CN115177321A - Multifunctional thrombus clearing device - Google Patents
Multifunctional thrombus clearing device Download PDFInfo
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- CN115177321A CN115177321A CN202210667899.7A CN202210667899A CN115177321A CN 115177321 A CN115177321 A CN 115177321A CN 202210667899 A CN202210667899 A CN 202210667899A CN 115177321 A CN115177321 A CN 115177321A
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Abstract
The invention provides a multifunctional thrombus removal device. It includes: the thrombus taking device comprises a thrombus taking support, a suction catheter and a plugging component; the thrombus taking support is of a self-expansion type support structure; the proximal end of the thrombus taking bracket is connected with an aspiration catheter, the distal end of the aspiration catheter is provided with an aspiration port, the aspiration port is positioned in the thrombus taking bracket, and the aspiration catheter is used for aspirating thrombus collected by the thrombus taking bracket in an expansion state through the aspiration port; the distal end of the suction catheter is also provided with an infusion tube section which is positioned at the proximal end side of the thrombus removal bracket; the plugging assembly can enter the perfusion tube section and plug the far end of the perfusion tube section so that the suction catheter can be used for perfusing thrombolytic medicines through the perfusion tube section. According to the embodiment of the invention, the infusion thrombolysis, the stent thrombus removal and the negative pressure suction are combined into a whole, so that the advantages are gained and the disadvantages are compensated, and a better thrombus removal effect can be achieved aiming at different thrombus types and lumen sizes.
Description
Technical Field
The invention relates to the technical field of medical instruments, in particular to a multifunctional thrombus removing device.
Background
Vascular disease has become the first fatal disease in our country, and vascular embolism has become a major factor in vascular disease. In particular, the total annual new disease rate of patients with cerebral arterial thrombosis, pulmonary embolism and lower limb venous embolism is over 500 ten thousand.
Currently, medical interventional thrombus removal is gradually an effective recommended mode for the mainstream of vascular thrombus treatment. The interventional thrombus removal 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 better.
In the clinical practice of endovascular embolus treatment, the existing interventional technical scheme mainly comprises treatment means such as systemic thrombolysis, catheter contact thrombolysis and mechanical embolus extraction, and different means have different advantages and disadvantages: systemic thrombolytic treatment regimens are at risk of inducing cerebral or systemic bleeding; the contact of the catheter with the thrombolysis reduces the dosage of the thrombolytic drugs, but still has bleeding complications, and meanwhile, the long-time catheter thrombolysis has the risk of infection; although the pure negative pressure suction type thrombus removal is economical, the blood loss in the operation process is large, and the thrombus removal effect in a large lumen cannot achieve a good effect; the mechanical thrombus taking process of the rheological type requires attention to monitoring of the using time, hemoglobinuria frequently occurs after operation, and meanwhile, the 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 or even chronic thrombus. Therefore, there is a need for a thrombus clearing device that can achieve better clearing effect for different positions and different types of thrombus.
It is to be noted that the information disclosed in the above background section is only for enhancement of understanding of the background of the present application and therefore may include information that does not constitute prior art known to a person of ordinary skill in the art.
Disclosure of Invention
The embodiment of the invention aims to provide a multifunctional thrombus removal device, which is economic and can achieve a better removal effect on different parts and different types of thrombus.
In order to solve the above technical problem, an embodiment of the present invention provides a multifunctional thrombus removal device, including:
the thrombus taking support is of a self-expansion type support structure;
an aspiration catheter, wherein the proximal end of the embolectomy stent is connected with the aspiration catheter, the distal end of the aspiration catheter is provided with an aspiration port, the aspiration port is positioned in the embolectomy stent, and the aspiration catheter is used for aspirating thrombus collected by the embolectomy stent in an expanded state through the aspiration port; the distal end of the suction catheter is also provided with an infusion pipe section which is positioned on the proximal side of the embolectomy bracket; and
a blocking assembly capable of entering into the infusion tube section and blocking the distal end of the infusion tube section for the aspiration catheter to infuse thrombolytic drugs through the infusion tube section.
As one example, the aspiration catheter includes a tube body and a tube interface coupled to a proximal end of the tube 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 infusing thrombolytic drugs into the infusion tube section.
As one embodiment, the tube interface comprises: handle portion, operating joint and perfusion joint;
the tube body, the handle part and the operating joint are coaxially connected in sequence from the far end to the near end and form a suction channel of the suction catheter;
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 filling joint is connected with the peripheral wall of the connecting pipe section, the filling joint is provided with a filling channel, and the filling channel is connected with the connecting pipe section.
