CN223731934U - Interventional sheath and blood pumping device - Google Patents

Abstract

The application discloses an intervention sheath tube and a blood pumping device, wherein the intervention sheath tube comprises a sheath tube body, a first pipeline and a second pipeline are formed in the sheath tube body, at least one of the first pipeline and the second pipeline is used as a circulation channel for circulating perfusion liquid, a constraint layer is arranged in at least one of the sheath tube body, the second pipeline and the first pipeline, and at least part of the circulation channel is not provided with the constraint layer. According to the application, the restriction layer is arranged in at least one of the sheath tube body, the second pipeline and the first pipeline, and at least part of the circulation channel is not provided with the restriction layer, so that the restriction layer can absorb vibration generated by the sheath tube body, and the restriction layer is reduced to block the flow of the perfusion fluid when being positioned in the circulation channel, thereby reducing the residual air bubbles in the circulation channel and reducing the risks of perfusion fluid flow interruption, blood backflow or air bubbles entering the blood vessel.

Description

Interventional sheath and blood pumping device

Technical Field

The application belongs to the technical field of medical instruments, and particularly relates to an interventional sheath tube and a blood pumping device.

Background

In cardiac surgery, the heart function of a patient is weakened and the pumping capacity is insufficient due to the disease of the patient or the operation requirement. In this case, an active interventional medical device such as a ventricular assist device is required to assist the heart in pumping blood. The existing ventricular assist device utilizes the heart pumping principle to pump blood in the heart through a pumping mechanism and guide the blood to the aorta outside the heart to flow to the whole body.

In some scenarios, ventricular assist devices are classified into extracorporeal and intracorporeal transmissions, which refer to the intervention of a motor into a blood vessel along with an intervention catheter. The motor is positioned outside the body in the external transmission and is inserted into the blood vessel for transmission through the flexible transmission shaft, and meanwhile, an elastic layer is arranged in a perfusate pipeline at the periphery of the transmission shaft and used for absorbing vibration generated by the flexible transmission shaft.

However, the elastic layer can affect the exhaust of the perfusion pipeline, so that residual bubbles exist in the perfusion pipeline, and the risk of perfusion fluid interruption, blood backflow or bubbles entering the blood vessel is caused.

Disclosure of utility model

The embodiment of the application provides an interventional sheath tube which can reduce bubble residues in a perfusion pipeline.

The embodiment of the application provides an interventional sheath tube, which comprises a sheath tube body, wherein a first pipeline and a second pipeline are formed in the sheath tube body, at least one of the first pipeline and the second pipeline is used as a circulation channel for circulating perfusion liquid, a constraint layer is arranged in at least one of the sheath tube body, the second pipeline and the first pipeline, and at least part of the circulation channel is not provided with the constraint layer.

According to the embodiment of the first aspect of the application, the sheath pipe body comprises a flexible rotating shaft, an isolation pipe wall and a sheath pipe wall, wherein the isolation pipe wall is sleeved outside the flexible rotating shaft, a first pipeline is formed by a gap between the isolation pipe wall and the flexible rotating shaft, the sheath pipe wall is sleeved outside the isolation pipe wall, a second pipeline is formed by a gap between the sheath pipe wall and the isolation pipe wall, and a constraint layer is arranged in at least one of the isolation pipe wall, the sheath pipe wall, the second pipeline and the first pipeline.

According to an embodiment of the first aspect of the application, the flow channel comprises a first line and a second line, the second line being a perfusion line for delivering perfusion fluid distally, the first line being a return line for draining perfusion fluid.

According to the embodiment of the first aspect of the application, at least one of the following conditions is satisfied, namely 1) one of the first pipeline and the second pipeline is internally provided with a constraint layer, the other one is not provided with a constraint layer, 2) the first pipeline and the second pipeline are internally provided with no constraint layer, 3) part of the first pipeline is internally provided with a constraint layer, the rest of the first pipeline is internally provided with no constraint layer, 4) part of the second pipeline is internally provided with a constraint layer, the rest of the second pipeline is internally provided with no constraint layer, 5) the constraint layer is embedded in the isolation pipeline wall, and 6) the constraint layer is embedded in the sheath pipeline wall.

According to an embodiment of the first aspect of the application, the constraining layer comprises a first constraining layer which is positioned in the first pipeline and/or the second pipeline, and/or a second constraining layer which is embedded in the isolating pipe wall, and/or a third constraining layer which is embedded in the sheath pipe wall.

According to an embodiment of the first aspect of the application, the sheath wall covers the same axial area of the flexible shaft as the constraining layer covers the flexible shaft.

According to an embodiment of the first aspect of the application, the flexible shaft, the spacer tube wall, the sheath tube wall and the constraining layer all extend along a first direction, the second tube and the first tube are annular cavities extending along the first direction, wherein the first direction is the direction that the distal end of the interventional sheath tube points to the proximal end, and/or the constraining layer is an elastic member, and the cross section of the elastic member in the first direction is circular, elliptical or rectangular.

According to an embodiment of the first aspect of the application, the material of the sheath wall and the spacer wall comprises at least one of polytetrafluoroethylene, a block polyether amide resin and polyethylene terephthalate, and/or the material of the constraining layer comprises a metallic material.

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

An embodiment of the second aspect of the present application provides an interventional sheath, including a sheath body, wherein a first pipeline is formed in the sheath body, the first pipeline is used as a circulation channel for circulating a 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 circulation channel is not provided with the constraint layer.

An embodiment of a third aspect of the present application provides a blood pumping device comprising a distal assembly and an interventional sheath according to any of the embodiments of the first aspect, a transition lumen being provided in the distal assembly, the first and second lines being in communication with the transition lumen, respectively.

According to an embodiment of the third aspect of the present application, the distal end assembly comprises a distal end support and an impeller, the sheath body comprises a flexible rotating shaft, a first opening for communicating the inside and the outside of the transition cavity is formed in the distal end support, and the distal end of the flexible rotating shaft in the sheath body extends out of the transition cavity from the first opening and then is connected with the impeller.

