Integrated apparatus for vascular dilation and aneurysm coil delivery and use method therefor

Abstract

An integrated apparatus for vascular dilation and aneurysm coil delivery, comprising a catheter (1) and a deformable balloon (2). The catheter (1) is connected to a proximal end of the balloon (2). At least three channels are arranged in the catheter (1): a balloon inflation channel (101), a guide channel (103), and a coil channel (102). The balloon inflation channel (101) is in communication with an inner cavity of the balloon (2) so as to inject the balloon (2) with a contrast agent to expand the balloon (2). The guide channel (103) penetrates through the inner cavity of the balloon (2) from the proximal end of the balloon (2) and out of a distal end of the balloon (2) and is configured for sleeving a micro-guide wire (4) or delivering a stent. The coil channel (102) penetrates through the inner cavity of the balloon (2) from the proximal end of the balloon (2) and out of a side wall of the balloon (2). A coil (3) is arranged in the coil channel (102) in a penetrating manner for delivery of the coil (3). The integrated apparatus is beneficial to efficient, accurate, and stable delivery of the coil and the stent and vascular dilation, thereby reducing the surgical risk.

Description

Integrated device for vasodilation and aneurysm coil delivery and method of use thereof Technical Field

[0001] The present invention relates to the field of medical devices, and in particular to an integrated device for vascular dilation and aneurysm coil delivery and a method for using the device. Background Art

[0002] An aneurysm is a localized or diffuse dilation or bulging of the arterial wall caused by disease or damage to the arterial wall. Aneurysms carry the risk of rupture, and numerous surgical treatment options are available, including surgery and minimally invasive endovascular interventions. Current interventional treatments include simple coil packing, stent-assisted coil packing, balloon-assisted coil packing, flow-directing mesh device implantation, and intra-aneurysm flow-disrupting device implantation. For wide-necked aneurysms, stent-assisted coil packing and balloon-assisted coil packing are currently the mainstream treatment options. However, due to limitations in equipment, each of these procedures requires a separate procedure: pre-implanting a microcatheter for coil placement, followed by stent- or balloon-assisted embolization of the aneurysm. Technical issues

[0003] The problem this brings is that because the microcatheter is pre-implanted separately, it may shift or dislodge during stent or balloon expansion or coil packing, making the surgery difficult and risky. The cumbersome and complex operating procedures significantly increase the operation time, which will increase the surgical risks of local thrombosis, bleeding, contrast agent-related, and anesthesia-related. For some aneurysms with combined parent artery stenosis, traditional surgical methods based on existing equipment cannot simultaneously reduce the dual risks of ischemia caused by vascular stenosis and bleeding caused by aneurysm rupture. Technical Solutions

[0004] The purpose of the present invention is to provide an integrated device for vascular dilation and aneurysm coil placement and a method for using the same. The integrated device is easy to operate, can simplify the operating steps, shorten the operation time, and is conducive to completing the operation efficiently, accurately and stably, thereby reducing surgical risks.

[0005] In order to achieve the above-mentioned purpose, the technical solution adopted by the present invention is: an integrated device for vascular dilation and aneurysm coil delivery, comprising a catheter and a changeable balloon, the catheter being connected to the proximal end of the balloon, and the catheter having at least three channels: a balloon filling channel, a guide channel and a coil channel, the balloon filling channel being connected to the inner cavity of the balloon to fill the balloon to expand it, the guide channel passing through the inner cavity of the balloon from the proximal end of the balloon and exiting from the distal end of the balloon, and being used for sheathing a microguidewire or delivering a stent, the coil channel passing through the inner cavity of the balloon from the proximal end of the balloon and exiting from the side wall of the balloon, and a coil being passed through the coil channel to deliver the coil.

[0006] Furthermore, the balloon and catheter are sheathed on the micro-guidewire through the guide channel, and reach the target position under the guidance of the micro-guidewire during operation; when the stent needs to be deployed, the micro-guidewire is withdrawn and the stent is deployed from the distal end of the balloon along the guide channel.

[0007] Furthermore, the balloon is formed with a fluid channel along the distal and proximal directions, the fluid channel is isolated from the inner cavity of the balloon and passes through the distal and proximal ends of the balloon so that the fluid can still pass through the balloon after the balloon is filled.

[0008] Furthermore, the catheter is provided with a plurality of coil channels, and the plurality of coil channels all pass through the same side of the balloon so as to simultaneously deliver coils to the aneurysm during operation.

[0009] Furthermore, the catheter is provided with a plurality of spring coil channels, and the plurality of spring coil channels respectively pass through different sides of the balloon so as to selectively release the spring coils in corresponding directions during operation.

