CN108744232A - Subtract stream apparatus and system for preventing bleeding is perfused - Google Patents

Subtract stream apparatus and system for preventing bleeding is perfused Download PDF

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Publication number
CN108744232A
CN108744232A CN201810672035.8A CN201810672035A CN108744232A CN 108744232 A CN108744232 A CN 108744232A CN 201810672035 A CN201810672035 A CN 201810672035A CN 108744232 A CN108744232 A CN 108744232A
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CN
China
Prior art keywords
current limiting
limiting element
subtracting
stream device
main body
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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.)
Granted
Application number
CN201810672035.8A
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Chinese (zh)
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CN108744232B (en
Inventor
沈碧峰
朱大伟
付亮辉
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Jieruo Medical Technology Shanghai Co ltd
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Enodar Medical Shanghai Co Ltd
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Priority to CN201810672035.8A priority Critical patent/CN108744232B/en
Priority to PCT/CN2018/096662 priority patent/WO2020000548A1/en
Publication of CN108744232A publication Critical patent/CN108744232A/en
Application granted granted Critical
Publication of CN108744232B publication Critical patent/CN108744232B/en
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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/10Balloon catheters
    • A61M25/104Balloon catheters used for angioplasty
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022Occluding by internal devices, e.g. balloons or releasable wires
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12099Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
    • A61B17/12109Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/12163Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a string of elements connected to each other
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/12181Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device formed by fluidized, gelatinous or cellular remodelable materials, e.g. embolic liquids, foams or extracellular matrices
    • A61B17/12195Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device formed by fluidized, gelatinous or cellular remodelable materials, e.g. embolic liquids, foams or extracellular matrices comprising a curable material
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/0043Catheters; Hollow probes characterised by structural features
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M29/00Dilators with or without means for introducing media, e.g. remedies
    • A61M29/02Dilators made of swellable material
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M2025/0001Catheters; Hollow probes for pressure measurement
    • A61M2025/0002Catheters; Hollow probes for pressure measurement with a pressure sensor at the distal end
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/10Balloon catheters
    • A61M2025/1043Balloon catheters with special features or adapted for special applications
    • A61M2025/105Balloon catheters with special features or adapted for special applications having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes

Abstract

Subtracting stream apparatus and system for preventing bleeding is perfused the invention discloses a kind of, specifically, it includes n current limiting element that this, which subtracts stream device, wherein 1≤n≤5, current limiting element flow the distal end of device positioned at subtracting.Main body:The wall of the main body is equipped with n fluid passage, and current limiting element is set to the distal end in main body, and is connected to fluid passage, and current limiting element is connected to fluid passage one-to-one correspondence;And n liquid injection port, liquid injection port are located at the proximal end for subtracting stream device, are fixed in main body, and be connected to fluid passage, liquid injection port is connected to fluid passage one-to-one correspondence.This, which subtracts stream device, can be furnished with pressure measurement silk.As partition apparatus, the blood in blood vessel can be carried out to subtract stream controllablely current limiting element in the present invention by being filled by control current limiting element.

Description

Subtract stream apparatus and system for preventing bleeding is perfused
Technical field
The present invention relates to medical instruments field, relates more specifically to a kind of carrying out blood vessel to carotid artery stenosis or cerebral arterial stenosis After plasty, subtract stream apparatus and system for preventing bleeding is perfused.
Background technology
In recent years, clinically there are many cerebral arterial stenosis or carotid artery stenosis illness.In order to give these patients to solve disease Bitterly, it improves the quality of living, it will usually carry out angioplerosis or stent-assisted angioplasty.
Angioplasty can make narrow blood vessel be restored to the similar size of blood vessel full size, former narrow to allow Narrow place's restoration of blood flow.But while the recovery of the vascular flows such as arteria carotis or cerebral artery, new problem or complication are will produce, In an important symptom be exactly high perfusion.
Brain Hyper-perfusion syndrome (Cerebral Hyperper-fusion Syndrome (CHS)) is due to original low filling Note area's cerebral blood flow (CBF) is increased significantly over a kind of severe complication caused by brain tissue metabolism needs.The risk of usual CHS because It is known as:Age is more than 75 years old, has history of stroke, long-term hypertension history, homonymy internal carotid severe stenosis, offshoot circulation foundation is not Fully, preoperative TCD (transcranial Doppler ultrasound) prompt Ipsilateral blood flow velocity in middle cerebral is less than 40% or more normal value, offside Internal carotid severe stenosis or occlusion etc..
Clinically slowly expanded on a small quantity to reach operation every time using the angioplasty being performed in multiple times sometimes now The sectional area at big narrow position reaches the perfusion for being slowly increased blood in blood vessel, but repeatedly angioplasty increases operation Expense and operating difficulty psychologically can also increase the pressure of sufferer and patient' s family to can psychologically contradict Repeated Operation; Also the blood pressure for reducing sufferer using the drug of blood pressure lowering sometimes, to reach the hemoperfusion for reducing postangioplasty, But when using antihypertensive drugs, come when being depressured, when being depressured to the blood pressure of needs from very high pressure, difficulty is big, effect is poor, and it is difficult Control the stabilization of blood pressure.
Therefore, clinically still lack a kind of effective medical instrument for preventing high perfusion bleeding.
Invention content
Subtracting stream apparatus and system for preventing perfusion bleeding the purpose of the present invention is to provide a kind of, of the invention subtract stream N (1≤n≤5) a current limiting element is arranged in device, can be filled by adjusting current limiting element controllably may be used to the blood progress in blood vessel Ground is adjusted to subtract stream.
