Interventional catheter pump and cardiac assist device

Abstract

An interventional catheter pump and heart assist equipment wherein the interventional catheter pump comprises a pump body, a fluid outflow chamber and a leak-proof member, the pump body is used for pumping fluid, the fluid outflow chamber is arranged at the distal end and provided with a plurality of fluid outlets, and the leak-proof member sleeves the outside of the fluid outflow chamber. The inner wall face of the leakage-proof piece is tightly attached to the outer wall face of the fluid outflow chamber so as to block the fluid outlet. An intrusive catheter pump is usually implanted into a patient body in an arterial puncture mode, and when a fluid inlet is located in the patient body and a fluid outflow chamber is not completely implanted, the intrusive catheter pump can form an open channel communicated with the outside of the patient body. Therefore, the leakage-proof piece capable of blocking the fluid outlet is arranged outside the fluid outflow chamber in a sleeving mode, sealing of the open channel is achieved, meaningless outflow of blood is effectively reduced, the implantation mode and the treatment effect of the intrusive catheter pump are improved, and operation safety is improved.

Description

Technical Field

[0001] The present application relates to the technical field of medical devices, and in particular to an interventional catheter pump and a cardiac assist device. Background Art

[0002] In recent years, the number of patients with cardiovascular diseases has increased dramatically. Among them, heart failure, as a common cardiovascular disease, has had a serious impact on people's lives. At present, for patients with heart failure, blood pumps are usually implanted clinically to maintain the patient's normal blood pumping function. Compared with long-term implanted blood pumps, short-term implanted interventional micro-intrusive pumps are implanted into the heart and arteries through minimally invasive methods such as femoral artery puncture or incision. They have the advantage of less trauma and are often used in high-risk PCI surgery and cardiogenic shock indications. Since the catheter pump requires arterial puncture to establish a pathway during the implantation process, the blood pressure in the blood vessel is higher than the atmospheric pressure. Under the action of the pressure difference, the blood will flow out of the artery through the catheter pump. If the implantation method is incorrect or the implantation time is too long, it will cause a large amount of blood loss in the patient, which seriously affects the treatment effect of the operation. If the amount of blood leakage can be reduced during the implantation of the catheter pump, it will play a vital role in reducing the difficulty of surgical operations for clinicians and improving clinical treatment effects.

[0003] Therefore, how to improve the technical defects existing in the prior art has always been a problem that ordinary technicians in this field need to solve urgently. Utility Model Content

[0004] The purpose of this application is to provide an interventional catheter pump and a cardiac assist device with a blood leakage prevention function, which can seal the established puncture pathway during the implantation of the interventional catheter pump, reduce unnecessary blood outflow, improve the implantation method and treatment effect of the interventional catheter pump, and improve the safety of the operation.

[0005] The technical solutions provided by this application are as follows:

[0006] An interventional catheter pump, comprising:

[0007] A pump body, used for pumping fluid;

[0008] A fluid outflow chamber is disposed at the distal end of the pump body, and the fluid outflow chamber is provided with a fluid outlet;

[0009] The leak-proof component is sleeved on the outside of the fluid outflow chamber, and the inner wall surface of the leak-proof component is closely attached to the outer wall surface of the fluid outflow chamber to block the fluid outlet.

[0010] In some embodiments, the leakage-proof member is a deformable elastic member;

[0011] In some embodiments, the leak-proof member has a through cylindrical chamber, and the wall surface of the chamber forms the inner wall surface of the leak-proof member;

[0012] The radial dimension of the chamber is smaller than the radial dimension of the outflow chamber.

[0013] In some embodiments, a tear opening is provided on the outer wall of the leakage preventing member.

[0014] In some embodiments, the length dimension of the tear opening in the axial direction of the chamber is 1 / 5-1 / 2 of the length dimension of the leak-proof component in the axial direction of the chamber; and / or, the depth dimension of the tear opening in the radial direction of the chamber is 1 / 5-2 / 5 of the thickness dimension of the leak-proof component in the radial direction of the chamber.

[0015] In some embodiments, a cutting slit is provided on the inner wall surface of the leakage prevention member, the cutting slit extends to the proximal end of the leakage prevention member, and the cutting slit extends to the outer wall surface of the leakage prevention member.

[0016] In some embodiments, the thickness dimension of the proximal end of the leakage preventing member is smaller than the thickness dimension of the distal end of the leakage preventing member.

[0017] In some embodiments, the leak-proof member is made of easily deformable silicone rubber material;

[0018] or

[0019] The leak-proof component comprises a first material layer, a second material layer and a sealing layer in sequence from the inner wall surface to the outer wall surface. The first material layer is made of elastic bio-silicone and the second material layer is a mesh-shaped metal braided layer.

