Sliding bearing and ventricular assist device

Abstract

A sliding bearing and a ventricular assist device, the sliding bearing being configured to be adapted to mount an expandable stent of the ventricular assist device and comprising a bearing body comprising a bearing proximal section, a bearing distal section, and a bearing channel provided in the bearing body; the bearing channel is configured to be suitable for mounting a rotor of the ventricular auxiliary equipment, so that the rotor and the bearing near section form axial sliding and circumferential running fit; the bearing distal section is configured to be adapted to mount a pigtail tube of a ventricular assist device. According to the sliding bearing, integrated installation of the expandable stent, the rotor and the pigtail tube of the ventricular auxiliary equipment is achieved, and the strength and reliability of a connecting structure of the expandable stent, the rotor and the pigtail tube are ensured without affecting axial sliding and circumferential rotation of the rotor on the sliding bearing; and meanwhile, the structural size can be reduced as much as possible due to matching and integrated installation, so that the injury degree of the ventricular auxiliary equipment to a human body in an operation is reduced, and the success probability of the operation is improved.

Description

Technical Field

[0001] This application relates to the field of medical device technology, and more particularly to a sliding bearing and a ventricular assist device. Background Technology

[0002] The main characteristic of heart failure is that the heart cannot function properly, resulting in insufficient blood flow from the veins and insufficient blood supply to the arteries. Left ventricular failure is more common under normal circumstances. Heart failure may occur as a complication or acute symptom. Common situations include: (1) Patients with high-risk coronary artery disease who need to undergo percutaneous coronary intervention (PCI) often have heart failure. During the treatment, myocardial ischemia or arrhythmia may occur, making it difficult to tolerate and posing a risk of malignant hemodynamics. Therefore, cardiac assist devices are needed to restore ventricular function during the treatment, and restoring left ventricular function is particularly urgent; (2) Cardiogenic shock is an acute manifestation of heart failure, with severe heart failure causing acute peripheral circulatory failure. This sudden disease also requires a fast and efficient cardiac assist device to help patients restore ventricular function.

[0003] Compared to other mechanical circulatory support devices, interventional catheter pumps are characterized by minimal invasiveness and ease of implantation, and have good therapeutic effects for high-risk patients, such as those with severe cardiogenic shock. However, due to their small diameter (e.g., 6 mm), in order to provide the mechanical circulatory support flow rate required for clinical use (e.g., 1 L / min at 40–60 mmHg), the foldable impeller of the catheter pump often needs to operate at high speeds (e.g., 10,000–60,000 rpm). Such high speeds cause a rapid change in the local flow field, which will exert extremely strong non-physiological shearing and collision effects on the blood, leading to complications such as hemolysis and even thrombosis, posing a great risk to the patient's life.

[0004] Against this backdrop, the combination of variable diameter foldable impellers and expandable stents effectively resolves the contradiction between interventional size and clinical circulatory support flow requirements. Variable diameter foldable impellers necessarily require variable diameter foldable impeller chambers to confine the fluid. The current common method is to use deformable hyperelastic alloy stents and coat them with a membrane.

[0005] As an interventional device, the structure of a ventricular assist device (such as its structural dimensions, strength, and connection reliability) determines the degree of damage to the human body during the procedure and the probability of surgical success. Utility Model Content

[0006] The purpose of this application is to provide a sliding bearing and a ventricular assist device, which improves the structural strength and connection reliability of the ventricular assist device, and can reduce the structural size as much as possible through the cooperation of various components, thereby reducing the degree of damage to the human body during surgery and increasing the probability of surgical success.

[0007] The technical solution provided in this application is as follows:

[0008] This application provides a sliding bearing for a ventricular assist device, the sliding bearing being configured to accommodate an expandable support for the ventricular assist device, comprising:

[0009] The bearing body includes a bearing proximal section, a bearing distal section, and a bearing channel disposed within the bearing body.

[0010] The bearing channel is configured to accommodate the rotor of the ventricular assist device, allowing the rotor and the proximal section of the bearing to slide axially and rotate circumferentially; the distal section of the bearing is configured to accommodate the pig tail tube of the ventricular assist device.

[0011] In some embodiments, a mounting hole is provided on the proximal end face of the bearing body, and the mounting hole is configured to accommodate an expandable bracket.

[0012] In some implementations, the proximal end face is configured to limit the rotor.

[0013] In some implementations, the contact surface between the distal end of the bearing and the pig tail tube is a threaded surface.

[0014] In some embodiments, the bearing channel extends through the bearing body, and the inner diameter of the bearing channel located in the proximal section of the bearing is not greater than the inner diameter of the bearing channel located in the distal section of the bearing.

[0015] In some embodiments, the bearing channel is configured as a conductive path suitable for guide wire insertion and / or injection fluid infusion.

[0016] In some embodiments, the bearing body is further provided with a bearing side channel, which penetrates the bearing body to form a conductive path suitable for the guide wire to pass through, and is located on the outside of the bearing channel.

[0017] In some embodiments, the sliding bearing further includes a bearing sleeve fitted onto the outside of the bearing body.

[0018] In some embodiments, the proximal end face of the bearing sleeve is provided with a second mounting hole, which is configured to accommodate the expandable bracket.

[0019] In some embodiments, the pig tail tube is clamped between the bearing sleeve and the bearing body.

[0020] In some implementations, the bearing sleeve is a flexible bearing sleeve.

