Ventricular auxiliary circulation device and control method

Abstract

The embodiment of the invention provides a ventricular auxiliary circulation device and a control method. The ventricular auxiliary circulation device comprises at least one shell, and the shell is attached to a specific area of the outer surface of a ventricular chamber in shape; and a drive device linked to the at least one housing, where the drive device exerts a periodic external effect on the housing to cause the housing to periodically contract, thereby periodically extruding the ventricular cavity to promote ventricular blood circulation.

Description

Technical Field

[0001] The present disclosure relates to the field of medical devices, and more specifically, to a ventricular assist circulation device and a control method thereof. Background Art

[0002] At present, there are two types of ventricular assist circulation devices: one is inserted into the ventricular cavity through the artery in reverse, and the other is inserted into the ventricular cavity through the apical surgical window. Both methods directly contact and interfere with blood flow, and there are many complications, such as damage to blood cells, hemolysis, bleeding, thromboembolism, bacteremia and sepsis. In order to greatly reduce complications, it is necessary to develop new methods, new materials, new technologies and new devices for ventricular assist circulation.

[0003] With the progress in fields such as soft humanoid robots and dexterous hands, a large number of new technologies and new materials have emerged, providing feasibility and opportunities for breakthroughs in ventricular assist circulatory devices that rely on high-speed pumps. Summary of the invention

[0004] In view of this, an embodiment of the present disclosure provides a ventricular assist circulation device and a control method. The ventricular assist circulation device assists blood circulation in the ventricular cavity through the outer surface of the ventricle without destroying the integrity of the heart's own structure and without contacting blood, which is expected to greatly reduce complications.

[0005] According to a first aspect of the present disclosure, there is provided a ventricular assist circulation device, comprising:

[0006] at least one housing that conforms to a specific area of ​​the outer surface of the ventricle;

[0007] a drive device connected to at least one of the housings,

[0008] The driving device applies periodic external force to the shell to cause the shell to contract periodically, thereby periodically squeezing the ventricular cavity, thereby promoting ventricular blood circulation.

[0009] In some embodiments, a plurality of the shells are spaced apart with gaps therebetween to expose blood vessels on the outer surface of the ventricle.

[0010] In some embodiments, the gaps between the plurality of shells are connected by a mesh-like flexible material.

[0011] In some embodiments, the gaps between the plurality of housings are connected by tiny hoses.

[0012] In some embodiments, according to the housing

[0013] The materials exert different external effects.

[0014] In some embodiments, the material of the shell is one of the following materials: shape memory polymer, photostrictive material, and heat shrinkable material.

[0015] In some embodiments, the at least one shell is 5 shells, which are respectively fitted to the shape of the right ventricular free wall and outflow tract, the left ventricular anterior wall, the left ventricular posterior wall, the right ventricular posterior wall and the apex.

[0016] In some embodiments, a plurality of said housings are connected to said drive device via separate links.

[0017] In some embodiments, the invention further includes: a sensor disposed on the housing, wherein the sensor is electrically connected to the driving device.

[0018] In some embodiments, the driving device controls the contraction of the shell according to the natural activity law of the ventricle.

[0019] According to a second aspect of the present disclosure, a control method for the above-mentioned ventricular assist circulation device is provided, the control method comprising:

[0020] Continuously monitor the sensing signal;

[0021] Determining whether the sensing signal is normal;

[0022] If the sensing signal is normal, the external action is applied to each housing in a normal mode, and if the sensing signal is abnormal, the external action is applied to each housing in an abnormal mode.

[0023] In some embodiments, in the normal mode, the external force applied to the shell is adjusted according to the change in ventricular pressure according to a predetermined algorithm to adjust the contraction force and amplitude of the shell, and the external force applied to the shell is adjusted according to the change in heart rate of the electrocardiogram according to a predetermined algorithm to adjust the contraction frequency of the shell; in the abnormal mode, the external force on the shell covering the outer surface of the left ventricle or the right ventricle is temporarily increased.

[0024] The disclosed embodiments provide a ventricular assist circulation device and a control method. The device causes a shell to contract and recover periodically through a driving device connected to the shell, thereby periodically squeezing the outer surface of the ventricle and the ventricular cavity, causing the volume of the ventricular cavity to shrink periodically, thereby promoting ventricular blood circulation. BRIEF DESCRIPTION OF THE DRAWINGS

[0025] The above and other objects, features and advantages of the present disclosure will become more apparent through the description of the embodiments of the present disclosure with reference to the following drawings, in which:

[0026] Figure 1 A stereoscopic view of the cardiac structure is given;

[0027] Figure 2 Given and Figure 1 Schematic diagram of the five shells corresponding to the five partitions;

[0028] Figure 3 A stereoscopic diagram of a ventricular assist circulation device provided by an embodiment of the present disclosure is provided;