[0020] In some embodiments, the invasive catheter pump further comprises:

[0021] Fluid inflow chambers, cannulas and cable guides;

[0022] The cable conduit is disposed at the proximal end of the pump body, the cannula is disposed at the distal end of the fluid outflow chamber, and the fluid inflow chamber is disposed at the distal end of the cannula;

[0023] The fluid inflow chamber and the fluid outflow chamber are connected through the cannula, and the fluid inflow chamber is provided with a plurality of fluid inlets, and the fluid is pumped into the cannula through the fluid inlets and pumped out through the fluid outlets;

[0024] Wherein, the radial dimension of the chamber is larger than the outer diameter dimension of the cable conduit; or, the radial dimension of the chamber is smaller than the outer diameter dimension of the cable conduit, so as to be used in conjunction with an artificial blood vessel.

[0025] The present application also provides a cardiac assist device, comprising:

[0026] A delivery sheath and an interventional catheter pump as described in any one of the above;

[0027] The delivery sheath is used to deliver the interventional catheter pump.

[0028] The leak-proof member has a through cylindrical chamber inside, and the wall surface of the chamber forms the inner wall surface of the leak-proof member;

[0029] The radial dimension of the distal end of the leak-proof component in the pump body is larger than the inner diameter of the proximal end of the delivery sheath, and the radial dimension of the chamber is smaller than the outer diameter of the proximal end of the delivery sheath.

[0030] The technical effects of this application are:

[0031] 1. In the present application, by setting a leak-proof part to block the fluid outlet on the fluid outflow chamber, the outflow of fluid from the fluid outlet can be greatly reduced. In this way, during the implantation of the interventional catheter pump, blood is difficult to flow out of the patient's body through the fluid outlet, reducing unnecessary blood outflow, thereby improving the implantation method and treatment effect of the interventional catheter pump, reducing the difficulty of implanting the interventional catheter pump, and improving the safety of the operation.

[0032] 2. In the present application, the radial dimension of the distal end of the leak-proof part in the pump body is larger than the inner diameter dimension of the proximal end of the delivery sheath, and at the same time, the radial dimension of the chamber is smaller than the outer diameter dimension of the proximal end of the delivery sheath, so that the distal end of the leak-proof part can overlap with the proximal end of the delivery sheath, and the two can conflict with each other, so that the leak-proof part cannot penetrate into the delivery sheath, and the delivery sheath cannot penetrate into the chamber of the leak-proof part, so that the leak-proof part can be always located outside the delivery sheath during the implantation of the interventional catheter pump, and the influence of the external environment on the connected environment in the patient's body can be avoided. Especially when part of the fluid outflow chamber has entered the delivery sheath, the distal end of the leak-proof part can be against the proximal end of the delivery sheath, and the part of the fluid outflow chamber that has not entered the delivery sheath is blocked until the fluid outflow chamber completely enters the inside of the delivery sheath. Moreover, the leak-proof part and the delivery sheath in the present application are independent of each other and do not affect each other. Medical staff can directly use the leak-proof part provided by the present application with the existing delivery sheath without changing the structure of the delivery sheath, thereby improving the universal applicability of the leak-proof part.

[0033] 3. In the present application, the radial dimension of the chamber formed in the leak-proof part is larger than the outer diameter of the cable conduit arranged at the proximal end of the pump body. When the fluid flows out of the chamber and completely enters the interior of the delivery sheath, the leak-proof part moves to the cable conduit under the action of the delivery sheath. The medical staff pinches the leak-proof part and cuts it open with scissors, so the leak-proof part can be easily removed. The operation is convenient and quick.

[0034] 4. In the present application, a cutting slit is provided on the inner wall of the leak-proof part, and the cutting slit extends to the proximal end of the leak-proof part. On the one hand, the deformation ability of the leak-proof part can be improved, making it easier for the leak-proof part to be put on the fluid outflow chamber, and the assembly is convenient; on the other hand, the part of the guide wire guide tube extending out of the fluid outflow chamber can be embedded in the cutting slit, and the squeezing of the guide wire guide tube and its inner guide wire by the leak-proof part is reduced without affecting the leak-proof function of the leak-proof part, and it is not easy to leave scratches on the outer wall of the pump body, and the structural setting is more reasonable and practical. BRIEF DESCRIPTION OF THE DRAWINGS

[0035] The present application is further described in detail below with reference to the accompanying drawings and specific implementation methods:

[0036] Figure 1 is a schematic diagram of the structure of a heart assist device provided in one embodiment of the present application;

[0037] Figure 2 yes Figure 1 A partial enlarged perspective view of the leakage-proof part shown;

[0038] Figure 3 is a schematic diagram of the three-dimensional structure of a leakage prevention member provided in one embodiment of the present application;

[0039] Figure 4 is a schematic diagram of the three-dimensional structure of a leakage-proof component provided in another embodiment of the present application;

[0040] Figure 5 is a schematic structural diagram of a heart assist device provided in another embodiment of the present application;

[0041] Figure 6 yes Figure 5 A partial enlarged perspective view of the leakage-proof part shown;

[0042] Figure 7 It is a schematic diagram of the structure of a heart assist device provided in yet another embodiment of the present application.

