CN212853572U - Balloon catheter for thrombus removal - Google Patents
Balloon catheter for thrombus removal Download PDFInfo
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- CN212853572U CN212853572U CN202022242726.XU CN202022242726U CN212853572U CN 212853572 U CN212853572 U CN 212853572U CN 202022242726 U CN202022242726 U CN 202022242726U CN 212853572 U CN212853572 U CN 212853572U
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- thrombus
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Abstract
The application relates to a thrombus taking balloon catheter, which comprises a balloon, a catheter body, a connecting piece and a catheter seat, wherein the balloon is nested outside the catheter body to form a balloon cavity, a thread guide cavity is formed in the catheter body, a thread guide inlet of the thread guide cavity is formed in the middle of the catheter body, a thread guide outlet of the thread guide cavity is formed at the far-side section end of the catheter body, and the connecting piece is connected with the balloon cavity, so that fluid can be injected through the connecting piece to expand the balloon; wherein, the periphery of the balloon is provided with a bulge which protrudes outwards along the circumferential direction of the embolectomy balloon catheter, and when the balloon is in an expanded state, the bulge is unfolded to scrape thrombus in a blood vessel, so that the thrombus falls off. The thrombus removal balloon catheter can be used for removing thrombus simply and conveniently.
Description
Technical Field
The present application relates to a medical device, and more particularly, to an embolectomy balloon catheter.
Background
Acute ischemic stroke is damage to nervous tissue caused by ischemic necrosis of local brain tissue due to sudden blockage of blood flow to the brain. Emboli or thrombus blockage can be seen in 70-80% of patients with severe symptoms who require arteriography. The lethality of larger vessel embolism is 53% -92%. The recanalization of blood vessels is the key to the treatment of acute ischemic stroke. The current conventional methods for treating acute ischemic stroke include two major categories, interventional thrombolysis and mechanical embolectomy.
The interventional thrombolysis is that the thrombolysis machine is injected into the vicinity of a focus in a blood vessel where a lesion is located by a catheter, and a high thrombolysis agent concentration is formed in the local part of the focus instantly, so that the thrombolysis speed is accelerated, and the opportunity of recanalization of the blood vessel is increased. However, intravenous or arterial thrombolytic therapy has poor thrombus effectiveness in the proximal segment of the distal carotid artery and M1 segment of the middle cerebral artery, which is largely related to the absolute volume of the clot being too large. Thus, very large doses of thrombolytic drugs are required to dissolve such large blood clots, but this is associated with complications and a high risk.
Mechanical embolectomy, laser embolectomy, capture type embolectomy and capture net embolectomy. Thrombectomy is relatively thorough in thrombus removal, but the injury to the blood vessel wall is too large, and various complications are easily caused. The laser thrombus breaking operation is difficult, the laser energy is low and ineffective, the blood vessel is damaged when the energy is too high, and various complications are easily caused. The catching type thrombus taking operation is simple, the injury to the blood vessel wall is small, but the blood clot can not be sleeved frequently. The grasping net is simple to operate, but cannot be used in intracranial blood vessels due to the large volume of the grasping net.
SUMMERY OF THE UTILITY MODEL
There is therefore a need for an improved intracranial thrombectomy device which is simple and convenient in thrombectomy, has a high capture rate, and allows the thrombi to be firmly fixed and not to easily fall off when recovered after the thrombi are captured.
Further, the improved intracranial thrombectomy device preferably also has the following characteristics: small volume, good adherence and flexibility. Thanks to such features, the intracranial thrombectomy device can be conveniently delivered to the intracranial distal blood vessel without damaging the inner wall of the blood vessel during the thrombectomy process.
In order to solve the above problems, the present application aims to provide a novel thrombectomy balloon catheter, which can effectively correct the limitations of the existing treatment measures for thromboembolic diseases and benefit patients.
