CN115252219A - Adjustable pre-plastic balloon catheter - Google Patents

Abstract

The invention belongs to the technical field of medical devices, in particular to the field of A61F2/24, and in particular to an adjustable pre-plastic balloon catheter. The invention provides an adjustable pre-plastic balloon catheter, which includes an inner tube, the inner tube is made of nickel-titanium memory alloy, and the inner tube is pre-molded into the anatomical shape of the human body; The inner tube is coaxially arranged, and the inner tube moves axially in the lumen of the outer tube; the balloon is arranged at the distal ends of the inner tube and the outer tube, and the outer side of the balloon is close to The end is fixedly connected with the distal end of the outer tube, and the inner distal end of the balloon is fixedly connected with the distal end of the inner tube. In the present invention, the middle part of the balloon is set in the shape of an inner circular arc with a thin middle and thick ends, which is helpful for the accurate positioning of the balloon in the blood vessel, and automatic position locking can be performed in the blood vessel through the hollowed-out balloon structure in the middle. , to solve the problem of balloon slippage.

Description

An adjustable preplastic balloon catheter

technical field

The invention belongs to the technical field of medical devices, in particular to the field of A61F2/24, in particular to an adjustable preplastic balloon catheter.

Background technique

Different from traditional surgical operations, minimally invasive interventional medical technology has many advantages such as less trauma, easy operation, less pain for patients, and faster recovery. It has been applied to the problem of heart valve regurgitation and achieved remarkable results. In the minimally invasive interventional treatment of heart valves, catheters are usually delivered from femoral arteries or veins to replace valves or implant valve repair devices. A balloon catheter is essential as an auxiliary device.

At present, the international mainstream minimally invasive interventional catheters usually use coaxial or rapid exchange straight tube balloon catheters. The main problems are as follows: not suitable for the anatomical structure of the human body, kinking occurs during the advancement of blood vessels, resulting in excessive internal stress and product breakage; it is difficult to push in the human body; scraping with blood vessels, causing blood vessel damage; the balloon is easy to slip off at the lesion , the positioning is inaccurate, causing tissue damage; the balloon drives the guide wire during the slippage process, and the guide wire punctures the tissue; the balloon is not filled centrally, resulting in insufficient expansion, etc.

Contents of the invention

In view of the above problems, the present invention provides an adjustable preplastic balloon catheter, comprising

An inner tube, the inner tube is made of nickel-titanium memory alloy, and the inner tube is pre-molded to form an anatomical shape of a human body;

an outer tube, the outer tube is arranged coaxially with the inner tube, and the inner tube moves axially in the lumen of the outer tube;

a balloon, the balloon is arranged at the distal ends of the inner tube and the outer tube, the outer proximal end of the balloon is fixedly connected with the outer tube distal end, the inner distal end of the balloon is connected with the inner tube The distal end of the tube is fixedly connected.

As a preferred technical solution, the balloon includes a proximal end, a middle portion, and a distal end in sequence from the proximal end to the distal end.

As a preferred technical solution, the wall thickness of the middle part is thinner at the middle part and thicker at the proximal and distal parts.

As a preferred technical solution, the middle part of the balloon is arranged as a tubular structure with a smaller cross-section radius at the middle position and a larger cross-section radius at both ends in the axial direction; The section radius at the middle position becomes smaller gradually, and the section radius of the balloon gradually increases from the middle position to the distal end.

As a preferred technical solution, the outer surface of the middle section of the balloon in the axial direction is coated with a heparin coating.

As a preferred technical solution, a pit is provided on the surface of the balloon in the middle in the axial direction.

As a preferred technical solution, the proximal end of the balloon is configured as a trumpet-shaped structure whose cross-sectional radius continuously increases from the proximal to the distal; the maximum cross-sectional radius of the proximal end is equal to the The radius of the largest section of the proximal end of the middle portion; the smallest section radius of the proximal end equal to the radius of the outer tube.

