CN113384319B

CN113384319B - Catheter

Info

Publication number: CN113384319B
Application number: CN202110612270.8A
Authority: CN
Inventors: 夏顺
Original assignee: Shanghai Tendfo Medical Technologies Co Ltd
Current assignee: Shanghai Tendfo Medical Technologies Co Ltd
Priority date: 2021-06-02
Filing date: 2021-06-02
Publication date: 2023-04-25
Anticipated expiration: 2041-06-02
Also published as: CN113384319A

Abstract

The invention relates to the technical field of medical instruments and discloses a catheter. The catheter includes: the control device comprises a tube body, a control handle and at least one control wire; the proximal end of the tube body is fixedly connected with the control handle; the control handle comprises: controlling a wire winding and unwinding mechanism; one end of the control wire is fixed at the distal end of the tube body, the other end of the control wire is connected with the control wire winding and unwinding mechanism, the control wire spirally winds the bendable tube body section at the distal end of the tube body and then extends along the tube body, and the control wire winding and unwinding mechanism is used for adjusting the length of the control wire in the tube body. The catheter of the embodiment of the invention can change the shape of the catheter body in the blood vessel, so that the catheter body is bent, thereby increasing the action area of the catheter and thrombus, improving the problem of the deflection of the catheter in the blood vessel, achieving omnibearing thrombus taking and thrombolysis, and enabling the thrombus to be removed more thoroughly; and the curved catheter can also prevent the occurrence of distal embolism complications in the process of thrombolysis and thrombolysis, thereby greatly improving the treatment effects of aspiration and thrombolysis.

Description

Catheter

Technical Field

The invention relates to the technical field of medical appliances, in particular to a catheter which is used for intravascular thrombus removal interventional therapy, and thrombus or embolus is pumped out of the body by negative pressure suction through the catheter or thrombolytic medicine is injected into the body to dissolve the thrombus, so that the vascular obstruction is relieved, the blood circulation system of a human body is improved, and cardiopulmonary dysfunction, myocardial infarction, cerebral apoplexy and the like caused by the vascular obstruction are avoided.

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 thrombolysis and catheterization thrombolysis are gradually becoming a main recommended effective mode for vascular embolism treatment. The interventional thrombolysis and catheterization thrombolysis have the advantages of small trauma, short postoperative recovery time, few complications after treatment, good surgical effect and the like, and can be accepted by patients. Both interventional thrombolysis and catheterization thrombolysis require the use of a catheter-like medical device, such as an aspiration catheter for interventional thrombolysis and a thrombolysis catheter for catheterization thrombolysis.

The inventors have found that catheters currently on the market are mainly straight catheters, which when inside a blood vessel have a number of problems due to the fact that the diameter of the blood vessel is usually significantly larger than the diameter of the catheter: 1. the catheter is positioned with the wall-attached biasing property, so that the thrombus on the wall of the annular blood vessel cannot be sucked or sprayed in an omnibearing manner; 2. the action area of the straight catheter and thrombus is small, and the thrombus taking or thrombolysis efficiency is low; 3. the catheter may cause the large thrombus to break up and escape to the distal end of the vessel during aspiration or thrombolysis, further causing distal embolization.

Disclosure of Invention

Therefore, an object of the embodiments of the present invention is to provide a catheter, which can change the shape of the catheter body in a blood vessel, so as to bend the catheter body, thereby increasing the acting area of the catheter and thrombus, and improving the wall-attaching deviation of the catheter in the blood vessel, so as to achieve omnibearing thrombus removal and thrombolysis, and enable the thrombus removal to be more thorough; and the curved catheter can also prevent the occurrence of distal embolism complications in the process of thrombolysis and thrombolysis, thereby greatly improving the treatment effects of aspiration and thrombolysis.

To solve the above technical problems, embodiments of the present invention provide a catheter, including: the control device comprises a tube body, a control handle and at least one control wire;

the proximal end of the tube body is fixedly connected with the control handle; the control handle comprises: controlling a wire winding and unwinding mechanism; one end of the control wire is fixed at the distal end of the tube body, the other end of the control wire is connected with the control wire winding and unwinding mechanism, the control wire spirally winds the bendable tube body section at the distal end of the tube body and then linearly extends along the tube body, and the control wire winding and unwinding mechanism is used for adjusting the length of the control wire in the tube body.

