WO2023134695A1 - Catheter pump housing structure and catheter pump apparatus - Google Patents

Abstract

A catheter pump housing structure and a catheter pump apparatus. The catheter pump housing structure comprises: a support base (100); a transmission assembly (200), comprising a rotating shaft (210) provided on the support base (100) and an impeller (220) suspended at the distal end of the rotating shaft (210); a pump housing (300), comprising a pressure relief portion (310) enclosed by multiple elastic bending strips (311) and a pressure-bearing portion (320) connected to and integrally formed with the pressure relief portion (310), the proximal end of the pressure-bearing portion (320) being connected to the support base (100), the pressure-bearing portion (320) being enclosed by an elastic mesh structure so as to enclose the impeller (220), and a blood suction port (340) and a blood outflow port (350) being respectively provided at the distal end of the pressure relief portion (310) and the proximal end of the pressure-bearing portion (320); and an elastic covering layer (400), covering mesh openings (321) of the pressure-bearing portion (320), so as to sealingly form a first cavity (330) communicated with the blood suction port (340) and the blood outflow port (350).

Description

Catheter pump housing structure and catheter pump device

Cross References to Related Applications

This application claims the priority of Chinese patent application 202210028923.2 entitled "Catheter Pump Housing Structure and Catheter Pump Device" filed on January 11, 2022, the entire content of which is incorporated herein by reference.

technical field

The embodiments of the present application belong to the technical field of cardiac assist devices, and in particular relate to a catheter pump casing structure and a catheter pump device.

Background technique

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

Existing catheter pumps generally include a pump casing, an impeller disposed in the pump casing, a catheter or a sheath, and a flexible drive shaft arranged inside the catheter or the sheath and connected to the impeller. The proximal end of the flexible drive shaft is connected to a drive motor to pass The driving motor drives the impeller to rotate to realize the function of pumping blood. In the above-mentioned catheter pumps, the distal end and the proximal end of the impeller are generally installed in the pump casing through bearing elements, and the bearing elements play the role of supporting and assisting the rotation. During the process, the insoluble particles generated by the rotation of the bearing element at the far end of the impeller cannot be discharged and recycled, resulting in a large amount of insoluble particles entering the human body and causing harm to the human body.

In addition, in the existing catheter pump, in order to obtain greater pump blood flow, both the pump casing and the impeller can be compressed and expanded. The percutaneous surgery enters the designated position in the body in a compressed state, and then the pump casing and impeller return to an expanded state. This easy-to-compress catheter pump is inserted into the human body and in the process of operation in the human body. The outer wall of the pump casing is very easy to contact and collide with the blood vessel wall of the human body, causing the radial and axial deformation of the pump casing, thereby changing the pump casing. The preset gap between the inner wall and the outer wall of the impeller may even cause bad situations such as contact, scratching or even jamming between the outer wall of the impeller and the inner wall of the deformed pump casing, resulting in adverse consequences such as mechanical hemolysis and thrombus in the human body. Cause the operation fault of whole catheter pump, bring great inconvenience to operation.

Contents of the invention

The embodiments of the present application aim to solve at least one of the technical problems existing in the related art. To this end, the embodiment of the present application provides a catheter pump casing structure and a catheter pump device. The structure is ingenious, and the preset gap between the pump casing and the impeller can be ensured within a controllable range, ensuring that the pump casing and the impeller are in the controllable range. Intervening in the human body and its structural stability during operation in the human body can avoid mechanical hemolysis and mechanical failure, and at the same time, it can discharge insoluble particles and heat generated during the operation of the catheter pump device.

In the first aspect, the embodiment of the present application provides a catheter pump housing structure, including: a support base; a transmission assembly, including a rotating shaft arranged on the supporting base and an impeller suspended at the distal end of the rotating shaft; the pump housing, including The pressure relief part surrounded by a plurality of elastic bending strips and the pressure receiving part docked with the pressure relief part, the proximal end of the pressure receiving part is connected to the support seat, and the pressure receiving part is surrounded by an elastic mesh structure to surround the impeller and relieve the pressure The far end of the part and the proximal end of the pressure part are respectively provided with a blood suction port and a blood outflow port; the elastic covering layer covers the net port of the pressure part to seal and form the first connecting port with the blood inhalation port and the blood outflow port. A cavity; in which both the pump casing and the impeller are configured as self-expanding structures after compression.

The casing structure of the catheter pump according to the embodiment of the first aspect of the present application has at least the following beneficial effects:

The casing structure of the catheter pump in the embodiment of the present application, by setting the pump casing as a pressure relief part and a pressure receiving part, when the whole casing structure of the catheter pump is inserted into the corresponding ventricle or blood vessel of the human body through percutaneous surgery, if the pump The distal end of the casing collides with the blood vessel wall, and the pressure relief part at the far end of the pump casing will be preferentially subjected to the external force of the blood vessel wall. Since the pressure relief part is surrounded by multiple elastic bending bars, the elastic bending bars constituting the pressure relief part The elastic deformation occurs when the external force is applied, so that the entire pressure relief part realizes the buffering and pressure relief of the external force, avoiding the transmission of the external force to the pressure receiving part and causing a large deformation of the pressure receiving part, and preventing the impeller inside the pressure receiving part from contacting the pressure receiving part. The gap between the parts is reduced, reducing the probability of mechanical hemolysis and impeller stuck on the pressure part due to contact with the inner wall of the pressure part. In addition, since the pressure-receiving part connected to the pressure-relieving part is surrounded by an elastic mesh structure, the pressure-receiving part has a certain hardness and can withstand large radial and axial bending torques. When the human ventricle or blood vessel is working and running, if the outer wall of the pressure-bearing part contacts and collides with the human ventricle or blood vessel wall, the force of the pressure-bearing part due to its strong strength and bending resistance will basically not make it The pressure-receiving part is deformed, so as to ensure that the gap between the pressure-receiving part and the impeller is maintained within a predetermined range, further reducing the probability of mechanical hemolysis, and at the same time, ensuring the stability of the impeller's rotation. In the casing structure of the catheter pump in the embodiment of the present application, by setting the pump casing as a pressure relief part and a pressure receiving part, with the help of the structural characteristics of the pressure relief part and the pressure receiving part, not only the entire pump casing and the impeller can be self-contained after compression. The expanded function enables the catheter pump device to obtain greater flow rate, and ensures that the preset clearance between the pump casing and the impeller is within a controllable range, meeting the casing support requirements of the impeller suspended at the far end of the rotating shaft , At the same time, ensure the structural stability of the pump casing and impeller when they are involved in the human body and operate in the human body, and avoid mechanical hemolysis and mechanical failure.

According to some embodiments of the present application, the elastic bending strips are formed by sequentially connecting multiple "S"-shaped or "W"-shaped connecting segments, and two adjacent elastic bending strips do not intersect.

According to some embodiments of the present application, the network port is diamond-shaped.

According to some embodiments of the present application, the pressure receiving part includes a radial pressure receiving part abutted with the pressure relief part and an axial pressure receiving part connected to the support base, and the radial pressure receiving part is formed by enveloping a plurality of first elastic ribs Cage-shaped, the axial pressure-receiving part is enveloped by a plurality of second elastic ribs to form a cage shape and is connected to the radial pressure-bearing part, and the thickness of the second elastic ribs is greater than that of the first elastic ribs.

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 disposed on the hub along a circumferential direction.

According to some embodiments of the present application, it also includes a pigtail tube connected to the distal end of the pressure relief part and a guide wire for passing through the pigtail tube. The blood suction port can be extended.

