CN117244170A

CN117244170A - Delivery assembly and interventional blood pump system

Info

Publication number: CN117244170A
Application number: CN202210653679.9A
Authority: CN
Inventors: 谢超宇; 李剑青; 张振江; 卢飞; 李俊菲
Original assignee: Minimally Invasive Investment Holdings Ltd
Current assignee: Minimally Invasive Investment Holdings Ltd
Priority date: 2022-06-09
Filing date: 2022-06-09
Publication date: 2023-12-19

Abstract

The present invention provides a delivery assembly and an interventional blood pump system, the delivery assembly comprising: an outer sheath, an inner sheath, a blocking assembly and a transmission member; the outer sheath tube is provided with a lumen, the inner sheath tube is movably penetrated in the lumen along the axial direction, and the distal end of the inner sheath tube is used for being connected with the interventional blood pump; the blocking component is arranged on the outer sheath tube and/or the inner sheath tube; the occlusion assembly has an occluded state and an unblocked state; when the blocking component is in the blocking state, the blocking component is propped against the inner sheath tube to seal a gap between the outer sheath tube and the inner sheath tube; unblocking the gap while the occlusion assembly is in the unblocked state to allow the interventional blood pump to be retracted into the outer sheath; the transmission piece is arranged in the gap in an axially movable mode, the distal end of the transmission piece is connected with the blocking assembly, and the transmission piece is used for moving in the axial direction so as to drive the blocking assembly to switch between the dredging state and the blocking state.

Description

Delivery assembly and interventional blood pump system

Technical Field

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

Background

Short-term transvalvular blood pumps are mainly used for emergency treatment of cardiogenic shock and for assisted circulation during high-risk PCI surgery. The heart valve is arranged on an aortic valve, can provide flow support of up to 4L/min, so that the heart pump function is replaced, the life of a patient suffering from cardiogenic shock 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 pump head of the blood pump is made of a contractile material, enters the heart through a catheter sheath, is unfolded and fixed on an aortic valve after reaching the position, and achieves the blood pumping function. The power of the blood pump is provided by an external driving device and is connected with the pump head through a flexible shaft. The blood pump has at least two tube-sheath structures, an inner sheath and an outer sheath. The inner sheath is used for wrapping the flexible shaft so as to prevent the flexible shaft rotating at high speed from contacting with the outside during working; the outer sheath is arranged outside the inner sheath and can move back and forth to perform contraction and expansion operations on the pump head. In order to retract the pump head, a gap is required between the inner sheath and the outer sheath. Thus, the existing short-term transvalve blood pump has a certain disadvantage that blood can enter into the gap between the inner sheath and the outer sheath, and thrombus can be formed due to the fact that the blood does not flow for a long time or is influenced by the high temperature of the inner sheath.

Disclosure of Invention

The invention aims to provide a conveying component and an interventional blood pump system so as to solve the problem that thrombus is easy to form in the existing interventional blood pump.

To solve the above technical problem, the present invention provides a delivery assembly for an interventional blood pump system, the delivery assembly comprising: an outer sheath, an inner sheath, a blocking assembly and a transmission member;

the outer sheath tube is provided with a lumen, the inner sheath tube is movably penetrated in the lumen along the axial direction, and the distal end of the inner sheath tube is used for being connected with the interventional blood pump;

the occlusion assembly is disposed on one of the outer sheath and the inner sheath; the occlusion assembly has an occluded state and an unblocked state; when the blocking component is in the blocking state, the blocking component is abutted against the other of the outer sheath tube and the inner sheath tube to seal a gap between the outer sheath tube and the inner sheath tube; releasing abutment and closing of the gap when the occlusion assembly is in the unblocked state to allow the interventional blood pump to be received into the outer sheath;

the transmission piece is arranged in the gap in an axially movable mode, the distal end of the transmission piece is connected with the blocking assembly, and the transmission piece is used for moving in the axial direction so as to drive the blocking assembly to switch between the dredging state and the blocking state.

Optionally, the blocking assembly includes an opening and closing member having a ring shape around the circumference of the inner sheath, the opening and closing member having a first end and a second end opposite to each other in an axial direction, the first end being a free end and being connected to the transmission member; the second end is connected to one of the outer sheath and the inner sheath;

the first end is radially distal from the other of the outer sheath and the inner sheath when the occlusion assembly is in the occluded state; the first end radially abuts the other of the outer sheath and the inner sheath when the occlusion assembly is in the occluded state.

Optionally, the second end is connected to a distal end portion of the outer sheath, and the opening and closing member is in a flared shape expanding toward the distal end when the blocking assembly is in the unblocked state.

Optionally, the opening and closing member is provided with a plurality of skirt petals which are circumferentially arranged, when the blocking assembly is in the dredging state, triangular notches are formed between the adjacent skirt petals, and one corner of each triangular notch faces the second end; when the blocking assembly is in the blocking state, the adjacent skirt petals are adjacent to each other.

Optionally, the blocking assembly includes a moving member, a first sealing member, and a fixing member sequentially arranged along an axial direction; the moving part is axially movable and connected with the transmission part; the first sealing piece is annular around the inner sheath tube, and the fixing piece is fixedly connected with one of the outer sheath tube and the inner sheath tube; when the blocking assembly is in the blocking state, the moving part moves towards the fixed part under the drive of the transmission part, and the first sealing part is extruded so that the first sealing part expands radially to be abutted against the other of the outer sheath pipe and the inner sheath pipe.

Optionally, the driving medium includes many traction wires that extend along the axial, remove the piece with the mounting is all encircleed the interior sheath pipe is annular, the mounting with first sealing member has a plurality of through-going passageway of following the axial, every through-going passageway supplies one traction wire movably wears to establish.

