CN115154889A - Interventional type heart and kidney combined auxiliary assembly - Google Patents

Interventional type heart and kidney combined auxiliary assembly Download PDF

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Publication number
CN115154889A
CN115154889A CN202210897912.8A CN202210897912A CN115154889A CN 115154889 A CN115154889 A CN 115154889A CN 202210897912 A CN202210897912 A CN 202210897912A CN 115154889 A CN115154889 A CN 115154889A
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CN
China
Prior art keywords
shell
mechanical circulation
blood
impeller
interventional
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Pending
Application number
CN202210897912.8A
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Chinese (zh)
Inventor
解启莲
陈宏凯
刘欢
冯启涛
李帅康
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Anhui Tongling Bionic Technology Co Ltd
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Anhui Tongling Bionic Technology Co Ltd
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Publication of CN115154889A publication Critical patent/CN115154889A/en
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/10Location thereof with respect to the patient's body
    • A61M60/122Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body
    • A61M60/126Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable via, into, inside, in line, branching on, or around a blood vessel
    • A61M60/13Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable via, into, inside, in line, branching on, or around a blood vessel by means of a catheter allowing explantation, e.g. catheter pumps temporarily introduced via the vascular system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/10Location thereof with respect to the patient's body
    • A61M60/122Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body
    • A61M60/126Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable via, into, inside, in line, branching on, or around a blood vessel
    • A61M60/135Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable via, into, inside, in line, branching on, or around a blood vessel inside a blood vessel, e.g. using grafting
    • A61M60/139Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable via, into, inside, in line, branching on, or around a blood vessel inside a blood vessel, e.g. using grafting inside the aorta, e.g. intra-aortic balloon pumps
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/20Type thereof
    • A61M60/205Non-positive displacement blood pumps
    • A61M60/216Non-positive displacement blood pumps including a rotating member acting on the blood, e.g. impeller
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/20Type thereof
    • A61M60/205Non-positive displacement blood pumps
    • A61M60/216Non-positive displacement blood pumps including a rotating member acting on the blood, e.g. impeller
    • A61M60/237Non-positive displacement blood pumps including a rotating member acting on the blood, e.g. impeller the blood flow through the rotating member having mainly axial components, e.g. axial flow pumps
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/30Medical purposes thereof other than the enhancement of the cardiac output
    • A61M60/31Medical purposes thereof other than the enhancement of the cardiac output for enhancement of in vivo organ perfusion, e.g. retroperfusion
    • A61M60/33Medical purposes thereof other than the enhancement of the cardiac output for enhancement of in vivo organ perfusion, e.g. retroperfusion of kidneys
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/40Details relating to driving
    • A61M60/403Details relating to driving for non-positive displacement blood pumps
    • A61M60/408Details relating to driving for non-positive displacement blood pumps the force acting on the blood contacting member being mechanical, e.g. transmitted by a shaft or cable
    • A61M60/411Details relating to driving for non-positive displacement blood pumps the force acting on the blood contacting member being mechanical, e.g. transmitted by a shaft or cable generated by an electromotor
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/40Details relating to driving
    • A61M60/403Details relating to driving for non-positive displacement blood pumps
    • A61M60/408Details relating to driving for non-positive displacement blood pumps the force acting on the blood contacting member being mechanical, e.g. transmitted by a shaft or cable
    • A61M60/411Details relating to driving for non-positive displacement blood pumps the force acting on the blood contacting member being mechanical, e.g. transmitted by a shaft or cable generated by an electromotor
    • A61M60/414Details relating to driving for non-positive displacement blood pumps the force acting on the blood contacting member being mechanical, e.g. transmitted by a shaft or cable generated by an electromotor transmitted by a rotating cable, e.g. for blood pumps mounted on a catheter
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/80Constructional details other than related to driving
    • A61M60/802Constructional details other than related to driving of non-positive displacement blood pumps
    • A61M60/81Pump housings
    • A61M60/812Vanes or blades, e.g. static flow guides
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/80Constructional details other than related to driving
    • A61M60/855Constructional details other than related to driving of implantable pumps or pumping devices
    • A61M60/861Connections or anchorings for connecting or anchoring pumps or pumping devices to parts of the patient's body
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/33Controlling, regulating or measuring
    • A61M2205/3331Pressure; Flow
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/02Holding devices, e.g. on the body
    • A61M25/04Holding devices, e.g. on the body in the body, e.g. expansible
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02ATECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A50/00TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
    • Y02A50/30Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

Abstract

The invention belongs to the technical field of medical instruments, and particularly relates to an interventional type heart and kidney combined auxiliary assembly. The invention comprises a second mechanical circulation supporting device positioned in the descending aorta of a patient, wherein the second mechanical circulation supporting device comprises a tubular shell arranged at the far end of a second conduit, a second impeller is coaxially arranged in the shell, the second impeller is driven by a flexible driving shaft penetrating through the second conduit so as to generate rotary motion in a shell cavity, and the near end of the flexible driving shaft is connected with a power output shaft of an external motor; the proximal end of the housing is provided with a second blood outflow opening, the distal end of the housing is provided with a second blood inflow opening, and the proximal and/or distal outer wall of the housing is provided with a support body for positioning and supporting the second mechanical circulation support device at the vessel wall of the descending aorta. The invention can realize the secondary acceleration effect on the blood flow in the descending aorta, thereby effectively unloading the ventricular pressure and ensuring the blood flow perfusion of the terminal organ.

