Left ventricle auxiliary instrument

Abstract

The invention provides a left ventricle auxiliary instrument which comprises a supporting ring, a driving device, fan blades, a power output shaft, a supporting rod, a safety fence and a power line, the supporting ring is of an annular structure, the driving device is fixed to one side of the annular structure through the supporting rod, the power output shaft is connected with the driving device, and the fan blades are arranged on the supporting rod. And the power output shaft is connected with the fan blades, so that the energy of the driving device can be output to the fan blades through the power output shaft. The left ventricle auxiliary instrument is small in overall size and can be integrally implanted into the heart, a blood flow channel is consistent with a channel in a natural physiological state, blood supply is stable, blood meeting the whole-body blood supply requirement can be pumped into the aorta and the coronary artery by driving the fan blades at a low rotating speed, whole-body blood supply is maintained, and the hemolysis risk is avoided; and the blood pumping function of the heart can be replaced by long-term placement in vivo.

Description

Technical Field

[0001] The present invention relates to the field of medical technology, and in particular to a left ventricular assist device. Background Art

[0002] A ventricular assist device (VAD) or total artificial heart (TAH) is a mechatronic device that partially or completely replaces the heart's function of pumping blood. It has become an important means of treating end-stage heart failure, and its core component is the blood pump. Artificial hearts in the prior art usually place the blood pump outside the heart, draw blood from the heart, increase the pressure, and then deliver it to the aorta to maintain human blood circulation. Such a device requires punching a hole in the heart and drawing blood out, which changes the blood flow path under physiological conditions, making the blood flow path more complicated and posing a risk that the blood supply does not meet the actual needs of the human body. Summary of the invention

[0003] The present invention provides a left ventricular assist device, which includes the following embodiments:

[0004] Embodiment 1, a left ventricular assist device, comprising: a support ring, a driving device, a fan blade, a power output shaft, a support rod, a safety fence, and a power cord, characterized in that the support ring has an annular structure, which is used to be set at the base of the aortic valve ring, the driving device is fixed by the support rod on one side of the annular structure, the power output shaft is connected to the driving device, and the power output shaft is connected to the fan blade, so that the energy of the driving device can be output to the fan blade through the power output shaft, the safety fence is arranged on the other side of the annular structure, the fan blade is located between the safety fence and the driving device, and the safety fence is used to prevent the aortic valve from contacting the fan blade; the power cord is arranged along the support rod, and one end of the power cord is connected to the driving device.

[0005] Embodiment 2: According to the left ventricular assist device described in embodiment 1, the driving device includes an electromagnetic coil, and a permanent magnet is provided on the power output shaft corresponding to the electromagnetic coil.

[0006] Embodiment 3. A left ventricular assist device according to embodiment 1, wherein the power cord is arranged along the support rod, one end of the power cord is connected to the drive device, or the power cord is arranged along at least one of the support ring, the support rod, and the safety fence, optionally extending from the top of the safety fence or the top of the support rod.

[0007] Embodiment 4: A left ventricular assist device according to embodiment 1, wherein the height of the support ring is 0.3-4 cm, for example, 1.1 to 3 cm; the outer diameter is 15-33 mm, for example, 20-28 mm, and the inner diameter is 1-6 mm smaller than the outer diameter, for example, 3-5 mm.

[0008] Embodiment 5: According to the left ventricular assist device described in embodiment 1, the support rod and the safety fence are integrated and fixed on the support ring.

[0009] Embodiment 6. The left ventricular assist device according to embodiment 1 further includes a limiting device, which is connected to at least one of the support ring, the support rod, and the safety fence, and is used to provide axial limiting to the power output shaft while allowing the power output shaft to rotate freely. For example, the limiting device is two limiting blocks, and the two limiting blocks are respectively connected to the support rod and the safety fence, and have two oppositely arranged accommodating holes, which are used to provide axial limiting to the power output shaft from both sides while allowing the power output shaft to rotate freely. For example, both ends of the power output shaft are magnetic, which is opposite to the magnetic poles of the corresponding limiting blocks, so that the power output shaft is in a suspended state and does not directly contact the limiting blocks.

[0010] Embodiment 7: A left ventricular assist device according to embodiment 1, wherein the support ring has a two-layer structure, an inner layer is a rigid support material (such as metal, metal alloy, etc.), and an outer layer is a biocompatible material (such as nylon, polyurethane, etc.).

[0011] Embodiment 8. A left ventricular assist device according to embodiment 1, wherein an outer surface of the left ventricular assist device is provided with a coating having anti-oxidation and / or anti-coagulation function.

[0012] Embodiment 9. A left ventricular assist device according to embodiment 8, wherein the coating with anti-oxidation and / or anti-coagulation function comprises one or both of a metal coating and an anticoagulant coating.

[0013] Embodiment 10. A left ventricular assist device according to embodiment 1, wherein the operating speed of the power output shaft is 1000 to 5000 rpm, the power is 1 to 6 watts, for example, 1.5 to 5 watts, and the area and inclination angle of the fan blades enable a blood flow of 3 to 15, for example, 4-6 liters / minute to be provided at this speed.

[0014] Embodiment 11. A left ventricular assist device according to embodiment 10, wherein the inclination angle of the fan blades is 12 to 20 degrees, the number of the fan blades can optionally be 2-8, a guide component is provided above the fan blades, the guide component is directly or indirectly connected to the fan blades and rotates with the fan blades, and the guide component includes a plurality of guide blades.

[0015] Embodiment 12. A left ventricular assist device according to embodiment 1, wherein the power cord comprises at least one selected from the following: enameled copper wire, gold wire, silver wire, other conductive metal wires, and combinations thereof, and optionally at least one of an anti-coagulation coating and a waterproof plastic sealing layer is provided on the outside of the power cord.

[0016] Embodiment 13: According to the left ventricular assist device described in Embodiment 1, it also includes an artificial arterial blood vessel wall, and the power cord passes through the artificial arterial blood vessel wall.

[0017] Embodiment 14: A left ventricular assist device according to embodiment 13, wherein the artificial arterial vessel wall is a section of an artificial arterial vessel.

[0018] Embodiment 15. A left ventricular assist device according to embodiment 14, wherein one end of the artificial arterial blood vessel is connected to the support ring.

