CN115429382A - Thrombolysis device - Google Patents
Thrombolysis device Download PDFInfo
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- CN115429382A CN115429382A CN202211062835.0A CN202211062835A CN115429382A CN 115429382 A CN115429382 A CN 115429382A CN 202211062835 A CN202211062835 A CN 202211062835A CN 115429382 A CN115429382 A CN 115429382A
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- thrombolysis
- thrombolytic
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- 238000002604 ultrasonography Methods 0.000 claims abstract description 29
- 230000002262 irrigation Effects 0.000 claims abstract description 10
- 238000003973 irrigation Methods 0.000 claims abstract description 10
- 230000000903 blocking effect Effects 0.000 claims abstract description 9
- 238000001802 infusion Methods 0.000 claims description 54
- 230000010412 perfusion Effects 0.000 claims description 36
- 230000000149 penetrating effect Effects 0.000 claims description 9
- 238000004806 packaging method and process Methods 0.000 claims description 8
- 238000000034 method Methods 0.000 claims description 7
- 238000003698 laser cutting Methods 0.000 claims description 5
- 238000009434 installation Methods 0.000 claims description 4
- 238000009941 weaving Methods 0.000 claims description 4
- 230000007704 transition Effects 0.000 claims description 3
- 230000002093 peripheral effect Effects 0.000 claims description 2
- 230000012782 tube fusion Effects 0.000 claims description 2
- 208000007536 Thrombosis Diseases 0.000 abstract description 20
- 210000004204 blood vessel Anatomy 0.000 abstract description 12
- 239000003814 drug Substances 0.000 description 18
- 230000000694 effects Effects 0.000 description 9
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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
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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
- A61B17/221—Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions
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- A—HUMAN NECESSITIES
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- 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
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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
- A61B2017/22082—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
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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
- A61B17/221—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 thrombolysis device. It comprises the following steps: thrombolysis catheter and ultrasound transducer; the far end of the ultrasonic transducer is provided with a bracket capable of expanding and contracting radially, and the ultrasonic transducer can penetrate into the thrombolytic catheter from the near end of the thrombolytic 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 ultrasound transducer and the thrombolysis catheter and the ultrasound transducer is used for radiating ultrasound energy. According to the embodiment of the invention, the ultrasonic energy radiated by the ultrasonic transducer assists in thrombolysis, so that the thrombolysis efficiency is effectively improved, and the thrombus far end is blocked by the support to prevent the broken thrombus from blocking the far 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 fatal disease in our country, and vascular embolism has become a major factor in vascular disease. In particular, the total annual new disease rate of patients with cerebral arterial thrombosis, pulmonary embolism and lower limb venous embolism is over 500 ten thousand.
Medical intervention thrombus removal is gradually an effective recommended mode for the mainstream of vascular embolism treatment at present. The interventional thrombus removal has the advantages of small wound, short postoperative recovery time, few complications after treatment, good operation effect and the like, and can be accepted by patients better.
In the clinical practice of endovascular embolism treatment, the existing systemic thrombolysis has very high bleeding risk due to the problem of drug dosage, and direct thrombolysis (CDT) through a catheter can reduce the use of thrombolytic drug dosage to a certain extent and increase the benefit of a patient, but the operation efficiency is low, and the possibility of distal re-embolism cannot be avoided. The ultrasonic thrombolysis catheter can strip thrombus through the far-end expandable stent, enhance the combination area of thrombolysis medicines and the thrombus, introduce ultrasonic energy, increase the combination capacity of the medicines and the thrombus, shorten the operation time and avoid the risk of re-embolization at the far end.
Disclosure of Invention
The embodiment of the invention aims to provide a thrombolysis device, which can effectively improve thrombolysis efficiency by assisting thrombolysis through ultrasonic energy radiated by an ultrasonic transducer, and can prevent broken thrombus from blocking a far end of a blood vessel by blocking a far end of the thrombus through a support.
In order to solve the above technical problem, an embodiment of the present invention provides a thrombolysis device, including: a thrombolytic catheter; and
an ultrasonic transducer having a distal end provided with a radially expandable and contractible stent, the ultrasonic transducer being capable of penetrating into the thrombolytic catheter from a proximal end thereof; the ultrasonic transducer can move relative to the thrombolytic catheter along the axial direction so that the bracket extends out of the distal end of the thrombolytic catheter and the ultrasonic transducer can seal the thrombolytic catheter or open the distal end of the thrombolytic catheter; an irrigation channel is formed between the ultrasonic transducer and the thrombolysis catheter and the ultrasonic transducer is used for radiating ultrasonic energy.
