CN115708925A

CN115708925A - Blood pumping catheter and blood pump device

Info

Publication number: CN115708925A
Application number: CN202110970869.9A
Authority: CN
Inventors: 唐智荣; 赵贤忠
Original assignee: Forqaly Medical Shanghai Co ltd
Current assignee: Forqaly Medical Shanghai Co ltd
Priority date: 2021-08-23
Filing date: 2021-08-23
Publication date: 2023-02-24

Abstract

The invention discloses a blood pumping duct and a blood pump device, wherein the blood pumping duct comprises a front leading-in pipe, a suction channel, a connecting hose and an outflow channel which are sequentially connected, the front leading-in pipe is used for guiding the duct to enter a human blood vessel or a heart, the front leading-in pipe is provided with a butting part which protrudes along the radial direction, the radial dimension of the butting part when in implantation configuration is smaller than or equal to the outer diameter dimension of the connecting hose, and the radial dimension of the butting part after implantation is the maximum radial dimension of the front leading-in pipe. The blood pumping catheter and the blood pump device provided by the invention can solve the problem that the inner wall of a blood vessel or the inner wall of a heart is easily scratched when the device enters the blood vessel or the heart, and avoid the problem that blood is blocked due to the adherence of a suction channel, so that thrombus or hemolysis is easily formed.

Description

Blood pumping catheter and blood pump device

Technical Field

The invention relates to a medical apparatus, in particular to a blood pumping catheter and a blood pump device.

Background

Blood pump devices are a type of circulatory assist device that can be classified as an intracardiac or intravascular blood pump, based on the location, that can be percutaneously or surgically implanted in the patient's heart or vascular system (e.g., vein or artery) to assist in the removal of blood from the left or right side of the heart. Blood pump devices of this type generally comprise a rotor or impeller, which can form a passage for the inflow and outflow of blood, and a conduit located outside the rotor or impeller, which can be applied by mechanical or, for example, magnetic connection and drive.

When the blood pump device enters a blood vessel or a heart, the size difference between the inner wall of the blood vessel and the heart caused by the individual difference of a human body and the displacement of a catheter caused by the beating of the heart possibly cause the catheter to be excessively close to the inner wall of the blood vessel and the heart, so that the inner wall of the blood vessel and the inner wall of the heart are scratched to form thrombus, and hemolysis and other adverse conditions caused by too narrow blood inflow channel are urgently needed to be improved.

Disclosure of Invention

The technical problem to be solved by the invention is to provide a blood pumping catheter and a blood pump device, which can solve the problem that the inner wall of a blood vessel or the inner wall of a heart is easy to scratch when the device enters the blood vessel or the heart, and avoid the problem that thrombus or hemolysis is easy to form due to blood blockage caused by the wall adhesion of a suction channel.

The present invention has been made to solve the above problems, and an aspect of the present invention is to provide a blood-pumping catheter including a front introduction tube, a suction channel, a connection tube, and an outflow channel, which are connected in this order, the front introduction tube being configured to guide a catheter into a blood vessel or a heart of a human body, wherein the front introduction tube has an abutment portion protruding in a radial direction, a radial dimension of the abutment portion when in an implantation configuration is smaller than an outer diameter dimension of the connection tube, and a radial dimension of the abutment portion after completion of implantation is a maximum radial dimension of the front introduction tube.

In the blood pumping catheter, the abutting part is a protruding sphere, and the outer diameter of any cross section of the sphere is smaller than or equal to the outer diameter of the connection hose.

In the blood pumping catheter, the spheroid is a self-expanding spheroid.

In the blood pump catheter, the abutment portion is a pre-curled front end disk formed by extending the distal end of the front introduction tube in the axial direction.

In the blood pump catheter, the front end disc is in a straightened state under the action of the guide wire or the guide sheath when the front end disc is in the implantation configuration, and is restored to be in a disc shape after the guide wire or the guide sheath is withdrawn, and the outer diameter of the restored disc is the maximum outer diameter of the front introduction tube.

In the blood pumping catheter, a plane on which the front end disk is located is substantially perpendicular to a central axis of the straight pipe portion of the front introduction pipe, which is not bent.

In the blood pumping catheter, the abutting portion is a spiral structure formed by extending the end of the front introducing tube in the axial direction.

