Multi-lumen catheter sheath set

Abstract

This disclosure provides a multi-lumen catheter sheath assembly, including a sheath tube, a connector portion at the proximal end of the sheath tube, the connector portion including a connector body and a pressure cap connected to each other, a cavity within the connector body, and a hemostatic valve between the connector body and the pressure cap, characterized in that it further includes at least one lateral branch. This disclosure enables hemostasis control during the passage of guidewires, catheters, and other instruments, effectively reduces downward pressure resistance, and allows multiple instruments to enter the patient's body through the sheath.

Description

Technical Field

[0001] This disclosure relates to the field of medical devices, and in particular to a multi-lumen catheter sheath assembly. Background Technology

[0002] Valvular heart disease is a common heart condition in my country, with valvular damage caused by rheumatic fever being the most prevalent. With the increasing aging of the population, valvular disease in the elderly, as well as valvular lesions caused by coronary heart disease and myocardial infarction, are becoming increasingly common. The four valves in the human body are called the mitral valve, tricuspid valve, aortic valve, and pulmonary valve. Valve lesions caused by rheumatic fever, myxoid degeneration, degenerative changes, congenital malformations, ischemic necrosis, infection, or trauma can impair normal blood flow, leading to abnormal heart function and ultimately heart failure in cases of single or multiple valvular heart disease.

[0003] Treatment for valvular heart disease includes medical treatment (such as medication), surgical treatment, and interventional treatment. Among the medical treatments, diuretics are used for patients exhibiting signs of heart failure such as sodium and water retention; digoxin, beta-blockers, and non-dihydropyridine calcium channel blockers are used to control the ventricular rate for patients with rapid atrial fibrillation; and anticoagulation therapy such as warfarin is used for patients at risk of thrombosis and complications. It also emphasizes avoiding factors that can induce heart failure, such as fatigue, emotional excitement, appropriate restriction of sodium and water intake, and prevention of infection. In surgical procedures, artificial heart valve replacement or valve repair is the radical cure for valvular heart disease. For patients with valvular heart disease who already have symptoms of heart failure, the indications and contraindications for surgery should be actively evaluated to strive for surgical treatment opportunities. Interventional treatment mainly involves balloon dilation and valve replacement for stenotic valves. For patients with severe isolated mitral stenosis, aortic stenosis, and congenital pulmonary valve stenosis, percutaneous balloon dilation and transcatheter valve replacement can be chosen to increase the valve orifice area, reduce valvular stenosis, and improve hemodynamics and clinical symptoms. These procedures include transcatheter aortic valve replacement (TAVR), transcatheter mitral valve repair / replacement (TMVr / TMVR), transcatheter tricuspid valve repair, and transcatheter pulmonary valve implantation and replacement.

[0004] The catheter sheath assembly is a device used to establish a pathway for valves to enter the blood vessels and reach the lesion site. Therefore, it must meet several clinical requirements: 1. Hemostasis: The catheter enters the blood vessel through the femoral artery, where the pressure is high, so the catheter sheath assembly must have excellent hemostatic effect; 2. Device compatibility: It must be able to pass through guidewires with a minimum diameter of 0.035 (0.89 mm) and catheters with a maximum diameter of 30F (10 mm), and it needs to have good patency and very low resistance; 3. Catheter flexibility: Due to the very large size of the catheters (10F-30F), the catheters must have excellent flexibility to ensure vascular safety; 4. Ease of use: It must be simple and convenient for the operator to operate, and prevent misoperation.

[0005] Currently, the main type of catheter sheath used is a hydrophilic coated guide sheath from a certain company, such as... Figure 1 and 2 As shown, the hydrophilic coating guiding sheath here includes a sheath tube a with a hemostatic valve, a dilator b, and a syringe c. The sheath tube a is a polyethylene tube with a tapered front end. Its tip is provided with a marking strip d embedded in the sheath material for easy identification under fluoroscopy. Its tail end is provided with a connector e, and a hemostatic valve f is embedded in the connector e. The hemostatic valve f here consists of a silica outer tube f1 and a thin membrane inner tube f2. By injecting physiological saline into the syringe c, pressure is applied between the silica outer tube f1 and the thin membrane inner tube f2, causing the thin membrane inner tube f2 to expand, thereby achieving the hemostatic effect. This hydrophilic coated guide sheath has good hemostatic effect, and the hemostatic valve f is expanded and sealed by pressure injection. However, it is not easy to use. The operator needs to connect the valve port through the syringe c, and it is easy to confuse the valve port with the side tube three-way switch, which can lead to misuse. In terms of instrument compatibility, the resistance of the hemostatic valve f when passing through instruments can be controlled by controlling the pressure of the syringe c. When passing through instruments with very small outer diameters, such as guidewires, the injection pressure can be higher; while when passing through instruments with large outer diameters, such as catheters, the injection pressure can be reduced.