As one embodiment, the tube body comprises a distal tube part, a suction port part and an infusion tube part which are sequentially connected from the distal end to the proximal end; the catheter is characterized in that a partition wall extending from the proximal end of the catheter to the suction opening is arranged in the catheter, the partition wall is used for partitioning the catheter into a suction cavity and a guide wire cavity, and the guide wire cavity is eccentrically arranged relative to the catheter.
As an embodiment, the distal end pipe portion is the toper and extends along the axial, distal end pipe portion with the body coaxial arrangement just has the wire guide hole that is used for passing through the seal wire, the wire guide hole with the wire guide chamber links to each other.
As an embodiment, the guidewire lumen includes a distal guidewire lumen and a proximal guidewire lumen that are connected, the distal guidewire lumen is a circumferentially closed loop guidewire lumen, and the proximal guidewire lumen is a circumferentially open channel-shaped guidewire lumen.
As an embodiment, an axially extending stiffening core is provided in the partition wall.
As an embodiment, the suction port portion forms the suction port, and the suction port is a side-chamfered suction port which gradually increases and then gradually decreases from the distal end to the proximal end;
optionally, the sidecut suction port extends from the proximal end of the distal tube portion to the junction of the thrombectomy stent and the tube.
As one example, the irrigation segment comprises a blocking segment and an irrigation segment connected from a distal end to a proximal end; the filling section is provided with filling structures at intervals along the axial direction and the circumferential direction;
the plugging component 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 tube body through the tube interface and reach the plugging section, and the balloon body can plug the plugging section when being inflated; thrombolytic drugs can be filled into the tube body through the tube interface, and the thrombolytic drugs can be sprayed out of the filling structure of the peripheral wall of the filling section.
As an 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 occlusion section by matching the positions of the developing mark and the developing ring.
As one example, the embolectomy stent is spherical, ellipsoidal, or spindle shaped.
As one embodiment, the thrombectomy support comprises: the fixing head, the collecting part and the bolt taking part are sequentially connected from the far end to the near end;
the far end of the collecting part is connected with the near end of the fixed head; the fixing head can move axially relative to the suction catheter to enable the embolectomy support to be in an expanded or contracted state;
optionally, the collecting part comprises a mesh structure formed by connecting a plurality of connecting rods in a staggered manner, the embolectomy part comprises a plurality of connecting rods arranged at intervals along the circumferential direction, the distal ends of the connecting rods are smoothly connected with the proximal end of the collecting part, and the proximal ends of the connecting rods are connected with the suction catheter;
the tube body comprises a far-end tube part, a suction opening part and a perfusion tube section which are sequentially connected from a far end to a near end; optionally, the fixing head is tapered and extends axially, the fixing head and the thrombus removal support are coaxially arranged and are arranged on the distal end side of the distal tube part, a through hole for a guide wire to pass through is arranged in the fixing head, and the distal tube part is tapered; or
The fixing head is tubular and is sleeved on the far-end tube part in a sliding mode, and the far end of the far-end tube part is conical.
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 can enter the suction catheter and reach the irrigation tube section, and the ultrasound transducer can radiate ultrasound energy in a radial direction after being electrified.
According to the technical scheme, the invention at least has the following advantages and positive effects:
in the multifunctional thrombus removal device provided by the embodiment of the invention, the proximal end of the thrombus taking support is connected with the distal end of the suction catheter, the distal end of the suction catheter extends into the thrombus taking support, the thrombus taking support can be retracted through the suction catheter, and the thrombus can be stripped and collected through the thrombus taking support, so that the thrombus is easier to suck, and meanwhile, the thrombus in the thrombus taking support can be quickly sucked out of a body through the suction catheter, so that the thrombus taking difficulty is reduced, and the thrombus taking efficiency is improved; and, because the suction catheter distal end has the filling pipe section, and can block up the filling pipe section distal end through the shutoff subassembly, the rethread filling pipe section fills the thrombolysis medicine to can annotate the medicine thrombolysis accurately, with further reducing the support and get the thrombus degree of difficulty. Therefore, the multifunctional thrombus removal device of the embodiment skillfully combines means such as stent thrombus taking, tube placing thrombolysis and negative pressure suction, makes up for deficiencies by taking the advantages, reduces the thrombus taking difficulty, can achieve better thrombus taking effect aiming at thrombus with different tube cavity sizes and different types, is favorable for reducing complications, and has 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 used in the embodiments or the prior art descriptions will be briefly introduced below, it is understood that the drawings in the following description are only examples of the present invention, and for those skilled in the art, other drawings can be obtained according to the provided drawings without creative efforts.
