Interventional sheath tube and blood pumping device

Abstract

The utility model discloses an intervention sheath tube and a blood pumping device, the intervention sheath tube comprises a sheath tube body, a first pipeline and a second pipeline are formed in the sheath tube body, and at least one of the first pipeline and the second pipeline is used as a circulation channel for perfusate circulation; a restraint layer is arranged in at least one of the sheathing canal body, the second pipeline and the first pipeline, and at least part of the interior of the circulation channel is not provided with the restraint layer. The restraint layer is arranged in at least one of the sheathing canal body, the second pipeline and the first pipeline, and at least part of the interior of the circulation channel is not provided with the restraint layer, so that the restraint layer can absorb vibration generated by the sheathing canal body, and the obstruction of the restraint layer on flowing of perfusate when the restraint layer is located in the circulation channel is reduced; therefore, bubble residues in the circulation channel are reduced, and the risk that perfusion fluid is cut off, blood flows backwards or bubbles enter blood vessels is reduced.

Description

Technical Field

[0001] This application belongs to the field of medical device technology, and in particular relates to interventional sheaths and blood pumping devices. Background Technology

[0002] During cardiac surgery, due to the patient's underlying medical condition or the needs of the procedure, the patient's heart function may be weakened, resulting in insufficient pumping capacity. In such cases, active interventional medical devices, such as ventricular assist devices (VADs), are needed to assist the heart in pumping blood. Existing VADs utilize the principle of cardiac pumping, pumping blood out of the heart through a pumping mechanism and diverting it to the aorta outside the heart for distribution throughout the body.

[0003] In some scenarios, ventricular assist devices are divided into external and internal drive systems. In internal drive systems, the motor is inserted into the blood vessel along with the interventional catheter. In external drive systems, the motor is located outside the body and is driven through a flexible drive shaft inserted into the blood vessel. At the same time, an elastic layer is installed in the perfusion tubing around the drive shaft to absorb the vibration generated by the flexible drive shaft.

[0004] However, because the elastic layer can affect the air release in the perfusion tubing, residual air bubbles may remain in the perfusion tubing, posing a risk of interrupted perfusion fluid flow, backflow of blood, or air bubbles entering the blood vessels. Utility Model Content

[0005] This application provides an interventional sheath that can reduce air bubble residue in the infusion line.

[0006] This application provides an interventional sheath, including a sheath body, a first conduit and a second conduit formed within the sheath body, at least one of the first conduit and the second conduit serving as a flow channel for the flow of perfusion fluid; at least one of the sheath body, the second conduit and the first conduit is provided with a restraining layer, and at least a portion of the flow channel is not provided with a restraining layer.

[0007] According to an embodiment of the first aspect of this application, the sheath body includes: a flexible rotating shaft, an isolation tube wall, and a sheath wall. The isolation tube wall is sleeved outside the flexible rotating shaft, and the gap between the isolation tube wall and the flexible rotating shaft forms a first pipeline. The sheath wall is sleeved outside the isolation tube wall, and the gap between the sheath wall and the isolation tube wall forms a second pipeline. At least one of the isolation tube wall, the sheath wall, the second pipeline, and the first pipeline has a constraint layer inside.

[0008] According to an embodiment of the first aspect of this application, the flow channel includes a first pipeline and a second pipeline, the second pipeline being an infusion pipeline for delivering infusion fluid to a remote end, and the first pipeline being a return pipeline for discharging infusion fluid.

[0009] According to the embodiments of the first aspect of this application, at least one of the following conditions is met: 1) a constraint layer is provided in one of the first pipeline and the second pipeline, and no constraint layer is provided in the other; 2) no constraint layer is provided in either the first pipeline or the second pipeline; 3) a constraint layer is provided in a portion of the path of the first pipeline, and no constraint layer is provided in the remaining portion of the path of the first pipeline; 4) a constraint layer is provided in a portion of the path of the second pipeline, and no constraint layer is provided in the remaining portion of the path of the second pipeline; 5) the constraint layer is embedded in the isolation pipe wall; 6) the constraint layer is embedded in the sheath wall.

[0010] According to an embodiment of the first aspect of this application, the constraint layer includes: a first constraint layer located within a first conduit and / or a second conduit; and / or a second constraint layer embedded within an isolation pipe wall; and / or a third constraint layer embedded within a sheath wall.

[0011] According to an embodiment of the first aspect of this application, the axial region of the sheath wall covering the flexible shaft is the same as the axial region of the constraint layer covering the flexible shaft.

[0012] According to an embodiment of the first aspect of this application, the flexible rotating shaft, the isolation tube wall, the sheath wall, and the constraint layer all extend along a first direction, and the second pipeline and the first pipeline are both annular cavities extending along the first direction, wherein the first direction is the direction from the distal end to the proximal end of the intervention sheath; and / or, the constraint layer is an elastic element, and the cross-sectional shape of the elastic element in the first direction is circular, elliptical, or rectangular.

[0013] According to an embodiment of the first aspect of this application, the materials of the sheath wall and the isolation tube wall include at least one of polytetrafluoroethylene, block polyetheramide resin and polyethylene terephthalate; and / or, the material of the restraint layer includes a metallic material.

[0014] According to the embodiment of the first aspect of this application, the distance between the isolation tube wall and the sheath wall in the radial direction of the interventional sheath is greater than 0 mm and less than or equal to 0.5 mm, and the distance between the isolation tube wall and the flexible rotating shaft in the radial direction of the interventional sheath is greater than 0 mm and less than or equal to 0.5 mm.

[0015] An embodiment of the second aspect of this application provides an interventional sheath, including a sheath body, a first conduit formed within the sheath body, the first conduit serving as a flow channel for the flow of perfusion fluid; at least one of the sheath body and the first conduit has a restraint layer inside, and at least a portion of the flow channel does not have a restraint layer.

[0016] An embodiment of the third aspect of this application provides a blood pumping device, including a distal component and an interventional sheath as described in any of the first aspect embodiments, wherein the distal component has a transition cavity, and a first conduit and a second conduit are respectively connected to the transition cavity.