Subtracting stream device for preventing bleeding is perfused the present invention provides a kind of, which is characterized in that described subtract flows device packet Include n current limiting element, wherein 1≤n≤5, the current limiting element are located at the distal end for subtracting stream device;Main body, in the main body Equipped with n fluid passage, the current limiting element is set to the distal end of the main body, and is connected to the fluid passage, the limit Fluid element is connected to fluid passage one-to-one correspondence;And n liquid injection port, the liquid injection port are located at described The proximal end for subtracting stream device, is fixed on the proximal end of the main body, and be connected to the fluid passage, the liquid injection port and described Fluid passage is to correspond connection.
In another preferred example, the outer diameter of the current limiting element is d, and the internal diameter of the blood vessel is D, wherein d < D.
In another preferred example, channel centered on the hollow channel of the main body.
In another preferred example, the main body is hollow elongated tubular.
In another preferred example, a length of l of the main body, a diameter of r, wherein l/r >=20.
In another preferred example, the current limiting element can be fusiformis, cylindrical, spherical shape (such as:Elliposoidal, ball Shape etc.), apple shape, the various rules such as wax gourd shape or irregular shapes.
It should be noted that the interlude that " the wax gourd shape " refers to the current limiting element is cylindrical, and its both ends For hemispheric shape;" apple shape " refers to that the both ends of the current limiting element are hemispherical, and the hemispheric diameter in one end Larger, the hemispheric diameter of the other end is smaller, and the interlude of the current limiting element is truncated cone-shaped, and the interlude is by the half of both ends Spherical structure connects to form entirety.
In another preferred example, when the interlude of the current limiting element is cylindrical, both ends are hemispherical or circle Taper type.
In another preferred example, a current limiting elements of n (2≤n≤5) can be that shape is identical, can also be shape Different.
In another preferred example, when multiple current limiting element shapes are identical, multiple current limiting elements can be big It is small the same, can also be in different size.
In another preferred example, according to actual demand, a current limiting element can be all or part of (as 2≤n≤5) by n It is used.
In another preferred example, the central passage of the main body passes through for seal wire.
In another preferred example, the current limiting element surface is coated with anticoagulant, such as heparin.
In another preferred example, when having multiple current limiting elements, the adjacent current limiting element is spaced a distance.
In another preferred example, when having multiple current limiting elements, the current limiting element is equally spacedly set in turn in the master On body.
In another preferred example, the diameter after the n current limiting elements are full is identical.
In another preferred example, the diameter after the n current limiting elements are full is from the proximal end for subtracting stream device to distal end It reduces successively.
In another preferred example, the center of the main body is set there are one central passage, is passed through for seal wire, the fluid passage It is evenly distributed on the periphery of the central passage.
In another preferred example, the eccentric channel is located at the side of main body section, passes through for seal wire, the fluid passage Positioned at the other side of the eccentric channel.
In another preferred example, when the current limiting element is 1, the current limiting element is compliance current limiting element;When Current limiting element be 2-5 when, the current limiting element for compliance, non-compliance or semi-compliant current limiting element in one kind or It is a variety of.
In another preferred example, shrinkage operation is carried out to the current limiting element after filling, which is by more What a stage carried out, for only there are one stream device is subtracted described in the current limiting element, once only shrinking the current limiting element body A long-pending part, and twice 0.5-5h is spaced between shrinkage operation;Preferably, 2-4h;More preferably, 2.5-3.5h;It is more for having The described of a current limiting element subtracts stream device, once only shrinks a current limiting element, and twice between shrinkage operation between Every 0.5-5h;Preferably, 2-4h;More preferably, 2.5-3.5h.
In another preferred example, the stream device that subtracts includes guiding catheter.
In another preferred example, it is described subtract stream device controllable adjusting can be carried out to the blood flow in blood vessel, to blood flow into Can slowly it become larger again while row current limliting.The either single current limiting element or multiple current limiting elements, it is described to subtract It is all point multiple stage gradients incrementally regulating blood flow to flow device.I.e. blood flow is initially adjusted to the value of a very little, then more It is secondary incremental, finally increase to it is intravascular unobstructed when blood flow it is suitable.
In another preferred example, when it is described subtract stream device and adjust intravascular flow when, the blood flow regulation amount in each stage can be with It is definite value, can also be to fluctuate in a certain range.The blood flow regulation amount in each stage can have because divided stage quantity is different Different regulated quantity, as the regulated quantity of the adjacent stage blood flow of stage quantity more multidate is fewer;It is each when the stage, quantity was identical Stage blood flow regulation amount also can be different, and such as each stage blood flow regulation amount is suitable, each stage blood flow regulation amount is linearly increasing, each rank The non-linear increase of section blood flow regulation amount, each stage blood flow regulation amount, which linearly reduce, each stage blood flow regulation amount is non-linear reduces, is each Stage blood flow regulation amount is irregular etc..
In another preferred example, the material of the current limiting element for subtracting stream device is elastomeric material, the elastomer material Material is selected from the group:Silica gel, latex, TPU and TPE.
In the second aspect of the present invention, a kind of streaming system that subtracts for preventing that bleeding is perfused is provided, it is described to subtract streaming system Including sacculus, the sacculus is for expanding blood vessel;Current limiting element, the current limiting element are located at the distal end for subtracting streaming system, and It is located at the more distal end for subtracting streaming system compared to the sacculus current limiting element, the current limiting element is used to reduce the blood of blood vessel Flow;Main body, the wall of the main body are equipped with fluid passage, and the current limiting element is set in the main body, and with the liquid Body channel is connected to, and the current limiting element and the fluid passage connect one to one;And liquid injection port, the liquid Inlet is located at the proximal end for subtracting streaming system, fixes on the body, and be connected to the fluid passage, the liquid note Entrance and the fluid passage are one-to-one.