Description

Interventional type heart and kidney combined auxiliary assembly
The application claims priority of an interventional combined heart and kidney auxiliary system with application number 202210844673.X, applied on number 07/19/2022, and the former acceptance institution is China.
Technical Field
The invention belongs to the technical field of medical instruments, and particularly relates to an interventional type heart and kidney combined auxiliary assembly.
Background
The blood flow of the whole body of the human body is completed by pumping blood by the heart. The occurrence of cardiovascular diseases can cause heart failure, which is manifested as the failure of the systolic function and/or diastolic function of the heart, and the venous return blood volume cannot be sufficiently discharged out of the heart, so that the blood stasis of the venous interventional heart-kidney combined auxiliary assembly is caused, the arterial blood perfusion is insufficient, the heart blood circulation disorder is caused, and the life risks of organ failure, shock and the like are caused. Currently, there are mechanical circulatory support devices, or blood pumps, located in the descending aorta that can assist or replace the heart's pumping function, unload ventricular pressure, and increase blood perfusion in the end organs (e.g., kidneys). However, the driving motor of this kind of device is located in vivo, the whole length of device is long, intervenes the degree of difficulty greatly, and the motor takes place the temperature rise when high-speed rotatory, has the damage to blood moreover.
Disclosure of Invention
The present invention aims to overcome the defects of the prior art and provide an interventional type heart-kidney combination auxiliary assembly capable of working in a descending aorta, which can realize a secondary acceleration effect on blood flow in the descending aorta, thereby effectively unloading ventricular pressure and ensuring blood perfusion of a terminal organ.
In order to realize the purpose, the invention adopts the following technical scheme:
an interventional cardiorenal combination aid, comprising: the second mechanical circulation supporting device comprises a tubular shell arranged at the far end of a second conduit, a second impeller is coaxially arranged in the shell, the second impeller is driven by a flexible driving shaft penetrating through the second conduit to generate rotary motion in a shell cavity, and the near end of the flexible driving shaft is connected with a power output shaft of an external motor; the proximal end of the housing is provided with a second blood outflow opening, the distal end of the housing is provided with a second blood inflow opening, and the proximal and/or distal outer wall of the housing is provided with a support body for positioning and supporting the second mechanical circulation support device at the vessel wall of the descending aorta.
Preferably, the first mechanical circulation support device is located in a ventricle of the patient, and the first mechanical circulation support device and the second mechanical circulation support device are connected to the outside of the human body through a first catheter and a second catheter, respectively.
Preferably, the shell is a tube body which is made of biocompatible metal/nonmetal materials and has two open ends, the far end of the shell is open and forms a second blood inflow port, and the near end of the shell is connected with the second catheter through a connecting column; in the circumferential direction of the shell, the hole paths formed between every two adjacent connecting columns form the second blood outlet; the second impeller is a hard impeller and is arranged in the pipe cavity of the shell.
Preferably, the second impeller and the shell are both of radial expandable and contractible structures; the shell comprises a bracket and a thin film covered at the inner layer and/or the outer layer and/or the interlayer of the bracket; the support is a hollow tube body formed by weaving or laser cutting a deformable memory alloy material, and a hollow tube type protective peripheral wall structure of the shell is formed after the hollow tube body is covered by a film; of the two ends of the stent, the proximal region not covered by the membrane constitutes a second blood outlet port, and the distal region not covered by the membrane constitutes a second blood inlet port.
