Vascular perfusion device

Abstract

The invention discloses a blood vessel perfusion device which comprises an inner catheter assembly used for perfusion, a supporting component arranged outside the inner catheter assembly in a sleeving mode and an outer sheath tube arranged outside the supporting component in a sleeving mode. The inner catheter assembly comprises an inner catheter, a plurality of perfusion holes communicated to a catheter cavity of the inner catheter are formed in the catheter wall of the far end side of the inner catheter, the supporting component comprises a middle sleeve and a supporting assembly connected to the far end of the middle sleeve, and the supporting assembly at least partially surrounds the peripheral sides of the perfusion holes. The supporting assembly has a contracted state in which the supporting assembly is contracted between the inner catheter and the outer sheath tube and an unfolded state in which the supporting assembly is separated from the outer sheath tube and is self-unfolded, and a gap exists between the supporting assembly in the unfolded state and the inner catheter; a passage which penetrates through the near-end end face and the far-end end face of the supporting assembly and allows blood flow to pass through is formed between the supporting assembly and the inner catheter. According to the blood vessel perfusion device, the risk caused by long-time blood vessel blockage is reduced, time is won for patients and doctors, and the efficiency is higher.

Description

Technical Field

[0001] The present invention relates to the technical field of interventional medical devices, and in particular to a vascular perfusion device. Background Art

[0002] Vascular diseases have become the leading cause of death in my country, and vascular embolism has become the main factor in vascular diseases. In particular, the total number of new cases of ischemic stroke, pulmonary embolism, and lower extremity venous embolism exceeds 100,000 per year.

[0003] Systemic anticoagulation therapy can only prevent the growth and spread of blood clots and prevent pulmonary embolism and recurrence of blood clots, but cannot dissolve blood clots, remove thrombotic substances on venous valves, or prevent embolic sequelae. Therefore, catheter-based thrombolysis has become the first choice for thrombus treatment, but existing thrombolytic devices are all directly perfused, which is not easy to operate in cases where blood clots are more serious, and the efficiency is low, and the thrombolytic effect is not good; in addition, the structure of existing perfusion devices is generally a catheter and a blocking guidewire to achieve blocking, which is complex in structure and prone to problems of loose blocking. Summary of the invention

[0004] The present invention provides a vascular perfusion device to solve at least part of the above technical problems.

[0005] In order to solve the above technical problems, the embodiment of the present invention provides and adopts the following technical solutions:

[0006] The present invention provides a blood vessel perfusion device, comprising an inner catheter assembly for perfusion, a support member sleeved outside the inner catheter assembly and an outer sheath tube sleeved outside the support member; the inner catheter assembly comprises an inner catheter, a tube wall on the distal side of the inner catheter is provided with a plurality of perfusion holes connected to the lumen of the inner catheter, the support member comprises a middle sleeve and a support assembly connected to the distal end of the middle sleeve, the support assembly is at least partially arranged around the outer circumference of the perfusion hole, the support assembly has a contracted state contracted between the inner catheter and the outer sheath tube and an expanded state self-expanded after being freed from the restraint of the outer sheath tube, a gap exists between the support assembly and the inner catheter in the expanded state, so that a passage for blood flow to pass through the proximal end face and the distal end face of the support assembly is formed between the support assembly and the inner catheter.

[0007] In one embodiment, the support assembly in the expanded state includes a radially expanded distal support disk and a proximal support disk, and a support member connecting the distal support disk and the proximal support disk, the proximal side of the proximal support disk is fixedly connected to the distal end of the middle sleeve, and the disk diameters of the proximal support disk and the distal support disk are larger than the maximum outer diameter of the support assembly.

[0008] In one of the embodiments, the distal support disk and the proximal support disk each include an inner disk surface and an outer disk surface that are connected, the inner disk surfaces of the distal support disk and the proximal support disk are respectively connected to the distal end and the proximal end of the support member, and the outer disk surface of the proximal support disk is fixedly connected to the middle sleeve; the middle sleeve can move axially relative to the inner catheter, and when the distal support disk and the proximal support disk move toward the proximal end relative to the inner catheter, the outer disk surface and the inner disk surface are gradually straightened from the radial extension in the expanded state to the axial extension state as the middle sleeve moves.

[0009] In one embodiment, an annular flow-blocking membrane is provided in the proximal support disk and / or the distal support disk. The inner edge of the flow-blocking membrane is provided with a predetermined distance from the outer wall of the inner catheter; and / or,

[0010] It also includes a pulling wire, the distal end of which is connected to the distal support plate and / or the proximal support plate, and the proximal end passes through one of the perfusion holes and extends along the lumen of the inner catheter to the proximal end of the vascular perfusion device.

[0011] In one embodiment, the support member includes a plurality of support rods, and the plurality of support rods are sequentially spaced around the circumference of the vascular perfusion device.