An embodiment of a fourth aspect of the application provides a blood pumping device comprising a distal assembly and an interventional sheath according to any of the embodiments of the second aspect, a transition lumen being provided in the distal assembly, the first conduit being in communication with the transition lumen.

The interventional sheath comprises a sheath body, a first pipeline and a second pipeline are formed in the sheath body, at least one of the first pipeline and the second pipeline is used as a circulation channel for circulating perfusion liquid, a constraint layer is arranged in at least one of the sheath body, the second pipeline and the first pipeline, and at least part of the circulation channel is not provided with the constraint layer. According to the application, the restriction layer is arranged in at least one of the sheath tube body, the second pipeline and the first pipeline, and at least part of the circulation channel is not provided with the restriction layer, so that the restriction layer can absorb vibration generated by the sheath tube body, and the restriction layer is reduced to block the flow of the perfusion fluid when being positioned in the circulation channel, thereby reducing the residual air bubbles in the circulation channel and reducing the risks of perfusion fluid flow interruption, blood backflow or air bubbles entering the blood vessel.

Drawings

In order to more clearly illustrate the technical solution of the embodiments of the present application, the drawings that are needed to be used in the embodiments of the present application will be briefly described, and it is possible for a person skilled in the art to obtain other drawings according to these drawings without inventive effort.

FIG. 1 is a schematic view in partial longitudinal section of a blood pumping device incorporating an interventional sheath according to some embodiments of the present application;

FIG. 2 illustrates a partial longitudinal cross-sectional schematic view of an exemplary interventional sheath;

FIG. 3 shows a partial longitudinal cross-sectional schematic view of another example interventional sheath;

FIG. 4 shows a partial longitudinal cross-sectional schematic view of yet another example interventional sheath;

FIG. 5 shows a partial longitudinal cross-sectional schematic view of yet another example interventional sheath;

FIG. 6 shows a partial longitudinal cross-sectional schematic view of yet another example interventional sheath;

fig. 7 shows a schematic view of a partial longitudinal section of yet another example interventional sheath.

Reference numerals:

10. an interventional sheath, 20, a distal end component, 21, a distal end bracket, 211, a transition cavity, 212, a first opening, 22, and a bearing;

100. A flexible shaft;

200. isolating the pipe wall;

300. a sheath wall;

400. Constraint layer 410, first constraint layer 420, second constraint layer 430, third constraint layer;

500. A first pipeline;

600. A second pipeline;

x, first direction.

Detailed Description

Features and exemplary embodiments of various aspects of the present application will be described in detail below, and in order to make the objects, technical solutions and advantages of the present application more apparent, the present application will be described in further detail below with reference to the accompanying drawings and the detailed embodiments. It should be understood that the particular embodiments described herein are meant to be illustrative of the application only and not limiting. It will be apparent to one skilled in the art that the present application may be practiced without some of these specific details. The following description of the embodiments is merely intended to provide a better understanding of the application by showing examples of the application.

It is noted that relational terms such as first and second, and the like are used solely to distinguish one entity or action from another entity or action without necessarily requiring or implying any actual such relationship or order between such entities or actions. Moreover, the terms "comprises," "comprising," or any other variation thereof, are intended to cover a non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements does not include only those elements but may include other elements not expressly listed or inherent to such process, method, article, or apparatus. Without further limitation, an element defined by the phrase "comprising" does not exclude the presence of additional identical elements in a process, method, article, or apparatus that comprises the element.

In order to solve the technical problems involved in the background technology, the applicant provides an interventional sheath tube, which comprises a sheath tube body, wherein a first pipeline and a second pipeline are formed in the sheath tube body, at least one of the first pipeline and the second pipeline is used as a circulation channel for circulating perfusion liquid, a constraint layer is arranged in at least one of the sheath tube body, the second pipeline and the first pipeline, and at least part of the circulation channel is not provided with the constraint layer.

According to the application, the restriction layer is arranged in at least one of the sheath tube body, the second pipeline and the first pipeline, and at least part of the circulation channel is not provided with the restriction layer, so that the restriction layer can absorb vibration generated by the sheath tube body, and the restriction layer is reduced to block the flow of the perfusion fluid when being positioned in the circulation channel, thereby reducing the residual air bubbles in the circulation channel and reducing the risks of perfusion fluid flow interruption, blood backflow or air bubbles entering the blood vessel.

In some of these embodiments, the first and second conduits are independent of each other within the sheath body and communicate distally through lumens within the other components.

In some of these embodiments, the constraining layer includes an elastic member. It is noted that the elastic member is not the only implementation of the constraining layer, and other forms of constraining layers that can achieve the constraining effect (e.g., absorb vibration) are within the scope of the present application. For ease of understanding, the constraining layer will be described below as an example of an elastic member.

In some embodiments, the distal end of the interventional sheath is connected to the distal end assembly, the sheath body comprises a flexible rotating shaft, an isolation tube wall and a sheath tube wall, the isolation tube wall is sleeved outside the flexible rotating shaft, a first pipeline is formed by a gap between the isolation tube wall and the flexible rotating shaft, the sheath tube wall is sleeved outside the isolation tube wall, a second pipeline is formed by a gap between the sheath tube wall and the isolation tube wall, at least one of the first pipeline and the second pipeline is used as a circulation channel for circulating perfusion fluid, a constraint layer is arranged in at least one of the isolation tube wall, the sheath tube wall, the second pipeline and the first pipeline, and at least part of the circulation channel is not provided with the constraint layer.

In some of these embodiments, the barrier tube wall is comprised of flexible metal tubing or a multi-layer braided tubing that can be liquid-tight.

In some implementations, the flexible shaft is circular shaft shaped, and the spacer tube wall and the sheath tube wall are tubes coaxial with the flexible shaft.

In other implementations, rather than a layer-by-layer sleeved tubular shaft-like structure, two axially extending cylindrical cavities are formed on the sheath body that are relatively independent and separate.