In order to achieve the above object, the present application provides a thrombus removal balloon catheter, which includes a balloon, a catheter body, a connector and a catheter seat, wherein the balloon is nested outside the catheter body to form a balloon cavity, a guide wire cavity is formed in the catheter body, a guide wire inlet of the guide wire cavity is formed in the middle of the catheter body, a guide wire outlet of the guide wire cavity is formed at the distal section end of the catheter body, and the connector is connected with the balloon cavity, so that fluid can be injected through the connector to expand the balloon; wherein, the periphery of the balloon is provided with a bulge which protrudes outwards along the circumferential direction of the embolectomy balloon catheter, and when the balloon is in an expanded state, the bulge is unfolded to scrape thrombus in a blood vessel, so that the thrombus falls off.
In a preferred embodiment of the present application, the embolectomy balloon catheter further comprises an introducer sheath, and corresponding concave portions which are concave inwards are formed on the periphery of the balloon at the proximal end of the convex portion along the circumferential direction of the embolectomy balloon catheter, and the concave portions receive the fallen thrombus and move the thrombus into the introducer sheath along with the embolectomy balloon catheter.
In a preferred embodiment of the present application, the proximal surface of the protrusion facing the corresponding recess forms an angle of between 10 and 90 degrees with the axial direction, and the height of the protrusion is between 0.5mm and 10 mm.
In a preferred embodiment of the present application, a plurality of convex portions and concave portions are alternately formed along the axial direction of the embolectomy balloon catheter.
In a preferred embodiment of the present application, the number of said protrusions is between 2 and 15.
In a preferred embodiment of the present application, the lobes are affixed to the shaft when the balloon is not in the expanded state.
In a preferred embodiment of the present application, the protrusions are attached to the shaft by a folding structure.
In a preferred embodiment of the present application, the balloon catheter has a length of between 1000mm and 2500 mm.
In a preferred embodiment of the present application, the balloon is inflated by injecting a contrast agent through the connector.
In a preferred embodiment of the present application, the balloon is a semi-compliant balloon.
The methods and apparatus of the present application may have other features and advantages which will be apparent from or are set forth in detail in the accompanying drawings and the following detailed description, which are incorporated herein, and which together serve to explain certain principles of the application.
Drawings
Fig. 1 shows an overall schematic view of an embolectomy balloon catheter according to the present application.
Fig. 2 illustrates a partial cross-sectional view along a longitudinal axis of an embolectomy balloon structure according to the present application, with the embolectomy balloon in an expanded state.
Fig. 3 shows a partial cross-sectional view perpendicular to the longitudinal axis of an embolectomy balloon structure according to the present application, with the embolectomy balloon in a deflated state.
Fig. 4 shows a partial perspective view of an embolectomy balloon structure according to the present application, with the embolectomy balloon in a deflated state.
It is to be understood that the appended drawings are not necessarily drawn to scale, but are merely drawn to illustrate various features of the basic principles of the application, with a reasonable simplification. The specific design features of the present application, including, for example, specific dimensions, orientations, locations, and shapes, will be determined in part by the environment in which it is used and intended to be used.
In the drawings, like reference numerals refer to like or equivalent parts of the present application.
Detailed Description
Reference will now be made in detail to various embodiments of the present application, examples of which are illustrated in the accompanying drawings and described below. While the present application will be described in conjunction with the exemplary embodiments, it will be understood that this description is not intended to limit the present application to those exemplary embodiments. On the contrary, the application is intended to cover not only these exemplary embodiments, but also various alternatives, modifications, equivalents and other embodiments that may be included within the spirit and scope of the application as defined by the appended claims.
The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the application. Furthermore, unless the context clearly dictates otherwise, a single expression should be understood to include multiple expressions. It will be understood that the terms "comprises," "comprising," "includes" or "having" are intended to specify the presence of stated features, steps, operations, elements, and components, or combinations thereof, but do not preclude the presence or addition of one or more other features, steps, operations, elements, and components, combinations thereof, or other possibilities.
