Inflatable balloon of common carotid artery penetrating sheath

Abstract

The invention relates to the technical field of medical instruments, in particular to a common carotid artery piercing sheath with an inflatable balloon, which comprises a first catheter and a second catheter, the first catheter is communicated with the second catheter, and the first catheter is used for being inserted into an artery and used for guiding blood in the artery to enable the blood to flow into the second catheter; a limiting assembly is arranged on the outer side wall of the first catheter and is used for inserting the first catheter into a blood vessel and blocking and closing the blood vessel; the tail end of the second catheter is connected with an adjusting assembly, and the other end, away from the first catheter, of the second catheter is connected with an external conveying pipe. The air bag is divided into a plurality of independent inflation cavities by the diaphragms, and can be inflated and expanded in a partitioned mode in sequence, so that the air bag can adapt to the shape of a blood vessel, uniform sealing attached to the wall of the blood vessel is achieved, and local compression or incomplete sealing caused by deviation of the air bag is avoided; suddenly impact of one-time overall expansion of a traditional air bag on the blood vessel wall is avoided through partitioned inflation, and the risk of injury or spasm of the endangium is reduced.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, specifically to a carotid artery perforation sheath with a built-in inflatable balloon. Background Technology

[0002] TCAR uses reverse blood flow technology, which establishes reverse blood flow to the femoral vein through a small incision in the neck, draining plaque debris to the outside of the body. When occluding blood vessels, a balloon is used to seal the vessels. After the arterial incision is completed, the catheter and inflatable balloon are inserted into the blood vessel. When the catheter is inserted into the blood vessel, if the inflatable balloon is not located in the central area of ​​the blood vessel, when the balloon is fully inflated, the balloon is close to the inner wall of the blood vessel and is prone to uneven pressure and excessive expansion of the inner wall of the blood vessel.

[0003] Therefore, the proposed solution is to incorporate an inflatable balloon into the carotid artery perforation sheath to address the aforementioned issues. Summary of the Invention

[0004] To achieve the above objectives, the present invention provides the following technical solution: It includes a first catheter and a second catheter, which are interconnected. The first catheter is inserted into an artery to guide blood flow into the second catheter. A limiting component is provided on the outer wall of the first catheter, which is used to block and close the blood vessel after the first catheter is inserted. An adjustment component is connected to the end of the second catheter, and the other end of the second catheter, away from the first catheter, is connected to an external delivery tube, allowing blood in the second catheter to flow back to the patient's femoral vein. Multiple sets of pressure guidewires are fixedly connected to the surface of the outer wall of the first catheter at both ends of the limiting component. These pressure guidewires are used to monitor blood pressure between the two ends of the blood vessel when the limiting component expands and blocks the blood vessel.

[0005] Preferably, the restraint component includes an airbag, which is fixedly connected to the outer wall of the first conduit, and multiple sets of diaphragms are fixedly connected to the inner wall of the airbag.

[0006] Preferably, multiple diaphragms divide the inner wall of the airbag into multiple inflation cavities, and the multiple inflation cavities are connected to the delivery tube.

[0007] Preferably, multiple sets of delivery pipes are connected to the receiving sleeve through control valves. The receiving sleeve is installed in the inner interlayer space of the first conduit. The space inside the receiving sleeve is connected to the connecting pipe, and the connecting pipe is connected to the external inflation equipment.

[0008] Preferably, the adjustment assembly includes a connecting sleeve disposed on the outer wall of the second conduit.

[0009] Preferably, an inner membrane is fixedly connected to the inner wall of the second conduit, and the outer wall of the inner membrane is connected to a connecting plate. The connecting plate is connected to the connecting sleeve via a telescopic rod and an electromagnetic spring.

[0010] Preferably, a sealed space is formed between the inner side wall of the adapter sleeve and the outer side wall of the inner membrane, and a plurality of sets of adapter plates, telescopic rods and electromagnetic springs are arranged in the sealed space.

[0011] Preferably, the plurality of sets of adapter plates, telescopic rods and electromagnetic springs are used to adjust the expanded inner diameter of the inner membrane, and the flow rate of blood flowing through the second catheter is adjusted by adjusting the size of the inner diameter of the inner membrane.

[0012] Preferably, the plurality of inflation cavities in the airbag are inflated respectively, so that the airbag can adapt to the shape of the blood vessel and achieve uniform and close sealing of the blood vessel wall.

[0013] Preferably, when the airbag is inflated, the airbag is trumpet-shaped, and the cross-sectional view of the contact area between the airbag and the blood vessel is V-shaped, so that the end of the airbag is close to the inner wall of the blood vessel.

[0014] Compared with the prior art, the present application provides a carotid artery sheath with an inflatable balloon, which has the following advantages: 1. The airbag in the present application is divided into a plurality of independent inflation cavities by a diaphragm, which can be inflated and expanded in sequence in a partitioned manner, so that the airbag can adapt to the shape of the blood vessel and achieve uniform and close sealing of the blood vessel wall, avoiding local compression or incomplete sealing caused by airbag misalignment; the partitioned inflation avoids the sudden impact of the traditional airbag on the blood vessel wall when inflated in one piece, reducing the risk of blood vessel intima damage or spasm.

[0015] 2. The pressure guide wire at the front and rear ends of the airbag in the present application can monitor the blood pressure difference between the two ends of the blocked area in real time, indirectly verifying the integrity of the airbag sealing, and if the blood pressure difference is abnormal, the inflation can be adjusted in time to ensure that the carotid artery blood flow is completely blocked and prevent plaque debris from flowing to the brain.

[0016] 3. The electromagnetic spring and adapter plate in the adjusting assembly can change the inner diameter of the inner membrane of the second catheter in real time, actively adjust the blood flow rate and flow according to the principle of fluid mechanics, and the doctor can accurately control it according to the needs of the operation or the patient's condition; combined with the reliable blocking of the airbag and the adjustment of the inner diameter of the catheter, stable reverse blood flow can be maintained.

[0017] 4. The inflation control valve, connecting pipe and adjusting assembly in the present application are located outside the body, which is convenient for real-time operation and adjustment during the operation; when the airbag is inflated, the airbag is trumpet-shaped, and the cross-sectional view of the contact area between the airbag and the blood vessel is V-shaped, so that the end of the airbag is close to the inner wall of the blood vessel, avoiding the situation that when the airbag is inflated in a spherical shape, the airbag is wide in the middle and narrow at the front and rear, and there is a groove gap between the airbag and the blood vessel, and impurities in the blood accumulate in the gap. BRIEF DESCRIPTION OF DRAWINGS

[0018] The accompanying drawings, which are included to provide a further understanding of the application and are incorporated in and constitute a part of this application, illustrate embodiments of the application and together with the description serve to explain the application. In the drawings: Figure 1 The schematic diagram of the connection structure of the application and the blood flow system Figure 2 The schematic diagram of the connection structure of the application and the blood flow system Figure 3 The schematic diagram of the structure of the application Figure 1 ; Figure 4 The schematic diagram of the structure of the application Figure 2 ; Figure 5 The schematic diagram of the structure of the application Figure 3 ; Figure 6 The schematic diagram of the structure of the application Figure 4 .

[0019] In the figure: 1, first catheter; 2, limiting assembly; 3, second catheter; 4, adjusting assembly; 5, pressure guide wire; 21, air bag; 22, diaphragm; 23, delivery tube; 24, receiving sleeve; 25, control valve; 26, connecting tube; 41, connecting sleeve; 42, inner membrane; 43, connecting plate; 44, telescopic rod; 45, electromagnetic spring. DETAILED DESCRIPTION

[0020] The technical solutions in the embodiments of the application will be clearly and completely described below with reference to the drawings in the embodiments of the application. Obviously, the described embodiments are only part of the embodiments of the application, rather than all the embodiments of the application. Based on the embodiments in the application, all other embodiments obtained by a person of ordinary skill in the art without creative work fall within the protection scope of the application.

[0021] Please refer to Figures 1-6 , the common carotid artery sheath in the embodiment is provided with an inflatable balloon, the inflatable balloon is used in TCAR, TCAR adopts reverse blood flow technology, including a backflow blood vessel sheath assembly and a filtering and speed regulating assembly and an extracted blood vessel sheath assembly (for reference, the existing technology is disclosed in CN217566956U), the extracted blood vessel sheath assembly is used to guide the blood in the artery to the inside of the filtering and speed regulating assembly, then the blood is transmitted to the inside of the backflow blood vessel sheath assembly after being treated, the backflow blood vessel sheath assembly transmits the blood to the femoral vein of the patient to form a backflow; a reverse blood flow from the femoral vein to the artery is established through a small incision in the neck, and plaque debris is drained to the outside of the body; Specifically, the inflatable balloon includes a first catheter 1 and a second catheter 3, the first catheter 1 and the second catheter 3 are in communication with each other, the first catheter 1 is used for inserting into the artery for guiding the blood flow in the artery to flow into the second catheter 3; Wherein, the outer side wall of the first catheter 1 is provided with a limiting assembly 2, the limiting assembly 2 is used for plugging and closing the blood vessel when the first catheter 1 is inserted into the blood vessel; Specifically, the end of the second catheter 3 is connected with an adjusting assembly 4, the other end of the second catheter 3 away from the first catheter 1 is connected with a filtering and speed regulating assembly outside, so that the blood in the second catheter 3 is filtered through the filtering and speed regulating assembly and then flows back into the backflow blood vessel sheath assembly and then flows back to the femoral vein of the patient; Specifically, the outer side wall of the first catheter 1 is fixedly connected with a plurality of pressure guide wires 5 at the upper and lower end regions of the limiting assembly 2, the pressure guide wires 5 are used for monitoring the blood pressure between the front and back of the blood vessel when the limiting assembly 2 is inflated to plug and close the blood vessel; More specifically, the tip of the pressure guide wire 5 integrates a miniature high-fidelity pressure sensor, the pressure guide wire 5 can measure the pressure difference, and the stability of the data can also indirectly reflect the integrity of the balloon 21 sealing; the first catheter 1 and the second catheter 3 are made of flexible material, so that the second catheter 3 and the first catheter 1 can be deformed for subsequent insertion into the blood vessel; Wherein, the inner side wall surface of the second catheter 3 and the first catheter 1 is extremely smooth, which greatly reduces the blood flow resistance.

[0022] Please refer to Figures 1-6 , the limiting assembly 2 includes a balloon 21, the balloon 21 is fixedly connected to the outer side wall of the first catheter 1, the first catheter 1 penetrates through the center of the balloon 21, the inner side wall of the balloon 21 is fixedly connected with a plurality of diaphragms 22, the plurality of diaphragms 22 divides the inner side wall of the balloon 21 to form a plurality of inflatable cavities, the plurality of inflatable cavities are in communication with a plurality of delivery tubes 23, the plurality of delivery tubes 23 are respectively in communication with the inner space of a receiving sleeve 24 through a control valve 25, the receiving sleeve 24 is arranged in the inner sandwich space of the first catheter 1, the inner space of the receiving sleeve 24 is in communication with a connecting pipe 26, the connecting pipe 26 is connected with an inflation device outside, and the inflation of the balloon 21 is stopped by monitoring the change of the inflation pressure in the inflation device; Specifically, when the balloon 21 is inflated, the balloon 21 is trumpet-shaped, and the cross-sectional view of the contact area between the balloon 21 and the blood vessel is V-shaped, so that the end of the balloon 21 is attached to the inner wall of the blood vessel, avoiding the balloon 21 being inflated in a spherical shape, the middle of the balloon 21 is wide and the front and back are flat, and a gap is formed between the balloon and the blood vessel, so that impurities in the blood accumulate in the gap; Please refer to Figures 1-5The adjusting component 4 includes a connecting sleeve 41, which is disposed on the outer side wall of the second conduit 3. An inner membrane 42 is fixedly connected to the inner wall of the second conduit 3. The outer side wall of the inner membrane 42 is connected to a connecting plate 43. The connecting plate 43 is connected to the connecting sleeve 41 through a telescopic rod 44 and an electromagnetic spring 45. A sealed space is formed between the inner wall of the connecting sleeve 41 and the outer wall of the inner membrane 42. Multiple sets of connecting plates 43, telescopic rods 44, and electromagnetic springs 45 are provided in the sealed space. Among them, multiple sets of connecting plates 43, telescopic rods 44, and electromagnetic springs 45 are used to adjust the inner diameter of the intima 42 and adjust the flow rate of blood flowing through the second catheter 3 by adjusting the size of the inner diameter of the intima 42. The inlet end of the external filter device can be connected to one end of the intima 42 to facilitate the blood to enter the filter device and then flow back to the patient's femoral vein.

[0023] like Figures 1-6 As shown in this embodiment, the principle of the carotid artery perforation sheath with built-in inflatable balloon is as follows: In use, a small incision is made in the neck beforehand, and then the first catheter 1 and the restricting component 2 are inserted into the artery. The adjusting component 4, the receiving sleeve 24, the control valve 25, and the connecting tube 26 are located at the external end of the body. The receiving sleeve 24 is inflated through the connecting tube 26, and then the control valve 25 in the receiving sleeve 24 is opened to deliver gas into the inflation chamber, filling the inflation chamber with gas. The airbag 21 in this inflation chamber area expands and contacts the blood vessel. Then, the inflation in this area is stopped and the control valve 25 in this area is closed. Then, another set of control valves 25 is opened and another set of inflation chambers and the surface of the airbag 21 are inflated. This cycle is repeated to inflate multiple areas of the entire airbag 21 separately. This prevents the airbag 21 from expanding as a whole after the first catheter 1 drives the restricting component 2 into the blood vessel, and the airbag 21 is not located in the central area of ​​the blood vessel. When the airbag 21 expands as a whole, the airbag 21 is close to the surface of the blood vessel area and contacts the blood vessel in advance. During the subsequent expansion process, pressure is continuously applied to the blood vessel. When the airbag 21 blocks the blood vessel, the pressure guide wires 5 at both ends of the airbag 21 are used to perform multi-directional pressure detection on the upper and lower ends of the blocked blood vessel. When the contact between a single area of ​​the airbag 21 and the inner wall of the blood vessel is insufficient, the blood flows to the other end of the airbag 21. The carotid artery is not completely blocked, and some blood flow can still flow to the brain. And the blood enters the second conduit 3 through the first conduit 1, and then enters the delivery pipeline outside through the second conduit 3, and then the blood is delivered to the femoral vein area of the patient for circulation, and since the diameter of the first conduit 1 itself is smaller than the diameter of the blood vessel, when the blood flowing in the blood vessel enters the inside of the first conduit 1, the flow rate of the blood increases after entering the inside of the first conduit 1 due to the reduction of the inner diameter of the first conduit 1, and when the blood flows to the area of the regulating assembly 4, a plurality of electromagnetic springs 45 can be controlled to drive the abutment plate 43 to move, so that the abutment plate 43 drives the inner membrane 42 to expand or shrink, according to the principle of fluid mechanics (Q = v * A, flow rate = flow rate × cross-sectional area), under the condition that the upstream and downstream pressures are relatively stable, reducing the inner diameter will increase the blood flow rate, and expanding the inner diameter will reduce the speed, and the doctor can actively and real-time adjust the blood flow rate and flow.

[0024] The mounting manner, connecting manner or setting manner disclosed in the embodiment are all common mechanical connecting manners, and any connecting manner that can achieve the beneficial effects can be implemented, so the specific structural components and working principles will not be described in detail.

[0025] It should be noted that, in this document, the terms such as first and second are used only to distinguish one entity or operation from another entity or operation, and do not necessarily require or imply that there is any such actual relationship or order between these entities or operations. Moreover, the terms "include", "contain" or any other variants thereof are intended to cover non-exclusive inclusion, so that the process, method, article or device including a series of elements not only includes those elements, but also includes other elements not explicitly listed or inherent to such process, method, article or device. Without more limitations, the element defined by the statement "including a" does not exclude the presence of another identical element in the process, method, article or device including the element.