In the blood pumping catheter, the spiral body structure is in a straightened state under the action of the guide wire or the guide sheath when in implantation configuration, and is restored to be in a spiral body after the guide wire or the guide sheath is withdrawn, and the outer diameter of the restored spiral body is the maximum outer diameter of the front introducing pipe.

In the blood pumping catheter, a central axis of the spiral structure substantially coincides with a central axis of the straight pipe portion of the front introduction pipe, which is not bent.

In the above blood pumping catheter, the front end disc or the spiral structure at least includes a hard portion and a flexible portion made of two different materials, the hard portion is connected to the connection hose, and the flexible portion is connected to the hard portion.

In the above blood pumping catheter, the abutting portion includes a plurality of metal wires distributed along the circumferential direction of the anterior introduction tube, and the plurality of metal wires are bunched together in the guide sheath tube when being implanted and configured, and are spread apart from the guide sheath tube in an umbrella shape after being implanted.

In the blood pumping catheter, the metal wire is made of memory alloy.

In the blood pumping catheter described above, when the blood pumping catheter is an expandable catheter pump, the ratio of the outer diameter of the abutment portion of the front introduction tube to the maximum outer diameter of the expanded connection tube is 1.5:1-2.5:1.

the invention also provides a blood pump device for solving the technical problems, which comprises a pump and a driving part, wherein the pump and the driving part are connected through a flexible transmission structure, the pump comprises an impeller and a conduit positioned outside the impeller, and the conduit is the blood pumping conduit.

Compared with the prior art, the invention has the following beneficial effects: according to the blood pump catheter and the blood pump device, the front introducing pipe is provided with the abutting part protruding along the radial direction, and when the blood pump catheter enters a specified position of a heart or a blood vessel, the abutting part structure can abut against a muscle group or the inner wall of the blood vessel in the heart in advance, so that a certain distance is kept between the suction channel and the heart or the inner wall of the blood vessel, and the problem of thrombosis or hemolysis caused by blood blockage due to adherence of the suction channel is avoided.

Drawings

FIG. 1 is a schematic view of a conventional blood pumping catheter;

FIG. 2 is a schematic view of the position of the blood-pumping catheter into the heart;

FIG. 3 is a schematic view of the position of the blood pumping catheter into the blood vessel;

FIG. 4 is a schematic view of the adherent state of the pump catheter entering the blood vessel;

FIG. 5 is a schematic view of a first blood pumping catheter according to the present invention;

FIG. 6 is a schematic view of the pump catheter of FIG. 5 in a position to enter the heart;

FIG. 7 is a schematic diagram of the adherence caused by the absence of a spheroid entering the heart in the prior art blood pumping catheter;

FIG. 8 is a schematic view of the bulb of the blood-pumping catheter of FIG. 5 in contact with the interior wall of the heart; (ii) a

FIG. 9 is a schematic view of a second blood-pumping catheter according to the present invention;

FIG. 10 is a schematic view of the pump catheter of FIG. 9 in a position to enter the heart;

FIG. 11 is a schematic view of a third blood pumping catheter according to the present invention;

FIG. 12 is a schematic view of the pump catheter of FIG. 11 in a position to enter the heart;

FIG. 13 is a schematic view showing a configuration in which an abutting portion of a fourth blood pumping tube according to the present invention is closed;

FIG. 14 is a schematic structural view showing a state in which an abutment portion of a fourth blood pumping catheter of the present invention is developed;

fig. 15 is a schematic view of the pump catheter of fig. 13 in position for entry into the heart.

In the figure:

1 front part leading-in pipe 2 suction channel 3 connecting hose

4 outflow channel 5 spheroid 6 front end disc

7 spiral body 8 guiding sheath 9 metal wire

Detailed Description

The invention is further described below with reference to the figures and examples.

Taking an intracardiac blood pump device as an example, the blood pump device is a type of left heart or right ventricle auxiliary device and can help the human heart to pump more blood under abnormal conditions.

