CN107929918B - A balloon dilatation catheter - Google Patents

Abstract

A balloon dilation catheter described in the present application, the dilation catheter includes an outer tube, an inner tube partly located inside the outer tube, the distal end of the inner tube protrudes from the distal end of the outer tube, and the The dilatation catheter also includes a balloon that can be folded into multiple valves, and a binding layer made of elastic material coated outside the balloon, and the distal end of the balloon and the distal end of the binding layer are connected to the The outer wall of the inner tube is in sealing connection, and the proximal end of the balloon is in sealing connection with the outer wall of the outer tube. With the binding layer, the balloon can still shrink to the original small size after multiple expansions, so that the product can repeatedly enter new lesions for expansion, which not only saves the cost of the product, but also facilitates the doctor operation, and can be easily retracted into the sheath for removal after dilation is complete.

Description

A balloon dilatation catheter

technical field

The present application relates to a balloon dilation catheter, in particular to a balloon dilation catheter that can be used repeatedly.

Background technique

Currently, balloon catheters originated in the 1960s. In 1963, Dotter inadvertently found that when the peripheral artery was intubated, the catheter passed through the stenotic and obstructed iliac artery and successfully performed abdominal aortography, which made him think of using this method to use a flexible guide wire to guide the catheter directly and gradually. Dilate narrowed arteries. In 1964, Dotter et al. used a coaxial catheter for the first time to successfully perform PTA on patients with severe lower extremity arterial stenosis. Then came the stage of bare metal stents, drug-eluting stents, and the emerging stage of fully degradable stents. Although stents have initially replaced simple PTA balloon dilation, PTA balloon catheters must be used for pre-dilation before stent implantation. Therefore, PTA balloon dilation catheter pre-dilation is still an indispensable treatment tool for stent implantation.

Existing PTA products mainly include the structure shown in Figure 1: the balloon 1 will form three or more flaps as shown in Figures 2 and 3 through the flaps, which can greatly reduce product insertion. The size is also convenient for the balloon to pass through the narrow lesion. After the product enters the blood vessel and crosses the lesion, the balloon is inflated and expanded, and then the pressure is relieved and withdrawn, or it is placed in another lesion to continue the expansion.

It is difficult for the product to return to its original shape and size after the balloon is expanded and decompressed, and it often forms two flat lobes, so the shape of the balloon will be much larger than the original multi-lobed size, which increases the recovery of the product into the sheath It also increases the difficulty of passing the lesion position when the product is used for the expansion of other lesions, thus losing the ability of a product to repeatedly expand multiple lesions. For multiple lesions or longer lesions, it may be necessary to increase the quantity of consumed products, increasing the economic burden on patients.

application content

In order to solve the above technical problems, the purpose of the present application is to provide a balloon dilatation catheter that can be reused many times.

A balloon dilatation catheter described in the present application, the dilation catheter includes an outer tube, an inner tube partly located inside the outer tube, the distal end of the inner tube protrudes from the distal end of the outer tube, and the The dilatation catheter also includes a balloon that can be folded into multiple valves, and a binding layer made of elastic material coated outside the balloon, and the distal end of the balloon and the distal end of the binding layer are connected to the The outer wall of the inner tube is in sealing connection, and the proximal end of the balloon is in sealing connection with the outer wall of the outer tube.

Preferably, the balloon dilation catheter has a contracted state and an inflated state. When the balloon dilation catheter is in the contracted state, the balloon is folded into multiple lobes, and the binding layer covers Outside the balloon, it is in a contracted state; when the balloon dilation catheter is in a filled state, the balloon is in an inflated state, and the binding layer is stretched by the balloon to inflated state.

Preferably, at least one developing ring is also provided on the inner tube.

Preferably, the balloon dilator further includes a stress diffusion tube arranged at the proximal end of the outer tube, and a Y-shaped catheter seat connected to the proximal end of the stress diffusion tube.