FIG. 1 is a schematic structural view of a multifunctional thrombus removal device provided by an embodiment of the present invention;
FIG. 2 is a partial structural view of an aspiration catheter of the multifunctional thrombectomy device according to an embodiment of the present invention;
FIG. 3 is a schematic cross-sectional view of FIG. 2;
FIG. 4 is a partial structural view of an aspiration catheter of the multifunctional thrombectomy device according to another embodiment of the present invention;
FIG. 5 is a partial structural view of the thrombectomy stent of the multifunctional thrombectomy device provided in the embodiment of the present invention;
FIG. 6 is a partial sectional view schematically showing the construction of an aspiration catheter of the multifunctional thrombus removal device according to the embodiment of the present invention;
FIG. 7 is a schematic cross-sectional view of the distal end of the aspiration catheter of the multifunctional thrombectomy device according to the embodiment of the present invention;
FIG. 8 is a schematic cross-sectional view of the proximal end of the aspiration catheter of the multifunctional thrombectomy device according to the embodiment of the present invention;
FIG. 9 is a schematic view of the thrombectomy stent and aspiration catheter combined thrombectomy device provided by the embodiment of the invention;
FIG. 10 is a schematic view of the multi-functional thrombus removal device according to an embodiment of the present invention;
fig. 11 is a schematic diagram of an ultrasonic catheter thrombolysis structure of the multifunctional thrombus removal device provided by the embodiment of the present invention.
Detailed Description
In order to make the objects, technical solutions and advantages of the embodiments of the present invention more apparent, embodiments of the present invention will be described in detail below with reference to the accompanying drawings. However, it will be appreciated by those of ordinary skill in the art that numerous technical details are set forth in order to provide a better understanding of the present invention in its various embodiments. However, the technical solution claimed in the present invention can be implemented without these technical details and various changes and modifications based on the following embodiments.
In the description of the present invention, it should be noted that the terms "upper", "lower", "inside", "outside", and the like indicate orientations or positional relationships based on the orientations or positional relationships shown in the drawings, and are only for convenience in describing the present invention and simplifying the description, but do not indicate or imply that the referred device or element must have a specific orientation, be constructed in a specific orientation, and be operated, 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 is to be understood that, unless expressly stated otherwise, the terms "connected" and "coupled" are intended to be used broadly, and may include, for example, fixed and removable connections as well as integral connections; they may be connected directly or indirectly through intervening media, or they may be interconnected 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 center of the distal end and the center of the proximal end of the medical device in its natural state. The foregoing definitions are for convenience only and are not to be construed as limiting the present invention.
Referring to fig. 1, 3 and 9, the embodiment of the present invention provides a multifunctional thrombus removal device, which can be used for effectively removing different types of thrombus at different positions. The multifunctional thrombus removal device of the embodiment mainly comprises: a thrombectomy stent 12, a suction catheter and a plugging assembly.
The thrombectomy stent 12 is a self-expanding stent structure that can be expanded to conform to the inner wall of a vessel to strip and collect thrombi.
The proximal end of the thrombectomy stent 12 is connected to the aspiration catheter, i.e. the thrombectomy stent 12 and the aspiration catheter form an integrated thrombectomy structure 1, through which the thrombectomy stent 12 can be withdrawn. The distal end of the aspiration catheter has an aspiration port 1321, and the aspiration port 1321 is located in the thrombectomy stent 12, and the aspiration catheter is used for aspirating thrombi collected by the thrombectomy stent 12 in the expanded state through the aspiration port 1321. After the thrombus is stripped and collected by the thrombus taking support 12, the thrombus suction difficulty can be obviously reduced, the collected thrombus can be directly sucked out of the body by the suction catheter, meanwhile, the thrombus concentrated together is sucked, the suction efficiency is higher, and the difficult problem that the large lumen is difficult to suck is also solved.
