CN117159908A - Transmission conveying assembly and intervention type blood pump system - Google Patents

Abstract

The invention provides a transmission conveying assembly and an interventional blood pump system, wherein the transmission conveying assembly comprises a flexible shaft, a vibration reduction layer and a sheath tube which are sequentially arranged from inside to outside; the vibration reduction layer is provided with a hollow-out part which penetrates through in the radial direction, the inner diameter of the vibration reduction layer is matched with the outer diameter of the flexible shaft, and the flexible shaft is rotatably arranged around the axis of the flexible shaft; the flexible shaft is arranged at intervals with the sheath tube through the vibration reduction layer. So configured, the vibration damping layer changes the overall vibration mode of the transmission conveying assembly, effectively reduces the vibration and friction of the transmission conveying assembly, and reduces the damage to blood cells. Furthermore, the flexible shaft is separated from the sheath tube through the vibration reduction layer, and the contact surface of the vibration reduction layer relative to the flexible shaft is smaller, so that the heat generated by friction can be effectively reduced, and the damage to blood cells is further reduced.

Description

Transmission conveying assembly and intervention type blood pump system

Technical Field

The invention relates to the technical field of medical equipment, in particular to a transmission conveying assembly and an interventional blood pump system.

Background

Percutaneous interventional collapsible blood pumps are mainly used for emergency treatment of cardiogenic shock and for auxiliary circulation during high-risk PCI surgery. The blood pump arranged on the aortic valve can provide flow support of up to 4L/min, so that the blood pump function of the heart is replaced, the life of a cardiogenic shock patient can be saved, or the heart state is stabilized during the operation of a high-risk PCI patient, the occurrence of arrhythmia is reduced, the operation risk is reduced, and the success rate of the high-risk PCI operation is ensured.

The head end of the percutaneous interventional type foldable blood pump enters the heart through a femoral artery interventional mode through a conveying system, the head end of the blood pump is unfolded after reaching the left ventricle position and is fixed on an aortic valve, and a blood pump motor positioned outside the body transmits power to a paddle positioned in the left ventricle through a transmission flexible shaft so as to pump blood. Because the rotating speed of the transmission flexible shaft is 20000-40000 r/min in normal operation, the transmission flexible shaft inevitably causes severe vibration of the conveying system under the condition of high rotating speed, and the generated vibration can cause mechanical damage to blood vessels and blood cells. When the transmission flexible shaft runs at a high speed, the transmission flexible shaft rubs with the sheath tube wrapping the transmission flexible shaft, so that the temperature of the transmission flexible shaft and the sheath tube layer is increased, blood cells can be destroyed when the high-temperature part is contacted with blood, and the problems of hemolysis and thrombus are caused, thereby influencing the normal operation of the blood pump.

Disclosure of Invention

The invention aims to provide a transmission conveying assembly and an intervention type blood pump system so as to solve the problem that the existing intervention type blood pump is large in vibration and friction.

In order to solve the above technical problems, the present invention provides a transmission and conveying assembly for an interventional blood pump system, which includes: the flexible shaft, the vibration reduction layer and the sheath tube are sequentially arranged from inside to outside;

the vibration reduction layer is provided with a hollow-out part which penetrates through in the radial direction, the inner diameter of the vibration reduction layer is matched with the outer diameter of the flexible shaft, and the flexible shaft is rotatably arranged around the axis of the flexible shaft; the flexible shaft is arranged at intervals with the sheath tube through the vibration reduction layer.

Optionally, the sheath tube comprises an inner sheath tube, the transmission conveying assembly further comprises a rear bearing sleeve arranged at the distal end of the inner sheath tube, and the rear bearing sleeve is used for propping against or being connected with the distal end surface of the vibration reduction layer so as to limit the vibration reduction layer to move towards the distal end relative to the inner sheath tube.

Optionally, the vibration reduction layer is rotatably arranged around the self axis, and the vibration reduction layer is used for following rotation when the flexible shaft rotates.

Optionally, the vibration reduction layer is a spring tube, the spring tube comprises at least one spiral section formed by winding a spring wire, the pitch of the spiral section is 0.5-4 mm, and the wire diameter of the spring wire is 0.05-0.5 mm.

Optionally, the spring tube comprises at least two spiral sections, wherein the spiral directions of the at least two spiral sections are opposite.

