Blood pump system

Abstract

The invention relates to a guide wire tube, a blood pump system and a manufacturing method thereof. The blood pump system comprises a blood pump and a guide wire tube; the blood pump comprises a sleeve assembly and a far-end component. The sleeve assembly is provided with a connecting end, a first opening and a second opening; wherein the connecting end is connected with the far-end component; the first opening is adjacent to the connecting end; the second opening is far away from the connecting end; the guide wire tube is configured to be separably arranged in the blood pump in a penetrating manner; the guide wire tube is provided with a first end and a second end, the first end can penetrate through the sleeve assembly and extend outwards from the second opening of the sleeve assembly, and the second end can be contained and positioned in the far-end component or the connecting end.

Description

Technical Field

[0001] This application relates to the field of medical device technology, and in particular to a blood pump system. Background Technology

[0002] A blood pump, also known as an intravascular blood pump, is designed to be inserted percutaneously into a patient's blood vessel and protrude into the heart to function as a left ventricular assist device or right ventricular assist device. In related techniques, the blood pump is inserted into the patient by threading it onto a guidewire, and then pushing the pump into the patient's body along the guidewire. However, during the insertion of the blood pump and guidewire, the guidewire is easily rubbed or impacted by the internal components of the blood pump. The substances generated by this friction or impact may contaminate or damage the blood, affecting the patient's health. Summary of the Invention

[0003] This application provides a guidewire, a blood pump system, and a method for manufacturing the same, which aims to reduce the occurrence of blood damage during the blood pump's intervention in the patient's body and improve product safety.

[0004] In one embodiment, the blood pump system includes: A blood pump, comprising a cannula assembly and a distal component; the cannula assembly having a connecting end, a first opening, and a second opening; wherein the connecting end is connected to the distal component; the first opening is adjacent to the connecting end; the second opening is distal to the connecting end; and A guidewire is configured to be detachably inserted into the blood pump for guidewire insertion; the guidewire has a first end and a second end; wherein the first end is capable of passing through the cannula assembly and extending outward from the second opening, and the second end is capable of being received and positioned inside the distal component or the connecting end.

[0005] In one embodiment, the second end of the guide wire is provided with a positioning part; the interior of the distal component or the connecting end is provided with a mating part that cooperates with the positioning part for positioning; at least one of the positioning part and the mating part can elastically deform and separate from the other.

[0006] In one embodiment, the connecting end includes a guide portion and a connecting tube; wherein the guide portion is adjacent to the first opening and has an inner cavity; the connecting tube is disposed at the distal end of the guide portion and communicates with the inner cavity of the guide portion, and the connecting tube is connected to the distal component; the mating portion is disposed inside the guide portion or inside the connecting tube.

[0007] In one embodiment, the distal component is sleeved on the outer peripheral surface of the connecting tube and bonded to the connecting tube, and the connecting tube has a first end face extending into the interior of the distal component; the second end of the guide wire has a second end face, and a diaphragm gap is formed between the second end face and the first end face.

[0008] In one embodiment, the distal component includes a distal end, a proximal end, and a tube located between the distal end and the proximal end; wherein the proximal end is connected to the connecting end; and the mating portion is disposed on the inner wall of one of the distal end, the proximal end, and the tube.

[0009] In one embodiment, the positioning part and the mating part are positioned by interference fit; or, the positioning part and the mating part are positioned by snap-fit ​​fit.

[0010] In one embodiment, the positioning part is configured as a trumpet shape, and the outer diameter of the positioning part gradually decreases in the direction from the distal component to the sleeve assembly; the mating part is at least a portion of the inner circumferential surface of the distal component or the connecting end, so as to have an interference fit with the outer circumferential surface of the positioning part.

[0011] In one embodiment, the diameter of the mating portion remains constant in the direction from the distal component to the sleeve assembly; or, the diameter of the mating portion gradually decreases in the direction from the distal component to the sleeve assembly to conform to the shape of the positioning portion.

[0012] In one embodiment, the positioning part is configured as a positioning flange that protrudes radially from the outer periphery of the second end of the guide wire tube; the mating part is a stop surface that is disposed in the distal component or the connecting end and extends radially, so as to be able to abut against the side of the positioning flange for locking and positioning.

[0013] In one embodiment, the positioning flange extends around the outer periphery of the second end in a ring shape; or, the positioning flange includes at least two positioning petals arranged at intervals along the outer periphery of the second end, with a gap formed between adjacent positioning petals for deformation of the positioning flange.

[0014] In one embodiment, the stop surface is disposed on the inner peripheral surface of the distal component or the connecting end, and extends circumferentially around the inner peripheral surface; or, the connecting end has a first end face extending into the distal component, the first end face forming the stop surface.

[0015] In one embodiment, the cannula assembly includes an inlet tube, a cannula, and an outlet tube connected in sequence; wherein, the inlet tube has a first opening; the outlet tube has a second opening; the connecting end is located at the distal end of the inlet tube; the guide wire is a different color from the wall color of the cannula, and the color of the guide wire can be seen outward through the wall of the cannula; Alternatively, the second end of the guidewire is housed inside the distal component; at least the color of the second end of the guidewire is different from the color of the distal component, and at least the color of the second end can be seen outward through the wall of the distal component.

[0016] In one embodiment, the guidewire has a first length; the connecting end has a first end face away from the first opening, and the connecting end has a second length extending from its first end face to the second opening; the distal component has a third length; wherein the first length is greater than the second length and less than the sum of the second length and the third length.

[0017] In one embodiment, the blood pump further includes an impeller disposed within the cannula assembly and rotatable relative to the cannula assembly, the impeller being adjacent to the second opening.

[0018] This application also provides a guidewire cannula suitable for detachable insertion into a blood pump for guidewire insertion. The blood pump includes a cannula assembly and a distal component. The cannula assembly has a connecting end, a first opening, and a second opening. The connecting end is connected to the distal component. The first opening is adjacent to the connecting end, and the second opening is away from the connecting end. The guidewire cannula has a first end and a second end. The first end of the guidewire cannula is configured to pass through the cannula assembly of the blood pump and extend outward from the second opening of the cannula assembly. The second end is configured to be movable into and positioned inside the distal component or the connecting end of the blood pump.

[0019] In one embodiment, the second end of the guidewire is provided with a positioning part, which is used to be positioned by correspondingly engaging with the mating part of the blood pump; the positioning part is capable of elastic deformation and separating from the mating part.

[0020] In one embodiment, the positioning part is configured as a trumpet shape, and the outer diameter of the positioning part gradually decreases in the direction from the distal component to the connecting end; or, the positioning part is configured as a positioning flange that protrudes radially from the outer periphery of the second end of the guide wire tube.

[0021] In one embodiment, the positioning flange extends around the outer periphery of the second end in a ring shape; or, the positioning flange includes at least two positioning petals arranged at intervals along the outer periphery of the second end, with a gap formed between adjacent positioning petals for deformation of the positioning flange.

[0022] This application also provides a method for manufacturing a blood pump system, comprising the following steps: A blood pump is provided, the blood pump including a cannula assembly and a distal component; the distal component and the cannula assembly are in a non-connected state; the cannula assembly has a connecting end, a first opening adjacent to the connecting end and a second opening away from the connecting end; A guide wire is provided, the guide wire having a first end and a second end, the first end of the guide wire being inserted into the sleeve assembly from the connecting end and extending outward from a second opening of the sleeve assembly, the second end of the guide wire being received and positioned inside the connecting end; The distal component is connected and fixed to the connecting end of the sleeve assembly.