[0019] Embodiment 16, a left ventricular assist device, comprising: a support ring, a drive device, a fan blade, a fixed power output shaft, a support rod, a safety fence, and a power cord, characterized in that the support ring has an annular structure, which is used to be set at the base of the aortic valve ring, and the fixed power output shaft is fixed by the support rod on one side of the annular structure, the fixed power output shaft is connected to the drive device, and the drive device is connected to the fan blade, so that the drive device drives the fan blade to rotate when power is turned on, and the safety fence is arranged on the other side of the annular structure, one end of the drive device is dynamically connected to the safety fence, and the other end is dynamically connected to the fixed power output shaft, and the safety fence is used to prevent the aortic valve from contacting the fan blade.

[0020] Embodiment 17: According to the left ventricular assist device described in embodiment 16, the driving device includes a permanent magnet, and the fixed power output shaft is provided with an electromagnetic coil corresponding to the permanent magnet.

[0021] Embodiment 18. A left ventricular assist device according to embodiment 16, wherein the power cord is arranged along the support rod, one end of the power cord is connected to the drive device, or the power cord is arranged along at least one of the support ring, the support rod, and the safety fence, optionally extending from the top of the safety fence or the top of the support rod.

[0022] Embodiment 19. A left ventricular assist device according to embodiment 16, wherein the height of the support ring is 0.3-4 cm, for example, 1.1 to 3 cm; the outer diameter is 15-33 mm, for example, 20-28 mm, and the inner diameter is 1-6 mm smaller than the outer diameter, for example, 3-5 mm.

[0023] Embodiment 20: A left ventricular assist device according to embodiment 16, wherein the support rod and the safety fence are integrated and fixed to the support ring.

[0024] Embodiment 21. A left ventricular assist device according to embodiment 16, wherein the support ring has a two-layer structure, an inner layer is a rigid support material (such as metal, metal alloy, etc.), and an outer layer is a biocompatible material (nylon, polyurethane, etc.).

[0025] Embodiment 22. A left ventricular assist device according to embodiment 16, wherein an outer surface of the left ventricular assist device is provided with a coating having anti-oxidation and / or anti-coagulation function.

[0026] Embodiment 23. A left ventricular assist device according to embodiment 22, wherein the coating with anti-oxidation and / or anti-coagulation function comprises one or both of a metal coating and an anticoagulant coating.

[0027] Embodiment 24. A left ventricular assist device according to embodiment 16, wherein the operating speed of the fixed power output shaft is 1000 to 5000 rpm, the power is 1 to 6 watts, for example, 1.5 to 5 watts, and the area and inclination angle of the fan blades enable a blood flow of 3 to 15 liters / minute, for example, 4-6 liters / minute, to be provided at this speed.

[0028] Embodiment 25. A left ventricular assist device according to embodiment 16, wherein the inclination angle of the fan blades is 12 to 20 degrees, the number of the fan blades can optionally be 2-8, a guide component is provided above the fan blades, the guide component is directly or indirectly connected to the fan blades and rotates with the fan blades, and the guide component includes a plurality of guide blades.

[0029] Embodiment 26. A left ventricular assist device according to embodiment 16, wherein the power cord comprises at least one selected from the following: enameled copper wire, gold wire, silver wire, other conductive metal wires, and combinations thereof, and optionally at least one of an anti-coagulation coating and a waterproof plastic sealing layer is provided on the outside of the power cord.

[0030] Embodiment 27: The left ventricular assist device according to embodiment 16 further includes an artificial arterial vessel wall, and the power cord passes through the artificial arterial vessel wall.

[0031] Embodiment 28. A left ventricular assist device according to embodiment 27, wherein the artificial arterial vessel wall is a section of an artificial arterial vessel.

[0032] Embodiment 29. A left ventricular assist device according to embodiment 28, wherein one end of the artificial arterial blood vessel is connected to the support ring.

[0033] Embodiment 30: An artificial heart, comprising: a left ventricular assist device according to any one of embodiments 1 to 29, and

[0034] A power source connected to the other end of the power cord. The power source is a battery that can be placed subcutaneously or outside the body. The batteries described in this application are all rechargeable batteries, and the specific model and capacity can be selected according to actual needs.

[0035] Embodiment 31. The artificial heart according to embodiment 30 is characterized in that the storage capacity of the subcutaneous battery is greater than or equal to 6000 mAh, for example, 10000-120000 mAh.

[0036] Embodiment 32: A treatment method for replacing a natural heart, comprising:

[0037] Implanting the left ventricular assist device of any one of embodiments 1 to 12 and 16 to 26 into the left ventricle of the subject, and fixing the annular structure of the support ring to the base of the aortic valve ring;

[0038] The other end of the power line used for connecting to the power source is passed through the ventricular septum, guided to the subclavian vein through the right ventricle and the superior vena cava, and connected to the power source.

[0039] Embodiment 33: A treatment method for replacing a natural heart, comprising:

[0040] Implanting the left ventricular assist device of any one of embodiments 13 to 15 and 27 to 29 into the left ventricle of the subject, and fixing the annular structure of the support ring to the base of the aortic valve ring;

[0041] Suturing the artificial arterial wall to the subject's arterial blood vessel;

[0042] The power line passing through the artificial artery wall is led out to the subcutaneous area or outside the body and connected to a power source.

[0043] Those skilled in the art should understand that when the left ventricular assist device of the present application is used, if the aortic valve of the subject is removed, then the safety fence is no longer needed. Therefore, the present application also provides a set of solutions without setting the safety fence, as follows:

[0044] Solution 1: A left ventricular assist device, comprising: a support ring, a driving device, a fan blade, a power output shaft, a support rod, and a power cord.

[0045] It is characterized in that

[0046] The support ring has an annular structure and is used to be set at the base of the aortic valve ring. The driving device is fixed on one side of the annular structure through the support rod. The power output shaft is connected to the driving device, and the power output shaft is connected to the fan blades, so that the energy of the driving device can be output to the fan blades through the power output shaft.

[0047] Solution 2: According to the left ventricular assist device described in Solution 1, the driving device includes an electromagnetic coil, and a permanent magnet is provided on the power output shaft corresponding to the electromagnetic coil.