[0043] Description of Figure Numbers:

[0044] 110, pump body; 111, impeller; 120, fluid outflow chamber; 121, fluid outlet; 130, optical fiber sensor; 140, leak-proof part; 141, chamber; 142, tear opening; 150, pigtail; 160, fluid inflow chamber; 161, fluid inlet; 170, cannula; 180, cable conduit;

[0045] 200, guide wire guide tube; 210, label;

[0046] 300, stitched wing;

[0047] 400, repositioning device;

[0048] 500, handle;

[0049] 600. Plug. DETAILED DESCRIPTION

[0050] In the following description, specific details such as specific system structures, technologies, etc. are provided for the purpose of illustration rather than limitation, so as to provide a thorough understanding of the embodiments of the present application. However, it should be clear to those skilled in the art that the present application may also be implemented in other embodiments without these specific details. In other cases, detailed descriptions of well-known systems, devices, circuits, and methods are omitted to prevent unnecessary details from obstructing the description of the present application.

[0051] In order to more clearly illustrate the embodiments of the present application or the technical solutions in the prior art, the specific implementation methods of the present application will be described below with reference to the accompanying drawings. Obviously, the drawings described below are only some embodiments of the present application. For ordinary technicians in this field, other drawings and other implementation methods can be obtained based on these drawings without creative work.

[0052] In order to simplify the drawings, only the parts related to the present application are schematically shown in each figure, and they do not represent the actual structure of the product. In addition, in order to simplify the drawings and facilitate understanding, in some figures, only one of the parts with the same structure or function is schematically drawn or marked.

[0053] In this document, it should be noted that, unless otherwise clearly specified and limited, the term "connection" should be understood in a broad sense, for example, it can be a fixed connection, or a detachable connection, or an integral connection; or it can be a mechanical connection, or it can be an electrical connection; or it can be a direct connection, or it can be indirectly connected through an intermediate medium. For ordinary technicians in this field, the specific meanings of the above terms in this application can be understood according to specific circumstances.

[0054] In the embodiments shown in the drawings, directional indications (such as up, down, left, right, front, and back, etc.) are not absolute but relative when describing the structure and movement of each component, and are not used to limit the direction of the product in actual use.

[0055] In addition, in the description of this application, ordinal numbers, such as "first", "second", etc., are only used to distinguish and describe related objects, and cannot be understood as indicating or implying the relative importance or order between related objects. Also, in the description of this application, "proximal end" refers to the end of the interventional catheter pump that is close to the operator along the length direction, and "distal end" refers to the end of the interventional catheter pump that is away from the operator along the length direction.

[0056] During the implantation process, the interventional catheter pump is usually implanted into the patient's body by arterial puncture to achieve the function of pumping blood. Specifically, blood enters the interventional catheter pump through the fluid inflow chamber 160, is pressurized by the impeller 111, and then flows out through the fluid outlet 121 on the fluid outflow chamber 120.

[0057] The fluid inflow chamber 160 is connected to the fluid outflow chamber 120. Thus, when the fluid inflow chamber 160 on the interventional catheter pump has been implanted into the artery and the fluid outflow chamber 120 has not yet been implanted, the interventional catheter pump will form an open passage connected to the outside of the patient's body. Because the blood pressure in the blood vessels is higher than the atmospheric pressure, the blood will enter the interventional catheter pump through the fluid inflow chamber 160 under the action of the blood pressure, and flow out of the fluid outflow chamber 120 to the outside of the patient's body, causing the patient to lose a large amount of blood instantly. If the interventional catheter pump is implanted for too long or medical staff need to push and pull the interventional catheter pump back and forth to enter and exit the human body, it will further increase the patient's blood loss and have a serious impact on the patient's life safety.

[0058] In this regard, the present application provides an interventional catheter pump, see Figures 1 to 3 , comprising a pump body 110, a fluid outflow chamber 120 and a leak-proof component, wherein the pump body 110 is used to pump fluid, the fluid outflow chamber 120 is disposed at the distal end of the pump body 110, and the fluid outflow chamber 120 is provided with a plurality of fluid outlets 121, and the fluid pumped by the pump body 110 can flow out through the fluid outlets 121. The leak-proof component 140 is sleeved outside the fluid outflow chamber 120, and the inner wall surface of the leak-proof component 140 is closely attached to the outer wall surface of the fluid outflow chamber 120 to block the fluid outlets 121.

