Blood guide valve and ventricular assist pump device comprising same

Abstract

A blood guide valve and a ventricular assist pump device comprising same. The blood guide valve comprises: a valve seat and a valve body, wherein the valve body is provided in a valve seat inner cavity and can rotate between a first position and a second position around a pivot; at the first position, the valve body blocks a side hole of the valve seat and allows blood in the valve seat to flow axially; at the second position, the valve body opens the side hole to enable fluid inside and outside the valve seat to be communicated, and blocks an axial channel of the valve seat inner cavity to block axial flowing of the blood in the valve seat on one side of the valve body; the pivot is perpendicular to a valve seat axis in different planes; and a plane formed across the pivot and parallel to the valve seat axis divides the valve body into a first portion and a larger second portion, such that the blood guide valve can be more quickly opened / closed.

Description

[0001]A blood flow directing valve and a ventricular assist pump device therefor. The present invention relates to a blood flow directing valve and a ventricular assist pump device therefor, which are used to assist in pumping blood in a circulatory system. Background: Conventional ventricular assist pumps include a substantially rigid housing defining an interior space divided into two compartments by a flexible membrane. During operation, one compartment contains blood and the other contains gas. The ventricular assist pump is also connected to the heart via a single-lumen catheter having an inlet channel and an outlet channel spaced apart at its distal end for conveying blood from the inlet to the outlet via the catheter at a distance sufficient between the inlet and outlet. The ventricular assist pump has an opening for connection to a catheter in communication with a drive unit. The drive unit generates negative and positive pressures (relative to the current pressures in the inner cavity and the blood compartment), thereby alternately removing gas from the gas chamber and forcing gas into the gas chamber, respectively. During the suction phase, the negative pressure pulls the membrane toward a first side of the housing, drawing blood through the inlet channel and, to a certain extent, through the outlet channel of the single-lumen catheter into the membrane pump. This is followed by the ejection phase, during which pressure pushes the membrane from the first side of the housing back to the second, opposite side, thereby expelling blood from the housing and into the catheter lumen. As blood is expelled, minimal blood flows out through the inlet channel, resulting in a sequential pattern of alternating aspiration and ejection of blood, resulting in a net pumping effect. This pumping effect is achieved by the blood flow guidance valve. However, existing blood flow guidance valves still require improvement in terms of opening and closing response and sealing performance. This aims to further enhance the follow-up opening and closing response speed and the sealing performance of the valve body, thereby further improving and optimizing the pumping capacity of the ventricular assist pump. SUMMARY OF THE INVENTION To overcome the aforementioned problem, the present invention provides a blood flow guide valve comprising: a valve seat and a valve body; wherein the valve body is disposed in an inner cavity of the valve seat and is rotatable about a pivot between a first position and a second position; wherein, in the first position, the valve body closes a side hole of the valve seat and allows axial flow of blood in the valve seat; in the second position, the valve body opens the side hole and connects the fluid inside and outside the valve seat, and closes the axial passage of the inner cavity of the valve seat, preventing axial flow of blood in the valve seat on one side of the valve body; the pivot is not perpendicular to the axis of the valve seat; the valve body is an arc-shaped sheet structure, and in the first position closing the side hole, its side wall is adjacent to the corresponding side wall of the valve seat and the two are substantially parallel; in the second position, a generatrix of the valve body is substantially perpendicular to the axis of the valve seat; a plane passing through the pivot and parallel to the axis of the valve seat divides the valve body into a first part and a second part, wherein the longest generatrix ratio of the first part to the second part is 0.75:1 to 0.85:1. To achieve faster opening and closing response; the bevel angle of the first part is greater than the bevel angle of the second part.As described above, the blood flow guiding valve comprises an axial hole at each end; the outer contours of the axial hole, the first portion, and the second portion are connected by arcuate connecting portions; the outer