[0048] Option 3. A left ventricular assist device according to Option 1, wherein the power cord is arranged along the support rod, one end of the power cord is connected to the drive device, or the power cord is arranged along at least one of the support ring and the support rod, optionally extending from the top of the support rod.

[0049] Option 4: A left ventricular assist device according to Option 1, wherein the height of the support ring is 0.3-4 cm, for example, 1.1 to 3 cm; the outer diameter is 15-33 mm, for example, 20-28 mm, and the inner diameter is 1-6 mm smaller than the outer diameter, for example, 2-6 mm, for example, 3-5 mm.

[0050] Solution 5: The left ventricular assist device according to Solution 1 further comprises a limiting device, wherein the limiting device is connected to at least one of the support ring and the support rod and is used to provide axial limiting for the power output shaft while allowing the power output shaft to rotate freely.

[0051] For example, the limiting device is two limiting blocks and has two oppositely arranged receiving holes, which are used to provide axial limiting to the power output shaft from both sides respectively, while allowing the power output shaft to rotate freely.

[0052] For example, both ends of the power output shaft are magnetic, and the magnetic poles are opposite to the corresponding limit blocks, so that the power output shaft is in a suspended state and does not directly or reduces contact with the limit blocks.

[0053] Option 6. A left ventricular assist device according to Option 1, wherein the support ring has a two-layer structure, an inner layer is a rigid support material (such as metal, metal alloy, etc.), and an outer layer is a biocompatible material (nylon, polyurethane, etc.).

[0054] Option 7. A left ventricular assist device according to Option 1, wherein the outer surface of the left ventricular assist device is provided with a coating having anti-oxidation and / or anti-coagulation function.

[0055] Option 8. A left ventricular assist device according to Option 7, wherein the coating with anti-oxidation and / or anti-coagulation function comprises one or both of a metal coating and an anticoagulant coating.

[0056] Option 9. A left ventricular assist device according to Option 1, wherein the operating speed of the power output shaft is 1000 to 5000 rpm, the power is 1 to 6 watts, for example, 1.5 to 5 watts, and the area and inclination angle of the fan blades enable a blood flow of 3 to 15 liters / minute, for example, 4-6 liters / minute, to be provided at this speed.

[0057] Option 10. A left ventricular assist device according to Option 9, wherein the inclination angle of the fan blades is 12 to 20 degrees, the number of the fan blades can optionally be 2-8, a guide component is provided above the fan blades, the guide component is directly or indirectly connected to the fan blades and rotates with the fan blades, and the guide component includes a plurality of guide blades.

[0058] Option 11. A left ventricular assist device according to Option 1, wherein the power cord comprises at least one selected from the following: enameled copper wire, gold wire, silver wire, other conductive metal wires, and combinations thereof, and optionally at least one of an anti-coagulation coating and a waterproof plastic sealing layer is provided on the outside of the power cord.

[0059] Option 12. The left ventricular assist device according to Option 1 further includes an artificial arterial vessel wall, and the power cord passes through the artificial arterial vessel wall.

[0060] Option 13. A left ventricular assist device according to Option 12, wherein the artificial arterial vessel wall is a section of an artificial arterial vessel.

[0061] Option 14. A left ventricular assist device according to Option 13, wherein one end of the artificial artery is connected to the support ring.

[0062] Scheme 15, a left ventricular assist device, comprising: a support ring, a driving device, fan blades, a fixed power output shaft, a support rod, and a power cord, characterized in that the support ring has an annular structure for being set at the base of the aortic valve ring, and the fixed power output shaft is fixed on one side of the annular structure by the support rod, the fixed power output shaft is connected to the driving device, and the driving device is connected to the fan blades, so that the driving device drives the fan blades to rotate when power is turned on.

[0063] Solution 16. According to the left ventricular assist device described in Solution 15, the driving device includes a permanent magnet, and the fixed power output shaft is provided with an electromagnetic coil corresponding to the permanent magnet.

[0064] Option 17. A left ventricular assist device according to Option 15, wherein the power cord is arranged along the support rod, one end of the power cord is connected to the drive device, or the power cord is arranged along at least one of the support ring and the support rod, optionally extending from the top of the support rod.

[0065] Option 18. A left ventricular assist device according to Option 15, wherein the height of the support ring is 0.3-4 cm, for example, 1.1 to 3 cm; the outer diameter is 15-33 mm, for example, 20-28 mm, and the inner diameter is 1-6 mm smaller than the outer diameter, for example, 2-6 mm, for example, 3-5 mm.

[0066] Option 19. A left ventricular assist device according to Option 15, wherein the support ring has a two-layer structure, an inner layer is a rigid support material (such as metal, metal alloy, etc.), and an outer layer is a biocompatible material (nylon, polyurethane, etc.).

[0067] Option 20. A left ventricular assist device according to Option 15, wherein the outer surface of the left ventricular assist device is provided with a coating having anti-oxidation and / or anti-coagulation function.

[0068] Option 21. A left ventricular assist device according to Option 20, wherein the coating with anti-oxidation and / or anti-coagulation function comprises one or both of a metal coating and an anticoagulant coating.

[0069] Option 22. A left ventricular assist device according to Option 15, wherein the operating speed of the fixed power output shaft is 1000 to 5000 rpm, the power is 1 to 6 watts, for example, 1.5 to 5 watts, and the area and inclination angle of the fan blades enable a blood flow of 3 to 15 liters / minute, for example, 4-6 liters / minute, to be provided at this speed.

[0070] Scheme 23. A left ventricular assist device according to Scheme 15, wherein the inclination angle of the fan blades is 12 to 20 degrees, the number of the fan blades can optionally be 2-8, a guide component is arranged above the fan blades, the guide component is directly or indirectly connected to the fan blades and rotates with the fan blades, and the guide component includes a plurality of guide blades.

[0071] Option 24. A left ventricular assist device according to Option 15, wherein the power cord comprises at least one selected from the following: enameled copper wire, gold wire, silver wire, other conductive metal wires, and combinations thereof, and optionally at least one of an anti-coagulation coating and a waterproof plastic sealing layer is provided on the outside of the power cord.