The pump part comprises an impeller and a conduit which is positioned outside the impeller, the conduit is structured as shown in figure 1, the lowest end of the whole conduit is a flexible front introducing pipe 1 which has the function of guiding the conduit into a human blood vessel or heart, and a suction channel 2, a connecting hose 3 and an outflow channel 4 are sequentially arranged behind the front introducing pipe, the conduit is basically positioned in the position state shown in figure 2 when entering the heart, and the position of inserting the conduit into the blood vessel is shown in figure 3. Due to the difference between the inner diameter of the blood vessel and the size of the heart caused by the individual difference of the human body and the displacement of the catheter caused by the pulsation of the heart, the suction channel may be excessively close to the inner walls of the heart and the artery, as shown in fig. 4, so that the inner walls of the heart and the artery are scratched to form thrombus, and hemolysis is caused by the excessively narrow blood flow channel.

This phenomenon can be observed very obviously in animal experiments, and obvious indentation and subcutaneous congestion exist on the ventricular wall corresponding to the suction channel of the catheter, which is caused by the fact that the suction channel adheres to the tissue. Once the suction channel 2 is attached to the wall, the negative pressure formed by the liquid flow sucks the tissue into the window to generate local subcutaneous blood stasis, and the scar formed by the blood stasis can cause arrhythmia; in addition, the inflow area is reduced after the adherence, and the flow velocity and the shearing force are increased, so that the occurrence of mechanical hemolysis is caused.

The invention provides a blood pumping catheter, wherein a front leading-in pipe 1 is provided with a butting part which protrudes along the radial direction, and the radial dimension of the butting part when in implantation configuration is less than or equal to the outer diameter dimension of a connecting hose 3, so as to avoid the influence on the implantation process caused by the increase of the whole outer diameter dimension of the catheter; the radial dimension of the abutment after implantation is greater than the outer diameter dimension of the anterior introducer tube 1, i.e., the radial dimension of the abutment after implantation is the maximum radial dimension of the anterior introducer tube 1. The outer diameter of the implanted abutting part can be smaller than that of the connecting hose 3 or larger than that of the connecting hose 3; if the pump blood line is adherent, the abutment with the largest radial outer diameter at the front introduction tube 1 can be in contact with the inner wall of the heart or blood vessel in advance, so that the rear suction channel 2 is kept at a certain distance from the inner wall of the heart or blood vessel.

Specifically, the front introducing tube 1 is a hollow tube, the lumen of which is communicated with the lumen of the connecting hose, and the catheter structure is suitable for being introduced into the human body by using a guide wire, and certainly, for some special application occasions, a guide sheath tube can be used for conveying the catheter into the human body.

The abutting part can be a sphere formed by the radial protrusion of the pipe diameter of the hollow pipe, so that the hollow pipe comprises sections with different diameters, and the abutting part can also be formed by the hollow pipe by coiling the hollow pipe along the hollow pipe to form a disc shape or a spiral shape, and the diameters of the hollow pipes can be selected to be the same or different.

The invention provides a blood pump device which comprises a pump and a driving part, wherein the pump and the driving part are connected through a flexible transmission structure, the pump comprises an impeller and a conduit positioned outside the impeller, and the conduit is the blood pumping conduit.

The impeller may be configured in an incompressible, fixed shape configuration or in an expandable configuration, either of which may be suitable for use in the pumping catheter described above.

The first embodiment of the present invention provides a blood-pumping catheter as shown in FIG. 5, in which a convex ball 5 is formed on the front introducing tube 1, and this ball 5 can be previously brought into contact with the inner wall of the heart or blood vessel, so that the suction channel 1 at the rear can be kept at a certain distance from the inner wall of the heart or blood vessel. The scheme is simple and easy to implement, but the catheter needs to be limited by the tearable sheath, and the outer diameter of any section on the catheter is not larger than that of the connecting hose 3, so that the outer diameter of the spheroid 5 is limited to a certain extent, and the outflow channel in the aortic vessel is not protected, so the scheme has certain limitation. In order to solve the problem of the limited outer diameter of the spherical body, the spherical body 5 is preferably a self-expanding spherical body, the material can be silica gel, and the radial dimension of the spherical body 5 before expansion is less than or equal to the outer diameter dimension of the connecting hose 3. The first scheme of the invention provides a state of the blood pumping catheter in the heart as shown in fig. 6, and the catheter may adhere to the wall because no spheroid exists in the original scheme as shown in fig. 7; with the presence of the protruding spheroids 5, the presence of the spheroids 5 keeps the suction channel 2 at a distance from the inner wall of the heart, as shown in figure 8.

