CN217066415U

CN217066415U - Ultrasound catheter

Info

Publication number: CN217066415U
Application number: CN202123076262.0U
Authority: CN
Inventors: 甘耀�; 何志华; 包俊伟; 其他发明人请求不公开姓名
Original assignee: Shenzhen Weizhong Trace Medical Equipment Co ltd
Current assignee: Shenzhen Microport Trace Medical Equipment Co ltd
Priority date: 2021-12-07
Filing date: 2021-12-07
Publication date: 2022-07-29
Anticipated expiration: 2031-12-07

Abstract

The utility model provides an ultrasonic catheter, it includes: the device comprises an outer sheath, an inner core assembly with a transducer and an operation assembly; the outer sheath tube is detachably and coaxially connected with the operating assembly; the proximal end of the inner core assembly is disposed in the operating assembly; the distal end part of the inner core component is movably arranged through the outer sheath tube and is used for withdrawing the outer sheath tube along with the separation of the operating component and the outer sheath tube; the outer sheath tube is also used for the guide wire to penetrate after the outer sheath tube is separated from the operation assembly. When the ultrasonic probe is used, the outer sheath tube is coaxially assembled and connected with the operation assembly, the distal end part of the inner core assembly penetrates into the outer sheath tube and intervenes in a human body along with the outer sheath tube, and ultrasonic probe can be realized. When the outer sheath tube is clamped once during withdrawal, the outer sheath tube can be separated from the operation assembly, the distal end part of the inner core assembly is withdrawn from the outer sheath tube, the unfreezing guide wire is penetrated into the outer sheath tube, and the outer sheath tube can be driven to be unlocked through the unfreezing guide wire, so that the problem that the outer sheath tube is difficult to separate after being clamped during withdrawal is solved.

Description

Ultrasound catheter

Technical Field

The utility model relates to the technical field of medical equipment, in particular to ultrasonic catheter.

Background

In recent years, the incidence of coronary heart disease has increased year by year, which is one of the main causes of death of cardiovascular and cerebrovascular diseases, and therefore, early detection and early diagnosis are particularly important. Coronary angiography is currently a common and effective method for diagnosing coronary heart disease. The diagnosis method is a safe and reliable invasive diagnosis technology, is widely applied to clinic at present, and is considered as the 'gold standard' for diagnosing the coronary heart disease. However, coronary angiography has a great limitation in evaluating the characteristics of vessel walls and plaques: firstly, angiography can only reflect the contour of the filling of the vascular cavity contrast agent, and when the stenosis degree of a coronary artery is below 40%, the angiography cannot find the abnormality of the coronary artery; second, because the lesion in the coronary artery is often biased to one side of the lumen or irregularly shaped, the limitations of contrast projection also affect the assessment of the degree of stenosis in the vessel.

In recent years, new-technology intravascular ultrasound (ivus) imaging has been widely used in interventional cardiology as a new diagnostic tool for evaluating diseased vessels (e.g., arteries) in humans to determine the need for treatment, guide intervention, and/or evaluate its effectiveness. Intravascular ultrasound scans a blood vessel by (high-frequency) ultrasound emitted by the front end of an IVUS catheter, and reflected ultrasonic signals with blood vessel wall information are used for reconstructing a blood vessel wall structure; the frequency band of the intravascular ultrasound is mainly concentrated in 20MHz-80MHz, the higher the frequency, the better the resolution, but the larger the attenuation, the imaging depth and the image contrast are affected; different vascular tissue components have different effects on the signal intensity and frequency (phase) of ultrasound, such as weak reflection of the ultrasound signal by lipid plaques (dark on the image) and strong reflection of ultrasound by calcium (brighter on the image).

However, in some cases of clinical use of the conventional IVUS catheter, a position (a guide wire port) where a guide wire penetrates through the IVUS catheter often blocks a protrusion such as a stent, the IVUS catheter pulls the stent to cause the stent to deviate from a position when being withdrawn, and the stent is blocked more tightly by being withdrawn harder, so that the inner wall of a blood vessel is damaged, and even the life of a patient is damaged.

