Folding method of a pump head of a collapsible catheter pump and a sterile sleeve assembly, interventional system

Abstract

The application discloses a pump head folding method of a foldable catheter pump, a sterile sleeve assembly and an interventional system. The pump head folding method comprises the following steps: sleeving the sterile sleeve assembly on the pump head in an unfolded state, wherein a distal connector of the sterile sleeve assembly is located on the side of the protection tip of the pump head, and a proximal connector of the sterile sleeve assembly is located on the side of the proximal catheter connected to the pump head; opening one of the distal connector and the proximal connector of the sterile sleeve assembly and clamping the other one, injecting pre-flushing liquid into the sterile sleeve assembly from the clamped connector, and pre-flushing and exhausting the pump head and the sterile sleeve; sleeving the opened pressure holder on the sleeve body of the pump head, and operating the pressure holder to compress the pump head to a folded state. The pre-folding operation of the pump head is performed based on the pressure holder, the pushing force can be reduced, the operation convenience is good, and the overall configuration management cost is low. Meanwhile, after the sleeve body of the sterile sleeve assembly is filled with liquid, the frictional resistance of the pump head when being pushed into the introducer can be reduced.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, specifically to a method for folding the pump head of a foldable catheter pump, a sterile sheath assembly, and an interventional system. Background Technology

[0002] Heart disease is a highly fatal condition, and mechanical circulatory support (MCS) systems and ventricular assist devices (VADs) are commonly used clinically to treat heart failure. It is well known that equipment for treating acute heart failure needs to provide rapid support to patients and facilitate quick, minimally invasive deployment of treatment plans by physicians.

[0003] A typical implementation of an MCS system involves a rotary catheter pump placed percutaneously via a catheter. In conventional methods, the catheter pump is inserted into the body and connected to the cardiovascular system (e.g., connecting the left ventricle and ascending aorta) to assist the heart's pumping function, reducing myocardial load for a period of time, stabilizing patients before heart transplantation, or providing continuous support. For example, it can stabilize patients after cardiogenic shock during the treatment of acute myocardial infarction (MI) or compensated heart failure; or provide support to patients during high-risk percutaneous coronary intervention (PCI).

[0004] Existing catheter pumps come in two basic forms: one with a built-in, non-foldable motor, and the other with an external, foldable motor. The foldable catheter pump's pump head can switch between an extended and retracted state, meaning it has a relatively small interventional size and a large extended size. The smaller interventional size allows it to enter the patient's body through a smaller puncture site, reducing patient discomfort and puncture site complications. Simultaneously, the larger extended size provides better hydraulic performance, enabling a larger auxiliary flow rate.

[0005] In actual interventional procedures, the pump head of the foldable catheter pump needs to be folded externally. Specifically, the inserter with a pre-folding channel is slidable around the outside of the catheter. By pushing the inserter or pulling the catheter, the pump head is folded into the pre-folding channel of the inserter. This process involves significant resistance and is not very convenient.

[0006] In view of this, there is an urgent need to optimize the pump head folding operation method of the foldable duct pump. Summary of the Invention

[0007] To address the aforementioned technical problems, this invention provides a method for folding the pump head of a foldable catheter pump, a sterile sleeve assembly, and an interventional system. By optimizing the pump head folding method, the operability of pump head delivery can be effectively improved.

[0008] The present invention provides a method for folding the pump head of a foldable tubing pump. The foldable tubing pump includes a pump head, a tubing, and a coupler. The pump head is disposed at the distal end of the tubing, and the coupler is disposed at the proximal end of the tubing. The pump head can be switched between an unfolded state and a folded state. The method is characterized by comprising: fitting a sterile sleeve assembly onto the unfolded pump head, wherein the distal connector of the sterile sleeve assembly is located on the protective tip side of the pump head, and the proximal connector of the sterile sleeve assembly is located on the side of the tubing connected to the proximal end of the pump head; opening one of the distal and proximal connectors of the sterile sleeve assembly and clamping the other; injecting a pre-flushing liquid into the sterile sleeve assembly through the clamped connector to pre-flush and vent the pump head and the sterile sleeve; fitting an open gripper onto the sleeve of the sterile sleeve assembly around the pump head, and operating the gripper to close and compress the pump head to the folded state.

