Monofilament balloon dilatation catheter

Abstract

The utility model relates to a monofilament balloon dilatation catheter which is formed by sequentially connecting a handle, a near-end rod, a far-end rod, a balloon and a tip tube, a core wire is arranged in the handle, the near-end rod, the far-end rod, the balloon and the tip tube in a penetrating mode, the far end of the core wire is connected with the tip tube, and the near end of the core wire penetrates out of the handle. Compared with the prior art, no inner tube is arranged in the balloon, and the outlet of the guide wire channel is located at the far end of the balloon. The core wire is wrapped through constraint of the balloon, the near end of the core wire extends out of the near end of the handle so that an operator can control the core wire, the passing outer diameter can be reduced, and meanwhile the balloon can be supported; and the near-end suspended part can control the trend of the far end of the catheter, so that the catheter can reach a target lesion part through tortuous lesion. A guide wire is inserted from the tip end of the catheter and led out from the guide wire channel, when the balloon is expanded, the guide wire can be fixed and guided through the friction force between the balloon and the blood vessel wall, and an interventional instrument which is convenient and easy to operate is provided.

Description

Technical Field

[0001] This utility model relates to a balloon dilation catheter, and more particularly to a monofilament balloon dilation catheter, belonging to the field of medical devices. Background Technology

[0002] Percutaneous transluminal coronary angioplasty (PTCA) commonly involves coronary balloon dilation, stent implantation, rotational atherectomy, and thrombus aspiration. During the procedure, complications such as vascular tortuosity, severe stenosis, occluded segment twisting, calcification, and poor guide catheter support can arise, preventing the balloon from passing through and hindering the delivery of treatment instruments to the lesion site, significantly impacting the success rate. Common methods to overcome vascular tortuosity include coaxial catheter techniques, balloon anchoring, ultra-stiff guidewire support, and long guidewire exchange. Among these, balloon anchoring is more commonly used clinically due to its superior support and high success rate. Balloon anchoring techniques can be further divided into side branch anchoring, distal ipsilateral anchoring, and main branch anchoring. Distal ipsilateral balloon anchoring (i.e., coaxial anchoring) provides stronger support and is more in line with clinical practice.

[0003] Currently, most balloons used for intravascular anchoring are PTCA balloons. However, these devices have a large outer diameter, making balloon retraction difficult after depressurization. Furthermore, when using PTCA balloons for anchoring, two guidewires and two balloons or one balloon and one stent need to be delivered simultaneously, which is challenging for devices with large outer diameters. Therefore, reducing the number of instruments used in PTCA anchoring procedures, decreasing the outer diameter of instruments used in parallel procedures, improving surgical efficiency and cure rates, and reducing the economic burden on patients are urgent clinical problems that need to be addressed. Utility Model Content

[0004] To address the aforementioned technical problems, the main objective of this invention is to provide a monofilament balloon dilation catheter, the technical solution of which is as follows:

[0005] A monofilament balloon dilation catheter is composed of a handle, a proximal rod, a distal rod, a balloon, and a tip tube connected in sequence. A core wire is inserted through the handle, the proximal rod, the distal rod, the balloon, and the tip tube. The distal end of the core wire is connected to the tip tube, and the proximal end of the core wire passes through the handle.

[0006] Preferably, the tip tube is a dual-lumen structure consisting of a guidewire channel and a core wire channel. The distal and proximal ends of the tip tube are respectively provided with openings communicating with the guidewire channel. The distal end of the core wire channel is a closed structure, and the proximal end of the core wire channel is connected to the core wire. The guidewire channel will lead out a guidewire for implantation of a drug-eluting stent or an interventional drug-coated balloon.

[0007] Preferably, the proximal and distal rods are connected in an overlapping manner at their joints. The distal rod is connected to the balloon.

[0008] Preferably, the portion connected by overlapping is made of a flexible material.

[0009] Preferably, the balloon surface is radially provided with balloon papillary structures. Their function is to increase the friction between the balloon and the blood vessel.

[0010] Preferably, the balloon is a cylindrical structure with a constant or variable axial diameter.

[0011] Preferably, the distal and proximal ends of the balloon are respectively provided with a distal imaging marker and a proximal imaging marker.

[0012] Preferably, the handle is connected to the proximal rod via a flexible tube. The handle is used by the surgeon to manipulate the balloon and transmit force. Simultaneously, the handle is connected to the inflation device to expand the balloon. The proximal rod is primarily used to push the balloon to the designated position and is connected to both the handle and the distal rod.