Preferably, the flexible drive shaft is woven from flexible cables; and a pipe orifice at the far end of the second guide pipe is matched with a rigid shaft through a bearing at the near end, and two ends of the rigid shaft are respectively and coaxially fixedly connected with a flexible driving shaft and a second impeller hub.
Preferably, a gap for passing through the cleaning fluid is reserved between the flexible driving shaft and the second conduit; cleaning fluid flows in from an inlet pipe preset on a second catheter outside the body and flows out from a near-end bearing of a far-end pipe orifice of the second catheter; the pressure of the purge fluid is in the range of 50mmHg to 1500 mmHg.
Preferably, the support body is made of a deformable memory alloy material and has an expansion structure in an expansion state and a contraction structure in a stressed state; the supporting body comprises a strut fixed on the outer wall of the shell, the strut extends from a near end to a far end, the radial distance between the strut and the outer wall of the shell is gradually increased along the extending direction, and more than three groups of struts are sequentially arranged around the axis of the shell so as to form claw-shaped supporting claws; the extending end of the strut is provided with a contact pad used for improving the anchoring effect relative to the vessel wall, and the middle section of the strut is provided with a knee part which is bent and arched outwards.
Preferably, the proximal ends of the first mechanical circulation support device and the second mechanical circulation support device both pass through the same double-cavity connecting pipe and then are communicated to the outside of the body, and the double-cavity connecting pipe is internally provided with two independent cavities for respectively accommodating the first catheter and the second catheter.
Preferably, the shell is provided with a preformed groove or a preformed hole for the second conduit to pass through; the preformed groove and the preformed hole are arranged in a penetrating mode along the axis direction of the shell and are mutually avoided with the action path of the second impeller in the shell.
Preferably, the first mechanical circulation supporting device and the second mechanical circulation supporting device are respectively provided with a pressure sensor; the pressure sensor is an optical fiber pressure sensor; the first mechanical circulation support device is in communication with a first controller configured to operate the first mechanical circulation support device at a first rate; the second mechanical circulation support device is in communication with a second controller configured to operate the second mechanical circulation support device at a second rate; the second rate is 30% to 80% of the first rate.
The invention has the beneficial effects that:
1) According to the scheme, on one hand, the axial flow pump structure formed by the shell and the second impeller driven by the extracorporeal motor to rotate is adopted, so that the axial flow pumping effect of blood is realized. When in design, the invention can be independently used, and also can be additionally arranged at the descending aorta close to the ventricle on the basis of a percutaneous ventricular assist device, so that a pump group formed by connecting two pump bodies in series can realize the primary acceleration effect on the blood flow in the ventricle and the secondary acceleration effect on the blood flow in the descending aorta, and the blood can overcome the pressure difference between the left ventricle and the descending aorta to finish the blood flow discharge movement. Due to the fact that an in-vitro motor driving scheme is used, the whole power system can be completely arranged externally, and the power transmission function is achieved by means of the flexible driving shaft in the second guide pipe, so that the power transmission device has the advantages of being small in size, strong in function and convenient to operate, ventricular pressure can be effectively relieved, and blood perfusion of a terminal organ can be finally guaranteed. On the other hand, on the basis of the structure, the invention additionally arranges a support outside the shell. The function of the support body is to ensure the constancy of the position of the main structure at the descending aorta, so that a reliable operation of the main structure is ensured even under high-speed flushing of the blood flow in the descending aorta. During actual installation, the support body can keep a contraction state under the action of the sheath tube, and can also keep the contraction state due to special materials such as deformable memory alloy materials and the like; when the descending aorta is placed, the supporting body can be expanded in the radial direction, so that the fixed purpose of stably supporting and fixing the main structures such as the shell and the second impeller at the designated position of the descending aorta is realized by depending on the supporting and positioning functions of the supporting body relative to the blood vessel wall after the supporting body is expanded, and the effect is very obvious.
2) Furthermore, the invention utilizes the pump set formed by connecting the two pump bodies in series to realize the double acceleration function of blood, so as to ensure that the blood can overcome the pressure difference between the left ventricle and the descending aorta to finish the blood flow discharge movement, effectively reduce the occurrence rate of hemolysis and have simple and convenient clinical operation.
Drawings
FIG. 1 is a schematic view of the structure of the present invention;
FIG. 2 is a schematic view of a second mechanical circulation support device;
FIG. 3 is a schematic view of the assembly of one embodiment of the housing, the second conduit and the second impeller in operation;
FIG. 4 is a schematic view of the second impeller in a contracted state;
FIG. 5 is a schematic structural view of another embodiment of the housing in an operating state;
FIG. 6 is a schematic view of the engagement of the flexible drive shaft with the second conduit;
fig. 7 and 8 are schematic structural views of two embodiments of the support body.