[0021] This application also provides a ventricular assist device, comprising:

[0022] The pump head includes an expandable bracket, a rotor, a pigtail tube, and a sliding bearing as described in any one of the above.

[0023] The expandable bracket is installed on the sliding bearing; the rotor and the near section of the sliding bearing form an axial sliding and circumferential rotational fit; the pig tail tube is installed on the far section of the sliding bearing.

[0024] In some embodiments, the pump head further includes: a flow channel, an inlet, an outlet, a foldable impeller, and an internal motor; wherein, one end of the expandable bracket forms an inlet and is mounted on a sliding bearing, and the other end of the expandable bracket is mounted on the internal motor; the end of the flow channel away from the expandable bracket has an outlet; the internal motor is built into the flow channel and is driven by the rotor; the end of the rotor away from the internal motor is axially sliding and circumferentially rotating with the sliding bearing; the foldable impeller is mounted on the rotor and built into the expandable bracket.

[0025] The technical advantages of this application are as follows:

[0026] 1. In this application, the expandable stent, rotor and pig tail tube of the ventricular assist device are integrated and installed by means of a sliding bearing. This ensures the strength and reliability of the connection structure of the expandable stent, rotor and pig tail tube without affecting the axial sliding and circumferential rotation of the rotor on the sliding bearing. At the same time, the structural size can be reduced as much as possible due to its fit and integrated installation, thereby reducing the degree of damage to the human body during the operation of the ventricular assist device and increasing the success rate of the operation.

[0027] 2. In this application, the sliding bearing can realize the guide wire insertion and perfusion fluid perfusion path through its bearing channel or bearing side channel, which improves the function and product diversity of this application without changing the structure of the ventricular assist device, making it highly practical and meeting different surgical scenarios.

[0028] 3. In this application, the sliding bearing can be set separately or it can be composed of a sleeved bearing body and a flexible bearing sleeve, which enriches its structure and product types. The axial dimension of the sleeved bearing body can be smaller than the axial dimension of the bearing body that constitutes the sliding bearing alone, thereby shortening the axial dimension of this application while ensuring the length requirements of the motor inside the body. The flexible bearing sleeve can further reduce the harm to the human body and provide the possibility for multi-scenario application of the product. Attached Figure Description

[0029] The present application will be further described in detail below with reference to the accompanying drawings and specific embodiments:

[0030] Figure 1 This is a front view of a sliding bearing provided in one embodiment of this application;

[0031] Figure 2 yes Figure 1 The right view;

[0032] Figure 3 yes Figure 1 Cross-sectional view;

[0033] Figure 4 yes Figure 1 The cross-sectional view shown is provided for one embodiment of a sliding bearing used in a ventricular assist device.

[0034] Figure 5 yes Figure 4 A magnified view of a portion of the image;

[0035] Figure 6 This is a cross-sectional view of a sliding bearing provided in another embodiment of this application;

[0036] Figure 7 yes Figure 6 The right view of the sliding bearing shown;

[0037] Figure 8 yes Figure 6 The cross-sectional view shown is provided for one embodiment of a sliding bearing used in a ventricular assist device.

[0038] Figure 9 yes Figure 6 The front view shown is provided for an embodiment of a sliding bearing used in a ventricular assist device.

[0039] Figure 10 This is a cross-sectional view of an embodiment of the sliding bearing provided in this application applied to a ventricular assist device;

[0040] Figure 11 yes Figure 10 The image shows a front view of the bearing body of a sliding bearing.

[0041] Figure 12 yes Figure 11 Cross-sectional view;

[0042] Figure 13 This is a front view of a ventricular assist device provided in one embodiment of this application;

[0043] Figure 14 This is a front view of one embodiment of the pump head of the ventricular assist device of this application;

[0044] Figure 15 yes Figure 14 Cross-sectional view;

[0045] Figure 16 This is a front view of another embodiment of the pump head of the ventricular assist device of this application;

[0046] Figure 17 This is a front view of one embodiment of the junction box side branch of the ventricular assist device of this application.

[0047] Explanation of icon numbers:

[0048] 1000 Pump head; 1100 Pig tail pipe; 1110 Proximal section of pig tail; 1120 Distal section of pig tail; 1121 Distal pipe section one; 1122 Distal pipe section two; 1123 Distal pipe section three; 1124 Distal pipe section four;

[0049] 1200, Sliding bearing; 1210, Bearing channel; 1211, Channel section one; 1212, Channel section two;

[0050] 1213. Channel section three; 1220. Bearing body; 1221. Bearing proximal section; 1222. Proximal section end face one;

[0051] 1223. Assembly hole one; 1224. Bearing distal section; 1225. External thread; 1226. Smooth transition section;

[0052] 1227. Bearing side passage; 1230. Bearing sleeve; 1231. Assembly hole two; 1300. Expandable bracket;

[0053] 1310, Mesh support; 1320, Mesh; 1330, Proximal section of support; 1340, Distal section of support; 1400, Flow channel tube; 1410, Flow channel tube section one; 1420, Flow channel tube section two; 1430, Flow channel tube section three;

[0054] 1431, Flow channel through hole; 1440, Flow channel section four; 1450, Annular support; 1500, Inlet;

[0055] 1600, Outlet; 1700, Foldable impeller; 1800, Rotor; 1810, Large diameter section; 1820, Small diameter section; 1830, Abutting annular surface; 1840, Rotor channel; 1900, Internal motor;

[0056] 2000, sheath;

[0057] 3000, catheter;

[0058] 4000, junction box;

[0059] 5000, hybrid fiber optic cable;

[0060] 6000, Junction box side branch; 6100, Check valve; 6200, Accumulator valve; 6300, Filter; 6400, Luer connector. Detailed Implementation

[0061] In the following description, specific details such as particular system architectures and techniques are set forth for illustrative purposes and not for limitation, in order to provide a thorough understanding of the embodiments of this application. However, those skilled in the art will understand that this application can also be implemented in other embodiments without these specific details. In other instances, detailed descriptions of well-known systems, apparatuses, circuits, and methods have been omitted so as not to obscure the description of this application with unnecessary detail.

