Guidewire tube, blood pump system and method of manufacturing thereof

Abstract

The application 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 distal end component; the sleeve assembly is provided with a connecting end, a first opening and a second opening; the connecting end is connected with the distal end component; the first opening is adjacent to the connecting end; the second opening is away from the connecting end; the guide wire tube is configured to be detachably arranged in the blood pump; the guide wire tube has a first end and a second end; the first end can pass through the sleeve assembly and extend outward from the second opening of the sleeve assembly; and the second end can be accommodated and positioned in the interior of the distal end component or the connecting end.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical devices, in particular to a guide wire tube, a blood pump system and a manufacturing method thereof. BACKGROUND

[0002] A blood pump, also known as an intravascular blood pump, is designed to be inserted into a blood vessel of a patient percutaneously and can be inserted into a heart of the patient along the blood vessel to function as a left ventricular assist device or a right ventricular assist device. In the related art, when the blood pump is inserted into the patient, the blood pump is arranged on a guide wire, and then the blood pump is pushed into the patient along the guide wire. However, in the process of arranging the blood pump and the guide wire, the guide wire is easily rubbed or collided by internal components of the blood pump, and substances generated by the rubbing or collision can contaminate and damage blood, affecting the health of the patient. SUMMARY

[0003] The present application provides a guide wire tube, a blood pump system and a manufacturing method thereof, which aims to reduce the occurrence of blood damage during the process of inserting the blood pump into the patient and improve the safety performance of the product.

[0004] In one embodiment, the blood pump system comprises:

[0005] a blood pump comprising a cannula assembly and a distal component; the cannula assembly is provided with a connecting end, a first opening and a second opening; wherein the connecting end is connected with the distal component; the first opening is adjacent to the connecting end; and the second opening is away from the connecting end; and

[0006] a guide wire tube configured to be detachably arranged on the blood pump for arranging a guide wire; the guide wire tube has a first end and a second end; wherein the first end can pass through the cannula assembly and extend outward from the second opening, and the second end can be accommodated and positioned in the interior of the distal component or the connecting end.

[0007] In one embodiment, the second end of the guide wire tube is provided with a positioning portion; the interior of the distal component or the connecting end is provided with a cooperating portion cooperating with the positioning portion; at least one of the positioning portion and the cooperating portion can be elastically deformed and separated from the other.

[0008] In one embodiment, the connecting end comprises a flow guide portion and a connecting tube; wherein the flow guide portion is adjacent to the first opening, and the flow guide portion has an inner cavity; the connecting tube is arranged at a distal end of the flow guide portion and communicates with the inner cavity of the flow guide portion, and the connecting tube is connected with the distal component; and the cooperating portion is arranged in the interior of the flow guide portion or the interior of the connecting tube.

[0009] In one of the embodiments, the distal component is sleeved on the outer circumferential surface of the connecting pipe and is bonded to the connecting pipe, and the connecting pipe has a first end surface extending into the inside of the distal component; the second end of the guide wire tube has a second end surface, and a glue spacing is formed between the first end surface and the second end surface.

[0010] In one of the embodiments, the distal component comprises a distal end, a proximal end and a pipe body between the distal end and the proximal end; the proximal end is connected to the connecting end; the matching part is arranged on the inner wall of one of the distal end, the proximal end and the pipe body of the distal component.

[0011] In one of the embodiments, the positioning part is in interference fit with the matching part; or the positioning part is in clamping fit with the matching part.

[0012] In one of the embodiments, the positioning part is arranged in a trumpet shape, and the outer diameter of the positioning part is gradually reduced in the direction from the distal component to the sleeve assembly; the matching part is at least a part of the inner circumferential surface of the distal component or the connecting end, so as to be in interference fit with the outer circumferential surface of the positioning part.

[0013] In one of the embodiments, the diameter of the matching part remains unchanged in the direction from the distal component to the sleeve assembly; or the diameter of the matching part is gradually reduced in the direction from the distal component to the sleeve assembly, so as to be in a shape matching arrangement with the positioning part.

[0014] In one of the embodiments, the positioning part is arranged as a positioning flange protruding radially from the outer circumferential edge of the second end of the guide wire tube; the matching part is a stop surface arranged in the distal component or the connecting end and extending radially, so as to be clamped and positioned with the side surface of the positioning flange.

[0015] In one of the embodiments, the positioning flange extends around the outer circumferential edge of the second end and is arranged in a ring shape; or the positioning flange comprises at least two positioning petals arranged at intervals along the outer circumferential edge of the second end, and a gap for deforming the positioning flange is formed between adjacent two positioning petals.

[0016] In one of the embodiments, the stop surface is arranged on the inner circumferential surface of the distal component or the connecting end and extends in a ring shape around the inner circumferential surface; or the connecting end has a first end surface extending into the distal component, and the first end surface forms the stop surface.

[0017] In one embodiment, the cannula assembly comprises an inlet tube, a cannula and an outlet tube connected in sequence; the first opening is provided on the inlet tube; the second opening is provided on the outlet tube; the connecting end is provided at the distal end of the inlet tube; the color of the guide wire tube is different from the color of the tube wall of the cannula, and the color of the guide wire tube can be displayed outwardly through the tube wall of the cannula.

[0018] Alternatively, the second end of the guide wire tube is accommodated inside the distal end part; at least the color of the second end of the guide wire tube is different from the color of the distal end part, and at least the color of the second end can be displayed outwardly through the tube wall of the distal end part.

[0019] In one embodiment, the guide wire tube 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 the first end face of the connecting end to the second opening; the distal end part 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.

[0020] In one embodiment, the blood pump further comprises an impeller, the impeller is arranged in the cannula assembly, and the impeller can rotate relative to the cannula assembly, and the impeller is adjacent to the second opening.

[0021] The application also provides a guide wire tube suitable for being detachably arranged in a blood pump for a guide wire to pass through, the blood pump comprising a cannula assembly and a distal end part; the cannula assembly is provided with a connecting end, a first opening and a second opening, the connecting end is connected with the distal end part, the first opening is adjacent to the connecting end, and the second opening is away from the connecting end; the guide wire tube has a first end and a second end; wherein the first end of the guide wire tube is arranged to pass through the cannula assembly of the blood pump and extend outwardly from the second opening of the cannula assembly; and the second end is arranged to be moved into and positioned inside the distal end part or the connecting end of the blood pump.

[0022] In one embodiment, the second end of the guide wire tube is provided with a positioning part for corresponding and connecting positioning with a matching part of the blood pump; the positioning part can be elastically deformed to be separated from the matching part.

[0023] In one embodiment, the positioning part is arranged in a trumpet shape, and the outer diameter of the positioning part is gradually reduced in the direction from the distal end part to the connecting end; or the positioning part is arranged as a positioning flange protruding radially from the outer periphery of the second end of the guide wire tube.

[0024] In one embodiment, the positioning flange is annularly arranged along the outer periphery of the second end; or the positioning flange comprises at least two positioning petals arranged along the outer periphery of the second end at intervals, and a gap is formed between two adjacent positioning petals for deformation of the positioning flange.

[0025] The application also provides a manufacturing method of a blood pump system, comprising the following steps:

[0026] Providing a blood pump comprising a cannula assembly and a distal end component; the distal end component and the cannula assembly are in an unconnected state; the cannula assembly is provided with a connecting end, a first opening adjacent to the connecting end, and a second opening away from the connecting end;

[0027] Providing a guide wire tube having a first end and a second end, the first end of the guide wire tube is inserted into the cannula assembly from the connecting end and outwardly from the second opening of the cannula assembly, and the second end of the guide wire tube is accommodated and positioned inside the connecting end;

[0028] Connecting and fixing the distal end component and the connecting end of the cannula assembly.