As one example, the thrombolytic catheter comprises a tube and a thrombolytic handle; the proximal end of the tube body is connected with the distal end of the thrombolytic handle;
the tube body comprises an infusion tube with a near end connected with the far end of the thrombolytic handle; at least one axially extending boss is disposed in the infusion tube.
As an embodiment, the thrombolysis device further comprises a temperature sensor;
the temperature sensor comprises at least one group of temperature sensing element, a sensor lead and a sensor joint;
an installation cavity with a closed far end and an open near end is arranged in the boss, and the temperature sensing element is arranged in the installation cavity;
the temperature sensing piece is connected with the sensor connector through the sensor lead, and the near end of the sensor lead extends out of the thrombolytic handle.
As an embodiment, the number of the convex parts is at least 2, the convex parts are distributed along the circumferential direction, and the number of the temperature sensing pieces is at least 2; optionally, each group of temperature sensing pieces is arranged in the mounting cavity of each protruding part in a one-to-one correspondence manner;
optionally, each set of temperature sensing elements includes at least 2 temperature sensing elements distributed at intervals along the axial direction;
optionally, the sensor wires of the temperature sensing elements of each group converge at the proximal end of the thrombolytic handle and extend out of the proximal end of the thrombolytic handle.
As an 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, the distal end of which is connected with the proximal end of the guide tube, and perfusion structures are distributed on the peripheral wall of the perfusion tube section;
optionally, the thrombolytic handle is in a conical shape 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 thrombolytic catheter further comprises an infusion tube connected to the catheter body, and the outer end of the infusion tube is provided with at least one infusion port capable of being switched on and off.
As one embodiment, the ultrasonic transducer includes an ultrasonic assembly, an ultrasonic handpiece, and an ultrasonic joint;
the ultrasound assembly includes: a plurality of ultrasonic radiators and packaging structures which are electrically connected through ultrasonic leads;
the 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 near end of the ultrasonic assembly is connected with the far end of the ultrasonic handle, the ultrasonic assembly and the ultrasonic handle are coaxially arranged, and the ultrasonic lead penetrates through the ultrasonic handle and is connected with the ultrasonic joint.
As an example, the ultrasound transducer further comprises a blocking 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 pipe and can penetrate into or withdraw from the guide pipe to block or open the guide pipe;
optionally, the distal end of the occluding member has a tip.
As an embodiment, the ultrasonic transducer further comprises: the movable conical head, the lining core and the inner pipe;
the ultrasonic transducer is provided with a lining core channel which penetrates through the near end of the ultrasonic handle and the far end of the plugging piece and is used for penetrating the lining core, and the far end of the plugging piece is connected with the near end of the inner pipe;
the lining core is movably arranged in the lining core channel and the inner tube in a penetrating way, the far end of the lining core penetrates out of the far end of the bracket and is connected with the far end of the bracket, and the near end of the movable conical head is connected with the far end of the lining core; the far end of the inner tube penetrates into the bracket, and the near end of the bracket is connected with the near end of the inner tube.
As an embodiment, the proximal end of the thrombolytic handle is provided with a transducer interface which is tubular and protrudes out of the proximal end of the thrombolytic handle and is used for penetrating into 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 disposed coaxially with the tubular body and has a diameter greater than a diameter of the tubular body; the transducer interface is also used to secure the ultrasonic handle to the thrombolytic handle.
As an example, the scaffold is spherical or fusiform;
optionally, the stent is made using a braided wire weaving process and/or a laser cutting process.
According to the technical scheme, the invention at least has the following advantages and positive effects:
in the thrombolysis device provided by the embodiment of the invention, the ultrasonic transducer forms the perfusion channel between the ultrasonic transducer and the thrombolysis catheter when inserted into the thrombolysis catheter, and the ultrasonic transducer can be controlled to move relative to the thrombolysis catheter along the axial direction to seal the far end of the perfusion channel, so that medicine can be injected through the perfusion channel, the far end of the perfusion channel can be opened, the ultrasonic energy emitted by the ultrasonic transducer can accelerate the thrombolysis effect of thrombolysis medicine, the thrombolysis efficiency and the thrombolysis effect are improved, and meanwhile, the bracket extends out of the far end of the thrombolysis catheter to prevent broken thrombus from escaping to the far end of the 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 used in the embodiments or the prior art descriptions will be briefly introduced below, it is understood that the drawings in the following description are only examples of the present invention, and for those skilled in the art, other drawings can be obtained according to the provided drawings without creative efforts.
