Thrombus separation device

Abstract

The invention provides a thrombus separation device. The thrombus separation device comprises a separation support and a support control assembly. The separation support is of a support structure capable of expanding in the radial direction and twisting in the circumferential direction. The stent control assembly is connected with the far end and the near end of the separation stent and used for controlling axial compression and circumferential torsion of the separation stent so that the separation stent can form a target shape. The support control assembly comprises a conical head, a pushing pipe, a control rod, a control part and a connecting piece. The conical head, the separating support, the pushing pipe and the connecting piece are sequentially connected from far to near. The far end of the operating rod is connected with the near end of the conical head and sequentially penetrates through the separating support, the pushing pipe and the connecting piece, the outer end of the operating rod is connected with the operating part, and the operating part is located on the near end side of the connecting piece; the operating rod can axially move and circumferentially rotate relative to the separating support, the pushing pipe and the connecting piece. The thrombus separation stent is controlled by axial compression and torsion to form various different thrombus separation structures, so that diversified thrombus separation requirements can be met.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and particularly to a thrombus separation device. Background Art

[0002] Intravascular thrombus is a systemic disease with a very wide range of incidence. It may affect the upper limbs, lower limbs, visceral blood vessels and carotid arteries. When a thrombus occurs in the heart, myocardial infarction may occur; when it occurs in the brain, cerebral infarction may be caused; when it occurs in the lungs, pulmonary embolism may be caused... According to statistics, the death caused by thromboembolic diseases accounts for 51% of the global death toll, far exceeding the deaths caused by tumors, infectious diseases, respiratory diseases, etc.

[0003] At present, the main treatment methods for intravascular thrombus are anticoagulant drug treatment, interventional surgery and surgical operation. For patients with mild symptoms, conservative treatment with anticoagulant drugs can be used; for patients who cannot be treated with drugs, necessary surgery must be performed. Compared with surgical operation, interventional treatment has obvious advantages, such as less trauma, faster recovery and is more easily accepted by patients. At present, although there are various interventional thrombectomy devices, such as thrombectomy stents, aspiration catheters and other products, due to the diversity of the lesion sites of thrombus diseases and the complexity of thrombus morphology, especially for lesions with a large amount and old age of thrombus, higher requirements are imposed on thrombectomy products. The common problems of current products include: 1. The thrombus adheres to the blood vessel wall, and it is difficult to completely remove the thrombus during the thrombectomy process, resulting in residual thrombus in the blood vessel. 2. Thrombus formation in the stent, making it difficult to remove the thrombus.

[0004] It should be noted that the information disclosed in the above background art section is only used to enhance the understanding of the background of the present disclosure, and thus may include information that does not constitute the prior art known to those skilled in the art. Summary of the Invention

[0005] The purpose of the embodiments of the present invention is to provide a thrombus separation device, which can control the thrombus separation stent to form a variety of different thrombus separation structures through axial compression and torsion, so as to meet diverse thrombus separation requirements, improve the thrombus clearance efficiency and thrombectomy effect.

[0006] To solve the above technical problems, the embodiments of the present invention provide a thrombus separation device, including:

[0007] A separation stent, which is a stent structure capable of radially expanding and circumferentially twisting;

[0008] A stent control assembly, which is connected to the distal end and the proximal end of the separation stent and is used to control the axial compression and circumferential torsion of the separation stent so that the separation stent forms a target shape.

[0009] As an embodiment, the stent manipulation assembly includes: a conical head, a push tube, a joystick, a manipulation part, and a connecting piece;

[0010] The conical head, the separation stent, the push tube, and the connecting piece are connected in sequence from far to near;

[0011] The distal end of the joystick is connected to the proximal end of the conical head, and sequentially passes through the separation stent, the push tube, and the connecting piece. The outer end of the joystick is connected to the manipulation part, and the manipulation part is located on the proximal side of the connecting piece;

[0012] The joystick can axially move and circumferentially rotate relative to the separation stent, the push tube, and the connecting piece.

[0013] As an embodiment, the distal end of the push tube is provided with an infusion section, and an array of infusion holes is arranged on the peripheral wall of the infusion section; the push tube has a plurality of infusion cavities extending along its axis, and the array of infusion holes is communicated with the plurality of infusion cavities;

[0014] The side wall of the connecting piece is connected to an infusion tube, and the infusion tube is connected to the plurality of infusion cavities; a two-way valve is provided on the infusion tube.