It will be appreciated that when only one primary conduit is formed within the sheath body, the principles are the same as those of the several implementations described above, and the structure is similar, and will not be described in detail.

According to the intervention sheath pipe provided by the application, the constraint layer is arranged in at least one of the isolation pipe wall, the sheath pipe wall, the second pipeline and the first pipeline, and at least part of the circulation channel is not provided with the constraint layer, so that the constraint layer can absorb vibration generated by the flexible rotating shaft, and the obstruction of the constraint layer on the flow of perfusion liquid when the constraint layer is arranged in the circulation channel is reduced, the bubble residue in the circulation channel is further reduced, and the risks of perfusion liquid interruption, blood backflow or bubble entering a blood vessel are reduced.

It is understood that the interventional sheath of the present application may be applied to an application scenario of a blood pumping device, a tissue fluid pumping device, a digestive juice pumping device, etc. to achieve the purpose of pumping fluids such as blood, tissue fluid, digestive juice, etc., and for convenience of understanding and description, the following description will be given by taking an application scenario of the interventional sheath applied to the blood pumping device as an example.

Before describing the specific structure of the interventional sheath, a blood pumping device including the interventional sheath will be briefly described with reference to the accompanying drawings in order to understand the working environment of the interventional sheath. Fig. 1 is a schematic partial longitudinal cross-sectional view of a blood pumping device incorporating an interventional sheath according to some embodiments of the present application, and fig. 2 shows a schematic partial longitudinal cross-sectional view of an exemplary interventional sheath. As can be seen in fig. 1 and 2, the present application provides a blood pumping device comprising an interventional sheath, the blood pumping device comprising an interventional sheath 10, a distal assembly 20 and a proximal assembly (not shown), the distal assembly 20 being connected to the distal end of the interventional sheath 10, the proximal assembly being connected to the proximal end of the interventional sheath 10. The interventional sheath 10 includes a sheath body including a flexible shaft, a second pipeline and a first pipeline, a proximal assembly including a motor, an infusion pump, a liquid discharge pump, a liquid storage tank, a liquid collecting tank, and the like, the motor being connected to a proximal end of the flexible shaft for driving the flexible shaft to rotate, the first pipeline and the second pipeline being a circulation channel for circulating a perfusion liquid, one of the first pipeline and the second pipeline being a perfusion pipeline, and the other being a return pipeline. The infusion pump is communicated with the liquid storage tank and is used for driving the perfusion liquid in the liquid storage tank to flow into the perfusion pipeline. The liquid discharge pump is communicated with the liquid collecting tank and is used for driving the perfusion liquid in the intervention sheath pipe 10 to flow into the liquid collecting tank from the return pipeline. The distal assembly 20 comprises a distal support 21, an impeller (not shown), an inflow channel (not shown) and an outflow channel (not shown), the outflow channel being located between the inflow channel and the interventional sheath 10 and being in communication with the inflow channel, at least part of the impeller being located in the outflow channel, the inflow channel being provided with a suction inlet and the outflow channel being provided with an outflow outlet. The distal end of the flexible rotating shaft passes through the distal end bracket 21 and then is connected with the impeller, so that the motor outside the blood pumping device can drive the impeller in the body to rotate by driving the flexible rotating shaft to rotate when the blood pumping device is in operation. The distal assembly 20 is advanced through the patient's vascular intervention during use by means of the intervention sheath 10 until the inflow and outflow channels are located at prescribed locations in the patient's blood circulation system. In this case, the outflow and the suction opening are located in different positions of the blood circulation system, for example the suction opening is located in the left ventricle of the patient and the outflow opening is located in the aorta of the patient.

When the motor positioned outside the body is started, the motor drives the impeller in the outflow channel to rotate through the transmission of the flexible rotating shaft, so that the impeller drives blood to enter the inflow channel from the suction inlet and flow out of the outflow channel from the outflow port, and the blood flows into the aorta of the patient from the left ventricle of the patient through the inflow channel and the outflow channel, so that the blood pumping function of the blood pumping device is realized. Simultaneously, the infusion pump outside the body pumps the infusion liquid into the infusion pipeline to the distal end bracket 21 without interruption, so that the distal end bracket 21 keeps certain pressure, and blood in the blood vessel is prevented from entering the interventional sheath 10 and coagulation to generate thrombus. The perfusate at the distal end support 21 is driven by the drainage pump and flows out of the body through the return line and is collected by the sump.

Wherein the perfusate comprises at least one of physiological saline, glucose and anticoagulant, and the anticoagulant can be heparin. The anticoagulant in the perfusate reduces the probability of blood coagulation, thereby reducing the probability of failure of the pump blood function caused by coagulation of the motor.

It will be appreciated that in the present application, proximal refers to the end facing the operator or physician and distal refers to the end facing away from the operator or physician. The proximal end of the access sheath 10 is directed towards the proximal assembly and the distal end of the access sheath 10 is directed towards the distal assembly 20.

Having described the structure of a blood pumping device, an interventional sheath 10 provided in accordance with an embodiment of the present application is described below with reference to the accompanying drawings. In this illustration, the drawing is taken along the line connecting the proximal and distal ends of the interventional sheath 10, and the direction from the distal end to the proximal end is denoted as the first direction and is denoted as x. In the drawings, the dimensions in the drawings are not necessarily to scale with real dimensions for convenience in drawing.

As can be seen from fig. 1 and 2, the present application provides an interventional sheath 10, wherein a distal end of the interventional sheath 10 is connected to a distal assembly 20, the interventional sheath 10 includes a sheath body, a first pipeline 500 and a second pipeline 600 are formed in the sheath body, and at least one of the first pipeline 500 and the second pipeline 600 is used as a flow channel for flowing perfusion fluid. At least one of the sheath body, the second conduit 600 and the first conduit 500 is provided with a restriction layer 400 therein, and at least a portion of the flow channel is not provided with the restriction layer 400 therein.