[0023] In one embodiment, the connecting end has a first end face that extends into the interior of the distal component; the second end of the guide wire has a second end face, and a diaphragm gap is formed between the second end face and the first end face; The manufacturing method specifically includes the following steps in the step of connecting and fixing the distal component to the connecting end of the sleeve assembly: Adhesive is provided on the outer peripheral surface of the connecting tube at the connecting end or on the inner peripheral surface of the proximal end of the distal component; The proximal end of the distal component is fitted onto the outer circumferential surface of the connecting tube so that the distal component and the connecting tube are bonded together.

[0024] In one embodiment, the second end of the guide wire is provided with a positioning part; the interior of the distal component or the connecting end is provided with a mating part that cooperates with the positioning part for positioning; at least one of the positioning part and the mating part can elastically deform and separate from the other. The positioning part is configured in the shape of a trumpet, and the outer diameter of the positioning part gradually decreases in the direction from the distal component to the sleeve assembly; the mating part is the inner circumferential surface of the connecting end and is interference-fitted with the positioning part. Alternatively, the positioning part is configured as a positioning flange that protrudes radially from the outer periphery of the second end of the guide wire tube, and the mating part is a stop surface that is disposed inside the connecting end and extends radially, the stop surface being able to fit against the side of the positioning flange for locking and positioning.

[0025] In one embodiment, the guidewire has a first length; the connecting end has a first end face away from the first opening, and the connecting end has a second length extending from its first end face to the second opening; the distal component has a third length; wherein the first length is greater than the second length and less than the sum of the second length and the third length.

[0026] The aforementioned guidewire cannula, blood pump system, and manufacturing method involve inserting the blood pump into the guidewire. The guidewire enters from the first end of the guidewire cannula and exits through the second end. The guidewire cannula is then pulled outwards from the second opening of the blood pump. The blood pump is then moved along the guidewire to the target position, completing the interventional procedure. Thus, during the insertion of the blood pump into the guidewire, because the guidewire passes through the lumen of the guidewire cannula, and the cannula encloses the guidewire, it reduces the likelihood of the guidewire rubbing against the internal components of the blood pump (such as the impeller). This reduces the risk of the coating on the outer surface of the guidewire being scraped off, thereby lowering the risk of blood contamination due to the coating being scraped into the blood and effectively improving product performance.

[0027] Because the second end of the guidewire in this application is housed and positioned inside the distal component or connector (i.e., the second end of the guidewire does not extend outward from the distal end of the distal component), this design makes the guidewire more stable. During the insertion of the guidewire, the guidewire is less likely to be moved along the length of the blood pump by the guidewire, greatly facilitating the operator's guidewire insertion. Furthermore, since the distal component is typically pigtail-shaped, during the insertion of the guidewire onto the blood pump, the physician needs to use one hand to straighten or unfold the distal component. If the second end of the guidewire extends outward from the distal end of the distal component, the physician also needs to use the other hand to hold the second end of the guidewire, requiring another physician to perform the subsequent guidewire insertion. In this application, since the second end of the guidewire is moved into and positioned inside the distal component or connecting end, this design allows the physician to simply use one hand to straighten or unfold the distal component during the process of inserting the guidewire into the blood pump, eliminating the need to hold and fix the guidewire, thus reducing the difficulty of operation. The physician's other hand can then be used to perform the subsequent insertion of the guidewire, allowing one physician to complete the insertion of the guidewire and blood pump independently, thereby improving assembly efficiency. Attached Figure Description

[0028] Figure 1 This is a structural diagram showing the guidewire prepared for insertion into a blood pump according to an embodiment of this application.

[0029] Figure 2 This is a structural diagram of a guidewire tube inserted into a blood pump according to an embodiment of this application.

[0030] Figure 3 for Figure 2 Enlarged structural diagram at point A.

[0031] Figure 4 for Figure 2 Enlarged structural diagram at point B.

[0032] Figure 5 for Figure 2 An axial sectional view of the structure shown.

[0033] Figure 6 for Figure 2 A schematic diagram of the blood pump system after the guidewire has been inserted.

[0034] Figure 7 for Figure 6 An enlarged structural diagram of an embodiment at point C.

[0035] Figure 8 This is a structural diagram of one embodiment of the guide wire tube of this application.

[0036] Figure 9 for Figure 8 Enlarged structural diagram at point D.

[0037] Figure 10 for Figure 8 A schematic diagram of one of the interference fit methods between the second end of the guide wire tube and the distal component.

[0038] Figure 11 for Figure 8 A schematic diagram of one of the interference fit methods between the second end of the guide wire tube and the connecting end.

[0039] Figure 12 for Figure 8 A schematic diagram of the second interference fit between the second end of the guide wire tube and the distal component.

[0040] Figure 13 for Figure 8 A schematic diagram of the second interference fit between the second end of the guide wire tube and the connecting end.

[0041] Figure 14 This is a structural diagram of another embodiment of the guide wire tube of this application.

[0042] Figure 15 for Figure 14 A schematic diagram showing the engagement between the second end of the guide wire tube and the distal component.

[0043] Figure 16 for Figure 15 A schematic diagram showing the second end of the guide wire tube being pulled out from the distal component.

[0044] Figure 17 for Figure 14 A schematic diagram showing the engagement between the second end of the guide wire tube and the connecting end.

[0045] Figure 18 for Figure 17 A schematic diagram showing the second end of the guide wire tube being pulled out from the connection end.

[0046] Figure 19 for Figure 14 A structural diagram of the guide wire tube from an external perspective.

[0047] Figure 20 This is a structural diagram of another embodiment of the guide wire tube of this application.

[0048] Figure 21 This is a schematic diagram of the guide wire tube being prepared for insertion into the connection end of the blood pump in the manufacturing method of the blood pump system of this application.

[0049] Figure 22 for Figure 21 A schematic diagram showing the guide wire inserted through the blood pump connection and passing through the cannula assembly.

[0050] Figure 23 for Figure 22 A schematic diagram showing the connection between the blood pump's connecting end and the distal component after the guidewire has been inserted.

[0051] 10. Blood pump; 100. Cannula assembly; 101. First opening; 102. Second opening; 110. Cannula; 120. Inlet tube; 130. Outlet tube; 140. Connecting end; 141. Guide section; 142. Connecting tube; 143. First end face; 200. Distal component; 210. Distal end; 220. Proximal end; 230. Tube body; 201. Threading port; 300. Drive device; 400. Impeller; 500. Guide wire tube; 510. First end; 520. Second end; 521. Second end face; 530. Positioning part; 501. Lumen; 600. Fitting part; 601. Inner circumferential surface; 602. Stop surface. Detailed Implementation

[0052] To make the above-mentioned objectives, features, and advantages of this application more apparent and understandable, the specific embodiments of this application are described in detail below with reference to the accompanying drawings. Many specific details are set forth in the following description to provide a thorough understanding of this application. However, this application can be implemented in many other ways different from those described herein, and those skilled in the art can make similar modifications without departing from the spirit of this application. Therefore, this application is not limited to the specific embodiments disclosed below.

[0053] In related technologies, when inserting a blood pump into a patient's body, an incision is first made in the patient's body. A guidewire is then inserted through the incision, passing through a blood vessel to reach the heart. The guidewire has an internal portion inside the patient's body and an external portion outside. The external portion of the guidewire is then inserted into the distal component of the blood pump, passes through the pump's cannula assembly, and finally exits from the proximal end of the cannula assembly, allowing the blood pump to be positioned onto the guidewire. This allows the blood pump to be pushed along the guidewire to the target location within the patient's body. Once the blood pump reaches the target location, the guidewire is withdrawn. However, the cannula assembly of the blood pump typically contains internal components, such as an impeller located in the proximal end of the cannula assembly. During the insertion of the blood pump and guidewire, the guidewire is easily rubbed or impacted by the internal components of the blood pump (such as the impeller). The protective coating on the outer surface of the guidewire can easily be detached due to friction or impact, and the detached material can easily enter the bloodstream, leading to blood contamination.