In another preferred example, the diameter of the sacculus in the expanded state is greater than or equal to the caliber of the blood vessel.
In another preferred example, the sacculus is arranged in the distal end of foley's tube.
In another preferred example, the guiding catheter for subtracting stream device is for guiding the foley's tube to introduce blood vessel.
In another preferred example, the foley's tube enters the guiding catheter, and the distal end of the foley's tube is stretched Go out the guiding catheter and enter blood vessel, the sacculus for being located at the foley's tube distal end also enters blood vessel, and blood described in expanse Pipe.
In another preferred example, after expansion, the sacculus is shunk, and the sacculus is withdrawn from described with the foley's tube Main body.
In another preferred example, after the balloon inflation is expanded, the current limiting element is started to work.
In another preferred example, after expansion, the sacculus is shunk, and the sacculus is withdrawn in the catheter channel, The foley's tube stays in the main body, last entire described to subtract streaming system and withdraw from blood vessel together.
In another preferred example, the sacculus is arranged in the distal end of the main body, and the main body is equipped with balloon inflation channel, institute It states sacculus with the balloon inflation channel to be connected, the sacculus carries out expanse by the balloon inflation channel.
In another preferred example, the sacculus is to carry out expanse by injecting liquid.
In another preferred example, the balloon surface is coated with anticoagulant.
In another preferred example, injection liquid expansion is carried out to the sacculus by the balloon inflation channel, and then expands blood Pipe.
In another preferred example, after blood vessel dilatation, the sacculus release controls the blood vessel by the current limiting element Blood flow.
In another preferred example, the stream device that subtracts is furnished with pressure measurement silk.
In another preferred example, the streaming system that subtracts is furnished with pressure measurement silk.
In another preferred example, pressure measurement silk navigates within the guidewire lumen subtracted inside stream device, and pressure measurement silk distal end is equipped with pressure and passes There are pressure monitoring device in sensor, proximal end, and the pressure display screen on pressure monitoring device shows instant pressure, can play real-time prison Survey the effect of current limiting element distal end blood pressure.Pressure measurement silk can will subtract fluid element and be transported to as the guide wire for subtracting stream device simultaneously Need to position, this pressure measurement silk and subtract stream device be two parts, can separate, be seperated.
It should be noted that.The guidewire lumen is the central passage or eccentric channel.
In another preferred example, pressure measurement silk is embedded in subtracting inside stream device, and pressure measurement silk distal end is equipped with pressure sensor, and proximal end has Pressure monitoring device, the pressure display screen in supervision equipment show instant pressure, can play monitoring current limiting element distal end in real time The effect of blood pressure.Simultaneously pressure measurement silk can be used as subtract stream device built-in supporting wire, subtract fluid element be delivered to need reach Enhancing push power when position, while pressure measurement silk can will subtract fluid element and be transported to needs in place as the guide wire for subtracting stream device Set, this pressure measurement silk and subtract stream device be an entirety, can not separate, be integrated.
In another preferred example, the material of pressure measurement silk is selected from the group:Stainless steel, NiTi, platinum, iridium, macromolecule (such as PTFE, Pebax, Nylon etc.).
In another preferred example, the outer diameter of pressure measurement silk is 0.005-0.05 inches, more preferably 0.01-0.04 inches, optimal Ground 0.010-0.038 inches;Its outer diameter can be certain value, can also be variation.
In another preferred example, the length of pressure measurement silk be 500-5000 millimeters, more preferably 1000-3500 millimeters, optimally 1200-3000 millimeters.
It should be understood that within the scope of the present invention, above-mentioned each technical characteristic of the invention and have in below (eg embodiment) It can be combined with each other between each technical characteristic of body description, to form a new or preferred technical solution.As space is limited, exist This no longer tires out one by one states.
Description of the drawings
In order to more clearly explain the embodiment of the invention or the technical proposal in the existing technology, to embodiment or will show below There is attached drawing needed in technology description to do simply to introduce, it should be apparent that, the accompanying drawings in the following description is only this Some embodiments of invention for those of ordinary skill in the art without creative efforts, can be with Obtain other attached drawings according to these attached drawings.
Fig. 1 is tool in an example of the invention also to exist there are three the fusiformis current limiting element of identical maximum outside diameter and sacculus The structural schematic diagram for subtracting streaming system in its main body.
Fig. 2 is tool in an example of the invention also to exist there are three the fusiformis current limiting element of different maximum gauges and sacculus The structural schematic diagram for subtracting streaming system in its main body.
Fig. 3 is the sectional view of the Section A-A in Fig. 1 and/or Fig. 2.
Fig. 4 is another sectional view of the Section A-A in Fig. 1 and/or Fig. 2.
Fig. 5 is that there are three the elliposoidal current limiting elements and sacculus of identical maximum outside diameter for the tool in an example of the invention The structural schematic diagram for subtracting streaming system in its main body.
Fig. 6 is that there are three the elliposoidal current limiting elements and sacculus of different maximum outside diameters for the tool in an example of the invention The structural schematic diagram for subtracting streaming system in its main body.
Fig. 7 is that there are three the wax gourd shape current limiting elements and sacculus of identical maximum outside diameter for the tool in an example of the invention The structural schematic diagram for subtracting streaming system in its main body.
