Supporting catheter with controllable far-end flexibility

Abstract

The invention provides a supporting catheter with controllable far-end flexibility, and belongs to the technical field of medical instruments. Comprising a supporting tube body, the supporting tube body is provided with a protective layer, a supporting layer and a lining layer which are sequentially arranged from outside to inside, the far end of the supporting tube body is provided with a flexible controllable section, the flexible controllable section is used for extending to the thrombus position from the far end of an outer sheath tube, and the supporting layer of the flexible controllable section comprises a plurality of movable joints which are sequentially connected. The flexible controllable section is arranged in the flexible joint to increase the flexibility of the flexible controllable section, a telescopic filling piece is arranged in at least one end of the flexible joint, and the filling piece can extend out of the two ends of the flexible joint to fill a gap between the two adjacent flexible joints and is used for increasing the supporting performance of the flexible controllable section; according to the supporting catheter, the flexibility and supporting performance can be accurately regulated and controlled according to different stages of an operation, the structural design is optimized, the operation safety and operation convenience are improved, and the supporting catheter has extremely high application value.

Description

Technical Field

[0001] The invention belongs to the technical field of medical devices, and in particular relates to a support catheter with controllable distal flexibility. Background Art

[0002] For patients with acute ischemic stroke, if the onset time is within a certain time window (currently usually 6-24 hours, the specific time window will be determined based on the individual patient's condition and imaging evaluation), and meets specific imaging criteria (such as the presence of large vessel occlusion, a small infarct core, etc.), and traditional drug thrombolytic therapy is ineffective or not applicable, mechanical thrombectomy is an important treatment option.

[0003] Mechanical thrombectomy refers to the use of interventional technology to deliver a special thrombectomy device through the blood vessels to the site of the thrombus, directly grasp or aspirate the thrombus, thereby reopening the blocked blood vessels and restoring blood supply to the brain.

[0004] Patent document number CN104068909A discloses an intracranial vascular thrombus remover and thrombus remover device. When removing a thrombus, the thrombus remover is first introduced into the blood vessel, a guide wire is used to pass through the lesion site, an inner tube is passed through the lesion site along the guide wire, and the thrombus remover is released through the inner tube to perform a thrombus removal operation. After the thrombus removal is completed, the thrombus remover is withdrawn into the inner tube, the inner tube is retracted into the outer sheath tube and withdrawn from the body together with the outer sheath tube.

[0005] The above-mentioned technical solution is generally applicable to the sections of the brain blood vessels that are slightly thicker. If the thrombus is located in a thinner position of the blood vessel, the outer sheath cannot directly reach the lesion due to its larger diameter. At this time, a supporting catheter is generally required. The supporting catheter is nested in the outer sheath. During the operation, the outer sheath is first transported to a position close to the thrombus. Then, the supporting catheter is extended from the distal end of the outer sheath and continues to advance toward the thrombus position until it reaches the thrombus position. Then the inner tube carrying the thrombus remover reaches the thrombus position along the supporting catheter to perform the thrombus removal operation.

[0006] During the above operation, when the support catheter extends from the distal end of the outer sheath and is pushed toward the thrombus position, the overall flexibility of the support catheter is required to be good, so that it can pass through the tortuous blood vessels without damaging the blood vessels. However, when the support catheter is in place, the support catheter needs to have corresponding support performance in the process of pushing the thrombus remover to the thrombus position through the support catheter, so that it is not easy to move so that the thrombus remover can be accurately pushed to the thrombus position. However, the flexibility of the existing support catheter cannot be properly adjusted according to the needs of different stages.

[0007] Therefore, it is necessary to provide an improved technical solution to address the above-mentioned deficiencies in the prior art. Summary of the invention

[0008] The purpose of the present invention is to provide a support catheter with controllable distal flexibility, so as to solve the technical problem that the existing support catheter cannot adjust the flexibility according to the requirements of different stages.

[0009] In order to achieve the above-mentioned purpose, the support catheter with controllable distal flexibility of the present invention provides the following technical solutions:

[0010] A support catheter with controllable distal flexibility comprises a support tube body, wherein the support tube body has a protective layer, a support layer and an inner lining layer arranged in sequence from the outside to the inside, the support tube body has a controllable flexibility section at the distal end, the controllable flexibility section is used to extend from the distal end of an outer sheath tube to a thrombus location, the support layer of the controllable flexibility section comprises a plurality of movable joints connected in sequence to increase the flexibility of the controllable flexibility section, at least one end of the movable joint is provided with a retractable filling piece, the filling piece can extend from both ends of the movable joint to fill a gap between two adjacent movable joints, so as to increase the support of the controllable flexibility section.