[0059] This embodiment blocks the fluid outlet 121 on the fluid outflow chamber 120 by setting a leak-proof member 140, which can significantly reduce the outflow of fluid from the fluid outlet 121. In this way, during the implantation of the interventional catheter pump, blood is difficult to flow out of the patient's body through the fluid outlet 121, thereby achieving the effect of preventing bleeding, reducing the patient's blood loss during the operation, and improving the safety of the operation. In addition, a large amount of blood loss during the implantation process will not only affect the patient's life safety, but also have a certain adverse effect on the advancement of the operation. Therefore, this embodiment reduces the amount of blood leakage by setting a leak-proof member 140, and can also reduce the difficulty of operation during the implantation of the interventional catheter pump to a certain extent, which helps to quickly advance the operation and improve the treatment effect.

[0060] Specifically, the pump body 110 includes a pump casing, a motor and an impeller 111, wherein the fluid outflow chamber 120 is arranged at the far end of the pump casing, and is enclosed together with the pump casing to form a first installation space capable of accommodating the impeller 111, and a second installation space capable of installing the motor is formed inside the pump casing. At this time, the driving shaft of the motor passes through the pump casing and extends into the first installation space of the fluid outflow chamber 120, and is drivingly connected to the impeller 111 to drive the impeller 111 to rotate, thereby realizing the pumping function of the pump body 110 on the fluid.

[0061] In one example embodiment, see Figures 1 to 4 The leak-proof member 140 has a through cylindrical chamber 141, and the wall of the chamber 141 forms the inner wall of the leak-proof member 140. The leak-proof member 140 is an elastic member that is easily deformed, and the radial dimension of the chamber 141 is preferably smaller than the radial dimension of the fluid outflow chamber 120. In this way, it is convenient for medical staff to cover the leak-proof member 140 on the fluid outflow chamber 120, and when the leak-proof member 140 is covered on the outside of the fluid outflow chamber 120, the inner wall of the leak-proof member 140 is tightly attached to the outer wall of the fluid outflow chamber 120, so that the sealing effect is better, the blood is less likely to flow out through the gap between the leak-proof member 140 and the outer wall of the fluid outflow chamber 120, and the patient loses less blood.

[0062] Of course, in actual production, the radial size of the chamber 141 should not be too small, and the leak-proof part 140 must be able to move along the outer wall of the pump body 110 so that medical staff can arrange the position of the leak-proof part 140 according to the scene requirements when using it.

[0063] In addition, in this embodiment, the radial contour size of the distal end of the leak-proof component 140 in the pump body 110 should be larger than the inner diameter size of the proximal end of the delivery sheath to prevent the leak-proof component 140 from entering the interior of the delivery sheath during the implantation of the interventional catheter pump and avoid the influence of the external environment on the connecting environment in the patient's body.

[0064] At the same time, the radial dimension of the chamber 141 on the leak-proof member 140 should be smaller than the outer diameter of the proximal end of the delivery sheath to prevent the delivery sheath from entering the chamber 141 of the leak-proof member 140, so that the distal end of the leak-proof member 140 and the proximal end of the delivery sheath partially overlap and the two can conflict with each other. The delivery sheath is used to deliver an interventional catheter pump, so that when the fluid outflow chamber 120 moves from the proximal end to a position near the delivery sheath, the distal end of the leak-proof member 140 abuts against the proximal end of the delivery sheath and continues to advance, and the fluid outflow chamber 120 partially enters the delivery sheath. At this time, the distal end of the leak-proof member 140 is still tightly against the proximal end of the delivery sheath, and the part of the fluid outflow chamber 120 that has not entered the delivery sheath is blocked until the fluid outflow chamber 120 completely enters the interior of the delivery sheath.

[0065] After the fluid flows out of the chamber 120 and enters the delivery sheath, the leak-proof member 140 can move along the outer wall of the pump housing to the cable conduit 180. The cable conduit 180 is disposed at the proximal end of the pump body 110 to accommodate the motor cable, and the outer diameter of the cable conduit 180 is smaller than the outer diameter of the pump body 110.

[0066] In an exemplary embodiment, the radial dimension of the chamber 141 is larger than the outer diameter of the cable duct 180. Thus, when the leak-proof member 140 moves onto the cable duct 180, a gap is formed between the leak-proof member 140 and the cable duct 180. When the medical staff pinches the leak-proof member 140 to deform it, the through cylindrical chamber 141 on the leak-proof member 140 becomes approximately elliptical under the effect of squeezing. At this time, the leak-proof member 140 can be easily cut open by passing a pair of scissors through the deformed chamber 141, thereby removing the leak-proof member 140 from the cable duct 180. The operation is convenient and quick.

