CN116636903A - Thrombus compression take-out device - Google Patents
Thrombus compression take-out device Download PDFInfo
- Publication number
- CN116636903A CN116636903A CN202310461702.9A CN202310461702A CN116636903A CN 116636903 A CN116636903 A CN 116636903A CN 202310461702 A CN202310461702 A CN 202310461702A CN 116636903 A CN116636903 A CN 116636903A
- Authority
- CN
- China
- Prior art keywords
- thrombus
- compression
- balloon
- delivery catheter
- aspiration
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
- 208000007536 Thrombosis Diseases 0.000 title claims abstract description 284
- 238000007906 compression Methods 0.000 title claims abstract description 100
- 230000006835 compression Effects 0.000 title claims abstract description 94
- 230000000903 blocking effect Effects 0.000 claims abstract description 27
- 238000000605 extraction Methods 0.000 claims abstract description 18
- 230000002792 vascular Effects 0.000 claims abstract description 12
- 208000005189 Embolism Diseases 0.000 claims abstract description 6
- 230000008602 contraction Effects 0.000 claims abstract description 4
- 230000001732 thrombotic effect Effects 0.000 claims description 27
- 239000011248 coating agent Substances 0.000 claims description 17
- 238000000576 coating method Methods 0.000 claims description 17
- 239000003146 anticoagulant agent Substances 0.000 claims description 9
- 239000003527 fibrinolytic agent Substances 0.000 claims description 7
- 239000000463 material Substances 0.000 claims description 6
- 230000002785 anti-thrombosis Effects 0.000 claims description 4
- 239000000853 adhesive Substances 0.000 claims description 3
- 230000005294 ferromagnetic effect Effects 0.000 claims description 3
- 230000002439 hemostatic effect Effects 0.000 claims description 3
- 239000002245 particle Substances 0.000 claims description 3
- 230000002787 reinforcement Effects 0.000 claims description 3
- 230000000694 effects Effects 0.000 abstract description 4
- 208000032382 Ischaemic stroke Diseases 0.000 abstract description 3
- 210000004204 blood vessel Anatomy 0.000 description 17
- 238000000034 method Methods 0.000 description 12
- 210000005077 saccule Anatomy 0.000 description 9
- 239000002872 contrast media Substances 0.000 description 6
- 230000005291 magnetic effect Effects 0.000 description 4
- 102000009123 Fibrin Human genes 0.000 description 3
- 108010073385 Fibrin Proteins 0.000 description 3
- BWGVNKXGVNDBDI-UHFFFAOYSA-N Fibrin monomer Chemical compound CNC(=O)CNC(=O)CN BWGVNKXGVNDBDI-UHFFFAOYSA-N 0.000 description 3
- 230000017531 blood circulation Effects 0.000 description 3
- 230000006378 damage Effects 0.000 description 3
- 229950003499 fibrin Drugs 0.000 description 3
- 230000002537 thrombolytic effect Effects 0.000 description 3
- BSYNRYMUTXBXSQ-UHFFFAOYSA-N Aspirin Chemical compound CC(=O)OC1=CC=CC=C1C(O)=O BSYNRYMUTXBXSQ-UHFFFAOYSA-N 0.000 description 2
- 239000005552 B01AC04 - Clopidogrel Substances 0.000 description 2
- 230000004568 DNA-binding Effects 0.000 description 2
- HTTJABKRGRZYRN-UHFFFAOYSA-N Heparin Chemical compound OC1C(NC(=O)C)C(O)OC(COS(O)(=O)=O)C1OC1C(OS(O)(=O)=O)C(O)C(OC2C(C(OS(O)(=O)=O)C(OC3C(C(O)C(O)C(O3)C(O)=O)OS(O)(=O)=O)C(CO)O2)NS(O)(=O)=O)C(C(O)=O)O1 HTTJABKRGRZYRN-UHFFFAOYSA-N 0.000 description 2
- 102000003978 Tissue Plasminogen Activator Human genes 0.000 description 2
- 108090000373 Tissue Plasminogen Activator Proteins 0.000 description 2
- 102000003990 Urokinase-type plasminogen activator Human genes 0.000 description 2
- 108090000435 Urokinase-type plasminogen activator Proteins 0.000 description 2
- 208000027418 Wounds and injury Diseases 0.000 description 2
- 229960001138 acetylsalicylic acid Drugs 0.000 description 2
- 230000001070 adhesive effect Effects 0.000 description 2
- 229960003318 alteplase Drugs 0.000 description 2
- 238000002583 angiography Methods 0.000 description 2
- 238000005452 bending Methods 0.000 description 2
- 210000005013 brain tissue Anatomy 0.000 description 2
- GKTWGGQPFAXNFI-HNNXBMFYSA-N clopidogrel Chemical compound C1([C@H](N2CC=3C=CSC=3CC2)C(=O)OC)=CC=CC=C1Cl GKTWGGQPFAXNFI-HNNXBMFYSA-N 0.000 description 2
- 229960003009 clopidogrel Drugs 0.000 description 2
- 150000001875 compounds Chemical class 0.000 description 2
