CN115177321B - Multifunctional thrombus removing device - Google Patents
Multifunctional thrombus removing device Download PDFInfo
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- CN115177321B CN115177321B CN202210667899.7A CN202210667899A CN115177321B CN 115177321 B CN115177321 B CN 115177321B CN 202210667899 A CN202210667899 A CN 202210667899A CN 115177321 B CN115177321 B CN 115177321B
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Abstract
The invention provides a multifunctional thrombus removing device. It comprises the following steps: a thrombus taking support, a suction catheter and a plugging component; the thrombus taking support is of a self-expansion support structure; the proximal end of the thrombus taking support is connected with a suction catheter, the distal end of the suction catheter is provided with a suction port, the suction port is positioned in the thrombus taking support, and the suction catheter is used for sucking thrombus collected by the thrombus taking support in an expanded state through the suction port; the distal end of the suction catheter is also provided with a perfusion tube section which is positioned at the proximal end side of the thrombus taking bracket; the blocking component can enter the perfusion tube section and block the distal end of the perfusion tube section so as to allow the suction catheter to perfuse thrombolytic drugs through the perfusion tube section. According to the embodiment of the invention, the perfusion thrombolysis, the stent thrombolysis and the negative pressure suction are combined into a whole, so that the advantages and the disadvantages are overcome, and a better thrombolysis effect can be achieved for different thrombus types and lumen sizes.
Description
Technical Field
The invention relates to the technical field of medical equipment, in particular to a multifunctional thrombus removing device.
Background
Vascular disease has become the first leading fatal disease in China, and vascular embolism has become a major factor in vascular disease. Especially ischemic cerebral apoplexy, pulmonary embolism and venous embolism of lower limb, the total annual new incidence rate of patients exceeds 500 ten thousand people.
At present, medical intervention thrombus taking is gradually becoming an effective mode recommended by the main flow of vascular embolism treatment. The interventional thrombus taking has the advantages of small wound, short postoperative recovery time, few complications after treatment, good operation effect and the like, and can be accepted by patients.
In clinical practice of intravascular embolism treatment, the existing interventional technical scheme mainly comprises treatment means such as systemic thrombolysis, catheter contact thrombolysis, mechanical thrombolysis and the like, and different means have different advantages and disadvantages: systemic thrombolytic therapy regimens have the risk of eliciting cerebral or systemic bleeding; catheter contact thrombolysis reduces the dosage of thrombolytic drugs, but has bleeding complications, and long-term catheter placement thrombolysis also has the risk of infection; although the pure negative pressure suction type thrombus taking is economical, the blood loss in the operation process is large, and the thrombus taking effect in a large lumen often cannot achieve a good effect; the rheological mechanical thrombus taking process needs to pay attention to the monitoring of the using time, the postoperative hemoglobinuria often occurs, and meanwhile, the rheological mechanical thrombus taking process has a certain effect on acute thrombus, and has a very limited effect on thrombus in a large lumen, particularly subacute and even chronic thrombus. Therefore, there is a need for a thrombus removal device that achieves better removal of different types of thrombus at different locations.
It should be noted that the information disclosed in the foregoing background section is only for enhancing understanding of the background of the present application and thus may include information that does not form the prior art that is already known to those of ordinary skill in the art.
Disclosure of Invention
The embodiment of the invention aims to provide a multifunctional thrombus removing device, so as to provide a thrombus removing device which is economical and can achieve better removing effect for different parts and different types of thrombus.
In order to solve the above technical problems, an embodiment of the present invention provides a multifunctional thrombus removal device, including:
the thrombus taking bracket is of a self-expansion bracket structure;
the proximal end of the thrombus taking support is connected with the suction catheter, the distal end of the suction catheter is provided with a suction port, the suction port is positioned in the thrombus taking support, and the suction catheter is used for sucking thrombus collected by the thrombus taking support in an expanded state through the suction port; the distal end of the suction catheter is also provided with a perfusion tube section, and the perfusion tube section is positioned at the proximal end side of the thrombus taking bracket; and
a blocking assembly capable of entering into the irrigation tube segment and blocking the distal end of the irrigation tube segment for infusion of thrombolytic drugs by the aspiration catheter through the irrigation tube segment.
As one embodiment, the suction catheter comprises a tube and a tube connector connected to a proximal end of the tube;
the tube interface is used for connecting a negative pressure source and providing suction negative pressure for the tube body, and the tube interface is also used for pouring thrombolytic drugs into the pouring tube section.
As an embodiment, the pipe interface includes: a handle portion, an operating joint and a priming joint;
the tube body, the handle part and the operation joint are sequentially and coaxially connected from the distal end to the proximal end, and a suction channel of the suction catheter is formed;
the operating joint comprises a connecting pipe section and a joint part, wherein the connecting pipe section is connected between the proximal end of the handle part and the distal end of the joint part; the inner end of the pouring joint is connected with the peripheral wall of the connecting pipe section, the pouring joint is provided with a pouring channel, and the pouring channel is connected with the connecting pipe section.