[0009] Optionally, a flushing syringe is connected to the input interface of the clamped connector in the distal and proximal connectors to inject pre-flushing fluid into the sterile sheath assembly.

[0010] Optionally, after operating the pressure gripper to close and compress the pump head to the folded state, the method further includes the steps of: connecting the flushing pump to the flushing port of the coupler of the foldable tubing pump, and opening the distal connector of the sterile sheath; starting the flushing pump, and the pre-flushing solution entering the tubing through the coupler to pre-flushing and vent the tubing; after the pre-flushing and venting of the tubing is completed, operating the distal connector of the sterile sheath to clamp the tubing.

[0011] Optionally, after pre-flushing and venting the catheter, the procedure further includes the steps of: coupling the distal connector of the sterile sheath to the proximal end of the introducing device, starting the flushing pump, and pre-flushing and venting the introducing device.

[0012] Optionally, after pre-flushing and venting the catheter, the procedure further includes the steps of: coupling the distal end of the introducer to the proximal end of the interventional sheath, and transferring the pump head located in the gripper to the interventional channel of the interventional sheath via the introducer.

[0013] Optionally, after the introducer is transferred into the interventional channel of the interventional sheath, the procedure further includes the steps of: opening and removing the gripper, opening at least the distal connector of the sterile sheath assembly, manipulating the introducer and the distal connector of the sterile sheath assembly to move backward together, and removing the introducer from the proximal end of the interventional sheath.

[0014] Optionally, after opening the gripper, the gripper is moved to the proximal end of the coupler and removed.

[0015] Optionally, after removing the introducing device from the proximal end of the interventional sheath, the procedure further includes the steps of: moving the distal connector of the sterile sheath distally and coupling it with the proximal end of the interventional sheath, and then clamping the distal connector.

[0016] The present invention also provides a sterile sleeve assembly, including a sleeve body and a distal connector and a proximal connector located at both ends of the sleeve body, wherein both the distal connector and the proximal connector have a locking portion; at least one of the distal connector and the proximal connector has an input interface, and the input interface communicates with the inner cavity of the corresponding locking portion.

[0017] Optionally, there is unidirectional communication between the input interface and the inner cavity of the locking part.

[0018] The present invention also provides an interventional system for pre-folding the pump head of a foldable catheter pump, comprising a gripper and a sterile sheath assembly, wherein the sterile sheath assembly can be fitted onto the pump head of the foldable catheter pump, and the gripper can be fitted onto the sheath of the sterile sheath assembly, wherein the sterile sheath assembly is as described above.

[0019] For foldable tubing pumps, this solution proposes a novel pump head folding method based on a pressure gripper. Specifically, firstly, a sterile sheath assembly is fitted onto the unfolded pump head, with the distal connector of the sterile sheath assembly located on the protective tip side of the pump head, and the proximal connector located on the tubing side connected to the proximal end of the pump head; that is, the sheath covers the outer periphery of the pump head. Then, one of the distal and proximal connectors of the sterile sheath assembly is opened, while the other is clamped. The clamped connector, for example, but not limited to, opening the proximal connector and clamping the tubing with the distal connector, is used. Pre-flushing fluid is then injected into the sterile sheath assembly to pre-flush and vent the pump head and sterile sheath. Finally, the opened pressure gripper is fitted onto the sheath around the pump head, and the pressure gripper is operated to close and compress the pump head to the folded state. Applying the pump head folding method provided in this solution has the following beneficial technical effects: First, the pump head is pre-folded and retracted based on the pressure gripper, and then the guide tube is pushed forward to transfer the pump head, which can effectively reduce the pushing force of the pump head and has good operational convenience.