[0054] Please see Figures 1 to 4 Based on the above, this application provides a guidewire 500 and a blood pump system including the guidewire 500, which can reduce the occurrence of blood damage during blood pump intervention in the patient's body and improve product safety. In the description of this application, it should be noted that "proximal" refers to the end of the instrument or component closer to the operator, and "distal" refers to the end of the instrument or component farther from the operator; "axial" refers to the direction parallel to the line connecting the center of the distal and proximal ends of the instrument or component, "radial" refers to the direction perpendicular to the axial direction, and "circumferential" refers to the direction surrounding the axial direction.

[0055] Please see Figures 1 to 4 In some embodiments of this application, the blood pump system includes a guidewire 500 and a blood pump 10; wherein, the blood pump 10 includes a cannula assembly 100 and a distal component 200; the cannula assembly 100 has a connecting end 140 connected to the distal component 200, a first opening 101 adjacent to the connecting end 140, and a second opening 102 away from the connecting end 140; the guidewire 500 is configured to be detachably inserted into the blood pump 10 for the guidewire 700 to pass through; the guidewire 500 has a first end 510 and a second end 520, the second end 520 being away from the first end 510. The first end 510 of the guidewire 500 can pass through the cannula assembly 100 and extend outward from the second opening 102 of the cannula assembly 100, while the second end 520 of the guidewire 500 is received and positioned inside the distal component 200 or the connecting end 140 (e.g., Figure 5 (As shown).

[0056] Specifically, the distal component 200, connecting end 140, and cannula assembly 100 of the blood pump 10 are hollow structures to form a guidewire channel extending along the length of the blood pump 10. The distal component 200 is used to stabilize the position of the blood pump 10 in the heart and provide non-invasive support to the cardiac tissue. The distal component 200 can be configured in a pigtail shape, commonly referred to as a pigtail cannula. Of course, in other embodiments, the distal component 200 can also be configured in other shapes. The distal end of the distal component 200 is provided with a suture port 201, which communicates with the guidewire channel within the distal component 200.

[0057] The guidewire 500 is also a hollow tubular structure, with a cavity 501 formed inside, through which the guidewire 700 passes. When the guidewire 500 is inserted into the blood pump 10, the first end 510 of the guidewire 500 is first passed through the connecting end 140 and the guidewire channel of the cannula assembly 100 in sequence, and finally extends outward from the second opening 102 of the cannula assembly 100. During this process, the second end 520 of the guidewire 500 moves in the same direction and enters the interior of the distal component 200 or the connecting end 140, so that the second end 520 of the guidewire 500 is received and positioned in the guidewire channel of the distal component 200 or the connecting end 140 (i.e., the second end 520 does not extend outward from the threading port 201 of the distal component 200).

[0058] It is understood that the second end 520 of the guidewire 500 is housed and positioned inside the distal component 200 or the connecting end 140. This "positioning" should be such that the positioning force between the guidewire 500 and the blood pump 10 can be overcome or released by external force, allowing the guidewire 500 to separate from the blood pump 10. For example, if the "positioning" is achieved through an interference fit between the guidewire 500 and the distal component 200 or the connecting end 140, then by applying a certain external force to pull the guidewire 500, when this external force is greater than the frictional force generated by the interference fit, the guidewire 500 can be pulled out from the blood pump 10, thus separating the guidewire 500 from the blood pump 10. For example, if the "positioning" is achieved by the snap-fit ​​between the guidewire 500 and the distal component 200 or the connecting end 140, then applying a certain external force to deform the structure forming the snap-fit, thereby releasing the connection between the guidewire 500 and the blood pump 10, can also separate the guidewire 500 from the blood pump 10. As another example, if the "positioning" is achieved by using a small amount of adhesive to bond the guidewire 500 and the distal component 200 or the connecting end 140, then applying a certain external force to detach the second end 520 of the guidewire 500 from the bonded position can also release the connection between the guidewire 500 and the blood pump 10, thus separating the guidewire 500 from the blood pump 10. More details will be provided later.

[0059] Please see Figure 5 and Figure 6 When the blood pump 10 is inserted into the patient's body, after the guidewire 700 is inserted into the patient's body, the guidewire 700 has an internal part remaining inside the patient's body and an external part outside the patient's body; then the external part of the guidewire 700 is inserted from the suture port 201 of the distal component 200 of the blood pump 10, and enters the lumen 501 of the guidewire tube 500 through the second end 520; then the external part of the guidewire 700 is inserted along the lumen 501 of the guidewire tube 500 and moved to the first end 510 of the guidewire tube 500. Since the first end 510 of the guidewire tube 500 extends outward from the second opening 102 of the blood pump 10, when the external part of the guidewire 700 passes through the first end 510 of the guidewire tube 500, the external part of the guidewire 700 can pass through the blood pump 10, thereby completing the insertion of the blood pump 10 onto the guidewire 700. Finally, the guidewire 500 is pulled out from the second opening 102 of the blood pump 10, so that the guidewire 500 is separated from the blood pump 10, and the blood pump 10 can be moved along the internal part of the guidewire 700 to the target position in the patient's body.

[0060] Therefore, the blood pump system of this application, because a guide wire tube 500 is provided inside the blood pump 10 and the guide wire tube 500 is designed to be detachably inserted into the blood pump 10, allows the guide wire 700 to pass through the lumen 501 of the guide wire tube 500 during the insertion of the blood pump 10 and the guide wire 700. In other words, the guide wire tube 500 is used to wrap around the guide wire 700, which can effectively reduce the friction between the guide wire 700 and the internal components of the blood pump 10 (such as the impeller 400), thereby reducing the occurrence of the coating on the outer surface of the guide wire 700 being scraped off, reducing the risk of the coating of the guide wire 700 being scraped off into the blood and causing blood contamination, and greatly improving the safety performance of the blood pump system.

[0061] Because the second end 520 of the guidewire 500 in this application is housed and positioned inside the distal component 200 or the connecting end 140 (i.e., the second end 520 of the guidewire 500 does not extend outward from the distal end of the distal component 200), this design makes the position of the guidewire 500 more stable. During the insertion of the guidewire 700 into the guidewire 500, the guidewire 500 is less likely to be moved along the length of the blood pump 10 by the guidewire 700, greatly facilitating the operator's insertion of the guidewire 700. Furthermore, as... Figure 6As shown, since the distal component 200 is usually designed in the shape of a pig's tail, during the process of inserting the guidewire 700 onto the blood pump 10, the physician needs to use one hand to straighten or unfold the distal component 200. If the second end 520 of the guidewire tube 500 extends outward from the distal end of the distal component 200, the physician will also need to use the other hand to fix the second end 520 of the guidewire tube 500. The subsequent insertion of the guidewire 700 will then require another physician to perform the procedure. In this application, since the second end 520 of the guidewire 500 is moved into and positioned inside the distal component 200 or the connecting end 140, this design allows the physician to simply use one hand to straighten or unfold the distal component 200 during the process of threading the guidewire 700 onto the blood pump 10, without needing to hold and fix the guidewire 500, thus reducing the difficulty of operation. The physician's other hand can then be used to perform the subsequent threading of the guidewire 700, allowing one physician to complete the threading of the guidewire 700 and the blood pump 10 independently, thereby improving assembly efficiency.

[0062] In this application, there are at least two possible assembly methods for threading the guidewire 500 onto the blood pump 10. Please refer to [link / reference]. Figure 1 and Figure 2 One assembly scheme for the guidewire 500 and blood pump 10 is that the guidewire 500 and blood pump 10 are two independent components before and after leaving the factory. During the surgery, the physician inserts the guidewire 500 into the blood pump 10. For example, during the surgery, the physician can insert the first end 510 of the guidewire 500 through the suture port 201 at the distal end of the distal component 200 (e.g., ...). Figure 1 (as shown in F), and passes through the sleeve assembly 100 sequentially from the distal component 200 and the connecting end 140, and finally outward from the second opening 102, while the second end 520 of the guide wire tube 500 is received and positioned in the distal component 200 or the connecting end 140.