Optionally, the vibration reduction layer is a cut mesh tube or a woven mesh tube.

Optionally, the sheath tube comprises an inner sheath tube and an outer sheath tube which can move relatively axially from inside to outside, a first cavity is formed between the inner sheath tube and the outer sheath tube, and the first cavity is used for the circulation of a first perfusion fluid; the interior of the inner sheath tube forms a second cavity which is used for circulating a second perfusion fluid.

Optionally, the surface of the flexible shaft and/or the vibration reduction layer is provided with a barrier coating.

Optionally, the sheath tube comprises an outer sheath tube, the outer sheath tube comprises an inner layer, an intermediate layer and an outer layer which are sequentially overlapped, and the intermediate layer is a woven and/or wound spring tube layer.

Optionally, the flexible shaft comprises at least two winding layers which are sequentially overlapped from inside to outside, the winding layers are formed by winding metal wires, and the winding directions of the two adjacent winding layers are opposite.

To solve the above technical problem, the present invention further provides an interventional blood pump system, which comprises an interventional blood pump and the transmission and delivery assembly as described above, wherein the interventional blood pump is connected with the distal end of the transmission and delivery assembly.

In summary, in the transmission conveying assembly and the intervention type blood pump system provided by the invention, the transmission conveying assembly comprises a flexible shaft, a vibration reduction layer and a sheath tube which are sequentially arranged from inside to outside; the vibration reduction layer is provided with a hollow-out part which penetrates through in the radial direction, the inner diameter of the vibration reduction layer is matched with the outer diameter of the flexible shaft, and the flexible shaft is rotatably arranged around the axis of the flexible shaft; the flexible shaft is arranged at intervals with the sheath tube through the vibration reduction layer.

So configured, the vibration damping layer changes the overall vibration mode of the transmission conveying assembly, effectively reduces the vibration and friction of the transmission conveying assembly, and reduces the damage to blood cells. Furthermore, the flexible shaft is separated from the sheath tube through the vibration reduction layer, and the contact surface of the vibration reduction layer relative to the flexible shaft is smaller, so that the heat generated by friction can be effectively reduced, and the damage to blood cells is further reduced.

Drawings

Those of ordinary skill in the art will appreciate that the figures are provided for a better understanding of the present invention and do not constitute any limitation on the scope of the present invention. Wherein:

FIG. 1 is a schematic diagram of an interventional blood pump system in accordance with the present invention;

FIG. 2 is a schematic illustration of an interventional blood pump and transmission assembly of an embodiment of the present invention;

FIG. 3 is a schematic illustration of an interventional blood pump of the present invention being inserted into a ventricle;

FIG. 4a is a schematic view of a distal portion of an interventional blood pump of an embodiment of the present invention;

FIG. 4b is an enlarged partial view of a distal portion of an interventional blood pump of an embodiment of the present invention;

FIG. 5 is a schematic view in transverse cross-section of a drive transfer assembly of an embodiment of the present invention;

FIG. 6 is a schematic view of a longitudinal section of a flexible shaft of an embodiment of the invention;

FIG. 7a is a schematic view of a preferred example of a spring tube of an embodiment of the present invention;

FIG. 7b is a schematic view of another preferred example of a spring tube of an embodiment of the present invention;

FIG. 7c is a schematic view of a cutting tube according to an embodiment of the present invention;

FIG. 8 is a schematic illustration of a spring tube and flexible shaft assembly according to an embodiment of the present invention;

FIG. 9 is a schematic view of an outer sheath of an embodiment of the present invention;

fig. 10 is a schematic view of a proximal portion of a drive delivery assembly of an embodiment of the present invention.

In the accompanying drawings:

01-ascending aorta; 02-aortic valve; 03-left ventricle; 10-an interventional blood pump; 11-pigtail catheter; 12-basket; 13-an impeller; 14-basket membrane; 15-a flow channel membrane; 16-front bearing sleeve; 17-a rear bearing sleeve; 30-a drive assembly; 40-a control assembly;

20-a drive conveyor assembly; 21-flexible shaft; 211-winding layers; 22-a vibration damping layer; 23-an inner sheath; 24-connecting piece; 25-an outer sheath; 251-outer layer; 252-an intermediate layer; 253-inner layer; 26-a hemostatic valve; 261-hemostatic valve base; 262-seals; 263-front end of hemostatic valve; 264-a first access port; 27-a handle base; 271-a front end of the base; 272-the rear end of the base; 273-second port.