[0020] Secondly, compared to the method of using an inlet device to fold the pump head and venting the gas inside the pump head underwater, the embodiments of this application implement the pump head based on a sterile sleeve assembly, realizing the pre-filling and venting operation of the pump head. This can reduce the configuration and management costs of underwater venting. In addition, after the sleeve is filled with liquid, it can form lubrication between the pump head and the sterile sleeve, reducing the frictional resistance between the pump head and the sleeve when pushing the pump head into the inlet device, and preventing the sterile sleeve and pump head from being torn or damaged.

[0021] In addition, due to the barrier of the sterile sleeve, there is no direct contact between the pressure gripper and the pump head, so the pressure gripper can be reused, which can further control costs rationally. Attached Figure Description

[0022] Figure 1 This is a schematic diagram of the structure of a foldable tubular pump provided in an embodiment of this application; Figure 2 for Figure 1 A schematic diagram of the assembly relationship of the foldable tubing pump in one of its folded states; Figure 3 A schematic diagram of the initial state of the sterile sleeve assembly in a pump head folding method provided in an embodiment of this application; Figure 4 This is a schematic diagram of the aseptic sleeve assembly in a pump head folding method provided in an embodiment of this application; Figure 5 This is a schematic diagram of the aseptic sleeve assembly and pre-filling state in a pump head folding method provided in an embodiment of this application; Figure 6 This is a schematic diagram of the assembly state of the pressure gripper in a pump head folding method provided in an embodiment of this application; Figure 7 This is a schematic diagram illustrating the closed and folded state of the pump head in a pump head folding method provided in an embodiment of this application; Figure 8 This is a schematic diagram of the pre-flushing and venting state of the conduit in a pump head folding method provided in an embodiment of this application; Figure 9 This is a schematic diagram illustrating the pre-flushing and venting state of the inlet in a pump head folding method provided in this application embodiment; Figure 10 This is a schematic diagram illustrating the coupling state between the introducing device and the interventional sheath in a pump head folding method provided in an embodiment of this application. Figure 11 This is a schematic diagram showing the state of the pump head entering the intervention sheath in a pump head folding method provided in an embodiment of this application.

[0023] In the picture: Pump head 1, protective tip 11, catheter 2, coupler 3, flushing interface 31, introducer 4, pre-folded channel 41, intervention sheath 5, intervention channel 51, sterile sheath assembly 6, sheath body 61, distal connector 62, input interface 64, proximal connector 63, flushing syringe 7, pressure gripper 8, flushing pump 9. Detailed Implementation

[0024] To enable those skilled in the art to better understand the technical solutions of the present invention, the present invention will be further described in detail below with reference to the accompanying drawings and specific embodiments.

[0025] Without loss of generality, this embodiment is based on Figure 1 The foldable duct pump shown is the main subject of this description, detailing the implementation schemes for pump head folding and pre-flushing / venting. It should be understood that the specific functional implementation and dimensional proportions of this foldable duct pump do not constitute a substantial limitation on the technical solution claimed in this application.

[0026] Please see Figure 1 The figure is a schematic diagram of the structure of a foldable conduit pump according to a specific embodiment.

[0027] Figure 1 As shown, the foldable catheter pump includes a foldable pump head 1, a catheter 2, and a coupler 3. The distal end of the catheter 2 is connected to the pump head 1 to deliver the pump head 1 into the patient's body. A protective tip 11 is provided at the distal end of the pump head 1. The protective tip 11 is a flexible structure that can be supported on the ventricular wall in a non-invasive or non-damaging manner, separating the suction port of the pump body 1 from the ventricular wall to prevent the suction port of the pump body 1 from adhering to the ventricular wall during operation and to ensure the effective suction area of ​​the pump.

[0028] Coupler 3 is located at the proximal end of catheter 2. The power transmission path and the perfusion fluid communication path are established through coupler 3. On the one hand, coupler 3 is connected to a drive motor (not shown in the figure) to drive the impeller of pump head 1 to rotate through the flexible shaft (not shown in the figure) built into catheter 2, so as to realize the pumping function of assisting the heart. On the other hand, the fluid flow channel between catheter 2 and flexible shaft can be connected to an external fluid source through the flushing interface of coupler 3 to establish a communication relationship.

