A diaphragm pump, a ventricular assist device and a ventricular assist equipment

Abstract

The present application relates to the technical field of medical devices, and particularly relates to a diaphragm pump, a ventricular assist device, and a ventricular assist equipment. Since the compliance of the first flexible diaphragm in the diaphragm assembly of the diaphragm pump in the present application is greater than that of the second flexible diaphragm, the deformability of the first flexible diaphragm is greater than that of the second flexible diaphragm. The first flexible diaphragm with high compliance can respond faster to the change in the volume of the blood chamber, and has higher elasticity and lower hardness, better compatibility with blood, and can reduce the damage to blood cells. The second flexible diaphragm can withstand higher pressure in the medium chamber, ensuring the pressure-bearing performance of the diaphragm assembly. The first flexible diaphragm and the second flexible diaphragm cooperate to improve the problems that the current diaphragm responds slowly to the change in the volume of the blood chamber and the cells in the blood chamber are greatly damaged.

Description

Technical Field

[0001] The present application relates to the technical field of medical devices, and particularly to a diaphragm pump, a ventricular assist device, and a ventricular assist equipment. Background Art

[0002] A percutaneous ventricular assist device (pVAD) can assist the heart in working or temporarily replace the heart's work when the heart is unable to work. This device is usually inserted into the body (such as the femoral artery) through the skin (percutaneously), and then connected to the heart to assist or take over the heart's blood pumping function, increase blood flow, enhance blood perfusion, and reduce myocardial oxygen consumption. It empties blood from the left ventricle and discharges it into the ascending aorta synchronously with the cardiac cycle. Usually, in emergency situations, such as during and after short-term cardiac support for high-risk percutaneous coronary intervention (PCI) patients and cardiogenic shock patients. Therefore, the design of pVAD needs to focus more on miniaturization, convenience, and minimally invasive. Its greatest feature is its small size, strong function, and convenient operation, which can quickly intervene in a short time, allowing acute heart failure patients to quickly establish blood circulation and win precious treatment time.

[0003] A percutaneous ventricular assist device usually includes a catheter, a diaphragm pump, and a main unit. The catheter is used to extend into the heart. The chamber of the diaphragm pump is divided into a medium chamber and a blood chamber by a diaphragm. The blood chamber is connected to the catheter inserted into the body to receive the blood pumped out by the heart. The medium chamber is connected to the main unit and houses the fluid medium for pumping blood. When the heart is in the systolic phase, blood is input into the blood chamber of the diaphragm pump through the catheter. At this time, the diaphragm deforms, allowing the blood to occupy the blood chamber to the greatest extent, and there is almost no medium in the fluid medium chamber. When the heart is in the diastolic phase, the main unit controls the fluid medium to fill the medium chamber. At this time, due to the continuous filling of the medium, the diaphragm gradually deforms in the opposite direction, thereby pushing the blood out of the diaphragm pump and flowing into the ascending aorta through the two-way valve at the proximal end of the catheter.

[0004] During the operation of the diaphragm pump, since the diaphragm needs to be able to withstand the pressure of the medium chamber, currently the compliance of the diaphragm is low, the response to the volume change of the blood chamber is slow, and the cells in the blood chamber are damaged relatively large. Summary of the Invention

[0005] The present application provides a diaphragm pump for improving the problem that the current diaphragm has a slow response to the volume change of the blood chamber and the cells in the blood chamber are damaged greatly.

[0006] In addition, the present application also provides a ventricular assist device and a ventricular assist equipment using the above diaphragm pump.

[0007] In a first aspect, in one embodiment, a diaphragm pump is provided, comprising:

[0008] a pump housing having a chamber therein;

[0009] and a diaphragm assembly that divides the chamber into a blood chamber and a medium chamber; the pump housing has a blood passage communicating with the blood chamber, and the blood passage is used for allowing blood to enter and exit the blood chamber; the pump housing further has a medium passage communicating with the medium chamber, and the medium passage is used for allowing a fluid medium to enter and exit the medium chamber; the diaphragm assembly includes at least two layers of flexible diaphragms, one of the flexible diaphragms being a first flexible diaphragm and one of the flexible diaphragms being a second flexible diaphragm; one side surface of the first flexible diaphragm faces the blood chamber, and one side surface of the second flexible diaphragm faces the medium chamber;

[0010] The compliance of the first flexible diaphragm is greater than the compliance of the second flexible diaphragm.

[0011] Further, in one embodiment, a part of the first flexible diaphragm in the chamber is a first part, and a part of the second flexible diaphragm in the chamber is a second part, and the area of the first part is smaller than the area of the second part.

