Magnetic coupling driven auxiliary pressurization system for paddles in heart chamber

Abstract

The invention discloses a magnetic-coupling-driven auxiliary pressurization system for a paddle in a ventricle, relates to the technical field of medical instruments, and can solve a series of problems caused by integrated design of a motor and a paddle of an existing auxiliary pressurization device for the ventricle. The embodiment of the invention discloses a magnetic coupling driven heart chamber inner paddle auxiliary pressurization system which comprises a paddle part used for being sewn and fixed to the inner wall of a heart chamber and a driving part used for being sewn and fixed to the outer wall of the heart, and the paddle part comprises an inner sleeve, a paddle structure and a driven magnetic disc coaxially and fixedly connected with the paddle structure. The paddle structure is rotationally connected into the inner sleeve; the driving part comprises an outer sleeve, a driving motor and a driving magnetic disc coaxially and fixedly connected with an output shaft of the driving motor, and the driving motor is fixed in the outer sleeve; when the paddle part and the driving part are in a sewed and fixed state, the driven magnetic disk and the driving magnetic disk are coaxial and are magnetically coupled, and the paddle structure is driven by the driving motor to rotate through the driving magnetic disk and the driven magnetic disk which are magnetically coupled.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, specifically to a magnetically coupled intracardiac paddle-assisted pressurization system. Background Technology

[0002] A ventricular assist device (VAP) is a medical device used to assist the ventricles in pumping blood in patients with severe heart failure. It partially or completely replaces the heart's pumping function by mechanically pumping blood, supporting and maintaining blood circulation in the patient's body.

[0003] Left ventricular assist devices (LVAPs) are one of the most common applications. Their core mechanical component is a centrifugal or axial-flow LVAP device implanted within the ventricle to propel blood flow. However, in existing LVAPs, both the impeller that propels blood flow and the motor that drives it are implanted within the left ventricle, with the power cable routed from the heart wall tissue to the outside. This method, where both the impeller and motor are implanted within the ventricle, requires extremely high sealing, and the motor casing is in direct contact with the blood, posing a series of problems such as potential damage to the blood due to heat dissipation from the motor.

[0004] Based on the above background, the inventors designed a magnetically coupled intracardiac paddle-assisted pressurization system to solve at least one of the above problems, and thus, this application is filed. Summary of the Invention

[0005] The purpose of this application is to provide a magnetically coupled intraventricular paddle-assisted pressurization system to solve a series of problems caused by the integrated design of the motor and paddle in existing intraventricular assist pressurization devices.

[0006] To address the above problems, this application provides the following technical solution: This application provides a magnetically coupled intracardiac paddle-assisted pressurization system, comprising a paddle portion for suturing and fixing to the intracardiac wall, and a drive portion for suturing and fixing to the outer wall of the heart, wherein: The blade section includes an inner sleeve and a blade structure, as well as a driven disk coaxially and fixedly connected to the blade structure. The blade structure is rotatably connected inside the inner sleeve. The drive unit includes an outer tube and a drive motor, as well as an active disk that is coaxially and fixedly connected to the output shaft of the drive motor. The drive motor is fixed inside the outer tube. With the blade section and drive section sewn together and fixed in place, the driven disk is coaxial with and magnetically coupled to the active disk, and the blade structure is driven to rotate by the drive motor through the magnetically coupled active and driven disks.

[0007] Optionally, the inner cannula is used to sew an inner wall blocking plate at one end to the ventricular wall, and / or the outer cannula is used to sew an outer wall blocking plate at one end to the ventricular wall. Both the outer and inner core wall blocking plates are made of non-magnetic materials.

[0008] Optionally, there are gaps between the inner wall blocking plate and the driven disk, and between the outer wall blocking plate and the active disk.

[0009] Optionally, the blade section is further provided with a flow guide fixing shell that is rotatably connected to the inner sleeve. The flow guide fixing shell is fixedly and sealed to the bottom of the blade structure. The driven disk is fixed to the bottom of the flow guide fixing shell and sealed to it. The inner sleeve is provided with several liquid inlets distributed around the circumference of the flow guiding and fixing shell.

[0010] Optionally, a rotating shaft is provided between the driven disk and the bottom of the blade structure. The two ends of the rotating shaft are fixedly connected to the driven disk and the blade structure, respectively. The driven disk, rotating shaft, and blade structure are coaxially arranged. The flow guide fixing shell is provided with a weight reduction cavity.