[0012] In one embodiment, the support member includes a distal connecting segment, a proximal connecting segment and an intermediate connecting segment connecting the distal connecting segment and the proximal connecting segment, and the intermediate connecting segment includes a plurality of radially protruding bending structures; and / or,

[0013] A cutting piece is provided on the outer side wall of the support piece. The cutting piece is arranged obliquely relative to the central axis of the vascular perfusion device, and the angle between the extending direction of the cutting piece and the central axis is an acute angle.

[0014] In one embodiment, a plurality of perfusion holes are provided, and a plurality of the perfusion holes are arranged in a plurality of groups along the axial direction of the inner catheter. The vascular perfusion device further comprises a blocking component sleeved outside the inner catheter, the blocking component comprising a sleeve and a connecting rod connected to the proximal end of the sleeve, the sleeve being driven by the connecting rod to be axially movable relative to the inner catheter, and the movable sleeve being able to selectively block or avoid at least one group of the perfusion holes.

[0015] In one of the embodiments, a blocking structure is further provided on the inner catheter, and the blocking structure includes a connecting hole provided on the inner catheter and connected to the lumen of the inner catheter, and the connecting hole is located between two adjacent groups of the perfusion holes. The blocking structure also includes a balloon provided on the inner catheter and covering the connecting hole, and the balloon surrounds the inner catheter. The balloon can be placed in the sleeve during the axial movement of the sleeve and abut against the inner wall of the sleeve in a filled state.

[0016] In one embodiment, the blocking structure is provided on the distal side and the proximal side of each group of the perfusion holes. When the sleeve covers a group of the perfusion holes, the balloons of the blocking structure on the distal side and the proximal side of the group of the perfusion holes are against the inner wall of the sleeve in a filled state.

[0017] In one embodiment, the proximal end of the connecting rod is fixedly connected to the distal end of the middle sleeve, or the proximal end of the connecting rod axially extends from the inner side of the middle sleeve to the proximal end of the vascular perfusion device.

[0018] In one embodiment, a limit portion for controlling the injection angle of the injection hole is provided at the edge of the orifice of the injection hole; and / or,

[0019] The distal end of the inner catheter is a closed structure, and the inner catheter assembly also includes an inner core connected to the distal end of the inner catheter and a tip connected to the distal end of the inner core, and coaxial and axially through guide wire holes are provided on the tip and on the tube wall of the inner catheter.

[0020] After the vascular perfusion device of the present invention passes through the thrombus embolism site, the outer sheath is withdrawn, the supporting structure is released and self-expanded, thereby squeezing the thrombus tissue to a certain extent, and at the same time forming a passage for blood circulation on the outer peripheral side of the inner catheter, and then further performing jet perfusion through the inner catheter assembly to directly perfuse high-concentration thrombolytic drugs around the thrombus tissue to dissolve the thrombus tissue; using the vascular perfusion device of the present invention, a blood passage can be established first, and then perfusion and thrombolysis can be performed, which reduces the risk of long-term blockage of the blood vessel, saves time for patients and doctors, and is more efficient; at the same time, the lumen at the distal end of the inner catheter assembly of the present invention is a closed structure, which does not need to be matched with a special blocking guide wire. Compared with the existing method that requires detachable matching with the blocking guide wire, the structure is simple and the blocking effect is more reliable. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] In order to more clearly illustrate the scheme of the present invention, the following briefly introduces the drawings required for the description of the embodiments. Obviously, the drawings described below are some embodiments of the present invention or corresponding prior art. For ordinary technicians in this field, other drawings can be obtained based on these drawings without creative work. Among them:

[0022] Figure 1 is an overall schematic diagram of an exemplary vascular perfusion device of the present invention, in which the support member is accommodated between the inner catheter assembly and the outer sheath;

[0023] Figure 2 yes Figure 1 A schematic diagram of the structure in which the outer sheath tube in the support structure moves backward so that the support assembly of the support structure is in a self-expanding expanded state;

[0024] Figure 3 is a partial stereoscopic schematic diagram of a support assembly in an exemplary vascular perfusion device of the present invention in a self-expanding expanded state;

[0025] Figure 4 yes Figure 3 A schematic diagram of a half-section structure of the accompanying drawing shown;

[0026] Figure 5 is a schematic structural diagram of an exemplary support assembly in a vascular perfusion device of the present invention when it is in a contracted state;

[0027] Figure 6 is a schematic structural diagram of an exemplary vascular perfusion device of the present invention when a pull wire is provided;

[0028] Figure 7 yes Figure 2 An enlarged schematic diagram of part A in FIG.

[0029] Figure 8 yes Figure 2 Another structural schematic diagram of the A part in FIG.

[0030] Fig. 9 is a partial three-dimensional schematic diagram of an inner catheter assembly of an exemplary vascular perfusion device of the present invention;

[0031] Fig.10 yes Figure 4 An enlarged schematic diagram of part B in FIG.

[0032] Fig.11 yes Figure 3 An enlarged schematic diagram of the C portion in FIG.