Terms including a serial number (e.g., "first" or "second," etc.) may be used to describe various components, but the components are not limited by the order of the terms. The terminology is used for the purpose of distinguishing one element from another. For example, a first element could be termed a second element, and, similarly, a second element could be termed a first element, without departing from the scope of the claims herein. The term "and/or" includes a plurality of items or a combination of any of a plurality of items.
Hereinafter, various exemplary embodiments of the present application will be described in more detail with reference to the accompanying drawings.
First, in order to more clearly describe embodiments of the present application, the "proximal end" and the "distal end" are defined according to common terms in the medical field.
When a physician is facing a patient and holding a tool or instrument for the usual operation, and the tool or instrument is located between the physician and the patient, the end closer to the physician is called the "proximal end" or "proximal end", and the end further from the physician (the end closer to the patient) is called the "distal end" or "distal end".
The above definitions of "proximal end" and "distal end" are merely for convenience in describing embodiments of the present application and do not limit the structure of the present application. Alternatively, the "proximal end" may also be referred to as the first end, and the "distal end" may be referred to as the second end, respectively.
The structure of the thrombectomy balloon catheter 1 of the exemplary embodiment of the present application will now be described with reference to fig. 1 to 4.
Referring to fig. 1 and 2, an embolectomy balloon catheter 1 according to an exemplary embodiment of the present application includes a balloon 10, a shaft 20, a connector, a sheath, and a catheter hub, in a rapid exchange configuration to facilitate a clinician's clinical procedure.
The balloon 10 is nested outside the shaft 20 and secured together. The distal end of the balloon 10 is secured to the outer wall of the shaft 20 forming an air-tight structure at the connection site 19, such that the balloon 10 forms an enclosed space. The balloon 10 and the tube body 20 are of a double-cavity structure, a guide wire cavity 21 in the tube body 20 is used for entering and exiting a guide wire, and the balloon cavity 11 is used for expanding the balloon 10. Sufficient space remains in the balloon 10 to allow fluid to pass through. A fluid, such as a contrast agent, can be injected through the connector to expand the balloon 10. The balloon 10 is attached to the shaft 20 so that the interior thereof allows passage of a guidewire lumen 21, the guidewire lumen 21 extending through the middle of the shaft 20 to form a guidewire entry while maintaining a lumen between the shaft 20 and the catheter hub. A guidewire exit 22 of the guidewire lumen is formed at the distal segment end of the shaft.
The connection and fixation between the respective portions are performed by, for example, laser welding, hot air fusion welding, physical adhesion, or the like, and among them, welding is preferable, and laser welding is more preferable.
Preferably, balloon 10 is a semi-compliant balloon that when expanded reduces damage to the vessel wall as compared to a compliant balloon. Those skilled in the art will appreciate that a compliant balloon means that the balloon can continue to increase in size as the filling pressure increases after the pressure has increased to a nominal pressure, or after expansion to a predetermined size. By semi-compliant balloon, in contrast, it is meant that the size of the balloon can be increased to a lesser extent as the inflation pressure increases, after the pressure has been increased to a nominal pressure, or after expansion to a predetermined size.
By using specific materials, structures, specific processes (e.g., an electrical thermoforming process, etc.), the wall thickness of the balloon 10 and shaft 20 of the exemplary embodiments of the present application are thinner and softer than the prior art. For example, the balloon 10 is made of a softer material selected from block polyetheramide elastomer (commercially available under the name PEBAX), nylon, Polyurethane (PU), polyester, polyamide compound, and the like, or a mixture thereof. The balloon 10 has a single wall thickness of about 10-15 microns, such as 10 microns, 11 microns, 12 microns, 13 microns, 14 microns, 15 microns. In contrast, the wall thickness of prior art balloons is 20 to 25 microns. For balloons of the same gauge, the curvature of the balloon 10 of the exemplary embodiment of the present application in the erect state is up to about 45 degrees, much larger than prior art balloons. The smaller passing outer diameter and the better flexibility greatly improve the passing property of the balloon catheter entering lesion, and the injury to the vessel wall in the thrombus removal process is very small.