[0017] According to an embodiment of the third aspect of this application, the distal component includes a distal support and an impeller, the sheath body includes a flexible rotating shaft, the distal support is provided with a first opening communicating with the inside and outside of the transition cavity, and the distal end of the flexible rotating shaft in the sheath body extends out of the first opening into the transition cavity and is connected to the impeller.

[0018] An embodiment of the fourth aspect of this application provides a blood pumping device, including a distal component and an interventional sheath as described in any of the second aspects of the embodiment, wherein the distal component has a transition cavity and a first conduit communicates with the transition cavity.

[0019] The interventional sheath of this application embodiment includes a sheath body, within which a first conduit and a second conduit are formed. At least one of the first and second conduits serves as a flow channel for the flow of perfusion fluid. At least one of the sheath body, the second conduit, and the first conduit contains a restraint layer, while at least a portion of the flow channel is free of a restraint layer. By including a restraint layer in at least one of the sheath body, the second conduit, and the first conduit, and ensuring that at least a portion of the flow channel is free of a restraint layer, the restraint layer can absorb vibrations generated by the sheath body and reduce obstruction to the flow of perfusion fluid when located within the flow channel. This reduces the amount of residual air bubbles within the flow channel, thereby lowering the risk of perfusion fluid interruption, blood backflow, or air bubbles entering the blood vessels. Attached Figure Description

[0020] To more clearly illustrate the technical solutions of the embodiments of this application, the accompanying drawings used in the embodiments of this application will be briefly introduced below. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0021] Figure 1 This is a partial longitudinal cross-sectional schematic diagram of a blood pumping device including an interventional sheath according to some embodiments of this application;

[0022] Figure 2 A partial longitudinal cross-sectional schematic diagram of an example interventional sheath is shown;

[0023] Figure 3 A partial longitudinal cross-sectional schematic diagram of another example of an interventional sheath;

[0024] Figure 4 A partial longitudinal cross-sectional schematic diagram of another example of an interventional sheath is shown;

[0025] Figure 5 A partial longitudinal cross-sectional schematic diagram of another example of an interventional sheath is shown;

[0026] Figure 6 A partial longitudinal cross-sectional schematic diagram of another example of an interventional sheath is shown;

[0027] Figure 7A partial longitudinal cross-sectional schematic diagram of another example of an interventional sheath is shown.

[0028] Figure label:

[0029] 10. Intervention sheath; 20. Distal assembly; 21. Distal stent; 211. Transition cavity; 212. First opening; 22. Bearing;

[0030] 100. Flexible hinge;

[0031] 200. Isolation pipe wall;

[0032] 300. Sheath wall;

[0033] 400, Constraint Layer; 410, First Constraint Layer; 420, Second Constraint Layer; 430, Third Constraint Layer;

[0034] 500, First Pipeline;

[0035] 600, Second pipeline;

[0036] x, the first direction. Detailed Implementation

[0037] The features and exemplary embodiments of various aspects of this application will be described in detail below. To make the objectives, technical solutions, and advantages of this application clearer, the application will be further described in detail below with reference to the accompanying drawings and specific embodiments. It should be understood that the specific embodiments described herein are only intended to explain this application and not to limit it. For those skilled in the art, this application can be implemented without some of these specific details. The following description of the embodiments is merely to provide a better understanding of this application by illustrating examples.

[0038] It should be noted that, in this document, relational terms such as "first" and "second" are used only to distinguish one entity or operation from another, and do not necessarily require or imply any such actual relationship or order between these entities or operations. Furthermore, the terms "comprising," "including," or any other variations thereof are intended to cover non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements includes not only those elements but also other elements not expressly listed, or elements inherent to such a process, method, article, or apparatus. Without further limitations, an element defined by the phrase "comprising..." does not exclude the presence of other identical elements in the process, method, article, or apparatus that includes said element.

[0039] In order to solve the technical problems involved in the background art, the applicant proposes an interventional sheath, including a sheath body, a first conduit and a second conduit formed within the sheath body, at least one of the first conduit and the second conduit serving as a flow channel for the flow of perfusion fluid; at least one of the sheath body, the second conduit and the first conduit is provided with a restraining layer, and at least part of the flow channel is not provided with a restraining layer.

[0040] This application provides a constraint layer in at least one of the sheath body, the second tubing, and the first tubing, while at least part of the flow channel is not provided with a constraint layer. This allows the constraint layer to absorb vibrations generated by the sheath body and reduce the obstruction of the perfusion fluid flow when the constraint layer is located in the flow channel. This reduces the amount of residual air bubbles in the flow channel and lowers the risk of perfusion fluid interruption, blood backflow, or air bubbles entering the blood vessels.

[0041] In some embodiments, the first and second conduits are independent of each other within the sheath body and are connected at the distal end via cavities within other components.

[0042] In some embodiments, the constraint layer includes an elastic element. It is worth noting that an elastic element is not the only implementation of a constraint layer; other forms of constraint layers capable of achieving constraint (e.g., vibration absorption) are also within the scope of this application. For ease of understanding, the following description will use an elastic element as an example of a constraint layer.

[0043] In some embodiments, the distal end of the interventional sheath is connected to a distal assembly. The sheath body includes a flexible rotating shaft, an isolation tube wall, and a sheath wall. The isolation tube wall is sleeved outside the flexible rotating shaft, and the gap between the isolation tube wall and the flexible rotating shaft forms a first conduit. The sheath wall is sleeved outside the isolation tube wall, and the gap between the sheath wall and the isolation tube wall forms a second conduit. At least one of the first and second conduits serves as a flow channel for the flow of perfusion fluid. At least one of the isolation tube wall, sheath wall, second conduit, and first conduit has a restraint layer inside, and at least a portion of the flow channel does not have a restraint layer.

[0044] In some embodiments, the isolation tube wall is made of a flexible metal tube or a multi-layered braided tube that can isolate liquids.