[0010] Furthermore, except for the balloon filling channel which is connected to the balloon lumen, the other channels are isolated from the balloon lumen.

[0011] Furthermore, the various channels are integrated into one catheter, and the various channels are separated at the proximal end of the catheter, which are used to connect a contrast agent filling device, insert a spring coil, place a stent, or realize other corresponding functions.

[0012] Furthermore, metal marks are provided on the distal and proximal ends of the balloon and the exit end of the spring coil channel on the balloon side wall, respectively, so as to facilitate positioning of the balloon and the spring coil placement position during operation.

[0013] The present invention also provides a method for using the above-mentioned integrated device for vascular dilation and aneurysm coil delivery, comprising:

[0014] 1) Place the balloon and catheter over the microguidewire through the guide channel;

[0015] 2) The balloon and catheter reach the target location under the guidance of the microguidewire;

[0016] 3) Adjust the direction of the spring channel outlet so that it is facing the object to be filled;

[0017] 4) Inject contrast agent into the balloon through the balloon filling channel to expand the balloon and seal the object to be filled, preventing the spring coil from falling out during the filling process;

[0018] 5) Place the spring coil into the object to be filled through the spring channel.

[0019] Furthermore, after the coil is deployed, if it is necessary to dilate the stenotic blood vessel, the balloon is aligned with the position of the stenotic blood vessel and contrast agent is injected into the balloon to achieve the purpose of dilating the stenotic blood vessel; if it is necessary to deploy a stent into the blood vessel, the microguidewire is withdrawn from the proximal end of the guide channel and the contrast agent injected into the balloon is withdrawn, and then the stent is transported along the guide channel and deployed from the distal end of the balloon, thereby achieving the simultaneous and step-by-step completion of blood vessel dilation, aneurysm coil deployment and stent deployment through the integrated device. Beneficial effects

[0020] Compared with the prior art, the present invention has the following beneficial effects: the present invention combines a balloon for expanding blood vessels and a microcatheter for placing spring coils into an integrated device. The integrated device is easy to operate and does not require pre-buried spring coil microcatheters, which can simplify the operating steps, avoid displacement or dislodgment of the spring coil microcatheter during the operation, ensure efficient and accurate placement of the spring coils, and shorten the operation time. Only one catheter is needed to simultaneously solve the problems of vascular stenosis and aneurysm, solving the aneurysm without aggravating the vascular stenosis, solving the vascular stenosis problem without causing aneurysm rupture due to increased blood flow, and minimizing the dual risks of ischemia caused by vascular stenosis and bleeding caused by aneurysm. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] FIG1 is a schematic structural diagram of an integrated device according to a first embodiment of the present invention (without a spring coil);

[0022] FIG2 is a partial enlarged schematic diagram of FIG1 ;

[0023] FIG3 is a schematic diagram of a first working state of the integrated device according to the first embodiment of the present invention;

[0024] FIG4 is a schematic diagram of a second working state of the integrated device according to the first embodiment of the present invention;

[0025] FIG5 is a schematic diagram of the expanded state of the integrated device according to the second embodiment of the present invention (without the spring coil). Modes for Carrying Out the Invention

[0026] The present invention will be further described below with reference to the accompanying drawings and embodiments.

[0027] It should be noted that the following detailed descriptions are exemplary and are intended to provide further explanation of the present application. Unless otherwise specified, all technical and scientific terms used herein have the same meaning as commonly understood by those skilled in the art to which the present application belongs.

[0028] It should be noted that the terms used herein are only for describing specific embodiments and are not intended to limit the exemplary embodiments according to the present application. As used herein, unless the context clearly indicates otherwise, the singular form is also intended to include the plural form. In addition, it should be understood that when the terms "comprise" and / or "include" are used in this specification, they indicate the presence of features, steps, operations, devices, components and / or combinations thereof.

[0029] As shown in Figures 1-4, this embodiment provides an integrated device for vascular dilation and aneurysm coil delivery, including a catheter 1 and a variable balloon 2. The catheter 1 is connected to the distal end of the balloon 2. The catheter 1 has at least three channels: a balloon filling channel 101, a guide channel 103 and a coil channel 102. The balloon filling channel 101 is connected to the inner cavity of the balloon 2 to fill the balloon with contrast agent to expand it. The guide channel 103 passes through the inner cavity of the balloon 2 from the proximal end of the balloon and exits from the distal end of the balloon 2, and is used to sheath a microguidewire 4 or deliver a stent. The coil channel 102 passes through the inner cavity of the balloon 2 from the distal end of the balloon 2 and exits from the side wall of the balloon 2. A coil 3 is inserted into the coil channel 102 to deliver the coil 3 to the aneurysm 6 during operation.

