Catheter sheath assembly

Abstract

The application discloses a catheter sheath assembly, which comprises a catheter sheath and a dilator, wherein the catheter sheath comprises a sheath tube for establishing a first instrument channel, the sheath tube is an expandable sheath, the sheath tube has a compressed state when not expanded and an expanded state when an instrument passes through, and a bypass seat, a distal end of the bypass seat is a connecting end for connecting a proximal end of the sheath tube, the bypass seat is further provided with an adapting end and a bypass end; the dilator is used for pre-expanding the sheath tube, the dilator comprises a tube body which is configured to have an internal channel and a hand-held part which is fixedly connected with the tube body. Through the arrangement of the bypass seat and a sealing device, the application realizes the mutual communication between different instrument channels and access channels, thereby reducing the risk of blood vessel damage under the premise of meeting the use conditions, and providing a structural basis for more abundant treatment schemes.

Description

[0001] This application is a divisional application of application number 202311295274.3 filed on October 8, 2023, entitled "Catheter Sheath and Catheter Sheath Assembly". Technical Field

[0002] This application relates to the field of medical devices, and in particular to catheter sheaths and catheter sheath assemblies. Background Technology

[0003] A catheter sheath is a medical device used in interventional medical procedures, typically to guide medical devices, catheters, or medications into the body during surgery or treatment. To prevent blood loss, a sealing valve is usually placed inside the catheter sheath.

[0004] In transcatheter interventional procedures, it is usually necessary to establish a main approach and an auxiliary approach. The interventional device reaches the lesion area through the main approach vessel, while auxiliary devices used for angiography and other functions often need to enter the body through the auxiliary approach vessel. In current techniques, establishing the main and auxiliary approaches requires creating a wound point at each approach vessel for inserting a catheter sheath. Furthermore, a single catheter sheath is typically only suitable for a single interventional device, resulting in the need to insert a catheter sheath into each of the main and auxiliary approach vessels to establish the access. This approach places high demands on the patient's vascular condition and easily increases the risk of vascular complications. Summary of the Invention

[0005] To address the aforementioned technical problems, this application discloses a catheter sheath, characterized in that it comprises: Sheath, used to establish the first instrument channel; A bypass seat, the distal end of which is a connecting end for connecting to the proximal end of the sheath, the bypass seat also having an adapter end and a bypass end, a first access channel being formed between the connecting end and the adapter end, and a second access channel being formed between the connecting end and the bypass end, the first access channel and the second access channel converging and communicating within the bypass seat; A first sealing device is connected to the adapter end and is used to pass through the first conveying device; The second sealing device is connected to the bypass end and is used to pass through the second conveying device.

[0006] Several alternative methods are provided below, but they are not intended as additional limitations on the overall solution above. They are merely further additions or optimizations. Provided there are no technical or logical contradictions, each alternative method can be combined individually with respect to the overall solution above, or multiple alternative methods can be combined with each other.

[0007] Optionally, the bypass seat includes: The main body is cylindrical and has the first access channel inside. The two ends of the main body form the connecting end and the adapter end. A bypass pipe is connected to the side wall of the main body, and the end of the bypass pipe is the bypass end; An exhaust port or exhaust pipe, wherein the exhaust port or exhaust pipe is directly connected to the main body or the bypass pipe.

[0008] Optionally, from the distal end to the proximal end, both the internal cavity diameter and the external radial dimension of the main body have an expanding tendency; the main body is a split structure, which includes a connecting section and a transition section arranged sequentially from the distal end to the proximal end, and the radial expansion tendency of the transition section is greater than or equal to the radial expansion tendency of the connecting section; on the extension axis of the main body, the bypass end protrudes from the proximal side face of the connecting section.

[0009] Optionally, the extension direction of the exhaust pipe or the exhaust port is perpendicular to the extension axis of the body.

[0010] Optionally, the bypass seat is provided with two exhaust pipes or two exhaust holes, which are located on both sides of the first access channel.

[0011] Optionally, one exhaust pipe or exhaust port is connected to the bypass pipe, and the other exhaust pipe or exhaust port is connected to the main body.

[0012] Optionally, the bypass seat is provided with a suture portion for positioning relative to the surrounding tissue at the access location.

[0013] Optionally, the suture portion is disposed on the body and includes at least one through hole, through which a suture for suturing to the surrounding tissue at the access site is passed. Optionally, the extension axis of the bypass tube intersects the extension axis of the body, and the angle between them towards the proximal side is an acute angle.