[0006] Furthermore, existing catheter sheath assemblies often only allow one instrument to enter the patient's body through the sheath, which often leads to complicated surgical procedures. Summary of the Invention

[0007] The purpose of this disclosure is to provide a multi-lumen catheter sheath assembly to address the problems existing in the prior art. To solve these technical problems, the embodiments of this disclosure adopt the following technical solutions:

[0008] This disclosure provides a multi-lumen catheter sheath assembly, including a sheath tube, a connector portion provided at the proximal end of the sheath tube, the connector portion including a connector body and a pressure cap connected to each other, a cavity provided in the connector body, a hemostatic valve provided between the connector body and the pressure cap, a boss provided inside the pressure cap for pressing a second valve body, and at least one side branch.

[0009] In some embodiments, the first valve body and the second valve body are sequentially disposed in the cavity.

[0010] In some embodiments, the connector further includes a snap-fit ​​element for pressing and fixing the first valve body and the second valve body in the cavity.

[0011] In some embodiments, the first valve body is disposed near the connector body, and the second valve body is disposed near the pressure cap.

[0012] In some embodiments, the first valve body and the second valve body are flat disc-shaped and both are made of elastomer.

[0013] In some embodiments, the first valve body and the second valve body are made of silicone rubber, and the hardness of the second valve body is less than that of the first valve body.

[0014] In some embodiments, a positioning element is fixedly provided on the connector body, and the positioning element is used in conjunction with the pressure cap.

[0015] In some embodiments, a through-hole is provided on the first valve body through a single groove opening, and a circular groove is provided at the center of the second valve body.

[0016] In some embodiments, cuts of the same or different shapes are provided on two sides of the first valve body, wherein the cuts on each side do not cut through to the other side, and the shape of the cuts is at least one of the following: a straight line, a cross, a star shape, or a multi-lobed shape.

[0017] In some embodiments, the first side of the first valve body is configured with a cross-shaped cut, and the second side of the first valve body is configured with a cross-shaped cut.

[0018] In some embodiments, the second valve body is gear-shaped, comprising a circular body, a plurality of teeth evenly spaced along the edge of the body, a through hole in the center of the body, and the ends of the teeth extending beyond the end face of the body that is close to the first valve body.

[0019] In some embodiments, a marking strip is provided at the distal end of the sheath.

[0020] In some embodiments, the connector is connected to the expander.

[0021] In some embodiments, the sheath and the connector are sealed by a seam loop.

[0022] In some embodiments, the multi-lumen catheter sheath assembly further includes a side tube connected to the connector portion.

[0023] In some embodiments, a side tube port is provided on the connector portion, and the side tube is connected to the side tube port.

[0024] In some embodiments, a first three-way seat is provided at the end of the side pipe, and a first three-way valve is provided on the first three-way seat, through which cleaning liquid is introduced into the side pipe.

[0025] In some embodiments, the side branch includes a first side branch tube and a hemostatic valve assembly, one end of the side branch tube being connected to the connector portion, and the other end being connected to the hemostatic valve assembly via a connector.

[0026] In some embodiments, the hemostatic valve assembly includes a hemostatic valve connector and an end cap, and a third valve body is disposed between the hemostatic valve connector and the end cap. The third valve body is plate-shaped, with arc-shaped cross-shaped cuts on both sides.

[0027] In some embodiments, the hemostatic valve connector is connected to the second three-way valve seat via a second side branch pipe, and a second three-way valve is provided in the second three-way valve seat.

[0028] In some embodiments, a plurality of first buckles are provided along the outer edge of the connector body, and a groove is provided between adjacent first buckles. The connector body is connected to the buckle member through the first buckles and the groove.

[0029] In some embodiments, a second buckle is provided on the buckle member, and a button spring is provided on the end face of the buckle member, the button spring sliding on the groove; a compression buckle is also provided on the button spring.

[0030] In some embodiments, an assembly slot and a compression slot are provided on the pressure cap. The assembly slot cooperates with the second buckle, and the compression slot cooperates with the compression buckle. The second valve body is squeezed by the boss while the second buckle moves in the assembly slot, and the button spring moves in the groove, thereby forming different pressing effects.