[0029] In one embodiment, the connecting end has a first end face extending into the inside of the distal end component; the second end of the guide wire tube has a second end face, and a glue spacing is formed between the second end face and the first end face;

[0030] The step of connecting and fixing the distal end component and the connecting end of the cannula assembly in the manufacturing method specifically comprises the following steps:

[0031] Providing adhesive on the outer peripheral surface of the connecting pipe of the connecting end, or the inner peripheral surface of the proximal end of the distal end component;

[0032] Sleeving the proximal end of the distal end component on the outer peripheral surface of the connecting pipe to adhesively connect the distal end component and the connecting pipe.

[0033] In one embodiment, the second end of the guide wire tube is provided with a positioning portion; the inside of the distal end component or the connecting end is provided with a cooperating portion cooperating with the positioning portion; at least one of the positioning portion and the cooperating portion can be elastically deformed and separated from the other;

[0034] In one embodiment, the positioning portion is trumpet-shaped, and the outer diameter of the positioning portion gradually decreases in the direction from the distal end component to the cannula assembly; the cooperating portion is the inner peripheral surface of the connecting end and is in interference fit with the positioning portion.

[0035] Alternatively, the positioning portion is provided as a positioning flange protruding radially from the outer periphery of the second end of the guide wire tube, and the fitting portion is provided as a stop surface extending radially in the connecting end and capable of being engaged with the side surface of the positioning flange.

[0036] In one embodiment, the guide wire tube has a first length; the connecting end has a first end surface distal to the first opening, the connecting end has a second length extending from the first end surface thereof to the second opening; the distal end 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.

[0037] The guide wire tube, the blood pump system and the manufacturing method thereof described above, in the process of threading the blood pump into the guide wire, the guide wire is threaded into the guide wire tube from the first end and threaded out from the second end of the guide wire tube, and then the guide wire tube is pulled out from the second opening of the blood pump, and then the blood pump is moved along the guide wire to the target position to complete the interventional action. As can be seen, in the process of threading the blood pump into the guide wire, since the guide wire passes through the lumen of the guide wire tube, the guide wire tube wraps the guide wire, which can reduce the scratching of the guide wire with the internal components (such as the impeller) of the blood pump, and can also reduce the situation that the coating on the outer surface of the guide wire is scraped off, thereby reducing the risk of blood contamination caused by the coating of the guide wire being scraped off into the blood, and effectively improving the performance of the product.

[0038] Since the second end of the guide wire tube of the present application is accommodated and positioned inside the distal end component or the connecting end (i.e. the second end of the guide wire tube does not protrude outward from the distal end of the distal end component), this design can make the position of the guide wire tube more stable, and in the process of threading the guide wire into the guide wire tube, the guide wire tube is not easily driven to jump along the length direction of the blood pump, which can greatly facilitate the operator to thread the guide wire. In addition, since the distal end component is usually provided in a pigtail shape, in the process of threading the guide wire onto the blood pump, the physician needs to use one hand to straighten or unfold the distal end component, and if the second end of the guide wire tube protrudes outward from the distal end of the distal end component, the physician also needs to use the other hand to fix the second end of the guide wire tube, and the subsequent threading operation of the guide wire needs to be performed by another physician. In the present application, since the second end of the guide wire tube of the present application is moved into and positioned inside the distal end component or the connecting end, this design only requires the physician to use one hand to straighten or unfold the distal end component in the process of threading the guide wire onto the blood pump, without the need to hold and fix the guide wire tube, the operation difficulty is reduced, and the other hand of the physician can be used to perform the subsequent threading operation of the guide wire, so that one physician can complete the threading of the guide wire and the blood pump by himself, improving the assembly efficiency. BRIEF DESCRIPTION OF DRAWINGS

[0039] Figure 1 A structure diagram of the guide wire tube of one embodiment of the present application is prepared for threading into a blood pump.

[0040] Figure 2 This is a structural diagram of a guidewire tube inserted into a blood pump according to an embodiment of this application.

[0041] Figure 3 for Figure 2 Enlarged structural diagram at point A.

[0042] Figure 4 for Figure 2 Enlarged structural diagram at point B.

[0043] Figure 5 This is an axial sectional view of the structure shown in Figure 2.

[0044] Figure 6 for Figure 2 A schematic diagram of the blood pump system after the guidewire has been inserted.

[0045] Figure 7 for Figure 6 An enlarged structural diagram of an embodiment at point C.

[0046] Figure 8 This is a structural diagram of one embodiment of the guide wire tube of this application.

[0047] Figure 9 for Figure 8 Enlarged structural diagram at point D.

[0048] 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.

[0049] 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.

[0050] 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.

[0051] 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.

[0052] Figure 14 This is a structural diagram of another embodiment of the guide wire tube of this application.

[0053] Figure 15 for Figure 14 A schematic diagram showing the engagement between the second end of the guide wire tube and the distal component.

[0054] Figure 16 for Figure 15Schematic view of the second end of the middle guidewire tube being extracted from the distal part.

[0055] Figure 17 To Figure 14 Schematic view of the second end of the middle guidewire tube being extracted from the distal part.

[0056] Figure 18 To Figure 17 Schematic view of the second end of the middle guidewire tube being extracted from the distal part.

[0057] Figure 19 To Figure 14 Schematic view of the middle guidewire tube from an external perspective.

[0058] Figure 20 Schematic view of a further embodiment of the guidewire tube according to the application.

[0059] Figure 21 Schematic view of the middle guidewire tube being inserted into the connection end of the blood pump and passing through the cannula assembly during the manufacturing method of the blood pump system according to the application.

[0060] Figure 22 To Figure 21 Schematic view of the middle guidewire tube being inserted into the connection end of the blood pump and passing through the cannula assembly during the manufacturing method of the blood pump system according to the application.

[0061] Figure 23 To Figure 22 Schematic view of the middle guidewire tube being inserted into the connection end of the blood pump and passing through the cannula assembly during the manufacturing method of the blood pump system according to the application.

[0062] 10. Blood pump; 100. Cannula assembly; 101. First opening; 102. Second opening; 110. Cannula; 120. Inlet tube; 130. Outlet tube; 140. Connection end; 141. Flow guide; 142. Connection tube; 143. First end face; 200. Distal part; 210. Distal end; 220. Proximal end; 230. Tube body; 201. Thread port; 300. Drive device; 400. Impeller; 500. Guidewire tube; 510. First end; 520. Second end; 521. Second end face; 530. Positioning portion; 501. Lumen; 600. Mating portion; 601. Inner circumferential surface; 602. Stop surface. DETAILED DESCRIPTION

[0063] In order to make the above objectives, features and advantages of the application more apparent, specific embodiments of the application will be described in detail below with reference to the accompanying drawings. In the following description, numerous specific details are set forth in order to provide a thorough understanding of the application. However, the application can be practiced in a number of ways beyond the specific embodiments described and claimed herein, and it is understood that it can have employed similar modifications or changed arrangements as forms specific to the application without departing from the scope of the application.

[0064] In the related art, when a blood pump is inserted into a patient's body, a surgical incision is first made on the patient's body, and then a guide wire is inserted from the surgical incision and passes through a blood vessel to the heart. At this time, the guide wire has an in-vivo portion located in the patient's body and an ex-vivo portion located outside the patient's body. Then the ex-vivo portion of the guide wire is inserted into the distal part of the blood pump and passes through the cannula assembly of the blood pump, and finally passes out from the proximal end of the cannula assembly, so that the blood pump is arranged on the guide wire, and thus the blood pump can be pushed along the guide wire to the target position in the patient's body. When the blood pump reaches the target position, the guide wire is withdrawn. However, the inside of the cannula assembly of the blood pump is usually also provided with internal components, such as an impeller arranged in the proximal end of the cannula assembly. During the process of arranging the blood pump and the guide wire, the guide wire is easily rubbed or collided by the internal components (such as the impeller) of the blood pump, and the protective coating on the outer surface of the guide wire is easily rubbed or collided and falls off, and the falling-off material is easily entered into the blood, thereby causing the blood to be contaminated.