Detailed Description

The invention will be described in further detail with reference to the drawings and the specific embodiments thereof in order to make the objects, advantages and features of the invention more apparent. It should be noted that the drawings are in a very simplified form and are not drawn to scale, merely for convenience and clarity in aiding in the description of embodiments of the invention. Furthermore, the structures shown in the drawings are often part of actual structures. In particular, the drawings are shown with different emphasis instead being placed upon illustrating the various embodiments.

As used in this disclosure, the singular forms "a," "an," and "the" include plural referents, the term "or" are generally used in the sense of comprising "and/or" and the term "several" are generally used in the sense of comprising "at least one," the term "at least two" are generally used in the sense of comprising "two or more," and the term "first," "second," and "third" are used for descriptive purposes only and are not to be construed as indicating or implying any relative importance or number of features indicated. Thus, a feature defining "first," "second," "third," or the like, may explicitly or implicitly include one or at least two such features, with "one end" and "another end" and "proximal end" and "distal end" generally referring to the corresponding two portions, including not only the endpoints. The terms "proximal" and "distal" are defined herein with respect to an interventional blood pump having one end for intervention in a human body and a manipulation end extending outside the body. The term "proximal" refers to the position of the element closer to the manipulation end of the interventional blood pump system that protrudes outside the body, and the term "distal" refers to the position of the element closer to the end of the interventional blood pump system that is to be accessed by the human body and thus further from the manipulation end of the interventional blood pump system. Alternatively, in a manual or hand-operated application scenario, the terms "proximal" and "distal" are defined herein with respect to an operator, such as a surgeon or clinician. The term "proximal" refers to a location of an element that is closer to the operator, and the term "distal" refers to a location of an element that is closer to the interventional blood pump system and thus further from the operator. Furthermore, as used in this disclosure, "mounted," "connected," and "disposed" with respect to another element should be construed broadly to mean generally only that there is a connection, coupling, mating or transmitting relationship between the two elements, and that there may be a direct connection, coupling, mating or transmitting relationship between the two elements or indirectly through intervening elements, and that no spatial relationship between the two elements is to be understood or implied, i.e., that an element may be in any orientation, such as internal, external, above, below, or to one side, of the other element unless the context clearly dictates otherwise. The specific meaning of the above terms in the present invention can be understood by those of ordinary skill in the art according to the specific circumstances. Furthermore, directional terms, such as above, below, upper, lower, upward, downward, left, right, etc., are used with respect to the exemplary embodiments as they are shown in the drawings, upward or upward toward the top of the corresponding drawing, downward or downward toward the bottom of the corresponding drawing.

The invention aims to provide a transmission conveying assembly and an intervention type blood pump so as to solve the problem that the existing intervention type blood pump is large in vibration and friction.

The following description refers to the accompanying drawings.

Referring to fig. 1, there is shown an interventional blood pump system comprising: an interventional blood pump 10, a transmission delivery assembly 20 and a drive assembly 30; the interventional blood pump 10 is located at a distal end for intervention in a human body. Referring to fig. 2 in combination, the proximal end of the interventional blood pump 10 is connected to the driving assembly 30 through the transmission assembly 20, and the driving assembly 30 drives the impeller of the interventional blood pump 10 to act through the transmission assembly 20. Alternatively, in some embodiments, the drive assembly 30 may be integrated into a handle. Optionally, the interventional blood pump system may further comprise a control assembly 40 for monitoring and controlling other components of the interventional blood pump system. The individual components of the interventional blood pump system will be understood by those skilled in the art and will not be described in detail herein.

Referring to fig. 3, in use, the interventional blood pump 10 in a compressed and folded state is inserted through the femoral artery by means of the transmission and delivery assembly 20, and passes through the descending aorta and the ascending aorta 01, a portion of the distal end of the interventional blood pump 10 passes through the aortic valve 02 and enters the left ventricle 03, and the transmission and delivery assembly 20 is operated to expand the interventional blood pump 10 from the compressed and folded state to an expanded state, and the impeller in the interventional blood pump 10 is operated (e.g., rotated) by the distal end driving assembly 30, so as to pump blood from the left ventricle 03 to the ascending aorta 01.

