Double-cavity quick exchange type suction catheter

By setting up a fast exchange channel at the distal end of the suction catheter body, allowing the guide wire to shuttle within the catheter, solving the problems of prolonged surgical time and risk of vascular damage in the prior art, achieving a more efficient vascular re-enrollment and a safer treatment process.

CN119770834APending Publication Date: 2025-04-08JILIN UNIVERSITY
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Patent Information

Application Number
CN202510048951.4
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2025-01-13
Publication Date
2025-04-08

AI Technical Summary

Technical Problem

In the treatment of acute ischemic stroke, the existing aspiration catheter requires repeated use of guide wire to build a pathway, resulting in an extended surgical time and an increased risk of vascular damage.

Method used

A double-cavity fast-exchange suction catheter is designed, and a fast exchange channel is set at the distal end of the catheter body, allowing the guide wire to shuttle in the fast exchange channel, avoiding the reuse of the guide wire to build a path.

Benefits of technology

It significantly shortens the surgical time, improves the surgical efficiency, reduces the risk of vascular damage in patients, and allows vascular re-enrollment to be achieved faster, winning more valuable treatment time for patients with acute ischemic stroke.

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Abstract

The invention provides a double-cavity quick exchange type suction catheter, and belongs to the technical field of interventional operation medical equipment, the suction catheter comprises a catheter body, the outer side wall of the far end of the catheter body is provided with a quick exchange channel for a guide wire to penetrate through, and the quick exchange channel and a catheter cavity of the catheter body are mutually independent; the rapid exchange channel is parallel to the catheter cavity of the catheter body and used for enabling the guide wire to smoothly penetrate through the rapid exchange channel so as to guide the catheter body to establish a channel in a blood vessel, the situation that the guide wire is repeatedly used for establishing the channel in an operation can be avoided, the operation time is effectively shortened, blood vessel injuries are reduced, and the operation efficiency is improved; the method has a wide application prospect in the aspect of interventional therapy of acute ischemic stroke and other vascular diseases.
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Description

Technical Field

[0001] The invention belongs to the technical field of interventional surgery medical equipment, and in particular relates to a double-lumen quick-exchange suction catheter. Background Art

[0002] Stroke, also known as "stroke", is an acute cerebrovascular disease, which can generally be divided into two categories: ischemic and hemorrhagic. Stroke has the "five highs" characteristics of high incidence, high recurrence rate, high disability rate, high mortality rate and high economic burden. It is one of the main chronic non-communicable diseases that threaten human health. Among all stroke cases, acute ischemic stroke accounts for about 80%. The core point of acute ischemic stroke treatment is to open the blocked blood vessels as soon as possible and save the ischemic penumbra.

[0003] Thrombectomy by suction is a commonly used treatment for acute ischemic stroke. In this treatment method, the intracranial suction catheter is first delivered to the target position proximal to the thrombus, and then negative pressure is applied to the proximal end of the catheter, so that the thrombus can be drawn into the suction catheter, and then the thrombus is finally removed from the human body through the lumen, thereby achieving vascular recanalization. Compared with thrombectomy stents, thrombectomy by suction has the advantages of short recanalization time, prevention of thrombus rupture and escape, and high surgical success rate.

[0004] At present, as an intravascular treatment method, aspiration thrombectomy requires the use of a guide wire and coaxial technology to deliver the aspiration catheter to the proximal end of the lesion. After the guide wire is withdrawn, the appropriate aspiration time is selected to use negative pressure to absorb the thrombus, and the thrombus and the aspiration catheter are pulled out of the body at the same time. For patients with a large thrombus load, tandem lesions or posterior circulation lesions, doctors need to use a guide wire and aspiration catheter to build a pathway and repeat the thrombus aspiration operation until all the thrombi are removed from the body.

[0005] In actual clinical applications, the primary consideration for intracranial thrombectomy is the time window requirement. However, the current thrombectomy catheter repeatedly uses the guide wire to build a pathway, which will undoubtedly increase the duration of the operation, increase the risk of vascular damage to the patient, and prolong the time the patient suffers.

[0006] Therefore, it is necessary to provide an improved technical solution to address the above-mentioned deficiencies in the prior art. Summary of the invention

[0007] The purpose of the present invention is to provide a double-lumen rapid exchange suction catheter to solve the technical problem that the existing suction catheter needs to repeatedly use a guide wire to construct a pathway, thereby prolonging the operation time and increasing the risk of vascular damage to the patient.

