CN116327313A

CN116327313A - Thrombus cleaning system

Info

Publication number: CN116327313A
Application number: CN202310220658.2A
Authority: CN
Inventors: 邹运; 岳蕾; 左斌; 周毅; 桂宝珠
Original assignee: Jiangsu Pupeng Medical Technology Co ltd
Current assignee: Jiangsu Pupeng Medical Technology Co ltd
Priority date: 2023-03-08
Filing date: 2023-03-08
Publication date: 2023-06-27

Abstract

A thrombus cleaning system for pulmonary arteries, comprising a suction device and a scraping device, wherein the scraping device can be inserted into the suction device; the suction device comprises a catheter group and a handle group from the distal end to the proximal end; the catheter group comprises a first catheter and a second catheter which are sleeved in sequence from outside to inside, and the second catheter is provided with a bendable extension section which extends out of the first catheter. Aims at solving the problems of low suction efficiency, incomplete thrombus suction and increased bleeding caused by multiple times of suction.

Description

Thrombus cleaning system

Technical Field

The invention relates to the technical field of medical instruments, in particular to a thrombus cleaning system.

Background

Pulmonary thromboembolism (Pulmonary Embolism, PE) belongs to venous thromboembolism (Venous Thromboembolism, VTE) and is a clinical and pathophysiological syndrome in which an endogenous or exogenous embolic obstruction of a pulmonary artery causes non-circulatory disorders. More than 95% of emboli originate from deep vein thrombosis (Deep Vein Thrombosis, DVT) of lower limbs, fall off after formation, and the life of a patient can be endangered when pulmonary thrombosis is serious.

The traditional treatment means comprise surgical thrombus taking, catheter thrombus dissolving, drug anticoagulation treatment and the like, and the stent thrombus taking is a mode of taking out thrombus through stent scraping and using a sheath tube. Thrombus aspiration is a new method used in clinic in recent years, and the thrombus blocked in the lesion vessel is rapidly aspirated by means of a negative pressure aspiration through a sheath.

The thrombus taking difficulty in the surgical operation is high, the wound surface is large, the tiny thrombus remained in the blood vessel after thrombolysis can not be thoroughly removed, and the medicine anticoagulation can cause more complications, so that the thrombus taking device is eliminated. The stent thrombus can be smashed and scraped aiming at massive thrombus, but the residual thrombus in the blood vessel cannot be completely carried out, and free thrombus blocks are easy to cause blockage of blood vessel branches, so that danger is caused. The thrombus sucking operation is simple and convenient and quick, but the whole thrombus cannot be sucked at one time, and excessive blood loss of a patient is easily caused by repeated sucking.

Disclosure of Invention

In view of the above, the present invention aims to provide a thrombus cleaning system, which aims to solve the problems of low suction efficiency, incomplete thrombus suction and increased bleeding caused by multiple suction.

The invention provides a thrombus cleaning system, which comprises a suction device and a scraping device, wherein the scraping device can be inserted into the suction device;

the suction device comprises a catheter group and a handle group from the distal end to the proximal end;

the catheter group comprises a first catheter and a second catheter which are sleeved in sequence from outside to inside, and the second catheter is provided with a bendable extension section which extends out of the first catheter.

In one embodiment, the bending length of the extension section is 80mm-120mm.

In one embodiment, the central angle of the extension section is 180-260 degrees, and the curvature radius of the extension section is 18-39 mm.

In one embodiment, the handle set comprises a hemostatic valve member connected with the first catheter and a thrombolytic device connected with the hemostatic valve member for cooperation, and the scraping device can sequentially reach the thrombus through the hemostatic valve member and the first catheter set and scrape the thrombus.

In one embodiment, the scraping device comprises a thrombus taking bracket set and an outer sheath tube set which are sleeved from inside to outside;

the thrombus taking support group comprises an end head, an inner tube, a support, a fixed catheter and a first joint, and the outer sheath tube group comprises a sheath tube and an adjustable hemostatic valve connected to the proximal end of the sheath tube;

the end head is connected with the distal end of the inner tube, the first joint is connected with the proximal end of the fixed catheter, and the inner tube is sleeved in the fixed catheter; the distal end of the bracket is connected with the proximal end of the inner tube, and the proximal end of the bracket is connected with the distal end of the fixed catheter; the sheath tube is sleeved outside the fixed catheter and compresses the stent therein.

In one embodiment, the inner tube extends beyond the distal end of the stent by a distance of 1.5mm to 2.5mm.

In one embodiment, the stent is a mesh structure, and the mesh density at the proximal end of the stent is less than the mesh density at the distal end of the stent.

In one embodiment, the stent has a maximum length of 40mm to 60mm in the contracted state and a maximum diameter width of 16mm to 26mm in the expanded state.

In one embodiment, the bolt remover is provided with a negative pressure cylinder body and a piston plunger, wherein the piston plunger is adjustably sleeved in the negative pressure cylinder body, and the inner diameter of a conical opening of the bolt remover is larger than the inner diameter of the guide tube group.

According to the thrombus cleaning system provided by the invention, the handle group arranged at the proximal end of the first catheter can be matched with the intervention or connection of the scraping device and the thrombus extractor, and the first catheter, the handle group and the thrombus extractor are mutually communicated to form a thrombus suction channel capable of sucking thrombus, and the thrombus suction channel can also provide an intervention channel for the scraping device; the use of the bolt remover generally has higher requirements on negative pressure, frequent disassembly or installation is not beneficial to the air tightness of the bolt remover, the scraping device needs a slightly wide caliber to intervene in the bolt remover, and the scraping device and the bolt remover are respectively connected with the first connecting port and the second connecting port of the handle set, so that the mutual influence of the bolt remover and the scraping device in the use process is avoided.

