Auxiliary blood pumping device and ventricular auxiliary blood pumping system

Abstract

The application provides an auxiliary blood pumping device and a ventricular auxiliary blood pumping system, and relates to the technical field of medical instruments. The auxiliary blood pumping device comprises a driving assembly and a deformation body. The deformation body is arranged in a left ventricle. A power cavity is arranged on the deformation body. The driving assembly is connected with the deformation body and is used for driving the deformation body to reversibly deform so as to change the volume of the power cavity. First and second valves are arranged on the deformation body. The first valve is used for controlling the communication between the power cavity and the left ventricle. The second valve is used for controlling the communication between the power cavity and a main artery. The driving assembly can drive the deformation body to reversibly reciprocate from expansion to contraction. Then, the pressure change caused by the volume change of the power cavity is used to provide additional blood pumping energy for the left ventricle, so as to assist blood pumping. Compared with the prior art, the auxiliary device for blood pumping through the axial rotation of the blood pump does not form shear force on the blood, and the damage to various cells of the blood is reduced.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical devices, in particular to an auxiliary blood pumping device and a ventricular auxiliary blood pumping system. BACKGROUND

[0002] Various heart diseases, such as heart failure, myocardial infarction, myocardial injury, etc., can cause the pumping function of the ventricle to be damaged. In the treatment of these patients, the main means at present is to use an auxiliary ventricular auxiliary blood pumping device. The auxiliary ventricular auxiliary blood pumping device not only helps the heart to pump blood to reduce the burden on the myocardium, which is helpful for the recovery of the myocardium, but also can avoid the damage to important organs of the human body, such as the brain and the kidney, caused by ischemia when the pumping function of the heart is decreased or even disappeared.

[0003] At present, the percutaneous catheter ventricular auxiliary device mainly uses a centrifugal pump to suck blood from the ventricle to the axial rotating blood pump device at the position of the aorta. When the blood pump device is working, the rotor in the catheter rotates at high speed, which can form shear force on the blood, and further cause damage to various cells in the blood, and easily form blood clots in the blood vessels, causing thrombosis.

[0004] The present application aims at the shortcoming that the existing ventricular auxiliary blood pumping device can easily cause damage to the blood, and provides a catheter-implanted auxiliary blood pumping device for the left ventricle which has less damage to the blood and lower cost. SUMMARY

[0005] The present application aims to provide an auxiliary blood pumping device and a ventricular auxiliary blood pumping system to solve the technical problem that the existing ventricular auxiliary blood pumping device can easily cause damage to the blood.

[0006] The auxiliary blood pumping device provided by the present application comprises a driving assembly and a deformation body, the deformation body is arranged in the left ventricle, a power cavity is arranged on the deformation body, the driving assembly is connected with the deformation body and is used to drive the deformation body to reversibly deform so as to change the volume of the power cavity.

[0007] The first valve is used to control the communication between the power cavity and the left ventricle, and the second valve is used to control the communication between the power cavity and the aorta. When the driving assembly expands the deformation body, the first valve is opened and the second valve is closed. When the driving assembly shrinks the deformation body, the second valve is opened and the first valve is closed.

[0008] Further, the deformation body has a folded posture and an unfolded posture, the deformation body can be transported to the left ventricle in the folded posture through a guide tube and automatically unfolded to the unfolded posture when being transported to the left ventricle, and the driving assembly is used to drive the deformation body in the unfolded posture to reversibly deform.

[0009] Further, the deformation body comprises a support frame and a first film, the first film is covered on the support frame, and the first film forms the power cavity.

[0010] The driving assembly is connected with the support frame, the driving assembly can drive the support frame to reversibly deform, and the support frame has the ability to restore to a natural state to drive the first film to deform.

[0011] Further, the first film is wrapped and connected on the inner side wall of the support frame, the first film comprises a first sub-portion, the first sub-portion can protrude outward relative to the support frame, and a first through hole is arranged on the first sub-portion.

[0012] The deformation body further comprises a second film, the second film is wrapped on the outer side wall of the support frame, the second film comprises a second sub-portion, the second sub-portion is tensioned on the support frame, a second through hole is arranged on the second sub-portion, the first sub-portion and the second sub-portion are arranged in correspondence with the inside and outside, and the first through hole and the second through hole are arranged in dislocation.

[0013] The first sub-portion and the second sub-portion cooperate to form the first valve.

[0014] Further, the support frame is connected with a valve control pipe, a third sub-portion is arranged on the valve control pipe, a third through hole is arranged on the third sub-portion, a third film is wrapped outside the third sub-portion, the third film is provided with a fourth sub-portion, a fourth through hole is arranged on the fourth sub-portion, the fourth through hole is arranged in dislocation with the third through hole, and the third film can move away from the third sub-portion to switch between being arranged in adhesion with the third sub-portion and being arranged in spacing from the third sub-portion.

[0015] The third sub-portion and the valve control pipe cooperate to form the second valve.

[0016] Further, the support frame has a folding posture and an unfolding posture, and the driving assembly is used to drive the support frame in the unfolding posture to reversibly deform.

[0017] The support frame comprises a first end portion, a main body portion and a second end portion which are connected in sequence, the first end portion is connected with the valve control pipe, and the driving assembly is connected with the second end portion; in the unfolding posture, the inner wall of the main body portion is concave outward and the outer wall is convex outward, and the first film is attached to the support frame.

[0018] Further, from the first end portion to the second end portion, the main body portion is smoothly transitioned so that the main body portion is in a spherical or ellipsoidal shape.