According to the catheter provided by the embodiment of the invention, the control wire is wound on the bendable pipe body section at the far end of the pipe body, one end of the control wire is fixed at the far end of the pipe body, the other end of the control wire is connected with the control wire retracting mechanism, and when the length of the control wire in the pipe body is shortened by the control wire retracting mechanism, the control wire drives the bendable pipe body section to deform to form the spiral bent pipe, so that the action area of the catheter and thrombus can be increased, the problem of the adherence deviation of the catheter in a blood vessel can be improved, and the omnibearing thrombus taking and thrombolysis can be realized, so that the thrombus is more thoroughly removed; and the curved catheter can also prevent the occurrence of distal embolism complications in the process of thrombolysis and thrombolysis, thereby greatly improving the treatment effects of aspiration and thrombolysis.

In addition, a control wire channel is formed in the pipe wall of the pipe body, and the control wire is arranged in the control wire channel.

In addition, the pipe body comprises an inner layer pipe and an outer layer pipe which are integrally formed, a gap between the inner layer pipe and the outer layer pipe forms the control wire channel, and the control wire is wound on the outer wall of the inner layer pipe of the bendable pipe body section and then linearly extends along the control wire channel; or alternatively

The control wire passage includes: the control wire is arranged in the spiral pore canal and the straight pipe section pore canal in a penetrating way, wherein the spiral pore canal extends in a spiral way along the pipe body in the pipe wall of the bendable pipe body section, the straight pipe section pore canal extends along the pipe body in the pipe wall of the rest pipe body section of the pipe body.

In addition, the control handle comprises a shell, the shell is provided with an installation cavity, the control wire winding and unwinding mechanism comprises a wire winding disc and a knob, the wire winding disc is arranged in the installation cavity, the wire winding disc is connected with the knob, and the knob is used for driving the wire winding disc to rotate.

In addition, the control wire retracting mechanism comprises a sliding block and a sliding block positioning structure, wherein the sliding block and the sliding block positioning structure are arranged on the control handle shell, the sliding block is connected with the proximal end of the control wire, and the sliding block positioning structure is used for positioning the sliding block on the shell.

In addition, the catheter also comprises a head end which is fixedly arranged at the far end of the catheter body; and a thread guide hole is formed in the edge of the head end.

In addition, the catheter is used for thrombus suction, the far end of the tube body is also provided with a plurality of suction holes, and the suction holes are communicated with a suction cavity in the tube body; or alternatively

The catheter is used for medicament infusion, and a plurality of liquid injection holes are further formed in the distal end of the catheter body.

In addition, the head end middle part is big both ends are little, and from the head end middle part to the head end both ends are the arc surface.

In addition, the spiral shape is an equal-diameter spiral shape or a variable-diameter spiral shape; the diameter of the reducing helix increases from the distal end to the proximal end.

In addition, the outer end of the control handle is provided with a joint for connecting a liquid injection device or a suction device; the inner cavity of the joint is communicated with the inner cavity of the pipe body.

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 view of a catheter according to a first embodiment of the present invention;

FIGS. 2 and 3 are schematic views of the catheter shown in FIG. 1 in a bent state;

FIG. 4 is a schematic view showing a partial structure of a distal end of a catheter according to a first embodiment of the present invention;

FIG. 5 is a schematic view of a catheter according to a first embodiment of the present invention;

FIG. 6 is a schematic view of a bending structure of a catheter according to a first embodiment of the present invention;

fig. 7 is a schematic structural diagram of a catheter according to a second embodiment of the present invention;

FIG. 8 is a schematic view of a partially enlarged construction of the catheter shown in FIG. 7;

fig. 9 is a schematic view of a catheter according to an embodiment of the 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.

Unless otherwise specified, references to proximal and distal in this invention have the same meaning in the direction, i.e., in the use state, the distal is the end distal from the operator, the proximal is the end proximal to the operator, and the operator controls the catheter at the proximal.

