Pigtail device and fluid pumping system

Abstract

The invention provides a pigtail device and a fluid pumping system. The pigtail device is arranged at the far end of the fluid pumping device and comprises a pigtail body, a blocking valve is arranged on the pigtail body, and the blocking valve comprises a flow control unit; the flow control unit is arranged to be capable of being penetrated by a target element, and the flow control unit is in a closed state under the action of the maximum pulsating pressure difference of the environment. In addition, the invention further provides a fluid pumping system. Stable sealing performance is provided through the flow control unit, and the safety risk caused by the fact that thrombus in the pigtail falls into the human body is prevented.

Description

[0001] Cross Reference to Related Applications

[0002] This application claims priority to Chinese Patent Application No. 202411188251.7, filed on August 28, 2024, entitled “A pigtail device and a fluid pumping system”, the entire contents of which are incorporated herein by reference. Technical Field

[0003] This disclosure relates to the field of medical device technology, specifically to a pig tail device and a fluid pumping system. Background Technology

[0004] In related technologies, fluid pumping systems include a fluid pumping device and a pigtail structure. In some scenarios, the fluid pumping device is a blood pumping conduit, and the pigtail structure is located at the distal end of the fluid pumping device. A guide wire enters from the distal end of the pigtail structure and exits from the distal end of the fluid pumping device. It should be understood that the pigtail structure is immersed in blood, and its interior is filled with blood. However, due to its small pores, the blood hardly flows within its internal pores, thus prolonged stagnation can lead to thrombosis.

[0005] In certain scenarios, such as when a fluid pumping system is withdrawn from the human body, blood clots can easily dislodge and enter the body, posing a health risk. Therefore, preventing blood clots from dislodging from fluid pumping systems and entering the human body is an urgent problem to be solved. Summary of the Invention

[0006] To overcome at least one of the many problems in the related art, a first aspect of this disclosure provides a pigtail device disposed at a distal end of a fluid pumping device, the pigtail device comprising:

[0007] The pig tail body has a shut-off valve installed on it, and the shut-off valve includes a flow control unit.

[0008] The flow control unit is configured to be able to be penetrated by the target element, and to be in the closed state under the action of the maximum ambient pulsating pressure difference.

[0009] Furthermore, in some embodiments, an axially penetrating pig tail channel is provided within the pig tail body, and a flow control unit is disposed on the pig tail channel. The flow control unit is configured to be able to be penetrated by the target element along the extension direction of the pig tail channel.

[0010] Furthermore, in some embodiments, the flow control unit is provided with a slot;

[0011] Under the influence of maximum ambient pulsating pressure differential, the slot is in a closed state. Specifically, a slot is formed on the flow control unit for the target component to pass through; when the flow control unit is in a closed state, the slot is closed.

[0012] Furthermore, in some embodiments, the flow control unit is made of a flexible material that provides restoring force to keep the slot closed.

[0013] Furthermore, in some embodiments, the pig tail body includes a first segment and a second segment that are separated from each other;

[0014] One end of the shut-off valve is connected to the first section, and the other end is connected to the second section.

[0015] Furthermore, in some embodiments, one end of the shut-off valve is sleeved on the outside of the first segment and the other end is sleeved on the outside of the second segment; or, one end of the shut-off valve is embedded in the inside of the first segment and the other end is embedded in the inside of the second segment; or, one end of the shut-off valve is embedded in the inside of the first segment and the other end is sleeved on the outside of the second segment; or, one end of the shut-off valve is sleeved on the outside of the first segment and the other end is embedded in the inside of the second segment.

[0016] Furthermore, in some embodiments, the first segment is located at the distal end of the shut-off valve;

[0017] The shut-off valve deforms under the lateral force applied to the first section.

[0018] Furthermore, in some embodiments, the blocking valve is flexible, with a gap between the end face of the first section facing the second section and the end face of the second section facing the first section.

[0019] Furthermore, in some embodiments, the blocking valve is located at the proximal end of the pig tail body.

[0020] Furthermore, in some embodiments, the blocking valve is capable of deforming under the action of lateral forces on the pig tail body.

[0021] Furthermore, in some embodiments, the shut-off valve also includes a mounting unit connected to the flow control unit, the mounting unit being located on one side of the flow control unit and stacked inside the pig tail body for connection to a fluid pumping device.

[0022] Furthermore, in some embodiments, the shut-off valve is configured to be relatively separate from the pig tail body, and the shut-off valve is configured to connect the distal end of the fluid pumping device to the proximal end of the pig tail body.

[0023] A second aspect of this disclosure provides a fluid pumping system, including a fluid pump suction device and the aforementioned pigtail device:

[0024] The pigtail device is located at the distal end of the fluid pumping device; in the intervention state, the fluid pumping system draws in ambient fluid from the distal end and pumps it out from the proximal end.

[0025] Furthermore, in some embodiments, the distal end of the fluid pumping device is provided with a connection portion, and the proximal end of the shut-off valve is connected to the connection portion;

[0026] The proximal end of the pigtail device body is fitted onto at least one of the connecting part and the shut-off valve.

[0027] Furthermore, in some embodiments, the shut-off valve is fitted onto the connection portion, and the pig tail is fitted onto the shut-off valve.

[0028] Furthermore, in some embodiments, the connecting portion is provided with at least two protrusions that protrude radially outward, and the protrusions are spaced apart along the axial direction of the connecting portion.

[0029] An adhesive is provided on the outer surface of at least one protrusion and / or at the interval between two adjacent protrusions for connecting the connection to the shut-off valve.

[0030] Furthermore, in some embodiments, the protrusion includes three parts, which are arranged sequentially from the distal end to the proximal end as a first protrusion, a second protrusion, and a third protrusion.

[0031] An adhesive is provided on the outer surface of at least one of the first protrusion and the second protrusion, and / or at the gap between the first protrusion and the second protrusion to connect the shut-off valve.

