A pulsating pump bidirectional valve and ventricular assist device

Abstract

The present invention provides a pulsating pump bidirectional valve and a ventricular assist device. The pulsating pump bidirectional valve comprises a valve disc, a valve seat and a connecting piece. The valve seat is a tubular structure and has a first end and a second end. The side wall of the valve seat is provided with a valve seat hole. The connecting piece is provided at the end of the valve seat hole close to the first end, connecting the valve disc and the valve seat, and allowing the valve disc to rotate between a first position and a second position relative to the valve seat; the valve disc and the valve seat have the same circumferential curvature and the same outer contour as the valve seat hole. In the first position, the valve disc and the valve seat are located on the same cylindrical surface to close the valve seat hole, and allow blood in the valve seat to flow from the first end to the second end; in the second position, the valve disc is located inside the valve seat to open the valve seat hole and close the first end of the valve seat, allowing blood in the valve seat to flow from the second end to the valve seat hole. The present invention realizes the overlap of the valve disc and the valve seat hole through the valve disc and the valve disc connecting structure, so that the valve disc and the valve seat fit at the edge, the inner wall of the valve seat flow channel is smooth, and the occurrence of hemolysis is reduced.

Description

Technical Field

[0001] The present invention relates to the field of medical devices, and in particular to a pulsating pump bidirectional valve and a ventricular assist device. Background Art

[0002] Existing ventricular assist devices (VAD) are divided into pulsatile pumps and non-pulsatile pumps according to the way blood flow is pumped out; non-pulsatile pumps work on blood flow through high-speed rotation of the impeller, reduce the heart load, and improve hemodynamics; the high-speed rotation of the impeller and the interaction between the moving and static parts lead to a series of non-physiological flow characteristics such as strong shear, turbulence, and vortex in the internal flow field of the blood pump, which are more likely to cause damage to blood components. Some studies in recent years have found that continuous-flow VAD increases the risk of some complications, which are likely to be related to non-pulsatile flow. Continuous unloading of the ventricle by continuous-flow VAD will reduce the frequency of aortic valve opening, promote valve leaflet fusion, and may eventually lead to aortic valve insufficiency. Generating a certain pulsatile flow during operation is one of the current development trends of VAD. Pulsatile pumps simulate the working state of the natural heart and generate pulsatile blood flow. Most common pulsatile pumps are pneumatic pulsatile pumps outside the body, which contain two chambers separated by a flexible film, one chamber receives blood from the catheter; the other chamber is filled with helium and connected to an IABP console. In operation, the console generates negative pressure and overpressure (relative to the current pressure in the inner cavity and blood compartment), thereby alternately sucking gas out of the gas chamber and pressing gas into the gas chamber, respectively. During the suction phase, the negative pressure pulls the membrane toward the first side of the housing, and the catheter draws blood through the inlet channel and, to some extent, also draws blood into the membrane pump through the outlet channel of the single-lumen catheter. This is followed by the ejection phase, when the pressure pushes the flexible membrane from the first side of the housing back to the second side of the housing opposite the first side, thereby expelling blood from the housing and into the inner cavity of the catheter. When the blood is ejected, very little blood flows out through the inlet channel, thereby alternately sucking and ejecting blood in a sequential mode, resulting in a net pumping effect. The above-mentioned pumping effect is achieved by the cooperation of the two-way valve to achieve the guidance of blood flow.

[0003] However, the valve plate of the existing two-way valve is arranged inside the tubular valve seat, and is hinged to the valve seat on both sides of the valve plate to realize the rotation of the valve plate. The valve plate arranged inside the valve seat must occupy part of the flow area, and a step is formed on the inner wall of the valve seat. The existence of the step will increase flow turbulence and increase the possibility of hemolysis.

[0004] Therefore, it is necessary to design a pulsating pump bidirectional valve and a ventricular assist device to solve the above problems. Summary of the invention

[0005] An embodiment of the present invention provides a pulsating pump bidirectional valve and a ventricular assist device. Through the valve plate and the valve plate connection structure, the valve plate and the valve seat hole can be overlapped, so that the valve plate and the valve seat fit together at the edge, and the inner wall of the valve seat flow channel is smooth, thereby reducing the occurrence of hemolysis.

