Intrusive artificial heart catheter window-entering and ventricle-entering auxiliary device

Abstract

The utility model relates to the technical field of medical instruments, and discloses an interventional artificial heart catheter window-entering and ventricle-entering auxiliary device. Comprising a proximal end tip, a catheter head middle section and a catheter head distal end, and the interior of the proximal end tip is provided with a proper inner surface to prevent the formation of thrombus; the total area and the surface area of the window in the middle section of the catheter head have a certain ratio, so that the heart can be prevented from being blocked by myocardium during contraction on the premise of ensuring blood flux; the distal end of the catheter head has a thickness slightly lower than the thickness of the above part, and can be better joined with the catheter. According to the blood inflow catheter head and device, retention and vortex of blood at the front end of the catheter head can be well avoided, and thrombus is further avoided.

Description

Technical Field

[0001] The present application relates to the technical field of medical devices, and in particular to an interventional artificial heart catheter access window and a ventricular assist device. Background Art

[0002] Vascular disease (CVD) has become one of the leading causes of disease burden globally and in China. From 1990 to 2019, the number of people suffering from cardiovascular disease worldwide surged from 270 million to 523 million, a rapid increase. The number of deaths from cardiovascular disease has also continued to rise, from 12.1 million in 1990 to 18.6 million in 2019, posing a serious threat to public health. Studies have shown that among cardiovascular diseases, the number of patients with coronary heart disease and cardiogenic shock is also increasing annually, and the mortality rate remains high.

[0003] Coronary heart disease and its complications. The heart pumping function of such patients drops sharply, leading to insufficient perfusion of multiple organs throughout the body, and then to multiple organ failure. Although traditional treatments for cardiovascular diseases can alleviate the condition to a certain extent, they are often powerless when faced with complex and critical cardiovascular diseases. Especially in emergency situations such as high-risk percutaneous coronary intervention (HR-PCI) and cardiogenic shock, it may not be possible to quickly and effectively improve the patient's heart function. Faced with cardiovascular emergencies such as coronary heart disease and high-risk percutaneous coronary intervention, there is an urgent need in clinical practice for a treatment method that can quickly and effectively provide circulatory support. It is in this context that pVAD came into being.

[0004] A percutaneous ventricular assist device (pVAD) is a device that helps the heart work in the short term, or temporarily replaces the heart's work when the heart is unable to work. It is usually inserted into the body through the skin (percutaneously) and then connected to the heart to assist or take over the heart's pumping function. It is used in emergency situations, such as for short-term cardiac support during and after coronary intervention for high-risk patients. Therefore, the design of the pVAD focuses more on miniaturization, convenience, and minimal invasiveness.

[0005] The problem with the existing technology is that the inner cavity space near the guidewire outlet at the front end of the PVAD catheter is not suitable, so that blood will be retained near the guidewire outlet and generate vortexes, which is easy to cause thrombosis. At the same time, there are too few openings for blood to flow out, which are easily blocked by the myocardium during heart contraction, thereby reducing the flow of blood into the openings. In addition, the cavity of the guidewire outlet of the existing technology can only pass a 0.025-inch guidewire and is not compatible with the 0.035-inch guidewire commonly used in China. The depth of its guidewire outlet cavity is too deep, which is easy to cause thrombosis to accumulate and is not easy for the guidewire to pass through. In terms of process, the proximal end of the catheter front end and the opening are separated designs, so it is inevitable to use welding technology to connect the two. However, the connection position of this design and manufacturing process will produce an uneven interface, which may hinder blood flow and accumulate into thrombosis.