The distal end of the aspiration catheter is also formed with an infusion tube segment 133, with the infusion tube segment 133 being located on the proximal side of the thrombectomy stent 12. The occlusion assembly is capable of entering the infusion tube segment 133 and occluding the distal end of the infusion tube segment 133 to allow the aspiration catheter to infuse thrombolytic drugs through the infusion tube segment 133. The suction catheter can be used as an infusion catheter for drug injection and thrombolysis. The thrombus which is difficult to strip by the thrombus taking stent 12 or chronic thrombus can be dissolved in advance, and thrombus can be taken by the thrombus taking stent 12 after the bonding 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 far end of the perfusion tube section 133 is blocked by matching the blocking component with the suction catheter and then is filled with the medicine, so that the medicine can be applied more accurately, the medicine dosage is saved, and the risk of complication occurrence is reduced.
The embolectomy stent 12 can be spherical, ellipsoidal, or spindle shaped. The thrombus-taking support 12 has the main effects that the thrombus-taking support can expand and cling to the inner wall of a blood vessel after being released, thrombus on the inner wall of the blood vessel can be completely peeled off when being withdrawn, and meanwhile, a proper amount of thrombus can be collected and stored without providing a storage space for a large amount of thrombus, so that the axial length of the thrombus-taking support 12 can be shorter, the whole volume can be smaller, and compared with the thrombus-taking support which needs to directly take the thrombus out of the body, the manufacturing cost can be lower.
Referring to fig. 2 and 5, the embolectomy support 12 may include: a fixing head 11, a collecting part 121 and a bolt taking part 122 which are connected in sequence from the far end to the near end. Illustratively, the collecting portion 121 includes a net structure formed by connecting a plurality of connecting rods 1211 alternately, and the distal end of the collecting portion 121 is connected to the proximal end of the fixing head 11. The embolectomy portion 122 may include a plurality of circumferentially spaced rods 1221, the distal ends of the rods 1221 being smoothly connected to the proximal end of the collection portion 121, and the proximal ends of the rods 1221 being connected to the aspiration catheter. The thrombus extraction portion 122 has a mesh-thinning structure, and an opening through which thrombus enters is formed between adjacent links 1221, so that the thrombus can be cut by the links 1221. The collecting part 121 has a dense mesh structure, and can filter and intercept thrombus and allow blood to pass through. The fixation head 11 is axially movable relative to the aspiration catheter to place the embolectomy support 12 in an expanded or contracted state. When the thrombus removal 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 removal support 12 can be in a contraction state, and after the thrombus removal support 11 is released, the fixing head 11 can be driven to move towards the near end relative to the suction catheter by virtue of the self elastic force so as to enable the thrombus removal support to be in an expansion state.
The connecting rods 1211 of the collecting part 121 extend spirally in the forward and reverse directions and are connected in a staggered manner to form a mesh structure, and the peripheral wall of the collecting part 121 can form diamond-shaped meshes. The thrombectomy support 12 may further include a distal connection portion 123, and is fixedly connected to the proximal end of the fixation head 11 via the distal connection portion 123, such as by welding. The distal connecting portion 123 may include a plurality of distal fixing rods 1231, and the distal fixing rods 1231 may be formed by extending connecting rods 1211. The collecting part 121 can be reliably fixed to the fixing head 11 by the plurality of distal end fixing rods 1231.
The several rods 1221 of the embolectomy portion 122 may originate from the intersection of the connecting rods 1211 of the collection portion 121 and extend proximally or may extend proximally directly from the connecting rod 1211 at the proximal end of the collection portion 121 and be constrained 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 plug portion 122. The embolectomy portion 122 may further include a proximal fixation portion 124, and the proximal fixation portion 124 may include a plurality of proximal fixation rods 1241 formed by extending rods 1221, and the proximal fixation rods 1241 may be fixedly connected to the suction catheter by welding.
The thrombectomy stent 12 can be made of a nickel-titanium tube by laser cutting and heat setting, or can be woven by using a woven wire with shape memory capability, such as a nickel-titanium alloy wire. It is understood that the present embodiment is not particularly limited to the structure of the thrombectomy support 12, as long as the desired thrombectomy performance is achieved.
Referring to fig. 3, the fixing head 11 is tapered and extends axially, the fixing head 11 is coaxial with the thrombectomy stent 12, and the fixing head 11 can improve the propelling capability of the device in blood vessels. The fixing head 11 is provided with a through hole 113 for passing a guide wire (not shown) which is used for guiding the device to the thrombus site. The fixing head 11 may include a tapered portion 111 and a bracket connecting portion 112, and the distal fixing portion 1212 of the embolectomy bracket 12 is fixedly connected to the bracket connecting portion 112.
The aspiration catheter may include a tube body 13 and a tube interface 15 connected to a proximal end of the tube body 13.