[0031] The embodiments disclosed herein can achieve hemostasis control when guidewires, catheters, and other instruments pass through, effectively reduce pressure resistance, and allow multiple instruments to enter the patient's body through the sheath. Attached Figure Description

[0032] To more clearly illustrate the technical solutions in the embodiments of this disclosure or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments recorded in this disclosure. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0033] Figure 1 This is a schematic diagram of the structure of an existing hydrophilic coating guide sheath;

[0034] Figure 2 This is a schematic diagram of the structure of an existing hydrophilic coating guide sheath;

[0035] Figure 3 This is a schematic diagram of the assembly of the multi-lumen catheter sheath assembly according to the first embodiment of this disclosure;

[0036] Figure 4 This is a schematic diagram of the first valve body in the multi-lumen catheter sheath assembly according to the first embodiment of this disclosure;

[0037] Figure 5 This is a schematic diagram of the first valve body in the multi-lumen catheter sheath assembly according to the first embodiment of this disclosure;

[0038] Figure 6 This is a schematic diagram of the second valve body in the multi-lumen catheter sheath assembly according to the first embodiment of this disclosure;

[0039] Figure 7 This is a schematic diagram of the structure of the multi-lumen catheter sheath assembly according to the second embodiment of this disclosure;

[0040] Figure 8 This is a schematic diagram of the assembly of the multi-lumen catheter sheath assembly according to the second embodiment of this disclosure;

[0041] Figure 9 This is a schematic diagram of the structure of the multi-lumen catheter sheath assembly according to the second embodiment of this disclosure;

[0042] Figure 10 This is a schematic diagram of the structure of the multi-lumen catheter sheath assembly according to the second embodiment of this disclosure;

[0043] Figure 11 This is a schematic diagram of the structure of the multi-lumen catheter sheath assembly according to the second embodiment of this disclosure;

[0044] Figure 12 This is a schematic diagram of the structure of the first valve body in the multi-lumen catheter sheath assembly according to the second embodiment of this disclosure;

[0045] Figure 13 This is a schematic diagram of the first valve body in the multi-lumen catheter sheath assembly according to the second embodiment of this disclosure;

[0046] Figure 14 This is a schematic diagram of the structure of the second valve body in the multi-lumen catheter sheath assembly according to the second embodiment of this disclosure;

[0047] Figure 15 This is a schematic diagram of the forces acting on the multi-lumen catheter sheath assembly according to the second embodiment of this disclosure;

[0048] Figure 16 This is a schematic diagram of the structure of a multi-lumen catheter sheath assembly according to another embodiment of the present disclosure.

[0049] Figure label:

[0050] 1-Multi-lumen catheter sheath assembly; 2-Sheath tube; 3-Side tube; 4-Pressure cap; 6-Snap fastener; 8-First three-way seat; 9-First three-way valve; 10-Connector; 11-Positioning element; 12-Connector body; 13-First valve body; 14-Second valve body; 141-Body; 142-Tooth; 143-Through hole; 15-Side tube port; 16-Suture coil; 17-First snap fastener; 18-Groove; 19-Second snap fastener; 20-Expander; 21-Button spring; 22-Compression snap fastener; 23-Assembly slot; 24-Compression slot; 25-Boss; 30-Side branch; 31-First side branch; 32-Connector; 33-Hemostatic valve assembly; 331-Hemostatic valve connector; 332-End cap; 333-Third valve body; 34-Second side branch; 35-Second three-way seat; 36-Second three-way valve. Detailed Implementation

[0051] Various embodiments and features of this disclosure are described herein with reference to the accompanying drawings.

[0052] It should be understood that various modifications can be made to the embodiments described herein. Therefore, the above description should not be considered as limiting, but merely as an example of embodiments. Other modifications within the scope and spirit of this disclosure will be apparent to those skilled in the art.

[0053] The accompanying drawings, which are included in and form part of this specification, illustrate embodiments of the present disclosure and, together with the general description of the disclosure given above and the detailed description of the embodiments given below, serve to explain the principles of the disclosure.

[0054] These and other features of this disclosure will become apparent from the following description of preferred forms of embodiments given as non-limiting examples, with reference to the accompanying drawings.

[0055] It should also be understood that although this disclosure has been described with reference to some specific examples, those skilled in the art can certainly implement many other equivalent forms of this disclosure, which have the features described in the claims and are therefore all within the scope of protection defined herein.