Through the scraping device that is used for scraping the thrombus and the first pipe that is used for sucking the thrombus combines the cover, the scraping device intervenes the human body through first pipe and scrapes behind the thrombus, again suction is carried out, avoid sucking repeatedly, the hemorrhagic volume increases, and complete set combination only need use the seal wire to introduce first pipe into the human body, need not to use the seal wire again to guide when scraping and the operation of drawing switch, improve the clearance efficiency of thrombus, the extension section of second pipe is through holding in the distal end of first pipe or exposing from the distal end of first pipe, can adjust the crookedness and the length of extension section, expose the length of first pipe through adjusting the second pipe bending section, control the second pipe is close to the wall attached thrombus on the vascular wall, the cooperation bolt-drawing machine carries out the pertinence suction, the bolt-drawing machine is connected on the connector of second pipe this moment, reduce operation time, can more high-efficient, thoroughly, scrape and suck the thrombus in the blood vessel, solve the unable problem of sucking of current suction apparatus completion.

Compared with the prior art, the invention has the beneficial effects that:

1. in the mechanical thrombus taking process, the invention adopts a mode of combining the suction device and the scraping device to thoroughly and rapidly stir, scrape and suck thrombus in pulmonary arteries, improves the suction efficiency, reduces the total blood volume sucked, more efficiently and thoroughly eliminates the thrombus, and solves the problem that the traditional suction device cannot suck completely; simultaneously, the thrombus taking support and the suction catheter with different specifications can be selected, the root, the branch and other positions of the pulmonary artery are different in size, the specifications of the support and the suction catheter can be selected according to the pulmonary artery positions needing to be sucked and thrombus taken, and the suction efficiency is improved;

2. the invention designs the coaxial suction catheter with different sizes and lengths to be matched with each other, so that the longer suction catheter can be rapidly used when the problem of insufficient length of the suction catheter is encountered in operation, the original suction catheter is not required to be withdrawn, the operation time is greatly saved, the operation safety is improved, and the operation risk is reduced;

3. when the suction catheter with the bent distal end is used together, the invention can more simply and rapidly perform targeted suction on thrombus on the wall of a blood vessel at a specific position of a pulmonary artery, can more thoroughly remove the thrombus, and improves the suction efficiency;

4. the invention selects the high-capacity bolt extractor, improves the suction efficiency, and the needle cylinder selects the large-caliber conical head, thereby being convenient for efficiently and rapidly sucking thrombus into the needle cylinder and avoiding the blockage of a passage by thrombus with larger size; the connection of the suction catheter and the thrombolytic device ensures continuous and rapid suction and improves the suction efficiency.

Drawings

In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings that are needed in the embodiments will be briefly described below, it being understood that the following drawings only illustrate some embodiments of the present invention and therefore should not be considered as limiting the scope, and other related drawings may be obtained according to these drawings without inventive effort for a person skilled in the art.

Fig. 1 is a schematic view showing a suction operation state in a thrombus cleaning system according to an embodiment of the present invention.

Fig. 2 is a schematic view of a first state of the first conduit and the second conduit.

Fig. 3 is a second state schematic diagram of the first conduit and the second conduit.

Fig. 4 is a schematic structural view of the catheter group.

Fig. 5 is a schematic view of a second conduit structure.

Fig. 6 is a schematic view of the structure of the stent.

Fig. 7 is a schematic structural view of a thrombolysis stent assembly.

Fig. 8 is a schematic structural view of the outer sheath tube set.

Fig. 9 is a schematic structural view of the outer sheath and the second developing ring.

FIG. 10 is a schematic cross-sectional view of the outer sheath and the second developer ring.

Fig. 11 is a schematic structural view of the bracket.

Fig. 12 is a schematic structural view of a thrombolytic stent assembly.

Fig. 13 is a schematic structural view of a thrombus remover according to an embodiment of the present invention.

Reference numerals illustrate: 10. a suction device; 11. a conduit group; 111. a first conduit; 112. a second conduit; 1121. an extension section; 12. a handle set; 121. a hemostatic valve member; 1211. a connecting piece; 1212. a housing; 1213. a knob; 122. a bolt remover; 1221. a negative pressure cylinder; 1222. a piston plunger; 1223. a seal ring; 13. a suction connection assembly; 131. a first hose; 132. a three-way cock seat; 133. a three-way plug cap; 134. a needleless connector; 135. a second hose; 136. a connecting body; 20. a scraping device; 21. a thrombus taking bracket set; 211. an end head; 212. an inner tube; 213. a bracket; 214. fixing the catheter; 215. a first joint; 22. an outer sheath tube set; 221. a sheath; 2211. a second developing ring; 222. an adjustable hemostatic valve; 223. a second joint; 224. a two-way standard; 30. an expansion device; 31. expanding the catheter; 32. expanding the head end; 33. a dilator seat.

Detailed Description

Specific embodiments of the present invention will be described in detail below with reference to the accompanying drawings. It will be apparent that the described embodiments are only some, but not all, embodiments of the invention. All other embodiments, which can be made by those skilled in the art without making any inventive effort, are intended to be within the scope of the present invention.

In the description of the present invention, unless explicitly stated and limited otherwise, the terms "disposed," "mounted," "connected," and the like are to be construed broadly, and may be, for example, fixedly connected, detachably connected, or integrally connected; can be directly connected or indirectly connected through an intermediate medium. The specific meaning of the terms described above will be understood to those of ordinary skill in the art in a specific context.

The terms "upper," "lower," "left," "right," "front," "rear," "top," "bottom," "inner," "outer," and the like are used as references to orientations or positional relationships based on the orientation or positional relationships shown in the drawings, or the orientation or positional relationships in which the inventive product is conventionally disposed in use, merely for convenience of description and simplicity of description, and do not indicate or imply that the devices or elements referred to must have a particular orientation, be configured and operated in a particular orientation, and therefore are not to be construed as limiting the invention.

