CN108211093A - Sacculus and foley's tube - Google Patents

Abstract

The present invention relates to a balloon, comprising a proximal part, a distal part and a middle part for carrying a stent, the middle part is arranged between the proximal part and the distal part, and the middle part The surface has a rough structure. The present invention also relates to a balloon catheter, comprising an inner tube, the balloon, a developing ring, a distal tube, a hypotube and a catheter adapter, the developing ring is crimped and embedded on the inner tube, and the inner tube The distal end of the hypotube is fixed in the distal portion of the balloon, the distal end of the distal tube is fixed in the proximal end of the balloon, and the distal end of the hypotube is fixed in the proximal end of the distal tube In the end, the proximal end of the hypotube is fixed in the catheter adapter. The present invention adopts a textured rough structure in the middle part of the balloon, which significantly improves the removal force after the balloon is matched with the stent, and prevents the stent from shifting or falling off during delivery.

Description

Balloons and Balloon Catheters

technical field

The invention relates to the technical field of medical devices, in particular to a balloon and a balloon catheter.

Background technique

Coronary heart disease is one of the most common heart diseases. It refers to myocardial dysfunction or organic disease caused by coronary artery stenosis and insufficient blood supply, so it is also called ischemic cardiomyopathy. At present, there are mainly three treatment options for coronary heart disease: drug therapy, percutaneous vascular interventional therapy, and cardiac surgery bypass surgery. Percutaneous vascular interventional therapy has become the main treatment method for coronary heart disease because of its small trauma, quick recovery, rapid elimination of coronary artery stenosis, and relief of myocardial ischemia.

Interventional therapy for coronary heart disease goes through three stages of development: bare balloon, bare metal stent, and drug stent. When stents are used to treat coronary heart disease, the stents are usually pressed or embedded on the surface of the balloon in advance, and it is expected that through this cooperation, the stents can remain on the balloon before reaching the target position through the curved and complicated vascular access. shift or fall off. However, in clinical applications, the incidence of stent falling off due to insufficient adhesion of the stent on the surface of the balloon is about 0.2-0.5%. If the stent falls off and is not handled properly, acute myocardial infarction is very likely to occur, resulting in the death of the patient. Insufficient adhesion of the stent to the surface of the balloon can also result in incomplete expansion of the stent. Solving the removal force between the stent and the balloon has become an important indicator in the design of the stent-balloon.

Contents of the invention

Based on this, it is necessary to provide a balloon and a balloon catheter to improve the adhesion of the balloon expansion stent on the surface of the balloon.

The present invention solves the above technical problems through the following technical solutions:

A balloon comprising a proximal portion, a distal portion and a middle portion for carrying a stent, the middle portion is arranged between the proximal portion and the distal portion, the middle portion has a rough surface structure. The surface of the middle part of the balloon has a rough structure, which can significantly enhance the friction between the surface of the balloon and the stent, and prevent the stent from shifting or falling off during delivery.

In one embodiment, the rough structure is a textured rough structure. The provision of textures can further enhance the surface bonding friction between the balloon and the stent, and reduce the possibility of the stent being unloaded during delivery.

In one embodiment, the texture is at least one of striped texture, mesh texture or pitted texture.

In one embodiment, the pitch of the lines is 0.5-5 microns. If the distance between the lines is less than 0.5 microns or greater than 5 microns, the stent may not be supported.

In one embodiment, the roughness of the rough structure is 0.1-0.8. In this range of roughness, the friction between the surface of the balloon and the stent is the strongest.

In one embodiment, the material of the balloon is nylon 11, nylon 12, PBEAX7233, PEBAX 7033, PEBAX6333, PEBAX5533, polyurethane (PU), polyethylene phthalate (PET) or polyethylene (PE) at least one of the

In one embodiment, the balloon is a single-layer or double-layer balloon.

In one embodiment, the thickness of the balloon is 0.005-0.1 mm.

The present invention also provides a balloon catheter, comprising an inner tube, the balloon, a developing ring, a distal tube, a hypotube, and a catheter adapter. The developing ring is crimped and embedded in the inner tube, and the inner tube The distal end of the hypotube is fixed in the distal portion of the balloon, the distal end of the distal tube is fixed in the proximal end of the balloon, and the distal end of the hypotube is fixed in the proximal end of the distal tube In the end, the proximal end of the hypotube is fixed in the catheter adapter.

In one embodiment, the fixing is achieved by laser welding or hot air welding.

In one embodiment, the proximal end of the hypotube is fixed in the catheter adapter by glue bonding.

In one embodiment, the stent is compressed on the balloon in the deflated and folded state by crimping.