[0056] The above and other aspects, features and advantages of this disclosure will become more apparent when taken in conjunction with the accompanying drawings and in view of the following detailed description.

[0057] Specific embodiments of this disclosure are described thereafter with reference to the accompanying drawings; however, it should be understood that the claimed embodiments are merely examples of this disclosure, which may be implemented in various ways. Well-known and / or repeated functions and structures are not described in detail to avoid unnecessary or redundant details that could obscure this disclosure. Therefore, the specific structural and functional details claimed herein are not intended to be limiting, but merely to serve as the basis and representative basis for the claims to teach those skilled in the art to use this disclosure in a variety of substantially any suitable detailed structures.

[0058] This specification may use the phrases “in one embodiment,” “in another embodiment,” “in yet another embodiment,” or “in still another embodiment,” all of which may refer to one or more of the same or different embodiments according to this disclosure.

[0059] The first embodiment of this disclosure relates to a multi-lumen catheter sheath assembly, which is used to guide the movement of instruments such as guidewires and catheters. Figure 3 As shown, the multi-lumen catheter sheath assembly 1 includes a sheath 2, which can be a nylon composite tube with a tapered tip. During surgical procedures, instruments such as guidewires and catheters pass through the sheath 2 and are guided by the multi-lumen catheter sheath assembly 1 to the operating position within the patient's body. Specifically, a marking strip that is easily identifiable under fluoroscopy can be placed at the distal end of the sheath 2. This marking strip can be embedded in the end face of the sheath 2 to indicate the position of the distal end of the sheath 2 within the patient's body; here, the distal end refers to the end furthest from the operator. Of course, the adjustable sheath 1 can also be used in conjunction with a dilator.

[0060] Furthermore, a connector 10 is provided at the proximal end of the sheath 2, where the proximal end refers to the end closest to the operator. The connector 10 can, for example, be connected to an expander used in conjunction with the sheath 2. Additionally, a sealing device such as a sew-locking coil 16 is used to seal the sheath 2 and the connector 10.

[0061] Furthermore, the connector 10 includes a connector body 12 and a pressure cap 4. The connector body 12 can be made of injection molding. A cavity is provided in the connector body 12. The pressure cap 4 can be engaged or screwed into the connector body 12. When the pressure cap 4 is pressed, the pressure cap 4 has a certain pressing stroke relative to the connector body 12.

[0062] In one embodiment, the multi-lumen catheter sheath assembly 1 further includes a side tube 3, which is used to clean the inside of the sheath 2 after a cleaning liquid is introduced. The side tube 3 is connected to the connector 10. For example, a side tube port 15 can be provided on the connector 10, and the side tube 3 is connected to the side tube port 15. In addition, a first three-way seat 8 is provided at the distal end of the side tube 3, and a first three-way valve 9 is provided on the first three-way seat 8. The first three-way valve 9 can control the input of cleaning liquid into the side tube 3.

[0063] Furthermore, a hemostatic valve for hemostasis is provided between the connector body 12 and the pressure cap 4, continuing as follows. Figure 3 As shown, the hemostatic valve here includes a first valve body 13a and a second valve body 14a. Since the connector body 12 has a cavity structure, the first valve body 13a and the second valve body 14a are sequentially arranged in the cavity structure. The first valve body 13a is arranged close to the connector body 12, and the second valve body 14a is arranged close to the pressure cap 4 and away from the connector body 12.

[0064] To facilitate the installation of the hemostatic valve and ensure its hemostatic function, the first valve body 13a and the second valve body 14a are flat discs and both are made of elastomers to achieve their own compression deformation. For example, the first valve body 13a and the second valve body 14a can be made of silicone rubber. In some embodiments, the second valve body 14a has relatively low hardness, while the first valve body 13a has relatively high hardness.

[0065] Furthermore, in order to achieve hemostasis through the hemostatic valve, such as Figure 4 and Figure 5 As shown, a through-cut, for example, straight-line cut is provided on the first valve body 13a through a single groove opening. This cut cuts through the first valve body 13a. Figure 6 As shown, a circular groove is provided in the center of the second valve body 14a, and the incision is connected to the circular groove to facilitate the passage of devices such as guide wires and catheters during the operation.

[0066] In this way, the first valve body 13a and the second valve body 14a are accommodated in the cavity structure of the connector body 12, and the hemostatic valve can be compressed to a certain extent by pressing the pressure cap 4 through the cooperation of the cut and the circular groove, so as to be used for hemostasis.