Optionally, the first seal is an elastomer.

Optionally, the blocking component has self-resetting property, and is in the dredging state or the blocking state when no external force is applied; when the transmission piece moves along the axial direction, the state of the blocking assembly is driven to be changed by overcoming the self-resetting property of the blocking assembly.

Optionally, the transmission member includes a plurality of traction wires extending along an axial direction, and the plurality of traction wires are circumferentially arranged around the inner sheath; one end of the blocking component is connected with a plurality of traction wires, and the other end of the blocking component is connected with the outer sheath tube or the inner sheath tube.

Optionally, the conveying assembly further comprises a base and a driving wire, wherein the distal end of the driving wire is connected with the traction wire, and the proximal end of the driving wire is fixed on the base; the base is provided with a platform section, and the driving wires are arranged at intervals with the platform section along the radial direction; the drive wire is configured to drive the traction wire to move proximally when pressed by an external force toward the platform segment.

Optionally, the delivery assembly further comprises a pressing assembly for pressing the drive wire to move the drive wire towards the platform segment.

Optionally, the platform section extends along the axial, the drive wire with the axial of platform section is arranged at an angle, the base has along the axial screw thread section of arranging, the extrusion subassembly with screw thread section passes through the screw thread adaptation to be connected, the extrusion subassembly includes the briquetting, the briquetting is used for the extrusion the drive wire, the extrusion subassembly is through rotating around the screw thread section and realize along axial removal, in order to drive the drive wire orientation the platform section removes.

Optionally, the base is provided with a driving wire hole, the driving wire hole is used for the driving wire to pass through, and one end of the driving wire hole is communicated with the gap; the base also comprises a sealing table, the extrusion assembly moves between an initial position and a pressing position along the axial direction, and the driving wire is extruded in the process of moving the extrusion assembly from the initial position to the pressing position so as to enable the blocking assembly to be switched from the dredging state to the blocking state; and when the extrusion assembly is positioned at the pressing position, the extrusion assembly is abutted against the sealing table so as to seal the other end of the driving wire hole.

Optionally, the base is provided with an accommodating hole penetrating along the axial direction, the inner sheath tube is penetrated in the accommodating hole, a cavity is formed between the inner sheath tube and the hole wall of the accommodating hole at intervals, and the gap is communicated with the cavity; the delivery assembly further includes a second seal member that is annular about the inner sheath, and the compression assembly further compresses the second seal member during movement from the initial position to the compressed position such that the second seal member radially expands to seal the proximal end of the lumen.

In order to solve the technical problems, the invention also provides an interventional blood pump system which comprises a transmission flexible shaft, a foldable interventional blood pump and the conveying component, wherein the transmission flexible shaft is movably arranged in the inner sheath tube in a penetrating way, and the far end of the transmission flexible shaft is connected with the interventional blood pump.

In summary, in the delivery assembly and the interventional blood pump system provided by the present invention, the delivery assembly includes: an outer sheath, an inner sheath, a blocking assembly and a transmission member; the outer sheath tube is provided with a lumen, the inner sheath tube is movably penetrated in the lumen along the axial direction, and the distal end of the inner sheath tube is used for being connected with the interventional blood pump; the blocking component is arranged on the outer sheath tube and/or the inner sheath tube; the occlusion assembly has an occluded state and an unblocked state; when the blocking component is in the blocking state, the blocking component is propped against the inner sheath tube to seal a gap between the outer sheath tube and the inner sheath tube; unblocking the gap while the occlusion assembly is in the unblocked state to allow the interventional blood pump to be retracted into the outer sheath; the transmission piece is arranged in the gap in an axially movable mode, the distal end of the transmission piece is connected with the blocking assembly, and the transmission piece is used for moving in the axial direction so as to drive the blocking assembly to switch between the dredging state and the blocking state.

So dispose, can change the state of blocking the subassembly through the driving medium, when blocking the subassembly and being in the mediation state, do not influence the folding income pipe of intervention blood pump, when blocking the subassembly and being in the blocking state, can effectively block the clearance that blood got into between inner sheath pipe and the outer sheath pipe, prevent the formation of thrombus.

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 in accordance with the present invention;

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

FIG. 4 is a schematic illustration of an occlusion assembly in an occluded state according to an embodiment of the present invention;

FIG. 5 is an axial cross-sectional view of an occlusion assembly of an embodiment of the present invention in an occluded state;

FIG. 6 is a schematic view of an occlusion assembly in an occluded state according to an embodiment of the present invention;

FIGS. 7 a-7 c are schematic illustrations of different forms of pleats formed when a first end of a different number of pull wire actuated shutters is closed in accordance with an embodiment of the present invention;

FIGS. 8a and 8b are schematic views of an opening and closing member having a skirt according to an embodiment of the present invention;

FIG. 9 is a schematic view of a base and drive wire of an embodiment of the present invention;

FIG. 10 is an axial cross-sectional view of the base and drive wire shown in FIG. 9;

FIG. 11 is a schematic view of the drive wire of FIG. 10 being pressed by an external force to move toward a platform segment;

FIG. 12 is a schematic view of the base and drive wire of FIG. 9 mated with a compression assembly, wherein the compression assembly is in an initial position;

FIG. 13 is a schematic view of the compression assembly of FIG. 12 distally advanced with the compression assembly in a press-fit position;

fig. 14 is a schematic view of a blocking assembly according to another embodiment of the present invention in a unblocked state;

FIG. 15 is an axial cross-sectional view of a blocking assembly according to another embodiment of the present invention in a unblocked state;

FIG. 16 is an axial cross-sectional view of a blocking assembly according to another embodiment of the present invention in a blocked state;