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

In the second aspect, the embodiment of the present application provides a catheter pump device, including: the above-mentioned catheter pump housing structure; wherein, the support base is a support sleeve, and the distal end of the support sleeve is provided with a perfusion chamber; the transmission assembly also includes a The bearing sleeve and the transmission bearing in the support sleeve, the rotating shaft is installed in the bearing sleeve through the transmission bearing, the outer wall of the bearing sleeve is provided with an outer flow channel connected with the perfusion cavity, and the gap between the inner ring and the outer ring of the transmission bearing forms The inner flow channel communicated with the perfusion cavity; the multi-cavity sheath, the distal end is connected to the proximal end of the support sleeve, and an inflow channel communicated with the outer flow channel and an outflow channel communicated with the inner flow channel are provided.

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

In the catheter pump device of the embodiment of the present application, the bearing sleeve is arranged in the support sleeve, and the outer layer flow channel is opened on the outer wall of the bearing sleeve. When the device is running, the operator can pour liquid into the inflow channel, so that the liquid flows into the perfusion cavity at the far end of the support sleeve after passing through the inflow channel and the outer flow channel, thanks to the connection between the inner ring and the outer ring of the transmission bearing. The inner flow channel formed by the gap communicates with the perfusion cavity and the outflow channel in the multi-cavity sheath respectively. The liquid in the perfusion cavity will continue to flow through the inner layer flow channel and the outflow channel, and finally flow out from the outlet of the outflow channel. The liquid passes through the above-mentioned The unique flow mode can effectively discharge the insoluble particles generated when the rotating shaft and the transmission bearing perform synchronous high-speed rotation, and prevent the insoluble particles from entering the blood of the human body and causing danger to the human body. At the same time, during the circulating flow of the liquid along the above-mentioned flow path, it can also continuously exchange heat with the rotating shaft and the transmission bearing, so as to discharge the heat generated by the rotating shaft and the transmission bearing during high-speed rotation in time, thereby avoiding the rotation of the rotating shaft. Structural damage to the transmission bearing due to overheating ensures the rotating function of the impeller suspended at the far end of the rotating shaft, thereby ensuring the normal and stable blood pumping function of the entire catheter pump device.

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

According to some embodiments of the present application, an installation cavity is opened in the middle of the multi-cavity sheath, and the proximal end of the rotating shaft is connected to the driving member through a transmission twisted wire, and the transmission twisted wire passes through the installation cavity.

According to some embodiments of the present application, a flexible tube is also included. The flexible tube is arranged on the outer wall of the pressure-receiving part and covers the blood outflow port. At least one outflow window is opened on the outer wall of the flexible tube. The cavity of the flexible tube is formed with the blood The flow cavity communicates with the outflow port and the outflow window, and the flexible tube is configured as an elastic hose structure whose outer wall can expand and contract.

According to some embodiments of the present application, the flexible pipe includes a straight line interface section, a rounded corner section, a circular arc transition section, a middle straight line section, and a lead-out section that are smoothly connected in sequence, the arc transition section is tangent to the middle straight line section, and the outflow window is opened The leading-out section, the distal end of the flexible tube is connected to the outer wall of the pressure-bearing part through a straight line interface section to cover the blood outflow port, the proximal end of the flexible tube is connected to the outer wall of the multi-lumen sheath through the leading-out section, the inner diameter of the rounded section and the circle The inner diameter of the arc transition section gradually increases from the far end to the proximal end, the inner diameter of the rounded section is larger than that of the straight interface section, and the inner diameter of the arc transition section is larger than that of the rounded section.

According to some embodiments of the present application, the shape of the flexible pipe is configured to meet the following conditions:

The diameter of the straight interface section is D1; the diameter of the middle straight section is D2; the axial length of the pump casing that allows radial stretching and deformation is L1; the sum of the axial lengths of the straight interface section, the fillet section and the arc transition section is L2; the angle between the line between the midpoint of the main boundary of the straight line interface segment and the midpoint of the main boundary of the intermediate straight line segment and the central axis of the pump casing is α; the radius of the circle where the fillet section is located is R1 , the radius of the circle where the arc transition section is located is R2; among them, the value range of α is 0°～10°; the value range of R1 is 0～L1/tan(α/2); the value range of R2 is 0 ~(D2-D1)/(2*tan(α/2)*sin(α)); the value range of L2 is 0~(D2-D1)/(2*tan(α)).

According to some embodiments of the present application, the shape of the flexible pipe is configured to satisfy the following conditions: α=5°; R1=L1/tan(α/2); R2=(D2-D1)/(2*tan(α/ 2)*sin(α)); L2=(D2−D1)/(2*tan(α)).

Description of drawings

In order to more clearly illustrate the technical solutions of the embodiments of the present application, the following will briefly introduce the accompanying drawings that need to be used in the embodiments of the present application. Obviously, the accompanying drawings described below are only some embodiments of the present application. Those of ordinary skill in the art can also obtain other drawings based on these drawings without making creative efforts.

Fig. 1 is a structural schematic diagram of a casing structure of a catheter pump and a catheter pump device according to some embodiments of the present application;

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

Fig. 3 is another structural schematic diagram of the pump casing of some embodiments of the present application;

Fig. 4 is a partial structural schematic diagram of the housing structure of the catheter pump in some embodiments of the present application;

Fig. 5 is a partial enlarged view of place A in Fig. 4;

Fig. 6 is another structural schematic diagram of the casing structure of the catheter pump and the catheter pump device according to 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 diagram of the structure of the catheter pump device in some embodiments of the present application after being inserted into the patient's body;

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

Fig. 10 is a simulation diagram of blood flow in the flexible tube of some embodiments of the present application;

Fig. 11 is another simulation diagram of blood flow in the flexible tube of some embodiments of the present application.

In the drawings: support seat 100; perfusion cavity 110; transmission assembly 200; rotating shaft 210; impeller 220; hub 221; elastic blade 222; transmission bearing 230; inner flow channel 231; Transmission strand 250; pump casing 300; pressure relief part 310; elastic bending bar 311; pressure bearing part 320; mesh port 321; radial pressure bearing part 322; axial pressure bearing part 323; Port 340; blood outflow port 350; elastic cover 400; multilumen sheath 500; inflow channel 510; outflow channel 520; flexible tube 600; outflow window 610; flow-through lumen 620; 900 ; blood vessel 10 ; ventricle 20 ; heart valve 30 .

Detailed ways

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 application. It will be apparent, however, to one skilled in the art that embodiments of the present application may be practiced without some of these specific details. The following description of the embodiments is only to provide a better understanding of the present application by showing examples of the present application.

In the description of the present application, it should be understood that the orientation descriptions, such as up, down, front, back, left, right, etc. indicated orientations or positional relationships are based on the orientations or positional relationships shown in the drawings, and are only For the convenience of describing the embodiment of the present application and simplifying the description, it does not indicate or imply that the referred device or element must have a specific orientation, be constructed and operated in a specific orientation, and thus should not be construed as a limitation on the embodiment of the present application.

In the description of the embodiments of the present application, several means one or more, and multiple means two or more. Greater than, less than, exceeding, etc. are understood as not including the original number, and above, below, within, etc. are understood as Include this number. If the description of the first and second is only for the purpose of distinguishing the technical features, it cannot be understood as indicating or implying the relative importance or implicitly indicating the number of the indicated technical features or implicitly indicating the order of the indicated technical features relation.