The actual correspondence between each label and the part name of the invention is as follows:
10-first mechanical circulation support means 11-first catheter 12-first blood outflow port
13-cannula 14-first blood inflow 15-pigtail
20-second mechanical circulation support means 21-second conduit
22-housing 22 a-support 22 b-membrane
23-second blood flow inlet 24-second blood flow outlet
25-second impeller 26-flexible driving shaft 27-external motor
28 a-rigid shaft 28 b-proximal bearing
29-support 29 a-strut 29 b-contact pad 29 c-knee 29 d-curved strut
Detailed Description
For ease of understanding, the specific construction and operation of the present invention is further described herein with reference to FIGS. 1-8:
for ease of understanding, the term "proximal" is defined herein first as the end of the interventional medical device that is closer to the operator, and the term "distal" is defined as the end of the interventional medical device that is farther from the operator.
The invention aims to unload left ventricular pumping pressure, relieve hemolytic injury of the device and increase kidney perfusion. In this design concept, the second mechanical circulation support device 20 of the present invention has a combined structure of "the external motor 27+ the second impeller 25+ the housing 22+ the flexible drive shaft 26+ the claw-like support body 29". In operation, the front end components of the present invention, i.e., the main body structures of the housing 22, the second impeller 25 and the proximal bearing 28b, are positioned in the descending aorta and are supported and positioned at designated locations in the descending aorta by the support 29.
Under the above design concept, the housing 22 and the second impeller 25 of the second mechanical circulation support device 20 have two design modes, that is, a radially expandable and contractible casing and a blade made of a rigid material, which are specifically as follows:
example 1
In this embodiment, the second impeller 25 and the casing 22 of the present invention are made of radially expandable and contractible materials. Wherein:
the second catheter 21 is a tubular elongated body extending from a proximal end to a distal end and may extend from within the body to outside the body for connection to a second controller. A rotatable flexible drive shaft 26 is provided within the second catheter 21, the proximal or drive end of the flexible drive shaft 26 being attached to an extracorporeal motor 27, and the distal end of the flexible drive shaft 26 being attached to the hub of the second impeller 25, as shown with particular reference to figures 2-3. When designed, the flexible drive shaft 26 may be braided from flexible cable for transmitting torque from the extracorporeal motor 27 to the second impeller 25. When assembled, the rigid shaft 28a is disposed at the distal end of the flexible drive shaft 26, and the rigid shaft 28a is disposed in the proximal bearing 28b for supporting the second impeller 25 for rotation by the proximal bearing 28 b.
The flexible drive shaft 26, as shown in fig. 2 and 6, is spaced from the second guide duct 21. In operation, the purging fluid extends outwardly from the body into the gap and toward the proximal bearing 28b so that, on the one hand, blood is less likely to enter the gap of the proximal bearing 28b in the cleaned proximal bearing 28b, which helps reduce thrombosis. On the other hand, purging the proximal bearing 28b with a cleaning fluid may lubricate the proximal bearing 28b and may transfer frictional heat away from the proximal bearing 28b, which may increase rotational speed, reduce power consumption, and extend the useful life of the present invention. The cleaning fluid may be any biocompatible fluid suitable for cleaning proximal bearing 28b, such as a heparin-containing saline solution, a heparin-free saline solution, a glucose solution, and/or water, among others. The pressure of the washing fluid is preferably in the range of 50mmHg (0.4 bar) to 1500mmHg (2 bar), more preferably in the range of 600mmHg (0.8 bar) to 1100mmHg (1.5 bar), over the washing pressure. In operation, a constriction or an annular protrusion may be disposed in the lumen of the second guide tube 21, so as to rapidly form a water film between the constriction or the annular protrusion and the shaft body of the flexible driving shaft 26, thereby further improving the high-speed rotation effect of the flexible driving shaft 26 relative to the second guide tube 21. Of course, it is preferred that the constriction is located at the desired bend of the second conduit 21.