[0011] As a further optimized technical solution, a receiving cavity for placing a filling piece is provided on the side wall of the movable joint, and a movable channel facing the adjacent movable joint is opened on the receiving cavity, and the filling piece is used to enter and exit the receiving cavity from the movable channel.

[0012] As a further optimized technical solution, the filling piece is an airbag, and a conveying component for filling the interior of the airbag with fluid is arranged on the protective layer or the inner lining layer.

[0013] As a further optimized technical solution, the conveying component is a filling channel arranged on the protective layer or the lining layer, and the filling channel is used to connect the accommodating cavity on each of the movable joints in the flexibility controllable section.

[0014] As a further optimized technical solution, arc-shaped notches are respectively provided at both ends of the movable joint to increase the gap between the two movable joints.

[0015] As a further optimized technical solution, the movable channel is arranged in the middle of the arc-shaped notch.

[0016] As a further optimized technical solution, any two adjacent movable joints are connected via a connecting component.

[0017] As a further optimized technical solution, the connecting component includes a connecting ear and a limiting groove, the connecting ear is arranged at one end of the movable joint, and the limiting groove is arranged at the other end of the movable joint. The connecting ear on one movable joint is used to cooperate with the limiting groove on the adjacent movable joint to realize the connection of the movable joint, and the limiting groove and the connecting ear are both circular.

[0018] As a further optimized technical solution, the volume of the limiting groove is larger than the volume of the connecting ear to increase the flexibility of the movable joint connection.

[0019] As a further optimized technical solution, the connecting components are arranged in two groups symmetrically along the radial direction.

[0020] Beneficial effects:

[0021] (1) By setting a flexible controllable section at the distal end of the support tube body, and the support layer of this section adopts a plurality of sequentially connected movable joint structures, combined with a retractable filling piece, the support catheter can flexibly adjust its own flexibility and support at different stages according to the actual surgical needs; in the process of advancing from the distal end of the outer sheath to the thrombus position, the filling piece retracts, and the gap between the movable joints is larger. The support catheter shows good flexibility and can easily pass through the tortuous and complex blood vessels, effectively reducing the friction and damage to the inner wall of the blood vessels, and reducing the risk of complications such as vascular rupture and spasm during surgery. When the support catheter reaches the thrombus position and the thrombus remover needs to be pushed, the filling piece extends to fill the gap between the movable joints, significantly enhancing the support performance of the support catheter, ensuring that the support catheter can remain stable and not easily displaced during the process of pushing the thrombus remover, so that the thrombus remover can accurately reach the thrombus position, greatly improving the success rate of the thrombus removal surgery.

[0022] (2) The design of the accommodating cavity and movable channel on the side wall of the movable joint provides a reasonable space and path for the placement and extension of the filling piece, ensuring that the filling piece can move in and out smoothly, thereby achieving effective adjustment of the performance of the supporting catheter; at the same time, the arc-shaped notches at both ends of the movable joint not only increase the gap between the movable joints, further improving the flexibility of the flexible controllable section, but also set the movable channel in the middle, optimizing the extension and retraction path of the filling piece, making the entire structure more compact and reasonable, and the operation more convenient and efficient.

[0023] (3) Adjacent movable joints are connected by connecting components consisting of connecting ears and limiting grooves. This design not only ensures the stability of the connection between the movable joints, but also gives the movable joints relatively flexible movement capabilities by setting the volume of the limiting groove larger than the volume of the connecting ears, thereby ensuring the performance requirements of the supporting catheter under different conditions as a whole; moreover, the two groups of connecting components arranged symmetrically along the radial direction further enhance the stability of the connection, so that the supporting catheter can withstand various forces in a complex vascular environment and maintain the integrity and functionality of the structure.

[0024] (4) When the filling part adopts the airbag design, the delivery components arranged on the protective layer or the inner lining layer, such as the filling channel, can conveniently fill or release fluid into the airbag to achieve precise control of the airbag state; this collaborative design is not only simple to operate, but also can quickly and effectively change the flexibility and support of the support catheter, meeting the need for rapid adjustment of the support catheter performance during surgery. At the same time, the filling channel connects the accommodating cavity on each active joint, ensuring that each airbag can be inflated and deflated synchronously, so that the performance of the support catheter in different parts remains consistent, improving the reliability and stability of the surgical operation. BRIEF DESCRIPTION OF THE DRAWINGS

[0025] 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:

[0026] Figure 1 A cross-sectional schematic diagram of a compliance controllable section according to an embodiment of the present invention;

[0027] Figure 2 This is a schematic diagram of the support layer structure of a controllable compliance section according to an embodiment of the present invention;

[0028] Figure 3 The figure is a schematic diagram of the structure of an active joint according to an embodiment of the present invention.