[0030] The balloon 2 and catheter 1 are sheathed on the micro-guidewire 4 through the guide channel 103 and, during operation, are guided by the micro-guidewire 4 to the target location, i.e., the location of the lesion in the blood vessel 5. When a stent needs to be deployed, the micro-guidewire is withdrawn through the guide channel 103 and the stent is deployed from the distal end of the balloon along the guide channel 103.

[0031] In this integrated device, except for the balloon filling channel 101, which communicates with the inner lumen of the balloon 2, all other channels are isolated from the inner lumen of the balloon 2 and the balloon filling channel 101. That is, when the other channels pass through the balloon, the connections between the channels and the balloon are sealed, ensuring that each channel can operate independently without interfering with each other. Each channel is integrated into a single catheter 1, the distal end of which is connected to the proximal end of the balloon 2. Separate channels are separated from the rear end of the catheter 1 to perform corresponding functions such as connecting a contrast agent filling device, inserting a spring coil, inserting a microguidewire, and deploying a stent.

[0032] The method for using the above-mentioned integrated device for vascular dilation and aneurysm coil delivery comprises:

[0033] 1) Place the balloon and catheter over the microguidewire through the guide channel;

[0034] 2) The balloon and catheter reach the target location under the guidance of the microguidewire;

[0035] 3) Adjust the direction of the spring channel outlet so that it is facing the object to be filled;

[0036] 4) Inject contrast agent into the balloon through the balloon filling channel to expand the balloon and block the object to be filled, preventing the spring coil from falling out during the filling process;

[0037] 5) Place the spring coil into the object to be filled through the spring channel.

[0038] After the coil is deployed, if it is necessary to dilate the stenotic blood vessel, the balloon is aligned with the position of the stenotic blood vessel and contrast agent is injected into the balloon to achieve the purpose of dilating the stenotic blood vessel; if it is necessary to deploy a stent into the blood vessel, the microguidewire is withdrawn from the proximal end of the guide channel and the contrast agent injected into the balloon is withdrawn, and then the stent is transported along the guide channel and deployed from the distal end of the balloon, thereby achieving the simultaneous and step-by-step completion of blood vessel dilation, aneurysm coil deployment and stent deployment through the integrated device.

[0039] In this embodiment, metal marks 7, 8, and 9 are respectively provided on the distal and proximal ends of the balloon 2 and the end where the spring coil passage of the side wall of the balloon 2 passes through, so as to facilitate positioning of the balloon and the spring coil placement during operation.

[0040] Balloon-assisted coil tamponade can temporarily block blood vessels during surgery, resulting in poor blood flow. To address this issue, as shown in Figure 5 , in Example 2, the balloon is formed with fluid channels 10 along the proximal and distal directions. These channels are isolated from the balloon lumen and extend through the proximal and distal ends of the balloon, allowing fluid to flow through the balloon even after it is inflated.

[0041] In order to improve the efficiency of coil delivery, in a preferred embodiment of the present invention, several coil channels can be set in the catheter and corresponding metal markers can be set. The several coil channels all pass through the same side of the balloon so that the coils can be delivered to the aneurysm at the same time during operation.

[0042] In order to avoid the need to adjust the direction of coil delivery to face the aneurysm during operation, in a preferred embodiment of the present invention, several coil channels can be set in the catheter and corresponding metal markers can be set. The several coil channels respectively pass through different sides of the balloon to select the corresponding direction for coil delivery during operation.

[0043] The integrated device provided by the present invention can be manufactured and implemented by any feasible method such as integrated injection molding, and will not be further described here.

[0044] During operation, the integrated device provided by the present invention places the balloon 2 and catheter 1 over the microguidewire 4 via the guide channel 103. Guided by the microguidewire 4 and guided by the metal markers 7 and 8, the balloon 2 and catheter 1 are positioned at the lesion site. Then, guided by the metal marker 9, the orientation of the outlet of the spring channel 102 is adjusted so that it faces the aneurysm. Next, a contrast agent is injected into the balloon 2 via the balloon filling channel 101 using a contrast agent injection device, causing the balloon to expand and occlude the aneurysm, preventing the coils from dislodging during the occlusion process. The coils 3 are then deployed through the spring channel 102 toward the aneurysm. After coil deployment, if a stenotic vessel needs to be dilated, the balloon is aligned with the stenotic vessel and contrast agent is injected into the balloon to achieve this. If a stent needs to be deployed into the vessel, the microguidewire is removed from the proximal end of the guide channel, removing the contrast agent injected into the balloon. The stent is then transported along the guide channel and released from the distal end of the balloon.