As one embodiment, the tube body comprises a distal tube part, a suction opening part and a perfusion tube segment which are connected in sequence from the distal end to the proximal end; the tube body is internally provided with a separation wall extending from the proximal end of the tube body to the suction opening, the separation wall is used for separating the tube body into a suction cavity and a guide wire cavity, and the guide wire cavity is eccentrically arranged relative to the tube body.
As an embodiment, the distal tube part is tapered and extends in an axial direction, and the distal tube part is coaxially arranged with the tube body and has a wire guide hole for passing a wire, and the wire guide hole is connected with the wire guide cavity.
As one embodiment, the guide wire cavity comprises a distal guide wire cavity and a proximal guide wire cavity which are connected, wherein the distal guide wire cavity is a closed loop guide wire cavity which is circumferentially closed, and the proximal guide wire cavity is a groove-shaped guide wire cavity which is circumferentially opened.
As an embodiment, an axially extending reinforcing core is provided in the partition wall.
As one embodiment, the suction port is formed by a side-cut suction port which is gradually increased and then gradually decreased from the distal end to the proximal end;
optionally, the lateral oblique suction port extends from the proximal end of the distal tube portion to a junction of the thrombolytic stent and the tube body.
As one embodiment, the irrigation tube segment comprises an occlusion segment and an irrigation segment connected from a distal end to a proximal end; the pouring section is provided with pouring structures along the axial direction and the circumferential direction at intervals;
the plugging assembly is a balloon catheter, the balloon catheter comprises a balloon body and a catheter, and the balloon body is connected with the catheter;
the balloon body can enter the pipe body through the pipe joint and reach the plugging section, and the plugging section can be plugged when the balloon body is inflated; thrombolytic drugs can also be infused into the tube body through the tube joint, and the thrombolytic drugs can be sprayed out from the infusion structure of the peripheral wall of the infusion section.
As one embodiment, the distal end of the perfusion tube section is provided with a developing ring, and the catheter is provided with a developing mark; and determining whether the balloon body reaches the plugging section by matching the positions of the developing mark and the developing ring.
As one example, the thrombus-taking support is spherical, ellipsoidal or spindle-shaped.
As one embodiment, the thrombolytic stent comprises: a fixed head, a collecting part and a thrombus taking part which are connected in sequence from a distal end to a proximal end;
the distal end of the collecting part is connected with the proximal end of the fixed head; the fixed head can axially move relative to the suction catheter so as to enable the thrombus taking support to be in an expanded or contracted state;
optionally, the collecting part comprises a net structure formed by connecting a plurality of connecting rods in a staggered way, the thrombus taking part comprises a plurality of connecting rods which are arranged at intervals along the circumferential direction, the distal ends of the connecting rods are smoothly connected with the proximal ends of the collecting part, and the proximal ends of the connecting rods are connected with the suction catheter;
the tube body comprises a distal tube part, a suction opening part and a perfusion tube section which are sequentially connected from the distal end to the proximal end; optionally, the fixing head is conical and extends along the axial direction, the fixing head and the thrombus taking support are coaxially arranged and are arranged at the far end side of the far end pipe part, a through hole for a guide wire to pass through is formed in the fixing head, and the far end pipe part is conical; or alternatively
The fixing head is tubular and is sleeved on the distal tube part in a sliding manner, and the distal end of the distal tube part is tapered.
As an embodiment, the apparatus further comprises: an ultrasound catheter; ultrasonic transducers which are arranged at intervals along the axial direction are arranged in the ultrasonic catheter;
the ultrasound catheter is capable of entering the aspiration catheter and reaching into the irrigation tubing segment, and the ultrasound transducer is capable of radiating ultrasound energy in a radial direction upon energization.
According to the technical scheme, the invention has at least the following advantages and positive effects:
in the multifunctional thrombus removing device provided by the embodiment of the invention, the proximal end of the thrombus removing bracket is connected with the distal end of the suction catheter, the distal end of the suction catheter stretches into the thrombus removing bracket, the thrombus removing bracket can be retracted through the suction catheter, thrombus can be peeled and collected through the thrombus removing bracket, so that the thrombus is easier to suck, and simultaneously, the thrombus in the thrombus removing bracket can be rapidly sucked out of the body through the suction catheter, thereby being beneficial to reducing thrombus removing difficulty and improving thrombus removing efficiency; and because the distal end of the suction catheter is provided with the perfusion tube section, the distal end of the perfusion tube section can be plugged through the plugging component, and then the thrombolytic drug is infused through the perfusion tube section, so that the thrombolytic drug can be accurately infused, and the difficulty of stent thrombolysis is further reduced. Therefore, the multifunctional thrombus removing device of the embodiment skillfully combines the means of stent thrombus removing, catheter thrombolysis, negative pressure suction and the like, makes up for the advantages of reducing thrombus removing difficulty, achieving better thrombus removing effect for different lumen sizes and different types, being beneficial to reducing complications and having better treatment effect.