[0008] In order to achieve the above-mentioned purpose, the dual-lumen rapid exchange suction catheter of the present invention provides the following technical solutions:

[0009] A double-lumen rapid exchange type suction catheter comprises a catheter body, wherein a rapid exchange channel for a guide wire to pass through is arranged on the outer side wall at the distal end of the catheter body, the rapid exchange channel and the lumen of the catheter body are independent of each other, and the rapid exchange channel and the lumen of the catheter body are arranged in parallel, so as to allow the guide wire to pass through the rapid exchange channel smoothly to guide the catheter body to establish a passage in the blood vessel.

[0010] As a further optimized technical solution, short tubes are integrally arranged in parallel on the outside of the catheter body, and the lumen of the short tubes constitutes the rapid exchange channel.

[0011] As a further optimized technical solution, the radial dimension of the short tube is smaller than the radial dimension of the catheter body, and is not smaller than the radial dimension of the guide wire.

[0012] As a further optimized technical solution, at least the proximal end surface of the short tube is arranged with an oblique cut.

[0013] As a further optimized technical solution, the distal end face of the short tube is arranged with an oblique cut, and the inclination direction of the distal end face gradually moves away from the catheter body from the distal end to the proximal end.

[0014] As a further optimized technical solution, the length of the short tube is 15-30 cm.

[0015] As a further optimized technical solution, the catheter body includes a protective layer, a support layer and a guide layer arranged in sequence from the outside to the inside; the guide layer is composed of an inner membrane of a smooth polymer material, and the support layer is a metal wire winding or braided wire structure; and the support layer is a spiral wire winding structure near the short tube position.

[0016] As a further optimized technical solution, a first developing structure is provided at the distal end of the catheter body.

[0017] As a further optimized technical solution, a second developing structure is provided at the proximal end of the rapid exchange channel.

[0018] As a further optimized technical solution, the double-lumen rapid exchange suction catheter also includes a handle and a stress diffusion tube connected in sequence, and the catheter body is arranged at an end of the stress diffusion tube away from the handle.

[0019] Beneficial effects:

[0020] First, the efficiency of the operation is improved. The invention adds a quick exchange channel at the distal end of the catheter body. This design eliminates the need to repeatedly use the guide wire to establish a pathway during the operation, thereby effectively avoiding the time wasted by establishing pathways multiple times. By reducing these unnecessary operating steps, the operation time can be significantly shortened, and vascular recanalization can be achieved more quickly, greatly improving the efficiency of the operation, reducing the risk of vascular damage to patients, and gaining more valuable treatment time for patients with acute ischemic stroke.

[0021] Second, the performance of the catheter is optimized. The dual-lumen structure design in which the rapid exchange channel and the catheter body have independent lumens not only ensures the large inner lumen suction capacity required for the catheter body as the main suction pathway, but also ensures that the rapid exchange channel as a microcatheter pathway can efficiently and quickly realize the guiding function of guide wire crossing. BRIEF DESCRIPTION OF THE DRAWINGS

[0022] The drawings constituting a part of the present application are used to provide a further understanding of the present invention. The exemplary embodiments of the present invention and their descriptions are used to explain the present invention and do not constitute an improper limitation of the present invention. Among them:

[0023] Figure 1 It is a schematic diagram of the overall structure of an embodiment of the present invention;

[0024] Figure 2 A schematic cross-sectional view of a catheter body and a short tube according to an embodiment of the present invention;

[0025] Figure 3 This is a schematic diagram of the proximal end structure of a short tube according to an embodiment of the present invention;

[0026] Figure 4 This is a schematic diagram of the distal end structure of a short tube according to an embodiment of the present invention;

[0027] Figure 5 It is a schematic cross-sectional view of a catheter body and a short tube according to another embodiment of the present invention.

[0028] In the figure: 11, handle; 12, stress diffusion tube; 13, catheter body; 131, protective layer; 132, support layer; 133, guide layer; 14, short tube; 141, proximal end face; 142, second development structure; 143, distal end face; 15, first development structure. DETAILED DESCRIPTION

[0029] The technical solutions in the embodiments of the present invention are described clearly and completely below. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. All other embodiments obtained by ordinary technicians in this field based on the embodiments of the present invention belong to the scope of protection of the present invention.