[0067] Of course, see Figure 4 In one embodiment, a tear opening 142 may be further provided on the outer wall surface of the leakage prevention member 140. The tear opening 142 is preferably provided at the proximal end of the leakage prevention member 140. When the leakage prevention member 140 is moved onto the cable duct 180, medical staff can easily tear the leakage prevention member 140 through the tear opening 142, thereby removing the leakage prevention member 140 from the cable duct 180. No limitation is made herein and all are within the protection scope of the present application.

[0068] Specifically, the depth dimension of the tear opening 142 in the radial direction of the chamber 141 is 1 / 5-2 / 5 of the thickness dimension of the leakage prevention component 140 in the radial direction of the chamber 141. This depth dimension makes it easier for medical staff to tear open the tear opening 142. At the same time, the tear opening 142 on the leakage prevention component 140 will not be easily broken due to its own deformation, thereby avoiding failure of the leakage prevention component 140 during the blocking process. The structural setting is more reasonable and practical.

[0069] Relatively speaking, the length dimension of the tear opening 142 in the axial direction of the chamber 141 is 1 / 5-1 / 2 of the length dimension of the leak-proof component 140 in the axial direction of the chamber 141. It is easier for medical staff to tear open the entire leak-proof component 140 through the tear opening 142, which is convenient to operate and highly practical.

[0070] As a preference, see Figures 1 to 6 The leak-proof member 140 is an annular columnar structure, with an axial length of 15-30 mm, an outer diameter of 10-20 mm, and an inner diameter of 3-6 mm. Also, the width of the tear opening 142 on the leak-proof member 140 (i.e., the size of the tear opening 142 along the tangent direction of the leak-proof member 140) is 1-2 mm.

[0071] Of course, in actual production, the leak-proof member 140 does not necessarily have to be a columnar structure with uniform thickness, and the thickness of the proximal end of the leak-proof member 140 may also be smaller than the thickness of the distal end of the leak-proof member 140. Specifically, during the entire blocking process, a portion of the proximal end of the leak-proof member 140 is always attached to the outer wall of the fluid outflow chamber 120 or the pump body 110, and does not need to cover the fluid outlet 121. The thickness of this portion can be less than the thickness of the remaining portion of the leak-proof member 140, so as to apply a smaller radial pressure to the fluid outflow chamber 120 or the pump body 110. Relatively speaking, the friction between the portion of the proximal end of the leak-proof member 140 that is not used to cover the fluid outlet 121 and the fluid outflow chamber 120 or the pump body 110 is also smaller, which is conducive to the relative sliding between the leak-proof member 140 and the fluid outflow chamber 120, or the leak-proof member 140 and the pump body 110.

[0072] Furthermore, a lubricating material, such as medical silicone oil, may be coated on the inner surface of the leak-proof member 140 to further reduce the friction between the leak-proof member 140 and the fluid outflow chamber 120 , or between the leak-proof member 140 and the pump body 110 .

[0073] In a preferred embodiment, the inner wall of the leak-proof member 140 is provided with a cutting slit, which extends to the proximal end of the leak-proof member 140. To prevent the cutting slit from affecting the blocking effect of the leak-proof member 140 on the fluid outlet 121, the cutting slit in this example is provided at a portion of the proximal end of the leak-proof member 140 that does not cover the fluid outlet 121.

[0074] See also Figure 5 and Figure 6 By setting the cutting seam in this embodiment, on the one hand, the deformation ability of the proximal end of the leak-proof member 140 can be improved, which is more conducive to the medical staff to put the leak-proof member 140 on the fluid outflow chamber 120, and the assembly is simple and convenient; on the other hand, the medical staff can embed the guide wire guide tube 200 passing through the fluid outlet 121 and the guide wire inside the guide wire outside the fluid outflow chamber 120 into the cutting seam on the leak-proof member 140, reducing the squeezing of the guide wire guide tube 200 and the guide wire inside the guide wire by the leak-proof member 140. In this way, the guide wire guide tube 200 and the guide wire inside the guide wire are not easy to scratch the outer wall of the pump body 110, which effectively reduces the equipment failure rate.

[0075] Preferably, the cutting slit extends radially along the leak-proof member 140. The cutting slit may extend all the way to the outer wall of the leak-proof member 140, thereby penetrating the side wall of the leak-proof member 140 radially along the leak-proof member 140; or, the cutting slit may not penetrate the side wall of the leak-proof member 140, but form a structure similar to a slot, which is not limited here and is within the protection scope of the present application.