[0013] Preferably, the handle is made of a rigid polymer material.

[0014] Preferably, the mandrel has an axially variable diameter structure, with the distal diameter being smaller than the proximal diameter. The mandrel is fixed only at the distal end, while its proximal end is suspended, with a portion extending beyond the handle. The operator can adjust the mandrel to control the distal end of the catheter to accurately reach the designated position.

[0015] Compared with existing technologies, the advantages of this invention are as follows: There is no inner tube inside the balloon; the guidewire channel outlet is located at the distal end of the balloon. The core wire connects to the tip tube at the distal end and is wrapped by the balloon. The proximal end of the core wire extends beyond the handle, allowing the operator to manipulate it, reducing the outer diameter and supporting the balloon. The proximal suspended portion allows control of the distal catheter's trajectory, facilitating the catheter's passage through tortuous lesions to reach the target lesion. A single guidewire is inserted from the catheter tip and exits through the guidewire channel. When the balloon inflates, the friction between the balloon and the vessel wall can be used to fix the guidewire.

[0016] The guidewire is connected to the balloon dilation catheter only at its tip, making it easy to separate from the balloon dilation catheter. It can deliver two instruments through a single guidewire, simultaneously dilating the lesion and anchoring the guidewire. It can also directly place a stent through the guidewire, reducing the number of instruments used during balloon anchoring and lowering the outer diameter. Its larger filling lumen can reduce the inflation and deflation time and improve surgical efficiency. Attached Figure Description

[0017] Figure 1 This is a schematic diagram of the overall structure of a monofilament balloon dilation catheter according to the present invention;

[0018] Figure 2 This is a schematic diagram of the cross-sectional structure of the shaft of a monofilament balloon dilation catheter according to the present invention;

[0019] Figure 3 This invention relates to a single-filament balloon dilation catheter, including the balloon and the papillary structure of the balloon.

[0020] Figure 4 This is a schematic diagram of the tip cross-sectional structure of a monofilament balloon dilation catheter according to the present invention;

[0021] Figure 5 This is a schematic diagram of another embodiment of the monofilament balloon dilation catheter of this utility model;

[0022] In the diagram: 1. Handle, 2. Tube, 3. Proximal rod, 3-1. Proximal insertion marker, 3-2. Distal insertion marker, 3-3. Flexible structure of the proximal rod, 4. Distal rod, 5. Proximal imaging marker of the balloon, 6. Core wire, 7. Balloon, 7-1. Papillary structure of the balloon, 8. Distal imaging marker of the balloon, 9. Tip tube, 10. Guidewire channel, 11. Guidewire, 12. Connection point between the handle and the proximal rod, 13. Connection point between the proximal rod and the distal rod, 14. Connection point between the distal rod and the balloon, 15. Connection point of the tip tube, 16. Connection point between the balloon and the core wire. Detailed Implementation

[0023] To facilitate understanding and implementation of this utility model by those skilled in the art, the present utility model will be further described in detail below with reference to the accompanying drawings and specific embodiments. The following embodiments are used to illustrate the present utility model, but it should be understood that the protection scope of the present utility model is not limited to the specific embodiments. Example

[0024] like Figure 2 As shown, there is a partial overlap between the proximal rod 3 and the distal rod 4, i.e., they are connected by an overlapping method. The overlapping part is made of metal-based or polymer-based compliant materials or compliant structural materials, such as nickel-titanium alloy braided tubing, polytetrafluoroethylene tubing, etc. Example

[0025] like Figure 3 As shown, a balloon with a papillary structure is presented. To meet different application scenarios, the balloon 7 is a cylindrical structure with a constant or variable axial diameter. Its inflated diameter is 2-5 mm and its length is 15-25 mm. The materials used can be polymers such as nylon or thermoplastic polyurethane. The papillary structure on its surface can be obtained during the molding of the balloon 7, or it can be constructed on the surface after the balloon 7 is molded. Example

[0026] like Figure 4As shown, the tip tube 9 has a dual-lumen structure, including a guidewire channel 10 and a core wire channel. Its function is to implant either a drug-eluting stent or an interventional drug-coated balloon. The core wire channel is connected to the balloon 7 and the core wire 6 to fix the balloon 7 and push the balloon 7 to the designated position. Example