As a preferred technical solution, the distal end of the balloon is configured as a trumpet-shaped structure with a continuously decreasing section radius from the proximal side to the distal side; the maximum section radius of the distal end is equal to the The radius of the largest cross-section of the distal end of the middle part; the distal end of the distal end is provided with a tip, and the tip is a cone-shaped structure of a dome.

As a preferred technical solution, the part of the inner tube located inside the balloon is wrapped with a developing tube, and the developing tube is mixed and extruded from several materials and then thermally fused to the inner tube.

As a preferred technical solution, the material of the developing tube is a mixed material of polymer material, barium sulfate, and bismuth trioxide.

As a preferred technical solution, the outer tube is set as a polymer braided bending adjustment tube containing metal wires, and the bending direction of the outer tube is within 0-90° of the plane formed by the inner tube pre-shaping structure. within the adjustable range.

Beneficial effects: the present invention provides an adjustable preplastic balloon catheter, which is used as an implanted medical device, enters the valve annulus under the cooperation of the guide wire, and coats the balloon with medicine or squeezes the artificial valve Mitral valve regurgitation or other cardiovascular diseases; in the present invention, including the inner tube supported by the memory alloy pre-shaped in vitro, the shape of the inner tube conforms to the human body structure, and does not affect the human body structure in the process of functioning The pre-shaped inner tube provides support during balloon inflation without the need for a guide wire.

In the present invention, the outer surface of the middle section of the balloon in the axial direction is coated with a heparin coating. The heparin coating is used to prevent blood coagulation on the surface of the balloon, which will cause thrombus blockage and cause adverse effects.

In the present invention, the middle part of the balloon is set in the shape of an inner circular arc with a thin middle and thick ends, which helps the positioning of the balloon in the blood vessel accurately, and the balloon structure in the middle can be automatically locked in the blood vessel. , to solve the problem of balloon slippage.

Furthermore, the surface of the middle part of the balloon is provided with a dimple structure. On the one hand, the dimple structure further increases the friction between the balloon and human tissue, increasing the positioning accuracy and stability; on the other hand, the dimple structure also It provides a good landing point for the heparin and prevents the heparin coating from falling off due to friction, which can better ensure the anticoagulant effect of the heparin coating.

In the present invention, the axial position is adjusted by using the pre-shaped structure of the inner tube, and the radial position is adjusted through the bending adjustment function of the outer tube, and the bending is centered to fill the balloon, so as to ensure that the force of balloon expansion on all directions of the blood vessel is the same, and the balloon The capsule expansion process will not deviate, and will not cause stress damage to blood vessels caused by uneven compression.

In the present invention, the developing tube abandons the commonly used precious metal developing material, and is mixed and extruded by polymer and BaSo4 or Bi2O3, and then hot-melted to the inner tube of the balloon to avoid contact damage caused by the metal developing ring and the polymer balloon.

Description of drawings

Fig. 1 is a schematic structural view of an adjustable preplastic balloon catheter provided by the present invention;

Figure 2 is a schematic diagram of the enlarged structure of the balloon;

3 to 7 are schematic diagrams of the working principle of the present invention;

Among them, 1-inner tube, 11-developing tube, 2-outer tube, 3-balloon, 31-proximal end, 32-middle, 33-distal end, 34-tip, 4-guide wire.

Detailed ways

An adjustable preplastic balloon catheter comprising

An inner tube 1, the inner tube 1 is made of nickel-titanium memory alloy, and the inner tube 1 is pre-molded to form an anatomical shape of a human body;

An outer tube 2, the outer tube 2 is arranged coaxially with the inner tube 1, and the inner tube 1 moves axially in the inner cavity of the outer tube 2;

A balloon 3, the balloon 3 is arranged on the distal end of the inner tube 1 and the outer tube 2, the outer proximal end of the balloon 3 is fixedly connected with the distal end of the outer tube 2, the balloon 3 The inner distal end is fixedly connected with the distal end of the inner tube 1 .

In some preferred embodiments, the balloon 3 includes a proximal end portion 31 , a middle portion 32 , and a distal end portion 33 sequentially from the proximal end to the distal end.