Fig. 1 is a schematic structural diagram of a thrombolysis device according to an embodiment of the present invention;
fig. 2 is a schematic structural diagram of a thrombolysis catheter of the thrombolysis device according to an embodiment of the present invention;
fig. 3 is a schematic structural diagram of an ultrasonic ring energy device of a thrombolysis device according to an embodiment of the present invention;
FIG. 4 is a schematic view of a partially enlarged thrombolytic device according to an embodiment of the present invention;
FIG. 5 is a schematic longitudinal sectional view of the structure of FIG. 4;
FIG. 6a is a schematic cross-sectional view of an infusion tube section of an infusion tube of a thrombolysis device according to an embodiment of the present invention;
FIG. 6b is a schematic cross-sectional view of the delivery tube section of the infusion tube of the thrombolytic device according to the 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 illustrating a thrombolytic infusion condition of the thrombolytic device according to an embodiment of the present invention;
fig. 9 is a schematic diagram of an ultrasonic thrombolysis condition of the thrombolysis device according to an embodiment of the present invention.
Detailed Description
In order to make the objects, technical solutions and advantages of the embodiments of the present invention more apparent, embodiments of the present invention will be described in detail below with reference to the accompanying drawings. However, it will be appreciated by those of ordinary skill in the art that numerous technical details are set forth in order to provide a better understanding of the present invention in its various embodiments. However, the technical solution claimed in the present invention can be implemented without these technical details and various changes and modifications based on the following embodiments.
In the description of the present invention, it should be noted that the terms "upper", "lower", "inner", "outer", etc. indicate orientations or positional relationships based on the orientations or positional relationships shown in the drawings, which are only for convenience of description and simplification of the description, but do not indicate or imply that the referred device or element must have a specific orientation, be constructed in a specific orientation, and operate, 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 expressly stated otherwise, the terms "connected," "connected," and the like are intended to be inclusive and mean, for example, that they may be fixedly connected, detachably connected, or integrally connected; they may be connected directly or indirectly through intervening media, or they may be interconnected between two elements.
In the description of the present invention, it should be noted that, in the field of interventional medical devices, the proximal end refers to the end closer to the operator, and the distal end refers to the end farther from the operator; axial refers to a direction parallel to the line connecting the center of the distal end and the center of the proximal end of the medical device in its natural state. The foregoing definitions are for convenience only and are not to be construed as limiting the present invention.
Referring to fig. 1 to 3, an embodiment of the present invention provides a thrombolysis device for vascular thrombolysis treatment. The thrombolysis device of this embodiment mainly includes: a thrombolysis catheter 1, an ultrasonic transducer 2 and a temperature sensor.
The distal end of the ultrasonic transducer 2 is provided with a stent 21 capable of radial expansion and contraction. The ultrasound transducer 2 can be passed into the thrombolytic catheter 1 from the proximal end of the thrombolytic catheter 1. The ultrasound transducer 2 is axially movable relative to the thrombolysis catheter 1 such that the stent 21 protrudes beyond the distal end of the thrombolysis catheter 1. The ultrasound transducer 2 is also capable of occluding the distal end of the thrombolytic catheter 1 or opening the distal end of the thrombolytic catheter 1 by axially moving the stent 21 relative to the thrombolytic catheter 1 when the stent 1 is positioned at the distal end of the thrombolytic catheter 1. An infusion channel is formed between the ultrasonic transducer 2 and the thrombolysis catheter 1, and when the far end of the thrombolysis catheter 1 is closed, thrombolysis medicament is infused through the infusion channel, so that the thrombolysis medicament accurately acts on the thrombus position; the far end of the thrombolysis catheter 1 is opened after the thrombolysis medicament is filled, ultrasonic energy is radiated through the ultrasonic transducer 2, for example, high-frequency ultrasonic energy with certain frequency is emitted to accelerate the thrombolysis effect of thrombolysis medicaments, and the thrombolysis efficiency and the thrombolysis effect are improved, so that the ultrasonic transducer 2 can move in the lumen of the thrombolysis catheter 1, and the thrombolysis medicament and the ultrasonic energy can be switched to two working states of thrombolysis medicament filling and ultrasonic energy reinforcing thrombolysis effect through the matching of different positions. Meanwhile, the expanded stent 21 can prevent thrombus from floating to the far end to block a far-end blood vessel by blood flow and intercept broken thrombus, and in addition, the thrombus can be stripped from the inner wall of the blood vessel by the stent 21, so that thrombolytic drugs can act on the thrombus more fully.
