CN115429382B - Thrombolysis device - Google Patents
Thrombolysis device Download PDFInfo
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- CN115429382B CN115429382B CN202211062835.0A CN202211062835A CN115429382B CN 115429382 B CN115429382 B CN 115429382B CN 202211062835 A CN202211062835 A CN 202211062835A CN 115429382 B CN115429382 B CN 115429382B
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- thrombolytic
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- 230000002537 thrombolytic effect Effects 0.000 title claims abstract description 171
- 239000003146 anticoagulant agent Substances 0.000 claims abstract description 98
- 230000000903 blocking effect Effects 0.000 claims abstract description 15
- 230000008602 contraction Effects 0.000 claims abstract description 4
- 238000001802 infusion Methods 0.000 claims description 42
- 230000010412 perfusion Effects 0.000 claims description 41
- 238000002604 ultrasonography Methods 0.000 claims description 15
- 238000004806 packaging method and process Methods 0.000 claims description 9
- 230000000149 penetrating effect Effects 0.000 claims description 8
- 238000000034 method Methods 0.000 claims description 7
- 230000008569 process Effects 0.000 claims description 7
- 238000009434 installation Methods 0.000 claims description 5
- 238000003698 laser cutting Methods 0.000 claims description 5
- 230000007704 transition Effects 0.000 claims description 5
- 238000009954 braiding Methods 0.000 claims description 4
- 230000002093 peripheral effect Effects 0.000 claims description 4
- 238000004378 air conditioning Methods 0.000 claims description 2
- 208000007536 Thrombosis Diseases 0.000 abstract description 20
- 210000004204 blood vessel Anatomy 0.000 abstract description 12
- 230000002262 irrigation Effects 0.000 abstract description 9
- 238000003973 irrigation Methods 0.000 abstract description 9
- 230000005855 radiation Effects 0.000 abstract 1
- 239000003814 drug Substances 0.000 description 21
- 230000000694 effects Effects 0.000 description 8
- 208000005189 Embolism Diseases 0.000 description 6
- 230000008901 benefit Effects 0.000 description 5
- 238000004891 communication Methods 0.000 description 3
- 238000010586 diagram Methods 0.000 description 3
- 239000000919 ceramic Substances 0.000 description 2
- 230000008092 positive effect Effects 0.000 description 2
- 239000000243 solution Substances 0.000 description 2
- 230000002792 vascular Effects 0.000 description 2
- 208000019553 vascular disease Diseases 0.000 description 2
- 206010008190 Cerebrovascular accident Diseases 0.000 description 1
- 208000032843 Hemorrhage Diseases 0.000 description 1
- 208000010378 Pulmonary Embolism Diseases 0.000 description 1
- 208000006011 Stroke Diseases 0.000 description 1
- HZEWFHLRYVTOIW-UHFFFAOYSA-N [Ti].[Ni] Chemical compound [Ti].[Ni] HZEWFHLRYVTOIW-UHFFFAOYSA-N 0.000 description 1
- 230000009471 action Effects 0.000 description 1
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- 230000000740 bleeding effect Effects 0.000 description 1
- 230000017531 blood circulation Effects 0.000 description 1
- 230000002490 cerebral effect Effects 0.000 description 1
- 239000002826 coolant Substances 0.000 description 1
- 238000001816 cooling Methods 0.000 description 1
- 239000000110 cooling liquid Substances 0.000 description 1
- 201000010099 disease Diseases 0.000 description 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 1
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- 239000003527 fibrinolytic agent Substances 0.000 description 1
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- 238000002347 injection Methods 0.000 description 1
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- 210000003141 lower extremity Anatomy 0.000 description 1
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- 229910001000 nickel titanium Inorganic materials 0.000 description 1
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Classifications
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- 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
- A61B17/22004—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 using mechanical vibrations, e.g. ultrasonic shock waves
-
- 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
- A61B17/221—Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B2017/00831—Material properties
- A61B2017/00867—Material properties shape memory effect
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- 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
- A61B2017/22038—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 a guide wire
-
- 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
- A61B2017/22082—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 after introduction of a substance
- A61B2017/22084—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 after introduction of a substance stone- or thrombus-dissolving
-
- 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
- A61B17/221—Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions
- A61B2017/2212—Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions having a closed distal end, e.g. a loop
Abstract
The invention provides a thrombolytic device. It comprises the following steps: thrombolysis catheter and ultrasonic transducer; the distal end of the ultrasonic transducer is provided with a bracket capable of radial expansion and contraction, and the ultrasonic transducer can penetrate into the thrombolysis catheter from the proximal end of the thrombolysis catheter; the ultrasonic transducer can move axially relative to the thrombolysis catheter so that the stent extends out of the distal end of the thrombolysis catheter and the ultrasonic transducer can block the thrombolysis catheter or open the distal end of the thrombolysis catheter; an irrigation channel is formed between the ultrasonic transducer and the thrombolytic catheter and the ultrasonic transducer is used to radiate ultrasonic energy. According to the embodiment of the invention, the thrombolysis efficiency is effectively improved by the aid of ultrasonic energy radiation of the ultrasonic transducer, and the distal end of the thrombus is blocked by the support to prevent the broken thrombus from blocking the distal end of the blood vessel.