FIG. 17 is a schematic view of a base, drive wire and compression assembly in accordance with another 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; 20-a transport assembly; 200-gap; 21-a transmission flexible shaft; 22-an inner sheath; 23-an outer sheath; a 24-occlusion assembly; 241—an shutter; 2411-a first end; 2412-a second end; 2413-leak; 2414-a skirt; 2415-triangular notch; 242-moving member; 243-a first seal; 244-fixing piece; 245-arranging a channel in a penetrating way; 25-a transmission member; 251-drawing wire; 26-a base; 261-platform section; 262-thread segments; 263-driving a wire hole; 264-sealing table; 2641-sealing rings; 265-receiving holes; 266-blind hole; 267-side injection holes; 27-driving wires; 28-an extrusion assembly; 281-branch; 282-flaps; 283-briquetting; 29-a second seal; 30-drive assembly.

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 limited to "first," "second," "third," or "third" may explicitly or implicitly include one or at least two such features, with "one end" and "another end" and "proximal" and "distal" 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 system 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 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 conveying component 20, a transmission flexible shaft 21 and a driving component 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 delivery assembly 20 and the transmission flexible shaft 21, and the driving assembly 30 drives the impeller of the interventional blood pump 10 to act through the transmission flexible shaft 21. 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 or other components for monitoring and controlling 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 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 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 driven (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. 2, in an exemplary embodiment, 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 the like, and the delivery assembly 20 includes an inner sheath 22 and an outer sheath 23. 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 impeller 13 can be made of flexible materials such as silica gel or rubber, and the basket covering film 14 can be coated on the outer wall of the skeleton main body of the basket 13 through thermal shrinkage or dip coating and other processes. The runner membrane 15 may be made of a flexible polymer film, and the runner membrane 15 may be connected to the basket covering membrane 14 at a distal end and the inner sheath tube 22 at a proximal end by thermal shrinkage or thermal melting, so as to form a passage through which blood is pumped out of the basket 13. The proximal end of the basket 12 is assembled on the distal end of the inner sheath tube 22, the transmission flexible shaft 21 is rotatably arranged in the inner sheath tube 22 in a penetrating way, the distal end of the transmission flexible shaft 21 is connected with the impeller 13, the proximal end of the transmission flexible shaft 21 is connected with the driving component 30, the driving component 30 can transmit power to the impeller 13 through the transmission flexible shaft 21, the impeller 13, the basket 12 and the runner membrane 15 form an axial flow pump structure, the impeller 13 rotates to generate suction force, and blood is pumped to the ascending aorta 01 from the left ventricle 03 through the aortic valve 02.

The components of the basket 12, the impeller 13, the basket membrane 14, the runner membrane 15 and the like can be radially contracted or folded. The outer sheath 23 is movable axially relative to the inner sheath 22, and when the interventional blood pump 10 is loaded or is ready to be withdrawn after the operation is completed, the outer sheath 23 is moved distally to radially constrain the various collapsible components of the interventional blood pump 10 so that the outer diameter of the interventional blood pump 10 is contracted to be no greater than the inner diameter of the outer sheath 23 and fully received into the outer sheath 23, completing the collapsed receiving. The outer sheath 23 is used to constrain the radial expansion of the interventional blood pump 10 and is used to deliver the interventional blood pump 10 to a target site, and the inventors have found that due to the presence of the flow path membrane 15, there is a gap between the inner sheath 22 and the outer sheath 23 at least in part so that the flow path membrane 15 can be folded and accommodated therein. If the gap is not plugged, blood enters the gap during the interventional use of the interventional blood pump 10, and thrombus is formed due to the problems of no flow for a long time, high temperature of the inner sheath tube 22 (the transmission flexible shaft 21 rotates at a high speed during use, and certain friction with the inner sheath tube 22 causes temperature rise), and the like, so that the safety of an operation is affected.

Based on the above-mentioned study, please refer to fig. 4 to 13 in combination with fig. 1, a delivery assembly 20 is provided according to an embodiment of the present invention, which is used for an interventional blood pump system, the delivery assembly 20 includes: an outer sheath 23, an inner sheath 22, a blocking assembly 24 and a transmission 25; the outer sheath 23 has a lumen, the inner sheath 22 is movably arranged in the lumen in an axial direction, and the distal end of the inner sheath 22 is used for being connected with the interventional blood pump 10; it should be noted that, the axial direction refers to the direction in which the central axis of the entire conveying assembly 20 is located, and in practice, the conveying assembly 20 may bend, and the axial direction also bends accordingly. For example, in the state shown in fig. 1, the conveying assembly 20 is disposed in a horizontal direction, and then its axial direction is the horizontal direction of fig. 1, and otherwise can be understood with reference to fig. 1.

The occlusion assembly 24 is disposed on one of the outer sheath 23 and the inner sheath 22; the occlusion assembly 24 has an occluded state and an unblocked state; when the occlusion means 24 is in the occluded state, the gap 200 between the outer sheath 23 and the inner sheath 22 is closed by abutting against the other of the outer sheath 23 and the inner sheath 22; with the occlusion assembly 24 in the unblocked state, the abutment and closure of the gap 200 are released to allow the interventional blood pump 10 to be received into the outer sheath 23; the transmission member 25 is movably disposed in the gap 200 along the axial direction, the distal end of the transmission member 25 is connected with the blocking assembly 24, and the transmission member 25 is used for moving along the axial direction to drive the blocking assembly 24 to switch between the dredging state and the blocking state. So configured, the state of the occlusion assembly 24 can be changed by the transmission member 25, when the occlusion assembly 24 is in the dredging state, the insertion of the interventional blood pump 10 into the tube is not affected, and when the occlusion assembly 24 is in the occluding state, blood can be effectively prevented from entering the gap 200 between the inner sheath 22 and the outer sheath 23, and thrombus formation is prevented.