Example 1

As shown in fig. 1, embodiment 1 of the present invention provides a catheter. The catheter 1 comprises: a tube 10, a control handle 11 and at least one control wire (not shown). The proximal end of the tube 10 is fixedly connected with a control handle 11, the control handle 11 comprising: and one end of the control wire is fixed at the distal end of the pipe body 10, the other end of the control wire is connected with the control wire winding and unwinding mechanism, and the control wire spirally winds around the bendable pipe body section at the distal end of the pipe body 10 and then extends along the rest pipe body section, and the control wire winding and unwinding mechanism is used for adjusting the length of the control wire in the pipe body 10. The control wire is fixed at one end of the control wire at the far end of the catheter, the control wire retracting mechanism is connected with the other end of the control wire, the control wire is spirally wound at the bendable pipe body section, the control wire can linearly extend at the rest pipe body sections which do not need to be bent, when the control wire is pulled by the control wire retracting mechanism to shorten the control wire positioned in the pipe body, the bendable pipe body section deforms under the pulling of the control wire to form a bent pipe which is spirally bent, so that the action area of the catheter and thrombus can be increased, the problem of the deflection of the catheter on the wall in a blood vessel can be improved, and omnibearing thrombus taking and thrombolysis can be achieved, and thrombus removal is more thorough; and the curved catheter can also prevent the occurrence of distal embolism complications in the process of thrombolysis and thrombolysis, thereby greatly improving the treatment effects of aspiration and thrombolysis.

In this embodiment, a control wire channel is formed in the wall of the tube body 10, and a control wire is disposed in the control wire channel. Alternatively, the tube body 10 includes an inner tube and an outer tube integrally formed, and a gap between the inner tube and the outer tube forms a control wire channel, and the control wire is wound around an outer wall of the inner tube of the bendable tube section and then linearly extends along the control wire channel. The length of the bendable tube body section may be determined empirically from the thrombi removal treatment and is not particularly limited herein. The control wire channel of this embodiment is an annular control wire channel. As shown in fig. 6, since the control wire is freely movable within the annular control wire passage, the helical diameter D and pitch L of the curved tube segment can be adjusted by adjusting the length of the control wire in the tube.

As an alternative to the control wire channels described above, in some examples, the control wire channels may include: the control wire is arranged in the spiral pore canal and the straight pipe pore canal in a penetrating way. The size of the control wire channel in this embodiment may be determined according to the size of the control wire, so that the control wire can freely move in the control wire channel. Compared with the annular control wire channel in the previous embodiment, the annular control wire channel is beneficial to reducing the whole cross-sectional area of the pipe body and controlling the bending shape of the catheter. It will be appreciated that the present embodiment is not particularly limited as to the implementation of pulling the tube into a curved catheter by controlling the wire. In some examples, the tube body may be provided with a spirally distributed drawing portion, each drawing portion having a drawing hole, and the control wire is sequentially threaded through the drawing holes, so that the tube body becomes a spirally curved conduit when the control wire is pulled.

Alternatively, as shown in fig. 2 or 3, the spiral may be an equal-diameter spiral. Alternatively, as shown in fig. 5, the spiral may be a variable diameter spiral having a diameter that increases from the distal end to the proximal end. In this embodiment, the shape of the spiral is not particularly limited, and in practical application, the pitch and diameter of the spiral may also be irregularly changed.

In this embodiment, one control wire may be used, and in other examples, 2 or more control wires may be used. One end of one or more control wires is/are fixed at the most distal end of the tube body, and the other end of the control wires extends out of the tube body and then is connected with the control wire winding and unwinding mechanism. When a plurality of control wires are adopted, the diameter of a single control wire can be made smaller, so that the area ratio of a suction cavity or a liquid injection cavity of the catheter is favorably improved, and the usability of the catheter is improved.

In this embodiment, the control handle 11 includes a housing, the housing is provided with a mounting cavity, the control wire winding and unwinding mechanism includes a wire winding disc and a knob 110, the wire winding disc is disposed in the mounting cavity, the wire winding disc is connected with the knob 110, and the knob 110 is used for driving the wire winding disc to rotate. In practical applications, the control wire retracting mechanism may further include a knob positioning structure for positioning the knob. The specific implementation manner of the knob and the knob positioning structure is not particularly limited in this embodiment, so long as the winding disc can be driven to rotate, thereby winding the control wire on the winding disc. The knob positioning structure can realize positioning according to gear, namely the control wire can be positioned when being wound or released for a certain length, but is not limited to the positioning.