[0012] Further, in one embodiment, the range of the ratio a of the area of the first part to the area of the second part is: 0.7 ≤ a < 1.

[0013] Further, in one embodiment, the range of the ratio a of the area of the first part to the area of the second part is: 0.85 ≤ a < 1.

[0014] Further, in one embodiment, any adjacent flexible diaphragms are adsorbed together by vacuum.

[0015] Further, in one embodiment, a lubricating medium is provided between any adjacent flexible diaphragms, or at least one of the adjacent flexible diaphragms has a lubricating coating, and at least one of the two opposite side surfaces of the adjacent flexible diaphragms is the surface of the lubricating coating.

[0016] Further, in one embodiment, the number of the flexible diaphragms is two, or the number of the flexible diaphragms is three or more, and the flexible diaphragm between the first flexible diaphragm and the second flexible diaphragm is an intermediate flexible diaphragm, and the compliance of the intermediate flexible diaphragm is less than or equal to the compliance of the first flexible diaphragm and greater than or equal to the compliance of the second flexible diaphragm.

[0017] Further, in one embodiment, the hardness of the first flexible diaphragm ranges from 20 to 65 HA, and the elastic modulus ranges from 0.3 to 2.3 Mpa, and / or the hardness of the second flexible diaphragm ranges from 50 to 85 HA, and the elastic modulus ranges from 11 to 25 Mpa.

[0018] In a second aspect, in one embodiment, a ventricular assist device is provided, including a catheter and a diaphragm pump;

[0019] The diaphragm pump includes:

[0020] A pump housing having a chamber therein;

[0021] And a diaphragm assembly that divides the chamber into a blood chamber and a medium chamber; the catheter is used to intervene in the human body and communicate with the blood chamber; the pump housing has a blood passage communicating with the blood chamber, and the blood passage is used for blood to enter and exit the blood chamber; the pump housing also has a medium passage communicating with the medium chamber, and the medium passage is used for a fluid medium to enter and exit the medium chamber; the diaphragm assembly includes at least two layers of flexible diaphragms, one of the flexible diaphragms is a first flexible diaphragm, and one of the flexible diaphragms is a second flexible diaphragm; one side of the first flexible diaphragm faces the blood chamber, and one side of the second flexible diaphragm faces the medium chamber;

[0022] The compliance of the first flexible diaphragm is greater than the compliance of the second flexible diaphragm.

[0023] Further, in one embodiment, the part of the first flexible diaphragm in the chamber is the first part, and the part of the second flexible diaphragm in the chamber is the second part, and the area of the first part is smaller than the area of the second part.

[0024] Further, in one embodiment, the range of the ratio a of the area of the first part to the area of the second part is: 0.7 ≤ a < 1.

[0025] Further, in one embodiment, the range of the ratio a of the area of the first part to the area of the second part is: 0.85 ≤ a < 1.

[0026] Further, in one embodiment, any adjacent flexible diaphragms are adsorbed together by vacuum.

[0027] Further, in one embodiment, a lubricating medium is provided between any adjacent flexible diaphragms, or at least one of the adjacent flexible diaphragms has a lubricating coating, and at least one of the two opposite sides of the adjacent flexible diaphragms is the surface of the lubricating coating.

[0028] Further, in one embodiment, the number of the flexible diaphragms is two, or the number of the flexible diaphragms is three or more, and the flexible diaphragm between the first flexible diaphragm and the second flexible diaphragm is an intermediate flexible diaphragm, and the compliance of the intermediate flexible diaphragm is less than or equal to the compliance of the first flexible diaphragm and greater than or equal to the compliance of the second flexible diaphragm.

[0029] Further, in one embodiment, the hardness range of the first flexible diaphragm is 20-65HA, the elastic modulus range is 0.3-2.3 Mpa, and / or the hardness range of the second flexible diaphragm is 50-85HA, the elastic modulus range is 11-25 Mpa.

[0030] In a third aspect, in one embodiment, a ventricular assist device is provided, including a pumping main body and a ventricular assist device;

[0031] The ventricular assist device includes a catheter and a diaphragm pump;

[0032] The diaphragm pump includes:

[0033] A pump housing having a chamber therein;

[0034] And a diaphragm assembly, the chamber being separated by the diaphragm assembly into a blood chamber and a medium chamber; the catheter is used to intervene in the human body and communicate with the blood chamber; the pumping main body communicates with the medium chamber for pumping or extracting a fluid medium into the medium chamber; the pumping main body includes a pressure sensor for detecting the pressure in the medium chamber; the pump housing has a blood passage communicating with the blood chamber, the blood passage being used for blood to enter and exit the blood chamber; the pump housing also has a medium passage communicating with the medium chamber, the medium passage being used for the fluid medium to enter and exit the medium chamber; the diaphragm assembly includes at least two layers of flexible diaphragms, one of the flexible diaphragms being a first flexible diaphragm and one of the flexible diaphragms being a second flexible diaphragm; one side of the first flexible diaphragm faces the blood chamber, and one side of the second flexible diaphragm faces the medium chamber;

[0035] The compliance of the first flexible diaphragm is greater than the compliance of the second flexible diaphragm.