[0065] Referring to Figures 1 to 4 , based on the above situation, the present application provides a guide wire 500 and a blood pump system comprising the guide wire tube 500, which can reduce the damage to the blood during the process of inserting the blood pump into the patient's body and improve the safety performance of the product. In the description of the present application, it still needs to be explained that the proximal end refers to the end of the instrument or component close to the operator, and the distal end refers to the end of the instrument or component away from the operator; the axial direction refers to the direction parallel to the center line connecting the distal end and the proximal end of the instrument or component, the radial direction refers to the direction perpendicular to the axial direction, and the circumferential direction refers to the direction around the axial direction.

[0066] Referring to Figures 1 to 4 , in some embodiments of the present application, the blood pump system comprises a guide wire tube 500 and a blood pump 10; wherein the blood pump 10 comprises a cannula assembly 100 and a distal part 200; the cannula assembly 100 is provided with a connecting end 140 connected with the distal part 200, a first opening 101 adjacent to the connecting end 140 and a second opening 102 away from the connecting end 140; the guide wire tube 500 is arranged to be detachably arranged in the blood pump 10 for the guide wire 700 to pass through; the guide wire tube 500 has a first end 510 and a second end 520, and the second end 520 is away from the first end 510. The first end 510 of the guide wire tube 500 can pass through the cannula assembly 100 and extend out from the second opening 102 of the cannula assembly 100, and the second end 520 of the guide wire tube 500 is accommodated and positioned in the inside of the distal part 200 or the connecting end 140 (as shown in Figure 5 ).

[0067] Specifically, the distal member 200, the connecting end 140 and the cannula assembly 100 of the blood pump 10 are hollow structures to form a guide wire channel extending along the length direction of the blood pump 10. The distal member 200 is used to stabilize the position of the blood pump 10 in the heart and to provide non-invasive support for the heart tissue. The distal member 200 can be provided in a pigtail shape, and such a pigtail-shaped distal member 200 is also commonly known as a pigtail tube. Of course, in other embodiments, the distal member 200 can also be provided in other shapes. The distal end of the distal member 200 is provided with a wire port 201 which communicates with the guide wire channel in the distal member 200.

[0068] The guide wire tube 500 is also a hollow tubular structure, and the inside of the guide wire tube 500 forms a lumen 501 for the guide wire 700 to pass through. When the guide wire tube 500 is fitted onto the blood pump 10, the first end 510 of the guide wire tube 500 is first passed through the guide wire channel of the connecting end 140 and the cannula assembly 100 in sequence, and finally extends outward from the second opening 102 of the cannula assembly 100; in this process, the second end 520 of the guide wire tube 500 moves in the same direction and moves into the inside of the distal member 200 or the connecting end 140, so that the second end 520 of the guide wire tube 500 is accommodated and positioned in the guide wire channel of the distal member 200 or the connecting end 140 (i.e. the second end 520 does not extend outward from the wire port 201 of the distal member 200).

[0069] It can be understood that the second end 520 of the guide wire tube 500 is accommodated and positioned in the inside of the distal member 200 or the connecting end 140, and the "positioning" should be that the positioning force between the guide wire tube 500 and the blood pump 10 can be overcome or removed by using external force, so that the guide wire tube 500 can be separated from the blood pump 10. For example, the "positioning" is achieved by interference fit between the guide wire tube 500 and the distal member 200 or the connecting end 140, and when a certain external force is used to pull the guide wire tube 500, the external force is greater than the friction force generated by the interference fit, the guide wire tube 500 can be pulled out of the blood pump 10, and the guide wire tube 500 can be separated from the blood pump 10. For another example, the "positioning" is achieved by snap fit between the guide wire tube 500 and the distal member 200 or the connecting end 140, and when a certain external force is used to deform the structure forming the snap fit, the connection between the guide wire tube 500 and the blood pump 10 is removed, and the guide wire tube 500 can be separated from the blood pump 10. For another example, the "positioning" is achieved by using a small amount of adhesive to bond the guide wire tube 500 and the distal member 200 or the connecting end 140, and when a certain external force is used to make the second end 520 of the guide wire tube 500 fall off from the bonded position, the connection between the guide wire tube 500 and the blood pump 10 is removed, and the guide wire tube 500 can be separated from the blood pump 10. Details will be described later.

[0070] Please refer to Figure 5 and Figure 6 When the blood pump 10 is inserted into the patient, after the guide wire 700 is inserted into the patient, the guide wire 700 has an in-vivo portion remaining in the patient and an ex-vivo portion outside the patient; then the ex-vivo portion of the guide wire 700 is inserted from the threading port 201 of the distal part 200 of the blood pump 10 and enters the lumen 501 of the guide wire tube 500 through the second end 520 of the guide wire tube 500; then the ex-vivo portion of the guide wire 700 is continuously inserted along the lumen 501 of the guide wire tube 500 and moves to the first end 510 of the guide wire tube 500, since the first end 510 of the guide wire tube 500 extends outward from the second opening 102 of the blood pump 10, when the ex-vivo portion of the guide wire 700 passes out of the first end 510 of the guide wire tube 500, the ex-vivo portion of the guide wire 700 can partially pass out of the blood pump 10, thereby completing the threading of the blood pump 10 on the guide wire 700. Finally, the guide wire tube 500 is pulled out of the second opening 102 of the blood pump 10, so that the guide wire tube 500 is separated from the blood pump 10, and the blood pump 10 can be moved along the in-vivo portion of the guide wire 700 to the target position in the patient.

[0071] Therefore, the blood pump system of the present application, since the guide wire tube 500 is arranged in the blood pump 10 and is arranged to be separably threaded in the blood pump 10, so that during the threading of the blood pump 10 and the guide wire 700, the guide wire 700 can pass through the lumen 501 of the guide wire tube 500, and the guide wire tube 500 can wrap the guide wire 700, so that the guide wire 700 can effectively reduce the scratching of the internal components (such as the impeller 400) of the blood pump 10, thereby reducing the situation that the coating on the outer surface of the guide wire 700 is scraped off, reducing the risk that the coating of the guide wire 700 is scraped off into the blood and causes the blood to be contaminated, and greatly improving the safety performance of the blood pump system.

[0072] Since the second end 520 of the guide wire tube 500 is accommodated and positioned in the interior of the distal part 200 or the connecting end 140 (i.e. the second end 520 of the guide wire tube 500 does not extend outward from the distal end of the distal part 200), such design can make the position of the guide wire tube 500 more stable, and during the threading of the guide wire 700 into the guide wire tube 500, the guide wire tube 500 is not easy to be driven by the guide wire 700 to jump along the length direction of the blood pump 10, which can greatly facilitate the threading of the guide wire 700 by the operator. In addition, 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.

[0073] 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 surgical procedure, the physician inserts the guidewire 500 into the blood pump 10. For example, during the surgical procedure, 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 exits 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.

[0074] 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.

[0075] Please see Figure 3 and Figure 4In some embodiments, the first opening 101 is located on the sidewall of the distal end of the cannula assembly 100, and the second opening 102 is located on the sidewall of the proximal end of the cannula assembly 100. In this case, when the first opening 101 is the blood flow inlet, the second opening 102 is the blood flow outlet; otherwise, the first opening 101 is the blood flow outlet, and the second opening 102 is the blood flow inlet.

[0076] Referring to Figure 6 and Figure 7 In some embodiments, the second end 520 of the guide wire tube 500 is provided with a positioning portion 530, and the inner part of the distal end part 200 or the connecting end 140 is provided with a cooperating portion 600 that cooperates with the positioning portion 530. That is, the cooperating portion 600 cooperates with the positioning portion 530 to position the second end 520 of the guide wire tube 500 in the blood pump 10. In addition, at least one of the positioning portion 530 and the cooperating portion 600 can elastically deform and separate from the other.

