 300, so as to facilitate the blood flow from the blood suction port 340 into the first cavity 330 and from the blood outflow port 350 into the blood vessel.

Referring to fig. 6, it should be noted that, before the catheter pump housing structure of the embodiment of the present application is inserted into the patient, the catheter pump housing structure as a whole may be located in a delivery device, which may be a delivery tube 900 with a smaller diameter, at which time, the pump housing 300 and the impeller 220 located in the pump housing 300 are both forcibly compressed by the delivery tube 900 and located in the delivery tube 900 in a compressed state with a minimum volume; when the catheter pump housing structure needs to be inserted into the patient, a physician can perform a percutaneous operation, insert the whole catheter pump housing structure into a target position in the patient by using the carrier effect of the delivery tube 900, and then extract the delivery tube 900 out of the body to be integrally separated from the catheter pump housing structure, at this time, the pump housing 300 and the impeller 220 in the pump housing 300 are not subjected to the acting force of the delivery tube 900, namely, are respectively expanded in the radial direction at the target position to be restored to the initial maximum volume state, and at this time, the first cavity 330 is in the maximum volume state.

Specifically, the blood inlet 340 located at the distal end of the pressure releasing portion 310 is located in the ventricle, the blood outlet 350 located at the proximal end of the pressure receiving portion 320 is located in a blood vessel communicating with the ventricle, and the blood in the ventricle flows from the blood outlet 350 into the first cavity 330 under the rotational attraction of the impeller 220, and then flows from the blood outlet 350 into the blood vessel. Obviously, through the mode, the operation wound area generated in the whole catheter pump shell structure through percutaneous operation intervention in a patient body can be reduced, and larger pump blood flow can be obtained.

Referring to fig. 1, 2 and 3 again, in the catheter pump housing structure according to the embodiment of the present application, since only the proximal end of the pressure-bearing portion 320 is connected and positioned with the support base 100, the impeller 220 is suspended at the distal end of the rotating shaft 210 and surrounded by the pressure-bearing portion 320, the distal end of the impeller 220 is a free end, and the pressure-relief portion 310 integrally abutted to the distal end of the pressure-bearing portion 320 has no corresponding support and has a certain distance in the axial direction with respect to the impeller 220, if the distal end or the outer wall of the pump housing 300 is subjected to a non-forced external force action, i.e., the distal end and the outer wall of the pressure-relief portion 310 and the outer wall of the pressure-bearing portion 320 are subjected to a non-forced external force action, such as the distal end and the outer wall of the pressure-relief portion 310 contact and collide with the blood vessel wall, the pressure-relief portion 310 at the distal end of the pump housing 300 is preferentially subjected to the external force action of the blood vessel wall. In the present application, since the pressure relief portion 310 is surrounded by the plurality of elastic bending strips 311, the elastic bending strips 311 forming the pressure relief portion 310 are elastically deformed under the action of the external force, so that the whole pressure relief portion 310 can buffer and relieve the external force, the large deformation of the pressure bearing portion 320 caused by the external force transmitted to the pressure bearing portion 320 is effectively avoided, the gap between the impeller 220 inside the pressure bearing portion 320 and the pressure bearing portion 320 is prevented from being reduced, and the mechanical hemolysis and the probability that the impeller 220 is jammed on the pressure bearing portion 320 due to the contact with the inner wall of the pressure bearing portion 320 are reduced.

Meanwhile, in the present application, since the pressure-bearing portion 320 abutting against the pressure-relief portion 310 is surrounded by the elastic net structure, the pressure-bearing portion 320 has a certain hardness, and can bear large radial and axial bending torques, when the outer wall of the pressure-bearing portion 320 contacts and collides with the blood vessel wall, the pressure-bearing portion 320 basically does not deform the pressure-bearing portion 320 in the radial and circumferential directions due to the strong strength and bending resistance of the pressure-bearing portion 320, so as to ensure that the gap between the pressure-bearing portion 320 and the impeller 220 is maintained in a predetermined range, further reduce the probability of occurrence of mechanical hemolysis, and simultaneously ensure the stability of the impeller 220 in rotating.

Through the above arrangement, compared with the conventional pump casing 300 with the strength of each part basically consistent, the pressure relief part 310 and the pressure bearing part 320 which form the pump casing 300 are respectively designed to have the structures with different bending strength capabilities, that is, the integral bending strength of the pressure relief part 310 is designed to be smaller than that of the pressure bearing part 320, so that the pressure bearing part 320 is not greatly deformed under the action of non-forced external force at the far end of the pump casing 300 or the outer wall of the pump casing 300, the gap between the inner wall of the pressure bearing part 320 and the impeller 220 is maintained in a predetermined range, the probability of occurrence of mechanical hemolysis is reduced, and the impeller 220 can be well adapted to the structural characteristics of being suspended inside the pressure bearing part 320.