[0011] Optionally, a bearing assembly is provided between the inner sleeve of the blade section and the flow guide fixing shell. The bearing assembly includes an outer ring structure, an inner ring structure, and a plurality of rolling elements located between the outer ring structure and the inner ring structure. The outer ring structure is fixed to the inner circumferential wall of the inner sleeve, and the inner ring structure is fitted and fixed to the flow guide fixing shell.

[0012] Optionally, the bottom of the liquid inlet is a slope, and the top of the outer ring structure is also a slope with the same slope as the bottom slope of the liquid inlet. Furthermore, the lower end of the outer ring structure is connected to and overlaps with the higher end of the liquid inlet.

[0013] Optionally, the portion of the flow guide fixing shell located between the blade structure and the driven disk gradually narrows along the direction from the driven disk to the blade structure, specifically in the shape of an inwardly concave trumpet.

[0014] Optionally, the inner sheath is provided with an inner suture skirt at one end for suturing to the ventricular wall; The outer sheath is used to sew an outer suture skirt at one end of the outer wall of the heart.

[0015] Optionally, the inner and outer sewn hems are respectively provided with inner positioning holes and outer positioning holes for alignment during sewing; With the blade section and drive section sewn and fixed in place, the central axes of the inner positioning hole and the outer positioning hole coincide.

[0016] The beneficial effects of this invention are: This application separates the blade section and the drive section, and sets magnetically coupled active and driven disks on the blade structure of the blade section and the power transmission path of the drive motor of the drive section, so that the blade section and the drive section can be sewn and fixed to the inside and outside of the left ventricle respectively, avoiding a series of problems caused by the existing technology of fixing the motor and blade as a whole, which requires the drive motor to be fixed in the left ventricle. Attached Figure Description

[0017] Figure 1 This is a cross-sectional structural diagram of an embodiment of this application.

[0018] Figure 2 This is a cross-sectional view of the blade section in an embodiment of this application.

[0019] Figure 3 for Figure 2 A magnified view of a portion of point A in the middle.

[0020] Figure 4 This is a cross-sectional view of the drive unit in an embodiment of this application.

[0021] Figure 5 This is a cross-sectional view of the structure after being sutured to the left ventricle according to an embodiment of this application.

[0022] Explanation of reference numerals in the attached figures: 1-Blade section, 11-Inner sleeve, 111-Inner stitched skirt, 112-Inlet, 12-Blade structure, 13-Driven disk, 14-Inner core wall baffle, 15-Flow guide and fixing shell, 151-Weight reduction chamber, 16-Shaft, 17-Bearing assembly, 171-Outer ring structure, 172-Inner ring structure, 173-Rolling element, 2-Drive section, 21-Outer sleeve, 211-Outer stitched skirt, 22-Drive motor, 23-Active disk, 24-Outer core wall baffle, 31-Left ventricle. Detailed Implementation

[0023] The present invention will be further described in detail below with reference to the embodiments and accompanying drawings, but the embodiments of the present invention are not limited thereto.

[0024] In the description of this invention, it should be noted that the terms "center," "upper," "lower," "left," "right," "vertical," "longitudinal," "lateral," "horizontal," "inner," "outer," "front," "rear," "top," and "bottom," etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings, or the orientation or positional relationship commonly used when the product of this invention is in use. They are only for the convenience of describing this invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on this invention.

[0025] In the description of this invention, it should also be noted that, unless otherwise explicitly specified and limited, the terms "set up," "have," "install," "connect," and "connect" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal communication between two components. Those skilled in the art can understand the specific meaning of the above terms in this invention based on the specific circumstances.

[0026] The present invention will now be described in detail with reference to the accompanying drawings and embodiments.

[0027] like Figures 1 to 5 As shown, this embodiment provides a magnetically coupled intracardiac paddle-assisted pressurization system, including a paddle portion 1 for suturing and fixing to the intracardiac wall, and a drive portion 2 for suturing and fixing to the outer wall of the heart, wherein: The blade section 1 includes an inner sleeve 11 and a blade structure 12, as well as a driven disk 13 coaxially and fixedly connected to the blade structure 12. The blade structure 12 is rotatably connected inside the inner sleeve 11. The drive unit 2 includes an outer sleeve 21 and a drive motor 22, as well as an active disk 23 that is coaxially and fixedly connected to the output shaft of the drive motor 22. The drive motor 22 is fixed inside the outer sleeve 21. With the blade section 1 and the drive section 2 in a fixed, sewn state, the driven disk 13 is coaxial with and magnetically coupled to the active disk 23. The blade structure 12 is driven to rotate by the drive motor 22 through the magnetically coupled active disk 23 and driven disk 13.