[0077] In the process of inserting the guide wire tube 500 into the blood pump 10, when the positioning portion 530 of the guide wire tube 500 moves to the cooperating portion 600, the positioning portion 530 and the cooperating portion 600 are cooperatively connected, thereby positioning the second end 520 of the guide wire tube 500 in the blood pump 10. When the guide wire tube 500 needs to be removed, an external force is used to drive the guide wire tube 500 to move towards the second opening 102 of the blood pump 10, so that at least one of the positioning portion 530 and the cooperating portion 600 elastically deforms, thereby overcoming the force between the positioning portion 530 and the cooperating portion 600 of the guide wire tube 500, so that the positioning portion 530 and the cooperating portion 600 are separated, and the guide wire tube 500 can be pulled out of the blood pump, so that the guide wire tube 500 and the blood pump are separated from each other.

[0078] Referring to Figure 6 and Figure 7 In one embodiment, the second end 520 of the guide wire tube 500 is accommodated and positioned in the inner part of the connecting end 140. Specifically, the connecting end 140 includes a flow guide portion 141 and a connecting tube 142. The flow guide portion 141 is adjacent to the first opening 101, and the flow guide portion 141 can guide fluid from the outside of the blood pump 10 to the first opening 101 of the blood pump 10. The flow guide portion 141 has an inner cavity that forms part of the guide wire channel of the connecting end 140. The connecting tube 142 is provided at the distal end of the flow guide portion 141 and communicates with the inner cavity of the flow guide portion 141, and the connecting tube 142 is connected with the distal end part 200. Optionally, the cooperating portion 600 is arranged in the inner part of the flow guide portion 141 or the inner part of the connecting tube 142.

[0079] In some embodiments, the matching portion 600 is arranged inside the connecting tube 142. In this way, the positioning of the guide wire tube 500 in the connecting end 140 can be longer and more stable. Of course, in other embodiments, the matching portion 600 is arranged inside the guide flow portion 141. The guide flow portion 141 is closer to the first opening 101 than the connecting tube 142. When the guide wire tube 500 is pulled out, the guide wire tube 500 only needs to overcome the internal resistance of the guide flow portion 141 to separate from the connecting end 140, without friction with the connecting tube 142, so that the guide wire tube 500 can be pulled out more quickly.

[0080] Referring to Figure 6 and Figure 7 In some embodiments, the distal end part 200 is sleeved on the outer circumferential surface of the connecting tube 142 and is adhesively connected with the connecting tube 140. The matching portion 600 is arranged inside the connecting tube 142. That is, the second end 520 of the guide wire tube 500 is positioned and matched with the matching portion 600 inside the connecting tube 142 through the positioning portion 530. It is considered here that if the scheme of the guide wire tube 500 and the blood pump 10 is adopted in the second assembly scheme described above, the distal end part 200 is usually adhesively connected with the connecting end 140. During the adhesive connection process, the adhesive may extend from the distal end of the connecting tube 142 into the inside of the connecting tube 142 and contact the guide wire tube 500, so that the guide wire tube 500 and the connecting tube 142 are further adhesively connected together. This may cause the guide wire tube 500 to be positioned too tightly in the connecting tube 142, and a larger external force is required to pull out the guide wire tube 500 subsequently.

[0081] In view of the above, optionally, the connecting tube 142 has a first end surface 143 extending into the inside of the distal end part 200, and the second end 520 of the guide wire tube 500 has a second end surface 521, and a glue separation distance is formed between the second end surface 521 and the first end surface 143. The glue separation distance is indicated by D1 in Figure 7 In this way, during the adhesive connection of the distal end part 200 and the connecting tube 142, the adhesive for adhesively connecting the distal end part 200 and the connecting end 140 does not easily extend to the distal end of the connecting tube 142 or contact the second end 520 of the guide wire tube 500, so that the guide wire tube 500 and the connecting tube 142 are not further adhesively connected together. Subsequently, only the force between the positioning portion 530 of the second end 520 of the guide wire tube 500 and the matching portion 600 inside the connecting tube 142 needs to be overcome to pull out the guide wire tube 500.

[0082] It should be noted that the size of the glue separation distance can be flexibly adjusted and arranged according to actual needs, which is not limited here, as long as the adhesive can be prevented from extending into the guide wire tube 500 inside the connecting end 140 during the adhesive connection of the distal end part 200 and the connecting tube 142.

[0083] Referring to Figure 1、 Figure 10 and Figure 12 In some embodiments, the second end 520 of the guide wire tube 500 is received and positioned inside the distal member 200. Specifically, the distal member 200 comprises a distal portion 210, a proximal portion 220 and a tube body 230. The proximal portion 220 is connected to the connection end 140, and the tube body 230 is located between the distal portion 210 and the proximal portion 220. The first end 510 of the guide wire tube 500 is capable of penetrating the sleeve assembly 100 from the distal member 200 and the connection end 140. Optionally, the cooperating portion 600 is arranged on the inner circumferential surface of one of the distal portion 210, the proximal portion 220 and the tube body 230 of the distal member 200. That is, the second end 520 of the guide wire tube 500 is positioned inside one of the distal portion 210, the proximal portion 220 and the tube body 230 of the distal member 200.

[0084] The specific structure and cooperation mode of the positioning portion 530 of the guide wire tube 500 and the cooperating portion 600 in the blood pump 10 can have various design modes. The positioning portion 530 is capable of elastically deforming and separating from the cooperating portion 600.

[0085] Referring to Figures 9 to 11 In some embodiments, the positioning portion 530 of the guide wire tube 500 is positioned in interference fit with the cooperating portion 600 in the blood pump 10. The cooperating portion 600 is formed by the inner circumferential surface 601 (as shown in Figure 10 ) of the distal member 200, or the cooperating portion 600 is formed by the inner circumferential surface 601 (as shown in Figure 11 ) of the connection end 140, and the outer circumferential surface of the positioning portion 530 tightly fits with the inner circumferential surface 601, so as to realize the interference fit positioning of the positioning portion 530 and the cooperating portion 600. When disassembling, the guide wire tube 500 can be pulled out of the blood pump 10 by overcoming the friction between the outer circumferential surface of the positioning portion 530 and the inner circumferential surface 601.

[0086] Referring to Figures 8 to 13 , in the illustration, D2 represents the outer diameter of the positioning portion 530, and D3 represents the diameter of the cooperating portion 600 (i.e. the inner circumferential surface 601). As shown in Figures 8 to 11 In some embodiments, the positioning portion 530 is arranged in a trumpet shape, and the outer diameter D2 of the positioning portion 530 is in the direction from the distal member 200 to the sleeve assembly 100 (as shown in Figure 9The gradually decreasing setting is shown in FIG. 6B. The mating portion 600 is the inner circumferential surface 601 of the distal end member 200 or the connecting end 140, and is in interference fit with the outer circumferential surface of the positioning portion 530. The diameter of the mating portion 600 (i.e., the inner circumferential surface 601) gradually decreases in the direction from the distal end member 200 to the cannula assembly 100, so as to be in a contoured setting with the positioning portion 530. In this way, the area of contact between the positioning portion 530 and the inner circumferential surface 601 is increased, and the stability of the positioning is enhanced, so that the positioning portion 530 is not easily detached. As shown in FIG. 6B, Figure 12 and Figure 13 In other embodiments, the diameter D3 of the mating portion 600 (i.e., the inner circumferential surface 601) can also remain unchanged in the direction from the distal end member 200 to the cannula assembly 100.