[0032] An adhesive is provided on the outer surface of the third protrusion and / or at the interval between the second and third protrusions for connecting the connector to the proximal end of the pig tail device.

[0033] The technical solution disclosed herein has the following advantages or beneficial effects:

[0034] (1) The pig tail device in this disclosure includes a pig tail body and a blocking valve. The blocking valve includes a flow control unit. The target element can pass through the flow control unit, thereby enabling the target element to pass through the pig tail device. Under the action of the maximum pulsating pressure difference in the environment, the flow control unit is in a closed state. Thus, the flow control unit provides stable sealing to prevent the blood clot in the pig tail device or fluid pumping device from falling into the human body and causing safety risks.

[0035] (2) The pig tail body of this disclosure adopts a segmented structure, and a flexible blocking valve is set between the segments to connect the segments of the pig tail body, or to connect the pig tail body to the fluid pumping device; thereby preventing the force from the far end of the fluid pumping system from being transmitted to the near end, avoiding many problems such as hemolysis and friction of the inner wall of the conduit or fluid pumping system caused by the reduction of the gap between the conduit or fluid pumping system and the impeller.

[0036] (3) The fluid pumping system disclosed herein has a connecting part at the far end, and the proximal end of the aforementioned shut-off valve is connected to the aforementioned connecting part; the proximal end of the aforementioned pig tail body is sleeved on the outside of the aforementioned connecting part and the aforementioned shut-off valve; thereby avoiding cutting off the pig tail body and simply realizing the guide wire passage, sealing and venting characteristics of the fluid pumping system. Attached Figure Description

[0037] The accompanying drawings are provided to better understand this disclosure and do not constitute an undue limitation thereof. Wherein:

[0038] Figure 1 This is a schematic diagram of a pig tail device according to the first embodiment of the present disclosure;

[0039] Figure 2 This is a cross-sectional schematic diagram of the pig tail device according to the first embodiment of the present disclosure;

[0040] Figure 3 This is a schematic diagram of a pig tail device according to a second embodiment of the present disclosure;

[0041] Figure 4 This is a cross-sectional schematic diagram of a pig tail device according to a second embodiment of the present disclosure;

[0042] Figure 5 This is a cross-sectional schematic diagram of a pig tail device according to a third embodiment of the present disclosure;

[0043] Figure 6 This is a side view of a shut-off valve according to an embodiment of the present disclosure, showing the direction of the longitudinal section;

[0044] Figure 7 yes Figure 6 A cross-sectional view of position AA in the middle;

[0045] Figure 8 This is a schematic diagram of the deformation of the pig tail device according to the first embodiment of this disclosure after being subjected to lateral force;

[0046] Figure 9 yes Figure 8 A longitudinal sectional view;

[0047] Figure 10 This is a schematic diagram of the deformation of the pig tail device according to the second embodiment of this disclosure after being subjected to lateral force;

[0048] Figure 11 yes Figure 10 A cross-sectional view;

[0049] Figure 12 This is a partially enlarged view of the connection portion of the fluid pumping system in the third embodiment;

[0050] Figure 13 This is a partial cross-sectional schematic diagram of the connection state of the pig tail device according to the third embodiment of this disclosure; and in the various figures, the same or corresponding reference numerals indicate the same or corresponding parts.

[0051] Explanation of reference numerals in the attached figures:

[0052] 100. Pig tail device; 101. First section; 102. Second section; 103. Blocking valve; 1031. Flow control unit; 104. Head end of suction channel; 105. Groove; 106. Head end of suction channel; 1061. First protrusion; 1062. Second protrusion; 1063. Third protrusion; 107. End of pig tail device. Detailed Implementation

[0053] The exemplary embodiments of this disclosure are described below with reference to the accompanying drawings, including various details of the embodiments to aid understanding, and should be considered merely exemplary. Therefore, those skilled in the art will recognize that various changes and modifications can be made to the embodiments described herein without departing from the scope and spirit of this disclosure. Similarly, for clarity and brevity, descriptions of well-known functions and structures are omitted in the following description.

[0054] The terminology used in this application is for the purpose of describing particular embodiments only and is not intended to be limiting of the application. The singular forms “a,” “the,” and “the” used in this application and the appended claims are also intended to include the plural forms unless the context clearly indicates otherwise. It should also be understood that the term “and / or” as used herein refers to and includes any or all possible combinations of one or more of the associated listed items.

[0055] It should be understood that although the terms first, second, third, etc., may be used in this application to describe various information, such information should not be limited to these terms. These terms are only used to distinguish information of the same type from one another. For example, without departing from the scope of this application, first information may also be referred to as second information, and similarly, second information may also be referred to as first information. Depending on the context, the word "if" as used herein may be interpreted as "when," "when," or "in response to determination."

[0056] Furthermore, it should be noted that in the description of the embodiments of this application, unless otherwise explicitly defined, "in vivo" means inside the patient's tissues and organs, and "outside the body" means outside the patient's tissues and organs. Also, in the embodiments of this application, "distal" refers to the direction away from the physician, and "proximal" refers to the direction closer to the physician.

[0057] As described in the background section, in existing fluid pumping systems, the distal end of the fluid pumping device and the pig tail structure are prone to thrombosis due to blood stasis and long-term intervention, which can lead to thrombus detachment during the withdrawal of the fluid pumping system from the body. It is understood that the "pig tail" mentioned in this article can also be referred to as a "pig tail tube," "drainage tube," "flexible tube," "soft distal end," "J-shaped distal end," "curled catheter," etc.