SUMMERY OF THE UTILITY MODEL

An object of the utility model is to provide an ultrasonic catheter to block the problem that the back is difficult to break away from when solving current ultrasonic catheter and withdrawing.

In order to solve the above technical problem, the utility model provides an ultrasonic catheter, it includes: the device comprises an outer sheath, an inner core assembly with a transducer and an operation assembly;

the outer sheath tube is detachably and coaxially connected with the operating assembly;

the proximal end of the inner core assembly is disposed in the operating assembly; the distal end part of the inner core assembly is movably arranged through the outer sheath tube and is used for withdrawing the outer sheath tube after the operation assembly is separated from the outer sheath tube;

the outer sheath tube is also used for the guide wire to penetrate after the outer sheath tube is separated from the operation assembly.

Optionally, the outer sheath comprises a first clamping structure, the operating assembly comprises a second clamping structure, and the operating assembly and the outer sheath are coaxially clamped or separated through the first clamping structure and the second clamping structure.

Optionally, one of the first engaging structure and the second engaging structure has a buckle, and the other has a slot adapted to the buckle.

Optionally, one of the first engaging structure and the second engaging structure has a protruding portion, and the other has a recessed portion adapted to the protruding portion; the convex part gradually shrinks towards the installation direction of the clamping structure where the convex part is located to form a cone shape, and the concave part gradually expands towards the installation direction of the clamping structure where the concave part is located to form a flared shape.

Optionally, the core assembly comprises a base body and a flexible connecting pipe which are sequentially connected from a proximal end to a distal end;

the basal body rotationally set up in the operating assembly, the basal body pass through flexible connection pipe with the transducer is connected, in order to drive the transducer rotates.

Optionally, the flexible connection pipe includes a hypotube or an inner and outer double-layer spring pipe.

Optionally, the winding directions of the inner and outer layers of spring tubes are opposite; and/or the winding direction of the spring tube at the outer layer is opposite to the rotating direction of the inner core component.

Optionally, when no external force is applied, adjacent spring turns of the spring tube abut against each other; and/or the inner and outer spring tubes are radially abutted against each other when no external force is applied.

Optionally, the proximal end of the inner core assembly is rotatably disposed in the operating assembly about the axis of the operating assembly; the inner core component is used for rotating in the operating component and the outer sheath after the operating component and the outer sheath are assembled and connected; the proximal end of the inner core assembly is restrained from axial movement by the handle assembly, and the distal end of the inner core assembly is withdrawn from the outer sheath with the handle assembly after the handle assembly is separated from the outer sheath.

Optionally, the outer sheath tube has an accommodating cavity extending along its own axial direction; the outer sheath tube is also provided with a guide wire cavity which runs through the outer sheath tube and is used for guiding a guide wire to penetrate through; the axis of the guide wire cavity and the axis of the containing cavity are arranged at an angle, the far end of the containing cavity is closed, and the far end of the containing cavity is adjacent to the guide wire cavity.

To sum up, the utility model provides an ultrasonic catheter includes: the device comprises an outer sheath, an inner core assembly with a transducer and an operation assembly; the outer sheath tube is detachably and coaxially connected with the operating assembly; the proximal end of the inner core assembly is disposed in the operating assembly; the distal end part of the inner core component is movably arranged through the outer sheath tube and is used for withdrawing the outer sheath tube along with the separation of the operating component and the outer sheath tube; the outer sheath tube is also used for the guide wire to penetrate after the outer sheath tube is separated from the operation assembly.

With the configuration, the outer sheath tube is coaxially assembled and connected with the operation component during use, the distal end part of the inner core component penetrates into the outer sheath tube, and the ultrasonic exploration can be realized along with the intervention of the outer sheath tube into a human body. When the ultrasonic catheter is removed, once the ultrasonic catheter is clamped, the outer sheath tube can be separated from the operation assembly, the distal end part of the inner core assembly is withdrawn from the outer sheath tube, the unfreezing guide wire penetrates into the outer sheath tube, the outer sheath tube can be driven to be unlocked from the clamped position through the unfreezing guide wire, and therefore the problem that the ultrasonic catheter is difficult to separate after being clamped when being withdrawn is solved.