[0087] When the guide wire tube 500 is pulled with force, the positioning portion 530 can be radially contracted and deformed, so as to overcome the friction between the positioning portion 530 and the inner circumferential surface 601, and the positioning portion 530 can be moved to be separated from the inner circumferential surface 601. In this way, the guide wire tube 500 can be pulled out of the second opening 102 to be separated from the blood pump 10. Of course, in combination with the specific structural setting of the positioning portion 530 and the mating portion 600, other ways can also be used to make the positioning portion 530 separate from the mating portion 600 and be separated from each other, for example, when the positioning portion 530 is arranged at the first end 510 of the guide wire tube 500, and the mating portion 600 is arranged at the second opening 102, after the guide wire 700 is arranged in the blood pump 10, the positioning portion 530 and the mating portion 600 can be separated from each other by using medical instruments, and then the guide wire tube 500 can be smoothly taken out of the second opening 102.

[0088] In addition, during the process of the guide wire 700 being inserted into the blood pump 10, the gradually decreasing diameter of the positioning portion 530 facilitates the insertion of the guide wire 700 into the guide wire tube 500. Optionally, the inner diameter of the end of the distal end member 200 away from the connecting end 140 (i.e., the distal end 210) is smaller than the maximum outer diameter of the positioning portion 530. When the positioning portion 530 of the guide wire tube 500 is in interference fit with the mating portion 600, the positioning portion 530 of the guide wire tube 500 is not easily displaced outwardly from the threading opening 201 of the distal end member 200, and the second end 520 of the guide wire tube 500 is prevented from extending out of the threading opening 201 of the distal end member 200. As an example, the guide wire tube 500 is an elastic tube or a plastic tube. Optionally, the guide wire tube 500 can be, but is not limited to, a silicone tube, a polyurethane tube, a PVC hose, a resin hose, etc.

[0089] In other embodiments, the positioning portion 530 of the guide wire tube 500 is snap-fitted and positioned with the cooperating portion 600 in the blood pump 10. For example, one of the positioning portion 530 and the cooperating portion 600 is provided as a resiliently deformable protrusion, a flange or a bump, and the other is provided as a recess or a stop surface capable of snap-fitting and limiting the positioning of the protrusion, the flange or the bump.

[0090] Referring to Figure 14 , Figure 15 and Figure 16 In some embodiments, the positioning portion 530 is provided as a positioning flange 531 protruding radially from the outer periphery of the second end 520 of the guide wire tube 500, and the cooperating portion 600 is provided as a stop surface 602 extending radially in the distal end member 200, the stop surface 602 being capable of abutting against the side surface of the positioning flange 531 to snap-fit and position the guide wire tube 500.

[0091] When the guide wire tube 500 is threaded onto the blood pump 10, the first end 510 of the guide wire tube 500 enters the distal end member 200 from the threading port 201 of the distal end member 200, and then passes through the distal end member 200 and the cannula assembly 100 in sequence, and exits from the second opening 102 of the cannula assembly 100. In this process, the second end 520 of the guide wire tube 500 moves into the distal end member 200 from the threading port 201 of the distal end member 200, until the positioning flange 531 on the second end 520 of the guide wire tube 500 encounters the stop surface 602 in the distal end member 200 and abuts against the stop surface 602, and the stop surface 602 blocks the guide wire tube 500 from moving further, so that the second end 520 of the guide wire tube 500 is positioned in the distal end member 200. When it is necessary to detach the guide wire tube 500, the guide wire tube 500 is pulled in the direction indicated by the arrow F in Figure 11 In this process, the positioning flange 531 of the guide wire tube 500 deforms and is radially retracted, so that the positioning flange 531 is separated from the stop surface 602, and the guide wire tube 500 can then pass through the cannula assembly 100 completely and be pulled out from the second opening 102 of the blood pump 10.

[0092] Referring to Figure 17 and Figure 18 In other embodiments, the positioning portion 530 is provided as a positioning flange 531 protruding radially from the outer periphery of the second end 520 of the guide wire tube 500, and the cooperating portion 600 is provided as a stop surface 602 extending radially in the connecting end 140, the stop surface 602 being capable of abutting against the side surface of the positioning flange 531 to snap-fit and position the guide wire tube 500.

[0093] When the guide wire tube 500 is mounted on the blood pump 10, after the first end 510 of the guide wire tube 500 passes through the sleeve assembly 100 and comes out of the second opening 102 of the sleeve assembly 100, the second end 520 of the guide wire tube 500 moves into the connecting end 140 until the positioning flange 531 on the second end 520 of the guide wire tube 500 meets the stop surface 602 in the connecting end 140 and abuts against the stop surface 602, and the second end 520 of the guide wire tube 500 is positioned in the distal end part 200. When it is needed to separate the guide wire tube 500, the guide wire tube 500 is pulled in the direction indicated by the arrow F in Figure 16 , the positioning flange 531 of the guide wire tube 500 is deformed and contracted radially, so that the positioning flange 531 is separated from the stop surface 602, and then the guide wire tube 500 can be pulled out of the second opening 102 of the blood pump 10.

[0094] Optionally, as shown in Figure 19 , the positioning flange 531 is annularly arranged along the outer periphery of the second end 520. Alternatively, as shown in Figure 20 , the positioning flange 531 includes at least two positioning petals 532 arranged at intervals along the outer periphery of the second end 520, and a gap 533 is formed between the adjacent two positioning petals 532 for the deformation of the positioning flange 531. The gap 533 can form a deformation space for the positioning flange 531, which is beneficial to the deformation of the positioning flange 531.

[0095] The stop surface 602 is annularly arranged along the inner periphery of the distal end part 200 or the connecting end 140; or the connecting end 140 has a first end surface 143 extending into the inside of the distal end part 200, and the first end surface 143 forms the stop surface 602.

[0096] Based on any one of the above embodiments, the guide wire tube 500 has a first length (assumed as L1); the connecting end 140 has a second length (assumed as L2) extending from the first end surface 143 to the second opening 102; the distal end part 200 has a third length (assumed as L3); if the first end 510 of the guide wire tube 500 is outwardly extended from the second opening 102 and the second end 520 of the guide wire tube 500 is also outwardly extended from the threading opening 201 of the distal end part 200, it is necessary that the first length is greater than the sum of the second length and the third length (i.e. L1>L2+L3). However, in the present embodiment, when the second end 520 of the guide wire tube 500 is positioned in the connecting end 140 of the cannula assembly 100, as long as the first length is greater than the second length (i.e. L1>L2), the first end 510 of the guide wire tube 500 can be outwardly extended from the second opening 102, and it is not necessary to satisfy L1>L2+L3. In this case, the guide wire tube 500 can be connected with the blood pump 10 by using the second assembly scheme as described above, and as long as L1>L2 (even if L1 does not satisfy L1>L2+L3), the guide wire tube 500 can be connected to the blood pump 10.

[0097] Further, 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

[0098] Please refer to Figure 1 and Figure 2 Based on any one of the above embodiments, the cannula assembly 100 comprises the inlet tube 120, the cannula 110 and the outlet tube 130 connected in sequence. The inlet tube 120 is provided with the first opening 101, and the outlet tube 130 is provided with the second opening 102. It can be understood that when the cannula assembly 100 is designed in a split structure of the inlet tube 120, the cannula 110 and the outlet tube 130, and the inlet tube 120, the cannula 110 and the outlet tube 130 are assembled in sequence, the inlet tube 120, the cannula 110 and the outlet tube 130 can be machined respectively, so that the machining difficulty of the cannula assembly 100 is reduced.

[0099] Of course, in other embodiments, the inlet tube 120 can be a part of the cannula 110, i.e. the inlet tube 120 is integrally manufactured with the cannula 110; or the inlet tube 120 can be separately manufactured with other parts of the cannula 110 and then connected together. Similarly, the outlet tube 130 can also be a part of the cannula 110, i.e. the outlet tube 130 is integrally manufactured with the cannula 110; or the outlet tube 130 can be separately manufactured with the cannula 110 and then connected together.