Referring to fig. 4a and 4b, in an alternative example, the interventional blood pump 10 includes a pigtail catheter 11, a basket 12, an impeller 13, a basket membrane 14, a runner membrane 15, and a front bearing housing 16. The pigtail catheter 11 is used for assisting the interventional blood pump 10 to fix in the left ventricle 03, and ensures that the part contacted with the ventricle wall is smoother, so as to avoid damaging the ventricle wall. Basket 12 is made of a shape memory metal such as nitinol that is capable of compression folding and expansion, in the expanded state, for forming a space for impeller 13 to rotate. The distal end of the impeller 13 is threaded into the front bearing housing 16. The basket coating 14 can be coated on the outer wall of the skeleton main body of the basket 13 through a thermal shrinkage process, a dip coating process or the like. The flow-path membrane 15 is connected to the basket covering membrane 14 at a distal end thereof by heat shrinkage or heat fusion, and to an inner sheath 23 (described in detail below) of the transmission assembly 20 at a proximal end thereof, thereby forming a passage through which blood is pumped out of the basket 13, and pumping the blood from the left ventricle 03 to the ascending aorta 01 via the aortic valve 02. Further, the drive transmission assembly 20 includes: the flexible shaft 21, the vibration reduction layer 22 and the sheath tube are sequentially arranged from inside to outside, preferably, the sheath tube comprises an inner sheath tube 23 and an outer sheath tube 25 which are arranged from inside to outside, and the inner sheath tube 23 is movably arranged relative to the outer sheath tube 25 along the axial direction. The distal end of the flexible shaft 21 is connected to the connecting member 24, e.g. by welding, and the outer diameter of the flexible shaft 21 is preferably equal to the outer diameter of the connecting member 24. The connector 24 is preferably a hollow structure (as shown in fig. 4 b), such as a metal tube, which allows passage of a guidewire during an interventional procedure; of course, in other embodiments, the connector 24 may be a solid metal rod. The distal end of the connector 24 is connected to the impeller 13, and the proximal end of the flexible shaft 21 is connected to the drive assembly 30, so configured that the drive assembly 30 is capable of driving the impeller 13 to rotate via the flexible shaft 21 and the connector 24.

Referring to fig. 4a and 5, the vibration reduction layer 22 has a hollow hole penetrating in a radial direction, an inner diameter of the vibration reduction layer 22 is adapted to an outer diameter of the flexible shaft 21, the flexible shaft 21 is rotatably disposed around an axis (in a horizontal direction in fig. 4 a), and the flexible shaft 21 is disposed at intervals with the sheath tube through the vibration reduction layer 22. The vibration damping layer 22 is circumferentially arranged around the axis of the flexible shaft 21, and it is to be noted that the inner diameter of the vibration damping layer 22 is slightly larger than the outer diameter of the flexible shaft 21, so that the flexible shaft 21 can smoothly rotate in the vibration damping layer 22, but the radial position of the flexible shaft 21 can be limited by the vibration damping layer 22, so that radial deflection of the flexible shaft 21 can be avoided, thereby limiting the radial vibration space of the flexible shaft 21, changing the vibration mode of the transmission conveying assembly 20, greatly reducing vibration and noise of the flexible shaft 21 during high-speed rotation, and effectively reducing damage to blood cells. Further, the flexible shaft 21 is spaced from the inner sheath tube 23 by the vibration reduction layer 22, and the contact area between the vibration reduction layer 22 and the flexible shaft 21 is relatively small due to the hollow vibration reduction layer 22, so that heat generated by friction can be effectively reduced, damage to blood cells is further reduced, and abrasion of the transmission conveying assembly 20 in use is reduced. In one example, the difference between the inner diameter of the vibration reduction layer 22 and the outer diameter of the flexible shaft 21 is between 0.05mm and 0.3mm, preferably 0.1mm, so that a good vibration prevention effect can be obtained.