[0076] Specifically, see Figure 1 , Figure 2 and Figure 5 , Figure 6The leak-proof member 140 provided in all the above embodiments can be made of silicone rubber material. In particular, for an interventional catheter pump in which an optical fiber sensor 130 is arranged on the outer wall of the pump body 110 and / or a guide wire guide tube 200 is passed through the fluid outflow chamber 120, the leak-proof member 140 is preferably made of a soft silicone rubber material, such as LSR3003, with a material hardness of 0-10 SHORE A. In this way, when the leak-proof member 140 is sleeved outside the fluid outflow chamber 120, because the radial dimension of the upper chamber 141 of the leak-proof member 140 is smaller than the radial dimension of the fluid outflow chamber 120, and the silicone rubber material is easy to deform, the leak-proof member 140 can elastically press the optical fiber sensor 130 and / or the guide wire guide tube 200 to make it fit the outer wall of the pump body 110. At the same time, the inner wall of the leak-proof member 140 can well wrap the optical fiber sensor 130 and / or the guide wire guide tube 200, so that the gap between the fluid outflow chamber 120, the leak-proof member 140 and the guide wire guide tube 200 and / or the optical fiber sensor 130 is very small, thereby effectively reducing the amount of blood leakage during the implantation of the interventional catheter pump, and the leak-proof effect is significant.

[0077] In addition, the leak-proof member 140 is made of a soft silicone rubber material, which can also make the leak-proof member 140 meet the anti-blood leakage requirements of interventional catheter pumps of different diameters. Specifically, the leak-proof member 140 with a radial dimension of 4 mm in the upper chamber 141 of the leak-proof member 140 has good elasticity, and can be used for the anti-blood leakage requirements of 18Fr interventional catheter pumps, and can also meet the anti-blood leakage requirements of 14Fr interventional catheter pumps, thereby improving the universal applicability of the leak-proof member 140 to a certain extent, reducing the mold cost of the leak-proof member 140, and reducing the production cost. Of course, in actual production, the interventional catheter pump and the leak-proof member 140 to which it is applicable must meet the following conditions: the radial dimension of the upper chamber 141 of the leak-proof member 140 is smaller than the radial dimension of the fluid outflow chamber 120.

[0078] In a specific embodiment, the leak-proof member 140 can also be made of elastic silicone rubber material, which has a very low hardness and soft material, which can reduce the surface scratches of the pump body 110 when the leak-proof member 140 moves along the outer wall of the pump body 110, reduce the damage to the pump body 110, and thus reduce the equipment failure rate to a certain extent. In addition, because the silicone rubber material is a medical material with good biocompatibility, it will not cause clinical problems such as hemolysis and thrombosis after the interventional catheter pump is implanted, and the safety factor is high. Of course, for the interventional catheter pump with the optical fiber sensor 130 arranged on the outer wall of the pump body 110, the optical fiber sensor 130 is a consumable part and is easily damaged under the action of external force, while the leak-proof member 140 made of elastic silicone rubber material is soft and elastic. Therefore, when the interventional catheter pump is implanted, although the leak-proof member 140 moves along the outer wall of the pump body 110, it will not damage the optical fiber sensor 130, and the safety of the interventional catheter pump is guaranteed while preventing blood leakage, and the equipment failure rate is reduced.

[0079] In an exemplary embodiment, in addition to being made of the above-mentioned silicone rubber material, the leak-proof member 140 can also be set to a multi-layer structure that can shrink and expand radially. Specifically, the leak-proof member 140 includes a first material layer, a second material layer, and a sealing layer from the inner wall surface to the outer wall surface. The first material layer is made of elastic bio-silicone and plays a sealing role; the second material layer is a mesh-shaped metal braided layer, which is formed with a plurality of diamond-shaped grids. When subjected to radial force (i.e., when the leak-proof member 140 is sleeved on the fluid outflow chamber 120 or the pump body 110), the diamond-shaped grids are deformed to achieve radial expansion. When the radial force is eliminated, the diamond-shaped grids return to the initial state to achieve radial contraction; the sealing layer covers the metal braided layer, so that the leak-proof member 140 can have a smoother outer wall surface. Because the braided layer provides inward pressure, the overall structural thickness of the leak-proof member 140 can be relatively smaller.

[0080] In a specific embodiment, see Figure 1 and Figure 5 The interventional catheter pump may further include a fluid inflow chamber 160 and a cannula 170, wherein the cannula 170 is disposed at the distal end of the fluid outflow chamber 120, and the fluid inflow chamber 160 is disposed at the distal end of the cannula 170. At this time, the fluid inflow chamber 160 and the fluid outflow chamber 120 are connected through the cannula 170, and the fluid inflow chamber 160 is provided with a plurality of fluid inlets 161, and the fluid flows into the cannula 170 through the fluid inlet 161 and then flows out through the fluid outlet 121.