[0019] Further, the support frame comprises a plurality of support bones arranged in a ring shape in sequence, so that the support frame is in a grid shape in the unfolded posture; or, part of the support bones are arranged in a ring shape in sequence, and the remaining support bones are arranged staggered with the support bones arranged in a ring shape in sequence, so that the support frame is in a mesh shape in the unfolded posture.

[0020] Further, the support frame is a memory metal framework, and the material of the first film, the second film or the third film is PET, eTFP or biological tissue film.

[0021] And / or, the number of the first through holes is a plurality of holes arranged at intervals.

[0022] And / or, the number of the second through holes is a plurality of holes arranged at intervals.

[0023] And / or, the number of the third through holes is a plurality of holes arranged at intervals.

[0024] And / or, the number of the fourth through holes is a plurality of holes arranged at intervals.

[0025] Further, the deformation body is connected with a catheter, the driving assembly comprises an execution mechanism and a transmission mechanism, the execution mechanism is arranged outside the body, the transmission mechanism is arranged in the catheter and connected between the execution mechanism and the deformation body, and the transmission mechanism is a pull wire or a push rod.

[0026] And / or, the auxiliary blood pumping device further comprises a fixing support connected with the deformation body, and used for limiting the movement of the deformation body in cooperation with the blood vessel wall.

[0027] And / or, a pressure measuring mechanism is arranged in the power cavity, the pressure measuring mechanism comprises a pressure measuring pipe and a pressure sensor, the pressure sensor is arranged outside the body, the pressure measuring pipe is communicated with the power cavity and can be connected with the pressure sensor outside the body.

[0028] The ventricular auxiliary blood pumping system provided by the application comprises an ECG, a control unit and the auxiliary blood pumping device provided by the application.

[0029] The ECG and the driving assembly are connected with the control unit.

[0030] The auxiliary blood pumping device provided by the application comprises a driving assembly and a deformation body, the deformation body is arranged in the left ventricle, a power cavity is arranged on the deformation body, the driving assembly is connected with the deformation body and is used for driving the deformation body to reversibly deform so as to change the volume of the power cavity; a first valve and a second valve are arranged on the deformation body, the first valve is used for controlling the communication between the power cavity and the left ventricle, and the second valve is used for controlling the communication between the power cavity and the aorta. In use, the deformation body is arranged in the left ventricle, when the left ventricle is in the diastolic phase, the deformation body is inflated under the action of the driving assembly, the volume of the power cavity is increased, at this time, the pressure of the power cavity is smaller than the pressure of the ventricle, and the blood in the ventricle flows into the power cavity through the first valve; when the left ventricle is in the systolic phase, the deformation body is reversibly deformed under the action of the driving assembly, so that the volume of the power cavity is reduced, the pressure of the power cavity is greater than the pressure of the aorta, and at this time, the blood is passively discharged from the second valve to the aorta under the pressure of the deformation body. The driving assembly of the auxiliary blood pumping device can drive the deformation body to reversibly deform from inflation to contraction, and then the pressure change caused by the volume change of the power cavity is used to provide additional pumping energy for the left ventricle to assist blood pumping. Compared with the auxiliary device of the blood pump in the prior art which pumps blood by axial rotation, the auxiliary blood pumping device of the application does not form shear force on the blood, and the damage to various cells of the blood is reduced.

[0031] The ventricular auxiliary blood pumping system provided by the application comprises an ECG, a control unit and the auxiliary blood pumping device provided by the application; the ECG and the driving assembly are connected with the control unit. The ventricular auxiliary blood pumping system provided by the application has the same beneficial effects as the auxiliary blood pumping device provided by the application, and will not be described here. BRIEF DESCRIPTION OF DRAWINGS

[0032] In order to more clearly illustrate the specific embodiments of the application or the technical solutions in the prior art, the drawings needed in the following specific embodiments or prior art description will be briefly introduced. Obviously, the drawings in the following description are some embodiments of the application, and other drawings can also be obtained by those skilled in the art without creative labor.

[0033] Figure 1 The use schematic diagram of the ventricular auxiliary blood pumping system provided by the embodiment of the application;

[0034] Figure 2 The schematic diagram of the auxiliary blood pumping device provided by the embodiment of the application in the diastolic phase;

[0035] Figure 3 The schematic diagram of the auxiliary blood pumping device provided by the embodiment of the application in the systolic phase;

[0036] Figure 4 The schematic diagram of the auxiliary blood pumping device provided by the embodiment of the application;

[0037] Figure 5 is a sectional view of the auxiliary blood pumping device provided by the embodiment of the present application; Figure 4

[0038] Figure 6 is a schematic view of a support frame of the auxiliary blood pumping device provided by the embodiment of the present application;

[0039] Figure 7 is a schematic view of an inflated state of a first covering film of the auxiliary blood pumping device provided by the embodiment of the present application;

[0040] Figure 8 is a schematic view of a second covering film of the auxiliary blood pumping device provided by the embodiment of the present application;

[0041] Figure 9 is a schematic view of a valve control pipe of the auxiliary blood pumping device provided by the embodiment of the present application;

[0042] Figure 10 is a schematic view of a third covering film of the auxiliary blood pumping device provided by the embodiment of the present application;

[0043] Figure 11 is a schematic view of the auxiliary blood pumping device provided by the embodiment of the present application mounted through a fixing support;

[0044] Figure 12 is a schematic view of another implementation form of the auxiliary blood pumping device provided by the embodiment of the present application;

[0045] Figure 13 is a schematic view of the auxiliary blood pumping device provided by the embodiment of the present application combined with a pressure measuring mechanism.