[0036] Further, in one embodiment, the part of the first flexible diaphragm in the chamber is a first part, the part of the second flexible diaphragm in the chamber is a second part, and the area of the first part is smaller than the area of the second part.

[0037] Further, in one embodiment, the range of the ratio a of the area of the first part to the area of the second part is: 0.7 ≤ a < 1.

[0038] Further, in one embodiment, the ratio a of the area of the first part to the area of the second part ranges from 0.85 ≤ a < 1.

[0039] Further, in one embodiment, any adjacent flexible diaphragms are adsorbed together by vacuum.

[0040] Further, in one embodiment, a lubricating medium is provided between any adjacent flexible diaphragms, or at least one of the adjacent flexible diaphragms has a lubricating coating, and at least one of the two opposite side surfaces of the adjacent flexible diaphragms is the surface of the lubricating coating.

[0041] Further, in one embodiment, the number of the flexible diaphragms is two, or the number of the flexible diaphragms is more than three, and the flexible diaphragm between the first flexible diaphragm and the second flexible diaphragm is an intermediate flexible diaphragm, and the compliance of the intermediate flexible diaphragm is less than or equal to the compliance of the first flexible diaphragm and greater than or equal to the compliance of the second flexible diaphragm.

[0042] Further, in one embodiment, the hardness range of the first flexible diaphragm is 20 - 65 HA, the elastic modulus range is 0.3 - 2.3 Mpa, and / or the hardness range of the second flexible diaphragm is 50 - 85 HA, and the elastic modulus range is 11 - 25 Mpa.

[0043] According to the diaphragm pump of the above embodiment, since the compliance of the first flexible diaphragm in the diaphragm assembly of the diaphragm pump in the present application is greater than the compliance of the second flexible diaphragm, the second flexible diaphragm can withstand higher pressure in the medium chamber, ensuring the pressure-bearing performance of the diaphragm assembly. The deformability of the first flexible diaphragm is greater than that of the second flexible diaphragm. The first flexible diaphragm with high compliance can respond faster to the volume change of the blood chamber, improving the problem that the current diaphragm responds slowly to the volume change of the blood chamber. Since the first flexible diaphragm with high compliance has higher elasticity and lower hardness, it has better compatibility with blood and can reduce damage to blood cells, improving the problem that cells in the blood chamber are severely damaged.

[0044] Further, the area of the first part is smaller than the area of the second part, increasing the area of the second flexible diaphragm in the chamber, so that the second flexible diaphragm can better cooperate with the first flexible diaphragm to quickly respond to the volume change of the blood chamber under the given physical properties. Description of the Drawings

[0045] Figure 1 It is a schematic structural diagram of a ventricular assist device in one embodiment;

[0046] Figure 2 It is a schematic structural diagram of a diaphragm pump in one embodiment;

[0047] Figure 3 It is a cross-sectional view of a diaphragm pump in an embodiment;

[0048] Figure 4 It is a cross-sectional view of the diaphragm pump when the heart is in systole in an embodiment.

[0049] List of the names of the features corresponding to the reference numerals in the figure: 1. Pumping main body; 2. Conduit; 21. Window; 22. Check valve; 3. Diaphragm pump; 31. Pump housing; 311. First housing; 312. Second housing; 313. Conduit joint; 314. Fluid medium joint; 32. Diaphragm assembly; 321. First flexible diaphragm; 3211. First part; 3212. First clamping part; 322. Second flexible diaphragm; 3221. Second part; 3222. Second clamping part; 33. Chamber; 331. Blood chamber; 332. Medium chamber; 34. Blood passage; 35. Medium passage. Detailed implementation manners

[0050] The present application will be further described in detail below in conjunction with the accompanying drawings through specific implementation manners. Similar elements in different implementation manners are labeled with related similar reference numerals. In the following implementation manners, many detailed descriptions are provided to enable a better understanding of the present application. However, those skilled in the art can easily recognize that some of the features can be omitted in different situations, or can be replaced by other elements, materials, or methods. In some cases, some operations related to the present application are not shown or described in the specification, which is to avoid the core part of the present application being overwhelmed by excessive descriptions. For those skilled in the art, it is not necessary to describe these related operations in detail, and they can fully understand the related operations based on the description in the specification and the general technical knowledge in the art.