[0026] Although the embodiments of the present application have been shown and described, it will be understood by those of ordinary skill in the art that various changes, modifications, replacements and variations of the embodiments can be made without departing from the principles and spirits of the present application, and the scope of the present application is defined by the appended claims and their equivalents.​

Claims

1. A carotid artery sheath with inflatable balloon, comprising a first catheter (1) and a second catheter (3), the first catheter (1) and the second catheter (3) are in communication with each other, the first catheter (1) is used for inserting into the artery for guiding the blood flow in the artery to flow into the second catheter (3); characterized in that the outer wall of the first catheter (1) is provided with a limiting assembly (2), the limiting assembly (2) is used for plugging and closing the blood vessel when the first catheter (1) is inserted into the blood vessel; the distal end of the second catheter (3) is connected with an adjusting assembly (4), the other end of the second catheter (3) away from the first catheter (1) is connected with a delivery tube to the outside, so that the blood in the second catheter (3) flows back to the femoral vein of the patient; a plurality of pressure guide wires (5) are fixedly connected to the surface of the upper and lower end regions of the limiting assembly (2) on the outer wall of the first catheter (1), and the pressure guide wires (5) are used for monitoring the blood pressure between the front and back of the blood vessel when the limiting assembly (2) expands to plug and close the blood vessel.

2. The carotid artery sheath with inflatable balloon of claim 1, wherein: The limiting assembly (2) comprises a balloon (21), the balloon (21) is fixedly connected to the outer wall of the first catheter (1), and the inner wall of the balloon (21) is fixedly connected with a plurality of diaphragms (22).

3. The carotid artery sheath with inflatable balloon of claim 2, wherein: The plurality of diaphragms (22) divide the inner wall of the balloon (21) into a plurality of inflation cavities, and the plurality of inflation cavities are in communication with the delivery tube (23).

4. The carotid artery sheath with inflatable balloon of claim 3, wherein: A plurality of delivery tubes (23) are respectively in communication with the inner space of the receiving sleeve (24) through control valves (25), the receiving sleeve (24) is arranged in the interlayer space of the first catheter (1), the inner space of the receiving sleeve (24) is in communication with a connecting pipe (26), and the connecting pipe (26) is connected with an inflation device outside.

5. The carotid artery sheath with inflatable balloon of claim 1, wherein: The adjusting assembly (4) comprises a connecting sleeve (41) arranged on the outer wall of the second catheter (3).

6. The carotid artery sheath with inflatable balloon of claim 5, wherein: An inner membrane (42) is fixedly connected to the inner wall of the second catheter (3), the outer wall of the inner membrane (42) is connected with a connecting plate (43), and the connecting plate (43) is connected with the connecting sleeve (41) through an extension rod (44) and an electromagnetic spring (45).

7. The carotid artery sheath with inflatable balloon of claim 6, wherein: A closed space is formed between the inner wall of the connecting sleeve (41) and the outer wall of the inner membrane (42), and a plurality of connecting plates (43), extension rods (44) and electromagnetic springs (45) are arranged in the closed space.

8. The carotid artery sheath with inflatable balloon of claim 6 or 7, wherein: The plurality of connecting plates (43), extension rods (44) and electromagnetic springs (45) are used for adjusting the opening diameter of the inner membrane (42), and the flow rate of the blood flowing through the second catheter (3) is adjusted by adjusting the size of the inner diameter of the inner membrane (42).

9. The carotid artery sheath with inflatable balloon of any one of claims 2 to 4, wherein: The plurality of inflation cavities in the balloon (21) are inflated respectively, so that the balloon (21) can adapt to the shape of the blood vessel, realize uniform and close sealing of the blood vessel wall; When the balloon (21) is inflated, the balloon (21) is in a trumpet shape, and the cross-sectional view of the contact area between the balloon (21) and the blood vessel is in a V shape, so that the distal end of the balloon (21) is close to the inner wall of the blood vessel.

10. A blood flow switching system characterized by; The carotid artery sheath with inflatable balloon according to any one of claims 1 to 9.

Images