[0063] Please see Figures 21 to 23 A second assembly scheme for the guidewire 500 and blood pump 10 is to pre-insert and position the guidewire 500 within the blood pump 10 during its manufacturing process. This means the guidewire 500 is already installed within the blood pump 10 before it leaves the factory, eliminating the need for the physician to insert the guidewire 500 and reducing physician intervention. For example, before the distal component 200 of the blood pump 10 is connected to the connecting end 140, the first end 510 of the guidewire 500 can be sequentially passed through the connecting end 140 and the cannula assembly 100, and then exits through the second opening 102. The second end 520 of the guidewire 500 is then received and positioned inside the connecting end 140. Finally, the distal component 200 is connected and fixed to the connecting end 140.

[0064] Please see Figure 3 and Figure 4In some embodiments, the first opening 101 is located on the side wall of the distal end of the cannula assembly 100, and the second opening 102 is located on the side wall of the proximal end of the cannula assembly 100. Wherein, when the first opening 101 serves as a blood inlet, the second opening 102 is correspondingly a blood outlet; conversely, when the first opening 101 serves as a blood outlet, the second opening 102 is correspondingly a blood inlet.

[0065] Please see Figure 6 and Figure 7 In some embodiments, the second end 520 of the guidewire 500 is provided with a positioning portion 530; the distal component 200 or the connecting end 140 is provided with a mating portion 600 that cooperates with the positioning portion 530 for positioning. That is, the mating portion 600 and the positioning portion 530 are correspondingly mated and connected to position the second end 520 of the guidewire 500 within the blood pump 10. Furthermore, at least one of the positioning portion 530 and the mating portion 600 can elastically deform and separate from the other.

[0066] During the insertion of the guidewire 500 into the blood pump 10, when the positioning part 530 of the guidewire 500 moves and reaches the mating part 600, the positioning part 530 and the mating part 600 engage and connect, thereby positioning the second end 520 of the guidewire 500 within the blood pump 10. When it is necessary to remove the guidewire 500, an external force is used to drive the guidewire 500 toward the second opening 102 of the blood pump 10, causing at least one of the positioning part 530 and the mating part 600 to undergo elastic deformation, thereby overcoming the force between the positioning part 530 and the mating part 600 of the guidewire 500, causing the positioning part 530 and the mating part 600 to separate, and then the guidewire 500 can be pulled out of the blood pump, thus separating the guidewire 500 from the blood pump.

[0067] Please see Figure 6 and Figure 7 In one embodiment, the second end 520 of the guidewire 500 is received and positioned inside the connecting end 140. Specifically, the connecting end 140 includes a flow guide 141 and a connecting tube 142. The flow guide 141 is adjacent to the first opening 101 and allows fluid to flow from the outside of the blood pump 10 to the first opening 101 of the blood pump 10; the flow guide 141 has an inner cavity that forms part of the guidewire channel of the connecting end 140. The connecting tube 142 is located at the distal end of the flow guide 141 and communicates with the inner cavity of the flow guide 141, and is connected to the distal component 200. Optionally, the mating part 600 is located inside the flow guide 141 or inside the connecting tube 142.

[0068] In some embodiments, the mating portion 600 is disposed inside the connecting tube 142. This allows the guide wire 500 to be positioned at the connecting end 140 for a longer length, resulting in more stable positioning. Of course, in other embodiments, the mating portion 600 is disposed inside the flow guiding portion 141. The flow guiding portion 141 is closer to the first opening 101 than the connecting tube 142. When the guide wire 500 is withdrawn, it only needs to overcome the internal resistance of the flow guiding portion 141 to separate from the connecting end 140, without friction with the connecting tube 142, allowing for faster withdrawal of the guide wire 500.

[0069] Please see Figure 6 and Figure 7 In some embodiments, the distal component 200 is sleeved on the outer peripheral surface of the connecting tube 142 and bonded to the connecting tube 142. A mating portion 600 is disposed within the connecting tube 142. That is, the second end 520 of the guidewire 500 is positioned by engaging the mating portion 600 within the connecting tube 142 via a positioning portion 530. Considering that if the guidewire 500 and the blood pump 10 are installed using the aforementioned second assembly scheme, the distal component 200 and the connecting end 140 are typically bonded with adhesive. During the bonding process, the adhesive may extend from the distal end of the connecting tube 142 into the interior of the connecting tube 142 and contact the guidewire 500, further bonding the guidewire 500 and the connecting tube 142 together. This could result in excessive strength of the guidewire 500 within the connecting tube 142, requiring significant external force to remove the guidewire 500 subsequently.

[0070] In view of the above, optionally, the connecting tube 142 has a first end face 143 extending into the distal component 200, and the second end 520 of the guide wire tube 500 has a second end face 521, with a septum gap formed between the second end face 521 and the first end face 143. The septum gap is as follows: Figure 7 As shown in D1. With this configuration, during the bonding process between the distal component 200 and the connecting tube 142, the adhesive bonding the distal component 200 and the connecting end 140 will not easily penetrate into the distal end of the connecting tube 142, nor will it easily come into contact with the second end 520 of the guide wire tube 500. This prevents the guide wire tube 500 and the connecting tube 142 from further bonding together. Subsequently, it is only necessary to overcome the force between the positioning part 530 of the second end 520 of the guide wire tube 500 and the mating part 600 inside the connecting tube 142 to pull out the guide wire tube 500.

[0071] It should be noted that the size of the adhesive spacing can be flexibly adjusted and set according to actual needs, and is not limited here, as long as it can prevent the adhesive from seeping into the guide wire tube 500 inside the connecting end 140 during the bonding process between the remote component 200 and the connecting tube 142.

[0072] Please see Figure 1, Figure 10 and Figure 12 In some embodiments, unlike the embodiments described above, the second end 520 of the guidewire 500 is received and positioned inside the distal component 200. Specifically, the distal component 200 includes a distal end 210, a proximal end 220, and a tube body 230. The proximal end 220 is connected to the connecting end 140; the tube body 230 is located between the distal end 210 and the proximal end 220. The first end 510 of the guidewire 500 can pass through the distal component 200 and the connecting end 140 into the sheath assembly 100. Optionally, a mating portion 600 is disposed on the inner circumferential surface of one of the distal end 210, the proximal end 220, and the tube body 230 of the distal component 200. That is, the second end 520 of the guidewire 500 can be positioned inside one of the distal end 210, the proximal end 220, and the tube body 230 of the distal component 200.

[0073] The specific structure and mating method of the positioning part 530 of the guidewire 500 and the mating part 600 in the blood pump 10 can be designed in various ways. The positioning part 530 can be elastically deformed to separate from the mating part 600.

[0074] Please see Figures 9 to 11 In some embodiments, the positioning portion 530 of the guidewire 500 is positioned by an interference fit with the mating portion 600 within the blood pump 10. The mating portion 600 is positioned by the inner circumferential surface 601 of the distal component 200 (e.g., ...). Figure 10 (as shown) is formed; or, the mating part 600 is formed by the inner peripheral surface 601 of the connecting end 140 (as shown). Figure 11 As shown in the figure; the outer peripheral surface of the positioning part 530 is tightly fitted with the inner peripheral surface 601, thereby achieving interference fit positioning between the positioning part 530 and the mating part 600. During disassembly, the guidewire tube 500 can be pulled out from the blood pump 10 by overcoming the friction between the outer peripheral surface and the inner peripheral surface 601 of the positioning part 530.