[0030] In the description of the present invention, the terms "longitudinal", "lateral", "upper", "lower", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom" and the like indicate orientations or positional relationships based on the orientations or positional relationships shown in the accompanying drawings. They are only for the convenience of describing the present invention and do not require that the present invention must be constructed and operated in a specific orientation. Therefore, they cannot be understood as limitations on the present invention. The terms "connected" and "connected" used in the present invention should be understood in a broad sense. For example, it can be a fixed connection or a detachable connection; it can be directly connected or indirectly connected through an intermediate component. For ordinary technicians in this field, the specific meanings of the above terms can be understood according to the specific circumstances. In addition, the term "proximal end" uniformly refers to the end close to the operator, and the "distal end" refers to the end away from the operator.

[0031] The present invention will be described in detail below with reference to the accompanying drawings and in combination with embodiments. It should be noted that the embodiments and features in the embodiments of the present invention can be combined with each other without conflict.

[0032] The present invention provides a dual-lumen rapid exchange type suction catheter, which is provided with a rapid exchange channel at the distal end of the catheter body, the rapid exchange channel is used for the guide wire to pass through, and the catheter body is used to aspirate thrombus. This design completely changes the surgical operation process of the traditional suction catheter. In the traditional way, if the catheter position needs to be adjusted or aspiration is required after each aspiration operation, the guide wire must be reinserted to construct a pathway, which is extremely cumbersome and time-consuming. The dual-lumen rapid exchange type suction catheter of the present invention allows the guide wire to shuttle conveniently in the rapid exchange channel without repeating the steps of extracting and inserting from the catheter body. For example, in complex acute ischemic stroke surgery, in the case of multiple thrombi or the need to adjust the suction position multiple times, the use of the catheter of the present invention can shorten the time for each pathway construction from the original several minutes to more than ten seconds or even shorter. This not only greatly improves the efficiency of the operation, so that vascular recanalization can be achieved in a shorter time, but also effectively reduces the risk of vascular damage faced by patients due to long-term surgery, and significantly reduces the incidence of complications such as vascular spasm and endothelial damage. At the same time, it has won extremely valuable treatment time for patients with acute ischemic stroke, greatly improved the patients' prognosis, rehabilitation and quality of life, and reduced the risk of disability and death caused by delayed treatment.

[0033] Example 1

[0034] like Figure 1-4 For details, please refer to Figure 1The double-lumen rapid exchange suction catheter includes a handle 11, a stress diffusion tube 12 and a catheter body 13 connected in sequence from the proximal end to the distal end. The catheter body 13 includes a protective layer 131, a support layer 132 and a guide layer 133 arranged in sequence from the outside to the inside, wherein the protective layer 131 is made of a heat shrink tube made of Pebax material. The support layer 132 is a metal wire winding or braided wire structure, which can provide support for catheter delivery and ensure the placement of the catheter, while also enhancing the torsion control of the catheter and providing anti-kink capability. The guide layer 133 is composed of a slippery polymer material inner membrane. The slippery polymer material inner membrane as the guide layer 133 can reduce the friction resistance to the suction of thrombus and enhance the ability of thrombus passage.

[0035] A rapid exchange channel for a guide wire (not shown in the figure) to pass through is provided on the outer side wall at the distal end of the catheter body 13. The rapid exchange channel is independent of the lumen of the catheter body 13, and the rapid exchange channel is arranged parallel to the lumen of the catheter body 13, so as to allow the guide wire to pass through the rapid exchange channel smoothly to guide the catheter body 13 to establish a passage in the blood vessel.

[0036] In this embodiment, a short tube 14 is integrally arranged in parallel on the outside of the catheter body 13, and the lumen of the short tube 14 constitutes the above-mentioned rapid exchange channel. In this way, during the operation, after the guide wire passes through the short tube 14 to guide the catheter body 13 to the target position where the thrombus needs to be aspirated, there is no need to remove the guide wire, and the thrombus can be directly aspirated through the lumen of the catheter body 13. In the case of heavy thrombus load, tandem lesions, and posterior circulation lesions, after the catheter body 13 aspirates the thrombus at one position, the guide wire can directly guide the catheter body 13 to another position for treatment, so there is no need to reinsert the guide wire to construct a pathway, which realizes the continuity of the surgical operation and greatly improves the surgical efficiency.