[0045] In some implementations, the flexible shaft is circular, and the isolation tube wall and sheath wall are tubes coaxial with the flexible shaft.

[0046] In some other implementations, the sheath body is not a nested tubular structure, but rather two relatively independent and separate cylindrical cavities extending along the axial direction are formed on the sheath body.

[0047] It is understandable that when only one primary channel is formed within the sheath body, the principle is the same as the aforementioned implementation methods, and the structure is similar, so it will not be described in detail later.

[0048] The interventional sheath provided in this application has a constraint layer in at least one of the isolation tube wall, sheath wall, second tubing and first tubing, and at least part of the flow channel is not provided with a constraint layer. This allows the constraint layer to absorb the vibration generated by the flexible rotating shaft and reduce the obstruction of the perfusion fluid flow when the constraint layer is located in the flow channel. This reduces the amount of residual air bubbles in the flow channel and lowers the risk of perfusion fluid interruption, blood backflow or air bubbles entering the blood vessel.

[0049] It is understood that the interventional sheath in this application can be used in applications such as blood pumping devices, tissue fluid pumping devices, and digestive fluid pumping devices to achieve the purpose of pumping fluids such as blood, tissue fluid, and digestive fluid. For ease of understanding and description, the following description will continue to take the application scenario of the interventional sheath in a blood pumping device as an example.

[0050] Before describing the specific structure of the interventional sheath, let's briefly describe the blood pumping device that includes the interventional sheath, with reference to the accompanying drawings, in order to understand the working environment of the interventional sheath. Figure 1 This is a partial longitudinal cross-sectional schematic diagram of a blood pumping device including an interventional sheath according to some embodiments of this application; Figure 2 A partial longitudinal cross-sectional schematic diagram of an example interventional sheath is shown. Combined with... Figure 1 and Figure 2As can be seen, this application provides a blood pumping device including an interventional sheath. The blood pumping device includes an interventional sheath 10, a distal component 20, and a proximal component (not shown). The distal component 20 is connected to the distal end of the interventional sheath 10, and the proximal component is connected to the proximal end of the interventional sheath 10. The interventional sheath 10 includes a sheath body, which includes a flexible rotating shaft, a second tubing, and a first tubing. The proximal component includes a motor, an infusion pump, a drainage pump, a storage tank, and a collection tank. The motor is connected to the proximal end of the flexible rotating shaft to drive the flexible rotating shaft to rotate. The first and second tubings serve as flow channels for perfusion fluid, one of which is an infusion tubing and the other is a return tubing. The infusion pump is connected to the storage tank to drive the perfusion fluid in the storage tank into the infusion tubing. The drainage pump is connected to the collection tank to drive the perfusion fluid in the interventional sheath 10 from the return tubing into the collection tank. The distal component 20 includes a distal stent 21, an impeller (not shown), an inflow channel (not shown), and an outflow channel (not shown). The outflow channel is located between and communicates with the inflow channel and the interventional sheath 10. At least a portion of the impeller is located within the outflow channel. The inflow channel has an aspiration port, and the outflow channel has an outlet. The distal end of the flexible shaft passes through the distal stent 21 and connects to the impeller, allowing an external motor to drive the flexible shaft and, in turn, the internal impeller to rotate during operation. During use, the distal component 20 is pushed through the patient's blood vessels by the interventional sheath 10 until the inflow and outflow channels are located at designated positions within the patient's circulatory system. At this point, the outlet and aspiration port are located at different positions within the circulatory system; for example, the aspiration port may be located within the patient's left ventricle, and the outlet within the patient's aorta.

[0051] When the externally located motor is activated, it drives the impeller in the outflow channel via a flexible shaft. This impeller drives blood from the suction port into the inflow channel and outflow from the outlet channel. Blood flows from the patient's left ventricle into the aorta through the inflow and outflow channels, thus realizing the pumping function of the blood pumping device. Simultaneously, an external infusion pump continuously pumps perfusion fluid into the perfusion tubing to the distal stent 21, maintaining a certain pressure at the distal stent 21 to prevent blood from entering the interventional sheath 10 and causing thrombus formation. The perfusion fluid at the distal stent 21 is driven by the drainage pump and flows out of the body through the return tubing to be collected by the collection tank.

[0052] The perfusion fluid includes at least one of physiological saline, glucose, and an anticoagulant, such as heparin. The anticoagulant in the perfusion fluid reduces the probability of blood clotting, thereby reducing the probability of pump failure due to blood clotting.

[0053] It is understood that in this application, the proximal end refers to the end facing the operator or physician, and the distal end refers to the end away from the operator or physician. The proximal end of the interventional sheath 10 faces the proximal component, and the distal end of the interventional sheath 10 faces the distal component 20.

[0054] After describing the structure of the blood pumping device, the interventional sheath 10 provided in the embodiments of this application will be introduced below with reference to the accompanying drawings. It should be noted that in the drawings, the direction extending along the line connecting the proximal and distal ends of the interventional sheath 10, and pointing from the distal end to the proximal end, is the first direction, denoted as x. In the drawings, for ease of drawing, the dimensions are not necessarily proportional to the actual dimensions.

[0055] Combination Figure 1 and Figure 2 As can be seen, this application provides an interventional sheath 10, the distal end of which is connected to a distal assembly 20. The interventional sheath 10 includes a sheath body, within which a first conduit 500 and a second conduit 600 are formed. At least one of the first conduit 500 and the second conduit 600 serves as a flow channel for the flow of perfusion fluid. At least one of the sheath body, the second conduit 600, and the first conduit 500 is provided with a restraining layer 400, and at least a portion of the flow channel is not provided with a restraining layer 400.

[0056] In some embodiments, the sheath body includes a flexible rotating shaft 100, an isolation tube wall 200, and a sheath wall 300. The isolation tube wall 200 is sleeved outside the flexible rotating shaft 100, and the gap between the isolation tube wall 200 and the flexible rotating shaft 100 forms a first conduit 500. The sheath wall 300 is sleeved outside the isolation tube wall 200, and the gap between the sheath wall 300 and the isolation tube wall 200 forms a second conduit 600. At least one of the isolation tube wall 200, the sheath wall 300, the first conduit 500, and the second conduit 600 has a constraint layer 400 internally provided.