The temperature sensor is arranged in the thrombolysis catheter 1 and can detect the temperature of the thrombolysis catheter 1, when the energy radiated by the ultrasonic transducer 2 causes the temperature of the thrombolysis catheter 1 to be overhigh, cooling liquid can be filled into the filling channel to adjust the temperature of the thrombolysis catheter 1, and blood vessels are prevented from being damaged due to overhigh temperature of the thrombolysis catheter 1. It will be appreciated that in some instances, a temperature sensor may not be provided and the injection flow rate of the cooling fluid may be controlled to ensure that the thrombolysis catheter 1 operates within a safe temperature range based on the thermal efficiency of the ultrasound transducer 2 during operation.
Referring to fig. 2, the thrombolytic catheter 2 mainly includes: a tube body 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 11 includes a guide tube 111 and an infusion tube 112. At least one axially extending projection 113 is provided in the infusion tube 112. Optionally, the number of the protrusions 113 is at least 2 and is distributed along the circumferential direction. Illustratively, 3 protrusions 113 are arranged in the infusion tube 112, and the 3 protrusions 113 are evenly distributed at intervals along the circumferential direction. The perfusion tube 112 and the inner wall of the boss 113 enclose a special perfusion lumen, which can reduce the volume of the perfusion lumen, thereby reducing the volume of the perfusion channel 1123 and reducing the amount of the perfusion medicament consumed in the perfusion 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, and the guide tube 111 is smoothly and transitionally connected 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 smoothly and transitionally transited.
Referring to fig. 2, and fig. 6a and 6b, each of the protrusions 113 has a mounting cavity 1131 therein, which is closed at a distal end and opened at a proximal end. The temperature sensor may comprise at least one set of temperature sensing elements 31, sensor leads 32 and sensor contacts 33. The temperature sensing member 31 is disposed in the mounting cavity 1131. The temperature sensing element 31 is connected to a sensor connector 33 by a sensor wire 32, and the proximal end of the sensor wire 32 extends out of the thrombolytic handle 12. The mounting cavity 1131 of the protruding portion 113 of the perfusion tube 112 is closed at the distal end and opened at the proximal end, and the proximal opening of the mounting cavity 1131 can connect the temperature sensing element 31 with the sensor lead 32. Temperature sensing element 31 is configured to sense the temperature of irrigation tube segment 1121 of irrigation tube 112. Each set of temperature sensing elements 31 may comprise one or more temperature sensing elements. Illustratively, the temperature-sensitive element may be a thermistor or a thermocouple. The thermistor may be a positive temperature coefficient thermistor or a negative temperature coefficient thermistor. The temperature sensing element can be made into a circle or a sector, etc., and is adapted to the shape of the mounting cavity 1131, so that the temperature sensing element 31 can be reliably mounted in the mounting cavity 1131 and can sensitively detect the temperature of the perfusion tube 112. The sensor connector 33 is used for connecting with a host computer, so that the host computer can acquire the temperature signal collected by the temperature sensing element 31. The number of the temperature sensing elements 31 may be the same as the number of the protrusions 113, and may be not less than two, for example, 3 sets of the temperature sensing elements 31 and 3 protrusions 113 are provided, and the 3 sets of the temperature sensing elements 31 are disposed in the mounting cavity 1131 of each protrusion 113 in a one-to-one correspondence manner. 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 sensors 31 converge at the proximal end of the thrombolytic handle 12 and extend out of the proximal end of the thrombolytic handle 12, thereby facilitating connection to a host. Of course, the number of the temperature sensing element 31 may be smaller than the number of the boss portions. For example, the number of the projections may be 4, and the temperature sensing element 31 may be 3.
The proximal end of the thrombolytic handle 12 is provided with a transducer interface 122, which is tubular and protrudes out of the proximal end of the thrombolytic handle 12 and is used for penetrating the ultrasound transducer 2. The distal end of the transducer interface may be connected to the proximal end of the body 11. The transducer interface 122 is disposed coaxially with the tubular body 11 and has a diameter larger than that of the tubular body 11, and the tubular body 11 is connected to the transducer interface 122 in a smooth transition manner. 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 is understood that the transducer interface 122 and the ultrasonic handle 24 may be secured by a tight fit, a snap fit, or the like, and are not particularly limited herein.
