Balloon catheter

Abstract

The utility model relates to a balloon catheter, belongs to the technical field of medical instruments, and solves the problems that an existing balloon catheter is poor in folding memorability and difficult to restore after pressure relief. A balloon catheter is composed of a tip tube, a balloon, a compression spring, an inner tube, a developing ring, an outer tube, a stress expansion tube and a catheter base. The developing ring is fixed on the inner pipe through bonding or forging and pressing; the compression spring is nested on the inner tube and the developing ring; the stress expansion pipe is a variable-diameter guide pipe and is arranged on the outer pipe in a sleeving mode. According to the balloon catheter, the compression spring is nested on the inner tube of the balloon to provide axial force for the balloon, and under the action of axial tension of the compression spring, the balloon is completely recovered from an expansion state in use to a folding state before use, so that the balloon catheter is easy to fully withdraw.

Description

Technical Field

[0001] This utility model relates to the field of medical device technology, and in particular to a balloon catheter. Background Technology

[0002] Balloon catheters have been developed for decades and are widely used in various medical departments, primarily for dilating stenotic lesions. After the balloon is pushed to the site of the stenosis, fluid is injected into the balloon through the catheter's filling lumen, applying pressure to inflate the balloon and physically supporting the stenotic lesion. After treatment, the pressure is released, the balloon returns to its original shape along the crease, and is finally withdrawn.

[0003] Current balloon catheters typically employ balloon folding technology for retraction. Folding involves segmentation and coiling, usually dividing the balloon into different numbers of segments, such as 3, 6, or 8, depending on its size. These segments are then coiled in the same direction to reduce the balloon diameter. Ideally, the balloon should return to its original segmented and coiled folded state after depressurization, allowing for safe withdrawal. However, in reality, balloons have poor fold memory, making it difficult for them to return to their original shape after depressurization. This results in a balloon diameter far exceeding its unused folded diameter, hindering retraction into the guiding catheter and potentially prolonging surgery time, increasing surgical risks, and even leading to complications. Therefore, further optimization of the balloon catheter structure is necessary to improve its folding performance. Utility Model Content

[0004] Based on the above analysis, the present invention aims to provide a balloon catheter to solve the problem that existing balloon catheters have poor foldability, cannot be restored to their original diameter after use, and cannot be smoothly withdrawn into the guide tube.

[0005] The objective of this utility model is mainly achieved through the following technical solutions:

[0006] This utility model provides a balloon catheter, which is composed of a tip tube (1), a balloon (2), a compression spring (3), an inner tube (4), a radiopaque ring (5), an outer tube (6), a stress expansion tube (7), and a catheter seat (8);

[0007] The developing ring (5) is fixed to the inner tube (4) by bonding or forging;

[0008] The compression spring (3) is sleeved on the outside of the inner tube (4);

[0009] The stress expansion tube (7) is a variable diameter conduit, which is sleeved on the outer tube (6).

[0010] Furthermore, the tip tube (1) is frustum-shaped, and the stress expansion tube (7) is a variable diameter conduit, both including a proximal end, a distal end, and a transition section;

[0011] The balloon (2) includes a proximal end, a distal end, and a middle section; the proximal end and the distal end of the balloon each have a tube.

[0012] Furthermore, the compression spring (3) includes a spring proximal end, a spring distal end, and a spring coil;

[0013] The compression spring has a wire diameter of 0.2-0.5mm, an inner diameter of 1.3-1.8mm, and an outer diameter of 1.5-2.8mm; the spring pitch is 0.42-1.15mm, the helix angle is 5°-36.1°, the rotation ratio is 4.6-7.5, the free height is 108-135mm, and the working height is 18-45mm.

[0014] Furthermore, the total number of coils of the compression spring is 96-323, and the effective number of coils is 94-321.

[0015] Furthermore, the inner diameter of the compression spring (3) is greater than the outer diameter of the imaging ring (5), and the outer diameter of the compression spring (3) is less than the inner diameter of the distal end of the balloon.

[0016] Furthermore, both the inner tube (4) and the outer tube (6) are conduits of equal diameter, each comprising a distal end, a proximal end, and a transition section.