[0015] As an embodiment, a first imaging layer and a second imaging layer are provided at both ends of the infusion section.

[0016] As an embodiment, a locking mechanism for locking the joystick is provided at the proximal end of the connecting piece.

[0017] As an embodiment, the conical head is provided with a third imaging layer, and the manipulation part is a Luer connector.

[0018] As an embodiment, the joystick is a stainless steel hypotube or a composite braided tube.

[0019] As an embodiment, when the distal end of the separation stent moves axially towards the proximal end, the separation stent can radially expand and form an inner concave structure with a distal depression and a protruding outer ring of the separation stent.

[0020] As an embodiment, the separation stent can first circumferentially twist and then axially contract to radially expand to form a series of spherical structures.

[0021] As an embodiment, the separation stent can first axially contract and then radially expand and then circumferentially twist to form a three-dimensional spiral structure.

[0022] From the above technical solutions, it can be seen that the embodiments of the present invention have at least the following advantages and positive effects:

[0023] Axially compress and circumferentially twist the separation stent for thrombus through the stent manipulation component, so that the separation stent can form various morphological structures to meet different thrombus removal requirements respectively, thereby improving the thrombus removal efficiency and effect. Description of the Drawings

[0024] In order to more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the following will briefly introduce the drawings required for use in the description of the embodiments or the prior art. It can be understood that the drawings in the following description are only the embodiments of the present invention. For those of ordinary skill in the art, without creative efforts, other drawings can also be obtained according to the provided drawings.

[0025] Figure 1 Overall structural schematic diagram of the thrombus separation device according to the embodiment of the present invention;

[0026] Figure 2 is Figure 1 Cross-sectional schematic diagram of the push tube of the thrombus separation device shown;

[0027] Figure 3 is Figure 1 Structural schematic diagram of the separation stent of the thrombus separation device shown in a concave shape;

[0028] Figure 4 is Figure 1 Structural schematic diagram of the separation stent of the thrombus separation device shown in a double-ball shape;

[0029] Figure 5 is Figure 1 Structural schematic diagram of the separation stent of the thrombus separation device shown in a spiral shape.

[0030] In the figure: 10, separation stent; 101, mesh hole; 20, conical head; 21, push tube; 211, infusion section; 212, infusion hole array; 213, infusion cavity; 214, first imaging layer, 215, second imaging layer; 22, joystick; 23, connecting piece; 24, manipulation part; 25, infusion tube; 26, two-way valve. Detailed Embodiments

[0031] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the following will elaborate on each embodiment of the present invention in conjunction with the drawings. However, those of ordinary skill in the art can understand that in each embodiment of the present invention, many technical details are proposed for the readers to better understand the present invention. However, even without these technical details and various changes and modifications based on the following embodiments, the technical solutions required to be protected by the present invention can still be achieved.

[0032] In the description of the present invention, it should be noted that the orientation or positional relationship indicated by terms such as "upper", "lower", "inner", "outer", etc. is based on the orientation or positional relationship shown in the drawings. It is only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation. Therefore, it should not be construed as a limitation to the present invention. In addition, terms such as "first", "second", etc. are only used for descriptive purposes and cannot be construed as indicating or implying relative importance.

[0033] It should be noted that unless otherwise clearly specified, terms such as "connected" and "coupled" should be understood in a broad sense. For example, it can be a fixed connection, a detachable connection, or an integral connection; it can be directly connected, or indirectly connected through an intermediate medium, and it can be the communication inside two elements.

[0034] In the description of the present invention, it should be noted that in the field of interventional medical devices, the proximal end refers to the end closer to the operator, and the distal end refers to the end farther from the operator. The above definitions are only for the convenience of expression and should not be construed as a limitation to the present invention.

[0035] Please refer to Figures 1 to 5 As shown, Embodiment 1 of the present invention provides a thrombus separation device, which can be used for clearing thrombus in blood vessels. The thrombus separation device includes: a separation stent 10 and a stent control assembly.