[0072] Option 25. The left ventricular assist device according to Option 15 further includes an artificial arterial vessel wall, and the power cord passes through the artificial arterial vessel wall.

[0073] Option 26. A left ventricular assist device according to Option 25, wherein the artificial arterial vessel wall is a section of an artificial arterial vessel.

[0074] Option 27. A left ventricular assist device according to Option 26, wherein one end of the artificial artery is connected to the support ring.

[0075] The left ventricular assist device provided by the present application has a main working part fixed to the base of the aortic valve ring through the annular structure of the support ring. With the help of the larger accommodation space of the aortic root, the driving device drives the fan blades to rotate at a lower speed to pump blood that meets the blood supply needs of the whole body into the aorta and coronary arteries to maintain the blood supply of the whole body. The left ventricular assist device of the present application has a small overall size and can be implanted in the heart as a whole; it adopts an innovative fully open design, thereby avoiding the problem of waterproofing the electric pump and greatly extending the working life of the pump; the blood flow path is consistent with the path under the natural physiological state, reducing the energy internal consumption caused by blood flow collision; the lower fan blade speed has little shear force on blood cells, greatly reducing the risk of hemolysis. In addition, since the working power of the left ventricular assist device of the present application is much smaller than the power of the artificial heart in the prior art, a smaller battery can meet the needs of continuous operation of the device, and a smaller battery can be attached with a wireless charging structure and can be directly implanted subcutaneously, which has little impact on the daily life of the implantee. BRIEF DESCRIPTION OF THE DRAWINGS

[0076] In order to more clearly illustrate the technical solutions of the embodiments of the present disclosure, the drawings of the embodiments will be briefly introduced below. Obviously, the drawings in the following description only relate to some embodiments of the present disclosure, but are not limitations of the present disclosure.

[0077] Figure 1 This is a schematic diagram of the structure of the left ventricular assist device described in Example 1 of the present application;

[0078] Figure 2 This is a cross-sectional view of the left ventricular assist device described in Example 1 of the present application;

[0079] Figure 3 This is a schematic diagram of the artificial heart described in Example 2 of the present application after being implanted into a human body;

[0080] Figure 4 This is a schematic diagram of the structure of another left ventricular assist device described in Example 3 of the present application;

[0081] Figure 5 This is a schematic diagram of the structure of another left ventricular assist device of the present application.

[0082] Figure markings: 1-support ring, 2-driving device, 21-electromagnetic coil, 22-permanent magnet, 3-fan blades, 4-power output shaft, 5-support rod, 6-safety fence, 7-power cord, 8-limiting block, 9-subcutaneous battery, 10-base of aortic valve ring, 11-artificial artery, 12-fixed power output shaft, 13-guide vane. DETAILED DESCRIPTION

[0083] In order to make the purpose, technical scheme and advantages of the embodiments of the present disclosure clearer, the technical scheme of the embodiments of the present disclosure will be clearly and completely described below in conjunction with the drawings of the embodiments of the present disclosure. Obviously, the described embodiments are part of the embodiments of the present disclosure, rather than all of the embodiments. Based on the described embodiments of the present disclosure, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present disclosure. The specific implementation method of this application uses a solution with a safety fence to illustrate the technical solution of the present application, but it should be understood that these descriptions are also suitable for solutions without a safety fence. In actual application, if the aortic valve of the subject is removed, the safety fence can be omitted in the left ventricular assist device.

[0084] The present application provides a left ventricular assist device, comprising: a support ring, a driving device, a fan blade, a power output shaft, a support rod, a safety fence, and a power cord, characterized in that the support ring has an annular structure for being arranged at the base of the aortic valve ring, the driving device is fixed by the support rod on one side of the annular structure, the power output shaft is connected to the driving device, and the power output shaft is connected to the fan blade, so that the energy of the driving device can be output to the fan blade through the power output shaft, the safety fence is arranged on the other side of the annular structure, the fan blade is located between the safety fence and the driving device, and the safety fence is used to prevent the mitral valve leaflet from contacting the fan blade; the power cord is arranged along the support rod, and one end of the power cord is connected to the driving device.

[0085] The aorta is the main conduit for transporting blood to all parts of the body. It has a large size. At the root of the aorta, the arterial wall opposite to the aortic valve bulges outward, forming a larger inner cavity between the valve and the aortic wall. The larger inner cavity provides a space for implanting the left ventricular assist device of the present application, and after the drive device occupies part of the blood flow channel and forms a block to the blood flow, the remaining blood flow channel can still meet the blood supply needs of the whole body. The left ventricular assist device of the present application is arranged at the base of the aortic valve ring through the annular structure of the support ring. The drive device drives the fan blades to rotate, and the blood in the left ventricle is continuously introduced into the aorta, thereby achieving the effect of replacing the heart's pumping function. In the working state, with the direction of blood flow as a reference, the safety fence of the left ventricular assist device of the present application is located upstream of the fan blades and in the left ventricular outflow tract, so as to prevent the mitral valve leaflets from contacting the fan blades. The drive device is located downstream of the fan blades, and the drive device provides power for the rotation of the fan blades through the power output shaft. The setting of the left ventricular assist device of the present application can restore the heart's blood supply pathway under normal physiological conditions to the greatest extent possible, and can meet the body's blood supply needs by operating at lower energy consumption and lower fan blade speed with almost no damage to the blood. It can be placed in the body for a long time to replace the heart's pumping function.

[0086] The "annular structure" in the present application may be a complete ring or a ring larger than a semicircle.

[0087] The term "the power output shaft is connected to the drive device" in the present application does not only refer to a physical contact connection, but also refers to various forms of matching between the power output shaft and the drive device so that the power output shaft can rotate under the drive of the drive device. That is, the term means that the drive device has a driving effect on the power output shaft.

[0088] Similarly, the term "the power output shaft is connected to the fan blades" in the present application does not only refer to a physical contact connection, but also refers to various forms of matching between the power output shaft and the fan blades so that the power output shaft can drive the rotation of the fan blades when it rotates, that is, the term means that the power output shaft has a driving effect on the fan blades.