The second aspect of the present invention provides a blood-pumping catheter as shown in FIG. 9, which is inserted into the heart as shown in FIG. 10. The front end of the front inlet pipe 1 is a pre-curled front end disc 6, which is formed by extending the end of the front inlet pipe 1 along the axial direction, the maximum outer diameter of the front inlet pipe can be larger than the maximum outer diameter of the guide pipe according to a certain proportion, and the diameter of the neutral circle of the front end disc 6 is recommended to be 8-12 mm, and is more suitable to be 9-11 mm.

The front end disc 6 at least comprises a hard part and a flexible part which are made of two different materials, the hard part is connected with the connecting hose, and the flexible part is connected with the hard part. The hard part is made of nylon, polyamide, block polyether amide and the like, and has certain supporting strength; the flexible part is made of elastic materials with good flexibility, such as silicon rubber, polyurethane, PTFE and the like.

In the process of inserting the catheter along the aorta blood vessel, the front end circular disc 6 is forced to be straightened due to the action of the guide wire, when the front part of the catheter enters a preset position, the guide wire is withdrawn, the front end circular disc 6 returns to a disc-shaped shape, and when the front end circular disc 6 is contacted with the heart or the inner wall of the blood vessel, the suction channel keeps a certain distance from the heart or the inner wall of the blood vessel.

For the expandable catheter pump, i.e. the impeller, configured as an expandable structure, the front end disk 6 may also be in a straightened state under the action of the guiding sheath, and after the guiding sheath is withdrawn, the front end disk 6 returns to a disk-shaped state. For the expandable pump body, the ratio of the outer diameter of the abutment at the front end thereof to the maximum outer diameter of the expanded connection hose is preferably 1.5-2.5 to 1, more preferably 1.8-2.2 to 1.

In a particular embodiment, the connection hose may alternatively be a collapsible and expandable pump housing made of a shape memory material or a suitable memory alloy in the shape of a lattice, which is formed with suction and outflow channels.

The plane of the front end circular disc 6 is approximately vertical to the central axis of the unbent straight pipe part of the front leading-in pipe 1, and the outer diameter of the front end circular disc 6 is the maximum outer diameter of the front leading-in pipe 1, so that when the blood pumping catheter adheres to the wall, the front end circular disc 6 can be attached to the inner wall of the heart or the blood vessel in advance, and the suction channel 2 is kept a certain distance from the inner wall of the heart or the blood vessel. A third aspect of the present invention provides a blood-pumping catheter as shown in FIG. 11, which is inserted into the heart as shown in FIG. 12. The shape of the front leading-in pipe at the most front position is a spiral body 7 which is formed by extending the tail end of the front leading-in pipe 1 along the axial direction, when the spiral body 7 is implanted and configured, the spiral body is in a straightening state under the action of a guide wire, and the spiral body is recovered after the guide wire is withdrawn, and the outer diameter of the recovered spiral body 7 is the maximum outer diameter of the front leading-in pipe 1.

Similarly, for an expandable catheter pump, the spiral 7 may also be straightened by the guiding sheath, and after the guiding sheath is withdrawn, the spiral 7 returns to the disk shape. The diameter of the neutral circle of the spiral body 7 is recommended to be 8-12 mm, and is more suitably 9-11 mm; the number of turns is 1-4 turns, preferably 1-3 turns.

The spiral body 7 at least comprises a hard part and a flexible part which are made of two different materials, the hard part is connected with the connecting hose, and the flexible part is connected with the hard part. The hard part is made of nylon, polyamide, block polyether amide and the like, and has certain supporting strength; the flexible part is made of elastic materials with good flexibility, such as silicon rubber, polyurethane, PTFE and the like.

The catheter is inserted into the heart or artery by the same method of the third scheme, and the supporting function is more stable. The central axis of the spiral body 7 is approximately coincident with the central axis of the unbent straight pipe part of the front ingress pipe 1, and because the outer diameter of the spiral body 7 is the maximum outer diameter of the front ingress pipe 1, when the blood pumping conduit has the condition of adherence, the spiral body 7 can be ensured to be attached to the heart or the inner wall of the blood vessel in advance, so that the suction channel 2 keeps a certain distance from the heart or the inner wall of the blood vessel.