Description
Technical Field
The invention relates to the technical field of medical instruments, in particular to a thrombolysis device.
Background
Vascular disease has become the first leading fatal disease in China, and vascular embolism has become a major factor in vascular disease. Especially ischemic cerebral apoplexy, pulmonary embolism and venous embolism of lower limb, the total annual new incidence rate of patients exceeds 500 ten thousand people.
At present, medical intervention thrombus taking is gradually becoming an effective mode recommended by the main flow of vascular embolism treatment. The interventional thrombus taking has the advantages of small wound, short postoperative recovery time, few complications after treatment, good operation effect and the like, and can be accepted by patients.
Aiming at the clinical practice of intravascular embolism treatment, the existing systemic thrombolysis has very high bleeding risk due to the medicine dosage problem, the use of thrombolytic medicine dosage can be reduced to a certain extent by direct catheter thrombolysis (CDT), the benefit of patients is increased, but the operation efficiency is low, and the possibility of remote re-embolism cannot be avoided. The ultrasonic thrombolysis catheter can strip thrombus through the far-end expandable bracket, enhance the bonding area of thrombolytic drugs and thrombus, simultaneously introduce ultrasonic energy, increase the bonding capability of drugs and thrombus, shorten the operation time and avoid the risk of remote re-embolism.
Disclosure of Invention
The invention aims to provide a thrombolysis device, which can effectively improve thrombolysis efficiency by using ultrasonic energy radiated by an ultrasonic transducer to assist thrombolysis and prevent broken thrombus from blocking the distal end of a blood vessel by blocking the distal end of the thrombus by a bracket.
In order to solve the above technical problems, an embodiment of the present invention provides a thrombolytic device, including: thrombolysis catheter; a kind of electronic device with high-pressure air-conditioning system
An ultrasonic transducer, the distal end of which is provided with a bracket capable of radial expansion and contraction, and the ultrasonic transducer can penetrate into the thrombolysis catheter from the proximal end of the thrombolysis catheter; the ultrasonic transducer can move relative to the thrombolysis catheter along the axial direction so that the bracket extends out of the distal end of the thrombolysis catheter and the ultrasonic transducer can seal the thrombolysis catheter or open the distal end of the thrombolysis catheter; an irrigation channel is formed between the ultrasonic transducer and the thrombolytic catheter and the ultrasonic transducer is used to radiate ultrasonic energy.
As one embodiment, the thrombolytic catheter comprises a tube body and a thrombolytic handle; the proximal end of the tube body is connected with the distal end of the thrombolysis handle;
the tube body comprises a perfusion tube with a proximal end connected with the distal end of the thrombolytic handle; at least one protruding part extending along the axial direction is arranged in the pouring tube.
As an embodiment, the thrombolytic device further comprises a temperature sensor;
the temperature sensor comprises at least one group of temperature sensing pieces, sensor wires and sensor connectors;
the temperature sensing piece is arranged in the installation cavity;
the temperature sensing piece is connected with the sensor connector through the sensor wire, and the proximal end of the sensor wire extends out of the thrombolytic handle.
As one embodiment, the number of the protruding parts is at least 2, the protruding parts are distributed along the circumferential direction, and the number of the temperature sensing parts is at least 2; optionally, each group of temperature sensing elements is arranged in the installation cavity of each protruding part in a one-to-one correspondence manner;
optionally, each group of the temperature sensing elements comprises at least 2 temperature sensing elements which are distributed at intervals along the axial direction;
optionally, the sensor wires of each set of temperature sensing elements merge together at the proximal end of the thrombolytic handle and extend beyond the proximal end of the thrombolytic handle.
As one embodiment, the tube body further comprises a guide tube with a proximal end connected with the distal end of the perfusion tube, the diameter of the guide tube is smaller than that of the perfusion tube, and the guide tube is in smooth transition connection with the perfusion tube;
optionally, the perfusion tube comprises a perfusion tube section with a distal end connected with the proximal end of the guide tube, and a perfusion structure is distributed on the peripheral wall of the perfusion tube section;
optionally, the thrombolytic handle is tapered with a small distal end and a large proximal end, and the distal end of the thrombolytic handle is symmetrically provided with fixing holes;
optionally, the thrombolysis catheter further comprises an infusion tube connected with the tube body, and at least one on-off infusion interface is arranged at the outer end of the infusion tube.
As one embodiment, the ultrasonic transducer comprises an ultrasonic assembly, an ultrasonic handle and an ultrasonic joint;
the ultrasonic assembly comprises: a plurality of ultrasonic radiators and a packaging structure which are electrically connected through ultrasonic leads;
the plurality of ultrasonic radiators are arranged at intervals along the axial direction, and the packaging structure is used for packaging the ultrasonic radiators into a whole;
the ultrasonic assembly is connected with the distal end of the ultrasonic handle, the ultrasonic assembly and the ultrasonic handle are coaxially arranged, and the ultrasonic wire penetrates through the ultrasonic handle and is connected with the ultrasonic connector.