[0089] In some embodiments, the driving device includes an electromagnetic coil, and a permanent magnet is disposed on the power output shaft at a position corresponding to the electromagnetic coil. The electromagnetic coil and the permanent magnet convert electrical energy into mechanical energy and drive the power output shaft to rotate.

[0090] In some embodiments, the power cord is arranged along the support rod, and one end of the power cord is connected to the driving device, or the power cord is arranged along at least one of the support ring, the support rod, and the safety fence, optionally extending from the top of the safety fence or the top of the support rod.

[0091] In some embodiments, the height of the support ring is 0.3-4 cm, such as 1.1 to 3 cm; the outer diameter is 15-33 mm, such as 20-28 mm, and the inner diameter is 1-6 mm, such as 2-6 mm, such as 3-5 mm, smaller than the outer diameter. The support ring is used to suture and fix the left ventricular assist device to the base of the aortic valve ring, and the blood flow channel is formed by the internal channel of the support ring. The support ring with a height of 1-2 cm can accommodate the blades, so as to form a long-term stable blood flow channel with the help of the inner wall of the support ring.

[0092] In some embodiments, the support rod and the safety fence are integrated and fixed to the support ring.

[0093] In some embodiments, the left ventricular assist device also includes a limit device, which is connected to at least one of the support ring, the support rod, and the safety fence, and is used to provide axial limitation to the power output shaft while allowing the power output shaft to rotate freely. For example, the limit device is two limit blocks, and the two limit blocks are respectively connected to the support rod and the safety fence, and have two oppositely arranged accommodating holes, which are used to provide axial limitation to the power output shaft from both sides respectively, while allowing the power output shaft to rotate freely. For example, both ends of the power output shaft are magnetic, and the magnetic poles are opposite to those of the corresponding limit blocks, so that the power output shaft is in a suspended state and does not directly contact the limit blocks.

[0094] In some embodiments, the support ring has a two-layer structure, the inner layer is a rigid support material (such as metal, metal alloy, etc.), and the outer layer is a biocompatible material (such as nylon, polyurethane, etc.).

[0095] In some embodiments, the outer surface of the left ventricular assist device is provided with a coating having anti-oxidation and / or anti-coagulation function.

[0096] In some embodiments, the coating with anti-oxidation and / or anti-coagulation function includes one or both of a metal coating and an anticoagulant coating. There is no particular restriction on the type of metal coating, as long as it can produce an anti-oxidation effect, and in actual use, a pure gold or pure silver coating can be used. There is no restriction on the type of anticoagulant, as long as it can produce an anti-coagulation function, and in actual use, a heparin coating or a heparin-like coating can be used, and optionally the anticoagulant coating is hydrophilic.

[0097] In some embodiments, the operating speed of the power output shaft is 1000 to 5000 rpm, the power is 1 to 6 watts, for example, 1.5 to 5 watts, and the area and inclination angle of the fan blades enable a blood flow of 3 to 15, for example, 4-6 liters / minute to be provided at this speed. Estimated with a pump with a power of 1.5 watts and a head of 1 meter / second, according to the power and flow formula of the axial flow pump, flow = power / (head × density × acceleration of gravity), the density of blood is about 1050 kg / m3, and the acceleration of gravity is 9.8 m / s2. Substituting the numerical value into the above formula, it can be obtained that: flow = 1.5 watts / (1 m / s × 1050 kg / m3 × 9.8 m / s2) × 60 × 1000 = 5.83 liters / minute. That is, a smaller power can meet the blood needs of the human body. The inner cavity of the aorta allows for the installation of larger equipment, which can meet the blood supply demand at a lower rotation speed. Preferably, the operating speed of the power output shaft is 2000 to 2500 rpm. The lower operating speed is less likely to cause hemolysis, thereby improving safety, extending service life and the life of the user.

[0098] In some embodiments, the inclination angle of the fan blades is 12 to 20 degrees, and the number of the fan blades can be optionally 2-8. A guide component is arranged above the fan blades, and the guide component is directly or indirectly connected to the fan blades and rotates with the fan blades. The guide component includes a plurality of guide blades. In a specific embodiment, the guide blades have a streamlined shape facing the fan blades. The guide component is connected to the rotating component, and the guide blades rotate with the fan blades. The guide component plays a guiding role. On the one hand, it can eliminate blood vortexes, and on the other hand, it can shunt blood into the aorta and coronary arteries, thereby achieving a better blood supply effect, improving the direction of blood flow, and improving blood pumping efficiency. Those skilled in the art can design the specific forms of the guide component and the guide blades according to actual needs.

[0099] In some embodiments, the power cord includes at least one selected from the following: enameled copper wire, gold wire, silver wire, other conductive metal lines, and combinations thereof, and optionally at least one of an anti-coating and a waterproof plastic sealing layer is disposed on the outside of the power cord.

[0100] In some embodiments, the left ventricular assist device further comprises an artificial arterial wall, and the power cord passes through the artificial arterial wall. The artificial arterial described in the present application may be those known in the prior art. The raw materials for manufacturing artificial blood vessels include nylon, polyester, Teflon and natural mulberry silk, etc. The manufacturing method of the artificial blood vessel includes weaving, and the weaving methods include knitting, braiding and weaving. After being woven into a tubular fabric, it is post-processed into a spiral artificial blood vessel, which can be bent at will without being sucked and deflated. In the present application, the terms "artificial blood vessel" and "artificial arterial blood vessel" have the same meaning and can be used interchangeably. They all refer to blood vessels made by artificial methods, which can replace human arterial blood vessels and are not prone to serious side effects. They are used in direct contact with blood, meet blood compatibility requirements, have both anti-coagulation properties and do not affect the composition and properties of blood, and are strong enough that when the wire passes through the artificial blood vessel wall, it will not be damaged in use.

[0101] In some embodiments, the artificial arterial vessel wall is a segment of an artificial arterial vessel.

[0102] In some embodiments, one end of the artificial artery is connected to the support ring.