In the blood pumping catheter provided by the fourth aspect of the invention, a plurality of metal wires 9 are distributed on the periphery of the front guide tube 1 along the circumferential direction to form a protruding abutting part, the material is memory alloy, the scheme needs the help of a guide sheath tube when being inserted into a human blood vessel or heart, and the guide sheath tube 8 is in a bundle-shaped furled state, as shown in fig. 13; when the detachment guide sheath 8 is constrained and opened, it assumes an umbrella-shaped spread state, as shown in fig. 14. When the catheter is withdrawn after the work is finished, the guiding sheath 8 needs to be inserted again, the metal wire 9 is folded, and then the catheter is withdrawn; the situation in which the protocol is inserted into the heart is shown in figure 15. When the pump blood catheter is attached to the wall, the umbrella-shaped expanded multiple metal wires 9 can be attached to the inner wall of the heart or the blood vessel in advance, so that the suction channel 2 and the inner wall of the heart or the blood vessel keep a certain distance.

The blood pumping catheter of the above embodiment is located in a blood vessel, and when the blood pumping function is realized, the abutting part of the front introduction tube 1 abuts against the inner wall of the blood vessel, so that a certain fixing effect can be achieved, and the blood pumping catheter is beneficial to the stabilization and positioning in the blood vessel.

Although the present invention has been described with respect to the preferred embodiments, it will be understood by those skilled in the art that various changes in form and details may be made therein without departing from the spirit and scope of the invention as defined by the appended claims.

Claims

1. A blood-pumping duct comprising a front introducing tube, a suction passage, a connecting hose and an outflow passage connected in sequence, the front introducing tube being for introducing the duct into a blood vessel or heart of a human body, characterized in that the front introducing tube has an abutment portion projecting in a radial direction, the radial dimension of the abutment portion in an implanted configuration being equal to or smaller than the outer diameter dimension of the connecting hose, the radial dimension of the abutment portion after completion of implantation being the maximum radial dimension of the front introducing tube.

2. The blood-pumping catheter of claim 1, wherein the abutment is a raised bulb having an outer diameter at any cross-section that is equal to or less than the outer diameter of the connection tube.

3. The blood-pumping catheter of claim 2, wherein the spheroid is a self-expanding spheroid.

4. The blood-pumping catheter of claim 1, wherein the abutment is a pre-crimped leading end disk formed by extending the distal end of the leading introducer tube in the axial direction.

5. The blood-pumping catheter of claim 4, wherein the front end disk is straightened by the guide wire or guide sheath in the implanted configuration and returns to a disk shape after withdrawal of the guide wire or guide sheath, and the outer diameter of the recovered disk is the maximum outer diameter of the anterior introducer.

6. The blood-pumping catheter of claim 4, wherein the plane of the front end disk is substantially perpendicular to the central axis of the straight unbent tube portion of the front introducer tube.

7. The blood-pumping catheter of claim 1, wherein the abutment portion is a spiral structure formed by extending the distal end of the front introduction tube in the axial direction.

8. The blood-pumping catheter of claim 7, wherein the helical structure is straightened by the guide wire or guide sheath in the implanted configuration and returns to the helical shape after withdrawal of the guide wire or guide sheath, and the outer diameter of the returned helical structure is the maximum outer diameter of the anterior introducer.

9. The blood-pumping catheter of claim 7, wherein the central axis of the helical structure is substantially coincident with the central axis of the straight unbent portion of the front introducer tube.

10. The blood-pumping catheter of claim 4 or 7, wherein the front end disc or spiral structure comprises at least a hard portion and a flexible portion made of two different materials, the hard portion being connected to the connection hose, and the flexible portion being connected to the hard portion.

11. The blood-pumping catheter of claim 1, wherein the abutment comprises a plurality of wires distributed along the circumference of the anterior introducer sheath, the plurality of wires converging in a bundle within the introducer sheath in the implanted configuration and spreading in an umbrella shape after detachment from the introducer sheath after implantation.

12. The blood-pumping catheter of claim 11, wherein the wire is formed of a memory alloy.

13. The blood-pumping catheter according to claim 1, wherein when the blood-pumping catheter is an expandable catheter pump, the ratio of the outer diameter of the abutment portion of the front introduction tube to the maximum outer diameter of the connection tube after expansion is 1.5:1-2.5:1.

14. a blood pump device comprising a pump and a drive member connected by a flexible drive structure, the pump comprising an impeller and a conduit external to the impeller, wherein the conduit is a blood pumping conduit according to any of claims 1 to 13.