[0062] To more clearly illustrate the technical solutions in the embodiments of this application or the prior art, the specific implementation methods of this application will be described below with reference to the accompanying drawings. Obviously, the accompanying drawings described below are only some embodiments of this application. For those skilled in the art, other drawings and other implementation methods can be obtained based on these drawings without creative effort.

[0063] To keep the drawings concise, each figure only schematically shows the parts relevant to the utility model, and these do not represent the actual structure of the product. Furthermore, for ease of understanding, in some figures, only one of the components with the same structure or function is schematically depicted, or only one is labeled. In this document, "one" not only means "only one," but can also mean "more than one."

[0064] It should also be further understood that the term “and / or” as used in this application specification and the appended claims means any combination of one or more of the associated listed items and all possible combinations, and includes such combinations.

[0065] In this document, it should be noted that, unless otherwise explicitly specified and limited, the terms "installation," "connection," and "linking" should be interpreted broadly. For example, they can refer to fixed connections, detachable connections, or integral connections; they can refer to mechanical connections or electrical connections; they can refer to direct connections or indirect connections 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 application based on the specific circumstances.

[0066] In the embodiments shown in the accompanying drawings, the directional indications (such as up, down, left, right, front, and back) used to explain the structure and movement of the various components of this application are relative rather than absolute. These descriptions are appropriate when these components are in the positions shown in the drawings. If the descriptions of the positions of these components change, these directional indications also change accordingly.

[0067] Furthermore, in the description of this application, the terms "first," "second," etc., are used only to distinguish descriptions and should not be construed as indicating or implying relative importance.

[0068] In the embodiments of this application, "near" refers to the side of the associated object closer to the operator; "far" refers to the side of the associated object farther from the operator. "Near" and "far" are the position or orientation of the associated object (e.g., a component of the medical device) relative to the operator (e.g., a doctor) from the perspective of the operator using the device (e.g., a medical device). For example, "near" refers to the side closer to the doctor during normal operation of the medical device, while "far" refers to the side farther from the doctor during normal operation of the medical device, that is, the side that enters the patient's body first.

[0069] According to a specific embodiment provided in this application, see [link to specific embodiment]. Figures 1 to 5 A sliding bearing 1200 for a ventricular assist device is configured to accommodate an expandable support 1300. It includes a bearing body 1220 comprising a proximal bearing section 1221, a distal bearing section 1224, and a bearing channel 1210 disposed within the bearing body 1220. The bearing channel 1210 located in the proximal bearing section 1221 is configured to accommodate a rotor 1800 of the ventricular assist device, such that the rotor 1800 and the proximal bearing section 1221 form an axial sliding and circumferential rotational fit. The distal bearing section 1224 is configured to accommodate a pigtail tube 1100 of the ventricular assist device.

[0070] In practical applications, one end of the rotor 1800, which is used to mount the foldable impeller 1700, is driven by the internal motor 1900 of the ventricular assist device. The other end of the rotor 1800 is axially sliding and circumferentially rotating with the bearing channel 1210 of the sliding bearing 1200. The expandable bracket 1300, which is sleeved on the outside of the foldable impeller 1700, is also mounted on the bearing proximal section 1221 of the sliding bearing 1200. For example, the end face of the sliding bearing 1200 is close to the rotor 1800 or the expandable bracket 1300, so that the rotor 1800 is built into the expandable bracket. The interior of 1300; while the distal section 1224 of the bearing is equipped with the pig tail tube 1100, thus the sliding bearing 1200 achieves the integrated installation of the rotor 1800, the expandable support 1300 and the pig tail tube 1100, ensuring the strength and reliability of the connection structure of the expandable support 1300, the rotor 1800 and the pig tail tube 1100 without affecting the axial sliding and circumferential rotation of the rotor 1800 in the sliding bearing 1200. At the same time, due to its fit and integrated installation, the structural size can be reduced as much as possible, thereby reducing the degree of damage to the human body during the operation of this ventricular assist device and increasing the probability of surgical success.

[0071] Of course, it is worth noting that, in order to ensure the function of this ventricular assist device, it is easy to understand that the rotor 1800 should have a minimum requirement of not disengaging from this sliding bearing 1200 when the expandable support 1300 switches between radial expansion and radial contraction states.