The terms "first," "second," "third," and the like, are merely used for distinguishing between similar elements and not necessarily for indicating or implying a relative importance or order.

The terms "comprises," "comprising," or any other variation thereof, are intended to cover a non-exclusive inclusion, such that a list of elements does not include only those elements but may include other elements not expressly listed.

Referring to fig. 1 to 13, one embodiment of the present invention provides a thrombus cleaning system, which includes a suction device 10 and a scraping device 20, wherein the scraping device 20 can be inserted into the suction device 10; the suction device 10 comprises, from distal to proximal, a catheter set 11 and a handle set 12; the catheter group 11 includes a first catheter 111 and a second catheter 112 which are sequentially sleeved from outside to inside, and the second catheter 112 has a bendable extension 1121 extending out of the first catheter 111.

For ease of description, the end proximal to the operator will be referred to as the proximal end and the end distal to the operator will be referred to as the distal end.

Specifically, the distal end of the second catheter 112 has elasticity and curvature, and at least the distal end thereof has a hardness smaller than that of the first catheter 111, and the distal end portion of the second catheter 112 protruding from the first catheter 111 can be pressed or released by the first catheter 111, thereby adjusting the extension length and curvature of the extension section 1121, and the length of the extension section 1121 is adjusted intraoperatively according to the residual amount of thrombus and the thrombus distribution position. The arrangement of the second conduit 112 has the following beneficial effects: the distal end of the second catheter 112 is flexible and has a curvature such that the extension 1121 extending beyond the first catheter 111 may be adapted to expand the aspiration range of the second catheter 112 in both the axial and radial directions, to precisely align the thrombus, to increase the aspiration efficiency of the thrombus, and to avoid intervention of the scraping device 20 as much as possible.

In this embodiment, the handle set 12 includes a hemostatic valve member 121 connected to the catheter set 11, and a thrombolytic device 122 connected to and cooperating with the hemostatic valve member 121, and the scraping device 20 can sequentially reach the thrombus through the hemostatic valve member 121 and the catheter set 11 and scrape the thrombus.

Specifically, the proximal end of the first catheter 111 and the proximal end of the second catheter 112 are both provided with a handle set 12, the handle set 12 provided on the second catheter 112 has a first connection port for accessing the scraping device 20 and a second connection port for connecting the thrombolytic device 122, and the second catheter 112, the handle set 12 and the thrombolytic device 122 are communicated to form a thrombolytic channel for aspirating thrombus. The hemostatic valve member 121 comprises a connecting member 1211, a housing 1212 and a knob 1213 which are sequentially connected to the proximal end of the catheter set 11 in a superimposed manner, wherein the connecting member 1211 arranged at the proximal end of the first catheter 111 is selected according to different sizes of the first catheter 111 and is adapted to the first catheter 111, a sealing valve made of silica gel or silicone rubber is arranged in the housing 1212, the sealing valve is fixed by two silica gel fixing members, the sealing valve comprises a spiral flow passage axially arranged in the middle of the sealing valve and straight-through flow passages arranged at two ends of the spiral flow passage, and the function of adjusting the opening size of the sealing valve is realized by compressing and rotating the spiral flow passage in the center of the sealing valve by rotating the knob 1213. The size of the opening of the sealing valve in the hemostatic valve member 121 is adjusted to accommodate the passage of different sized surgical instruments and to maintain good sealing and pushing properties as they pass.

With continued reference to fig. 4, in this embodiment, the suction device 10 further includes a suction connection assembly 13 for connecting the handle set 12 disposed at the proximal end of the second catheter 112 to the thrombolytic device 122, and the catheter set 11 is in communication with the suction connection assembly 13 via the handle set 12.

Specifically, the suction connection assembly 13 includes a first hose 131, a three-way cock seat 132, a three-way cock cap 133, a needleless connector 134, a second hose 135 and a connector 136 that are connected end to end, wherein the needleless connector 134 is screwed on the three-way cock seat 132, so as to ensure the tightness of the three-way cock seat 132 and the three-way cock cap 133; the first hose 131 and the second hose 135 tightly connect the housing 1212 in the hemostatic valve member 121 with the two ends of the three-way cock seat 132 and the connector 136, thereby improving the connection tightness. Further, one end of the connecting body 136 is provided with a connecting buckle, and one end of the connecting body 136 provided with the connecting buckle can be directly connected with the bolt drawing device 122, and the first hose 131 is connected to the handle set 12.

The sequence of the catheter group 11 and the scraping device 20 to intervene in the human body is as follows:

firstly, the distal end of the guide wire is arranged outside the furthest end of thrombus, and the guide wire is ensured not to generate displacement in the operation;

next, the first catheter 111 is advanced along the guidewire into the pulmonary artery, the distal end of the first catheter 111 is brought to a position near the proximal end of the thrombus, and the second catheter 112 is introduced from the handle set 12 provided at the proximal end of the first catheter 111 until the distal end of the second catheter 112 is exposed from the distal end of the first catheter 111. The thrombus-extracting device 122 is communicated with the thrombus-absorbing channel through a second connecting port provided on the handle set 12 of the second catheter 112, and thrombus is sucked into the thrombus-extracting device 122 through the catheter set 11.

In the combination of the first catheter 111 and the second catheter 112, the inner diameter of the first catheter 111 is preferably 4mm-8mm according to the size of the common aspiration catheter used in the field surgery, the first catheter 111 may be a catheter of type PE20 according to the type of catheter used in the field, and the second catheter 112 may be a catheter of type PE 16. Further, at least the first tube 111 is subjected to a hydrophilic coating treatment, preferably, the first tube 111 of model PE20 and the second tube 112 of model PE16 are both subjected to a hydrophilic coating treatment, and the inner diameter of the tube of model PE20 is larger than the outer diameter of the tube of model PE 16. The second conduit 112 needs to be longer than the first conduit 111 for use with; the first catheter 111 having a large inner diameter needs to have a larger wall thickness to provide support for intravascular travel. In actual use, the catheter of the model PE20 is inserted into the blood vessel along the guide wire, the expansion device 30 in the catheter of the model PE20 is pulled out, and then the second catheter 112 of the model PE16 is inserted into the first catheter 111 of the model PE20 along the guide wire, so that the second catheter 112 of the model PE16 can be sent to a proper thrombus taking position, thereby greatly improving the operation efficiency, reducing the operation time and reducing the operation risk.