As one embodiment, the ultrasound transducer further comprises a closure member having a proximal end connected to the distal end of the ultrasound assembly;
the blocking piece is matched with the inner cavity of the guide tube and can penetrate into or withdraw from the guide tube to block or open the guide tube;
optionally, the closure distal end has a tip.
As an embodiment, the ultrasonic transducer further comprises: a movable conical head, a lining core and an inner tube;
the ultrasonic transducer is provided with a lining core channel which penetrates through the proximal end of the ultrasonic handle and the distal end of the blocking piece and is used for penetrating through the lining core, and the distal end of the blocking piece is connected with the proximal end of the inner tube;
the lining core is movably arranged in the lining core channel and the inner tube in a penetrating way, the distal end of the lining core penetrates out of the distal end of the support and is connected with the distal end of the support, and the proximal end of the movable conical head is connected with the distal end of the lining core; the distal end of the inner tube penetrates into the bracket and the proximal end of the bracket is connected with the proximal end of the inner tube.
As one embodiment, the proximal end of the thrombolytic handle is provided with a tubular transducer interface protruding out of the proximal end of the thrombolytic handle and used for penetrating the ultrasonic transducer, and the distal end of the transducer interface is connected with the proximal end of the tube body;
optionally, the transducer interface is coaxially arranged with the tube body and has a diameter larger than the diameter of the tube body; the transducer interface is also used to secure the ultrasonic handle to the thrombolytic handle.
As an example, the bracket is spherical or fusiform;
optionally, the stent is made using a braided wire braiding process and/or a laser cutting process.
According to the technical scheme, the invention has at least the following advantages and positive effects:
in the thrombolysis device provided by the embodiment of the invention, the ultrasonic transducer forms a perfusion channel between the ultrasonic transducer and the thrombolysis catheter when the ultrasonic transducer is inserted into the thrombolysis catheter, and the ultrasonic transducer can be controlled to move axially relative to the thrombolysis catheter to block the distal end of the perfusion channel, so that medicine is injected through the perfusion channel, the distal end of the perfusion channel can be opened, at the moment, the ultrasonic transducer can emit ultrasonic energy to accelerate thrombolysis of thrombolysis medicine, thrombolysis efficiency and thrombolysis effect are improved, and meanwhile, the stent extends out of the distal end of the thrombolysis catheter to prevent broken thrombus from escaping to the distal end of a blood vessel to block the blood vessel.
Drawings
In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings that are required in the embodiments or the description of the prior art will be briefly described below, it being understood that the drawings in the following description are only embodiments of the present invention and that other drawings may be obtained according to the drawings provided without inventive effort for a person skilled in the art.
Fig. 1 is a schematic structural diagram of a thrombolytic device according to an embodiment of the present invention;
fig. 2 is a schematic structural view of a thrombolytic catheter of a thrombolytic device according to an embodiment of the present invention;
FIG. 3 is a schematic view of an ultrasonic energy-saving device of a thrombolysis device according to an embodiment of the present invention;
fig. 4 is a schematic view of a partial enlarged structure of a thrombolytic device according to an embodiment of the present invention;
FIG. 5 is a schematic view of the longitudinal cross-sectional structure of FIG. 4;
FIG. 6a is a schematic cross-sectional view of a perfusion tube section of a perfusion tube of a thrombolytic device according to an embodiment of the present invention;
FIG. 6b is a schematic cross-sectional view of a delivery tube segment of a perfusion tube of a thrombolytic device according to an embodiment of the present invention;
FIG. 7 is a schematic cross-sectional view of a guide tube of a thrombolytic device according to an embodiment of the present invention;
FIG. 8 is a schematic diagram of a perfusion thrombolytic condition of a thrombolytic device according to an embodiment of the present invention;
fig. 9 is a schematic diagram of an ultrasonic thrombolysis condition of a thrombolysis device according to an embodiment of the present invention.
Detailed Description
For the purpose of making the objects, technical solutions and advantages of the embodiments of the present invention more apparent, the following detailed description of the embodiments of the present invention will be given with reference to the accompanying drawings. However, those of ordinary skill in the art will understand that in various embodiments of the present invention, numerous technical details have been set forth in order to provide a better understanding of the present invention. However, the claimed invention may be practiced without these specific details and with various changes and modifications based on the following embodiments.
In the description of the present invention, it should be noted that the directions or positional relationships indicated by the terms "upper", "lower", "inner", "outer", etc. are based on the directions or positional relationships shown in the drawings, are merely for convenience of describing the present invention and simplifying the description, and do not indicate or imply that the apparatus or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and thus should not be construed as limiting the present invention. Furthermore, the terms "first," "second," "third," and the like are used for descriptive purposes only and are not to be construed as indicating or implying relative importance.
It should be noted that, unless explicitly stated otherwise, the terms "connected," "connected," and the like should be construed broadly, and may be, for example, fixedly connected, detachably connected, or integrally connected; can be directly connected or indirectly connected through an intermediate medium, and can be communication between two elements.
In the description of the present invention, it should be noted that, in the field of interventional medical devices, the proximal end refers to the end closer to the operator, and the distal end refers to the end farther from the operator; axial refers to a direction parallel to the line connecting the distal center and the proximal center of the medical device in its natural state. The above definitions are for convenience of description only and are not to be construed as limiting the invention.