In the description of the embodiments of the present application, unless otherwise clearly defined, words such as setting, installation, and connection should be understood in a broad sense, and those skilled in the art can reasonably determine the specific meanings of the above words in this application in combination with the specific content of the technical solution .

It should be noted that, in the case of no conflict, the embodiments in the present application and the features in the embodiments can be combined with each other. The embodiments will be described in detail below in conjunction with the accompanying drawings.

In addition, it should be noted that, in the description of the embodiments of the present application, unless otherwise clearly defined, "in vivo" means inside the tissues and organs of the patient, and "in vitro" means outside the tissues and organs of the patient. At the same time, in the embodiments of the present application, "distal" refers to the direction away from the doctor, and "proximal" refers to the direction close to the doctor, and, in the embodiments of the present application, "docking" refers to the direction corresponding to and connect.

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 the blood in the left ventricle flows into the aorta under systolic pressure, so that the aorta The arteries transfuse blood into the tissues and organs of the human body; at the same time, the pulmonary valve between the right ventricle and the pulmonary artery opens, and the blood in the right ventricle flows into the pulmonary artery, so that the pulmonary artery can transfuse blood to the pulmonary vein and branch organs of the human body. When the heart relaxes, the aortic valve closes to prevent blood in the aorta from flowing back into the left ventricle; at the same time, the pulmonary valve closes to prevent blood in the pulmonary artery from flowing back into the right ventricle. The aorta of the human body is divided into ascending aorta, aortic arch and descending aorta sequentially along the direction of blood flow, and the ascending aorta, aortic arch and descending aorta are connected in turn.

The etiology of coronary heart disease or other cardiovascular diseases mainly reflects that blood cannot flow to the myocardium or brain in time, resulting in hypoxia and necrosis of organs and tissues. The casing structure of the catheter pump and the catheter pump device of the present application can provide stable blood circulation support for the patient's heart, improve the perfusion of the coronary arteries and distal organs while reducing the burden on the heart, which is beneficial to the stability of the patient's signs during the operation and postoperative recover.

Referring to FIG. 1 , FIG. 2 , FIG. 3 and FIG. 4 , the embodiment of the present application discloses a catheter pump casing structure, which includes a support base 100 , a transmission assembly 200 , a pump casing 300 and an elastic covering layer 400 . Wherein, both the pump casing 300 and the impeller 220 are configured as structures that can be compressed under an external force, and can be expanded and restored to an initial state of maximum volume when the external force disappears under the action of its own elastic force.

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 housing 300 includes a pressure relief part 310 surrounded by a plurality of elastic bending bars 311 and a pressure receiving part 320 docked with the pressure relief part 310. The proximal end of the pressure receiving part 320 is connected to the support base 100. The pressure receiving part 320 is elastically The network structure is surrounded to surround the impeller 220, wherein, the plurality of gaps existing in the elastic network structure surrounding the pressure-receiving part 320 are called network ports 321, the far end of the pressure-relieving part 310 and the near end of the pressure-receiving part 320 The two ends 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 seal and form the first cavity 330 communicating with the blood inlet 340 and the blood outlet 350 . That is, the first cavity 330 is surrounded by the pressure receiving portion 320 covered with the elastic covering layer 400 .

It should be noted that the support base 100 can be tubular with both ends basically sealed, and the support base 100 is a rigid structure, which can be made of stainless steel, PEEK, POM and other materials with mechanical strength and high density, to ensure that the support base 100 is in the There is no unacceptable deformation under certain pressure and bending force, so as to carry and support the pressure-bearing part 320 of the pump casing 300 , and then provide an installation carrier for the entire pump casing 300 .

The proximal end of the rotating shaft 210 can be rotatably installed in the support seat 100 through a rotating member such as a bearing, and the distal end of the rotating shaft 210 protrudes from the support seat 100 to facilitate the installation of the impeller 220, thereby facilitating the pressure bearing of the pump casing 300 The portion 320 surrounds the impeller 220 so that the impeller 220 is suspended in the pump casing 300 . It should be noted that the proximal end of the rotating shaft 210 can also be directly connected to the rotating driving member installed on the support base 100; of course, the proximal end of the rotating shaft 210 can also be indirectly connected to the rotating driving member located outside the body through a transmission twisted wire to rotate The driving part can be a motor, a motor, etc., so that the rotating driving part directly or indirectly drives the rotating shaft 210 to rotate, and then drives the impeller 220 suspended in the pump casing 300 to rotate to realize the function of pumping blood.

Referring to Fig. 2 and Fig. 3 again, in the pump casing 300 of the embodiment of the present application, the plurality of elastic bending bars 311 constituting the pressure relief portion 310 and the elastic mesh structure constituting the pressure receiving portion 320 are all made of elastic memory materials. In addition, the impeller 220 is also made of elastic memory material. The elastic memory material can be high-strength memory plastic or memory alloy, which is not specifically limited. Through the above arrangement, the entire pump casing 300 and the impeller 220 inside the pump casing 300 can be compressed to a compressed state, and at the same time, can be expanded to an initial state after compression.

It should be noted that, in the description of this application, the forced compression of the pump casing 300 and the impeller 220 inside the pump casing 300 means that the physician compresses the outer wall of the pump casing 300 through a delivery tube or other compression devices, thereby making 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 under the forced external force and are in a contracted state. When the corresponding compression device is withdrawn from the pump When the shell 300 is used, the pump shell 300 and the impeller 220 inside the pump shell 300 expand and return to the initial maximum volume state under the action of their own elastic force.

The non-forced external force on the pump casing 300 means that the pressure relief part 310 and the pressure receiving part 320 of the pump casing 300 contact the blood vessel wall in the patient's body when the entire catheter pump casing structure is working in the patient's body. is subjected to the compressive force of the vessel wall. It is not difficult to understand that the non-forced external force received by the pump casing 300 will be much smaller than the artificially given mandatory force. Compared with the artificially given mandatory force, the size of the non-forced external force is not enough to push the pump casing 300 and The impeller 220 in the pump casing 300 is compressed into a contracted state, and non-forced external force can only cause radial or axial bending deformation of the pump casing 300 .

In addition, referring to Fig. 2 and Fig. 3 again, it should be noted that in the pump casing 300 of the embodiment of the present application, the pressure relief part 310 and the pressure receiving part 320 abutting with the pressure relief part 310 are basically in the shape of a cage in the expanded state. , and the central axes of the pressure relief part 310 and the pressure receiving part 320 coincide to ensure the regularity of the pump casing 300 . At the same time, it should be noted that, in the embodiment of the present application, since the pressure relief part 310 is surrounded by a plurality of elastic bending bars 311, there is a gap between two adjacent elastic bending bars 311, and the elastic covering layer 400 The gap formed between two adjacent elastic bending bars 311 on the outer periphery of the pressure relief part 310 can also be covered, so that the gap between two adjacent elastic bending bars 311 on the pressure relief part 310 can be sealed.

Of course, referring to Fig. 1 to Fig. 4 again, when the gap formed between two adjacent elastic bending bars 311 on the pressure relief part 310 is not covered by the elastic covering layer 400 or is only partially covered by the elastic covering layer 400, the blood sucks The opening 340 can be formed by the gap between two adjacent elastic bending bars 311 located at the far end of the pressure relief part 310; or, one or more blood suction ports 340 can be opened separately at the far end of the pressure relief part 310; similarly , the blood outflow port 350 may be one or more mesh ports 321 located at the proximal end of the pressure receiving portion 320, in this case, the one or more mesh ports 321 serving as the blood outflow port 350 are not sealed by the elastic covering layer 400 , to ensure that the blood flows out smoothly from the mesh port; alternatively, one or more blood outflow ports 350 can be independently opened at the proximal end of the pressure-receiving part 320 .