[0058] To address the aforementioned technical problems, this disclosure provides a pigtail device (i.e., a pigtail structure), wherein the pigtail device is located at the distal end of a fluid pumping device. The pigtail device includes a pigtail body, on which a shut-off valve is provided, and the shut-off valve includes a flow control unit. The target element is disposed through the flow control unit, and under the action of the maximum ambient pulsating pressure difference, the flow control unit is in a closed state. It should be noted that this disclosure also provides a fluid pumping system, which includes a fluid pumping device and any of the aforementioned pigtail devices. In the intervention state, the fluid pumping system draws in ambient fluid from the distal end and pumps it out from the proximal end; the distal end of the fluid pumping device is provided with any of the aforementioned pigtail devices. The fluid pumped by the fluid pumping device of this application can be blood or other bodily fluids in humans or animals. In the scenario where the fluid is blood, the fluid pumping device can be a blood pumping catheter or a thrombus aspiration catheter. The above are merely some examples of application scenarios and do not constitute a limitation on the scope of protection of this application.

[0059] like Figures 1 to 5 As shown, a pig tail device 100 is connected to the suction channel head 104 of the fluid pumping system. The pig tail device 100 has a pig tail channel penetrating its body. The pig tail channel can be a channel within the pig tail body, extending from one end of the pig tail body along its extension direction to the other end. In use, a target element, such as a guide wire (not shown), enters from the distal end of the pig tail device 100, passes sequentially through the pig tail channel inside the pig tail device 100 and the fluid pumping device, and exits from the proximal end of the fluid pumping device. In another use configuration, the target element, such as a guide wire (not shown), enters from the distal end of the pig tail device 100, passes through the pig tail channel inside the pig tail device 100, and exits from the proximal end of the pig tail device 100.

[0060] It should be noted that the terms "proximal end" and "distal end" mentioned above are relative to the operator. When one end of the instrument or component is close to the operator, it is called the proximal end; when one end of the instrument or component is far from the operator, it is called the distal end. Furthermore, there are various ways in which the fluid pumping system and the target component can be coupled. The two methods mentioned above are only some implementations of the target component within the pig tail device 100 and the fluid pumping system. It is understood that other forms of the pig tail device 100 and the fluid pumping system are also within the scope of protection of this application. When the structure of the pig tail device 100 and the fluid pumping system changes, the insertion and exit methods of the target component relative to the pig tail device 100 and the fluid pumping system will also be adaptively adjusted, which does not constitute a limitation on the scope of protection of this disclosure.

[0061] Due to the aforementioned channel configuration, environmental fluid may flow back into these channels under pressure pulsation, leading to thrombus formation during prolonged operation of the fluid pumping system. There is a risk of thrombus detaching and entering the human body during the withdrawal of the fluid pumping system. While some technical solutions incorporate valve structures within the pigtail structure, this does not completely resolve the thrombus detachment issue. Therefore, in some embodiments of this disclosure, a blocking valve 103 is incorporated into the pigtail body of the pigtail device 100 to address this problem. A detailed description will follow with reference to the accompanying drawings.

[0062] In some embodiments, such as Figures 1 to 5 As shown, in the pig tail device 100, the aforementioned blocking valve 103 can be embedded inside the pig tail body or sleeved on the outside of the pig tail body. In some alternative embodiments, the aforementioned blocking valve 103 can be disposed between the proximal and distal ends of the pig tail body or disposed at the proximal end of the pig tail body. Figure 7 In the illustrated embodiment, the aforementioned blocking valve 103 includes a flow control unit 1031. This flow control unit 1031 controls the opening and closing of the channel within the pig tail body and allows the target element to pass through it. Therefore, although the flow control unit 1031 has a passageway (in some embodiments, this may also be referred to as a slot 105) allowing the guide wire to pass through, it remains closed under the influence of maximum ambient pulsating pressure differential (in some embodiments, the slot 105 remains closed). In practice, after a fluid pumping system is introduced into the human body, its ports connected to the internal environment are constantly subjected to the pulsating pressure of the human environment, particularly the pressure of the aorta and the left ventricle.

[0063] In one example, the flow control unit can be penetrated by the target element, and the flow control unit blocks the interior of the pig tail body. Under the action of the maximum pulsating pressure difference in the environment, the flow control unit is in the closed state.

[0064] In some examples, the pigtail device can be a flexible hose, part of a coiled end structure, or all of it.

[0065] In some embodiments of this application, an axially penetrating pig tail channel is provided within the pig tail body, and a flow control unit 1031 is disposed on the pig tail channel. The flow control unit 1031 is configured to be able to be penetrated by a target element along the extension direction of the pig tail channel. The flow control unit 1031 can be in a closed state under the influence of maximum ambient pressure differential. In some application scenarios, the flow control unit 1031 is in contact with ambient fluid on opposite sides along the extension direction of the pig tail channel.

[0066] It is understood that the flow control unit 1031 can be located at any point on the pig tail passage. In some implementations, the flow control unit 1031 can be located between the proximal and distal ends of the pig tail passage. In other alternative implementations, the flow control unit 1031 can also be located at either the proximal or distal end of the pig tail passage.

[0067] In scenarios where the flow control unit 1031 is located at the proximal or distal end of the pig tail channel: in some implementations, the pig tail body is directly connected to the shut-off valve 103; in other alternative implementations, the pig tail body is indirectly connected to the shut-off valve 103 via other components. For example, as described below, the pig tail body is connected to the shut-off valve 103 via a connecting part, which will be described in detail below and will not be elaborated here.

[0068] In this embodiment, the maximum pressure difference between the aortic pressure and the left ventricular pressure is insufficient to open the flow control unit 1031 of the aforementioned blocking valve 103. In other words, the opening pressure of the aforementioned flow control unit 1031 is greater than the aforementioned maximum pressure difference (or preset value). In some embodiments, the aforementioned preset value is at least greater than or equal to 16 kPa (i.e., 120 mmHg).