[0072] In some implementations, see Figures 2 to 5 The proximal end face 1222 of the bearing body 1220 is provided with mounting holes 1223, which are configured to accommodate the expandable support 1300. Specifically, the proximal end face 1222 has several mounting holes 1223 to accommodate the distal section 1340 of the expandable support 1300. In practical applications, the expandable support 1300 and the sliding bearing 1200 can be connected by adhesive bonding, melting, tight fitting, or welding. To ensure the smoothness of their axial movement, the mounting holes 1223 are evenly distributed on the proximal end face 1222, ensuring the balance of the push and pull of the expandable support 1300 on the sliding bearing 1200, thereby ensuring the linearity of the relative movement between the rotor 1800 and the sliding bearing 1200 and improving the stability of the operation of this ventricular assist device.

[0073] Specifically, see Figure 2 and Figure 3 The expandable support 1300 includes a mesh support 1310. When the mesh structure 1310 is in a radially expanded state, its mesh openings 1320 are open to form an inlet 1500. Alternatively, in other embodiments, a membrane may be provided on the inner and / or outer sides of the mesh support 1310, in which case the inlet 1500 may be formed by the mesh openings 1320 not covered by the membrane, or the inlet 1500 may be formed by openings in the membrane.

[0074] Preferably, the outer diameter of the bearing proximal section 1221 is larger than the outer diameter of the bearing distal section 1224. To facilitate the installation of the expandable bracket 1300 and the pigtail tube 1100 on the sliding bearing 1200, the pigtail tube 1100 is fitted onto the bearing distal section 1224, while the expandable bracket 1300 is installed on the bearing proximal section 1221. Therefore, the outer diameter of the bearing proximal section 1221 is generally set to be larger than that of the bearing distal section 1224, making the installation of the expandable bracket 1300 easier.

[0075] In some implementations, see Figures 1 to 5The outer contours of the proximal bearing section 1221 and the distal bearing section 1224 are smoothly transitioned. This smooth transition reduces the risk of vascular damage during intervention. More preferably, the end of the proximal bearing section 1221 away from the distal bearing section 1224 is rounded and chamfered, further reducing the risk of vascular damage during intervention. The shaft segment corresponding to the smooth outer contour transition is a smooth transition section 1226, with one end smoothly connected to the proximal bearing section 1221 and the other end smoothly connected to the distal bearing section 1224. Of course, in other embodiments, if the outer diameter of the proximal bearing section 1221 is larger than the outer diameter of the distal bearing section 1224 by a certain value, such that the smooth transition section 1226 and the distal bearing section 1224 will not cause vascular damage even without a smooth transition, then a smooth connection between the smooth transition section 1226 and the distal bearing section 1224 is not required.

[0076] In some implementations, see Figure 4 and Figure 5 The proximal end face 1222 of the bearing body 1220 is configured to limit the rotor 1800. Specifically, the rotor 1800 includes a large-diameter section 1810 and a small-diameter section 1820, wherein the outer diameter of the large-diameter section 1810 is larger than the outer diameter of the small-diameter section 1820, thereby forming an abutting annular surface 1830 at the connection between the large-diameter section 1810 and the small-diameter section 1820, and the abutting annular surface 1830 is axially opposite to the proximal end face 1222. When the expandable stent 1300 is in a radially expanded state, the foldable impeller 1700 extends inside the expandable stent 1300. At this time, the abutting annular surface 1830 and the proximal end face 1222 axially abut against each other, ensuring that the expansion diameter of the expandable stent 1300 is within a reasonable range. This ensures that the mechanical circulation auxiliary flow rate meets the clinical needs of this application, while also ensuring that the rotational speed of the foldable impeller 1700 is moderate. This avoids the extreme non-physiological shearing and collision effects that the rapidly changing flow field would exert on the blood, leading to complications such as hemolysis and even thrombosis, posing a significant risk to the patient's life. When the expandable stent 1300 changes from a radially expanded state to a radially contracted state, the expandable stent 1300 drives the sliding bearing 1200 axially away from the rotor 1800. Therefore, the small-diameter section will slide radially away from the sliding bearing but still slide within the bearing channel 1210 of the bearing proximal section 1221. In practical applications, the length of the small-diameter section 1820 can be 2-4 mm. Of course, this application does not limit this, and the specific requirements shall prevail, but all such provisions shall fall within the scope of protection of this application.

[0077] In some implementations, see Figure 2 and Figure 3The bearing channel 1210 penetrates the bearing body 1220, and the inner diameter of the bearing channel 1210 located in the near section 1221 of the bearing is no larger than the inner diameter of the bearing channel 1210 located in the far section 1224 of the bearing. In this way, the rotor 1800 can extend to the far section 1224 of the bearing, thereby minimizing the length of the rigid tubing and improving the structural compactness and operational stability of this application. Of course, in other embodiments, the bearing channel 1210 may not penetrate the bearing body 1220, and this should also fall within the scope of protection of this application.

[0078] In one specific embodiment, the bearing channel 1210 comprises, from near to far, three channels: channel segment 1211, channel segment 1212, and channel segment 1213. The inner diameter of channel segment 1212 is larger than that of channel segment 121, and channel segment 1213 is a gradually widening channel, with the inner diameter of the side of channel segment 1213 closest to channel segment 1212 being the same as that of channel segment 1212. In other embodiments, the inner diameter of channel segment 1213 is larger than that of channel segment 1212. In other embodiments, the bearing channel 1210 comprises, from near to far, two channels: channel segment 1211 and channel segment 1212, with the inner diameter of channel segment 1212 being larger than that of channel segment 121. In other embodiments, the bearing channel 1210 is a straight channel with a fixed inner diameter.

