CN113384319A

CN113384319A - A catheter

Info

Publication number: CN113384319A
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: 2021-09-14
Anticipated expiration: 2041-06-02
Also published as: CN113384319B

Abstract

The invention relates to the technical field of medical instruments and discloses a catheter. The catheter includes: the device comprises a pipe body, a control handle and at least one control wire; the near end of the tube body is fixedly connected with the control handle; the control handle includes: a control wire take-up and pay-off mechanism; one end of the control wire is fixed at the end part of the far end of the tube body, the other end of the control wire is connected with the control wire retracting and releasing mechanism, the control wire spirally winds the bendable tube body section arranged at the far end of the tube body and then extends along the tube body, and the control wire retracting and releasing 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 a blood vessel and bend the catheter body, thereby increasing the action area of the catheter and thrombus, improving the problem of wall sticking bias of the catheter in the blood vessel, achieving all-round thrombus removal and thrombolysis and enabling the thrombus to be removed more thoroughly; and the bent catheter can also prevent the occurrence of distal embolism complications in the process of thrombus removal and thrombolysis, thereby greatly improving the treatment effect of suction and thrombolysis.

Description

A catheter

Technical Field

The invention relates to the technical field of medical instruments, in particular to a catheter which is used for intravascular thrombus removal interventional therapy, thrombus or embolus is sucked out of a body by negative pressure suction mainly through the catheter or thrombolytic drugs are injected to dissolve thrombus, so that the blockage of blood vessels is relieved, the blood circulation system of a human body is improved, and the heart and lung dysfunction, the myocardial infarction, the death of cerebral apoplexy and the like caused by the blockage of the blood vessels are avoided.

Background

Vascular disease has become the first fatal disease in our country, and vascular embolism has become a major factor in vascular disease. Especially, the new illness rate of patients suffering from cerebral arterial thrombosis, pulmonary embolism and lower limb venous embolism is over 500 ten thousand per year.

At present, medical intervention thrombus removal and catheterization thrombolysis are gradually an effective recommended mode for the mainstream of vascular embolism treatment. The interventional thrombus taking and catheterization thrombolysis 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. The interventional thrombus removal and the catheterization thrombolysis both need to use a catheter type medical instrument, for example, the interventional thrombus removal needs a suction catheter, and the catheterization thrombolysis needs a thrombolysis catheter.

The inventors have found that the catheters on the market today are mainly straight catheters, which present problems in the blood vessel when the catheter is inside the blood vessel due to the fact that the blood vessel diameter is usually significantly larger than the catheter diameter: 1. the position of the catheter has the bias of adherence, and the thrombus around the vessel wall cannot be sucked or sprayed with the medicine in all directions; 2. the action area of the straight catheter and the thrombus is small, and the thrombus taking or dissolving efficiency is low; 3. the catheter may cause large thrombi to fragment and escape to the distal end of the vessel during aspiration or thrombolysis, further causing distal embolization.

Disclosure of Invention

In view of the above, 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 to bend the catheter body, thereby increasing the effective area of the catheter and thrombus, and improving the problem of the catheter sticking to the wall in the blood vessel, so as to achieve all-directional thrombus removal and thrombolysis, and thus remove the thrombus more thoroughly; and the bent catheter can also prevent the occurrence of distal embolism complications in the process of thrombus removal and thrombolysis, thereby greatly improving the treatment effect of suction and thrombolysis.

To solve the above technical problem, an embodiment of the present invention provides a catheter including: the device comprises a pipe body, a control handle and at least one control wire;

the near end of the tube body is fixedly connected with the control handle; the control handle includes: a control wire take-up and pay-off mechanism; one end of the control wire is fixed at the end part of the far end of the pipe body, the other end of the control wire is connected with the control wire retracting and releasing mechanism, the control wire spirally winds the bendable pipe body section arranged at the far end of the pipe body and then linearly extends along the pipe body, and the control wire retracting and releasing mechanism is used for adjusting the length of the control wire in the pipe body.