[0029] Please see also Figure 2 , Figure 1 The diagram shows the assembly relationship of a folded-down type of collapsible tubing pump.

[0030] In actual use, such as Figure 2 As shown, the pump head 1 can be inserted into the intervention channel 51 of the intervention sheath 5 in conjunction with the introducing device 4, and reach the predetermined position of the vascular system based on the intervention sheath 5 inserted into the body through the puncture port.

[0031] The introducer 4 includes a pre-folding channel 41 to accommodate the pump head 1 in its deployed state, allowing it to switch to a folded state. The distal end of the introducer 4 can dock with the proximal end of the interventional sheath 5, connecting the pre-folding channel 41 and the interventional channel 51. This allows the pump head 1 to be inserted into the interventional sheath 5 in its folded state, thus enabling a relatively small puncture site to meet the needs of the interventional procedure. Furthermore, the pump head 1, once at the predetermined position, can return to its deployed state, providing a stronger auxiliary pumping function.

[0032] It is understandable that during the pre-folding operation of the pump head 1 using the inlet 4, the pump head 1 is radially compressed while moving axially; that is, the pump head 1 is simultaneously subjected to axial force and radial pressure, and the radial pressure will generate frictional resistance to axial movement, so the actual operating force for pushing the inlet or pulling the tube is relatively large.

[0033] Based on this, embodiments of this application provide a method for folding the pump head of a foldable tubing pump, the method comprising: Step S10: The sterile sleeve assembly 6 is fitted onto the pump head 1 in the unfolded state. The sleeve body 61 of the sterile sleeve assembly 6 covers the outer periphery of the pump head 1, and the distal connector 62 of the sterile sleeve assembly 6 is located on the side of the protective tip 11 of the pump head 1, and its proximal connector 63 is located on the side of the catheter 2 connected to the proximal end of the pump head 1.

[0034] In specific implementations, such as Figure 3 As shown, the sterile sheath assembly 6 can first be fitted onto the catheter 2; then, the distal connector 62 of the sterile sheath assembly 6 is pushed distally until it crosses the pump head 1 and reaches the side of its protective tip 11. Figure 4 As shown, the sleeve 61 completely covers the pump head 1, and the two connectors of the sterile sleeve are located on both sides of the pump head 1 in the unfolded state.

[0035] Step S20: Open the proximal connector 63 of the sterile sheath assembly 6 and clamp the catheter with the distal connector 62, as follows. Figure 5 As shown, pre-flushing fluid is injected into the sterile sleeve assembly 6 through the distal connector 62 on the clamping side to expel air from the pump head 1 and the sleeve 61 through the proximal connector 63 on the open side. After the air in the pump head 1 is expelled, the proximal connector 63 clamps the tubing.

[0036] In other specific implementations, the pre-flushing and venting operation can also be achieved by using the proximal connector 63 of the sterile sleeve assembly 6 to clamp the catheter and the distal connector 62 to open.

[0037] In other words, one of the distal connector 62 and the proximal connector 63 is opened while the other is clamped. Then, pre-flushing fluid is injected into the sterile sleeve assembly 6 through the clamped connector of the distal connector 62 and the proximal connector 63, thereby expelling the air inside the pump head 1 and the sleeve 61 through the open connector of the distal connector 62 and the proximal connector 63. Alternatively, after injecting pre-flushing fluid through the clamped connector, the internal gas can be expelled through the open connector.

[0038] Specifically, the sterile sleeve assembly 6 has a functional structure that enables the opening and clamping operation. This can be achieved using existing technologies as needed. For example, but not limited to, the distal connector 62 and proximal connector 63 of the sterile sleeve assembly 6 can use locking parts to clamp and fix the catheter 2. This application embodiment does not limit this.