Drawings
In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings that are required in the embodiments or the description of the prior art will be briefly described below, it being understood that the drawings in the following description are only embodiments of the present invention and that other drawings may be obtained according to the drawings provided without inventive effort for a person skilled in the art.
FIG. 1 is a schematic view of a multifunctional thrombi removing device according to an embodiment of the present invention;
FIG. 2 is a schematic view showing a partial structure of a suction catheter of the multifunctional thrombus cleaning device according to an embodiment of the present invention;
FIG. 3 is a schematic cross-sectional view of FIG. 2;
FIG. 4 is a schematic view showing a partial structure of a suction catheter of a multifunctional thrombi elimination device according to another embodiment of the invention;
fig. 5 is a schematic view of a partial structure of a thrombus removal stent of a multifunctional thrombus removal device according to an embodiment of the present invention;
FIG. 6 is a schematic view showing a partial cross-sectional structure of a suction catheter of the multifunctional thrombi elimination device according to the embodiment of the invention;
FIG. 7 is a schematic cross-sectional view of the distal end of the aspiration catheter of the multifunctional thrombi elimination device according to the present invention;
FIG. 8 is a schematic cross-sectional view of the proximal end of the aspiration catheter of the multifunctional thrombi elimination device according to the present invention;
FIG. 9 is a schematic view of a combined thrombus removal stent and aspiration catheter of a multifunctional thrombus removal device according to an embodiment of the present invention;
FIG. 10 is a schematic diagram of infusion thrombolytic drugs of a multifunctional thrombi elimination device according to an embodiment of the invention;
fig. 11 is a schematic view of an ultrasonic catheter thrombolysis structure of a multifunctional thrombus removal device according to an embodiment of the present invention.
Detailed Description
For the purpose of making the objects, technical solutions and advantages of the embodiments of the present invention more apparent, the following detailed description of the embodiments of the present invention will be given with reference to the accompanying drawings. However, those of ordinary skill in the art will understand that in various embodiments of the present invention, numerous technical details have been set forth in order to provide a better understanding of the present invention. However, the claimed invention may be practiced without these specific details and with various changes and modifications based on the following embodiments.
In the description of the present invention, it should be noted that the directions or positional relationships indicated by the terms "upper", "lower", "inner", "outer", etc. are based on the directions or positional relationships shown in the drawings, are merely for convenience of describing the present invention and simplifying the description, and do not indicate or imply that the apparatus or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and thus should not be construed as limiting the present invention. Furthermore, the terms "first," "second," "third," and the like are used for descriptive purposes only and are not to be construed as indicating or implying relative importance.
It should be noted that, unless explicitly stated otherwise, the terms "connected," "connected," and the like should 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, and can be communication between two elements.
In the description of the present invention, it should be noted that, in the field of interventional medical devices, the proximal end refers to the end closer to the operator, and the distal end refers to the end farther from the operator; axial refers to a direction parallel to the line connecting the distal center and the proximal center of the medical device in its natural state. The above definitions are for convenience of description only and are not to be construed as limiting the invention.
Referring to fig. 1, 3 and 9, the embodiment of the invention provides a multifunctional thrombus cleaning device which can be used for effectively cleaning thrombus at different positions and different types. The multifunctional thrombus removal device of this embodiment mainly includes: a thrombolytic stent 12, a suction catheter and a plugging assembly.
The embolic stent 12 is a self-expanding stent structure that is capable of following expansion against the inner wall of a vessel to detach and collect a thrombus.
The proximal end of the thrombus-taking support 12 is connected with a suction catheter, namely, the thrombus-taking support 12 and the suction catheter form an integrated thrombus-taking structure 1, and the thrombus-taking support 12 can be retracted through the suction catheter. The aspiration catheter has an aspiration port 1321 at the distal end thereof, and the aspiration port 1321 is located within the embolic stent 12, the aspiration catheter being used to aspirate thrombus collected by the embolic stent 12 in an inflated state through the aspiration port 1321. After the thrombus is stripped and collected by the thrombus taking support 12, the thrombus sucking difficulty can be remarkably reduced, the collected thrombus can be directly sucked out of the body by the suction catheter, and meanwhile, the collected thrombus is sucked, so that the suction efficiency is higher, and the problem that the large lumen size is difficult to suck is solved.