[0033] Fig.12 is a partial stereoscopic schematic diagram of an exemplary vascular perfusion device of the present invention when a limiting portion is provided;

[0034] Fig.13 is a schematic diagram of the three-dimensional structure of an exemplary vascular perfusion device of the present invention;

[0035] Figure 14(a) to Figure 14(d) It is a schematic diagram of the process of perfusion thrombolysis using an exemplary vascular perfusion device of the present invention. DETAILED DESCRIPTION

[0036] The technical solutions in the embodiments of the present invention will be described clearly and completely below in conjunction with the accompanying drawings. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0037] In the description of the present invention, it should be noted that the orientation or positional relationship indicated by the terms "upper", "lower", "inner", "outer", etc. is based on the orientation or positional relationship shown in the accompanying drawings, and is only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as a limitation of the present invention. In addition, the terms "first", "second", etc. are only used for descriptive purposes and cannot be understood as indicating or implying relative importance; when an element is referred to as "fixed to" or "disposed on" another element, the element may be directly connected to the other element, or indirectly connected to the other element through one or more connecting elements. When an element is referred to as being "connected to" another element, it may be directly connected to the other element, or connected to the other element through one or more connecting elements.

[0038] It should also be noted that in the field of interventional medical devices, the proximal end refers to the end closer to the operator, while the distal end refers to the end farther from the operator; the direction of the central axis of rotation of an object such as a cylinder or a tube is defined as the axial direction; the circumferential direction is the direction around the axis of an object such as a cylinder or a tube (perpendicular to the axis and perpendicular to the cross-sectional radius); the radial direction refers to the direction along the wire diameter or radius. It is worth noting that the "end" in the terms "proximal end", "distal end", "one end", "the other end", "first end", "second end", "initial end", "end", "two ends", "free end", "upper end", "lower end", etc. is not limited to the end, endpoint or end face, but also includes a portion extending from the end, endpoint, or end face on the element to which the end, endpoint, or end face belongs for an axial distance and / or radial distance. The above definitions are only for the convenience of expression and cannot be understood as limitations on the present invention.

[0039] See also Figure 1 and Figure 2The present invention exemplarily provides a vascular perfusion device 100, which includes an inner catheter assembly 10 for perfusion, a support member 20 sleeved outside the inner catheter, and an outer sheath tube 30 sleeved outside the support member 20. The sleeve described in the present invention can be a partial sleeve or a whole sleeve, and the specific sleeve range can be set according to actual needs. Among them, the support member 20 of this embodiment can be accommodated between the inner catheter assembly 10 and the outer sheath tube 30, and the outer sheath tube 30 can move axially relative to the support member 20 and the inner catheter assembly 10.

[0040] Please refer to Figure 1 to Figure 3As shown, specifically, the inner catheter assembly 10 includes an inner catheter 11, which is a hollow tubular structure. The distal end of the inner catheter 11 is a closed structure. A plurality of perfusion holes 111 connected to the tubular cavity of the inner catheter 11 are provided on the tube wall on the distal side of the inner catheter 11. The support member 20 includes a middle sleeve 21 and a support assembly 22 connected to the distal end of the middle sleeve 21. The support assembly 22 is at least partially arranged around the outer peripheral side of the perfusion hole 111. The support assembly 22 has a contracted state that can be contracted between the inner catheter 11 and the outer sheath 30 and an expanded state that is free from the restraint of the outer sheath 30 and expands by itself. There is a gap h between the support assembly 22 in the expanded state and the inner catheter 11, so that a passage S is formed between the support assembly 22 and the inner catheter 11, which passes through the proximal end face and the distal end face of the support assembly 22 and is available for blood flow to pass through. The support assembly 22 in this embodiment has shape memory characteristics, and the support assembly 22 has a preset extended shape in the natural state. The support assembly 22 can be woven by metal wire or cut by metal tube, and can further be made to have a preset extended shape through a heat setting process. The support member 20 can be accommodated between the inner catheter assembly 10 and the outer sheath tube 30. At this time, the support assembly 22 is constrained by the outer sheath tube 30 and is in a contracted state; the outer sheath tube 30 can move axially relative to the support member 20 and the inner catheter assembly 10. When the outer sheath tube 30 moves toward the proximal side relative to the support member 20, the support assembly 22 is freed from the constraint of the outer sheath tube 30 and presents a preset extended shape, which is now in an expanded state. In addition, it should be noted that there is a gap h between the support assembly 22 and the inner catheter 11 in the expanded state, and this gap h can have multiple different h values ​​due to the different peripheral expansion diameters when the support assembly 22 is expanded. After the vascular perfusion device of the present invention passes through the thrombus embolism site, the outer sheath is withdrawn, and the support structure 20 is released and self-expanded, thereby squeezing the thrombus tissue to a certain extent, and at the same time forming a passage for blood circulation on the outer peripheral side of the inner catheter, and then further performing jet perfusion through the inner catheter assembly to directly perfuse high-concentration thrombolytic drugs around the thrombus tissue to dissolve the thrombus tissue; the method of the present invention first establishes a blood pathway and then performs perfusion and thrombolysis, which reduces the risk of long-term blood vessel blockage and buys time for patients and doctors; at the same time, the lumen of the distal end of the inner catheter assembly of the present invention is a closed structure, which does not need to be matched with a special blocking guide wire. Compared with the existing method that requires detachable matching with the blocking guide wire, the structure is simple and the blocking effect is more reliable.