[0039] Among them, such as Figure 5 As shown, an input interface 64 can be provided on the distal connector 62 and / or the proximal connector 63. This input interface 64 can communicate with the inner cavity of the locking part (not shown in the figure) and has unidirectional flow from the outside to the inside to allow the pre-flushing fluid to be introduced to lubricate the pump head and the sleeve, thereby reducing the pushing force of the pump head. In a specific implementation, a one-way valve (not shown in the figure) can be provided inside the input interface 64 to establish a unidirectional flow path from the outside to the inside.

[0040] In actual operation, the flushing syringe 7 can be connected to the input interface 64 of the distal connector 62 of the clamping catheter 2. Pre-flushing solution is injected into the sterile sheath through the flushing syringe 7. When no tiny air bubbles are observed adhering to the sheath 61, the gas in the pump head has been vented, and the open sterile sheath connector is closed. The pre-flushing solution injection through the flushing syringe 7 has good operability.

[0041] Step S30, as follows Figure 6 As shown, the open gripper 8 is fitted onto the sleeve 61 on the outer periphery of the pump head 1; the gripper 8 is closed to compress the pump head 1 into a folded state.

[0042] Specifically, such as Figure 7 As shown, the pressure gripper 8 applies a radial force to the outer periphery of the pump head 1. At the same time, the distal connector 62 and proximal connector 63 of the sterile sheath assembly 6 are both in a clamped state. While the pressure gripper 8 radially compresses the pump head 1, the pre-flushing fluid filling the sheath 61 partially enters the catheter 2. That is to say, the pre-folding and pre-flushing / venting operations of the pump head 1 are completed simultaneously before entering the introducer 4.

[0043] Here, the pressure gripper 8 can compress and fold the pump head 1 to a predetermined size so that it can be inserted into the intervention sheath 5 via the introducer. In specific implementations, the pressure gripper 8 can adopt different structural forms, such as, but not limited to, a structure that converts axial movement into radial contraction movement to realize the pre-folding operation of the pump head 1; it should be understood that any function that can reliably compress and fold the pump head 1 while meeting the transfer and pushing requirements is acceptable, and the embodiments of this application are not limited to this. The pump head folding method of the foldable tubing pump provided in this application embodiment is based on the pre-folding operation of the pump head 1 performed by the pressure gripper 8, and then the tubing 2 is pushed forward to transfer the pump head 1, which can effectively reduce the pushing force and has good operation convenience.

[0044] Meanwhile, compared to the method of using an inlet device to fold the pump head and venting the gas inside the pump head underwater, the embodiment of this application uses a sterile sleeve assembly 6 to realize the pre-filling and venting operation of the pump head. This can reduce the configuration and management costs of underwater venting. In addition, after the sleeve is filled with liquid, it can form lubrication between the pump head and the sterile sleeve, reducing the frictional resistance between the pump head 1 and the sleeve when it is pushed into the inlet device 4, and preventing the sterile sleeve from being torn or damaged.

[0045] Furthermore, due to the barrier of the sterile sleeve, there is no direct contact between the pressure gripper 8 and the pump head 1, so the pressure gripper 8 can be reused and costs can be reasonably controlled.

[0046] Based on the aforementioned embodiments, pre-purging and venting of the conduit 2 can also be achieved. Furthermore, the pump head folding method of this foldable conduit pump may further include: Step S40: Connect the flushing pump 9 to the flushing port 31 on the coupler 3, and open the distal connector 62 of the sterile sheath assembly 6, while keeping the proximal connector 63 clamping the catheter. Figure 8 As shown, the flushing pump 9 is started, and the pre-flushing liquid enters the conduit 2 through the coupler to pre-flush and vent the conduit 2.

[0047] During the pre-flushing and venting process, the gas in the catheter 2 is squeezed from the proximal end to the distal end, discharged from the distal end of the catheter 2 and enters the sterile sleeve assembly 6, and is discharged through the open distal connector 62 of the sterile sleeve assembly 6.