[0079] In some implementations, see Figures 1 to 4 The contact surface between the distal bearing section 1224 and the pig tail tube 1100 is a friction surface. This friction surface increases the connection strength between the distal bearing section 1224 and the pig tail tube 1100, thereby limiting the pig tail tube 1100's axial movement or torsion relative to the distal bearing section 1224, and consequently preventing the pig tail tube 1100 from detaching from the distal bearing section 1224. Therefore, even if the angle of the instruments inside the body needs to be adjusted during surgery, the pig tail tube 1100 will not easily detach from the distal bearing section 1224, making it highly practical and widely applicable, ensuring surgical safety. In practical applications, the friction surface can be located on the distal bearing section 1224 or the pig tail tube 1100, or simultaneously on both.

[0080] In one specific embodiment, see Figures 1 to 4 The outer surface of the bearing distal section 1224 is provided with an external thread 1225, that is, the contact surface between the bearing distal section 1224 and the pig tail tube 1100 is a threaded surface, which facilitates the screwing of the bearing distal section 1224 into and out of the pig tail tube 1100 to achieve a firm connection. At the same time, the external thread 1225 also improves the sealing performance of the connection between the bearing distal section 1224 and the pig tail tube 1100, thereby improving the reliability and stability of this application. Of course, in other embodiments, the external thread 1225 can also be replaced by a concave-convex surface.

[0081] For example, an adhesive layer is provided between the bearing distal section 1224 and the pig tail tube 1100. Specifically, the connection between the bearing distal section 1224 and the pig tail tube 1100 can be further strengthened by adhesive bonding, thereby further improving the connection strength between the two.

[0082] In some embodiments, the bearing body 1220 is a hardened bearing body. A hardened bearing body ensures the structural strength and rigidity of this application, and ensures operational reliability. In practical applications, the bearing body 1220 can be made of ceramic, stainless steel, nickel-titanium alloy, etc.

[0083] In some embodiments, the bearing body 1220 is fitted tightly to the pig tail tube 1100. This tight fit ensures a secure connection between the bearing distal section 1224 and the pig tail tube 1100.

[0084] In some implementations, see Figure 4 The bearing channel 1210 extends through the bearing body 1220 and is configured as a conduction path suitable for the guidewire and / or perfusion fluid. Specifically, the rotor 1800 is provided with a rotor channel 1840, through which the guidewire or perfusion fluid can pass. Of course, in other embodiments, if the ventricular assist device does not require a conduction path for the guidewire and / or perfusion fluid, the rotor 1800 can be solid. In practical applications, the rotor 1800 can be made of stainless steel, nickel-titanium alloy, etc.

[0085] In some implementations, see Figures 6 to 9 Unlike any of the above embodiments, the bearing body 1220 also has a bearing bypass channel 1227. The bearing bypass channel 1227 penetrates the bearing body 1220 to form a conductive path suitable for guide wire insertion. The bearing bypass channel 1227 is located outside the bearing channel 1210 and is independently arranged. Thus, the guide wire can pass through the expandable bracket 1300, the bearing bypass channel 1227, and the pigtail tube 1100. Specifically, the bearing bypass channel 1227 is located between the bearing channel 1210 and the first mounting hole 1223, and in this case, the rotor 1800 can be solid or hollow. Of course, in other embodiments, the bearing bypass channel 1227 can be concentric with the first mounting hole 1223 and spaced apart. In other embodiments, the bearing channel 1210 does not penetrate the bearing body 1220. More preferably, the bearing channel 1210 is only located in the bearing proximal section 1221. Of course, in other embodiments, the bearing channel 1210 extends through the bearing proximal section 1221 and extends toward the bearing distal section 1224 but does not extend through the bearing distal section 1224.

[0086] As can be seen, the sliding bearing 1200 can realize the guide wire insertion path through its bearing channel 1210 or bearing side channel 1227, which improves the function and product diversity of this application without changing the structure of the ventricular assist device, making it highly practical and meeting different surgical scenarios.

[0087] In one specific embodiment, see Figures 10 to 12 The sliding bearing 1200 further includes a bearing sleeve 1230, which is sleeved on the outside of the bearing body 1220. In this embodiment, the structural performance of the ventricular assist device is further improved by the bearing sleeve 1230 sleeved on the outside of the bearing body 1220, thereby improving its connection strength and firmness. More preferably, due to the presence of the bearing sleeve 1230, the axial dimension of the bearing body 1220 in this embodiment can be smaller than the axial dimension of the bearing body 1220 in any of the above embodiments. This allows for the shortening of the axial dimensions of rigid connections, particularly the flow channel tube, rotor 1800, expandable support 1300, bearing body 1220, and pig tail tube 1100, while ensuring that the length of the internal motor 1900 (the longer the internal motor 1900, the better its performance) meets product requirements.

[0088] In some implementations, see Figures 10 to 12 The bearing sleeve 1230 has a second mounting hole 1231 on its proximal end face, which is configured to accommodate the expandable bracket 1300. In this embodiment, the expandable bracket 1300 is inserted into the proximal end face of the bearing sleeve 1230 near the expandable bracket 1300. Since the expandable bracket 1300 is inserted into the bearing sleeve, its installation in the bearing sleeve 1230 is independent and extended as much as possible. This also makes the bearing proximal section 1221 used for installing the expandable bracket 1300 in any of the above embodiments as short as possible or even non-existent. As a result, the axial dimension of the bearing body 1220 only needs to meet the installation and sliding distance of the rotor 1800, especially when the bearing body 1220 is sleeved inside the pig tail tube 1100.