It should be noted that the entire pump housing 300 is basically in the shape of a rugby ball in the unfolded state, that is, the distal end of the pressure relief part 310 and the proximal end of the pressure receiving part 320 are basically tapered, and the blood suction port 340 and the blood outflow port 350 are respectively The tapered positions at both ends of the pump casing 300 facilitate blood flowing 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's body, the entire catheter pump housing structure can be placed in the delivery device, and the delivery device can be a delivery tube 900 with a small diameter. At this time, the pump casing 300 and the impeller 220 inside the pump casing 300 are forcibly compressed by the delivery tube 900, and are in the compressed state of the minimum volume in the delivery tube 900; when the catheter pump casing structure needs to be inserted into the patient's body, the doctor can Through percutaneous surgery, the entire catheter pump casing structure is inserted into the target position in the patient's body by using the delivery tube 900 as a carrier, and then the delivery tube 900 is pulled out of the body or partially withdrawn to integrate with the catheter pump casing structure At this time, the pump casing 300 and the impeller 220 in the pump casing 300 are not subjected to the force of the delivery tube 900, that is, they are respectively deployed in the radial direction at the target position, and return to the initial maximum volume state. At this time, the first The cavity 330 is in the maximum volume state.

Specifically, the blood suction port 340 located at the far end of the pressure relief part 310 is located in the ventricle, and the blood outlet 350 located at the proximal end of the pressure receiving part 320 is located in the blood vessel connected with the above-mentioned ventricle. The blood flows into the first cavity 330 from the blood outflow port 350 under the action of rotating gravity, and then flows into the blood vessel from the blood outflow port 350 . Apparently, the above method can not only reduce the surgical wound area caused by the percutaneous operation of the entire catheter pump casing structure in the patient's body, but also obtain a greater pump blood flow.

Referring to Fig. 1, Fig. 2 and Fig. 3 again, in the casing structure of the catheter pump according to the embodiment of the present application, since only the proximal end of the pressure-receiving part 320 is connected and positioned with the support seat 100, the impeller 220 is suspended on the far side of the rotating shaft 210. end and is surrounded by the pressure receiving part 320, the distal end of the impeller 220 is a free end, and the pressure relief part 310 integrally connected to the far end of the pressure receiving part 320 has no corresponding support and has a certain distance from the impeller 220 in the axial direction, If the far end or the outer wall of the pump housing 300 is subjected to non-forced external force, that is, the far end and the outer wall of the pressure relief part 310 and the outer wall of the pressure receiving part 320 are subjected to a non-forced external force, such as the far end of the pressure relief part 310 and the outer wall of the pressure relief part 310. When the outer wall contacts and collides with the heart, the pressure relief portion 310 at the far end of the pump housing 300 will be preferentially affected by the external force inside the heart. In the present application, since the pressure relief part 310 is surrounded by a plurality of elastic bending bars 311, the elastic bending bars 311 constituting the pressure relief part 310 undergo elastic deformation when subjected to the external force, so that the entire pressure relief part 310 realizes the external force. The cushioning and pressure relief effectively prevent the external force from being transmitted to the pressure receiving part 320, resulting in a large deformation of the pressure receiving part 320, preventing the gap between the impeller 220 inside the pressure receiving part 320 and the pressure receiving part 320 from decreasing, reducing the Mechanical hemolysis and the probability that the impeller 220 is stuck on the pressure-receiving part 320 due to contact with the inner wall of the pressure-receiving part 320 .

At the same time, in this application, since the pressure receiving part 320 that is connected to the pressure relief part 310 is surrounded by an elastic mesh structure, the pressure receiving part 320 has a certain hardness and can withstand large radial and axial bending torques. When the outer wall of the pressure-receiving part 320 contacts and collides with the blood vessel wall, the force of the pressure-receiving part 320 due to its strong strength and bending resistance, the force of the ventricular wall or the blood vessel wall will basically not cause the pressure-receiving part 320 to produce radial and circumferential pressure. The upward deformation ensures that the gap between the pressure receiving part 320 and the impeller 220 is maintained within a predetermined range, which further reduces the probability of mechanical hemolysis, and at the same time, ensures the stability of the impeller 220 in rotation.

Through the above settings, compared with the traditional pump casing 300 whose strength is basically the same in each part, the present application specially designs the pressure relief part 310 and the pressure receiving part 320 of the pump casing 300 as structures with different bending strength capabilities, that is, through Designing the overall bending strength of the pressure relief part 310 to be smaller than the overall bending strength of the pressure receiving part 320 can ensure that the pressure receiving part 320 can No large deformation occurs, so as to ensure that the gap between the inner wall of the pressure-receiving part 320 and the impeller 220 is maintained within a predetermined range, reduce the probability of mechanical hemolysis, and better adapt the impeller 220 to be suspended on the bearing. Structural properties of the interior of the pressure portion 320.

Obviously, in the casing structure of the catheter pump in the embodiment of the present application, by setting the pump casing 300 as a pressure relief part 310 and a pressure receiving part 320, by virtue of the structural characteristics of the pressure relief part 310 and the pressure receiving part 320, not only the entire pump casing is maintained 300 and the impeller 220 can self-expand after being compressed, so that the catheter pump device can obtain a larger flow rate, and can ensure that the preset gap between the pump casing 300 and the impeller 220 is within a controllable range, meeting the requirements of being suspended in the The housing support requirements of the impeller 220 at the far end of the rotating shaft 210, at the same time, ensure the structural stability of the pump housing 300 and the impeller 220 when they are inserted into the human body and operate in the human body, so as to avoid mechanical hemolysis and mechanical failure.

Referring to Fig. 1, Fig. 2 and Fig. 3 again, in some embodiments of the present application, the elastic bending strip 311 is formed by sequentially connecting multiple segments in an "S" or "W" shape, and two adjacent elastic bending strips The strips 311 do not intersect, and the structure of the elastic bending strips 311 can be made relatively soft through the design of the "S"-shaped or "W"-shaped connecting section. The overall structural strength of the pressure relief part 310 is smaller than that of the network-shaped pressure receiving part 320. When the distal end of the pump casing 300 is subjected to a non-forced external force, the pressure relief part 310 will preferentially deform greatly, thereby Most of the force is buffered and carried, so that only a small amount or even no force is transmitted to the pressure receiving part 320 through the pressure relief part 310, so as to avoid large deformation of the pressure receiving part 320 and affect the relationship between the pressure receiving part 320 and the impeller 220 Preset gap.

Of course, in other embodiments, the connecting section constituting the elastic bending strip 311 may also be in other non-closed bending shapes, which are not specifically limited.

Referring to Fig. 2 and Fig. 3 again, in some embodiments of the present application, the network port 321 is in the shape of a rhombus, and the better stability of the rhombus is used to improve the strength of the entire pressure-receiving part 320, and further prevent the outer wall of the pressure-receiving part 320 from being damaged. Large deformation occurs due to forced external force. Of course, in other embodiments, the mesh opening 321 of the pressure receiving part 320 can also be a triangle, a circle, a rectangle or other closed shapes with excellent stability, so as to enhance the overall strength of the pressure receiving part 320 .