A housing 22 having a hollow tubular structure. When assembling, one end of the housing 22 is connected with the second conduit 21 through the hollow bracket 22a, and the other end of the housing 22 is connected with the expandable support 29. More specifically, the housing 22 includes a support 22a and a film 22b covering an inner layer and/or an outer layer and/or an interlayer of the support 22 a. The preferred mode is as follows: the stent 22a is a hollow tube body formed by weaving or laser cutting a deformable memory alloy material such as nitinol wire, and the like, and forms a protective peripheral wall after being covered by a thin film 22b, for example, a film supported by a grid mesh, and the thin film 22b is made of a biocompatible material such as polyurethane.
A second impeller 25, having a hub and blades, is received and rotatably acts in the housing 22. The second impeller 25 is radially compressible or expandable, and may be manufactured, for example, by an injection molding process, an extrusion process, an injection molding process, etc., and is stressed such that the blades of the second impeller 25 can be bent and attached to the hub. The material for manufacturing the second impeller 25 may be PU, TPU, PEBAX, or a combination of two or more of these materials, or a mixture of these materials and a carbonate/polycarbonate fiber. The bracket 22a has smooth-transition inner and outer edges; in fig. 2-3 and 5, it can be seen that the region covered by the film 22b in the stent 22a forms a pump casing, and the front and rear ends form a second blood outlet port 24 and a second blood inlet port 23. In a specific embodiment, the second blood inlet 23 can be mounted on the adapter tube section between the housing 22 and the second catheter tube 21 when the adapter tube section is provided separately, can be arranged separately on the housing body at the proximal end of the housing 22, or can be both. Similarly, the second blood outlet 24 may be directly disposed at the tube opening at the distal end of the housing 22 as shown in fig. 2-3, or may be separately provided with a corresponding hole at the shell body at the distal end of the housing 22, or both; whatever the arrangement, it is ultimately mounted to the distal outer wall of the housing 22.
On the basis of the structure, the invention is additionally provided with a supporting body 29. The support 29 has an anchoring function capable of positioning and supporting the main structure in the descending aorta. The shape of the support 29 may be horn-shaped or mushroom-shaped or cage-shaped or egg-breaker-shaped or claw-shaped, so as to ensure the anchoring function and to facilitate the blood circulation and the insertion and extraction of the device. When designed, the supporting bodies 29 may be arranged in multiple sets along the axial direction of the respective pumps to increase stability when anchoring.
For the present invention, a claw-shaped support 29 with a support 29a as shown in fig. 2 and 7 to 8 is preferably used. As shown in fig. 7, the pillar 29a does not need to have a contact pad 29b at the top end, so as to increase the anchoring effect and promote climbing stability; at the same time, the support 29a should be provided with a bow-shaped bent structure, that is, the knee part 29c, so that a gap is ensured between the support 29 and the sheath tube during storage, thereby reducing friction. Of course, the three-claw shape in fig. 7 is also applicable to the two-claw type arch shape, provided that the positioning stability is ensured. The modified structure of fig. 8 can also be extended on the basis of the structure of fig. 7. In other words, taking three-jaw support as an example, in fig. 8, three legs 29a constituting three jaws may connect adjacent two legs 29a to each other by an elastic member such as a curved pressing bar 29 d. When the descending aorta is put in, since the sheath is sleeved on the outer wall of the blood circulation tube in the early stage, each strut 29a is radially compressed and folded, and the sheath is forced to bend the curve compression bar 29d to be in a force storage state. When the descending aorta is fed and the sheath is removed, the curved pressure lever 29d releases the force to drive the three struts 29a to reset and open to the state shown in fig. 8, thereby achieving the purpose of climbing and positioning the top-supporting vessel wall. Similarly, the curved pressing rod 29d can be replaced by other elastic force-storing structures, and only the force-storing and releasing effects are needed. In addition, in fig. 8, the positions of the knee part 29c and the contact pad 29b can also be seen, and will not be described herein.
In operation, the second mechanical circulation support device 20 is capable of communicating with a second controller. The second controller is configured to operate the second mechanical circulation support device 20 at a second rate at which the second mechanical circulation support device 20 can provide an operating flow rate of 1.5-6L/min, such as the second mechanical circulation support device 20 operating at a flow rate of 1.0L/min, 1.5L/min, 2.5L/min, or 3.0L/min. The second mechanical circulation support device 20 may also be provided with a pressure sensor, more preferably an optical fiber pressure sensor, for detecting the pressure of the blood flow at the descending aorta, so as to improve the effectiveness of monitoring physiological information, which will not be described herein again. In the actual design rate, the second rate is 30% to 80%, preferably 40% to 60%, and more preferably 50% of the first rate.