[0029] In the figure: 1. Flexibility controllable section; 101. Protection layer; 102. Support layer; 1021. Movable joint; 1022. Accommodating cavity; 1023. Movable channel; 1024. Arc-shaped notch; 103. Lining layer; 2. Filling piece; 3. Conveying component; 4. Connecting ear; 5. Limiting groove. DETAILED DESCRIPTION

[0030] 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.

[0031] 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.

[0032] The shapes and sizes of the components in the drawings do not reflect the actual proportions of the products, and are only intended to illustrate the contents of the present invention.

[0033] 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.

[0034] The present invention provides a support catheter with controllable distal flexibility. The support catheter is mainly composed of a support tube body. The support tube body is sequentially provided with a protective layer, a support layer and an inner lining layer from the outside to the inside. A controllable flexibility section is specially provided at the distal end of the support tube body. The support layer of this section is composed of a plurality of movable joints connected in sequence, and retractable filling pieces are provided at both ends of the movable joints. When the support catheter needs to have higher flexibility, the filling piece shrinks inside the movable joint. At this time, the overall flexibility of the controllable flexibility section is higher, thereby facilitating reaching the thrombus position. When a thrombus remover needs to be delivered, the filling piece extends from both ends of the movable joint to fill the movable gap between the movable joints, thereby reducing the flexibility of the controllable flexibility section and increasing the support.

[0035] Example 1

[0036] like Figure 1-3 For details, please refer to Figure 1. The support catheter with controllable distal flexibility includes a support tube body, which has a protective layer 101, a support layer 102 and an inner lining layer 103 arranged in sequence from the outside to the inside. Among them, the protective layer 101 is made of polyetheretherketone PEEK material with biocompatibility and excellent wear resistance. This material can not only provide reliable external protection for the support catheter when it moves in the complex environment inside the blood vessel, effectively resist possible physical damage, but also greatly reduce the friction coefficient between the support catheter and the blood vessel wall by virtue of its smooth surface characteristics, reduce the stimulation and potential damage to the blood vessel wall, and reduce the risk of vascular inflammation or other complications during surgery. The support layer 102 can be made of shape memory alloy - Nitinol. Nitinol alloy has a unique shape memory effect and superelastic properties, which enables the support layer 102 to provide stable and reliable support for the support catheter while also adapting to the natural curvature and physiological movement of the blood vessel to a certain extent, ensuring that the support catheter can always maintain a stable shape and position in the blood vessel, providing a solid support foundation for subsequent thrombectomy operations. The inner lining layer 103 may be made of medical grade silicone rubber material, which has an extremely low surface friction coefficient and good biocompatibility, and can provide an ideal internal environment for the smooth pushing and withdrawal of the inner tube or thrombus remover in the supporting catheter.

[0037] The flexible controllable section 1 is located at the distal end of the support tube body. The flexible controllable section 1 is used to extend from the distal end of the outer sheath tube to the thrombus position and is a key part for realizing flexible conversion between the flexibility and support of the support catheter.

[0038] like Figure 2 , Figure 3 As shown, the support layer 102 of the flexible controllable segment 1 is composed of a plurality of movable joints 1021 connected in sequence, and these movable joints 1021 are connected stably and flexibly through connecting components. Specifically, the connecting components include a connecting ear 4 and a limiting groove 5. The connecting ear 4 is integrally formed at one end of the movable joint 1021, and is in the shape of a circular sheet and protrudes; the limiting groove 5 is processed at the other end of the movable joint 1021, and is a circular groove adapted to the connecting ear 4. The connecting ear 4 on one movable joint 1021 is tightly embedded in the limiting groove 5 on the adjacent movable joint 1021, so as to realize a reliable connection between the movable joints 1021. This facilitates the relative rotation between the movable joints 1021, and further facilitates the flexible swinging of the entire flexible controllable segment 1 in the blood vessel.