In some of these embodiments, the sheath body includes a flexible shaft 100, a spacer tube wall 200, and a sheath tube wall 300. The isolation tube wall 200 is sleeved outside the flexible rotating shaft 100, and a gap between the isolation tube wall 200 and the flexible rotating shaft 100 forms a first pipeline 500. The sheath wall 300 is sleeved outside the isolation tube wall 200, and a gap between the sheath wall 300 and the isolation tube wall 200 forms a second pipeline 600. At least one of the barrier tube wall 200, the sheath tube wall 300, the primary tubing 500, and the secondary tubing 600 is provided with a constraining layer 400.

In some of these implementations, the flexible shaft 100, the spacer tube wall 200, the sheath tube wall 300, and the constraining layer 400 all extend along the first direction x, and the second tube 600 and the first tube 500 are annular cavities that all extend along the first direction x.

For convenience of drawing and description, the x direction in the drawing is a straight line direction, but in practice, the insertion sheath 10 has a certain bending property, so that the insertion sheath 10 can be conveniently inserted into a blood vessel, and the extending direction of the central axis of the insertion sheath 10 can also be curved.

In some implementations, the isolation tube wall 200 and the sheath tube wall 300 may be cylinders, or may be polygonal tubular structures such as square cylinders. The present embodiment illustrates the spacer tube wall 200 and the sheath tube wall 300 as cylinders.

Here, since the spacer tube wall 200 and the sheath tube wall 300 are both axisymmetric, the spacer tube wall 200 and the sheath tube wall 300 each have a central axis, and the central axis extends in a direction consistent with the direction of the line connecting the proximal end and the distal end of the interventional sheath tube 10, i.e., the direction x in the drawing. The separator wall 200 and the sheath wall 300 have a cylindrical structure, and thus have two circumferential surfaces, the circumferential surface of the cylinder outer wall being the outer circumferential surface, and the circumferential surface of the cylinder inner wall being the inner circumferential surface. Further, the axial direction of the separator wall 200 and the sheath wall 300 refers to the direction in which the central axis extends, the circumferential direction refers to the circumferential direction of the cylinder periphery, and the radial direction refers to the direction passing through the central axis in a radial plane, and generally also refers to a straight line direction along the diameter or radius, or a straight line direction perpendicular to the central axis. Radial dimensions generally refer to the radius or diameter of an axisymmetric part. It is understood that other components of the present application, axial, circumferential, radial, circumferential surfaces, may be referred to in the foregoing description of the spacer tube wall 200 and sheath tube wall 300.

According to the interventional sheath 10 provided by the embodiment, the constraint layer 400 is arranged in at least one of the isolation tube wall 200, the sheath tube wall 300, the second pipeline 600 and the first pipeline 500, and the constraint layer 400 is not arranged in at least part of the circulation channel, so that the constraint layer 400 can absorb vibration generated by the flexible rotating shaft 100, and the obstruction of the constraint layer 400 on the flow of perfusion fluid when being positioned in the circulation channel is reduced, thereby reducing the residual air bubble in the circulation channel and reducing the risk of perfusion fluid flow interruption, blood backflow or air bubble entering the blood vessel.

In some of these embodiments, at least one of first tubing 500 and second tubing 600 is used to deliver perfusion fluid to distal assembly 20.

In some embodiments, the distal assembly 20 further comprises a distal support 21 and a bearing 22, the distal support 21 having a transition cavity 211 therein for receiving the bearing 22, the second conduit 600 and the first conduit 500 each communicating with the transition cavity 211. The distal end bracket 21 is further provided with a first opening 212 for communicating the inside and the outside of the transition cavity 211, and the distal end of the flexible rotating shaft 100 extends out of the transition cavity 211 from the first opening 212 and is connected with the impeller.

In some embodiments, the flow-through channel includes only the first tubing 500 and does not include the second tubing 600, and the first tubing 500 is an infusion tubing for delivering infusion fluid distally, which flows into the distal assembly 20 and ultimately into the patient's blood vessel. The first conduit 500 is at least partially devoid of the constraining layer 400, and the second conduit 600 may be provided with the constraining layer 400. The present application prevents intravascular blood from entering the access sheath 10 through the first opening 212 and clotting to create a thrombus by allowing the perfusate to flow to the distal assembly 20, maintaining the perfusate at a pressure in the transition chamber 211. By flushing the bearing 22 and entraining particles generated by rotation of the bearing 22 as the perfusate flows through the transition chamber 211, product safety and service life are improved.

In other embodiments, the flow channel includes only the second tubing 600, excluding the first tubing 500, and the second tubing 600 is an infusion tubing for delivering infusion fluid distally, which flows into the distal assembly 20 and ultimately into the patient's blood vessel. The second pipeline 600 is at least partially free of the constraining layer 400, and the first pipeline 500 may have the constraining layer 400 disposed therein.

In other embodiments, the flow channel includes a first line 500 and a second line 600, the second line 600 being a perfusion line for delivering perfusion fluid distally, the first line 500 being a return line for draining perfusion fluid from the interventional sheath 10. By allowing the perfusate to flow from the second pipeline 600 to the distal assembly 20 and then out of the first pipeline 500, the particles in the first pipeline 500 can flow out directly with the perfusate, so that the content of particles in the perfusate at the distal assembly 20 is extremely low, the total amount of particles flowing into the patient from the distal assembly 20 is reduced, and the product safety is further improved.

In other embodiments, the flow channel includes a first line 500 and a second line 600, the first line 500 being a perfusion line for delivering perfusion fluid distally and the second line 600 being a return line for draining perfusion fluid.

In other embodiments, both the first and second lines 500, 600 are used to distally deliver perfusate that collects in the transition chamber 211 and flows from the first opening 212 into the patient's blood vessel. Since a large amount of perfusate will enter the patient's blood vessel in this manner, in order to reduce the risk of air embolism caused by air bubbles entering the patient's blood vessel in the first and second lines 500, 600, the interventional sheath 10 will begin to inject perfusate before it is inserted into the patient's blood vessel, filling the first and second lines 500, 600 and the transition chamber 211 in advance, and evacuating the gas in each line and chamber. The application reduces the volume and cost of the blood pumping device by using both the first and second lines 500, 600 to deliver perfusate to the distal assembly 20, reducing the backflow lines and the collection tanks of perfusate.