[0014] Optionally, the first sealing device includes a first hemostatic valve; the first hemostatic valve may be fluid-driven or elastically driven. When the first hemostatic valve is fluid-driven, it includes a housing and a tubular sealing membrane. The inner cavity of the sealing membrane forms a second instrument channel. A first end of the housing is sealed to a first end of the sealing membrane, and a second end of the housing is sealed to a second end of the sealing membrane, forming a drive chamber for filling with fluid between the housing and the sealing membrane. The housing is made of an elastic or rigid material. When the housing is made of a rigid material, the first hemostatic valve further includes an energy storage mechanism that is linked to the fluid. The energy storage mechanism stores or releases energy when the state of the sealing membrane changes, and when releasing energy, it drives the sealing membrane to seal the second instrument channel. The distal end of the second instrument channel has an installation port. When the first hemostatic valve is elastically driven, the first hemostatic valve includes a housing and a sealing element located inside the housing, the sealing element being a silicone sealing element.

[0015] Optionally, the sealing membrane material is a multi-layered porous material with hanging properties.

[0016] Optionally, a second hemostatic valve is disposed on the distal side of the first hemostatic valve, the second hemostatic valve being used to control the connection or disconnection between the second instrument channel and the first instrument channel.

[0017] Optionally, the second hemostatic valve is located near the bypass seat.

[0018] Optionally, the main body is an integral structure or a split structure, and the split structure includes a connecting section and a transition section arranged sequentially from the distal end to the proximal end; The connecting section has a first limiting shoulder inside that abuts against the proximal end of the sheath. The side of the first limiting shoulder facing the distal end is a stop surface, and the side facing the proximal end is a guide slope.

[0019] Optionally, the main body is a split structure, the connecting section has a second limiting shoulder inside, and the transition section is cylindrical, inserted into the connecting section and abutting against the second limiting shoulder.

[0020] Optionally, the inner circumferential surfaces at the junction of the connecting segment and the transition segment are smoothly transitioned.

[0021] Optionally, the sheath is an expandable sheath, having a compressed state when not expanded and an expanded state when the instrument passes through it.

[0022] Optionally, the sheath includes a tube wall, which has a rolled-up structure and a coiled cross-section. The tube wall has an expanded state where the rolled-up structure of the corresponding part is unfolded, and a pre-formed state where the rolled-up structure is self-restored.

[0023] Optionally, a metal layer is provided in the wall of the sheath, and the metal layer is a helical spring, a braided mesh, or a cut metal tube.

[0024] Optionally, the length of the sheath is 300~420mm.

[0025] Optionally, the second sealing device is a third hemostatic valve, which is connected to the bypass end and forms a third instrument channel.

[0026] Optionally, the first delivery device is a catheter device for delivering implants or repairing intracavitary tissue; The second delivery device is an auxiliary measuring catheter or guide wire.

[0027] This application also discloses a catheter sheath assembly, including: The catheter sheath refers to the catheter sheath described in the above technical solution. An expander for pre-expanding the sheath, the expander comprising: a tube body configured to have an internal channel through which a guidewire can pass; and a handheld portion fixedly connected to the tube body.

[0028] Optionally, the distal end of the dilator tube is provided with a radially protruding protrusion; when the dilator is fully assembled into the catheter sheath, the protrusion is located inside the catheter sheath.

[0029] The technical solution disclosed in this application, through the setting of bypass seat and hemostatic valve, enables auxiliary instruments and interventional instruments to enter the human body through the same access route during transcatheter heart valve intervention surgery. This reduces the risk of vascular rupture while meeting the usage conditions, and also provides a structural basis for a wider range of treatment options.

[0030] The specific beneficial technical effects will be further explained in the specific implementation methods in conjunction with the specific structures or steps. Attached Figure Description

[0031] Figure 1 This is a schematic diagram of a catheter sheath in one embodiment; Figure 2 for Figure 1 Schematic diagram of the proximal portion of the middle duct sheath; Figure 3 for Figure 2 Schematic diagram of the explosion of the duct sheath; Figure 4 This is a schematic diagram of the bypass seat explosion in one embodiment; Figure 5 This is a schematic diagram of the internal structure of the bypass seat in one embodiment; Figures 6 to 7 This is a schematic diagram of the bypass seat structure in one embodiment; Figures 8 to 9 This is a schematic diagram of the bypass seat structure in another embodiment; Figures 10 to 18 These are schematic diagrams showing different states of the sheath in different embodiments; Figures 19 to 23 This is a schematic diagram of the first hemostatic valve in one embodiment; Figure 24 This is a schematic diagram of the expander in one embodiment; Figure 25 This is a schematic diagram of a catheter sheath assembly in one embodiment; Figures 26 to 28 This is a schematic diagram of the catheter sheath in yet another embodiment; Figures 29 to 31 This is a schematic diagram of the catheter sheath in another embodiment.

