Carotid composite balloon catheter

Abstract

The utility model provides a carotid artery composite balloon catheter relates to medical instrument technical field, including catheter body, proximal end balloon, far end balloon, first reinforced catheter and second reinforced catheter, first reinforced catheter and second reinforced catheter are sequentially arranged along the axial direction of catheter body, and the hardness of first reinforced catheter and second reinforced catheter is all greater than the hardness of catheter body, and proximal end balloon and far end balloon are connected on first reinforced catheter and second reinforced catheter respectively, when the balloon is filled, and the outer diameter of far end balloon is greater than the outer diameter of proximal end balloon, realize far end protection, and the effect of proximal end pressure expansion, solve the problem that plaque shedding causes the embolism of far end blood vessel, the operation difficulty, first reinforced catheter and second reinforced catheter play the effect of preventing the mixed liquid of saline and contrast medium extruding catheter body when the balloon is filled, thereby avoid causing the problem of the inside cavity space of catheter narrowing, influence the problem of the patency of inserted instrument.

Description

Technical Field

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

[0002] Carotid artery stenosis refers to the narrowing of the lumen of the carotid artery, the most common cause being atherosclerotic plaques in the carotid artery. The unique hemodynamic characteristics at the carotid bifurcation make this area prone to atherosclerosis. Most patients have mild to moderate-sized plaques, while some develop severe stenosis. A small percentage of plaques may rupture and become emboli, blocking intracranial arteries and leading to transient ischemic attacks (TIAs) or stroke. The incidence of carotid artery stenosis increases with age, and it is more common in middle-aged and elderly people. The incidence is higher in men than in women, and smoking, hypertension, hyperlipidemia, and diabetes are high-risk factors. In stroke patients, ischemic stroke accounts for 74%, and approximately 30% of these strokes are caused by extracranial carotid artery stenosis.

[0003] There are various treatment methods for carotid artery stenosis, among which surgical treatment uses intracranial balloon catheters. However, current intracranial balloon catheters have problems such as plaque detachment causing distal vessel embolism and operational difficulties. In order to address the above-mentioned shortcomings, this application is proposed. Utility Model Content

[0004] The purpose of this invention is to provide a carotid artery composite balloon catheter with a distal balloon and a proximal balloon, which can protect the distal end and perform proximal inflation, thus solving the problems of plaque detachment causing distal vascular embolism and operational difficulties.

[0005] To address the aforementioned problems, this invention provides a carotid artery composite balloon catheter, comprising a catheter body, a proximal balloon, a distal balloon, a first reinforcing catheter, and a second reinforcing catheter. The first and second reinforcing catheters are sequentially arranged along the axial direction of the catheter body and fitted onto the catheter body. They can be connected to the catheter body by adhesive bonding. The second reinforcing catheter is located near the distal end of the catheter. The rigidity of both the first and second reinforcing catheters is greater than that of the catheter body. This is to prevent the mixture of saline and contrast agent from squeezing the catheter during balloon inflation, thereby avoiding the problem of reduced internal space of the catheter and affecting the patency of insertion devices. The proximal and distal balloons are respectively connected to the first and second reinforcing catheters. When the balloons are inflated, the outer diameter of the distal balloon is larger than that of the proximal balloon, achieving distal protection and proximal decompression. This solves the problem of distal vessel embolism and operational difficulties caused by plaque detachment. At least one of the proximal and distal balloons is provided with a contrast-enhancing structure for imaging during surgical procedures to indicate the location of the balloon.

[0006] Preferably, the hardness of both the first reinforcing catheter and the second reinforcing catheter is at least twice that of the catheter body.

[0007] According to one embodiment of the present invention, the catheter body is provided with an interventional device channel, a proximal balloon filling channel and a distal balloon filling channel. The proximal balloon filling channel and the distal balloon filling channel are both located at the center of the annulus of the catheter body, and the distance to the outer edge of the annulus is equal to the distance to the inner edge of the annulus, ensuring that the material inside the annulus is uniform.

