Balloon catheter for assisting in reflexing of guide wire

Abstract

The balloon catheter comprises a catheter body internally provided with a main cavity, the catheter body sequentially comprises a handle section, an extension section and a functional section, the surface of the near end of the extension section is provided with a rapid exchange cavity inlet, the far end of the main cavity penetrates out of the catheter body through a main branch guide wire outlet, and the main branch guide wire outlet is communicated with the main branch guide wire outlet. An auxiliary cavity parallel to the main cavity is formed in the tube body, the far end of the auxiliary cavity penetrates out of a branch guide wire outlet formed in the side wall of the far end of the functional section, a pre-shaped balloon is arranged on the periphery of the far end of the branch guide wire outlet, and the balloon is provided with a reflexed guide groove in a full state. And the branch guide wire outlet is over against the reverse folding guide groove. The branch guide wire is guided to the bifurcation lesion position through the main branch guide wire, the reversely-folded guide groove is formed after the filling balloon is filled, medical staff can easily feed the branch guide wire through the auxiliary cavity, and the branch guide wire is guided and reversely folded at the branch guide wire outlet through the reversely-folded guide groove and easily enters an acute-angle branch blood vessel.

Description

Technical Field

[0001] This invention belongs to the field of interventional medical device technology, and in particular relates to a balloon catheter for assisting guidewire folding. Background Technology

[0002] When using existing dual-lumen microcatheters (such as Sasuke and Crusade) to treat acute angular branch lesions, it is often necessary to manually pre-shape the guidewire tip into a large, reversed bend outside the body before attempting to advance the guidewire into the branch. This process has significant drawbacks: 1. Repeated attempts and low efficiency: The reversed bend of the guidewire is easily altered during advancement, requiring multiple attempts; 2. Cumbersome operation and increased risk: After each failure, the entire microcatheter and guidewire must be withdrawn and reshaped, prolonging the operation time and increasing the risk of vascular injury.

[0003] Furthermore, the conventional design of existing distal balloon catheters is spindle-shaped or cylindrical, typically used for occluding blood vessels or dilating lesions. If such balloons are simply integrated, the guidewire can easily enter the gap between the balloon and the vessel wall, making effective guidewire folding and guidance impossible. Summary of the Invention

[0004] The purpose of this invention is to provide a balloon catheter for assisting guidewire folding, thereby solving the technical problems mentioned in the background art.

[0005] The technical solution adopted by this invention to solve its technical problem is as follows: A balloon catheter for assisting guidewire folding is provided, comprising a tube body with an internal main lumen. The tube body sequentially includes a handle section, an extension section, and a functional section. A rapid exchange lumen inlet is provided on the proximal surface of the extension section, and the rapid exchange lumen inlet communicates with the main lumen. The distal end of the main lumen exits the tube body through a main branch guidewire outlet located at the distal end of the functional section. A secondary lumen parallel to the main lumen is provided within the tube body. The distal end of the secondary lumen exits through a branch guidewire outlet located on the distal sidewall of the functional section. The distal periphery is provided with a pre-shaped balloon, which has a folded guide groove when inflated. The branch guidewire outlet smoothly transitions to the folded guide groove. When the balloon is inflated, the end of the folded guide groove points backward to an acute-angled branch vessel that forms an acute angle with the main stop vessel. A three-way handle is provided outside the handle section. The surface of the three-way handle is provided with an inflation port, a branch guidewire infusion port, and a catheter outlet. The proximal end of the secondary lumen communicates with the branch guidewire infusion port. The inflation port communicates with the balloon through an inflation tube located in the catheter body.

[0006] Preferably, the pre-shaped balloon is heart-shaped, with the tip of the heart facing the distal end of the catheter, and the anti-folding guide groove is located at the concave end of the heart shape.

[0007] Preferably, the filling port is provided with a self-sealing diaphragm or a one-way valve.

[0008] Preferably, the balloon is located between the main guidewire outlet and the branch guidewire outlet.

[0009] Preferably, radiofrequency imaging marker rings are provided on the outer periphery of the tube body near the outlets of the main guidewire and the branch guidewire, respectively.

[0010] Preferably, the distal end of the secondary cavity is smoothly connected to the junction of the branch guidewire outlet.

[0011] This invention combines a main guidewire and a branch guidewire within a catheter. The branch guidewire is guided to the bifurcation lesion via the main guidewire. After inflation of the balloon, a folded guide groove is formed, allowing medical personnel to easily insert the branch guidewire through the secondary lumen. The branch guidewire folds back at its exit point via the folded guide groove and easily enters the acute-angle branch vessel. This approach offers the following advantages: 1. Active guidance: The balloon bevel provides physical guidance, transforming passive "blind probing" into active "rebound," significantly improving the pass rate of guidewires through tricky branches.