In fact, the first mechanical circulation support device 10 pumps the blood in the ventricle into the ascending aorta, wherein one part of the blood is used for supplying brain tissue, and the other part of the blood is guided to each terminal organ by the second mechanical circulation support device 20, so as to adapt to the physiological characteristics of the human body.
Example 2
Unlike embodiment 1, the casing 22 and the second impeller 25 in embodiment 2 are made of rigid materials, that is, the casing 22 and the second impeller 25 are made of conventional rigid materials with biocompatibility. Wherein:
the housing 22 is preferably a tube body made of biocompatible metal/nonmetal material and having two open ends, in which case, the distal end of the housing 22 is open and forms a second blood inflow port 23, and the housing 22 is connected to the second conduit 21 through a connecting column; the aperture formed between the adjacent connecting posts along the circumference of the housing 22 constitutes a second blood outflow port 24. Of course, the distal end of the housing 22 is likewise extended with a connection post, in which case the distal post replaces the open structure to form said second blood flow inlet 23.
The second catheter 21 is a tubular elongated body extending from a proximal end to a distal end and may extend from within the body to outside the body for connection to a controller. A rotatable flexible drive shaft 26 is disposed within the second conduit 21. Since the second impeller 25 is a rigid wheel, an axle extending from its hub may be substituted for the rigid axle 28a, i.e., the rigid axle 28a may be considered as the axle of the second impeller 25. At this point, the proximal, i.e., drive, end of the flexible drive shaft 26 is attached to the extracorporeal motor 27, and the distal end of the flexible drive shaft 26 is attached to the hub of the second impeller 25. When designed, the flexible drive shaft 26 may be braided from flexible cable for transmitting torque from the extracorporeal motor 27 to the second impeller 25. During assembly, the wheel shaft extending out of the wheel hub is matched with the near-end bearing 28b, so that the single-end rotary supporting effect is realized.
The flexible driving shaft 26, the supporting body 29 and the controller are the same as those of embodiment 1, and the description thereof is omitted.
Example 3
With further reference to fig. 1, the present invention actually comprises a first mechanical circulation support device 10 located in a ventricle of a patient and a second mechanical circulation support device 20 located in a descending aorta of the patient, the first mechanical circulation support device 10 and the second mechanical circulation support device 20 being connected to the outside of the human body through a first catheter 11 and a second catheter 21, respectively. By operating the first mechanical circulation support device 10 and the second mechanical circulation support device 20, the cardiac output of the patient is maintained or enhanced.
In the case of connecting the first mechanical circulation support device 10 and the second mechanical circulation support device 20 in series, the interference between the two pipes of the first mechanical circulation support device 10 and the second mechanical circulation support device 20 is considered. Therefore, the present invention is further provided with the double lumen connecting tube 30, thereby ensuring the motion avoidance feature of the first catheter tube 11 and the second catheter tube 21 each other by using two sets of lumens independent of each other in the double lumen connecting tube 30. Due to the existence of the double-cavity connecting pipe 30, a protective sheath for femoral artery and a guide sheath for forming a corresponding catheter can be formed, so that the invention can be quickly introduced in a shorter time, and can quickly establish blood circulation for sudden heart failure patients such as myocardial infarction and the like, thereby gaining precious life-saving time and synchronously improving the safety of operation and corresponding blood pump work. Once the invention is started, the unique serial blood double-acceleration design is utilized, the blood flow rate of the whole aorta can be rapidly increased, the high-efficiency blood circulation can be always maintained, the sufficiency of blood perfusion to human organs can be effectively ensured, and the operation is reliable and stable.