[0006] A pulsating pump bidirectional valve provided in an embodiment of the present invention comprises a valve disc, a valve seat and a connecting piece, wherein the valve seat is a tubular structure and has a first end and a second end, a valve seat hole is provided on a side wall of the valve seat, and the connecting piece is provided at the end of the valve seat hole close to the first end, connects the valve disc and the valve seat, and allows the valve disc to rotate relative to the valve seat between a first position and a second position; the valve disc and the valve seat have the same circumferential curvature and the same outer contour as the valve seat hole, in the first position, the valve disc and the valve seat are located on the same cylindrical surface to close the valve seat hole, and allow blood in the valve seat to flow from the first end to the second end; in the second position, the valve disc is located inside the valve seat, opens the valve seat hole and closes the first end of the valve seat, and allows blood in the valve seat to flow from the second end to the valve seat hole.

[0007] Optionally, the edge of the valve plate is a first inclined surface whose top is inclined toward the inside of the valve plate; the wall surface of the valve seat hole is a second inclined surface whose top is inclined toward the inside of the valve seat hole, and when the valve plate is in the first position, the first inclined surface abuts against the second inclined surface, preventing the valve plate from rotating toward the outside of the valve seat.

[0008] Optionally, an inclination angle of the first inclined surface relative to the vertical direction is 8°-12°, and an inclination angle of the second inclined surface relative to the vertical direction is 8°-12°.

[0009] Optionally, the valve sheet includes a connecting portion and a main body portion, the connecting portion is connected to the connecting piece, the orthographic projection of the main body portion on a plane is elliptical, and in the first position, the connecting portion is located at an end of the main body portion close to where blood flows in.

[0010] Optionally, the main body has a first axis and a second axis. When in the first position, the first axis is arranged along the axial direction, and the ratio of the length of the second axis of the main body to the length of the first axis is 0.85-0.98.

[0011] Optionally, the length of the second axis of the main body is slightly smaller than the inner diameter of the valve seat, so that the main body can rotate into the interior of the valve seat, and the length of the valve plate rotating into the valve seat is slightly greater than or equal to the inner diameter of the valve seat, so that the angle between the main body and the horizontal direction in the second position is 85°-86°.

[0012] Optionally, the connecting member is a pin shaft, a first connecting hole is provided at the end of the valve seat hole close to the first end, a first axial hole is provided through the connecting portion, a second axial hole is provided on the side wall of the first connecting hole, and the end of the pin shaft passes through the first axial hole and is provided in the second axial hole.

[0013] Optionally, the aperture of the first axial hole is d=0.4(R2-R1)-0.6(R2-R1), wherein R2 is the outer diameter of the valve seat, and R1 is the inner diameter of the valve seat.

[0014] Optionally, the connecting member is a connecting spring sheet, which includes a mounting portion and a bending portion. A second connecting hole is provided at the end of the valve seat hole close to the first end. The connecting spring sheet is placed in the second connecting hole. The two ends of the mounting portion are respectively connected to the two sides of the second connecting hole. The bending portion is bent from the middle of the mounting portion to the inside of the valve seat. The bending portion is connected to the connecting portion, and the bending angle can be adjusted as the valve sheet rotates.

[0015] Optionally, when the valve plate is located at the first position, the bending portion is parallel to the mounting portion, and the connecting portion is located between the mounting portion and the bending portion, so that the valve plate overlaps with the valve seat hole to close the valve seat hole.

[0016] Based on the same concept, an embodiment of the present invention further provides a ventricular assist device, comprising the above-mentioned pulsatile pump bidirectional valve.

[0017] Compared with the prior art, the technical solution of the embodiment of the present invention has beneficial effects.

[0018] For example, the valve plate is set on the side wall of the valve seat, and a connecting piece is set at one end of the valve seat hole to connect the valve plate. The valve plate rotates relative to the valve seat at one end, so that in the first position, the valve plate coincides with the valve seat hole, the valve plate and the valve seat fit together at the edge, and the inner wall of the valve seat flow channel is smooth, thereby reducing the occurrence of hemolysis; when the valve plate is switched from the first position to the second position, the valve plate can move to the second position faster under the action of its own gravity and the additional fluid push, thereby improving the conversion efficiency.