Fig. 8 is that there are three the wax gourd shape current limiting elements and sacculus of different maximum outside diameters for the tool in an example of the invention The structural schematic diagram for subtracting streaming system in its main body.
Fig. 9 be tool in an example of the invention there are one fusiformis current limiting element subtract streaming system and sacculus is also in its master Structural schematic diagram on body.
Figure 10 is tool in an example of the invention, and there are one elliposoidal current limiting element and sacculus also in its main body Subtract the structural schematic diagram of streaming system.
Figure 11 is tool in an example of the invention, and there are one wax gourd shape current limiting element and sacculus also in its main body Subtract the structural schematic diagram of streaming system.
Figure 12 is the sectional view of the section B-B of any figure in Fig. 9, Figure 10, Figure 11 and Figure 17.
Figure 13 is another sectional view of the section B-B of any figure in Fig. 9, Figure 10, Figure 11 and Figure 17.
Figure 14 is that there are three the fusiformis current limiting elements and sacculus of identical maximum outside diameter for the tool in an example of the invention The streaming system that subtracts in its main body integrally closes at structural schematic diagram in guiding catheter.
Figure 15 is that there are three the fusiformis current limiting elements and sacculus of identical maximum outside diameter for the tool in an example of the invention Three current limiting elements for subtracting streaming system and sacculus in its main body all stretch out guiding catheter and full structural schematic diagram.
Figure 16 is that there are three the fusiformis current limiting elements and sacculus of identical maximum outside diameter for the tool in an example of the invention Subtract streaming system in its main body, two current limiting elements of distal end stretch out guiding catheter and full structural schematic diagram.
Figure 17 is tool in an example of the invention, and there are one cylindrical current limiting element and sacculus also in its main body Subtract the structural schematic diagram of streaming system.
Figure 18 be tool in an example of the invention there are one fusiformis current limiting element and sacculus is independent on foley's tube Subtract the structural schematic diagram of streaming system.
Figure 19 be tool in an example of the invention there are one cylindrical current limiting element and sacculus is independent on foley's tube The structural schematic diagram for subtracting streaming system.
Figure 20 be tool in an example of the invention there are one oval current limiting element and sacculus is independent on foley's tube The structural schematic diagram for subtracting streaming system.
Figure 21 be tool in an example of the invention there are one wax gourd shape current limiting element and sacculus is independent on foley's tube The structural schematic diagram for subtracting streaming system.
Figure 22 is the sectional view in the sections C-C of any figure in Figure 18, Figure 19, Figure 20 and Figure 21.
Figure 23 is another sectional view in the sections C-C of any figure in Figure 18, Figure 19, Figure 20 and Figure 21.
It should be noted that the sectional view in the sections D-D of any figure can also be configured to Figure 22 in Figure 19, Figure 20 and Figure 21 Or the structure in Figure 23, only 8 indicate be foley's tube central passage or eccentric channel, 7 indicate be foley's tube Fluid passage, 6 indicate foley's tubes outer wall.
Figure 24 be tool in an example of the invention there are one fusiformis current limiting element and sacculus is independent on foley's tube, and There are the structural schematic diagram for subtracting streaming system of one and the pressure measurement silk for subtracting stream device independent separate.
Figure 25 be tool in an example of the invention there are one fusiformis current limiting element and sacculus is independent on foley's tube, and There is an insertion to subtract the structural schematic diagram for subtracting streaming system for the pressure measurement silk that stream device is integral with.
In each attached drawing, each mark is as follows:
1- subtracts streaming system;
2- current limiting elements;
3- main bodys;
4- liquid injection ports;
5- guiding catheters;
6- body outer walls;
7- fluid passages;
8- central passages or eccentric channel;
9- sacculus;
10- foley's tubes;
11- pressure measurement silks.
Specific implementation mode
The present inventor after extensive and in-depth study, by largely screening, develops a kind of for preventing perfusion for the first time Bleeding subtracts stream apparatus and system, and the protective device for subtracting stream device and being postoperative as carotid artery vascular of the invention, this subtracts stream dress It sets including one or more current limiting elements, when in use, this is subtracted into stream device and is placed in blood vessel, current limiting element is adjusted by full (it is full adjust after current limiting element as partition apparatus) blood is carried out to subtract stream, reach reduction blood flow to reduce perfusion Purpose completes the present invention on this basis.
Term
As used herein, term " compliance " refers to the variation of the current limiting element volume in one unit pressure of every change Value, under normal conditions:Compliance is non-compliance current limiting element when being not more than 1.1;It is semi-compliant when compliance is 1.3-1.8 Current limiting element;Compliance is compliance current limiting element when being more than 2.
Subtracting stream device for preventing bleeding is perfused the present invention provides a kind of, it be it is a kind of there is specific structure subtract stream Device.
Typically, the protective device for subtracting stream device and being postoperative as carotid artery vascular of the invention, specifically, including master Body, current limiting element and liquid injection port.Channel centered on the center of main body, main body are equipped with n fluid passage, the fluid passage One end be connected to current limiting element, the other end is connected to liquid injection port, wherein current limiting element is fixed on the distal end of main body, liquid Body inlet is fixed on the proximal end of main body, and the quantity of current limiting element is n, wherein this is subtracted stream device and is placed on blood by 1≤n≤5 Guan Zhonghou subtracts stream by the way that its current limiting element is adjusted to fill to blood.
It should be noted that " multiple " described herein refer to two or more.