In one embodiment, the manufacturing method of the balloon includes the following steps:

(1) Make a balloon forming mold, the balloon forming mold is composed of a balloon proximal end mold, a balloon intermediate mold and a balloon distal end mold, the inner surface of the balloon intermediate mold is in contact with the balloon The surface of the middle part has the same roughness.

(2) Carry out pre-stretching treatment on the material tube of the balloon, and the two ends of the material tube are thinned so as to pass through the proximal end mold and the distal end mold of the balloon, and retain 1/4-1 times of the length of the balloon in the middle The length is the unstretched section, which is used as the final balloon forming section.

(3) Insert the pre-stretched balloon tube in step (2) into the balloon molding machine with the balloon molding mold installed, the molding pressure is 20-40bar, the molding temperature is 85-110°C, and the heat setting temperature is 120°C -140℃, heat setting time 30-90s.

The roughness (Ra) in step (1) is 0.1-0.8.

The present invention adopts a textured rough structure on the surface of the middle part of the balloon, which significantly enhances the combined friction force between the surface of the balloon and the stent, prevents the stent from shifting or falling off during the delivery process, and effectively improves the matching between the balloon and the stent subsequent removal force.

Description of drawings

The present invention will be further described below in conjunction with accompanying drawing and embodiment, in the accompanying drawing:

Fig. 1 is the structural representation of the stent delivery system of embodiment 1;

Figure 2 is a schematic diagram of the assembly of the balloon stent;

Fig. 3 is the structural representation of the balloon of embodiment 1;

4 is a schematic diagram of the rough surface structure of the balloon of Example 1;

5 is a schematic diagram of the rough surface structure of the balloon of Example 2;

Figure 6 is a schematic diagram of the surface roughness structure of the balloon of Example 3;

7 is a schematic diagram of the surface roughness structure of the balloon of Example 4;

Fig. 8 is the assembly schematic diagram of the balloon mold of embodiment 1;

Figure 9 is an atomic force microscope image of the surface of a commercially available balloon;

Figure 10 is an atomic force microscope image of the surface of the balloon of Example 1;

Fig. 11 is a graph showing the removal force test results of the balloon of the present invention and a control group (commercially available).

Detailed ways

In order to have a clearer understanding of the technical features, purposes and effects of the present invention, the specific implementation manners of the present invention will now be described in detail in conjunction with the accompanying drawings.

Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the technical field of the invention. The terms used herein in the specification are for the purpose of describing specific embodiments only, and are not intended to limit the present invention.

Example 1

As shown in Figure 3, a single-layer balloon 102 includes a proximal portion 1023, a distal portion 1022 and an intermediate portion 1021 for carrying a stent, and the intermediate portion 1021 is arranged between the proximal portion 1023 and the distal portion 1022 , the surface of the middle portion 1021 has a rough structure. The surface of the middle part of the balloon has a rough structure, which can significantly enhance the friction between the surface of the balloon and the stent, and prevent the stent from shifting or falling off during delivery.

The material of the balloon 102 is nylon 12 (Grilamid L25), the diameter of the balloon is 3.0 mm, the length is 15 mm, and the thickness is 0.005-0.1 mm. The surface roughness Ra of the middle part 1021 of the balloon is 0.5, and its surface roughness structure is shown in Figure 4, and its texture is a net texture, including two groups of intersecting textures, and each group of textures includes a plurality of parallel linear mesh mosquitoes. , the distance between two adjacent textures is 0.5-5 microns.

As shown in Figure 1, a balloon catheter includes an inner tube 101, the balloon 102, a developing ring 104, a distal tube 105, a hypotube 106, and a catheter adapter 107, and the developing ring 104 is crimped and embedded in the inner tube 101 Above, the distal end of the inner tube 101 is fixed in the distal end of the balloon 102 by laser welding or hot air welding, and the distal end of the far outer tube 105 is fixed in the proximal end of the balloon 102 by laser welding or hot air welding. The distal end of the wave tube 106 is fixed in the proximal end of the distal outer tube 105 by laser welding or hot air welding, and the proximal end of the hypotube 106 is fixed in the catheter adapter 107 by glue bonding. The bracket 103 is pressed against the middle part 1021 of the balloon 102 in the collapsed and folded state by pressing.

The manufacturing method of balloon 102 comprises the following steps:

(1) Barrel pre-stretching: use a double-end stretching machine (CPS1000, Interface), stretching temperature 150°C, stretching distance 90mm, stretching speed 200mm/s, heating time 5s, cooling time 2s, unstretched The distance is 20mm; after the material tube is stretched, the unstretched section will serve as the main body of the balloon molding.