[0037] like Figure 2 As shown, in this embodiment, during the connection process between the short tube 14 and the catheter body 13, the short tube 14 is partially embedded in the catheter body 13 to reduce the overall outer contour size of the short tube 14 and the catheter body 13, thereby making it easier for the catheter body 13 to pass through the blood vessel.

[0038] The short tube 14 is composed of a two-layer structure, wherein the outer layer is made of a heat shrink tube made of Pebax material. The inner layer is composed of a polymer material inner membrane with smoothness. The polymer material inner membrane with smoothness as the inner layer can reduce the friction resistance of the guide wire during the delivery process, thereby creating extremely favorable conditions for the smooth passage of the guide wire in the catheter body 13, effectively reducing the friction resistance between the guide wire and the inner wall of the catheter body 13, and making the pushing process of the guide wire smoother and more accurate.

[0039] Furthermore, the radial dimension of the short tube 14 is smaller than the radial dimension of the catheter body 13, and is not smaller than the radial dimension of the guide wire. In the present invention, the short tube 14 is only for the guide wire to pass through. If the size is too large, the overall size of the suction catheter will be increased, making the suction catheter less passable in the blood vessel. If the size is too small, it will be inconvenient for the guide wire to pass through. In this embodiment, the diameter of the short tube 14 is slightly larger than the guide wire, which can facilitate the smooth passage of the guide wire without increasing the overall size of the suction catheter too much.

[0040] Furthermore, if Figure 3 , Figure 4 As shown, at least the proximal end face 141 of the short tube 14 is arranged with an oblique cut. In this embodiment, the proximal end face 141 and the distal end face 143 of the short tube 14 are both arranged with an oblique cut, and the inclination direction of the distal end face 143 gradually moves away from the catheter body 13 from the distal end to the proximal end, and the inclination direction of the proximal end face 141 gradually approaches the catheter body 13 from the distal end to the proximal end. The oblique cut design of the proximal end face 141 is realized by a precise machining process. This design makes the proximal end face 141 of the short tube 14 open, so that the proximal end of the short tube 14 presents a state that is more conducive to the insertion of the guide wire, which can minimize the difficulty of inserting the guide wire, so that the guide wire can quickly and accurately enter the lumen of the short tube 14. The oblique cut of the distal end face 143 is also made by high-precision machining. This design can effectively reduce the fluid resistance when the catheter body 13 travels in the blood vessel, reduce the disturbance to the blood vessel wall, and improve the smoothness of pushing the catheter body 13 in the blood vessel.

[0041] Furthermore, the short tube 14 can provide a guide for the guide wire. If it is too short, the stability of the guide wire delivery process will be affected. If it is too long, the hardness of the tip of the catheter body 13 will increase, which may easily damage the patient's blood vessels. Therefore, the length of the short tube 14 needs to be controlled within a reasonable length range. In this embodiment, the length of the short tube 14 is 15-30 cm. Such a length can fully meet the effective operating range in the blood vessel, and will not affect the overall performance of the catheter due to excessive length, such as increasing the rigidity of the catheter and reducing its maneuverability.

[0042] In order to reduce the impact of the short tube 14 on the hardness of the catheter body 13, the support layer 132 is a metal spiral wire structure near the position of the short tube 14, so that the hardness of the catheter body 13 at the position of the short tube 14 is reduced without sacrificing the flexibility of the catheter body 13, thereby improving the operability of the suction catheter.

[0043] Furthermore, a first developing structure 15 is provided at the distal end of the catheter body 13, and a second developing structure 142 is provided at the proximal end of the rapid exchange channel. The first developing structure 15 is an annular mark made of a high-density material such as a platinum-iridium alloy, so that during the operation, the position of the suction catheter can be clearly observed with the help of imaging equipment such as X-rays, providing an accurate positioning reference for the doctor's operation. The second developing structure 142 is also an annular structure made of developing materials such as platinum-iridium alloys. This annular structure can clearly observe the position of the proximal end of the short tube 14 with the help of imaging equipment such as X-rays, which facilitates the precise positioning of the guide wire in the early stage of the operation and its smooth entry into the rapid exchange channel, and facilitates the positioning of the guide wire during the operation.