The aspiration catheter distal end also defines a perfusion tube segment 133, with the perfusion tube segment 133 being located proximal to the thrombolytic stent 12. The shutoff assembly is capable of entering the irrigation tube segment 133 and sealing off the distal end of the irrigation tube segment 133 for infusion of thrombolytic drug through the irrigation tube segment 133 by the aspiration catheter. The suction catheter can be used as a perfusion catheter for injection thrombolysis. Some thrombus which is difficult to be stripped by the chronic or thrombus-taking support 12 can be firstly and properly thrombolytically taken, and thrombus is taken by the thrombus-taking support 12 after the binding force between the thrombus and the blood vessel wall is reduced, so that a better thrombus-taking effect can be achieved for different types of thrombus. The drug can be more accurately applied by injecting the drug after the distal end of the perfusion tube section 133 is plugged by matching the plugging component and the suction catheter, so that the drug consumption is saved, and the occurrence risk of complications is reduced.
The thrombus-taking stand 12 can be spherical, ellipsoidal or spindle-shaped. The main function of the thrombus taking support 12 is that the thrombus taking support can be expanded and clung to the inner wall of a blood vessel after being released, thrombus on the inner wall of the blood vessel can be completely stripped off when the thrombus taking support is retracted, and meanwhile, a proper amount of thrombus can be collected and stored without providing a large amount of thrombus storage space, so that the axial length of the thrombus taking support 12 can be shorter, the whole volume can be smaller, and the manufacturing cost can be lower compared with that of a thrombus taking support which directly brings thrombus out of the body.
Referring to fig. 2 and 5, the thrombolytic stent 12 may include: the fixed head 11, the collecting part 121 and the thrombus removing part 122 are connected in this order from the distal end to the proximal end. Illustratively, the collection portion 121 includes a mesh structure formed by a plurality of connecting rods 1211 that are staggered, with the distal end of the collection portion 121 being connected to the proximal end of the stationary head 11. The thrombolytic portion 122 may comprise a plurality of circumferentially spaced links 1221, the distal ends of the links 1221 being smoothly connected to the proximal end of the collecting portion 121, the proximal ends of the links 1221 being connected to the aspiration catheter. The thrombus taking-out portion 122 has an open mesh structure, and an opening for entering thrombus is formed between the adjacent links 1221, so that the thrombus can be cut by the links 1221. The collection unit 121 has a dense mesh structure, and can filter and intercept thrombus and pass through the blood stream. The fixed head 11 can be moved axially relative to the aspiration catheter to place the thrombolytic stent 12 in an expanded or contracted state. When the thrombus taking support 12 drives the fixing head 11 to move towards the far end relative to the suction catheter under the action of external force, the thrombus taking support 12 can be in a contracted state, and after the thrombus taking support 11 is released, the fixing head 11 can be driven to move towards the near end relative to the suction catheter by means of self elastic force so as to enable the thrombus taking support to be in an expanded state.
The plurality of connecting rods 1211 of the collecting part 121 respectively extend in the forward and reverse directions in a spiral manner and are mutually staggered to form a net structure, and the peripheral wall of the collecting part 121 can form diamond meshes. The thrombolytic device 12 may further comprise a distal connection 123 and is connected to the proximal end of the fixation head 11 via the distal connection 123, for example by welding. The distal connecting portion 123 may include a number of distal fixation rods 1231, and the distal fixation rods 1231 may be formed by extending the connecting rod 1211. The collection portion 121 can be reliably fixed to the fixing head 11 by the plurality of distal fixing rods 1231.
The several connecting rods 1221 of the embolectomy 122 may extend proximally from the intersection of the connecting rods 1211 of the harvesting portion 121 or directly proximally from the connecting rods 1211 proximal to the harvesting portion 121 and convergent fixed to the distal end of the aspiration sheath. The number of connecting rods of the collecting portion 121 is greater than the number of connecting rods 1221 of the thrombectomy portion 122. The thrombolysis portion 122 may further comprise a proximal fixation portion 124, the proximal fixation portion 124 may comprise a plurality of proximal fixation rods 1241 formed by extending connecting rods 1221, and the proximal fixation rods 1241 may be fixedly connected to the aspiration catheter by welding.
The thrombus taking support 12 can be made of nickel-titanium pipe material through laser cutting and heat setting, or can be made of braided wires with shape memory capability, such as nickel-titanium alloy wires. It will be appreciated that the present embodiment is not particularly limited in terms of the configuration of the thrombolytic stent 12, so long as the desired thrombolytic performance is achieved.
Referring to fig. 3, the fixing head 11 is tapered and extends axially, the fixing head 11 and the thrombus taking support 12 are coaxially arranged, and the fixing head 11 can improve the advancing capability of the device in a blood vessel. The fixing head 11 is provided with a through hole 113 for a guide wire (not shown) to pass through, and the device can be matched with the guide wire to guide the thrombus position in operation. The fixation head 11 may include a tapered portion 111 and a bracket connection portion 112, with the distal fixation portion 1212 of the thrombolytic bracket 12 fixedly connected to the bracket connection portion 112.