[0057] In some of these implementations, the flexible rotating shaft 100, the isolation tube wall 200, the sheath wall 300, and the constraint layer 400 all extend along the first direction x, and the second pipeline 600 and the first pipeline 500 are both annular cavities extending along the first direction x.

[0058] For ease of drawing and description, the x-direction in the figure is a straight line. However, the interventional sheath 10 actually has a certain degree of flexibility, which makes it easier for the interventional sheath 10 to be inserted into the blood vessel. Therefore, the extension direction of the central axis of the interventional sheath 10 can also be curved.

[0059] In some implementations, the isolation tube wall 200 and the sheath wall 300 can be cylindrical, or they can be polygonal cylindrical structures such as square tubes. This embodiment illustrates the example where both the isolation tube wall 200 and the sheath wall 300 are cylindrical.

[0060] It should be noted that since both the isolation tube wall 200 and the sheath wall 300 are axisymmetric figures, both have a central axis, and the direction of the central axis is consistent with the direction of the line connecting the proximal and distal ends of the interventional sheath 10, i.e., direction x in the figure. The isolation tube wall 200 and the sheath wall 300 are cylindrical structures, thus having two circumferential surfaces: the circumferential surface of the outer wall of the cylinder is the outer circumferential surface, and the circumferential surface of the inner wall of the cylinder is the inner circumferential surface. Furthermore, the axial direction of the isolation tube wall 200 and the sheath wall 300 refers to the direction of the central axis, the circumferential direction refers to the circumferential direction of the outer perimeter of the cylinder, and the radial direction refers to the direction through the central axis in the radial plane, usually also referring to a straight line along the diameter or radius, or a straight line perpendicular to the central axis. The radial dimension generally refers to the radius or diameter of the axisymmetric part. It is understood that in this application, the axial, circumferential, radial, and circumferential surfaces of other components can be referred to the aforementioned descriptions of the isolation tube wall 200 and the sheath wall 300.

[0061] The interventional sheath 10 provided in this embodiment has a constraint layer 400 inside at least one of the isolation tube wall 200, sheath wall 300, second tube 600 and first tube 500, and the constraint layer 400 is not provided in at least part of the flow channel. This allows the constraint layer 400 to absorb the vibration generated by the flexible rotating shaft 100 and reduce the obstruction of the perfusion fluid flow when the constraint layer 400 is located in the flow channel. This reduces the amount of air bubbles remaining in the flow channel and lowers the risk of perfusion fluid interruption, blood backflow or air bubbles entering the blood vessels.

[0062] In some embodiments, at least one of the first conduit 500 and the second conduit 600 is used to deliver infusion fluid to the distal component 20.

[0063] In some embodiments, the distal assembly 20 further includes a distal support 21 and a bearing 22. The distal support 21 has a transition cavity 211 for accommodating the bearing 22. The second conduit 600 and the first conduit 500 are both connected to the transition cavity 211. The distal support 21 also has a first opening 212 connecting the inside and outside of the transition cavity 211. The distal end of the flexible shaft 100 extends out of the transition cavity 211 from the first opening 212 and is connected to the impeller.

[0064] In some embodiments, the flow channel includes only the first conduit 500 and excludes the second conduit 600. The first conduit 500 is an infusion conduit used to deliver infusion fluid to the distal end. The infusion fluid flows into the distal component 20 and eventually into the patient's blood vessel. The first conduit 500 is at least partially without a restraint layer 400, while the second conduit 600 may have a restraint layer 400. This application prevents blood from entering the interventional sheath 10 through the first opening 212 and forming a thrombus by maintaining a certain pressure in the transition cavity 211 while allowing the infusion fluid to flow to the distal component 20. Furthermore, by flushing the bearing 22 and removing particles generated by the rotation of the bearing 22 as it flows through the transition cavity 211, the safety and lifespan of the product are improved.

[0065] In other embodiments, the flow channel includes only the second conduit 600 and excludes the first conduit 500. The second conduit 600 is an infusion conduit used to deliver infusion fluid to a distal end. The infusion fluid flows into the distal component 20 and eventually into the patient's blood vessel. The second conduit 600 is at least partially without a restraint layer 400, while the first conduit 500 may have a restraint layer 400.

[0066] In other embodiments, the flow channel includes a first conduit 500 and a second conduit 600. The second conduit 600 is an infusion conduit used to deliver infusion fluid to the distal end, and the first conduit 500 is a return conduit used to drain the infusion fluid from the interventional sheath 10. By having the infusion fluid flow from the second conduit 600 to the distal component 20 before flowing out from the first conduit 500, the particles in the first conduit 500 will flow out directly with the infusion fluid, resulting in extremely low particle content in the infusion fluid at the distal component 20. This reduces the total amount of particles flowing into the patient's body from the distal component 20, further improving product safety.

[0067] In other embodiments, the flow channel includes a first pipe 500 and a second pipe 600, the first pipe 500 being an infusion pipe for delivering infusion fluid to a distal end, and the second pipe 600 being a return pipe for discharging infusion fluid.

[0068] In other embodiments, both the first conduit 500 and the second conduit 600 are used to deliver perfusion fluid distally. The perfusion fluid collects in the transition chamber 211 and then flows into the patient's blood vessel through the first opening 212. Since a large amount of perfusion fluid enters the patient's blood vessel in this method, to reduce the risk of air embolism caused by air bubbles entering the patient's blood vessel from the first conduit 500 and the second conduit 600, the interventional sheath 10 begins injecting perfusion fluid before intervention into the patient's blood vessel, pre-filling the first conduit 500, the second conduit 600, and the transition chamber 211, and purging any gas from the conduits and chambers. This application reduces the size and cost of the blood pumping device by using both the first conduit 500 and the second conduit 600 to deliver perfusion fluid to the distal component 20, thereby reducing the number of return lines and collection tanks for the perfusion fluid.