Obviously, the catheter pump housing structure of the embodiment of the present application, by setting the pump housing 300 as the integrally formed pressure relief portion 310 and pressure bearing portion 320, with the help of the structural characteristics of the pressure relief portion 310 and pressure bearing portion 320, not only the function that the whole pump housing 300 and impeller 220 can be automatically unfolded after being compressed is maintained, so that the catheter pump device can obtain a larger flow, but also the preset gap between the pump housing 300 and the impeller 220 can be ensured within a controllable range, the housing support requirement of the impeller 220 suspended at the distal end of the rotating shaft 210 is met, meanwhile, the structural stability of the pump housing 300 and the impeller 220 in the process of intervening and running in the human body is ensured, and the occurrence of mechanical hemolysis and mechanical failure is avoided.

Referring again to fig. 1, 2 and 3, in some embodiments of the present application, the elastic bending strip 311 is formed by connecting a plurality of sections of connecting sections in an "S" shape or a "W" shape in sequence, and two adjacent elastic bending strips 311 do not cross, by designing the connecting section in an "S" shape or a "W" shape, the structure of the elastic bending strip 311 can be made relatively flexible, meanwhile, two adjacent elastic bending strips 311 are arranged in a non-crossed manner, so that the structural strength of the whole pressure relief part 310 is smaller than that of the pressure bearing part 320 in a net structure, when the distal end of the pump housing 300 is subjected to an unforced external force, the pressure relief portion 310 is preferentially deformed to a large extent, therefore, most of acting force is buffered and borne, only a small amount of acting force or even no acting force is transmitted to the pressure bearing part 320 through the pressure relief part 310, and the influence of large deformation of the pressure bearing part 320 on the preset gap between the pressure bearing part 320 and the impeller 220 is avoided.

Of course, in other embodiments, the connecting segment constituting the elastic bending strip 311 may also have other non-closed bending shapes, and is not limited in particular.

Referring to fig. 2 and 3 again, in some embodiments of the present application, the mesh opening 321 is a diamond shape, and the strength of the whole pressure-bearing portion 320 is improved by using the better stability of the diamond shape, so as to further prevent the outer wall of the pressure-bearing portion 320 from being deformed greatly due to non-forced external force. Of course, in other embodiments, the mesh opening 321 of the pressure receiving portion 320 may be a closed figure with excellent stability, such as a triangle, a circle, or a rectangle, so as to enhance the overall strength of the pressure receiving portion 320.

Referring again to fig. 3, in some embodiments of the present disclosure, the pressure-bearing portion 320 includes a radial pressure-bearing portion 322 abutting the pressure-relief portion 310 and an axial pressure-bearing portion 323 connected to the support seat 100, the radial pressure-bearing portion 322 is formed by enveloping a plurality of first elastic ribs into a cage shape, the axial pressure-bearing portion 323 is formed by enveloping a plurality of second elastic ribs into a cage shape and abutting the radial pressure-bearing portion 322, and a thickness of the second elastic ribs is greater than a thickness of the first elastic ribs.

The cage-shaped radial pressure receiving portion 322 and the cage-shaped axial pressure receiving portion 323 are integrally formed by abutting to each other, thereby forming the overall cage-shaped pressure receiving portion 320. It can be understood that, the outer peripheral wall of the radial pressing portion 322 has a plurality of openings formed by a plurality of first elastic ribs in a pairwise crossing arrangement, each opening is covered by a corresponding elastic covering layer 400 to ensure the sealing performance of the radial pressing portion 322, each opening is preferably diamond-shaped and has substantially the same size, so as to ensure that the strength of each position of the radial pressing portion 322 is relatively consistent or uniform, the impeller 220 is integrally suspended inside the radial pressing portion 322, when the outer wall of the radial pressing portion 322 is subjected to a non-forced external force, the strong strength characteristic of the radial pressing portion 322 can ensure that the radial deformation of the radial pressing portion 322 is relatively small, so as to control the gap between the inner wall of the radial pressing portion 322 and the outer wall of the impeller 220 within a predetermined range, further avoid the probability of mechanical hemolysis of blood flowing through the inner portion of the radial pressing portion 322, and further prevent the impeller 220 from contacting and colliding with the inner wall of the radial pressing portion 322 and even being stuck in the inner portion 322 A bad condition of the wall occurs.