[0046] Figure legend: 1-left ventricle; 2-aorta; 3-ECG; 4-control unit; 100-deformation body; 101-power cavity; 110-support frame; 111-support bone; 112-first end; 113-second end; 114-main body; 120-second valve; 121-valve control pipe; 1211-third through hole; 122-third covering film; 1221-fourth through hole; 130-first covering film; 131-first sub; 132-first through hole; 140-second covering film; 141-second through hole; 150-first valve; 200-catheter; 300-fixing support; 400-driving assembly; 410-executive mechanism; 420-transmission mechanism; 500-pressure measuring mechanism; 510-pressure measuring pipe; 520-pressure sensor. DETAILED DESCRIPTION

[0047] ​The technical solution of the present invention will be clearly and completely described below with reference to the embodiments. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0048] Example

[0049] like Figures 1-12 As shown, this embodiment provides an auxiliary blood pumping device, including a driving assembly 400 and a deformable body 100. The deformable body 100 is installed in the left ventricle 1 and has a power chamber 101. The driving assembly 400 is connected to the deformable body 100 and is used to drive the deformable body 100 to undergo reversible deformation to change the volume of the power chamber 101. The deformable body 100 is provided with a first valve 150 and a second valve 120. The first valve 150 is used to control the communication between the power chamber 101 and the left ventricle 1, and the second valve 120 is used to control the communication between the power chamber 101 and the aorta 2. When the driving assembly 400 expands the deformable body 100, the first valve 150 opens and the second valve 120 closes; when the driving assembly 400 shrinks the deformable body 100, the second valve 120 opens and the first valve 150 closes.

[0050] In this embodiment, the auxiliary blood pump device is used such that the deformable body 100 is installed inside the left ventricle 1. When the left ventricle 1 is in diastole, the deformable body 100 expands under the action of the drive assembly 400, increasing the volume of the power chamber 101. At this time, the pressure in the power chamber 101 is less than the pressure in the left ventricle, and the blood in the left ventricle flows into the power chamber 101 through the first valve 150. When the left ventricle 1 is in systole, the deformable body 100 contracts and deforms under the action of the drive assembly 400, reducing the volume of the power chamber 101. The pressure in the power chamber 101 is greater than the pressure in the aorta, and at this time, under the pressure of the deformable body 100, the blood passively flows out from the second valve 120 into the aorta 2.

[0051] In this embodiment, the drive component 400 of the auxiliary blood pumping device can drive the deformable body 100 to undergo reversible reciprocating deformation from expansion to contraction. This deformation, combined with the pressure change caused by the volume change of the power chamber 101, provides additional pumping energy to the left ventricle 1 to assist in blood pumping. Compared to existing auxiliary devices that pump blood via axial rotation, this invention's auxiliary blood pumping device does not exert shear force on the blood, thus reducing damage to various blood cells.

[0052] The driving assembly 400 comprises an actuating mechanism 410 and a transmission mechanism 420. The actuating mechanism 410 provides power and drives the reversible deformation of the deformation body 100 through the transmission mechanism 420. The actuating mechanism 410 can be arranged inside or outside the body. Specifically, the actuating mechanism 410 is arranged outside the body, and the transmission mechanism 420 can be a push rod or a pull wire.

[0053] When the transmission mechanism 420 is a push rod, the push rod is flexible and deformable to adapt to the environment of the left ventricle 1 and the aorta 2, thereby avoiding damage to the left ventricle 1 and the aorta 2. In addition, the push rod should also have a certain hardness to enable it to push the deformation body 100 to deform. The push rod can be in the form of a plastic tube. The actuating mechanism 410 can drive the deformation body 100 to deform through the single pushing action of the push rod. At this time, the deformation body 100 can automatically restore to the initial state when the pushing force of the push rod is removed. Meanwhile, the push rod can also be used as a pull rod. The actuating mechanism 410 drives the deformation body 100 to deform reciprocatingly by pushing and pulling the push rod. When the actuating mechanism 410 is a pull wire, the deformation body 100 is driven to deform by the pulling action of the pull wire. At this time, the deformation body 100 can automatically restore to the initial state when the pulling force of the pull wire is removed. In this embodiment, the transmission mechanism 420 is taken as a push rod as an example for description.

[0054] Specifically, the actuating mechanism 410 can be in the form of a motor cooperating with a lead screw to realize the extension and retraction of the transmission mechanism 420. Naturally, the actuating mechanism 410 can also be other devices capable of driving the reciprocating movement of the transmission mechanism 420.

[0055] It can be understood that the actuating mechanism 410 is arranged outside the body, thereby reducing the volume of the device in the body, facilitating the placement of the device into the left ventricle 1, and reducing the harm to the patient during the operation.

[0056] The ventricular assist device in the prior art mainly establishes a passage outside the heart at the apex of the left ventricle 1 and the aorta 2 position, and uses a centrifugal pump to pump blood from the ventricle to the aorta 2 position. Since the passage is located outside the heart, the operation needs to be performed through a thoracotomy. Thoracotomy causes great trauma to the patient, and many elderly heart failure patients cannot tolerate the trauma caused by the operation, and the prognosis is poor. To solve this problem, the auxiliary blood pumping device of the present embodiment provides a deformation body 100 implanted through a guide tube. Specifically, the deformation body 100 has a folded posture and an unfolded posture. The deformation body 100 can be transported into the left ventricle 1 in the folded posture and automatically unfolded to the unfolded posture when transported into the left ventricle 1. The driving assembly 400 is used to drive the reversible deformation of the deformation body 100 in the unfolded posture.