Having described the overall structure of the interventional sheath 10, several implementations of the constraining layer 400 are described below in connection with the figures. The following embodiment will be described with reference to the second line 600 being a perfusion line (reference numeral 600 a) and the first line 500 being a return line (reference numeral 500 a).

In some embodiments, the constraining layer 400 satisfies at least one of 1) no constraining layer 400 disposed in one of the first and second conduits 500, 600, 2) no constraining layer 400 disposed in either of the first and second conduits 500, 600, 3) no constraining layer 400 disposed in a portion of the path of the first conduit 500, no constraining layer 400 disposed in a remaining portion of the path of the first conduit 500, 4) no constraining layer 400 disposed in a portion of the path of the second conduit 600, and no constraining layer disposed in a remaining portion of the path of the second conduit 600, 5) the constraining layer 400 embedded in the barrier tube wall 200, and 6) the constraining layer 400 embedded in the sheath tube wall 300.

Wherein the constraint layer 400 is disposed in a portion of the path of the first pipeline 500, and the constraint layer 400 is not disposed in another portion of the path, which means that the constraint layer 400 may be located only in one section of the first pipeline 500 (500 a), see fig. 7 in particular. The constraint layer 400 is disposed in a portion of the path of the second pipeline 600, which is not described herein.

Here, the constraining layer 400 located in the first pipeline 500 or the second pipeline 600 is named as a first constraining layer 410, the constraining layer 400 embedded in the barrier tube wall 200 is named as a second constraining layer 420, and the constraining layer embedded in the sheath tube wall 300 is named as a third constraining layer 430.

In some of these embodiments, the constraint layer 400 includes a first constraint layer 410, and/or a second constraint layer 420, and/or a third constraint layer 430.

In some of these embodiments, the constraining layer 400 is a resilient member, such as a spring, that extends helically around the flexible shaft 100 in a first direction x, and the resilient member has a circular, elliptical, or rectangular cross-sectional shape in the first direction x. The constraining layer 400 may be formed into a spring shape by winding a wire, or may be formed by cutting a round tube.

In some of these embodiments, the material of the confinement layer 400 includes a metallic material, such as stainless steel, nitinol, cobalt chrome, or the like.

According to the interventional sheath 10 provided by the embodiment, the constraint layer 400 is spirally extended from the metal material and forms the spring encircling the outer side of the flexible rotating shaft 100, so that the constraint layer 400 can be bent to a certain angle to adapt to a blood vessel, and can absorb vibration generated in the rotating process of the flexible rotating shaft 100, and further the influence of the vibration of the interventional sheath 10 on the blood vessel is reduced.

As can be seen in conjunction with fig. 2, in some embodiments, the constraint layer 400 includes two first constraint layers 410, the two first constraint layers 410 are both located in the first pipeline 500, one first constraint layer 410 is sleeved outside the other first constraint layer 410, and the constraint layer 400 is not disposed in the second pipeline 600. Because the first constraining layer 410 is a helically extending spring-like structure, the reflux of the first tubing 500 is not completely blocked even if the first constraining layer 410 is positioned within the first tubing 500, and the perfusate can still flow through the gaps in the first constraining layer 410 to the proximal end of the interventional sheath 10 and eventually out of the body.

Wherein the axial dimensions of the two first constraining layers 410, the dimensions of the spring wire, may all be different.

In some embodiments, one of the first constraining layers 410 may be sleeved on the flexible shaft 100, and the other first constraining layer 410 may be embedded on the inner circumferential surface of the isolating pipe wall 200.

According to the interventional sheath 10 provided by the embodiment, the two first constraint layers 410 are located in the first pipeline 500, and the first constraint layers 410 do not need to be embedded in the pipe wall, so that the preparation difficulty of the first constraint layers 410 is reduced. Because the perfusate is flowing from the second pipeline 600 to the distal assembly 20, and the constraint layer 400 is not arranged in the second pipeline 600, the residual air bubbles in the second pipeline 600 are reduced, and then the perfusate flow interruption at the distal assembly 20 and the risk that the air bubbles enter the blood are reduced. Second, even if air bubbles remain in the first tube 500 due to the first constraining layer 410 being located in the first tube 500, the air bubbles in the first tube 500 do not cause the flow of the perfusate at the distal end assembly 20 to break, and the air bubbles are not easy to retrograde into the blood vessel in the first tube 500 due to the flow direction of the perfusate from the second tube 600 to the distal end assembly 20 and out of the body through the first tube 500.

Fig. 3 shows a partial longitudinal cross-sectional schematic view of another example interventional sheath. As can be seen in conjunction with fig. 3, in some embodiments, the constraining layers 400 include two first constraining layers 410 and one third constraining layer 430, wherein the two first constraining layers 410 are located in the first pipeline 500, one of the first constraining layers 410 is sleeved outside the other first constraining layer 410, and the third constraining layer 430 is embedded in the sheath wall 300. The confinement layer 400 is not disposed within the second conduit 600.

The sheath wall 300 may be prepared by two layers, namely, an inner layer and an outer layer, and the third constraint layer 430 is sandwiched between the inner layer and the outer layer of the sheath wall 300. The sheath wall 300 may be formed by taking the third constraint layer 430 as a skeleton and coating the surface of the third constraint layer 430 with a material through vapor deposition, spray coating, electroplating, injection molding, or the like.