Referring to fig. 1 to 3, an embodiment of the present invention provides a thrombolytic device for thrombolytic therapy. The thrombolytic device of this embodiment mainly includes: thrombolysis catheter 1, ultrasonic transducer 2 and temperature sensor.
The distal end of the ultrasound transducer 2 is provided with a support 21 which can be radially expanded and contracted. The ultrasound transducer 2 is capable of penetrating into the thrombolytic catheter 1 from the proximal end of the thrombolytic catheter 1. The ultrasound transducer 2 is movable axially relative to the thrombolytic catheter 1 such that the stent 21 extends out of the distal end of the thrombolytic catheter 1. The ultrasound transducer 2 is also capable of plugging the distal end of the thrombolytic catheter 1 or opening the distal end of the thrombolytic catheter 1 by axially moving the distal end of the thrombolytic catheter 1 relative to the stent 21 when the stent is positioned at the distal end of the thrombolytic catheter 1. A perfusion channel is formed between the ultrasonic transducer 2 and the thrombolytic catheter 1, and when the distal end of the thrombolytic catheter 1 is closed, thrombolytic medicament is infused through the perfusion channel, so that the thrombolytic medicament precisely acts on the thrombus position; after the thrombolytic medicament is infused, the distal end of the thrombolytic catheter 1 is opened, ultrasonic energy is radiated by the ultrasonic transducer 2, for example, high-frequency ultrasonic energy with a certain frequency is emitted, so that the thrombolysis effect of the thrombolytic medicament is accelerated, and the thrombolysis efficiency and the thrombolysis effect are improved, therefore, the ultrasonic transducer 2 can move in the lumen of the thrombolytic catheter 1, and the two working states of thrombolytic medicament infusion and thrombolysis effect enhancement by the ultrasonic energy can be switched through the cooperation of different positions. The expanded stent 21 can prevent thrombus from drifting to the distal end to block the distal end blood vessel by blood flow and intercepting broken thrombus, and in addition, the thrombus can be peeled off from the inner wall of the blood vessel by the stent 21, so that thrombolytic medicine can act on the thrombus more sufficiently.
The temperature sensor is arranged in the thrombolysis catheter 1 and can detect the temperature of the thrombolysis catheter 1, and when the energy radiated by the ultrasonic transducer 2 makes the temperature of the thrombolysis catheter 1 too high, the perfusion channel can be filled with cooling liquid to adjust the temperature of the thrombolysis catheter 1, so that the damage to the blood vessel caused by the too high temperature of the thrombolysis catheter 1 is avoided. It will be appreciated that in some examples, a temperature sensor may not be provided, and the injection flow rate of the coolant may be controlled according to the thermal efficiency generated when the ultrasonic transducer 2 is operated to ensure that the thrombolytic catheter 1 is operated within a safe temperature range.
Referring to fig. 2, the thrombolytic catheter 2 mainly comprises: a tube 11, a thrombolytic handle 12 and an infusion set.
The proximal end of the tube 11 is connected to the distal end of the thrombolytic handle 12. The tube body 11 includes a guide tube 111 and a perfusion tube 112. At least one axially extending boss 113 is provided within the irrigation tube 112. Optionally, the number of the protrusions 113 is at least 2 and distributed in the circumferential direction. Illustratively, the perfusion tube 112 has 3 protrusions 113,3 with evenly circumferentially spaced protrusions 113 disposed therein. The inner walls of the infusion tube 112 and the boss 113 enclose a shaped infusion lumen, which may reduce the volume of the infusion lumen, thereby reducing the volume of the infusion channel 1123 to reduce the amount of infusion medicament consumed in the infusion channel.
The proximal end of the guide tube 111 is connected with the distal end of the perfusion tube 112, the diameter of the guide tube 111 is smaller than that of the perfusion tube 112, the guide tube 111 is in smooth transition connection with the perfusion tube 112, namely, the outer contour and the inner contour of the connection part of the guide tube 111 and the perfusion tube 112 are in smooth transition.
The infusion tube 112 includes an infusion tube segment 1121 and a delivery tube segment 1122 connected in series from the distal end to the proximal end. The peripheral wall of the pouring tube section 1121 is provided with a pouring structure 11211. The irrigation structure 11211 is for communicating the irrigation lumen with the outside. Illustratively, the infusion structure 11211 may be a pressure-controlled open-close infusion structure, i.e., the infusion structure 11211 is capable of opening at a certain infusion pressure and is in a closed state when the infusion pressure is low, thereby facilitating the saving of medicament usage. The pouring structure 11211 may be a pouring hole with a suitable shape such as rectangular, circular, oval, etc., or a pouring slit structure with other suitable shape. The plurality of irrigation structures 11211 may be evenly distributed circumferentially and axially along the irrigation tube segment. No pouring structure is required at the pouring tube section corresponding to the boss 113. The specific structure and the distribution manner of the infusion structure are not particularly limited in this embodiment, as long as the infusion structure 11211 can accurately infuse medicine.