[0051] In addition, the features, operations, or characteristics described in the specification can be combined in any appropriate manner to form various implementation manners. At the same time, the steps or actions in the method description can also be reordered or adjusted in an obvious manner by those skilled in the art. Therefore, the various sequences in the specification and the drawings are only for clearly describing a certain embodiment and do not mean that they are the necessary sequences, unless it is stated that a certain sequence must be followed.

[0052] In the description of the present application, it should be understood that the orientation or positional relationship indicated by the terms "center", "longitudinal", "transverse", "length", "width", "thickness", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", "clockwise", "counterclockwise", "axial", "radial", "circumferential", etc. is based on the orientation or positional relationship shown in the drawings, and is only for the convenience of describing the present application and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore should not be construed as a limitation on the present application.

[0053] In addition, the terms "first" and "second" are only used for descriptive purposes and should not be construed as indicating or implying relative importance or implicitly specifying the quantity of the indicated technical features.

[0054] In the present application, unless otherwise clearly specified and limited, the terms "mounted", "connected", "connected to", "fixed", etc. should be understood in a broad sense. For example, it may be a fixed connection, a detachable connection, or integrated; it may be a mechanical connection or an electrical connection; it may be directly connected, abutted, or indirectly connected through an intermediate medium, and may be the communication inside two elements or the interaction relationship between two elements. For those of ordinary skill in the art, the specific meanings of the above terms in the present application can be understood according to specific circumstances.

[0055] In the present application, unless otherwise clearly specified and limited, the first feature being "on" or "under" the second feature may be that the first and second features are in direct contact, or the first and second features are indirectly in contact through an intermediate medium. Moreover, the first feature being "above", "over" and "on" the second feature may be that the first feature is directly above or obliquely above the second feature, or simply means that the first feature is at a higher level than the second feature in terms of horizontal height. The first feature being "under", "beneath" and "under" the second feature may be that the first feature is directly below or obliquely below the second feature, or simply means that the first feature is at a lower level than the second feature in terms of horizontal height.

[0056] In the specific embodiments described, the various embodiments, without conflict, can be combined in any suitable manner. For example, different embodiments can be combined to form different implementation manners. To avoid unnecessary repetition, the various possible combination manners of the embodiments will not be described separately.

[0057] The diaphragm pump is divided into two chambers by a flexible diaphragm. The two chambers contain two different fluids, namely blood and a fluid medium. Since there are substances such as blood cells, proteins, and inorganic salts in the blood, which have a different density from the fluid medium and respond differently to the same pressure, it is difficult to meet the physical properties of the two different fluids with a traditional flexible diaphragm made of a single material. The diaphragm pump only plays a role of transferring and pumping. The blood entering the blood chamber of the diaphragm pump still needs to return to the patient's body. Therefore, as a structure for applying pressure to the blood, the flexible diaphragm in the diaphragm pump needs to consider the biocompatibility of the material and minimize the damage to easily damaged substances such as blood cells in the blood.

[0058] In view of the requirement that the flexible diaphragm in the diaphragm pump needs to withstand the relatively large pressure of the fluid medium while reducing the damage to blood cells, the present application provides a diaphragm assembly including at least two layers of flexible diaphragms. The first flexible diaphragm and the second flexible diaphragm in the diaphragm assembly are made of materials with different compliances, so that the first flexible diaphragm is more suitable for the blood chamber and the second flexible diaphragm is more suitable for the medium chamber. In this way, it can not only enable the first flexible diaphragm to respond to the changes in the blood chamber in a timely manner and reduce the damage to blood cells, but also enable the second flexible diaphragm to withstand a large pressure and ensure the pressure-bearing performance of the diaphragm assembly.

[0059] The ventricular assist device, the assist device, and the diaphragm pump in the present application will be introduced in detail below with reference to the accompanying drawings.

[0060] In some embodiments, please refer to Figures 1 to 4 , the ventricular assist device includes a pumping main body 1 and a ventricular assist device. The ventricular assist device includes a catheter 2 and a diaphragm pump 3. The diaphragm pump 3 includes a pump housing 31 and a diaphragm assembly 32. There is a chamber 33 in the pump housing 31. The chamber 33 is divided into a blood chamber 331 and a medium chamber 332 by the diaphragm assembly 32. The catheter 2 is used to intervene in the human body and communicate with the blood chamber 331. The pump housing 31 has a blood passage 34 communicating with the blood chamber 331. The blood passage 34 is used to communicate with the catheter 2 to allow blood to enter and exit the blood chamber 331. The pump housing 31 also has a medium passage 35 communicating with the medium chamber 332. The medium passage 35 is used to allow the fluid medium to enter and exit the medium chamber 332. The medium chamber 332 is used to communicate with the pumping main body 1 through the medium passage 35, so that the fluid medium can enter the medium chamber 332 through the medium passage 35. The pumping main body 1 can either fill the fluid medium into the medium chamber 332 or extract the fluid medium from the medium chamber 332.