Referring to fig. 2 and 3, the tube 13 may include: a distal tube part 131, a suction port part 132 and an irrigation tube segment 133 connected in sequence from the distal end to the proximal end.
The distal tube portion 131 extends in the axial direction, and the distal tube portion 131 is provided 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 thrombectomy holder 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 portion 131. When the embolectomy stent 12 is in the contracted state, the fixation head 11 is away from the distal tube 131, and when the embolectomy stent 11 is in the expanded state, the fixation head is close to the distal tube 131.
Referring to fig. 4, as an alternative, the fixing head 11 may be tubular, the fixing head 11 is fixed to and coaxially disposed with the distal end of the embolectomy support 12, and the fixing head 11 is slidably sleeved on the distal tube 131, that is, the fixing head 11 can freely slide along the axial direction of the distal tube 131 to make the embolectomy support 12 in an expanded or contracted state. The distal end of the distal tube portion 131 is tapered to facilitate advancement of the device within the blood vessel. The distal tube portion also has a sliding section with an equal diameter, and the length of the sliding section is the axial sliding distance required when the embolectomy stent 12 expands and contracts.
Referring to fig. 7 and 8, a partition wall 134 extending from the proximal end of the tube 13 to the suction port 132 is disposed in the tube 13, and the partition wall 134 is used to partition the tube 13 into a suction lumen 1301 and a guidewire lumen eccentrically disposed with respect to the tube 13.
Optionally, an axially extending reinforcing core 135 may be provided within the dividing wall 134. The strength member 135 may be a round cross-section strength member or a rectangular cross-section strength member. Illustratively, the strength member 135 may be formed from stainless steel or a nickel titanium alloy. The strength of the tubular body 13 is enhanced by the reinforcing core 135, which prevents the tubular body 13 from being deformed or broken during operation.
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 body 13 includes a distal guidewire lumen 1302 and a proximal guidewire lumen 1303 which are connected. The distal guidewire lumen 1302 is distally connected 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 in the form of a circumferentially closed, closed loop guidewire lumen. Referring to fig. 8, the proximal end guide wire cavity 1303 may be a groove-shaped guide wire cavity with a circumferential opening, that is, the tube body 13 is recessed inward to form a groove-shaped guide wire cavity, and the proximal end of the suction catheter adopts an open groove-shaped guide wire cavity, which is convenient for the guide wire to penetrate and is beneficial for the suction catheter to advance in the blood vessel.
The suction port portion 132 is formed with a suction port 1321, and the suction port 1321 is a side-chamfered suction port which is gradually increased and then gradually decreased 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-beveling suction port, and the suction effect is good due to the larger suction port. Further, a side-cutting suction port 1321 extends from the proximal end of the distal tube portion 131 to the junction of the thrombectomy stent 12 and the tubular body 13. Therefore, the suction port can directly suck thrombus in a large range in the axial direction of the thrombus taking support, and the high suction efficiency is achieved. And the axial length of the suction port 1321 from the distal opening to the maximum incision is longer than the axial length from the maximum incision to the proximal incision, for example, the former may be 2 times or more than 2 times of the latter, so that the suction port has better suction performance.
The suction catheter also includes a tube interface 15 connected to the proximal end of the tube body 13. The tube interface 15 is used to connect to a source of negative pressure and provide suction negative pressure within the tube body 13. The tubing interface 15 is also used to prime the infusion tubing segment 133 with thrombolytic drug.
Referring to fig. 6, the pipe interface 15 may include: handle portion 151, operating joint 152 and irrigation joint 153. The distal to proximal tube body 13, the handle portion 151 and the operating joint 152 are coaxially connected in sequence and form a suction channel of the suction catheter. The operating joint 152 may include a connecting tube segment 1522 and a joint portion 1521, the connecting tube segment 1522 being connected between the proximal end of the handle portion 151 and the distal end of the joint portion 1521. The inner end of the filling connector 153 is connected to the peripheral wall of the connecting tube 1522, the filling connector 153 has a filling channel 1531, and the filling channel 1531 is connected to the connecting tube 1522. The infusion connector 153 may be connected to a drug infusion device to infuse a drug into the aspiration catheter. The connector portion 1521 may be connected to a negative pressure source, such as a negative pressure pump, to provide suction negative pressure within the suction catheter.