[0089] It is worth noting that, in order to reduce the radial dimension of the sliding bearing 1200, this embodiment is preferably only applicable to the case where the bearing channel 1210 and the rotor channel 1840 of the rotor 1800 jointly form a conductive path suitable for guide wire insertion and / or injection fluid injection, and not applicable to the case where a conductive path suitable for guide wire insertion and / or injection fluid injection is achieved through the bearing bypass channel 1227.

[0090] In some implementations, see Figures 10 to 12The pig tail tube 1100 is sandwiched between the bearing sleeve 1230 and the bearing body 1220. In this embodiment, the bearing sleeve 1230 is fitted onto the outside of the bearing body 1220 and the pig tail tube 1100. Specifically, the outer diameter of the bearing proximal section 1221 is larger than the outer diameter of the bearing distal section 1224. The bearing channel 1210 is a straight channel. The proximal end face 1222 of the bearing body 1220 is flush with the proximal end face 2 of the bearing sleeve 1230. The proximal end face of the pig tail tube 1100 abuts against the end face of the bearing proximal section 1221 near the bearing distal section 1224, and the outer diameter of the pig tail tube 1100 is the same as the outer diameter of the bearing proximal section 1221. The bearing sleeve 1230 is fitted onto the outside of the bearing proximal section 1221 and the pig tail tube 1100, thereby ensuring the firmness and strength of the connection between the pig tail tube 1100 and the sliding bearing 1200.

[0091] In some embodiments, an adhesive layer is provided between the bearing sleeve 1230 and the pig tail tube 1100. More preferably, an adhesive layer is provided between the bearing sleeve 1230 and the bearing body 1220. The adhesive layer further improves the connection strength and security between the three components. The adhesive layer can be an adhesive layer, a welding layer, or a fusion layer, etc.

[0092] In some embodiments, the bearing sleeve 1230 is tightly fitted to the pig tail tube 1100. More preferably, the bearing sleeve 1230 is tightly fitted to the bearing body 1220. This tight-fitting installation ensures a secure and strong connection between the three components.

[0093] In some embodiments, the bearing sleeve 1230 is a flexible bearing sleeve. A smaller bearing sleeve causes less damage to blood vessels. To ensure connection strength, the bearing body 1220 is a rigid bearing body. In practical applications, the flexible bearing sleeve can be made of materials with low hardness, such as silicone or rubber bearing sleeves. Because the bearing sleeve 1230 is a flexible bearing sleeve, the expandable stent 1300 can be heat-fused together. Alternatively, a second mounting hole 1231 can be provided in the flexible bearing sleeve to accommodate the distal segment 1340 of the expandable stent 1300, and then heat-fused or glued to achieve the connection between the two. Because the flexible bearing sleeve allows the distal segment 1340 of the stent to extend as far as possible within it, the connection strength between the two is ensured, and the structural strength of the flexible bearing sleeve is also improved.

[0094] It is worth noting that the hollow rotor 1800 can pass through the in-body motor 1900 and connect to the conduit 3000. Of course, in other embodiments, the drive shaft of the in-body motor 1900 can be a hollow drive shaft, with its two ends connected to the conduit 3000 and the rotor 1800, respectively.

[0095] According to a specific embodiment provided in this application, see [link to specific embodiment]. Figures 1 to 17A ventricular assist device, as shown in the figure, includes: a pump head 1000, which includes an expandable support 1300, a rotor 1800, a pig tail tube 1100, and a sliding bearing 1200 as described in any one of the above; wherein, the expandable support 1300 is mounted on the sliding bearing 1200; the rotor 1800 and the proximal bearing section 1221 of the sliding bearing 1200 form an axial sliding and circumferential rotational fit; the pig tail tube 1100 is mounted on the distal bearing section 1224 of the sliding bearing 1200.

[0096] In some implementations, see Figure 15 The pig tail tube 1100 includes a proximal pig tail segment 1110 and a distal pig tail segment 1120 that are connected in communication. The pig tail tube 1100 is connected to a sliding bearing 1200. One end of the proximal pig tail segment 1110, away from the distal pig tail segment 1120, is mounted on the distal bearing segment 1224. The end of the distal pig tail segment 1120, away from the proximal pig tail segment 1110, is configured to conform to the contour of the ventricular wall. In this embodiment, the distal pig tail segment 1120 is adapted to the contour of the ventricular wall, thereby reducing its potential damage to the ventricle. Specifically, the distal pig tail segment 1120 is bent towards the proximal pig tail segment 1110.

[0097] In some implementations, see Figure 15 The pig tail tube 1100 includes a proximal pig tail segment 1110 and a distal pig tail segment 1120 that are connected in communication. The proximal pig tail segment 1110 is a rigid proximal pig tail segment, while the distal pig tail segment 1120 is a flexible distal pig tail segment. The flexible distal pig tail segment effectively avoids damage to blood vessels or the ventricle, while the rigid proximal pig tail segment ensures the connection strength and firmness between the pig tail tube 1100 and the sliding bearing. In practical applications, the rigid proximal pig tail segment is made of materials with higher hardness, such as TPU, while the flexible distal pig tail segment is made of materials with lower hardness, such as rubber or silicone. That is, in practical applications, the hardness of the material used in the proximal pig tail segment 1110 is preferably higher than that of the material used in the distal pig tail segment 1120. For example, if both the proximal pig tail segment 1110 and the distal pig tail segment 1120 are made of TPU, but the TPU used in the proximal pig tail segment 1110 has a higher hardness than that used in the distal pig tail segment 1120.