[0103] The present application also discloses a left ventricular assist device, such as Figure 5 As shown, it includes: a support ring 1, a driving device 2, a fan blade 3, a fixed power output shaft 12, a support rod 5, a safety fence 6, and a power line 7, characterized in that the support ring 1 has an annular structure, which is used to be set at the base of the aortic valve ring, and the fixed power output shaft 12 is fixed by the support rod 5 on one side of the annular structure (as shown by point a in the figure), the fixed power output shaft 12 is connected to the driving device 2, and the driving device 2 is connected to the fan blade 3, the fixed power output shaft 12 has an electromagnetic coil 21, and the electromagnetic coil 21 is sealed in the fixed power output shaft 12, the driving device 2 has a permanent magnet 22, and the permanent magnet 22 is sealed in the driving device 2, the power line 7 is electrically connected to the electromagnetic coil 21 in a sealed manner, so that when the power is turned on, the driving device 2 drives the fan blade 3 to rotate, and a guide component is arranged above the fan blade, the guide component includes a plurality of guide blades 13, and the guide component is directly or indirectly connected to the fan blade and rotates with the fan blade. Figure 5 The guide component is connected to the driving device 2, and the guide vane 13 rotates with the fan blade. The safety fence 6 is arranged on the other side of the annular structure, one end of the driving device 2 is dynamically connected to the safety fence 6, and the other end is dynamically connected to the fixed power output shaft 12, and the safety fence is used to prevent the mitral valve leaf from contacting the fan blade.

[0104] In some embodiments, the driving device includes a permanent magnet, and the fixed power output shaft is provided with an electromagnetic coil at a position corresponding to the permanent magnet. Figure 5 As shown, the fixed power output shaft 12 has an electromagnetic coil 21, and the electromagnetic coil 21 is sealed in the fixed power output shaft 12. The driving device 2 is provided with a permanent magnet 22 corresponding to the electromagnetic coil, and the permanent magnet 22 is sealed in the driving device 2. The power cord 7 is electrically connected to the electromagnetic coil 21 in a sealed manner, so that when power is turned on, the driving device 2 drives the fan blades 3 to rotate.

[0105] In some embodiments, the power cord is arranged along the support rod, and one end of the power cord is connected to the driving device, or the power cord is arranged along at least one of the support ring, the support rod, and the safety fence, optionally extending from the top of the safety fence or the top of the support rod.

[0106] In some embodiments, the support ring has a height of 0.3-4 cm, such as 1.1 to 3 cm; an outer diameter of 15-33 mm, such as 20-28 mm, and an inner diameter that is 1-6 mm smaller than the outer diameter, such as 2-6 mm, such as 3-5 mm.

[0107] In some embodiments, the support rod and the safety fence are integrated and fixed to the support ring.

[0108] In some embodiments, the support ring has a two-layer structure, the inner layer is a rigid support material (such as metal, metal alloy, etc.), and the outer layer is a biocompatible material (nylon, polyurethane, etc.).

[0109] In some embodiments, the outer surface of the left ventricular assist device is provided with a coating having anti-oxidation and / or anti-coagulation function.

[0110] In some embodiments, the coating with anti-oxidation and / or anti-coagulation function comprises one or both of a metal coating and an anticoagulant coating.

[0111] In some embodiments, the operating speed of the fixed power output shaft is 1000 to 5000 rpm, the power is 1 to 6 watts, for example 1.5 to 5 watts, and the area and inclination angle of the fan blades enable a blood flow of 3 to 15 liters / minute, for example 4-6 liters / minute, to be provided at this speed.

[0112] In some embodiments, the inclination angle of the fan blades is 12 to 20 degrees, and the number of the fan blades can be optionally 2-8. A guide component is arranged above the fan blades, and the guide component is directly or indirectly connected to the fan blades and rotates with the fan blades, and the guide component comprises a plurality of guide blades. The guide component is connected to the rotating component, and the guide blades rotate with the fan blades. The guide component plays a guiding role. On the one hand, it can eliminate the vortex of blood, and on the other hand, it can shunt blood into the aorta and coronary artery, which has a better blood supply effect, improves the direction of blood flow, and improves the efficiency of pumping blood. Those skilled in the art can design the specific forms of the guide component and the guide blades according to actual needs.

[0113] In some embodiments, the power cord includes at least one selected from the following: enameled copper wire, gold wire, silver wire, other conductive metal lines, and combinations thereof, and optionally at least one of an anti-coating and a waterproof plastic sealing layer is disposed on the outside of the power cord.

[0114] In some embodiments, the left ventricular assist device further comprises an artificial arterial vessel wall, and the power cord passes through the artificial arterial vessel wall.

[0115] In some embodiments, the artificial arterial vessel wall is a segment of an artificial arterial vessel.

[0116] In some embodiments, one end of the artificial artery is connected to the support ring.

[0117] The present application also discloses an artificial heart, comprising: the left ventricular assist device, and a subcutaneous battery, wherein one end of the power cord of the left ventricular assist device is connected to the driving device, and the other end of the power cord is connected to the subcutaneous battery.

[0118] The artificial heart in the prior art uses a blood pump and catheter placed outside the heart to draw blood from the left ventricle to the outside of the heart, and then transports it back to the aorta. Since this blood flow channel does not conform to the blood flow channel under normal physiological conditions, and the pipeline is longer and has greater resistance, a higher-power blood pump and a correspondingly larger battery are required. The larger battery has a larger weight and size, and thus cannot be placed in the body. The weight of the artificial heart battery in the prior art can even reach 5 to 10 kilograms, which is not only impossible to implant in the body, but also causes serious inconvenience to the patient's daily life if placed outside the body. The present application utilizes the blood flow channel under normal physiological conditions, and can meet the blood supply needs of the human body through a smaller size and lower power device, thereby making it possible to implant the power supply in the body, and minimizing the impact on the patient's daily life.

[0119] In some embodiments, the storage capacity of the subcutaneous battery is greater than or equal to 6000 mAh, for example, 10000-120000 mAh. Those skilled in the art can set a subcutaneous wireless rechargeable battery with a reasonable storage capacity according to the power of the left ventricular assist device. Generally, the storage capacity of the battery needs to ensure that the left ventricular assist device can continue to operate for more than 1 to 2 days.