[0028] In this embodiment, the blade section 1 and the drive section 2 are separated, and magnetically coupled active disk 23 and driven disk 13 are set on the power transmission path of the blade structure 12 of the blade section 1 and the drive motor 22 of the drive section 2. This allows the blade section 1 and the drive section 2 to be sewn and fixed inside and outside the left ventricle 31 respectively, avoiding a series of problems caused by the existing technology where the motor and blade are fixed as a whole, which requires the drive motor 22 to be fixed inside the left ventricle 31.

[0029] In this embodiment, the coupled driven disk 13 and active disk 23 are existing technologies. By coupling the driven disk 13 and active disk 23, when the drive motor 22 rotates, thereby driving the active disk 23 to rotate, the active disk 23 can apply torque to its coupled driven disk 13, thereby driving the paddle structure 12 to rotate in the inner sleeve 11, thereby providing an auxiliary pressurization function for the blood in the left ventricle 31.

[0030] The advantages of this separate design of the blade section 1 and the drive section 2 in this embodiment are obvious. First, the wires supplying current to the drive motor 22 no longer need to pass through the heart wall tissue. Second, the drive motor 22 does not need to be completely immersed in the blood of the left ventricle 31, eliminating the need to consider high-precision sealing and heat dissipation issues. Furthermore, with the separate design approach, the lifespan of the blade section 1 without circuit design can be greatly improved. Even if the drive motor 22 of the drive section 2 malfunctions, or if a different model of drive motor 22 needs to be replaced to meet different driving forces, this separate magnetic coupling drive approach in this embodiment is also more convenient.

[0031] In this embodiment, the inner tube 11 is used to sew an inner wall blocking piece 14 at one end to the ventricular wall, and the outer tube 21 is used to sew an outer wall blocking piece 24 at one end to the ventricular wall. Both the external cardiac wall blocking plate 24 and the internal cardiac wall blocking plate 14 are made of non-magnetic materials. In this embodiment, due to the characteristics of magnetic coupling, the distance between the coupled active disk 23 and the driven disk 13 should not be too far. Therefore, in this embodiment, both the active disk 23 and the driven disk 13 are fixed as close as possible to the cardiac wall tissue. However, due to the special nature of this application, under normal circumstances, the heart is in a state of continuous beating. When the heart beats, the cardiac wall tissue will contract and relax to a certain extent, resulting in a certain degree of change in its thickness. When the heart contracts, the cardiac wall tissue will move closer to the active disk 23 and the driven disk 13. Since the active disk 23 and the driven disk 13 need to rotate continuously, there is a possibility that the active disk 23 and the driven disk 13 will rub against the cardiac wall tissue. Therefore, in order to avoid this problem, this embodiment sets up a non-magnetic internal cardiac wall blocking plate 14 and external cardiac wall blocking plate 24, which can provide a protective layer structure between the active disk 23 and the driven disk 13 and the cardiac wall tissue, avoiding friction between the active disk 23 and the driven disk 13. In this embodiment, both the inner heart wall blocking sheet 14 and the outer heart wall blocking sheet 24 are made of existing materials. Both are flexible materials, which can avoid excessive compression of the heart wall tissue.

[0032] In this embodiment, there are gaps between the inner wall blocking plate 14 and the driven disk 13, and between the outer wall blocking plate 24 and the active disk 23, which can provide sufficient margin for the slight deformation of the heart wall tissue and the deformation of the inner wall blocking plate 14 and the outer wall blocking plate 24.

[0033] In this embodiment, the blade section 1 is further provided with a flow guiding and fixing shell 15 that is rotatably connected to the inner sleeve 11. The flow guiding and fixing shell 15 is fixedly and sealed to the bottom of the blade structure 12. The driven disk 13 is fixed to the bottom of the flow guiding and fixing shell 15 and sealed to it. The inner tube 11 is provided with several inlets 112 distributed around the circumference of the flow-guiding and fixing shell 15. By providing inlets 112 on the inner tube 11 and providing the flow-guiding and fixing shell 15, it can assist in guiding the pressurized flow of blood in the left ventricle 31, so that after the blood enters the inner catheter, it is quickly guided to the rear end of the guide vane structure 12, and the vane structure 12 pressurizes and pushes the blood to the position of the aortic valve.

[0034] In this embodiment, a rotating shaft 16 is also provided between the bottom of the driven disk 13 and the blade structure 12. The two ends of the rotating shaft 16 are fixedly connected to the driven disk 13 and the blade structure 12 respectively. The driven disk 13, the rotating shaft 16, and the blade structure 12 are coaxially arranged. The flow guide and fixing shell 15 is provided with a weight reduction cavity 151. By setting the rotating shaft 16, the power transmission stability between the entire driven disk 13, the rotating shaft 16, and the blade structure 12 can be improved. The weight reduction cavity 151 in the flow guide and fixing shell 15 can reduce the weight of the entire blade section 1 and reduce the burden on the heart when it beats.