[0075] Please see Figures 8 to 13 In the diagram, D2 represents the outer diameter of the positioning part 530, and D3 represents the diameter of the mating part 600 (i.e., the inner circumferential surface 601). Figures 8 to 11 As shown, in some embodiments, the positioning part 530 is configured in a trumpet shape, and the outer diameter D2 of the positioning part 530 is in the direction from the distal component 200 to the sleeve assembly 100 (e.g., Figure 9As shown in Figure S, the diameter of the mating part 600 (i.e., the inner circumferential surface 601 of the distal component 200 or the connecting end 140) gradually decreases; it is interference-fitted with the outer circumferential surface of the positioning part 530. The diameter of the mating part 600 (i.e., the inner circumferential surface 601) gradually decreases in the direction from the distal component 200 to the sleeve assembly 100, so as to conform to the shape of the positioning part 530. This increases the contact area between the positioning part 530 and the inner circumferential surface 601, enhances the stability of positioning, and prevents easy loosening. Figure 12 and Figure 13 As shown, in other embodiments, the diameter D3 of the mating portion 600 (i.e., the inner circumferential surface 601) may also remain unchanged in the direction along the distal component 200 to the sleeve assembly 100.

[0076] When the guidewire 500 is pulled forcefully, the positioning part 530 contracts and deforms radially, thereby overcoming the friction between the positioning part 530 and the inner circumferential surface 601. This allows the positioning part 530 to move and separate from the inner circumferential surface 601, thus allowing the guidewire 500 to be pulled out from the second opening 102 and separated from the blood pump 10. Of course, depending on the specific structural arrangement of the positioning part 530 and the mating part 600, other methods can also be used to allow the positioning part 530 to be released from the restraint of the mating part 600 and to separate from each other. For example, when the positioning part 530 is located at the first end 510 of the guidewire 500 and the mating part 600 is located at the second opening 102, after the guidewire 700 is inserted into the blood pump 10, a medical instrument can be used to separate the positioning part 530 and the mating part 600, and then the guidewire 500 can be smoothly removed from the second opening 102.

[0077] Furthermore, as the guidewire 700 is inserted into the blood pump 10, the diameter of the positioning part 530 gradually decreases, facilitating the insertion of the guidewire 700 into the guidewire tube 500. Optionally, the inner diameter of the end of the distal component 200 furthest from the connecting end 140 (i.e., the distal end 210) is smaller than the maximum outer diameter of the positioning part 530. When the positioning part 530 of the guidewire tube 500 is press-fitted with the mating part 600, the positioning part 530 of the guidewire tube 500 is less likely to displace outward from the threading port 201 of the distal component 200, preventing the second end 520 of the guidewire tube 500 from protruding from the threading port 201 of the distal component 200. As an example, the guidewire tube 500 is an elastic tube or a plastic tube. Optionally, the guidewire tube 500 can be, but is not limited to, a silicone tube, a polyurethane tube, a PVC tube, a resin tube, etc.

[0078] In some other embodiments, the difference from the above embodiments is that the positioning part 530 of the guidewire 500 engages with the mating part 600 inside the blood pump 10 for positioning. For example, one of the positioning part 530 and the mating part 600 may be configured as a protrusion, flange, or bump that can be elastically deformed, while the other may be configured as a recess or stop surface that can engage and limit the movement of the aforementioned protrusion, flange, or bump.

[0079] Please see Figure 14 , Figure 15 and Figure 16 In some embodiments, the positioning part 530 is configured as a positioning flange 531 that protrudes radially from the outer periphery of the second end 520 of the guide wire tube 500; the mating part 600 is a stop surface 602 that is disposed in the distal component 200 and extends radially, and the stop surface 602 can abut against the side of the positioning flange 531 for locking and positioning.

[0080] When the guidewire 500 is inserted into the blood pump 10, the first end 510 of the guidewire 500 enters the distal component 200 through the suture port 201, then passes through the distal component 200 and the cannula assembly 100 in sequence, and exits through the second opening 102 of the cannula assembly 100. During this process, the second end 520 of the guidewire 500 moves into the distal component 200 through the suture port 201 until the positioning flange 531 on the second end 520 of the guidewire 500 encounters and abuts against the stop surface 602 inside the distal component 200. The stop surface 602 then prevents the guidewire 500 from moving further, thus positioning the second end 520 of the guidewire 500 within the distal component 200. When it is necessary to separate the guidewire 500, along... Figure 11 When the arrow F in the diagram is pulled in the direction indicated, the guide wire 500 is pulled out, and the positioning flange 531 of the guide wire 500 is deformed and radially contracted, thereby separating the positioning flange 531 from the stop surface 602, so that the guide wire 500 can be completely passed through the cannula assembly 100 and pulled out from the second opening 102 of the blood pump 10.

[0081] Please see Figure 17 and Figure 18 In other embodiments, the positioning part 530 is a positioning flange 531 that protrudes radially from the outer periphery of the second end 520 of the guide wire tube 500; the mating part 600 is a stop surface 602 that is disposed in the connecting end 140 and extends radially, and the stop surface 602 can fit against the side of the positioning flange 531 for locking and positioning.

[0082] When the guidewire 500 is inserted into the blood pump 10, after the first end 510 of the guidewire 500 passes through the cannula assembly 100 and exits through the second opening 102 of the cannula assembly 100, the second end 520 of the guidewire 500 moves into the connecting end 140 until the positioning flange 531 on the second end 520 of the guidewire 500 encounters and abuts the stop surface 602 in the connecting end 140, at which point the second end 520 of the guidewire 500 is positioned within the distal component 200. When it is necessary to disassemble the guidewire 500, along... Figure 16 When the guide wire 500 is pulled in the direction indicated by arrow F, the positioning flange 531 of the guide wire 500 deforms and radially retracts, thereby separating the positioning flange 531 from the stop surface 602, and then the guide wire 500 can be pulled out from the second opening 102 of the blood pump 10.

[0083] Optionally, such as Figure 19 As shown, the positioning flange 531 extends in a ring along the outer periphery of the second end 520. Alternatively, as... Figure 20 As shown, the positioning flange 531 includes at least two positioning petals 532 spaced apart along the outer periphery of the second end 520, and a gap 533 is formed between two adjacent positioning petals 532 to allow the positioning flange 531 to deform. The gap 533 can form a deformation space for the positioning flange 531, which is beneficial to the deformation of the positioning flange 531.

[0084] The stop surface 602 extends in a ring around the inner circumference of the distal component 200 or the connecting end 140; or, the connecting end 140 has a first end face 143 that extends into the interior of the distal component 200, and the first end face 143 forms the stop surface 602.

[0085] Based on any of the above embodiments, the guidewire 500 has a first length (assumed to be L1); the connecting end 140 has a second length (assumed to be L2) extending from its first end face 143 to the second opening 102; the distal component 200 has a third length (assumed to be L3). If the first end 510 of the guidewire 500 extends outward from the second opening 102, and the second end 520 of the guidewire 500 also extends outward from the threading port 201 of the distal component 200, then the first length must necessarily be greater than the sum of the second length and the third length (i.e., L1 > L2 + L3). However, in this embodiment, when the second end 520 of the guidewire 500 is positioned within the connecting end 140 of the sleeve assembly 100, as long as the first length is greater than the second length (i.e., L1 > L2), the first end 510 of the guidewire 500 can extend outward from the second opening 102, without necessarily satisfying L1 > L2 + L3. In this case, the guidewire 500 can be connected to the blood pump 10 by the aforementioned second assembly scheme. As long as L1 > L2 (even if L1 does not satisfy L1 > L2 + L3), the guidewire 500 can be connected to the blood pump 10.