[0061] During the systolic phase of the heart, the blood chamber 331 can receive the blood pumped out by the heart through the blood passage 34, and the fluid medium in the medium chamber 332 flows out through the medium passage 35. During the diastolic phase of the heart, the pumping main body 1 controls the filling of the medium chamber 332 with the fluid medium. Due to the continuous filling of the fluid medium, the diaphragm assembly 32 deforms towards the blood chamber 331, pushing the blood in the blood chamber 331 out of the diaphragm pump 3 and flowing into the ascending aorta through the catheter 2.

[0062] Regarding the structure of the diaphragm assembly 32, the diaphragm assembly 32 includes at least two layers of flexible diaphragms. One layer of flexible diaphragm is the first flexible diaphragm 321, and one layer of flexible diaphragm is the second flexible diaphragm 322; one side of the first flexible diaphragm 321 is exposed in the blood chamber 331 and can contact the blood. One side of the second flexible diaphragm 322 is exposed in the medium chamber 332 and can contact the fluid medium. The compliance of the first flexible diaphragm 321 is greater than that of the second flexible diaphragm 322. The second flexible diaphragm 322 can withstand higher pressure in the medium chamber 332, ensuring the pressure-bearing performance of the diaphragm assembly 32. The deformability of the first flexible diaphragm 321 is greater than that of the second flexible diaphragm 322. The first flexible diaphragm 321 with high compliance can respond faster to the volume change of the blood chamber 331, improving the problem that the current diaphragm responds slowly to the volume change of the blood chamber 331. Since the first flexible diaphragm 321 with high compliance has higher elasticity and lower hardness, it has better compatibility with blood and reduces the damage to blood cells. In addition, the flexible diaphragms with more than two layers in the present application can also reduce the impact caused by diaphragm rupture. When one layer of flexible diaphragm is damaged and ruptured, the other layers of flexible diaphragms can prevent the fluid medium in the medium chamber 332 from flowing into the blood chamber 331, thus avoiding secondary harm to the patient. In this way, the present application not only solves the unacceptable clinical risk caused by diaphragm breakage, but also improves the problem that the diaphragm responds slowly to the volume change of the blood chamber.

[0063] In some embodiments, the pumping main body 1 includes a pressure sensor (not shown in the figure), and the pressure sensor can detect the pressure in the medium chamber 332. Specifically, the pressure sensor is a pneumatic pressure sensor integrated in the pumping main body 1, located at the front end of the air path output interface in the pumping main body 1, and can detect the air pressure of the air path communicated with the medium chamber 332 and the medium chamber 332. When the medium chamber 332 needs to be filled with the medium, the measured value of the pneumatic pressure sensor is a positive pressure value. When the medium in the medium chamber 332 needs to be discharged, the measured value of the pneumatic pressure sensor is a negative pressure value. Therefore, since the pressure sensor can sense the pressure in the medium chamber 332, when one layer of flexible diaphragm ruptures, an instantaneous pressure change will occur, and during the operation of the remaining flexible diaphragms, the driving force of the pumping main body 1 on the diaphragm assembly 32 will also change. Based on the pressure change, the pumping main body 1 will give an emergency high-level alarm, which can remind the operator to pay attention, stop the operation of the membrane pump and replace the membrane pump.

[0064] Specifically, in some embodiments, the material of the flexible diaphragm can be silicone, such as PDMS; it can also be rubber, such as TPU or TPE. According to different processes, the compliance of the flexible diaphragm can be changed to meet the compliance requirements of the flexible diaphragm.

[0065] In some embodiments, please refer to Figure 3 and Figure 4 , in order to make the second flexible diaphragm 322 better adapt to the compliance of the first flexible diaphragm 321, the part of the first flexible diaphragm 321 in the chamber 33 is the first part 3211, and the part of the second flexible diaphragm 322 in the chamber 33 is the second part 3221. The area of the first part 3211 is smaller than the area of the second part 3221. Due to the insufficient elasticity of the second flexible diaphragm 322, under the same area and the same acting force, the deformation that can occur is smaller than that of the first flexible diaphragm 321. Compared with the case where the areas of the first part 3211 and the second part 3221 are the same, when pushing blood, the area of the first part 3211 being smaller than the area of the second part 3221 is more likely to reduce or even eliminate the residual blood in the blood chamber 331. When blood flows into the blood chamber 331, it is also easier to make the blood fill the entire chamber 33. In addition, during diastole of the heart, the second flexible diaphragm 322 in contact with the fluid medium has a lower compliance but a higher hardness, so its pressure resistance ability will be stronger, and it can withstand a relatively higher pressure in the medium chamber 332, improving the service life of the diaphragm pump 3.