[0048] In other specific implementations, the pre-purging and venting of the aforementioned conduit 2 can be performed by submerging the pump head side underwater. When bubbles emerge, it indicates that there is still gas venting from conduit 2. The pre-purging and venting of the conduit is confirmed to be complete when no more bubbles emerge. At this point, the pre-purging and venting of the intervention pump section is fully completed.

[0049] Here, after the catheter 2 is pre-flushed, the distal connector of the sterile sleeve clamps the catheter to prevent the sterile sleeve assembly 6 from detaching from the introducer 4 when the catheter 2 is pushed forward to transfer the pump head 1.

[0050] Optionally, the pump head folding method of the foldable tubing pump may further include: Step S50, as follows Figure 9 As shown, the distal connector 62 of the sterile sleeve assembly 6 is coupled to the proximal end of the introducing device 4, and the flushing pump 9 is started again to pre-flush and vent the introducing device 4. The pre-flushing is complete when the introducing device 4 is filled with pre-flushing liquid and all the gas is expelled; specifically, when no more bubbles emerge from the distal end of the introducing device 4, the pre-flushing of the introducing device 4 can be confirmed as complete.

[0051] Furthermore, the pump head folding method of this foldable tubing pump may also include: Step S60, as follows Figure 10As shown, the distal end of the introducing device 4 is coupled to the proximal end of the interventional sheath 5 (the interventional sheath 5 can be located in the patient's puncture site at this time, with the proximal end outside the body and the distal end inside the body); as Figure 11 As shown, the pump head 1 located in the pressure gripper 8 is transferred to the intervention channel 51 of the intervention sheath 5 via the introducer 41.

[0052] In practice, the catheter 2 is pushed forward, and the pump head 1, in its folded state, can sequentially enter the interventional sheath 5 through the gripper 8 and the introducer 4. As the catheter 2 continues to be pushed forward, the pump head 1 moves out from the distal end of the interventional sheath 5 and enters the body, at which point the pump head 1 releases its stored energy and unfolds.

[0053] Next, the method for folding the pump head of this foldable tubing pump may also include: Step S70: Open and remove the pressure gripper 8, open the distal connector 62 of the sterile sheath assembly 6, and move the inlet 4 and the distal connector 62 of the sterile sheath assembly 6 backward together. Figure 11 As shown, the injector 4 is removed from the proximal end of the intervention sheath 5.

[0054] Specifically, after the pressure gripper 8 is opened, it can be moved to the proximal end of the coupler 3 to remove the pressure gripper 8, thus avoiding interference with the subsequent connection between the sterile sheath and the interventional sheath. Here, the introducer 4 can be a tear-away introducer, which can be peeled off and removed after the pump head 1 enters the interventional sheath 5.

[0055] In practice, the introducer 4 is torn open as it moves proximally. Of course, if the proximal connector 63 of the sterile sleeve is far from the coupler 3, the proximal connector 63 should also be moved backward synchronously.

[0056] In step S80, the distal connector 62 of the sterile sheath assembly 6 is moved distally and coupled to the proximal end of the interventional sheath 5, and then the distal connector 62 is clamped. In this way, the sterile sheath assembly 6 can clamp and fix the portion of the catheter 2 adjacent to the proximal end of the interventional sheath 5, and can also be fixed to the patient's skin by the suture buckle (not shown in the figure) integrated into the sterile sheath assembly 6. Thus, a sterile barrier can be formed for the external portion of the catheter 2 during catheter pump operation.

[0057] Based on the aforementioned foldable catheter pump head folding method, after the pump head 1 is reliably inserted into the predetermined position of the vascular system, the drive motor is connected to the coupler 3, and the drive motor is started to realize the pumping function to assist the heart.

[0058] In addition to the aforementioned sterile sheath assembly and the folding method for the pump head of the foldable catheter pump, this embodiment also provides an interventional system for pre-folding the pump head of the foldable catheter pump. The interventional system includes a gripper 8 and a sterile sheath assembly 6 as described above. The sterile sheath assembly 6 can be fitted onto the pump head 1 of the foldable catheter pump, and the gripper 8 can be fitted onto the sheath body 61 of the sterile sheath assembly 6.