Compared with the previous embodiment, the interventional sheath 10 provided in this embodiment has the advantages that the constraining layers 400 include the first constraining layer 410 and the third constraining layer 430, and the constraining layers further absorb the vibration generated by the flexible shaft 100, so as to reduce the influence of the interventional sheath 10 on the blood vessel. By embedding the third constraining layer 430 within the sheath wall 300, the vibration of the flexible shaft 100 is absorbed without affecting the flow of perfusate within the tubing or the outside diameter of the interventional sheath 10. Second, the third constraining layer 430 is embedded in the sheath wall 300, which can further improve the stability of the constraining layer 400 and reduce the probability of displacement of the constraining layer 400 in the first and second pipelines 500, 600.

Fig. 4 shows a schematic partial longitudinal cross-section of yet another example interventional sheath. As can be appreciated in conjunction with fig. 4, in some of these embodiments, the constraint layer 400 includes a first constraint layer 410, a second constraint layer 420, and a third constraint layer 430. The first constraining layer 410 is disposed in the first pipeline 500, the second constraining layer 420 is embedded in the isolating pipe wall 200, and the third constraining layer 430 is embedded in the sheath pipe wall 300. The confinement layer 400 is not disposed within the second conduit 600.

The isolation tube wall 200 may be made of an inner and an outer layer, and the second constraining layer 420 may be sandwiched between the inner and the outer sheath walls 300. The second constraint layer 420 may be taken as a skeleton, and then the surface of the second constraint layer 420 is coated with a material to form the isolation tube wall 200 through vapor deposition, spray coating, electroplating, injection molding, and other processes.

In the interventional sheath 10 provided in this embodiment, the second constraining layer 420 is embedded in the sheath wall 300, so that the vibration of the flexible shaft 100 is absorbed, and meanwhile, the flow of the perfusate in the pipeline is not affected, and the external diameter size of the interventional sheath 10 is not affected. Compared with the above embodiment, the constraining layer 400 is embedded in the sheath wall 300 in this embodiment, which not only further absorbs the vibration of the flexible shaft 100, but also reduces the influence of the perfusion fluid flowing in the second pipeline 600 on the blood vessel of the patient, and further improves the safety of the interventional sheath 10.

Fig. 5 shows a schematic partial longitudinal cross-section of yet another example interventional sheath. As can be appreciated in conjunction with fig. 5, in some of these embodiments, the constraining layer 400 includes a first constraining layer 410 and a third constraining layer 430, with the constraining layer 400 not being disposed within the second conduit 600. Compared with the above embodiment, the present embodiment has no constraining layer 400 in the isolation tube wall 200, which can reduce the radial dimension of the interventional sheath 10, thereby reducing the interventional difficulty of the interventional sheath 10. However, in this embodiment, the first constraint layer 410 disposed in the first pipeline 500 can directly absorb the vibration of the flexible shaft 100, and the third constraint layer 430 disposed in the sheath wall 300 can not only absorb the vibration of the flexible shaft 100, but also reduce the influence of the perfusion fluid flowing in the second pipeline 600 on the blood vessel of the patient.

Fig. 6 shows a schematic partial longitudinal cross-section of yet another example interventional sheath. As can be appreciated in connection with fig. 6, in some of these embodiments, the constraining layer 400 includes a second constraining layer 420 and a third constraining layer 430, and the constraining layer 400 is not disposed within the first and second conduits 500, 600. In the interventional sheath 10 provided in this embodiment, the constraint layer 400 is not disposed in the first pipeline 500 and the second pipeline 600, so that the bubble residue in the first pipeline 500 and the second pipeline 600 is reduced, the constraint layer 400 does not affect the perfusion and the reflux of the perfusate completely, and compared with the above embodiment, the perfusion in this embodiment has better fluidity, and the perfusate flow-stopping, detention and bubble entering the blood vessel of the patient have lower probability.

Fig. 7 shows a schematic view of a partial longitudinal section of yet another example interventional sheath. As can be seen in conjunction with fig. 7, in some of these embodiments, the sheath wall 300 covers the same axial area of the flexible shaft 100 as the constraining layer 400 covers the flexible shaft 100.

In some of these embodiments, the constraining layer 400 includes a first constraining layer 410 and a second constraining layer 420, where the constraining layer 400 is not disposed in the second conduit 600. The first constraining layer 410 is located at the proximal end of the first tubing 500 and the distal end of the first tubing 500 is not provided with the constraining layer 400. The second constraining layer 420 is embedded in the distal end of the spacer tube wall 200, and the constraining layer 400 is not disposed on the proximal end of the spacer tube wall 200. And the orthographic projections of the first constraining layer 410 and the second constraining layer 420 in the radial direction at least partially overlap.

Compared with the above embodiments, the interventional sheath 10 provided in this embodiment has the first constraining layer 410 located only in a partial region of the first pipeline 500, thereby further reducing the residual air bubbles in the first pipeline 500. And because the area of the flexible rotating shaft 100, which is not covered by the first constraint layer 410, is still covered by the second constraint layer 420, the axial area of the sheath wall 300 covering the flexible rotating shaft 100 is the same as the axial area of the flexible rotating shaft 100 covered by the constraint layers 400, and the first constraint layer 410 and the second constraint layer 420 absorb the vibration of the flexible rotating shaft 100 together, so that the influence of the flexible rotating shaft 100 on the blood vessel of the patient can still be reduced.

Of course, in other embodiments, the constraining layer 400 may be provided in other forms, as long as the constraining layer 400 includes at least one of the first constraining layer 410, the second constraining layer 420 and the third constraining layer 430, and at least part of the first pipeline 500 and the second pipeline 600 is not provided with the constraining layer 400, and other combinations of the first constraining layer 410, the second constraining layer 420 and the third constraining layer 430 in the interventional sheath 10 are also included in the protection scope of the present embodiment and will not be described herein.

Having described the implementation of the constraining layer 400 in the interventional sheath 10, the implementation of other structures in the interventional sheath 10 will be described below in conjunction with the accompanying drawings. As can be seen in conjunction with fig. 2-6, in some of these embodiments, the materials of the sheath wall 300 and the spacer wall 200 include at least one of polytetrafluoroethylene, a block polyether amide resin, and polyethylene terephthalate.