Referring to fig. 2 and fig. 6a and 6b, each of the protruding portions 113 is provided with a mounting cavity 1131 having a closed distal end and an open proximal end. The temperature sensor may comprise at least one set of temperature sensing elements 31, sensor wires 32 and sensor connectors 33. The temperature sensing element 31 is disposed within the mounting cavity 1131. The temperature sensing element 31 is connected to the sensor connector 33 by a sensor wire 32, the proximal end of the sensor wire 32 extending beyond the thrombolytic handle 12. The mounting cavity 1131 of the boss 113 of the perfusion tube 112 is closed at the distal end and open at the proximal end, and the proximal opening of the mounting cavity 1131 allows the temperature sensing element 31 to be connected with the sensor wire 32. The temperature sensing element 31 is used to sense the temperature of the irrigation tube segment 1121 of the irrigation tube 112. Each set of temperature sensing elements 31 may comprise one or more temperature sensing elements. The temperature sensing element may be a thermistor or thermocouple, for example. The thermistor may be a positive temperature coefficient thermistor or a negative temperature coefficient thermistor. The temperature sensing element may be made in a circular shape or a fan shape, etc., and is adapted to the shape of the installation cavity 1131, so that the temperature sensing element 31 may be reliably installed in the installation cavity 1131 and the temperature of the perfusion tube 112 may be sensitively detected. The sensor connector 33 is used for being connected with a host machine, so that the host machine can acquire the temperature signal acquired by the temperature sensing element 31. The number of the groups of the temperature sensing elements 31 may be the same as the number of the protruding portions 113, and may be not less than two groups, for example, the temperature sensing elements 31 are 3 groups, the protruding portions 113 are 3, and the 3 groups of the temperature sensing elements 31 are disposed in the mounting cavities 1131 of the protruding portions 113 in a one-to-one correspondence. Each group of temperature sensing elements can comprise 2 temperature sensing elements which are arranged at intervals along the axial direction, so that temperature information of a plurality of positions along the axial direction can be detected. Optionally, the sensor wires 32 of the 3 sets of temperature sensing elements 31 converge into a single strand at the proximal end of the thrombolytic handle 12 and extend beyond the proximal end of the thrombolytic handle 12, thereby facilitating connection to a host computer. Of course, the number of groups of temperature sensing elements 31 may be smaller than the number of protruding portions. For example, the number of the projections may be 4, and the number of the temperature sensing elements 31 may be 3.
The proximal end of the thrombolytic handle 12 is provided with a transducer interface 122 which is tubular and protrudes beyond the proximal end of the thrombolytic handle 12 and is adapted to penetrate the ultrasound transducer 2. The transducer interface distal end may be connected to the proximal end of the tube 11. The transducer interface 122 is coaxially arranged with the tube body 11, and the diameter of the transducer interface is larger than that of the tube body 11, and the tube body 11 is in smooth transition connection with the transducer interface 122. The larger diameter transducer interface 122 facilitates insertion of the ultrasound transducer 2 into the thrombolytic catheter 1 via the transducer interface 122. The transducer interface 122 is also used to secure the ultrasound handle 24 of the ultrasound transducer 2 to the thrombolytic handle 12, thereby securing the ultrasound transducer 2 to the thrombolytic catheter 1. It will be appreciated that the transducer interface 122 and the ultrasonic handle 24 may be secured by a tight fit, snap fit, or the like, without limitation.
The infusion assembly may comprise an infusion tube 13 connected to the tube body 11 and in communication with the infusion channel 1123, the outer end of the infusion tube 13 being provided with at least one on-off infusion port 15. Specifically, the outer end of the infusion tube 13 is provided with two infusion interfaces 15, and the outer end of the infusion tube 13 is also provided with a control valve 14 for controlling the on-off of the two infusion interfaces 15 and the infusion tube 13. For example, the control valve 14 can control both infusion ports 15 to be closed or either infusion port 15 to be open. The number of the infusion ports 15 and the structure of the control valve 14 are not particularly limited in this embodiment.
Illustratively, the thrombolytic handle 12 is tapered with a small distal end and a large proximal end. The thrombolytic handle 12 may be fixedly sleeved on the proximal end of the tube 11, and the connection mode between the thrombolytic handle 12 and the tube 11 is not particularly limited in this embodiment. The inner end of the infusion tube 13 may be connected to the transducer interface 122 or to a peripheral wall of the proximal end of the tube body 11 such that the infusion tube 13 communicates with the infusion channel 1123.
The distal end of the thrombolytic handle 12 may be symmetrically provided with fixation holes 121. Specifically, the distal end of the thrombolytic handle 12 may be symmetrically provided with two wing plates, and the two fixing holes 121 are respectively provided on the two wing plates. The fixing hole 121 may be a circular through hole, and the thrombolysis device may be conveniently fixed to the human body through the fixing hole 121 during the operation.
Referring to fig. 3-5 and fig. 8 and 9, the ultrasonic transducer 2 may include a support 21, an ultrasonic assembly 22, an ultrasonic handle 23, an ultrasonic joint 24, a plug 25, a movable cone 26, a core 27, and an inner tube 28.