Similarly, the outer peripheral wall of the axial pressure-bearing portion 323 has a plurality of openings formed by the plurality of second elastic ribs in a pairwise crossing arrangement, each opening is covered by a corresponding elastic covering layer 400, each opening is preferably diamond-shaped and substantially equal in size, the size of the mesh opening of the axial pressure-bearing part 323 is larger than that of the radial pressure-bearing part 322, meanwhile, the thickness of the second elastic rib is designed to be larger than that of the first elastic rib, so that the whole axial bearing part 323 can bear larger axial bending torque, when the outer wall of the axial bearing part 323 is acted by non-forced external force, the radial and axial deformation of the bearing part is small, the bending deformation resistance of the whole bearing part 320 is further enhanced, so as to ensure that the gap between the inner wall of the pressure-bearing part 320 and the outer wall of the impeller 220 is in a stable and unchangeable state, and prevent the mechanical hemolysis of the blood flowing through the pressure-bearing part 320.

Referring to fig. 6, in some embodiments of the present application, the impeller 220 includes a hub 221 coaxially connected to the rotating shaft 210, and a plurality of elastic blades 222 circumferentially provided to the hub 221. Specifically, the elastic blade 222 may be a helical blade to improve the blood pumping flow rate of the whole catheter pump housing structure, the hub 221 and the elastic blade 222 are integrally formed, and moreover, the hub 221 may be coaxially connected with the rotating shaft 210 in a manner of being sleeved on the distal end of the rotating shaft 210, so as to improve the convenience of the overall disassembly and assembly of the impeller 220.

Referring to fig. 1, 4 and 5, in some embodiments of the present application, the support seat 100 is tubular, the central axis of the support seat 100 coincides with the central axis of the pump casing 300, and the proximal end of the pressure receiving portion 320 is sealingly connected to the peripheral wall of the support seat 100.

Specifically, the supporting seat 100 is a supporting tube with two substantially sealed ends, the rotating shaft 210 can be rotatably disposed at the central axis of the supporting tube through a transmission bearing, and the distal end of the rotating shaft 210 penetrates through the distal end of the supporting tube and then extends into the pressure-bearing portion 320 of the pump casing 300, so as to provide a carrier for the suspension of the impeller 220 and prevent blood in the first cavity from entering the supporting tube as much as possible. Meanwhile, the central axis of the support base 100 is designed to coincide with the central axis of the pump casing 300, so that irregular expansion of the pump casing 300 after forced compression can be avoided, the pump casing 300 is ensured to expand in a general cage shape or rugby shape after forced compression, and the overall stability of the whole pump casing 300 is improved.

Referring to fig. 1, 6 and 7, in some embodiments of the present application, the catheter pump housing structure of the embodiments of the present application further includes a pigtail 700 connected to the distal end of the pressure relief portion 310, and a guide wire 800 for passing through the pigtail 700, a distal end of the guide wire 800 may extend out of the distal end of the pigtail 700, and a proximal end of the guide wire 800 may extend out of the blood suction port 340.

Specifically, in this embodiment, the distal end of the pressure relief portion 310 and the proximal end of the pressure bearing portion 320 both have connectors with smaller inner diameters, the proximal end and the sleeve portion of the pigtail 700, the support base 100 is tubular, the distal end of the support base 100 is also the sleeve portion, when the pigtail 700, the pump housing 300 and the support base 100 are installed and connected, the connector at the distal end of the pressure relief portion 310 and the connector at the proximal end of the pressure bearing portion 320 can be respectively sealed and connected to the sleeve portion of the pigtail 700 and the support base 100, so as to complete the installation and connection of the pigtail 700, the pump housing 300 and the support base 100, so that the pigtail 700 and the support base 100 respectively play a role in bearing and supporting the distal end and the proximal end of the pump housing 300, thereby ensuring that the pump housing 300 is stably and regularly expanded after being forcibly compressed, and further reducing the probability of mechanical hemolysis of blood flowing through the pump housing 300.

In addition, in this embodiment, the distal end of the pigtail 700 has a curved section for positioning and supporting, so as to prevent the blood sucking port 340 from adhering to the heart chamber, which would cause tissue congestion if the blood sucking port 340 adheres to the heart chamber. Referring to fig. 6, in the present embodiment, the pump further includes a delivery pipe 900, and the delivery pipe 900 is used for sleeving the support base 100 and the pump casing 300 and forcibly compressing the pump casing 300 and the impeller 220 into a contracted state.