Referring to fig. 4-6, in an exemplary embodiment, the occlusion assembly 24 includes an opening and closing member 241 that is annular about the circumference of the inner sheath 22, the opening and closing member 241 having axially opposed first and second ends 2411, 2412, the first end 2411 being a free end and being coupled to the transmission member 25. In this example, the driver 25 includes a plurality of axially extending traction wires 251, and the second end 2412 is coupled to the distal end of the outer sheath 23. Here, the first end 2411 is connected to the traction wire 251, and the traction wire 251 is fixed to a region of the first end 2411, and is not limited to the end face of the first end 2411, but the traction wire 251 may be fixed to an inner side wall of the shutter 241 near the first end 2411. Thus, the first end 2411 may expand or contract under the drive of the traction wire 251. When the occlusion assembly 24 is in the occluded state, the first end 2411 expands radially away from the inner sheath 22, and the entire shutter 241 has a flared shape expanding distally, at which point the shutter 241 allows the interventional blood pump 10 to be folded and received into the outer sheath 23. Further, the opening angle of the flared shape of the opening and closing member 241 may be selected to be between 30 ° and 45 °, and is preferably larger than the proximal angle of the basket 12, so that the interventional blood pump 10 can be smoothly folded into the outer sheath 23, and the resistance of the edge of the outer sheath 23 to the interventional blood pump 10 is reduced. When the interventional blood pump 10 is stored, the outer sheath 23 is pushed distally, and the position of the inner sheath 22 is maintained, so that the interventional blood pump 10 can be folded and stored in the outer sheath 23.

As shown in fig. 5 and 6, when the pull wire 251 is pulled proximally, the first end 2411 of the shutter 241 will be pulled to move proximally while collapsing radially inwardly closed until abutting the inner sheath 22, thereby closing the gap 200 between the inner sheath 22 and the outer sheath 23, with the occlusion assembly 24 in an occluded state, preventing blood from entering the gap 200. It should be noted that, in the example shown in fig. 4 to 6, the shutter 241 is annularly disposed at the distal end portion of the outer sheath 23 and extends distally, and after the inner sheath 22 penetrates the outer sheath 23, it should be understood that the gap 200 also extends distally to the distal end portion of the shutter 241 correspondingly, and at this time, a portion of the pulling wire 251 extends distally out of the distal end portion of the outer sheath 23 and into the inside of the shutter 241, but still is considered to be penetrated in the gap 200.

In the above examples shown in fig. 4 to 6, the second end 2412 of the shutter 241 is connected to the outer sheath 23 (i.e., the blocking component 24 is disposed on the outer sheath 23), it will be appreciated that in other embodiments, the second end 2412 of the shutter 241 may be connected to the outer peripheral wall of the inner sheath 22 (i.e., the blocking component 24 is disposed on the inner sheath 22), and the first end 2411 is disposed in the gap 200. The first end 2411 can be expanded against the inner wall of the outer sheath 23 under the drive of the pulling wire 251, closing the gap 200, while the occlusion assembly is in an occluded state; the first end 2411 may also be radially inwardly contracted to form a space with the outer sheath 23, exposing the gap 200 to allow the interventional blood pump 10 to be received into the outer sheath 23, with the occlusion assembly in an occluded state. In particular, the flaring of the shutter 241 is not limited to being flared distally as shown in fig. 4 to 6, but may be flared proximally, and in the case where the shutter 241 is connected to the inner sheath 22, the flaring of the flaring is particularly preferably configured to be flared proximally, and thus the configuration effectively reduces the resistance of the shutter 241 to the interventional blood pump 10 when the interventional blood pump 10 is received in the outer sheath 23.

Preferably, the blocking assembly 24 has a self-resetting property, and the blocking assembly 24 is in the unblocked state or the blocked state when no external force is applied; when the transmission member 25 moves in the axial direction, the state of the blocking assembly 24 is driven against the self-resetting property of the blocking assembly 24 to be changed. It should be noted that, when not subjected to external force, the blocking assembly 24 may be in a unblocked state or a blocked state. And the state of the blocking assembly 24 is changed by the movement of the transmission member 25. After the driving force to the driving member 25 is removed, the state of the blocking assembly 24 is restored to the original state under the action of the self-resetting property. For example, in the example shown in fig. 4 to 6, the blocking assembly 24 is in the unblocked state when not subjected to an external force, and the blocking assembly 24 is changed to the blocked state by pulling the pulling wire 251. After the driving force to the traction wire 251 is removed, the blocking assembly 24 is restored to the original dredging state under the self-resetting effect. In other embodiments, such as those wherein the shutter 241 is attached to the inner sheath 22, the flared flare of the shutter 241 is configured to expand proximally when the occlusion assembly 24 is in an occluded state when not subjected to an external force, with the first end 2411 of the shutter 241 abutting against the inner wall of the outer sheath 23 to close the gap 200. Under the pulling of the pull wire 251, the occlusion assembly 24 will change to the occluded state. Upon removal of the driving force to the pull wire 251, the occluding component 24 will return to its original occluding state under the influence of the self-resetting nature. The self-resettability of the blocking assembly 24 may be achieved by the properties of the material itself, for example, the shutter 241 is made of a material having elasticity, which has a certain deformability, for example, silica gel or rubber, etc. In other embodiments, the opening and closing member 241 may be configured to be self-resetting by an additional potential energy member, for example, a reed, a magnetic member, or other potential energy members may be additionally provided to enable the opening and closing member 241 to be in a specific state when no external force is applied. This may be configured by those skilled in the art based on the actual implementation.