[0029] Figure 4 A stereoscopic view of a housing of a ventricular assist circulation device and a link connected to the housing in another embodiment of the present disclosure is provided;

[0030] Figure 5 and Figure 6 Two connection methods between the shells of ventricular assist circulation devices are given;

[0031] Figure 7 A flow chart of a control method of a ventricular assist circulation device according to an embodiment of the present disclosure is provided. DETAILED DESCRIPTION

[0032] The present disclosure is described below based on embodiments, but the present disclosure is not limited to these embodiments. In the detailed description of the present disclosure below, some specific details are described in detail. It is possible for a person skilled in the art to fully understand the present disclosure without the description of these details. In order to avoid confusing the essence of the present disclosure, well-known methods, processes, and procedures are not described in detail. In addition, the drawings are not necessarily drawn to scale.

[0033] The core purpose of the disclosed embodiment is to provide a ventricular assist circulation device, which includes: at least one shell, each shell is in shape with a specific area of ​​the outer surface of the ventricle; a drive device is connected to each shell, wherein the drive device periodically applies external force to each shell, causing the shell to periodically contract and recover, thereby periodically squeezing the outer surface of the ventricle and the ventricular cavity, so that the volume of the ventricular cavity is periodically reduced, thereby promoting ventricular blood circulation. The following embodiments will describe various aspects of the ventricular assist circulation device in conjunction with the accompanying drawings.

[0034] Figure 1 The heart structure is shown from different angles. Figure 1 In the diagram, the outer surface of the ventricles (left ventricle and right ventricle) is divided into five areas according to the direction and definition of the superficial cardiac blood vessels, and marked with numbers 1 to 5: 1 is the free wall and outflow tract of the right ventricle; 2 is the anterior wall of the left ventricle; 3 is the posterior wall of the left ventricle; 4 is the posterior wall of the right ventricle; 5 is the apex, and the number 5 indicates the front and back sides of the apex.

[0035] Figure 2A schematic diagram of five shells corresponding to the five partitions is provided, and the five shells correspond to the five partitions one by one, and each shell is marked with a corresponding number. The five shells are separated by gaps, and the blood vessels on the outer surface of the ventricle are exposed through the gaps to prevent the blood vessels on the outer surface of the ventricle from being covered by the shells.

[0036] Figure 3 A three-dimensional diagram of a ventricular assist circulation device 100 provided in an embodiment of the present disclosure is given. As shown in the figure, the ventricular assist circulation device 100 includes Figure 1 The five partitions 1 to 5 shown correspond to the housings 11 to 15, respectively, and the housings 11 to 15 are respectively fitted to the Figure 1 The housings 11 to 15 may be irregularly shaped and may be solid or hollow.

[0037] The auxiliary circulation device 100 also includes a driving device 17, which is connected to the shells 11 to 15 respectively. The driving device 17 is used to apply external forces to the shells 11 to 15. After receiving the external forces, the shells 11 to 15 will shrink inward, thereby squeezing the corresponding area on the outer surface of the ventricle, and then squeezing the ventricular cavity. The volume of the ventricular cavity will decrease under the squeezing, thereby pushing the blood out of the ventricular cavity. When the external force disappears, the shell returns to its original state, the squeezing of the ventricular cavity disappears, and the blood flow is no longer pushed. Therefore, the driving device 17 periodically applies external forces to the shells 11 to 15 to cause the shells to shrink and recover periodically, thereby driving the periodic squeezing of the outer surface of the ventricle and the ventricular cavity, so that the volume of the ventricular cavity is periodically reduced and restored, thereby promoting ventricular blood circulation.

[0038] The drive device 17 can drive the contraction and recovery of each shell according to the activity law of the ventricle itself. Under normal circumstances, the left and right ventricles begin to contract almost at the same time. This synchronization ensures that blood can be pumped into the pulmonary circulation and systemic circulation at the same time. At the same time, the left and right ventricles also relax almost at the same time, which allows the blood in the atrium to flow smoothly into the ventricle to prepare for the next contraction. Therefore, the drive device 17 can synchronously squeeze the shells 2 and 3 covering the left ventricle and the shells 1 and 4 covering the right ventricle, and squeeze the shell 5 again after a short interval. Under normal circumstances, the wall of the right ventricle is relatively thin, the contraction force is weak, and the pressure generated when the right ventricle contracts is low, while the wall of the right ventricle is relatively thin, the contraction force is weak, and the pressure generated when the left ventricle contracts is high. Therefore, the external force applied by the drive device 17 to the shells 1 and 4 can be slightly greater than the external force applied to the shells 2 and 3. Of course, these are all conventional situations, and the external force applied by the drive device 17 to each shell can be configurable so as to be adjusted according to the physical condition of each patient.