[0081] Further, see Figure 1 , Figure 5 and Figure 7The interventional catheter pump also includes a pigtail tube 150, a suture wing 300, a repositioning device 400, a handle 500 and a plug 600, and the pigtail tube 150, the fluid inflow chamber 160, the cannula 170, the fluid outflow chamber 120, the pump body 110, the suture wing 300, the repositioning device 400, the handle 500 and the plug 600 are connected in sequence from the distal end to the proximal end.

[0082] When the interventional catheter pump provided in this embodiment is used, the leak-proof member 140 should be sleeved on the cannula 170 first, and then the guide wire should be inserted into the guide wire guide tube 200. When the guide wire passes through the guide wire guide tube 200, the interventional catheter pump should be pushed toward the distal end so that the distal end of the leak-proof member 140 abuts against the proximal end of the delivery sheath. Then, pinch the guide wire guide tube 200 and the label 210 thereon, and pull out the guide wire guide tube 200. Subsequently, the leak-proof member 140 is moved so that it can block the fluid outlet 121 on the fluid outflow chamber 120. The medical staff pinches the pump body 110 to quickly advance it toward the delivery sheath along the guide wire. When the fluid outflow chamber 120 partially enters the delivery sheath, the leak-proof member 140 always abuts against the proximal end of the delivery sheath until the fluid outflow chamber 120 completely enters the delivery sheath. Then, the interventional catheter pump is continuously advanced, and the leak-proof member 140 slides onto the cable conduit 1805 under the blocking effect of the delivery sheath, and finally the leak-proof member 140 is cut open with scissors or torn open through the tearing opening 142, so that the leak-proof member 140 is separated from the cable conduit 180, so as to facilitate the subsequent movement of the repositioning device 400 and the fixation of the multi-catheter pump.

[0083] Under the blocking effect of the leak-proof member 140, this embodiment can significantly reduce the amount of blood leaking out of the fluid outlet 121 of the fluid outflow chamber 120 during the implantation of the interventional catheter pump, thereby reducing the patient's blood loss, improving the safety of the operation, and facilitating the rapid recovery of the patient's body functions.

[0084] It is worth noting that during the process of medical staff implanting the interventional catheter pump into the patient's body, the leak-proof component 140 and the delivery sheath are independent of each other, and the two only involve a mutually conflicting relationship. Therefore, medical staff can directly use the leak-proof component 140 provided in the above-mentioned embodiments of the present application with the existing delivery sheath without changing the structure of the delivery sheath, thereby improving the universal applicability of the leak-proof component 140.

[0085] In actual use, the leak-proof member 140 can also cooperate with an artificial blood vessel to prevent blood leakage when the catheter pump is implanted. Specifically, the leak-proof member 140 is configured so that the radial dimension of the chamber 141 is slightly smaller than the outer diameter of the cable conduit 180. The leak-proof member 140 can be moved onto the cable conduit 180 so that the outlet of the artificial blood vessel is sheathed on the outer wall of the leak-proof member 140 and the outer wall of the leak-proof member 140 is fastened with a medical binding rope or clamp. The inner wall of the leak-proof member 140 presses the cable conduit 180 to achieve an interference fit, but relative sliding can still be ensured. During the delivery process of the interventional catheter pump, the leak-proof member 140 can prevent blood from leaking out from the cable conduit 180.

[0086] The interventional catheter pump provided in this embodiment can not only reduce blood leakage during the implantation process, but also solve the blood leakage between the artificial blood vessel and the leakage prevention component 140, thereby comprehensively reducing the amount of blood leakage during the implantation of the interventional catheter pump and the assistance of the interventional catheter pump, and improving the actual use performance and clinical treatment effect of the interventional catheter pump. In addition, the interventional catheter pump provided in this application has a simple structure, is easy to operate, and has a high clinical value.