Preferably, an inflation channel for inflating the balloon is formed between the inner tube and the outer tube, and an inflation channel for inflating the balloon is formed at the distal end of the outer tube. The Y-shaped catheter adapter includes a first conduit for communicating with the inner tube, and a second conduit for communicating with the inflation channel.

Preferably, the hardness of the binding layer is made of silica gel or latex or polyurethane material, preferably, the binding layer is made of TPU material, and the TPU (Thermoplastic polyurethanes) is named thermoplastic polyurethane elastomer rubber.

Preferably, the hardness of the binding layer is 20a-50a.

Preferably, the balloon and the outer tube are made of polyamide materials, and the inner tube is made of single-layer polyamide materials or multi-layer composite materials.

By means of the above solution, the present application has at least the following advantages:

A balloon dilatation catheter described in the present application, compared with the prior art, has a binding layer outside the balloon. When the balloon is in a multi-valve folded state, the binding layer covers the balloon Outside the capsule, it is in a contracted state. When the balloon is inflated, the balloon gradually expands from the multi-valve folded state. During this process, the multi-lobes of the balloon are twisted. During the twisting process, the binding layer is driven to twist; when the balloon shrinks from the expanded state, the binding layer is reversely twisted, generating an anti-rotation force and restoring force on the balloon, driving the balloon to one side Inflated, one side is folded into multiple flaps, so that the balloon can almost completely return to its original folded state.

Only under the anti-rotation force and restoring force of the binding layer, the winged balloon with a certain memory function will return to the folded state. The rotational force makes the balloon return to three wings or multiple wings, and the contraction force makes the balloon return to a tight fit. combined state.

With the binding layer, the balloon can still shrink to the original small size after multiple expansions, so that the product can repeatedly enter new lesions for expansion, which saves the cost of the product and is also convenient. The doctor's operation, and can be easily retracted into the sheath for removal after the dilation is completed.

The above description is only an overview of the technical solution of the present application. In order to understand the technical means of the present application more clearly and implement it according to the contents of the specification, the following is a detailed description of the preferred embodiment of the present application with accompanying drawings.

Description of drawings

FIG. 1 is a schematic structural view of a balloon dilatation catheter in the prior art;

2 is a schematic cross-sectional structure diagram of a balloon dilatation catheter in a contracted state in the prior art;

Fig. 3 is a structural schematic diagram of a balloon dilatation catheter in a contracted state in the prior art;

FIG. 4 is a schematic structural view of the balloon dilatation catheter described in the present application;

Fig. 5 is a schematic structural view of the balloon dilatation catheter described in the present application in a filling state;

Fig. 6 is a schematic cross-sectional structure diagram of the balloon dilatation catheter described in the present application in a folded state;

Fig. 7 is a schematic structural view of the balloon dilatation catheter described in the present application in a folded state;

Fig. 8 is a schematic diagram of the force state of the binding layer during the filling process of the balloon dilatation catheter described in the present application;

Fig. 9 is a schematic diagram of the stress state of the binding layer during the contraction of the balloon dilatation catheter described in the present application;

Fig. 10 is a schematic structural view of the balloon dilator according to Embodiment 1 of the present application;

Fig. 11 is a schematic structural view of the balloon dilator in Example 2 of the present application;

Fig. 12 is a schematic structural view of the balloon dilator in Example 2 of the present application,

Among them: 1', balloon; 3', developing ring; 4', inner tube; 5', outer tube; 6', stress diffusion tube; 7', catheter seat; 1, balloon; 2, binding layer; 3 , developing ring; 4, inner tube; 5, outer tube; 6, stress diffusion tube; 7, catheter seat.

Detailed ways

The specific implementation manners of the present application will be further described in detail below in conjunction with the drawings and embodiments. The following examples are used to illustrate the present application, but not to limit the scope of the present application.

