CN110193131B

CN110193131B - Pulmonary artery thrombolysis catheter

Info

Publication number: CN110193131B
Application number: CN201910382600.1A
Authority: CN
Inventors: 朱紫阳; 李发久; 李承红
Original assignee: Jianghan University Affiliated Hospital (the Sixth Hospital Of Wuhan)
Current assignee: Jianghan University Affiliated Hospital (the Sixth Hospital Of Wuhan)
Priority date: 2019-05-09
Filing date: 2019-05-09
Publication date: 2021-03-16
Anticipated expiration: 2039-05-09
Also published as: CN110193131A

Abstract

The invention provides a pulmonary artery thrombolysis catheter, which comprises a wire guide body, wherein the wire guide body is formed by twisting a plurality of metal wires and at least one liquid tube, the outer wall of the wire guide body is coated with a first outer coating layer and a second outer coating layer, the first outer coating layer is provided with two notches which are distributed along the axial direction, the positions of the notches are covered with the second outer coating layer, the second outer coating layer is used for forming a first balloon and a second balloon at the positions of the notches, and the front end opening of the liquid tube penetrates through the first outer coating layer and the second outer coating layer and is positioned between the first balloon and the second balloon; the channel formed by the first outer coating is communicated with the first connecting port, and the liquid pipe is communicated with the second connecting port. Through adopting the integrated configuration of wire, liquid pipe, first cladding and second cladding to make the scheme of second cladding formation sacculus, reduced the diameter of pipe by a wide margin, minimum external diameter can accomplish 0.4mm, and bigger diameter can reach 1.5mm, and can be convenient for pass crooked blood vessel.

Description

Pulmonary artery thrombolysis catheter

Technical Field

The invention relates to the field of a blood vessel thrombolysis medical instrument, in particular to a pulmonary artery thrombolysis catheter.

Background

In the prior art, a balloon catheter is adopted for thrombolysis treatment, so that a balloon of the catheter is expanded in a blood vessel with thrombus, and the inner diameter of the narrower blood vessel can be expanded. In the prior art, a scheme that a closed section is formed by utilizing double balloons within a section of a blood vessel and then thrombolytic agents are injected into the closed section is adopted to improve local drug concentration. In certain parts of the human body, such as bronchial artery embolization, it is possible to block blood flow in a short time, for example, 20 minutes, without affecting vital signs, such as a double-balloon thrombolysis catheter described in chinese patent document CN 108114361A. In this solution, the supply channel of the balloon is arranged on the wall of the catheter, and the double balloon solution is provided with two channels, in addition to the channel for supplying the liquid, which makes it difficult to make the diameter of the catheter smaller. This solution can therefore only be applied to vessels with a large diameter.

Existing catheterization procedures for thrombolysis include pre-forming catheters that are pre-molded to different curved configurations to facilitate insertion into the vessel to be treated during the procedure. However, this method is only applicable to a specific blood vessel, resulting in a high overall cost. And the diameter of the catheter is thick and is not suitable for certain blood vessels with thin diameters.

The catheter-guide wire method is characterized in that a preformed catheter is inserted into the 1 st branch of a blood vessel, then a guide wire is penetrated into a target blood vessel, the guide wire is used as a guide, a thin and soft catheter is penetrated, and the guide wire is taken out after the catheter is in place. The passage of guide wires and catheters through blood vessels is prone to damage at the opening and the inner wall of the vessel.

In addition to the steerable guidewire approach and the coaxial catheter approach, it is desirable to guide the catheter with a guidewire.

Disclosure of Invention

The invention aims to provide a pulmonary artery thrombolysis catheter, which can reduce the number of intubation times, reduce the diameter of an instrument and improve the success rate of an operation.

In order to solve the technical problems, the technical scheme adopted by the invention is as follows: a pulmonary artery thrombolysis catheter comprises a wire guide body, wherein the wire guide body is formed by twisting a plurality of metal wires and at least one liquid tube, the outer wall of the wire guide body is coated with a first outer coating and a second outer coating, the first outer coating is provided with two notches which are distributed along the axial direction, the positions of the notches are covered with the second outer coating, the second outer coating is used for forming a first balloon and a second balloon at the positions of the notches, and the front end opening of the liquid tube penetrates through the first outer coating and the second outer coating and is positioned between the first balloon and the second balloon;

the channel formed by the first outer coating is communicated with the first connecting port, and the liquid pipe is communicated with the second connecting port.

In a preferred scheme, the wire guide body is formed by twisting a plurality of metal wires and two liquid tubes, and front end openings of the two liquid tubes penetrate through a first outer cladding and a second outer cladding and are positioned between a first balloon and a second balloon;

the two liquid pipes are respectively communicated with the second connecting port and the third connecting port.