Referring again to FIG. 3 , in some embodiments of the present application, the pressure receiving portion 320 includes a radial pressure receiving portion 322 connected to the pressure relief portion 310 and an axial pressure receiving portion 323 connected to the support seat 100 , the radial pressure receiving portion 323 The part 322 is surrounded by a plurality of first elastic ribs to form a cage shape, and the axial pressure receiving part 323 is surrounded by a plurality of second elastic ribs to form a cage shape and is docked with the radial pressure receiving part 322. The thickness of the second elastic rib is greater than The thickness of the first elastic rib.

It should be noted that the cage-shaped radial pressure receiving portion 322 and the cage-shaped axial pressure receiving portion 323 are butted to form the overall cage-shaped pressure receiving portion 320 . It can be understood that, the outer peripheral wall of the radial pressure receiving portion 322 has a plurality of mesh openings formed by a plurality of first elastic ribs in a two-by-two cross arrangement, and each mesh opening is covered by a corresponding elastic covering layer 400, In order to ensure the tightness of the radial pressure receiving part 322, the shape of each mesh port can be rhombus and the size is basically equal, so as to ensure that the strength of each position of the radial pressure receiving part 322 is relatively consistent or uniform, and the impeller 220 is suspended on the whole Inside the radial pressure receiving portion 322, when the outer wall of the radial pressure receiving portion 322 is subjected to non-forced external force, its strong strength characteristics can ensure that the radial deformation of the radial pressure receiving portion 322 is small, so that The gap between the inner wall of the radial pressure receiving part 322 and the outer wall of the impeller 220 is controlled within a predetermined range to further avoid the probability of mechanical hemolysis of the blood flowing through the inside of the radial pressure receiving part 322 and further prevent the impeller 220 from The unfavorable situation of contacting and colliding with the inner wall of the radial pressure receiving portion 322 or even being stuck on the inner wall of the radial pressure receiving portion 322 occurs.

Similarly, the outer peripheral wall of the axial pressure-receiving part 323 has a plurality of network openings formed by a plurality of second elastic ribs in a two-by-two cross arrangement, each network opening is covered by a corresponding elastic covering layer 400, each The shape of the net mouth can be rhombus and the size is basically equal, and the size of the net mouth of the axial pressure-bearing part 323 is larger than the size of the net mouth of the radial pressure-bearing part 322. At the same time, the thickness of the second elastic rib is designed to be greater than the first elastic rib. The thickness of the ribs is such that the axial pressure receiving part 323 as a whole can withstand a large axial bending torque, so that when the outer wall of the axial pressure receiving part 323 is subjected to a non-forced external force, its radial and axial deformations are relatively small. small, which further strengthens the overall bending resistance of the pressure-receiving part 320 to ensure that the gap between the inner wall of the pressure-receiving part 320 and the outer wall of the impeller 220 is basically in a stable and unchanged state, preventing the blood flowing through the inside of the pressure-receiving part 320 Mechanical hemolysis occurs.

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 disposed on the hub 221 . Specifically, the elastic blade 222 can be a helical blade to improve the pumping blood flow rate of the whole catheter pump casing structure, the hub 221 and the elastic blade 222 are integrally formed, and the hub 221 can be sleeved on the distal end of the rotating shaft 210 to achieve the same The coaxial connection of the rotating shaft 210 improves the convenience of disassembling and assembling the impeller 220 as a whole.

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 part 320 is tightly connected to the support The surrounding wall of seat 100.

Specifically, the support seat 100 is a support tube with both ends substantially sealed, and the rotating shaft 210 can be rotatably arranged at the central axis of the supporting tube through a transmission bearing, and the distal end of the rotating shaft 210 passes through the distal end of the supporting tube and extends Into the pressure-receiving part 320 of the pump casing 300, provide a carrier for the suspension of the impeller 220, and also prevent the blood in the first cavity from entering the support tube as much as possible. At the same time, by designing the central axis of the support seat 100 to coincide with the central axis of the pump casing 300, it is possible to avoid irregular expansion of the pump casing 300 after being forcibly compressed, and to ensure that the pump casing 300 expands into a roughly caged shape after being forcibly compressed. Shape or football shape, improve the overall stability of the whole pump casing 300.

Referring to Fig. 1, Fig. 6 and Fig. 7, in some embodiments of the present application, the casing structure of the catheter pump of the embodiment of the present application further includes a pigtail tube 700 connected to the distal end of the pressure relief part 310 and a pigtail tube for passing through 700 of the guide wire 800 , the distal end of the guide wire 800 can extend out from the distal end of the pigtail tube 700 , and the proximal end of the guide wire 800 can extend out of the blood suction port 340 .

Specifically, in this embodiment, both the distal end of the pressure relief part 310 and the proximal end of the pressure receiving part 320 have an interface with a small inner diameter, the proximal end of the pigtail tube 700 and the sleeve part, the support seat 100 is tubular, and supports The distal end of the seat 100 is also a socket part. When the pigtail pipe 700, the pump casing 300 and the support seat 100 are installed and connected, the port at the far end of the pressure relief part 310 and the port at the proximal end of the pressure receiving part 320 can be respectively sealed and socketed. On the socket part of the pigtail pipe 700 and the support seat 100, to complete the installation and connection of the pigtail pipe 700, the pump casing 300 and the support seat 100, so that the pigtail pipe 700 and the support seat 100 are respectively opposite to the far end of the pump casing 300 and the proximal end play a bearing and supporting role to ensure the stable and regular expansion of the pump housing 300 after being forcibly compressed, further reducing the probability of mechanical hemolysis of the blood flowing through the pump housing 300 .

In addition, in this embodiment, the distal end of the pigtail tube 700 has a curved section, which plays the role of positioning and support, and avoids the phenomenon of the blood suction port 340 sticking to the wall in the ventricle. If the blood suction port 340 sticks to the wall, it will cause tissue congestion. In addition, referring to FIG. 6 , in this embodiment, a delivery tube 900 is also included, and the delivery tube 900 is used to sheath the support base 100 and the pump casing 300 , and force the pump casing 300 and the impeller 220 into a contracted state.

Referring to Fig. 6 again, it should be noted that before the casing structure of the catheter pump in the embodiment of the present application is inserted into the patient's body, the casing structure of the catheter pump as a whole can be placed in a delivery tube 900 with a smaller diameter, and the delivery device can be a delivery tube with a smaller diameter. A small delivery tube, at this time, the pump housing 300 and the impeller 220 inside the pump housing 300 are forcibly compressed by the delivery tube 900 , and are in the delivery tube in a compressed state with a minimum volume. At this time, the plurality of elastic blades 222 disposed on the hub 221 along the circumferential direction are wound around the outer wall of the hub 221 under the forced compression force to maintain a compressed state with 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 casing structure of the catheter pump needs to be inserted into the patient's body, the doctor can first insert the distal end of the guide wire 800 into the target position in the patient's body according to a predetermined path, and make the guide wire 800 extend along the path of the blood vessel so that its proximal end Stretch out of the body, and then set the pigtail tube 700 connected to the distal end of the pressure relief part 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 tube 700 can be placed on the guide wire Under the guidance of 800, the whole casing structure of the catheter pump is driven to the target position. At this time, the proximal end of the guide wire 800 passes through the guiding cavity in the guiding hose 500 and the blood sucked at the distal end of the pressure relief part 310 in sequence. The port 340 protrudes from the opening on the outer wall of the distal end of the delivery tube 900, thus completing the precise intervention of the entire catheter pump housing structure. Then, the doctor 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 inside the pump casing 300 are not forced by the delivery tube 900, that is, they move radially at the target position. Expand, the pump casing 300 and the plurality of elastic blades 222 on the hub 221 expand radially and return to the initial maximum volume state, at this time the first cavity 330 is also in the maximum volume state, so as to obtain greater pumping blood flow.