edge of the first portion of the valve body comprises a first beveled portion, which further comprises a first chamfered bevel; the outer edge of the second portion of the valve body comprises a second beveled portion, which further comprises a second chamfered bevel and an outer chamfered end portion. As described above, the outer edges of the first and second portions have different wall thicknesses. As described above, the valve seat comprises an enlarged diameter section within the lumen of the tube section with the side hole, and the inner lumens of the distal and proximal portions at both ends are connected by a reducing section. As described above, the distal and proximal portions of the valve seat are used to engage a catheter, such that the outer diameter of the valve seat is substantially consistent with that of the catheter. As described above, the blood flow guiding valve has a catheter insertion groove at both the distal end and the proximal end for engaging the catheter, forming a secure connection and a smooth transition. As described above, the blood flow guiding valve is made of titanium alloy or stainless steel. A blood flow guide valve is also provided, comprising: a valve seat and a valve body; wherein the valve body is disposed in an inner cavity of the valve seat and is rotatable about a pivot between a first position and a second position; wherein, in the first position, the valve body closes a side hole of the valve seat and allows axial flow of blood in the valve seat; in the second position, the valve body opens the side hole and allows fluid in and out of the valve seat to communicate, and closes an axial passage in the inner cavity of the valve seat, preventing axial flow of blood in the valve seat on one side of the valve body; the pivot is not perpendicular to the axis of the valve seat; the valve body is an arc-shaped sheet structure, and in the first position closing the side hole, its side wall is adjacent to the corresponding side wall of the valve seat, and the two are substantially parallel; in the second position, a generatrix of the valve body is substantially perpendicular to the axis of the valve seat, preferably 80-90 degrees; 85 degrees; a plane passing through the pivot and parallel to the axis of the valve seat divides the valve body into a first part and a second part, wherein the longest generatrix ratio of the first part to the second part is 0.75:1 to 0.85:1, For faster opening and closing response; the pivot is positioned away from the side hole and offset from the main axis by approximately 43% to 46% of its diameter. In the aforementioned blood flow pilot valve, the outer edge of the first portion of the valve body can be further divided into a first curved portion, a second curved portion, and a third curved portion; the outer edge of the second portion of the valve body can be further divided into a fourth curved portion, a fifth curved portion, and a sixth curved portion; the area ratio of the first and second portions is 0.7:1 to 0.9:1. In the aforementioned blood flow pilot valve, each curved portion is chamfered to reduce the risk of hemolysis and coagulation caused by the valve body.The blood flow guide valve described above is made of titanium alloy or stainless steel. The pivot of the blood flow guide valve is a movable yoke, and the corresponding inner wall of the valve seat has an axial pivot groove, allowing the blood flow guide valve to rotate while moving radially along the direction of the internal and external pressures of the valve seat, thereby better sealing the side hole. A ventricular assist pump device comprising the blood flow guide valve described above is also provided, further comprising a catheter and a diaphragm pump. The catheter of the ventricular assist pump device described above is a titanium-reinforced single-channel catheter. Advantageous Effects: By optimizing the configuration and inclination angle of the valve body, the valve body can respond more quickly to opening and closing, reducing blood flow loss caused by delayed response time. Beveling increases the interface between the valve body and the side hole of the valve seat, better sealing the side hole. Chamfering the edges of the valve body reduces the risk of blood clotting caused by sharp edges. The valve seat is provided with an expanded diameter section, giving the valve body a larger swing arm, thereby providing a larger generatrix dimension, allowing the larger valve body to seal the side hole. Figure 2 of the accompanying drawings is a schematic diagram of a ventricular assist device in use. Figure 3 is a schematic diagram of the blood flow guide valve in its first and second positions. Figure 4 is a longitudinal cross-sectional view of the blood flow guide valve in its first position. Figure 5 is a perspective schematic diagram of the blood flow guide valve. Figure 6 is a front view of the blood flow guide valve. Figure 7 is a longitudinal