[0120] The Bentall operation described in this application has the meaning commonly known to those skilled in the art, and its full name is ascending aorta replacement with artificial blood vessel with aortic valve, which belongs to the thoracic aortic aneurysm surgery of cardiovascular surgery. The Bentall operation is to use artificial blood vessel with valve to replace the ascending aorta root and aortic valve. The medical device of this application can be implanted in human or animal body through Bentall operation technique.

[0121] There are no particular restrictions on the manufacturing method and raw materials of the left ventricular assist device or artificial heart described in this application, and the device can be manufactured using methods and materials known in the prior art, as long as they can meet the specific human use environment. After understanding the structure disclosed in this application, a person of ordinary skill in the art can select materials and methods known in the prior art to manufacture the corresponding product.

[0122] The present application also discloses a method of treating a natural heart, comprising:

[0123] Place the left ventricular assist device into the left ventricle of the subject, and fix the annular structure of the support ring to the base of the aortic valve ring;

[0124] The other end of the power cord for connecting to the power source is passed through the ventricular septum, and then guided to the subclavian vein through the right ventricle and the superior vena cava, and connected to the power source. The treatment method for replacing the natural heart disclosed in the present application guides the power cord through the right ventricle to the subclavian vein through ventricular septal puncture, that is, converts from the arterial high pressure system to the venous low pressure system. In the vein at low pressure, it is easy to pass the power cord out of the blood vessel wall and connect to the power source.

[0125] The present application also discloses another treatment method for replacing the natural heart, comprising:

[0126] Place the left ventricular assist device into the left ventricle of the subject, and fix the annular structure of the support ring to the base of the aortic valve ring;

[0127] Suturing the artificial arterial vessel wall to the subject's arterial vessel;

[0128] The power line passing through the artificial artery wall is led out to the subcutaneous area or outside the body and connected to a power source.

[0129] The treatment method for replacing the natural heart disclosed in the present application is to lead the power cord through the artificial blood vessel wall or artificial artery wall through which the power cord can be easily passed out, and connect it to an external or subcutaneous battery. Since the battery capacity requirement is not high, the volume is not large, and it can be placed in the body, the patient's daily activities are basically not affected.

[0130] The above ranges can be used alone or in combination. The present application can be more easily understood through the following examples.

[0131] Example

[0132] Example 1

[0133] like Figure 1 and Figure 2 As shown, this embodiment discloses a left ventricular assist device, which includes: a support ring 1, a driving device 2, a fan blade 3, a power output shaft 4, a support rod 5, a safety fence 6, and a power line 7. The support ring has an annular structure and is used to be arranged at the base of the aortic valve ring. The driving device is fixed by the support rod on one side of the annular structure. The power output shaft is connected to the driving device, and the power output shaft is connected to the fan blade, so that the energy of the driving device can be output to the fan blade through the power output shaft. The safety fence is arranged on the other side of the annular structure, and the fan blade is located between the safety fence and the driving device. The safety fence is used to prevent the mitral valve leaf from contacting the fan blade; the power line is arranged along the support rod, and one end of the power line is connected to the driving device. The driving device 2 includes an electromagnetic coil 21, and the power output shaft is provided with a permanent magnet 22 corresponding to the electromagnetic coil.

[0134] The left ventricular assist device also includes a limiting device, which is two limiting blocks 8. The two limiting blocks 8 are respectively connected to the support rod 5 and the safety fence 6, and have two oppositely arranged accommodating holes for providing axial limiting to the power output shaft 4 from both sides respectively, while allowing the power output shaft to rotate freely.

[0135] The power cord 7 is arranged along the support rod 5 , the support ring 1 and the safety fence 6 , and extends out from the middle of the safety fence 6 .

[0136] The support ring has a height of 2 cm, an outer diameter of 22 mm, and an inner diameter of 18 mm, which is 4 mm smaller than the outer diameter. The support ring has a two-layer structure, the inner layer is a metal alloy rigid support material, and the outer layer is a biocompatible material nylon.

[0137] The outer surface of the left ventricular assist device is provided with a coating with anti-oxidation and anti-coagulation functions, which includes a gold coating and an anticoagulant coating.

[0138] The fan blades have an inclination angle of 12 to 20 degrees, and the number of the fan blades is 5. The operating speed of the power output shaft is 1000 to 5000 rpm, the power is 1.5 watts, and the area and inclination angle of the fan blades enable a blood flow of 3 to 6 liters per minute to be provided at this speed.

[0139] Example 2

[0140] This embodiment discloses an artificial heart, which is used to replace a natural heart, and includes the left ventricular assist device and a subcutaneous battery described in Embodiment 1. The subcutaneous battery has a storage capacity of 12000 mAh.

[0141] like Figure 3 As shown, the artificial heart is implanted into a human body in the following manner: the left ventricular assist device is placed into the left ventricle, and the annular structure of the support ring is fixed to the base 10 of the aortic valve ring;

[0142] The subcutaneous battery 9 is placed near the subclavian vein in the body;

[0143] The other end of the power line 7 for connecting to the power source is passed through the interventricular septum, guided to the subclavian vein via the right ventricle and the superior vena cava, and connected to the subcutaneous battery 9 placed near the subclavian vein.

[0144] After the artificial heart is implanted in the human body, the drive device drives the fan blades to rotate at a relatively low speed to pump blood that meets the blood supply needs of the whole body into the aorta and coronary arteries to maintain blood supply to the whole body. The blood flow path is consistent with the path under the natural physiological state, the blood supply is stable, and the relatively low fan blade speed has little shear force on blood cells, and there is no risk of hemolysis.

[0145] Through ventricular septal puncture, the power cord 7 is guided through the right ventricle to the subclavian vein, that is, the arterial high pressure system is converted to the venous low pressure system. In the vein at low pressure, it is easy to pass the power cord 7 through the blood vessel wall and connect to the subcutaneous battery 9 implanted near the subclavian vein in the body. Since the battery is implanted in the body, the patient's daily activities are basically not affected.