- 238000012669 compression test Methods 0.000 description 2
- 239000003814 drug Substances 0.000 description 2
- 230000003073 embolic effect Effects 0.000 description 2
- 230000003511 endothelial effect Effects 0.000 description 2
- 229960002897 heparin Drugs 0.000 description 2
- 229920000669 heparin Polymers 0.000 description 2
- 238000002347 injection Methods 0.000 description 2
- 239000007924 injection Substances 0.000 description 2
- 208000014674 injury Diseases 0.000 description 2
- 239000003550 marker Substances 0.000 description 2
- 230000003287 optical effect Effects 0.000 description 2
- 229960005356 urokinase Drugs 0.000 description 2
- 238000012800 visualization Methods 0.000 description 2
- 206010008132 Cerebral thrombosis Diseases 0.000 description 1
- 201000001429 Intracranial Thrombosis Diseases 0.000 description 1
- 229940127219 anticoagulant drug Drugs 0.000 description 1
- 230000015572 biosynthetic process Effects 0.000 description 1
- 239000008280 blood Substances 0.000 description 1
- 210000004369 blood Anatomy 0.000 description 1
- 230000007423 decrease Effects 0.000 description 1
- 238000013156 embolectomy Methods 0.000 description 1
- 230000010102 embolization Effects 0.000 description 1
- 238000002474 experimental method Methods 0.000 description 1
- 238000001125 extrusion Methods 0.000 description 1
- 239000012634 fragment Substances 0.000 description 1
- 230000003993 interaction Effects 0.000 description 1
- 210000005036 nerve Anatomy 0.000 description 1
- 238000005086 pumping Methods 0.000 description 1
- 238000011084 recovery Methods 0.000 description 1
- 230000002040 relaxant effect Effects 0.000 description 1
- 239000000725 suspension Substances 0.000 description 1
- 238000002560 therapeutic procedure Methods 0.000 description 1
- 230000009424 thromboembolic effect Effects 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
- A61B2017/22051—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation
- A61B2017/22065—Functions of balloons
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
- A61B2017/22079—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for with suction of debris
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
- Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
- Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
- Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change
Landscapes
- Health & Medical Sciences (AREA)
- Surgery (AREA)
- Life Sciences & Earth Sciences (AREA)
- Heart & Thoracic Surgery (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Vascular Medicine (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Medical Informatics (AREA)
- Molecular Biology (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Surgical Instruments (AREA)
Abstract
The invention relates to a thrombus compression and extraction device which is delivered to an embolism part for working in a vascular intervention mode. The device consists of a thrombus blocking part, a thrombus compression part and a thrombus suction part; the thrombus compression component comprises a delivery catheter and a thrombus compression balloon, the thrombus compression balloon is fixed at the distal end of the delivery catheter, and the expansion and contraction degree of the thrombus compression balloon can be controlled; the thrombus-aspiration member is tubular in configuration and the delivery catheter is relatively movable within the lumen of the thrombus-aspiration member, and the thrombus-compression balloon is retractable with the delivery catheter into the lumen of the thrombus-aspiration member in the contracted state. The device utilizes the mechanical property that the thrombus is compressed and kept compressed for a period of time, so that the stress is greatly reduced, and the thrombus is compressed and relaxed by using the thrombus compression balloon. The thrombus can be moved out of the body by the thrombus sucking component. The thrombus compression and extraction device is convenient to use, so that thrombus is more easily sucked and extracted, the success rate of thrombus extraction is improved, the side effect of thrombus extraction is reduced, and the treatment effect of acute ischemic stroke large vessel occlusion is improved.