[0069] Taking a fluid pumping system as an example, specifically one used to assist the left ventricle, after the pumping system has been in operation for a certain period, it needs to be withdrawn from the body. During the withdrawal from the ventricle to the aorta, a situation arises where the pressure on the distal side of the blocking valve 103 is greater than the pressure on the proximal side at the distal and proximal ends of the pig tail structure. Under this pressure difference, the blood between the blocking valve 103 and the distal opening of the pig tail body is blocked within the pig tail body. Since the blocking valve 103 blocks the passage between the distal opening of the pig tail body and the pumping window (located on the fluid control device and connected to the pig tail device), the blood between the blocking valve 103 and the pumping window will not flow out from the pumping window, thus preventing thrombi in the pig tail device from flowing into the human body. In other words, the passage between the blocking valve 103 and the pumping window and the distal opening of the pig tail body avoids the risk of thrombi detaching from the human body due to the pressure difference during the withdrawal of the pumping system.

[0070] like Figure 6 and 7 As shown, in some embodiments of this application, the flow control unit 1031 described above is a valve plate. When the opening pressure is greater than a preset value, the valve plate will open; otherwise, it will close. Specifically, as... Figure 6 As shown in the illustrated embodiment, the cross-section of the valve plate is a circular structure, which is cut into two halves from directly above the center to directly below, forming a so-called slot 105. It should be understood that the valve plate is circular, and its circumference is sealed to the inner cavity (inner surface) of the shut-off valve 103. When the liquid pressure is sufficiently high, it can pass through the valve plate by squeezing open the slot 105 (of course, the guide wire can also pass through the slot 105 that is squeezed together). Generally, because the valve plate is squeezed by the inner cavity of the shut-off valve 103, the slot 105 is usually in a sealed state (similar to two silicone sheets squeezed together). It should be understood that... Figure 7 As shown, when subjected to pressure, for example, from left to right, greater than the maximum set pressure, the valve plate is forced open by liquid from the slot 105, thereby enabling liquid communication between the left and right sides of the valve plate. In some embodiments of this disclosure, the opening pressure of the flow control unit 1031 is greater than the maximum pulsating pressure, thereby effectively resisting the pulsating pressure difference within the human body and maintaining a good sealing state, thus preventing fluid leakage through the flow control unit 1031 and preventing the thrombus at both ends of the valve plate from falling off.

[0071] In practice, while the opening pressure of the flow control unit 1031 can be increased to further enhance the sealing performance, excessively high sealing will make it difficult for target components such as guide wires to pass through the flow control unit 1031, causing considerable inconvenience to operators. For Figure 6 and 7In the illustrated embodiment, the opening pressure of the shut-off valve 103 is related to many parameters such as the thickness of the valve plate, the size of the opening, the shape of the opening, and the hardness of the material. Generally, the thicker the valve plate, the greater the opening pressure of the shut-off valve 103; the harder the material of the valve plate, the greater the opening pressure of the shut-off valve 103; or the smaller the opening, the greater the opening pressure of the shut-off valve 103, and so on. The above parameters are merely examples and do not constitute a limitation on the scope of protection of this disclosure. In practice, one or more of the above parameters can be selected to control the opening pressure of the shut-off valve according to the actual required opening pressure. Furthermore, the shut-off valve 103 can be in a bidirectional interconnection form, that is, fluid can flow from the distal end to the proximal end through the flow control unit 1031, or fluid can flow from the proximal end to the distal end through the flow control unit 1031.

[0072] In some examples, the shut-off valve includes a pipe body and a fluid control unit connected to the pipe body. The fluid control unit includes multiple valve discs. In the open state, at least some of the valve discs have gaps between them. In the closed state, the valve discs abut against each other to block the pipe body. It can be understood that the gaps between the valve discs are similar to the slots described below, and their structure, location, and parameters can be found in the relevant description of the slots.

[0073] In other embodiments of this application, the shut-off valve 103 may also be other types of valve bodies. For example, the shut-off valve 103 may be a rigid one-way valve, wherein the flow direction of the one-way valve is from the distal end to the proximal end.

[0074] The fluid pumping system in some embodiments of this disclosure can be internally driven or externally driven; or, the fluid pumping system can be of a fixed diameter or a variable diameter form; or, the fluid pumping system can be double-supported or cantilevered, etc. The above are only examples of some application scenarios and do not constitute a limitation on the scope of protection of this disclosure.

[0075] In some embodiments of this application, the fluid pumping system is a cantilevered structure. The fluid pumping device includes an impeller, which is also a cantilevered structure. When the fluid pumping system is in operation, the impeller rotates to achieve fluid pumping.

[0076] The cantilever-supported fluid pumping system will be described below with reference to specific application scenarios. In some implementations, the fluid pumping device includes a suction channel, an outlet channel, a pumping structure, and a drive structure. The outlet channel is located between the suction channel and the pumping structure, and the three together form a flow channel. The suction channel has a suction window, and the outlet channel has an outlet window, both of which are connected to the flow channel. The pumping structure includes a housing and a shaft, with the shaft portion located within the housing and its distal end extending into the flow channel. The impeller is located within the flow channel and connected to the distal end of the shaft, achieving cantilever support. The drive structure drives the shaft to rotate, which in turn drives the impeller to rotate. When the drive structure is activated, the shaft drives the impeller to rotate, driving fluid to enter the flow channel from the suction window and exit from the outlet window, thus achieving the fluid pumping function.

[0077] Following the description of the fluid pumping device, the fluid pumping system is further described. The pigtail device is installed at the distal end of the suction channel, and the pigtail channel within the pigtail device is connected to the flow channel.

[0078] In other application scenarios of this application, the pumping direction of the fluid pumping system can also be opposite to the aforementioned application scenarios, that is, the pig tail device is installed at the far end of the outflow channel, and the pig tail channel inside the pig tail device is connected to the flow channel.

[0079] In some embodiments of this application, the drive structure is located inside the pump flow structure. In other embodiments of this application, the drive structure is located outside the pump flow structure and transmits the driving force to the rotating shaft inside the pump flow structure via a transmission shaft.