[0057] In an implementable manner, the deformation body 100 comprises a support frame 110 and a first film 130, the first film 130 is covered on the support frame 110, and the first film 130 forms the power cavity 101. The driving assembly 400 is connected with the support frame 110, and the driving assembly 400 can drive the support frame 110 to reversibly deform to drive the first film 130 to deform. The support frame 110 can be a memory metal material, for example, a nickel-titanium alloy. The first film 130 is generally a soft material, which can be a high polymer material, for example, PET (polyethylene terephthalate) and eTFP (ethylene-tetrafluoroethylene copolymer), or a biological tissue film, for example, one or more materials of animal pericardium.

[0058] It can be understood that, since the support frame 110 is made of a memory metal material, it can be folded and compressed into a guide tube and automatically unfolded when being delivered to the left ventricle 1, that is, it has a folded posture and an unfolded posture. At the same time, the first film 130 itself is a film, which can deform following the deformation of the support frame 110, so that the deformation body 100 can be delivered into the left ventricle 1 by a guide tube implantation method. The driving assembly 400 of the auxiliary blood pumping device in the embodiment is used to drive the support frame 110 in the unfolded posture to reversibly deform, that is, the driving assembly 400 drives the deformation body 100 to deform in the unfolded posture.

[0059] It can be understood that, the unfolded posture of the support frame 110 in the embodiment is a state in which the first film 130 of the deformation body 100 can be expanded to form the power cavity 101. As shown in Figure 6 The support frame 110 in the embodiment comprises a first end portion 112, a main body portion 114 and a second end portion 113 connected in sequence, the first end portion 112 is connected with the valve control tube 121, and the driving assembly 400 is connected with the second end portion 113; in the unfolded posture, the inner wall of the main body portion 114 is outwardly concave and the outer wall is outwardly convex, and the first film 130 is attached to the support frame 110.

[0060] In a preferred form, the main body portion 114 smoothly transitions from the first end portion 112 to the second end portion 113, so that the main body portion 114 is in a generally spherical or ellipsoidal shape. It can be understood that the spherical or ellipsoidal shape refers to the shape of the connecting line of the overall contour frame of the main body portion 114 in the expanded state of the unfolded posture, and the spherical or ellipsoidal shape is not strictly limited, and similar shapes can also be included in the ellipsoidal shape, for example, the main body portion 114 in the form of two conical bodies with their bases abutting, which can also be understood as a non-standard ellipsoidal shape.

[0061] Regarding the support frame 110 of the above form, when the support frame 110 is in a folded posture, the first end 112 and the second end 113 are typically compressed close to each other, and the main body 114 is radially compressed and tightened to make the support frame 110 as small as possible. When the support frame 110 is in an unfolded posture, the main body 114 unfolds radially outward, forming a generally spherical or ellipsoidal shape. The deformation of the support frame 110 under the action of the drive assembly 400 is along the axial direction ( Figure 6 The movement (shown in the up-down direction) means that the first end 112 and the second end 113 move closer or further apart through the deformation of the main body 114. Specifically, whether the first end 112 and the second end 113 move closer or further apart, the volume of the power cavity 101 increases, depending on the shape of the power cavity 101 formed by the deformable body and the initial state of the deformable body 100. Specifically, the actuator 410 of the drive assembly 400 can drive the second end 113 to move closer to the first end 112 via the transmission mechanism 420, compressing the main body 114 to reduce the volume of the power cavity 101; when the actuator 410 prevents the transmission mechanism 420 from applying force to the second end 113, the second end 113, under the elastic action of the main body 114 itself, returns to its original position away from the first end 112, thereby increasing the volume of the power cavity 101. Alternatively, it can be as follows... Figure 3 As shown, the actuator 410 of the drive assembly 400 drives the second end 113 to move away from the first end 112 via the transmission mechanism 420, and the main body 114 shrinks to reduce the volume of the power cavity 101; as Figure 2 As shown, when the actuator 410 does not apply force to the second end 113, the second end 113 is reset close to the first end 112 under the elastic action of the main body 114 itself, so as to increase the volume of the power cavity 101.

[0062] It is understood that in this embodiment, the support frame 110 has a main body 114 that protrudes outward to form a roughly spherical or ellipsoidal shape, increasing the internal space of the support frame 110. Consequently, the volume of the power cavity 101 formed by the first membrane 130 covering the support frame 110 increases, thereby enhancing the auxiliary blood pumping function of the auxiliary blood pumping device. At the same time, the outward protruding shape of the main body 114 makes it easier to deform under the action of the drive assembly 400 to change the volume of the power cavity 101, facilitating operation.

[0063] It should also be noted that the main body 114 may not be spherical or ellipsoidal, such as cylindrical or waist-shaped, but spherical or ellipsoidal shapes are usually more suitable for the structure of the left ventricle 1, and are larger in volume and easier to perform deformation operations.

[0064] Furthermore, the specific structure of the support frame 110 in this embodiment includes multiple support bones 111, which are arranged sequentially in a ring to make the support frame 110 form a grid in the unfolded state; or, some of the support bones 111 are arranged sequentially in a ring, and the remaining support bones 111 are arranged alternately with the support bones 111 arranged sequentially in a ring to make the support frame 110 form a mesh in the unfolded state.