[0069] After describing the overall structure of the interventional sheath 10, several implementation methods of the constraint layer 400 are described below with reference to the accompanying drawings. The following embodiments will be illustrated using the second conduit 600 as the infusion conduit (labeled 600a in the drawings) and the first conduit 500 as the return conduit (labeled 500a in the drawings) as examples.

[0070] In some embodiments, the constraint layer 400 satisfies at least one of the following conditions: 1) the constraint layer 400 is provided in one of the first conduit 500 and the second conduit 600, and the constraint layer 400 is not provided in the other; 2) the constraint layer 400 is not provided in either the first conduit 500 or the second conduit 600; 3) the constraint layer 400 is provided in a portion of the path of the first conduit 500, and the constraint layer 400 is not provided in the remaining portion of the path of the first conduit 500; 4) the constraint layer 400 is provided in a portion of the path of the second conduit 600, and the constraint layer is not provided in the remaining portion of the path of the second conduit 600; 5) the constraint layer 400 is embedded in the isolation pipe wall 200; 6) the constraint layer 400 is embedded in the sheath wall 300.

[0071] The provision that a constraint layer 400 is provided within a portion of the first conduit 500, while no constraint layer 400 is provided within another portion, means that the constraint layer 400 may be located only within a segment of the first conduit 500 (500a). See details [link to relevant documentation]. Figure 7 Similarly, constraint layer 400 is set within a portion of the path of the second pipeline 600, and will not be elaborated further here.

[0072] It is hereby explained that the constraint layer 400 located in the first pipeline 500 or the second pipeline 600 is named the first constraint layer 410, the constraint layer 400 embedded in the isolation pipe wall 200 is named the second constraint layer 420, and the constraint layer embedded in the sheath wall 300 is named the third constraint layer 430.

[0073] In some embodiments, constraint layer 400 includes a first constraint layer 410, and / or a second constraint layer 420, and / or a third constraint layer 430.

[0074] In some embodiments, the constraint layer 400 is an elastic element, such as a spring, that surrounds the flexible pivot 100 and extends spirally along a first direction x. The cross-sectional shape of the elastic element in the first direction x is circular, elliptical, or rectangular. The constraint layer 400 can be formed by winding wire into a spring shape, or it can be formed by cutting a round tube.

[0075] In some embodiments, the material of the constraint layer 400 includes metallic materials, such as stainless steel, nickel-titanium alloy, cobalt-chromium alloy, etc.

[0076] The interventional sheath 10 provided in this embodiment has a constraint layer 400 that is spirally extended from a metal material and forms a spring surrounding the outside of the flexible rotating shaft 100. This allows the constraint layer 400 to bend at a certain angle to fit the blood vessel and absorb the vibration generated during the rotation of the flexible rotating shaft 100, thereby reducing the impact of the vibration of the interventional sheath 10 on the blood vessel.

[0077] Combination Figure 2 It is understood that in some embodiments, the constraint layer 400 includes two first constraint layers 410, both of which are located in the first conduit 500, with one first constraint layer 410 sleeved over the other, and no constraint layer 400 is provided in the second conduit 600. Since the first constraint layer 410 has a spirally extended spring-like structure, even if the first constraint layer 410 is located in the first conduit 500, it will not completely block the return flow to the first conduit 500. The infusion fluid can still flow through the gaps in the first constraint layer 410 to the proximal end of the interventional sheath 10 and eventually flow out of the body.

[0078] The axial dimensions and spring wire dimensions of the two first constraint layers 410 can be different.

[0079] In some embodiments, one first constraint layer 410 may be sleeved on the flexible rotating shaft 100, and the other first constraint layer 410 may be embedded in the inner circumferential surface of the isolation tube wall 200.

[0080] The interventional sheath 10 provided in this embodiment reduces the difficulty of fabricating the first constraint layer 410 by having both first constraint layers 410 located within the first conduit 500, eliminating the need for the first constraint layer 410 to be embedded in the tube wall. Since the perfusion fluid flows from the second conduit 600 to the distal component 20 channel, and no constraint layer 400 is provided within the second conduit 600, residual air bubbles within the second conduit 600 are reduced, thereby reducing the risk of perfusion fluid interruption at the distal component 20 and air bubbles entering the bloodstream. Furthermore, even if residual air bubbles are generated within the first conduit 500 due to the first constraint layer 410 being located within it, the perfusion fluid flows from the second conduit 600 to the distal component 20 and then out through the first conduit 500. Therefore, air bubbles in the first conduit 500 will not cause perfusion fluid interruption at the distal component 20, and air bubbles are unlikely to retrograde into the blood vessels within the first conduit 500.

[0081] Figure 3 A partial longitudinal cross-sectional schematic diagram of another example of an interventional sheath is shown. Combined with... Figure 3It is understood that in some embodiments, the constraint layer 400 includes two first constraint layers 410 and one third constraint layer 430. Both first constraint layers 410 are located in the first conduit 500, with one first constraint layer 410 sleeved outside the other. The third constraint layer 430 is embedded in the sheath wall 300. No constraint layer 400 is provided in the second conduit 600.

[0082] The sheath wall 300 can be prepared in two layers, inner and outer, with a third constraint layer 430 sandwiched between the two layers. Alternatively, the third constraint layer 430 can be used as a framework, and the surface of the third constraint layer 430 can be coated with materials through processes such as vapor deposition, spraying, electroplating, and injection molding to form the sheath wall 300.

[0083] Compared to the previous embodiment, the interventional sheath 10 provided in this embodiment, by including a first constraint layer 410 and a third constraint layer 430 in the constraint layer 400, provides more constraint layers, which can further absorb the vibration generated by the flexible rotating shaft 100, thereby reducing the impact of the interventional sheath 10 on blood vessels. By embedding the third constraint layer 430 within the sheath wall 300, the vibration of the flexible rotating shaft 100 is absorbed without affecting the flow of the perfusion fluid within the tubing or the outer diameter of the interventional sheath 10. Furthermore, embedding the third constraint layer 430 within the sheath wall 300 also improves the stability of the constraint layer 400, reducing the probability of the constraint layer 400 shifting within the first tubing 500 and the second tubing 600.