The ultrasonic assembly 22 may include: a plurality of ultrasonic radiators 221 and a package structure 222 electrically connected by ultrasonic leads 224. The plurality of ultrasonic radiators 221 are arranged at intervals along the axial direction, and the packaging structure 222 is used for packaging the ultrasonic radiators 221 into a whole, and the cross section of the packaged ultrasonic assembly 22 can be circular. The proximal end of the ultrasonic assembly 22 is connected to the distal end of the ultrasonic handle 23, the ultrasonic assembly 22 is coaxially disposed with the ultrasonic handle 23, and an ultrasonic wire 224 passes through the ultrasonic handle 23 and is connected to the ultrasonic joint 24.
The ultrasonic radiator 221 may be a piezoelectric ceramic structure, and a plurality of piezoelectric ceramics may be uniformly spaced along the axial direction and connected by an ultrasonic wire 224, and the ultrasonic wire 224 may extend out of the ultrasonic handle 23 and be connected to the ultrasonic joint 24. The package structure 222 has insulating properties to prevent leakage of the ultrasonic leads 224. It will be appreciated that the plurality of ultrasonic radiators 221 may be correspondingly distributed in the perfusion tube segment 1121, and that the delivery tube segment 1122 is not provided with ultrasonic radiators, and that no ultrasonic energy is radiated within the delivery tube segment 1122.
The proximal end of the blocking member 25 is connected to the distal end of the ultrasonic assembly 22 and may be integral with the ultrasonic assembly 22. The guide tube 111 is of a single-lumen tubular structure and has an annular channel 1111, and the blocking member 25 is adapted to the inner lumen of the guide tube 111 and is capable of penetrating into or exiting out of the guide tube 111 to block or unblock the guide tube 111, thereby blocking or unblocking the distal end of the thrombolytic catheter 1. I.e. the outer dimensions of the blocking member 25 match the annular channel 1111 of the guide tube 111 such that the blocking member 25 can enter or exit the annular channel of the guide tube 111 from the proximal end of the guide tube 111. The distal end of the occluding component 25 may have a pointed end to facilitate penetration into the guiding tube 111. It will be appreciated that the occluding component 25 may also be positioned distally of the distal end of the ultrasonic assembly 22, into or out of the annular channel of the guide tube 111 from the distal end of the guide tube 111; alternatively, the packaging structure at the distal end of the ultrasonic assembly 22 may be used as a closure.
The ultrasound transducer 2 has a core passage 223 through the proximal end of the ultrasound handle 23 and the distal end of the closure member 25 for threading the core 27. The core passage 223 may be circular and may have the same diameter as the inner lumen of the inner tube 28. The distal end of the closure member 25 is connected to the proximal end of the inner tube 28 such that the core passage 223 is in communication with the inner tube 28. The core 27 is movably disposed through the core passage 223 and the inner tube 28, and has a distal end extending out of the distal end of the bracket 21 and connected to the distal end of the bracket 21. The proximal end of the movable cone 26 is connected to the distal end of the core 27. The distal end of the inner tube 28 penetrates into the stent 21 and the proximal end of the stent 21 is connected to the proximal end of the inner tube 28. Thus, by controlling the axial movement of the core 27 relative to the ultrasonic assembly 22, pushing or pulling the core 27 forward or back can control the axial expansion and contraction of the stent 21, thereby adjusting the radial expansion degree of the stent 21. The proximal end of the movable conical head 26 is fixedly connected with the distal end of the lining core 27, and the movable conical head 26 is controlled to axially move by pushing or pulling the lining core 27.
The stent 21 may be a proximally-closed stent structure such as a sphere or a shuttle. The support 21 may be made of a shape memory material. The stent 21 may be formed using a braided wire braiding process and/or a laser cutting process. For example, the bracket 21 may be formed by interweaving shape memory alloy wires, or be made of nickel-titanium tube by laser cutting and heat setting, and of course, the bracket 21 may also be made by two processes of braiding and laser cutting. The stent 21 can be supported on the inner wall of a blood vessel after being expanded, thrombus can be stripped by the stent and then thrombolysis can be carried out, and meanwhile, the stent 21 can also prevent broken thrombus from drifting towards the distal end of the blood vessel.
Referring to fig. 1, 8 and 9, the thrombolytic device of the present embodiment is used as follows:
in operation, after the thrombolytic catheter 1 is placed to a designated position, the ultrasonic transducer 2 is inserted to enable the bracket 21 to extend out of the distal end of the thrombolytic catheter 1, the ultrasonic transducer 2 is used for plugging the distal end of the thrombolytic catheter 1, the ultrasonic transducer 2 is fixedly connected with the thrombolytic catheter 1, then thrombolytic medicine is infused under pressure through an infusion interface 15, and the thrombolytic medicine enters through an infusion channel between the ultrasonic transducer 2 and the thrombolytic catheter and is ejected from the infusion structure 11211, so that the thrombolytic medicine can directly act on thrombus. After the thrombolysis medicine is infused, the ultrasonic transducer 2 is slightly retracted, the far end of the thrombolysis catheter 1 (i.e. the annular channel 1111 of the guide tube 111 is opened), the sensor joint 33 and the ultrasonic joint 24 are respectively connected with a host, and the ultrasonic transducer 2 can radiate ultrasonic energy after being electrified so as to accelerate the action effect of the thrombolysis medicine on thrombus; and meanwhile, the cooling physiological saline is poured into the pouring channel through the other pouring interface, and can cool the surface of the ultrasonic assembly, so that the damage to blood vessels caused by overhigh temperature is prevented. After the operation is finished, the thrombolysis catheter and the ultrasonic transducer are retracted.