[0012] 2. Simplified operation: It enables in-body guidewire retraction, avoids repeated system withdrawal, shortens operation time, and reduces radiation exposure.

[0013] 3. Excellent support: The balloon provides additional support after being anchored at low pressure.

[0014] 4. Safe and controllable: Short-term low-pressure filling has little impact on blood flow and the risk is controllable.

[0015] Furthermore, the essence of this design lies in: 1. The structure follows tradition: It adopts the "rapid exchange of main lumen + full exchange of auxiliary lumen" structure that clinicians are most familiar with, without having to change basic operating habits.

[0016] 2. Key innovations: The integrated balloon and its surface-mounted anti-reflective guide grooves are the core innovations, which solve the problem of "where the guidewire has nowhere to go" and provide a definite rebound path.

[0017] 3. Safety design: The independent, sealed filling port ensures operational safety and is completely isolated from the guidewire cavity.

[0018] 4. Precise positioning: Multiple imaging markers ensure that the relative positions of the balloon and the branch opening can be clearly determined under X-ray. Attached Figure Description

[0019] Figure 1 This is a schematic diagram of a balloon catheter structure used to assist in guidewire folding. Figure 2 for Figure 1 Enlarged cross-sectional view of the mid-to-rear functional section; Figure 3 for Figure 1 A schematic diagram of the working state of the mid-to-distal segment within the blood vessel; Figure 4 for Figure 1 Enlarged sectional view of the proximal handle segment; Among them, 1-tube body; 101-main lumen; 102-secondary lumen; 103-filling tubing; 104-radiofrequency imaging marker ring; 2-handle section; 201-three-way handle; 202-filling port; 203-branch guidewire irrigation port; 204-catheter outlet; 3-extension section; 301-rapid exchange lumen inlet; 4-functional section; 401-main branch guidewire outlet; 402-branch guidewire outlet; 5-balloon; 501-reverse guide groove; 6-main branch vessel; 7-acute-angle branch vessel.

[0020] The same markings in each diagram represent the same component. Detailed Implementation

[0021] The present invention will be further illustrated below with reference to specific embodiments. It should be understood that these embodiments are for illustrative purposes only and are not intended to limit the scope of the invention. Furthermore, it should be understood that after reading the teachings of this invention, those skilled in the art can make various alterations or modifications to the invention, and these equivalent forms also fall within the scope defined by the appended claims. In this document, "distal end" refers to the end furthest from the medical staff's operating end, and "proximal end" refers to the end closest to the medical staff's operating end.

[0022] like Figure 1 As shown, the present invention provides a balloon catheter for assisting guidewire folding, comprising a tube body 1 with a main lumen 101, the tube body 1 comprising a handle section 2, an extension section 3 and a functional section 4 in sequence, the proximal surface of the extension section 3 having a rapid exchange chamber inlet 301, the rapid exchange chamber inlet 301 communicating with the main lumen 101, and the distal end of the main lumen 101 exiting the tube body 1 through a main branch guidewire outlet 401 located at the distal end of the functional section 4.

[0023] The tube body 1 has a secondary lumen 102 parallel to the main lumen 101. The distal end of the secondary lumen 102 passes through a branch guidewire outlet 402 opened on the distal side wall of the functional segment 4. A pre-shaped balloon 5 is provided on the outer periphery of the distal end of the branch guidewire outlet 402. The balloon 5 has a reverse guide groove 501 when inflated. The branch guidewire outlet 402 and the reverse guide groove 501 are smoothly transitioned. When the balloon 5 is inflated, the end of the reverse guide groove 501 points backward to an acute-angled branch vessel that forms an acute angle with the main stop vessel.

[0024] The pre-shaped balloon 5 is heart-shaped, with the tip of the heart facing the distal end of the catheter, and the anti-folding guide groove 501 is located at the concave end of the heart shape.

[0025] The handle section 2 is provided with a three-way handle 201. The surface of the three-way handle 201 is provided with an inflation port 202, a branch guidewire irrigation port 203 and a catheter outlet 204. The proximal end of the secondary lumen 102 is connected to the branch guidewire irrigation port 203. The inflation port 202 is connected to the balloon 5 through an inflation tube 103 provided in the tube body 1.

[0026] The filling port 202 is equipped with a self-sealing diaphragm or a one-way valve to prevent the filling medium from overflowing from the filling port 202.

[0027] The balloon 5 is located between the main guidewire outlet 401 and the branch guidewire outlet 402.