[0019] For another example, the shape of the valve plate is set to an ellipse close to a circle, maximizing the rotatable angle of the valve plate, so that the valve plate closes a larger axial channel area of ​​the valve seat cavity when in the second position, reducing the amount of blood flowing back to the ventricle through the valve seat during the diaphragm pump discharges blood, thereby improving the actual pumping effect of the ventricular assist pump. BRIEF DESCRIPTION OF THE DRAWINGS

[0020] Figure 1 It is a top view of a bidirectional valve plate of a pulsating pump in an embodiment of the present invention when the valve plate is located at a first position;

[0021] Figure 2It is a cross-sectional view of a bidirectional valve of a pulsating pump in an embodiment of the present invention when the valve plate is located at a first position;

[0022] Figure 3 It is a side view of a bidirectional valve of a pulsating pump in an embodiment of the present invention when the valve plate is located in a first position;

[0023] Figure 4 It is a top view of a bidirectional valve of a pulsating pump in an embodiment of the present invention when the valve plate is located at the second position;

[0024] Figure 5 It is a cross-sectional view of a bidirectional valve of a pulsating pump in an embodiment of the present invention when the valve plate is located at the second position;

[0025] Figure 6 It is a side view of a bidirectional valve of a pulsating pump in an embodiment of the present invention when the valve plate is located at the second position;

[0026] Figure 7 It is a schematic diagram of the valve plate structure of a bidirectional valve of a pulsating pump in an embodiment of the present invention;

[0027] Figure 8 It is a top view of a valve plate of a bidirectional valve of a pulsating pump according to an embodiment of the present invention;

[0028] Fig. 9 It is a front view of a valve plate of a bidirectional valve of a pulsating pump according to an embodiment of the present invention;

[0029] Fig.10 It is a side view of a valve plate of a bidirectional valve of a pulsating pump according to an embodiment of the present invention;

[0030] Fig.11 yes Figure 2 Enlarged view of point B in the middle;

[0031] Fig.12 yes Figure 5 Enlarged view of point D in the middle;

[0032] Fig.13 yes Figure 2 Enlarged view of point C in the middle;

[0033] Fig.14 It is a structural schematic diagram of another bidirectional valve of a pulsating pump in an embodiment of the present invention when the valve plate is removed;

[0034] Fig.15 It is a top view of another bidirectional valve of a pulsating pump according to an embodiment of the present invention when the valve plate is located at a first position;

[0035] Fig.16 It is a cross-sectional view of another bidirectional valve of a pulsating pump according to an embodiment of the present invention when the valve plate is located at a first position;

[0036] Fig.17It is a side view of another bidirectional valve of a pulsating pump in an embodiment of the present invention when the valve plate is located at a first position;

[0037] Fig.18 yes Fig.16 Enlarged view of point E in the middle;

[0038] Fig.19 It is a top view of another bidirectional valve of a pulsating pump in an embodiment of the present invention when the valve plate is located at the second position;

[0039] Fig. 20 It is a cross-sectional view of another bidirectional valve of a pulsating pump in an embodiment of the present invention when the valve plate is located at the second position;

[0040] Fig.21 It is a side view of another bidirectional valve of a pulsating pump in an embodiment of the present invention when the valve plate is located at the second position;

[0041] Fig. 22 yes Fig. 20 Enlarged view of point F in the middle;

[0042] Fig.23 It is a schematic diagram of the structure of connecting spring pieces when another valve piece of a bidirectional valve of a pulsating pump is located at a first position in an embodiment of the present invention;

[0043] Fig.24 It is a schematic diagram of the structure of connecting springs when the valve plate of another bidirectional valve of a pulsating pump is located at the second position in an embodiment of the present invention.

[0044] Description of reference numerals:

[0045] 1. Connecting piece; 11. Pin shaft; 12. Connecting spring; 121. Mounting part; 122. Bending part;

[0046] 2. valve plate; 21. first inclined surface; 22. connecting portion; 221. first axial hole; 23. main body;

[0047] 3. Valve seat; 31. First end; 32. Second end; 33. Valve seat hole; 331. First connecting hole; 332. Second connecting hole; 34. Second inclined surface. DETAILED DESCRIPTION

[0048] In order to make the purpose, features and beneficial effects of the present invention more obvious and easy to understand, the specific embodiments of the present invention are described in detail in conjunction with the accompanying drawings. It is understood that the specific embodiments described below are only used to explain the present invention, rather than to limit the present invention. In addition, the same or similar reference numerals may be used in the figures to refer to the same or similar elements in different embodiments, and the description of the same or similar elements in different embodiments and the description of the prior art elements, features, effects, etc. may be omitted. It should be noted that the axial, radial and circumferential directions described in the embodiments of the present invention respectively represent the axial, radial and circumferential directions of the valve seat 3.