[0027] like Figure 5 As shown, during use, a monofilament balloon dilation catheter of appropriate diameter is selected according to the size of the blood vessel at the lesion site. The monofilament balloon dilation catheter is delivered to the lesion site along the guide wire 11. The dilation balloon 7 pre-dilates the lesion site. After the balloon 7 is depressurized, it is pushed 5-20 mm beyond the distal end of the lesion. The balloon 7 is dilated again, and the guide wire 11 is fixed by the compression between the balloon 7 and the blood vessel wall. After the guide wire 11 is fixed, the drug-eluting stent system can be implanted along the guide wire 11 and delivered to the lesion site. Then the balloon is depressurized and separated from the guide wire 11. The balloon 7 is withdrawn from the body by sliding along the short rail through the core wire 6. The stent position is adjusted according to the lesion condition. The drug-eluting stent system is inflated with an appropriate dilation pressure to dilate the drug-eluting stent. The drug-eluting stent system is fully dilated to ensure that the stent is fully adhered to the wall. After the stent implantation is completed, the delivery balloon part of the drug-eluting stent system is withdrawn from the body. Example

[0028] For lesions located far away and with tortuous blood vessels, the balloon dilation catheter is first delivered to the distal end of the lesion vessel along the guide wire 11. After dilation, the vessel is anchored. The angle of the tip tube 9 is adjusted by pushing the operating handle and adjusting the mandrel 6, and then gently pushed further to facilitate the implantation / intervention of subsequent treatment devices. Example

[0029] The monofilament balloon dilatation catheter contains a core wire 6, which has an axially variable diameter structure, being thinner at the distal end and thicker at the proximal end. The thinner distal end ensures greater flexibility and a smaller outer diameter for the catheter, while the thicker proximal end ensures torque transmission. The distal end of the core wire 6 connects to the tip tube 9, with a connection length of 3-10 mm. The proximal end, extending beyond the handle 1, can be controlled by the operator. By pulling the core wire 6, the direction of the tip tube 9 can be controlled, ensuring the dilatation catheter reaches the lesion smoothly. Especially for lesions with dissection, the operator can adjust the bending angle of the tip tube 9 by controlling the core wire 6 to ensure the dilatation catheter is delivered within the true lumen, thereby improving surgical efficiency. Example

[0030] The handle is made of rigid polymer materials such as polypropylene and polyethylene; the proximal rod is made of non-degradable metal-based or non-degradable polymer-based tubing such as precision metal tubing, braided metal tubing, or polytetrafluoroethylene.

[0031] The embodiments described above are merely the best implementations listed to fully illustrate this utility model patent, and the scope of protection of this application is not limited thereto.

Claims

1. A monofilament balloon dilation catheter, comprising a handle (1), a proximal rod (3), a distal rod (4), a balloon (7), and a tip tube (9) connected sequentially, characterized in that, A core wire (6) is provided through the handle (1), proximal rod (3), distal rod (4), balloon (7) and tip tube (9), with the distal end of the core wire connected to the tip tube (9) and the proximal end of the core wire (6) passing through the handle (1).

2. The monofilament balloon dilation catheter according to claim 1, characterized in that, The tip tube (9) is a dual-cavity structure consisting of a guide wire channel (10) and a core wire channel. The distal and proximal ends of the tip tube (9) are respectively provided with openings that communicate with the guide wire channel (10). The distal end of the core wire channel is a closed structure, and the proximal end of the core wire channel is connected to the core wire (6).

3. The monofilament balloon dilation catheter according to claim 1, characterized in that, The proximal rod (3) and the distal rod (4) are connected by an overlapping method.

4. The monofilament balloon dilation catheter according to claim 3, characterized in that, The parts connected by overlapping are made of a flexible material.

5. The monofilament balloon dilation catheter according to claim 1, characterized in that, The surface of the balloon (7) is radially provided with a balloon papillary structure (7-1).

6. The monofilament balloon dilation catheter according to claim 1, characterized in that, The balloon (7) is a cylindrical structure with equal or variable axial diameter.

7. The monofilament balloon dilation catheter according to claim 1, characterized in that, The balloon (7) has distal imaging markers (8) and proximal imaging markers (5) on its distal and proximal ends, respectively.

8. The monofilament balloon dilation catheter according to claim 1, characterized in that, The handle (1) is connected to the proximal rod (3) via a hose (2).

9. A monofilament balloon dilation catheter according to claim 1, characterized in that, The handle (1) is made of a hard polymer material.

10. A monofilament balloon dilation catheter according to claim 1, characterized in that, The core wire (6) has an axially variable diameter structure, and the diameter of the distal end of the core wire (6) is smaller than that of the proximal end.

Images