Optionally, the transmission member 25 includes a plurality of traction wires 251 extending in an axial direction, and the plurality of traction wires 251 are circumferentially arranged around the inner sheath 22, preferably uniformly circumferentially distributed; one end of the blocking assembly 24 is connected to the plurality of traction wires 251, and the other end of the blocking assembly 24 is connected to the outer sheath 23 or the inner sheath 22. Generally, the pulling wire 251 is used to transmit pulling force, but not pushing force, and the self-resetting occlusion assembly 24 can be used to repeatedly change the state of the occlusion assembly 24. In other embodiments, the transmission member 25 is not limited to include the traction wire 251, but may include a transmission tube or a stiffer wire within the gap 200, which may be used to transmit not only tensile forces but also pushing forces, at which time the blocking assembly 24 may not have a self-resetting nature, and may be fully passively changed in state upon actuation of the transmission member 25.

Referring to fig. 7a to 7c, when the first end 2411 of the shutter 241 is pulled by the pulling wire 251 to deform, the portion near the connection point of the shutter 241 and the pulling wire 251 will deform first, shrink towards the center and cling to the inner sheath 22, and the portion far from the connection point will deform less, possibly still maintaining its original shape, so that wrinkles will be formed. As shown in fig. 7a, when the number of the pulling wires 251 is 4, the wrinkles are more remarkable, the leak 2413 between the first end 2411 of the shutter 241 and the inner sheath 22 is more remarkable, and the gap 200 is not tightly sealed. As shown in fig. 7b, when the number of the traction wires 251 is 6, the number of the leaks 2413 increases but the area becomes smaller. As shown in fig. 7c, when the number of the traction wires 251 is sufficiently large, the inner surface of the first end 2411 of the shutter 241 may be completely adhered to the inner sheath 22 to realize sealing without the existence of the slit 2413, and at this time, the outer contour of the first end 2411 of the shutter 241 may still have some insignificant wrinkles, but does not affect the closing of the gap 200 and does not affect the use. It will be appreciated that the number of traction wires 251 is preferably greater than 6. Of course, if the transmission member 25 is a transmission tube, the first end 2411 of the shutter 241 can be continuously and uniformly forced in the circumferential direction, so that the gap 200 can be sealed more tightly.

Referring to fig. 8a and 8b, in another example, the shutter 241 has a plurality of circumferentially arranged skirt segments 2414, when the blocking assembly 24 is in the unblocked state (as shown in fig. 8 a), a triangular notch 2415 is formed between adjacent skirt segments 2414, and a corner of the triangular notch 2415 faces the second end 2412; when the occlusion assembly 24 is in the occluded state (as shown in fig. 8 b), adjacent ones of the skirt petals 2414 abut against each other. When the opening and closing piece 241 is closed, the skirt petals 2414 can be mutually abutted, and at the moment, the opening and closing piece 241 cannot form folds, so that the generation of a leak 2413 is avoided, and the risk of blood leakage is avoided. It will be appreciated that when the occlusion assembly 24 is in the open position, the triangular notch 2415 should be an isosceles triangle with its base at the first end 2411 of the shutter 241 and its apex angle toward the second end 2412, the size of the triangular notch 2415 and the angle of the apex angle being adapted to the number of skirting segments 2414 and the configuration of the shutter 241 when closed. Preferably, the skirt petals 2414 are in one-to-one correspondence with the traction wires 251.

Referring to fig. 9 to 13, the delivery assembly 20 further includes a base 26 and a driving wire 27, the base 26 is connected to the proximal end of the outer sheath 23, the distal end of the driving wire 27 is connected to the traction wire 251, and the proximal end of the driving wire 27 is fixed on the base 26; the base 26 has a platform section 261, and the driving wires 27 are radially spaced from the platform section 261; the drive wire 27 is configured to drive the traction wire 251 proximally when pressed by an external force to move toward the platform segment 261. In one example, the driving wire 27 and the pulling wire 251 may be integrally formed, and the wire diameters and materials of the two may be the same, and in fact the same wire may be divided into different sections. In the example shown in fig. 9-13, the platform 261 is an axially extending segment, and the drive wire 27 extends radially outwardly from the proximal end of the pull wire 251, and turns to extend proximally, radially spaced from the platform 261 as it passes over the platform 261. As shown in FIG. 10, upon compression by an external force, the drive wire 27 moves toward the platform segment 261, which will exert a pulling force on the pull wire 251, thereby driving the distally located occlusion assembly 24 to change state.

As shown in fig. 11 and 12, the delivery assembly 20 preferably further includes a pressing assembly 28, the pressing assembly 28 being configured to press the drive wire 27 to move the drive wire 27 toward the platform segment 261. In some embodiments, the compression assembly 28 is removably coupled to the base 26, and the compression assembly 28, when assembled to the base 26, may compress the drive wire 27 to move the pull wire 251 proximally. In other embodiments, the compression assembly 28 may be an additional attachment device without being connected to the base 26, as the invention is not limited in this regard.

Referring to fig. 11, 12 and 13, in one example, the platform 261 extends axially, the driving wire 27 is disposed at an angle to the axial direction of the platform 261, the base 26 has a threaded section 262 disposed axially, the pressing assembly 28 is connected to the threaded section 262 by a threaded fit, the pressing assembly 28 includes a pressing block 283, the pressing assembly 28 is configured to press the driving wire 27, and the pressing assembly 28 is configured to move axially by rotating around the threaded section 262 to drive the driving wire 27 toward the platform 261, such that the driving wire 27 applies a pulling force to the pulling wire 251 to drive the distally located blocking assembly 24 to change the state. In the example shown in fig. 12 and 13, the drive wire 27 is angled inwardly from the distal end to the proximal end, while the platform segment 261 remains axially extended, with the drive wire 27 being angularly spaced from the platform segment 261. The pressing assembly 28, when rotated, may move distally, where the press blocks 283 gradually press the drive wire 27, causing the drive wire 27 to move toward the platform segment 261 and pull the pull wire 251. It will be appreciated that upon counter-rotation of the compression assembly 28, the compression assembly 28 moves proximally and the press block 283 progressively un-compresses the drive wire 27, the occlusion assembly 24 returns to its original state from its self-healing state and the drive wire 27 is returned to a straightened state by the pull wire 251.