(2) Forming mold making: The balloon mold in this embodiment is a mold with a micron-level surface roughness, forming a frosting-like effect. The balloon mold assembly schematic diagram is shown in Figure 8, and is made up of balloon middle mold 202, balloon proximal end mold 201 and balloon distal end mold 204, balloon proximal end mold 201 and balloon distal end mold 204 It is nested in the middle mold of the balloon 202 through a gap of 0.1-1 mm. The middle mold of the balloon has a surface roughness of Ra0.5 (different from the mirror effect of Ra0.02-0.05 for general balloon product molds), while the proximal end mold and the distal end mold of the balloon still remain as mirror surfaces, so It does not create an assembly relationship with the bracket.

(3) Balloon molding: using a balloon molding machine (BFM3310, Interface), the molding temperature is 105°C, the molding pressure is 36bar, the heat setting temperature is 140°C, and the heat setting time is 60s; after forming, the surface roughness of the middle part can be obtained. Balloon of Ra0.5.

Example 2

The structure of the single-layer balloon in this embodiment is the same as that of the embodiment 1, except that the material of the single-layer balloon is PEBAX7233SA01 (ARKEMA), the diameter of the balloon is 3.0 mm, the length is 15 mm, and the thickness is 0.005-0.1 mm. The surface roughness Ra of the middle portion 1021 of the balloon is 0.3, and its surface roughness structure is shown in FIG. 5 .

The manufacturing method of balloon comprises the steps:

(1) Tube pre-stretching: using a double-end stretching machine (CPS1000, Interface), stretching temperature 145°C, stretching distance 110mm, stretching speed 200mm/s, heating time 5s, cooling time 2s, unstretched The distance is 20mm. After the material tube is stretched, the unstretched section will serve as the main body when the balloon is formed.

(2) Forming mold making: The balloon mold in this embodiment is a mold with a micron-level surface roughness, forming a frosting-like effect. The balloon mold assembly schematic diagram is shown in Figure 8, and is made up of balloon middle mold 202, balloon proximal end mold 201 and balloon distal end mold 204, balloon proximal end mold 201 and balloon distal end mold 204 It is nested in the middle mold of the balloon 202 through a gap of 0.1-1 mm. The middle mold of the balloon has a surface roughness of Ra0.3 (different from the mirror effect of Ra0.02-0.05 for general balloon product molds), while the proximal end mold of the balloon and the distal end mold of the balloon still maintain a mirror surface, so It does not create an assembly relationship with the bracket.

(3) Balloon molding: using a balloon molding machine (BFM3310, Interface), the molding temperature is 100°C, the molding pressure is 34bar, the heat setting temperature is 135°C, and the heat setting time is 60s. After molding, a balloon with a surface roughness of Ra0.3 in the middle part can be obtained.

Example 3

The structure of the single-layer balloon in this embodiment is the same as that of the embodiment 1, the difference is that the material of the single-layer balloon is PEBAX7033SA01 (ARKEMA), the diameter of the balloon is 3.0mm, the length is 15mm, and the thickness is 0.005-0.1mm. The surface roughness Ra of the middle part 1021 of the balloon is 0.15, and its surface roughness structure is shown in FIG. 6 , and its texture is pitted texture, and the distance between the textures is 0.5-5 microns.

The manufacturing method of balloon comprises the steps:

(1) Barrel pre-stretching: use a double-end stretching machine (CPS1000, Interface), stretching temperature 140°C, stretching distance 110mm, stretching speed 200mm/s, heating time 5s, cooling time 2s, unstretched The distance is 20mm. After the material tube is stretched, the unstretched section will serve as the main body when the balloon is formed.

(2) Forming mold making: The balloon mold in this embodiment is a mold with a micron-level surface roughness, forming a frosting-like effect. The balloon mold assembly schematic diagram is shown in Figure 8, and is made up of balloon middle mold 202, balloon proximal end mold 201 and balloon distal end mold 204, balloon proximal end mold 201 and balloon distal end mold 204 It is nested in the middle mold of the balloon 202 through a gap of 0.1-1 mm. The middle mold of the balloon has a surface roughness of Ra0.15 (different from the mirror effect of Ra0.02-0.05 for general balloon product molds), while the proximal end mold of the balloon and the distal end mold of the balloon still maintain a mirror surface, so It does not create an assembly relationship with the bracket.

(3) Balloon molding: using a balloon molding machine (BFM3310, Interface), the molding temperature is 95°C, the molding pressure is 34bar, the heat setting temperature is 130°C, and the heat setting time is 60s. After molding, a balloon with a surface roughness of Ra0.15 at the middle part can be obtained.