Drawings

Those skilled in the art will appreciate that the drawings are provided for a better understanding of the invention and do not constitute any limitation on the scope of the invention. Wherein:

fig. 1 is a schematic view of an ultrasound catheter of an embodiment of the present invention;

fig. 2 is a schematic view of the distal end of an outer sheath of an embodiment of the invention;

fig. 3 is a schematic view of the distal end of the outer sheath of the embodiment of the present invention after the guide wire is inserted therein;

FIG. 4a is a schematic diagram of a kernel component according to an embodiment of the present invention;

FIG. 4B is an enlarged view of portion B of FIG. 4 a;

fig. 5a to 5d are schematic views of a double-layer wound spring tube according to an embodiment of the present invention;

fig. 6 is a schematic view of an operating assembly of an embodiment of the present invention;

fig. 7a is a schematic view illustrating a first engaging structure and a second engaging structure engaging with each other according to an embodiment of the present invention;

fig. 7b is a schematic view illustrating the first engaging structure and the second engaging structure being separated according to the embodiment of the present invention;

in the drawings:

10-sheath canal; 11-a housing chamber; 12-a guidewire lumen; 13-a liquid outlet; 14-a developing ring; 15-depth marker ring;

20-a core component; 20 a-proximal end portion; 20 b-a distal portion; 21-a substrate; 211-a limiting surface; 22-flexible connecting tube; 23-a transducer; 24-a PCB board; 25-a metal sleeve; 26-additional casing; 27-a protective sleeve;

30-an operating component; 31-liquid inlet; 311-one-way valve; 32-a cavity; 33-a seal;

42-a guide wire; 51-a first engagement structure; 511-fastening; 512-a boss; 52-a second engagement structure; 521-a card slot; 522-recessed portion.

Detailed Description

To make the objects, advantages and features of the present invention clearer, the present invention will be described in further detail with reference to the accompanying drawings and specific embodiments. It is to be noted that the drawings are in simplified form and are not to scale, but rather are provided for the purpose of facilitating and distinctly claiming the embodiments of the present invention. Further, the structures illustrated in the drawings are often part of actual structures. In particular, the drawings may have different emphasis points and may sometimes be scaled differently.

As used in this application, the singular forms "a", "an" and "the" include plural referents, the term "or" is generally employed in a sense including "and/or," the terms "a", "an" and "the" are generally employed in a sense including "at least one", the terms "at least two" and "two or more" are generally employed in a sense including "two or more", and moreover, the terms "first", "second" and "third" are used for descriptive purposes only and are not to be construed as indicating or implying relative importance or imply that there is a number of technical features being indicated. Thus, a feature defined as "first," "second," or "third" may explicitly or implicitly include one or at least two of that feature, "one end" and "the other end" and "proximal end" and "distal end" generally refer to the corresponding two parts, including not only the endpoints. The terms "proximal" and "distal" are defined herein with respect to an ultrasound catheter having one end for insertion into the human body and a steering end extending out of the body. The term "proximal" refers to the location of the element closer to the steering end of the ultrasound catheter that extends outside the body, and the term "distal" refers to the location of the element closer to the end of the ultrasound catheter that is inserted into the body and thus further from the steering end of the ultrasound catheter. Alternatively, in a manual or hand-operated application scenario, the terms "proximal" and "distal" are defined herein with respect to an operator, such as a surgeon or clinician. The term "proximal" refers to a position of the element closer to the operator, and the term "distal" refers to a position of the element closer to the ultrasound catheter and thus further from the operator. Furthermore, as used in the present application, the terms "mounted," "connected," and "disposed" on another element should be construed broadly, and generally only mean that there is a connection, coupling, fit, or drive relationship between the two elements, and that the connection, coupling, fit, or drive between the two elements can be direct or indirect through intervening elements, and should not be construed as indicating or implying any spatial relationship between the two elements, i.e., an element can be located in any orientation within, outside, above, below, or to one side of another element unless the content clearly dictates otherwise. The specific meaning of the above terms in the present invention can be understood according to specific situations by those skilled in the art. Moreover, directional terminology, such as above, below, up, down, upward, downward, left, right, etc., is used with respect to the exemplary embodiments as they are shown in the figures, with the upward or upward direction being toward the top of the corresponding figure and the downward or downward direction being toward the bottom of the corresponding figure.