In addition, current limiting element, which can not only be shunk, becomes as low as one tiny size, but also intracavitary can fill in the blood vessels to one Fixed size.Current limiting element can be filled under external force (pressure of application) effect, is removed external force (unloading pressure) and is passed through One hollow tube (guiding catheter) and it may return to former fine size.
Current limiting element can be pulled in guiding by a guiding catheter, after current limiting element release and led by the contraction of current limiting element The process of tube cavity is exactly the process that current limiting element is shunk, and after current limiting element is released guiding catheter inner cavity, current limiting element is full Injection liquid keeps it full.
Can be fusiformis, cylinder, spherical shape or other shapes in single current limiting element shape.Current limiting element is cylinder When, both ends are dome-type or cone type.Entire current limiting element is high molecular material.
Gap section between current limiting element and vascular wall can have blood flow to pass through.Current limiting element pair in this way under expanded state The transport of blood has barrier effect, can reduce blood flow.When product only has single current limiting element, pass through current limiting element cross section Change to control the variation of blood flow;When product has multiple current limiting elements, multiple current limiting elements just have multiple blocking, repeatedly step by step Reduce blood flow.Different current limiting element diameters can be the same or different.
It, can when multiple current limiting elements in the blood vessels work under expanded state when product has multiple current limiting elements To work simultaneously, can also it is therein some or certain it is several work, in this way by the quantity of the current limiting element to work Difference will have blood flow different blocking reduction effect.Adjacent current limiting element is spaced a distance.Wherein, between barriers Away from for 5-50mm;Preferably, 10-30mm;More preferably, 15-30mm.
When product only has single current limiting element, single current limiting element works under expanded state in the blood vessels, current limliting member Part from a cross section when being converted to another cross section, it should it stays for some time in the state of previous cross section, Purpose be allow the brain vessel blood of original low perfusion region of sufferer be slowly increased and to the increase of each blood flow there are one slowly Adaptation process, rather than instantaneous a large amount of blood flow enters former Low perfusion region.When product has multiple current limiting elements, multiple current limlitings During element works under expanded state in the blood vessels, each current limiting element need to be perisystolic in the current limiting element before shrinking It is stopped the regular hour under blood flow state, purpose is also that the brain vessel blood of original low perfusion region of sufferer is allowed to be slowly increased and right There are one slow adaptation process for the increase of each blood flow, rather than instantaneous a large amount of blood flow enters former Low perfusion region.In this way The brain tissue metabolism of former low perfusion region is slowly increased enhancing, is also become larger to blood flow demand, is not easy because of original low perfusion region brain blood Flow is increased significantly over brain tissue metabolism and needs and high perfusion bleeding be in the presence of.
The operating process for subtracting stream device of the present invention:
A) developed by medicine and determined at carotid artery stenosis;
B) under medicine development, the stream device that subtracts for alleviating high perfusion bleeding is transported to arteria carotis by guiding catheter and worn It crosses at carotid artery stenosis, subtracts stream device and stretched out from guiding catheter front end, current limiting element is sent to outside guiding catheter, to current limiting element Injection liquid keeps current limiting element full;
C) under medicine development, the instrument (such as stent system) of Percutaneous Transluminal Angioplasty of carotid is transported to narrow arteria carotis At blood vessel, and angioplasty is implemented to carotid artery vascular, narrow carotid artery vascular is filled;
D) blood flow increases at former stenotic carotid artery full at this time, when blood flow is at full current limiting element, Blood is influenced flow by full current limiting element and is become smaller step by step.The blood flow of the distal end of current limiting element is than current limiting element proximal end Blood flow is small;
E) in (such as 3 hours) after a certain period of time of postangioplasty:
For only there are one current limiting elements, the liquid volume of injection current limiting element is reduced, its volume is made to reduce, it is horizontal at this time Section also reduces, and the blood flow in blood vessel becomes larger;Keep current limiting element volume that above-mentioned volume for a period of time after, after The continuous liquid volume for reducing injection current limiting element, current limiting element volume are again reduced to a smaller value, at this time cross section It is decreased to a smaller value, the blood flow in blood vessel continues to become larger;Keep the volume of current limiting element in that above-mentioned volume After a period of time, continue the liquid volume for reducing injection current limiting element, current limiting element volume is again reduced to smaller value, same horizontal Section is also again reduced to smaller value, and the blood flow in blood vessel continues to become bigger;And so on shunk completely to current limiting element, At this moment the blood flow in blood vessel and original blood flow (blood flow in blood vessel when without hindrance block material) quite, subtract stream device and exit people Body;For there are multiple current limiting elements, first current limiting element of proximal end is shunk, at this moment in current limiting element device distal vessels Blood flow become larger;After shrinking the current limiting element of proximal end first, the blood flow state (such as 3 hours) for a period of time is kept, then Continue to shrink next (proximal end second) current limiting element;And so on, it all needs to stop one section before often shrinking a current limiting element Time subtracts stream device and exits human body until all current limiting elements all shrink completion.
In addition, particularly, any time before the current limiting element of the present invention is full, in filling, after filling, using pressure measurement Silk is monitored the blood flow in intracranial vessel.Sufferer lesion both can be quickly understood in time by the monitoring means of pressure measurement silk Locate the blood flow state of blood vessel, and can feed back the present invention by the blood flow result measured subtracts control of the stream device to blood flow Situation.
Main advantages of the present invention include:
(a) present invention is placed on blood vessel using the partition apparatus of fusiformis, cylindrical shape, spherical shape, elliposoidal or other shapes In stream is subtracted to blood, achieve the purpose that reduce blood flow to reduce perfusion.