[0084] Figure 4 This diagram shows a partial longitudinal cross-sectional view of yet another example of an interventional sheath. (Combined with...) Figure 4 It is understood that in some embodiments, the constraint layer 400 includes a first constraint layer 410, a second constraint layer 420, and a third constraint layer 430. The first constraint layer 410 is located within the first conduit 500, the second constraint layer 420 is embedded within the isolation pipe wall 200, and the third constraint layer 430 is embedded within the sheath wall 300. No constraint layer 400 is provided within the second conduit 600.

[0085] The isolation tube wall 200 can be prepared in two layers, inner and outer, with the second constraint layer 420 sandwiched between the two layers of sheath wall 300. Alternatively, the second constraint layer 420 can be used as a skeleton, and the surface of the second constraint layer 420 can be coated with materials through processes such as vapor deposition, spraying, electroplating, and injection molding to form the isolation tube wall 200.

[0086] The interventional sheath 10 provided in this embodiment, by embedding the second constraint layer 420 within the sheath wall 300, absorbs the vibration of the flexible rotating shaft 100 without affecting the flow of the perfusion fluid within the tubing or the outer diameter of the interventional sheath 10. Furthermore, compared to the previous embodiment, this embodiment also embeds a constraint layer 400 within the sheath wall 300, which not only further absorbs the vibration of the flexible rotating shaft 100 but also reduces the impact of the perfusion fluid flow within the second tubing 600 on the patient's blood vessels, further improving the safety of the interventional sheath 10.

[0087] Figure 5 A partial longitudinal cross-sectional schematic diagram of another example of an interventional sheath is shown. Combined with... Figure 5 It is understood that in some embodiments, the constraint layer 400 includes a first constraint layer 410 and a third constraint layer 430, and the second conduit 600 does not contain a constraint layer 400. Compared with the above embodiments, in this embodiment, the isolation tube wall 200 does not contain a constraint layer 400, which can reduce the radial dimension of the interventional sheath 10, thereby reducing the difficulty of interventional procedures. However, since the first constraint layer 410 in the first conduit 500 can directly absorb the vibration of the flexible shaft 100, and the third constraint layer 430 embedded in the sheath wall 300 can not only absorb the vibration of the flexible shaft 100, but also reduce the impact of the perfusion fluid flow in the second conduit 600 on the patient's blood vessels.

[0088] Figure 6 A partial longitudinal cross-sectional schematic diagram of another example of an interventional sheath is shown. Combined with... Figure 6 It is known that in some embodiments, the constraint layer 400 includes a second constraint layer 420 and a third constraint layer 430, and no constraint layer 400 is provided in the first conduit 500 and the second conduit 600. In the interventional sheath 10 provided in this embodiment, no constraint layer 400 is provided in either the first conduit 500 or the second conduit 600, reducing the residual air bubbles in the first conduit 500 and the second conduit 600. The constraint layer 400 does not affect the perfusion and return of the perfusion fluid at all. Compared with the above embodiments, the perfusion fluid in this embodiment has better fluidity, and the probability of perfusion fluid interruption, stagnation, and air bubbles entering the patient's blood vessels is lower.

[0089] Figure 7 A partial longitudinal cross-sectional schematic diagram of another example of an interventional sheath is shown. Combined with... Figure 7 It is understood that in some embodiments, the axial region of the sheath wall 300 covering the flexible shaft 100 is the same as the axial region of the constraint layer 400 covering the flexible shaft 100.

[0090] In some embodiments, the constraint layer 400 includes a first constraint layer 410 and a second constraint layer 420, while the second conduit 600 does not contain a constraint layer 400. The first constraint layer 410 is located at the proximal end of the first conduit 500, and the distal end of the first conduit 500 does not contain a constraint layer 400. The second constraint layer 420 is embedded at the distal end of the isolation wall 200, and the proximal end of the isolation wall 200 does not contain a constraint layer 400. Furthermore, the radial orthographic projections of the first constraint layer 410 and the second constraint layer 420 at least partially overlap.

[0091] Compared with the above embodiments, the interventional sheath 10 provided in this embodiment has a first constraint layer 410 located only in a portion of the first conduit 500, further reducing air bubble residue in the first conduit 500. Furthermore, since the area of ​​the flexible shaft 100 not covered by the first constraint layer 410 is still covered by the second constraint layer 420, the axial region of the flexible shaft 100 covered by the sheath wall 300 is the same as the axial region of the flexible shaft 100 jointly covered by multiple constraint layers 400. The first constraint layer 410 and the second constraint layer 420 jointly absorb the vibration of the flexible shaft 100, still reducing the impact of the flexible shaft 100 on the patient's blood vessels.

[0092] Of course, in other embodiments, the constraint layer 400 may have other configurations. As long as the constraint layer 400 includes at least one of the first constraint layer 410, the second constraint layer 420, and the third constraint layer 430, and the first conduit 500 and the second conduit 600 are not partially provided with the constraint layer 400, other combinations of the first constraint layer 410, the second constraint layer 420, and the third constraint layer 430 in the intervention sheath 10 are also within the protection scope of this embodiment, and will not be elaborated here.

[0093] After describing the implementation of the constraint layer 400 in the interventional sheath 10, the implementation of other structures in the interventional sheath 10 will be described below with reference to the accompanying drawings. Figures 2 to 6 It is understood that, in some embodiments, the materials of the sheath wall 300 and the isolation tube wall 200 include at least one of polytetrafluoroethylene, block polyether amide resin and polyethylene terephthalate.

[0094] In some of these implementations, the sheath wall 300 has a high surface finish and low roughness, and the outer peripheral surface of the sheath wall 300 is treated with a hydrophilic coating.