[0032] The annotations in the figure are explained as follows: 1. Housing; 12. Drive chamber; 14. First end cover; 15. Second end cover; 2. Sealing membrane; 21. Inner cavity; 3. Energy storage mechanism; 31. Balance chamber; 32. First pressure regulating port; 33. Energy storage chamber; 34. Piston; 341. Elastic element; 342. Support element; 4. Expander; 41. Protrusion; 9. Interventional devices; 204. Pipe wall; 206. Elastic sleeve; 207. Ending side boundary; 208. Pressure-bearing part; 209. Starting side; 210. Ending side; 211. Exceeding part; 212. Not exceeding part; 213. Overlapping area; 214. Flexible enveloping membrane; 401. First sealing device; 402. Second sealing device; 500. Catheter sheath; 510. Sheath; 520. First hemostatic valve; 521. Second instrument channel; 522. Installation port; 530. Transition section; 532. Pipe fitting; 533. Threaded joint; 540. Second hemostatic valve; 700, Bypass seat; 701, Connecting end; 702, Adaptor end; 703, Bypass end; 704, Connecting cavity; 705, Main body; 706, Bypass pipe; 707, First limiting shoulder; 708, Second limiting shoulder; 709, Exhaust pipe; 710, Connecting section; 711, Seam section. Detailed Implementation

[0033] The technical solutions of the embodiments of this application will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of this application, and not all embodiments. Based on the embodiments of this application, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of this application.

[0034] It should be noted that when a component is said to be "connected" to another component, it can be directly connected to the other component or there may be an intervening component. When a component is said to be "set on" another component, it can be directly set on the other component or there may be an intervening component.

[0035] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this application belongs. The terminology used herein is for the purpose of describing particular embodiments only and is not intended to limit the scope of the application. The term "and / or" as used herein includes any and all combinations of one or more of the associated listed items.

[0036] Reference Appendix Figure 1 This application discloses a catheter sheath 500, comprising: Sheath 510, used to establish the first instrument channel; Bypass seat 700, see reference Figure 4 The distal end of the bypass seat 700 is a connecting end 701 for connecting the proximal end of the sheath 510. The bypass seat 700 is also provided with an adapter end 702 and a bypass end 703. A first access channel is formed between the connecting end 701 and the adapter end 702, and a second access channel is formed between the connecting end 701 and the bypass end 703. The first access channel and the second access channel intersect and are connected inside the bypass seat 700. The first sealing device 401 is connected to the adapter end 702 and is used to pass through the first conveying device; The second sealing device 402 is connected to the bypass end 703 and is used to pass through the second conveying device.

[0037] In interventional procedures, the first delivery device can be a catheter device for delivering implants or repairing endovascular tissue; the second delivery device can be an auxiliary measurement catheter or guidewire. In artificial heart valve implantation or repair systems, the auxiliary measurement catheter is, for example, a pigtail catheter used to deliver contrast agents or measure transvalvular pressure gradients.

[0038] The technical solution disclosed in this application, through the setting of the bypass seat 700, the first sealing device 401 and the second sealing device 402, enables the auxiliary instruments and interventional instruments to enter the human body through the same access route during the transcatheter interventional procedure. This reduces the number of access routes required during the interventional procedure while meeting the usage conditions, avoids damage to the human body caused by multiple access routes, and also provides a structural basis for richer treatment options.

[0039] For the specific configuration of the bypass connector 700, please refer to the appendix. Figure 2 To be continued Figure 9In the illustrated embodiment, the bypass seat 700 includes a main body 705 for forming a first access channel and a bypass pipe 706 for forming a second access channel. The main body 705 is cylindrical, and its two ends form a connecting end 701 and an adapter end 702. A connecting cavity 704 is formed between the connecting end 701 and the adapter end 702. The bypass pipe 706 penetrates the side wall of the main body 705 and connects to the connecting cavity 704. The proximal end of the bypass pipe 706 forms a bypass end 703. In a specific configuration, the configuration of the main body 705 can be referred to the attached diagram. Figure 3 Or attach Figure 27 Or attach Figure 30 The main body 705 is designed as a single integrated structure; You can also refer to the appendix Figure 4 As shown, the main body 705 is a split structure, including a connecting section 710 and a transition section 530 arranged sequentially from the distal end to the proximal end. The transition section 530 connects to the first access channel and the second instrument channel 521 mentioned below. The first instrument channel is connected to the second instrument channel 521 via the first access channel. You can also refer to the appendix Figures 5 to 9 As shown, the main body 705 is an integral structure in another configuration. Different configurations of the main body 705 expand the adaptability of the bypass connector 700.