Preferably, the length of the balloon catheter is between 1000mm and 2500mm, preferably 1500mm or 2000 mm. Such a length facilitates the arrival of more distant lesions, covering the need for more patients.
With further reference to fig. 2, the embolectomy balloon according to an exemplary embodiment of the present application includes alternating raised portions 12 and recessed portions 13 along the axial direction of the embolectomy balloon catheter 1. The convex portion 12 is formed at the outer periphery thereof along the circumferential direction of the embolectomy balloon catheter 1, and protrudes outward. When the balloon 10 is in the expanded state, the lobes 12 assume a spread umbrella or rake shape. The balloon 10 and the protrusions 12 are sized such that when the balloon 10 is in an expanded state, the protrusions 12 contact the vessel wall, and can scrape thrombus in the vessel, causing the thrombus to fall off.
Preferably, the height of the lobes 12 is between 0.5mm and 10mm, preferably 2mm, 5mm or 10mm when the balloon 10 is in the expanded state. The height of the convex portion 12 refers to the difference between the maximum outer diameter at the convex portion 12 and the outer diameter of the concave portion 13. The proximal surface of the convex portion 12 facing the corresponding concave portion 13 forms an angle of between 10 and 90 degrees, preferably 30 degrees, 60 degrees or 90 degrees, with the axial direction. Such a size and shape are advantageous for causing the thrombus to fall off and for containing the fallen thrombus, and for preventing the thrombus from moving to other positions via the blood vessel.
Preferably, a plurality of convex portions 12 and concave portions 13 are formed. In the exemplary embodiment shown in fig. 1 and 4, the number of the protrusions 12 is 7, but the embolectomy balloon catheter 1 of the present application is not limited thereto. For example, the number of projections 12 may be between 2 and 15, preferably 4, 6, 7 or 8.
The advantage of forming a plurality of convex portions 12 and concave portions 13 is that if more thrombus is unable to be received in a single concave portion 13, or the thrombus is separated from the concave portion 13 in the process of dragging the balloon catheter, other grooves on the far side can receive the thrombus again, and the one-time success rate of thrombus extraction is greatly improved.
Referring to fig. 3 and 4, the balloon 10 according to an exemplary embodiment of the present application is in a deflated state, and the protrusions 12 are attached to the shaft 20, so that the outer diameter of the balloon 10 is reduced and the passability is improved. In a preferred embodiment, the projections 12 are attached to the shaft 20 by a folding structure. The folding manner is, for example, a five-fold spiral type as shown in fig. 3, but the present application is not limited thereto.
A method of using the thrombectomy balloon catheter 1 according to an exemplary embodiment of the present application will now be described.
In interventional therapy, firstly, the lesion position of an intracranial blood vessel is determined through angiography, then a catheter sheath is sent into the blood vessel from a femoral artery or a brachial artery, a guide wire penetrates through the catheter sheath and penetrates through the lesion position, a thrombus taking balloon catheter 1 is guided into the blood vessel and pushed to enable the thrombus taking balloon catheter 1 to reach the lesion position along the guide wire, a catheter seat is connected with a pressurizing device, a proper volume of contrast solution is filled into a balloon cavity 11, and the balloon 10 is expanded. Drag the near-end of sacculus 10, scrape the thrombus in the blood vessel through bellying 12, make the thrombus drop. The dropped thrombus is received by the concave portion 13. The balloon 10 is removed from the vessel with the thrombus and into the sheath. And withdrawing the thrombus removal balloon catheter 1 and the catheter sheath from the blood vessel together to finish thrombus removal operation.