[0006] Purpose of the invention: The area near the guidewire outlet at the front end of the catheter of the present application is provided with an inner cavity with a suitable angle to the axis of the catheter head, which can avoid blood stagnation near the guidewire outlet and the possibility of generating vortexes, thereby reducing the occurrence of thrombus; and providing a suitable number of openings, which can avoid myocardial blockage during heart contraction and ensure the flow of blood into the openings; the guidewire outlet of the present application is compatible with the 0.035-inch guidewire commonly used in China; at the same time, the depth of the guidewire outlet cavity is moderate, which is not easy to cause thrombus accumulation, and can also make the guidewire easier to pass; in terms of process, the proximal end of the front end of the catheter and the openings use precision machining technology, and the interface between the connection position of this design and manufacturing process will be smoother, thereby reducing the possibility of obstructing blood flow and accumulating into thrombus. Summary of the Invention

[0007] The embodiments of the present application provide an interventional artificial heart catheter access window and a ventricular assist device, comprising: a proximal end tip, a middle section of the catheter tip, and a distal end of the catheter tip. The cross-section of the proximal end tip forms a line segment with a suitable inner cavity space between the line segment and the axis of the catheter tip to prevent the formation of thrombus; the total area of the window in the middle section of the catheter tip has a certain ratio to its surface area, which can avoid myocardial blockage during heart contraction while ensuring blood flux; the distal end of the catheter tip has a thickness slightly lower than the aforementioned portion, which can better engage with the catheter. The blood inflow catheter tip and device of the present application can effectively avoid the retention and vortex of blood at the front end of the catheter tip, further avoiding the formation of thrombus.

[0008] The embodiments of the present application disclose an interventional artificial heart catheter access window and a ventricular assist device, comprising: a proximal end tip (10), an outer surface (101), an inner surface (102), a guide wire passage port (103), an inner cavity (104), a catheter tip middle section (20), a support (201), a window (202), a catheter tip distal end (30), a first catheter portion (40), a flow direction switching valve (50), a second catheter portion (60), a blood pumping device (70), and a driving device (80).

[0009] Furthermore, the proximal end tip (10) includes a dome-shaped or arc-shaped outer surface (101); a smooth inner surface (102); a longitudinal cross-sectional line segment of the inner surface (102), and a space enclosed by the inner surface (102) is an inner cavity (104); and also includes a guide wire passage port (103) with a certain depth and a certain diameter.

[0010] Furthermore, the radial length of the inner cavity (104) is m, the horizontal distance between the edge point k of the guide wire through the port (103) and the distal end of the inner cavity (104) on its proximal side is n, a straight line with the point k as an endpoint is defined as l, and there is an angle α between l and n; the area where the line formed by the longitudinal section of the inner surface (102) falls is set to S, and the range of S is the area enclosed by l, m and n, which can make blood flow more convenient and reduce the formation of eddy currents;

[0011] Furthermore, the angle α has a value range of 45° to 70°.

[0012] Furthermore, the guide wire passage opening (103) has a certain depth and diameter, wherein the depth ranges from 0.5 to 2 mm and the diameter ranges from 0.5 to 1.5 mm.

[0013] Furthermore, the preferred depth value of the guide wire passage opening (103) is 1 mm.

[0014] Furthermore, the preferred diameter value of the guide wire passage (103) is 1 mm.

[0015] Furthermore, the radial length of the proximal end tip (10) is in the range of 0.4D-1D, preferably 0.5D.

[0016] Furthermore, the middle section (20) of the catheter head is a hollow cylinder with an outer diameter of D, and the outer diameter D ranges from 4 to 8 mm. The middle section (20) of the catheter head includes a plurality of pillars (201), and arc-shaped windows (202) are enclosed between the pillars.

[0017] Furthermore, the number of the open windows (202) ranges from 4 to 6.

[0018] Furthermore, the ratio of the total area of the windows (202) to the surface area of the middle section (20) of the catheter head is constant, ranging from 0.5 to 0.9, and the preferred area ratio is 0.75. Since the area ratio remains unchanged, when the number of the windows (202) changes, the unit area will also change accordingly.

[0019] Furthermore, the middle section (20) of the catheter head has a first thickness, specifically a thickness range of 0.02D-0.1D.