In some of these implementations, the wall surface of the sheath wall 300 has high smoothness and low roughness, and the outer circumferential surface of the sheath wall 300 is subjected to a hydrophilic coating treatment.

The interventional sheath 10 according to the present embodiment separates the first pipeline 500 from the second pipeline 600 by providing the isolation tube wall 200. By making the sheath wall 300 of a polymer material and performing hydrophilic coating treatment on the outer peripheral surface, the friction between the sheath wall 300 and the wall of the patient's blood vessel is reduced, and the damage to the patient's blood vessel caused by the interventional sheath 10 is reduced.

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

In some of these embodiments, the flexible shaft 100 is braided from a plurality of wires such that the flexible shaft 100 has both a strength to perform a transmission function and a bending capability to be introduced into a blood vessel with the insertion sheath 10.

In addition, the application also provides another interventional sheath, which comprises a sheath body, wherein a first pipeline is formed in the sheath body and is used as a circulation channel for circulating perfusion fluid. At least one of the sheath body and the first pipeline is internally provided with a constraint layer, and at least part of the circulation channel is not internally provided with the constraint layer.

In some embodiments, the sheath body includes a flexible shaft and a sheath wall, the sheath wall is disposed around the flexible shaft, and a gap between the sheath wall and the flexible shaft forms a first conduit. The first pipeline is used as a circulating channel for circulating perfusion fluid. At least one of the sheath wall and the primary pipeline is internally provided with a restraint member, and at least part of the flow channel is not internally provided with the restraint member.

Compared with the interventional sheath of the above embodiment, the sheath body of the present embodiment has no second pipeline, and the perfusate flows from the first pipeline to the distal end assembly and then directly enters the patient's blood vessel. The constraining layer may be located in a partial region of the primary conduit and embedded in the sheath body, but at least a partial region of the primary conduit is not provided with the constraining layer.

In addition, the present application provides a blood pumping device comprising a proximal end assembly, a distal end assembly 20 and the interventional sheath 10 according to any of the above embodiments, wherein the distal end assembly 20 is connected to the distal end of the interventional sheath 10 and the proximal end assembly is connected to the proximal end of the interventional sheath 10. A transition lumen 211 is provided within the distal assembly 20, and the first conduit 500 and the second conduit 600 are in communication with the transition lumen, respectively.

In some embodiments, the proximal assembly includes a motor, an infusion pump, a liquid discharge pump, a liquid storage tank, a liquid collection tank, and the like, the motor being coupled to the proximal end of the flexible shaft for driving the flexible shaft in rotation, the first and second lines being flow channels for flow of the perfusate, one of which is a perfusion line, and the other of which is a return line. The infusion pump is communicated with the liquid storage tank and is used for driving the perfusion liquid in the liquid storage tank to flow into the perfusion pipeline. The liquid discharge pump is communicated with the liquid collecting tank and is used for driving the perfusion liquid in the intervention sheath pipe 10 to flow into the liquid collecting tank from the return pipeline.

In some of these 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), a transition chamber 211 is provided within the distal support 21 for receiving the bearing 22, and the second conduit 600 and the first conduit 500 are both in communication with the transition chamber 211. In use, the infusion pump continuously pumps the perfusate into the second tubing 600 to the transition chamber 211, so that the transition chamber 211 maintains a certain pressure, and blood in the blood vessel is prevented from entering the interventional sheath 10 and clotting to generate thrombus. The perfusate at the transition chamber 211 will again flow out of the body through the first tubing.

In some alternative embodiments, the outflow channel is located between and in communication with the inflow channel and the access sheath 10, at least a portion of the impeller is located within the outflow channel, the inflow channel is provided with a suction inlet, and the outflow channel is provided with an outflow outlet. The distal end bracket 21 is provided with a first opening 212 which is communicated with the inside and the outside of the transition cavity 211, and the distal end of the flexible rotating shaft 100 passes through the transition cavity 211, then extends out of the transition cavity 211 from the first opening 212 and is connected with the impeller in the outflow channel, so that the motor can drive the impeller to rotate by driving the flexible rotating shaft 100 to rotate. The distal assembly 20 is advanced through the patient's vascular intervention during use by means of the intervention sheath 10 until the inflow and outflow channels are located at prescribed locations in the patient's blood circulation system. In this case, the outflow and the suction opening are located in different positions of the blood circulation system, for example the suction opening is located in the left ventricle of the patient and the outflow opening is located in the aorta of the patient. When the motor positioned outside the body is started, the motor drives the impeller in the outflow channel to rotate through the transmission of the flexible rotating shaft 100, so that the impeller drives blood to enter the inflow channel from the suction inlet and flow out of the outflow channel from the outflow port, and the blood flows into the aorta of the patient from the left ventricle of the patient through the inflow channel and the outflow channel, so that the blood pumping function of the blood pumping device is realized. In addition, the application also provides a blood pumping device, which comprises a distal end component and an intervention sheath tube, wherein the intervention sheath tube comprises a sheath tube body, a first pipeline is formed in the sheath tube body, and a transition cavity communicated with the first pipeline is arranged in the distal end component. In contrast to the previous blood pumping device, the blood pumping device in this embodiment is different in that the second tube is not provided in the sheath body.