[0039] Furthermore, the inner diameter of the limiting groove 5 is slightly larger than the outer diameter of the connecting ear 4, that is, the volume of the limiting groove 5 is larger than the volume of the connecting ear 4, and a pair of mutually matching limiting grooves 5 and the connecting ear 4 form a certain movable gap, ensuring that the movable joints 1021 can be relatively flexibly rotated and bent within a certain range to adapt to the complex geometric shape of the blood vessel. At the same time, two groups of such connecting parts are arranged radially symmetrically along the movable joint 1021. Through this symmetrical layout, the stability and reliability of the connection are further enhanced, and the loose connection or structural deformation caused by uneven force in a complex vascular environment is effectively avoided to increase the flexibility of the flexible controllable section 1.

[0040] Retractable filling pieces 2 are provided inside both ends of the movable joint 1021 . The filling pieces 2 can extend from both ends of the movable joint 1021 to fill the gap between two adjacent movable joints 1021 , so as to increase the support of the flexible controllable section 1 .

[0041] Specifically, a receiving cavity 1022 for placing the filling piece 2 is provided on the side wall of the movable joint 1021, and a movable channel 1023 facing the adjacent movable joint 1021 is opened on the receiving cavity 1022, and the filling piece 2 is used to enter and exit the receiving cavity 1022 through the movable channel 1023. The diameter of the movable channel 1023 is moderate, which can ensure that the filling piece 2 can pass smoothly, and can also provide necessary constraints when the filling piece 2 is extended or retracted to prevent it from excessive movement or deviation.

[0042] In this embodiment, the filling member 2 is a high-performance medical-grade airbag, which is partially fixed in the accommodating cavity 1022. The airbag has good elasticity, flexibility and biocompatibility, and can work stably under different pressure conditions. Specifically, when filling the gap between the two active joints 1021, the airbag is deformed as a whole through the volume change and extends out of the accommodating cavity 1022 along the active channel 1023 to complete the filling action.

[0043] A delivery component 3 for filling the airbag with fluid is arranged on the protective layer 101. In this embodiment, the delivery component 3 is a filling channel opened on the protective layer 101. In this embodiment, the filling channel is specifically a groove opened on the protective layer 101. The filling channel is used to connect the accommodating cavity 1022 on each active joint 1021 in the controllable compliance section 1. The proximal end of the filling channel is equipped with a common high-precision fluid control device, which can accurately control the injection and discharge of the fluid to achieve precise regulation of the airbag state.

[0044] Specifically, in the process of the support catheter being pushed from the distal end of the outer sheath toward the thrombus position, the fluid in the airbag is discharged through the fluid control device, so that the filling member 2 retracts into the accommodating chamber 1022. At this time, the gap between the active joints 1021 is large, and the flexible controllable section 1 exhibits good flexibility, and can easily bend and move along the tortuous path of the blood vessel, reducing the pressure and damage to the blood vessel wall. When the support catheter reaches the thrombus position and the thrombus remover needs to be pushed, an appropriate amount of fluid is injected into the airbag through the fluid control device, and the airbag rapidly expands and extends from the active channel 1023, tightly filling the gap between adjacent active joints 1021. This significantly enhances the support of the flexible controllable section 1, and can provide stable and reliable support for the pushing of the thrombus remover, ensuring that the thrombus remover can accurately reach the thrombus position.

[0045] Furthermore, in order to optimize the degree of compliance adjustment of the compliance controllable section 1, arc-shaped notches 1024 are respectively provided at both ends of the movable joint 1021, which can increase the gap between the two movable joints 1021. This allows the compliance controllable section 1 to have greater freedom when bending. When the support catheter passes through a tortuous blood vessel, the arc-shaped notch 1024 can effectively reduce the mutual interference between the movable joints 1021, so that the support catheter can more naturally conform to the curved shape of the blood vessel, further improving its flexibility and adaptability in the blood vessel, and reducing the risk of damage to the blood vessel wall. In addition, the active channel 1023 is cleverly arranged in the middle of the arc-shaped notch 1024. This layout optimizes the extension and retraction path of the filling piece 2. When the filling piece 2 is extended, it can smoothly fill the gap between the movable joints 1021 along the central axis direction of the arc-shaped notch 1024, ensuring uniform and stable filling; when the filling piece 2 is retracted, it can also smoothly return to the accommodating cavity 1022 along the original path, avoiding the performance of the supporting catheter being affected by the offset or jamming of the filling piece 2, and the movable channel 1023 is set in the middle of the arc-shaped notch 1024.

[0046] Example 2

[0047] This embodiment provides another support catheter with controllable distal flexibility. Almost all structures in this embodiment are the same as those in Embodiment 1, and the only difference is the number of filling pieces provided.