The following description refers to the accompanying drawings.

Referring to fig. 1 to 4b, an embodiment of the present invention provides an ultrasound catheter, including: an outer sheath 10, an inner core assembly with transducer 20 and an operational assembly 30; the sheath tube 10 is detachably connected coaxially with the operating assembly 30; the proximal end 20a of the inner core assembly 20 is disposed in the operating assembly 30; the distal end 20b of the inner core assembly 10 is movably threaded into the outer sheath 10; and for withdrawing the outer sheath 10 with the operating assembly 30 separated from the outer sheath 10; the sheath 10 is also used for passing a guide wire for unfreezing after being separated from the operating assembly 30. It should be noted that fig. 4a only exemplarily shows one division of the proximal portion 20a and the distal portion 20b of the core assembly 20, and the division of the proximal portion 20a and the distal portion 20b can be adjusted according to the practical application, which is not limited by the present invention.

With such a configuration, when the sheath 10 is coaxially assembled and connected with the operation component 30 in use, the distal end portion 20b of the inner core component 20 penetrates into the sheath 10, and the ultrasonic exploration can be realized along with the intervention of the sheath 10 into the human body. When the ultrasonic catheter is withdrawn, once the clamping occurs, the outer sheath 10 and the operation assembly 30 can be separated, the distal end part 20b of the inner core assembly 20 is withdrawn from the outer sheath 10, the unfreezing guide wire is further penetrated into the outer sheath 10, the outer sheath 10 can be driven to be unlocked from the clamping position through the unfreezing guide wire, and therefore the problem that the ultrasonic catheter is difficult to separate after the clamping is carried out when the ultrasonic catheter is withdrawn is solved.

Optionally, the sheath tube 10 has a receiving cavity 11 extending axially along itself, and the receiving cavity 11 is open towards the proximal end for the inner core assembly 20 or the unfreezing guide wire to pass through. In one example, the core assembly 20 includes a base 21, a flexible connecting tube 22 and a transducer 23 connected in sequence from a proximal end to a distal end, wherein the transducer 23 is used for converting electrical power into mechanical power (i.e., ultrasonic waves) and then emitting the mechanical power. During assembly, the transducer 23 and a portion of the flexible connecting tube 22 are threaded from the proximal end of the receiving chamber 11 until the transducer 23 reaches a predetermined position. Thus, the accommodating chamber 11 is filled with the transducer 23 and the flexible connection tube 22, and the guide wire 42 cannot be inserted therethrough. While the sheath 10 needs to be guided over the guide wire 42 during the intervention. Therefore, the sheath tube 10 further has a guide wire cavity 12, and the guide wire cavity 12 penetrates through the sheath tube 10 for the guide wire 42 to pass through. Thus, the outer sheath 10 can be advanced and retracted along with the guide wire 42 to be inserted into a predetermined region of the human body.

Preferably, the axis of the guide wire cavity 12 and the axis of the accommodating cavity 11 are arranged at an angle, the distal end of the accommodating cavity 11 is closed, and the distal end of the accommodating cavity 11 is adjacent to the guide wire cavity 12. As shown in fig. 3, in an exemplary embodiment, the axis of the guide wire lumen 12 is at a small angle (e.g., less than 15 °) to the axis of the receiving lumen 11 to reduce the bending angle of the guide wire 42, so that the sheath tube 10 has less resistance to move along the guide wire 42. The distal end of the accommodating cavity 11 is arranged adjacent to the guide wire cavity 12, so that the maximum radial dimension (position A in fig. 3) of the juxtaposition position of the sheath tube 10 and the guide wire 42 can be reduced, and the passing performance of the ultrasonic catheter is improved. In a preferred example, the distal end of the receiving lumen 11 tapers to a cone shape, and the side of the tapered side wall adjacent to the guidewire lumen 12 is parallel to the axis of the guidewire lumen 12. So configured, it is advantageous to reduce the thickness of the adjacent portions of the accommodating chamber 11 and the guide wire chamber 12, thereby further reducing the maximum radial dimension where the sheath tube 10 and the guide wire 42 are juxtaposed.