Based on the technical scheme, the invention has at least the following advantages and positive effects:
the ultrasonic transducer of the thrombolysis device forms a perfusion channel between the two when the ultrasonic transducer is inserted into the thrombolysis catheter, and can be controlled to move axially relative to the thrombolysis catheter to block the distal end of the perfusion channel, so that medicine can be injected through the perfusion channel, the distal end of the perfusion channel can be opened, at the moment, the thrombolysis effect of thrombolysis medicine can be accelerated by the ultrasonic energy emitted by the ultrasonic transducer, the thrombolysis efficiency and thrombolysis effect can be improved, and meanwhile, the broken thrombus can be prevented from escaping to the distal end of a blood vessel to block the blood vessel when the bracket extends out of the distal end of the thrombolysis catheter.
It will be understood by those of ordinary skill in the art that the foregoing embodiments are specific examples of carrying out the invention and that various changes in form and details may be made therein without departing from the spirit and scope of the invention.
Claims (15)
1. A thrombolytic device comprising:
thrombolysis catheter; a kind of electronic device with high-pressure air-conditioning system
An ultrasonic transducer, the distal end of which is provided with a bracket capable of radial expansion and contraction, and the ultrasonic transducer can penetrate into the thrombolysis catheter from the proximal end of the thrombolysis catheter; the ultrasonic transducer can move relative to the thrombolysis catheter along the axial direction so that the bracket extends out of the distal end of the thrombolysis catheter and the ultrasonic transducer can seal the thrombolysis catheter or open the distal end of the thrombolysis catheter; a perfusion channel is formed between the ultrasonic transducer and the thrombolysis catheter and the ultrasonic transducer is used for radiating ultrasonic energy;
the thrombolysis catheter comprises a catheter body and a thrombolysis handle; the proximal end of the tube body is connected with the distal end of the thrombolysis handle;
the tube body comprises a perfusion tube with a proximal end connected with the distal end of the thrombolytic handle; at least one protruding part extending along the axial direction is arranged in the pouring tube;
the tube body further comprises a guide tube, the proximal end of which is connected with the distal end of the perfusion tube, the diameter of the guide tube is smaller than that of the perfusion tube, and the guide tube is in smooth transition connection with the perfusion tube;
the ultrasonic transducer comprises an ultrasonic assembly, an ultrasonic handle and an ultrasonic joint;
the ultrasonic assembly comprises: a plurality of ultrasonic radiators and a packaging structure which are electrically connected through ultrasonic leads;
the plurality of ultrasonic radiators are arranged at intervals along the axial direction, and the packaging structure is used for packaging the ultrasonic radiators into a whole;
the ultrasonic assembly is connected with the distal end of the ultrasonic handle, and is coaxially arranged with the ultrasonic handle, and the ultrasonic wire penetrates through the ultrasonic handle and is connected with the ultrasonic connector;
the ultrasonic transducer further comprises a blocking piece with a proximal end connected with the distal end of the ultrasonic assembly;
the blocking piece is matched with the inner cavity of the guide tube and can penetrate into or withdraw from the guide tube to block or open the guide tube.
2. The thrombolytic device of claim 1, further comprising a temperature sensor;
the temperature sensor comprises at least one group of temperature sensing pieces, sensor wires and sensor connectors;
the temperature sensing piece is arranged in the installation cavity;
the temperature sensing piece is connected with the sensor connector through the sensor wire, and the proximal end of the sensor wire extends out of the thrombolytic handle.
3. The thrombolytic device of claim 2, wherein said number of protrusions is at least 2 and circumferentially distributed, and said number of temperature sensing elements is at least 2.
4. A thrombolytic device according to claim 3 wherein each group of said temperature sensing elements is disposed in a one-to-one correspondence within the mounting cavity of each boss.
5. A thrombolytic device according to claim 3 wherein each set of said temperature sensitive elements comprises at least 2 axially spaced temperature sensitive elements.
6. A thrombolytic device according to claim 3 wherein the sensor wires of each set of temperature sensing elements merge together at the proximal end of said thrombolytic handle and extend beyond the proximal end of said thrombolytic handle.
7. The thrombolytic device according to claim 1, wherein said perfusion tube comprises a perfusion tube section having a distal end connected to a proximal end of said guide tube, and wherein perfusion structures are distributed around a peripheral wall of said perfusion tube section.
8. The thrombolytic device according to claim 1, wherein said thrombolytic handle has a taper shape with a small distal end and a large proximal end, and the distal end thereof is symmetrically provided with fixing holes.
9. The thrombolytic device according to claim 1, wherein said thrombolytic catheter further comprises an infusion tube connected to said tube body, said infusion tube having at least one on-off infusion port at an outer end thereof.