[0039] The shells 11 to 15 are made of a material that can achieve controllable contraction and recovery under external action. Depending on the shell material, the external action applied to the shell is also different. The external action can be temperature change, mechanical stress, chemical stimulation, electric / magnetic field, etc. For example, shape memory polymer (SMP) is a type of intelligent polymer material that can change shape under specific conditions (such as heat, light, chemistry, electric / magnetic field, etc.) and restore the initial shape under external stimulation. Photostrictive materials will undergo phase change under light irradiation, resulting in changes in the volume or shape of the material. This change usually occurs after the light disappears, and the material can return to its original state. Heat shrinkable materials shrink when heated. As a more industrial preparation method, it is preferred to use a shape memory alloy to prepare the shell, and heat the alloy by inputting a weak current into the shell, thereby achieving shell shrinkage.

[0040] The surfaces of the housings 11 to 15 are also provided with Figure 4 The sensor 18 shown. The sensor 18 is connected to the driving device 17 through a conductive wire. The sensor 18 is, for example, an electrocardiogram (ECG) sensor, a pressure sensor, and a temperature sensor, which respectively provide the sensing signals of the ECG, pressure, and temperature to the driving device 17. The driving device 17 processes and analyzes the received sensing signals in real time through an internal processor (such as a microcontroller or a computer chip), and adjusts the external effects applied to the shell according to the analysis results. For example, if the electrocardiogram shows an abnormally high heart rate, the driving device 17 can increase the current input to the shell to increase the contraction degree of the shell, thereby helping the heart to return to a normal heart rate. This feedback mechanism ensures that the contraction degree of the shells 11 to 15 is always in an optimal state to adapt to different physiological needs and environmental changes.

[0041] The driving device 17 may include a circuit box and a battery box. The circuit box and the battery box are encapsulated with insulating and sealing materials. The battery box encapsulates a high-density solid battery and an external rechargeable coil. The circuit box encapsulates a solid or flexible electronic circuit board and a chip, and is electrically connected to the battery box to obtain electrical energy from the battery box. The circuit and chip inside the circuit box amplify, filter, convert analog to digital, and analyze the sensing signal.

[0042] exist Figure 3 and Figure 4In the example, the drive device 17 is physically linked to the housings 11 to 15 through the link 16, which can be an independent component or a component integrated in the drive device 17. Since the drive device 17 needs to apply external forces to the housings 11 to 15 via the link 16, the material and properties of the link 16 need to be compatible with the drive device 17 and the housings. For example, when current is applied to the housings 11 to 15 through the link 16, the link 16 is a conductive wire. The link 16 can also be a column that is flexible and extendable as a whole, or a column that is flexible and extendable in sections. The column can be round or flat, solid or hollow. The drive device 17 applies external force to the column, thereby causing the housing to shrink and deform.

[0043] exist Figures 2 to 3 In the embodiment, the housings 11 to 15 are separate components from each other, but Figure 5 and Figure 6 Two connection modes between the housings 11 to 15 are given. Figure 5 In the embodiment, the gaps between the shells 11 to 15 are connected by a mesh of flexible material, and when the shells contract and squeeze the ventricular muscles, the flexible material will not squeeze the blood vessels on the ventricular surface. Figure 6 In the embodiment, the shells 11 to 15 are made of cystic hollow materials, and the gaps between the shells 11 to 15 are connected by tiny hoses.

[0044] Accordingly, the present disclosure also provides a control method for the above ventricular assist circulation device, such as Figure 7 As shown, the control method includes the following steps.

[0045] In step S701 , the sensing signal is continuously monitored.

[0046] In step S702, it is determined whether the sensing signal is normal, if yes, step S703 is executed, if no, step S704 is executed.

[0047] In step S703, external action is applied to each housing in a normal mode.

[0048] In step S704, external action is applied to each housing in an abnormal mode.

[0049] The sensing signals in this embodiment include but are not limited to sensing signals of ventricular pressure changes and sensing signals of heart rate changes in the electrocardiogram. After the ventricular assist circulation device is implanted inside the heart structure, for most of the time, the driving device applies external effects to each shell in a normal mode, including: adjusting the external effects applied to the shell according to a predetermined algorithm according to the ventricular pressure changes to adjust the contraction force and amplitude of the shell, and adjusting the external effects applied to the shell according to a predetermined algorithm according to the heart rate changes in the electrocardiogram to adjust the contraction frequency of the shell, but when the sensing signal is monitored to be abnormal, applying external effects to each shell in an abnormal mode, including: temporarily increasing the external effects on the shell covering the outer surface of the left ventricle or the right ventricle to temporarily enhance the contraction force, amplitude and / or frequency of the corresponding shell, thereby temporarily enhancing the compression of the left ventricle or the right ventricle. Here, the predetermined algorithm is a predetermined correspondence between the ventricular pressure change and the contraction force and amplitude of the shell, and a correspondence between the heart rate change of the electrocardiogram and the compression frequency, or all these parameters can also be integrated into the same correspondence.