[0044] In actual use, the guide wire is first inserted through the rapid exchange channel of the short tube 14. During the insertion process, the doctor can use the X-ray imaging device to observe the movement of the guide wire in the short tube 14 to ensure that it enters the blood vessel smoothly. Subsequently, the catheter body 13 is pushed to the target position proximal to the thrombus along the blood vessel. Due to the unique design of the rapid exchange channel, there is no need to repeatedly insert and remove the guide wire to build a pathway like a traditional suction catheter, which greatly shortens the operation time and reduces the risk of damage to the blood vessel wall. When the catheter body 13 reaches the specified position, a negative pressure suction device is connected to the proximal end of the catheter body 13, and an appropriate negative pressure is applied. The specific value is adjusted according to the nature of the thrombus and the condition of the blood vessel. Under the action of negative pressure, the thrombus is smoothly sucked into the lumen of the catheter body 13 under the suction of negative pressure. Finally, the thrombus and the catheter are slowly and steadily taken out of the body to complete the thrombus extraction operation. During the entire operation, the doctor can observe the position of the catheter body 13 and the guide wire at any time through the X-ray imaging device to ensure the accuracy and safety of the operation.

[0045] Example 2

[0046] like Figure 5 As shown, this embodiment provides a different arrangement of the short tube 14 and the catheter body 13. Except for the arrangement of the short tube 14 and the catheter body 13, the other structures of this embodiment are the same as those of Embodiment 1, and are not repeated here. In this embodiment, the short tube 14 can continue to deviate outward, but the connecting part of the catheter body 13 and the short tube 14 needs to be closely connected to ensure the airtightness of the catheter body 13 under negative pressure suction.

[0047] It should be understood that the above description is merely exemplary and the embodiments of the present application do not limit this.

[0048] The above are only preferred embodiments of the present invention and are not intended to limit the present invention. Any modifications, equivalent substitutions, improvements, etc. made within the spirit and principles of the present invention are within the scope of protection of the pending claims of the present invention.

Claims

1. A double-lumen rapid exchange suction catheter, characterized in that: The invention comprises a catheter body (13), wherein a rapid exchange channel for allowing a guide wire to pass through is arranged on the outer side wall at the distal end of the catheter body (13), the rapid exchange channel and the lumen of the catheter body (13) are independent of each other, and the rapid exchange channel and the lumen of the catheter body (13) are arranged in parallel, so as to allow the guide wire to pass through the rapid exchange channel smoothly to guide the catheter body (13) to establish a passage in the blood vessel.

2. The double-lumen rapid exchange suction catheter according to claim 1, characterized in that: A short tube (14) is integrally arranged in parallel on the outside of the catheter body (13), and the lumen of the short tube (14) constitutes the rapid exchange channel.

3. The double-lumen rapid exchange suction catheter according to claim 2, characterized in that: The radial dimension of the short tube (14) is smaller than the radial dimension of the catheter body (13), and is not smaller than the radial dimension of the guide wire.

4. The double-lumen rapid exchange suction catheter according to claim 2, characterized in that: At least the proximal end surface (141) of the short tube (14) is arranged with an oblique cut.

5. The double-lumen rapid exchange suction catheter according to claim 4, characterized in that: The distal end surface (143) of the short tube (14) is arranged with an oblique cut, and the inclination direction of the distal end surface (143) gradually moves away from the catheter body (13) from the distal end to the proximal end.

6. The double-lumen rapid exchange suction catheter according to claim 2, characterized in that: The length of the short tube (14) is 15-30 cm.

7. The double-lumen rapid exchange suction catheter according to any one of claims 1 to 6, characterized in that: The catheter body (13) comprises a protective layer (131), a support layer (132) and a guide layer (133) which are arranged in sequence from the outside to the inside; the guide layer (133) is composed of an inner film of a polymer material having smoothness, and the support layer (132) is a metal wire winding or braided wire structure; and the support layer (132) is a spiral wire winding structure near the position of the short tube (14).

8. The double-lumen rapid exchange suction catheter according to any one of claims 1 to 6, characterized in that: A first developing structure (15) is provided at the distal end of the catheter body (13).

9. The double-lumen rapid exchange suction catheter according to any one of claims 1 to 6, characterized in that: A second developing structure (142) is disposed at the proximal end of the rapid exchange channel.

10. The double-lumen rapid exchange suction catheter according to any one of claims 1 to 6, characterized in that: The double-lumen rapid exchange type suction catheter also includes a handle (11) and a stress diffusion tube (12) which are connected in sequence, and the catheter body (13) is arranged at one end of the stress diffusion tube (12) away from the handle (11).

Citation Information

Patent Citations

  • Double-cavity rapid exchange micro catheter

    CN113384797A