As shown in Figure 4, a balloon dilatation catheter described in the present application, the dilation catheter includes an outer tube, an inner tube partly located in the outer tube, the distal part of the inner tube is connected from the distal end of the outer tube Stretching out, the dilatation catheter also includes a balloon that can be folded into multiple valves, a binding layer made of elastic material wrapped outside the balloon, the distal end of the balloon and the The distal end of the binding layer is in sealing connection with the outer wall of the inner tube, and the proximal end of the balloon is in sealing connection with the outer wall of the outer tube. The inner tube is also provided with at least one developing ring. The balloon dilator also includes a stress diffusion tube arranged at the proximal end of the outer tube, and a Y-shaped catheter seat connected to the proximal end of the stress diffusion tube. An inflation channel for inflating the balloon is formed between the inner tube and the outer tube, and the distal end of the outer tube forms an inflation port for inflating the balloon. The Y-shaped catheter base includes a first conduit for communicating with the inner tube, and a second conduit for communicating with the inflation channel. The hardness of the binding layer is made of silica gel or latex or polyurethane material. Preferably, the binding layer is made of TPU material, and the TPU (Thermoplastic polyurethanes) is thermoplastic polyurethane elastomer rubber. The hardness of the binding layer is 20a-50a. The balloon and the outer tube are made of polyamide materials, and the inner tube is made of single-layer polyamide materials or multi-layer composite materials.

As shown in FIG. 5 , the balloon dilation catheter is in an inflated state, the balloon is in an inflated state, and the binding layer is stretched to an inflated state by the balloon.

As shown in Figures 6 and 7, the balloon dilatation catheter is in a contracted state, the balloon is in a state of being folded into multiple petals, and the binding layer is coated on the outside of the balloon in a contracted state. state.

As shown in Figure 8, it is a schematic diagram of the force state of the binding layer during the filling process of the balloon dilation catheter described in this application. The direction of the arrow is the force direction of the binding layer. When the balloon is inflated, the balloon moves from The multi-lobe folded state is gradually inflated. During this process, the multi-lobes of the balloon are twisted. Since the tethering layer has high elasticity, the multi-lobes drive the tethering layer to twist during the twisting process.

As shown in Figure 9, it is a schematic diagram of the force state of the binding layer during the contraction process of the balloon dilation catheter described in the present application. The direction of the arrow is the force direction of the binding layer. When the balloon shrinks from the expanded state, The binding layer reversely twists to generate a counter-rotating force and restoring force on the balloon, which drives the balloon to shrink and fold into multiple lobes, so that the balloon can almost completely return to its original folded state. Only under the anti-rotation force and restoring force of the binding layer, the winged balloon with a certain memory function will return to the folded state. The rotational force makes the balloon return to three wings or multiple wings, and the contraction force makes the balloon return to a tight fit. combined state.

In Example 1, the manufacturing process of the balloon dilatation catheter is as follows, the PTA balloon catheter 4.0×40 balloon is tri-wing folded, and then the restraint tube with an inner diameter of 1.1 mm and a wall thickness of 0.15 mm is cut to 65 mm length. The restraint tube is made of TPU with a hardness of 40a. Put the cut tethering tube over the flapped balloon so that the balloon is in the middle of the tethering tube. Drop glue into the gap between the binding tube at the distal end of the balloon, the inner tube and the balloon pin to bond and seal the three; drip glue onto the binding tube at the proximal end of the balloon, the balloon pin and the outer tube Seal the gaps with adhesive. The completed balloon dilatation catheter is shown in FIG. 10 .

In Example 2, the manufacturing process of the balloon dilatation catheter is as follows, a PTA, 5.0×100 balloon is tri-wing folded, and then a highly elastic silicone membrane with a width of 65mm, a thickness of 0.05mm, and a hardness of 30a is used. Tightly wrap 1-2 circles along one direction, as shown in Figure 11 and 12, and then glue them together in the axial direction to form a tubular shape. Then, the two ends of the film are respectively connected and sealed with the balloon pin, the inner tube and the outer tube to form an airtight wrapping film.