[0080] In some optional embodiments, the flow control unit 1031 described above is provided with a slot 105; under the action of the maximum ambient pulsating pressure difference, the slot 105 is in a closed state. For example... Figure 6 and 7 As shown, the flow control unit 1031 described above is a valve plate. In some embodiments, the outer periphery of the valve plate is fixedly disposed on the portion of the shut-off valve 103 that connects with the pig tail body (i.e., as shown in the figure, the outer periphery of the valve plate forms a connection relationship with the inner cavity (inner surface) of the shut-off valve 103), and the two are sealed together. The valve plate described above is provided with a slot 105 that penetrates the valve plate. Figure 6In the above-mentioned groove 105, the groove is straight. In practice, the groove 105 can also adopt different shapes such as round hole, S-shape, cross shape, etc. It is worth noting that the shape of the groove 105 can be a shape within a cross-section or a shape within other planes (such as a plane approximately parallel to the cross-section), and this application does not make specific limitations. It can be understood that, regardless of the shape of the groove 105, it can allow target components such as guide wires to pass smoothly through the valve plate, while the flow control unit 1031 can provide stable sealing performance to prevent fluid from leaking through the groove 105 or along the guide wire under the action of environmental pulsating pressure.

[0081] In some embodiments of this application, when the valve disc is manufactured separately, the width of the slot 105 of the valve disc can be cut to be less than 0.5 mm. It is understood that the width of the slot 105 can be the shortest distance between the valve disc portions on opposite sides of the slot 105. Preferably, the width of the slot 105 is less than 0.3 mm. It should be noted that when the valve disc is installed internally (e.g., inside the cavity of the shut-off valve 103), the slots 105 are pressed together to form a sealing structure. Figure 6 In the example embodiment, the valve plate is cut into two halves in a straight line from directly above to directly below the center. Obviously, the section that is divided (cut) can also be circular, or it can be a circular hole, S-shaped, or cross-shaped.

[0082] In some optional embodiments, the flow control unit 1031 is made of a flexible material that provides a restoring force to close the slot 105. Thus, even after the slot 105 is provided and the target element is allowed to pass through it, the flexible material of the flow control unit 1031 can provide a restoring force to bring the materials on both sides of the slot 105 closer together and compress them, preventing fluid leakage from the slot 105.

[0083] In some optional embodiments, the pigtail device 100 includes a first segment 101 and a second segment 102 that are separated from each other; the shut-off valve 103 is flexible or, in other embodiments, rigid, with one end of the shut-off valve 103 connected to the first segment 101 and the other end connected to the second segment 102. It should be understood that one end of the shut-off valve 103 may refer to the distal segment of the shut-off valve 103, and the other end may refer to the proximal segment of the shut-off valve 103; the target element may pass through the shut-off valve 103 from the proximal end to the distal end, and the shut-off valve 103 can prevent liquid from flowing from the distal end to the proximal end.

[0084] like Figures 1 to 4In the illustrated embodiment, the blocking valve is configured to be separate from the pig tail body; that is, the pig tail device 100 adopts a segmented structure. Specifically, the pig tail body includes an independent and separate first segment 101 and a second segment 102. The blocking valve 103 is used to connect the first segment 101 and the second segment 102. The two-section design of the pig tail body facilitates the installation of the blocking valve 103 between the proximal and distal ends of the pig tail body, reducing the molding difficulty of the pig tail device 100.

[0085] like Figures 1 to 4 In the illustrated embodiment, the blocking valve is configured to be separate from the pig tail body; that is, the pig tail device 100 adopts a segmented structure. Specifically, the pig tail body includes an independent and separated first segment 101 and a second segment 102. The blocking valve 103 is used to connect the first segment 101 and the second segment 102, and is flexible, with a gap between the end face of the first segment 101 facing the second segment 102 and the end face of the second segment 102 facing the first segment 101. In some embodiments of this application, the first segment 101 may be curved, and / or the second segment 102 may be straight. The blocking valve 103 is made of a flexible material, including but not limited to silicone, TPU (Thermoplastic Polyurethane), etc.

[0086] In some of these implementations, the first segment 101 of the bendable form bends from its distal end toward its proximal end. It should be understood that as long as the first segment 101 is made of a flexible material, the first segment 101 can bend in the manner described above when subjected to external forces.

[0087] Furthermore, after describing the specific structure of the shut-off valve 103 and the pig tail body, the following will describe in detail several connection methods between the shut-off valve 103 and the pig tail body.

[0088] In some optional embodiments, the shut-off valve 103 may be configured to consist of a distal pipe section, a valve plate, and a proximal pipe section connected sequentially from the distal end to the proximal end. One end (e.g., the distal end) of the shut-off valve 103 is sleeved on the outside of the first segment 101, and the other end (e.g., the proximal end) is sleeved on the outside of the second segment 102; or, one end (e.g., the distal end) of the shut-off valve 103 is embedded in the inside of the first segment 101, and the other end (e.g., the proximal end) is embedded in the inside of the second segment 102; or, one end (e.g., the distal end) of the shut-off valve 103 is embedded in the inside of the first segment 101, and the other end (e.g., the proximal end) is sleeved on the outside of the second segment 102; or, one end (e.g., the distal end) of the shut-off valve 103 is sleeved on the outside of the first segment 101, and the other end (e.g., the proximal end) is embedded in the inside of the second segment 102. The two ends of the aforementioned blocking valve 103 can be connected to the pig tail body of the corresponding pig tail device 100 in various forms. It should be understood that in some embodiments, the blocking valve 103 can be configured as an independent section between the first segment 101 and the second segment 102; thereby strengthening the connection between the first segment 101 (curved segment) and the second segment 102 (straight segment).