[0049] Reference Figures 1 to 22 , an embodiment of the present invention provides a pulsating pump bidirectional valve.

[0050] In a specific implementation, the pulsating pump bidirectional valve includes a valve disc 2, a valve seat 3 and a connecting member 1. The valve seat 3 is a tubular structure and has a first end 31 and a second end 32. A valve seat hole 33 is provided on the side wall of the valve seat 3. The connecting member 1 is provided at the end of the valve seat hole 33 close to the first end 31, connecting the valve disc 2 and the valve seat 3, and allowing the valve disc 2 to rotate relative to the valve seat 3 between a first position and a second position; the valve disc 2 and the valve seat 3 have the same circumferential curvature and the same outer contour as the valve seat hole 33. In the first position, the valve disc 2 and the valve seat 3 are located on the same cylindrical surface to close the valve seat hole 33, and allow blood in the valve seat 3 to flow from the first end 31 to the second end 32; in the second position, the valve disc 2 is located inside the valve seat 3 to open the valve seat hole 33 and close the first end 31 of the valve seat 3, allowing blood in the valve seat 3 to flow from the second end 32 to the valve seat hole 33.

[0051] In a specific implementation, the valve plate 2 is cut and formed using a pipe of the same size as the valve seat 3, so that the valve plate 2 has the same circumferential curvature as the valve seat 3 in the first position, and the valve plate 2 and the valve seat 3 are made of the same material, both 316LVM stainless steel.

[0052] See also Figure 7-10 In some embodiments, the valve sheet 2 includes a connecting portion 22 and a main body portion 23. The connecting portion 22 is connected to the connector 1. The orthographic projection of the main body portion 23 on the plane is elliptical. In the first position, the connecting portion 22 is located at the end of the main body portion 23 close to the blood inflow.

[0053] In some embodiments, the main body has a first axis (corresponding to the major axis or minor axis of the orthographic projection) and a second axis (corresponding to the minor axis or major axis of the orthographic projection). In the first position, the first axis is arranged axially, and the ratio of the length of the second axis of the main body 23 to the first axis is 0.85-0.98, and the preferred ratio is 0.95-0.98.

[0054] In some embodiments, the length of the second axis of the main body 23 is slightly smaller than the inner diameter R1 of the valve seat 3, so that the main body 23 can rotate into the interior of the valve seat 3 and close as much axial area of ​​the inner cavity of the valve seat as possible in the second position; the length of the valve plate 2 rotating into the valve seat 3 (the length of the first axis of the main body 23 and the inner diameter R1 of the valve seat 3) is slightly smaller than the inner diameter R1 of the valve seat 3, so that the main body 23 can rotate into the interior of the valve seat 3 and close as much axial area of ​​the inner cavity of the valve seat as possible in the second position; Fig. 9 The sum of the distances D in the second position is slightly greater than or equal to the inner diameter R1 of the valve seat 3, so that the angle α between the main body 23 and the horizontal direction is close to 90° when in the second position. Preferably, the angle α is in the range of 84°-87°; more preferably, the angle α is in the range of 85°-86°. The rotation angle of the valve plate 2 is as large as possible, thereby closing a larger axial channel area of ​​the inner cavity of the valve seat.

[0055] See also Figure 11-Figure 12 In some embodiments, the connecting member 1 is a pin shaft 11, a first connecting hole 331 is provided at the end of the valve seat hole 33 near the first end 31, a first axial hole 221 is penetrated by the connecting portion 22, a second axial hole is provided on the side wall of the first connecting hole 331, the end of the pin shaft 11 passes through the first axial hole 221 and is provided in the second axial hole, and the pin shaft 11 is connected with the clearance in the second axial hole.