[0020] Furthermore, the distal end (30) of the catheter head mainly refers to the portion connected to the catheter.

[0021] Furthermore, the distal end (30) of the catheter head has a second thickness, specifically a thickness range of 0.015D-0.05D.

[0022] Furthermore, the overall diameter of the catheter head is in the range of 4-8 mm.

[0023] Furthermore, the material of the catheter tip includes but is not limited to: SUS304, SUS316, NITI alloy, implantable polymer material, etc.

[0024] The present application also provides a ventricular assist device, comprising any one of the catheter access windows described above, the device further comprising a first catheter portion (40), a flow direction switching valve (50), a second catheter portion (60), a blood pumping device (70), and a drive device (80), wherein the components are integrated to jointly realize a blood pumping function. Furthermore, the first catheter portion (40) is in an angularly bent state, and the exterior may further include a shape memory coil such as an elastic metal member to facilitate catheter bending, and may be formed so that it includes one or more bends or curves in a relaxed state.

[0025] The advantages of the present application are: an inner cavity with a suitable angle to the axis of the catheter head is set in the area near the guidewire outlet of the front end of the catheter of the present application, which can avoid blood stagnation near the guidewire outlet and the possibility of generating vortexes, thereby reducing the occurrence of thrombus; and providing a suitable number of openings, which can avoid myocardial blockage during heart contraction and ensure the flow of blood into the openings; the guidewire outlet of the present application is compatible with the 0.035-inch guidewire commonly used in China; at the same time, the depth of the guidewire outlet cavity is moderate, which is not easy to cause thrombus accumulation, and can also make the guidewire easier to pass; in terms of process, the proximal end of the front end of the catheter and the opening use precision machining technology, and the interface between the connection position of this design and manufacturing process will be smoother, thereby reducing the possibility of obstruction of blood flow and accumulation of thrombus. BRIEF DESCRIPTION OF THE DRAWINGS

[0026] The accompanying drawings are only used to illustrate the preferred embodiments and are not to be considered as limiting the present invention. In addition, the same reference symbols are used to identify the same components throughout the accompanying drawings. In the accompanying drawings:

[0027] Figure 1 An overall diagram of the catheter entry window

[0028] Figure 2 Cross-sectional view of the catheter entrance window

[0029] Figure 3 Enlarged view of the front end of the catheter entrance window

[0030] Figure 4 A three-dimensional diagram of the catheter entry window

[0031] Figure 5 Illustration of the cross section of the catheter entrance window

[0032] Figure 6 Components for ventricular assist devices

[0033] Description of reference numerals:

[0034] 10: Proximal end, 101: Outer surface, 102: Inner surface, 103: Guidewire passage, 104: Inner cavity, 20: Middle section of catheter head, 201: Support, 202: Window, 30: Distal end of catheter head, 40: First catheter part, 50: Flow direction switching valve, 60: Second catheter part, 70: Blood pumping device, 80: Driving device. DETAILED DESCRIPTION

[0035] Exemplary embodiments of the present disclosure will be described in more detail below with reference to the accompanying drawings. Although exemplary embodiments of the present disclosure are shown in the accompanying drawings, it should be understood that the present disclosure can be implemented in various forms and should not be limited by the embodiments set forth herein. Rather, these embodiments are provided to enable a more thorough understanding of the present disclosure and to fully convey the scope of the present disclosure to those skilled in the art.

[0036] It should be understood that the terms used herein are for the purpose of describing specific example embodiments only and are not intended to be limiting. Unless the context clearly indicates otherwise, the singular forms "one", "an", and "said" as used herein may also be meant to include plural forms. The terms "comprise", "include", "contain", and "have" are inclusive and therefore specify the presence of stated features, steps, operations, elements, and / or parts, but do not exclude the presence or addition of one or more other features, steps, operations, elements, parts, and / or combinations thereof. The method steps, processes, and operations described herein are not to be construed as necessarily requiring the specific order in which they are described or illustrated, unless the order of execution is clearly indicated. It should also be understood that additional or alternative steps may be used.

