CN112237680A

CN112237680A - Axial-flow type heart auxiliary device with heparin coating and hydrophobic protection

Info

Publication number: CN112237680A
Application number: CN202010968939.2A
Authority: CN
Inventors: 解启莲; 王昆; 刘欢
Original assignee: Anhui Tongling Bionic Technology Co Ltd
Current assignee: Anhui Tongling Bionic Technology Co Ltd
Priority date: 2020-09-15
Filing date: 2020-09-15
Publication date: 2021-01-19
Anticipated expiration: 2040-09-15
Also published as: CN112237680B

Abstract

The invention belongs to the technical field of medical instruments, and particularly relates to an axial-flow type heart auxiliary device with a heparin coating and hydrophobic protection, which comprises a blood flow channel, an axial-flow impeller and a driving motor, wherein the driving motor comprises a stator shell which is integrally cylindrical, the stator shell is provided with an accommodating space for arranging a cylindrical rotor, two ends of the cylindrical rotor are provided with rotating shafts, bearings are arranged between shaft bodies at two ends of the rotating shafts and two ends of the stator shell, and heparin is attached to the surfaces of the stator shell and the cylindrical rotor; through all having attached to heparin on stator housing and the adjacent surface of column rotor, the effectual formation that restraines the thrombus is all attached to hydrophobic material on the internal surface of the bearing that closes on the blood outflow simultaneously to and the axle body that corresponds the pivot, the effectual inside that blocks blood and enter into driving motor.

Description

Axial-flow type heart auxiliary device with heparin coating and hydrophobic protection

Technical Field

The invention belongs to the technical field of medical instruments, and particularly relates to an axial-flow type heart assist device with a heparin coating and hydrophobic protection.

Background

For left heart failure patients, in case of ineffective medication, it is often necessary to provide a left heart assist device for purposes including: 1) waiting for the donor, preparing for heart transplantation; 2) the heart can be rested and the heart function can be recovered. The current left heart auxiliary device mainly comprises a temporary left heart auxiliary device and a long-term left heart auxiliary device; the temporary left heart auxiliary device comprises a partial axial flow pump and an air bag pulsating device and is mainly characterized by percutaneous puncture or incision and transvascular implantation; the advantages that the device can be implanted quickly, is relatively simple to drive, and is suitable for emergency rescue conditions of sudden cardiac failure; however, temporary left heart assist devices are not suitable for long term assistance, are placed in the neck or groin area, are only suitable for bedridden patients, require sedation during use, and are susceptible to infection at the transvascular delivery site. The long-term left heart auxiliary device comprises a pneumatic pump, a centrifugal pump and a partial axial flow pump, and is mainly characterized in that the device is placed in the chest by opening, a hole is formed in the apex of the left ventricle, the left ventricle blood is drained to enter the long-term left heart auxiliary device, and the pressurized blood is pumped into the aorta through an artificial blood vessel; the advantage lies in that the consumptive material is changed easily, and drive arrangement design is simple, but the shortcoming is also very obvious, and drive arrangement is comparatively huge, is unsuitable to be arranged in vivo, and exposes to the external pump body and the visual pump blood activity, causes harmful effects easily to patient's psychology to and, need pipe connection heart chamber and aorta, increased the energy consumption, and easily form the thrombus.

In the prior art, Impella is a commonly used temporary left heart assist device, which comprises a pigtail, a blood inflow port, a blood flow channel, a blood outflow port, an axial flow impeller, a driving motor and other components, wherein in the specific working process, the driving motor drives the axial flow impeller to rotate, so that blood is pumped from a left ventricle to an aorta, and the blood circulation of a patient is assisted. There is a bearing seal above the shaft of the driving motor, the purpose of the bearing seal is to prevent that when the axial impeller draws blood out, blood can enter the inside of the driving motor through the air gap of the bearing, thereby cause the short circuit of the driving motor and cause a series of bad accidents, and the existence of the bearing seal blocks the blood from flowing into the inside of the driving motor, but the blood ceaselessly strikes the bearing seal, thereby the blood cells receive huge impact force and produce stress response, secrete platelets, therefore the blood cells on the surface of the bearing can be gradually coagulated, finally form embolism, in case the embolism drops and enters the blood vessel and can block up direct less blood vessel, seriously affect the life safety of patients. Aiming at the problem, the scheme adopted by Impella is to add a shaft seal flushing system, namely, a plurality of holes of 0.9mm are arranged at the shaft seal position of a driving motor, a physiological saline supply device is externally connected with a pipeline to continuously flush the shaft seal position, the flushing amount is 240mL every 24 hours, and the pressure at the flushing position is up to 600 mmHg. The shaft seal flushing system described above presents significant drawbacks: firstly, the manufacturing difficulty of the driving motor is increased, the shaft seal flushing hole needs to be connected to external equipment through a pipeline to complete the flushing function, so that the hole needs to be punched through the driving motor, and the diameter of the hole is only 0.9mm, which brings great challenges to the processing and manufacturing of the driving motor; the other is that the shaft seal flushing system is equivalent to the continuous liquid injection into the blood circulation system of the patient, which increases the circulation flow and the afterload of the heart, which is extremely unfavorable for the recovery of the heart function of the heart failure patient.