Referring again to fig. 6, it should be noted that, before the catheter pump housing structure of the embodiment of the present application is inserted into the patient, the catheter pump housing structure as a whole may be located in the smaller diameter delivery tube 900, and the delivery device may be the smaller diameter delivery tube, in which case, the pump housing 300 and the impeller 220 located in the pump housing 300 are both forcibly compressed by the delivery tube 900 and located in the delivery tube in a minimum volume compressed state. At this time, the plurality of elastic blades 222 provided to the hub 221 in the circumferential direction are wound around the outer wall of the hub 221 by a forced compression force, and maintain a compressed state of a minimum volume. In addition, the outer wall of the distal end of the delivery tube 900 is provided with an opening for the guide wire 800 to pass through.

When the catheter pump housing structure needs to intervene in a patient, a physician can insert the distal end of the guide wire 800 into a target position in the patient according to a predetermined path in advance, extend the guide wire 800 along the path of a blood vessel to enable the proximal end of the guide wire 800 to extend out of the patient, then sleeve the pigtail 700 connected to the distal end of the pressure relief portion 310 on the proximal end of the guide wire 800 and enter the target position along the track of the guide wire 800, so that the pigtail 700 can integrally drive the catheter pump housing structure to the target position under the guidance of the guide wire 800, at the moment, the proximal end of the guide wire 800 sequentially passes through a guide cavity in the guide hose 500 and the blood suction port 340 at the distal end of the pressure relief portion 310 and extends out of the opening of the outer wall at the distal end of the delivery tube 900, and thus, accurate intervention on the whole catheter pump housing structure is completed. Then, the physician can sequentially withdraw the guide wire 800 and the delivery tube 900 from the body, so that the pump casing 300 and the impeller 220 in the pump casing 300 are not forced by the delivery tube 900, i.e. are respectively radially expanded at the target position, the pump casing 300 and the plurality of elastic blades 222 on the hub 221 are radially expanded to return to the initial maximum volume state, and the first cavity 330 is also in the maximum volume state at this time, thereby obtaining a larger pumping blood flow.

It is not difficult to understand, this application through the setting of pigtail 700, seal wire 800 and delivery pipe 900, not only made things convenient for the doctor swiftly intervene whole catheter pump shell structure to corresponding blood transfusion organ in, still improved the accuracy that whole catheter pump shell structure intervened to corresponding blood transfusion organ, simultaneously, can effectively reduce whole catheter pump shell structure and intervene the operation wound area that produces in the patient through percutaneous surgery to can acquire bigger pump blood flow. Meanwhile, the smoothness of the whole catheter pump shell structure introduced into the patient body can be ensured, the surgical injury to the patient can be reduced to the maximum extent, and the injury of the whole catheter pump shell structure to native tissues at positions such as angiostenosis, aortic arch and ventricular valve can be better avoided.

It can be understood that, when the pigtail 700 enters the target position along the trajectory of the guide wire 800 and the pigtail 700 contacts or collides with the blood vessel wall, similarly, the pressure relief portion 310 connected to the pigtail 700 preferentially receives the acting force transmitted by the pigtail 700, and the elastic bending strip 311 forming the pressure relief portion 310 is elastically deformed when receiving the acting force, so that the whole pressure relief portion 310 buffers and relieves the acting force, thereby effectively avoiding the acting force from being further transmitted to the pressure bearing portion 320 to cause the large deformation of the pressure bearing portion 320, preventing the gap between the impeller 220 inside the pressure bearing portion 320 and the pressure bearing portion 320 from being reduced, and further reducing the probability that the blood is mechanically hemolyzed and the impeller 220 is jammed on the pressure bearing portion 320 due to the contact with the inner wall of the pressure bearing portion 320.

In addition, referring to fig. 1, 4 and 5, embodiments of the present application also provide a catheter pump device including a multi-lumen sheath 500 and a catheter pump housing structure as described above.

Wherein, the supporting seat 100 is a supporting sleeve, the distal end of the supporting sleeve is provided with a perfusion cavity 110, the transmission assembly 200 further comprises a bearing sleeve 240 and a transmission bearing 230 which are arranged in the supporting sleeve, the rotating shaft 210 is installed in the bearing sleeve 240 through the transmission bearing 230, the outer wall of the bearing sleeve 240 is provided with an outer layer runner 241 communicated with the perfusion cavity 110, a gap between the inner ring and the outer ring of the transmission bearing 230 forms an inner layer runner 231 communicated with the perfusion cavity 110, the distal end of the multi-cavity sheath 500 is connected to the proximal end of the supporting sleeve, the multi-cavity sheath 500 is provided with an inflow channel 510 communicated with the outer layer runner 241 and an outflow channel 520 communicated with the inner layer runner 231. It should be noted that the number of the driving bearings 230 may be one or more, and the specific number is not limited.