[0048] Specifically, in the present embodiment, a retractable filling piece is arranged inside one end of the movable joint, and the filling pieces on all the movable joints are arranged at the same end. For example, the filling pieces on all the movable joints are arranged at the distal end. Then, when it is necessary to adjust the support of the flexible controllable section, the filling piece at the distal end of each movable joint is used to fill the gap between the proximal end of the adjacent movable joint.

[0049] Example 3

[0050] This embodiment provides another support catheter with controllable distal flexibility. Almost all structures in this embodiment are the same as those in Embodiment 1. The only difference is the location of the filling channel. In this embodiment, the filling channel can also be set on the inner lining layer.

[0051] Example 4

[0052] This embodiment also provides a support catheter with controllable distal flexibility. Almost all structures in this embodiment are the same as those in Example 1. The only difference lies in the specific structure of the filling channel. In this embodiment, the filling channel is a tube body fixedly arranged on the protective layer or the inner lining layer.

[0053] In summary, the support catheter with controllable distal flexibility provided by the present invention, through the precise design and coordinated work of the above parts, shows excellent performance in mechanical thrombectomy surgery, and can flexibly and accurately adjust its own flexibility and support according to the actual needs of the surgery, providing a strong guarantee for the successful implementation of the surgery and significantly improving the treatment effect and prognosis quality of patients.

[0054] It should be understood that the above description is merely exemplary and the embodiments of the present application do not limit this.

[0055] 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 support catheter with controllable distal flexibility, comprising a support tube body, wherein the support tube body has a protective layer (101), a support layer (102) and an inner lining layer (103) arranged in sequence from the outside to the inside, characterized in that: The support tube body has a controllable compliance section (1) at the distal end thereof, and the controllable compliance section (1) is used to extend from the distal end of the outer sheath tube to the location of the thrombus. The support layer (102) of the controllable compliance section (1) includes a plurality of movable joints (1021) connected in sequence to increase the flexibility of the controllable compliance section (1). A retractable filling piece (2) is provided inside at least one end of the movable joint (1021), and the filling piece (2) can extend from both ends of the movable joint (1021) to fill the gap between two adjacent movable joints (1021), so as to increase the support of the controllable compliance section (1).

2. The support catheter with controllable distal flexibility according to claim 1, characterized in that: A receiving cavity (1022) for accommodating a filling piece (2) is provided on the side wall of the movable joint (1021); a movable channel (1023) facing the adjacent movable joint (1021) is provided on the receiving cavity (1022); and the filling piece (2) is used to enter and exit the receiving cavity (1022) through the movable channel (1023).

3. The support catheter with controllable distal flexibility according to claim 2, characterized in that: The filling member (2) is an airbag, and a conveying component (3) for filling a fluid into the airbag is arranged on the protective layer (101) or the inner lining layer (103).

4. The support catheter with controllable distal flexibility according to claim 3, characterized in that: The conveying component (3) is a filling channel arranged on the protective layer (101) or the inner lining layer (103), and the filling channel is used to connect the accommodating cavity (1022) on each of the movable joints (1021) in the controllable compliance section (1).

5. The support catheter with controllable distal flexibility according to claim 2, characterized in that: Arc-shaped notches (1024) are respectively provided at both ends of the movable joint (1021) for increasing the gap between the two movable joints (1021).

6. The support catheter with controllable distal flexibility according to claim 5, characterized in that: The movable channel (1023) is arranged in the middle of the arc-shaped notch (1024).

7. The support catheter with controllable distal flexibility according to claim 1, characterized in that: Any two adjacent movable joints (1021) are connected via a connecting component.

8. The support catheter with controllable distal flexibility according to claim 7, characterized in that: The connecting component comprises a connecting ear (4) and a limiting groove (5); the connecting ear (4) is arranged at one end of the movable joint (1021), and the limiting groove (5) is arranged at the other end of the movable joint (1021); the connecting ear (4) on one movable joint (1021) is used to cooperate with the limiting groove (5) on an adjacent movable joint (1021) to achieve the connection of the movable joints (1021); and the limiting groove (5) and the connecting ear (4) are both circular.

9. The support catheter with controllable distal flexibility according to claim 8, characterized in that: The volume of the limiting groove (5) is greater than the volume of the connecting ear (4), so as to increase the flexibility of the connection of the movable joint (1021).

10. The support catheter with controllable distal flexibility according to claim 7, characterized in that: The connecting parts are symmetrically arranged in two groups along the radial direction.

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