With continued reference to fig. 4a and 4b, the drive transmission assembly 20 may further include a rear bearing sleeve 17 disposed at a distal end of the inner sheath 23, wherein the rear bearing sleeve 17 is configured to abut against or connect with a distal surface of the damping layer 22 to limit distal movement of the damping layer 22 relative to the inner sheath 23. Optionally, the rear bearing sleeve 17 is fixedly connected with the inner sheath tube 23, and the inner wall of the rear bearing sleeve 17 is used for supporting the connecting piece 24, and the connecting piece 24 can smoothly rotate in the rear bearing sleeve 17. In one example, the inner diameter of the rear bearing sleeve 17 is equal to or approximately equal to the inner diameter of the vibration reduction layer 22, and the proximal end surface of the rear bearing sleeve 17 can abut against the distal end surface of the vibration reduction layer 22, so that the vibration reduction layer 22 is prevented from falling out of the rear bearing sleeve 17; the abutment is understood to be a non-fixed connection, in practice, a certain gap may exist between the damping layer 22 and the rear bearing sleeve 17, so configured, the damping layer 22 may rotate along with the rotation of the flexible shaft 21, and friction between the damping layer 22 and the rear bearing sleeve 17 is smaller, during the rotation of the flexible shaft 21, the damping layer 22 may generate an axial deflection motion, and at this time, the damping layer 22 is abutted and blocked by the proximal end surface of the rear bearing sleeve 17 and cannot be separated. In another example, the proximal end face of the rear bearing housing 17 may also be fixedly connected to the distal end face of the vibration damping layer 22. Preferably, the outer diameter of the rear bearing housing 17 is the same as the outer diameter of the inner sheath tube 23, and the roughness of the inner and outer surfaces of the rear bearing housing 17 is in the range of Ra0.02-0.04 to reduce surface friction. The rear bearing housing 17 is provided for the connection piece 24 to pass through. With this arrangement, the impeller 13 can be stably supported by the front bearing housing 16 and the rear bearing housing 17. Alternatively, the material of the inner sheath 23 may be a fluorine-containing material (such as PTFE or FEP) or a special polymer material PEEK, etc., so as to have good blood compatibility.

In some embodiments, the damping layer 22 is rotatably arranged around its own axis, and the damping layer 22 is configured to follow the rotation of the flexible shaft 21. Preferably, the outer diameter of the damping layer 22 is adapted to the inner diameter of the inner sheath 23. It should be noted that, the outer diameter of the damping layer 22 is adapted to the inner diameter of the inner sheath tube 23, which means that the inner diameter of the inner sheath tube 23 is slightly larger than the outer diameter of the damping layer 22, so that the damping layer 22 can rotate in the inner sheath tube 23, but the inner sheath tube 23 can also limit the radial position of the damping layer 22, so that the damping layer 22 can be prevented from deflecting radially. It will be appreciated that the damping layer 22 itself does not have a power input and its rotation is a follow-up rotation by friction as the flexible shaft 21 inside it rotates. The rotational speed of the damping layer 22 and the rotational speed of the flexible shaft 21 are decoupled from each other and there may be no correlation whereby the vibration mode of the entire drive transmission assembly 20 is changed, thereby enabling the vibration of the entire drive transmission assembly 20 to be greatly reduced. Referring to fig. 8, in an exemplary embodiment, the difference between the inner diameter of the inner sheath tube 23 and the outer diameter of the vibration damping layer 22 is between 0.01mm and 0.2mm, preferably 0.02mm, so that the position of the vibration damping layer 22 can be well defined, and the radial dimension of the vibration damping layer 22 can be ensured, so as not to increase the friction resistance between the vibration damping layer 22 and the flexible shaft 21.

In other embodiments, the damping layer 22 may also be fixed to the inner sheath 23, for example, the distal end surface of the damping layer 22 is fixedly connected to the proximal end surface of the rear bearing housing 17, and the rear bearing housing 17 is fixed to the inner sheath 23; or both ends of the vibration damping layer 22 in the axial direction are respectively and directly fixedly connected with the inner sheath tube 23, thereby preventing the vibration damping layer 22 from following rotation along with the flexible shaft 21. The invention is not limited in this regard.