[0066] Since the diaphragm assembly 32 needs to continuously change its shape back and forth between the two chambers with the heart rate cycle, when the areas of the first part 3211 and the second part 3221 are the same, due to the need to match the deformation amount of the first flexible diaphragm 321, the deformation amount required for the second flexible diaphragm 322 will be larger. The second flexible diaphragm 322 is more likely to generate fatigue and then be damaged during continuous back-and-forth pulling, increasing the use risk of the diaphragm pump 3. By making the area of the second part 3221 larger than the area of the first part 3211, this problem can be improved, and the deformation amount of the second flexible diaphragm 322 can be reduced, making the second flexible diaphragm 322 less likely to be damaged.

[0067] It should be noted that the part of the first flexible diaphragm 321 in the chamber 33, i.e., the first part 3211, refers to the part that separates the chamber 33, and the part used to mount the first flexible diaphragm 321 on the pump housing 31 (such as the first clamping part 3212 adhesively bonded or clamped on the pump housing 31) should not belong to the first part 3211. Similarly, the part of the second flexible diaphragm 322 in the chamber 33, i.e., the second part 3221, refers to the part that separates the chamber 33, and the part used to mount the second flexible diaphragm 322 on the pump housing 31 (such as the second clamping part 3222 adhesively bonded or clamped on the pump housing 31) should not belong to the second part 3221.

[0068] Regarding the area ratio of the first part 3211 to the second part 3221, in some embodiments, the range of the area ratio a of the first part 3211 to the second part 3221 is: 0.7 ≤ a < 1. Further, in some embodiments, the range of the area ratio a of the first part 3211 to the second part 3221 is: 0.85 ≤ a < 1. Specifically, the value of a can be 0.7, 0.75, 0.8, 0.85, 0.9, 0.95, etc. Of course, in some other embodiments, the value of a can also be 1, that is, the area of the first part is equal to the area of the second part.

[0069] In order to make the diaphragm assembly 32 operate more stably, in some embodiments, any adjacent flexible diaphragms are adsorbed together by vacuum. By evacuating the air between adjacent two layers of flexible diaphragms, a vacuum state is formed between the adjacent flexible diaphragms. Under the action of the external pressure, during the operation of the diaphragm assembly 32, the adjacent two layers of flexible diaphragms can still be tightly attached to each other and will not separate due to the pushing and pulling movement.

[0070] In some embodiments, since the area of the second part 3221 is larger than that of the first part 3211, after the space between the second part 3221 and the first part 3211 is evacuated, based on the compliance gap between the second part 3221 and the first part 3211, the second part 3221 and the first part 3211 present different states:

[0071] For example, in some embodiments, when the compliance gap between the second part 3221 and the first part 3211 is large, that is, the second part 3221 is harder and the first part 3211 is softer, the first part 3211 deforms closely adhering to the second part 3221 and together with the second part 3221 sags towards the medium chamber 332 or the blood chamber 331.

[0072] For another example, in one embodiment, the compliance gap between the second part 3221 and the first part 3211 is small, and the area ratio of the second part 3221 to the first part 3211 is large. When the second part 3221 is slightly stiffer than the medium compliance and the first part 3211 is slightly softer than the medium compliance, the second part 3221 may be wrinkled. In some embodiments, in order to reduce the friction between adjacent flexible diaphragms and avoid damage caused by relative sliding between adjacent flexible diaphragms, lubrication treatment is performed on the adjacent flexible diaphragms. Specific treatment methods include: in some embodiments, a lubricating medium (not shown in the figure) is provided between any adjacent flexible diaphragms. The specific lubricating medium can be physiological saline or glucose solution (about 5%). In still other embodiments, at least one of the adjacent flexible diaphragms has a lubricating coating, and at least one of the two opposite sides of the adjacent flexible diaphragms is the surface of the lubricating coating. Specifically, the lubricating coating can be a silicone oil coating, a hydrophilic coating: PVP (polyvinylpyrrolidone), zwitterionic polymers (sulfobetaine SBMA, carboxymethyl chitosan CMC). Through the lubrication treatment, the loss caused by mutual friction between the diaphragms can be reduced, and the risk of diaphragm rupture can be reduced.