Disclosure of Invention

In view of the problems in the prior art, the invention aims to provide an axial-flow type heart assist device with a heparin coating and a hydrophobic protection, which effectively prevents blood from coagulating at a motor shaft seal and ensures the stability of the operation of Impella.

In order to achieve the purpose, the invention adopts the following technical scheme:

an axial flow cardiac assist device with heparin coating and hydrophobic protection, comprising:

a blood flow channel having a blood inflow port and a blood outflow port;

the axial flow impeller is rotationally connected inside the blood flow channel; and

the driving motor is positioned outside the blood outflow port and used for driving the axial flow impeller to rotate and propelling the blood in the blood flow channel to flow;

the driving motor comprises a cylindrical stator shell, the stator shell is provided with an accommodating space for arranging the columnar rotor, rotating shafts are arranged at two ends of the columnar rotor, bearings are arranged between shaft bodies at two ends of the rotating shafts and two ends of the stator shell, and heparin is attached to the surfaces of the stator shell and the columnar rotor.

Preferably, the inner surface of the bearing of the driving motor adjacent to the blood outflow port and the shaft body corresponding to the rotation shaft are attached with hydrophobic materials.

Compared with the prior art, the invention has the following technical effects:

according to the axial-flow type heart auxiliary device provided by the invention, heparin is adhered to the surfaces of the stator shell and the columnar rotor which are adjacent to each other, so that the formation of thrombus is effectively inhibited, and meanwhile, hydrophobic materials are adhered to the inner surface of the bearing close to the blood outflow port and the shaft body corresponding to the rotating shaft, so that the blood is effectively prevented from entering the driving motor;

compared with the prior art, the axial-flow type heart auxiliary device provided by the invention can not damage blood, and avoids the increase of blood circulation flow and afterload increase, and has side effect on the recovery of cardiac function of a patient; in addition, the invention avoids the traditional scheme that holes are formed in the motor body, namely the design and processing difficulty of the motor is reduced, and simultaneously, a normal saline water supply system of a left-heart auxiliary system is abandoned, so that the device is simpler.

Additional features and advantages of the invention will be set forth in the detailed description which follows.

Drawings

Fig. 1 is a schematic structural diagram of an axial flow type heart assist device with a heparin coating and hydrophobic protection according to an embodiment of the invention;

fig. 2 illustrates a sectional view of a driving motor provided according to an embodiment of the present invention;

the reference numbers in the figures illustrate: 10-blood flow channel, 11-blood inflow port, 12-blood outflow port, 20-driving motor, 21-stator shell, 22-columnar rotor, 23-rotating shaft and 24-bearing.

Detailed Description

In order to make the technical means, the creation characteristics, the achievement purposes and the effects of the invention easy to understand, the invention is further clarified by combining the specific drawings.

It will be understood that when an element is referred to as being "secured to" another element, it can be directly on the other element or intervening elements may also be present. When an element is referred to as being "connected" to another element, it can be directly connected to the other element or intervening elements may also be present. The terms "vertical," "horizontal," "left," "right," and the like as used herein are for illustrative purposes only and do not denote a unique embodiment.

Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. The terminology used herein in the description of the invention is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. As used herein, the term "and/or" includes any and all combinations of one or more of the associated listed items.

As shown in fig. 1 and 2, the present invention provides an axial flow type heart assist device with heparin coating and hydrophobic protection, which includes a blood flow channel 10, an axial flow impeller (not shown in the figure) and a driving motor 20;

the blood flow channel 10 is provided with a blood inlet 11 and a blood outlet 12, the axial flow impeller is rotatably connected inside the blood flow channel 10, and the driving motor is located outside the blood outlet 12 and used for driving the axial flow impeller to rotate and impel the blood in the blood flow channel 10 to flow;

the driving motor 20 includes a stator housing 21 integrally formed in a cylindrical shape, the stator housing 21 has an accommodating space for arranging a cylindrical rotor 22, rotating shafts 23 are provided at two ends of the cylindrical rotor 22, bearings 24 are provided between shaft bodies at two ends of the rotating shafts 23 and two ends of the stator housing 21, and heparin is attached to surfaces of the stator housing 21 and the cylindrical rotor 22.