cross-sectional view of the blood flow guide valve in its first and second positions in another embodiment; and Figure 8 is a longitudinal cross-sectional view of the blood flow guide valve in its first and second positions in yet another embodiment. DETAILED DESCRIPTION As shown in Figure 2, a ventricular assist device 5 includes a diaphragm pump 6, a catheter 10, a pneumatic catheter 11, and a blood flow guide valve 14. As shown in Figure 3, the blood flow pilot valve 14 includes a valve seat 17 and a valve body 16. The valve body 16 is disposed within the valve seat cavity 34 and is rotatable about a pivot 35 of the valve seat 17 between a first position and a second position. In the first position, the valve body 16 blocks the side hole 15 of the valve seat 17 and allows axial blood flow within the valve seat 17. In the second position, the valve body 16 opens the side hole 15, allowing fluid communication between the inside and outside of the valve seat 17, and blocks the axial passage of the valve seat cavity 34, preventing axial blood flow within the valve seat 17 on one side of the valve body 16. The pivot 35 is oriented unequally and perpendicularly to the valve seat axis 40. Referring to Figures 5-6, the valve body 16 is an arcuate, sheet-like structure made of titanium alloy or stainless steel.In the first position of the closed side hole 15, its side wall is adjacent to the corresponding side wall of the valve seat 17, and the two are substantially parallel. In the second position, the generatrix of the valve body 16 is substantially perpendicular to the valve seat axis 40. A plane passing through the pivot 35 and parallel to the valve seat axis 40 divides the valve body 16 into a first portion 161 and a second portion 162. The ratio of the longest generatrixes L1 and L2 of the first and second portions is 0.75:1 to 0.85:1, which allows for faster opening and closing response. The bevel angle a1 of the first portion 161 is greater than the bevel angle θ(2) of the second portion 162. The valve body 16 further includes an axial hole portion 163 at both ends. The outer contours of the axial hole portion 163 and the first and second portions 161 and 162 are connected by arc-shaped connecting portions 1603 and 604, respectively. The outer edge of the first portion 161 of the valve body 16 includes a first bevel portion 1611. The first beveled portion 1611 further comprises a first chamfered beveled surface; the outer edge of the second portion 162 of the valve body 16 includes a second beveled portion 1621; the second beveled portion 1621 further comprises a second chamfered beveled surface 16211 and an end peripheral chamfer 16212. The end peripheral chamfer 16212 is used to reduce the protrusion of the valve body relative to the valve seat 17 when in the second position, reduce turbulence, and smooth the edge to avoid the end being too sharp and prone to blood clotting. The arcuate connecting portions 1603 and 1604 have the same curvature; the arcuate connecting portions 1603 and 1604 have straight sections 1601 and 1602 respectively between them and the axial hole 163, wherein the length of the straight section 1601 is greater than that of the straight section 1602. The axial proximal end of the side hole 15 has a proximal beveled cut 152 to match the second chamfered beveled surface 16211. The contact area between the side wall of the valve body and the side wall of the valve seat is increased, thereby increasing the i-inch closing area and reducing the assembly and processing accuracy. In addition, the end edge of the second part 162 has a wall thickness h2, which is greater than the larger wall thickness hi of the end edge of the first part 161, so that the second part 162 has a wider second chamfered bevel 16211 to engage the proximal bevel 152 of the side hole 15. In a preferred embodiment, the axial distal end of the side hole 15 is symmetrically provided with a distal bevel 51 and the proximal bevel 52, thereby reducing the installation direction requirements of the valve seat 17 during assembly. The valve seat 17 has an enlarged diameter section 171 with an enlarged inner diameter in the inner cavity of the pipe section with the side hole 5, which is connected to the inner cavity of the distal end 18 and the proximal end 19 at both ends through a reducing section 172. The enlarged diameter section 171 allows the valve body 16 to have a larger arm length / rotation radius when it is rotatable. This reduces the radial clearance between the valve body 16 and the valve seat 17 in the first position, and allows for better engagement and sealing with the pipe wall of the valve seat 17.In addition, the expanded diameter section 171 allows the valve body 16 to overlap the proximal bevel cut 152 at the axial proximal end of the side hole 15, so that the inner edge of the valve body [6] basically does not exceed the inner surface of the distal end portion 18 and the proximal