The aspiration catheter may include a tube 13 and a tube connector 15 connected to the proximal end of the tube 13.
Referring to fig. 2 and 3, the tube 13 may include: a distal tube portion 131, a suction port portion 132, and a perfusion tube portion 133, which are connected in this order from the distal end to the proximal end.
The distal tube part 131 extends in the axial direction, and the distal tube part 131 is disposed coaxially with the tube body 13 and has a guide wire hole 1311 for passing a guide wire. The distal tube portion 131 is tapered and pointed at the distal end to facilitate insertion of the distal end of the aspiration catheter into the thrombolytic stent 12. The fixing head 11, the thrombus taking support 12 and the tube body 13 can be coaxially arranged. When the fixing head 11 is a tapered head as shown in fig. 3, the fixing head 11 is disposed on the distal end side of the distal tube part 131. The fixed head 11 is far away from the distal tube 131 when the thrombus-taking stand 12 is in a contracted state, and is near the distal tube 131 when the thrombus-taking stand 11 is in an expanded state.
Referring to fig. 4, as an alternative example, the fixing head 11 may be tubular, where the fixing head 11 is fixedly connected to the distal end of the thrombus taking stand 12 and coaxially disposed, and the fixing head 11 is slidably sleeved on the distal tube portion 131, that is, the fixing head 11 can slide freely along the axial direction of the distal tube portion 131 so as to make the thrombus taking stand 12 in an expanded or contracted state. The distal end of the distal tube segment 131 is tapered to facilitate advancement of the device within the vessel. The distal tube portion also has a constant diameter sliding section, the length of which meets the axial sliding distance of the thrombolytic stent 12 during expansion and contraction.
Referring to fig. 7 and 8, a partition wall 134 is provided in the tube 13, extending from the proximal end of the tube 13 to the suction port 132, the partition wall 134 being used to divide the tube 13 into a suction lumen 1301 and a guide wire lumen, and the guide wire lumen being disposed eccentrically with respect to the tube 13.
Optionally, an axially extending stiffening core 135 may be provided within the dividing wall 134. The reinforcing core 135 may be a reinforcing rod having a circular cross section or a reinforcing rod having a rectangular cross section. Illustratively, the reinforcing core 135 may be made of stainless steel or nitinol. The strength of the tube 13 can be enhanced by reinforcing the core 135, and deformation or folding of the tube 13 during operation is avoided.
The guidewire port 1311 of the distal tube portion 131 is connected to the guidewire lumen to form a guidewire channel. Optionally, the guidewire lumen on the tube 13 includes a distal guidewire lumen 1302 and a proximal guidewire lumen 1303 connected. The distal end of the distal guidewire lumen 1302 is coupled to the guidewire port 1311 of the distal tube portion 131 such that the aspiration catheter has a guidewire channel therethrough. With continued reference to fig. 7, the distal guidewire lumen 1302 is a circumferentially closed loop guidewire lumen. Referring to fig. 8, the proximal guidewire lumen 1303 may be a circumferentially open groove guidewire lumen, i.e., the tube 13 is recessed inward to form a groove guidewire lumen, and the proximal end of the aspiration catheter is an open groove guidewire lumen, which facilitates penetration of the guidewire and advancement of the aspiration catheter within the blood vessel.
The suction port 132 is formed with a suction port 1321, and the suction port 1321 is a side-cut suction port that gradually increases and then gradually decreases from the distal end to the proximal end. The thrombus can be sucked in the axial direction of the thrombus taking support 12 through the side oblique cutting suction port, and the thrombus taking support has a larger suction port and good suction effect. Further, a side-cut suction port 1321 extends from the proximal end of the distal tube segment 131 to the junction of the thrombolytic stent 12 and the tube body 13. Therefore, the suction port can directly suck thrombus in a large range in the axial direction of the thrombus taking support, and has high suction efficiency. And the axial length of the suction port 1321 from the distal opening to the maximum incision is greater than the axial length from the maximum incision to the proximal incision, for example, the former may be 2 times or more than the latter, so that the suction port may have better suction performance.
The suction catheter further comprises a tube connector 15 connected to the proximal end of the tube body 13. The tube connector 15 is used to connect to a source of negative pressure and provide suction negative pressure within the tube body 13. The tube interface 15 is also used to infuse thrombolytic drugs into the infusion tube segment 133.
Referring to fig. 6, the pipe joint 15 may include: a handle portion 151, an operating joint 152 and a priming joint 153. The distal to proximal tube 13, handle portion 151 and operating joint 152 are coaxially connected in sequence and form a suction channel of a suction catheter. The handle coupling 152 may include a connecting tube segment 1522 and a coupling portion 1521, the connecting tube segment 1522 being connected between the proximal end of the handle portion 151 and the distal end of the coupling portion 1521. The inner end of the filling connection 153 is connected to the peripheral wall of the section 1522 of the connection pipe, the filling connection 153 having a filling channel 1531, the filling channel 1531 being connected to the section 1522 of the connection pipe. The infusion connector 153 may be connected to an infusion device to infuse medication into the aspiration catheter. The junction 1521 may be connected to a negative pressure source, such as a negative pressure pump, to provide suction negative pressure within the suction conduit.