[0100] In some embodiments, the connection end 140 is formed at an end of the inlet tube 120 distal to the cannula 110. The tube wall of the cannula 110 is configured as a transparent tube wall. The color of the guide wire tube 500 is different from the color of the tube wall of the cannula 110, and the color of the guide wire tube 500 can be shown outwardly through the tube wall of the cannula 110. In this way, the specific position of the guide wire tube 500 can be directly observed through the blood pump 10 during the process of the guide wire tube 500 being inserted into or pulled out of the cannula 110, thereby facilitating the operation.

[0101] In other embodiments, the second end 520 of the guide wire tube 500 is moved into the interior of the distal end part 200; at least the color of the second end 520 of the guide wire tube 500 is different from the color of the distal end part 200, and at least the color of the second end 520 can be shown outwardly through the tube wall of the distal end part 200. In this way, the specific position of the guide wire tube 500 can be directly observed through the distal end part 200 during the process of the guide wire tube 500 being inserted into or pulled out of the distal end part 200, thereby facilitating the operation.

[0102] Based on any of the above embodiments, the blood pump 10 further comprises an impeller 400 arranged in the cannula assembly 100, the impeller 400 is rotatable relative to the cannula assembly 100, and the impeller 400 is adjacent to the second opening 102. Since the material of the guide wire tube 500 is configured as a deformable flexible or elastic material, the guide wire tube 500 is not prone to rigid contact friction or collision with the impeller 400 when passing through the gap between the impeller 400 and the inner wall of the cannula assembly 100. When the guide wire 700 is subsequently threaded, the guide wire 700 passes through the lumen 501 of the guide wire tube 500, and the guide wire 700 is wrapped and protected by the guide wire tube 500, so as not to easily contact the impeller 400, thereby effectively avoiding the coating on the outer surface of the guide wire 700 being scratched by the impeller 400.

[0103] Optionally, the blood pump 10 can further comprise a driving device 300 connected to an end of the cannula assembly 100 adjacent to the second opening 102, and the driving device 300 has a motor shaft extending into the cannula assembly 100 and connected to the impeller 400. When the driving device 300 is in operation, the driving device 300 drives the impeller 400 to rotate, and the impeller 400 provides power to make the blood flow between the first opening 101 and the second opening 102 when rotating. Of course, the driving device 300 is not necessary. In other embodiments, the impeller 400 can also be driven by an extracorporeal motor.

[0104] Please refer to Figures 21 to 23 To achieve the second assembly scheme of the guide wire tube 500 and the blood pump 10 threading, the application further provides a manufacturing method of a blood pump system, which comprises the following steps:

[0105] Step S10: providing a blood pump 10, the blood pump 10 comprising a cannula assembly 100 and a distal component 200; the cannula assembly 100 is provided with a connection end 140, a first opening 101 adjacent to the connection end 140, and a second opening 102 away from the connection end 140; the distal component 200 and the connection end 140 of the cannula assembly 100 are in an unconnected state.

[0106] Step S20: providing a guide wire tube 500 having a second end 520 and a first end 510, the first end 510 of the guide wire tube 500 is inserted into the cannula assembly 100 from the connection end 140 and is outwardly drawn out from the second opening 102 of the cannula assembly 100, and the second end 520 of the guide wire tube 500 is received and positioned inside the connection end 140. Figure 22 The arrow F represents the moving direction of the second end 520 of the guide wire tube 500 into the connection end 140.

[0107] Step S30: connecting the distal component 200 of the blood pump 10 with the connection end 140 of the cannula assembly 100.

[0108] The manufacturing method of the blood pump system described above, in the process of inserting the blood pump 10 into the guide wire 700, the guide wire 700 is inserted into the first end 510 of the guide wire tube 500 and drawn out from the second end 520 of the guide wire tube 500, and then the guide wire tube 500 is drawn out from the second opening 102 of the blood pump 10, and then the blood pump 10 is moved along the guide wire 700 to the target position to complete the interventional action. As can be seen, in the process of inserting the blood pump 10 into the guide wire 700, since the guide wire 700 is passed through the lumen 501 of the guide wire tube 500, the guide wire tube 500 wraps the guide wire 700, which can avoid the guide wire 700 from being scratched by the impeller 400 to cause the coating on the outer surface of the guide wire 700 to be damaged, so that the coating on the outer surface of the guide wire 700 will not be scraped off into the blood to cause the blood to be damaged, so that the performance of the product is improved. Moreover, the guide wire tube 500 is configured in the blood pump 10 before the blood pump 10 is shipped, so that the physician does not need to set the guide wire tube 500 by himself, which can reduce the physician's operation.

[0109] In addition, since the distal part 200 is usually arranged in a pigtail shape, during the process of threading the guide wire 700 onto the blood pump 10, the physician needs to use one hand to straighten or unfold the distal part 200, and if the second end 520 of the guide wire tube 500 extends outward from the distal end of the distal part 200, the physician also needs to use the other hand to fix the second end 520 of the guide wire tube 500, and the subsequent threading operation of the guide wire 700 needs to be performed by another physician. In the present application, since the second end 520 of the guide wire tube 500 of the present application is moved into and positioned inside the distal part 200 or the connecting end 140, this design only needs the physician to use one hand to straighten or unfold the distal part 200 during the process of threading the guide wire 700 onto the blood pump 10, without the need to hold the guide wire tube 500, the operation difficulty is reduced, and the other hand of the physician can be used to perform the subsequent threading operation of the guide wire 700, so that one physician can complete the threading of the guide wire 700 and the blood pump 10 by himself, improving the assembly efficiency.

[0110] Specifically, the distal part 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, and the tube body 230 is located between the distal end 210 and the proximal end 220. In the above step S30, the distal part 200 is connected to the connecting end 140 through the proximal end 220, and the specific connection mode of the two can be, but is not limited to, adhesive connection or hot melt connection. Specifically, in the present embodiment, the proximal end 220 of the distal part 200 is connected to the connecting end 140 by adhesive connection.

[0111] Further, the second end 520 of the guide wire tube 500 has a second end face 521, the connecting end 140 has a first end face 143 extending into the inside of the distal part 200, and a glue spacing is formed between the first end face 143 and the second end face 521. The step of connecting and fixing the distal part 200 to the connecting end 140 of the sleeve assembly 100 in the manufacturing method (i.e., the above step S30) specifically includes the following steps:

[0112] Step S31: Adhesive is arranged on the outer peripheral surface of the connecting tube 142 of the connecting end 140 or the inner peripheral surface of the proximal end of the distal part 200;

[0113] Step S32: The proximal end of the distal part 200 is sleeved on the outer peripheral surface of the connecting tube 142, so that the distal part 200 and the connecting tube 142 are adhesively connected.

[0114] Please refer to 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.

[0115] 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.

[0116] 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)). This 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.

[0117] 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.

[0118] In the process of threading the guide wire tube 500 into the blood pump 10, when the positioning portion 530 of the guide wire tube 500 moves and reaches the cooperating portion 600, the positioning portion 530 and the cooperating portion 600 are correspondingly connected in cooperation, thereby positioning the second end of the guide wire tube 500 in the blood pump. When the guide wire tube 500 needs to be removed, an external force is used to drive the guide wire tube 500 to move towards the second opening 102 of the blood pump 10, so that at least one of the positioning portion 530 and the cooperating portion 600 elastically deforms, thereby overcoming the force between the positioning portion 530 and the cooperating portion 600 of the guide wire tube 500, so that the positioning portion 530 and the cooperating portion 600 are separated, and then the guide wire tube 500 can be pulled out of the blood pump, so that the guide wire tube 500 and the blood pump are separated from each other.