It is not difficult to understand that the arrangement of the pigtail tube 700, the guide wire 800 and the delivery tube 900 in this application not only facilitates the doctor to quickly insert the entire catheter pump housing structure into the corresponding blood transfusion organ, but also improves the overall catheter pump. The accuracy of the casing structure being inserted into the corresponding blood transfusion organ can effectively reduce the surgical wound area caused by the whole catheter pump casing structure being inserted into the patient's body through percutaneous surgery, and can obtain greater pump blood flow. At the same time, it can ensure the smooth introduction of the entire catheter pump casing structure into the patient's body and minimize the surgical damage to the patient, and can better prevent the entire catheter pump casing structure from being placed in the position of vascular stenosis, aortic arch, and ventricular valve. Damage to native tissue.

It can be understood that when the pigtail tube 700 enters the target position along the track of the guide wire 800, when the pigtail tube 700 contacts or collides with the blood vessel wall, similarly, the pressure relief part 310 connected to the pigtail tube 700 First, it will be subjected to the force transmitted by the pigtail tube 700, and the elastic bending bar 311 constituting the pressure relief part 310 will undergo elastic deformation when it receives the force, so that the entire pressure relief part 310 can realize the buffering and pressure relief of the force, effectively avoiding The force is further transmitted to the pressure-receiving part 320, resulting in a large deformation of the pressure-receiving part 320, preventing the gap between the impeller 220 inside the pressure-receiving part 320 and the pressure-receiving part 320 from reducing, and further reducing the occurrence of mechanical hemolysis and The probability that the impeller 220 is stuck on the pressure receiving part 320 due to contact with the inner wall of the pressure receiving part 320 .

In addition, referring to FIG. 1 , FIG. 4 and FIG. 5 , the embodiment of the present application also provides a catheter pump device, which includes a multi-chamber sheath 500 and the above-mentioned catheter pump casing structure.

Wherein, the support seat 100 is a support sleeve, and the far end of the support sleeve is provided with a perfusion cavity 110. The transmission assembly 200 also includes a bearing sleeve 240 and a transmission bearing 230 arranged in the support sleeve. The rotating shaft 210 is installed on the bearing sleeve through the transmission bearing 230. 240, the outer wall of the bearing sleeve 240 is provided with an outer layer flow channel 241 communicating with the perfusion chamber 110, and the gap between the inner ring and the outer ring of the transmission bearing 230 forms an inner layer flow channel 231 that communicates with the perfusion cavity 110. The distal end of the body sheath 500 is connected to the proximal end of the support sleeve, and the multi-cavity sheath 500 is provided with an inflow channel 510 communicating with the outer layer flow channel 241 and an outflow channel 520 communicating with the inner layer flow channel 231 . It should be noted that there may be one or more transmission bearings 230, and the specific number is not limited.

In the catheter pump device of the embodiment of the present application, a bearing sleeve 240 is provided in the support sleeve, and an outer layer flow channel 241 is opened on the outer wall of the bearing sleeve 240. 500, so that when the whole catheter pump device is in operation, the operator can perfuse liquid into the inflow channel 510, so that the liquid flows into the perfusion chamber 110 at the distal end of the support sleeve after passing through the inflow channel 510 and the outer layer flow channel 241, thanks to the transmission The inner flow channel 231 formed by the gap between the inner ring and the outer ring of the bearing 230 communicates with the perfusion cavity 110 and the outflow channel 520 in the multi-cavity sheath 500 respectively, and the liquid in the perfusion cavity 110 will continue to flow through the inner layer The flow channel 231 and the outflow channel 520 finally flow out from the outlet of the outflow channel 520. Through the above flow mode, the liquid can effectively discharge the insoluble particles generated when the rotating shaft 210 and the transmission bearing 230 perform synchronous high-speed rotating motion, avoiding insoluble particles Entering the human blood and causing danger to the human body. Since the impeller 220 is suspended on the support base 100, no particles are generated at the far end of the impeller 200, so the above structure can realize the elimination of insoluble particles generated during operation, and almost zero particles enter the human body, and the product is very safe.

At the same time, during the circulating flow of the liquid along the above-mentioned flow path, it can also continuously exchange heat with the rotating shaft 210 and the transmission bearing 230, so that the heat generated by the rotating shaft 210 and the transmission bearing 230 during high-speed rotation can be discharged in time. In this way, the structural damage of the rotating shaft 210 and the transmission bearing 230 due to overheating can be avoided, and the rotating operation function of the impeller 220 suspended at the distal end of the rotating shaft 210 can be ensured, thereby ensuring the normal and stable blood pumping function of the entire catheter pump device.

In addition, referring to FIG. 5 again, in some embodiments of the present application, the outer flow channel 241, the inflow channel 510, and the outflow channel 520 are all annular, so as to adapt to the cylindrical shape of the transmission bearing 230 and the transmission bearing 230. The annular inner flow channel 231 formed by the inner ring and the outer ring enables the perfusion liquid to more comprehensively take out insoluble particles and heat generated when the rotating shaft 210 and the transmission bearing 230 perform synchronous high-speed rotating motion.

In addition, referring to FIG. 5 again, in some embodiments of the present application, an installation cavity is opened in the middle of the multi-cavity sheath tube 500, and the proximal end of the rotating shaft 210 is connected to the driving member through the transmission twisted wire 250, and the transmission twisted wire 250 passes through located in the installation cavity.

Specifically, the multi-lumen sheath 500 includes a nested inner sheath and an outer sheath, and the distal ends of the inner sheath and the outer sheath are embedded on the inner wall of the proximal end of the support sleeve to realize the multi-lumen sheath. 500 docking assembly, the middle cavity of the inner sheath tube forms an installation cavity for the transmission twisted wire 250 to pass through, and the rotating shaft 210 can be connected to the driving part outside the body through the transmission twisted wire 250. The driving part can be a motor or a motor, etc. The rotating driving member provides rotating power for the rotating shaft 210 and the impeller 220 .

In addition, the outflow channel 520 is annularly opened on the inner or outer wall of the inner sheath, and the inflow channel 510 is annularly opened on the inner or outer wall of the outer sheath of the outer sheath, so as to ensure that the outflow channel 520 and the outflow channel 520 are respectively connected with the outer layer flow. The channel 241 and the inner layer flow channel 231 are annularly connected, so that the insoluble particles and heat generated when the rotating shaft 210 and the transmission bearing 230 perform synchronous high-speed rotating motion can be quickly taken 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 arranged on the outer wall of the pressure-receiving part 320 and covers the blood outflow port 350 , and the outer wall of the flexible tube 600 At least one outflow window 610 is opened, and the cavity of the flexible tube 600 forms a flow cavity 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 can also be connected to the outer wall of the pressure relief part 310 . In addition, in this embodiment, the distal end of the flexible tube 600 is sealingly connected to the outer wall of the pressure-receiving part 320, and the proximal end of the flexible tube 600 is sealingly connected to the outer wall of the multi-lumen sheath 500, so that the support sleeve and the multi-lumen sheath 500 Both are axially installed in the cavity of the flexible tube 600, so that the pressure-receiving part 320 and the multi-cavity sheath 500 simultaneously support and carry the flexible tube 600, ensuring stable expansion or contraction of the flexible tube 600.