[0067] Specifically, the pressure cap 4 has a protrusion inside, which facilitates the operator to press the second valve body 14a in the hemostatic valve. Specifically, when the operator presses the pressure cap 4, the second valve body 14a is subjected to the squeezing force from the protrusion and transmits the pressure to the first valve body 13a. The hemostatic effect is achieved by the change in the size of the incision in the first valve body 13a after squeezing.

[0068] Furthermore, such as Figure 3 As shown, the connector 10 also includes a locking member 6, which is used to press and fix the first valve body 13a and the second valve body 14a in the cavity structure of the connector body 12. Thus, when catheters or guidewires of different sizes pass through the multi-lumen catheter sheath assembly 1, the compression of the first valve body 13a and the second valve body 14a can be controlled by the cooperation of the locking member 6 and the pressure cap 4. Specifically, the compression force at the incision center of the first valve body 13a and the size of the circular groove at the center of the second valve body 14a can be changed to achieve hemostasis.

[0069] Specifically, when a device with a very small outer diameter, such as a guidewire, passes through the multi-lumen catheter sheath assembly 1, the user can press down the pressure cap 4 to squeeze the first valve body 13a through the second valve body 14a. By squeezing the incision of the first valve body 13a, the opening of the incision is reduced, thereby achieving a seal to achieve hemostasis. However, when a device with a large outer diameter, such as a catheter, passes through the multi-lumen catheter sheath assembly 1, the pressure on the pressure cap 6 can be released, allowing the first valve body 13a of the hemostatic valve to restore the opening size of the incision to achieve a seal to achieve hemostasis.

[0070] The multi-lumen catheter sheath assembly 1 of this embodiment is very easy to use, enabling one-handed operation by the operator; in addition, the compression of the hemostatic valve can be controlled by the cooperation of the buckle 6 and the pressure cap 4, so as to achieve the hemostatic effect.

[0071] However, the hemostatic valve in this embodiment, with its two disc-shaped valve bodies, has room for improvement. For example, the first valve body 13a, with its single-groove opening forming a straight incision, may not achieve good hemostatic effect on some instruments. Furthermore, the second valve body 14a, being disc-shaped, has a transitional fit with the cavity structure of the connector body 12. During the compression process via the protrusion of the pressure cap 4, the large surface contact area between the protrusion and the second valve body 14a, coupled with the lack of radial deformation space within the inner cavity, results in a large downward pressure required when pressing down the pressure cap 4, leading to significant resistance to instrument passage.

[0072] In the second embodiment of this disclosure, in order to overcome the defects in the valve body structure design of the multi-lumen catheter sheath assembly 1 in the first embodiment described above, another multi-lumen catheter sheath assembly 1 is provided, such as... Figures 7-10 As shown, the multi-lumen catheter sheath assembly 1 here can be used in conjunction with the dilator 20. One of the differences between this and the first embodiment is that a positioning member 11 is fixedly provided on the connector body 12. The positioning member 11 here can be used in conjunction with the pressure cap 4 in the connector part 10. When pressing the pressure cap 4, the operator can use his / her fingers to press against the positioning member 11 to increase the pressing pressure on the pressure cap 4.

[0073] Furthermore, in this embodiment, the shapes of the first valve body 13b and the second valve body 14b in the hemostatic valve are improved, wherein, for example... Figure 12 As shown, the first valve body 13b has cuts of the same or different shapes on two surfaces. These cuts can be, for example, straight, cross-shaped, or multi-lobed. Each cut on one surface of the first valve body 13b has a certain depth but does not penetrate to the other surface. However, the cuts on both surfaces connect after compression to facilitate the passage of instruments. This ensures that the first valve body 13b can expand radially; that is, when the cuts on the first valve body 13b are expanded by instruments, the outer periphery of the instrument can be enveloped by the first valve body 13b. For example, the first surface of the first valve body 13b can be set as a straight cut, and the second surface of the first valve body 13b can also be set as a straight cut. This forms a cross shape, ensuring that neither surface is completely cut through, but the centers of the straight cuts on both surfaces are connected.