Optionally, the second catheter 112 is a catheter of type PE20, the first catheter 111 is a catheter of type PE24, both the catheter of type PE20 and the catheter of type PE24 are treated by a hydrophilic coating, and the distal end of the catheter of type PE20 extends out of the distal end of the catheter of type PE24, and the specific intervention mode is the same as the combination of the catheter of type PE20 and the catheter of type PE 16. The combination of the catheter of model PE20 and the catheter of model PE24 has a wider extraction channel, and can more effectively extract large-scale thrombus and thrombus attached to the wall of the tube.

Further, if contrast medium is injected into the pulmonary artery to check the effect of aspiration of thrombus, it is determined whether or not intervention of the scraping device 20 is necessary, and if the catheter set 11 is capable of completely aspirating thrombus, the scraping device 20 does not need to intervene in the pulmonary artery. If more thrombus remains in the vessel, the scraping device 20 is inserted into the pulmonary artery along the second conduit 112, scraping the thrombus from the vessel wall, and carrying the thrombus out.

The scheme has the following beneficial effects: 1. the scraping device 20 is used in combination with the suction device 10, so that the introduction of surgical instruments for many times can be avoided without intervention of human bodies, the surgical difficulty is increased, the surgical time is long, and the rescuing work of patients is not facilitated; 2. the handle set 12 can be adapted to the thrombolytic device 122 and the scraping device 20, and the thrombolytic device 122 and the scraping device 20 are respectively inserted from different access ports or communicated with a thrombolytic channel, so that the air tightness of thrombus aspiration operation is prevented from being influenced by the insertion of the scraping device 20.

In this embodiment, the distal end of the first catheter 111 has a first developing ring made of Pt/Ir alloy or tungsten powder, and the first developing ring is O-shaped or C-shaped, preferably O-shaped, so that the actual position of the aspiration catheter can be observed under DSA (Digital Subtraction angiography, digital angiography), and the shape of the first developing ring can also reflect the angle between the distal end of the aspiration catheter and the horizontal plane to a certain extent, so as to assist the doctor in making a judgment.

In this embodiment, the distal end of the first catheter 111 has a curved section with a length of 80mm-120mm.

In particular, in a blood vessel, a part of thrombus may adhere to the wall of the blood vessel, and the suction force of a straight aspiration catheter is generally in the axial direction of the catheter, which is inconvenient for aspiration of thrombus adhering to the wall of the blood vessel perpendicular to the aspiration catheter. The flexible extension 1121 of the second catheter 112 extends beyond the distal end of the first catheter 111, so that the aspiration inlet is directed toward the vessel wall, thereby enabling more precise alignment of the thrombus attached to the vessel wall and improving the strength and efficiency of the primary aspiration. The length may be set by those skilled in the art to 80mm, 82mm, 85mm, 88mm, 91mm, 93mm, 97mm, 99mm, 100mm, 102mm, 103mm, 106mm, 107mm, 109mm, 110mm, 113mm, 115mm, 116mm, 118mm, 120mm, etc., and is not limited solely herein.

In this embodiment, the central angle of the extension 1121 is 180 ° -260 °, and the radius of curvature of the extension 1121 is 18mm-39mm.

Specifically, the radius of curvature of the extension 1121 is selected preoperatively according to the morphology of the patient's blood vessel and the distribution of thrombus, and is in the range of 18mm-39mm to satisfy most clinical patients. The initial central angle range of the extension section 1121 in the natural state is 180 ° -260 °, the second catheter 112 is located between the guide wire and the first catheter 111 during operation, and the angle of actually controllable bending is 0 ° -90 ° under the influence of the guide wire, and the suction inlet of the second catheter 112 is far away from the vascular wall and extends towards the far end close to the first catheter 111 due to the overlarge central angle, so that the effect of accurate suction on thrombus is difficult to be exerted. The central angle is 0 ° when the extension 1121 is fully positioned within the first tube 111, and is greater than 180 ° when the second tube 112 having an arc at the distal end is extended from the distal end of the first tube 111 to form the extension 1121, and the longer the extension 1121 is extended from the distal end of the first tube 111. The central angle may be set by those skilled in the art to 182 °, 185 °, 186 °, 188 °, 193 °, 196 °, 199 °, 201 °, 204 °, 205 °, 207 °, 209 °, 210 °, 213 °, 217 °, 219 °, 220 °, 225 °, 229 °, 232 °, 233 °, 237 °, 239 °, 241 °, 244 °, 248 °, 253 °, 256 °, 259 °, 260 °, etc., without being limited thereto.

More specifically, the principle of the first conduit 111 adjusting the central angle of the extension 1121 is: the distal end of the second catheter 112 is made elastic and has an arc, and when the distal end of the second catheter 112 is placed in the first catheter 111, the distal end thereof is pressed by the first catheter 111, restraining the distal end having an arc originally straight; the distal end of the second catheter 112 is exposed from the distal end of the first catheter 111, the first catheter 111 begins to release the restriction on the exposed portion, an extension 1121 is formed, the extension 1121 tends to return to the original curvature, and the longer the portion of the distal end of the second catheter 112 exposed to the first catheter 111, the larger the central angle thereof.

In this embodiment, the length of the extension 1121 is 80mm-120mm.