With continued reference to fig. 3 and 10, the irrigation section 133 of the tube body 13 includes an occluding section 1331 and an irrigation section 1332 connected from the distal end to the proximal end. The pouring section 1332 is provided with pouring structures 1333 at axial and circumferential intervals. The irrigation structure 1333 is used to establish a passageway of the aspiration lumen 1301 with the outside world, thereby enabling drug injection. The perfusion structure 1333 may be a tiny circular hole or a rectangular hole of a narrow slit type, or other types of structures capable of achieving drug perfusion under perfusion pressure, and is not particularly limited herein. The plurality of irrigation structures 1333 may be evenly distributed axially and circumferentially along the irrigation segment so that the medicament may be more evenly applied.
For example, the occlusion component may be a balloon catheter 2, and the balloon catheter 2 may include a balloon body 21 and a catheter 23. Balloon body 21 is connected to catheter 23. The balloon catheter 2 may be a compliant or semi-compliant balloon catheter. The outer end of the catheter 23 may be provided with a balloon catheter handle (not shown), and the balloon body 21 may be inflated and pressurized by the inflation and pressurization of the balloon body 21 or deflated to enable the balloon body 21 to be retracted through the catheter 23.
The balloon body 21 can enter the tube body 13 through the interface and reach the plugging section 1331, and the balloon body 21 can block the plugging section 1331 when inflated. The balloon body 21 may be a shaped balloon catheter that matches the shape of the suction lumen 1301 in the sealing section 1331, so that the sealing section 1331 can be better sealed, and the drug is prevented from flowing to the distal end of the suction catheter to cause excessive drug injection or waste. It is understood that the balloon body 21 may be a circular common balloon catheter as long as the plugging section 1331 can be blocked to a large extent.
The tube body 13 can be filled with thrombolytic drug through the tube interface, and the thrombolytic drug can be ejected from the filling structure 1333 of the peripheral wall of the filling section 1332. The balloon catheter 2 can enter the tube 13 through the operation joint 152, and when the balloon body 21 is inflated, the drug is filled into the tube 13 through the filling joint 153. The length of the irrigation pipe section 133 may be set as desired, and is not particularly limited herein.
The distal end of the irrigation segment 133 of the tube body 13 may be provided with a visualization ring 14, the position of the thrombectomy stent 12 may be located by the visualization ring 14, and the visualization ring 14 may be used to indicate the position of the aspiration catheter, facilitating the delivery of the thrombectomy stent 12 to the distal end of the thrombus. Visualization ring 14 may be made of a radiopaque alloy material and secured over the distal end of infusion tube segment 133. The catheter 23 may also be provided with a visualization marker 22. Whether the balloon body 21 reaches the blocking section 1331 is determined by matching the position of the development mark 22 with the position of the development ring 14 on the tube body 13. For example, the positional relationship between 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 it is convenient to accurately position the position of the balloon body 21. The visualization marker 22 may be made of a radiopaque alloy material and is fixed to the catheter 23 to indicate the position of the balloon catheter 2.
Referring to fig. 11, in some examples, the multifunctional thrombus removal device may further comprise: an ultrasound catheter 3. The ultrasonic catheter is provided with ultrasonic transducers 31 arranged at intervals along the axial direction. The ultrasound catheter 3 can enter the suction catheter and reach the irrigation tube section, and the ultrasound transducer 31 can radiate ultrasound sound volume in the radial direction after being energized. The ultrasonic transducer 31 is a device that converts electric energy into ultrasonic energy. The ultrasonic transducer 31 may be made of a suitable piezoelectric material, such as lead zirconate titanate. Each ultrasonic transducer 31 may extend in an axial direction and may radiate ultrasonic waves to its surroundings when energized. The number of the ultrasonic transducers 31 can be multiple, and the plurality of the ultrasonic transducers 31 can be connected in series through a wire to form a transducer group, so that ultrasonic waves can be radiated in a thrombus segment with a larger length.
The use method of the multifunctional thrombus removal device of the embodiment is as follows:
as shown in fig. 9, when the device is in the working state of thrombus extraction and negative pressure suction, the thrombus extraction stent 12 is tightly attached to the inner wall of the blood vessel due to the shape memory property, the thrombus extraction portion 122 can scrape and strip the thrombus 40 attached to the blood vessel wall and collect the thrombus in the collection portion 121, after the device is withdrawn for 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 internal space of the collection portion 121 is directly sucked to the outside of the body (the thrombus suction direction is shown by an arrow in fig. 9), thereby realizing the integrated operation of stent thrombus extraction and negative pressure suction. And firstly, the 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 drug-loading thrombolysis operating state, the balloon catheter 2 enters from the operating joint 152 and reaches the blocking section 1331, when the developing ring 14 of the tube body 13 is aligned with the developing mark 22 of the balloon catheter 2, for example, when the two are radially aligned, the balloon body 21 is inflated through the catheter 23, the balloon body 21 is inflated under the pressure and attached to the suction cavity in the blocking section 1331 until the blocking section is blocked, then the thrombolysis drug is injected through the infusion joint 153, the thrombolysis drug reaches the inner cavity of the infusion section 1332 through the suction channel and is sprayed out from the infusion structure 1333 (the drug flow infusion direction is shown by an arrow in fig. 10), so that the thrombolysis drug can accurately act on the thrombus to dissolve the thrombus.