[0040] In the above configuration, both the internal cavity diameter and the external radial dimension of the main body exhibit an expanding trend. In the split structure, the radial expansion trend of the transition section is greater than or equal to that of the connecting section; on the extension axis of the main body, the bypass end protrudes from the proximal end face of the connecting section. In the accompanying drawings, the first access channel, the first instrument channel, and the second instrument channel (described below) are coaxially arranged to facilitate the passage of interventional instruments. In this embodiment, the proximal ends of the main body 705 and the bypass tube 706 are independent, thus providing a basis for multiple instruments to extend within the same sheath 510. To better facilitate instrument intervention, the inner diameter of the sheath 510 and the bypass seat 700 can be enlarged, or the inner diameter of the bypass seat 700 can be optimized as described in the embodiments below. For example, in one embodiment, the internal diameter of the main body 705 is reduced from the proximal end to the distal end. This reduced diameter provides more ample proximal space while ensuring the distal end dimensions meet requirements, especially in scenarios involving multiple instrument access routes. In another embodiment, for example, the interior of the body 705 extends with a constant diameter from the proximal end to the distal end. This constant diameter extension prevents interference between the instrument and the inner wall of the body 705 during instrument insertion, especially at transition points. To ensure assembly accuracy, fittings often have limiting shoulders or steps at the connection points, which can lead to problems with instrument passage. To avoid this problem, refer to the appendix... Figure 7As shown, the connecting section 710 has a first limiting shoulder 707 inside that abuts against the proximal end of the sheath 510. The first limiting shoulder 707 has a stop surface on the distal side and a guide ramp on the proximal side. This arrangement allows for control of the overall dimensions of the bypass seat 700 as much as possible while ensuring smooth movement of the instrument within the main body 705. Similarly, as... Figure 4 The connecting section 710 has a second limiting shoulder 708 inside. The transition section 530 is cylindrical, with a pipe connector 532 for insertion at one end near the end of the connecting section 710, and a threaded hole 533 for screwing into the mounting port 522 (see reference). Figure 22 The axial ends of the transition section 530 smoothly transition with the outer peripheral surfaces of the corresponding components; the pipe joint 532 abuts against the second limiting shoulder 708; in the installed position, the inner peripheral surfaces of the joint between the connecting section 710 and the transition section 530 smoothly transition, for example, the inner peripheral surfaces of the joint are flush. Regarding the overall shape of the bypass seat 700, refer to the attached... Figure 6 In the illustrated embodiment, the extension axis of the bypass tube 706 intersects the extension axis of the main body 705, and the angle between them towards the proximal end is an acute angle. In this embodiment, the extension axis of the main body 705 is parallel to the extension axis of the second instrument channel 521, so it can also be understood that the extension axis of the bypass tube 706 intersects the extension axis of the second instrument channel 521, and the angle between them towards the proximal end is an acute angle.

[0041] In one embodiment, the second sealing device 402 is a third hemostatic valve, which is connected to the bypass end 703 and forms a third instrument channel. The third hemostatic valve may refer to the form of the first or second hemostatic valve described below. For example, the third hemostatic valve is a silicone seal.

[0042] As attached Figure 4 In the illustrated embodiment, the venting channel may be located on the side of the transition section 530, and venting liquid is injected into the transition section 530 to vent the bypass seat 700 and the entire sheath. (See attached document.) Figure 8 and attached Figure 9 In the illustrated embodiment, an exhaust pipe 709 is disposed on a bypass pipe 706 and extends from the side wall of the bypass pipe 706 toward the sheath 510. The exhaust pipe 709 may also be in the form of an exhaust port. In the figures, the extending direction of the exhaust pipe or exhaust port is perpendicular to the extending axis of the main body. (Refer to the attached figure.) Figure 26 To be continued Figure 28In the illustrated embodiment, the bypass seat 700 is provided with two exhaust pipes 709. The dual exhaust pipe configuration improves exhaust efficiency while ensuring effective exhaust, avoiding problems caused by the spatial orientation of the catheter sheath 500 that could hinder exhaust flow. Specifically, the two exhaust pipes 709 are located on either side of the first inlet channel. One exhaust pipe 709 is connected to the bypass pipe 706, and the other is connected to the main body 705. Similarly, the exhaust pipes mentioned above can also be configured as exhaust ports.

[0043] In addition to the change in exhaust method, the attached Figure 26 To be continued Figure 28 In the illustrated embodiment, the bypass seat 700 is provided with a suture portion 711 for positioning with the surrounding tissue at the access point. The suture portion 711 is disposed on the body 705 and includes at least one through-hole through which a suture thread for suturing with the surrounding tissue at the access point is passed. Similarly, the suture portion 711 can also be provided in other embodiments, such as those with... Figure 29 To be continued Figure 31 As shown.