[0056] In some embodiments, the aperture d of the first axial hole 221 is 0.4(R2-R1)~0.6(R2-R1), wherein R2 is the outer diameter of the valve seat 3, and R1 is the inner diameter of the valve seat 3. The aperture d of the first axial hole 221 should be as small as possible and is selected based on processing capabilities and costs. The preferred aperture d is 0.55(R2-R1). The first axial hole 221 is connected to the pin shaft 11 by an interference fit.

[0057] In a specific implementation, the first axial hole 221 should be located as close to the main body 23 as possible. Fig. 9 The distance D in the middle is as small as possible, so that the length of the valve disc 2 rotating into the valve seat 3 (the sum of the length of the first axis of the main body 23 and the distance D) is as close to the inner diameter of the valve seat 3 as possible, and it can rotate through a larger angle when moving from the first position to the second position, so that when the valve disc 2 is in the second position, the cross-section of the valve seat 3 pipeline can be closer to completely blocked.

[0058] See also Fig.13 In some embodiments, the edge of the valve disc 2 is a first inclined surface 21 whose top is inclined toward the inside of the valve disc 2; the wall surface of the valve seat hole 33 is a second inclined surface 34 whose top is inclined toward the inside of the valve seat hole 33. When the valve disc 2 is in the first position, the first inclined surface 21 abuts against the second inclined surface 34, preventing the valve disc 2 from rotating toward the outside of the valve seat 3.

[0059] In some embodiments, the first inclined surface 21 has an inclination angle of 8°-12° relative to the vertical direction, and the second inclined surface 34 has an inclination angle of 8°-12° relative to the vertical direction.

[0060] See also Figure 14-Figure 24 The connecting piece 1 is a connecting spring piece 12, which is a spring piece made of a bendable material, including a mounting portion 121 and a bending portion 122. A second connecting hole 332 is provided at the end of the valve seat hole 33 close to the first end 31. The connecting spring piece 12 is placed in the second connecting hole 332. The two ends of the mounting portion 121 are respectively connected to the two sides of the second connecting hole 332. The bending portion 122 is bent from the middle of the mounting portion 121 to the inside of the valve seat 3. The bending portion 122 is connected to the connecting portion 22, and the bending angle can be adjusted as the valve plate 2 rotates.

[0061] In some embodiments, when the valve plate 2 is in the first position, the bending portion 122 is parallel to the mounting portion 121 , and the connecting portion 22 is located between the mounting portion 121 and the bending portion 122 , so that the valve plate 3 overlaps with the valve seat hole 33 to close the valve seat hole 33 .

[0062] An embodiment of the present invention further provides a ventricular assist device, comprising the above-mentioned pulsatile pump bidirectional valve.

[0063] To summarize, the pulsating pump bidirectional valve provided in the embodiment of the present invention sets the valve plate 2 on the side wall of the valve seat 3, and sets a connecting piece 1 at one end of the valve seat hole 33 to connect the valve plate 2. The valve plate 2 rotates relative to the valve seat 3 at one end, so that in the first position, the valve plate 2 coincides with the valve seat hole 33, the valve plate 2 and the valve seat 3 fit together at the edge, and the inner wall of the valve seat flow channel is smooth, thereby reducing the occurrence of hemolysis; when the valve plate 2 is switched from the first position to the second position, the valve plate 2 can move to the second position faster under the action of its own gravity and the additional fluid push, thereby improving the conversion efficiency.

[0064] Furthermore, in the bidirectional valve of the pulsating pump provided in an embodiment of the present invention, the shape of the valve plate 2 is set to be an ellipse close to a circle, so as to maximize the rotatable angle of the valve plate 2, so that the valve plate 2 closes a larger axial channel area of ​​the inner cavity of the valve seat 3 when the valve plate 2 is in the second position, thereby reducing the amount of blood flowing back to the ventricle through the valve seat 3 during the blood discharge process of the diaphragm pump, thereby improving the actual blood pumping effect of the ventricular assist pump.

[0065] Although specific embodiments have been described above, these embodiments are not intended to limit the scope of the present disclosure, even when only a single embodiment is described with respect to specific features. The feature examples provided in the present disclosure are intended to be illustrative rather than limiting, unless otherwise stated. In specific implementations, the technical features of one or more dependent claims may be combined with the technical features of the independent claim, based on actual needs and where technically feasible, and may be derived from the technical features of the corresponding independent claim in any appropriate manner rather than simply through the specific combination listed in the claims.