As shown in fig. 11, when the apparatus is in an ultrasonic working state, after the thrombolytic drug is injected, negative pressure suction is performed through the catheter 23, the balloon body 21 is retracted, the balloon catheter 2 is integrally withdrawn from the suction catheter, the ultrasonic catheter 3 is then delivered to the inner cavity of the perfusion tube section 133 from the operation joint 152, and the plurality of ultrasonic transducers 31 in the ultrasonic catheter 3 respectively radiate ultrasonic waves in the circumferential direction after being powered on, so that the combination effect of the thrombolytic drug and the thrombus is accelerated by the mechanical energy of the ultrasonic waves, and the dissolution of the thrombus is accelerated. Meanwhile, in order to reduce the temperature generated during the operation of the ultrasonic transducer 31, the saline may be injected through the perfusion connector 153, and the saline may flow through the ultrasonic transducer 31 to reduce the temperature thereof, and finally the saline is discharged from the suction port.
In practical application, aiming at chronic thrombus, the thrombus can be firstly destroyed by means of perfusion thrombolysis, ultrasonic accelerated thrombolysis and the like, and then the thrombus is taken out by combining the thrombus taking support and the suction catheter, so that different types of thrombus with different lumen sizes can be better thrombus taking effects, complications can be reduced, and the treatment effect can be better improved.
Based on the technical scheme, the invention at least has the following advantages and positive effects:
the multifunctional thrombus removal device skillfully combines the means of stent thrombus removal, catheterization and thrombolysis, negative pressure suction and the like, makes up for deficiencies, reduces thrombus removal difficulty, can achieve better thrombus removal effect aiming at thrombus with different lumen sizes and different types, is favorable for 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 practicing the invention, and that various changes in form and detail may be made therein without departing from the spirit and scope of the invention in practice.
Claims (13)
1. A multi-functional thrombus removal device, comprising:
the thrombus taking support is of a self-expanding support structure;
the suction catheter is connected with the proximal end of the thrombus taking support, 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 an infusion tube section which is positioned on the proximal side of the embolectomy bracket; and
a blocking assembly capable of entering into and blocking the distal end of the infusion tube segment for infusion of thrombolytic drugs by the aspiration catheter through the infusion tube segment.
2. The multifunctional thrombus removal device according to claim 1, wherein the aspiration catheter comprises a tube body and a tube interface connected to a proximal end of the tube body;
the tube connector is used for connecting a negative pressure source and providing suction negative pressure for the tube body, and is also used for filling thrombolytic drugs into the filling tube section.
3. The multifunctional thrombus removal device of claim 2, wherein the tube interface comprises: handle portion, operating joint and perfusion joint;
the tube body, the handle part and the operating joint are coaxially connected in sequence from the far end to the near end and form a suction channel of the suction catheter;
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 filling joint is connected with the peripheral wall of the connecting pipe section, the filling joint is provided with a filling channel, and the filling channel is connected with the connecting pipe section.
4. The multifunctional thrombus removal device according to claim 2, wherein the tube body comprises a distal tube portion, an aspiration port portion and an infusion tube portion which are connected in sequence from a distal end to a proximal end; the catheter is characterized in that a partition wall extending from the proximal end of the catheter to the suction opening is arranged in the catheter, the partition wall is used for partitioning the catheter into a suction cavity and a guide wire cavity, and the guide wire cavity is eccentrically arranged relative to the catheter.
5. The multifunctional thrombus removal device according to claim 4, wherein the distal tube portion is tapered and extends in an axial direction, and is coaxially disposed with the tube body and has a guide wire hole for passing a guide wire, the guide wire hole being connected to the guide wire lumen.
6. The multifunctional thrombus removal device according to claim 4, wherein the guidewire lumen comprises a distal guidewire lumen and a proximal guidewire lumen connected, the distal guidewire lumen being a circumferentially closed loop guidewire lumen, the proximal guidewire lumen being a circumferentially open channel-shaped guidewire lumen.