[0050] It should be understood that the ventricular assist circulation device is applied to patients with left ventricular heart failure, right ventricular heart failure, abnormalities of both left and right ventricles, abnormalities of some ventricular aneurysms, etc. Therefore, the adjustment in the normal mode is a pre-set and expected adjustment, while the abnormal mode is an adjustment different from the expected situation. Therefore, the above control method can achieve the following effects: the left and right ventricles are forced to contract almost at the same time by external action, thereby ensuring that blood can be pumped into the pulmonary circulation and the systemic circulation at the same time, and the left and right ventricles are forced to relax almost at the same time by external action, thereby allowing the blood in the atrium to flow smoothly into the ventricle to prepare for the next contraction.

[0051] It should also be pointed out that the ventricular assist circulation device provided by the embodiment of the present disclosure can be customized individually. For example, the number of shells, the size of the shells, and the placement position in the heart structure can be determined with reference to the CT imaging and angiography results of the patient's heart. For example, if the patient is determined to have left ventricular heart failure with reference to the CT imaging and angiography results of the patient's heart, it is sufficient to design a shell covering the left ventricle and strengthen the contraction of the shell of the left ventricle. If the patient has right ventricular heart failure or partial ventricular aneurysm abnormality, it is sufficient to design a shell covering part of the right ventricle or a single ventricle (left or right ventricle) and strengthen the contraction of the shell. If the patient has both left and right ventricles abnormal, the shell can be customized with reference to the difference in heart failure between the left and right ventricles, and the sensing signals applied to the left and right ventricles can be adjusted. After the personalized customization is completed, the ventricular assist circulation device is implanted into the patient's heart structure through an implant device.

[0052] The embodiments of the present disclosure are described above, and these embodiments do not describe all the details in detail, nor do they limit the invention to the specific embodiments described. Obviously, many modifications and changes can be made based on the above description. This specification selects and specifically describes these embodiments in order to better explain the principles and practical applications of the present disclosure, so that those skilled in the art can make good use of the present disclosure and the modifications based on the present disclosure. Therefore, if these modifications and variations of the present disclosure fall within the scope of the claims of the present disclosure and their equivalents, the present disclosure is also intended to include these modifications and variations.

Claims

1. A ventricular assist circulation device, comprising: at least one housing that conforms to a specific area of ​​the outer surface of the ventricle; a drive device connected to at least one of the housings, The driving device applies periodic external force to the shell to cause the shell to contract periodically, thereby periodically squeezing the ventricular cavity, thereby promoting ventricular blood circulation.

2. The ventricular assist circulation device according to claim 1, wherein: Gaps are spaced between the plurality of shells to expose blood vessels on the outer surface of the ventricle.

3. The ventricular assist circulation device according to claim 2, wherein: The gaps between the multiple shells are connected by a mesh-like flexible material.

4. The ventricular assist circulation device according to claim 2, wherein: The gaps between the plurality of housings are connected by tiny hoses.

5. The ventricular assist circulation device according to claim 1, wherein: According to the shell The materials exert different external effects.

6. The ventricular assist circulation device according to claim 1 or 5, wherein: The material of the shell is one of the following materials: shape memory polymer, photostrictive material, and heat shrinkable material.

7. The ventricular assist circulation device according to claim 1, wherein: The at least one shell is five shells, which are respectively fitted with the shapes of the right ventricular free wall and outflow tract, the left ventricular anterior wall, the left ventricular posterior wall, the right ventricular posterior wall and the apex.

8. The ventricular assist circulation device according to claim 1, wherein: The plurality of housings are connected to the driving device via respective independent links.

9. The ventricular assist circulation device according to claim 1, further comprising: A sensor is arranged on the housing, and the sensor is electrically connected to the driving device.

10. The ventricular assist circulation device according to claim 1, wherein: The driving device controls the contraction of the shell according to the activity law of the ventricle itself.

11. A control method for a ventricular assist circulation device, wherein the ventricular assist circulation device is the ventricular assist circulation device according to any one of claims 1 to 10, the control method comprising: Continuously monitor the sensing signal; Determining whether the sensing signal is normal; If the sensing signal is normal, the external action is applied to each housing in a normal mode, and if the sensing signal is abnormal, the external action is applied to each housing in an abnormal mode.

12. The control method according to claim 11, wherein: In the normal mode, the external force applied to the housing is adjusted according to a predetermined algorithm based on changes in ventricular pressure to adjust the contraction force and amplitude of the housing, and the external force applied to the housing is adjusted according to a predetermined algorithm based on changes in heart rate of an electrocardiogram to adjust the contraction frequency of the housing; In the abnormal mode, the external action on the shell covering the outer surface of the left ventricle or the right ventricle is temporarily increased.

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