[0044] Different access routes converge at the bypass seat and ultimately extend distally through the sheath. Regarding the details of sheath 510, the sheath is an expandable sheath. The sheath has a compressed state when unexpanded and an expanded state when the instrument passes through. (See attached reference.) Figure 10 To be continued Figure 18In the illustrated embodiment, the sheath 510 includes a tube wall 204, which is a rolled-up structure with a coiled cross-section. The tube wall 204 has an expanded state where the rolled-up structure is unfolded at corresponding locations and a pre-formed state where it self-restores its rolled-up structure. The tube wall 204 is an elastic material capable of autonomously switching between the expanded state and the pre-formed state. The outer diameter of the tube wall 204 in the pre-formed state is 4-9 mm. The tube wall 204 in the pre-formed state is wound more than one circumference, with the portion exceeding 360 degrees overlapping the portion within 360 degrees. The overlapping portions have smooth contact surfaces. The tube wall 204 in the pre-formed state is wound less than 720 degrees. The starting side 209 and the ending side 210 of the rolled-up structure in the circumferential direction are connected by a flexible envelope membrane. The flexible envelope membrane has crease lines at its turning points. The wall thickness of the flexible envelope membrane is 0.1-1 mm. The flexible envelope membrane is a circumferentially closed tubular structure. The circumference of the tubular structure is greater than the wall length of the tube wall 204, which is fixedly attached to the outer wall of the flexible envelope membrane. In one embodiment, an elastic sleeve 206 is wrapped around the proximal periphery of the tube wall 204. The proximal end of the tube wall 204 is connected to the sheath handle, and the connection is wrapped by the elastic sleeve 206. The axial length of the elastic sleeve 206 is 5 to 50 cm. In the accompanying drawings, the axial length of the elastic sleeve 206 is preferably 5 to 20 cm. The tube wall 204 is covered with a retaining sleeve to confine it to a pre-shaped state, and this retaining sleeve bursts when the tube wall 204 is under expansion. The retaining sleeve extends axially from the distal end of the tube wall 204, and the extended portion is a tapered structure. The rolled wall structure has a chamfered structure near the distal end of the tube wall 204 on the circumferentially rolled-up end side 210. In the circumferential direction, the rolled-wall structure spirals from the starting side to the ending side. The boundary of the ending side of the starting side can extend along the sheath axis or spirally around the sheath axis. Figure 11 It can be seen that the end side boundary 207 is a straight line extending along the axial direction of the sheath. Using a helix allows for a more uniform force distribution when the sheath bends. In terms of dimensions, in the pre-formed state, the outer diameter of the sheath is 5 mm (15 Fr), and the inner diameter is 4 mm. Under expansion, the inner diameter can reach 8 mm (24 Fr), enabling the delivery of sheaths with corresponding diameters.

[0045] Combination Figures 12-15 The interventional device travels from right to left, compressing the inner side of the tube wall as it passes, causing the rolled-up structure of the tube wall to unfold accordingly, and the compressed part 208 enters an expanded state. After the interventional device 9 passes through, the elasticity of the tube wall 204 will allow it to recover on its own, returning to its initial predetermined shape. In this embodiment, the tube wall material is selected from polymer materials such as HDPE or TPU. To ensure that the tube wall can recover on its own and maintain a certain strength and compliance, the thickness of the tube wall is 0.5mm. In a specific implementation, the tube wall can be set as a double-layer composite structure, and the material of each layer in the double-layer composite structure is independently set as HDPE, TPU, or a composite of HDPE and TPU.

[0046] See Figure 16 This is a cross-sectional diagram of the sheath in its pre-formed state (initial state) without implanted devices. To cover and form a delivery channel for the sheath, the sheath wall in the pre-formed state is wound more than 360 degrees, that is, extending more than 360 degrees circumferentially from the starting side 209 to the ending side 210. The portion exceeding 360 degrees overlaps with the portion not exceeding 360 degrees. The exceeding portion 211 overlaps with the non-exceeding portion 212, with the exceeding portion 211 wrapping around the outer periphery of the non-exceeding portion 212, forming a complete channel inside the sheath wall.

[0047] Figure 18 This is a schematic diagram of the cross-section of the sheath when the interventional device 9 is implanted. To avoid exposure of the delivery sheath and the implanted device, especially in the swollen state, the tube wall is wound up to 360 degrees or more in the swollen state, meaning there is still an overlapping area 213.

[0048] Figure 17 In this embodiment, the starting side 209 and the ending side 210 of the sheath are connected by a flexible envelope 214. The flexible envelope provides radial support, restrains the implanted device, prevents its exposure, and also prevents blood or body fluid from leaking out of the sheath. In this embodiment, the flexible envelope 214 is made of PTFE material with a wall thickness of 0.25-0.5 mm. Regardless of the state of the sheath, the flexible envelope 214 can keep the sheath closed. The flexible envelope 214 can be fixed to the sheath by welding or other methods. To accommodate the flexible envelope 214, it is positioned in the middle layer of the overlapping portion of the sheath. The flexible envelope 214 can extend a certain distance in the circumferential direction, meaning it does not completely enclose the entire inner cavity of the tube wall. In its pre-formed state, the flexible envelope 214 is taut between the starting side 209 and the ending side 210 of the tube wall. The function of the flexible envelope 214 is to seal the gap formed between the starting side 209 and the ending side 210, preventing blood or body fluid from entering or leaving the tube wall. Therefore, the fixing points of the flexible envelope 214 to the tube wall are not strictly required to be at the starting side 209 and the ending side 210, and can be adjusted appropriately.

[0049] In addition to the sheath with the rolled-wall structure described above, the sheath can also refer to an embodiment in which the sheath includes a tube wall and the tube wall has an expanded state in which the diameter of the corresponding part is expanded and a predetermined state in which the diameter of the corresponding part is restored. The tube wall includes a first polymer layer, an elastic layer and a second polymer layer sequentially sleeved from the inside out. The elastic layer is used to drive the tube wall to remain in the predetermined state.