However, regardless of how to reduce the maximum radial dimension of the sheath 10 juxtaposed to the guide wire 42, it is the maximum dimension during the whole ultrasound catheter insertion and withdrawal process, and in particular, the portion of the guide wire 42 extending from the proximal end of the guide wire cavity 12 and extending toward the proximal end has a gap with the sheath 10, thereby easily catching the protrusion (such as a stent) in the blood vessel during the withdrawal process. The more forceful the withdrawal is, the tighter the clamp becomes, and the ultrasound catheter cannot be withdrawn smoothly during the operation. Therefore, in the ultrasound catheter provided in this embodiment, after the outer sheath 10 is separated from the operation member 30 and the distal end portion 20b of the inner core member 20 is withdrawn from the outer sheath 10, the guide wire for releasing the blockage is inserted from the proximal end of the accommodating cavity 11 until the distal end abuts against the distal end of the outer sheath 10, and the guide wire for releasing the blockage is further pushed in the distal direction, so that the outer sheath 10 can be further advanced, the blocked projection can be released, and the outer sheath 10 can be rotated appropriately to avoid the projection, so that the outer sheath can be withdrawn smoothly.

Optionally, the proximal end portion 20a of the inner core assembly 20 is rotatably disposed in the handle assembly 30 about the axis of the handle assembly 30; the inner core component 20 is configured to rotate in the operation component 30 and the outer sheath 10 after the operation component 30 and the outer sheath 10 are assembled and connected. Generally, the distal portion 20b (mainly the transducer 23) of the core assembly 20 needs to be moved relative to the scanned region for imaging, in this embodiment, the core assembly 20 is configured to be rotatably disposed in the operation assembly 30 and the outer sheath 10, the base 21 is rotatably disposed in the operation assembly 30, and the base 21 is connected to the transducer 23 through the flexible connection tube 22 to rotate the transducer 23. In operation, the transducer 23 rotates in the sheath 10 at a high speed, and then the scanning signal of the vessel wall can be obtained.

Optionally, the proximal end 20a of the inner core assembly 20 is restrained from axial movement by the handle assembly 30, and the distal end 20b of the inner core assembly 20 is withdrawn from the sheath 10 with the handle assembly 30 after the handle assembly 30 is separated from the sheath 10. In the example shown in fig. 4a, the base body 21 is constrained by the operating assembly 30 against axial movement, but not against circumferential rotation, after being arranged in the operating assembly 30. Optionally, the base 21 has a distally disposed limiting surface 211, which is limited by a corresponding portion of the operating element 30 after being assembled into the operating element 30, so that the base 21 cannot move distally. So configured, the handle assembly 30, when detached from the outer sheath 10, can be withdrawn out of the outer sheath 10 with the inner core assembly 20.

Since the outer sheath 10 is inserted into the body during use, the dynamic torque at the proximal base 21 can be effectively transmitted (e.g., 1: 1 torque transmission) to the distal transducer 23 position as the vessel bends, and the ultrasound catheter can be clearly imaged. And to be able to both flex and transmit torque efficiently, places high demands on the specific structure of flexible connection tube 22. Referring to fig. 5a to 5d, in an exemplary embodiment, the flexible connecting tube 22 includes an inner and an outer double-layered spring tube. Alternatively, the tube is tightly wound, i.e. adjacent spring turns of the tube abut against each other when no external force is applied. Optionally, when no external force is applied, the inner and outer spring tubes are radially abutted to each other. The spring tube with the inner layer and the outer layer arranged can effectively transmit torque, has good flexibility and can adapt to the bending shape of blood vessels.

In some embodiments, the winding directions of the spring tubes of the inner and outer double layers may be the same. For example, in the example shown in fig. 5c, the winding directions of the inner and outer spring tubes are both left (i.e., s direction); fig. 5d shows an example in which the winding directions of the spring tubes of the inner and outer double layers are both right (i.e., z-direction). In other embodiments, the winding directions of the spring tubes of the inner and outer double layers are opposite. For example, in the example shown in fig. 5a, the winding direction of the inner layer spring tube is right (i.e., z direction), and the winding direction of the outer layer spring tube is left (i.e., s direction); fig. 5b shows an example in which the winding direction of the inner layer spring tube is the left direction (i.e., s direction), and the winding direction of the outer layer spring tube is the right direction (i.e., z direction). When the winding directions of the inner layer and the outer layer of the spring pipe are opposite, the deformation of the inner layer and the outer layer of the spring pipe generated along with the rotation can be offset, so that a better effect can be obtained.