[0098] In some implementations, see Figure 15 The proximal segment 1110 of the pig's tail is a line segment, and the distal segment 1120 is an arc segment. In practical applications, the proximal segment 1110 can be a straight line segment or a sloping line segment with a certain gradient. The distal segment 1120 can be composed of one or more arc segments with different radii, specifically adapted to the intraventricular contour.

[0099] In some implementations, see Figure 16The proximal segment 1110 of the pig tail is a line segment, and the distal segment 1120 of the pig tail includes distal pipe segment one 1121, distal pipe segment two 1122, distal pipe segment three 1123, and distal pipe segment four 1124 connected in sequence; wherein, distal pipe segment one 1121 is a corner segment, distal pipe segment two 1122 is a line segment, distal pipe segment three 1123 is an arc segment, and distal pipe segment four 1124 is an arc segment. In this embodiment, the proximal segment 1110 of the pig tail is a line segment and the distal segment 1120 of the pig tail is located on the same plane, and the distal end of distal pipe segment four 1124 is set close to distal pipe segment two 1122.

[0100] In some implementations, see Figure 14 and Figure 15 The pump head 1000 also includes: a flow channel pipe 1400, an inlet 1500, an outlet 1600, a foldable impeller 1700, and an internal motor 1900; wherein, one end of the expandable bracket 1300 forms the inlet 1500 and is mounted on the sliding bearing 1200, and the other end of the expandable bracket 1300 is mounted on the internal motor 1900; the end of the flow channel pipe 1400 away from the expandable bracket 1300 is provided with an outlet 1600; the internal motor 1900 is built into the flow channel pipe 1400 and is drivenly connected to the rotor 1800; the end of the rotor 1800 away from the internal motor 1900 is axially sliding and circumferentially rotating with the sliding bearing 1200; the foldable impeller 1700 is mounted on the rotor 1800 and built into the expandable bracket 1300. In practical applications, driven by the in-body motor 1900, the expandable support 1300 rotates in a radially expanded state while the foldable impeller 1700 rotates in a stretched state, so that the blood entering from the inlet 1500 is pressurized and flows out from the outlet 1600.

[0101] Specifically, the inlet 1500 is formed by the distal section 1340 of the expandable support 1300, and the outlet 1600 is formed by the flow channel through-hole 1431 provided in the flow channel pipe 1400. Furthermore, multiple flow channel through-holes 1431 are circumferentially distributed in the flow channel pipe 1400. The number of them is preferably 3-6. Furthermore, the flow channel 1400 includes, from near to far, flow channel segment one 1410, flow channel segment two 1420, flow channel segment three 1430, and flow channel segment four 1440. The distal end of the conduit 3000 is built into and passes through the interior of the flow channel 1400, communicating with the internal motor 1900 to achieve communication with the rotor channel 1840 of the rotor 1800. The conduit 3000 is installed inside the flow channel 1400 through an annular support 1450 sleeved on it. At the same time, flow channel segment one 1410 is sealed to the conduit 3000. Flow channel segment four 1440 is fluidly connected to the proximal section 1330 of the expandable support 1300. Specifically, flow channel segment four 1440 and the proximal section 1330 are connected by adhesive or film. In practical applications, the flow channel is preferably a flow channel film, preferably made of TPU, EPTFE, or other similar polymer materials. Furthermore, the expandable support 1300 is made of a superelastic material, such as a shape memory material like nickel-titanium alloy, possessing strong elastic deformation capabilities. This allows the expandable support 1300 to expand or contract radially, enabling its use in conjunction with the foldable impeller 1700. The foldable impeller 1700 follows the radial expansion or contraction of the expandable support 1300. In practical applications, the expandable support 1300 is specifically installed in the housing of the internal motor 1900, or on other non-rotating components of the motor 1900 besides the rotor 1800 or components that rotate with the rotor 1800.

[0102] In some implementations, see Figure 13 The ventricular assist device also includes: a sheath 2000, a catheter 3000, a junction box 4000, a hybrid optical-electric cable 5000, and a junction box side branch 6000; wherein, one end of the catheter 3000 is connected to the pump head 1000, and the other end of the catheter 3000 is connected to the junction box 4000; the hybrid optical-electric cable 5000 and the junction box side branch 6000 are respectively installed in the junction box 4000; the sheath 2000 is slidably installed on the catheter 3000 to selectively expose or contain the pump head 1000. In this embodiment, the catheter 3000 contains an internal motor 1900 three-phase wire, optical fiber, guidewire, and irrigation tubing; the junction box 4000 integrates the guidewire, irrigation tubing, catheter, optical fiber connector, and hybrid cable, serving as a connection component between the external control device and internal consumables; the hybrid cable 5000 integrates the internal motor 1900 three-phase wire and optical fiber, and the plug at the proximal end (operator's end) of the hybrid cable 5000 is matched with the external intelligent control device.

[0103] In some implementations, see Figure 17The junction box side branch 6000 includes: a one-way valve 6100, a pressure accumulator valve 6200, a filter 6300 and a Luer connector 6400 connected in sequence; wherein, the Luer connector 6400 and the filter 6300 are detachably connected.