[0017] Furthermore, the distal ends of the balloon, the distal ends of the compression spring, the distal ends of the inner tube, and the distal ends of the tip tube are welded together to form the distal end of the balloon catheter;

[0018] The proximal end of the balloon, the proximal end of the compression spring, and the distal end of the outer tube are welded together to form the proximal end of the balloon catheter.

[0019] Furthermore, the catheter seat (8) includes a filling cavity (9), a guidewire cavity (10), a first arc-shaped tube (11), a second arc-shaped tube (12), and a third arc-shaped tube (13);

[0020] Both the filling cavity (9) and the guidewire cavity (10) are variable diameter passages, which respectively include a proximal end, a distal end and a transition section.

[0021] Furthermore, the filling cavity (9) is obliquely disposed on the guide wire cavity (10), and the distal end of the filling cavity is connected to the guide wire cavity through a hole disposed in the middle section of the guide wire cavity transition section;

[0022] The angle between the distal end of the filling cavity and the gradient section near the distal end of the guidewire cavity is 40-70°.

[0023] Furthermore, the two ends of the first arc-shaped tube (11) are respectively connected to the gradual section of the filling cavity and the distal end of the guidewire cavity, the two ends of the second arc-shaped tube (12) are respectively connected to the gradual section of the filling cavity and the proximal end of the guidewire cavity, and the two ends of the third arc-shaped tube (13) are respectively connected to the proximal end and the distal end of the guidewire cavity.

[0024] Compared with the prior art, the present invention can achieve at least one of the following beneficial effects:

[0025] 1. This utility model provides an axial force to the balloon by installing a compression spring on the outer sleeve of the inner tube of the balloon. Under the axial tension of the compression spring, the balloon returns from the inflated state during use to the folded state before use, making it easy for the balloon catheter to be fully retracted.

[0026] 2. This utility model provides a compression spring on the outer sleeve of the inner tube of the balloon. When the balloon is in use, the compression spring can provide axial tension. When the balloon catheter is folded, it helps to reduce the outer diameter of the entire folded balloon section and make the segments more uniform.

[0027] In this invention, the above-described technical solutions can be combined with each other to achieve more preferred combinations. Other features and advantages of this invention will be set forth in the following description, and some advantages will become apparent from the description or be learned by practicing the invention. The objectives and other advantages of this invention can be realized and obtained from the description and accompanying drawings, which are particularly pointed out. Attached Figure Description

[0028] The accompanying drawings are for illustrative purposes only and are not intended to limit the scope of the invention. Throughout the drawings, the same reference numerals denote the same parts.

[0029] Figure 1 This is a schematic diagram of the overall structure of the balloon catheter of this utility model;

[0030] Figure 2 This is an enlarged schematic diagram of a compression spring inside a balloon catheter;

[0031] Figure 3 This is a schematic diagram of the balloon catheter after it has been folded.

[0032] Figure label:

[0033] 1-Tip tube; 2-Balloon; 3-Compression spring; 4-Inner tube; 5-Iconizing ring; 6-Outer tube; 7-Stress dilation tube; 8-Catheter seat; 9-Filling lumen; 10-Guidewire lumen; 11-First arc-shaped tube; 12-Second arc-shaped tube; 13-Third arc-shaped tube. Detailed Implementation

[0034] The preferred embodiments of the present invention will now be described in detail with reference to the accompanying drawings, which constitute a part of this application and are used together with the embodiments of the present invention to illustrate the principles of the present invention, but are not intended to limit the scope of the present invention.

[0035] This utility model provides a balloon catheter, comprising a tip tube 1, a balloon 2, a compression spring 3, an inner tube 4, a contrast ring 5, an outer tube 6, a stress expansion tube 7, and a catheter seat 8;

[0036] The tip tube 1 is a frustum-shaped duct, including a proximal end, a distal end, and a tapering segment;

[0037] Balloon 2 includes a proximal balloon, a distal balloon, and a mid-balloon; the proximal balloon and the distal balloon each have tubes;