In some preferred embodiments, the wall thickness of the middle part 32 is thinner at the middle position and thicker at the proximal and distal positions. The shape of the balloon is set to be thinner in the middle and thicker at both ends, and the wall thickness of the balloon is set to be thinner at the middle and both ends, so as to ensure the overall shape of the waist when the force is applied during the filling process, and the middle part is a linear balloon when the pressure is reached. structure to complete the linear expansion of blood vessels.

In some preferred embodiments, the middle portion 32 of the balloon 3 is configured as a tubular structure with a smaller cross-sectional radius at the middle position and a larger cross-sectional radius at both ends in the axial direction; The section radius from the proximal end to the middle position becomes smaller gradually, and the section radius of the balloon 3 gradually increases from the middle position to the far end.

In some preferred embodiments, the outer surface of the middle section of the balloon 3 in the axial direction is coated with a heparin coating. By coating the heparin coating to avoid coagulation on the surface of the balloon, so as to ensure the smooth passage of the balloon in the blood vessel, and to maintain a stable position at the target working position, to avoid adverse effects caused by the coagulation effect; at the same time, the heparin coating is set on the balloon The middle position of the capsule, ie the thinner position during travel, also avoids frictional peeling off of the heparin coating during travel.

In some preferred embodiments, the balloon 3 is provided with a pit on the surface at the middle position in the axial direction. The positioning stability of the balloon is increased by the dimple structure or other structures that increase the frictional force, so as to prevent the balloon from moving or even falling off after inflation.

In some preferred embodiments, the proximal end 31 of the balloon 3 is configured as a trumpet-shaped structure whose cross-sectional radius continuously increases from the proximal side to the distal side; the maximum cross-sectional radius of the proximal end 31 is is equal to the radius of the largest section of the proximal end of the middle portion 32 ; the smallest section radius of the proximal end portion 31 is equal to the radius of the outer tube 2 .

In some preferred embodiments, the distal end portion 33 of the balloon 3 is configured as a trumpet-shaped structure whose cross-sectional radius decreases continuously from the proximal side to the distal side; the maximum cross-sectional radius of the distal end portion 33 is It is equal to the radius of the largest section of the distal end of the middle part 32; the distal end of the distal end part 33 is provided with a tip 34, and the tip 34 is a dome-shaped conical structure.

In some preferred embodiments, the part of the inner tube 1 located inside the balloon 3 is wrapped with a developing tube 11, and the developing tube 11 is mixed and extruded from several materials and then thermally fused to the inner tube 1 .

In some preferred embodiments, the material of the developing tube 11 is a mixed material of polymer material, barium sulfate, and bismuth trioxide. The imaging tube is a polymer imaging material to avoid damage to the balloon.

In some preferred embodiments, the outer tube 2 is set as a polymer braided bend-adjusting tube containing metal wires, and the bending direction of the outer tube 2 is in the same plane as the plane formed by the pre-shaped structure of the inner tube 1. Within the adjustable range of 0 to 90 degrees. The axial position is adjusted by pre-shaping the inner tube, and the radial position is adjusted by bending the outer tube, so as to realize the central filling and expansion of the balloon in the lesion.

Working principle: The present invention provides an adjustable pre-plastic balloon catheter, which is used as an implanted medical device, enters the valve annulus under the cooperation of the guide wire, and coats the balloon with medicine or presses the artificial valve. Mitral valve regurgitation or other cardiovascular diseases; in the present invention, including the inner tube supported by the memory alloy pre-shaped in vitro, the shape of the inner tube conforms to the human body structure, and does not affect the human body structure in the process of functioning The pre-shaped inner tube provides support during balloon inflation without the need for a guide wire. As shown in Figure 3, the present invention enters the aortic arch with the assistance of the guide wire; as shown in Figure 4, the present invention passes through the complex human body structure in the pre-shaped bending of the inner tube, and advances to the lesion site; as shown in Figure 5 As shown, the present invention enters the lesion during the pre-shaped bending adjustment of the inner tube, and realizes precise axial positioning and position locking through the inner arc structure of the balloon and the developing tube inside the balloon to prevent falling off; as shown in Figure 6 As shown in Fig. 7, the guide wire is retracted, and the radial positioning of the balloon is performed through the bending function of the outer tube to ensure that the balloon is inflated and inflated in the center of the blood vessel; as shown in Fig. Thick, the wall thickness of the balloon is set to be thinner in the middle and both ends, so as to ensure the overall shape of the waist when the force is applied during the filling process, and the middle part is a linear balloon structure when the pressure is reached, and the linear expansion of the blood vessel is completed. .