7. The multifunctional thrombus removal device according to claim 4, wherein an axially extending reinforcing core is provided in the partition wall.
8. The multifunctional thrombus removal device according to claim 4, wherein the suction port portion forms the suction port, and the suction port is a side-chamfered suction port which is gradually increased and then gradually decreased from a distal end to a proximal end;
optionally, the side-chamfer suction port extends from the proximal end of the distal tube portion to the junction of the thrombectomy support and the tube body.
9. The multifunctional thrombus removal device of claim 2, wherein the infusion tube segment comprises a blocking segment and an infusion segment connected from a distal end to a proximal end; the filling section is provided with filling structures at intervals along the axial direction and the circumferential direction;
the plugging component 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 tube body through the tube interface and reach the plugging section, and the balloon body can plug the plugging section when being inflated; thrombolytic drugs can be filled into the tube body through the tube interface, and the thrombolytic drugs can be sprayed out of the filling structure of the peripheral wall of the filling section.
10. The multifunctional thrombus removal device according to claim 9, wherein the distal end of the perfusion tube section is provided with a visualization ring, and the catheter is provided with a visualization mark; and determining whether the balloon body reaches the blocking section or not by matching the positions of the developing mark and the developing ring.
11. The multifunctional thrombus removal device according to claim 1, wherein the thrombus removal scaffold is spherical, ellipsoidal or spindle-shaped.
12. The multifunctional thrombus removal device according to claim 2, wherein the thrombectomy stent comprises: the fixing head, the collecting part and the bolt taking part are sequentially connected from the far end to the near end;
the distal end of the collecting part is connected with the proximal end of the fixed head, and the fixed head can axially move relative to the suction catheter to enable the embolectomy 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 manner; the bolt taking part comprises a plurality of connecting rods which are arranged at intervals along the circumferential direction, the far ends of the connecting rods are smoothly connected with the near end of the collecting part, and the near end of the connecting rods is connected with the suction catheter;
the tube body comprises a far-end tube part, a suction opening part and a perfusion tube section which are sequentially connected from a far end to a near end; optionally, the fixing head is tapered and extends axially, the fixing head and the thrombus removal support are coaxially arranged and are arranged on the distal end side of the distal tube part, a through hole for a guide wire to pass through is arranged in the fixing head, and the distal tube part is tapered; or
The fixing head is tubular and is sleeved on the far-end pipe part in a sliding mode, and the far end of the far-end pipe part is conical.
13. The multifunctional thrombus removal device according to any one of claims 1 to 12, further comprising: 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 into the aspiration catheter and reaching into the irrigation section, and the ultrasound transducer is capable of radiating ultrasound energy in a radial direction upon energization.
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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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| CN115177321B CN115177321B (en) | 2023-06-20 |
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| CN115530923A (en) * | 2022-12-02 | 2022-12-30 | 北京华通集智医疗器械有限公司 | Lumen opening instrument and lumen opening system |
| WO2024114764A1 (en) * | 2022-12-02 | 2024-06-06 | 北京华通集智医疗器械有限公司 | Ultrasonic thrombolysis device, ultrasonic thrombolysis system, and thrombolysis method |
| WO2024114761A1 (en) * | 2022-12-02 | 2024-06-06 | 北京华通集智医疗器械有限公司 | Lumen opening instrument, lumen opening system, and lumen opening method |
| CN116058922A (en) * | 2022-12-26 | 2023-05-05 | 上海心弘生命科学有限公司 | Ultrasonic-assisted thrombolysis device and system |
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| CN116196059A (en) * | 2022-12-29 | 2023-06-02 | 上海心弘生命科学有限公司 | Ultrasonic-assisted thrombolysis device and system |
| CN117084753B (en) * | 2023-10-19 | 2024-01-05 | 长沙金维医疗科技有限公司 | Double-channel thrombus aspiration catheter |
| CN117084753A (en) * | 2023-10-19 | 2023-11-21 | 长沙金维医疗科技有限公司 | Double-channel thrombus aspiration catheter |
| CN118058799A (en) * | 2024-02-22 | 2024-05-24 | 上海融脉医疗科技有限公司 | Double-net-disc deep venous thrombosis excision system capable of being released in segmented mode |
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| CN115177321B (en) | 2023-06-20 |
| WO2023240937A1 (en) | 2023-12-21 |
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