[0035] In this embodiment, a bearing assembly 17 is provided between the inner sleeve 11 of the blade portion 1 and the flow guide fixing shell 15. The bearing assembly 17 includes an outer ring structure 171, an inner ring structure 172 and a plurality of rolling elements 173 located between the outer ring structure 171 and the inner ring structure 172. The outer ring structure 171 is fixed to the inner circumferential wall of the inner sleeve 11, and the inner ring structure 172 is fitted and fixed to the flow guide fixing shell 15. By setting the bearing assembly 17, the resistance of the flow guide fixing shell 15, the blade structure 12, the rotating shaft 16, and the driven disk 13 relative to the inner sleeve 11 can be reduced, thereby improving the auxiliary pressurization efficiency of the blade section 1.

[0036] In this embodiment, the bottom of the inlet 112 is a slope, and the top of the outer ring structure 171 is also a slope with the same slope as the bottom slope of the inlet 112. The lower end of the outer ring structure 171 is connected to and overlaps with the higher end of the inlet 112. In this embodiment, by improving the bottom shape of the inlet 112 to be a slope and setting the top of the outer ring structure 171 to be a slope as well, and by connecting and overlapping the lower end of the outer ring structure 171 with the higher end of the inlet 112, the blood near the lower part of the inlet 112 flows upwards during the process of blood entering the inner cannula 11 from the left ventricle 31. This is more conducive to the subsequent flow diversion at the flow guiding and fixing shell 15 below the paddle structure 12.

[0037] In this embodiment, as Figure 3As shown, the higher end of the outer ring structure 171 is positioned close to the flow-guiding and fixing shell 15, allowing blood to be quickly guided to the outer periphery of the flow-guiding and fixing shell 15 after passing through the outer ring structure 171. Furthermore, in this embodiment, since the higher end of the outer ring structure 171 extends close to the flow-guiding and fixing shell 15, the top cross-section of the inner ring structure 172 is also an adaptive right-angled triangle. This avoids unnecessary gaps between the inner ring structure 172, the outer ring structure 171, and the flow-guiding and fixing shell 15, thereby preventing prolonged blood accumulation. Of course, in some embodiments, the top of the inner ring structure 172 can also maintain a planar design, which will not be elaborated upon here.

[0038] In this embodiment, as Figure 2 As shown, the portion of the flow-guiding and fixing shell 15 located between the paddle structure 12 and the driven disk 13 gradually narrows along the direction from the driven disk 13 to the paddle structure 12, and its specific shape is an inwardly concave trumpet shape, which can further improve the blood flow guiding effect.

[0039] In this embodiment, the inner sleeve 11 is used to sew a flexible inner suture skirt 111 at one end to the ventricular wall of the heart. The outer sheath 21 is used to suture a flexible outer suture skirt 211 at one end of the outer wall of the heart. The inner sheath 11 and the outer sheath 21 are sutured and fixed to the heart wall tissue by the inner suture skirt 111 and the outer suture skirt 211, respectively. The inner suture skirt 111 and the outer suture skirt 211 adopt a flexible structure, so that the inner sheath 11 and the outer sheath 21 can be appropriately shaped to the irregular heart wall tissue during suturing.

[0040] In this embodiment, the inner seam hem 111 and the outer seam hem 211 are respectively provided with an inner positioning hole and an outer positioning hole for alignment during sewing (not shown in the figure). With the blade portion 1 and drive portion 2 in a sutured and fixed state, the central axes of the inner and outer positioning holes coincide. By providing inner and outer positioning holes, the surgeon can easily position the components during surgery, avoiding the problem of the active disk 23 and driven disk 13 failing to couple and transmit torque after the blade portion 1 and drive portion 2 are sutured and fixed. In some embodiments, further positioning and fixation can be achieved by providing a fixing rod penetrating the inner and outer positioning holes and the cardiac wall tissue. For example, a screw penetrating the inner and outer positioning holes and the cardiac wall tissue, with the screw head located inside the left ventricle 31, and a nut screwed to the screw at the outer positioning hole outside the heart, serves as a positioning and auxiliary fixation mechanism.