Description
Technical Field
The invention relates to a vascular interventional medical instrument, in particular to a thrombus compression and extraction device.
Background
Intravascular interventional thrombolytic therapy is an important treatment method for large vessel occlusion of acute ischemic stroke. The existing cerebral thrombosis removing device is mainly divided into two main types of a thrombus removing bracket and a suction catheter. The thrombus taking stent is in a super-elastic stent-like structure, and is self-expanded and unfolded by withdrawing the microcatheter after being conveyed to the embolism position, so that thrombus is captured. The thrombus captured by the thrombus-taking bracket is taken out together by pulling back the thrombus-taking bracket. Patents of the thrombus taking bracket are CN 111544083B, CN 112568964B and the like. The thrombus rich in fibrin is hard in material and has a larger friction coefficient with the wall of a blood vessel, so that the thrombus taking stent is not easy to capture and pull, and the thrombus taking stent has lower success rate of opening the thrombus. In addition, the thrombus may be cut and pulled during the interaction of the stent with the thrombus, causing some of the thrombus fragments to fall off, which may result in embolization of the distal vessel.
Another type of intravascular interventional embolectomy is an aspiration catheter. The action principle is that the syringe or the vacuum suction pump at the proximal end of the suction catheter is used for generating negative pressure in the suction catheter, so that thrombus is sucked into the catheter and removed from the body. Such published patents are: CN 212940962U, CN 213910408U, etc. A problem with suction ducts is that they must have a sufficient tube diameter in order to have a sufficient suction force. But large pipe diameters can affect their conveying properties. When the patient's blood vessel is relatively tortuous, the aspiration catheter may not be delivered to the site of the embolism, and the effectiveness of the opening may be greatly reduced.
In the clinical treatment process, the thrombus taking bracket and the suction catheter can be used in combination. However, the current opening rate of the large vessel occlusion of acute ischemic stroke can only reach about 80% -90%, and the vessels of other patients cannot be effectively opened. And the better recovery rate of the nerve function of the patient after 90 days of operation is only about 50 percent. Therefore, in order to further improve the opening rate and the functional result after operation, a novel thrombolytic device and opening method are required.
Disclosure of Invention
The invention aims to solve the technical problem of providing a thrombus compression and extraction device, which improves the success rate of vascular opening, in particular to the opening rate of hard thrombus embolism which is difficult to open and is rich in fibrin.
In order to solve the technical problems, the technical scheme of the invention is as follows:
a thrombus compression and extraction device which is delivered to an embolism part for operation in a vascular intervention mode, and consists of a thrombus blocking part, a thrombus compression part and a thrombus suction part; the thrombus compression component comprises a delivery catheter and a thrombus compression balloon, the thrombus compression balloon is fixed at the distal end of the delivery catheter, and the expansion and contraction degree of the thrombus compression balloon can be controlled; the thrombus-aspiration member is tubular in configuration and the delivery catheter is relatively movable within the lumen of the thrombus-aspiration member, and the thrombus-compression balloon is retractable with the delivery catheter into the lumen of the thrombus-aspiration member in the contracted state.
The thrombus-blocking member is operatively positioned distally of the thrombus-compressing member and the thrombus-aspiration member, and also distally of the thrombus. It can act to prevent thrombus from being flushed distally by forward blood flow during a thrombus removal procedure. In particular, the thrombus compression and extraction device can collapse thrombus and relax stress, so that the adhesion force between the thrombus and a blood vessel is greatly reduced, and the thrombus blocking part is required to play a role of safety protection at the far end.
Optionally, the thrombus blocking member comprises a basket and a push guidewire. The basket is fixed at the distal end of the pushing guide wire, and the pushing guide wire is positioned in the lumen of the delivery catheter of the thrombus compression component; by controlling the pushing wire, the basket can be retracted into the delivery catheter in a compressed state, or can be pushed out of the delivery catheter to form a deployed state.
Alternatively, the thrombus blocking member is a thrombus blocking balloon attached to the delivery catheter and distal to the thrombus compression balloon.