[0008] According to one embodiment of the present invention, the catheter body has a catheter end, which is tapered in design. The outer diameter of this part of the catheter gradually decreases, and the outer diameter of the final end is half of that at the initial position. The purpose is to improve the efficiency of insertion into the blood vessel and reduce the resistance of the device when inserted into the blood vessel.

[0009] According to one embodiment of the present invention, the proximal balloon is provided with a protruding reinforcing structure to improve the strength of the proximal balloon, provide a stable inflation effect, and increase friction to improve the position retention capability of the proximal balloon.

[0010] According to one embodiment of the present invention, the reinforcing structure includes a plurality of protruding reinforcing ribs disposed on the proximal balloon, and the plurality of reinforcing ribs are uniformly arranged in an array along the circumference of the proximal balloon.

[0011] According to one embodiment of the present invention, the reinforcing structure includes a plurality of protruding balloons disposed on the outer surface of the proximal balloon.

[0012] According to one embodiment of the present invention, the maximum outer diameter of the proximal balloon after inflation is equal to the inner diameter of the blood vessel, and when the balloon is fully inflated, the outer diameter of the distal balloon is ≥ three times the outer diameter of the proximal balloon.

[0013] According to one embodiment of the present invention, when the balloon is fully inflated, the length of the proximal balloon is equal to the length of the distal balloon.

[0014] According to one embodiment of the present invention, the first reinforcing conduit and / or the second reinforcing conduit include a braided layer, wherein the braided layer is braided with stainless steel wire, nickel-titanium alloy wire, tungsten wire or polymer wire, and the braiding form is a straight grid, a diagonal grid or a single layer of diagonal winding.

[0015] Furthermore, the braided layer serves as the outer layer for reinforcing the catheter.

[0016] According to one embodiment of the present invention, the inner layer of the catheter body is made of a low-friction coefficient material, such as polytetrafluoroethylene (PTFE) and polyoxymethylene (POM), which serves to reduce the resistance encountered by the interventional device in sliding freely within the interventional device cavity.

[0017] According to one embodiment of the present invention, the distance between the proximal balloon and the distal balloon is 1~2cm.

[0018] According to one embodiment of the present invention, both the proximal balloon and the distal balloon are provided with a imaging structure. The imaging structure can be selected as imaging wires, imaging points, etc., preferably imaging wires. The imaging wires are embedded in the balloon and arranged around the circumference of the balloon axis to perform imaging during the surgical procedure and indicate the location of the distal balloon.

[0019] Furthermore, the developing wires are all made of metal materials containing platinum.

[0020] The beneficial effects of this invention are as follows: by setting a distal balloon and a proximal balloon, when the balloon is inflated, the outer diameter of the distal balloon is larger than that of the proximal balloon, achieving the effect of distal protection and proximal decompression, thus solving the problems of distal vascular embolism and operational difficulties caused by plaque detachment; by setting a first reinforcing catheter and a second reinforcing catheter, both of which are harder than the catheter body, the mixed liquid of saline and contrast agent can be used to prevent the catheter body from being squeezed by the balloon during inflation, thereby avoiding the problem of narrowing of the internal cavity space of the catheter and affecting the patency of the inserted device. Attached Figure Description

[0021] The present invention will be further described below with reference to the accompanying drawings and embodiments.

[0022] Figure 1 A schematic diagram of the overall structure of the carotid artery composite balloon catheter;

[0023] Figure 2 This is an enlarged structural diagram of the proximal balloon.

[0024] Figure 3 This is an enlarged structural diagram of the distal balloon.

[0025] Figure 4 This is an enlarged structural diagram of the catheter body;

[0026] Figure 5 This is a schematic diagram of the cross-section of the catheter body;

[0027] Figure 6 Diagram of the proximal balloon structure with reinforcing ribs;

[0028] Figure 7 Diagram of a proximal balloon structure with a protruding balloon.

[0029] Figure 8 This is a cross-sectional view of the proximal balloon.