[0074] Furthermore, considering that a single-line incision on any side of the first valve body 13b would increase the resistance to instrument passage, while a multi-lobed incision would prevent the hemostatic valve from completely enclosing the instrument, leading to blood leakage, a cross-shaped incision is preferred here. Figure 12 and Figure 13 As shown, the first surface of the first valve body 13b can be configured with a cross-shaped incision, and the second surface of the first valve body 13b can also be configured with a cross-shaped incision. The cross-section of the cross-shaped incision can be arc-shaped, thus forming a cross-shaped pattern. Neither surface will be completely cut through, but after compression, the centers of the cross-shaped incisions on both surfaces become connected, naturally forming a channel for inserting catheters or other instruments at the intersection. This cross-shaped incision allows for better instrument containment after the instrument passes through. Furthermore, to control the hemostatic effect, the incisions on both surfaces of the first valve body 13b are related to the diameter of the instruments that can pass through. For example, the incision depth on either surface can be adjusted according to the size of the instrument that needs to pass through.

[0075] Furthermore, such as Figure 14 As shown, the second valve body 14b is gear-shaped. Specifically, the second valve body 14b includes a circular body 141 with multiple teeth 142 evenly spaced along its edge. A through hole 143 is provided in the center of the body 141. The ends of the teeth 142 extend beyond the end face of the body 141 that is close to the first valve body 13b, so that when the second valve body 14b presses against the first valve body 13b, the teeth 142 can press against the outer edge of the first valve body 13b. This reduces the compression amount under the same compression stroke, and the teeth 142 along the edge of the body 141 increase the compression deformation space, reducing pressing resistance and resistance to instrument passage. The gear-shaped second valve body 14b can reduce the contact area between the surface of the hemostatic valve and the boss of the pressure cap 6. Moreover, during the pressing of the hemostatic valve, the deformation can be transmitted to the gap between adjacent teeth 142 of the second valve body 14b, thereby effectively reducing the pressing resistance.

[0076] Furthermore, in order to secure the hemostatic valve via the snap fastener 6 and to press the hemostatic valve by pressing the pressure cap 4, as follows: Figure 9 As shown, a plurality of first buckles 17 are provided along the outer edge of the connector body 12, and a groove 18 is provided between adjacent first buckles 17. The connector body 12 is connected to the buckle member 6 through the first buckles 17 and the grooves 18; Figure 10 As shown, a second buckle 19 is provided on the buckle 6, and a button spring 21 is provided on the end face of the buckle 6. The button spring 21 of the buckle 6 slides on the groove 18, so that the groove 18 on the connector body 12 forms the reserved pressing stroke of the button spring 21 of the buckle 6. A compression buckle 22 is also provided on the button spring 21.

[0077] On the other hand, such as Figure 11 As shown, the buckle 6 needs to be installed on the connector body 12 in conjunction with the pressure cap 4. For this purpose, the pressure cap 4 is provided with an assembly slot 23, a compression slot 24, and a boss 25. The assembly slot 23 cooperates with the second buckle 19, and the compression slot cooperates with the compression buckle 22. When the pressure cap 4, the buckle 6, and the connector body 12 are installed in sequence, the second valve body 14b is squeezed by the boss 25 according to the different pressing force of the pressure cap 4. At the same time, the second buckle 19 moves in the assembly slot 23, and the button spring 23 moves in the groove 18, thereby forming different pressing effects.

[0078] During the use of the multi-lumen catheter sheath assembly 1, the force analysis of different components in the multi-lumen catheter sheath assembly 1 is as follows: Figure 15 As shown, after the connector body 12, the first valve body 13b, the second valve body 14b, the snap fastener 6, and the pressure cap 4 are assembled in sequence, The vertical pressure F0 exerted by the pressure cap 6 on the second valve body 14b is due to the fact that the first valve body 13a is typically made of silicone rubber, meaning that the second valve body 14b has a lower hardness than the second valve body 13b. Therefore, F0 here can cause the second valve body 14b to be subjected to a force F1, which further generates a smaller force F2 on the first valve body 13b through the second valve body 14b. At the same time, due to the inward force F3 transmitted from the edge of the second valve body 14b, the first valve body 13b is squeezed inward by F3, causing the first valve body 13b, which is made of silicone rubber, to be squeezed towards the center cut. Thus, a smaller force F3 is formed inside the first valve body 13b, squeezing towards the center of the cut. Meanwhile, because the second valve body 14b has a lower hardness, when subjected to F0, it will generate an inward force F4, causing the through hole 143 of the second valve body 14b to be squeezed and become smaller. Thus, when an instrument is inserted, the pressure F3 exerted by the first valve body 13b towards the center of the incision and the pressure F4 exerted by the second valve body 14b towards the through hole 143 can maintain a seal and prevent blood leakage under a pressure of 0-380 mmHg; when no instrument is inserted, the hardness of the first valve body 13b itself and the pressure F3 maintain a seal and prevent blood leakage under a pressure of 0-380 mmHg.