Specifically, since the extension 1121 is elastic and soft, if the length of the extension 1121 is too long, the manipulation of the extension 1121 at the proximal end by the thrombus cleaning system is not facilitated; if the length of the extension 1121 is too short, the extension effect on the pumping distance is not significant. The length may be set by those skilled in the art to 80mm, 82mm, 85mm, 88mm, 91mm, 93mm, 97mm, 99mm, 100mm, 102mm, 103mm, 106mm, 107mm, 109mm, 110mm, 113mm, 115mm, 116mm, 118mm, 120mm, etc., and is not limited solely herein.

With continued reference to fig. 7 and 11, the scraping device 20 includes a thrombus-removing stent set 21 and an outer sheath tube set 22 which are sleeved from inside to outside; the thrombus taking support group 21 comprises a head 211, an inner tube 212, a support 213, a fixed catheter 214 and a first joint 215, and the outer sheath tube group 22 comprises a sheath tube 221 and an adjustable hemostatic valve 222 connected to the proximal end of the sheath tube 221; the tip 211 is connected with the distal end of the inner tube 212, the first joint 215 is connected with the proximal end of the fixed catheter 214, and the inner tube 212 is sleeved in the fixed catheter 214; the distal end of the stent 213 is connected to the distal end of the inner tube 212, and the proximal end of the stent 213 is connected to the distal end of the stationary catheter 214; sheath 221 is disposed over fixed conduit 214 and compresses stent 213 therein.

Specifically, the stent 213 may be expanded or contracted, the sheath tube 221 is used to adjust expansion and contraction of the stent 213, the stent 213 may be made of a nitinol which has a self-expandable property in a normal temperature range of a human body, the stent 213 may be disposed through a distal end of the sheath tube 221, and the stent 213 may be partially or entirely exposed to the sheath tube 221.

More specifically, the stent 213 may be expanded or contracted in the radial direction by being exposed or pressed against the distal end of the sheath tube 221, the stent 213 is preferably shaped like a football with both small ends and large middle, the distal end of the stent 213 is connected to the distal end of the inner tube 212, the proximal end is connected to the distal end of the fixing catheter 214, and the stent 213 is contracted or expanded by pressing or releasing the middle portion of the stent 213 through the sheath tube 221. In the operation, the stents 213 of different sizes are selected according to the residual amount, size, distribution position, etc. of thrombus, and the stents 213 are withdrawn from the proximal end of the catheter set 11 after the completion of thrombus crushing and scraping, and the thrombus is collected in the stents 213 during the contraction of the stents 213 and carried out of the human body through the catheter set 11.

With continued reference to fig. 8, in the present embodiment, the adjustable hemostasis valve 222 is connected to the sheath tube 221 through a second connector 223, a two-way standard 224 is connected to the proximal end of the adjustable hemostasis valve 222, and the sheath tube 221, the second connector 223, the adjustable hemostasis valve 222 and the two-way standard 224 are mutually communicated, and the second connector 223 is preferably a luer connector.

Specifically, the sheath 221 is a three-layer polymer composite structure, the outer layer of the material can include at least one of PE-BAX (block polyether-phthalamide polymer) and PI (Polyimide) according to different hardness requirements, the middle layer includes at least one of 304 steel and nylon material to form a braiding layer, the proximal braiding density of the middle layer of the sheath 221 can be larger than the distal braiding density, the middle layer has good tensile and compressive properties, can be held by pressure and accommodates brackets 213 with various sizes, does not expand a tube body, and the inner layer is PTFE (Poly tetra fluoroethylene ) or PI. Further, the distal end of the sheath 221 is provided with a second developing ring 2211, the second developing ring 2211 is made of Pt/Ir alloy or tungsten powder, the second developing ring 2211 can be O-shaped or C-shaped, so that the position where the sheath 221 actually arrives can be conveniently observed under DSA, and the relative position of the two is adjusted by combining with the development of the bracket 213, so as to complete thrombus scraping. The adjustable hemostasis valve 222 is preferably a T-shaped hemostasis valve that aids in achieving relative fixation of the fixation catheter 214 and the outer sheath tube assembly 22 so that it can be withdrawn into the catheter tube 11 in one piece after thrombus removal.

With continued reference to fig. 12, the proximal end of the support 213 is fixed to the fixing catheter 214 by a heat-shrinkable tube, and the distal end of the support 213 is preferably glued to the distal end of the inner tube 212 by epoxy glue, which is elastic and stable after solidification, so that the distal end of the support 213 can move relatively along the axial direction of the inner tube 212, thereby facilitating the expansion of the support 213 during contraction and expansion. Further, the epoxy integrally bonds the tip 211, the fixing catheter 214 and the stent 213, so that the distal end and the tip 211 together generate relative movement in the axial direction with the fixing catheter 214 when the stent 213 is expanded and contracted. The tip 211 can encapsulate the epoxy to avoid the epoxy from being rubbed or remained in the human body, and also can protect the connection stability of the support 213 and the fixing catheter 214, and the first connector 215 is preferably a luer connector and is located at the proximal end of the fixing catheter 214. Further, barium sulfate is added to the material of the tip 211 in an amount of 20% -40% by mass, thereby assisting the development of the support 213 under DSA and providing more clear positional information of the support 213. The fixed catheter 214 may be threaded with a stent 213 from a two-way standard 224 into the sheath 221. In other embodiments, the fixation catheter 214 may be replaced with a fixation rod.

In this embodiment, the inner tube 212 extends beyond the distal end of the support 213 by a distance of 1.5mm to 2.5mm. Specifically, the clearance between the end surface of the support 213 fixedly connected with the inner tube 212 and the tip 211 is 1.5mm-2.5mm, so that the distal end of the inner tube 212 and the distal end of the support 213 can be glued into the tip 211 by epoxy glue, and the tip is prevented from falling off when the thrombus is scraped during operation, and the distance is preferably 2mm.

In the present embodiment, the support 213 has a mesh structure, and the mesh density of the support 213 gradually decreases in a direction away from the tip 211.