[0073] Regarding the number of flexible diaphragms in the diaphragm assembly 32, in one embodiment, the number of flexible diaphragms is two. Such a diaphragm assembly 32 has a simple structure.

[0074] In one embodiment, when the number of flexible diaphragms is more than three, the flexible diaphragm between the first flexible diaphragm 321 and the second flexible diaphragm 322 is an intermediate flexible diaphragm. The compliance of the intermediate flexible diaphragm is less than or equal to the compliance of the first flexible diaphragm 321 and greater than or equal to the compliance of the second flexible diaphragm 322. The number of intermediate flexible diaphragms can be one or more. For example, in some embodiments, the number of flexible diaphragms is three, the number of intermediate flexible diaphragms is one, and the compliance of the intermediate flexible diaphragm can be less than the compliance of the first flexible diaphragm 321 and greater than the compliance of the second flexible diaphragm 322. Of course, the compliance of the intermediate flexible diaphragm can also be equal to the compliance of the first flexible diaphragm 321 or equal to the compliance of the second flexible diaphragm 322. Of course, in addition to the number of flexible diaphragms being three, it can also be four, five, six, seven, etc. according to needs.

[0075] The first flexible diaphragm 321 and the second flexible diaphragm 322 are respectively made of two materials with different compliances. In some embodiments, compliance can be defined by two values, namely Shore A hardness and elastic modulus. Among them, Shore A is used to describe the hardness of softer materials, and the larger the value, the greater the hardness; the elastic modulus is used to describe the stress of the material under unidirectional stress divided by the deformation in that direction, and the larger the value, the greater the rigidity of the material. In some embodiments, the hardness range of the first flexible diaphragm 321 is 20 - 65 HA, and the elastic modulus range is 0.3 - 2.3 Mpa. In some embodiments, the hardness range of the second flexible diaphragm 322 is 50 - 85 HA, and the elastic modulus range is 11 - 25 Mpa.

[0076] Regarding the structure of the pump housing 31, in some embodiments, please refer to Figures 1 to 4 , the pump housing 31 includes a first housing 311 and a second housing 312. After the first housing 311 and the second housing 312 are joined together, they enclose a cavity, and the diaphragm assembly 32 is clamped between the first housing 311 and the second housing 312. The first clamping portion 3212 of the first flexible diaphragm 321 and the second clamping portion 3222 of the second flexible diaphragm 322 are clamped between the first housing 311 and the second housing 312. Specifically, in some embodiments, the pump housing 31 is a semi-circular transparent housing.

[0077] In some embodiments, please refer to Figures 1 to 4 , the pump housing 31 includes a conduit connector 313 and a fluid medium connector 314. The medium channel 35 is located in the fluid medium connector 314, and the blood channel 34 is located in the conduit connector 313. The conduit 2 is connected to the conduit connector 313.

[0078] Regarding the structure of the conduit 2, in some embodiments, please refer to Figure 1 , a window 21 is opened at the front end of the conduit 2, and a two-way valve 22 is provided on the rear side of the window 21. The two-way valve 22 is configured to open only when the diaphragm pump 3 pushes blood into the conduit 2, establishing a passage between the inside of the conduit 2 and the ascending aorta.

[0079] In some embodiments, please refer to Figures 1 to 4 , the operation steps of the ventricular assist device are as follows:

[0080] For a patient in need of ventricular assistance, a puncture is performed on the femoral artery, and a conduit 2 with a two-way valve 22 is guided into the patient's large artery with a guide wire. Among them, the window 21 at the front end of the conduit 2 is located in the left ventricle, and the two-way valve section is located in the ascending aorta outside the heart. After the conduit 2 is filled with blood, the conduit 2, the external diaphragm pump 3, and the external pumping main unit 1 are connected. The pumping main unit 1 cooperates with the heart rate to push the fluid medium, and then pumps the blood.

[0081] Specifically, during the systolic phase of the heart, the pumping main body 1 sucks the medium in the medium chamber 332, and the blood in the heart enters the catheter 2 through the opening window at the front end of the catheter 2 and enters the blood chamber 331 of the diaphragm pump 3. Under the negative pressure of the medium chamber 332, the diaphragm assembly 32 deforms towards the medium chamber 332. During the diastolic phase of the heart, the pumping medium inside the pumping main body 1 is pumped into the medium chamber 332 of the diaphragm pump 3. At this time, the fluid medium (which can be a liquid or a gas) gradually fills the medium chamber 332, and the diaphragm assembly 32 is also pushed to deform, pushing the blood in the blood chamber 331 into the catheter 2. The pushed blood flows into the ascending aorta from the two-way valve 22. With one heartbeat, the diaphragm pump 3 pumps back and forth once, and the pumping main body 1 controls the pushing of the medium according to the heart rate of different patients, thereby realizing the function of assisting the ventricle in pumping blood.