[0041] See also Figure 3The support assembly 22 in the expanded state includes a radially expanded distal support disc 221 and a proximal support disc 222, and a support member 223 connecting the distal support disc 221 and the proximal support disc 222. The proximal side of the proximal support disc 222 is fixedly connected to the distal end of the middle sleeve 21. The disc diameters of the proximal support disc 222 and the distal support disc 221 are larger than the maximum outer diameter of the support member 223, that is, the radially expanded outer diameters of the proximal support disc 222 and the distal support disc 221 are larger than the support member 223, and the proximal support disc 222 and the distal support disc 221 protrude radially relative to the support member 223. Under this structure, the self-expanded support member 223 squeezes the thrombus tissue located on its circumferential side, and the proximal side and the distal side of the support member 223 each form a blocking surface, so that the thrombus tissue can be collected and intercepted to prevent it from falling off and flowing to cause other risks, and at the same time, the perfusion thrombolysis effect can be improved. In this embodiment, the distal support disk 221 and the proximal support disk 222 are formed, and the inner side of each center of the distal support disk 221 and the proximal support disk 222 is provided with a channel for blood flow to pass through, and the channel is connected with the gap h between the self-expanding support member 223 and the inner catheter 11, and together form the passage S. The diameters of the distal support disk 221 and the proximal support disk 222 can be the same, or the diameter of the distal support disk 221 can be larger than that of the proximal support disk 222, or the diameter of the proximal support disk 222 can be larger than that of the distal support disk 221.

[0042] See also Figure 4 and Figure 5 As an implementation mode, the distal support disk 221 and the proximal support disk 222 each include an inner disk surface and an outer disk surface connected to each other. The inner disk surfaces of the distal support disk 221 and the proximal support disk 222 are respectively connected to the distal end and the proximal end of the support member 223, and the outer disk surface of the proximal support disk 222 is connected to the middle sleeve 21; the middle sleeve 21 can move axially relative to the inner catheter 11, and when the distal support disk 221 and the proximal support disk 222 move toward the proximal end relative to the inner catheter 11, the outer disk surface and the inner disk surface are gradually straightened from the radial extension in the expanded state to the axial extension state as the middle sleeve 21 moves. Figure 4As shown, the distal support disk 221 includes a first inner disk surface 2211 and a first outer disk surface 2212 connected to each other, and the proximal support disk 222 includes a second inner disk surface 2221 and a second outer disk surface 2222 connected to each other. The second outer disk surface 2222 of the proximal support disk 222 is connected to the middle sleeve 21, and the middle sleeve 21 can move axially relative to the inner catheter 11. When the distal support disk 221 and the proximal support disk 222 move toward the proximal end relative to the inner catheter 11, the second outer disk surface 2222, the second inner disk surface 2221, the first inner disk surface 2211 and the first outer disk surface 2212 are gradually straightened from the radial extension of the expanded state to the axial extension state as the middle sleeve 21 moves, that is, at this time, the support assembly 22 is in a contracted state (see Figure 5 ). The support assembly 22 of this embodiment is basically tubular when it is contracted and in a contracted state. When it is released to expand, it forms a distal support disk 221, a proximal support disk 222 and a support member 223. This method not only forms a blood flow path after the outer sheath 30 is withdrawn, but also quickly collects the thrombus on the peripheral side in the interception cavity, and can be easily recovered during recovery.

[0043] See also Figure 3 and Figure 4 In order to further enhance the interception effect of the distal support disk 221 and the proximal support disk 222, an annular flow-blocking membrane 40 is provided inside the proximal support disk 222 and / or the distal support disk 221. The inner edge of the annular flow-blocking membrane 40 is provided with a predetermined spacing w from the outer wall of the inner catheter 11. The setting of the flow-blocking membrane 40 ensures that the weaving density or cutting density of the support disk can be appropriately reduced while ensuring the interception effect, thereby reducing the strength of the disk surface and facilitating recovery. At the same time, the flow-blocking membrane 40 is relatively soft and can be deformed with the deformation of the support assembly, and will not cause great resistance to recovery. In addition, the spacing w of the annular flow-blocking membrane avoids blocking the blood flow path.