[0036] The separation stent 10 is a stent structure capable of radially expanding and circumferentially twisting. The stent control assembly is connected to the distal end and the proximal end of the separation stent 10 and is used to control the axial compression and circumferential twisting of the separation stent 10 so that the separation stent 10 forms a target shape. The peripheral wall of the separation stent 10 has mesh holes 101, and the stent control assembly can control the axial contraction and circumferential rotation of the separation stent 10 through both ends. When the separation stent 10 axially contracts, it can radially expand and can support and adhere to the inner wall of the blood vessel. By controlling the withdrawal of the separation stent 10 through the stent control assembly, the thrombus on the inner wall of the blood vessel can be scraped off. The separation stent 10 is divided into two stent segments after circumferentially twisting at a certain axial position in the radially contracted state, and then when the separation stent 10 axially contracts, the two stent segments can respectively radially expand to form the required thrombus removal structure. The separation stent 10 first axially contracts and radially expands, and then the circumferential rotation of the separation stent 10 is controlled so that the separation stent 10 forms an expanded and twisted structure. By performing axial contraction and circumferential twisting on the separation stent 10, the separation stent can form various target shapes to meet different thrombus separation requirements.

[0037] The separation stent 10 can be a tubular stent structure woven by multiple nitinol braided wires, or the separation stent can also be made from a nitinol metal tube through one-piece laser cutting and then heat setting, without excessive limitation here. The separation stent 10 should have strong radial expansion ability and circumferential torsion ability. For example, when the separation stent 10 axially contracts, a stent structure with a distal concave can be formed, and after the separation stent 10 is circumferentially twisted, the two stent segments can independently expand to form multiple stent units.

[0038] The stent control assembly can include: a tapered head 20, a push tube 21, a joystick 22, a control part 24, and a connecting piece 23. The tapered head 20, the separation stent 10, the push tube 21, and the connecting piece 23 are connected in sequence from far to near. The connecting piece 23 can be cylindrical, and by holding the connecting piece 23, the proximal end of the separation stent 10 can be controlled. The distal end of the joystick 22 is connected to the proximal end of the tapered head 20 and sequentially passes through the separation stent 10, the push tube 21, and the connecting piece 23. The outer end of the joystick 22 is connected to the control part 24, and the control part 24 is located on the proximal side of the connecting piece 23. The joystick 22 can axially move and circumferentially rotate relative to the separation stent 10, the push tube 21, and the connecting piece 23. By operating the control part 24, the tapered head 20 can be controlled to drive the distal end of the separation stent 10 to axially move or circumferentially rotate, thereby controlling the axial contraction, elongation, and circumferential rotation of the separation stent 10, so that the separation stent 10 forms the required thrombus removal structure.

[0039] A locking mechanism for locking the joystick 22 is provided at the proximal end of the connecting piece 23. After the separation stent 10 forms a target shape through the joystick 22, the joystick 22 is locked to the connecting piece 23 through the locking mechanism, so that the axial and circumferential positions of the joystick 22 and the connecting piece 23 are fixed, so that the separation stent 10 maintains the target shape suitable for scraping thrombus. The locking mechanism can include a valve core and a locking knob. When the locking knob is rotated, the valve core of the locking mechanism can hold the operating rod 22 tightly, thereby realizing the locking of the joystick 22. The locking mechanism can be realized by known technologies and will not be elaborated here.

[0040] The joystick 22 can be a stainless steel hypotube or a composite braided tube, so that the joystick can achieve a 1:1 torque transmission ability, reduce torque transmission loss, improve the operation feel and accuracy. The distal end of the control part 24 is connected to the proximal end of the joystick 22, and the control part 24 can be a luer connector, which is convenient for the operator to control the separation stent 10. A guide wire can pass through the luer connector, the joystick 22, and the tapered head 20.