[0038] The compression spring 3 includes a proximal end, a distal end, and a spring coil; the spring wire diameter is 0.2-0.5mm, the inner diameter is 1.3-1.8mm, and the outer diameter is 1.5-2.8mm; the spring pitch is 0.42-1.15mm, the helix angle is 5°-36.1°, the rotation ratio is 4.6-7.5, the free height is 108-135mm, and the working height is 18-45mm. The two ends of the spring coil are tightly ground flat; the total number of spring coils is 96-323, and the effective number of coils is 94-321; the inner diameter of the compression spring 3 is greater than the outer diameter of the imaging ring 5, and the outer diameter of the compression spring 3 is less than the inner diameter of the distal end of the balloon's tube. Among these, the outer diameter of the inner tube 4 is 1.0-1.15mm, the inner diameter of the distal and proximal ends of the balloon's tube is 3.35-3.45mm, and the outer diameter of the imaging ring 5 is 1.2-1.3mm. The spring is made of 304 stainless steel, which has good biocompatibility and high strength. In addition, nickel-titanium material can also be used. As a superelastic memory alloy, nickel-titanium material maintains the bending shape of the spring at room temperature. When it enters the human body, the temperature rises and the nickel-titanium spring straightens, which also provides considerable axial force.

[0039] Both inner tube 4 and outer tube 6 are equal-diameter catheters, each consisting of a distal end, a proximal end, and a transition section.

[0040] The stress expansion tube 7 is a variable diameter conduit, which is sleeved on the outer tube 6 and includes a proximal end, a distal end and a transition section;

[0041] The catheter hub 8 includes a filling lumen 9, a guidewire lumen 10, a first arc-shaped tube 11, a second arc-shaped tube 12, and a third arc-shaped tube 13. Both the filling lumen 9 and the guidewire lumen 10 are variable-diameter catheters, each including a proximal end, a distal end, and a transition section. The filling lumen 9 is obliquely disposed on the guidewire lumen 10. The distal end of the filling lumen 9 communicates with the guidewire lumen 10 through a hole located in the middle section of the transition section of the guidewire lumen. The angle between the distal end of the filling lumen 9 and the transition section near the distal end of the guidewire lumen is 40-70°. The two ends of the first arc-shaped tube 11 are respectively connected to the transition section of the filling lumen and the distal end of the guidewire lumen. The two ends of the second arc-shaped tube 12 are respectively connected to the transition section of the filling lumen and the proximal end of the guidewire lumen. The two ends of the third arc-shaped tube 13 are respectively connected to the proximal end and the distal end of the guidewire lumen.

[0042] The developing ring 5 is fixed to the inner tube 4 by bonding or forging; the compression spring 3 is sleeved on the outside of the inner tube 4;

[0043] The distal end of the balloon catheter, the distal end of the compression spring, the distal end of the inner tube, and the distal end of the tip tube are welded together to form the distal end of the balloon catheter. The tip of the balloon catheter has a smooth arc to ensure that the inner wall of the blood vessel is not damaged when the catheter is pushed. The proximal end of the balloon catheter, the proximal end of the compression spring, and the distal end of the outer tube are welded together to form the proximal end of the balloon catheter. The proximal end of the outer tube is connected to the distal end of the guidewire lumen in the catheter seat.

[0044] The function of the imaging ring 5 is to provide imaging within the body, helping doctors determine the location of the woven balloon; the inner tube 4 is used to provide a passage for the guidewire; the compression spring 3 provides axial force for the contraction of the balloon catheter, ensuring that the balloon catheter returns to its original diameter after use; the outer tube 6 can deliver the balloon to the lesion site; the stress diffusion tube 7 can buffer the stress on the outer tube 6; the catheter seat 8 is used to inflate the balloon; the guidewire lumen 10 is used to provide a passage for the guidewire; and the filling lumen 9 is used for ventilation.

[0045] It should be noted that the distal end of the filling lumen and guidewire lumen in the tip tube 1, balloon 2, compression spring 3, inner tube 4, outer tube 6, stress diffusion tube 7, and catheter seat 8 refers to the end of the balloon catheter furthest from the operator, and the proximal end refers to the end of the balloon catheter closest to the operator. The part between the distal and proximal ends is called the transition section or gradual section.