[0041] It is understood that the above embodiments are merely exemplary embodiments used to illustrate the principles of the present invention, and the present invention is not limited thereto. For those skilled in the art, various modifications and improvements can be made without departing from the spirit and essence of the present invention, and these modifications and improvements are also considered to be within the scope of protection of the present invention.

Claims

1. A magnetically coupled intracardiac paddle-assisted pressurization system, characterized in that, It includes a paddle section (1) for suturing and fixing to the ventricular wall of the heart, and a drive section (2) for suturing and fixing to the lateral wall of the heart, wherein: The blade section (1) includes an inner sleeve (11) and a blade structure (12), as well as a driven disk (13) coaxially fixedly connected to the blade structure (12). The blade structure (12) is rotatably connected inside the inner sleeve (11). The drive unit (2) includes an outer tube (21) and a drive motor (22), as well as an active disk (23) that is coaxially fixedly connected to the output shaft of the drive motor (22). The drive motor (22) is fixed inside the outer tube (21). With the blade section (1) and drive section (2) in a fixed and sewn state, the driven disk (13) is coaxial with and magnetically coupled to the active disk (23), and the blade structure (12) is driven to rotate by the drive motor (22) through the magnetically coupled active disk (23) and driven disk (13).

2. The magnetically coupled intracardiac paddle-assisted pressurization system according to claim 1, characterized in that, The inner tube (11) is used to sew an inner wall blocking plate (14) at one end to the ventricular wall, and / or the outer tube (21) is used to sew an outer wall blocking plate (24) at one end to the outer wall of the heart. Both the outer core wall blocking plate (24) and the inner core wall blocking plate (14) are made of non-magnetic materials.

3. The magnetically coupled intracardiac paddle-assisted pressurization system according to claim 2, characterized in that, There are gaps between the inner wall blocking plate (14) and the driven disk (13), and between the outer wall blocking plate (24) and the active disk (23).

4. The magnetically coupled intracardiac paddle-assisted pressurization system according to claim 1, characterized in that, The blade section (1) is also provided with a flow guide fixing shell (15) that is rotatably connected to the inner sleeve (11). The flow guide fixing shell (15) is fixedly and sealed to the bottom of the blade structure (12). The driven disk (13) is fixed to the bottom of the flow guide fixing shell (15) and sealed to it. The inner sleeve (11) is provided with several liquid inlets (112) distributed around the flow guide fixing shell (15).

5. The magnetically coupled intracardiac paddle-assisted pressurization system according to claim 4, characterized in that, A rotating shaft (16) is also provided between the bottom of the driven disk (13) and the blade structure (12). The two ends of the rotating shaft (16) are fixedly connected to the driven disk (13) and the blade structure (12) respectively. The driven disk (13), the rotating shaft (16), and the blade structure (12) are coaxially arranged. The flow guide fixing shell (15) is provided with a weight reduction cavity (151).

6. The magnetically coupled intracardiac paddle-assisted pressurization system according to claim 4, characterized in that, A bearing assembly (17) is provided between the inner sleeve (11) of the blade section (1) and the flow guide fixing shell (15). The bearing assembly (17) includes an outer ring structure (171), an inner ring structure (172), and a number of rolling elements (173) located between the outer ring structure (171) and the inner ring structure (172). The outer ring structure (171) is fixed to the inner circumferential wall of the inner sleeve (11), and the inner ring structure (172) is fitted and fixed to the flow guide fixing shell (15).

7. The magnetically coupled intracardiac paddle-assisted pressurization system according to claim 6, characterized in that, The bottom of the inlet (112) is a slope, and the top of the outer ring structure (171) is also a slope with the same slope as the bottom slope of the inlet (112). The lower end of the outer ring structure (171) is connected to and overlaps with the higher end of the inlet (112).

8. The magnetically coupled intracardiac paddle-assisted pressurization system according to claim 4, characterized in that, The portion of the flow guide fixing shell (15) located between the blade structure (12) and the driven disk (13) gradually narrows along the direction from the driven disk (13) to the blade structure (12).

9. The magnetically coupled intracardiac paddle-assisted pressurization system according to claim 1, characterized in that, The inner sheath (11) is used to suture an inner suture skirt (111) at one end of the ventricle wall. The outer sheath (21) is used to suture an outer suture skirt (211) at one end of the outer wall of the heart.

10. The magnetically coupled intracardiac paddle-assisted pressurization system according to claim 9, characterized in that, The inner seam hem (111) and the outer seam hem (211) are respectively provided with an inner positioning hole and an outer positioning hole for alignment during sewing; With the blade section (1) and drive section (2) in a fixed and sewn state, the central axes of the inner positioning hole and the outer positioning hole coincide with each other.

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