Claims (12)

1. An adjustable pre-plastic balloon catheter, which is characterized by comprising

The inner tube (1), the inner tube (1) adopts nickel titanium memory alloy to make, the inner tube (1) is preformed to form the human anatomy shape;

the outer pipe (2) and the inner pipe (1) are coaxially arranged, and the inner pipe (1) axially moves in the inner cavity of the outer pipe (2);

the balloon (3), the balloon (3) sets up the distal end of inner tube (1) and outer tube (2), the outside near-end of balloon (3) with outer tube (2) distal end fixed connection, the inboard distal end of balloon (3) with the distal end fixed connection of inner tube (1).

2. Adjustable pre-plastic balloon catheter according to claim 1, wherein the balloon (3) comprises, in order from proximal to distal, a proximal end (31), an intermediate portion (32), a distal end (33).

3. The adjustable pre-plastic balloon catheter as recited in claim 2, wherein the wall thickness of the intermediate portion (32) is thinner at the intermediate location and thicker at the proximal and distal locations.

4. Adjustable pre-plastic balloon catheter according to claim 1, characterized in that the middle section (32) of the balloon (3) is provided as a tubular structure with a smaller cross-sectional radius at the middle position and a larger cross-sectional radius at the two end positions in the axial direction; the cross section radius of the balloon (3) is gradually reduced from the proximal end to the middle position, and the cross section radius of the balloon (3) is gradually increased from the middle position to the distal end.

5. Adjustable pre-plastic balloon catheter according to claim 4, characterized in that the balloon (3) is coated with a heparin coating on its middle section in the axial direction.

6. Adjustable pre-plastic balloon catheter according to claim 4, characterized in that the balloon (3) is provided with a recess in its surface at a central position in the axial direction.

7. The adjustable pre-plastic balloon catheter as claimed in claim 4, characterized in that the proximal end (31) of the balloon (3) is provided with a trumpet-like structure with an increasing radius of section from the proximal side to the distal side; the maximum section radius of the proximal end portion (31) is equal to the radius of the proximal maximum section of the intermediate portion (32); the smallest cross-sectional radius of the proximal end (31) is equal to the outer tube (2) radius.

8. The adjustable pre-plastic balloon catheter as claimed in claim 4, characterized in that the distal end (33) of the balloon (3) is provided as a trumpet-like structure with a decreasing cross-sectional radius from proximal to distal; the maximum cross-sectional radius of the distal end portion (33) being equal to the radius of the distal maximum cross-section of the intermediate portion (32)

9. The adjustable pre-plastic balloon catheter as recited in claim 6, wherein a distal end of the distal end (33) is provided with a tip (34), the tip (34) being a domed, conical structure.

10. The adjustable pre-plastic balloon catheter as claimed in claim 1, characterized in that the part of the inner tube (1) inside the balloon (3) is wrapped with a visualization tube (11), and the visualization tube (11) is hot-melted onto the inner tube (1) after several materials are mixed and extruded.

11. The adjustable pre-plastic balloon catheter as claimed in claim 8, wherein the developing tube (11) is made of a mixed material of a polymer material, barium sulfate and bismuth trioxide.

12. The adjustable pre-plastic balloon catheter as claimed in claim 1, wherein the outer tube (2) is provided as a polymeric braided bend tube containing metal wires, and the bending direction of the outer tube (2) and the plane formed by the pre-shaped structure of the inner tube (1) are within an adjustable range of 0-90 degrees.

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