[0046] When the balloon is inflated, the compression spring is compressed. When the balloon inflates, the spring returns to its original shape, exhibiting a rebound state. During use, when the balloon catheter is pushed to the narrowed area of ​​the lesion, fluid is injected through the filling chamber, causing the balloon to inflate. During inflation, the balloon stretches both axially and radially. After use, the pressure is released, and the balloon returns to its uninflated state under the axial tension of the compression spring, making the balloon catheter easy to retract. The compression spring provides continuous axial tension during balloon use. When the balloon catheter is folded, it helps reduce the outer diameter of the entire folded balloon section, resulting in more uniform flaps.

[0047] The larger and thicker the balloon, the greater the axial force required. The size parameters of the compression spring, such as wire diameter, inner diameter, outer diameter, pitch, helix angle, rotation ratio, free height, working height, and number of turns, can be changed according to the required axial tension. The larger the wire diameter and pitch, the greater the axial force.

[0048] Example

[0049] This embodiment provides a balloon catheter, comprising a tip tube 1, a balloon 2, a compression spring 3, an inner tube 4, a contrast ring 5, an outer tube 6, a stress-dilution tube 7, and a catheter seat 8;

[0050] The tip tube 1 is a variable diameter catheter, including a proximal end, a distal end, and a tapering section;

[0051] Balloon 2 includes a proximal balloon, a distal balloon, and a mid-balloon; the proximal balloon and the distal balloon each have tubes;

[0052] The compression spring 3 includes a proximal end, a distal end, and a spring coil; the spring wire diameter is 0.2 mm, the inner diameter is 1.5 mm, and the outer diameter is 1.9 mm; the spring pitch is 0.68 mm, the helix angle is 7.2°, the rotation ratio is 7.5, the free height is 135 mm, and the working height is 45 mm. The two ends of the spring coil are tightly ground flat; the total number of spring coils is 200, and the effective number of coils is 190; the outer diameter of the imaging ring 5 is 1.2 mm, and the inner diameter of the proximal and distal ends of the balloon is 3.35 mm, satisfying that the inner diameter of the compression spring 3 is greater than the outer diameter of the imaging ring 5, and the outer diameter of the compression spring 3 is less than the inner diameter of the distal end of the balloon coil.

[0053] The spring is made of 304 stainless steel;

[0054] Both inner tube 4 and outer tube 6 are equal-diameter catheters, each consisting of a distal end, a proximal end, and a transition section.

[0055] The stress expansion tube 7 is a variable diameter conduit, which is sleeved on the outer tube 6 and includes a proximal end, a distal end and a transition section;

[0056] The catheter hub 8 includes a filling lumen 9, a guidewire lumen 10, a first arc-shaped tube 11, a second arc-shaped tube 12, and a third arc-shaped tube 13. Both the filling lumen 9 and the guidewire lumen 10 are variable-diameter catheters, each including a proximal end, a distal end, and a transition section. The filling lumen 9 is obliquely disposed on the guidewire lumen 10. The distal end of the filling lumen 9 communicates with the guidewire lumen 10 through a hole located in the middle section of the transition section of the guidewire lumen. The angle between the distal end of the filling lumen 9 and the transition section near the distal end of the guidewire lumen is 40-70°. The two ends of the first arc-shaped tube 11 are respectively connected to the transition section of the filling lumen and the distal end of the guidewire lumen. The two ends of the second arc-shaped tube 12 are respectively connected to the transition section of the filling lumen and the proximal end of the guidewire lumen. The two ends of the third arc-shaped tube 13 are respectively connected to the proximal end and the distal end of the guidewire lumen.

[0057] The developing ring 5 is fixed to the inner tube 4 by bonding or forging; the compression spring 3 is sleeved on the outside of the inner tube 4;

[0058] The distal end of the balloon, the distal end of the compression spring, the distal end of the inner tube, and the distal end of the tip tube are welded together to form the catheter tip of the balloon catheter. The balloon catheter tip has a smooth arc to ensure that the inner wall of the blood vessel is not damaged when the catheter is pushed. The proximal end of the balloon, the proximal end of the compression spring, and the distal end of the outer tube are welded together to form the distal end of the balloon catheter. The proximal end of the outer tube is connected to the distal end of the guidewire lumen in the catheter seat.

[0059] The nominal diameter of the balloon catheter in this embodiment is 28 mm, the number of flaps is 8, and the diameter of the folded balloon is 3.4 mm. After use, the balloon can be restored to the 8-flap folded state by aspirating negative pressure, and can be smoothly withdrawn into the sheath.