The infusion assembly may include an infusion tube 13 connected to the tube 11 and communicating with the perfusion channel 1123, and at least one on-off infusion port 15 is disposed at an outer end of the infusion tube 13. Specifically, two infusion ports 15 are arranged at the outer end of the infusion tube 13, and a control valve 14 is arranged at the outer end of the infusion tube 13 and used for controlling the connection and disconnection between the two infusion ports 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 present embodiment is not particularly limited in the number of infusion interfaces 15 or the structure of the control valve 14.
Illustratively, the thrombolytic handle 12 is tapered with a small distal end and a large proximal end. The thrombolysis handle 12 can be fixedly sleeved on the proximal end of the tube 11, and the connection manner between the thrombolysis 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 port 122 or the circumferential wall of the proximal end of the tube 11 such that the infusion tube 13 is in communication with the perfusion channel 1123.
The distal end of the thrombolytic handle 12 can be symmetrically provided with fixing holes 121. Specifically, two wing plates may be symmetrically disposed at the distal end of the thrombolytic handle 12, and two fixing holes 121 are respectively disposed on the two wing plates. The fixing hole 121 may be a circular through hole, and the thrombolytic device may be conveniently fixed to the human body through the fixing hole 121 in the operation.
Referring to fig. 3 to 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 blocking member 25, a movable cone 26, a core 27 and an inner tube 28.
The ultrasound assembly 22 may include: a plurality of ultrasonic radiators 221 and package structures 222 electrically connected by ultrasonic wires 224. The plurality of ultrasonic radiators 221 are arranged at intervals along the axial direction, 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 the ultrasonic lead 224 passes through the ultrasonic handle 23 and is connected to the ultrasonic connector 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 lead 224, and the ultrasonic lead 224 may extend out of the ultrasonic handpiece 23 and be connected to the ultrasonic connector 24. The package structure 222 has an insulating property, and prevents the ultrasonic wire 224 from leaking electricity. It is understood that the plurality of ultrasonic radiators 221 may be correspondingly distributed on the irrigation pipe segment 1121, the delivery pipe segment 1122 is not provided with an ultrasonic radiator, and ultrasonic energy is not radiated inside the delivery pipe segment 1122.
The proximal end of the occluding member 25 is attached to the distal end of the ultrasound assembly 22 and may be integrally attached to the ultrasound assembly 22. The guide tube 111 is of a single-cavity tubular structure and is provided with an annular channel 1111, and the blocking piece 25 is matched with the inner cavity of the guide tube 111 and can penetrate into or withdraw from the guide tube 111 to block or open the guide tube 111 so as to block or open the distal end of the thrombolytic catheter 1. I.e., the profile of the occluding member 25 is sized to match the annular channel 1111 of the guide tube 111 such that the occluding 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 member 25 may have a pointed end to facilitate penetration into the guide tube 111. It will be appreciated that the occluding member 25 may also be positioned distally of the distal end of the ultrasound assembly 22, entering or exiting the annular passage of the guide tube 111 from the distal end of the guide tube 111; alternatively, the enclosing structure at the distal end of the ultrasound assembly 22 may also serve as a closure.
The ultrasonic transducer 2 has a core passage 223 through the proximal end of the ultrasonic handle 23 and the distal end of the block piece 25 for passing through the core 27. The liner 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 block piece 25 is connected to the proximal end of the inner tube 28 so that the core passage 223 communicates with the inner tube 28. The core 27 is movably disposed through the core passage 223 and the inner tube 28, and the distal end thereof extends out of the distal end of the stent 21 and is connected to the distal end of the stent 21. The proximal end of the movable cone 26 is connected to the distal end of the core 27. The distal end of inner tube 28 penetrates into stent 21 and the proximal end of stent 21 is connected to the proximal end of inner tube 28. Therefore, by controlling the axial movement of the core 27 relative to the ultrasound assembly 22, the axial expansion and contraction of the stent 21 can be controlled by pushing or pulling back the core 27, and the degree of radial expansion of the stent 21 can be adjusted. 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 move axially by pushing or pulling the lining core 27.