end portion 19, thereby avoiding affecting the diameter of the valve body and the blood flow rate; preferably, the inner surface of the valve body is basically consistent with the surface of the catheter. The distal end portion 18 and the proximal end portion 19 of the valve seat 17 are used to engage the catheter 10, so that the outer diameter of the valve seat 17 is basically consistent with the outer diameter of the catheter. In some embodiments, the distal end portion 18 and the proximal end portion 19 both have a catheter insertion groove 173 for engaging the catheter 10 to form a firm connection and a smooth transition. In some embodiments, the angle B between the generatrix of the valve body 16 and the valve seat axis 40 is 80 to 90 degrees, preferably 85 degrees; in the state of this inclination angle B, when the blood flow reverses, the valve body 16 can be more easily rotated from the second position to the first position. In addition, in order to increase the pressure difference between the blood flow on the second part 162 and the first part 161, the pivot 35 is set away from the side hole [5 and deviates from the main axis by about 43% to 46% of the diameter, thereby generating a larger torque on the valve body 16, thereby closing the side hole 15. Based on similar reasons, when the blood flow is reversed at the second position, it rotates from the first position to the second position, opening the side hole 15. The outer edge of the first part 161 of the valve body 16 can be divided into a first curved part 16121, a second curved part 16122, and a third curved part 16123; the outer edge of the second part 162 of the valve body 16 can be divided into a fourth curved part 16221, a fifth curved part 16222, and a sixth curved part 16223; the arrangement of the above-mentioned curved parts can better fit the inner wall of the valve seat and the edge of the side hole to form a better seal. Each curved portion is chamfered to reduce turbulent flow caused by the valve body 16 and mitigate the risks of hemolysis and coagulation. Furthermore, the area ratio of the first and second portions is 0.7:1 to 0.9:1. In summary, the above-described configuration of the blood flow guide valve enables the valve body 16 to rapidly respond to changes in blood flow direction and pressure, quickly opening and closing the side hole 15, reducing leakage losses during blood pumping and improving pumping capacity. In the above embodiment, the pivot 35 and the axial hole 163 can be disposed on the valve seat 17 and the valve body 16, respectively. In another embodiment, when the pivot 35 is disposed on the valve body 16, it is a movable pivot 35, and the inner wall of the corresponding valve seat 17 has an axial pivot groove 351. This allows the blood flow guide valve 14 to simultaneously rotate and move, thereby better sealing the side hole 15 or the axial passage of the catheter.For example, when valve body 16 is in the second position, it moves distally under the pressure within the catheter, thereby reducing gap 31 and, in turn, reducing blood backflow from outside the catheter into the catheter lumen. In summary, the blood flow guiding valve and its associated ventricular assist pump device optimize the valve body's configuration and tilt angle to enable faster valve body opening and closing responses, reducing blood flow loss due to delayed response time. Beveling increases the interface between the valve body and the side opening of the valve seat, effectively sealing the side opening. Chamfering the valve body edges reduces the risk of blood clotting caused by sharp edges. The valve seat is provided with an expanded diameter section 171, giving the valve body a larger pivot arm and, consequently, a larger generatrix dimension. This larger valve body seals the side opening, further improving the follow-up opening and closing response speed and the valve body's sealing effect, thereby further enhancing and optimizing the pumping capacity of the ventricular assist pump. Those skilled in the art will readily recognize other embodiments of the present disclosure after considering the specification and practicing the invention disclosed herein. This application is intended to cover any variations, uses, or adaptations of the present disclosure that follow the general principles of the present disclosure and include common knowledge or customary techniques in the art not disclosed herein. The description and examples are to be considered as exemplary only, with the true scope and spirit of the present disclosure being indicated by the following claims. It should be understood that the present disclosure is not limited to the precise structure described above and shown in the accompanying drawings, and that various modifications and variations may be made without departing from the scope of the present disclosure. The scope of the present disclosure is to be limited solely by the appended claims.