Specifically, increasing the grid density of the distal end of the stent 213 can make the stent 213 collect the thrombus in the stent 213 when the stent 213 grabs the thrombus, so as to prevent the thrombus from leaking and improve the thrombus taking efficiency, but if the overall grid density of the stent 213 is uniform and the density is high, the elasticity of the stent 213 is reduced, so in this embodiment, the grid density of the proximal end of the stent 213 is reduced, the expanding and shrinking function of the stent 213 can be ensured, and the scraping efficiency of the thrombus can be improved.

In this embodiment, the stent 213 has a maximum length of 40mm to 60mm in the contracted state, and the stent 213 has a maximum diameter width of 16mm to 26mm in the expanded state.

Specifically, the stent 213 has a maximum axial length when fully crimped in the sheath 221, the maximum axial length is selected according to the preoperative evaluation of the morphology of the blood vessel and the intravascular thrombus condition of the patient, and the stent 213 is controlled to be in the range of 40mm-60mm by referring to the past surgical experience in the art, so that the thrombus cleaning system can conveniently control the expansion and contraction of the stent 213 from the proximal end and can ensure the clearance rate of the stent 213 to the thrombus. The maximum axial length may be set by those skilled in the art to 40mm, 41mm, 42mm, 43mm, 44mm, 45mm, 46mm, 47mm, 48mm, 49mm, 50mm, 51mm, 52mm, 53mm, 54mm, 55mm, 56mm, 57mm, 58mm, 59mm, 60mm, etc., without limitation herein.

Further, the stent 213 has a maximum radial width when fully exposing the distal end of the sheath 221, the maximum radial width is selected and used according to the evaluation of the morphology of the blood vessel and the intravascular thrombus condition of the patient before the operation, and the diameter width of the stent 213 in the fully expanded state is controlled to be within the range of 16mm-26mm according to the past operation experience in the art, so that thrombus on the vessel wall can be scraped efficiently, a high thrombus breaking effect can be achieved, and the scraping device 20 can be adapted to more types of catheter sets 11. The maximum radial width can be set by those skilled in the art to 16mm, 17mm, 18mm, 19mm, 20mm, 21mm, 22mm, 23mm, 22mm, 25mm, 26mm, etc., without being limited solely herein.

Referring to fig. 13, in the present embodiment, the bolt remover 122 has a negative pressure cylinder 1221 and a piston plunger 1222, and the piston plunger 1222 is adjustably sleeved in the negative pressure cylinder 1221, and the inner diameter of the cone opening of the bolt remover 122 is larger than the inner diameter of the catheter set 11.

Specifically, the thrombus extractor 122 may be communicated with the catheter group 11 through the suction connection assembly 13 for extracting thrombus under the action of negative pressure, the thrombus extractor 122 is similar to a syringe, and has a negative pressure cylinder 1221, a piston plunger 1222 and a sealing ring 1223, wherein the piston plunger 1222 is adjustably sleeved in the negative pressure cylinder 1221, and the sealing ring 1223 is fixed at one end of a suction cylinder port of the negative pressure cylinder 1221.

More specifically, the inner wall of the negative pressure cylinder 1221, which is close to the suction cylinder port, is provided with a limit buckle, and the suction pump buckle may include materials such as PE and PC, and the setting of the limit buckle is convenient for limiting the piston plunger 1222 to the position of the limit buckle after the piston plunger 1222 is manually pulled, so that the piston plunger 1222 and the negative pressure cylinder 1221 can be locked and positioned at the set volume and volume scale, and the relative movement of the piston plunger 1222 and the negative pressure cylinder 1221 is avoided, and the negative pressure of the bolt extractor 122 is maintained. Further, thrombus size is limited by the catheter inner diameter and the bevel inner diameter; the size of the negative pressure cylinder 1221 primarily determines the amount of negative pressure provided, with a larger negative pressure cylinder 1221 representing the ability to provide a larger instantaneous negative pressure, better aspiration of large-size or recalcitrant thrombi. Further, the volume of the negative pressure cylinder 1221 is preferably 60mL, and the material thereof preferably includes PC (polycarbonate) material; the material of the piston plunger 1222 preferably comprises ABS material; the sealing ring 1223 has two specifications with different sizes, and the sealing ring 1223 with the two specifications can be made of silicone rubber. The thrombolytic device 122 is combined with the catheter group 11 to aspirate large and easily aspirated thrombus into the catheter group 11.

In this embodiment, the inner diameter of the cone opening of the thrombus extractor 122 is larger than the inner diameter of the catheter set 11, and the piston plunger 1222 is pulled in the negative pressure cylinder 1221 to create an instantaneous ultra-large negative pressure in the catheter set 11, so as to avoid blocking the thrombus suction channel by a large thrombus and improve the thrombus extraction efficiency.

With continued reference to fig. 6, in this embodiment, the thrombus cleaning system further includes an expansion device 30 for guiding the first catheter 111, and the expansion device 30 can be disposed inside the first catheter 111.

Specifically, when the first catheter 111 is inserted into a human body, the stent 30 is first detachably fixed to the first catheter 111 having a corresponding size, a guide wire is introduced through the perforation of the stent 30, a hole is formed in the femoral vein, the guide wire is introduced through the femoral vein, the inferior vena cava, the right atrium, and the right ventricle, and finally the guide wire is introduced into a target position of the pulmonary artery, and the first catheter 111 and the stent 30 reach the target position along the guide wire.

In this embodiment, the stent 30 includes a stent catheter 31, a stent tip 32 and a stent holder 33, the stent catheter 31 is capable of being inserted into the first catheter 111, the stent tip 32 is used for guiding the first catheter 111, is connected to the distal end of the stent catheter 31 and can be exposed to the distal end of the first catheter 111, and the stent holder 33 is connected to the proximal end of the stent catheter 31 and can be exposed to the proximal end of the catheter set 11 for guiding the stent 30.