In the catheter pump device according to the embodiment of the present application, the bearing sleeve 240 is disposed in the support sleeve, the outer flow channel 241 is disposed on the outer wall of the bearing sleeve 240, and the multi-lumen sheath 500 having the inflow channel 510 and the outflow channel 520 is disposed, so that when the whole catheter pump device is in operation, an operator can fill the inflow channel 510 with liquid, so that the liquid flows into the filling cavity 110 at the distal end of the support sleeve through the inflow channel 510 and the outer flow channel 241, the inner flow channel 231 formed by the gap between the inner ring and the outer ring of the driving bearing 230 is respectively communicated with the filling cavity 110 and the outflow channel 520 in the multi-lumen sheath 500, the liquid in the filling cavity 110 will continue to flow through the inner flow channel 231 and the outflow channel 520, and finally flows out from the outlet of the outflow channel 520, and the liquid can be effectively discharged from the insoluble particles generated when the rotating shaft 210 and the driving bearing 230 perform synchronous high-speed rotating motion through the above-mentioned flow manner, avoid the insoluble particles from entering the blood of the human body and causing danger to the human body. Because the impeller 220 is suspended on the supporting seat 100, no particles are generated at the far end of the impeller 200, so that all insoluble particles generated in the operation process can be removed, almost zero particles enter a human body, and the product safety is high.

Meanwhile, in the circulating flow process of the liquid along the flow path, the liquid can continuously exchange heat with the rotating shaft 210 and the transmission bearing 230, so that heat generated in the high-speed rotating process of the rotating shaft 210 and the transmission bearing 230 is timely discharged, structural damage to the rotating shaft 210 and the transmission bearing 230 due to overheating is avoided, the rotating operation function of the impeller 220 suspended at the far end of the rotating shaft 210 is ensured, and the normal and stable blood pumping function of the whole catheter pump device is further ensured.

In addition, referring again to fig. 5, in some embodiments of the present application, the outer flow passage 241, the inflow passage 510, and the outflow passage 520 are annular, thereby adapting to the cylindrical shape of the driving bearing 230 and the annular inner flow passage 231 formed by the inner ring and the outer ring of the driving bearing 230, so that the perfusion liquid can more completely carry out the insoluble particles and heat generated when the rotating shaft 210 and the driving bearing 230 perform the synchronous high-speed rotating motion.

In addition, referring again to fig. 5, in some embodiments of the present application, a mounting cavity is further defined in the middle of the multi-lumen sheath 500, the proximal end of the rotating shaft 210 is connected to the driving member via a transmission wire 250, and the transmission wire 250 is inserted into the mounting cavity.

Specifically, multi-chamber sheath 500 is including the interior sheath and the outer sheath of nested setting, the distal end of interior sheath and outer sheath is inlayed on the near-end inner wall of supporting the cover, realize the butt joint assembly of whole multi-chamber sheath 500, the middle part cavity of interior sheath forms the installation cavity that supplies transmission hank silk 250 to wear to establish, rotation axis 210 can be located external driving piece through transmission hank silk 250 connection, this driving piece can be rotary driving pieces such as motor or motor, provide rotary power for rotation axis 210 and impeller 220.

In addition, the outflow channel 520 is annularly disposed on the inner wall or the outer wall of the inner sheath, and the inflow channel 510 is annularly disposed on the inner wall or the outer wall of the outer sheath, so as to ensure that the outflow channel 520 and the outflow channel 520 are respectively and annularly abutted with the outer layer flow channel 241 and the inner layer flow channel 231, so that the insoluble particles and heat generated when the rotating shaft 210 and the transmission bearing 230 perform synchronous high-speed rotation can be rapidly carried out by the perfusion liquid.

In addition, referring to fig. 7, in some embodiments of the present application, the catheter pump device further includes a flexible tube 600, the flexible tube 600 is disposed on an outer wall of the pressure part 320 and covers the blood outflow port 350, at least one outflow window 610 is opened on the outer wall of the flexible tube 600, a cavity of the flexible tube 600 forms a circulation chamber 620 communicating with the blood outflow port 350 and the outflow window 610, and the flexible tube 600 is configured as an elastic hose structure whose outer wall can expand and contract. Of course, the flexible tube 600 may be attached to the outer wall of the pressure relief portion 310. In addition, in this embodiment, the distal end of the flexible tube 600 is hermetically connected to the outer wall of the pressure-bearing portion 320, and the proximal end of the flexible tube 600 is hermetically connected to the outer wall of the multi-lumen sheath 500, so that the support sleeve and the multi-lumen sheath 500 are both axially inserted into the cavity of the flexible tube 600, so that the pressure-bearing portion 320 and the multi-lumen sheath 500 simultaneously support and bear the flexible tube 600, and the flexible tube 600 is ensured to be stably expanded or contracted.