Referring to FIG. 7 and FIG. 8 , when the catheter pump device according to the embodiment of the present application is applied, the physician can insert the entire catheter pump device into the patient's body through a percutaneous operation and with the help of the delivery tube 900 as a carrier, so that the entire catheter pump device spans across the body as a whole. Pass through the heart valve 30, and make the pump housing 300 and the impeller 220 in the patient's ventricle 20 in an expanded state, so that the blood suction port 340 on the far end of the pressure relief part 310 communicates with the ventricle 20, and at the same time, the flexible tube 600 spans The heart valve 30 is located between the ventricle 20 and the blood vessel 10 communicating with the ventricle 20 , so that the outflow window 610 on the flexible tube 600 communicates with the blood vessel 10 , and the patient's heart valve 30 only touches the outer wall of the flexible tube 600 .

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

During the above-mentioned blood transportation process, due to the structural characteristics of the flexible tube 600 as an elastic tube, after the blood continuously enters the circulation chamber 620, the volume of the flexible tube 600 continues to expand. When the volume of the flexible tube 600 expands to the maximum state, the flexible tube 600 is in a full state, and the caliber of the outflow window 610 set on the flexible tube 600 is simultaneously expanded to the maximum. The flow reaches the maximum value, and the blood flow delivered to the blood vessel 10 by the entire catheter pump device is greatly increased without changing the rotation speed of the impeller 220 .

When the heart valve 30 is closed, the leaflets of the heart valve 30 are aligned with each other, thereby squeezing the outer wall of the flexible tube 600, so that the flexible tube 600 shrinks along the line of alignment of the leaflets, thereby greatly reducing the diameter of the flow chamber 620 or even closing it. The flow chamber 620 prevents blood from flowing into the blood vessel 10 ; when the heart valve 30 is opened, the flexible tube 600 expands to the maximum state under the pressure of the blood, and the blood flows into the blood vessel 10 again at the maximum flow rate. As the patient's heart valve 30 continues to open and close, the flexible tube 600 expands and contracts synchronously, thereby generating pulsatile blood flow or pulsatile blood flow output that matches the diastolic and systolic characteristics of the patient's heart, improving coronary and It reduces the burden on the heart while improving the perfusion of the distal organs, which is conducive to the stability of the patient's signs during the operation and postoperative recovery.

It should be noted that, in the above description, the ventricle 20 may correspond to the patient's left ventricle or right ventricle, and correspondingly, the blood vessel 10 corresponds to the aorta communicating with the left ventricle or the pulmonary artery communicating with the right ventricle, and the corresponding heart valve 30 corresponds to the aortic valve between the left ventricle and the aorta or the pulmonary valve between the right ventricle and the pulmonary artery. Of course, the application scenarios of the catheter pump device of the present application are not limited to the above-mentioned left ventricle and aorta, right ventricle and pulmonary artery, and can also be applied to other tissues and organs of the human body to assist in pumping blood.

In the catheter pump device of the embodiment of the present application, a flexible tube 600 is arranged on the pump casing 300, and the flexible tube 600 is configured as an elastic hose structure whose outer wall can expand and contract. At the same time, the flexible tube 600 is cleverly arranged on the pump casing 300, and utilize the expandable and contractible structural characteristics of the flexible tube 600, and make the pump casing 300 and the impeller 220 in the ventricle 20 in the unfolded state, without changing the rotation speed of the impeller 200, the pumping to The blood flow in the blood vessel 10, and makes the flexible tube 600 expand and contract synchronously under the opening and closing action of the heart valve 30, so that the whole catheter pump device can produce pulsating blood that matches the diastolic and contractile characteristics of the patient's heart. The flow or pulsatile blood output can improve the perfusion of coronary arteries and remote organs while reducing the burden on the heart, which is beneficial to the stability of the patient's signs during the operation and postoperative recovery.

In addition, using the expandable and contractible structural characteristics of the flexible tube 600, the flexible tube 600 is in an initial contracted state before being inserted into the patient's body. The flexible tube 600 is inserted into the position of the patient's heart valve 30 through percutaneous surgery, which can minimize the surgical wound area, and at the same time, increase the pumping blood flow rate of the entire catheter pump device under the same surgical wound area.

Referring to Fig. 9, in some embodiments of the present application, the pump housing 300, the support sleeve, the multi-chamber sheath 500 connected to the proximal end of the support base 100, and the two ends are respectively sealed and connected to the outer wall of the pump housing 300 and the multi-chamber sheath For the flexible tube 600 on the outer wall of the tube 500, the central axes of the above four are coincident. It should be noted that the multi-cavity sheath tube 500 is a flexible and bendable structure, which will not cause structural damage to the corresponding blood vessels or blood transfusion organs, and can be easily Adapts well to the curved or convoluted shape of the corresponding blood line.

And in this embodiment, the flexible pipe 600 includes a straight line interface segment, a rounded corner segment, a circular arc transition segment, a middle straight line segment, and a lead-out segment that are smoothly connected in sequence, and the circular arc transition segment is tangent to the middle straight line segment, so that the entire flexible pipe The overall outer wall profile of the tube 600 transitions smoothly. There are multiple outflow windows 610 and they are arranged at intervals along the circumferential direction on the outer wall of the outlet section. It can be understood that the distal end of the flexible tube 600 is sealed and connected to the outer wall of the pressure-receiving part 320 through the straight line interface section, and then will cover the blood outflow port 350, and the proximal end of the flexible tube 600 is sealed and connected to the multi-chamber sheath through the lead-out section. The outer wall of the tube 500.

It can be understood that, in this embodiment, the inner diameter of the rounded corner section and the inner diameter of the arc transition section gradually increase from the far end to the proximal end, the inner diameter of the round corner section is larger than the inner diameter of the straight line interface section, and the arc transition section The inside diameter of is larger than the inside diameter of the fillet segment.

Referring to FIG. 9 again, in this embodiment, the diameter of the straight line interface section is D1, and D1 is determined by the maximum radial dimension of the pump casing 300 that is allowed to expand radially. The diameter of the middle straight segment is D2, and D2 is determined by the diameter of the patient's blood vessel. The axial length of the pump casing 300 that allows radial stretching and deformation is L1. The sum of the axial lengths of the straight line interface section, the fillet section and the arc transition section is L2. The included angle between the line connecting the midpoint of the main boundary of the straight interface segment and the midpoint of the main boundary of the intermediate straight section and the central axis of the pump casing 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 embodiment, the value range of R1 is 0 to L1/tan(α/2), and the value range of R2 is 0 to (D2-D1)/(2*tan(α/2)*sin(α )), the value of L2 is (D2-D1)/(2*tan(α)).

It should be noted that if the value of R1 above is too small, it means that the overall profile of the fillet section is relatively curved, which is likely to cause a shedding vortex in the blood flow passing through the fillet section, which affects the stability of blood flow and causes hemolytic damage ;Similarly, if the value of R2 above is too small, it is easy to cause off-flow vortex in the blood flow passing through the arc transition section, which will affect the stability of blood flow and cause hemolytic damage; at the same time, the larger the value of α above, it means The larger the difference between the diameter of the straight line interface section and the diameter of the middle straight section, that is to say, the larger the change in the overall radial dimension of the flow cavity 620 formed by the cavity of the flexible tube 600, the greater the change in the overall radial dimension of the flow cavity 620 , the blood flowing through the flow chamber 620 is also prone to shedding vortices, which affects the stability of the blood flow and causes hemolytic damage.