As an alternative to the control wire retracting mechanism, in other examples, the control wire retracting mechanism includes a slider disposed on the control handle housing and a slider positioning structure connected to the proximal end of the control wire for positioning the slider on the housing. When the sliding block moves, the control wire is driven to move, so that the bendable catheter section becomes bent. In some examples, rollers may be used to move the control wire. The invention is not particularly limited to the control wire winding and unwinding mechanism. The length of the control wire in the pipe body can be accurately adjusted by operating the control wire retracting mechanism, for example, the spiral diameter of the pipe body is finely adjusted and maintained after the pipe body is deformed through scales, and the length of the control wire in the pipe body can be quickly adjusted according to hand feeling, so that the spiral diameter of the bendable section is maximum.

The outer end of the control handle is provided with a joint 13 for connecting with a priming device or a suction device. The inner cavity of the joint 13 communicates with the inner cavity of the pipe body 10. The priming device or the aspiration device can be connected quickly through the joint, so that the thrombus aspiration or medicament infusion function is realized. The priming device and the aspiration device may employ a syringe, and are not particularly limited herein. It will be appreciated that the lumen of the body, the lumen of the control handle and the lumen of the connector form a pumping or infusion lumen which needs to be kept sealed.

Fig. 4 is a schematic view of a partial structure of a distal end of the catheter, as shown in fig. 4, the catheter 1 further includes a head end 12, the head end 12 is fixedly arranged at the distal end of the catheter body 10, and a wire guiding hole 120 is formed at an edge of the head end 12. The head end 12, the tube body 10 and the housing of the control handle may be of unitary construction. By placing the guidewire port outside the body 10, the surgical need for aspiration or drug infusion channels within the catheter can be met while retaining the guidewire in place during surgery, while not causing a decrease in overall catheter bending compliance. Alternatively, the head end 12 is small at the large middle and small at both ends and has an arcuate surface from the middle of the head end to both ends of the head end. For example, but not limited to, the arcuate surfaces from the middle of the head end to the ends of the head end are frustoconical surfaces. The head end adopts an arc-shaped surface structure with a large middle part and small two ends, which is beneficial for the catheter to enter the target thrombus position and the catheter to be retracted, and simultaneously avoids damaging blood vessels.

In this embodiment, the catheter 1 is used for thrombus aspiration, and the distal end of the tube body 10 is further provided with a plurality of aspiration holes 101, and the aspiration holes 101 are communicated with an aspiration cavity in the tube body 10. The number of the suction holes 101 may be 1 to 3. The size of the suction hole is as large as possible, which is beneficial for thrombus to enter the catheter from the suction hole. The shape of the suction hole 101 includes, but is not limited to: circular, oval, bar-shaped cuts, or irregular polygons, etc.

It should be noted that, the distal end of the tube body is provided with a developing structure, and the developing structure may be a developing material disposed on the tube body. Development structures may be used to mark the extent of the flexible pipe body section.

Compared with the prior art, the embodiment of the invention has the advantages that the control wire spirally wound on the bendable pipe body section is pulled by the control wire retracting mechanism, so that the bendable pipe body section is changed into the spirally bent pipe, the action area of the catheter and thrombus can be increased, the problem of the wall deflection of the catheter in a blood vessel can be improved, the omnibearing thrombus removal is achieved, and the thrombus is removed more thoroughly; and the curved catheter can also prevent the occurrence of distal embolism complications in the thrombus taking process, thereby greatly improving the thrombus aspiration treatment effect.

Example 2

The catheter of this embodiment has substantially the same structure as the catheter of embodiment 1, and is mainly different in that the catheter of embodiment 1 is a thrombus aspiration catheter, the catheter body is provided with an aspiration hole, the catheter of this embodiment is a fluid infusion catheter, and the distal end of the catheter body is provided with a plurality of fluid infusion holes for infusing a medicament to a target thrombus site. The differences between the present embodiment and embodiment 1 are described below, and the details of the differences are not described herein.

In this embodiment, the catheter 1 is used for drug infusion, and as shown in fig. 7, the distal end of the catheter body 10 is further provided with a plurality of infusion holes 102. As shown in fig. 8, the injection hole 102 may be slit-type (or line-type), and the aperture of the injection hole 102 may be set as small as possible, so long as the medicine can be injected under pressure to the thrombus site. The number of the injection holes 102 can be set according to the injection requirement, for example, 100 injection holes 102 are set, and 100 injection holes can be uniformly set on the tube body 10. Of course, the injection holes may be arranged in other ways that are more advantageous for uniform injection and/or precise control of the dosage, and are not particularly limited herein.