[0086] Furthermore, the first length is greater than the second length and less than the sum of the second length and the third length (i.e., L2 < L1 < (L2 + L3)), which ensures that the first end 510 of the guide wire tube 500 extends outward from the second opening 102, and also reduces the length of the guide wire tube 500, thereby reducing the material cost of the guide wire tube 500.

[0087] Please see Figure 1 and Figure 2 Based on any of the above embodiments, the sleeve assembly 100 includes an inlet pipe 120, a sleeve 110, and an outlet pipe 130 connected in sequence. The inlet pipe 120 has a first opening 101, and the outlet pipe 130 has a second opening 102. It is understood that when the sleeve assembly 100 is designed with a separate structure for the inlet pipe 120, sleeve 110, and outlet pipe 130, and the inlet pipe 120, sleeve 110, and outlet pipe 130 are assembled together in sequence, the inlet pipe 120, sleeve 110, and outlet pipe 130 can be processed separately, thus reducing the processing difficulty of the sleeve assembly 100.

[0088] Of course, in other embodiments, the inlet pipe 120 can be a part of the sleeve 110, that is, the inlet pipe 120 and the sleeve 110 are integrally formed; or, the inlet pipe 120 can be independently formed from other parts of the sleeve 110 and then connected together. Similarly, the outlet pipe 130 can also be a part of the sleeve 110, that is, the outlet pipe 130 and the sleeve 110 are integrally formed; or, the outlet pipe 130 can be independently formed from the sleeve 110 and then connected together.

[0089] In some embodiments, a connecting end 140 is formed at the end of the inlet tube 120 away from the cannula 110. The wall of the cannula 110 is made transparent. The guidewire 500 is a different color from the wall of the cannula 110, and the color of the guidewire 500 is visible through the wall of the cannula 110. Thus, during the insertion or withdrawal of the guidewire 500 from the cannula 110, the specific position of the guidewire 500 can be directly observed through the blood pump 10, thereby facilitating operation.

[0090] In other embodiments, the second end 520 of the guidewire 500 is inserted into the interior of the distal component 200; at least the color of the second end 520 of the guidewire 500 is different from the color of the distal component 200, and at least the color of the second end 520 can be seen outward through the wall of the distal component 200. Thus, during the insertion or removal of the guidewire 500 from the distal component 200, the specific position of the guidewire 500 can be directly observed through the distal component 200, thereby facilitating operation.

[0091] Based on any of the above embodiments, the blood pump 10 further includes an impeller 400, which is disposed within the cannula assembly 100 and is rotatable relative to the cannula assembly 100. The impeller 400 is adjacent to the second opening 102. Since the guidewire 500 is made of a deformable flexible or elastic material, when the guidewire 500 passes through the gap between the impeller 400 and the inner wall of the cannula assembly 100, the guidewire 500 is less likely to experience rigid contact friction or collision with the impeller 400. When the guidewire 700 is subsequently inserted, the guidewire 700 passes through the lumen 501 of the guidewire tube 500. The guidewire 700 is wrapped and protected by the guidewire tube 500, making it less likely to come into contact with the impeller 400, effectively preventing the coating on the outer surface of the guidewire 700 from being scratched by the impeller 400.

[0092] Optionally, the blood pump 10 may further include a drive unit 300 connected to one end of the cannula assembly 100 adjacent to the second opening 102. The drive unit 300 has a motor shaft extending into the cannula assembly 100 and connected to the impeller 400. When the drive unit 300 is in operation, it drives the impeller 400 to rotate, and the rotation of the impeller 400 provides power to cause blood to flow between the first opening 101 and the second opening 102. Of course, the drive unit 300 is not essential. In other embodiments, the impeller 400 may also be driven by an external motor.

[0093] Please see Figures 21 to 23 To achieve the second assembly scheme for the guidewire 500 and blood pump 10, this application also provides a method for manufacturing a blood pump system, the method comprising the following steps: Step S10: Provide a blood pump 10, which includes a cannula assembly 100 and a distal component 200; the cannula assembly 100 has a connecting end 140, a first opening 101 adjacent to the connecting end 140, and a second opening 102 away from the connecting end 140; the distal component 200 and the connecting end 140 of the cannula assembly 100 are in an unconnected state.

[0094] Step S20: Provide a guide wire tube 500, which has a second end 520 and a first end 510. Insert the first end 510 of the guide wire tube 500 into the sleeve assembly 100 from the connecting end 140 and extend it outward from the second opening 102 of the sleeve assembly 100. The second end 520 of the guide wire tube 500 is received and positioned inside the connecting end 140. Figure 22 The letter F indicates the direction of movement of the second end 520 of the guide wire tube 500 into the connecting end 140.

[0095] Step S30: Connect the distal component 200 of the blood pump 10 to the connection end 140 of the cannula assembly 100.

[0096] In the aforementioned method of manufacturing the blood pump system, during the insertion of the blood pump 10 into the guidewire 700, the guidewire 700 is inserted from the first end 510 of the guidewire tube 500 and exits through the second end 520 of the guidewire tube 500. Then, the guidewire tube 500 is pulled outward from the second opening 102 of the blood pump 10. The blood pump 10 is then moved along the guidewire 700 to the target position, thus completing the intervention. As can be seen, during the insertion of the blood pump 10 into the guidewire 700, since the guidewire 700 passes through the lumen 501 of the guidewire tube 500, and the guidewire tube 500 wraps around the guidewire 700, it prevents the guidewire 700 from rubbing against the impeller 400, thus avoiding damage to the coating on the outer surface of the guidewire 700. This prevents the coating on the outer surface of the guidewire 700 from being scraped off and entering the blood, thus preventing blood contamination and improving product performance. Furthermore, the guidewire 500 is pre-installed within the blood pump 10 before it leaves the factory, eliminating the need for physicians to insert the guidewire 500 themselves and reducing physician workload.

[0097] In addition, since the distal component 200 is usually designed in the shape of a pig's tail, when inserting the guidewire 700 onto the blood pump 10, the physician needs to use one hand to straighten or unfold the distal component 200. If the second end 520 of the guidewire tube 500 extends outward from the distal end of the distal component 200, the physician will also need to use the other hand to fix the second end 520 of the guidewire tube 500. The subsequent insertion of the guidewire 700 will then need to be performed by another physician. In this application, since the second end 520 of the guidewire 500 is moved into and positioned inside the distal component 200 or the connecting end 140, this design allows the physician to simply use one hand to straighten or unfold the distal component 200 during the process of threading the guidewire 700 onto the blood pump 10, without needing to hold and fix the guidewire 500, thus reducing the difficulty of operation. The physician's other hand can then be used to perform the subsequent threading of the guidewire 700, allowing one physician to complete the threading of the guidewire 700 and the blood pump 10 independently, thereby improving assembly efficiency.

[0098] Specifically, the distal component 200 includes a distal end 210, a proximal end 220, and a tube body 230. The proximal end 220 is connected to the connecting end 140; the tube body 230 is located between the distal end 210 and the proximal end 220. In step S30, the distal component 200 is connected to the connecting end 140 via the proximal end 220. The specific connection method between the two can be, but is not limited to, adhesive bonding or heat fusion bonding. Specifically, in this embodiment, the proximal end 220 of the distal component 200 and the connecting end 140 are connected by adhesive bonding.

[0099] Furthermore, the second end 520 of the guide wire tube 500 has a second end face 521, and the connecting end 140 has a first end face 143 extending into the interior of the distal component 200, with a septum gap formed between the first end face 143 and the second end face 521; the step of connecting and fixing the distal component 200 to the connecting end 140 of the sleeve assembly 100 in the manufacturing method (i.e., the above-mentioned step S30) specifically includes the following steps: Step S31: Apply adhesive to the outer peripheral surface of the connecting tube 142 at the connecting end 140 or the inner peripheral surface of the proximal end of the distal component 200; Step S32: Place the proximal end of the distal component 200 onto the outer peripheral surface of the connecting tube 142 so that the distal component 200 and the connecting tube 142 are bonded together.