[0065] like Figure 6 As shown, in this embodiment, six equally spaced support ribs 111 are arranged sequentially in a ring shape, so that the support frame 110 forms a grid shape in its unfolded state. The first ends of the six support ribs 111 are close to each other and extend a certain length to form first end portions 112; the second ends of the six support ribs 111 are also close to each other and form second end portions 113. Figure 7 As shown, the first membrane 130 can cover all the supporting bones 111 and has the same structure as and is adapted to the support frame 110 formed by the supporting bones 111.

[0066] Understandably, the support frame 110 adopts a grid or lattice structure, which reduces the weight of the support frame 110, saves materials, and at the same time provides good support for the first coating 130.

[0067] In this embodiment, the first valve 150 and the second valve 120 of the auxiliary blood pumping device are crucial for the realization of the auxiliary blood pumping function. Specifically, in this embodiment, as... Figure 4 As shown, the first membrane 130 covers and connects to the inner wall of the support frame 110. The first membrane 130 includes a first sub-part 131, which can protrude outward relative to the support frame 110. The first sub-part 131 is provided with a first through hole 132. The deformable body 100 also includes a second membrane 140, which covers the outer wall of the support frame 110. The second membrane 140 includes a second sub-part, which is tensioned on the support frame 110. The second sub-part is provided with a second through hole 141. The first sub-part 131 and the second sub-part are correspondingly arranged inside and outside, and the first through hole 132 and the second through hole 141 are misaligned. The first sub-part 131 and the second sub-part cooperate to form a first valve 150. The support frame 110 is connected to a valve control pipe 121. The valve control pipe 121 is provided with a third sub-part, and the third sub-part is provided with a third through hole 1211. The third sub-part is covered with a third membrane 122. The third membrane 122 is provided with a fourth sub-part, and the fourth sub-part is provided with a fourth through hole 1221. The fourth through hole 1221 and the third through hole 1211 are misaligned. The third membrane 122 can move away from the third sub-part so that the third membrane 122 can switch between being fitted to the third sub-part and being spaced apart from the third sub-part. The third sub-part and the valve control pipe 121 cooperate to form a second valve 120.

[0068] The first valve 150 and the second valve 120 are both opened and closed according to the pressure change in the power cavity 101 of the deformation body 100, and only one of the first valve 150 and the second valve 120 is opened at the same time. The second film 140 and the third film 122 are also made of soft material and have elasticity like the first film 130. The materials of the second film 140 and the third film 122 can be the same as or different from the material of the first film 130, and the specific material can also be a high polymer material such as PET (polyethylene terephthalate) or eTFP (ethylene-tetrafluoroethylene copolymer), or a biological tissue film such as one or more materials of animal pericardium. The first film 130 can be fixed on the inner side of the support frame 110 by hot melt bonding or sewing, and the second film 140 can also be fixed on the outer side of the support frame 110 by hot melt bonding or sewing.

[0069] The valve control pipe 121 can be a plastic pipe with a certain flexibility to facilitate implantation in the ventricle through the guide pipe. The first end 112 of the support frame 110 is provided with a connecting pipe, and the first film 130 is also wrapped on the inner side of the connecting pipe. The connecting pipe is connected with the valve control pipe 121, the first film 130 is in communication with the valve control pipe 121, and the valve control pipe 121 can only flow blood out of the power cavity 101 through the third through hole 1211. The third film 122 can also be connected with the valve control pipe 121 by hot melt bonding or sewing.

[0070] The first sub-part 131 is usually a part of the first film 130. The first sub-part 131 can be arranged at any position of the first film 130 as long as it can be in communication with the blood in the left ventricle 1. As one of the preferred forms, as shown in Figure 1 、 Figure 2 、 Figure 3 、 Figure 4 、 Figure 5 、 Figure 11 and Figure 13 , the first sub-part 131 of the first film 130 is arranged on the side of the support frame 110 away from the valve control pipe 121, that is, the side away from the aorta 2, and the corresponding second sub-part of the second film 140 is arranged on the first sub-part 131 on the side to form the first valve 150. As another preferred form, as shown in Figure 12 , the first sub-part 131 of the first film 130 is arranged on the side close to the valve control pipe 121, that is, the side close to the aorta 2, and the corresponding second sub-part of the second film 140 is arranged on the first sub-part 131 on the side to form the first valve 150.

[0071] The control principle of the first valve 150 is to control the adhesion or separation of the two membranes through changes in internal and external pressure. In the separated state, the first valve 150 opens. During use, such as... Figure 3 As shown, when the deformable body 100 performs the blood pumping process, that is, when the heart contracts, the deformable body 100 is compressed, the volume of the power chamber 101 decreases, and the blood pressure inside the deformable body 100 increases and exceeds the internal pressure of the left ventricle 1. At this time, the first membrane 130 is compressed from the inside. Since the first membrane 130 can bulge outward, it causes the first membrane 130 to adhere to the second membrane 140. Because the first through hole 132 and the second through hole 141 are misaligned, the first membrane 130 can block the second through hole 141 on the second membrane 140, thereby achieving the closing action of the first valve 150. Similarly, as Figure 2 As shown, when the deformable body 100 expands, that is, when the heart relaxes, the internal pressure of the deformable body 100 is less than the pressure of the left ventricle 1. At this time, since the second membrane 140 is tensioned on the support frame 110, the second membrane 140 cannot protrude inward. Therefore, the second membrane 140 and the first membrane 130 separate, and blood flows into the power chamber 101 through the second through hole 141 on the second membrane 140 and the first through hole 132 on the first membrane 130, thus filling the chamber.