Claims

Claims 1. A blood flow guiding valve, comprising: A valve seat and a valve body; wherein the valve body is arranged in the inner cavity of the valve seat and can rotate around a pivot between a first position and a second position; characterized in that: in the first position, the valve body closes the side hole of the valve seat and allows the blood flow in the valve seat to flow axially; in the second position, the valve body opens the side hole and connects the fluid inside and outside the valve seat, and closes the axial channel of the inner cavity of the valve seat to prevent the blood flow in the valve seat on one side of the valve body from flowing axially; the pivot is perpendicular to the axis of the valve seat; the valve body is an arc-shaped sheet structure, and in the first position of closing the side hole, its side wall is adjacent to the corresponding side wall of the valve seat, and the two sides are parallel; in the second position, the generatrix of the valve body is perpendicular to the axis of the valve seat; the plane passing through the pivot and parallel to the axis of the valve seat divides the valve body into a first part and a second part, wherein the longest generatrix ratio of the first and second parts is 0.75:1~0.85:1, so as to respond faster to opening and closing.

2. The blood flow guiding valve according to claim [, wherein the bevel angle of the first portion is greater than the bevel angle of the second portion.

3. The blood flow guide valve as claimed in claim 2, wherein the valve body further comprises axial hole portions at both ends; the outer contours of the axial hole portion and the first portion and the second portion are connected via arc-shaped connecting portions; the outer edge of the first portion of the valve body comprises a first bevel portion; the first bevel portion further comprises a first chamfered bevel; the outer edge of the second portion of the valve body comprises a second bevel portion; the second bevel portion further comprises a second chamfered bevel surface and an outer peripheral chamfer.

4. The blood flow guiding valve according to any one of claims 1 to 3, wherein: The outer edges of the first part and the second part have the same wall thickness. 8 5. The blood flow guide valve according to claim 1, wherein: The valve seat has an enlarged diameter section with an enlarged inner diameter in the inner cavity of the pipe section with the side hole, and the inner cavities of the distal end and the proximal end at both ends are connected through the reduced diameter section.

6. The blood flow guiding valve according to claim 1, wherein: The distal end and the proximal end of the valve seat are used to engage the catheter so that the outer diameter of the valve seat is consistent with the outer diameter of the catheter.

7. The blood flow guiding valve according to claim 7, wherein: Both the distal end and the proximal end have catheter insertion grooves for engaging the catheter to form a firm connection and a smooth transition.

8. The blood flow guide valve as described in claim 1, in the second position, the generatrix of the valve body is substantially 80-90 degrees with the valve seat axis, preferably 85 degrees; the pivot is arranged away from the side hole and deviates from the main axis by about 43% to 46% of the diameter.

9. The blood flow guide valve as described in claim 8, wherein the outer edge of the first part of the valve body can be divided into a first arc portion, a second arc portion, and a third arc portion; the outer edge of the second part of the valve body can be divided into a fourth arc portion, a fifth arc portion, and a sixth arc portion; and the area ratio of the first and second parts is 0.7:1 to 0.9:

1. [0. The blood flow guide valve according to claim 9, wherein: Each arc portion is chamfered to reduce the tongue L flow caused by the valve body and reduce the risk of hemolysis and coagulation.

11. The blood flow guide valve as described in any one of claims 8 to 10, wherein the pivot is a movable pivot, and the corresponding inner wall of the valve seat has an axial pivot groove, so that the blood flow guide valve can rotate and move radially along the internal and external pressure directions of the valve seat, thereby achieving better sealing. [2. The blood flow guiding valve as described in any one of claims 1 to 11, which is made of titanium alloy or stainless steel. [3. A ventricular assist pump device comprising a blood flow guide valve as claimed in any one of claims 1 to 12, characterized in that Also includes catheters and diaphragm pumps.

14. The ventricular assist pump device as claimed in claim 13, wherein the catheter is a titanium reinforced single-channel catheter. 9

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