The inflation and the contraction of the thrombus blocking balloon and the thrombus compression balloon are controlled independently, and the delivery catheter is provided with mutually independent cavities which are communicated with the two balloons respectively. After the delivery catheter reached the embolic site, it was confirmed that the thrombus blocking balloon reached the distal end of the thrombus. The thrombus is then inflated to block the balloon, preventing emboli from escaping. And then carrying out the thrombus removing operation. The thrombus is removed and then the thrombus blocking balloon is contracted.
The function of the thrombus compression saccule is to apply a certain extrusion force to thrombus after filling, and compress the thrombus. By biomechanical analysis of thrombosis, after the thrombus is compressed, the thrombus maintains a compression state for a period of time, and the thrombus can generate stress relaxation effect and reduce the volume. The adhesion force between the thrombus and the vascular stent can be greatly reduced, so that the difficulty in thrombus removal is reduced. When the thrombus is compressed and stress is relaxed, the thrombus compression saccule is contracted, so that the subsequent thrombus taking operation is facilitated.
Preferably, the thrombus-compressing balloon is shuttle-shaped, the outline of the middle area is straight line or wave line, the length of the thrombus-compressing balloon is between 10 and 50 and mm, and the diameter of the balloon after the balloon is inflated is between 1 and 7 and mm.
Preferably, the thrombotic compression balloon has a thrombolytic drug or antithrombotic coating thereon. The thrombolytic drug coating has the function that when thrombus with overlarge volume or overlarge hardness is encountered, the thrombolytic drug loaded on the balloon can dissolve part of thrombus, so that vascular endothelial injury caused by thrombus compression and blood vessel compression due to the increase of the balloon volume is reduced when the thrombus compression balloon is filled, and the thrombus taking difficulty is also reduced. Thrombolytic drugs such as alteplase, urokinase, and the like. Antithrombotic or anticoagulant drugs include aspirin, clopidogrel, heparin, etc., which are used to prevent the formation of new thrombi during the process of thrombus removal.
Preferably, the thrombotic compression balloon has a thrombotic adhesion coating thereon. The function of the thrombus adhesion coating is to increase the adhesion force of the thrombus attached to the thrombus compression balloon after the thrombus is compressed, and the thrombus can be removed by contracting and removing the thrombus compression balloon, so that the convenience of the thrombus taking operation is increased. The thrombotic adhesion coating may be a DNA binding compound coating.
Preferably, the delivery catheter of the thrombotic compression member has a rapid exchange interface. The guide wire is convenient to pass through the rapid exchange interface.
After the thrombus is compressed and stress relaxation occurs, its adhesion to the vessel wall is greatly reduced. The thrombus-aspiration means is used to apply a suction force to the compressed thrombus and remove it from the body. At this point, less suction is required to remove it. The requirements on the suction pipe diameter and the suction vacuum degree are reduced, and the damage of high-power suction to blood vessels and brain tissues can be reduced.
Preferably, the wall of the thrombus-aspiration component has a woven or coiled reinforcement layer therein to increase the flexibility and resistance to bending of the thrombus-aspiration component. The thrombus sucking member has great proximal rigidity and small distal rigidity, so that it has excellent conveying performance and capacity of passing through tortuous blood vessel. The proximal end may be aspirated through a Y-shaped hemostatic valve coupled to a syringe or aspiration pump.
Preferably, the thrombus blocking member, thrombus compression member and thrombus aspiration member have radiopaque markers thereon. So that the relative positions of the components can be displayed under angiography.
Preferably, the materials of the thrombus-blocking, thrombus-compressing and thrombus-aspiration members, especially the polymeric materials, have uniformly dispersed ferromagnetic particles therein. The mechanical arm can control the movement of the permanent magnet outside the body. The positioning, moving and deflection of the thrombus taking-out device in the blood vessel can be controlled by controlling the permanent magnet, so that the thrombus taking-out part has magnetic navigation capability, and the omni-directional steering and navigation capability based on the magnetic driving of the permanent magnet is realized. The device also has good operability in a narrow vascular environment. The deflection direction of the thrombus compression and extraction device is precisely controlled by using the permanent magnet driven by the tail end of the mechanical arm, and meanwhile, the permanent magnet is positioned by using a structural optical method, so that the precise control of the device on a blood vessel is realized, and the accuracy and stability of operation are greatly improved.