Preferably, the spring tube of the outer layer is wound in a direction opposite to the direction of rotation of the core assembly 20. For example, fig. 5a shows an example in which the rotation direction of the core element 20 is right, i.e. the core element 20 rotates clockwise when viewed from the left side to the right side of fig. 5 a. The outer spring tube will rub against the outer sheath 10 and will be configured to rotate in the opposite direction of the inner core assembly 20, reducing its deformation during transmission. Optionally, the spring tube material includes stainless steel or nitinol, etc.

In another example, the flexible connection tube 22 includes a hypotube. A hypotube is a flexible tubing commonly used in the art, which is capable of bending to some degree and also capable of transmitting torque. Those skilled in the art can select a suitable hypotube as the flexible connecting tube 22 according to the prior art. Optionally, the material of the hypotube includes stainless steel or nitinol.

Referring to fig. 6 in combination with fig. 2, optionally, the operating assembly 30 has a liquid inlet 31, the sheath tube 10 has a liquid outlet 13, and after the operating assembly 30 and the sheath tube 10 are assembled and connected, the liquid inlet 31 is communicated with the liquid outlet 13 through the accommodating cavity 11. When in use, the inner core assembly 20 rotates at a high speed in the outer sheath 10, and a medium (such as physiological saline and the like) is injected into the liquid inlet 31 and flows out from the liquid outlet 13, so that the inner core assembly 20 can be lubricated. In addition, the medium fills the sheath 10 and may also act as a coupling for the transducer 23.

In an exemplary embodiment, the base 21 at the proximal end of the core assembly 20 may be connected to a driver (not shown, for example, may be disposed at the proximal end side of the operation assembly 30) through a transmission component (e.g., a transmission cable, etc.), and the driver drives the core assembly 20 to rotate through the transmission component. Suitably, the operating assembly 30 has a cavity 32 extending through the operating assembly in the axial direction, and the cavity 32 is used for the transmission component to pass through. Optionally, the liquid inlet 31 is disposed on the cavity 32 at an angle and is communicated with the cavity 32, and as shown in fig. 6, the liquid inlet 31 is perpendicular to the extending direction of the cavity 32. Of course, in other embodiments, the inlet 31 and the cavity 32 may intersect to form a Y-shape, which is not limited by the present invention. Further, the inlet port 31 includes a check valve 311 with a standard luer fitting for preventing the medium from flowing backward. Further, the operating assembly 30 comprises a sealing member 33, said sealing member 33 being located at the proximal end (left side in fig. 6) of the cavity 32 for sealing the transmission member against outflow of the medium injected from the loading port 31.

Optionally, with continued reference to fig. 4a, in an exemplary embodiment, the core assembly 20 further includes a PCB 24, a metal sleeve 25, an additional sleeve 26 and a protective sheath 27, wherein the PCB 24 is fixedly disposed on the base 21 and has two contacts thereon for electrically connecting with a connection wire (e.g., a coaxial cable) of the transducer 23. The metal sleeve 25 is fixedly disposed on the base 21 and extends a distance from the distal end of the base 21, and the flexible connection tube 22 is disposed inside the metal sleeve. The metal sleeve 25 can fix and support the proximal end of the flexible connection tube 22, so as to prevent the proximal end of the flexible connection tube 22 from being bent and broken due to stress concentration. Alternatively, the material of the metal sleeve 25 includes stainless steel or nitinol, etc. An additional sleeve 26, which may be, for example, a heat shrink tubing, may be wrapped around a portion of the flexible connecting tube 22, and may be made of, for example, PET, FEP, or PTFE. The provision of the additional sleeve 26 serves to isolate the flexible connection tube 22 from the metal sleeve 25, serving as a further protection for the flexible connection tube 22. The protective sheath 27 is disposed at the distal end of the flexible connection tube 22, for example, nested inside the flexible connection tube 22, and the protective sheath 27 has a cavity therein for receiving the transducer 23. The connection wires of the transducer 23 pass through the inside of the flexible connection tube 22 to be electrically connected with the contacts of the PCB board 24. In use, the core assembly 20 rotates as a unit.