Compared with the prior art, the embodiment of the invention has the advantages that the control wire spirally wound on the bendable pipe body section is pulled by the control wire retracting mechanism, so that the bendable pipe body section is changed into the spirally bent pipe, the action area of the catheter and thrombus can be increased, the problem of the attaching deviation of the catheter in a blood vessel can be improved, the omnibearing thrombolysis is achieved, and the thrombus is removed more thoroughly; and the bent catheter can also prevent the occurrence of distal embolism complications in the thrombolysis process, thereby greatly improving thrombolysis treatment effect.

Referring to fig. 9, the method and steps for using the catheter 1 according to the embodiment of the present invention are as follows:

in thrombi removal interventional procedures, instrument access is established through a needle, guidewire, catheter and small puncture sheath in the femoral artery (vein). The method comprises the steps of introducing a catheter to a blood vessel blocking position through a blood vessel intracavity interventional channel technology, and then carrying out selective radiography to determine the blood vessel position of thrombus. The replacement angiographic catheter is a guidewire (the guidewire is introduced and then withdrawn from the catheter). The adjustable bending suction catheter 1 according to the embodiment of the invention is taken out, the adjustable bending suction catheter is subjected to water injection and evacuation, and then a guide wire (not shown) is led through a guide wire hole at the head end, so that the catheter 1 is led to a thrombus along the guide wire, and the head end of the catheter 1 exceeds the thrombus 4. The guide wire is withdrawn, the distal end of the catheter 1 is adjusted to a helically curved shape by operation of the control handle 11, and the helical diameter of the curved catheter 1 is controlled according to the diameter of the blood vessel 3. The shape of the catheter 1 is observed by X-rays, suction is started by using the aspirator 2, the catheter 1 is retracted or twisted according to the operation requirement, the position of a nozzle is adjusted, and suction is performed for a plurality of times until the thrombus is completely extracted. Finally, the catheter 1 is withdrawn from the body, the wound is sutured, and the operation is completed.

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

1. A catheter, comprising: the control device comprises a tube body, a control handle and at least one control wire;

the proximal end of the tube body is fixedly connected with the control handle; the control handle comprises: controlling a wire winding and unwinding mechanism; one end of the control wire is fixed at the distal end of the tube body, the other end of the control wire is connected with the control wire retracting mechanism, the control wire spirally winds the bendable tube body section at the distal end of the tube body and then extends along the rest tube body section, and the control wire retracting mechanism is used for adjusting the length of the control wire in the tube body so as to enable the bendable tube body section to form a spirally bent tube;

a control wire channel is formed in the pipe wall of the pipe body; the control wire passage includes: the control wire is arranged in the spiral pore canal and the straight pipe body pore canal in a penetrating way, wherein the spiral pore canal extends in a spiral way along the pipe body in the pipe wall of the bendable pipe body section, the straight pipe body pore canal extends in the pipe wall of the rest pipe body section of the pipe body along the pipe body, and the control wire is arranged in the spiral pore canal and the straight pipe body pore canal in a penetrating way.

2. The catheter of claim 1, wherein the control handle comprises a housing provided with a mounting cavity, the control wire take-up and pay-off mechanism comprises a wire winding disc and a knob, the wire winding disc is disposed in the mounting cavity, the wire winding disc is connected with the knob, and the knob is used for driving the wire winding disc to rotate.

3. The catheter of claim 1, wherein the control wire retraction mechanism includes a slider disposed on the control handle housing, the slider being connected to the proximal end of the control wire, and a slider positioning structure for positioning the slider on the housing.

4. The catheter of claim 1, further comprising a head end secured to the distal end of the tube; and a thread guide hole is formed in the edge of the head end.

5. The catheter of claim 4, wherein the catheter is used for thrombus aspiration, and the distal end of the catheter body is further provided with a plurality of aspiration holes, wherein the aspiration holes are communicated with an aspiration cavity in the catheter body; or alternatively

6. The catheter of claim 4, wherein the head end middle portion is small at both ends and has an arcuate surface from the head end middle portion to the head end ends.

7. The catheter of claim 1, wherein the spiral is an equal-diameter spiral or a variable-diameter spiral; the diameter of the reducing helix increases from the distal end to the proximal end.

8. The catheter according to claim 1, wherein the control handle is provided at the outer end with a connector for connecting an priming device or a suction device; the inner cavity of the joint is communicated with the inner cavity of the pipe body.