[0095] The interventional sheath 10 provided in this embodiment separates the first conduit 500 from the second conduit 600 by setting an isolation wall 200. By making the sheath wall 300 into a polymer material and applying a hydrophilic coating to its outer circumference, the friction between the sheath wall 300 and the patient's blood vessel wall is reduced, thereby reducing the damage to the patient's blood vessels caused by the interventional sheath 10.

[0096] In some embodiments, the radial distance between the isolation tube wall 200 and the sheath wall 300 in the interventional sheath 10 is greater than 0 mm and less than or equal to 0.5 mm, for example, any one of 0.1 mm, 0.2 mm, 0.3 mm, 0.4 mm, and 0.5 mm. The radial distance between the isolation tube wall 200 and the flexible rotating shaft 100 in the interventional sheath 10 is greater than 0 mm and less than or equal to 0.5 mm, for example, any one of 0.1 mm, 0.2 mm, 0.3 mm, 0.4 mm, and 0.5 mm.

[0097] In some embodiments, the flexible shaft 100 is formed by winding and weaving multiple strands of metal wire, so that the flexible shaft 100 has a certain strength to realize the transmission function, as well as a certain bending ability, and can be inserted into the blood vessel along with the intervention sheath 10.

[0098] In addition, this application also provides another interventional sheath, including a sheath body, within which a first conduit is formed, serving as a flow channel for the flow of perfusion fluid. At least one of the sheath body and the first conduit has a restraining layer, and at least a portion of the flow channel does not have a restraining layer.

[0099] In some embodiments, the sheath body includes a flexible shaft and a sheath wall, the sheath wall being fitted over the flexible shaft, and the gap between the sheath wall and the flexible shaft forming a first conduit. The first conduit serves as a flow channel for the flow of perfusion fluid. At least one of the sheath wall and the first conduit contains a restraining element, and at least a portion of the flow channel is free of restraining elements.

[0100] Compared to the interventional sheath of the above embodiments, the sheath body in this embodiment does not have a second conduit. The perfusion fluid flows directly into the patient's blood vessel after flowing from the first conduit to the distal component. The restraint layer may be located in a portion of the first conduit and embedded in the sheath body, but at least a portion of the first conduit does not have a restraint layer.

[0101] In addition, this application also provides a blood pumping device, including a proximal component, a distal component 20, and an interventional sheath 10 as described in any of the above embodiments. The distal component 20 is connected to the distal end of the interventional sheath 10, and the proximal component is connected to the proximal end of the interventional sheath 10. The distal component 20 has a transition cavity 211, and the first conduit 500 and the second conduit 600 are respectively connected to the transition cavity.

[0102] In some embodiments, the proximal assembly includes a motor, an infusion pump, a drainage pump, a storage tank, and a collection tank. The motor is connected to the proximal end of the flexible shaft to drive its rotation. A first and a second conduit serve as flow channels for the perfusion fluid, one being the infusion conduit and the other the return conduit. The infusion pump is connected to the storage tank to drive the perfusion fluid in the storage tank into the infusion conduit. The drainage pump is connected to the collection tank to drive the perfusion fluid in the interventional sheath 10 from the return conduit into the collection tank.

[0103] In some embodiments, the distal assembly 20 includes a distal support 21, an impeller (not shown), an inflow channel (not shown), and an outflow channel (not shown). The distal support 21 has a transition cavity 211 for accommodating the bearing 22. Both the second conduit 600 and the first conduit 500 are connected to the transition cavity 211. During use, the infusion pump continuously pumps perfusion fluid into the second conduit 600 and into the transition cavity 211, maintaining a certain pressure at the transition cavity 211 to prevent blood from entering the interventional sheath 10 and clotting to form a thrombus. The perfusion fluid at the transition cavity 211 flows out of the body through the first conduit.

[0104] In some optional embodiments, the outflow channel is located between and communicates with the inflow channel and the interventional sheath 10. At least a portion of the impeller is located within the outflow channel. The inflow channel has an aspiration port, and the outflow channel has an outlet. The distal stent 21 has a first opening 212 communicating with the inside and outside of the transition cavity 211. The distal end of the flexible rotating shaft 100 passes through the transition cavity 211 and extends out of the transition cavity 211 from the first opening 212, connecting with the impeller in the outflow channel. This allows the motor to drive the flexible rotating shaft 100 to rotate, thereby driving the impeller to rotate. During use, the distal assembly 20 is pushed through the patient's blood vessels by the interventional sheath 10 until the inflow and outflow channels are located at designated positions in the patient's circulatory system. At this point, the outlet and aspiration port are located at different positions in the circulatory system; for example, the aspiration port is located in the patient's left ventricle, and the outlet is located in the patient's aorta. When the externally located motor is activated, the motor drives the impeller in the outflow channel to rotate via the flexible rotating shaft 100. This impeller then drives blood from the suction port into the inflow channel and outflow from the outlet channel. Blood flows from the patient's left ventricle into the patient's aorta through the inflow and outflow channels, thus realizing the pumping function of the blood pumping device. Furthermore, this application also provides a blood pumping device, including a distal component and an interventional sheath. The interventional sheath includes a sheath body, within which a first conduit is formed. The distal component has a transition cavity communicating with the first conduit. Compared to the previous blood pumping device, the difference in this embodiment is that the sheath body does not have a second conduit.

[0105] Furthermore, this application also provides a blood pumping device, including a proximal component, a distal component 20, and an interventional sheath 10 as described in any of the above embodiments. The distal component 20 is connected to the distal end of the interventional sheath 10, and the proximal component is connected to the proximal end of the interventional sheath 10. Compared with the previous blood pumping device, the difference in this embodiment is that the sheath body does not include a flexible shaft, the proximal component does not include a motor, and the distal component 20 includes a motor located in the transition cavity 211. The motor's wiring harness is connected to an external power supply device through a first conduit 500. The motor's shaft extends only from the transition cavity 211 to the outflow channel, and the distal end of the motor's shaft extends out of the transition cavity 211 from the first opening 212 and is connected to an impeller. Since the motor is built into the transition cavity 211, there is no need for a slender flexible shaft 100 as a transmission component between the inside and outside of the body. The flexible shaft 100 can be replaced with a rigid shaft with greater rigidity and higher transmission efficiency to improve the blood pumping efficiency of the blood pumping device. In this embodiment, the infusion fluid still needs to flow into the transition cavity 211 through the first conduit 500, and the sheath body is still provided with a second conduit 600 for discharging the infusion fluid. Therefore, in the above embodiment, at least one of the isolation tube wall 200, sheath wall 300, first conduit 500 and second conduit 600 is provided with a constraint layer 400, and at least part of the first conduit 500 and second conduit 600 is not provided with a constraint layer 400. The same technical effect can be achieved in this embodiment.