[0079] When a larger catheter (e.g., with an outer diameter larger than the inner diameter of the through hole 143 of the second valve body 14b) is inserted into the multi-lumen catheter sheath assembly 1, the catheter passes through the center of the incision in the first valve body 13b. The catheter will compress the silicone rubber, causing it to deform from the center outwards. The reaction force increases F0. The increase of F0 means that the silicone rubber around the center of the incision in the first valve body 13b wraps around the catheter, thus preventing blood leakage under pressure of 0-380 mmHg. Furthermore, since the first valve body 13b adopts a star-shaped incision, the silicone rubber at the center of the incision is easy to swing with the insertion or withdrawal of the catheter, so the resistance when the catheter passes through is small.

[0080] When a guidewire or a smaller catheter (e.g., smaller than the inner diameter of the through hole 143 of the second valve body 14b) is inserted into the multi-lumen catheter sheath assembly 1, the pressure cap 6 is pressed down to a certain stroke and locked by the compression buckle 22 on the buckle 6. At this time, F0 will increase, which will cause F1 and F2 to increase simultaneously. At this time, the effect of F2 is to make the silicone rubber at the center of the opening of the first valve body 13b tightly wrap the guidewire or smaller catheter, thereby preventing blood leakage under pressure of 0-380 mmHg.

[0081] In another embodiment of this disclosure, in order to enable multiple instruments to enter the patient's body through the multi-lumen catheter sheath assembly 1, such as... Figure 16 As shown, the multi-lumen catheter sheath assembly 1 may further include at least one side branch 30. The side branch 30 establishes a side channel in the multi-lumen catheter sheath assembly 1, allowing instruments such as guidewires to enter the multi-lumen catheter sheath assembly 1 through the side channel. By providing the side branch 30, the multi-lumen catheter sheath assembly 1 possesses a dual-lumen or even multi-lumen structure, that is, the main lumen of the sheath 2 and the branch lumen formed by the side branch 30. Instruments of different sizes can be selected based on the size of these at least two lumens without leakage. Here, the side branch 30 is used in conjunction with the sheath 2; for example, a catheter is inserted through the sheath 2, and a guidewire is inserted through the side branch 30, allowing the guidewire to enter the catheter in the connector 10.

[0082] Specifically, the side branch 30 includes a first side branch tube 31 and a hemostatic valve assembly 32. One end of the side branch tube 31 is connected to the connector 10, and the other end is connected to the hemostatic valve assembly 32 through a connector 33. The connector 33 can connect and lock the first side branch tube 31 and the hemostatic valve assembly 33.

[0083] Furthermore, the hemostatic valve assembly 33 includes a hemostatic valve connector 331 and an end cap 332, and a third valve body 333 is provided between the hemostatic valve connector 331 and the end cap 332. The third valve body 333 is plate-shaped, and each of its two sides is provided with, for example, an arc-shaped cross-shaped incision. Neither side will be cut through, but after compression, the center of the arc-shaped cross-shaped incision on both sides will be connected, and the intersection of the incisions will naturally form a channel for inserting catheters or other instruments.

[0084] The hemostatic valve connector 331 is connected to the second three-way seat 35 through the second side branch pipe 34. A second three-way valve 36 is provided in the second three-way seat 35. Cleaning liquid can also be introduced into the second side branch pipe 34 through the second three-way valve 36.

[0085] The embodiments disclosed herein can achieve hemostasis control when guidewires, catheters, and other instruments pass through, effectively reduce pressure resistance, and allow multiple instruments to enter the patient's body through the sheath.

[0086] Furthermore, while the operations are described in a specific order, this should not be construed as requiring these operations to be performed in the specific order shown or in a sequential order. In certain environments, multitasking and parallel processing may be advantageous. Similarly, while several specific implementation details are included in the above discussion, these should not be construed as limiting the scope of this disclosure. Certain features described in the context of individual embodiments may also be implemented in combination in a single embodiment. Conversely, various features described in the context of a single embodiment may also be implemented individually or in any suitable sub-combination in multiple embodiments.

[0087] Although the subject matter has been described using language specific to structural features and / or methodological logic, it should be understood that the subject matter defined in the appended claims is not necessarily limited to the specific features or actions described above. Rather, the specific features and actions described above are merely illustrative examples of implementing the claims.