[0044] In other embodiments, the vascular perfusion device 100 further includes a pull wire, the distal end of which is connected to the distal support disk 221 and / or the proximal support disk 222, and the proximal end of which passes through one of the perfusion holes 111 and extends along the lumen of the inner catheter 11 to the proximal end of the vascular perfusion device 100. Figure 6The distal end of the first pulling wire 51 is connected to the edge of the distal support disk 221, and then, after the first pulling wire 51 passes through the first perfusion hole 111a, the lumen of the proximal inner catheter 11 extends to the proximal end of the vascular perfusion device 100, and the axial position of the disk surface of the distal support disk 221 can be adjusted by the first pulling wire 51; similarly, a second pulling wire 52 can also be provided, and the distal end of the second pulling wire 52 is connected to the edge of the proximal support disk 222, and then, after the second pulling wire 52 passes through the second perfusion hole 111b, the lumen of the proximal inner catheter 11 extends to the proximal end of the vascular perfusion device 100, and the axial position of the disk surface of the proximal support disk 222 can be adjusted by the second pulling wire 52. Under this arrangement, after the support assembly 22 self-expands, there are other ways to retract it. When the residual thrombus needs to be recovered, the first pulling wire 51 and the second pulling wire 52 are pulled to make the distal support disk 221 and the proximal support disk 222 bend toward the pulling side and gather in the center. At the same time, the thrombus located between the two disks is migrated and gathered, and the outer sheath 30 is further moved toward the distal side to achieve the recovery of the residual thrombus. In a preferred embodiment, the diameter of the distal support disk 221 is slightly larger than the diameter of the proximal support disk 222, for example, 2mm to 3mm larger. On the one hand, the thrombus can be better intercepted on the distal side to prevent the thrombus from ascending with the blood flow. On the other hand, when recovering the thrombus, the first pulling wire 51 can be pulled first to make the distal support disk 221 bend and center first, and then the second pulling wire 52 can be pulled to make the proximal support disk 222 be centered after bending. In this way, the proximal support disk 222 can be pressed on the distal support disk 221, that is, the distal support disk 221 is inside and the proximal support disk 222 is outside. In this way, when the outer sheath tube 30 moves forward, the edge of the disk of the distal support disk 221 will not form a bulge, and the outer sheath tube 30 will obtain an excellent recovery path, which is convenient for sheath entry and recovery.

[0045] See also Figure 3 In one embodiment, the support member 223 includes a plurality of support rods 2231, which are arranged in sequence and at intervals around the circumference of the vascular perfusion device 100. Under this arrangement, the distal support plate 221 and the proximal support plate 222 can also be formed in a manner that the two sides of the plurality of support rods 2231 are extended in the same structure, thereby facilitating production and recycling, while ensuring the overall strength of the support assembly 22. It should be noted that the structure of the support member 223 is not limited to this, as long as it can achieve the above-mentioned effects of the present application, it is within the scope of protection of the present application, for example, it can be a mesh structure formed by weaving metal wires.

[0046] See also Figure 2 and Figure 7 ,as well as Figure 3In one embodiment, a cutting member 60 is provided on the outer wall of the support member 223, and the cutting member 60 is inclined relative to the central axis oo of the vascular perfusion device 100, and the angle α between the extending direction of the cutting member 60 and the central axis oo is set at an acute angle, wherein Figure 7 for Figure 2 The partial enlarged schematic diagram of the A part in the middle is used to illustrate the angle α. Figure 7 The axis o'-o' is shown in the figure, and the axis o'-o' is parallel to the central axis oo of the vascular perfusion device 100. Therefore, the angle between the extension direction of the cutting member 60 and the central axis oo is the angle α between the extension direction of the cutting member 60 and the axis o'-o'. In other embodiments, a plurality of cutting members 60 may be arranged at intervals along the axial and circumferential directions of the support member 223. The arrangement of the cutting member 60, on the one hand, when the support member 223 is self-expanding, the cutting member 60 can be anchored into the thrombus tissue on the surrounding side, which can enhance the stability of the entire device; on the other hand, when the support member 223 is twisted with the middle sleeve 21, the thrombus tissue on the surrounding side can be cut to further improve the speed and effect of eliminating the thrombus tissue. In addition, the cutting member 60 is arranged at an acute angle relative to the central axis to facilitate it when it is put into the sheath to avoid damage to the sheath.

[0047] See also Figure 2 , Figure 7 and Figure 8 ,in Figure 8 for Figure 7 Another structure of the middle support member 223 is shown, the support member 223 includes a distal connection section 223a and a proximal connection section 223b and an intermediate connection section 223c connecting the distal connection section 223a and the proximal connection section 223b, the intermediate connection section 223c includes a plurality of radially protruding bending structures 223c1, preferably, the plurality of bending structures 223c1 are arranged at intervals along the axial direction. Preferably, in order to facilitate recovery and to facilitate the bending structure 223c1 to straighten under the action of tension, the bending structure 223c1 is inclined relative to the central axis oo of the vascular perfusion device 100, and the extension direction of the bending structure 223c1 is also arranged at an acute angle with the central axis oo. The bending structure 223c1 ensures that the support member 223 has a certain amount of compression and extension space in the axial direction, so that the support member 223 can be compressed or extended as much as possible in the axial direction, thereby making the support assembly 22 have a wider range of applications and can cope with thrombi of different lengths, with higher flexibility in selection and operation during operation.