[0028] Radiofrequency imaging marker rings 104 are provided on the outer periphery of the tube body 1 near the main guidewire outlet 401 and the branch guidewire outlet 402, respectively, which helps physicians to confirm the location of the functional segment 4 during radiofrequency fluoroscopy.

[0029] The distal end of the secondary cavity 102 is smoothly connected to the junction of the branch guidewire outlet 402, so that the branch guidewire can pass through naturally and prevent obstruction.

[0030] The specific operating procedure for the balloon catheter used to assist guidewire folding provided in this application during the operation is as follows: S1. Establish access via radial artery approach and advance the guiding catheter to the target coronary ostium of the main branch vessel 6; S2. The balloon catheter 5, which is used to assist in guidewire folding, is combined with the main branch guidewire and advanced along the guiding catheter to the bifurcation lesion. S3. Insert the branch guidewire through the branch guidewire irrigation port 203 and push it forward until its tip passes through the branch guidewire outlet 402 and is blocked by the blood vessel wall. S4. Connect a 1mL syringe to the inflation port 202 of balloon 5, inject the medium and inflate balloon 5 to temporarily block blood flow. During the inflation process, the guide groove 501 guides the branch guidewire tip to gradually bend back. S5. As the inflation of balloon 5 changes, the inclination angle of the folded guide groove 501 also gradually changes until the tip of the branch guidewire is visible under fluoroscopy and aligned with the acute-angle branch vessel 7. The branch guidewire is continuously and gently pushed so that it slides along the folded guide groove 501 of balloon 5 and successfully enters the acute-angle branch vessel 7. S6. After the branch guidewire is successfully inserted, immediately apply negative pressure to aspirate the syringe to completely deflate the balloon 5 and restore blood flow. S7. After completing the guidance, withdraw the balloon catheter of the present invention.

[0031] In S4, the syringe is a 1ml syringe containing a 1:1 diluted contrast agent, and 0.3-0.5mL (usually 2-4atm) is slowly injected. Under X-ray fluoroscopy, the balloon 5 is seen to be heart-shaped and slightly anchored to the main branch vessel.

[0032] In other embodiments, the syringe may also inject air to inflate the balloon 5 by air pressure.

[0033] In other embodiments, the syringe may be replaced by a miniature metering pump or other similar solution to inject or extract the filling medium.

[0034] The guiding catheter, main branch guidewire, and branch guidewire used in conjunction with the balloon catheter for assisting guidewire folding provided in this application are all commonly used existing products and are not related to the inventive point of this application, so they will not be described in detail here.

Claims

1. A balloon catheter for assisting guidewire folding, comprising a tube body with an internal main lumen, the tube body sequentially comprising a handle section, an extension section, and a functional section, wherein a rapid exchange lumen inlet is provided on the proximal surface of the extension section, the rapid exchange lumen inlet communicating with the main lumen, and the distal end of the main lumen exits the tube body through a main branch guidewire outlet located at the distal end of the functional section, characterized in that, The tube contains a secondary lumen parallel to the main lumen. The distal end of the secondary lumen exits through a branch guidewire outlet located on the distal sidewall of the functional segment. A pre-shaped balloon is located on the outer periphery of the distal end of the branch guidewire outlet. When inflated, the balloon has a reverse guide groove. The branch guidewire outlet smoothly transitions into the reverse guide groove. When the balloon is inflated, the end of the reverse guide groove points backward to an acute-angled branch vessel forming an acute angle with the main terminal vessel. The handle section is provided with a three-way handle. The surface of the three-way handle is provided with an inflation port, a branch guidewire irrigation port and a catheter outlet. The proximal end of the secondary lumen is connected to the branch guidewire irrigation port. The inflation port is connected to the balloon through an inflation tube located in the tube body.

2. The balloon catheter for assisting guidewire folding according to claim 1, characterized in that, The pre-shaped balloon is heart-shaped, with the tip of the heart facing the distal end of the catheter, and the anti-folding guide groove is located at the concave end of the heart shape.

3. A balloon catheter for assisting guidewire folding according to claim 1, characterized in that, The filling port is equipped with a self-sealing diaphragm or a one-way valve.

4. A balloon catheter for assisting guidewire folding according to claim 1, characterized in that, The balloon is positioned between the main guidewire outlet and the branch guidewire outlet.

5. A balloon catheter for assisting guidewire folding according to claim 1, characterized in that, Radiofrequency imaging marker rings are provided on the outer periphery of the tube body near the outlets of the main guidewire and the branch guidewire, respectively.

6. A balloon catheter for assisting guidewire folding according to claim 1, characterized in that, The distal end of the secondary cavity is smoothly connected to the junction of the branch guidewire outlet.

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