[0089] For example Figure 1 and 2 As shown, both ends of the aforementioned blocking valve 103 are embedded inside the first section 101 and the second section 102. Alternatively, as... Figure 3 and 4 In the illustrated embodiment, the aforementioned shut-off valve 103 is sleeved on the outside of the first segment 101 and the second segment 102. Alternatively, one end of the shut-off valve 103 can be embedded in one of the first segment 101 or the second segment 102, while the other end is sleeved on the other. Compared to the embedded connection method, the externally sleeved shut-off valve 103 is larger, facilitating both manufacturing and installation. Regardless of the connection method, the flow control unit 1031 is located between the first segment 101 and the second segment 102, used to control the flow of fluid in the pig tail device 100. The connection methods between the shut-off valve 103 and the pig tail body of the pig tail device 100 include, but are not limited to, adhesive bonding and heat fusion bonding. When using adhesive bonding, a gap for adhesive filling can be reserved between the shut-off valve 103 and the pig tail body of the pig tail device 100. In some embodiments, the shut-off valve 103 has a symmetrical shape with the flow control unit 1031 as the axis of symmetry or plane of symmetry. Of course, the shut-off valve 103 can also adopt an asymmetrical structure.

[0090] It should be noted that in some embodiments of this application, one end (e.g., the distal end) of the blocking valve 103 is embedded inside the first segment 101, and the other end (e.g., the proximal end) is embedded inside the second segment 102, with the end face of the first segment 101 facing the second segment 102 and the end face of the second segment 102 facing the first segment 101 respectively. This arrangement allows the outer surface of the pig tail device 100 (pig tail body) to gradually transition, improving the overall smoothness of the outer surface.

[0091] In some optional embodiments, the first segment 101 is located at the distal end of the blocking valve 103; the blocking valve 103 deforms under the action of the lateral force on the first segment 101. In the prior art, because the pig tail structure has a certain rigidity, after the fluid pumping system enters the ventricle, the ventricular contraction generates a lateral thrust (or lateral force) F on the head end of the fluid pumping system. The lateral thrust is transmitted from the pig tail body (pig tail structure body) to the conduit or blood pumping device in the fluid pumping device, thereby causing the conduit or blood pumping device to bend laterally (or generating a force that forces it to bend), and affecting the gap between the impeller and the conduit or blood pumping device. In severe cases, the impeller may even scrape against the inner wall of the conduit or blood pumping device. Therefore, in some embodiments of this disclosure, the pig tail body of the pig tail device 100 is configured to include a first segment 101 and a second segment 102, and the two are connected by a flexible blocking valve 103.

[0092] For example, the deformation of the blocking valve 103 is an elastic deformation within an elastic limit.

[0093] In one embodiment of this application, the shut-off valve is deformable under lateral forces acting on the pig tail body. Specifically, the bending stiffness of the shut-off valve is less than the bending stiffness of at least a portion of the pig tail body. This causes the shut-off valve with the smaller bending stiffness to bend first when the pig tail body is subjected to lateral thrust, thereby relieving pressure on the pig tail device, reducing the impact of lateral thrust on the blood pumping device, reducing or preventing lateral bending of the blood pumping device, and preventing hemolysis caused by reduced clearance between the impeller and the conduit or the blood pumping device, or scraping between the impeller and the conduit or the blood pumping device.

[0094] In one example, the pig tail body includes a first segment and a second segment, a blocking valve is connected between the first segment and the second segment, and there is a gap between the first segment and the second segment. The bending stiffness of the blocking valve is less than the bending stiffness of the first segment.

[0095] For example, the first segment is located at the distal end of the pig tail body. When the first segment is subjected to lateral thrust, the blocking valve with low bending stiffness will bend to relieve the force, reduce or block the transmission of lateral thrust to the second segment, thereby preventing it from being transmitted to the blood pumping device and preventing hemolysis caused by the reduced gap between the impeller and the conduit or the blood pumping device, or scraping between the impeller and the conduit or the blood pumping device.

[0096] As an example, the bending stiffness of the shut-off valve is less than the bending stiffness of the first and second segments. The bending stiffness of the first and second segments can be the same or different. For example, the bending stiffness of the first and second segments can be the same.

[0097] In another example, at least a portion of the shut-off valve protrudes from the proximal end of the pig tail body along its length. Since the bending stiffness of the shut-off valve is less than that of the pig tail body, the bending stiffness of the portion of the shut-off valve protruding from the pig tail body is also less than that of the pig tail body. Therefore, when the pig tail body is subjected to lateral thrust, the protruding portion of the shut-off valve can bend, thereby reducing or blocking the transmission of lateral thrust to the blood pumping device, preventing hemolysis caused by a reduction in the clearance between the impeller and the conduit or the blood pumping device, or scraping between the impeller and the conduit or the blood pumping device.

[0098] For example, the blood pumping device is connected to the pig tail body via a shut-off valve. That is, there is a gap between the blood pumping device and the pig tail body to allow the shut-off valve sufficient bending space.

[0099] In some embodiments of this application, the blood pumping catheter can be a variable-diameter blood pumping catheter with a stent, having a variable-diameter pump housing. Ventricular contraction generates a lateral thrust (or lateral force) F on the head end of the fluid pumping system, which is transmitted from the pigtail body (pigtail structure body) to the stent side. However, during the transmission process, the blocking valve 103 in the pigtail device 100 unloads the lateral thrust, thereby preventing the catheter or blood pumping device from bending laterally (or generating a force that forces it to bend), avoiding affecting the clearance between the impeller and the catheter or blood pumping device, and thus preventing the impeller from scraping against the inner wall of the catheter or blood pumping device, improving the stability of the blood pumping catheter during use.