[0059] In the practical application of this interventional system, the pre-contraction and folding operation of the pump head 1 is performed based on the pressure gripper 8, and then the catheter 2 is pushed forward to transfer the pump head 1. This effectively reduces the pushing force and provides good operational convenience. It should be understood that the specific implementation of other functional components of this interventional system can be achieved using existing technologies, so it will not be elaborated upon in this paper.

[0060] It should be noted that the functions of the foldable catheter pump, pressure gripper, interventional sheath, and sterile sleeve in the foldable catheter pump head folding method described in the aforementioned implementation scheme can be achieved using existing technologies, so they will not be elaborated upon here.

[0061] The above are merely preferred embodiments of the present invention. It should be noted that those skilled in the art can make various improvements and modifications without departing from the principle of the present invention, and these improvements and modifications should also be considered within the scope of protection of the present invention.

Claims

1. A method for folding a pump head of a collapsible catheter pump, the collapsible catheter pump comprising a pump head, a catheter and a coupler, the pump head being arranged at a distal end of the catheter, the coupler being arranged at a proximal end of the catheter, and the pump head being switchable between an unfolded state and a folded state, characterized in that, The pump head folding method includes: The sterile sleeve assembly is fitted onto the pump head in its unfolded state, with the distal connector of the sterile sleeve assembly located on the protective tip side of the pump head and the proximal connector of the sterile sleeve assembly located on the side of the catheter connected to the proximal end of the pump head. Open one of the distal and proximal connectors of the sterile sleeve assembly and clamp the other. Inject pre-flushing liquid into the sterile sleeve assembly through the clamped connector between the distal and proximal connectors to pre-flush and vent the pump head and the sterile sleeve. Place the open gripper onto the sleeve of the sterile sleeve assembly around the pump head, and operate the gripper to close and compress the pump head to a folded state; During catheter pump operation, the sterile sheath assembly forms a sterile barrier for the external portion of the catheter.

2. The method for folding the pump head of the foldable tubular pump according to claim 1, characterized in that, A flushing syringe is connected to the input interface of the clamped connector in the distal and proximal connectors to inject pre-flushing fluid into the sterile sheath assembly.

3. The pump head folding method of the foldable tubular pump according to claim 1 or 2, characterized in that, After the operation of closing the pressure gripper to compress the pump head to the folded state, the method further includes the following steps: Connect the flushing pump to the flushing port of the coupler of the foldable catheter pump and open the distal connector of the sterile sheath; start the flushing pump, and the pre-flushing solution enters the catheter through the coupler to pre-flushing and vent the catheter; after the pre-flushing and venting of the catheter is completed, operate the distal connector of the sterile sheath to clamp the catheter.

4. The pump head folding method of the foldable tubular pump according to claim 3, characterized in that, After pre-flushing and venting the catheter, the procedure further includes the following steps: The distal connector of the sterile sleeve is coupled to the proximal end of the introducing device, and the flushing pump is started to pre-flush and vent the introducing device.

5. The pump head folding method of the foldable tubular pump according to claim 4, characterized in that, After pre-flushing and venting the catheter, the procedure further includes the following steps: The distal end of the introducing device is coupled to the proximal end of the interventional sheath, and the pump head located in the gripper is transferred via the introducing device into the interventional channel of the interventional sheath.

6. The pump head folding method of the foldable tubular pump according to claim 5, characterized in that, After the introducer is transferred into the interventional channel of the interventional sheath, the procedure further includes the following steps: Open and remove the pressure gripper, at least open the distal connector of the sterile sheath assembly, move the introducing device and the distal connector of the sterile sheath assembly backward together, and remove the introducing device from the proximal end of the intervention sheath.

7. The pump head folding method of the foldable tubular pump according to claim 6, characterized in that, After opening the gripper, move the gripper to the proximal end of the coupler and remove it.