[0072] It should be noted that the first sub-part 131 can protrude outward relative to the support frame 110 if the position where the first cover 130 forms the first sub-part 131 is loosely connected to the support frame 110, that is, the first sub-part 131 between adjacent support bones 111 is loose. The second cover 140 is tensioned on the support frame 110. This can be because the thickness of the second cover 140 prevents it from concave inward under the blood pressure of the left ventricle 1, or because the second cover 140 is stretched between adjacent support bones 111, and its own tension is large enough to prevent it from concave inward under the blood pressure of the left ventricle 1. The second cover 140 can cover the entire outer side of the support frame 110, in which case a portion of the second cover 140 forms the second sub-part; the second cover 140 can also only cover a portion of the support frame 110, in which case the second cover 140 can at least form the second sub-part. In this embodiment, as... Figure 4 or Figure 5 As shown, the second coating 140 is only provided in relation to the first sub-part 131, that is, the second coating 140 is also the second sub-part.

[0073] like Figure 4 or Figure 5 As shown, the third sub-section is typically part of the valve control tube 121, which communicates with the power chamber 101 formed by the first diaphragm 130. The fourth sub-section can be part of the third diaphragm 122, in which case the third diaphragm 122, in addition to corresponding to the third sub-section, also covers other positions of the valve control tube 121. Figure 4 orFigure 5 As shown, the third film 122 is entirely as the fourth sub-portion, and the third film 122 is arranged only for the fourth sub-portion.

[0074] The control principle of the second valve 120 is that when the deformation body 100 is compressed, i.e. the heart contracts, as shown in FIG. 6, the blood pressure of the power cavity 101 of the deformation body 100 is greater than the blood pressure of the aorta 2, and the internal blood flow can cause the third film 122 to separate from the valve control pipe 121, and the blood flows into the blood vessel of the aorta 2 from the power cavity 101 through the third through hole 1211 of the valve control pipe 121 and the second through hole 141 of the third film 122. Figure 3 As shown, the blood pressure of the power cavity 101 of the deformation body 100 is less than the blood pressure of the aorta 2, and the blood pressure of the aorta 2 causes the third film 122 to be attached to the valve control pipe 121, and since the third through hole 1211 and the fourth through hole 1221 are arranged in a staggered manner, the third film 122 seals the third through hole 1211 of the valve control pipe 121 at this time, and the closing action of the first valve 150 is realized. Figure 2 As shown, the blood pressure of the power cavity 101 of the deformation body 100 is less than the blood pressure of the aorta 2, and the blood pressure of the aorta 2 causes the third film 122 to be attached to the valve control pipe 121, and since the third through hole 1211 and the fourth through hole 1221 are arranged in a staggered manner, the third film 122 seals the third through hole 1211 of the valve control pipe 121 at this time, and the closing action of the first valve 150 is realized.

[0075] It should be noted that the number of the first through hole 132, the second through hole 141, the third through hole 1211 and the fourth through hole 1221 of the embodiment can be multiple arranged at intervals, wherein the multiple first through holes 132 and the multiple second through holes 141 are arranged in a staggered manner, the first through hole 132 can be an elliptical flat hole, and the second through hole 141 can be a circular hole. The multiple third through holes 1211 and the multiple fourth through holes 1221 are arranged in a staggered manner, the third through hole 1211 is a circular hole and is arranged in multiple rows at equal intervals along the circumference of the valve control pipe 121, and the fourth through hole 1221 is a strip-shaped hole.

[0076] In order to facilitate the arrangement of the transmission mechanism 420 of the driving assembly 400, as shown in FIG. 8, the auxiliary blood pumping device of the embodiment further comprises a catheter 200, the catheter 200 is fixedly connected with the valve control pipe 121, the outer end of the transmission mechanism 420 is connected with the execution mechanism 410, the transmission mechanism 420 is arranged in the catheter 200 and is connected with the second end of the support frame 110 after passing through the valve control pipe 121. Figure 1

[0077] Wherein, the catheter 200 can be an integrated structure with the valve control pipe 121.

[0078] In order to avoid the movement of the deformation body 100 relative to the left ventricle 1 when the execution mechanism 410 is in action, the auxiliary blood pumping device of the embodiment further comprises a fixing support 300, the fixing support 300 is connected with the deformation body 100 and is used to limit the movement of the deformation body 100 in cooperation with the blood vessel wall.

[0079] As shown in FIG. 9, the fixing support 300 is arranged on the left ventricle 1, and the deformation body 100 is arranged in the fixing support 300. Figure 11 ​As shown, the deformed body 100 of the embodiment is provided with a fixing bracket 300 through the catheter 200, specifically, the catheter 200 (or the valve control pipe 121) of the auxiliary blood pumping device of the embodiment is provided with the fixing bracket 300 on one end close to the support frame 110, the fixing bracket 300 is used to cooperate with the blood vessel wall to limit the movement of the catheter 200, and further limit the deformed body 100 from leaving the left ventricle 1 or from being displaced. The fixing bracket 300 can be a metal grid bracket, the fixing bracket 300 is sleeved outside the catheter 200, and the fixing bracket 300 can also be a memory metal material, which has a folded posture on the catheter 200 and a deployed posture relative to the catheter 200. When the deformed body 100 is released into the left ventricle 1, the fixing bracket 300 also needs to be completely released, and after the fixing bracket 300 is completely released, the fixing bracket 300 can play a fixing role on the deformed body 100 through the support force between the fixing bracket 300 and the blood vessel, so as to ensure that the deformed body 100 will not be pulled out to the aorta 2 during the working process.