10. The thrombolytic device of claim 1, wherein said occlusion member distal end has a tip.
11. The thrombolytic device of claim 1, wherein said ultrasound transducer further comprises: a movable conical head, a lining core and an inner tube;
the ultrasonic transducer is provided with a lining core channel which penetrates through the proximal end of the ultrasonic handle and the distal end of the blocking piece and is used for penetrating through the lining core, and the distal end of the blocking piece is connected with the proximal end of the inner tube;
the lining core is movably arranged in the lining core channel and the inner tube in a penetrating way, the distal end of the lining core penetrates out of the distal end of the support and is connected with the distal end of the support, and the proximal end of the movable conical head is connected with the distal end of the lining core; the distal end of the inner tube penetrates into the bracket and the proximal end of the bracket is connected with the proximal end of the inner tube.
12. The thrombolytic device according to claim 1, wherein said thrombolytic handle proximal end is provided with a transducer interface in the form of a tube protruding beyond said thrombolytic handle proximal end for penetrating said ultrasound transducer, said transducer interface distal end being connected to said tube proximal end.
13. The thrombolytic device of claim 12 wherein said transducer interface is coaxially disposed with said tube and has a diameter greater than a diameter of said tube; the transducer interface is also used to secure the ultrasonic handle to the thrombolytic handle.
14. The thrombolytic device of claim 11, wherein said scaffold is spherical or fusiform.
15. The thrombolytic device of claim 11, wherein said stent is made using a braided wire braiding process and/or a laser cutting process.
Priority Applications (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202211062835.0A CN115429382B (en) | 2022-09-01 | 2022-09-01 | Thrombolysis device |
| PCT/CN2022/135685 WO2024045386A1 (en) | 2022-09-01 | 2022-11-30 | Thrombolytic apparatus |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202211062835.0A CN115429382B (en) | 2022-09-01 | 2022-09-01 | Thrombolysis device |
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| Publication Number | Publication Date |
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| CN115429382A CN115429382A (en) | 2022-12-06 |
| CN115429382B true CN115429382B (en) | 2023-11-03 |
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| Application Number | Title | Priority Date | Filing Date |
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| CN202211062835.0A Active CN115429382B (en) | 2022-09-01 | 2022-09-01 | Thrombolysis device |
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| Country | Link |
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| CN (1) | CN115429382B (en) |
| WO (1) | WO2024045386A1 (en) |
Families Citing this family (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN116058922A (en) * | 2022-12-26 | 2023-05-05 | 上海心弘生命科学有限公司 | Ultrasonic-assisted thrombolysis device and system |
| CN116211402A (en) * | 2022-12-27 | 2023-06-06 | 上海心弘生命科学有限公司 | Ultrasonic thrombolysis device and system |
| CN116196059B (en) * | 2022-12-29 | 2024-01-26 | 上海心弘生命科学有限公司 | Ultrasonic-assisted thrombolysis device and system |
| CN116269639A (en) * | 2023-03-14 | 2023-06-23 | 上海心弘生命科学有限公司 | Ultrasonic guide core and ultrasonic thrombolysis device |
| CN117426833B (en) * | 2023-12-20 | 2024-03-08 | 北京华脉泰科医疗器械股份有限公司 | Thrombolysis catheter inner core and thrombolysis catheter |
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| WO2004060448A2 (en) * | 2003-01-03 | 2004-07-22 | Ekos Corporation | Ultrasonic catheter with axial energy field |
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| EP3307388B1 (en) * | 2015-06-10 | 2022-06-22 | Ekos Corporation | Ultrasound catheter |
| US10098651B2 (en) * | 2017-01-10 | 2018-10-16 | Inari Medical, Inc. | Devices and methods for treating vascular occlusion |
| CN113796924A (en) * | 2020-06-12 | 2021-12-17 | 苏州天鸿盛捷医疗器械有限公司 | Thrombus treatment system |
| CN112807058B (en) * | 2021-02-03 | 2022-05-17 | 清华大学 | Insertion type ultrasonic thrombolysis device |
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| US5997497A (en) * | 1991-01-11 | 1999-12-07 | Advanced Cardiovascular Systems | Ultrasound catheter having integrated drug delivery system and methods of using same |
| CN105744902A (en) * | 2013-11-18 | 2016-07-06 | 皇家飞利浦有限公司 | Guided thrombus dispersal catheter |
| CN111466997A (en) * | 2020-05-27 | 2020-07-31 | 江苏金泰医疗器械有限公司 | Thrombolytic device for promoting drug absorption by using ultrasonic waves |
| CN215778428U (en) * | 2021-04-13 | 2022-02-11 | 中国人民解放军火箭军特色医学中心 | Ultrasonic thrombolysis device |
| CN114916990A (en) * | 2022-01-30 | 2022-08-19 | 心凯诺医疗科技(上海)有限公司 | Combined type thrombolytic perfusion catheter assembly |
Also Published As
| Publication number | Publication date |
|---|---|
| CN115429382A (en) | 2022-12-06 |
| WO2024045386A1 (en) | 2024-03-07 |
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