In a preferable scheme, the front ends of the multiple metal wires are also provided with guide ends, and the guide ends are correspondingly bent according to vascular plastics.

In a preferred embodiment, the first outer cladding is located outside the second outer cladding.

In a preferred scheme, the metal wire is made of nickel-titanium alloy or stainless steel, and the guide end is made of nickel-titanium alloy.

In a preferred scheme, the front end of the metal wire is connected with the guide end in a welding mode.

In the preferred scheme, two ends of the position of the notch are provided with limiting rings, the limiting rings are made of materials which are not deformed under pressure and used for limiting the expansion of the second outer cladding, and the first outer cladding is positioned in the second outer cladding.

In a preferred scheme, a developing ring is further arranged at a position near the notch and used for indicating the position of the guide wire in the body.

In a preferred scheme, the surface of the metal wire is provided with a groove.

In the preferred scheme, the first outer wrapping layer is made of medical plastic materials which are not deformed under pressure;

the second outer coating is made of medical rubber and plastic materials which deform after being filled with pressure media.

In a preferred scheme, the first outer wrapping layer is one of medical polyether amide, polyether block amide, polyester, polytetrafluoroethylene, polypropylene or ultra-high molecular weight polyethylene;

the second outer coating is one of medical polyether block amide, rubber or silica gel.

The invention provides a pulmonary artery thrombolysis catheter, which greatly reduces the diameter of the catheter by adopting a scheme that a combined structure of a metal wire, a liquid tube, a first outer cladding and a second outer cladding and the second outer cladding forms a balloon, wherein the minimum outer diameter can reach 0.4mm, the larger diameter can reach 1.5mm, and the catheter can conveniently pass through a bent blood vessel. And the section of the target blood vessel can be blocked conveniently, the drug thrombolysis treatment can be performed, the local concentration of the drug can be improved, and the thrombolysis effect can be improved. The invention does not need to puncture the vessel for many times, thereby greatly reducing the damage of the puncture operation to the inner wall of the blood vessel. In a preferable scheme, a circulating thrombolysis scheme can be adopted to suck out fine emboli so as to avoid blocking capillary vessels. The guide end is arranged to further improve the ability to navigate in the blood vessel.

Drawings

The invention is further illustrated by the following examples in conjunction with the accompanying drawings:

fig. 1 is a schematic view of the overall structure of the present invention.

FIG. 2 is a schematic view of the overall structure of a preferred embodiment of the present invention.

Fig. 3 is a partially enlarged view of a portion a of fig. 1 according to the present invention.

FIG. 4 is a schematic sectional view of B-B in FIG. 3.

FIG. 5 is a schematic sectional view B-B of the preferred embodiment of FIG. 3.

FIG. 6 is a schematic cross-sectional view of C-C of FIG. 3.

FIG. 7 is a schematic cross-sectional view of the preferred embodiment of FIG. 3 taken at C-C.

FIG. 8 is a partially enlarged view illustrating the operation of the present invention.

In the figure: the thrombolytic drug thrombolytic treatment device comprises a first connecting port 1, a second connecting port 2, a wire guide body 3, a limiting ring 31, a developing ring 32, a first balloon 33, a second balloon 34, a connecting ring 35, a first outer cladding 36, a metal wire 37, a liquid tube 38, a second outer cladding 39, a guiding end 301, a third connecting port 4 and a thrombolytic drug 5.

Detailed Description

As shown in fig. 1, 3, 4, and 6, a pulmonary artery thrombolysis catheter includes a wire guide 3, the wire guide 3 is formed by twisting a plurality of wires 37 and at least one liquid tube 38, the outer wall of the wire guide 3 is covered with a first outer covering 36 and a second outer covering 39, the first outer covering 36 is provided with two notches distributed along the axial direction, the notches are covered with the second outer covering 39, the second outer covering 39 is used for forming a first balloon 33 and a second balloon 34 at the notches, and the front end opening of the liquid tube 38 passes through the first outer covering 36 and the second outer covering 39 and is located between the first balloon 33 and the second balloon 34;

preferably, the first outer cladding 36 is located outside the second outer cladding 39, in which state the first outer cladding 36 serves to limit expansion of the second outer cladding 39.