In one example, the outer sheath 10 is made of one or more of PC, PTFE, PEEK, PEBAX, TUP, PE, tantalum, platinum-iridium alloy, stainless steel, nickel-titanium alloy, and gold; the outer sheath pipe 10 can be the individual layer pipe, also can be for double-deck or multilayer pipe, can also be provided with the enhancement layer between double-deck or the multilayer pipe, and the enhancement layer includes but not limited to weaving layer or spring layer etc. and technical personnel in the art can carry out reasonable configuration to outer sheath pipe 10 according to prior art, the utility model discloses it is not limited to this.

Preferably, the hardness of the sheath tube 10 becomes gradually soft from the proximal end to the distal end; the outer diameter of the sheath 10 is tapered from the proximal end to the distal end. Here, the gradual softening and the gradual reduction are not limited to the linear change, and may be a nonlinear change or a stepwise change, which is not limited in the present embodiment. Preferably, the distal end of the outer sheath 10 is provided with a visualization ring 14, which facilitates operator confirmation of the interventional site of the outer sheath 10. Optionally, the proximal end of the sheath 10 may be further provided with a plurality of (e.g. two) depth marking rings 15 for indicating the depth of the insertion of the sheath 10.

Optionally, referring to fig. 7a and 7b, the sheath 10 includes a first engaging structure 51, the operating component 20 includes a second engaging structure 52, and the operating component 20 and the sheath 10 are coaxially engaged or disengaged by the first engaging structure 51 and the second engaging structure 52.

In an exemplary embodiment, the first engaging structure 51 is located at the proximal end of the sheath tube 10, and the first engaging structure 51 has a buckle 511. And a second clamping structure 52 is correspondingly arranged at the far end of the operating component 20, and the second clamping structure 52 is provided with a clamping groove 521 matched with the clamping buckle 511. When in use, the buckle 511 is inserted into the clamping groove 521, and the buckle and the clamping groove can be clamped to realize assembly connection. When the sheath is detached, the buckle 511 can be separated from the catch 521 by pressing the buckle 511, and then the first engaging structure 51 and the second engaging structure 52 are moved in opposite directions, so that the sheath 10 can be separated from the operating assembly 20. Of course, in other embodiments, the first engaging structure 51 may have the engaging groove 521, and the second engaging structure 52 may have the buckle 511, which is not limited by the present invention.

Further, one of the first engaging structure 51 and the second engaging structure 52 has a protrusion 512, and the other has a recess 522 matching with the protrusion 512; the convex portion 512 gradually shrinks towards the installation direction of the clamping structure where the convex portion is located to form a cone shape, and the concave portion 522 gradually expands towards the installation direction of the clamping structure where the concave portion is located to form a flared shape. Here, describing the installation direction of the engaging structure, if the protrusion 512 is located on the first engaging structure 51, and the installation direction of the first engaging structure 51 is toward the proximal end, that is, the protrusion 512 gradually tapers toward the proximal end. Accordingly, the recess 522 is located on the second engaging structure 52, and the installation direction of the second engaging structure 52 is toward the distal end, that is, the recess 522 gradually expands to be flared toward the distal end. It will be appreciated that in other embodiments, the protrusion 512 is located on the second snap structure 52 and tapers distally, and the recess 522 is located on the first snap structure 51 and flares proximally. The arrangement of the protrusion 512 and the recess 522 can play a guiding role when the first engaging structure 51 and the second engaging structure 52 are abutted. Specifically, when the first engaging structure 51 and the second engaging structure 52 are mated, if they are not coaxial, the protrusion 512 contacts the sidewall of the recess 522 and is restricted by the sidewall of the recess 522, so that the protrusion 512 can be guided to a position coaxial with the recess 522.