According to the catheter provided by the embodiment of the invention, the control wire is wound on the bendable catheter body section at the far end of the catheter body, one end of the control wire is fixed at the far end of the catheter body, the other end of the control wire is connected with the control wire retracting and releasing mechanism, and when the length of the control wire in the catheter body is shortened through the control wire retracting and releasing mechanism, the control wire drives the bendable catheter 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 wall sticking tendency of the catheter in a blood vessel can be solved, the omnibearing thrombus removal and thrombolysis can be achieved, and the thrombus can be removed more thoroughly; and the bent catheter can also prevent the occurrence of distal embolism complications in the process of thrombus removal and thrombolysis, thereby greatly improving the treatment effect of suction 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 control wire channel is formed in a gap between the inner layer pipe and the outer layer pipe, 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

The control wire channel includes: the control wire comprises a spiral duct which extends spirally along the pipe body in the pipe wall of the bendable pipe body section, and a straight pipe body section duct which extends along the pipe body in the pipe wall of the rest pipe body section of the pipe body, wherein the control wire penetrates through the spiral duct and the straight pipe body section duct.

In addition, the control handle includes the casing, the casing is equipped with the installation cavity, control wire jack includes wire winding dish and knob, the wire winding dish set up in the installation cavity, the wire winding dish with the knob is connected, the knob is used for driving the wire winding dish is rotatory.

In addition, the control wire retracting and releasing mechanism comprises a sliding block and a sliding block positioning structure, the sliding block is arranged on the control handle shell, the sliding block is connected with the near 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; the edge of head end is equipped with the seal wire hole.

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

The catheter is used for medicament perfusion, and the far end of the catheter body is also provided with a plurality of liquid injection holes.

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

In addition, the spiral is an equal-diameter spiral or a variable-diameter spiral; the diameter of the reducing spiral is gradually increased from the far end to the near end.

In addition, the outer end of the control handle is provided with a joint for connecting an 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 used in the description of the embodiments or the prior art will be briefly introduced below, it is understood that the drawings in the following description are only embodiments 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 catheter according to an embodiment of the present invention;

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

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

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

FIG. 6 is a structural diagram of a curved structure of a catheter according to an 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 an enlarged partial schematic view of the catheter shown in FIG. 7;

fig. 9 is a schematic view of a catheter according to an embodiment of the present invention in use.

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.

Unless otherwise stated, reference to proximal and distal ends in the present invention shall have the same meaning in the orientation, i.e. in the use state, the distal end is the end distal from the operator, the proximal end is the end proximal to the operator, and the operator controls the catheter at the proximal end.

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 near-end and the control handle 11 fixed connection of body 10, control handle 11 contains: and a control wire take-up and pay-off mechanism 110, wherein one end of the control wire is fixed at the distal end of the tube body 10, the other end of the control wire is connected with the control wire take-up and pay-off mechanism, the control wire spirally winds the bendable tube body section arranged at the distal end of the tube body 10 and then extends along the rest tube body section, and the control wire take-up and pay-off mechanism is used for adjusting the length of the control wire in the tube body 10. In the catheter of the embodiment, one end of the control wire is fixed at the far end of the catheter, the other end of the control wire is connected with the control wire retraction jack, the control wire is spirally wound at the bendable pipe body section, and the control wire can linearly extend at the rest pipe body sections which do not need to be bent; and the bent catheter can also prevent the occurrence of distal embolism complications in the process of thrombus removal and thrombolysis, thereby greatly improving the treatment effect of suction and thrombolysis.

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

As an alternative to the control wire channel described above, in some examples, the control wire channel may include: the control wire is arranged in the spiral pore channel which extends spirally along the pipe body in the pipe wall of the bendable pipe body section, and the pore channel of the straight pipe body section which extends along the pipe body in the pipe wall of the residual pipe body section of the pipe body, and the control wire is arranged in the spiral pore channel and the pore channel of the straight pipe body section in a penetrating mode. The size of the control wire channel of the embodiment can 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 embodiment, the cross-sectional area of the whole pipe body is reduced, and the bending shape of the catheter is controlled. It is understood that the present embodiment is not particularly limited to the implementation of pulling the tube body into the curved catheter by the control wire. In some examples, the tube body may be provided with a plurality of spirally distributed drawing parts, each drawing part has a drawing hole, and the control wire is sequentially inserted into each drawing hole, so that the tube body becomes a spirally bent tube when the control wire is drawn.