Referring to fig. 6, optionally, the flexible shaft 21 includes at least two winding layers 211 sequentially stacked from inside to outside, the winding layers 211 are formed by winding metal wires, and winding directions of the two adjacent winding layers 211 are opposite. When the wire is wound, it is substantially spiral. The winding direction refers to a spiral direction of a spiral shape. In the example shown in fig. 6, the winding direction of the winding layer 211 positioned at the inner side is inclined rightward, and conversely, the winding direction of the winding layer 211 positioned at the outer side is inclined leftward. Other embodiments may be understood with reference to this example. It will be appreciated that, for example, in a flexible shaft 21 including three winding layers 211, the winding direction of the winding layer 211 of the middle layer is inclined leftward, and the winding directions of the winding layers 211 on the inner and outer sides are inclined rightward. Preferably, the inner part of the innermost winding layer 211 forms a channel which is penetrated along the axial direction, so that on one hand, a guide wire or perfusate can conveniently pass through, and on the other hand, the flexible shaft 21 has better flexibility, and good aortic arch passing performance is realized; at least two winding layers 211 ensure the strength and the hardness of the flexible shaft 21, ensure enough transmission torque to drive the impeller 13 to rotate, and achieve the function of pumping blood. In addition, compared with a solid structure, the design of the hollow structure greatly reduces the weight of the flexible shaft 21 while providing flexibility, reduces the power consumption of the external motor and improves the transmission efficiency. Alternatively, the material used to wind the wire of the wrapping layer 211 may be selected from stainless steel or cobalt-chromium alloy, etc., such as stainless steel 316L or cobalt-chromium alloy L605, etc.

Referring to fig. 7a and 7b, in one embodiment, the vibration damping layer 22 is a spring tube including at least one spiral segment wound from a spring wire. The inventors have found that the pitch of the helical segment and the wire diameter of the spring wire will affect the friction performance, and in general the larger the pitch of the helical segment, the smaller the contact area with the flexible shaft 21, whereas the larger the pitch, the direct contact friction between the flexible shaft 21 and the inner sheath 23 will be caused, affecting the performance. Therefore, the selection of the thread pitch and the thread diameter is balanced to obtain better effect. In a preferred embodiment, the pitch of the helical section is 0.5mm to 4mm, preferably 2mm; the wire diameter of the spring wire is 0.05 mm-0.5 mm, preferably 0.25mm. Such a configuration can minimize frictional heat generation and reduce vibration. In the embodiment shown in fig. 7a, the spring tube comprises only one helical segment. In the embodiment shown in fig. 7b, the spring tube comprises two helical segments. Further, when the spring tube comprises at least two of the helical segments, the helical directions of at least two of the helical segments are opposite. As shown in fig. 7b, the spring tube comprises two spiral sections formed by winding two spring wires respectively, the spiral directions of the two spiral sections are opposite, and the two spiral sections are wound in an intersecting manner to form a shape similar to a braiding structure. It will be appreciated that if the spring tube includes a greater number of helical segments, it is only necessary to ensure that the helical directions of at least two of the helical segments are opposite.

Alternatively, the spring wire may be round wire, oval wire or flat wire, for example, wound and formed. Fig. 7a shows a spring tube wound from one spring wire, and fig. 7b shows a spring tube wound from two spring wires. It will be appreciated that in other embodiments, the spring tube may also include a greater number of spring wires. The spring wire of the vibration reduction layer 22 forms point contact or line contact with the flexible shaft 21, so that the friction area with the flexible shaft 21 is greatly reduced, and friction and heat generated by friction are reduced. Alternatively, the material used to wind the spring wire of the spring tube may be selected from stainless steel or cobalt chrome, etc., such as stainless steel 316L or cobalt chrome L605, etc.

Referring to fig. 7c, in another embodiment, the vibration reduction layer 22 is a cut mesh tube or a woven mesh tube, and the cut mesh tube or the woven mesh tube can be stretched in a radial direction. The cutting net pipe is a pipe which is formed by processing, carving or cutting a complete pipe, and is of an integrated structure, and the integrity of the pipe is better than that of the spring pipe. For example, in the example shown in fig. 7c, the cut mesh tube is cut into a diamond mesh shape, and the wall thickness of the tube before cutting is in the range of 0.05mm to 0.4mm, preferably 0.15mm; the width of each wire after cutting is about 0.1mm to 0.3mm, preferably 0.15mm; it should be noted that fig. 7c is only an exemplary embodiment of the cutting tube and is not a limitation of the cutting hollow manner of the cutting tube, and those skilled in the art may select other hollow cutting shapes of the cutting mesh tube according to the prior art. The woven mesh tube refers to a mesh tube woven from wires, including but not limited to shape memory wires. The diameter width of each wire is about 0.1mm to 0.3mm, preferably 0.15mm.