(b) present invention is placed on blood using one or more fusiformis, cylindrical shape or the partition apparatus of spherical shape or other shapes Stream is subtracted to blood in pipe, reach can different proportion, controllable reduce blood flow and allow sufferer slowly to adapt to reduce perfusion The purpose of hemoperfusion.
(c) partition apparatus in the present invention, can be used compliance, non-compliance or semi-compliant current limiting element are made, body Product is stably and controllable, and by adjusting current limiting element, expanded state accurately controls blood flow in the blood vessel.
Present invention will be further explained below with reference to specific examples.It should be understood that these embodiments are merely to illustrate the present invention Rather than it limits the scope of the invention.In addition, attached drawing is schematic diagram, therefore apparatus of the present invention and equipment are not shown by described The size or ratio of intention limit.
It should be noted that in the claim and specification of this patent, such as first and second or the like relationship Term is only used to distinguish one entity or operation from another entity or operation, without necessarily requiring or implying There are any actual relationship or orders between these entities or operation.Moreover, the terms "include", "comprise" or its Any other variant is intended to non-exclusive inclusion so that including the processes of a series of elements, method, article or Equipment includes not only those elements, but also includes other elements that are not explicitly listed, or further include for this process, Method, article or the intrinsic element of equipment.In the absence of more restrictions, being wanted by what sentence " including one " limited Element, it is not excluded that there is also other identical elements in the process, method, article or apparatus that includes the element.
Embodiment 1
The present embodiment for prevent high perfusion bleeding to subtract streaming system as shown in figs. 1 and 3.It includes master that this, which subtracts streaming system 1, Body 3, current limiting element 2, sacculus 9 and liquid injection port 4.The central passage 8 of main body 3, sets that there are four fluid passages on body outer wall 6 7,7 central symmetry of fluid passage is distributed in body outer wall 6, and one end of the fluid passage 7 is connected to current limiting element 2 or sacculus 9, The other end is connected to liquid injection port 4, wherein current limiting element 2, sacculus 9 are fixed on the distal end of main body 3, and liquid injection port 4 is fixed In the proximal end of main body 3, the quantity of current limiting element 2 is three, and three current limiting elements 2 are equally spaced, and current limiting element The quantity of diameter all same after full, sacculus 9 is one.
As illustrated in figures 14-16, streaming system 1 will be subtracted to take in guiding catheter 5, subtract streaming system 1 and blood is entered by guiding catheter 5 Pipe, will subtract streaming system 1 gradually release guiding catheter 5 until all current limiting elements 2, sacculus 9 release guiding catheter 5, to sacculus 9 into Row injection liquid, to narrow blood vessel dilatation, current limiting element 2 to be adjusted and fills to subtract stream to blood.
It is intravascular when subtracting three current limiting elements 2 of streaming system 1 from guiding catheter 5 and entering, when three current limiting elements in blood When all full, blood flow is only 25% or so (15%-35%) of blood flow in the case of current limiting element is not full, when contraction most proximal end Current limiting element after and when being removed guiding catheter 5 blood flow becomes larger to current limiting element 50% of blood flow in the case of not full Left and right (40%-60%), after two current limiting elements for shrinking most proximal end and when being removed into guiding catheter 5 blood flow become larger to 75% or so (65%-85%) of blood flow in the case of current limiting element is not full, wherein owns (three) current limiting elements when shrinking When, the blood flow in the case of blood flow becomes larger and do not filled with current limiting element is suitable.
The present embodiment subtract streaming system can different proportion, controllable reduce blood flow and reduce perfusion to reach and allow disease Suffer from the purpose for slowly adapting to hemoperfusion.
Embodiment 2
The present embodiment for prevent high perfusion bleeding to subtract streaming system as shown in Figures 2 and 3.The present embodiment subtracts streaming system Similar to Example 1, different, the diameter after three current limiting elements 2 of the present embodiment are full is different, and from subtracting The distal end of streaming system 1 to proximal end, current limiting element 2 it is full after diameter be sequentially increased.
When the diameter of current limiting element after full is identical, current limiting element cross section is the same, and each current limiting element is to blood vessel Interior Oligemia amount is the same;In contrast, when the diameter difference of current limiting element after full, current limiting element cross section is differed Sample, each current limiting element are different to endovascular Oligemia amount.Current limiting element makes Diameter Gradual Change, can be in different amounts To control the decrement of intravascular blood flow.
Embodiment 3
The present embodiment for prevent high perfusion bleeding to subtract streaming system as shown in figs. 1 and 4.The present embodiment subtracts streaming system Similar to Example 1, different, the eccentric channel 8 of the present embodiment is located at the side of catheter section, fluid passage 7 In the other side of catheter section so that seal wire is not easy to be intertwined with fluid passage.
Embodiment 4
Similar to Example 1, different, this reality that subtracts streaming system for preventing high perfusion bleeding of the present embodiment The quantity for applying the current limiting element of example is two, and the quantity of sacculus 9 is one, and the quantity of corresponding fluid passage is also three, right The quantity for the liquid injection port answered also three.
It is intravascular when subtracting two current limiting elements of streaming system from guiding catheter and entering, when two current limiting elements in blood all When full, blood flow is only 30% or so (20%-40%) of blood flow in the case of current limiting element is not full, when shrink wherein some Blood flow becomes larger to 65% or so (55%-75%) of current limiting element blood flow in the case of not full when current limiting element, works as contraction When the current limiting element of wherein all (two), the blood flow in the case of blood flow becomes larger and do not filled with current limiting element is suitable.