The invention provides a novel thrombus compression and extraction device based on biomechanical properties of thrombus found by experiments, namely, the phenomenon that the thrombus can be subjected to stress relaxation in a period of time when the thrombus is compressed and kept under compressive strain. The thrombus is decompressed by filling of the thrombus compression balloon. And after the balloon is filled, the balloon is kept in a filling state for a period of time, and the state that the thrombus is compressed is maintained. In the period, the volume of the compressed thrombus is reduced, the internal stress is relaxed, the normal contact pressure between the compressed thrombus and the wall of the blood vessel is greatly reduced, the tangential friction force between the compressed thrombus and the wall of the blood vessel is also greatly reduced, and the difficulty of taking out the thrombus is reduced. During compression and removal of the thrombus, the distal thrombus blocking member is in an expanded state, blocking the flow of thrombus distally. After the thrombus-compressing balloon is contracted, the thrombus-aspiration member is operated to aspirate the thrombus by negative pressure and remove it from the body. The thrombus compression and extraction device is simple and convenient to operate and high in thrombus extraction success rate. Especially has good effect on opening hard or heavy-load thrombus. In addition, as the adhesion force of the thrombus with the vessel wall is greatly reduced after the thrombus is compressed and subjected to stress relaxation, the thrombus suction component can remove the thrombus outside the body by only needing smaller suction force. The conditions of great blood loss caused by high-power suction and increased expansion of infarcted brain tissues are reduced. The requirements for vacuum pressure and pipe diameter of the suction pipe are also reduced. The thrombus compression and extraction device can improve the success rate of thrombus extraction, the vascular patency rate and the functional result of a patient after operation.
Drawings
The invention is described in further detail below with reference to the attached drawings and detailed description:
FIG. 1 shows a thrombus compression and retrieval device with a thrombus blocking member in the form of a net bag
FIG. 2 shows a thrombus compression retrieval device with a thrombus blocking member in the form of a balloon
FIG. 3 is a schematic view of a thrombotic compression test
FIG. 4 is a graph showing stress strain curves of a thrombus after compression
FIG. 5 is a schematic illustration of a thrombus removal procedure of a thrombus compression device
FIG. 6 is a thrombotic compression balloon with a thromboembolic coating
Detailed Description
Fig. 1 shows a thrombus compression-extraction device comprising a thrombus-blocking member 10, a thrombus-compression member 20 and a thrombus-aspiration member 30. The thrombotic component 20 includes a thrombotic balloon 21 and a delivery catheter 22. In this embodiment, the delivery catheter 22 is composed of an outer tube 23 and an inner tube 21, the inner tube 21 being located inside the outer tube 23 with a distal end longer than the outer tube. Contrast for filling the balloon can flow into and out of the thrombotic compression balloon 21 from the delivery catheter proximal end through the outer tube-to-inner tube gap. A thrombotic balloon is a compliant balloon whose magnitude of inflation and deflation can be controlled by how much contrast agent is injected. A visualization marker 23 is provided on the delivery catheter 22 near the connection end of the thrombotic compression balloon for marking the location of the thrombotic compression balloon 21 under an angiographic machine. The thrombus compression saccule is shuttle-shaped, the length of the thrombus compression saccule is between 10 and 50 and mm, and the diameter of the saccule after the saccule is inflated is between 1 and 7 and mm. In the embodiment of fig. 1, the outline of the middle region of the thrombocompression balloon is straight. In other embodiments, the outer contour of the middle region of the thrombocompression balloon may be wavy, i.e., the outer contour of the balloon is wavy, for increasing the contact area with the thrombus.
In the embodiment of fig. 1, the thrombus blocking member 10 comprises a basket 11 and a push wire 12. The basket 11 is fixed on the pushing guide wire 12 through the lantern ring 13 and can slide on the pushing guide wire, and the sliding range is limited by the limiting device 14. Basket 11 is located at the distal end of the thrombotic balloon 21. The push wire is located in the lumen of the inner tube 24. By pulling on the push wire 12, the basket 11 can be compressed back into the inner tube 24. In operation, basket 11 is in an open position to prevent thrombus from being flushed distally by forward blood flow.