The passage formed by the first outer covering 36 communicates with the first connection port 1, and the liquid pipe 38 communicates with the second connection port 2. From this structure, first surrounding layer 36 constitutes the inlet channel of first sacculus 33 and second sacculus 34, and liquid usually adopts normal saline to make first sacculus 33 and second sacculus 34 inflation, the inflation diameter of first sacculus 33 and second sacculus 34 is 1~5mm, preferably 1.5~3.5mm, and the length of first sacculus 33 and second sacculus 34 is 5~40mm, preferably 10~30 mm. The diameter of the yarn guide body 3 is 0.4 to 1.5mm, preferably 0.5 to 0.8 mm. The diameter of the metal wire 37 is 0.008-0.13 mm. The liquid tube 38 is used to deliver thrombolytic agent. When the thrombolysis device is used, the guide wire body 3 is directly inserted into a preset position of a target blood vessel through a preformed catheter, normal saline is injected from the first connecting port 1 to expand the first balloon 33 and the second balloon 34, thrombolytic medicaments are sent from the second connecting port 2 to perform thrombolysis, the thrombolysis device is kept for about 10-20 minutes, partial thrombolytic medicaments are sucked back from the second connecting port 2 by negative pressure, the injected normal saline is sucked back from the first connecting port 1, the next preset position of the target blood vessel is subjected to continuous thrombolysis, or the guide wire body 3 is taken out, and the thrombolysis operation is completed.

In a preferred embodiment, as shown in fig. 2, 3, 5 and 7, the wire guide body 3 is formed by twisting a plurality of metal wires 37 and two liquid tubes 38, wherein the front end openings of the two liquid tubes 38 pass through the first outer covering layer 36 and the second outer covering layer 39 and are positioned between the first balloon 33 and the second balloon 34;

the two liquid pipes 38 communicate with the second connection port 2 and the third connection port 4, respectively. With the structure, the thrombolytic medicament can be sucked under negative pressure in the thrombolytic process, so that tiny emboli can be prevented from entering the capillary.

In a preferred embodiment, as shown in fig. 2, a leading end 301 is further provided at the front end of the plurality of wires 37, and the leading end 301 is formed into a corresponding curved shape according to vascular modeling. The outer diameter of the leading end 301 is 0.08 mm-0.6 mm. Preferably 0.3 to 0.5 mm.

In a preferred embodiment, the wire 37 is made of nitinol or stainless steel, and the leading end 301 is made of nitinol.

Preferably, the leading end of the wire 37 is welded to the leading end 301.

Referring to fig. 3, the two ends of the notch are provided with stop rings 31, and the stop rings 31 are made of a material which is not deformed under pressure and is used for limiting the expansion of the second outer covering 39. The stop collar 31 is made of the same material as the first outer cladding 36. In this example, the first outer cladding 36 is located within the second outer cladding 39. While the second outer cladding 39 only partially covers the location of the gap in the first outer cladding 36.

In a preferred embodiment, as shown in fig. 3, a visualization ring 32 is further provided at a position near the notch for indicating the position of the guide wire in the body.

In a preferred embodiment, the surface of the wire 37 is provided with a groove. The wire 37 is drawn using a drawing die having an inner hole with protrusions so as to form grooves on the surface of the wire 37, thereby improving the flow aperture of the liquid channel formed by the first outer clad 36.

In a preferred embodiment, the first outer cladding 36 is made of medical plastic material that does not deform under pressure;

the second outer covering layer 39 is made of medical rubber and plastic material which deforms after being filled with pressure medium.

In a preferred embodiment, the first outer covering layer 36 is one of medical polyether amide, polyether block amide, polyester, polytetrafluoroethylene, polypropylene or ultra-high molecular weight polyethylene;

the second outer cladding 39 is one of polyether block amide, rubber or silicone for medical use.

To ensure the flow cross-section of the liquid channel formed by the first envelope 36. The preparation method of the silk guide body 3 comprises the following steps:

1. the twisting of the wires 37 with the liquid tube 38, wherein the wires are evenly distributed over the circumference, along which there are gaps for the passage of liquid between the wires. Preferably, 4-18 metal wires are adopted along the circumference. Preferably, a scheme of 4-6 metal wires in one layer and 8-10 metal wires in two layers is adopted.

2. The second outer covering layer 39 is wrapped by using one of polyether block amide, rubber or silica gel, preferably polyether block amide PEBAX. And heating and co-extruding after wrapping to enable the outer wall of the second outer cladding 39 to be smooth. Preferably, the twisted metal wire 37 and liquid pipe 38 assembly is protected by nano starch before wrapping, and the nano starch is removed by washing after wrapping.

And coating a protective layer, such as a nano starch protective layer, at the position needing notching. The thickness of the second outer cladding 39 is 0.03 to 0.1 mm.

3. Heating and extruding the first outer cladding layer 36 outside the second outer cladding layer 39, wherein the thickness of the first outer cladding layer 36 is 0.03-0.1 mm.

4. The second outer cladding 39 is exposed by a circular or partial circular cut at the location of the gap.

5. The front end or the position close to the end of the guide wire body 3 is sealed and closed by the same material of the first outer cladding 36.

The developer ring 32 is welded.