Claims (10)
1. A thrombus taking balloon catheter is characterized by comprising a balloon, a catheter body, a connecting piece and a catheter seat, wherein the balloon is nested outside the catheter body to form a balloon cavity, a guide wire cavity is formed in the catheter body, a guide wire inlet of the guide wire cavity is formed in the middle of the catheter body, a guide wire outlet of the guide wire cavity is formed at the far-side section end of the catheter body, and the connecting piece is connected with the balloon cavity so as to inject fluid through the connecting piece and expand the balloon;
wherein, form the bellied bellying to the outside in the sacculus periphery along the circumferential direction of getting the embolus sacculus pipe, when the sacculus was in the expanded state, the bellying expanded, dragged the near-end of sacculus, scraped the thrombus in the blood vessel through the bellying to make the thrombus drop.
2. The embolectomy balloon catheter of claim 1, wherein the embolectomy balloon catheter further comprises an introducer sheath, and corresponding concave portions which are concave inwards are formed on the periphery of the balloon at the proximal ends of the convex portions along the circumferential direction of the embolectomy balloon catheter, and the concave portions receive the fallen thrombus and move the thrombus into the introducer sheath along with the embolectomy balloon catheter.
3. The embolectomy balloon catheter of claim 2, wherein the proximal surfaces of the lobes facing the respective depressions form an angle of between 10 and 90 degrees to the axial direction, and the lobes have a height of between 0.5mm and 10 mm.
4. The embolectomy balloon catheter of claim 2, wherein a plurality of convex portions and concave portions are alternately formed along an axial direction of the embolectomy balloon catheter.
5. The embolectomy balloon catheter of claim 4, wherein the number of projections is between 2 and 15.
6. The embolectomy balloon catheter of claim 1, wherein the projections are affixed to the shaft when the balloon is not in the expanded state.
7. The embolectomy balloon catheter of claim 6, wherein the projections are affixed to the shaft by a folded configuration.
8. The embolectomy balloon catheter of claim 1, wherein the balloon catheter is between 1000mm and 2500mm in length.
9. The embolectomy balloon catheter of claim 1, wherein contrast is injected through the connector to expand the balloon.
10. The embolectomy balloon catheter of claim 1, wherein the balloon is a semi-compliant balloon.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202022242726.XU CN212853572U (en) | 2020-10-10 | 2020-10-10 | Balloon catheter for thrombus removal |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202022242726.XU CN212853572U (en) | 2020-10-10 | 2020-10-10 | Balloon catheter for thrombus removal |
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| Publication Number | Publication Date |
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| CN212853572U true CN212853572U (en) | 2021-04-02 |
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| CN202022242726.XU Active CN212853572U (en) | 2020-10-10 | 2020-10-10 | Balloon catheter for thrombus removal |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN113397653A (en) * | 2021-07-01 | 2021-09-17 | 哈尔滨医科大学 | Anchor hook balloon, manufacturing method and catheter system |
| WO2023087455A1 (en) * | 2021-11-17 | 2023-05-25 | 上海腾复医疗科技有限公司 | Vascular recanalization device |
-
2020
- 2020-10-10 CN CN202022242726.XU patent/CN212853572U/en active Active
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN113397653A (en) * | 2021-07-01 | 2021-09-17 | 哈尔滨医科大学 | Anchor hook balloon, manufacturing method and catheter system |
| WO2023087455A1 (en) * | 2021-11-17 | 2023-05-25 | 上海腾复医疗科技有限公司 | Vascular recanalization device |
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Address after: 215128 plant 3, Shicheng science and Technology Park, 1566 Yinzhong South Road, Wuzhong Economic Development Zone, Suzhou City, Jiangsu Province Patentee after: Sano Shenchang Medical Technology Co.,Ltd. Address before: Room 501, Shilu Jinling Plaza, 88 Nanxijiang Road, Yuexi, Wuzhong District, Suzhou City, Jiangsu Province, 215104 Patentee before: Sano Shenchang Medical Technology Co.,Ltd. |
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