8. The method for folding the pump head of the foldable tubular pump according to claim 6, characterized in that, After removing the introducing device from the proximal end of the interventional sheath, the procedure further includes the following steps: Move the distal connector of the sterile sheath distally and couple it to the proximal end of the interventional sheath, then clamp the distal connector.

9. A sterile sheath assembly adapted to a foldable tubing pump, the foldable tubing pump comprising a tubing and a foldable pump head, the sterile sheath assembly comprising a sheath body and distal and proximal connectors respectively located at both ends of the sheath body, the distal and proximal connectors each having a locking portion; characterized in that, The sterile sheath assembly is fitted onto the catheter, and the distal connector can be pushed distally so that the distal connector and the proximal connector are located on opposite sides of the pump head, respectively. At least one of the distal connector and the proximal connector is provided with an input interface, and the input interface is in communication with the inner cavity of the corresponding locking part; The distal connector also allows the pump head to extend distally, so that the sterile sheath assembly forms a sterile barrier for the external portion of the catheter.

10. The aseptic sleeve assembly according to claim 9, characterized in that, A one-way valve is installed in the input interface to establish a one-way conduction path from the outside to the inside.

11. The aseptic sleeve assembly according to claim 9, characterized in that, The input interface is used to connect a flushing syringe to inject pre-flushing fluid into the sterile sheath assembly.

12. An interventional system for pre-folding the pump head of a foldable tubing pump; characterized in that, The device includes a pressure gripper and a sterile sleeve assembly, the sterile sleeve assembly being fitted onto the pump head of the foldable tubing pump, the pressure gripper being fitted onto the sleeve of the sterile sleeve assembly, and the sterile sleeve assembly being the sterile sleeve assembly according to any one of claims 9 to 11.

13. The intervention system according to claim 12, characterized in that, In the first state of the interventional system, the sterile sheath assembly is fitted onto the catheter, and the distal connector can be pushed distally. In the second state of the interventional system, the distal connector spans the pump head and is located on the protective tip side of the foldable catheter pump, while the proximal connector is located on the side of the catheter connected proximal to the pump head. In the third state, one of the distal connector and the proximal connector of the intervention system is open, while the other clamps the catheter; wherein, the input interface is at least located on the connector on the clamping side and communicates with the inner cavity of the locking part on the clamping side, the connector on the clamping side is used to inject pre-flushing fluid, and the connector on the open side is used to vent air.

14. The intervention system according to claim 13, characterized in that, In the fourth state, the intervention system has the pressure gripper fitted around the outer periphery of the sleeve, which is capable of radially compressing the pump head to a folded state.

15. The intervention system according to claim 14, characterized in that, In the fourth state, both the distal connector and the proximal connector of the intervention system are in a clamped state.

16. The intervention system according to claim 13, characterized in that, In the third state, the connector on the open side of the interventional system is used to expel air between the sterile sheath assembly and the pump head, as well as to expel air from the catheter. In this process, the air inside the catheter is forced into the sterile sheath assembly by the pre-flushing liquid that enters the catheter.

17. The intervention system according to claim 13, characterized in that, The distal end of the sterile sheath can be coupled to the proximal end of the introducer, and the distal end of the introducer can be coupled to the proximal end of the interventional sheath. The pump head in the folded state can enter the interventional sheath sequentially through the gripper and the introducer.

18. The intervention system according to claim 17, characterized in that, In the fifth state, the pressure gripper is removed from the sleeve, the distal connector is opened, and the introducer and the distal connector are able to move proximally together while the distal connector is open.

19. The intervention system according to claim 18, characterized in that, The introducer is a tearable introducer, which can be peeled off and removed after the pump head enters the intervention sheath.

20. The intervention system according to claim 19, characterized in that, The distal connector can dock with the proximal end of the interventional sheath and clamp and fix the portion of the catheter adjacent to the interventional sheath to form a sterile barrier for a portion of the catheter.

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