[0037] Although the terms first, second, third, etc. can be used in the text to describe multiple elements, components, regions, layers and / or sections, these elements, components, regions, layers and / or sections should not be limited by these terms. These terms can only be used to distinguish an element, component, region, layer or section from another region, layer or section. Unless the context clearly indicates otherwise, terms such as "first", "second" and other numerical terms do not imply order or sequence when used in the text. Therefore, the first element, component, region, layer or section discussed below can be referred to as the second element, component, region, layer or section without departing from the teachings of the example embodiments.

[0038] For ease of description, spatially relative terms may be used herein to describe the relationship of one element or feature relative to another element or feature as shown in the figures, such as "inside", "outside", "inside", "outside", "below", "beneath", "above", "above", etc. Such spatially relative terms are intended to include different orientations of the device in use or operation other than the orientation depicted in the figure. For example, if the device in the figure is turned over, then the element described as "below other elements or features" or "below other elements or features" will then be oriented as "above other elements or features" or "above other elements or features". Thus, the example term "below..." can include both above and below orientations. The device can be oriented (rotated 90 degrees or in other directions) and the spatially relative descriptors used in the text are interpreted accordingly.

[0039] In the description of the present invention, unless otherwise expressly specified or limited, the terms "mounted," "connected," "connect," and "fixed" should be understood in a broad sense. For example, they may refer to fixed or detachable connections, or integration; mechanical or electrical connections; direct or indirect connections through an intermediate medium; and internal communication between two components or interaction between two components. Those skilled in the art will understand the specific meanings of the above terms in the present invention based on specific circumstances.

[0040] In the field of interventional medical devices, the end of a medical device implanted in the human or animal body that is closer to the operator is generally called the "proximal end", and the end farther from the operator is called the "distal end". The "proximal end" and "distal end" of any component of a medical device are defined based on this principle.

[0041] An interventional artificial heart catheter access window and ventricular assist device, such as Figures 1 to 4 As shown, it includes: a proximal end tip (10), an outer surface (101), an inner surface (102), a guide wire passage port (103), an inner cavity (104), a catheter head middle section (20), a support (201), a window (202), a catheter head distal end (30), a first catheter part (40), a flow direction switching valve (50), a second catheter part (60), a blood pumping device (70), and a driving device (80).

[0042] Figure 1The overall diagram of the catheter access port is depicted, wherein the proximal end tip (10) includes an outer surface (101), an inner surface (102), a guidewire passage port (103), and an inner cavity (104). The outer surface (101) is generally dome-shaped or arc-shaped, and may have any shape that facilitates insertion of the catheter of the ventricular assist device into the patient's vascular cavity, such as a conical or curved conical shape, or a cylindrical profile with rounded edges. The inner surface (102) is a smooth surface, which appears as a straight line or a curve or a combination of the two in a longitudinal section. The inner cavity channel is formed by gathering near the guide wire outlet, and the space enclosed by the inner surface (102) is the inner cavity (104). The radial length of the inner cavity (104) is m, and the horizontal distance between the edge point k of the guide wire passage (103) and the distal end of the inner cavity (104) proximal to it is n. A straight line with the k point as the endpoint is defined as l, and there is an angle α between l and n; the area where the line formed by the longitudinal section of the inner surface (102) falls is set as S, and the range of S is the area enclosed by l, m and n, and the value range of the angle α is between 45° and 70°, which can reduce the possibility of vortex generation when blood circulates here, and further reduce the possibility of blood retention here and thus the formation of thrombus. Furthermore, if the line formed by the longitudinal section of the inner surface (102) is a curve, the curve should be a curve of a quadratic function on a coordinate system with point k as the origin and its longitudinal tangent and horizontal line as the horizontal and vertical axes, and the slope of the curve is negative.