The stent 21 may be in the form of a balloon or shuttle like proximally closed stent structure. The stent 21 may be made of a shape memory material. The stent 21 may be formed using a braided wire weaving process and/or a laser cutting process. For example, the stent 21 may be formed by interweaving shape memory alloy wires, or by laser cutting and heat setting a nickel titanium tube, although the stent 21 may be formed by both weaving and laser cutting. The stent 21 can be supported on the inner wall of the blood vessel after being expanded, thrombus can be stripped through the stent and then thrombolytic, and meanwhile, the stent 21 can also prevent the thrombus from floating to the far end of the blood vessel.
Referring to fig. 1, 8 and 9, the use method of the thrombolysis device of the present embodiment is as follows:
in the operation, after the thrombolysis catheter 1 is placed to a designated position, the ultrasonic transducer 2 is inserted to enable the bracket 21 to extend out of the far end of the thrombolysis catheter 1, the ultrasonic transducer 2 seals off the far end of the thrombolysis catheter 1, the ultrasonic transducer 2 is fixedly connected with the thrombolysis catheter 1, then thrombolysis medicines are injected through the infusion interface 15 in a pressurizing mode, and the thrombolysis medicines enter through an infusion channel between the ultrasonic transducer 2 and the thrombolysis catheter in a thrombolysis mode and are ejected out of the infusion structure 11211 and can directly act on thrombus. After the infusion of the thrombolytic drug is finished, the ultrasonic transducer 2 is slightly withdrawn, the distal end of the thrombolytic catheter 1 is opened (i.e. the annular channel 1111 of the guide tube 111 is opened), the sensor connector 33 and the ultrasonic connector 24 are respectively connected with the host, and the ultrasonic transducer 2 can radiate ultrasonic energy after being electrified to accelerate the effect of the thrombolytic drug on thrombus; simultaneously, the other infusion interface is used for infusing cooling normal saline into the infusion channel, and the cooling normal saline can dissipate heat and cool the surface of the ultrasonic assembly to prevent blood vessels from being damaged due to overhigh temperature. After the operation is finished, the thrombolysis catheter and the ultrasonic transducer are withdrawn.
Based on the technical scheme, the invention at least has the following advantages and positive effects:
the ultrasonic transducer of the thrombolysis device provided by the embodiment of the invention forms an infusion channel between the ultrasonic transducer and the thrombolysis catheter when inserted into the thrombolysis catheter, and the ultrasonic transducer can be controlled to move relative to the thrombolysis catheter along the axial direction to seal the far end of the infusion channel, so that medicine can be infused through the infusion channel, the far end of the infusion channel can be opened, the thrombolysis effect of thrombolysis medicine can be accelerated by emitting ultrasonic energy through the ultrasonic transducer, the thrombolysis efficiency and the thrombolysis effect are improved, and meanwhile, the bracket extends out of the far end of the thrombolysis catheter to prevent broken thrombus from escaping to the far end of a blood vessel to block the blood vessel.
It will be understood by those of ordinary skill in the art that the foregoing embodiments are specific examples of practicing the invention, and that various changes in form and detail may be made therein without departing from the spirit and scope of the invention in practice.
Claims (10)
1. A thrombolysis device, comprising:
a thrombolysis catheter; and
an ultrasonic transducer having a distal end provided with a radially expandable and contractible stent, the ultrasonic transducer being capable of penetrating into the thrombolytic catheter from a proximal end thereof; the ultrasonic transducer can move relative to the thrombolysis catheter along the axial direction so as to enable the bracket to extend out of the distal end of the thrombolysis catheter and enable the ultrasonic transducer to seal off the thrombolysis catheter or open the distal end of the thrombolysis catheter; an irrigation channel is formed between the ultrasonic transducer and the thrombolysis catheter and the ultrasonic transducer is used for radiating ultrasonic energy.
2. The thrombolytic device of claim 1, wherein the thrombolytic catheter comprises a tube and a thrombolytic handle; the proximal end of the tube body is connected with the distal end of the thrombolytic handle;
the tube body comprises an infusion tube with a near end connected with the far end of the thrombolytic handle; at least one axially extending boss is disposed in the infusion tube.
3. The thrombolysis device according to claim 2, wherein the thrombolysis device further comprises a temperature sensor;
the temperature sensor comprises at least one group of temperature sensing element, a sensor lead and a sensor joint;
the bulge part is internally provided with an installation cavity with a closed far end and an open near end, and the temperature sensing element is arranged in the installation cavity;
the temperature sensing piece is connected with the sensor connector through the sensor lead, and the near end of the sensor lead extends out of the thrombolytic handle.