The first mechanical circulation support device 10 is a first blood pump having a first conduit 11, a coreless motor, a first impeller, a first blood flow outlet 12, a cannula 13, a first blood flow inlet 14 and a pigtail 15, the pigtail and the first blood flow inlet 14 being positioned in the left ventricle, the cannula 13 crossing the aortic valve, the coreless motor, the first impeller and the first blood flow outlet 12 being positioned in the ascending aorta, the first impeller being connected to a shaft in the coreless motor. When the hollow cup motor works, the first impeller is driven to rotate, blood in the left ventricle is sucked, and the blood is finally discharged into the aorta through the first blood inflow port 14, the sleeve 13 and the first blood outflow port 12, so that the load of the ventricle is unloaded, and the blood flow pressure of the aorta is increased. A first blood pump may be inserted into the body, for example via the femoral artery, the first catheter 11 extending from inside to outside the body and being connected to a first controller, a cable, corresponding sensors and flushing lines etc. being provided in the first catheter 11, so that the first blood pump can communicate with the first controller. The first controller is configured to operate the first blood pump at a first rate at which the first blood pump may provide an operating flow rate of 1.5-6L/min, for example the first blood pump is operated at a flow rate of 2.5L/min or 5L/min. When the first blood pump is operated at a higher flow rate, the pressure of the ventricle can be effectively unloaded, and accordingly, the non-physiological stress damage of the apparatus to blood is larger; when the first blood pump is operated at a lower flow rate, the unloading effect of ventricular pressure is weaker, and correspondingly, the blood compatibility of the apparatus is better. A sensor protection cap can be provided on the first blood flow inlet 14, for example, to protect the sensor probe from being damaged by the blood flow. The sensor is preferably a pressure sensor, more preferably a fiber optic pressure sensor, and is used for detecting the ventricular blood flow pressure and improving the monitoring effectiveness of physiological information.
The second mechanical circulation support device 20 is structured as in example 1 or example 2.
On the basis of the traditional left ventricle auxiliary blood pump, the invention simultaneously adds a group of mechanical circulation supporting devices at the descending aorta position adjacent to the ventricle, thereby utilizing a pump group formed by connecting two pump bodies in series to realize the double acceleration function of blood, ensuring that the blood can overcome the pressure difference between the left ventricle and the descending aorta to complete the blood flow discharge movement, forming higher arterial pressure to increase the blood flow flowing to the kidney, further enhancing the renal function and improving the urine discharge.
It will, of course, be evident to those skilled in the art that the invention is not limited to the details of the foregoing illustrative embodiments, but that the present invention may be embodied in other specific forms with the same or similar structures without departing from the spirit or essential attributes thereof. The present embodiments are therefore to be considered in all respects as illustrative and not restrictive, the scope of the invention being indicated by the appended claims rather than by the foregoing description, and all changes which come within the meaning and range of equivalency of the claims are therefore intended to be embraced therein. Any reference sign in a claim should not be construed as limiting the claim concerned.
Furthermore, it should be understood that although the present specification describes embodiments, not every embodiment includes only a single embodiment, and such description is for clarity purposes only, and it is to be understood that all embodiments may be combined as appropriate by one of ordinary skill in the art to form other embodiments as will be apparent to those of skill in the art from the description herein.
The techniques, shapes, and configurations not described in detail in the present invention are all known techniques.

Claims (10)

1. An interventional cardiorenal combination aid, comprising: the second mechanical circulation supporting device (20) is positioned in the descending aorta of the patient, the second mechanical circulation supporting device (20) comprises a tubular shell (22) arranged at the distal end of a second catheter (21), a second impeller (25) is coaxially arranged in the shell (22), the second impeller (25) is driven by a flexible driving shaft (26) penetrating into the second catheter (21) so as to generate rotary motion in a shell cavity, and the proximal end of the flexible driving shaft (26) is connected with a power output shaft of an external motor (27); the proximal end of the housing (22) is provided with a second blood outflow opening (24), the distal end of the housing (22) is provided with a second blood inflow opening (23), and the outer wall of the proximal and/or distal end of the housing (22) is provided with a support body (29) for positioning and supporting the second mechanical circulation support device (20) at the vessel wall of the descending aorta.
2. The interventional cardiorenal combination aid of claim 1, wherein: further comprising a first mechanical circulation support device (10) located in a ventricle of the patient, the first mechanical circulation support device (10) and the second mechanical circulation support device (20) being connected to the outside of the human body by a first catheter (11) and a second catheter (21), respectively.
3. The interventional cardiorenal combination aid of claim 1 or 2, wherein: the shell (22) is a tube body which is made of biocompatible metal/nonmetal materials and has two open ends, the far end of the shell (22) is open and forms a second blood inflow port (23), and the near end of the shell (22) is connected with the second catheter (21) through a connecting column; in the circumferential direction of the housing (22), the hole paths formed between the respective adjacent connecting posts constitute the second blood flow outlet (24); the second impeller (25) is a hard impeller and is arranged in the tube cavity of the shell (22).
4. The interventional cardiorenal combination aid of claim 1 or 2, wherein: the second impeller (25) and the shell (22) are both of radial expandable and contractible structures; the shell (22) comprises a bracket (22 a) and a film (22 b) covered on the inner layer and/or the outer layer and/or the interlayer of the bracket (22 a); the support (22 a) is a hollow tube body formed by weaving or laser cutting a deformable memory alloy material, and a hollow tube type protective peripheral wall structure of the shell is formed after the support is covered by a film (22 b); of both ends of the stent (22 a), a proximal region not covered by the film constitutes a second blood outlet (24), and a distal region not covered by the film (22 b) constitutes a second blood inlet (23).