With continued reference to fig. 3 and 10, the irrigation tube segment 133 of the tube body 13 includes a stopper segment 1331 and an irrigation segment 1332 connected from distal to proximal. The pouring section 1332 is provided with pouring structures 1333 at intervals in the axial direction and the circumferential direction. The infusion structure 1333 is used to establish access to the aspiration lumen 1301 and the environment to effect drug infusion. The infusion structure 1333 may be a tiny circular hole or a narrow slit type rectangular hole, or other types of structures capable of implementing drug infusion under infusion pressure, without specific limitation. The plurality of infusion structures 1333 may be evenly distributed axially and circumferentially along the infusion segment so that the drug may be more evenly applied.
For example, the occlusion assembly may be a balloon catheter 2, and the balloon catheter 2 may include a balloon 21 and a catheter 23. Balloon 21 is connected to catheter 23. The balloon catheter 2 may be a compliant or semi-compliant balloon catheter. The catheter 23 may be provided with a balloon catheter handle (not shown) at the outer end, and balloon 21 may be inflated by inflation of balloon 21 through catheter 23 or deflated by deflation of balloon catheter to retract balloon 21.
Thrombolytic drugs can be infused into the tube body 13 through the tube interface and can be ejected from the infusion structure 1333 at the peripheral wall of the infusion segment 1332. Wherein the balloon catheter 2 can be introduced into the tube 13 through the operation joint 152, and after the balloon 21 is inflated, the drug is infused into the tube 13 through the infusion joint 153. The length of the pouring tube section 133 may be set as desired, and is not particularly limited herein.
The distal end of the irrigation tube segment 133 of the tube body 13 may be provided with a visualization ring 14, through which the position of the thrombolytic stent 12 may be located, the visualization ring 14 may be used to indicate the position of the aspiration catheter, facilitating delivery of the thrombolytic stent 12 to the distal end of the thrombus. The visualization ring 14 may be made of a radiopaque alloy material and fixedly sleeved over the distal end of the irrigation tube segment 133. The catheter 23 may also be provided with a visualization mark 22. The position of the developing ring 14 on the tube 13 is matched with the developing mark 22 to determine whether the balloon body 21 reaches the plugging section 1331. For example, the positional relationship of the developing ring 14 and the developing mark 22 may be configured such that the balloon body 21 is just inside the blocking section 1331 when the positions of the developing ring 14 and the developing mark 22 coincide, but is not limited thereto, as long as accurate positioning of the position of the balloon body 21 is facilitated. The visualization mark 22 may be made of a radiopaque alloy material and is affixed to the catheter 23 to indicate the position of the balloon catheter 2.
Referring to fig. 11, in some examples, the multifunctional thrombi removal device may further comprise: an ultrasound catheter 3. The ultrasonic catheter is internally provided with ultrasonic transducers 31 which are arranged at intervals along the axial direction. The ultrasound catheter 3 can be brought into the aspiration catheter and into the irrigation tubing segment, and the ultrasound transducer 31 can radiate ultrasound sound energy in a radial direction upon energization. The ultrasonic transducer 31 is a device that converts electrical energy into ultrasonic energy. The ultrasonic transducer 31 may be made of a suitable piezoelectric material, such as lead zirconate titanate. Each of the ultrasonic transducers 31 may extend in the axial direction and may radiate ultrasonic waves therearound when energized. The number of the ultrasonic transducers 31 may be plural, and the plurality of ultrasonic transducers 31 may be connected in series by wires to form a transducer group, so that ultrasonic waves can be radiated in a thrombus segment of a greater length.
The method of using the multifunctional thrombus removal device of the present embodiment is as follows:
with continued reference to fig. 9, when the device is in the working state of thrombus removal and negative pressure suction, the thrombus removal bracket 12 is tightly attached to the inner wall of a blood vessel due to the shape memory property, the thrombus removal part 122 can scrape and strip the thrombus 40 attached to the wall of the blood vessel in the process of withdrawing the suction catheter and collect the thrombus in the collection part 121, after withdrawing a certain distance, an external negative pressure source connected to an operation joint of the suction catheter can be opened to perform negative pressure suction, so that the suction cavity 1301 is in the state of negative pressure suction, and the thrombus in the inner space of the collection part 121 is directly sucked outside the body (the thrombus suction direction is shown by an arrow in fig. 9), thereby realizing the integrated operation of thrombus removal and negative pressure suction of the bracket. And firstly, thrombus is collected into the thrombus taking support 12, and then the thrombus in the thrombus taking support 12 is sucked through the suction catheter, so that the blood loss can be obviously reduced, and the suction effect is improved.