[0048] See also Figure 3 , Figure 4 and Fig. 9There are multiple perfusion holes 111, and multiple perfusion holes 111 are arranged in multiple groups along the axial direction of the inner conduit 11. Exemplarily, in order to form a circumferential injection, as shown in the figure, each group includes multiple perfusion holes 111, and the multiple perfusion holes 111 in each group are sequentially spaced along the circumference of the inner conduit 11.

[0049] At present, the existing technology of catheter thrombolysis is that the doctor performs angiography before the operation, and then selects the length specification of the perfusion section of the perfusion catheter. If the perfusion section length specification is selected to be too long, it will cause the perfusion pressure of the drug solution to be too low, the amount of drug solution perfusion will increase, and other adverse effects on the patient; if the perfusion length specification is selected to be too short, it will cause incomplete coverage of the thrombolysis area, poor thrombolysis effect, and other adverse factors.

[0050] In view of this, in one embodiment, please continue to refer to Figure 3 and Figure 4 The vascular perfusion device 100 also includes a blocking assembly 70 sleeved outside the inner catheter 11. The blocking assembly 70 includes a sleeve 71 and a connecting rod 72 connected to the proximal end of the sleeve 71. The sleeve 71 can move axially relative to the inner catheter 11 under the drive of the connecting rod 72. The movable sleeve 71 can selectively block or avoid one of the perfusion holes 111. The blocking assembly 70 allows the perfusion position and the length of the perfusion section of the perfusion device to have more flexible selection space. The length of the perfusion section can be adjusted to adjust the perfusion pressure and thrombolytic coverage area of ​​the perfusion catheter, thereby achieving better thrombolysis and treatment effects, and at the same time, the surgical efficiency is greatly improved. Among them, two connecting rods 72 are arranged at intervals in the circumferential direction, and each connecting rod 72 is arranged to avoid the perfusion hole 111.

[0051] See also Figure 3 , Figure 4 and Fig.10On the basis of the above-mentioned setting of the blocking component 70, in order to facilitate the axial movement of the blocking component 70 and improve the sealing effect, in one embodiment, a blocking structure 80 is also provided on the inner catheter 11, and the blocking structure 80 includes a connecting hole 81 provided on the inner catheter 11 and connected to the lumen of the inner catheter 11, and the connecting hole 81 is located between two adjacent groups of perfusion holes 111. The blocking structure 80 also includes a capsule 82 provided on the inner catheter 11 and covering the connecting hole 81. The capsule 82 surrounds the inner catheter 11. The capsule 82 can be placed in the sleeve 71 during the axial movement of the sleeve 71 and abut against the inner wall of the sleeve 71 in a filled state, thereby ensuring the sealing performance. Among them, the connecting hole 81 is a through hole that penetrates the wall of the inner catheter 11. The balloon 82 can be hot-melted to the surface of the inner catheter 11 and circumferentially surround it. When perfusing, the liquid medicine in the lumen of the inner catheter 11 can enter the balloon 82 through the connecting hole 81, so that the balloon 82 is filled and slightly expanded, thereby sealing against the outer sleeve 71. At the same time, the sleeve 71 will give the balloon 82 a reverse squeeze to prevent the balloon 82 from further expanding. When it is necessary to adjust the perfusion position or perfusion length, the perfusion pressure is reduced, the balloon 82 becomes deflated, and the strength of the two against each other is reduced. At this time, the blocking component 70 can be easily moved forward and backward. After adjusting the position, the perfusion pressure is continued to be increased, and the balloon 82 is filled again to resist the sleeve 71.

[0052] See also Figure 4 and Fig.10 Preferably, in order to ensure the sealing effect, a sealing structure 80 is provided on the distal side and the proximal side of each group of perfusion holes 111. When the sleeve 71 covers a group of perfusion holes 111, the capsule 82 of the sealing structure 80 on the distal side and the proximal side of the group of perfusion holes 111 are against the inner wall of the sleeve 71 in a filled state.

[0053] See also Figure 3 and Fig.11 As an embodiment, the proximal end of the connecting rod 72 of the blocking assembly 70 is fixedly connected to the distal end of the middle sleeve 21. When the middle sleeve 21 moves axially, the support assembly 22 is adjusted and the blocking position of the blocking assembly 70 is adjusted at the same time, thereby adjusting the perfusion length of the perfusion position. In other embodiments, the proximal end of the connecting rod 72 of the blocking assembly 70 extends axially from the inner side of the middle sleeve 21 to the proximal end of the vascular perfusion device 100, thereby realizing the separate adjustment of the blocking assembly 70, increasing the flexibility of operation. In this embodiment, a groove (not shown) for the connecting rod 72 of the blocking assembly 70 to be placed can be provided on the inner wall of the middle sleeve 21 along its axial direction. This setting can not only reduce the overall radial size of the device, but more importantly, avoid the twisting of the connecting rod 72 during the axial process, thereby ensuring that the axial force can be quickly transmitted, realizing the rapid movement of the sleeve 71, and avoiding the twisting that causes the connecting rod 72 to block the perfusion hole 111, affecting the perfusion thrombolysis effect.