The present embodiment subtract streaming system can different proportion, controllable reduce blood flow and reduce perfusion to reach and allow disease Suffer from the purpose for slowly adapting to hemoperfusion.
Embodiment 5
As shown in figure 5, the present embodiment for prevent high perfusion bleeding to subtract streaming system similar to Example 1, therewith not Together, shape of the current limiting element of the present embodiment under expanded state is elliposoidal.
Embodiment 6
As shown in fig. 6, the present embodiment for prevent high perfusion bleeding to subtract streaming system similar to Example 2, therewith not Together, shape of the current limiting element 2 of the present embodiment under expanded state is elliposoidal.
Embodiment 7
As shown in fig. 7, the present embodiment for prevent high perfusion bleeding to subtract streaming system similar to Example 1, therewith not Together, shape of the current limiting element 2 of the present embodiment under expanded state is wax gourd shape.
Embodiment 8
As shown in figure 8, the present embodiment for prevent high perfusion bleeding to subtract streaming system similar to Example 2, therewith not Together, shape of the current limiting element 2 of the present embodiment under expanded state is wax gourd shape.
Embodiment 9
As shown in figure 9, the present embodiment for prevent high perfusion bleeding to subtract streaming system similar to Example 1, therewith not With the quantity of the current limiting element 2 of the present embodiment is 1, and the quantity of sacculus 9 is also 1, the number of corresponding fluid passage 7 Amount is also 2, the quantity of corresponding liquid injection port 4 also 2, wherein eccentric channel 8 is located at the one of main body section Side, fluid passage 7 are located at the other side of catheter section.The cross sectional shape of fluid passage 7 can be pisiform as shown in figure 12, It can also be round as shown in fig. 13 that, the cross sectional shape of fluid passage 7 do not limited specifically, as long as the fluid passage energy It is enough that liquid injection is carried out to current limiting element, sacculus.When product only has 1 current limiting element 2, which filled Size especially cross section is controllable in journey, and the size of current limiting element 2 is controlled into the liquid in current limiting element 2 by controlling (cross section).
Such as by controlling the liquid injected in current limiting element 2, to adjust the volume at current limiting element 2.For example pass through tune Section injects the volume of liquid at current limiting element 2 to adjust the volume of current limiting element 2, and when 2 volume of current limiting element increases, its is transversal Face also increases.
So that its cross section is increased by full current limiting element 2, endovascular blood flow can be reduced.In use, can adjust 2 volume of current limiting element is first increased to a larger value by the amount of liquid of injection, and same cross section also increases to a larger value, At this moment due to the blocking of current limiting element 2, the blood flow in blood vessel fades to the about original blood flow (blood flow in blood vessel when without hindrance block material Amount) 25% or so (15%-35%);Keep the volume of current limiting element 2 that above-mentioned volume for a period of time after (such as 3 Hour), at this moment the volume of current limiting element 2 is decreased to the value of a relatively centre, and same cross section is also decreased to a relatively centre Value, at this moment due to the blocking of current limiting element 2, the blood flow in blood vessel fades to about original blood flow (in blood vessel when without hindrance block material Blood flow) 50% or so (40%-60%);Keep current limiting element 2 volume that above-mentioned volume for a period of time after (such as 3 hours), at this moment continue the amount of liquid for reducing current limiting element 2, the volume of full current limiting element 2 be again reduced to one compared with Small value, same cross section are also decreased to a smaller value, at this moment due to the blocking of current limiting element 2, the blood flow in blood vessel Fade to 75% or so (65%-85%) of about original blood flow (blood flow in blood vessel when without hindrance block material);Keep current limiting element 2 Volume that above-mentioned volume for a period of time after (such as 3 hours), at this moment continue reduce current limiting element 2 amount of liquid, limit 2 volume of fluid element is decreased to minimum value, and same cross section is also decreased to minimum value, at this moment the blood flow in blood vessel and original blood flow It is suitable to measure (blood flow in blood vessel when without hindrance block material).
Embodiment 10
As shown in Figure 10, the present embodiment for prevent high perfusion bleeding to subtract streaming system similar to Example 9, therewith not With the shape of the current limiting element of the present embodiment is elliposoidal.
Embodiment 11
As shown in figure 11, the present embodiment for prevent high perfusion bleeding to subtract streaming system similar to Example 9, therewith not With the shape of the current limiting element of the present embodiment is wax gourd shape.
Embodiment 12
As shown in figure 17, the present embodiment for prevent high perfusion bleeding to subtract streaming system similar to Example 9, therewith not With the shape of the current limiting element of the present embodiment is cylinder.
Embodiment 13
As shown in figure 18, the present embodiment for prevent high perfusion bleeding to subtract streaming system similar to Example 1, therewith not Quantity with, the sacculus 9 of the present embodiment is also 1, but the sacculus is independent without in the main body for subtracting streaming system, the sacculus 9 in the distal end of an independent foley's tube 10.
Embodiment 14
As shown in figure 19, the present embodiment for prevent high perfusion bleeding to subtract streaming system similar to Example 13, therewith Unlike, the shape of the current limiting element of the present embodiment is cylinder.
Embodiment 15
As shown in figure 20, the present embodiment for prevent high perfusion bleeding to subtract streaming system similar to Example 13, therewith Unlike, the shape of the current limiting element of the present embodiment is ellipse.
Embodiment 16
As shown in figure 21, the present embodiment for prevent high perfusion bleeding to subtract streaming system similar to Example 13, therewith Unlike, the shape of the current limiting element of the present embodiment is wax gourd shape.