Optionally, the base 26 has a driving wire hole 263, the driving wire hole 263 is penetrated by the driving wire 27, and one end of the driving wire hole 263 is communicated with the gap 200; the base 26 further includes a sealing table 264, the pressing assembly 28 moves axially between an initial position (as shown in fig. 12) and a press-fit position (as shown in fig. 13), and the driving wire 27 is pressed during the pressing assembly 28 moves from the initial position to the press-fit position, so that the blocking assembly 24 is switched from the unblocking state to the blocking state; and, when the pressing assembly 28 is at the pressing position, it abuts against the sealing table 264 to seal the other end of the driving wire hole 263. In the example shown in fig. 12 and 13, the base 26 has a receiving hole 265 penetrating in an axial direction, the inner sheath 22 is inserted into the receiving hole 265, the inner sheath 22 and a wall of the receiving hole 265 are spaced to form a cavity, and the gap 200 is communicated with the cavity; one end of the driving wire hole 263 is arranged on the cavity, and the other end extends along the radial direction and turns to open to the proximal end. A sealing land 264 is disposed at the distal end of the land 261 in the form of an annulus about the axis of the base 26. Optionally, the sealing table 264 has an annular sealing ring 2641, and the sealing ring 2641 is made of a sealing material having elasticity, such as silica gel, etc. It will be appreciated that during the interventional procedure, the occlusion assembly 24 is in the occluded state and the distal end of the gap 200 is in the open state, where there is a significant amount of blood entering the gap 200 and oozing out the other end of the drive wire hole 263. When the intervention operation is finished, the other end of the driving wire hole 263 can be sealed by abutting the extrusion assembly 28 and the sealing table 264, so that the problem that blood seeps out from the other end of the driving wire hole 263 is solved.

Optionally, the delivery assembly 20 further comprises a second seal 29, the second seal 29 being annular around the inner sheath 22, and the compression assembly 28 further compresses the second seal 29 during movement from the initial position to the compressed position such that the second seal 29 radially expands to seal the proximal end of the lumen. The lumen between the inner sheath 22 and the wall of the receiving bore 265 is also in communication with the gap 200, as shown in fig. 10, and in some embodiments, the proximal end of the lumen may also be exuded if left unsealed. In one exemplary embodiment, the proximal end of the base 26 also has a blind bore 266 open toward the proximal end, the distal bottom surface of the blind bore 266 being in communication with the receiving bore 265, the compression assembly 28 including a branch 281, the branch 281 being insertable into the blind bore 266. The outer circumference of the second seal 29 abuts against the inner wall of the blind hole 266, and the distal end of the second seal 29 abuts against the distal bottom surface of the blind hole 266, so that the branch 281 will push against the proximal side of the second seal 29 during distal movement of the branch 281 with the compression assembly 28, and the second seal 29 will only expand inwardly due to the outer circumference being limited by the inner wall of the blind hole 266, i.e. will abut tightly against the outer wall of the inner sheath 22 to form a seal, closing the proximal end of the lumen. Further, the second sealing member 29 can also hold the inner sheath tube 22 and the base 26 tightly after abutting against the inner sheath tube 22, and the outer sheath tube 23 and the base 26 can be fixed relative to the inner sheath tube 22 due to the existence of friction force, so as to prevent the outer sheath tube 23 and the base 26 from moving during use.

It will be appreciated that the second seal 29 is made of a resilient sealing material, such as silicone or the like. Optionally, to conform to the shape of the second seal 29, the branch 281 may be connected to the second seal 29 by a flap 282. So configured, three functions are achieved in moving the compression assembly 28 from the initial position to the press-fit position, one to drive the distal occlusion assembly 24 from the open position to the occluded position, the other to close the other end of the drive wire hole 263, and the third to close the proximal end of the lumen. Optionally, the base 26 further has a bypass injection hole 267, and the bypass injection hole 267 communicates with the receiving hole 265. It will be appreciated that since the distal end of the gap 200 is open during the interventional procedure, more blood is present in the gap 200 after the interventional procedure has ended. At this time, the pressing assembly 28 is moved to the pressing position to close the other end of the driving wire hole 263 and the proximal end of the closed cavity, and a one-way valve is formed after the opening and closing member 241 is closed, which can effectively prevent blood from entering the gap 200, but at this time, a perfusion fluid such as heparinized physiological saline or glucose is injected through the bypass injection hole 267, and when the injection pressure is increased to a certain extent, the perfusion fluid can push the opening and closing member 241 to flow out from the opening and closing member 241, and then the perfusion fluid flows out from the opening and closing member 241 together with the blood flowing into the gap 200. After a certain amount of perfusion liquid is poured, the blood is washed clean, and the whole pipeline can be sealed by closing the washing liquid.