Optionally, a first cavity is formed between the inner sheath 23 and the outer sheath 25, and the first cavity is used for circulating a first perfusion fluid; the interior of the inner sheath 23 forms a second cavity for the flow of a second perfusate. The first perfusate and the second perfusate may be, for example, physiological saline, dextrose, or heparin solutions, and the first perfusate and the second perfusate may be the same or different. The function is as follows:

(1) The continuous perfusion can prevent blood from flowing into the sheath tube to coagulate;

(2) The first perfusion liquid can be used as a heat conduction medium to disperse and take away heat generated by friction between the flexible shaft 21 and the vibration reduction layer 22; the flexible shaft 21 and the vibration reduction layer 22 are integrally immersed in a second perfusion liquid which can be used as a heat conduction medium to disperse and take away heat generated by friction between the flexible shaft 21 and the vibration reduction layer 22;

(3) The first perfusion liquid and the second perfusion liquid can be used as isolation liquid, so that vibration is reduced and transferred to blood, and the vibration-proof effect is achieved.

So configured, the double-channel perfusion can greatly reduce friction and vibration generated during the operation of the flexible shaft 21, disperse and take away heat generated by friction, reduce the damage to blood during the operation of the interventional blood pump, and improve the reliability and stability of the operation of the interventional blood pump.

Optionally, the surface of the flexible shaft 21 and/or the vibration reduction layer 22 is provided with a barrier coating. The surface of the flexible shaft 21 and the surface of the vibration reduction layer 22 refer to all surfaces of the flexible shaft 21 and the vibration reduction layer 22, and the flexible shaft 21 and the vibration reduction layer 22 may be soaked by perfusate in use, so that the barrier coating can reduce direct contact between perfusate and metal materials, and the whole interventional blood pump system has better biocompatibility. Alternatively, the barrier coating may be a fluorine-containing coating, for example.

Referring to fig. 9, optionally, the outer sheath 25 includes an inner layer 253, an intermediate layer 253, and an outer layer 251 sequentially stacked, and the intermediate layer 252 is a woven and/or wound spring tube layer. In an alternative example, inner layer 253 is a film of a fluorine-containing material such as PTFE or FEP; outer layer 251 is PEBAX or PA material, and the three layers of inner layer 253, middle layer 253 and outer layer 251 are bonded together by a reflow process.

Optionally, the middle layer 252 includes a braided section and a winding section, the braided section being a braided (i.e., staggered in opposite winding directions) spring tube section that is primarily used in portions of the abdominal aorta and the outside body during operation, the braided section being advantageous for improved delivery. The winding section is a spring tube section formed by winding (sequentially arranged according to a single winding direction), is mainly applied to the part of the aortic arch in work, is beneficial to improving the passing performance, is convenient to pass through the curved aortic arch part, and can enable the distal end of the outer sheath tube 25 not to be broken easily. Preferably, the length of the woven section is 50mm to 80mm, preferably 70mm. The length of the winding section is 20mm to 40mm, preferably 25mm.

Optionally, in one example, the drive delivery assembly 20 further includes a hemostatic valve 26, the hemostatic valve 26 being coupled to the proximal end of the outer sheath 25, such as by being bonded to the proximal end of the outer sheath 25. The inner sheath 23 extends through the hemostatic valve 26. Further, the hemostasis valve 26 includes a hemostasis valve base 261, a seal 262, and a hemostasis valve front end 263, the hemostasis valve base 261 and the hemostasis valve front end 263 are connected by threads, and the two are sealed by the seal 262. The front end 263 of the hemostatic valve is provided with a first inlet and outlet 264 communicated with the first cavity, and in the working process, the first perfusion liquid can be infused into the first cavity between the inner sheath 23 and the outer sheath 25 through the first inlet and outlet 264, so that the first perfusion liquid can circulate into blood through the first cavity to play a role in vibration reduction and temperature reduction.

Optionally, the transmission conveying assembly 20 further includes a handle base 27, the handle base 27 is connected to the proximal end of the inner sheath 23, the handle base 27 includes a base front end 271 and a base rear end 272, the base front end 271 has a second inlet/outlet 273 that is communicated with the second cavity, and during operation, the second cavity may be filled with the second filling liquid through the second inlet/outlet 273. The base rear end 272 primarily serves as a seal.