Referring to fig. 7 and 8, in use, the catheter pump device of the embodiment of the present application is applied by a physician inserting the entire catheter pump device into a patient through percutaneous surgery and by means of the carrier function of the delivery tube 900, so that the entire catheter pump device entirely spans over the heart valve 30, and the pump housing 300 and the impeller 220 are both in a deployed state in the ventricle 20 of the patient, so that the blood suction port 340 at the distal end of the pressure relief portion 310 communicates with the ventricle 20, and at the same time, the flexible tube 600 spans over the heart valve 30 and is located between the ventricle 20 and the blood vessel 10 communicating with the ventricle 20, so that the outflow window 610 of the flexible tube 600 communicates with the blood vessel 10, and the heart valve 30 of the patient contacts only the outer wall of the flexible tube 600.

When the whole catheter pump device is operated, the rotating shaft 210 drives the impeller 220 to rotate, blood in the ventricle 20 continuously enters the first cavity 330 of the pump shell 300 from the blood suction port 340 under the power action of the impeller 220, then flows into the flow cavity 620 formed by the cavity of the flexible tube 600 through the blood outflow port 350, and finally flows into the blood vessel 10 from the outflow window 610, so that the blood delivery is completed.

In the blood conveying process, due to the structural characteristic that the flexible tube 600 is an elastic flexible tube, after blood continuously enters the circulation cavity 620, the volume of the flexible tube 600 is continuously expanded and increased, when the volume of the flexible tube 600 is expanded to the maximum state, the flexible tube 600 is in a filling state, the caliber of the outflow window 610 arranged on the flexible tube 600 is synchronously expanded to the maximum, at the moment, the blood flow flowing through the circulation cavity 620 and the blood flow flowing into the blood vessel 10 from the outflow window 610 both reach the maximum values, and the blood flow conveyed into the blood vessel 10 by the whole catheter pump device is greatly increased under the condition that the rotating speed of the impeller 220 is not changed.

When the heart valve 30 is closed, the valve leaflets of the heart valve 30 are mutually involuted, so that the outer wall of the flexible tube 600 is squeezed, the flexible tube 600 is contracted along the involution straight line of the valve leaflets, the caliber of the circulation cavity 620 is greatly reduced, and even the circulation cavity 620 is completely closed, so that blood cannot flow into the blood vessel 10; when the heart valve 30 opens, the flexible tube 600 is again expanded to a maximum state under the pressure of the blood, and the blood flow again flows into the blood vessel 10 at a maximum flow rate. As the patient's heart valve 30 is continuously opened and closed, the flexible tube 600 synchronously expands and contracts, thereby generating pulsatile blood flow or pulsatile blood flow output adapted to the diastolic and systolic characteristics of the patient's heart, improving perfusion of the coronary artery and distal organs while reducing cardiac burden, facilitating the stabilization of the patient's physical signs during surgery and postoperative rehabilitation.

It should be noted that, in the above description, the ventricle 20 may correspond to a left ventricle or a right ventricle of a patient, the blood vessel 10 corresponds to an aorta communicating with the left ventricle or a pulmonary artery communicating with the right ventricle, and the corresponding heart valve 30 corresponds to an aortic valve between the left ventricle and the aorta or a pulmonary valve between the right ventricle and the pulmonary artery. Of course, the application scenario of the catheter pump device of the present application is not limited to the left ventricle and aorta, the right ventricle and pulmonary artery, but can also be applied to other tissues and organs of the human body to play a role in assisting blood pumping.

The catheter pump device according to the embodiment of the present application is constructed by disposing the flexible tube 600 on the pump housing 300, and configuring the flexible tube 600 as an elastic hose structure whose outer wall is expandable and contractible, meanwhile, the flexible tube 600 is skillfully arranged on the pump casing 300, and the pump casing 300 and the impeller 220 are positioned in the ventricle 20 in the unfolded state by utilizing the expandable and contractible structural characteristics of the flexible tube 600, on the premise of not changing the rotating speed of the impeller 200, the flow rate of the blood pumped into the blood vessel 10 is greatly increased, but also allows the flexible tube 600 to expand and contract synchronously with the opening and closing action of the heart valve 30, therefore, the whole catheter pump device generates pulsatile blood flow or pulsatile blood flow output which is matched with the diastolic and the systolic characteristics of the heart of a patient, improves the perfusion of coronary artery and a far-end organ, simultaneously reduces the cardiac burden, and is beneficial to the physical sign stabilization and postoperative rehabilitation of the patient in operation.