[0119] Please refer to Figures 8 to 13 , in the diagram, D2 represents the outer diameter of the positioning portion 530, and D3 represents the diameter of the cooperating portion 600 (i.e. the inner circumferential surface 601). In some embodiments, as shown in Figure 10 and Figure 11 , the positioning portion 530 is provided in a trumpet shape, and the outer diameter D2 of the positioning portion 530 gradually decreases in the direction from the distal end part 200 to the sleeve assembly 100; the cooperating portion 600 is the inner circumferential surface 601 of the distal end part 200 or the connecting end 140, and is in interference fit with the outer circumferential surface of the positioning portion 530. Among them, the diameter of the cooperating portion 600 (i.e. the inner circumferential surface 601) gradually decreases in the direction from the distal end part 200 to the sleeve assembly 100, so as to be shaped with the positioning portion 530, so as to increase the contact area of the positioning portion 530 and the inner circumferential surface 601, and to enhance the stability of the positioning and not to be easily detached. As shown in Figure 12 and Figure 13 , in other embodiments, the diameter D3 of the cooperating portion (i.e. the inner circumferential surface 601) can also remain unchanged in the direction from the distal end part 200 to the sleeve assembly 100.

[0120] When disassembling, the guide wire tube 500 is pulled, so that the positioning portion 530 is radially contracted and deformed, thereby overcoming the friction between the positioning portion 530 and the inner circumferential surface 601, so that the positioning portion 530 can be moved and separated from the inner circumferential surface 601, and then the guide wire tube 500 can be pulled out of the second opening 102 to be separated from the blood pump 10. Of course, combined with the specific structural arrangement of the positioning portion 530 and the cooperating portion 600, other ways can also be used to make the positioning portion 530 separate from the cooperating portion 600 and separate from each other, for example, when the positioning portion 530 is arranged at the first end 510 of the guide wire tube 500 and the cooperating portion 600 is arranged at the second opening 102, after the guide wire 700 is threaded into the blood pump 10, the positioning portion 530 and the cooperating portion 600 can be separated from each other by using medical instruments, and then the guide wire tube 500 can be smoothly taken out of the second opening 102.

[0121] In addition, the diameter of the positioning portion 530 gradually decreases during the insertion of the guide wire 700 into the blood pump 10, which facilitates the insertion of the guide wire 700 into the guide wire tube 500. Optionally, the inner diameter of the end of the distal end member 200 distal to the connecting end 140 (i.e., the distal end 210) is smaller than the maximum outer diameter of the positioning portion 530. When the positioning portion 530 of the guide wire tube 500 is in interference fit with the cooperating portion 600, the positioning portion 530 of the guide wire tube 500 is less likely to be displaced outwardly from the threading opening 201 of the distal end member 200, thereby preventing the second end 520 of the guide wire tube 500 from extending out of the threading opening 201 of the distal end member 200. As an example, the guide wire tube 500 is an elastic tube or a plastic tube. Optionally, the guide wire tube 500 can be, but is not limited to, a silicone tube, a polyurethane tube, a PVC hose, a resin hose, etc.

[0122] Referring to Figure 15 and Figure 16 In other embodiments, the difference from the above embodiments is that the positioning portion 530 is configured as a positioning flange 531 protruding radially from the outer periphery of the second end 520 of the guide wire tube 500, and the cooperating portion 600 is a stop surface 602 arranged radially within the distal end member 200, which is capable of abutting against the side surface of the positioning flange 531 to be clamped and positioned.

[0123] When the guide wire tube 500 is threaded onto the blood pump, the first end of the guide wire tube 500 enters the distal end member 200 from the threading opening of the distal end member 200, and then passes through the distal end member 200 and the sleeve assembly 100 in sequence, and exits from the second opening 102 of the sleeve assembly 100. In this process, the second end 520 of the guide wire tube 500 moves into the distal end member 200 from the threading opening 201 of the distal end member 200, until the positioning flange 531 on the second end 520 of the guide wire tube 500 encounters the stop surface 602 within the distal end member 200 and comes into contact with the stop surface 602, and the stop surface 602 blocks the guide wire tube 500 from moving further, so that the second end 520 of the guide wire tube 500 is positioned within the distal end member 200. When it is necessary to detach the guide wire tube 500, the guide wire tube 500 is pulled in the direction indicated by the arrow F in Figure 11 In this process, the positioning flange 531 of the guide wire tube 500 deforms and is radially retracted, so that the positioning flange 531 is separated from the stop surface 602, and the guide wire tube 500 can then pass through the sleeve assembly 100 completely and be pulled out of the second opening 102 of the blood pump 10.

[0124] Referring to Figure 17 and Figure 18In some embodiments, the positioning portion 530 is a positioning flange 531 protruding radially from the outer periphery of the second end 520 of the guide wire tube 500, and the cooperating portion 600 is a stop surface 602 extending radially in the connecting end 140, the stop surface 602 being capable of abutting the side surface of the positioning flange 531 to be clamped and positioned.

[0125] When the guide wire tube 500 is mounted on the blood pump, after the first end of the guide wire tube 500 passes through the cannula assembly 100 and comes out of the second opening of the cannula assembly 100, the second end 520 of the guide wire tube 500 moves into the connecting end until the positioning flange 531 on the second end 520 of the guide wire tube 500 encounters the stop surface 602 in the connecting end 140 and abuts against the stop surface 602, and the second end 520 of the guide wire tube 500 is positioned in the distal part 200. When it is necessary to separate the guide wire tube 500, the guide wire tube 500 is pulled in the direction indicated by the arrow F in FIG. 6, and the positioning flange 531 of the guide wire tube 500 is deformed and radially retracted, so that the positioning flange 531 is separated from the stop surface 602, and the guide wire tube 500 can be pulled out of the second opening 102 of the blood pump 10. Figure 16

[0126] In the description of the present application, it should be understood that if these terms "center", "longitudinal", "transverse", "length", "width", "thickness", "upper", "lower", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", "clockwise", "counterclockwise", "axial", "radial", "circumferential" and the like appear, these terms indicate the orientation or positional relationship based on the orientation or positional relationship shown in the drawings, and are only for the convenience of describing the present application and simplifying the description, and therefore cannot be understood as indicating or implying that the devices or elements referred to must have a particular orientation, be constructed and operated in a particular orientation, and therefore cannot be understood as limiting the present application.

[0127] In addition, if these terms "first", "second" appear, these terms are only for the purpose of description, and cannot be understood as indicating or implying relative importance or implicitly indicating the number of technical features referred to. Therefore, the features defined as "first", "second" can explicitly or implicitly include at least one of the features. In the description of the present application, if the term "multiple" appears, the meaning of "multiple" is at least two, for example, two, three, etc., unless otherwise specifically limited.

[0128] ​In this application, unless otherwise clearly indicated and limited, if there are terms such as "mount", "connect", "connect", "fix", etc., these terms should be understood in a broad sense. For example, it can be fixedly connected, or it can be detachably connected, or it can be integrated; it can be mechanically connected, or it can be electrically connected; it can be directly connected, or it can be indirectly connected through an intermediate medium; it can be the internal communication of two elements or the interaction relationship between two elements, unless otherwise clearly limited. For those skilled in the art, the specific meaning of the above terms in this application can be understood according to the specific circumstances.

[0129] In this application, unless otherwise clearly indicated and limited, if there are terms such as "mount", "connect", "connect", "fix", etc., these terms should be understood in a broad sense. For example, it can be fixedly connected, or it can be detachably connected, or it can be integrated; it can be mechanically connected, or it can be electrically connected; it can be directly connected, or it can be indirectly connected through an intermediate medium; it can be the internal communication of two elements or the interaction relationship between two elements, unless otherwise clearly limited. For those skilled in the art, the specific meaning of the above terms in this application can be understood according to the specific circumstances.