An interventional blood pump system provided by an embodiment of the present invention comprises an interventional blood pump 10 and a transmission delivery assembly 20 as described above, wherein the interventional blood pump 10 is connected with a distal end of the transmission delivery assembly 20. Since the interventional blood pump system includes the drive delivery assembly 20 as described above, it also provides the benefits provided by the drive delivery assembly 20. The structure and principles of the other components of the interventional blood pump system are referred to in the prior art, and the present invention is not described in detail.

In summary, in the transmission conveying assembly and the intervention type blood pump system provided by the invention, the transmission conveying assembly comprises a flexible shaft, a vibration reduction layer and a sheath tube which are sequentially arranged from inside to outside; the vibration reduction layer is provided with a hollow-out part which penetrates through in the radial direction, the inner diameter of the vibration reduction layer is matched with the outer diameter of the flexible shaft, and the flexible shaft is rotatably arranged around the axis of the flexible shaft; the flexible shaft is arranged at intervals with the sheath tube through the vibration reduction layer. So configured, the vibration damping layer changes the overall vibration mode of the transmission conveying assembly, effectively reduces the vibration and friction of the transmission conveying assembly, and reduces the damage to blood cells. Furthermore, the flexible shaft is separated from the sheath tube through the vibration reduction layer, and the contact surface of the vibration reduction layer relative to the flexible shaft is smaller, so that the heat generated by friction can be effectively reduced, and the damage to blood cells is further reduced.

It should be noted that the above embodiments may be combined with each other. The above description is only illustrative of the preferred embodiments of the present invention and is not intended to limit the scope of the present invention, and any alterations and modifications made by those skilled in the art based on the above disclosure shall fall within the scope of the appended claims.

Claims (11)

1. A drive-transfer assembly for an interventional blood pump system, comprising: the flexible shaft, the vibration reduction layer and the sheath tube are sequentially arranged from inside to outside;

the vibration reduction layer is provided with a hollow-out part which penetrates through in the radial direction, the inner diameter of the vibration reduction layer is matched with the outer diameter of the flexible shaft, and the flexible shaft is rotatably arranged around the axis of the flexible shaft; the flexible shaft is arranged at intervals with the sheath tube through the vibration reduction layer.

2. The drive transmission assembly of claim 1, wherein the sheath comprises an inner sheath, the drive transmission assembly further comprising a rear bearing sleeve disposed at a distal end of the inner sheath, the rear bearing sleeve configured to abut or couple with a distal face of the vibration dampening layer to limit distal movement of the vibration dampening layer relative to the inner sheath.

3. A drive transfer assembly as in claim 1, wherein the damping layer is rotatably disposed about its own axis for following rotation as the flexible shaft rotates.

4. The drive transmission assembly of claim 1, wherein the vibration reduction layer is a spring tube comprising at least one helical segment wound from a spring wire, the helical segment having a pitch of 0.5mm to 4mm, and the spring wire having a wire diameter of 0.05mm to 0.5mm.

5. The drive transfer assembly of claim 4, wherein the spring tube comprises at least two helical segments, wherein the helical directions of at least two helical segments are opposite.

6. The drive transmission assembly of claim 1, wherein the vibration reduction layer is a cut mesh tube or a woven mesh tube.

7. The drive delivery assembly of claim 1, wherein the sheath comprises an inner sheath and an outer sheath axially movable relative to each other from inside to outside, the inner sheath and the outer sheath defining a first lumen therebetween for passage of a first perfusate; the interior of the inner sheath tube forms a second cavity which is used for circulating a second perfusion fluid.

8. The drive transfer assembly of claim 1, wherein the flexible shaft and/or the surface of the vibration damping layer has a barrier coating.

9. The drive transfer assembly of claim 1, wherein the sheath comprises an outer sheath comprising an inner layer, an intermediate layer and an outer layer laminated in sequence, the intermediate layer being a braided and/or wound spring tube layer.

10. The transmission conveying assembly according to claim 1, wherein the flexible shaft comprises at least two winding layers which are sequentially overlapped from inside to outside, the winding layers are formed by winding metal wires, and the winding directions of the two adjacent winding layers are opposite.

11. An interventional blood pump system comprising an interventional blood pump and a drive transmission assembly according to any one of claims 1-10, said interventional blood pump being connected to a distal end of said drive transmission assembly.