It should be noted that the first engaging structure 51 and the second engaging structure 52 shown in fig. 7a and fig. 7b are only an example and are not limited to the first engaging structure 51 and the second engaging structure 52, and those skilled in the art can reasonably modify the first engaging structure 51 and the second engaging structure 52 according to the actual situation, which is not limited to this embodiment.

To sum up, the utility model provides an ultrasonic catheter includes: the device comprises an outer sheath, an inner core assembly with a transducer and an operation assembly; the outer sheath tube is detachably and coaxially connected with the operating assembly; the proximal end of the inner core assembly is disposed in the operating assembly; the distal end part of the inner core assembly is movably arranged through the outer sheath tube and is used for withdrawing the outer sheath tube along with the separation of the operating assembly and the outer sheath tube; the outer sheath tube is also used for the guide wire to penetrate after the outer sheath tube is separated from the operation assembly. With the configuration, the outer sheath tube is coaxially assembled and connected with the operation component during use, the distal end part of the inner core component penetrates into the outer sheath tube, and the ultrasonic exploration can be realized along with the intervention of the outer sheath tube into a human body. When the ultrasonic catheter is removed, once the ultrasonic catheter is clamped, the outer sheath tube can be separated from the operation assembly, the distal end part of the inner core assembly is withdrawn from the outer sheath tube, the unfreezing guide wire penetrates into the outer sheath tube, the outer sheath tube can be driven to be unlocked from the clamped position through the unfreezing guide wire, and therefore the problem that the ultrasonic catheter is difficult to separate after being clamped when being withdrawn is solved.

It should be noted that, several of the above embodiments may be combined with each other. The above description is only for the preferred embodiment of the present invention and is not intended to limit the scope of the present invention, and any modification and modification made by those skilled in the art according to the above disclosure are all within the scope of the claims.

Claims

1. An ultrasound catheter, comprising: the device comprises an outer sheath, an inner core assembly with a transducer and an operation assembly;

2. The ultrasound catheter of claim 1, wherein the outer sheath includes a first snap feature and the operating assembly includes a second snap feature, the operating assembly being coaxially snap-coupled or decoupled from the outer sheath by the first snap feature.

3. The ultrasound catheter according to claim 2, wherein one of the first and second snap structures has a snap and the other has a snap groove adapted to the snap.

4. The ultrasound catheter of claim 2 or 3, wherein one of the first and second snap features has a protrusion and the other has a recess that fits the protrusion; the convex part gradually shrinks towards the installation direction of the clamping structure where the convex part is located to form a cone shape, and the concave part gradually expands towards the installation direction of the clamping structure where the concave part is located to form a flared shape.

5. The ultrasonic catheter of claim 1, wherein the core assembly comprises a base and a flexible connecting tube connected in series from a proximal end to a distal end;

6. The ultrasound catheter of claim 5, wherein the flexible connecting tube comprises a hypotube or an inner and outer double layer spring tube.

7. The ultrasound catheter according to claim 6, wherein the winding directions of the spring tube of the inner and outer double layers are opposite; and/or the winding direction of the spring tube at the outer layer is opposite to the rotating direction of the inner core component.

8. The ultrasound catheter of claim 6, wherein adjacent spring turns of the spring tube abut one another when not subjected to an external force; and/or the inner and outer spring tubes are radially abutted against each other when no external force is applied.

9. The ultrasonic catheter of claim 1, wherein the proximal end portion of the inner core assembly is rotatably disposed in the operating assembly about an axis of the operating assembly; the inner core component is used for rotating in the operating component and the outer sheath after the operating component and the outer sheath are assembled and connected; the proximal end of the inner core assembly is restrained from axial movement by the handle assembly, and the distal end of the inner core assembly is withdrawn from the outer sheath with the handle assembly after the handle assembly is separated from the outer sheath.

10. The ultrasound catheter of claim 1, wherein the sheath has a receiving lumen extending axially along the sheath; the outer sheath tube is also provided with a guide wire cavity which runs through the outer sheath tube and is used for guiding a guide wire to penetrate through; the axis of the guide wire cavity and the axis of the containing cavity are arranged at an angle, the far end of the containing cavity is closed, and the far end of the containing cavity is adjacent to the guide wire cavity.