Alternatively, the spiral may be a constant diameter spiral, as shown in fig. 2 or fig. 3. Alternatively, as shown in FIG. 5, the spiral shape may be a variable diameter spiral shape having a diameter that increases from the distal end to the proximal end. The spiral shape is not limited in this embodiment, and in practical applications, the pitch and diameter of the spiral may also vary irregularly.

In this embodiment, there may be one control wire, and in other examples, there may be 2 control wires or 2 or more control wires. One end of one or more control wires is fixed at the farthest end of the tube body, and the other end of the control wire extends out of the tube body and then is connected with the control wire take-up and pay-off 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 service performance of the catheter is improved.

In this embodiment, the control handle 11 includes the casing, and the casing is equipped with the installation cavity, and the control wire jack includes wire winding dish and knob 110, and the wire winding dish sets up in the installation cavity, and the wire winding dish is connected with knob 110, and knob 110 is used for driving the wire winding dish rotatory. In practical applications, the control wire retracting mechanism may further include a knob positioning structure for positioning the knob. The embodiment does not specifically limit the specific implementation manner of the knob and the knob positioning structure, and the control wire can be wound on the wire winding disc as long as the wire winding disc can be driven to rotate. The knob positioning structure can realize positioning in different steps, namely the control wire can be positioned every time the control wire is wound or released for a certain length, but not limited to the positioning structure.

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, the slider being coupled to the proximal end of the control wire, the slider positioning structure being configured to position the slider on the housing. The slider, when moved, drives the control wire to move, thereby bending the bendable catheter segment. In some examples, a roller may be used to move the control wire. The present invention is not particularly limited to controlling the filament winding and unwinding mechanism. Through operation control silk jack, can the accurate control silk length in the body of adjusting, for example through scale fine setting control body spiral diameter after warping and keep, also can be according to the control silk length in the quick adjustment body of feeling certainly for the spiral diameter of bendable section is the biggest.

The outer end of the control handle is provided with a joint 13 for connecting an injection device or a suction device. The lumen of the connector 13 communicates with the lumen of the tube body 10. The liquid injection device or the suction device can be quickly connected through the joint, so that the function of sucking thrombus or infusing the medicament is realized. The injection device and the suction device may employ a syringe, and are not particularly limited herein. It will be appreciated that the body lumen, the control handle lumen and the adapter lumen form a suction or infusion lumen which needs to be kept well sealed.

Fig. 4 is a partial structural schematic view of the distal end of the catheter, and as shown in fig. 4, the catheter 1 further includes a head end 12, the head end 12 is fixedly disposed at the distal end of the tube 10, and the edge of the head end 12 is provided with a guidewire hole 120. The head end 12, the tubular body 10 and the housing of the control handle may be of unitary construction. Through setting up the wire guide hole in body 10 outsidely, can keep the wire immobile operation demand of satisfying suction channel or injection passageway in the pipe in the art, can not lead to the whole crooked compliance of pipe to descend simultaneously. Alternatively, the head end 12 is large in the 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, the arc surface from the middle of the head end to the both ends of the head end is a frustum-shaped surface, but is not limited thereto. The head end adopts the big arc surface structure that both ends are little in middle part, is favorable to the pipe to get into target thrombus position and withdraw the pipe, avoids haring the blood vessel simultaneously.

In this embodiment, the catheter 1 is used for thrombus aspiration, and the distal end of the tube 10 is further provided with a plurality of aspiration holes 101, and the aspiration holes 101 communicate with an aspiration lumen in the tube 10. The number of the suction holes 101 may be 1 to 3. The size of the suction hole is as large as possible, so that thrombus can enter the catheter from the suction hole. The shape of the suction hole 101 includes, but is not limited to: circular, oval, strip-shaped cut, irregular polygon, or the like.

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 in the tube body. The development structure may be used to mark a range of bendable tube segments.

Compared with the prior art, the embodiment of the invention has the advantages that the control wire winding on the bendable pipe body section is pulled by the control wire winding and unwinding 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 wall sticking bias of the catheter in a blood vessel can be solved, the omnibearing thrombus removal is realized, and the thrombus is removed more thoroughly; and the bent catheter can also prevent the occurrence of distal embolism complications in the thrombus extraction process, thereby greatly improving the thrombus aspiration treatment effect.