4. The thrombolysis device according to claim 3, wherein the number of the protrusions is at least 2, and the protrusions are distributed along the circumferential direction, and the number of the temperature sensing members is at least 2; optionally, each group of the temperature sensing pieces is arranged in the mounting cavity of each boss in a one-to-one correspondence manner;
optionally, each group of temperature sensing elements includes at least 2 temperature sensing elements distributed at intervals along the axial direction;
optionally, the sensor wires of the temperature sensing elements of each group converge at the proximal end of the thrombolytic handle and extend out of the proximal end of the thrombolytic handle.
5. The thrombolysis device according to claim 2, wherein the tube body further comprises a guiding tube connected at a proximal end thereof to a distal end of the infusion tube, the guiding tube having a smaller diameter than the infusion tube, the guiding tube being in smooth transition connection with the infusion tube;
optionally, the perfusion tube comprises a perfusion tube section, the distal end of which is connected with the proximal end of the guide tube, and perfusion structures are distributed on the peripheral wall of the perfusion tube section;
optionally, the thrombolytic handle is in a conical shape 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 thrombolytic catheter further comprises an infusion tube connected to the catheter body, and the outer end of the infusion tube is provided with at least one infusion port capable of being switched on and off.
6. The thrombolysis device of claim 5, wherein the ultrasound transducer comprises an ultrasound assembly, an ultrasound handle, and an ultrasound adapter;
the ultrasonic assembly includes: a plurality of ultrasonic radiators and packaging structures which are electrically connected through ultrasonic leads;
the 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 near end of the ultrasonic assembly is connected with the far end of the ultrasonic handle, the ultrasonic assembly and the ultrasonic handle are coaxially arranged, and the ultrasonic lead penetrates through the ultrasonic handle and is connected with the ultrasonic joint.
7. The thrombolytic device of claim 6, wherein the ultrasound transducer further comprises a blocking member having a proximal end coupled to the distal end of the ultrasound assembly;
the blocking piece is matched with the inner cavity of the guide pipe and can penetrate into or withdraw from the guide pipe to block or open the guide pipe;
optionally, the distal end of the closure member has a tip.
8. The thrombolysis device of claim 7, wherein the ultrasound transducer further comprises: the movable conical head, the lining core and the inner pipe;
the ultrasonic transducer is provided with a lining core channel which penetrates through the near end of the ultrasonic handle and the far end of the plugging piece and is used for penetrating the lining core, and the far end of the plugging piece is connected with the near 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 far end of the lining core penetrates out of the far end of the bracket and is connected with the far end of the bracket, and the near end of the movable conical head is connected with the far end of the lining core; the far end of the inner tube penetrates into the bracket, and the near end of the bracket is connected with the near end of the inner tube.
9. The thrombolysis device according to claim 6, wherein the proximal end of the thrombolysis handle is provided with a transducer port which is tubular and protrudes out of the proximal end of the thrombolysis handle for penetrating into the ultrasonic transducer, and the distal end of the transducer port is connected with the proximal end of the tube body;
optionally, the transducer interface is disposed coaxially with the tubular body and has a diameter greater than a diameter of the tubular body; the transducer interface is also used to secure the ultrasonic handle to the thrombolytic handle.
10. The thrombolytic device of claim 8, wherein the scaffold is spherical or fusiform;
optionally, the stent is made using a braided wire weaving 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 true CN115429382A (en) | 2022-12-06 |
| CN115429382B 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) |
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| 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 |
| CN116196059A (en) * | 2022-12-29 | 2023-06-02 | 上海心弘生命科学有限公司 | Ultrasonic-assisted thrombolysis device and system |
| 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 |
| 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 |
| CN117426833A (en) * | 2023-12-20 | 2024-01-23 | 北京华脉泰科医疗器械股份有限公司 | Thrombolysis catheter inner core and thrombolysis catheter |
| CN116058922B (en) * | 2022-12-26 | 2024-04-30 | 上海心弘生命科学有限公司 | Ultrasonic-assisted thrombolysis device and system |
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Also Published As
| Publication number | Publication date |
|---|---|
| CN115429382B (en) | 2023-11-03 |
| WO2024045386A1 (en) | 2024-03-07 |
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