[0080] Further, the auxiliary blood pumping device of the embodiment can also be provided with a pressure measuring mechanism 500, the pressure measuring mechanism 500 is connected with the power assembly through the control unit 4, and the pressure measuring mechanism 500 is used to detect the pressure in the power cavity 101.

[0081] The control unit 4 is a conventional intelligent control unit 4, such as a medical computer. The pressure measuring mechanism 500 can include a pressure sensor 520 and a pressure measuring pipe 510, one end of the pressure measuring pipe 510 is communicated with the power cavity 101, the other end of the pressure measuring pipe 510 is connected with the pressure sensor 520 through the valve control pipe 121 and the catheter 200 and is exposed to the outside of the body, and the pressure sensor 520 is connected with the control unit 4. The pressure sensor 520 obtains the pressure in the power cavity 101 by detecting the pressure of the pressure measuring pipe 510, and the pressure sensor 520 can transmit the pressure signal to the control unit 4. The control unit 4 automatically adjusts the movement amplitude and frequency of the deformed body 100 according to the measured pressure, and medical staff and the like can also manually adjust the movement amplitude and frequency of the deformed body 100 according to the pressure reacted by the control unit.

[0082] It should be noted that the auxiliary blood pumping device of the embodiment can also be used in cooperation with an ECG 3 (electrocardiograph), and the control unit 4 can judge the heart contraction state according to the change of the electrocardiogram, and further timely adjust the driving assembly 400. The control unit 4 can be provided with gears, the frequency of the driving mechanism is controlled through different gears, and further the number of movements of the deformed body 100 in the contraction period is controlled.

[0083] In use, the auxiliary blood pumping device of the embodiment is installed in the left ventricle 1, the valve control pipe 121 is arranged at one end of the third covering film 122 and connected with the deformation body 100, and is arranged in the aorta 2, specifically, on the aortic valve, and the catheter 200 is arranged in the aorta 2. The deformation body 100, the valve control pipe 121 and the catheter 200 can be connected as a whole and implanted through the femoral artery by the guide pipe in a folded posture, so that the surgical process is small in trauma and short in time, and the trauma to the patient is small.

[0084] The heart can be mainly divided into two stages of systole and diastole in one cardiac cycle. In the diastole stage, the mitral valve is opened, the aortic valve is closed, and the blood flows from the atrium to the ventricle to achieve filling. In the systole stage, the aortic valve is opened, the mitral valve is closed, and the ventricle contracts to pump the blood in the ventricle to the position of the arterial blood vessel. The heart mainly provides kinetic energy for the blood by such working mode to achieve the circulation of the blood in the whole body. The auxiliary blood pumping device of the embodiment can assist the heart failure patient to provide additional energy to assist the heart to pump blood. The deformation body 100 is provided with two valves, in the working process, the first valve 150 is located in the left ventricle 1, and the second valve 120 is located on the position of the aortic valve. In the diastole stage of the left ventricle 1, the volume of the power cavity 101 is increased under the action of the self-recovery ability of the support frame 110, at this time, the first valve 150 is opened to fill the power cavity 101. In the systole stage of the heart, the power cavity 101 provides a pushing force through the driving assembly 400 to squeeze the deformation body 100, so that the deformation body 100 contracts and the volume of the deformation body 100 is reduced. In this process, the first valve 150 is closed, and the second valve 120 is opened, so that the blood can flow to the side of the aorta 2 through the second valve 120. For the whole device, the state of the left ventricle 1, i.e. whether it is in the systole stage or the diastole stage, can be judged by the electrocardiogram signal and the control unit 4.

[0085] As shown in Figures 1-3 , the embodiment also provides a ventricular auxiliary blood pumping system, which comprises an ECG 3 (electrocardiograph), a control unit 4 and the auxiliary blood pumping device provided by the embodiment. The ECG 3 and the driving assembly 400 are connected with the control unit 4.

[0086] The ECG 3 can adopt an existing conventional device. The ventricular auxiliary blood pumping system is used for monitoring the electrocardiogram of the heart of the patient through a signal receiver of the ECG 3, receiving signals, sending the received electrocardiogram signals to the control unit 4, converting the electrocardiogram signals into digital signals by the control unit 4, judging the systole and diastole states of the heart, converting the converted digital signals into control instructions, sending the control instructions to an executing mechanism 410, and outputting power through the executing mechanism 410 to realize the opening and closing functions of the deformation body 100, so as to achieve the function of pumping blood by the ventricle to the side of the aorta 2.

[0087] The ventricular assist pump blood system has the same beneficial effects as the assist pump blood device provided in the embodiment, and will not be described here.

[0088] Finally, it should be noted that: the above embodiments are only used to illustrate the technical solutions of the present application, but not to limit them; although the present application has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that: it can still modify the technical solutions recorded in the foregoing embodiments, or make equivalent replacement for part or all of the technical features; and these modifications or replacements do not make the essence of the corresponding technical solutions deviate from the scope of the technical solutions of the embodiments of the present application.