Example 4

The structure of the single-layer balloon of the present embodiment is the same as that of Example 1, the difference is that the material of the single-layer balloon is mixed with 30% nylon 12 (Grilamid L25) and 70% PEBAX7033SA01 (ARKEMA) by weight, The diameter of the balloon is 3.0mm, the length is 15mm, and the thickness is 0.005-0.1mm. The surface roughness Ra of the middle portion 1021 of the balloon is 0.8, and its surface roughness structure is shown in FIG. 7 , and its texture is a striped texture, and the distance between the textures is 0.5-5 microns.

The manufacturing method of balloon comprises the steps:

(1) Barrel pre-stretching: use a double-end stretching machine (CPS1000, Interface), stretching temperature 140°C, stretching distance 110mm, stretching speed 200mm/s, heating time 5s, cooling time 2s, unstretched The distance is 20mm. After the material tube is stretched, the unstretched section will serve as the main body when the balloon is formed.

(2) Forming mold making: The balloon mold in this embodiment is a mold with a micron-level surface roughness, forming a frosting-like effect. The balloon mold assembly schematic diagram is shown in Figure 8, and is made up of balloon middle mold 202, balloon proximal end mold 201 and balloon distal end mold 204, balloon proximal end mold 201 and balloon distal end mold 204 It is nested in the middle mold of the balloon 202 through a gap of 0.1-1 mm. The middle mold of the balloon has a surface roughness of Ra0.8 (different from the mirror effect of Ra0.02-0.05 for general balloon product molds), while the proximal end mold and the distal end mold of the balloon are still kept as mirror surfaces, so It does not create an assembly relationship with the bracket.

(3) Balloon molding: using a balloon molding machine (BFM3310, Interface), the molding temperature is 95°C, the molding pressure is 34bar, the heat setting temperature is 130°C, and the heat setting time is 60s. After molding, a balloon with a surface roughness of Ra0.8 in the middle part can be obtained.

Effect example

In order to further illustrate the balloon catheter prepared by the above-mentioned preparation method of the present invention, the products in Examples 1 and 2 are used to compare with commercially available products, and Fig. 9 is an atomic force microscope (AFM) of the untreated balloon surface of the control group. ) figure, and Figure 10 is an atomic force microscope image of the surface of the balloon of Example 1. As can be seen from the figure, the surface of the balloon of the present invention forms a difference in microstructure compared with the surface of the balloon (commercially available) without surface treatment under the conventional process, and the surface roughness is obviously improved, confirmed by product test results (See FIG. 11 ), the removing force after the assembly of the balloon and the stent in the present invention is significantly improved, which can effectively solve the problem of unloading of the stent during clinical operations.

Embodiments of the present invention have been described above in conjunction with the accompanying drawings, but the present invention is not limited to the above-mentioned specific implementations, and the above-mentioned specific implementations are only illustrative, rather than restrictive, and those of ordinary skill in the art will Under the enlightenment of the present invention, many forms can also be made without departing from the gist of the present invention and the protection scope of the claims, and these all belong to the protection of the present invention.

Claims (9)

1. A balloon, comprising a proximal portion, a distal portion and an intermediate portion for carrying a stent, wherein the intermediate portion is arranged between the proximal portion and the distal portion, wherein the The surface of the middle part has a rough structure. 2. The balloon according to claim 1, wherein the rough structure is a textured rough structure. 3 . The balloon according to claim 2 , wherein the texture is at least one of striped texture, mesh texture or pitted texture. 4 . 4. The balloon according to claim 2 or 3, wherein the pitch of the textures is 0.5-5 microns. 5. The balloon according to claim 1, wherein the roughness of the rough structure is 0.1-0.8. 6. The balloon according to claim 1, wherein the material of the balloon is nylon 11, nylon 12, PBEAX7233, PEBAX 7033, PEBAX6333, PEBAX5533, polyurethane, polyethylene phthalate or polyester at least one of ethylene. 7. The balloon according to claim 1, wherein the balloon is a single-layer or double-layer balloon. 8. The balloon according to claim 1, wherein the thickness of the balloon is 0.005-0.1 mm. 9. A balloon catheter, characterized in that it includes an inner tube, the balloon, a developing ring, a distal tube, a hypotube and a catheter adapter, and the developing ring is crimped and embedded in the inner tube, the The distal end of the inner tube is fixed in the distal portion of the balloon, the distal end of the distal outer tube is fixed in the proximal end of the balloon, and the distal end of the hypotube is fixed in the distal outer tube In the proximal end of the hypotube, the proximal end of the hypotube is fixed in the catheter adapter.