6. The front opening of the liquid tube 38 is opened and the surrounding is sealed by the material of the first outer cladding 36.

The above steps result in the guidewire body 3 being able to supply liquid to inflate the first balloon 33 and the second balloon 34.

An alternative method for producing the thread guide 3 comprises the following steps:

1. the twisting of the wires 37 with the liquid tube 38, wherein the wires are evenly distributed over the circumference, along which there are gaps for the passage of liquid between the wires.

2. And a nano starch protective layer is coated outside the assembly of the metal wire 37 and the liquid pipe 38.

3. After drying, the co-extruded first outer cover 36 is heated, and a notch is formed at the position of the notch by circular cutting or partial circular cutting.

4. And coating a nano starch protective layer at the position of the notch to enable the notch to be flush with the first outer cladding layer 36.

5. Heating and co-extruding the second outer cladding 39, and welding the limiting ring 31 and the developing ring 32;

6. and (4) washing with water to remove the nano starch.

7. The front end or the position close to the end of the guide wire body 3 is sealed and closed by the same material of the first outer cladding 36.

8. The front opening of the liquid tube 38 is opened and the surrounding is sealed by the material of the first outer cladding 36.

The above-described embodiments are merely preferred embodiments of the present invention, and should not be construed as limiting the present invention, and features in the embodiments and examples in the present application may be arbitrarily combined with each other without conflict. The protection scope of the present invention is defined by the claims, and includes equivalents of technical features of the claims. I.e., equivalent alterations and modifications within the scope hereof, are also intended to be within the scope of the invention.

Claims

1. A pulmonary artery thrombolysis catheter is characterized in that: the silk guide device comprises a silk guide body (3), wherein the silk guide body (3) is formed by twisting a plurality of metal wires (37) and at least one liquid tube (38), the outer wall of the silk guide body (3) is coated with a first outer coating layer (36) and a second outer coating layer (39), the first outer coating layer (36) is provided with two notches which are distributed along the axial direction, the positions of the notches are covered with the second outer coating layer (39), the second outer coating layer (39) is used for forming a first sacculus (33) and a second sacculus (34) at the positions of the notches, and the front end opening of the liquid tube (38) penetrates through the first outer coating layer (36) and the second outer coating layer (39) and is positioned between the first sacculus (33) and the second sacculus (34);

the channel formed by the first outer cladding (36) is communicated with the first connecting port (1), and the liquid pipe (38) is communicated with the second connecting port (2).

2. The pulmonary artery thrombolytic catheter of claim 1, wherein: the wire guide body (3) is formed by twisting a plurality of metal wires (37) and two liquid tubes (38), and the front end openings of the two liquid tubes (38) penetrate through a first outer cladding (36) and a second outer cladding (39) and are positioned between a first balloon (33) and a second balloon (34);

the two liquid pipes (38) are respectively communicated with the second connecting port (2) and the third connecting port (4).

3. The pulmonary artery thrombolytic catheter of claim 1, wherein: the first outer cladding (36) is located outside the second outer cladding (39).

4. The pulmonary artery thrombolytic catheter of claim 1, wherein: the front ends of the multiple metal wires (37) are also provided with guide ends (301), and the guide ends (301) form corresponding bending shapes according to vascular plastics;

the metal wire (37) is made of nickel-titanium alloy or stainless steel, and the guide end (301) is made of nickel-titanium alloy.

5. The pulmonary artery thrombolytic catheter of claim 4, wherein: the front end of the metal wire (37) is connected with the leading end (301) in a welding way.

6. The pulmonary artery thrombolytic catheter according to any one of claims 1 to 2 and 4 to 5, wherein: limiting rings (31) are arranged at two ends of the position of the notch, the limiting rings (31) are made of materials which are not deformed when being pressed and used for limiting the expansion of the second outer cladding (39), and the first outer cladding (36) is located in the second outer cladding (39).

7. The pulmonary artery thrombolytic catheter according to any one of claims 1 to 5, wherein: a visualization ring (32) is also provided at a location near the notch to indicate the position of the guidewire within the body.

8. The pulmonary artery thrombolytic catheter according to any one of claims 1 to 5, wherein: the surface of the metal wire (37) is provided with a groove.

9. The pulmonary artery thrombolytic catheter of claim 1, wherein: the first outer wrapping layer (36) is made of medical plastic materials which are not deformed under compression;

the second outer coating (39) is made of medical rubber and plastic materials which deform after being filled with pressure media.

10. The pulmonary artery thrombolytic catheter of claim 1, wherein: the first outer wrapping layer (36) is one of medical polyether amide, polyether block amide, polyester, polytetrafluoroethylene, polypropylene or ultrahigh molecular weight polyethylene;

the second outer cladding (39) is one of medical polyether block amide, rubber or silica gel.