[0030] Figure 9 This is a schematic diagram of the first reinforcing catheter structure;

[0031] Figure 10This is a schematic diagram of the first reinforcing catheter braided wire structure;

[0032] Figure 11 A detailed structural diagram of the distal balloon;

[0033] Figure 12 This is a map showing the distribution of balloons. Detailed Implementation

[0034] The following description is only intended to disclose the present invention so that those skilled in the art can implement it. The embodiments in the following description are merely examples, and those skilled in the art will conceive of other obvious modifications. The basic principles of the present invention defined in the following description can be applied to other embodiments, modifications, improvements, equivalents, and other solutions that do not depart from the spirit and scope of the present invention.

[0035] Example 1:

[0036] A carotid artery composite balloon catheter, such as Figures 1-3 As shown, it includes a catheter body 1, a proximal balloon 2, a distal balloon 3, a first reinforcing catheter 4, and a second reinforcing catheter 5.

[0037] A first reinforcing catheter 4 and a second reinforcing catheter 5 are respectively disposed on the outer surface of the catheter body 1. A proximal balloon 2 is disposed on the first reinforcing catheter 4, and a distal balloon 3 is disposed on the second reinforcing catheter 5.

[0038] like Figure 2 As shown, a first reinforcing catheter 4 is embedded in the proximal balloon 2, and then the first reinforcing catheter 4 is sheathed on the catheter body 1 and fixed with glue to prevent the mixture of saline and contrast agent from squeezing the catheter when the balloon is inflated, thereby reducing the internal cavity space of the catheter and affecting the patency of the inserted device.

[0039] Similarly, such as Figure 3 As shown, a second reinforcing catheter 5 is embedded in the distal balloon 3, and then the second reinforcing catheter 5 is sheathed on the catheter body 1; this prevents the mixture of saline and contrast agent from squeezing the catheter when the balloon is inflated, thereby reducing the internal cavity space of the catheter and affecting the patency of the inserted device.

[0040] The first reinforcing catheter 4 and the second reinforcing catheter 5 are preferably made of the same material, and their hardness is at least twice that of the catheter.

[0041] like Figure 4 , Figure 5 As shown, the catheter body 1 is provided with an interventional device channel 11, a proximal balloon inflation channel 12, a distal balloon inflation channel 13, an inner layer of the catheter 14, and a distal end of the catheter 15.

[0042] The proximal balloon inflation channel 12 is used to inflate the proximal balloon 2 with a mixture of saline and contrast agent, and the distal end of the channel is connected to the interior of the proximal balloon 2.

[0043] The distal balloon inflation channel 13 is used to inflate the distal balloon 3 with a mixture of saline and contrast agent, and the distal end of the channel is connected to the interior of the distal balloon.

[0044] The inner diameter d1 of the proximal balloon filling channel 12 and the distal balloon filling channel 13 are equal and symmetrical about the center of the interventional device channel. The filling channels are located at the center of the ring, and the distances to the outer edge and the inner edge of the ring are equal to ensure that the material inside the ring is uniform.

[0045] The interventional device channel 11 is used for the free entry and exit of interventional device products, and the inner diameter d2 is large enough to accommodate a 14F guidewire.

[0046] The inner layer 14 of the catheter is made of a material with a low coefficient of friction, such as polytetrafluoroethylene (PTFE) and polyoxymethylene (POM), which reduces the resistance encountered by the interventional device in sliding freely within the interventional device cavity.

[0047] The catheter tip 15 adopts a tapered design, with the outer diameter of the catheter gradually decreasing. The outer diameter of the final end is half that of the initial position. This is to improve the efficiency of insertion into the blood vessel and reduce the resistance of the device when inserted into the blood vessel.

[0048] The proximal balloon 2 is made of one or a combination of Nylon 66, Pebax, and PET materials.

[0049] When filled with a mixture of saline and contrast agent, the proximal balloon 2 expands uniformly circumferentially along the catheter axis, with the outer diameter of the balloon increasing proportionally to the inflated fluid pressure. The proximal balloon can withstand pressures up to 14 atm without rupturing.