[0100] Please see Figure 6 and Figure 7Specifically, the connecting end 140 includes a guide portion 141 adjacent to the first opening 101, and a connecting tube 142 protruding from the guide portion 141, the distal end face of the connecting tube 142 being the first end face 143. In the aforementioned step S20, the second end 520 of the guide wire tube 500 is moved into and positioned inside the connecting tube 142 of the connecting end 140, and the second end face 521 of the guide wire tube 500 and the first end face 143 of the connecting end 140 are spaced apart by the adhesive separation distance. Figure 7 In this design, when steps S31 and S32 are performed in subsequent operations, the adhesive is isolated by the septum spacing and is less likely to come into contact with the guide wire tube 500. This prevents the guide wire tube 500 and the connecting tube 142 from sticking together further, avoids the need for a large external force to pull out the guide wire tube 500, and facilitates the removal of the guide wire tube 500.

[0101] In some embodiments, the guidewire 500 has a first length (assumed to be L1); the connecting end 140 has a second length (assumed to be L2) extending from its first end face 143 to the second opening 102; and the distal component 200 has a third length (assumed to be L3). If the first end 510 of the guidewire 500 extends outward from the second opening 102, and the second end 520 of the guidewire 500 also extends outward from the threading port 201 of the distal component 200, then the first length must necessarily be greater than the sum of the second length and the third length (i.e., L1 > L2 + L3). However, in this application, since the second end 520 of the guidewire 500 is located within the connecting end 140 of the sleeve assembly 100, the first end 510 of the guidewire 500 can extend outward from the second opening 102 as long as the first length is greater than the second length (i.e., L1 > L2), without necessarily satisfying L1 > L2 + L3.

[0102] Furthermore, the first length is greater than the second length and less than the sum of the second length and the third length (i.e., L2 < L1 < (L2 + L3)), which ensures that the first end 510 of the guide wire tube 500 extends outward from the second opening 102, and also reduces the length of the guide wire tube 500, thereby reducing the material cost of the guide wire tube 500.

[0103] Please see Figure 6 and Figure 7 In one embodiment, and in some embodiments, the second end 520 of the guidewire 500 is provided with a positioning portion 530; the distal component 200 or the connecting end 140 is provided with a mating portion 600 that cooperates with and positions the positioning portion 530. That is, the mating portion 600 and the positioning portion 530 are correspondingly engaged and connected to position the guidewire 500. Furthermore, at least one of the positioning portion 530 and the mating portion 600 can elastically deform and separate from the other.

[0104] During the insertion of the guidewire 500 into the blood pump 10, when the positioning part 530 of the guidewire 500 moves and reaches the mating part 600, the positioning part 530 and the mating part 600 engage and connect, thereby positioning the second end of the guidewire 500 inside the blood pump. When it is necessary to remove the guidewire 500, an external force is used to drive the guidewire 500 towards the second opening 102 of the blood pump 10, so that at least one of the positioning part 530 and the mating part 600 undergoes elastic deformation, thereby overcoming the force between the positioning part 530 and the mating part 600 of the guidewire 500, causing the positioning part 530 and the mating part 600 to separate, and then the guidewire 500 can be pulled out of the blood pump, thus separating the guidewire 500 from the blood pump.

[0105] Please see Figures 8 to 13 In the diagram, D2 represents the outer diameter of the positioning part 530, and D3 represents the diameter of the mating part 600 (i.e., the inner circumferential surface 601). In some embodiments, such as Figure 10 and Figure 11 As shown, the positioning part 530 is flared, and its outer diameter D2 gradually decreases from the distal component 200 to the sleeve assembly 100. The mating part 600 is the inner circumferential surface 601 of the distal component 200 or the connecting end 140, and it is interference-fitted with the outer circumferential surface of the positioning part 530. The diameter of the mating part 600 (i.e., the inner circumferential surface 601) gradually decreases along the direction from the distal component 200 to the sleeve assembly 100 to conform to the shape of the positioning part 530. This increases the contact area between the positioning part 530 and the inner circumferential surface 601, enhancing positioning stability and preventing easy loosening. Figure 12 and Figure 13 As shown, in other embodiments, the diameter D3 of the mating part (i.e., the inner circumferential surface 601) may also remain unchanged in the direction from the distal component 200 to the sleeve assembly 100.

[0106] During disassembly, pulling the guidewire 500 forcefully causes the positioning part 530 to contract and deform radially, thereby overcoming the friction between the positioning part 530 and the inner circumferential surface 601. This allows the positioning part 530 to move and separate from the inner circumferential surface 601, thus enabling the guidewire 500 to be pulled out from the second opening 102 and separated from the blood pump 10. Of course, depending on the specific structural arrangement of the positioning part 530 and the mating part 600, other methods can also be used to allow the positioning part 530 to detach from the mating part 600 and separate from each other. For example, when the positioning part 530 is located at the first end 510 of the guidewire 500 and the mating part 600 is located at the second opening 102, after the guidewire 700 is inserted into the blood pump 10, a medical instrument can be used to separate the positioning part 530 from the mating part 600, and then the guidewire 500 can be easily removed from the second opening 102.

[0107] Furthermore, as the guidewire 700 is inserted into the blood pump 10, the diameter of the positioning part 530 gradually decreases, facilitating the insertion of the guidewire 700 into the guidewire tube 500. Optionally, the inner diameter of the end of the distal component 200 furthest from the connecting end 140 (i.e., the distal end 210) is smaller than the maximum outer diameter of the positioning part 530. When the positioning part 530 of the guidewire tube 500 is press-fitted with the mating part 600, the positioning part 530 of the guidewire tube 500 is less likely to displace outward from the threading port 201 of the distal component 200, preventing the second end 520 of the guidewire tube 500 from protruding from the threading port 201 of the distal component 200. As an example, the guidewire tube 500 is an elastic tube or a plastic tube. Optionally, the guidewire tube 500 can be, but is not limited to, a silicone tube, a polyurethane tube, a PVC tube, a resin tube, etc.

[0108] Please see Figure 15 and Figure 16 In some other embodiments, the difference from the above embodiments is that the positioning part 530 is a positioning flange 531 that protrudes radially from the outer periphery of the second end 520 of the guide wire tube 500; the mating part 600 is a stop surface 602 that is disposed in the distal component 200 and extends radially, and the stop surface 602 can abut against the side of the positioning flange 531 and engage for positioning.

[0109] When the guidewire 500 is inserted into the blood pump, the first end of the guidewire 500 enters the distal component 200 through the suture port, then passes sequentially through the distal component 200 and the cannula assembly 100, and exits through the second opening 102 of the cannula assembly 100. During this process, the second end 520 of the guidewire 500 moves into the distal component 200 from the suture port 201 until the positioning flange 531 on the second end 520 of the guidewire 500 encounters and abuts against the stop surface 602 inside the distal component 200. The stop surface 602 then prevents the guidewire 500 from moving further, thus positioning the second end 520 of the guidewire 500 within the distal component 200. When it is necessary to separate the guidewire 500, along... Figure 11 When the arrow F in the diagram is pulled in the direction indicated, the guide wire 500 is pulled out, and the positioning flange 531 of the guide wire 500 is deformed and radially contracted, thereby separating the positioning flange 531 from the stop surface 602, so that the guide wire 500 can be completely passed through the cannula assembly 100 and pulled out from the second opening 102 of the blood pump 10.