In the invention, the stator shell 21 and the columnar rotor 22 of the driving motor 20 are manufactured separately, and after the stator shell 21 is processed, the stator shell is soaked in heparin liquid by a chemical soaking method, so that a layer of heparin is adhered to the inner surface of the stator shell; the same method is used for the columnar rotor 22, so that a layer of heparin is attached to the surface of the columnar rotor 22; in specific use, because heparin is adhered to the surfaces of the stator housing 21 adjacent to the columnar rotor 22, blood coagulation can be effectively prevented.

Specifically, as a specific embodiment of the present invention, the stator housing 21 is made of polyurethane, the columnar rotor 22 is made of neodymium iron boron, the stator housing 21 and the columnar rotor 22 are immersed in 85% heparin aqueous solution, and the ultra-thin heparin film is formed on the surface by using an electrostatic self-assembly method and using a supermolecular electrostatic self-assembly principle to adsorb polyelectrolytes with opposite charges at a time under the action of electrostatic attraction. During the operation of the device, heparin can be continuously released to play an anticoagulation role, and the time can reach 7-14 days.

Further, according to the present invention, the inner surface of the bearing 24 of the driving motor 20 adjacent to the blood outflow port 12 and the shaft body corresponding to the rotation shaft 23 are attached with hydrophobic materials. In a specific embodiment, a hydrophobic material is electrochemically grafted on the inner surface of the bearing 24 of the driving motor 20 adjacent to the blood outflow port 12, and a hydrophobic material is grafted on the shaft body surface of the rotary shaft 23 in the same manner, so that the gap between the bearing 24 and the rotary shaft 23 is almost filled with the hydrophobic material having the same hydrophobic property as the substance on the surface of lotus leaves, and the stay of the liquid can be prevented, and even if a small amount of blood enters the air gap of the driving motor 20 through the hydrophobic surface, i.e., the area between the stator housing 21 and the cylindrical rotor 22, the heparin attached to the surface of the stator housing 21 adjacent to the cylindrical rotor 22 can effectively prevent the formation of thrombus.

Specifically, in one embodiment of the present invention, the hydrophobic material uses Sysmyk (SYSMEK GMBH AG & co., LTD, uk) commercially available hydrophobic coatings that have good hydrophobic properties; after the bearing 24 and the rotating shaft 23 are manufactured, the surfaces of the bearing and the rotating shaft are treated to remove dirt on the surfaces, and the requirements of no rust, no oil dirt, no dust and no water mark are met; spraying Sysmyk in clean environment after cleaning, and curing at normal temperature or baking at low temperature.

When the axial-flow type heart auxiliary device with the heparin coating and the hydrophobic protection is used specifically, the axial-flow type heart auxiliary device is implanted through a femoral artery of a human body in a minimally invasive mode, ascends and crosses an aortic arch, finally a blood inflow port enters a left ventricle, a blood outflow port is located in an aorta, and when a driving motor works, blood deposited in the left ventricle is pumped out and pumped into the aorta; based on the scheme provided by the invention, heparin is adhered to the surfaces of the stator shell 21 adjacent to the columnar rotor 22, so that the formation of thrombus is effectively inhibited, and meanwhile, hydrophobic materials are adhered to the inner surface of the bearing 24 close to the blood outflow port 12 and the shaft body corresponding to the rotating shaft 23, so that the blood is effectively prevented from entering the interior of the driving motor 20.

Compared with the prior art, the technical scheme provided by the invention has the advantages that the blood cannot be damaged, the increase of blood circulation flow and the rise of afterload are avoided, and the side effect on the recovery of the cardiac function of a patient is avoided; in addition, the invention avoids the traditional scheme that holes are formed in the motor body, namely the design and processing difficulty of the motor is reduced, and simultaneously, a normal saline water supply system of a left-heart auxiliary system is abandoned, so that the device is simpler.

The foregoing shows and describes the general principles, essential features, and inventive features of this invention. It will be understood by those skilled in the art that the present invention is not limited to the embodiments described above, which are described in the specification and illustrated only to illustrate the principle of the present invention, but that various changes and modifications may be made therein without departing from the spirit and scope of the present invention, which fall within the scope of the invention as claimed. The scope of the invention is defined by the appended claims and equivalents thereof.

Claims

1. An axial flow cardiac assist device with heparin coating and hydrophobic protection, comprising:

a blood flow channel having a blood inflow port and a blood outflow port;

2. The axial flow cardiac assist device with heparin coating and hydrophobic protection as claimed in claim 1, wherein the inner surface of the bearing of the driving motor adjacent to the blood outflow port and the shaft of the corresponding rotating shaft are attached with hydrophobic material.