[0060] Comparative Example

[0061] This comparative example provides a balloon catheter that does not contain a compression spring, and the rest of the structure is the same as in Example 1.

[0062] The nominal diameter of the braided balloon in this comparative example is 28mm, with 8 segments, and the diameter of the folded balloon is 3.8mm. After use, the negative pressure balloon can only be restored to a 4-5 segment folded state, requiring considerable force to pull the catheter back into the sheath, which can easily cause damage.

[0063] The above description is only a preferred embodiment of the present utility model, but the protection scope of the present utility model is not limited thereto. Any changes or substitutions that can be easily conceived by those skilled in the art within the technical scope disclosed in the present utility model should be included within the protection scope of the present utility model.

Claims

1. A balloon catheter, characterized by, The balloon catheter is composed of a tip tube (1), a balloon (2), a compression spring (3), an inner tube (4), a developing ring (5), an outer tube (6), a stress expansion tube (7) and a catheter seat (8). The developing ring (5) is fixed on the inner tube (4) by bonding or forging. The compression spring (3) is sleeved on the outer tube (4). The stress expansion tube (7) is a variable diameter catheter, which is sleeved on the outer tube (6).

2. The balloon catheter of claim 1, wherein, The tip tube (1) is a circular truncated cone catheter, and the stress expansion tube (7) is a variable diameter catheter, both of which include a proximal end, a distal end and a gradual change segment. The balloon (2) includes a balloon proximal end, a balloon distal end and a balloon middle segment, and the balloon proximal end and the balloon distal end are respectively provided with a tube foot.

3. The balloon catheter of claim 2, wherein, The compression spring (3) includes a spring proximal end, a spring distal end and a spring coil. The compression spring has a wire diameter of 0.2-0.5 mm, an inner diameter of 1.3-1.8 mm and an outer diameter of 1.5-2.8 mm; the spring has a pitch of 0.42-1.15 mm, a helix angle of 5°-36.1°, a rotation ratio of 4.6-7.5, a free height of 108-135 mm and a working height of 18-45 mm.

4. The balloon catheter of claim 3, wherein, The total number of spring coils of the compression spring is 96-323, and the effective number of coils is 94-321.

5. The balloon catheter of claim 4, wherein, The inner diameter of the compression spring (3) is greater than the outer diameter of the developing ring (5), and the outer diameter of the compression spring (3) is less than the inner diameter of the tube foot of the balloon distal end.

6. The balloon catheter of claim 5, wherein, The inner tube (4) and the outer tube (6) are both equal diameter catheters, each including a distal end, a proximal end and a transition segment.

7. The balloon catheter of claim 6, wherein, The tube foot of the balloon distal end, the compression spring distal end, the inner tube distal end and the tip tube distal end are welded together to form a catheter distal end of the balloon catheter. The tube foot of the balloon proximal end, the compression spring proximal end and the outer tube distal end are welded together to form a catheter proximal end of the balloon catheter.

8. The balloon catheter of claim 7, wherein, The catheter seat (8) includes a filling cavity (9), a guide wire cavity (10), a first vicious arc-shaped tube (11), a second vicious arc-shaped tube (12) and a third vicious arc-shaped tube (13). The filling cavity (9) and the guide wire cavity (10) are both variable diameter passages, each including a proximal end, a distal end and a gradual change segment.

9. The balloon catheter of claim 8, wherein, The filling cavity (9) is obliquely arranged on the guide wire cavity (10), and the distal end of the filling cavity is communicated with the guide wire cavity through a hole arranged in the middle segment of the gradual change segment of the guide wire cavity. The included angle between the distal end of the filling cavity and the gradual change segment close to the distal end of the guide wire cavity is 40-70°.

10. The balloon catheter of claim 9, wherein, The two ends of the first vicious arc-shaped tube (11) are connected to the gradual change segment of the filling cavity and the distal end of the guide wire cavity, respectively, the two ends of the second vicious arc-shaped tube (12) are connected to the gradual change segment of the filling cavity and the proximal end of the guide wire cavity, respectively, and the two ends of the third vicious arc-shaped tube (13) are connected to the proximal end and the distal end of the guide wire cavity, respectively.

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