[0130] It should be noted that if an element is referred to as "fixed to" or "disposed on" another element, it can be directly on another element or there can be a middle element. If an element is considered to be "connected" to another element, it can be directly connected to another element or there can be a middle element. If present, the terms "vertical", "horizontal", "up", "down", "left", "right" and similar expressions used in this application are for illustrative purposes only and do not represent the only implementation.

[0131] The technical features of the above-described embodiments can be combined in any manner. In order to make the description concise, not all possible combinations of the technical features in the above-described embodiments are described, but as long as the combination of the technical features does not exist Contradiction, it should be considered within the scope of the present application.

[0132] The above-described embodiments only express several embodiments of the present application, and the description is more specific and detailed, but it should not be construed as limiting the scope of the patent application. It should be noted that for those skilled in the art, without departing from the concept of the present application, some modifications and improvements can be made, which are within the scope of the present application. Therefore, the scope of the patent of the present application should be subject to the appended claims.

Claims

1. A blood pump system, characterized by, The blood pump system comprises: a blood pump comprising a cannula assembly and a distal part; the cannula assembly is provided with a connecting end, a first opening and a second opening; wherein the connecting end is connected with the distal part; the first opening is adjacent to the connecting end; the second opening is away from the connecting end; and a guide wire tube configured to be detachably arranged in the blood pump for the guide wire to pass through; the guide wire tube has a first end and a second end; wherein the first end can pass through the cannula assembly and extend outward from the second opening, and the second end can be accommodated and positioned inside the distal part or the connecting end; wherein the connecting end comprises a flow guide part and a connecting tube; wherein the flow guide part is adjacent to the first opening, and has an inner cavity; the connecting tube is arranged at the distal end of the flow guide part and communicates with the inner cavity of the flow guide part, and the connecting tube is connected with the distal part; the distal part is sleeved on the outer peripheral surface of the connecting tube and is adhesively connected with the connecting tube, and the connecting tube has a first end surface extending into the inside of the distal part; the second end of the guide wire tube has a second end surface, and a glue spacing is formed between the second end surface and the first end surface.

2. The blood pump system of claim 1, wherein, The second end of the guide wire tube is provided with a positioning part; the inside of the connecting end is provided with a matching part matched with the positioning part; at least one of the positioning part and the matching part can be elastically deformed and separated from the other.

3. The blood pump system of claim 2, wherein, The matching part is arranged inside the flow guide part or inside the connecting tube.

4. The blood pump system of claim 1, wherein, The distal part is used to stabilize the position of the blood pump in the heart and provide non-invasive support for the heart tissue; the distal part is a hollow structure, and a threading port is arranged at the distal end of the distal part, which communicates with a guide wire channel in the distal part.

5. The blood pump system of claim 2, wherein, The distal part comprises a distal end part, a proximal end part and a tube body between the distal end part and the proximal end part; wherein the proximal end part is connected with the connecting end; the matching part is arranged on the inner wall of one of the distal end part, the proximal end part and the tube body of the distal part.

6. The blood pump system of any of claims 2, 3, 5, wherein, The positioning part and the matching part are in interference fit or clamping fit.

7. The blood pump system of claim 6, wherein, The positioning part is arranged in a trumpet shape, and the outer diameter of the positioning part gradually decreases from the distal part to the cannula assembly; the matching part is at least a part of the inner peripheral surface of the distal part or the connecting end, which is in interference fit with the outer peripheral surface of the positioning part.

8. The blood pump system of claim 7, wherein, The diameter of the matching part remains unchanged in the direction from the distal part to the cannula assembly; or the diameter of the matching part gradually decreases in the direction from the distal part to the cannula assembly, and the shape of the matching part is shaped according to the shape of the positioning part.

9. The blood pump system of claim 6, wherein, The positioning part is arranged as a positioning flange protruding radially from the outer peripheral edge of the second end of the guide wire tube; the matching part is a stop surface arranged in the distal part or the connecting end and extending radially, which can be clamped and positioned with the side surface of the positioning flange.

10. The blood pump system of claim 9, wherein, The positioning flange is annularly arranged along the outer periphery of the second end; or the positioning flange comprises at least two positioning petals arranged along the outer periphery of the second end, and a gap is formed between two adjacent positioning petals for deformation of the positioning flange.

11. The blood pump system of claim 9, wherein, The stop surface is arranged on the inner periphery of the distal end component or the connecting end, and is annularly arranged along the inner periphery; or the connecting end has a first end surface extending into the distal end component, and the first end surface forms the stop surface.

12. The blood pump system of any one of claims 1 to 5, wherein, The sleeve assembly comprises an inlet tube, a sleeve and an outlet tube connected in sequence; the first opening is arranged on the inlet tube, and a distal end of the inlet tube forms the connecting end; the second opening is arranged on the outlet tube; the guide wire tube has a color different from that of the sleeve wall, and the color of the guide wire tube can be displayed outwardly through the sleeve wall; Or, the second end of the guide wire tube is accommodated in the interior of the distal end component; at least the color of the second end of the guide wire tube is different from that of the distal end component, and at least the color of the second end can be displayed outwardly through the sleeve wall of the distal end component.

13. The blood pump system of claim 1, wherein, The guide wire tube has a first length; the connecting end has a first end surface away from the first opening, and the connecting end has a second length extending from the first end surface to the second opening; the distal end 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.

14. The blood pump system of any one of claims 1 to 5, wherein, The blood pump further comprises an impeller arranged in the sleeve assembly, the impeller can rotate relative to the sleeve assembly, and the impeller is adjacent to the second opening.

15. A method of manufacturing a blood pump system, characterized by The method comprises the following steps: Providing a blood pump comprising a sleeve assembly and a distal end component; the distal end component and the sleeve assembly are in an unconnected state; the sleeve assembly is provided with a connecting end, a first opening adjacent to the connecting end and a second opening away from the connecting end; Providing a guide wire tube having a first end and a second end, inserting the first end of the guide wire tube into the sleeve assembly from the connecting end, and inserting the second end of the guide wire tube into the sleeve assembly from the second opening of the sleeve assembly; the second end of the guide wire tube is accommodated and positioned in the interior of the connecting end; Connecting and fixing the distal end component and the connecting end of the sleeve assembly; The connecting end has a first end surface extending into the interior of the distal end component; the second end of the guide wire tube has a second end surface, and a glue spacing is formed between the second end surface and the first end surface; The step of connecting and fixing the distal end component and the connecting end of the sleeve assembly in the manufacturing method comprises the following steps: Glue is arranged on the outer periphery of the connecting tube of the connecting end, or on the inner periphery of the proximal end of the distal end component; The proximal end of the distal end component is sleeved on the outer periphery of the connecting tube, so that the distal end component and the connecting tube are adhesively connected.

16. The production method according to claim 15, wherein The connecting end comprises a flow guide portion adjacent to the first opening, and a connecting tube protruding from the flow guide portion, and the distal end surface of the connecting tube is the first end surface.

17. The production method according to claim 15, wherein The guide wire tube has a first length; the connecting end has a first end surface away from the first opening, the connecting end has a second length extending from the first end surface thereof to the second opening; the distal end 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.

18. The production method according to claim 15, wherein The second end of the guide wire tube is provided with a positioning portion; the inside of the distal end component or the connecting end is provided with a cooperating portion cooperating with the positioning portion; at least one of the positioning portion and the cooperating portion can be elastically deformed and separated from the other; Wherein, the positioning portion is provided in a trumpet shape, the outer diameter of the positioning portion is gradually reduced in the direction from the distal end component to the sleeve assembly; the cooperating portion is the inner peripheral surface of the connecting end, and is in interference fit with the positioning portion; Or, the positioning portion is provided as a positioning flange protruding radially from the outer periphery of the second end of the guide wire tube, and the cooperating portion is a stop surface provided in the connecting end and extending radially, the stop surface can be in close contact with the side surface of the positioning flange to be clamped and positioned.

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