Example 2

The catheter of the present 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, and the catheter body is provided with aspiration holes, whereas the catheter of the present embodiment is an infusion catheter, and the distal end of the catheter body is provided with a plurality of infusion holes for infusing a medicament to a target thrombus site. The differences between the present embodiment and embodiment 1 will be described below, and the same parts will not be described again.

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 a slit type (or a line type), and the diameter of the injection hole 102 may be as small as possible, as long as the agent can be injected to the thrombus site under pressure. The number of the injection holes 102 can be set according to the injection requirement, for example, 100 injection holes 102 are provided, and 100 injection holes can be uniformly provided on the tube body 10. Of course, the injection holes may be disposed in other ways that are more conducive to uniform injection and/or precise control of the amount of drug, and are not limited herein.

Compared with the prior art, the embodiment of the invention has the advantages that the control wire winding on the bendable pipe body section is pulled by the control wire winding and unwinding 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 wall sticking bias of the catheter in a blood vessel can be solved, 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 the thrombolysis treatment effect.

With reference to fig. 9, the method of using the catheter 1 according to the embodiment of the present invention comprises the following steps:

in the thrombus clearing interventional operation treatment, an instrument interventional channel is established in the femoral artery (vein) vessel through a puncture needle, a guide wire, a catheter and a small-size puncture sheath. The catheter is guided into the position of the blocked blood vessel through the endovascular intervention channel technology, and then selective radiography is carried out to determine the position of the blood vessel of the thrombus. The replacement angiographic catheter is a guide wire (the guide wire is introduced and then withdrawn from the angiographic catheter). The adjustable bent suction catheter 1 according to the embodiment of the present invention is taken out, the adjustable bent suction catheter is filled with water and emptied, and then a guide wire (not shown) is passed through the guide wire hole at the head end, so that the catheter 1 is guided to the 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 into a spiral bending shape through the operation of the control handle 11, and the spiral diameter of the bent catheter 1 is controlled according to the diameter of the blood vessel 3. Observing the shape of the catheter 1 by X-ray, starting suction by using the suction device 2, withdrawing or twisting the catheter 1 according to the operation requirement, adjusting the position of a tube opening, and performing suction for multiple times until thrombus is completely sucked out. Finally, the catheter 1 is withdrawn from the body, and the wound is sutured, thereby completing the operation.

It will be understood by those of ordinary skill in the art that the foregoing embodiments are specific examples for 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 in practice.

Claims

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

the near end of the tube body is fixedly connected with the control handle; the control handle includes: a control wire take-up and pay-off mechanism; one end of the control wire is fixed at the end part of the far end of the pipe body, the other end of the control wire is connected with the control wire retracting and releasing mechanism, the control wire spirally winds the bendable pipe body section arranged at the far end of the pipe body and then extends along the rest pipe body section, and the control wire retracting and releasing mechanism is used for adjusting the length of the control wire in the pipe body.

2. The catheter of claim 1, wherein a control wire channel is formed within a wall of the tube, the control wire being disposed within the control wire channel.

3. The catheter according to claim 2, wherein the catheter body comprises an inner tube and an outer tube which are integrally formed, wherein a gap between the inner tube and the outer tube forms the control wire passage, and the control wire is wound around an outer wall of the inner tube of the bendable catheter body section and then linearly extends along the control wire passage; or

4. The catheter of claim 1, wherein the control handle comprises a housing having a mounting cavity, the control wire retraction mechanism comprising a wire spool disposed in the mounting cavity and a knob coupled to the wire spool for rotating the wire spool.

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

6. The catheter of claim 1, further comprising a tip fixedly disposed at the distal end of the tube; the edge of head end is equipped with the seal wire hole.

7. The catheter of claim 6, wherein the catheter is used for thrombus aspiration, and the distal end of the tube body is further provided with a plurality of aspiration holes which are communicated with an aspiration cavity in the tube body; or

8. The catheter of claim 6, wherein the tip middle is large and small at both ends, and wherein the tip middle is an arcuate surface from the tip middle to the tip ends.

9. The catheter of claim 1, wherein the spiral shape is an equal diameter spiral shape or a variable diameter spiral shape; the diameter of the reducing spiral is gradually increased from the far end to the near end.

10. The catheter of claim 1, wherein the outer end of the control handle is provided with a joint for connecting an injection device or a suction device; the inner cavity of the joint is communicated with the inner cavity of the pipe body.