[0050] In specific configurations, the first polymer layer is made of PTFE. The second polymer layer is made of Pebax. The elastic layer is a wound elastomer. The elastomer is a helical spring or braided mesh made of stainless steel or shape memory metal. In another embodiment, a metal layer is disposed in the wall of the sheath. The metal layer is a helical spring, braided mesh, or a cut metal tube. The metal layer can be configured to allow radial deformation or to disallow radial deformation.

[0051] In addition to optimizing the internal structure of the sheath, this application also provides optimization of the outer peripheral surface of the sheath. Referring to one embodiment, the outer wall of the distal portion of the sheath has graduated markings. These markings facilitate confirmation of the insertion length into the body. In actual use, the actual insertion length of the sheath may vary depending on the specific case. The markings can also be positioned axially along the sheath to meet different needs, such as extending to the middle or even proximal end of the sheath. The outer peripheral surface of the sheath is provided with a biomimetic coating to improve biocompatibility. In this embodiment, the sheath length is 300-420 mm, preferably 340-350 mm.

[0052] After the intervention channel is established, it is necessary to maintain the internal pressure of the channel to prevent the outflow of blood and body fluids. For details on the design of the first sealing device 401 in this application, please refer to the appendix. Figure 19 To be continued Figure 23As shown, the first sealing device 401 is disposed at the proximal end of the bypass seat 700 and includes a first hemostatic valve 520. In the figures, the first hemostatic valve is fluid-driven. Specifically, the first hemostatic valve 520 includes a housing 1 and a tubular sealing membrane 2 installed within the housing 1. The inner cavity 21 of the tubular sealing membrane 2 forms a second instrument channel 521. In this embodiment, the sealing membrane 2 is made of a multi-layered porous material with hanging properties. The porous material specifically refers to its porous structure at the microscopic level. When the number of layers is small, the material allows some fluid to pass through; when the number of layers is large, the material prevents fluid from passing through. The hanging property specifically refers to the material's softness and ability to easily conform to the outer peripheral surface of the interventional device. Thanks to the hanging property, the sealing membrane 2 can cover the interventional device and achieve a sealing effect. In driving the sealing membrane 2, the first end of the housing 1 is sealed to the first end of the sealing membrane 2, and the second end of the housing 1 is sealed to the second end of the sealing membrane 2, forming a driving chamber 12 for filling fluid between the housing and the sealing membrane. The housing 1 contains the driving chamber 12 for filling fluid located around the sealing membrane 2, and a balance chamber 31 located outside the driving chamber 12. The driving chamber 12 and the balance chamber 31 are interconnected, and the balance chamber 31 surrounds the outer periphery of the driving chamber 12. The first sealing device 401 also includes an energy storage mechanism 3 that is linked to the fluid. The energy storage mechanism 3 stores or releases energy according to changes in the state of the sealing membrane 2, and when releasing energy, it drives the sealing membrane 2 to seal the second instrument channel 521. The distal end of the second instrument channel 521 has an installation port 522. The number of balance chambers 31 is preferably six. Theoretically, the more balance chambers 31 provided, the better, without considering product volume and manufacturing processes. Based on the current volume of the drive chamber 12 and balance chamber 31 of the product, and considering the structural design, spring selection and mass production, as well as functionality and cost, the optimal number of chambers is currently 5 to 6.

[0053] The housing 1 is a solid with multiple cylindrical spaces. The central part is a second instrument channel. The cylindrical spaces surrounding the second instrument channel are used to install multiple pistons 34 to form an energy storage chamber 33 and a balance chamber 31. The balance chamber 31 is connected to the drive chamber 12. Each energy storage chamber 33 contains a spring. The piston 34 has three seals on its outer periphery and is connected to the elastic element 341 via a support member 342. The support member 342 has a higher hardness than the piston 34. The housing 1 is connected to a second end cap 15 and contains a sealing component for sealing. The second end cap 15 has a first pressure adjustment hole 32. The second end cap 15 and the first end cap 14 fix the sealing membrane 2 to the housing 1.

[0054] In addition to the individual elastic element 341, the energy storage element can also use gas as the compression medium, which facilitates the adjustment of the resistance of instruments of different diameters, making it more flexible. However, correspondingly, the sealing requirements of the energy storage chamber 33, the balance chamber 31 and the related components are higher, and the process is relatively complex.

[0055] As can be seen from the accompanying drawings, in this embodiment, each balancing chamber 31 is actually interconnected through the drive chamber 12. That is, the sealing membrane 2 is a single unit, and the drive chamber 12 is arranged around the sealing membrane 2 and connected to each balancing chamber 31. In other embodiments, the sealing membrane 2 may not be a single unit, and multiple sealing membranes 2 may be combined to achieve the closure of the second instrument channel. In this implementation, the drive chambers 12 between different sealing membranes 2 may not be connected, and correspondingly, the balancing chambers 31 between different drive chambers 12 are also not connected.