Referring to fig. 14 to 16, in another embodiment, the blocking assembly 24 includes a moving member 242, a first sealing member 243, and a fixing member 244 sequentially arranged along an axial direction; the moving member 242 is axially movable and connected to the plurality of traction wires 251; the first sealing member 243 is annular around the inner sheath 22, and the fixing member 244 is fixedly connected with one of the outer sheath 23 and the inner sheath 22; when the occlusion assembly 24 is in the occluded state, the moving member 242 is driven by the pulling wire 251 to move in the direction of the fixed member 244, and the first sealing member 243 is pressed so that the first sealing member 243 expands radially to abut against the other of the outer sheath 23 and the inner sheath 22.

In the example shown in fig. 15 and 16, the fixing member 244 is fixed to the inner sheath 22, and in particular, the fixing member 244 is fixed to the outer wall of the inner sheath 22. The first seal 243 is located at the distal end of the fixed member 244, and the moving member 242 is located at the distal end of the first seal 243. Optionally, the moving member 242 and the fixing member 244 each have a ring shape around the inner sheath 22, and the fixing member 244 and the first sealing member 243 have a plurality of penetrating channels 245 penetrating axially, and each penetrating channel 245 is provided for one of the traction wires 251 to movably penetrate. It will be appreciated that the securing members 244 are in one-to-one and in through-alignment with the through passages 245 of the first sealing member 243. The traction wire 251 is fixed to the mover 242 after passing through the penetrating passage 245 of the fixing member 244 and the first sealing member 243. So configured, when the pull wire 251 is pulled proximally, the mover 242 will be driven to move proximally to compress the first sealing member 243, and on the other hand, the first sealing member 243 will expand radially outwardly due to the blocking by the stator 244, as shown in fig. 16, after being compressed and expanded, the first sealing member 243 abuts against the inner wall of the outer sheath 23, and the blocking assembly is in a blocked state, thereby sealing the gap 200. Optionally, the first seal 243 is self-resetting, e.g., elastic, and after the pulling force on the pull wire 251 is removed, the first seal 243 is resiliently returned to a spaced apart position from the outer sheath 23, with the occlusion assembly in a clear position, exposing the gap 200 to allow the interventional blood pump 10 to be retracted into the outer sheath 23. It will be appreciated that the securing member 244 is not limited to being secured to the inner sheath 22, and in other embodiments, the securing member 244 may be secured to the inner wall of the outer sheath 23, such that the first seal 243 will expand radially inwardly when compressed against the outer wall of the inner sheath 22, as may be accomplished to seal the gap 200. In addition, the moving member 242, the first sealing member 243 and the fixing member 244 are not limited to being sequentially arranged from the distal end to the proximal end, and the three may be arranged from the proximal end to the distal end, where the moving member 242 at the proximal end may be connected to a transmission tube or a relatively hard wire, for example, and can move towards the distal end under the action of a pushing force, so as to press the first sealing member 243. It is understood that the penetrating channel 245 is not required to be formed on the moving member 242 and the first sealing member 243. In other embodiments, the first sealing member 243 may be in an expanded state when not subjected to an external force, for example, in the case where the fixing member 244 is fixed to the inner sheath 22, the first sealing member 243 may abut against the inner wall of the outer sheath 23 to seal the gap 200 when not subjected to an external force. The distal end of the first seal 243 is connected to the stationary member 244, the proximal end of the first seal 243 is connected to the movable member 242, and the movable member 242 is connected to the pull wire 251, at which time pulling the pull wire 251 proximally will axially stretch the first seal 243, thereby reducing the radial dimension of the first seal 243 and thereby spacing the inner wall of the outer sheath 23, exposing the gap 200 to allow the interventional blood pump 10 to be received within the outer sheath 23. Optionally, the first seal 243 is an elastomer, a material of this type that deforms significantly under external stress and returns to its original state and size quickly after the stress is removed. In some embodiments, the first seal 243 may be, for example, a silicone rubber elastomer, a polyurethane elastomer, a polyolefin elastomer, an SBS elastomer, or the like. Preferably, the material hardness of the first seal 243 should be between 30A and 60A, with a stress at 100% strain ranging from 100psi to 200psi. It will be appreciated that the materials of the second seal 29, the shutter 241, and the seal 2641 described above may also refer to and use the same or similar materials as the first seal 243.

Referring to fig. 17, another embodiment of the engagement of the base 26, drive wire 27 and compression assembly 28 is shown, in which the base 26 is fixedly mounted to the inner sheath 22. The distal end of the drive wire 27 is connected to the proximal end of the traction wire 251, and the proximal end of the drive wire 27 is secured to the base 26. Likewise, base 26 includes an axially extending platform segment 261 with drive wire 27 disposed at an angle to platform segment 261 and compression assembly 28 includes a press block 283 with compression assembly 28 movably mounted to base 26 by threads. When the squeezing component 28 is rotated, axial displacement is generated relative to the base 26, and the pressing block 283 is pushed to squeeze the driving wire 27, so that the pulling wire 251 is pulled, and the blocking component 24 can be switched from the dredging state to the blocking state. When the extrusion assembly 28 rotates reversely, the traction wire 251 moves distally under the elastic force of the first sealing member 243, so that the driving wire 27 is gradually straightened.

Based on the above-mentioned delivery assembly 20, the embodiment of the present invention further provides an interventional blood pump system, which comprises a transmission flexible shaft 21, a foldable interventional blood pump 10 and the above-mentioned delivery assembly 20, wherein the transmission flexible shaft 21 is movably arranged in the inner sheath tube 22, and the distal end of the transmission flexible shaft 21 is connected with the interventional blood pump 10. The specific structure and principles of the drive flexible shaft 21 and the interventional blood pump 10 will be understood by those skilled in the art from the prior art, and the present invention will not be described.