[0050] The relationship between the expansion of the balloon's outer diameter and the filling liquid pressure is: d3=kp1; where p1 is the filling liquid pressure and k is the material coefficient.

[0051] The maximum outer diameter of d3 is equal to the inner diameter of the blood vessel. When d3 reaches its maximum, d3 will not increase with the increase of the filling fluid pressure.

[0052] like Figure 8 The overall length L1 of the proximal balloon 2 is 5~50mm, and the thickness T1 of the proximal balloon 2 is less than 0.2mm.

[0053] like Figure 6 Several radiopaque fibers 22 are embedded inside the proximal balloon 2, arranged circumferentially along the balloon axis. These fibers are used for imaging during surgical procedures to indicate the location of the proximal balloon.

[0054] A reinforcing structure 21 is provided on the outer surface of the balloon to improve the strength of the proximal balloon, provide a stable inflation effect, and improve the position retention capability of the proximal balloon 2. In this embodiment, the reinforcing structure 21 includes several protruding reinforcing ribs, the cross-sectional shape of which is a semi-circular arc or an ellipse; the reinforcing ribs are arranged in a circumferential array along the outer surface of the balloon, with at least 6 reinforcing ribs.

[0055] like Figure 9 As shown, the first reinforcing catheter 4 includes: an outer layer 41 of the first reinforcing catheter and a through hole 42, the through hole 42 being equal to the inner diameter of the filling cavity; during installation, the through hole is concentric with the distal ends of the proximal balloon filling cavity 12 and the distal balloon filling cavity 13, respectively, to ensure that the mixture of saline and contrast agent can enter the balloon through the catheter filling cavity.

[0056] The outer layer 41 of the first reinforcing catheter is made of braided filaments, using materials such as stainless steel wire, nickel-titanium alloy wire, tungsten wire, nylon wire, polyester wire, and other polymer filaments; Figure 10 As shown, the weaving layer has the following three forms: a) straight grid type, b) diagonal grid type, and c) single-layer diagonal winding.

[0057] The methods for fixing the outer layer and inner layer of the first reinforcing conduit 4 can be: 1. Heating the outer and inner layers for heat fusion fixation; 2. Coating the inner part of the outer layer with glue and then bonding it to the inner layer.

[0058] The braided wire is used to strengthen the rigidity of the conduit, protect the conduit, and enhance the structural strength and pressure resistance of this part.

[0059] Optionally, the second reinforcing catheter 5 may adopt the same structural form as the first reinforcing catheter 4.

[0060] like Figure 11 As shown, the distal balloon 3 is made of one or a mixture of PVC, POC, PU, ​​PE, Nylon, and PET.

[0061] d4 is the outer diameter of the distal balloon 3, L2 is the overall length of the distal balloon 3, and when the balloon is fully inflated: d4≥3d3; L1=L2; the thickness of the distal balloon is equal to the thickness of the proximal balloon.

[0062] When filled with a mixture of saline and contrast agent, the distal balloon 3 preferentially expands towards the area with the least resistance to vascular dissection. At its maximum expansion, d4 does not exceed three times the inner diameter of the diseased vessel. When encountering varying resistance from the vascular dissection, the distal balloon 3 preferentially expands towards the area with less resistance. This characteristic allows the distal balloon 3 to adapt to various tortuous and irregular vessel shapes, further facilitating its complete adherence to the vessel wall.

[0063] Several imaging wires 31 are embedded inside the distal balloon 3. The imaging wires are arranged circumferentially along the axis of the balloon and are used to visualize the balloon during the surgical procedure to indicate the location of the distal balloon.

[0064] Preferably, the developing wires are all made of metal materials containing platinum.

[0065] like Figure 12 As shown, L3 is the overall length of the catheter body 1, L4 is the distance between the distal balloon 3 and the catheter tip, L5 is the distance between the proximal balloon 2 and the catheter tip, and L6 is the spacing between the balloons, where L3 = 145cm, L4 = 3cm, L5 = 135cm, and L6 = 1~2cm.