[0043] The guidewire passage port (103) is compatible with a 0.035-inch guidewire to further assist in positioning the ventricular assist device. Its diameter range is 0.5-1.5 mm, and the preferred diameter value is 1 mm. In order to reduce the risk of blood being retained in the guidewire passage port (103) after the guidewire is withdrawn, thereby generating thrombus, the guidewire passage port (103) needs to have a suitable depth, and its depth range is 0.5-2 mm, and the preferred depth value is 1 mm. Furthermore, the radial length range of the proximal end tip (10) should be 0.4D-1D, and preferably 0.5D.

[0044] Secondly, the middle section (20) of the catheter head is a hollow cylinder with an outer diameter of D, and the outer diameter D ranges from 4 to 8 mm. The middle section (20) of the catheter head includes a plurality of pillars (201), and the pillars enclose an arc-shaped window (202). At the proximal end, the middle section (20) of the catheter head is connected to the proximal end (10), and the pillars (201) extend in the middle section (20) of the catheter head and are parallel to each other, and can be extended to connect to the junction of the distal end (30) of the catheter head and the middle section (20) of the catheter head. A plurality of arc-shaped windows (202) are defined between the pillars, and blood can flow into the catheter head through these windows (202). Although Figure 2The exemplary blood inflow catheter head is shown as having five struts (201), but any number of struts (201) may be used, such as two or more struts (201). The inner and outer edges of the struts (201) are rounded. When the catheter assembly of the ventricular assist device is inserted into a blood vessel, the rounded edges reduce pressure and wear on the vascular system, and reduce damage to blood cells during blood circulation, thereby reducing the probability of hemolysis.

[0045] Furthermore, the ratio of the total area of all the windows (202) to the total surface area of the outer portion of the middle section (20) of the catheter head is constant, ranging from 0.5 to 0.9, with a preferred area ratio of 0.75. A suitable area ratio can provide openings that are more conducive to blood inflow, thereby increasing the blood flow flux. Since the area ratio remains unchanged, when the number of the windows (202) changes, their unit area will also change accordingly.

[0046] Furthermore, the distal end (30) of the catheter head is the part that connects to the middle section (20) of the catheter head. Its outer surface can be processed in various ways, including but not limited to etching, texturing, or coating with another material or laser engraving. Such processing can make the connection with the catheter more secure; while its inner surface is smooth to facilitate blood circulation. Furthermore, the aforementioned middle section (20) of the catheter head has a first thickness, specifically in the range of 0.02D-0.1D; and the distal end (30) of the catheter head has a second thickness, specifically in the range of 0.015D-0.05D. Such a thickness difference can ensure that when the catheter and the blood flow into the catheter head integral component are connected, the overall outer surface is smooth, reducing the possibility of damage to the interior of the blood vessel.

[0047] Furthermore, materials that can be used for the blood inflow catheter head of the ventricular assist device include but are not limited to: SUS304, SUS316, NITI alloy, implantable grade polymer materials, etc.

[0048] See also Figures 1 to 4 After the guide wire has positioned the ventricular assist device through the guide wire opening (103), the guide wire is withdrawn through the guide wire opening (103), and the ventricular assist device begins to work. Blood flows into the catheter head through the window (202). Since the total area of the window (202) is in a suitable ratio with the total external surface area of the middle section (20) of the catheter head, the blood flux can be guaranteed and the blood passing efficiency can be increased. At the same time, the inner surface (103) of the inner cavity (104) of the proximal end head (10) has a suitable curve, which can reduce the possibility of blood eddying therein, so that the blood stays here as little as possible, and it is not easy to cause thrombus accumulation.