[0066] Although the present invention is disclosed as above, the present invention is not limited thereto. Any person skilled in the art can make various changes and modifications without departing from the spirit and scope of the present invention. Therefore, the protection scope of the present invention shall be subject to the scope defined by the claims.

Claims

1. A pulsating pump bidirectional valve, characterized in that: The invention comprises a valve disc, a valve seat and a connecting piece, wherein the valve seat is a tubular structure and has a first end and a second end, a valve seat hole is arranged on a side wall of the valve seat, and the connecting piece is arranged at the end of the valve seat hole close to the first end, connects the valve disc and the valve seat, and allows the valve disc to rotate relative to the valve seat between a first position and a second position; the valve disc and the valve seat have the same circumferential curvature and the same outer contour as the valve seat hole, and in the first position, the valve disc and the valve seat close the valve seat hole, at which time, the valve disc, the valve seat and the valve seat hole are located on the same cylindrical surface, and allow blood in the valve seat to flow from the first end to the second end; in the second position, the valve disc is located inside the valve seat, opens the valve seat hole and closes the first end of the valve seat, and allows blood in the valve seat to flow from the second end to the valve seat hole.

2. The pulsating pump bidirectional valve according to claim 1, characterized in that: The edge of the valve plate is a first inclined surface with the top inclined toward the inside of the valve plate; the wall surface of the valve seat hole is a second inclined surface with the top inclined toward the inside of the valve seat hole. When the valve plate is in the first position, the first inclined surface abuts against the second inclined surface to prevent the valve plate from rotating toward the outside of the valve seat.

3. The pulsating pump bidirectional valve according to claim 2, characterized in that: The inclination angle of the first inclined surface relative to the vertical direction is 8°-12°, and the inclination angle of the second inclined surface relative to the vertical direction is 8°-12°.

4. The pulsating pump bidirectional valve according to claim 1, characterized in that: The valve sheet comprises a connecting portion and a main body portion, wherein the connecting portion is connected to the connecting piece, the orthographic projection of the main body portion on a plane is elliptical, and the connecting portion is located at an end of the main body portion close to the blood inflow.

5. The pulsating pump bidirectional valve according to claim 4, characterized in that: The main body has a first axis and a second axis. When in the first position, the first axis is arranged along the axial direction, and the ratio of the length of the second axis of the main body to the length of the first axis is 0.85-0.

98.

6. The pulsating pump bidirectional valve according to claim 5, characterized in that: The length of the second axis of the main body is slightly smaller than the inner diameter of the valve seat, so that the main body can rotate into the interior of the valve seat. The length of the valve plate rotating into the valve seat is slightly greater than or equal to the inner diameter of the valve seat, so that the angle between the main body and the horizontal direction in the second position is 85°-86°.

7. The pulsating pump bidirectional valve according to claim 4, characterized in that: The connecting member is a pin shaft, a first connecting hole is arranged at the end of the valve seat hole close to the first end, a first axial hole is arranged through the connecting portion, a second axial hole is arranged on the side wall of the first connecting hole, and the end of the pin shaft passes through the first axial hole and is arranged in the second axial hole.

8. The pulsating pump bidirectional valve according to claim 7, characterized in that: The aperture of the first axial hole is d=0.4(R2-R1)~0.6(R2-R1), wherein R2 is the outer diameter of the valve seat, and R1 is the inner diameter of the valve seat.

9. The pulsating pump bidirectional valve according to claim 4, characterized in that: The connecting member is a connecting spring sheet, which includes a mounting portion and a bending portion. A second connecting hole is provided at the end of the valve seat hole close to the first end. The connecting spring sheet is placed in the second connecting hole. The two ends of the mounting portion are respectively connected to the two sides of the second connecting hole. The bending portion is bent from the middle of the mounting portion to the inside of the valve seat. The bending portion is connected to the connecting portion and the bending angle can be adjusted as the valve sheet rotates.

10. The pulsating pump bidirectional valve according to claim 9, characterized in that: When the valve plate is located at the first position, the bent portion is parallel to the mounting portion, and the connecting portion is located between the mounting portion and the bent portion, so that the valve plate overlaps with the valve seat hole and closes the valve seat hole.

11. A ventricular assist device, characterized in that: It comprises the pulsating pump bidirectional valve as described in any one of claims 1-10.

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