Referring to Fig. 10 and Fig. 11, Fig. 10 is a flow diagram of blood flowing through the flow chamber 620 obtained by simulation software when the value of α above is 0; Fig. 11 is when the value of α above is 12°, The flow diagram of blood flowing through the flow chamber 620 is obtained by simulation software. It is not difficult to find that when the value of α is 0, that is, when the flexible tube 600 is similar to a long straight tube as a whole, the blood flow in the flow chamber 620 is smooth, and there is basically no shedding vortex phenomenon; when the value of α is When the angle is 12°, the shedding vortex phenomenon of the blood flowing through the flow chamber 620 is more obvious, indicating that in this case, the blood flowing through the flow chamber 620 is unstable and prone to hemolytic damage.

Therefore, in order to ensure that the flow chamber 620 formed by the entire flexible tube 600 can expand normally under the impact of blood, thereby increasing the pump blood flow rate of the entire catheter pump device, and at the same time, reduce the occurrence of blood flow through the flow chamber 620 as much as possible. The probability of shedding vortex, in a preferred embodiment, on the basis of the value of L2 (D2-D1)/(2*tan (α)), the value of above-mentioned R1 is L1/tan (α/ 2), the value of R2 is (D2-D1)/(2*tan(α/2)*sin(α)). According to the results of simulation calculations and experimental tests, in this embodiment, when the shapes and sizes of the straight interface section, rounded corner section, arc transition section and intermediate straight section that constitute the flexible pipe 600 meet the above conditions and parameters, Not only the flexible tube 600 can expand stably to increase the pumping blood flow rate of the catheter pump device, but also the blood flow through the flow chamber 620 formed by the flexible tube 600 cavity is the least likely to appear shedding vortices, avoiding hemolysis damage.

The above is only the specific implementation of the embodiment of the present application, but the protection scope of the embodiment of the present application is not limited thereto. Any person familiar with the technical field can easily think of various Equivalent modification or replacement, these modifications or replacement should be covered within the scope of protection of the embodiments of the present application. Therefore, the protection scope of the embodiments of the present application should be determined by the protection scope of the claims.

Claims (15)

1. A casing structure of a catheter pump, comprising:

   Support base;

   The transmission assembly includes a rotating shaft arranged on the support seat and an impeller arranged at the far end of the rotating shaft;

   The pump casing includes a pressure relief part surrounded by a plurality of elastic bending bars and a pressure receiving part abutted with the pressure relief part, the proximal end of the pressure receiving part is connected to the support seat, and the pressure receiving part is composed of An elastic mesh structure surrounds the impeller, and the distal end of the pressure relief part and the proximal end of the pressure receiving part are respectively provided with a blood suction port and a blood outflow port;

   an elastic covering layer covering the mesh opening of the pressure-receiving part to seal and form a first cavity communicating with the blood suction port and the blood outflow port;

   Wherein, both the pump casing and the impeller are configured as self-expandable structures after being compressed.
2. The housing structure of the catheter pump according to claim 1, wherein the elastic bending strips are formed by sequentially connecting multiple segments in the shape of an "S" or "W", and two adjacent elastic bending strips are not cross.
3. The casing structure of the catheter pump according to claim 1, wherein the mesh opening is in the shape of a rhombus.
4. The casing structure of the catheter pump according to claim 1, wherein the pressure receiving portion includes a radial pressure receiving portion abutting with the pressure relief portion and an axial pressure receiving portion connected to the support seat, the pressure receiving portion The radial pressure receiving part is surrounded by a plurality of first elastic ribs to form a cage shape, and the axial pressure receiving part is surrounded by a plurality of second elastic ribs to form a cage shape and is in contact with the radial pressure receiving part.
5. The casing structure of the catheter pump according to claim 4, wherein the thickness of the second elastic rib is greater than the thickness of the first elastic rib.
6. The housing structure of the catheter pump according to claim 1, wherein the impeller comprises a hub coaxially connected with the rotating shaft and a plurality of elastic blades disposed on the hub along a circumferential direction.
7. A catheter pump device, comprising:

   The casing structure of a catheter pump according to any one of claims 1 to 6; wherein, the support base is a support sleeve, and the distal end of the support sleeve is provided with a perfusion cavity;

   The transmission assembly also includes a bearing sleeve and a transmission bearing arranged in the support sleeve, the rotating shaft is installed in the bearing sleeve through the transmission bearing, and the outer wall of the bearing sleeve has a A connected outer layer flow channel, the gap between the inner ring and the outer ring of the transmission bearing forms an inner layer flow channel that communicates with the perfusion chamber;

   The multi-cavity sheath is connected to the proximal end of the support sleeve at the far end, and is provided with an inflow channel communicated with the outer layer flow channel and an outflow channel communicated with the inner layer flow channel.
8. The catheter pump device according to claim 7, wherein the outer flow channel, the inflow channel and the outflow channel are all annular.
9. The catheter pump device according to claim 7, wherein an installation cavity is opened in the middle of the multi-cavity sheath tube, and the proximal end of the rotating shaft is connected to the driving member through a transmission twisted wire, and the transmission twisted wire passes through in the installation cavity.
10. The catheter pump device according to claim 7, further comprising a flexible tube, the flexible tube is arranged on the outer wall of the pressure-receiving part and covers the blood outflow port, and at least one opening is opened on the outer wall of the flexible tube The outflow window, the cavity of the flexible tube forms a flow cavity communicating with the blood outflow port and the outflow window, and the flexible tube is configured as an elastic hose structure whose outer wall can expand and contract.
11. The catheter pump device according to claim 10, wherein the flexible tube includes a straight line interface section, a rounded corner section, a circular arc transition section, an intermediate straight line section, and a lead-out section that are smoothly connected in sequence, and the circular arc transition section is connected with the The middle straight section is tangent to the middle straight section, the outflow window is set in the outlet section, the distal end of the flexible tube is connected to the outer wall of the pressure-bearing part through the straight line interface section to cover the blood outflow port, and the flexible tube The proximal end of the tube is connected to the outer wall of the multi-cavity sheath through the lead-out section, and the inner diameter of the rounded section and the inner diameter of the arc transition section gradually increase from the distal end to the proximal end. The inner diameter of the corner section is larger than that of the straight line interface section, and the inner diameter of the arc transition section is larger than that of the round corner section.
12. The catheter pump device of claim 11 , wherein the flexible tube is shaped to:

    The diameter of the straight interface section is D1;

    The diameter of the middle straight section is D2;

    The axial length of the pump casing that allows radial stretching and deformation is L1;

    The sum of the axial lengths of the straight line interface section, the rounded corner section and the arc transition section is L2;

    The angle between the line between the midpoint of the main boundary of the straight interface section and the midpoint of the main boundary of the intermediate straight section and the central axis of the pump casing 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,

    The value range of α is 0°～10°;

    The value range of R1 is 0～L1/tan(α/2);

    The value range of R2 is 0～(D2-D1)/(2*tan(α/2)*sin(α));

    The value range of L2 is 0-(D2-D1)/(2*tan(α)).
13. The catheter pump device of claim 12, wherein the flexible tube is shaped to:

    The α=5°;

    Said R1=L1/tan(α/2);

    The R2=(D2-D1)/(2*tan(α/2)*sin(α));

    The L2=(D2-D1)/(2*tan(α)).
14. The housing structure of the catheter pump according to claim 7, further comprising a pigtail tube connected to the distal end of the pressure relief part and a guide wire for passing through the pigtail tube, the distal end of the guide wire The distal end of the guide wire can protrude from the distal end of the pigtail tube, and the proximal end of the guide wire can protrude from the blood suction port.
15. The casing structure of the catheter pump according to claim 7, further comprising a delivery tube, the delivery tube is used to sheath the support seat and the pump casing, and compress the pump casing and the impeller into a contracted state.

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