Specifically, after the guide wire is guided into the target position of the pulmonary artery through the perforation of the dilating catheter 31 of the dilating device 30, the dilating and dilating tip 32 of the distal end of the dilating device 30 exposes the distal end of the first catheter 111, and as a guide for the first catheter 111, the distal end of the dilating device 30 enters the human body along the guide wire from the proximal end of the guide wire, and brings the first catheter 111 into the target position of the blood vessel, thereby forming a delivery passage.

In the present embodiment, the stent head end 32 and the stent holder 33 comprise at least one of PE, ABS (Acrylonitrile Butadiene Styrene ), and the stent catheter 31 comprises PE.

In this embodiment, the material of the dilation catheter 31 and the dilation head 32 comprises barium sulfate, wherein the mass fraction of barium sulfate is 20% -40%.

Specifically, in the art, barium sulfate is mainly used in radiological examination to make the barium sulfate develop by absorbing X-rays in the human body, but not by the human body, and barium sulfate is integrally added to the materials of the dilating catheter 31 and the dilating tip 32 in this embodiment, so that the part of the dilating catheter extending into the blood vessel has an overall developing effect. According to a plurality of experiments, the adding amount of the barium sulfate has a great influence on the developing effect and the mechanical property, for example, when the mass fraction of the barium sulfate is less than 20%, the developing effect of the expansion conduit 31 and the expansion head end 32 is poor, and when the mass fraction of the barium sulfate exceeds 40%, the mechanical property of the expansion conduit 31 and the expansion head end 32 is too low to meet the requirement of supporting the first conduit 111. The content can be set by those skilled in the art to 20%, 21%, 22%, 23%, 24%, 25%, 26%, 27%, 28%, 29%, 30%, 31%, 32%, 33%, 34%, 35%, 36%, 37%, 38%, 39%, 40%, etc., and is not limited solely herein.

In this embodiment, the inner and outer diameters and wall thickness of the dilation catheter 31 are designed to be large at the proximal end and small at the distal end.

Specifically, one type of the first catheter 111 can be adapted to multiple types of the dilating catheter 31 and the dilator seat 33, and the dilating tip 32 needs to be adapted to the inner diameter of the first catheter 111, and the dilating tip 32 is one-to-one corresponding to the first catheter 111, so as to provide sufficient supporting force for the first catheter 111 in the blood vessel, and in addition, the rounded dilating tip 32 can prevent the first catheter 111 from damaging the wall of the blood vessel when advancing in the blood vessel. Further, the dilating catheter 31 may be a reducing catheter, and the materials for preparing the three regions of the dilating catheter 31 may be the same, wherein the three regions are respectively different in inner diameter and outer diameter and wall thickness from the proximal end to the distal end. Further, the three regions are respectively conduits with uniform outer diameter and wall thickness, and the three conduits are fused and combined to form the stepped reducing conduit, so that sufficient supporting force can be provided for the proximal end of the first conduit 111, and the requirements of the distal end on softness and flexibility are met. Preferably, the connection position between the proximal end of the expansion head end 32 and the expansion catheter 31 is smoothed, and the edge angle between the proximal end and the outer surface of the expansion catheter 31 is eliminated, so that the expansion head end 32 can be easily withdrawn into the first catheter 111 after exposing the distal end of the first catheter 111, and the vascular access of a human body is avoided.

The thrombus cleaning system is connected into a human body as follows:

s1: after a puncture needle, a guide wire and a puncture sheath are used for establishing a passage in a femoral vein, the guide wire is ascended to a pulmonary artery along the femoral vein, an angiography catheter is introduced, and after the guide wire is withdrawn, the DSA (digital radiography) of the pulmonary artery is performed to determine the position of the pulmonary artery thrombus. After introducing the 0.035 "guidewire into the pulmonary artery, the contrast catheter is withdrawn, the distal end of the guidewire is placed beyond the distal-most end of the thrombus, and it is ensured that no displacement of the guidewire occurs during the procedure.

S2: the first catheter 111 is advanced over the guidewire to a position near the proximal end of the thrombus (the O-ring at the distal end of the first catheter 111 aids in positioning), the knob 1213 of the handle set 12 is unscrewed, the first catheter 111 is secured to the guidewire while the dilation catheter 31 is withdrawn quickly and the knob 1213 is tightened. The second catheter 112 is introduced along the first catheter 111, and the thrombolytic device 122 at the proximal end of the second catheter 112 is connected to the connector 136 to perform a first thrombus aspiration. The piston plunger 1222 was first pulled to the 60mL scale of the negative pressure cylinder 1221 and the piston plunger 1222 was rotated until secured with a limit catch. The three-way screw cap 133 is rapidly rotated to a position where the catheter set 11 communicates with the thrombolytic device 122, at which time thrombus may be withdrawn into the thrombolytic device 122 through the catheter set 11, and the three-way screw cap 133 is rotated back to a position where the catheter set 11 communicates with the needleless connection 134. The thrombolytic device 122 is removed.

S3: if there is a large amount of thrombus remaining in the blood vessel, the scraping device 20 is required to remove the thrombus. At this point the stent 213 is crimped in the sheath 221, the knob 1213 of the handle set 12 is unscrewed, the scraping device 20 is inserted along the guidewire into the catheter set 11 and advanced to near the distal end of the thrombus, and after positioning the stent 213, the knob 1213 is tightened (the O-ring 2211 at the distal end of the sheath 221 aids in positioning). The distal tip 211 of the scraping device 20 and the stent 213 itself are developable under DSA, helping to locate the stent 213, the proximal end of the stent 213 being beyond the distal end of the thrombus. The knob switch of the adjustable hemostatic valve 222 is unscrewed, the sheath tube 221 is slowly withdrawn after the catheter set 11 and the fixed catheter 214 are relatively fixed, the stent 213 pressed and held in the sheath tube 221 is rapidly expanded to restore to the original size, and the knob switch of the adjustable hemostatic valve 222 is screwed after the stent 213 is completely exposed out of the sheath tube 221. Unscrewing the knob 1213 of the handle set 12 slowly withdraws the scraping device 20 entirely along the guidewire, whereupon the stent 213 agitates and breaks away the thrombus from the vessel wall, and the stent 213 is retracted into the catheter set 11 along with the scraped-off large thrombus. The scraping device 20 is continued to be withdrawn along the guidewire to the outside of the body, and the handle set 12 is tightened. Whether thrombus is scraped completely can be judged by the contrast effect.