With continued reference to fig. 10, when the device is in the infusion thrombolysis mode, the balloon catheter 2 enters from the operation joint 152 and reaches the plugging section 1331, and when the developing ring 14 of the tube body 13 is aligned with the developing mark 22 of the balloon catheter 2, for example, the two are aligned radially, the balloon body 21 is inflated by the catheter 23, and the balloon body 21 is inflated and attached to the suction cavity in the plugging section 1331 under the action of pressure until the plugging section is plugged, and then the thrombolytic drug is infused through the infusion joint 153, reaches the inner cavity of the infusion section 1332 through the suction channel and is sprayed from the infusion structure 1333 (the drug flow infusion direction is shown by the arrow in fig. 10), so that the thrombolytic drug acts on thrombus accurately, and thus the dissolution of thrombus is achieved.
With continued reference to fig. 11, when the device is in an ultrasonic working state, after the thrombolytic drug is injected, negative pressure suction is performed through the catheter 23, so that the balloon body 21 is retracted, the balloon catheter 2 is entirely withdrawn from the suction catheter, then the ultrasonic catheter 3 is conveyed from the operation joint 152 into the inner cavity of the perfusion tube section 133, and after the power is applied, the ultrasonic transducers 31 in the ultrasonic catheter 3 radiate ultrasonic waves to the circumferential direction respectively, so that the combination effect of the thrombolytic drug and thrombus is accelerated by ultrasonic mechanical energy, and the dissolution of thrombus is accelerated. Meanwhile, in order to reduce the temperature generated during the operation of the ultrasonic transducer 31, physiological saline may be injected through the injection joint 153, and the physiological saline may flow through the ultrasonic transducer 31 to cool down, and finally be discharged from the suction port.
In practical application, for chronic thrombus, thrombus can be destroyed by means of perfusion thrombolysis, ultrasonic thrombolysis and the like, and then combined thrombus taking is carried out by a thrombus taking bracket and a suction catheter, so that better thrombus taking effects can be achieved for thrombus of different types and different lumen sizes, complications can be reduced, and treatment effects can be improved better.
Based on the technical scheme, the invention has at least the following advantages and positive effects:
the multifunctional thrombus removing device of the embodiment of the invention skillfully combines the means of stent thrombus removing, catheter thrombolysis, negative pressure suction and the like, makes up for the advantages of short supply, reduced thrombus removing difficulty, better thrombus removing effect aiming at different lumen sizes and different types of thrombus, is beneficial to reducing complications and has better treatment effect. And the multifunctional thrombus removing device has reasonable structure and economic manufacturing cost, and is suitable for popularization and application.
It will be understood by those of ordinary skill in the art that the foregoing embodiments are specific examples of carrying out the invention and that various changes in form and details may be made therein without departing from the spirit and scope of the invention.
Claims (14)
1. A multifunctional thrombi removal device, comprising:
the thrombus taking bracket is of a self-expansion bracket structure;
the proximal end of the thrombus taking support is connected with the suction catheter, the distal end of the suction catheter is provided with a suction port, the suction port is positioned in the thrombus taking support, and the suction catheter is used for sucking thrombus collected by the thrombus taking support in an expanded state through the suction port; the distal end of the suction catheter is also provided with a perfusion tube section, and the perfusion tube section is positioned at the proximal end side of the thrombus taking bracket; and
a blocking assembly capable of entering into the irrigation tube section and blocking a distal end of the irrigation tube section for infusion of thrombolytic drugs by the aspiration catheter through the irrigation tube section;
the suction catheter comprises a catheter body and a catheter connector connected with the proximal end of the catheter body;
the tube interface is used for connecting a negative pressure source and providing suction negative pressure for the tube body, and is also used for pouring thrombolytic drugs into the pouring tube section;
the perfusion tube section comprises a plugging section and a perfusion section which are connected from the distal end to the proximal end; the pouring section is provided with pouring structures along the axial direction and the circumferential direction at intervals;
the plugging assembly is a balloon catheter, the balloon catheter comprises a balloon body and a catheter, and the balloon body is connected with the catheter;
the balloon body can enter the pipe body through the pipe joint and reach the plugging section, and the plugging section can be plugged when the balloon body is inflated; thrombolytic drugs can also be infused into the tube body through the tube joint, and the thrombolytic drugs can be sprayed out from the infusion structure of the peripheral wall of the infusion section.
2. The multifunctional thrombi elimination device of claim 1, wherein said tube interface comprises: a handle portion, an operating joint and a priming joint;
the tube body, the handle part and the operation joint are sequentially and coaxially connected from the distal end to the proximal end, and a suction channel of the suction catheter is formed;
the operating joint comprises a connecting pipe section and a joint part, wherein the connecting pipe section is connected between the proximal end of the handle part and the distal end of the joint part; the inner end of the pouring joint is connected with the peripheral wall of the connecting pipe section, the pouring joint is provided with a pouring channel, and the pouring channel is connected with the connecting pipe section.