[0082] In this process, the first flexible diaphragm 321 with higher compliance contacts the blood, and the second flexible diaphragm 322 with lower compliance contacts the fluid medium. Since the area of the second part 3221 is larger than that of the first part 3211, a vacuum is created between the first flexible diaphragm 321 and the second flexible diaphragm 322. Therefore, when the diaphragm pump 3 is not operating, the first flexible diaphragm 321 and the second flexible diaphragm 322 are closely attached to each other. When the heart is in the systolic phase, the first flexible diaphragm 321 in contact with the blood can respond faster to the change in the volume of the blood chamber 331 and deform faster because of its higher compliance; at this time, the second flexible diaphragm 322 has lower compliance, that is, higher hardness, so its compressive ability is stronger. Although the deformation ability of the second flexible diaphragm 322 is lower, because the area of the second part 3221 on the second flexible diaphragm 322 is larger, it can meet the requirement of blood filling the entire diaphragm pump 3. When the heart is in the diastolic phase, the second flexible diaphragm 322 can withstand a relatively higher pressure in the medium chamber 332 because of its lower compliance but higher hardness, which can extend the service life of the diaphragm pump 3 and reduce the risk brought by diaphragm rupture.

[0083] The above uses specific examples to elaborate on the present application, which is only used to help understand the present application and is not intended to limit the present application. For those skilled in the technical field to which the present application belongs, based on the idea of the present application, several simple deductions, deformations or substitutions can also be made.

Claims

1. A diaphragm pump, characterized in that, Comprising: A pump housing having a chamber therein; And a diaphragm assembly that divides the chamber into a blood chamber and a medium chamber; The pump housing has a blood passage communicating with the blood chamber, and the blood passage is used for allowing blood to enter and exit the blood chamber; The pump housing further has a medium passage communicating with the medium chamber, and the medium passage is used for allowing a fluid medium to enter and exit the medium chamber; The diaphragm assembly includes at least two layers of flexible diaphragms, one of the flexible diaphragms being a first flexible diaphragm and one of the flexible diaphragms being a second flexible diaphragm; one side surface of the first flexible diaphragm faces the blood chamber, and one side surface of the second flexible diaphragm faces the medium chamber; The compliance of the first flexible diaphragm is greater than the compliance of the second flexible diaphragm; A part of the first flexible diaphragm in the chamber is a first part, and a part of the second flexible diaphragm in the chamber is a second part, and the area of the first part is smaller than the area of the second part.

2. The diaphragm pump according to claim 1, characterized in that, The range of the ratio a of the area of the first part to the area of the second part is: 0.7 ≤ a < 1.

3. The diaphragm pump according to claim 2, wherein, The range of the ratio a of the area of the first part to the area of the second part is: 0.85 ≤ a < 1.

4. The diaphragm pump according to claim 1, characterized in that, Any adjacent flexible diaphragms are adsorbed together by vacuum.

5. The diaphragm pump according to any one of claims 1-4, characterized in that, A lubricating medium is provided between any adjacent flexible diaphragms, or at least one of the adjacent flexible diaphragms has a lubricating coating, and at least one of the two opposite side surfaces of the adjacent flexible diaphragms is the surface of the lubricating coating.

6. The diaphragm pump according to any one of claims 1-4, characterized in that, The number of the flexible diaphragms is two, or the number of the flexible diaphragms is three or more, and the flexible diaphragm between the first flexible diaphragm and the second flexible diaphragm is an intermediate flexible diaphragm, and the compliance of the intermediate flexible diaphragm is less than or equal to the compliance of the first flexible diaphragm and greater than or equal to the compliance of the second flexible diaphragm.

7. The diaphragm pump according to any one of claims 1-4, characterized in that, The hardness range of the first flexible diaphragm is 20 - 65 HA, the elastic modulus range is 0.3 - 2.3 Mpa, and / or the hardness range of the second flexible diaphragm is 50 - 85 HA, the elastic modulus range is 11 - 25 Mpa.

8. A ventricular assist device, characterized in that, Comprising a catheter and the diaphragm pump according to any one of claims 1 - 7; the catheter is used for intervening in the human body and communicating with the blood chamber.

9. A ventricular assist device, characterized in that, Comprising a pumping main body and the ventricular assist device according to claim 8; the pumping main body communicates with the medium chamber for pumping or extracting a fluid medium to the medium chamber; the pumping main body includes a pressure sensor for detecting the pressure in the medium chamber.

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