Embodiment 17
As shown in figure 24, the present embodiment for prevent high perfusion bleeding to subtract streaming system similar to Example 13, therewith Unlike, there are one pressure measurement silk in the present embodiment, the pressure measurement silk is independent without on subtracting stream device, this pressure measurement silk and subtracts stream dress Two parts are set to, can be separated, are seperated.Pressure measurement silk navigates within the guidewire lumen subtracted inside stream device and (subtracts in stream device Heart hole 8 or eccentric orfice 8).Pressure measurement silk distal end is equipped with pressure sensor, and there is pressure monitoring device in proximal end, the pressure in supervision equipment Display screen shows instant pressure, can play the role of monitoring current limiting element distal end blood pressure in real time.Pressure measurement silk can conduct simultaneously The guiding wire for subtracting stream device, will subtract fluid element and is transported to and need to position.
Embodiment 18
As shown in figure 25, the present embodiment for prevent high perfusion bleeding to subtract streaming system similar to Example 13, therewith Unlike, there are one pressure measurement silk in the present embodiment, which, which is embedded in, subtracts inside stream device, this pressure measurement silk is with stream device is subtracted One entirety, can not separate, and be integrated.Pressure measurement silk distal end is equipped with pressure sensor, and proximal end has pressure monitoring device, monitoring to set Standby upper pressure display screen shows instant pressure, can play the role of monitoring current limiting element distal end blood pressure in real time.It surveys simultaneously Silk pressing can push power as the built-in supporting wire for subtracting stream device to subtract enhancing when fluid element is delivered to the position for needing to reach, Pressure measurement silk can be used as the guiding wire for subtracting and flowing device simultaneously, will subtract fluid element and be transported to and need to position.
All references mentioned in the present invention is incorporated herein by reference, independent just as each document It is incorporated as with reference to such.In addition, it should also be understood that, after reading the above teachings of the present invention, those skilled in the art can To be made various changes or modifications to the present invention, such equivalent forms equally fall within model defined by the application the appended claims It encloses.

Claims (10)

1. a kind of subtracting stream device for preventing bleeding is perfused, which is characterized in that described subtract flows device and include
N current limiting element, wherein 1≤n≤5, the current limiting element are located at the distal end for subtracting stream device, the current limiting element Blood flow for reducing blood vessel;
Main body, the wall of the main body are equipped with n fluid passage, and the current limiting element is set to the distal end of the main body, and with The fluid passage connection, the current limiting element are connected to fluid passage one-to-one correspondence;And
N liquid injection port, the liquid injection port are located at the proximal end for subtracting stream device, fix on the body, and with The fluid passage connection, the liquid injection port are connected to fluid passage one-to-one correspondence.
2. subtracting stream device as described in claim 1, which is characterized in that the outer diameter of the current limiting element be d, the blood vessel it is interior Diameter is D, wherein d < D.
3. subtracting stream device as described in claim 1, which is characterized in that the current limiting element surface is coated with anticoagulant.
4. subtracting stream device as described in claim 1, which is characterized in that the diameter after the n current limiting elements are full is identical 's;Or
Diameter after n current limiting elements are full is from the proximal end for subtracting stream device to distally reducing successively.
5. subtracting stream device as described in claim 1, which is characterized in that the main body be equipped with for seal wire by central passage or Eccentric channel;
The central passage is located at the center of the main body, and the fluid passage is located in the main wall, and is evenly distributed on The periphery of the central passage;
The eccentric channel is located at the side of the main body section, and the eccentric channel passes through for seal wire, the fluid passage position In the other side of the main body section.
6. subtracting stream device as described in claim 1, which is characterized in that the stream device that subtracts is furnished with pressure measurement silk.
7. subtracting stream device as described in claim 1, which is characterized in that when the current limiting element is 1, the current limiting element For compliance current limiting element;Or
When current limiting element is 2-5, the current limiting element is in the current limiting element of compliance, non-compliance or semi-compliant It is one or more.
8. subtracting stream device as described in claim 1, which is characterized in that carry out contraction behaviour to the current limiting element after full Make, which is carried out by multiple stages, for only there are one stream device is subtracted described in the current limiting element, once A part for the current limiting element volume is only shunk, and is spaced 0.5-5h between shrinkage operation twice;
Subtract stream device described in multiple current limiting elements for having, once only shrinks a current limiting element, and receive twice It is spaced 0.5-5h between contracting operation.
9. subtracting stream device as described in claim 1, which is characterized in that the material of the current limiting element for subtracting stream device is elasticity Body material, the elastomeric material are selected from the group:Silica gel, latex, TPU and TPE.
10. a kind of subtracting streaming system for preventing perfusion bleeding, which is characterized in that the streaming system that subtracts includes
Sacculus, the sacculus is for expanding blood vessel;
Current limiting element, the current limiting element are located at the distal end for subtracting streaming system, and the current limiting element is used to reduce the blood of blood vessel Flow, when in use, the sacculus are arranged close to the proximal end of the current limiting element;
Main body, the wall of the main body are equipped with fluid passage, and the current limiting element is set in the main body, and with the liquid Channel is connected to, and the current limiting element and the fluid passage connect one to one;And
Liquid injection port, the liquid injection port are located at the proximal end for subtracting streaming system, it is fixed on the body, and with it is described Fluid passage is connected to, and the liquid injection port and the fluid passage are one-to-one.
CN201810672035.8A 2018-06-26 2018-06-26 Flow reducing device and system for preventing perfusion bleeding Active CN108744232B (en)

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