[0041] The conical head 20 is in the shape of a cone with a smaller distal end and a larger proximal end, facilitating the advancement of the thrombus separation device within a blood vessel. The conical head 20 is provided with a third imaging layer (not shown in the figure), facilitating the observation of the position of the distal end of the separation stent 10. The distal end of the push tube 21 is provided with an infusion section 211, and an infusion hole array 212 is arranged on the peripheral wall of the infusion section 211. The infusion holes are arranged in an array, which is conducive to uniform medicament perfusion. The infusion holes can be long and narrow holes or slits. The push tube 21 has a plurality of infusion cavities 213 extending along its axial direction, and the infusion hole array 212 communicates with the plurality of infusion cavities 213. The infusion cavities 213 can be arranged within the peripheral wall of the push tube 21. The plurality of infusion cavities 213, for example, are 4 in number, and can be evenly distributed along the circumferential direction of the push tube 21 and are parallel to the axial direction of the push tube 21. The plurality of infusion cavities 213 respectively communicate with the infusion hole array 212. The two ends of the infusion section 211 are provided with a first imaging layer 214 and a second imaging layer 215. The first imaging layer 214 is located at the distal end of the infusion section 211 and can be aligned with the distal end of the push tube 21. The position of the infusion section 211 within the blood vessel can be assisted in being determined through the first imaging layer 214 and the second imaging layer 215. The position of the separation stent 10 can be assisted in being located through the first imaging layer 214 and the third imaging layer. The side wall of the connecting member 23 is connected to the infusion tube 25. The connecting member 23 and the infusion tube 25 can be in a T shape. The infusion tube 25 is connected to the plurality of infusion cavities 213, and a two-way valve 26 is provided on the infusion tube 25. A therapeutic medicament, such as a thrombolytic drug, can be infused through the infusion tube 25, the plurality of infusion cavities 213, and the infusion hole array 212.

[0042] Please refer to Figure 3 As shown, the separation stent 10 can radially expand and form an inner concave structure with a distal depression and a protruding outer ring as its distal end moves axially towards the proximal end along the axis. After the separation stent 10 reaches the target blood vessel position, the distal end of the separation stent 10 is driven to retract by the joystick 22. The separation stent 10 gradually expands into a spherical shape and then continues to retract, making the distal side of the separation stent 10 present an inner concave structure with an inner ring depression and an outer ring bulge. Thereby, the separation stent 10 has a larger diameter and radial supporting force. At the same time, the proximal side surface of the separation stent 10 is in an umbrella shape, and the retraction resistance is small. Furthermore, thrombus can be scraped against the wall for large-diameter blood vessels.

[0043] Please refer to Figure 4 As shown, the separation stent 10 can first twist circumferentially and then axially contract to radially expand and form a series of spherical structures. After the separation stent 10 reaches the target blood vessel position, first, the separation stent 10 is driven to rotate circumferentially by the joystick 22, making the separation stent 10 form a distal side stent section 102 and a proximal side stent section 103. Then, the separation stent 10 is controlled to axially contract, making the distal side stent section 102 and the proximal side stent section 103 respectively radially expand to form two spherical structures. Exemplarily, the diameter of the proximal side spherical structure is larger than that of the distal side spherical structure. Thereby, the cleaning requirements for thrombus within blood vessels of different sizes can be flexibly met.

[0044] Please refer to Figure 5 As shown, the separation stent 10 can first axially contract and radially expand, and then circumferentially twist to form a three-dimensional spiral structure. After the separation stent 10 reaches the target blood vessel position, first drive the separation stent 10 to axially contract and radially expand to a certain extent through the joystick 22, and then drive the separation stent 10 to rotate circumferentially, so that the separation stent 10 forms a three-dimensional spiral stent structure, such as Figure 5 As shown in the three-dimensional spiral stent structure, after circumferential rotation, the separation stent 10 forms a three-dimensional spiral structure. The separation stent 10 includes a distal-side stent segment 102 and a proximal-side stent segment 103. Both the distal-side stent segment 102 and the proximal-side stent segment 103 are in a spiral structure, and the spiral structure on the proximal side can be made larger than that on the distal side, and the supporting force of the spiral structure on the proximal side is stronger. Therefore, the larger spiral structure can be used to scrape the thrombus with greater volume viscosity at the corresponding position in the blood vessel, which can improve the thrombus removal ability.

[0045] Since the separation stent 10 can axially contract and circumferentially twist, the shape of the separation stent 10 is controlled by a single or combined method, so that the separation stent can form a thrombus removal structure with variable shapes and sizes, thereby meeting the removal requirements of thrombi of different volumes and positions, and improving the versatility of the thrombus separation device and the thrombus removal ability.