5. The interventional cardiorenal co-ordination aid assembly according to claim 1 or 2, wherein: the flexible drive shaft (26) is woven from flexible cable; and a pipe orifice at the far end of the second guide pipe (21) is matched with a rigid shaft (28 a) through a near end bearing (28 b), and two ends of the rigid shaft (28 a) are respectively and coaxially fixedly connected with a flexible driving shaft (26) and a hub of a second impeller (25).
6. The interventional cardiorenal combination aid of claim 5, wherein: a gap for passing cleaning fluid is reserved between the flexible driving shaft (26) and the second conduit (21); the cleaning fluid flows in from an inlet pipe preset on a second catheter (21) at the outside of the body and flows out from a proximal bearing (28 b) of a distal nozzle of the second catheter (21); the pressure of the purge fluid is in the range of 50mmHg to 1500 mmHg.
7. The interventional cardiorenal combination aid of claim 1 or 2, wherein: the support body (29) is made of a deformable memory alloy material and has an expansion structure in an expansion state and a contraction structure in a stressed state; the supporting body (29) comprises struts (29 a) fixed on the outer wall of the shell (22), the struts (29 a) extend from a near end to a far end, the radial distance between the struts (29 a) and the outer wall of the shell (22) is gradually increased along the extending direction, and more than three groups of struts (29 a) are sequentially arranged around the axis of the shell (22) so as to form the claw-shaped supporting claw; the extending end of the strut (29 a) is provided with a contact pad (29 b) for improving the anchoring effect relative to the vessel wall, and the middle section of the strut (29 a) is provided with a knee part (29 c) with a zigzag arched outward bending shape.
8. The interventional cardiorenal combination aid of claim 2, wherein: the near ends of the first mechanical circulation supporting device (10) and the second mechanical circulation supporting device (20) penetrate through the same double-cavity connecting pipe (30) and then are communicated to the outside of the body, and two independent cavities are formed in the double-cavity connecting pipe (30) and are used for accommodating the first catheter (11) and the second catheter (21) respectively.
9. The interventional cardiorenal combination aid of claim 2, wherein: a preformed groove or a preformed hole for the second conduit (21) to pass through is formed in the shell (22); the preformed groove and the preformed hole are arranged in a penetrating mode along the axial direction of the shell (22) and are mutually avoided with the action path of the second impeller (25) in the shell (22).
10. The interventional cardiorenal co-ordination aid assembly according to claim or 2, wherein: the first mechanical circulation supporting device (10) and the second mechanical circulation supporting device (20) are respectively provided with a pressure sensor; the pressure sensor is an optical fiber pressure sensor; the first mechanical circulation support device (10) is in communication with a first controller configured to operate the first mechanical circulation support device (10) at a first rate; the second mechanical circulation support device (20) being in communication with a second controller, the second controller being configured to operate the second mechanical circulation support device (20) at a second rate; the second rate is 30% to 80% of the first rate.
CN202210897912.8A 2022-07-19 2022-07-28 Interventional type heart and kidney combined auxiliary assembly Pending CN115154889A (en)

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CN202210844673X 2022-07-19

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CN202221995269.4U Active CN219148993U (en) 2022-07-19 2022-07-28 Interventional type heart and kidney combined auxiliary assembly
CN202210897912.8A Pending CN115154889A (en) 2022-07-19 2022-07-28 Interventional type heart and kidney combined auxiliary assembly
CN202210897906.2A Pending CN115120867A (en) 2022-07-19 2022-07-28 Interventional type heart and kidney combined auxiliary system
CN202221995856.3U Active CN219355090U (en) 2022-07-19 2022-07-28 Interventional type intra-aortic blood pumping device
CN202221995738.2U Active CN219355089U (en) 2022-07-19 2022-07-28 Interventional type heart and kidney joint auxiliary system

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CN202221995856.3U Active CN219355090U (en) 2022-07-19 2022-07-28 Interventional type intra-aortic blood pumping device
CN202221995738.2U Active CN219355089U (en) 2022-07-19 2022-07-28 Interventional type heart and kidney joint auxiliary system

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CN219355090U (en) 2023-07-18

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