The thrombus-aspiration member 30 is tubular in shape and has a radiopaque marker 31 at its distal end. With the thrombotic balloon 21 in the contracted state, the thrombotic member 20 may be retracted into the thrombotic pumping member 30 by pulling the delivery catheter 22. The proximal end of the thrombus-aspiration member 30 is located outside the body and the syringe or aspiration pump thrombus-aspiration member 30 can be connected through a Y-shaped hemostatic valve for withdrawing the compressed stress-relaxed thrombus out of the body. The wall of the thrombus-aspiration member 30 has a braided or coiled reinforcement layer in it to increase the flexibility and resistance to bending of the thrombus-aspiration member. The thrombus sucking member has great proximal rigidity and small distal rigidity, so that it has excellent conveying performance and capacity of passing through tortuous blood vessel.
Fig. 2 shows another embodiment of a thrombus compression retrieval device. The thrombotic balloon 21 is secured to a delivery catheter 22. The delivery catheter is a three lumen catheter with three lumens 17 inside independent of each other. Wherein the two passages are respectively communicated with the thrombus compression balloon 21 and the thrombus blocking balloon 15 for filling of contrast agent. The other lumen is used for passing the guide wire. The delivery catheter 22 may also have a rapid exchange interface thereon, coupled to the lumen through the guidewire, for rapid exchange of the delivery guidewire.
In the embodiment of fig. 2, the thrombus blocking member 10 is a thrombus blocking balloon 15 which is secured to the delivery catheter 22 and is located distally of the thrombus compression balloon 21. The thrombus-blocking balloon has radiopaque markers 16 on both sides for marking the position of the thrombus-blocking balloon 15 under the angiography machine. The thrombus-blocking balloon 15 is a compliant balloon, the extent of which filling can be controlled by injection of a contrast agent. The thrombus-aspiration member 30 in the embodiment of fig. 2 corresponds to the embodiment of fig. 1.
In the embodiment of fig. 1 or 2, the outer layer of the thrombocompression balloon 21 may be coated with a thrombolytic drug or an antithrombotic coating. The thrombolytic medicine carried on the saccule can dissolve partial thrombus, reduce vascular endothelial injury caused by compression thrombus and blood vessel due to the increase of the saccule volume when the thrombus compression saccule is filled, and also reduce the thrombus taking difficulty. Thrombolytic drugs such as alteplase, urokinase, and the like. The anticoagulant medicine includes aspirin, clopidogrel, heparin, etc. and can reduce the generation of new thrombus in the process of thrombus taking. In the embodiment of fig. 1 or 2, the thrombotic compression balloon may also have a thrombotic adhesion coating thereon. The function of the thrombus adhesion coating is to increase the adhesion force of the thrombus attached to the thrombus compression balloon after the thrombus is compressed, and the thrombus can be removed by contracting and removing the thrombus compression balloon, so that the convenience of the thrombus taking operation is increased. The thrombotic adhesion coating may be a DNA binding compound coating.
In one embodiment, the materials of the thrombus-blocking, thrombus-compressing and thrombus-aspiration members, especially the polymeric materials, have uniformly dispersed ferromagnetic particles therein. The mechanical arm can control the movement of the permanent magnet outside the body. The positioning, moving and deflection of the thrombus taking-out device in the blood vessel can be controlled by controlling the permanent magnet, so that the thrombus taking-out part has magnetic navigation capability, and the omni-directional steering and navigation capability based on the magnetic driving of the permanent magnet is realized. The device also has good operability in a narrow vascular environment. The deflection direction of the thrombus compression and extraction device is precisely controlled by using the permanent magnet driven by the tail end of the mechanical arm, and meanwhile, the permanent magnet is positioned by using a structural optical method, so that the precise control of the device on a blood vessel is realized, and the accuracy and stability of operation are greatly improved.
Figure 3 shows a schematic representation of our compression test on thrombus. Fig. 3A is a shape before thrombus compression. Fig. 3B is a schematic illustration of the compression process, wherein the thrombus is compressed by upper and lower rigid planes. Fig. 3C shows the shape of the thrombus after it has been compressed and remains compressed for a period of time, the volume of the thrombus being reduced.