[0087] The present application also provides a cardiac assist device, including an interventional catheter pump provided in any of the above-mentioned embodiments of the delivery sheath. The delivery sheath is used to deliver the interventional catheter pump, and its proximal end may be a hub with a hemostatic valve. The radial dimension of the distal end of the leak-proof member 140 in the pump body 110 is larger than the inner diameter dimension of the proximal end of the delivery sheath. At the same time, the radial dimension of the distal end of the chamber of the leak-proof member 140 is smaller than the outer diameter dimension of the proximal end of the delivery sheath, i.e., the hub. The leak-proof member cannot penetrate into the delivery sheath, and the delivery sheath cannot penetrate into the chamber of the leak-proof member. Thus, when the fluid outflow chamber 120 moves from the proximal end to a position adjacent to the delivery sheath, the distal end of the leak-proof member 140 and the proximal end of the delivery sheath can be tightly abutted against each other, thereby preventing radial blood leakage from the contact surface of the two to a certain extent. Continue to push the interventional catheter pump, and part of the fluid outflow chamber 120 enters the delivery sheath. At this time, the distal end of the leak-proof component 140 is still pressed against the proximal end of the delivery sheath to block the portion of the fluid outflow chamber 120 that has not entered the delivery sheath until the fluid outflow chamber 120 completely enters the interior of the delivery sheath.

[0088] In the above embodiments, the description of each embodiment has its own emphasis. For parts that are not described or recorded in detail in a certain embodiment, reference can be made to the relevant descriptions of other embodiments.

[0089] It should be noted that the above embodiments can be freely combined as needed. The above are only preferred implementations of the present application. It should be pointed out that for ordinary technicians in this technical field, several improvements and modifications can be made without departing from the principles of the present application, and these improvements and modifications should also be regarded as the protection scope of the present application.

Claims

1. An interventional catheter pump, characterized in that: include: A pump body, used for pumping fluid; A fluid outflow chamber is disposed at the distal end of the pump body, and the fluid outflow chamber is provided with a fluid outlet; The leak-proof component is sleeved on the outside of the fluid outflow chamber, and the inner wall surface of the leak-proof component is closely attached to the outer wall surface of the fluid outflow chamber to block the fluid outlet.

2. The interventional catheter pump according to claim 1, characterized in that: The leakage-proof component is an elastic component that is easily deformed.

3. The interventional catheter pump according to claim 2, characterized in that: The leak-proof member has a through cylindrical chamber inside, and the wall surface of the chamber forms the inner wall surface of the leak-proof member; The radial dimension of the chamber is smaller than the radial dimension of the outflow chamber.

4. The interventional catheter pump according to claim 3, characterized in that: The outer wall surface of the leakage-proof component is provided with a tearing opening.

5. The interventional catheter pump according to claim 4, characterized in that: The length dimension of the tear opening in the axial direction of the chamber is 1 / 5-1 / 2 of the length dimension of the leakage-proof component in the axial direction of the chamber; and / or, the depth dimension of the tear opening in the radial direction of the chamber is 1 / 5-2 / 5 of the thickness dimension of the leakage-proof component in the radial direction of the chamber.

6. The interventional catheter pump according to claim 2, characterized in that: The inner wall surface of the leakage prevention member is provided with a cutting slit, the cutting slit extends to the proximal end of the leakage prevention member, and the cutting slit extends to the outer wall surface of the leakage prevention member.

7. The interventional catheter pump according to claim 2, characterized in that: The thickness dimension of the proximal end of the leakage preventing component is smaller than the thickness dimension of the distal end of the leakage preventing component.

8. The interventional catheter pump according to any one of claims 2 to 7, characterized in that: The leak-proof part is made of easily deformable silicone rubber material; or The leak-proof component comprises a first material layer, a second material layer and a sealing layer in sequence from the inner wall surface to the outer wall surface. The first material layer is made of elastic bio-silicone and the second material layer is a mesh-shaped metal braided layer.

9. The interventional catheter pump according to any one of claims 3 to 5, characterized in that: Also includes: Fluid inflow chambers, cannulas and cable guides; The cable conduit is disposed at the proximal end of the pump body, the cannula is disposed at the distal end of the fluid outflow chamber, and the fluid inflow chamber is disposed at the distal end of the cannula; The fluid inflow chamber and the fluid outflow chamber are connected through the cannula, and the fluid inflow chamber is provided with a fluid inlet, and the fluid is pumped into the cannula through the fluid inlet and pumped out through the fluid outlet; Wherein, the radial dimension of the chamber is larger than the outer diameter dimension of the cable conduit; or, the radial dimension of the chamber is smaller than the outer diameter dimension of the cable conduit, so as to be used in conjunction with an artificial blood vessel.

10. A cardiac assist device, characterized in that: include: A delivery sheath and an interventional catheter pump as claimed in any one of claims 1 to 9; The delivery sheath is used to deliver the interventional catheter pump, and the leak-proof component has a through cylindrical chamber, and the chamber wall forms the inner wall of the leak-proof component; The radial dimension of the distal end of the leak-proof component in the pump body is larger than the inner diameter of the proximal end of the delivery sheath, and the radial dimension of the chamber is smaller than the outer diameter of the proximal end of the delivery sheath.

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