In addition, by utilizing the expandable and contractible structural characteristics of the flexible tube 600, the flexible tube 600 is in an initial contraction state before being inserted into the patient, at this time, the inner diameter and the volume of the flexible tube 600 are both in a minimum state, and the physician can insert the flexible tube 600 in this state into the position of the heart valve 30 of the patient through percutaneous surgery, so as to reduce the operation wound area to the maximum extent, and at the same time, improve the pumping blood flow of the whole catheter pump device under the same operation wound area.

Referring to fig. 9, in some embodiments of the present application, the pump housing 300, the support sleeve, the multi-lumen sheath 500 connected to the proximal end of the support base 100, and the flexible tube 600 having both ends hermetically connected to the outer wall of the pump housing 300 and the outer wall of the multi-lumen sheath 500, respectively, have their central axes coinciding with each other, it should be noted that the multi-lumen sheath 500 is a flexible and bendable structure, does not cause structural damage to the corresponding blood vessel or blood transfusion organ, and can be well adapted to the bent or coiled shape of the corresponding blood line.

And in this embodiment, the flexible tube 600 includes a straight line interface section, a fillet section, a circular arc transition section, a middle straight line section and a lead-out section which are connected smoothly in sequence, and the circular arc transition section is tangent to the middle straight line section, so that the outer wall profile of the whole flexible tube 600 is in overall smooth transition. The outflow window 610 has a plurality and is provided on the outer wall of the lead-out section at intervals in the circumferential direction. It will be appreciated that the distal end of the flexible tube 600 is sealingly connected to the outer wall of the pressure bearing portion 320, i.e. via the straight access segment, and will thus sheath the blood flow outlet 350, and the proximal end of the flexible tube 600 is sealingly connected to the outer wall of the multi-lumen sheath 500, i.e. via the exit segment.

It will be appreciated that in this embodiment, the inside diameter of the radiused section and the inside diameter of the radiused transition section both increase progressively from the distal end to the proximal end, the inside diameter of the radiused section being greater than the inside diameter of the straight interface section, and the inside diameter of the radiused transition section being greater than the inside diameter of the radiused section.

Referring again to FIG. 9, in the present embodiment, the diameter of the straight interface section is D1, D1 being determined by the maximum radial dimension of the pump casing 300 that allows radial expansion. The diameter of the middle straight segment is D2, D2 is determined by the diameter of the patient's blood vessel. The axial length of the pump casing 300 that allows radial expansion deformation is L1. The sum of the axial lengths of the straight line interface section, the fillet section and the circular arc transition section is L2. The angle between the line connecting the midpoint of the main boundary of the straight line interface section and the midpoint of the main boundary of the middle straight line section and the central axis of the pump housing 300 is α. The radius of the circle where the fillet section is located is R1, and the radius of the circle where the arc transition section is located is R2. In this example, R1 has a value ranging from 0 to L1/tan (α/2), R2 has a value ranging from 0 to (D2-D1)/(2 tan (α/2) sin (α)), and L2 has a value ranging from (D2-D1)/(2 tan (α)).

It should be noted that, if the value of R1 is too small, the overall profile of the rounded section is relatively curved, which is likely to cause a deslow vortex in the blood flowing through the rounded section, thereby affecting the stability of the blood flow and causing hemolytic injury; similarly, when the value of R2 is too small, the blood flowing through the arc transition section may have vortex shedding, which may affect the stability of blood flow and may cause hemolytic injury; meanwhile, the larger the value of α is, the larger the difference between the diameter of the straight line interface section and the diameter of the middle straight line section is, that is, the larger the variation of the overall radial dimension of the circulation cavity 620 formed by the cavity of the flexible tube 600 is, and the larger the variation of the overall radial dimension of the circulation cavity 620 is, the larger the blood flowing through the circulation cavity 620 is, the vortex shedding is easily caused, the stability of the blood flow is affected, and the hemolytic injury is caused.

Referring to fig. 10 and 11, fig. 10 is a blood flow chart of the blood flowing through the flow-through chamber 620 simulated by the simulation software when the value of α is 0; fig. 11 is a blood flow diagram through the flow-through chamber 620 simulated by the simulation software when α is 12 as described above. It is easy to find that when the value of α is 0, that is, the flexible tube 600 is similar to a long straight tube as a whole, the blood flow streamline in the circulation cavity 620 is smooth, and basically no vortex phenomenon occurs; when the value of alpha is 12 degrees, the phenomenon of deswirling vortex of the blood flowing through the flow-through cavity 620 is obvious, which indicates that the blood flowing through the flow-through cavity 620 is unstable and easy to cause hemolytic injury.