In summary, in the delivery assembly and the interventional blood pump system provided by the present invention, the delivery assembly includes: an outer sheath, an inner sheath, a blocking assembly and a transmission member; the outer sheath tube is provided with a lumen, the inner sheath tube is movably penetrated in the lumen along the axial direction, and the distal end of the inner sheath tube is used for being connected with the interventional blood pump; the blocking component is arranged on the outer sheath tube and/or the inner sheath tube; the occlusion assembly has an occluded state and an unblocked state; when the blocking component is in the blocking state, the blocking component is propped against the inner sheath tube to seal a gap between the outer sheath tube and the inner sheath tube; unblocking the gap while the occlusion assembly is in the unblocked state to allow the interventional blood pump to be retracted into the outer sheath; the transmission piece is arranged in the gap in an axially movable mode, the distal end of the transmission piece is connected with the blocking assembly, and the transmission piece is used for moving in the axial direction so as to drive the blocking assembly to switch between the dredging state and the blocking state. So dispose, can change the state of blocking the subassembly through the driving medium, when blocking the subassembly and being in the mediation state, do not influence the folding income pipe of intervention blood pump, when blocking the subassembly and being in the blocking state, can effectively block the clearance that blood got into between inner sheath pipe and the outer sheath pipe, prevent the formation of thrombus.

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

1. A delivery assembly for an interventional blood pump system, comprising: an outer sheath, an inner sheath, a blocking assembly and a transmission member;

2. The delivery assembly of claim 1, wherein the occlusion assembly comprises an open-close member in the shape of a ring circumferentially around the inner sheath, the open-close member having axially opposed first and second ends, the first end being a free end and being coupled to the transmission member; the second end is connected to one of the outer sheath and the inner sheath;

3. The delivery assembly of claim 2, wherein the second end is coupled to the distal end of the outer sheath, and wherein the occluding component is flared distally when in the occluding state.

4. A delivery assembly as claimed in claim 3, wherein the shutter has a plurality of circumferentially arranged skirts, and wherein when the occlusion assembly is in the unblocked state, triangular notches are formed between adjacent skirts, a corner of the triangular notches being oriented toward the second end; when the blocking assembly is in the blocking state, the adjacent skirt petals are adjacent to each other.

5. The delivery assembly of claim 1, wherein the occlusion assembly comprises a moving member, a first sealing member, and a stationary member arranged in sequence along an axial direction; the moving part is axially movable and connected with the transmission part; the first sealing piece is annular around the inner sheath tube, and the fixing piece is fixedly connected with one of the outer sheath tube and the inner sheath tube; when the blocking assembly is in the blocking state, the moving part moves towards the fixed part under the drive of the transmission part, and the first sealing part is extruded so that the first sealing part expands radially to be abutted against the other of the outer sheath pipe and the inner sheath pipe.

6. The delivery assembly of claim 5, wherein the transmission member comprises a plurality of axially extending traction wires, the moving member and the fixed member each being annular about the inner sheath, the fixed member and the first seal member having a plurality of axially extending through passages, each of the through passages being configured to be movably threaded by one of the traction wires.

7. The delivery assembly of claim 5, wherein the first seal is an elastomer.

8. The delivery assembly of claim 1, wherein the occlusion assembly is self-resetting, the occlusion assembly being in the open state or the occluded state when not subjected to an external force; when the transmission piece moves along the axial direction, the state of the blocking assembly is driven to be changed by overcoming the self-resetting property of the blocking assembly.

9. The delivery assembly of claim 1 or 8, wherein the transmission member comprises a plurality of axially extending traction wires circumferentially arranged around the inner sheath; one end of the blocking component is connected with a plurality of traction wires, and the other end of the blocking component is connected with the outer sheath tube or the inner sheath tube.

10. The delivery assembly of claim 9, further comprising a base and a drive wire, a distal end of the drive wire being coupled to the traction wire, a proximal end of the drive wire being secured to the base; the base is provided with a platform section, and the driving wires are arranged at intervals with the platform section along the radial direction; the drive wire is configured to drive the traction wire to move proximally when pressed by an external force toward the platform segment.

11. The delivery assembly of claim 10, further comprising a squeeze assembly for squeezing the drive wire to move the drive wire toward the platform segment.

12. The delivery assembly of claim 11, wherein the platform section extends axially, the drive wire is disposed at an angle to the axial direction of the platform section, the base has an axially disposed threaded section, the compression assembly is threadably coupled to the threaded section, the compression assembly includes a press block for compressing the drive wire, and the compression assembly effects movement in the axial direction by rotation about the threaded section to urge the drive wire toward the platform section.

13. The delivery assembly of claim 11, wherein the base has a drive wire bore through which the drive wire passes, and wherein one end of the drive wire bore is in communication with the gap; the base also comprises a sealing table, the extrusion assembly moves between an initial position and a pressing position along the axial direction, and the driving wire is extruded in the process of moving the extrusion assembly from the initial position to the pressing position so as to enable the blocking assembly to be switched from the dredging state to the blocking state; and when the extrusion assembly is positioned at the pressing position, the extrusion assembly is abutted against the sealing table so as to seal the other end of the driving wire hole.

14. The delivery assembly of claim 13, wherein the base has an axially-extending receiving bore, the inner sheath being disposed through the receiving bore, the inner sheath being spaced from a bore wall of the receiving bore to form a cavity, the gap being in communication with the cavity; the delivery assembly further includes a second seal member that is annular about the inner sheath, and the compression assembly further compresses the second seal member during movement from the initial position to the compressed position such that the second seal member radially expands to seal the proximal end of the lumen.

15. An interventional blood pump system comprising a transmission flexible shaft, a collapsible interventional blood pump and a delivery assembly according to any one of claims 1-14, said transmission flexible shaft being movably threaded into said inner sheath, a distal end of said transmission flexible shaft being connected to said interventional blood pump.