[0054] See also Fig. 9 and Fig.12 The edge of the orifice of the injection hole 111 is provided with a limiting portion 90 for controlling the injection angle of the injection hole 111. Fig.12 As shown, the limiting part 90 can be a thin sheet limiting member provided on the perfusion hole 111, the root of the thin sheet limiting member is relatively fixed to the edge of the perfusion hole 111, and the other end is free. When the liquid medicine is sprayed out under pressure, the liquid medicine can be sprayed out from the end of the thin sheet limiting member along the extension direction, thereby forming a certain spray angle. Preferably, a thin sheet limiting member can be provided on both the proximal side and the distal side of a perfusion hole 111, and its free end is constantly away from the central axis, and a slit nozzle is formed between the two thin sheet limiting members, thereby increasing the spray range, which is conducive to the drug acting more quickly and directly on the thrombus tissue squeezed on the side of the support component 22.

[0055] See also Figure 3 , Figure 4 as well as Fig.13 The distal end of the inner catheter 11 of the vascular perfusion device 100 of the present invention is a closed structure. The inner catheter assembly 10 includes an inner core 12 connected to the distal end of the inner catheter 11 and a tip head 13 connected to the distal end of the inner core 12. The tip head 13 and the tube wall of the inner catheter 11 are provided with coaxial and axially penetrating guide wire holes. Exemplarily, as shown in the figure, the tube wall of the inner catheter 11 is provided with a first guide wire hole 112, and the tip head 13 is provided with a second guide wire hole 131. The second guide wire hole 131 axially penetrates the tip head 13. The first guide wire hole 112 and the second guide wire hole 131 are coaxial and connected, so that the guide wire can pass through. The inner core 12 can be a spring tube, so as to ensure the compliance of the distal side of the vascular perfusion device 100.

[0056] See also Figure 14(a) to Figure 14(d)A thrombus m is formed in the blood vessel p, blocking the blood vessel p. A guide wire n is transported along the access path. The guide wire n passes through the thrombus m to reach the predetermined position. The proximal end of the guide wire n is then passed through the second guide wire hole 131 and the first guide wire hole 112 of the vascular perfusion device 100. The vascular perfusion device 100 advances along the path of the guide wire n and causes its distal end to pass through the thrombus m. The outer sheath 30 is appropriately withdrawn to expose the distal side of the support assembly 22. At this time, the position of the vascular perfusion device 100 can be adjusted so that the distal side of the support assembly 22 is located on the distal side of the thrombus m, and the outer sheath 30 is withdrawn again to release the support assembly 22. When the position is not appropriate, the middle sleeve 21 can be moved proximally or distally relative to the inner catheter 11 to adjust the position of the support assembly 22. After being fully released, the self-expanding support member 223 squeezes the thrombus tissue so that it is surrounded by the peripheral side of the support member 223 and the blood vessel wall, and at the same time, a passage S for blood to pass through is formed between the support member 223 and the inner catheter 11, and at the same time, the distal support disk 221 and the proximal support disk 222 form an axial interception. On this basis, further perfusion can be performed so that the drug solution is ejected from the perfusion hole 111 through the lumen of the inner catheter 11 (the large black arrow in FIG. 14 (d) indicates the flow direction of the drug solution in the lumen of the inner catheter 11, and the black line and arrow at the edge of the perfusion hole 111 indicate the spraying direction of the drug solution), and the ejected drug solution dissolves the aggregated thrombus tissue, thereby improving the thrombolysis efficiency; wherein, during the dissolution process, the perfusion position and length can be adjusted according to the amount of thrombus tissue and the dissolution condition, for example, when it is necessary to enhance the dissolution of the thrombus tissue on the distal side and the proximal side, the connecting rod 72 is moved axially so that the sleeve 71 blocks the perfusion hole 111 at the middle position.

[0057] In addition, the vascular perfusion device of the present invention can also cut thrombotic tissue by rotating the middle sleeve 21. Since the distal end of the support component 22 is relatively fixed to the inner catheter 11, and the proximal end is relatively fixed to the distal end of the middle sleeve 21, the support component 22 can be twisted under the drive of the middle sleeve 21, and the cutting member 60 on the outer peripheral side of the support member 223 can cut the thrombus formation, and the twisting cutting can be performed as needed.

[0058] Among them, the fixing method of the distal end of the support component 22 and the inner catheter 11, and the fixing method of the proximal end and the distal end of the middle sleeve 21 relatively include but are not limited to welding, gluing, mortise, metal wire suturing, etc.

[0059] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. For those skilled in the art, the present invention may have various modifications and variations. Any modification, equivalent substitution, improvement, etc. made within the spirit and principle of the present invention should be included in the scope of the claims of the present invention.