Therefore, in order to ensure that the flow-through chamber 620 formed by the whole flexible tube 600 can be expanded normally under the impact of blood, thereby increasing the pumping blood flow of the whole catheter-pump device, and at the same time, to reduce the probability of occurrence of vortex shedding of the blood flow flowing through the flow-through chamber 620 as much as possible, in a preferred embodiment, the value of L2 is (D2-D1)/(2 tan (alpha)),

α＝5°；

R1＝L1/tan(α/2)；

R2＝(D2-D1)/(2*tan(α/2)*sin(α))；

according to the results of simulation calculation and experimental tests, in the preferred embodiment, when the shapes and sizes of the straight line interface section, the rounded corner section, the arc transition section and the middle straight line section which form the flexible tube 600 satisfy the above conditions and parameters, not only the flexible tube 600 can be stably expanded to increase the blood pumping flow of the catheter pump device, but also the blood flow flowing through the circulation cavity 620 formed by the cavity of the flexible tube 600 is most likely to have a vortex flow separation, thereby avoiding the occurrence of hemolytic injury.

The above description is only a specific implementation of the embodiments of the present application, but the scope of the embodiments of the present application is not limited thereto, and any person skilled in the art can easily conceive various equivalent modifications or substitutions within the technical scope of the embodiments disclosed in the present application, and these modifications or substitutions should be covered by the scope of the embodiments of the present application. Therefore, the protection scope of the embodiments of the present application shall be subject to the protection scope of the claims.

Claims

1. A catheter pump housing construction, comprising:

a supporting seat;

2. The catheter pump housing structure of claim 1, wherein the elastic bending strips are formed by connecting a plurality of sections of connecting sections in an "S" shape or a "W" shape in sequence, and adjacent two elastic bending strips do not intersect.

3. The catheter pump housing construction of claim 1 wherein the mesh openings are diamond shaped.

4. The catheter pump housing structure of claim 1, wherein the pressure bearing portion comprises a radial pressure bearing portion abutting against the pressure relief portion and an axial pressure bearing portion connected to the support base, the radial pressure bearing portion is formed in a cage shape by enveloping a plurality of first elastic ribs, the axial pressure bearing portion is formed in a cage shape by enveloping a plurality of second elastic ribs and abuts against the radial pressure bearing portion, and the thickness of the second elastic ribs is greater than that of the first elastic ribs.

5. The duct pump housing structure of claim 1, wherein the impeller includes a hub coaxially connected to the rotary shaft and a plurality of resilient blades circumferentially provided to the hub.

6. The catheter pump housing structure of any one of claims 1 to 5, further comprising a pigtail connected to a distal end of the pressure relief portion and a guide wire for threading the pigtail, a distal end of the guide wire being extendable out of a distal end of the pigtail and a proximal end of the guide wire being extendable out of the blood intake port.

7. The catheter pump housing structure according to any one of claims 1 to 5, further comprising a delivery tube for sleeving the support base and the pump casing and compressing the pump casing and the impeller into a contracted state.

8. A catheter pump device, comprising:

the catheter pump housing construction of any one of claims 1 to 7; the supporting seat is a supporting sleeve, and a perfusion cavity is arranged at the far end of the supporting sleeve;

9. The catheter pump device of claim 8 wherein the outer layer flow passage, the inflow channel and the outflow channel are all annular.

10. The catheter pump device of claim 8, wherein the multi-lumen sheath further defines a mounting cavity at a middle portion thereof, the proximal end of the rotating shaft is connected to the driving member via a transmission wire, and the transmission wire is inserted into the mounting cavity.

11. The catheter pump device according to claim 8, further comprising a flexible tube provided on an outer wall of the pressure-receiving portion and covering the blood outflow port, wherein at least one outflow window is opened on the outer wall of the flexible tube, a cavity of the flexible tube forms a circulation chamber communicating with the blood outflow port and the outflow window, and the flexible tube is configured as an elastic hose structure whose outer wall is expandable and contractible.

12. The catheter pump device according to claim 11, wherein the flexible tube comprises a linear interface section, a rounded section, an arc transition section, an intermediate straight section and a lead-out section which are smoothly connected in sequence, the arc transition section is tangent to the intermediate straight section, the outflow window is arranged on the lead-out section, the distal end of the flexible tube is connected with the outer wall of the pressure-bearing part through the linear interface section to cover the blood outflow port, the proximal end of the flexible tube is connected with the outer wall of the multi-cavity sheath tube through the lead-out section, the inner diameter of the rounded section and the inner diameter of the arc transition section both gradually increase from the distal end to the proximal end, the inner diameter of the rounded section is larger than that of the linear interface section, and the inner diameter of the arc transition section is larger than that of the rounded section.

13. The catheter pump device according to claim 12, wherein the shape of the flexible tube is configured to satisfy the following condition: