Thrombus removal system

Abstract

The thrombus removing system comprises a blood leading-out part, a filtering part and a blood leading-in part which are sequentially connected and communicated with one another, the blood leading-out part comprises a leading-out sheath and a first connecting pipe connected to one side of the leading-out sheath, and the blood leading-in part comprises a leading-in sheath and a second connecting pipe connected to one side of the leading-in sheath. An expansion balloon is arranged on the periphery of the far end of the leading-out sheath, the first connecting pipe is connected with the filtering part through a first external catheter, and the second connecting pipe is connected with the filtering part through a second external catheter so that blood can sequentially flow through the artery, the leading-out sheath, the first external catheter, the filtering part, the second external catheter and the leading-in sheath and return to the vein. By arranging the blood leading-out part, the filtering part and the blood leading-in part, blood with thrombus is led from the artery to the filtering part to be filtered and then flows back to the vein, blood waste is avoided, and thrombus residues are effectively avoided.

Description

Technical Field

[0001] This utility model relates to the field of medical device technology, and in particular to a thrombus removal system. Background Technology

[0002] Current surgical procedures for treating thrombosis typically use aspiration catheters to extract blood containing the thrombus from the patient's artery. However, the extracted blood cannot be returned to the body, resulting in blood waste. Furthermore, fear of excessive blood loss prevents the complete removal of the thrombus, leading to residual thrombi and posing a significant risk to the patient's safety. In addition, the aspiration catheter enters the carotid artery from the femoral artery. Due to the long interventional path and numerous vascular branches, the aspiration catheter cannot effectively reach the designated location in tortuous or narrow branch vessels for treatment. Summary of the Invention

[0003] The purpose of this invention is to provide a thrombus removal system that returns extracted blood containing thrombi to the body, thus avoiding blood waste and thrombus residue.

[0004] To achieve the above objectives, this utility model provides a thrombus removal system, comprising a blood outlet, a filter, and a blood inlet connected sequentially and in communication with each other. The blood outlet includes an outlet sheath and a first connecting tube connected to one side of the outlet sheath. The blood inlet includes an inlet sheath and a second connecting tube connected to one side of the inlet sheath. An inflatable balloon is provided on the outer periphery of the distal end of the outlet sheath. The first connecting tube is connected to the filter via a first external catheter, and the second connecting tube is connected to the filter via a second external catheter, so that blood flows sequentially through an artery, the outlet sheath, the first external catheter, the filter, the second external catheter, and the inlet sheath, and returns to the vein.

[0005] Preferably, the blood export section further includes a first proximal extension tube and a first Y-shaped connector. The proximal end of the export sheath is connected to the first Y-shaped connector, and the first Y-shaped connector is also connected to the distal end of the first proximal extension tube. A first hemostatic valve is provided at the proximal end of the first proximal extension tube.

[0006] Preferably, the blood outlet is further provided with an expansion channel, which is connected to the expansion balloon.

[0007] Preferably, the blood inlet further includes a second proximal extension tube and a second Y-shaped connector. The proximal end of the inlet sheath is connected to the second Y-shaped connector, and the second Y-shaped connector is also connected to the distal end of the second proximal extension tube. A second hemostatic valve is provided at the proximal end of the second proximal extension tube.

[0008] Preferably, the blood export section is further provided with an extension catheter, which includes a catheter body, a push rod, and a sealing balloon. The catheter body is fitted onto the distal end of the export sheath, and the distal end of the push rod is connected to the proximal end of the catheter body. The push rod has an inflation channel inside. The sealing balloon is fitted onto the catheter body and located near the proximal end of the catheter body. The inner cavity of the sealing balloon communicates with the inflation channel. After the extension catheter extends a predetermined length from the export sheath, the sealing balloon expands so that it abuts against the inner wall of the export sheath.

[0009] Preferably, the catheter body includes an inner layer, a reinforcing layer and an outer layer arranged sequentially from the inside to the outside. The catheter body has a metal connector at the proximal end of the reinforcing layer. The distal end of the push rod is connected to one end of the metal connector, and the other end of the metal connector is connected to the reinforcing layer.

[0010] Preferably, the filtration section includes a hollow outer shell and a filter element disposed within the outer shell. The filter element is a hollow column extending along the blood flow direction and its free end is closed. The filter element has a plurality of filter holes evenly distributed in its radial direction. The outer shell has an expansion section and an arc-shaped contraction section along the blood flow direction. The expansion section is trumpet-shaped and one end of the expansion section near the arc-shaped contraction section is aligned with the free end of the filter element.

[0011] Preferably, the free end of the filter element also extends outward with a guide portion that gradually narrows along the direction of blood flow.

[0012] Preferably, a flow control component is provided on the first connecting pipe, the second connecting pipe, the first external conduit, or the second external conduit.

[0013] Preferably, the flow control component includes a pump.

[0014] Compared with the prior art, this utility model sets up a blood outlet, a filter, and a blood inlet to guide blood containing thrombi from the artery to the filter for filtration and then back into the vein, which will not cause blood waste and effectively avoid thrombus residue. Attached Figure Description

[0015] Figure 1 This is a structural diagram of the thrombus removal system according to an embodiment of the present invention.

[0016] Figure 2 for Figure 1 Enlarged view of point A in the middle.

[0017] Figure 3 This is a structural diagram of the extension catheter in an embodiment of this utility model.

[0018] Figure 4 This is a structural diagram showing the connection between the catheter body and the push rod via a metal connector in an embodiment of this utility model.

[0019] Figure 5 This is a structural diagram showing the connection between the sealing balloon and the filling channel in an embodiment of this utility model.

[0020] Figure 6 for Figure 5 Enlarged view of point B in the middle.

[0021] Figure 7 This is a cross-sectional view of the catheter body in an embodiment of this utility model.

[0022] Figure 8 This is a structural diagram of the metal connector in an embodiment of this utility model.

[0023] Figure 9 This is a structural diagram of the extension catheter and the blood outlet portion in an embodiment of this utility model.

[0024] Figure 10 This is a structural diagram of the filter section in an embodiment of the present invention. Detailed Implementation

[0025] To explain in detail the technical content, structural features, and effects of this utility model, the following description is provided in conjunction with the embodiments and accompanying drawings.

[0026] like Figures 1 to 10 As shown, this embodiment of the present invention provides a thrombus removal system, including a blood outlet 1, a filter 2, and a blood inlet 3 connected sequentially and in communication with each other. The blood outlet 1 includes an outlet sheath 11 and a first connecting tube 14 connected to one side of the outlet sheath 11. The blood inlet 3 includes an inlet sheath 31 and a second connecting tube 34 connected to one side of the inlet sheath 31. An inflatable balloon 4 is provided on the outer periphery of the distal end of the outlet sheath 11. The first connecting tube 14 is connected to the filter 2 through a first external catheter 51, and the second connecting tube 34 is connected to the filter 2 through a second external catheter 52, so that blood flows sequentially through the artery, outlet sheath 11, first external catheter 51, filter 2, second external catheter 52, and inlet sheath 31 and returns to the vein. Specifically, the artery can be the carotid artery, the femoral artery, or other arteries, and the vein can be the jugular vein, the femoral vein, or other veins, for example, such as... Figure 1As shown, in this embodiment of the present invention, the vein is the femoral vein. At least a portion of the outlet sheath 11 extends from the femoral artery into the carotid artery. After the expansion balloon 4 is inflated, it abuts against the inner wall of the carotid artery, thereby blocking the blood flow in the carotid artery. The natural pressure gradient between the carotid artery and the femoral vein causes blood to flow into the venous system in the reverse direction from the carotid artery, the blood outlet 1, the filter 2, and the blood inlet 3, thereby completing the removal of the thrombus and realizing the return of the filtered blood to the body.

[0027] This embodiment of the invention provides a blood outlet 1, a filter 2, and a blood inlet 3 to guide blood containing thrombi 9 from the artery to the filter 2 for filtration and then back into the vein, thus avoiding blood waste and effectively preventing thrombus residue.

[0028] In this embodiment of the invention, the blood export section 1 further includes a first proximal extension tube 12 and a first Y-shaped connector 13. The proximal end of the export sheath 11 is connected to the first Y-shaped connector 13, and the first Y-shaped connector 13 is also connected to the distal end of the first proximal extension tube 12. A first hemostatic valve 15 is provided at the proximal end of the first proximal extension tube 12. Specifically, as shown... Figure 1 As shown, the delivery sheath 11, the first proximal extension tube 12, the first connecting tube 14, and the first Y-shaped connector 13 have communicating cavities. The first connecting tube 14 is connected to the filter section 2 via the first connector 61. The distal ends of the first proximal extension tube 12 and the first connecting tube 14 are both connected to the first Y-shaped connector 13. The proximal end of the first proximal extension tube 12 can be connected to a drug delivery tube, a first flushing tube 16, etc. Figure 1 As shown, the first flushing tube 16 can be specifically connected to one side of the first hemostatic valve 15 and may have a first thrombus 161 at its proximal or distal end. During the operation, saline, contrast agent, etc., can be infused through the first flushing tube 16. In addition, during the operation, the first flushing tube 16 can also be connected to a pressure measuring instrument.

[0029] In this embodiment of the invention, the blood extraction section 1 is further provided with an expansion channel (not shown in the figure), which communicates with the expansion balloon 4 and is separated from the blood flow cavity. Specifically, an expansion channel is provided inside the extraction sheath 11, which communicates with the interior of the expansion balloon 4. By injecting a medium such as saline, the expansion balloon 4 is inflated to press against the carotid artery, ensuring that blood in the artery flows only into the extraction sheath 11. It should be noted that the inflation process of the expansion balloon 4 is a conventional technique in this field and will not be described in detail here.

[0030] In this embodiment of the invention, the blood inlet 3 further includes a second proximal extension tube 32 and a second Y-shaped connector 33. The proximal end of the inlet sheath 31 is connected to the second Y-shaped connector 33, and the second Y-shaped connector 33 is also connected to the distal end of the second proximal extension tube 32. A second hemostatic valve is provided at the proximal end of the second proximal extension tube 32. Specifically, as shown... Figure 1 As shown, the inlet sheath 31 can be connected to the second connecting tube 34 via the second Y-shaped connector 33. The second connecting tube 34 is connected to the filter section 2 via the second connector 62. The proximal end of the second proximal extension tube 32 can be connected to the drug delivery tube, the second flushing tube 36, etc. The second flushing tube 36 can be specifically connected to one side of the second hemostatic valve 35 and can have a second thrombus 361 at its proximal or distal end. The second hemostatic valve 35 allows the insertion of a dilator to facilitate the introduction of the inlet sheath 31 into the vein.

[0031] In this embodiment of the utility model, such as Figure 1 As shown, a flow control assembly 7 is provided on the first connecting tube 14, the second connecting tube 34, the first external catheter 51, or the second external catheter 52. The flow control assembly 7 is used to regulate and / or monitor blood flow. The flow control assembly 7 may include various devices for controlling blood flow, including one or more pumps and / or variable resistance components. The flow control assembly 7 can be manually controlled by the user and / or automatically controlled by a controller to change the flow rate of circulating blood.

[0032] In this embodiment of the present invention, an extension catheter 8 is further provided in the blood export section 1. The extension catheter 8 includes a catheter body 81, a push rod 82, and a sealing balloon 83. The catheter body 81 is fitted into the distal end of the export sheath 11. The distal end of the push rod 82 is connected to the proximal end of the catheter body 81. The push rod 82 has an inflation channel 821 inside. The sealing balloon 83 is fitted onto the catheter body 81 and located near the proximal end of the catheter body 81. The inner cavity of the sealing balloon 83 communicates with the inflation channel 821. After the extension catheter 8 extends a predetermined length from the export sheath 11, the sealing balloon 83 expands so that the sealing balloon 83 abuts against the inner wall of the export sheath 11. Specifically, as shown... Figures 3 to 9As shown, the catheter body 81 includes an inner layer 812, a reinforcing layer 813, and an outer layer 814 arranged sequentially from the inside out. A metal connector 84 is provided near the proximal end of the reinforcing layer 813. The distal end of the push rod 82 is connected to one end of the metal connector 84, and the other end of the metal connector 84 is connected to the reinforcing layer 813. This embodiment of the invention sets the catheter body 81 as a three-layer composite structure, providing strong support, pressure resistance, and flexural strength. The inner layer 812 is made of polytetrafluoroethylene (PTFE) or linear low-density polyethylene (LLDPE). PTFE has high lubricity and non-stick properties, facilitating blood flow. LLDPE has a high softening and melting temperature, and advantages such as high strength, good toughness, high rigidity, good heat resistance, and good cold resistance. It also has good resistance to environmental stress cracking, impact strength, and tear strength. The outer layer 814 is made of one or more mixtures of polyether-tipped polyamide, nylon, and polyurethane elastomer, ensuring a smoother appearance and feel on the outer surface of the catheter body 81, effectively protecting the blood vessel from thrombosis and dissection. The hardness of the outer layer 814 decreases progressively from the proximal end to the distal end of the catheter body 81. This not only prevents deformation but also facilitates passage through tortuous lesion sites. The use of a flexible material at the distal end avoids damage to the blood vessel wall during advancement, better meeting the needs of catheter advancement within the human blood vessel. This allows for more precise and convenient operation by the doctor while reducing patient discomfort during surgery. The reinforcing layer 813 is a spring layer made of wound metal wire, which can be nickel-titanium alloy wire and / or stainless steel wire. The wire diameter has a pitch of 0.01mm-0.3mm, and the thread pitch is 0.03mm-0.3mm. In one embodiment, the proximal end of the spring layer is wound with stainless steel wire, and the distal end is wound with nickel-titanium alloy wire. In one embodiment, the pitch of the proximal end of the spring layer is greater than that of the distal end, which helps to ensure better flexibility and accessibility of the distal end of the fabricated catheter body 81, while providing better pushing performance at the proximal end. For example, the distal end of the spring layer uses a 0.05mm diameter nickel-titanium alloy wire with a pitch of 0.1mm, while the proximal end uses a 0.08mm diameter stainless steel wire with a pitch of 0.08mm. Figures 3 to 8 As shown, the metal connector 84 includes a connecting piece 841 and multiple connecting strips 842 connected to opposite sides of the connecting piece 841. The connecting piece 841 and each connecting strip 842 are connected to the reinforcing layer 813. A push rod 82 is connected to the connecting piece 841. Each connecting strip 842 is wrapped around and connected to the inner layer 812. The connecting strips 842 are wrapped around and connected to the outside of the inner layer 812, which can ensure that the metal connector 84 is firmly connected to the conduit body 81. Figures 1 to 9As shown, the push rod 82 has a first through hole 822 corresponding to the sealing balloon 83. The first through hole 822 communicates with the filling channel 821. The outer layer 814 has a second through hole, which is positioned corresponding to the first through hole 822. The filling channel 821 communicates with the inner cavity of the sealing balloon 83 through the first through hole 822 and the second through hole. The proximal end of the catheter body 81 is located in the export sheath 11 and has an export port 811 at the proximal end. The proximal end of the push rod 82 is located outside the proximal end of the export sheath 11, specifically outside the proximal end of the first hemostatic valve 15. The distal end of the catheter body 81 can extend from the distal end of the export sheath 11 and extend a preset length as needed. After the catheter body 81 extends the preset length, saline or other media are injected into the sealing balloon 83 through the filling channel 821 to inflate the sealing balloon 83 so that it abuts against the inner wall of the distal end of the export sheath 11 to fix the catheter body 81 in the export sheath 11. The extension catheter 8 facilitates its entry into tortuous and narrow branch vessels, solving the problem that existing catheters cannot effectively enter the designated locations of tortuous and narrow branch vessels for treatment. In this invention, the extension catheter 8 also features a sealing balloon 83 at the proximal end of the catheter body. The push rod has an inflation channel, allowing the sealing balloon 83 to be inflated. After inflation, the outer wall of the sealing balloon 83 is tightly fitted against the inner lumen of the export sheath 11, preventing the extension catheter from slipping or dislodging within the export sheath 11. This enhances the axial stability of the extension catheter 8 within the export sheath 11, prevents pressure leakage during aspiration through the gap between them, and fully utilizes the lumen of the export sheath 11, resulting in greater aspiration efficiency. Figure 2 As shown, when the thrombus removal system is working, the extension catheter 8 is inserted proximally into the first proximal extension tube 12, causing the catheter body 81 to extend out of the outlet sheath 11. The sealing balloon 83 is inflated through the filling channel 821 within the push rod 82, causing the sealing balloon 83 to quickly anchor into the lumen of the outlet sheath 11 and seal it, thus fixing the extension catheter 8 relative to the outlet sheath 11. Distal blood flows sequentially through (e.g., Figure 2 (As indicated by the middle arrow) The small branch vessels, catheter body 81, outlet sheath 11, first external catheter 51, filter section 2, second external catheter 52 and inlet sheath 31 return to the femoral vein to participate in blood circulation, which can effectively remove thrombi 9 and will not cause excessive blood loss.

[0033] Furthermore, such as Figure 3As shown, the extension catheter 8 also includes a catheter seat 85, the distal end of which is connected to the proximal end of the push rod 82. The catheter seat 85 has a through channel that communicates with the filling channel 821. The catheter seat 85, push rod 82, and sealing balloon 83 are interconnected to form a single-lumen channel. During operation, the physician can connect an injection fluid or other medium to the catheter seat 85 and inflate the sealing balloon 83 through the fluid channel within the push rod 82, causing the sealing balloon 83 to quickly anchor within the lumen of the delivery sheath 11 and seal it. The distal end of the catheter seat 85 is connected to the proximal end of the push rod 82; in this embodiment, the connection between the two is a welded connection.

[0034] In one embodiment, the sealing balloon 83 is made of one of silicone rubber, polyurethane elastomer, or thermoplastic elastomer. Silicone rubber also has the outstanding properties of being physiologically inert and not causing blood clotting, therefore it is widely used in the medical field. Polyurethane resin, as a polymer material with high strength, tear resistance, and wear resistance, is widely used in daily life, industrial and agricultural production, and medicine.

[0035] In this embodiment of the utility model, such as Figure 10 As shown, the filter section 2 includes a hollow outer shell 21 and a filter element 22 disposed within the outer shell 21. The filter element 22 is a hollow column extending along the blood flow direction, and its free end is closed. The filter element 22 has a plurality of filter holes 221 evenly distributed in its radial direction. The outer shell 21 has an expansion section 211 and an arc-shaped contraction section 212 along the blood flow direction. The expansion section 211 is funnel-shaped, and one end of the expansion section 211 near the arc-shaped contraction section 212 is aligned with the free end of the filter element 22. Specifically, blood containing thrombi 9 flows in from the inlet 33 of the filter section 2 for filtration. The filter element 22 includes a filter element seat 222, which is threadedly connected to the outer shell 21. The filter element 22 and the outer shell 21 are preferably made of metal for a more stable structure. In addition, the expansion section 211 and the arc-shaped contraction section 212 provided in the outer shell 21 along the blood flow direction ensure the smoothness of blood flow and prevent large pressure fluctuations.

[0036] Furthermore, such as Figure 10 As shown, the free end of the filter element 22 also extends outward with a guide portion 223 that gradually narrows along the direction of blood flow. The guide portion 223 guides blood to flow out of the outlet 34 of the filter element 2, resulting in smoother blood flow.

[0037] Please refer to Figure 1One method of using the thrombus removal system of this utility model: The blood outlet 13 enters the common carotid artery via the femoral artery. According to this femoral artery method, the blood outlet 13 ascends along the aortic arch AA through a skin perforation, for example, located in the groin, leading to the femoral artery FA, ​​and reaches the target common carotid artery CCA. The blood inlet 3 can communicate with the femoral vein FV. An inflatable balloon 4 is provided on the peripheral periphery of the distal end of the outlet sheath 11. The first connecting tube 14 is connected to the filter section 2 through the first external catheter 51, and the second connecting tube 34 is connected to the filter section 2 through the second external catheter 52. The blood flows sequentially through the common carotid artery CCA, outlet sheath 11, first external catheter 51, filter section 2, second external catheter 52, and inlet sheath 31, returning to the femoral vein to participate in blood circulation, effectively removing thrombi 9 without causing excessive blood loss.

[0038] Please refer to Figure 1-2 For small vessels or cerebral vessels distal to the common carotid artery (CCA), such as the external carotid artery (ECA), internal carotid artery (ICA), and vertebral artery (VA), if the thrombus 9 is attached to such vessels, and the diameter of the outlet sheath 11 is larger than the inner diameter of the distal small vessels or cerebral vessels, the outlet sheath 11 cannot reach the thrombus 9. In this case, the extension catheter 8 can be extended from the proximal end of the first proximal extension tube 12, so that the catheter body 81 extends out of the outlet sheath 11. The sealing balloon 83 is inflated through the filling channel 821 in the push rod 82, so that the sealing balloon 83 is quickly anchored in the lumen of the outlet sheath 11 and sealed to fix the extension catheter 8 relative to the outlet sheath 11. The distal blood flows sequentially through the small branch vessels, the catheter body 81, the outlet sheath 11, the first external catheter 51, the filter section 2, the second external catheter 52, and the inlet sheath 31, and returns to the femoral vein to participate in blood circulation. This can effectively remove the thrombus 9 without causing excessive blood loss.

[0039] The above-disclosed examples are merely preferred embodiments of the present utility model and should not be construed as limiting the scope of the present utility model. Therefore, any equivalent changes made in accordance with the scope of the present utility model application shall still fall within the scope of the present utility model.

Claims

1. A thrombus removal system, characterized in that, The device includes a blood export section, a filter section, and a blood import section that are connected and communicate with each other in sequence. The blood export section includes an export sheath and a first connecting tube connected to one side of the export sheath. The blood import section includes an import sheath and a second connecting tube connected to one side of the import sheath. An inflatable balloon is provided on the outer periphery of the distal end of the export sheath. The first connecting tube is connected to the filter section through a first external catheter, and the second connecting tube is connected to the filter section through a second external catheter so that blood flows sequentially through an artery, the export sheath, the first external catheter, the filter section, the second external catheter, and the import sheath and returns to the vein.

2. The thrombus removal system as described in claim 1, characterized in that, The blood export section further includes a first proximal extension tube and a first Y-shaped connector. The proximal end of the export sheath is connected to the first Y-shaped connector, and the first Y-shaped connector is also connected to the distal end of the first proximal extension tube. A first hemostatic valve is provided at the proximal end of the first proximal extension tube.

3. The thrombus removal system as described in claim 1, characterized in that, The blood export section is also provided with an expansion channel, which is connected to the expansion balloon.

4. The thrombus removal system as described in claim 2, characterized in that, The blood inlet section also includes a second proximal extension tube and a second Y-shaped connector. The proximal end of the inlet sheath is connected to the second Y-shaped connector, and the second Y-shaped connector is also connected to the distal end of the second proximal extension tube. A second hemostatic valve is provided at the proximal end of the second proximal extension tube.

5. The thrombus removal system as described in claim 1, characterized in that, An extension catheter is also provided in the blood export section. The extension catheter includes a catheter body, a push rod, and a sealing balloon. The catheter body is fitted onto the distal end of the export sheath. The distal end of the push rod is connected to the proximal end of the catheter body. The push rod has an inflation channel inside. The sealing balloon is fitted onto the catheter body and located near the proximal end of the catheter body. The inner cavity of the sealing balloon communicates with the inflation channel. After the extension catheter extends a predetermined length from the export sheath, the sealing balloon expands so that it abuts against the inner wall of the export sheath.

6. The thrombus removal system as described in claim 5, characterized in that, The catheter body includes an inner layer, a reinforcing layer, and an outer layer arranged sequentially from the inside to the outside. The catheter body has a metal connector at the proximal end of the reinforcing layer. The distal end of the push rod is connected to one end of the metal connector, and the other end of the metal connector is connected to the reinforcing layer.

7. The thrombus removal system as described in claim 1, characterized in that, The filtration unit includes a hollow outer shell and a filter element disposed within the outer shell. The filter element is a hollow column extending along the blood flow direction and its free end is closed. The filter element has a plurality of filter holes evenly distributed in its radial direction. The outer shell has an expansion section and an arc-shaped contraction section along the blood flow direction. The expansion section is trumpet-shaped and one end of the expansion section near the arc-shaped contraction section is aligned with the free end of the filter element.

8. The thrombus removal system as described in claim 7, characterized in that, The free end of the filter element also extends outward with a guide portion that gradually contracts along the direction of blood flow.

9. The thrombus removal system as described in claim 1, characterized in that, A flow control component is provided on the first connecting pipe, the second connecting pipe, the first external conduit, or the second external conduit.

10. The thrombus removal system as described in claim 9, characterized in that, The flow control component includes a pump.

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