In addition, the present application provides a blood pumping device comprising a proximal end assembly, a distal end assembly 20 and the interventional sheath 10 according to any of the above embodiments, wherein the distal end assembly 20 is connected to the distal end of the interventional sheath 10 and the proximal end assembly is connected to the proximal end of the interventional sheath 10. Compared to the previous blood pumping device, the blood pumping device in this embodiment is different in that the sheath body does not include a flexible shaft, the proximal assembly does not include a motor, the distal assembly 20 includes a motor located in the transition chamber 211, and a wire harness of the motor is connected to an external power supply through the first pipeline 500. The shaft of the motor extends only from the transition chamber 211 to the outflow channel, and the distal end of the shaft of the motor protrudes from the transition chamber 211 from the first opening 212 and is connected to the impeller. Because the motor is built in the transition cavity 211, the slender flexible rotating shaft 100 is not required to be used as a transmission part in the body or the outside, and the flexible rotating shaft 100 can be replaced by a hard rotating shaft with higher rigidity and higher transmission efficiency so as to improve the blood pumping efficiency of the blood pumping device. In this embodiment, the perfusate still needs to flow into the transition chamber 211 through the first pipeline 500, and the second pipeline 600 for discharging the perfusate is still provided in the sheath body, so that the constraining layer 400 is provided in at least one of the isolation pipeline 200, the sheath pipeline 300, the first pipeline 500 and the second pipeline 600 in the above embodiment, and the various cases where at least part of the constraining layer 400 is not provided in the first pipeline 500 and the second pipeline 600 can also produce the same technical effects in this embodiment.

In another embodiment, the blood pumping device differs from the previous blood pumping device in that the sheath body is not provided with a second tubing 600, and the perfusate flows from the first tubing 500 to the transition chamber 211 and then directly from the first opening 212 into the patient's blood vessel. In this embodiment, the perfusate still needs to flow into the transition chamber 211 through the first pipeline 500, so that the constraining layer 400 is disposed in at least one of the isolation pipeline 200, the sheath pipeline 300 and the first pipeline 500 in the above embodiment, and various situations where at least part of the constraining layer 400 is not disposed in the first pipeline 500 can also produce the same technical effect in this embodiment.

Since the blood pumping device includes the interventional sheath 10 according to any of the above embodiments, the blood pumping device can produce the same technical effects as the interventional sheath 10, and will not be described in detail herein.

In the foregoing, only the specific embodiments of the present application are described, and it will be clearly understood by those skilled in the art that, for convenience and brevity of description, the specific working processes of the systems, modules and units described above may refer to the corresponding processes in the foregoing method embodiments, which are not repeated herein. It should be understood that the scope of the present application is not limited thereto, and any equivalent modifications or substitutions can be easily made by those skilled in the art within the technical scope of the present application, and they should be included in the scope of the present application.

Claims (13)

1. An interventional sheath, comprising:

The perfusion device comprises a sheath body, wherein a first pipeline and a second pipeline are formed in the sheath body, and at least one of the first pipeline and the second pipeline is used as a circulation channel for circulating perfusion liquid;

And a constraint layer is arranged in at least one of the sheath body, the second pipeline and the first pipeline, and at least part of the circulation channel is not provided with the constraint layer.

2. The interventional sheath of claim 1, wherein the sheath body comprises:

A flexible shaft;

The isolating pipe wall is sleeved outside the flexible rotating shaft, and a gap between the isolating pipe wall and the flexible rotating shaft forms the first pipeline;

The sheath pipe wall is sleeved outside the isolation pipe wall, and a gap between the sheath pipe wall and the isolation pipe wall forms the second pipeline;

And a constraint layer is arranged in at least one of the isolation pipe wall, the sheath pipe wall, the second pipeline and the first pipeline.

3. The interventional sheath of claim 2, wherein the flow channel comprises the first tubing and the second tubing, the second tubing being a perfusion tubing for delivering perfusion fluid distally, the first tubing being a return tubing for draining perfusion fluid.

4. An interventional sheath according to claim 2 or 3, wherein at least one of the following conditions is fulfilled:

1) One of the first pipeline and the second pipeline is internally provided with the constraint layer, and the other one is not internally provided with the constraint layer;

2) The constraint layers are not arranged in the first pipeline and the second pipeline;

3) The constraint layer is arranged in a part of the paths of the first pipeline, and the constraint layer is not arranged in the rest of the paths of the first pipeline;

4) The constraint layer is arranged in a part of the paths of the second pipeline, and the constraint layer is not arranged in the rest of the paths 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.

5. The interventional sheath of claim 2, wherein the constraining layer comprises:

A first constraining layer located within the first and/or second tubing;

And/or, a second constraint layer embedded in the isolation pipe wall;

and/or a third constraint layer embedded in the sheath wall.

6. The interventional sheath of claim 2, wherein the sheath wall covers the same axial area of the flexible shaft as the constraining layer covers the flexible shaft.

7. The interventional sheath of claim 2, wherein the flexible shaft, the isolation tube wall, the sheath wall, and the constraining layer each extend in a first direction, the second tube and the first tube each being annular lumens extending in the first direction, wherein the first direction is a direction in which a distal end of the interventional sheath is directed proximally;

And/or the constraint layer is an elastic piece, and the cross section of the elastic piece in the first direction is circular, elliptical or rectangular.

8. The interventional sheath of claim 2, wherein the material of the sheath wall and the spacer wall comprises at least one of polytetrafluoroethylene, a block polyether amide resin, and polyethylene terephthalate;

and/or the material of the constraint layer comprises a metallic material.

9. The interventional sheath according to claim 2, wherein a distance between the spacer tube wall and the sheath tube wall in a radial direction of the interventional sheath is greater than 0mm and equal to or less than 0.5mm, and a distance between the spacer tube wall and the flexible shaft in a radial direction of the interventional sheath is greater than 0mm and equal to or less than 0.5mm.

10. An interventional sheath, comprising:

The perfusion device comprises a sheath body, wherein a first pipeline is formed in the sheath body, the first pipeline is used as a circulation channel for circulating perfusion liquid, a constraint layer is arranged in at least one of the sheath body and the first pipeline, and at least part of the circulation channel is not provided with the constraint layer.

11. A blood pumping device comprising a distal assembly and an interventional sheath according to any one of claims 1-9, wherein a transition lumen is provided in the distal assembly, and wherein the first and second lines are in communication with the transition lumen, 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 shaft, a first opening is formed in the distal end support and is used for communicating the inside and the outside of the transition cavity, and the distal end of the flexible 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 comprising a distal assembly having a transition lumen disposed therein and the interventional sheath of claim 10, the first conduit in communication with the transition lumen.