3. The device of claim 1, wherein the tube comprises a distal tube section, a suction port section, and a perfusion tube section connected in sequence from the distal end to the proximal end; the tube body is internally provided with a separation wall extending from the proximal end of the tube body to the suction opening, the separation wall is used for separating the tube body into a suction cavity and a guide wire cavity, and the guide wire cavity is eccentrically arranged relative to the tube body.
4. A multifunctional thrombi elimination device according to claim 3 and wherein said distal tube portion is tapered and extends axially, said distal tube portion being coaxially disposed with said tube body and having a guidewire port for passage of a guidewire, said guidewire port being connected to said guidewire lumen.
5. A multifunctional thrombi elimination device according to claim 3 and wherein said guidewire lumen comprises a distal guidewire lumen and a proximal guidewire lumen connected, said distal guidewire lumen being a circumferentially closed loop guidewire lumen and said proximal guidewire lumen being a circumferentially open channel guidewire lumen.
6. A multifunctional thrombi elimination device according to claim 3 and wherein said partition wall is provided with an axially extending stiffening core.
7. A multifunctional thrombi elimination device according to claim 3 and wherein said aspiration port forms said aspiration port which is a side-bevel aspiration port which increases gradually and then decreases gradually from distal to proximal end.
8. The device of claim 7, wherein the side-bevel suction port extends proximally from the distal tube section to a junction of the thrombus-aspiration stent and the tube body.
9. The device of claim 1, wherein the distal end of the perfusion tube segment is provided with a visualization ring and the catheter is provided with a visualization mark; and determining whether the balloon body reaches the plugging section by matching the positions of the developing mark and the developing ring.
10. The device of claim 1, wherein the thrombus removal stent is spherical, ellipsoidal or spindle-shaped.
11. The multifunctional thrombi elimination device of claim 1, wherein said thrombi elimination stent comprises: a fixed head, a collecting part and a thrombus taking part which are connected in sequence from a distal end to a proximal end;
the distal end of the collecting part is connected with the proximal end of the fixing head, and the fixing head can axially move relative to the suction catheter so as to enable the thrombus taking support to be in an expanded or contracted state.
12. The device of claim 11, wherein the collection portion comprises a mesh structure formed by a plurality of connecting rods connected in a staggered manner; the thrombus taking part comprises a plurality of connecting rods which are arranged at intervals along the circumferential direction, the distal ends of the connecting rods are smoothly connected with the proximal ends of the collecting parts, and the proximal ends of the connecting rods are connected with the suction catheter;
the tube body comprises a distal tube part, a suction opening part and a perfusion tube section which are sequentially connected from the distal end to the proximal end.
13. The device of claim 12, wherein the fixing head is tapered and extends in an axial direction, the fixing head and the thrombus taking support are coaxially arranged and are arranged on the far end side of the far end tube part, a through hole for a guide wire to pass through is formed in the fixing head, and the far end tube part is tapered; or alternatively
The fixing head is tubular and is sleeved on the distal tube part in a sliding manner, and the distal end of the distal tube part is tapered.
14. The multifunctional thrombi removal device of any one of claims 1-13, wherein said device further comprises: an ultrasound catheter; ultrasonic transducers which are arranged at intervals along the axial direction are arranged in the ultrasonic catheter;
the ultrasound catheter is capable of entering the aspiration catheter and reaching into the irrigation tubing segment, and the ultrasound transducer is capable of radiating ultrasound energy in a radial direction upon energization.
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| Application Number | Priority Date | Filing Date | Title |
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| CN202210667899.7A CN115177321B (en) | 2022-06-14 | 2022-06-14 | Multifunctional thrombus removing device |
| PCT/CN2022/135669 WO2023240937A1 (en) | 2022-06-14 | 2022-11-30 | Multifunctional thrombus removal apparatus |
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| CN202210667899.7A CN115177321B (en) | 2022-06-14 | 2022-06-14 | Multifunctional thrombus removing device |
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| CN115177321A CN115177321A (en) | 2022-10-14 |
| CN115177321B true CN115177321B (en) | 2023-06-20 |
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| CN115177321B (en) * | 2022-06-14 | 2023-06-20 | 上海腾复医疗科技有限公司 | Multifunctional thrombus removing device |
-
2022
- 2022-06-14 CN CN202210667899.7A patent/CN115177321B/en active Active
- 2022-11-30 WO PCT/CN2022/135669 patent/WO2023240937A1/en unknown
Also Published As
| Publication number | Publication date |
|---|---|
| CN115177321A (en) | 2022-10-14 |
| WO2023240937A1 (en) | 2023-12-21 |
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