[0066] Example 2:

[0067] Unlike in Example 1, as Figure 7 As shown, the reinforcing structure 21 consists of several circular or elliptical protruding balloons disposed on the outer surface of the proximal balloon 2.

[0068] Those skilled in the art should understand that the embodiments of the present invention described above and shown in the accompanying drawings are merely examples and do not limit the present invention. The purpose of the present invention has been fully and effectively achieved. The functional and structural principles of the present invention have been shown and explained in the embodiments. Without departing from the stated principles, the implementation of the present invention may have any variations and modifications.

Claims

1. A carotid artery composite balloon catheter, characterized in that: The catheter includes a catheter body (1), a proximal balloon (2), a distal balloon (3), a first reinforcing catheter (4), and a second reinforcing catheter (5). The first reinforcing catheter (4) and the second reinforcing catheter (5) are arranged sequentially along the axial direction of the catheter body (1) and are fitted over the catheter body (1). The hardness of the first reinforcing catheter (4) and the second reinforcing catheter (5) is greater than that of the catheter body (1). The proximal balloon (2) and the distal balloon (3) are respectively connected to the first reinforcing catheter (4) and the second reinforcing catheter (5). The first reinforcing catheter (4) and the second reinforcing catheter (5) are used to prevent the catheter body (1) from being squeezed when the balloon is inflated, thus avoiding damage to the catheter body (1). The internal cavity space is reduced, affecting the patency of the inserted device. The first reinforcing catheter (4) and the second reinforcing catheter (5) both include a braided layer made of woven wire. The proximal balloon (2) is provided with a raised reinforcing structure (21). The reinforcing structure (21) is distributed along the axial and circumferential directions of the proximal balloon (2). The reinforcing structure (21) is used to improve the strength of the proximal balloon (2), provide a stable inflation effect, and improve the position retention ability of the proximal balloon (2). When the balloon is inflated, the outer diameter of the distal balloon (3) is larger than the outer diameter of the proximal balloon (2). At least one of the proximal balloon (2) and the distal balloon (3) is provided with a radiopaque structure.

2. The carotid artery composite balloon catheter according to claim 1, characterized in that: The catheter body (1) is provided with an interventional device channel (11), a proximal balloon filling channel (12) and a distal balloon filling channel (13). The proximal balloon filling channel (12) and the distal balloon filling channel (13) are both located at the center of the annulus of the catheter body (1), and the distance to the outer edge of the annulus is equal to the distance to the inner edge of the annulus.

3. The carotid artery composite balloon catheter according to claim 1, characterized in that: The reinforcing structure (21) includes a plurality of protruding reinforcing ribs disposed on the proximal balloon (2), the plurality of reinforcing ribs extending along the axial direction of the proximal balloon (2) and distributed along its circumferential direction.

4. The carotid artery composite balloon catheter according to claim 1, characterized in that: The reinforcing structure (21) includes a plurality of protruding balloons disposed on the outer surface of the proximal balloon (2).

5. The carotid artery composite balloon catheter according to any one of claims 1-4, characterized in that: The maximum outer diameter of the proximal balloon (2) after inflation is equal to the inner diameter of the blood vessel. When the balloon is fully inflated, the outer diameter of the distal balloon (3) is ≥ three times the outer diameter of the proximal balloon (2).

6. The carotid artery composite balloon catheter according to claim 5, characterized in that: When the balloon is fully inflated, the length of the proximal balloon (2) is equal to the length of the distal balloon (3).

7. The carotid artery composite balloon catheter according to any one of claims 1-4, characterized in that: The braided layers of the first reinforcing catheter (4) and the second reinforcing catheter (5) are made of stainless steel wire, nickel-titanium alloy wire, tungsten wire or polymer wire, and the braiding form is a straight grid, a diagonal grid or a single layer of diagonal winding.

8. The carotid artery composite balloon catheter according to claim 7, characterized in that: The inner layer (14) of the catheter body (1) is made of a material with a low coefficient of friction.

9. The carotid artery composite balloon catheter according to claim 6, characterized in that: Both the proximal balloon (2) and the distal balloon (3) are provided with imaging structures.

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