Claims

1. A vascular perfusion device, characterized in that: It includes an inner catheter component for perfusion, a support member sleeved outside the inner catheter component and an outer sheath sleeved outside the support member; the inner catheter component includes an inner catheter, and a plurality of perfusion holes connected to the lumen of the inner catheter are provided on the tube wall on the distal side of the inner catheter, the support member includes a middle sleeve and a support component connected to the distal end of the middle sleeve, the support component is at least partially arranged around the outer circumference of the perfusion hole, the support component has a contracted state contracted between the inner catheter and the outer sheath tube and an expanded state self-expanded after being freed from the restraint of the outer sheath tube, there is a gap between the support component and the inner catheter in the expanded state, so that a passage for blood flow through the proximal end face and the distal end face of the support component is formed between the support component and the inner catheter.

2. The vascular perfusion device according to claim 1, characterized in that: The support assembly in the expanded state includes a radially expanded distal support plate and a proximal support plate, and a support member connecting the distal support plate and the proximal support plate, the proximal side of the proximal support plate is fixedly connected to the distal end of the middle sleeve, and the plate diameters of the proximal support plate and the distal support plate are larger than the maximum outer diameter of the support assembly.

3. The vascular perfusion device according to claim 2, characterized in that: The distal support disk and the proximal support disk both include an inner disk surface and an outer disk surface that are connected. The inner disk surfaces of the distal support disk and the proximal support disk are respectively connected to the distal end and the proximal end of the support member, and the outer disk surface of the proximal support disk is fixedly connected to the middle sleeve. The middle sleeve can move axially relative to the inner catheter. When the middle sleeve moves toward the proximal end relative to the inner catheter, the outer disk surface and the inner disk surface can be gradually straightened from the radial extension in the expanded state to the axial extension state as the middle sleeve moves.

4. The vascular perfusion device according to claim 2, characterized in that: An annular flow-blocking membrane is provided in the proximal support disk and / or the distal support disk. The inner edge of the flow-blocking membrane is provided with a predetermined distance from the outer wall of the inner catheter; and / or, It also includes a pulling wire, the distal end of which is connected to the distal support plate and / or the proximal support plate, and the proximal end passes through one of the perfusion holes and extends along the lumen of the inner catheter to the proximal end of the vascular perfusion device.

5. The vascular perfusion device according to claim 2, characterized in that: The support member includes a plurality of support rods, and the plurality of support rods are sequentially spaced around the circumference of the vascular perfusion device.

6. The vascular perfusion device according to claim 2, characterized in that: The support member comprises a distal connecting section, a proximal connecting section and an intermediate connecting section connecting the distal connecting section and the proximal connecting section, wherein the intermediate connecting section comprises a plurality of radially protruding bending structures; and / or, A cutting piece is provided on the outer side wall of the support piece. The cutting piece is arranged obliquely relative to the central axis of the vascular perfusion device, and the angle between the extending direction of the cutting piece and the central axis is an acute angle.

7. The vascular perfusion device according to any one of claims 1 to 6, characterized in that: There are multiple perfusion holes, and multiple groups of the perfusion holes are arranged at intervals along the axial direction of the inner catheter. The vascular perfusion device also includes a blocking component sleeved outside the inner catheter, and the blocking component includes a sleeve and a connecting rod connected to the proximal end of the sleeve. The sleeve can move axially relative to the inner catheter under the drive of the connecting rod, and the moving sleeve can selectively block or avoid at least one group of the perfusion holes.

8. The vascular perfusion device according to claim 7, characterized in that: The inner catheter is also provided with a blocking structure, which includes a connecting hole provided on the inner catheter and connected with the lumen of the inner catheter, wherein the connecting hole is located between two adjacent groups of the perfusion holes, and the blocking structure also includes a balloon provided on the inner catheter and covering the connecting hole, wherein the balloon surrounds the inner catheter, and the balloon can be placed in the sleeve during the axial movement of the sleeve and abut against the inner wall of the sleeve in a filled state.

9. The vascular perfusion device according to claim 8, characterized in that: The blocking structure is provided on the distal and proximal sides of each group of the perfusion holes. When the sleeve covers a group of the perfusion holes, the sacs of the blocking structure on the distal and proximal sides of the group of the perfusion holes are against the inner wall of the sleeve in a filled state.

10. The vascular perfusion device according to claim 7, characterized in that: The proximal end of the connecting rod is fixedly connected to the distal end of the middle sleeve, or the proximal end of the connecting rod axially extends from the inner side of the middle sleeve to the proximal end of the vascular perfusion device.

11. The vascular perfusion device according to claim 1, characterized in that: The edge of the orifice of the injection hole is provided with a limiting portion for controlling the injection angle of the injection hole; and / or, The distal end of the inner catheter is a closed structure, and the inner catheter assembly also includes an inner core connected to the distal end of the inner catheter and a tip connected to the distal end of the inner core, and coaxial and axially through guide wire holes are provided on the tip and on the tube wall of the inner catheter.

Images