The invention mainly protects the structure of the binding layer wrapped around the balloon and the material properties of the binding layer. The binding layer must be made of soft (hardness between 20a-50a) and highly elastic materials (such as silicone, latex, polyurethane materials, etc.), and the wall thickness of the binding layer should not be too thick, otherwise it will affect the folding of the balloon After the outer diameter and through performance. If the material is too rigid or the wall thickness is too thick, the inflation pressure of the balloon may increase, or the balloon may not be fully inflated, or may cause tearing of the tethering layer. The selection of materials for the balloon dilatation catheter described in this application can be selected by those skilled in the art according to the effect to be achieved in this application, as long as it can achieve the effect to be achieved in this application.

In the prior art, the balloon dilatation catheter has no binding layer structure, and once the balloon is expanded, the memory will become very poor, and it is difficult to return to the folded state of three or more wings, even if it can be restored to three Wings or multi-wings can’t restore the tight fit state, which makes the outline size of the balloon even in the state of decompression and contraction will be relatively large, and it will be difficult for the balloon to pass through and enter new stenotic lesions for expansion , due to the relatively large size of the balloon during recovery, it will also produce greater resistance when it is recovered into the sheath, especially the longer the balloon, the more difficult it is to recover into the sheath. With the binding layer, the balloon can still shrink to the original small size after multiple expansions, so that the product can repeatedly enter new lesions for expansion, which saves the cost of the product and is also convenient. The doctor's operation, and can be easily retracted into the sheath for removal after the dilation is completed.

The above description is only the preferred implementation mode of the present application, and is not intended to limit the present application. It should be pointed out that for those of ordinary skill in the art, some improvements can also be made without departing from the technical principle of the present application. and modifications, these improvements and modifications should also be considered as the protection scope of the present application.

Claims (6)

1. A balloon dilation catheter, characterized by:

the expansion catheter comprises an outer tube, an inner tube, a balloon and a binding layer, wherein the inner tube is partially positioned in the outer tube, the distal end part of the inner tube extends out of the distal end of the outer tube, the expansion catheter further comprises the balloon which can be folded into multiple petals, the binding layer is coated outside the balloon and made of elastic materials, the distal end of the balloon and the distal end of the binding layer are in sealing connection with the outer wall of the inner tube, and the proximal end of the balloon and the proximal end of the binding layer are in sealing connection with the outer wall of the outer tube; the hardness of the binding layer is made of silica gel or latex or polyurethane materials; the hardness of the binding layer is 20a-50 a; when the balloon is inflated, the balloon is gradually inflated from a multi-valve folding state, in the process, the multi-valve of the balloon is twisted, the multi-valve drives the binding layer to twist in the twisting process, and the binding layer is propped up by the balloon to an inflated state; when the balloon is contracted from the expansion state, the binding layer is reversely twisted, and a reverse rotation force and a restoring force are generated on the balloon, so that the balloon is driven to contract and fold to form multiple petals, and the contraction force enables the balloon to return to a tightly attached state.

2. A balloon dilation catheter according to claim 1 wherein:

the balloon dilation catheter has a contracted state and a filling state, when the balloon dilation catheter is in the contracted state, the balloon is folded into a multi-valve state, and the binding layer is coated outside the balloon and is in the contracted state; when the balloon dilation catheter is in a full state, the balloon is in an inflated state, and the binding layer is expanded to an inflated state by the balloon.

3. A balloon dilation catheter according to claim 1 wherein:

and at least one developing ring is arranged on the inner tube.

4. A balloon dilation catheter according to claim 1 wherein:

the balloon dilator also comprises a stress diffusion tube arranged at the proximal end of the outer tube and a Y-shaped catheter seat connected with the proximal end of the stress diffusion tube.

5. A balloon dilation catheter according to claim 4 wherein:

an inflation channel for inflating the balloon is formed between the inner tube and the outer tube, an inflation port for inflating the balloon is formed at the distal end of the outer tube, and the Y-shaped catheter seat comprises a first catheter communicated with the inner tube and a second catheter communicated with the inflation channel.

6. A balloon dilation catheter according to claim 1 wherein:

the balloon and the outer tube are made of polyamide materials, and the inner tube is made of single-layer polyamide materials or multi-layer composite materials.

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