[0046] Combined with Figures 1 to 5 As shown, the usage method of the thrombus separation device according to the embodiment of the present invention is as follows:

[0047] In the interventional surgical treatment of removing thrombus in peripheral vascular embolism, an instrument intervention channel is established in the femoral vein blood vessel on the affected side by percutaneous puncture under local anesthesia. After the guide wire is sent to the position passing through the thrombus, the thrombus separation device according to the embodiment of the present application is guided by the guide wire and travels in the blood vessel cavity to the blood vessel embolism site, and the separation stent 10 is positioned through the conical head 20 and the imaging layer at the distal end of the push tube 21. Control the axial contraction of the separation stent 10 and circumferentially rotate it when needed by operating the joystick 22, so that the separation stent 10 expands at the blood vessel embolism site and forms the required thrombus removal structure (i.e., the target shape), and then lock the joystick 22 to the connecting member 23 through the locking mechanism to keep the thrombus removal structure in the required shape. Then, the thrombus separation device is withdrawn as a whole. During the withdrawal process, the separation stent 10 scrapes the thrombus on the blood vessel wall, so that the thrombus is separated from the blood vessel wall or the inner wall of the stent, and the separated thrombus is aspirated and removed from the body by the aspiration catheter.

[0048] Compared with the prior art, in the embodiment of the present invention, the separation stent of the thrombus is axially compressed and circumferentially twisted through the stent control assembly, so that the separation stent can form a variety of morphological structures, respectively meeting the removal requirements of thrombi of different sizes and positions, improving the versatility of the thrombus separation device, and at the same time having a simple structure and can meet the complex and diverse thrombus removal requirements in clinical practice.

[0049] Those of ordinary skill in the art can understand that the above embodiments are specific examples for implementing the present invention, and in practical applications, various changes can be made to them in form and details without departing from the spirit and scope of the present invention.

Claims

1. A thrombus separation device, characterized in that: include: A separation stent, which is a stent structure capable of radial expansion and circumferential torsion; The stent manipulation assembly is connected to the distal end and the proximal end of the separation stent and is used for controlling the axial compression and circumferential torsion of the separation stent so as to form the separation stent into a target shape.

2. The thrombus separation device according to claim 1, characterized in that: The support control assembly includes: a conical head, a push tube, a control rod, a control part and a connecting piece; The conical head, the separation bracket, the push tube and the connecting piece are connected in sequence from far to near; The distal end of the operating rod is connected to the proximal end of the conical head, and is sequentially passed through the separation bracket, the pushing tube and the connecting piece, and the outer end of the operating rod is connected to the operating part, and the operating part is located at the proximal end side of the connecting piece; The operating rod can move axially and rotate circumferentially relative to the separation bracket, the pushing tube and the connecting piece.

3. The thrombus separation device according to claim 2, characterized in that: The push tube is provided with an infusion section at the distal end, and an infusion hole array is arranged on the peripheral wall of the infusion section; the push tube has a plurality of infusion cavities extending along its axial direction, and the infusion hole array is connected with the plurality of infusion cavities; The side wall of the connector is connected to an infusion tube, and the infusion tube is connected to the multiple infusion cavities; a two-way valve is provided on the infusion tube.

4. The thrombus separation device according to claim 3, characterized in that: The two ends of the infusion section are provided with a first developing layer and a second developing layer.

5. The thrombus separation device according to claim 2, characterized in that: A locking mechanism for locking the operating rod is provided at the proximal end of the connecting piece.

6. The thrombus separation device according to claim 2, characterized in that: The conical head is provided with a third developing layer, and the operating part is a Luer connector.

7. The thrombus separation device according to claim 2, characterized in that: The joystick is a stainless steel hypotube or a composite braided tube.

8. The thrombus separation device according to claim 1, characterized in that: The separation bracket can expand radially as its distal end moves axially toward the proximal end, and form an inner concave structure in which the distal end of the separation bracket is concave and the outer circle is convex.

9. The thrombus separation device according to claim 1, characterized in that: The separation bracket can be twisted circumferentially first and then axially contracted and radially expanded to form a series spherical structure.

10. The thrombus separation device according to claim 1, characterized in that: The separation bracket can first shrink axially, expand radially, and then twist circumferentially to form a three-dimensional spiral structure.

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