Further, after the scraping device 20 is completed to scrape the thrombus, the thrombus is sucked once again by connecting the thrombus extractor 122, and the remaining crushed thrombus is completely sucked.

According to the thrombus cleaning system provided by the invention, the handle group 12 arranged at the proximal end of the catheter group 11 can be matched with the intervention or connection of the scraping device 20 and the thrombus extractor 122, and the catheter group 11, the handle group 12 and the thrombus extractor 122 are mutually communicated to form a thrombus sucking channel capable of sucking thrombus, and the thrombus sucking channel can also provide an intervention channel for the scraping device 20; the use of the latch 122 generally requires a higher requirement for air tightness, frequent disassembly or installation is not favorable for air tightness, and the scraping device 20 needs a slightly wider caliber to be inserted into the latch scraping instrument, and the scraping device 20 and the latch 122 are respectively connected with a first connecting port and a second connecting port of the handle set 12 so as to avoid the mutual influence of the latch 122 and the scraping device 20 in the use process. By combining the scraping device 20 for scraping thrombus and the catheter set 11 for sucking thrombus, the scraping device 20 is inserted into a human body through the catheter set 11 to scrape thrombus, then suction is performed again, repeated suction is avoided, damage to the vessel wall is avoided, the blood output is increased, the first catheter 111 is only required to be led into the human body by the aid of a guide wire in a complete set of combination, the second catheter 112 and the scraping device 20 are led through the first catheter 111, the guide wire is not required to be used again when the operation of scraping and sucking is switched, the clearing efficiency of thrombus is improved, the operation time is reduced, the extension section 1121 of the second catheter 112 is held at the distal end of the first catheter 111 through the pressure or is exposed from the distal end of the first catheter 111, the bending degree and the length of the extension section 1121 can be adjusted, the suction range of the catheter set 11 is adjusted, thrombus in the vessel can be more efficiently, thoroughly and rapidly scraped, and the thrombus in the vessel can not be sucked completely by the conventional suction instrument.

The foregoing is merely illustrative of the present invention, and the present invention is not limited thereto, and any changes or substitutions easily contemplated by those skilled in the art within the scope of the present invention should be included in the present invention. Accordingly, the scope of the invention should be assessed as that of the appended claims.

Claims

1. A thrombus cleaning system, characterized by comprising a suction device (10) and a scraping device (20), said scraping device (20) being insertable in said suction device (10);

the suction device (10) comprises a catheter group (11) and a handle group (12) from the distal end to the proximal end;

the catheter set (11) comprises a first catheter (111) and a second catheter (112) which are sleeved in sequence from outside to inside, and the second catheter (112) is provided with a bendable extension section (1121) which extends out of the first catheter (111).

2. The thrombus cleaning system of claim 1, wherein the extension (1121) has a curved length of 80mm-120mm.

3. The thrombus cleaning system of claim 1, wherein the central angle of the extension (1121) is 180 ° -260 °, and the radius of curvature of the extension (1121) is 18mm-39mm.

4. The thrombus cleaning system of claim 1, wherein the handle set (12) comprises a hemostatic valve member (121) connected to the catheter set (11), and a thrombolytic device (122) connected to the hemostatic valve member (121) for use therewith, the scraping device (20) being capable of sequentially passing through the hemostatic valve member (121) and the catheter set (11) to a thrombus site and scraping the thrombus.

5. The thrombus cleaning system of claim 1, wherein the scraping means (20) comprises an inner-to-outer sleeved thrombus-removal stent set (21) and an outer sheath tube set (22);

the thrombus taking support group (21) comprises a head (211), an inner tube (212), a support (213), a fixed catheter (214) and a first joint (215), and the outer sheath tube group (22) comprises a sheath tube (221) and an adjustable hemostatic valve (222) connected to the proximal end of the sheath tube (221);

the end head (211) is connected with the distal end of the inner tube (212), the first joint (215) is connected with the proximal end of the fixed catheter (214), and the inner tube (212) is sleeved in the fixed catheter (214); the distal end of the bracket (213) is connected with the proximal end of the inner tube (212), and the proximal end of the bracket (213) is connected with the distal end of the fixed catheter (214); the sheath tube (221) is sleeved outside the fixed catheter (214) and compresses the bracket (213) therein.

6. The thrombus cleaning system of claim 5, wherein the inner tube (212) extends a distance of 1.5mm to 2.5mm beyond the distal end of the stent (213).

7. The thrombus cleaning system of claim 5, wherein the stent (213) is a mesh structure, the mesh density at the proximal end of the stent (213) being less than the mesh density at the distal end of the stent (213).

8. The thrombus cleaning system of claim 7, wherein the stent (213) has a maximum length of 40mm-60mm in the contracted state and the stent (213) has a maximum diameter width of 16mm-26mm in the expanded state.

9. The thrombus cleaning system of claim 4, wherein the thrombolytic device (122) has a negative pressure barrel (1221) and a piston plunger (1222), the piston plunger (1222) being adjustably sleeved within the negative pressure barrel (1221), the internal diameter of the tapered mouth of the thrombolytic device (122) being greater than the internal diameter of the catheter set (11).