[0100] like Figures 8 to 11 In the illustrated embodiment, when the head end of the fluid pumping system is subjected to a lateral thrust generated by ventricular contraction, the aforementioned lateral thrust will act on the first segment 101. Since a flexible shut-off valve 103 is provided between the first segment 101 and the second segment 102, the displacement will be absorbed by the first segment 101 and the flexible shut-off valve 103. That is, the lateral thrust will cause at least a portion of the first segment 101 and the shut-off valve 103 to displace, and at least a portion of the shut-off valve 103 to undergo bending deformation, thereby minimizing the transmission to the catheter or pumping device side, preventing hemolysis caused by a reduction in the clearance between the impeller and the catheter or pumping device, or scraping between the impeller and the catheter or pumping device.

[0101] In some embodiments of this application, such as Figures 8 to 11As shown, due to the lateral thrust acting on the pig tail body, the pig tail body bends. This bending is transmitted to the first segment 101, causing the first segment 101 to also bend. Due to the flexible structure of the shut-off valve 103, the lateral thrust in the figure is only transmitted to the shut-off valve 103 (through the first segment 101) and is dissipated by the bending of the shut-off valve 103. It is not transmitted to the second segment 102 connected to the proximal end of the shut-off valve 103, thereby protecting the second segment 102 and the mechanism that needs to be straight connected to the proximal end of the second segment 102.

[0102] A second aspect of this disclosure provides a fluid pumping system comprising a fluid pumping device and a pigtail device 100. In an intervention state, the fluid pumping system draws in ambient fluid from a distal end and pumps it out from a proximal end; the distal end of the fluid pumping device is provided with the pigtail device 100 according to any of the above-described embodiments of this disclosure.

[0103] In some optional embodiments, the distal end of the fluid pumping device is provided with a connecting portion, and the proximal end of the shut-off valve 103 is connected to the connecting portion; the proximal end of the pigtail device 100 is sleeved on at least one of the connecting portion and the shut-off valve 103. That is, the proximal end of the pigtail device 100 is connected to the connecting portion or the shut-off valve 103.

[0104] In some of these implementations, the shut-off valve 103 is fitted onto the outside of the connection, and the pig tail body is fitted onto the outside of the shut-off valve 103.

[0105] like Figure 12 and 13 In the illustrated embodiment, the shut-off valve 103 is located at the end 107 of the pigtail device, rather than in the middle. In this design, one end of the shut-off valve 103 needs to be fitted onto the connection of the fluid pumping system, for example... Figure 13 The inhalation channel head end 106 is shown. In some other embodiments, the other end of the aforementioned blocking valve 103 may be sleeved or embedded in the aforementioned pig tail device 100 (e.g., pig tail body).

[0106] In other embodiments, the aforementioned blocking valve 103 is embedded within the connecting portion; for example, the pig tail body is embedded within the connecting portion. Figure 13In a more preferred embodiment, after the aforementioned shut-off valve 103 is fitted onto the head end 106 of the aforementioned suction channel, the end 107 of the aforementioned pig tail device is fitted onto the outside of the aforementioned connecting portion and the aforementioned shut-off valve 103, thereby forming a multi-layered fitting configuration. The aforementioned multi-layered fitting can be achieved through heat fusion connection, adhesive connection, or other methods to form a stable fixed relationship; this application does not specifically limit the specific connection method. Preferably, the aforementioned pig tail device 100 has a flared structure at the end used to connect with the shut-off valve 103 to facilitate installation. Compared to the embodiment described above that divides the main body of the pig tail device 100 into a first segment 101 and a second segment 102, this solution avoids cutting off the pig tail device 100, simply achieving the guide wire passage, sealing, and exhaust characteristics of the fluid pumping system.

[0107] In some alternative implementations, the connecting part is sleeved on the outside of the blocking valve 103, and the pig tail body is sleeved on the outside of the connecting part.

[0108] In some optional embodiments, the distal end of the fluid pumping system is provided with a connecting portion, the proximal end of the shut-off valve 103 is connected to the connecting portion, and the proximal end of the pig tail device 100 is embedded inside the shut-off valve 103. In some implementations, the connecting portion is sleeved on the outside of the shut-off valve 103, and the pig tail body is embedded inside the shut-off valve 103. In other alternative implementations, the shut-off valve 103 is sleeved on the outside of the connecting portion, and the pig tail body is embedded inside the shut-off valve 103.

[0109] In some optional embodiments, the connecting portion is provided with at least two radially outwardly protruding portions, which are spaced apart along the axial direction of the connecting portion; an adhesive is provided on the outer surface of at least one protruding portion and / or at the interval between two adjacent protruding portions, the adhesive being used to connect the connecting portion to the blocking valve 103. Figure 12 and 13In the illustrated embodiment, the connecting portion is provided with multiple protrusions, each of which can be a complete annular boss or an intermittent boss. During connection, an adhesive substance can be coated onto the surface of the protrusions to enhance the connection strength between the connecting portion and the shut-off valve 103. Alternatively, adhesive substance can be filled between adjacent bosses to further enhance the connection strength. It should be understood that in some embodiments, the gap between the connecting portion, the proximal end of the pig tail body, and the shut-off valve 103 can also be filled with an adhesive. In other embodiments, the connection between the fluid pumping device, the shut-off valve 103, and the pig tail body can be achieved through the bonding force (e.g., friction) between the protrusion and the shut-off valve 103, and the bonding force (e.g., friction) between the shut-off valve 103 and the pig tail body. In more preferred embodiments, the protrusions include three parts, arranged sequentially from distal to proximal as a first protrusion 1061, a second protrusion 1062, and a third protrusion 1063. An adhesive is provided on the outer surface of at least one of the first protrusion 1061 and the second protrusion 1062, and / or at the interval between the first protrusion 1061 and the second protrusion 1062, to connect the shut-off valve 103. Furthermore, an adhesive is provided on the outer surface of the third protrusion 1063, and / or at the interval between the second protrusion 1062 and the third protrusion 1063, for connecting the connecting part to the proximal end of the pigtail device 100. In other embodiments, the shut-off valve 103 and the suction channel head end 106 are interference-fitted or clearance-fitted, with the interference or clearance amount less than 0.2 mm on each side.