Fig. 4 shows the change in stress of a thrombus over a period of time when the thrombus is compressed and remains under compressive strain. It can be seen that during the first few seconds, the thrombus receives a continuous compression, with a constant increase in stress value, reaching a peak. After reaching the maximum compression state, the compression clamp remains stationary for a period of time. During this time, the stress of the thrombus decreases rapidly until it stabilizes. This indicates that the thrombus was subjected to stress relaxation. We apply this mechanical property of the thrombus to the process of removing the thrombus, compressing the thrombus using a thrombus compression member, and stress relaxing the thrombus. After the thrombus is relaxed, the volume is reduced, and the thrombus is more easily sucked into the thrombus suction member. More importantly, the normal stress is relaxed to a large extent, and the contact force and friction between the thrombus and the vessel wall will be small, so that the thrombus is conveniently removed by aspiration. We have found experimentally that this stress relaxation phenomenon occurs even for hard thrombi having a high fibrin content.
Fig. 5 illustrates the flow of thrombus removal by the thrombus compression extraction device. In fig. 5A, 41 is a blood vessel, and 42 is a thrombus occluded in the blood vessel. In fig. 5B, the thrombus aspiration member 30 is delivered to the proximal end of the embolic site. The delivery catheter 22 is passed over the thrombus under the guidance of the guidewire 50, and the thrombus compression balloon is identified by the visualization mark as covering the thrombus. In fig. 5C, the thrombus blocking balloon 15 is inflated by injection of a contrast agent, preventing thrombus from being washed away by the forward blood flow during a thrombus removal procedure. In fig. 5D, the thrombus 42 is compressed by injecting a contrast agent, filling the thrombus-compressing balloon 21. The inflated state of the thrombocompression balloon is maintained for a period of time, such as 50-300 seconds, during which time the compressed thrombus 42 is stress relaxed and the stress of the thrombus is significantly reduced. In fig. 5E, the thrombotic compression balloon 21 is contracted by withdrawing the contrast agent. The volume of the thrombus 42 is significantly reduced relative to that before compression, and because of the stress relaxation that occurs, the contact stress between it and the vessel wall is significantly reduced. The compressed thrombus may be in suspension in the blood vessel. In fig. 5F, the compressed thrombus is sucked into the thrombus-aspiration member by generating a negative pressure in the thrombus-aspiration member by a syringe or a suction pump, thereby removing the thrombus from the body. The thrombus blocking balloon can then be contracted, the vascular opening confirmed by contrast, and the delivery catheter and aspiration catheter can then be pulled out of the body.
In the embodiment of fig. 6, the thrombotic compression balloon has a thrombotic adhesive coating thereon. After the thrombus is stress relaxed, the thrombus compression balloon is contracted. Because of the presence of the thrombotic adhesive coating, the thrombus is stuck to the balloon wall. By pulling back the delivery catheter, the thrombotic compression balloon can be retracted into the thrombus aspiration device along with the thrombus. In the process, negative pressure suction can be combined, so that the success rate of thrombus removal is increased.
Claims (10)
1. A thrombus compression and extraction device which is delivered to an embolism part for working in a vascular intervention mode, and is characterized in that the device consists of a thrombus blocking part, a thrombus compression part and a thrombus suction part; the thrombus compression component comprises a delivery catheter and a thrombus compression balloon, the thrombus compression balloon is fixed at the distal end of the delivery catheter, and the expansion and contraction degree of the thrombus compression balloon can be controlled; the thrombus-aspiration member is tubular in configuration and the delivery catheter is relatively movable within the lumen of the thrombus-aspiration member, and the thrombus-compression balloon is retractable with the delivery catheter into the lumen of the thrombus-aspiration member in the contracted state.
2. The thrombus compression retrieval device of claim 1, wherein the thrombus blocking member comprises a basket secured to the distal end of the pusher guidewire and a pusher guidewire positioned within the lumen of the delivery catheter; by controlling the pushing wire, the basket can be retracted into the delivery catheter of the thrombotic compression member in a compressed state, or can be pushed out of the delivery catheter to form a deployed state.
3. The thrombus compression retrieval device of claim 1, wherein the thrombus blocking member is a thrombus blocking balloon attached to the delivery catheter and distal to the thrombus compression balloon.
4. A thrombus compression retrieval device as in claim 3 wherein the inflation and deflation of the thrombus blocking balloon and the thrombus compression balloon are controlled independently of each other, and wherein the delivery catheter has independent lumens communicating with each of the two balloons.