[0045] The above description is merely a preferred embodiment of the present invention and is not intended to limit the present invention in any other manner. Any person skilled in the art may utilize the above-disclosed technical content to modify or modify the present invention into equivalent embodiments. However, any simple modifications, equivalent variations, and modifications to the above embodiments that do not depart from the technical content of the present invention and are based on the technical essence of the present invention remain within the scope of protection of the present invention.

Claims

1. An integrated device for vascular dilation and aneurysm coil placement, characterized in that: The invention comprises a catheter and a changeable balloon, wherein the catheter is connected to the proximal end of the balloon and has at least three channels therein: a balloon filling channel, a guide channel and a coil channel. The balloon filling channel is in communication with the inner cavity of the balloon so as to fill the balloon with a contrast agent to expand the balloon. The guide channel passes through the inner cavity of the balloon from the proximal end of the balloon and exits from the distal end of the balloon and is used for sheathing a microguidewire or placing a stent. The coil channel passes through the inner cavity of the balloon from the proximal end of the balloon and exits from the side wall of the balloon. A coil is inserted into the coil channel for placing the coil.

2. The integrated device for vascular dilation and aneurysm coil placement according to claim 1, characterized in that: The balloon and catheter are sheathed on the micro-guidewire through the guide channel and reach the target position under the guidance of the micro-guidewire during operation; when a stent needs to be deployed, the micro-guidewire is withdrawn and the stent is deployed from the distal end of the balloon along the guide channel.

3. The integrated device for vascular dilation and aneurysm coil placement according to claim 1, characterized in that: The balloon is formed with a fluid channel along the distal and proximal directions. The fluid channel is isolated from the inner cavity of the balloon and passes through the distal and proximal ends of the balloon so that the fluid can still pass through the balloon after the balloon is filled.

4. The integrated device for vascular dilation and aneurysm coil placement according to claim 1, characterized in that: The catheter is provided with a plurality of spring coil channels, and the plurality of spring coil channels all pass through the same side of the balloon so as to simultaneously deliver the spring coils to the aneurysm during operation.

5. The integrated device for vascular dilation and aneurysm coil placement according to claim 1, characterized in that: The catheter is provided with a plurality of spring coil channels, which respectively pass through different sides of the balloon so as to selectively release the spring coils in corresponding directions during operation.

6. The integrated device for vascular dilation and aneurysm coil placement according to claim 1, characterized in that: Except for the balloon filling channel which is connected to the balloon lumen, the other channels are isolated from the balloon lumen.

7. The integrated device for vascular dilation and aneurysm coil placement according to claim 1, characterized in that: Each channel is integrated into a catheter, and each channel is separated at the proximal end of the catheter, which is used to connect a contrast agent filling device, insert a spring coil, place a stent, or realize other corresponding functions.

8. The integrated device for vascular dilation and aneurysm coil placement according to claim 1, characterized in that: The distal and proximal ends of the balloon and the exit end of the spring coil channel on the balloon side wall are respectively provided with metal marks, so as to facilitate the positioning of the balloon and the spring coil placement position during operation.

9. The method for using the integrated device for vascular dilation and aneurysm coil placement according to claim 1, characterized in that: include: 1) Place the balloon and catheter over the microguidewire through the guide channel; 2) The balloon and catheter reach the target location under the guidance of the microguidewire; 3) Adjust the direction of the spring channel outlet so that it is facing the object to be filled; 4) Inject contrast agent into the balloon through the balloon filling channel to expand the balloon and seal the object to be filled, preventing the spring coil from falling out during the filling process; 5) Place the spring coil into the object to be filled through the spring channel.

10. The method for using the integrated device for vascular dilation and aneurysm coil placement according to claim 9, characterized in that: After the coil is deployed, if it is necessary to dilate the stenotic blood vessel, the balloon is aligned with the position of the stenotic blood vessel and contrast agent is injected into the balloon to achieve the purpose of dilating the stenotic blood vessel; if it is necessary to deploy a stent into the blood vessel, the microguidewire is withdrawn from the proximal end of the guide channel and the contrast agent injected into the balloon is withdrawn, and then the stent is transported along the guide channel and deployed from the distal end of the balloon, thereby achieving the simultaneous and step-by-step completion of blood vessel dilation, aneurysm coil deployment and stent deployment through the integrated device.

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