[0110] In one example, the shut-off valve also includes a mounting unit for connection to the flow control unit, located on one side of the flow control unit and stacked inside the pigtail body for connection to a fluid pumping device. As an example, the shut-off valve is U-shaped.

[0111] It is understood that the aforementioned connection method between the pig tail structure and the fluid pumping device is only a partial example, and other connection methods are also within the scope of protection of this application, which will not be listed here.

[0112] In addition, this application does not limit the specific type of fluid pumping device. In some embodiments of this application, the fluid pumping system includes a variable-diameter blood pumping conduit with a support. In other embodiments of this application, the fluid pumping system includes a blood pumping conduit with a fixed radial dimension.

[0113] The specific embodiments described above do not constitute a limitation on the scope of protection of this disclosure. Those skilled in the art, after considering the specification and practicing the technical solutions disclosed in this application, will readily conceive of other embodiments of this disclosure. This application is intended to cover any variations, uses, or adaptations of this disclosure that follow the general principles of this disclosure and include common knowledge or customary technical means in the art not disclosed in this disclosure. The specification and embodiments are considered exemplary only, and the true scope and spirit of this disclosure are indicated by the following claims.

[0114] It should be understood that this disclosure is not limited to the precise structures described above and shown in the accompanying drawings, and various modifications and changes can be made without departing from its scope. The scope of this disclosure is limited only by the appended claims.

Claims

1. A pigtail device arranged at a distal end of a fluid pumping device, characterized in that, the pigtail device comprises: a pigtail body, a shut-off valve arranged on the pigtail body, and the shut-off valve comprises a flow control unit; the flow control unit is arranged to be penetrated by a target element, and under the action of an ambient maximum pulsating pressure difference, the flow control unit is in a closed state.

2. The pigtail device according to claim 1, characterized in that, an axial pigtail channel is arranged in the pigtail body, and the flow control unit is arranged on the pigtail channel, and the flow control unit is arranged to be penetrated by the target element along the extension direction of the pigtail channel.

3. The pigtail device according to claim 1 or 2, characterized in that, a notch is formed on the flow control unit for the target element to penetrate; the notch is closed when the flow control unit is in a closed state.

4. The pigtail device according to claim 3, characterized in that, the flow control unit is made of a flexible material, and the flexible material provides a restoring force to close the notch.

5. The pigtail device according to claim 1, characterized in that, the pigtail body comprises a first segment and a second segment which are separated from each other; one end of the shut-off valve is communicated with the first segment, and the other end is communicated with the second segment.

6. The pigtail device according to claim 5, characterized in that, one end of the shut-off valve is sleeved on the outside of the first segment, and the other end is sleeved on the outside of the second segment; or, one end of the shut-off valve is embedded on the inside of the first segment, and the other end is embedded on the inside of the second segment; or, one end of the shut-off valve is embedded on the inside of the first segment, and the other end is sleeved on the outside of the second segment; or, one end of the shut-off valve is sleeved on the outside of the first segment, and the other end is embedded on the inside of the second segment.

7. The pigtail device according to claim 5 or 6, characterized in that, the first segment is arranged at the distal end of the shut-off valve; the shut-off valve can be deformed under the action of a lateral force on the first segment.

8. The pigtail device of claim 7, wherein, the shut-off valve has flexibility, and the end face of the first segment facing the second segment is arranged with a gap from the end face of the second segment facing the first segment.

9. The pigtail device according to claim 1, characterized in that, the shut-off valve is arranged at the proximal end of the pigtail body.

10. The pigtail device according to claim 9, characterized in that, the shut-off valve can be deformed under the action of a lateral force on the pigtail body.

11. The pigtail device of claim 9, wherein, the shut-off valve further comprises a mounting unit connected with the flow control unit, the mounting unit is located on one side of the flow control unit, and the mounting unit is stacked inside the pigtail body for connection with the fluid pumping device.

12. The pigtail device according to claim 9, characterized in that, The blocking valve is arranged separately from the pigtail body, and the blocking valve is arranged to connect a distal end of the fluid pumping device with a proximal end of the pigtail body.

13. A fluid pumping system characterized by, The fluid pumping system comprises a fluid pumping device and a pigtail device as claimed in any one of claims 1-12. The pigtail device is arranged at a distal end of the fluid pumping device; in an intervention state, the fluid pumping system sucks ambient fluid from the distal end and pumps it out from the proximal end.

14. The fluid pumping system according to claim 13, wherein The distal end of the fluid pumping device is provided with a connecting portion, and the proximal end of the blocking valve is connected with the connecting portion. The proximal end of the pigtail device is sleeved on at least one of the connecting portion and the blocking valve.

15. The fluid pumping system according to claim 14, wherein The blocking valve is sleeved on the connecting portion, and the pigtail body is sleeved on the blocking valve.

16. The fluid pumping system according to claim 14, wherein The connecting portion is provided with at least two protrusions protruding radially outward, and the protrusions are spaced along an axial direction of the connecting portion; An outer surface of at least one of the protrusions, and / or a space between two adjacent protrusions is provided with an adhesive for connecting the connecting portion with the blocking valve.

17. The fluid pumping system according to claim 16, wherein The protrusions include three protrusions, and the three protrusions are a first protrusion, a second protrusion and a third protrusion in a direction from the distal end to the proximal end; An outer surface of at least one of the first protrusion and the second protrusion, and / or a space between the first protrusion and the second protrusion is provided with an adhesive for connecting the blocking valve; An outer surface of the third protrusion, and / or a space between the second protrusion and the third protrusion is provided with an adhesive for connecting the connecting portion with the proximal end of the pigtail device.

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