5. The thrombus compression retrieval device of claim 1, wherein the thrombus compression balloon is shuttle-shaped with the outer contour of the central region being straight or wavy, the thrombus compression balloon having a length of between 10 and 50 mm and a balloon inflated diameter of between 1 and 7 mm.
6. The thrombus compression retrieval device of claim 1, wherein the thrombus compression balloon has a thrombolytic drug coating or an antithrombotic coating thereon.
7. The thrombus compression retrieval device of claim 1, wherein the thrombus compression balloon has a thrombo-adhesive coating thereon.
8. The device of claim 1, wherein the delivery catheter of the thrombus-compression member has a rapid exchange port, and the wall of the thrombus-aspiration member has a braided or coiled reinforcement layer, the thrombus-aspiration member having a high proximal stiffness and a low distal stiffness, and the proximal end being capable of aspiration through a Y-shaped hemostatic valve coupled to a syringe or aspiration pump.
9. The thrombus compression retrieval device of claim 1, wherein the thrombus blocking member, the thrombus compression member and the thrombus aspiration member have radiopaque markers thereon.
10. The thrombus compression retrieval device of claim 1, wherein the thrombus blocking member, thrombus compression member and thrombus aspiration member are of a material having uniformly dispersed ferromagnetic particles, and wherein the distal end of the mechanical arm has permanent magnets which control the positioning, movement and deflection of the thrombus retrieval device within the vessel.
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CN202310461702.9A CN116636903A (en) | 2023-04-26 | 2023-04-26 | Thrombus compression take-out device |
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CN202310461702.9A CN116636903A (en) | 2023-04-26 | 2023-04-26 | Thrombus compression take-out device |
Publications (1)
Publication Number | Publication Date |
---|---|
CN116636903A true CN116636903A (en) | 2023-08-25 |
Family
ID=87623761
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CN202310461702.9A Pending CN116636903A (en) | 2023-04-26 | 2023-04-26 | Thrombus compression take-out device |
Country Status (1)
Country | Link |
---|---|
CN (1) | CN116636903A (en) |
-
2023
- 2023-04-26 CN CN202310461702.9A patent/CN116636903A/en active Pending
Similar Documents
Publication | Publication Date | Title |
---|---|---|
JP7546309B2 (en) | Method and system for treating acute ischemic stroke | |
US11896246B2 (en) | Systems and methods for removing undesirable material within a circulatory system utilizing a balloon catheter | |
JP6732769B2 (en) | Rapid suction thrombectomy system and method | |
CN115177321B (en) | Multifunctional thrombus removing device | |
US8506512B2 (en) | Systems and methods for removing undesirable material within a circulatory system utilizing a balloon catheter | |
US7449010B1 (en) | Material removal catheter and method | |
US20130304082A1 (en) | Systems and methods for removing undesirable material within a circulaton system utilizing a balloon catheter | |
US20110301625A1 (en) | Hydrodynamic Thrombectomy Catheter | |
WO2009114277A1 (en) | Apparatus for visualization of coronary vein procedure | |
EP1922106A2 (en) | Gas inflation/evacuation system incorporating a multiple element valved guidewire assembly having an occlusive drive | |
US11628282B2 (en) | No preparation balloon guide catheter | |
CN114099910A (en) | Improved flexible balloon catheter | |
KR20200039583A (en) | Retrograde blood flow occlusion flushing device | |
CN116636903A (en) | Thrombus compression take-out device | |
US7318815B2 (en) | Angioplasty device with embolic recapture mechanism for treatment of occlusive vascular diseases | |
EP3838326B1 (en) | No preparation balloon guide catheter | |
US20240358383A1 (en) | Systems and methods for removing undesirable material within a circulatory system | |
CN117355267A (en) | Suction catheter | |
CN115969467A (en) | Pulmonary artery thrombus removal system and use method | |
CN111887934A (en) | Apparatus and method for aspiration of thrombus |
Legal Events
Date | Code | Title | Description |
---|---|---|---|
PB01 | Publication | ||
PB01 | Publication | ||
SE01 | Entry into force of request for substantive examination | ||
SE01 | Entry into force of request for substantive examination |