Claims

1. An auxiliary blood-pumping device, characterized by, The auxiliary blood pumping device comprises a driving assembly (400) and a deformation body (100), the deformation body (100) is arranged in a left ventricle (1), a power cavity (101) is arranged on the deformation body (100), and the driving assembly (400) is connected with the deformation body (100) and used for driving the deformation body (100) to reversibly deform so as to change the volume of the power cavity (101); The deformation body (100) comprises a support frame (110), a first coating film (130) wrapped on the inner side wall of the support frame (110), and a second coating film (140) wrapped on the outer side wall of the support frame (110); the first coating film (130) comprises a first subpart (131) capable of protruding outward relative to the support frame (110), and a first through hole (132) is arranged on the first subpart (131); the second coating film (140) comprises a second subpart (141) capable of being tensioned on the support frame (110); the first subpart (131) and the second subpart are arranged in correspondence with the inner and outer sides of each other, and the first through hole (132) and the second through hole (141) are arranged in a staggered manner; The deformation body (100) is provided with a first valve (150) and a second valve (120), the first valve (150) is used for controlling the communication between the power cavity (101) and the left ventricle (1), and the second valve (120) is used for controlling the communication between the power cavity (101) and the aorta (2); When the driving assembly (400) expands the deformation body (100), the second valve (120) is closed, the second coating film (140) is tensioned on the support frame (110) and separated from the first coating film (130), so that the first valve (150) is opened, and the blood in the left ventricle (1) flows into the power cavity (101) through the first through hole (132) and the second through hole (141); When the driving assembly (400) shrinks the deformation body (100), the second valve (120) is opened, the first coating film (130) protrudes outward from the inside and is attached to the second coating film (140), and the second through hole (141) is blocked, so that the first valve (150) is closed, and the blood in the power cavity (101) is passively discharged from the second valve (120) to the aorta (2); The auxiliary blood pumping device further comprises a fixing support (300) connected with the deformation body (100) and used for limiting the movement of the deformation body (100) in cooperation with the blood vessel wall.

2. The auxiliary blood pumping device of claim 1, wherein, The deformation body (100) has a folded posture and an unfolded posture, the deformation body (100) can be transported into the left ventricle (1) in the folded posture through a guide tube and automatically unfolded to the unfolded posture when being transported into the left ventricle (1), and the driving assembly (400) is used for driving the deformation body (100) in the unfolded posture to reversibly deform.

3. The auxiliary blood pumping device of claim 1, wherein, The first coating film (130) forms the power cavity (101). The driving assembly (400) is connected with the support frame (110), the driving assembly (400) can drive the support frame (110) to reversibly deform, and the support frame (110) has the ability to restore to the natural state to drive the first film (130) to deform.

4. The auxiliary blood pumping device of claim 1, wherein, The support frame (110) is connected with a valve control pipe (121), the valve control pipe (121) is provided with a third subpart, and the third subpart is provided with a third through hole (1211); the third subpart is coated with a third film (122), the third film (122) is provided with a fourth subpart, the fourth subpart is provided with a fourth through hole (1221), the fourth through hole (1221) is arranged in a staggered manner with the third through hole (1211), and the third film (122) can move away from the third subpart to switch the third film (122) between being arranged in close contact with the third subpart and being arranged in a spaced manner with the third subpart. The third subpart cooperates with the valve control pipe (121) to form the second valve (120).

5. The auxiliary blood pumping device of claim 4, wherein, The support frame (110) has a folded posture and an unfolded posture, and the driving assembly (400) is used for driving the support frame (110) in the unfolded posture to reversibly deform. The support frame (110) comprises a first end part (112), a main body part (114) and a second end part (113) connected in sequence, the first end part (112) is connected with the valve control pipe (121), and the driving assembly (400) is connected with the second end part (113); in the unfolded posture, the inner wall of the main body part (114) is concave outward, and the outer wall of the main body part (114) is convex outward, and the first film (130) is attached to the support frame (110).

6. The auxiliary blood pumping device of claim 5, wherein, From the first end part (112) to the second end part (113), the main body part (114) is smoothly transitioned, so that the main body part (114) is spherical or ellipsoidal.

7. The auxiliary blood pumping device of claim 4, wherein, The support frame (110) comprises a plurality of support bones (111), and the plurality of support bones (111) are arranged in sequence in a ring shape, so that the support frame (110) is in a grid shape in the unfolded posture; or, part of the support bones (111) in the plurality of support bones (111) are arranged in sequence in a ring shape, and the remaining support bones (111) are arranged in an interlaced manner with the support bones (111) arranged in sequence in a ring shape, so that the support frame (110) is in a mesh shape in the unfolded posture.

8. The auxiliary blood pumping device of claim 4, wherein, The support frame (110) is a memory metal framework, and the materials of the first film (130), the second film (140) and the third film (122) are PET, eTFP or biological tissue film; And / or, the number of the first through holes (132) is a plurality of through holes arranged at intervals; And / or, the number of the second through holes (141) is a plurality of through holes arranged at intervals; And / or, the number of the third through holes (1211) is a plurality of through holes arranged at intervals; And / or, the number of the fourth through holes (1221) is a plurality of through holes arranged at intervals.

9. The auxiliary blood pumping device of claim 1, wherein, The deformation body (100) is connected with a catheter (200), the driving assembly (400) comprises an actuator (410) and a transmission mechanism (420), the actuator (410) is arranged outside the body, the transmission mechanism (420) is arranged in the catheter (200) and is connected between the actuator (410) and the deformation body (100), and the transmission mechanism (420) is a push rod or a pull wire; And / or, a pressure measuring mechanism (500) is arranged in the power cavity (101), the pressure measuring mechanism (500) comprises a pressure measuring pipe (510) and a pressure sensor (520), the pressure sensor (520) is arranged outside the body, the pressure measuring pipe (510) is communicated with the power cavity (101) and can be connected with the pressure sensor (520) outside the body.

10. A ventricular assist pump blood system, characterized by, The device comprises an ECG (3), a control unit (4) and the auxiliary blood pumping device according to any one of claims 1-9. The ECG (3) and the driving assembly (400) are connected with the control unit (4).

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