[0146] Example 3

[0147] like Figure 4As shown, this embodiment discloses a left ventricular assist device, which is basically the same as Embodiment 1, except that a guide component is provided above the fan blades, the guide component includes a plurality of guide blades 13, the guide component is connected to the power output shaft 4, and the guide blades 13 rotate with the fan blades. The left ventricular assist device also includes an artificial arterial vessel wall, and the artificial arterial vessel wall is a section of an artificial arterial vessel 11. The power cord 7 is arranged along the support rod 5 and extends from the support ring 1, and passes through the artificial arterial vessel 11 for connection to a power source. When the left ventricular assist device is implanted in the body, one end of the artificial arterial vessel 11 can be connected to the aorta through a Bentall operation, and the left ventricular assist device is fixed to the base of the aortic valve ring through the annular structure of the support ring.

[0148] The above description is merely an exemplary embodiment of the present disclosure and is not intended to limit the protection scope of the present disclosure. The protection scope of the present disclosure is determined by the appended claims.

Claims

1. A left ventricular assist device, comprising: Support ring, drive unit, fan blades, power output shaft, support rod, safety fence, power cord, It is characterized in that The support ring has an annular structure and is used to be arranged at the base of the aortic valve ring. The driving device is fixed on one side of the annular structure through the support rod. The power output shaft is connected to the driving device, and the power output shaft is connected to the fan blades, so that the energy of the driving device can be output to the fan blades through the power output shaft. The safety fence is arranged on the other side of the annular structure, the fan blade is located between the safety fence and the driving device, and the safety fence is used to prevent the mitral valve leaflet from contacting the fan blade. The driving device comprises an electromagnetic coil, and a permanent magnet is arranged on the power output shaft corresponding to the electromagnetic coil.

2. The left ventricular assist device according to claim 1, wherein: The support ring has a height of 0.3-4 cm, such as 1.1 to 3 cm; an outer diameter of 15-33 mm, such as 20-28 mm, and an inner diameter that is 1-6 mm smaller than the outer diameter, such as 3-5 mm.

3. The left ventricular assist device according to claim 1, further comprising a limiting device, wherein the limiting device is connected to at least one of the support ring, the support rod, and the safety fence, and is used to provide axial limiting for the power output shaft while allowing the power output shaft to rotate freely. For example, the limiting device is two limiting blocks, which are respectively connected to the support rod and the safety fence and have two oppositely arranged receiving holes, which are used to provide axial limiting to the power output shaft from both sides respectively, while allowing the power output shaft to rotate freely. For example, both ends of the power output shaft are magnetic, and the magnetic poles are opposite to the corresponding limit blocks, so that the power output shaft is in a suspended state and does not directly or reduces contact with the limit blocks.

4. The left ventricular assist device according to claim 1, wherein: The outer surface of the left ventricular assist device is provided with a coating having anti-oxidation and / or anti-coagulation function, wherein the coating having anti-oxidation and / or anti-coagulation function comprises one or both of a metal coating and an anticoagulant coating.

5. The left ventricular assist device according to claim 1, wherein: The operating speed of the power output shaft is 1000 to 5000 rpm, the power is 1 to 6 watts, for example 1.5 to 5 watts, and the area and inclination angle of the fan blades enable a blood flow of 3 to 15 liters / minute, for example 4-6 liters / minute, to be provided at this speed.

6. The left ventricular assist device according to claim 5, wherein: The inclination angle of the fan blades is 12 to 20 degrees, and the number of the fan blades can be optionally 2-8. A flow guide component is arranged above the fan blades. The flow guide component is directly or indirectly connected to the fan blades and rotates with the fan blades. The flow guide component includes a plurality of guide blades.

7. The left ventricular assist device according to claim 1, wherein: The power cord comprises at least one selected from the following: enameled copper wire, gold wire, silver wire, other conductive metal lines, and combinations thereof. Optionally, at least one of an anti-coagulation coating and a waterproof plastic sealing layer is disposed on the outside of the power cord.

8. The left ventricular assist device according to claim 1, further comprising an artificial arterial vessel wall, wherein the power line passes through the artificial arterial vessel wall.

9. The left ventricular assist device according to claim 8, wherein the artificial arterial vessel wall is a section of an artificial arterial vessel, wherein one end of the artificial arterial vessel is connected to the support ring.

10. A left ventricular assist device, comprising: Support ring, drive unit, fan blades, fixed power output shaft, support rod, safety fence, power cord, It is characterized in that The support ring has an annular structure and is used to be arranged at the base of the aortic valve ring. The fixed power output shaft is fixed on one side of the annular structure through the support rod. The fixed power output shaft is connected to the driving device, and the driving device is connected to the fan blades, so that when power is turned on, the driving device drives the fan blades to rotate. The safety fence is arranged on the other side of the annular structure, one end of the driving device is dynamically connected to the safety fence, and the other end is dynamically connected to the fixed power output shaft, and the safety fence is used to prevent the mitral valve leaflet from contacting the fan blade.

11. The left ventricular assist device according to claim 10, wherein: The support ring has a height of 0.3-4 cm, such as 1.1 to 3 cm; an outer diameter of 15-33 mm, such as 20-28 mm, and an inner diameter that is 1-6 mm smaller than the outer diameter, such as 3-5 mm.

12. The left ventricular assist device according to claim 10, wherein: The outer surface of the left ventricular assist device is provided with a coating having anti-oxidation and / or anti-coagulation function, wherein the coating having anti-oxidation and / or anti-coagulation function comprises one or both of a metal coating and an anticoagulant coating.

13. The left ventricular assist device according to claim 10, wherein: The fixed power output shaft has an operating speed of 1000 to 5000 rpm and a power of 1 to 6 watts, such as 1.5 to 5 watts. The area and inclination angle of the fan blades enable a blood flow of 3 to 15 liters / minute, such as 4-6 liters / minute, to be provided at this speed.

14. The left ventricular assist device according to claim 10, wherein: The inclination angle of the fan blades is 12 to 20 degrees, and the number of the fan blades can be optionally 2-8. A flow guide component is arranged above the fan blades. The flow guide component is directly or indirectly connected to the fan blades and rotates with the fan blades. The flow guide component includes a plurality of guide blades.

15. The left ventricular assist device according to claim 10, further comprising an artificial arterial vessel wall, wherein the power line passes through the artificial arterial vessel wall. 16 . The left ventricular assist device according to claim 15 , wherein the artificial arterial vessel wall is a section of an artificial arterial vessel, wherein one end of the artificial arterial vessel is connected to the support ring.

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