[0088] The foregoing has provided a detailed description of several embodiments of this disclosure. However, this disclosure is not limited to these specific embodiments. Those skilled in the art can make various variations and modifications based on the concept of this disclosure, and all such variations and modifications should fall within the scope of protection claimed by this disclosure.

Claims

1. A multi-lumen catheter sheath assembly, characterized in that, The device includes a sheath with a connector at its proximal end. The connector includes a connector body and a pressure cap that are interconnected. A cavity is formed within the connector body, and a hemostatic valve is positioned between the connector body and the pressure cap. The hemostatic valve includes a first valve body and a second valve body, which are sequentially arranged within the cavity. The first valve body has two faces with cuts of the same or different shapes, each cut not penetrating to the other face. A boss is provided inside the pressure cap to press against the hemostatic valve, and it also includes at least one side support. The second valve body is gear-shaped and includes a circular body with multiple... A toothed structure increases the compression deformation space and reduces pressing resistance and resistance to instrument passage. A through hole is provided in the middle of the main body, and the ends of the teeth extend beyond the end face of the main body that is close to the first valve body. The second valve body generates a force on the first valve body, and at the same time, an inward force transmitted from the edge of the second valve body compresses the first valve body inward, causing the first valve body to be compressed towards the middle cut to form a compressive force towards the center of the cut inside the first valve body. When an instrument is inserted, the compression force of the first valve body towards the center of the cut and the compression force of the second valve body towards the through hole are used to maintain a seal. When no instrument is inserted, the hardness and compressive force of the first valve body itself are used to maintain a seal.

2. The multi-lumen catheter sheath assembly according to claim 1, characterized in that, The connector also includes a snap-fit ​​component, which is used to press and fix the first valve body and the second valve body in the cavity.

3. The multi-lumen catheter sheath assembly according to claim 1, characterized in that, The first valve body is located near the connector body, and the second valve body is located near the pressure cap.

4. The multi-lumen catheter sheath assembly according to claim 1, characterized in that, The first valve body and the second valve body are flat disc-shaped and are both made of elastomer.

5. The multi-lumen catheter sheath assembly according to claim 1, characterized in that, The first valve body and the second valve body are made of silicone rubber, and the hardness of the second valve body is less than that of the first valve body.

6. The multi-lumen catheter sheath assembly according to claim 1, characterized in that, A positioning element is fixedly installed on the connector body, and the positioning element is used in conjunction with the pressure cap.

7. The multi-lumen catheter sheath assembly according to claim 1, characterized in that, A through-hole is provided on the first valve body through a single groove opening, and a circular groove is provided in the center of the second valve body.

8. The multi-lumen catheter sheath assembly according to claim 1, characterized in that, The shape of the cut is at least one of the following: straight, cross, star-shaped, or multi-lobed.

9. The multi-lumen catheter sheath assembly according to claim 8, characterized in that, The first valve body has a cross-shaped cut on both its first and second surfaces.

10. The multi-lumen catheter sheath assembly according to claim 1, characterized in that, The teeth are arranged at equal intervals along the edge of the body.

11. The multi-lumen catheter sheath assembly according to any one of claims 1-10, characterized in that, The side branch includes a first side branch tube and a hemostatic valve assembly. One end of the side branch tube is connected to the connector, and the other end is connected to the hemostatic valve assembly via a connector.

12. The multi-lumen catheter sheath assembly according to claim 11, characterized in that, The hemostatic valve assembly includes a hemostatic valve connector and an end cap, and a third valve body is provided between the hemostatic valve connector and the end cap. The third valve body is plate-shaped, and arc-shaped cross-shaped cuts are provided on both sides.

13. The multi-lumen catheter sheath assembly according to claim 2, characterized in that, Multiple first buckles are provided along the outer edge of the connector body, and grooves are provided between adjacent first buckles. The connector body is connected to the buckle member through the first buckles and the grooves.

14. The multi-lumen catheter sheath assembly according to claim 13, characterized in that, A second buckle is provided on the buckle member, and a button spring is provided on the end face of the buckle member, the button spring sliding on the groove; a compression buckle is also provided on the button spring.

15. The multi-lumen catheter sheath assembly according to claim 14, characterized in that, The cap is provided with an assembly slot and a compression slot. The assembly slot cooperates with the second buckle, and the compression slot cooperates with the compression buckle. The second valve body is squeezed by the boss, while the second buckle moves in the assembly slot and the button spring moves in the groove, thereby forming different pressing effects.

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