[0056] In some embodiments, the housing 1 may also be made of an elastic material, which expands outward accordingly when the drive chamber is filled with fluid, providing a visual indication that the drive chamber is pressurized.

[0057] Independent of the above description, the first hemostatic valve can also be configured to be resiliently actuated. For example, in other embodiments, the first hemostatic valve includes a housing and a seal located within the housing, the seal being a silicone seal. The sealing method can be a disc seal or a cross-slit seal, etc.

[0058] Reference Appendix Figure 3In the illustrated embodiment, the first sealing device 401 further includes a second hemostatic valve 540 installed within the housing 1. The second hemostatic valve 540 is located distal to the first hemostatic valve 520 and is used to control the connection / disconnection between the second instrument channel 521 and the first instrument channel. In the figures, the second hemostatic valve 540 is located proximal to the bypass seat. Specifically, the second hemostatic valve 540 includes a base covering the distal opening of the second instrument channel 521 and at least two elastic valve plates movably mounted on the base. Each valve plate has an open state where it is far apart from each other and a closed state where they are close together. In the closed state, each valve plate prevents fluid from flowing from the first instrument channel to the second instrument channel 521. In different embodiments, the valve plates and the base can be made of the same or different materials. The valve plates are mounted on the base via a movable structure, or the valve plates are fixed to the base and switch between different states through their own deformation. In a top view of the central axis of the second hemostatic valve 540, each valve disc is V-shaped (with its edges) and the bottom (pointed corner) of the V-shape is close to the central axis of the second hemostatic valve 540. The bottoms and edges of the V-shapes of multiple valve discs are pressed together to achieve a closed state. The number of valve discs is preferably greater than or equal to three; in the figure, there are four valve discs. The valve discs can be arranged differently, for example, one large valve disc can be paired with multiple small valve discs, or one small valve disc can be paired with multiple large valve discs, or the valve discs can be of different sizes. Alternatively, the valve discs can be arranged identically; in the figure, the valve discs are evenly distributed circumferentially on the base. The included angle between each valve disc and the center of the base's central axis ranges from 90 degrees ± 30 degrees. The valve discs can be spaced apart or partially overlapped. When an interventional device passes through the second hemostatic valve 540, the valve discs are pushed away from each other by the force of the interventional device, but the valve discs can still adhere to the surface of the interventional device, thus maintaining a certain sealing effect. Thanks to the elastic design of the valve plates, when the valve plates receive a force in the direction of their deformation (in the attached diagram, this force is from proximal to distal, which in reality represents the passage of an instrument or guidewire), the valve plates move apart to achieve opening; when the valve plates receive a force in the opposite direction of their deformation (in the attached diagram, this force is from distal to proximal, which in reality represents the tendency of blood or other bodily fluids to leak out), the valve plates come together to achieve closure. The different states of the valve plates switch to achieve unidirectional conduction. In the embodiment shown in the attached diagram, the second hemostatic valve 540 is entirely made of rubber or silicone.

[0059] Based on the above description, it is easy to understand that this application also discloses a catheter sheath assembly, such as... Figures 24 to 25 As shown, it includes: The catheter sheath 500 is the catheter sheath described in the above technical solution; The expander 4 is used to pre-expand the sheath 510. The expander 4 includes: a tube body configured to have an internal channel through which a guidewire can pass; and a handheld part fixedly connected to the tube body.

[0060] The distal end of the dilator 4 tube is provided with a radially protruding protrusion 41; when the dilator is fully assembled into the catheter sheath, the protrusion 41 is located inside the catheter sheath. In other words, the length of the portion of the dilator that can extend into the catheter sheath 500 does not exceed the length of the catheter sheath 500 (see Appendix). Figure 25 As shown in the image).

[0061] The catheter sheath in the catheter sheath assembly can also be referenced in the appendix. Figure 26 To be continued Figure 28 and appendix Figure 29 To be continued Figure 31 As shown.

[0062] Compared to the attached Figure 25 Regarding the duct sheath in the middle, the appendage Figure 26 To be continued Figure 28 The main difference of the catheter sheath shown is that the bypass seat 700 is shorter in length along the axial direction of the sheath tube 510, the connection position of the bypass tube 706 is closer to the first sealing device 401, the bypass seat 700 is provided with two exhaust pipes 709, the connection positions of each exhaust pipe 709 and the bypass tube 706 are close to each other along the axial direction of the sheath tube 510, and the bypass seat 700 is provided with the suture part 711 mentioned above.

[0063] Compared to the attached Figure 26 To be continued Figure 28 Regarding the duct sheath in the middle, the appendage Figure 29 To be continued Figure 31 The main difference in the catheter sheath shown is that the bypass seat 700 is provided with an exhaust pipe 709, which is located on the same side as the bypass pipe 706, and the suture part 711, the exhaust pipe 709 and the bypass pipe 706 are close to each other.

[0064] For a detailed description, please refer to the corresponding description above, which will not be repeated here.

[0065] The technical features of the embodiments described above can be combined arbitrarily. For the sake of brevity, not all possible combinations of the technical features in the above embodiments are described. However, as long as the combination of these technical features does not contradict each other, it should be considered to be within the scope of this specification. When technical features of different embodiments are embodied in the same drawing, it can be regarded as the drawing also disclosing examples of combinations of the various embodiments involved.

[0066] The embodiments described above are merely examples of several implementation methods of this application, and while the descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the patent application. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of this application, and these modifications and improvements all fall within the protection scope of this application.

Claims

1. A catheter sheath assembly, characterized in that, Includes a catheter sheath and a dilator, the catheter sheath comprising: A sheath for establishing a first instrument channel, the sheath being an expandable sheath; the sheath having a compressed state when not expanded and an expanded state when the instrument passes through; A bypass seat, the distal end of which is a connecting end for connecting to the proximal end of the sheath, the bypass seat also having an adapter end and a bypass end, the bypass seat comprising: The main body is cylindrical, and both its internal cavity diameter and external radial dimension tend to expand. The two ends of the main body form the connecting end and the adapter end. The main body includes a connecting section and a transition section arranged sequentially from the distal end to the proximal end. The connecting section has a first limiting shoulder inside that abuts against the proximal end of the sheath. The side of the first limiting shoulder facing the distal end is a stop surface, and the side facing the proximal end is a guide slope. The transition section is cylindrical, and one end is a pipe connector for inserting the proximal end of the connecting section. The connecting section has a second limiting shoulder inside, and the pipe connector abuts against the second limiting shoulder. In the installed position, the inner circumferential surface of the joint position of the connecting section and the transition section transitions smoothly. A bypass pipe is connected to the side wall of the main body, and the end of the bypass pipe is the bypass end. On the extension axis of the main body, the bypass end protrudes from the proximal end face of the connecting section. An exhaust pipe, the exhaust pipe being connected to the bypass pipe; A suture section is disposed on the bypass seat and includes at least one through hole, through which a suture thread for suturing to the surrounding tissue at the access position is passed; the suture section, the vent pipe and the bypass pipe are in contact with each other. The expander is used to pre-expand the sheath, and the expander includes: A tube body, the tube body being configured to have an internal channel; The handle is fixedly connected to the tube body.

2. The catheter sheath assembly according to claim 1, characterized in that, The distal end of the dilator tube is provided with a radially protruding protrusion; when the dilator is fully assembled into the catheter sheath, the protrusion is located inside the catheter sheath.

3. The catheter sheath assembly according to claim 1, characterized in that, The sheath includes a tube wall, which has a rolled-up structure and a coiled cross-section. The tube wall has an expanded state where the rolled-up structure of the corresponding part is unfolded, and a pre-formed state where it self-restores the rolled-up structure.

4. The catheter sheath assembly according to claim 1, characterized in that, A first access channel is formed between the connecting end and the adapter end, and a second access channel is formed between the connecting end and the bypass end. The first access channel and the second access channel intersect and are connected inside the bypass seat. The catheter sheath also includes: A first sealing device is connected to the adapter end and is used to pass through the first conveying device; The second sealing device is connected to the bypass end and is used to pass through the second conveying device.

5. The catheter sheath assembly according to claim 4, characterized in that, The first sealing device includes a first hemostatic valve and a second hemostatic valve disposed at the distal end of the first hemostatic valve, wherein: The first hemostatic valve is fluid-driven and includes a housing and a sealing membrane in a tubular structure, with a drive chamber for filling with fluid formed between the housing and the sealing membrane; The inner cavity of the sealing membrane forms a second instrument channel, and the second hemostatic valve is used to control the connection and disconnection between the second instrument channel and the first instrument channel.

6. The catheter sheath assembly according to claim 5, characterized in that, The housing is made of a rigid material. The first hemostatic valve also includes an energy storage mechanism that can be linked with the fluid. The energy storage mechanism stores or releases energy when the state of the sealing membrane changes, and when releasing energy, it drives the sealing membrane to seal the second instrument channel.

7. The catheter sheath assembly according to claim 6, characterized in that, The second hemostatic valve includes a base covering the distal opening of the second instrument channel and at least two elastic valve plates movably disposed on the base. Each valve plate has an open state that is far apart from each other and a closed state that is close together. In the closed state, each valve plate prevents fluid from flowing from the first instrument channel to the second instrument channel.

8. The catheter sheath assembly according to claim 1, characterized in that, The extension axis of the bypass pipe intersects the extension axis of the main body, and the angle between them toward the proximal end is an acute angle.

9. The catheter sheath assembly according to claim 8, characterized in that, The main body has a split structure. The radial expansion trend of the transition section is greater than or equal to the radial expansion trend of the connecting section.

10. The catheter sheath assembly according to claim 9, characterized in that, The bypass seat is also provided with another exhaust pipe, which is connected to the main body.

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