[0049] The present application also provides a ventricular assist device, comprising any one of the catheter access windows described above. Figure 5The figure shows a schematic diagram of the assembly of the catheter access window and the ventricular assist device, including: a first catheter portion (40), a flow direction switching valve (50), a second catheter portion (60), a blood pumping device (70), and a driving device (80). The first catheter portion (40) is in an angled bending state, and the outside may further include a shape memory coil such as an elastic metal part to facilitate the bending of the catheter. It can be formed so that it includes one or more bends or curves in a relaxed state. The elastic metal part is made of, for example, nickel-titanium alloy, platinum, nickel, iridium and tungsten, such as a nickel-titanium wire spring, but this application is not limited thereto. The catheter head portion adopts the blood inflow catheter head of this application, which has a simple and stable structure, is more conducive to increasing the amount of blood drawn by the catheter and reducing risks.

[0050] The foregoing description is merely a preferred embodiment of the present invention, but the scope of protection of the present invention is not limited thereto. Any modifications or substitutions that can be readily conceived by a person skilled in the art within the technical scope disclosed herein are intended to be encompassed within the scope of protection of the present invention. Therefore, the scope of protection of the present invention shall be subject to the scope of protection of the claims.

Claims

1. An interventional artificial heart catheter access window, characterized in that: include: A proximal end cap (10), the proximal end cap (10) comprising a dome-shaped or arc-shaped outer surface (101); a smooth inner surface (102); and a guide wire passage opening (103) having a certain depth and a certain diameter, wherein the depth ranges from 0.5 to 2 mm and the diameter ranges from 0.5 to 1.5 mm; the space enclosed by the inner surface (102) is an inner cavity (104); The catheter head middle section (20) is a hollow cylinder with an outer diameter D ranging from 4 to 8 mm. The catheter head middle section (20) includes a plurality of pillars (201), wherein the pillars enclose a plurality of arc-shaped windows (202), and the number of the windows (202) ranges from 4 to 6. The distal end (30) of the catheter head is mainly the part connected with the catheter.

2. The catheter access window according to claim 1, characterized in that: The radial length of the inner cavity (104) is m, The horizontal distance between the edge point k of the guide wire passage opening (103) and the distal end of the inner cavity (104) proximal thereto is n, and a straight line with the point k as an endpoint is defined as l, and there is an angle α between l and n; the area where the line formed by the longitudinal section of the inner surface (102) falls is set to S, and the range of S is the area enclosed by l, m and n, and the value range of the angle α is between 45° and 70°.

3. The catheter access window according to claim 1, wherein: The radial length of the proximal end tip (10) ranges from 0.4D to 1D.

4. The catheter access window according to any one of claims 1 to 2, characterized in that: The depth of the guide wire passage opening (103) is 1 mm; the diameter of the guide wire passage opening (103) is 1 mm.

5. The catheter access window according to claim 1, wherein: The ratio of the total area of the windows (202) to the surface area of the middle section (20) of the catheter head is constant and ranges from 0.5 to 0.

9. Since the area ratio remains unchanged, when the number of the windows (202) changes, the unit area will also change accordingly.

6. The catheter access window according to claim 1, characterized in that: The catheter head middle section (20) has a first thickness, and the thickness ranges from 0.02D to 0.1D.

7. The catheter access window according to claim 1, characterized in that: The distal end (30) of the catheter head has a second thickness, and the thickness ranges from 0.015D to 0.05D.

8. The catheter access window according to claim 1, wherein: The overall diameter of the catheter entrance window is in the range of 4-8 mm.

9. A ventricular assist device, characterized in that: The device comprises the catheter inlet window according to any one of claims 1 to 8, and further comprises a first catheter portion (40), a flow direction switching valve (50), a second catheter portion (60), a blood pumping device (70) and a driving device (80), wherein the components are integrated to jointly realize a blood pumping function.

10. The ventricular assist device according to claim 9, wherein: The first catheter portion (40) is configured to be in an angularly bent state, and includes a shape memory coil on its exterior to facilitate catheter bending, so that it includes one or more bends or curves in a relaxed state.

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