[0106] In another embodiment, the difference between the blood pumping device and the previous one is that the sheath body does not have a second conduit 600. The perfusion fluid flows from the first conduit 500 to the transition cavity 211 and then directly flows into the patient's blood vessel from the first opening 212. In this embodiment, the perfusion fluid still needs to flow into the transition cavity 211 through the first conduit 500. Therefore, the various situations in the above embodiments where at least one of the isolation tube wall 200, sheath wall 300, and the first conduit 500 has a restraint layer 400, and where at least a portion of the first conduit 500 does not have a restraint layer 400, can also produce the same technical effect in this embodiment.

[0107] Since the blood pumping device includes the interventional sheath 10 of any of the above embodiments, the blood pumping device can produce the same technical effect as the interventional sheath 10, and will not be described in detail here.

[0108] The above description is merely a specific implementation of this application. Those skilled in the art will clearly understand that, for the sake of convenience and brevity, the specific working processes of the systems, modules, and units described above can be referred to the corresponding processes in the foregoing method embodiments, and will not be repeated here. It should be understood that the protection scope of this application is not limited thereto. Any person skilled in the art can easily conceive of various equivalent modifications or substitutions within the technical scope disclosed in this application, and these modifications or substitutions should all be covered within the protection scope of this application.

Claims

1. An intervention sheath, comprising: The sheath body is provided with a first tube and a second tube formed inside the sheath body, at least one of the first tube and the second tube serving as a flow channel for flowing perfusion fluid; At least one of the sheath body, the second tube and the first tube is provided with a constraint layer, and at least part of the flow channel is not provided with the constraint layer. The sheath body comprises:

2. The access sheath of claim 1, wherein, A flexible rotating shaft; An isolation tube wall sleeved outside the flexible rotating shaft, a gap between the isolation tube wall and the flexible rotating shaft forming the first tube; A sheath wall sleeved outside the isolation tube wall, a gap between the sheath wall and the isolation tube wall forming the second tube; At least one of the isolation tube wall, the sheath wall, the second tube and the first tube is provided with a constraint layer. The flow channel comprises the first tube and the second tube, the second tube being a perfusion tube for delivering perfusion fluid to a distal end, and the first tube being a return tube for discharging perfusion fluid.

3. The access sheath of claim 2, wherein, At least one of the following conditions is met:

4. The access sheath of claim 2 or 3, wherein, 1) The constraint layer is arranged in one of the first tube and the second tube, and the other one is not provided with the constraint layer; 2) Neither the first tube nor the second tube is provided with the constraint layer; 3) The constraint layer is arranged in part of the path of the first tube, and the constraint layer is not arranged in the remaining part of the path of the first tube; 4) The constraint layer is arranged in part of the path of the second tube, and the constraint layer is not arranged in the remaining part of the path of the second tube; 5) The constraint layer is embedded in the isolation tube wall; 6) The constraint layer is embedded in the sheath wall. The constraint layer comprises:

5. The access sheath of claim 2, wherein, A first constraint layer arranged in the first tube and / or the second tube; And / or, a second constraint layer embedded in the isolation tube wall; And / or, a third constraint layer embedded in the sheath wall. The sheath wall covers the same axial area of the flexible rotating shaft as the constraint layer.

6. The access sheath of claim 2, wherein, The flexible rotating shaft, the isolation tube wall, the sheath wall and the constraint layer all extend in a first direction, the second tube and the first tube are annular cavities extending in the first direction, wherein the first direction is a direction in which a distal end of the intervention sheath points to a proximal end; 7. The access sheath of claim 2, wherein, And / or, the constraint layer is an elastic member, and a cross-sectional shape of the elastic member in the first direction is circular, elliptical or rectangular. Materials of the sheath wall and the isolation tube wall comprise at least one of polytetrafluoroethylene, block polyether amide resin and polyethylene terephthalate; 8. The access sheath of claim 2, wherein, And / or, a material of the constraint layer comprises a metal material. A distance between the isolation tube wall and the sheath wall in a radial direction of the intervention sheath is greater than 0 mm and less than or equal to 0.5 mm, and a distance between the isolation tube wall and the flexible rotating shaft in the radial direction of the intervention sheath is greater than 0 mm and less than or equal to 0.5 mm.

9. The access sheath of claim 2, wherein, The sheath body is provided with a first tube formed inside the sheath body; 10. An intervention sheath, comprising: The first tube serves as a flow channel for flowing perfusion fluid; ​ ​ At least one of the sheath body and the first pipeline is provided with a constraint layer, and at least part of the flow passage is not provided with the constraint layer.

11. A blood pumping device, characterized by The intervention sheath comprises a distal end assembly and an intervention sheath as claimed in any one of claims 1-9, wherein the distal end assembly is provided with a transition cavity, and the first pipeline and the second pipeline are in communication with the transition cavity, respectively.

12. The blood pumping device of claim 11, wherein, The distal end assembly comprises a distal end support and an impeller, the sheath body comprises a flexible rotating shaft, the distal end support is provided with a first opening for communication between the inside and outside of the transition cavity, and the distal end of the flexible rotating shaft in the sheath body extends out of the transition cavity from the first opening and is connected with the impeller.

13. A blood pumping device, characterized by The intervention sheath comprises a distal end assembly and an intervention sheath as claimed in claim 10, wherein the distal end assembly is provided with a transition cavity, and the first pipeline is in communication with the transition cavity.

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