[0104] In some implementations, see Figure 4 The junction box side branch 6000, conduit 3000, flow channel 1400, internal motor 1900, rotor channel 1840 of rotor 1800, bearing channel 1210 of sliding bearing 1200, and pigtail tube 1100 together form a conductive path suitable for guidewire insertion and / or perfusion fluid injection. This embodiment is applicable to situations where the conductive path for guidewire insertion and / or perfusion fluid injection includes bearing channel 1210. In practical applications, during the guidewire insertion stage, the one-way valve 6100, accumulator valve 6200, and filter 6300 are removed from the Luer connector 6400, and the guidewire is inserted through the Luer connector 6400. After intervention, the guidewire is removed from the Luer connector 6400, and then the one-way valve 6100, accumulator valve 6200, and filter 6300 are installed back into the Luer connector 6400, and perfusion is started.

[0105] In some implementations, see Figure 8 and 9 The outlet 1600, flow channel 1400, expandable support 1300, bearing bypass channel 1227 of sliding bearing 1200, and pig tail tube 1100 together form a conductive path suitable for guidewire insertion. This embodiment is applicable to situations where the guidewire insertion conductive path includes bearing bypass channel 1227. In practical applications, during the guidewire insertion stage, the guidewire enters from the distal end of pig tail tube 1100, passes through bearing bypass channel 1227, and enters expandable support 1300 (the space between expandable support 1300 and foldable impeller 1700). After exiting expandable support 1300, the guidewire enters the interior of flow channel 1400 and finally exits from flow channel through hole 1400 (outlet 1600) of flow channel 1400. This embodiment ensures that intervention is performed entirely within the body under the guidance of the guidewire, and the guidewire does not need to exit from the infusion line, thus not affecting the infusion effect.

[0106] In the above embodiments, the descriptions of each embodiment have different focuses. For parts that are not described in detail or recorded in a certain embodiment, please refer to the relevant descriptions of other embodiments.

[0107] It should be noted that the above embodiments can be freely combined as needed. The above are merely preferred embodiments of this application. It should be pointed out that for those skilled in the art, several improvements and modifications can be made without departing from the principles of this application, and these improvements and modifications should also be considered within the scope of protection of this application.

Claims

1. A plain bearing of a ventricular assist device, characterized in that The sliding bearing is configured to be suitable for mounting the inflatable support of the ventricular assist device, comprising: a bearing body, the bearing body comprising a bearing proximal segment, a bearing distal segment, and a bearing channel provided in the bearing body; wherein the bearing channel is configured to be suitable for mounting the rotor of the ventricular assist device, so that the rotor forms an axial sliding and circumferential rotating fit with the bearing proximal segment; and the bearing distal segment is configured to be suitable for mounting the pigtail of the ventricular assist device.

2. The sliding bearing according to claim 1, wherein: a proximal end face of the bearing body is provided with an assembly hole, the assembly hole is configured to be suitable for inserting the inflatable support.

3. The sliding bearing according to claim 2, wherein: the proximal end face is configured to be suitable for limiting the rotor.

4. The sliding bearing according to claim 2, wherein: a contact surface of the bearing distal segment and the pigtail is a threaded surface.

5. The sliding bearing according to claim 2, wherein: the bearing channel penetrates through the bearing body, and an inner diameter size of the bearing channel at the bearing proximal segment is not greater than an inner diameter size of the bearing channel at the bearing distal segment.

6. The sliding bearing according to any one of claims 1-5, wherein: the bearing channel is configured to be suitable for a guide path for inserting a guide wire and / or perfusion of perfusion liquid; or the bearing body is further provided with a bearing side channel, the bearing side channel penetrates through the bearing body to form a guide path suitable for inserting a guide wire, and is provided outside the bearing channel.

7. The plain bearing according to any one of claims 1 to 5, characterized in that Further comprising: a bearing sleeve, the bearing sleeve is sleeved outside the bearing body.

8. The sliding bearing according to claim 7, wherein: a proximal end face of the bearing sleeve is provided with an assembly hole, the assembly hole is configured to be suitable for inserting the inflatable support.

9. The sliding bearing according to claim 7, wherein: the pigtail is clamped between the bearing sleeve and the bearing body.

10. The sliding bearing according to claim 7, wherein: the bearing sleeve is a flexible bearing sleeve.

11. A ventricular assist device, characterized by Comprising: a pump head, comprising an inflatable support, a rotor, a pigtail, and the sliding bearing according to any one of claims 1-10; wherein the inflatable support is mounted on the sliding bearing; the rotor forms an axial sliding and circumferential rotating fit with the bearing proximal segment of the sliding bearing; and the pigtail is mounted on the bearing distal segment of the sliding bearing.

12. The ventricular assist device according to claim 11, wherein: the pump head further comprises a flow channel tube, an inlet, an outlet, a foldable impeller, and an in-vivo motor; wherein one end of the inflatable support forms the inlet and is mounted on the sliding bearing, the other end of the inflatable support is mounted on the in-vivo motor; the flow channel tube is provided with the outlet at an end away from the inflatable support; the in-vivo motor is built in the flow channel tube and is drivingly connected with the rotor; an end of the rotor away from the in-vivo motor forms an axial sliding and circumferential rotating fit with the sliding bearing; and the foldable impeller is mounted on the rotor and is built in the inflatable support.

Images