[0110] Please see Figure 17 and Figure 18In other embodiments, the positioning part 530 is configured as a positioning flange 531 that protrudes radially from the outer periphery of the second end 520 of the guide wire tube 500; the mating part 600 is a stop surface 602 that is disposed inside the connecting end and extends radially, and the stop surface 602 can fit against the side of the positioning flange 531 for locking and positioning.

[0111] When the guidewire 500 is inserted into the blood pump, after the first end of the guidewire 500 passes through the cannula assembly 100 and exits through the second opening of the cannula assembly 100, the second end 520 of the guidewire 500 moves into the connecting end until the positioning flange 531 on the second end 520 of the guidewire 500 encounters and abuts the stop surface 602 in the connecting end 140, at which point the second end 520 of the guidewire 500 is positioned within the distal component 200. When it is necessary to disassemble the guidewire 500, along... Figure 16 When the guide wire 500 is pulled in the direction indicated by arrow F, the positioning flange 531 of the guide wire 500 deforms and radially retracts, thereby separating the positioning flange 531 from the stop surface 602, and then the guide wire 500 can be pulled out from the second opening 102 of the blood pump 10.

[0112] In the description of this application, it should be understood that if terms such as "center", "longitudinal", "lateral", "length", "width", "thickness", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", "clockwise", "counterclockwise", "axial", "radial", "circumferential" appear, these terms indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings, and are only for the convenience of describing this application and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation of this application.

[0113] Furthermore, where the terms "first" and "second" appear, these terms are for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of technical features indicated. Thus, a feature defined with "first" or "second" may explicitly or implicitly include at least one of that feature. In the description of this application, where the term "multiple" appears, "multiple" means at least two, such as two, three, etc., unless otherwise explicitly specified.

[0114] In this application, unless otherwise expressly specified and limited, the terms "installation," "connection," "joining," and "fixing," etc., should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral part; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; they can refer to the internal communication of two components or the interaction between two components, unless otherwise expressly limited. Those skilled in the art can understand the specific meaning of the above terms in this application based on the specific circumstances.

[0115] In this application, unless otherwise expressly specified and limited, the use of descriptions such as "above" or "below" the second feature indicates that the first and second features are in direct contact or indirect contact via an intermediate medium. Furthermore, "above," "on top of," and "over" the second feature can mean that the first feature is directly above or diagonally above the second feature, or simply that the first feature is at a higher horizontal level than the second feature. Similarly, "below," "below," and "under" the second feature can mean that the first feature is directly below or diagonally below the second feature, or simply that the first feature is at a lower horizontal level than the second feature.

[0116] It should be noted that if an element is referred to as being "fixed to" or "set on" another element, it can be directly on the other element or there may be an intervening element. If an element is considered to be "connected to" another element, it can be directly connected to the other element or there may be an intervening element. If so, the terms "vertical," "horizontal," "upper," "lower," "left," "right," and similar expressions used in this application are for illustrative purposes only and do not represent the only possible implementation.

[0117] The technical features of the above embodiments can be combined in any way. For the sake of brevity, not all possible combinations of the technical features in the above embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0118] The embodiments described above are merely illustrative of several implementation methods of this application, and while the descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the patent application. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of this application, and these all fall within the protection scope of this application. Therefore, the protection scope of this patent application should be determined by the appended claims.

Claims

1. A blood pump system, characterized in that, The blood pump system includes: A blood pump, comprising a cannula assembly and a distal component; the cannula assembly having a connecting end, a first opening, and a second opening; wherein the connecting end is connected to the distal component; the first opening is adjacent to the connecting end; the second opening is distal to the connecting end; and A guidewire, configured to be detachably inserted into the blood pump for guidewire insertion; the guidewire having a first end and a second end; wherein the first end is capable of passing through the cannula assembly from the distal component and extending outward from the second opening, such that the second end is capable of moving in the same direction to receive and position inside the distal component or the connecting end.

2. The blood pump system according to claim 1, characterized in that, The second end of the guidewire is provided with a positioning part; the interior of the distal component or the connecting end is provided with a mating part; at least one of the positioning part and the mating part can be elastically deformed and separated from the other, so that the guidewire can be pulled out from the second opening and separated from the blood pump.

3. The blood pump system according to claim 2, characterized in that, The positioning part is configured in the shape of a trumpet, and the outer diameter of the positioning part gradually decreases in the direction from the distal component to the sleeve assembly; the mating part is at least a portion of the inner circumferential surface of the distal component or the connecting end, and the positioning part contacts and mates with the inner circumferential surface.

4. The blood pump system according to claim 3, characterized in that, The inner diameter of the end of the distal component furthest from the connecting end is smaller than the maximum outer diameter of the positioning part.

5. The blood pump system according to claim 3, characterized in that, The diameter of the mating portion gradually decreases along the direction from the distal component to the sleeve assembly, so as to conform to the shape of the positioning portion.

6. The blood pump system according to claim 2, characterized in that, The positioning part is configured as a positioning flange protruding radially from the outer periphery of the second end of the guide wire tube; the mating part is a stop surface disposed within the distal component or the connecting end and extending radially, so as to abut against the side of the positioning flange for locking and positioning; wherein... The positioning flange extends around the outer periphery of the second end in a ring shape; or... The positioning flange includes at least two positioning petals arranged at intervals along the outer periphery of the second end, and a gap is formed between two adjacent positioning petals for the positioning flange to deform.

7. The blood pump system according to claim 2, characterized in that, The connecting end includes a guide portion and a connecting pipe; wherein, the guide portion is adjacent to the first opening and has an inner cavity; the connecting pipe is located at the distal end of the guide portion and communicates with the inner cavity of the guide portion, and the connecting pipe is connected to the distal component; the mating portion is located inside the guide portion or inside the connecting pipe.

8. The blood pump system according to claim 7, characterized in that, The distal component is sleeved on the outer peripheral surface of the connecting tube and bonded to the connecting tube, and the connecting tube has a first end face that extends into the interior of the distal component; the second end of the guide wire has a second end face, and a diaphragm gap is formed between the second end face and the first end face.

9. The blood pump system according to claim 2, characterized in that, The distal component includes a distal end, a proximal end, and a tube located between the distal end and the proximal end; wherein the proximal end is connected to the connecting end; the mating part is disposed on the inner wall of one of the distal end, the proximal end, and the tube.

10. The blood pump system according to claim 1, characterized in that, The guide wire tube has a cavity inside, which is used for the guide wire to pass through; the guide wire tube is an elastic tube or a plastic tube; The distal component is used to stabilize the position of the blood pump in the heart, providing non-invasive support to the heart; The distal end of the distal component is provided with a threading port, through which the guide wire can be inserted; The distal component is a pig tail tube.

11. The blood pump system according to claim 1, characterized in that, The cannula assembly includes an inlet tube, a cannula, and an outlet tube connected in sequence; wherein, the inlet tube has a first opening, and the distal end of the inlet tube forms the connecting end; the outlet tube has a second opening; the guide wire tube is a different color from the wall color of the cannula, and the color of the guide wire tube can be seen outward through the wall of the cannula; Alternatively, the second end of the guidewire is housed inside the distal component; at least the color of the second end of the guidewire is different from the color of the distal component, and at least the color of the second end can be seen outward through the wall of the distal component.

12. The blood pump system as claimed in claim 1, characterized in that, The guide wire has a first length; the connecting end has a first end face away from the first opening, and the connecting end has a second length extending from its first end face to the second opening; the distal component has a third length; wherein the first length is greater than the second length and less than the sum of the second length and the third length.

13. The blood pump system according to claim 1, characterized in that, The blood pump also includes an impeller disposed within the cannula assembly. The impeller is rotatable relative to the cannula assembly and is adjacent to the second opening. The first opening serves as a blood inlet and the second opening serves as a blood outlet; or, the first opening serves as a blood outlet and the second opening serves as a blood inlet.

Images