Interventional sheath and catheter pump delivery system

Abstract

The utility model relates to a kind of delivery system of intervention sheath and catheter pump, intervention sheath includes sheath pipe, sheath pipe includes outer tube and inner tube;The inner surface of inner tube has lubricating layer, and define hollow lumen through the both ends of sheath pipe, hollow lumen is used to transport catheter device;The outer surface of outer tube and the inner surface of inner tube are embedded with reinforcing structure, reinforcing structure is used to maintain the gap between the catheter of catheter pump and inner tube, gap is used to measure blood pressure.Because reinforcing structure can at least enhance the radial strength of sheath pipe, improve sheath pipe resistance axial pressure and torsion force, even if intervention sheath is curved or bent by external force factor, reinforcing structure can maintain the morphology of the hollow lumen of sheath pipe, so that the lumen of the two parts remains the state of fluid communication, prevent hollow lumen collapse and lead to inaccurate detected blood pressure.

Description

Technical Field

[0001] This utility model relates to the field of medical devices, and in particular to a delivery system for an interventional sheath and a catheter pump. Background Technology

[0002] Interventional medical devices are devices that, under the monitoring of imaging equipment such as digital subtraction angiography, CT, ultrasound, and MRI, use puncture needles, catheters, and other interventional instruments to insert specific instruments into the patient's lesion site through the patient's natural orifices or tiny incisions for diagnosis or minimally invasive treatment.

[0003] After the interventional sheath is pushed into the desired location within the subject's body, it remains temporarily inside to create a channel through its sheath. This allows doctors to easily deliver medications or catheters through the same sheath without repeated punctures, facilitating interventional treatments or examinations. However, during sheath placement, the sheath is prone to inner wall collapse due to bending, kinking, or compression. This collapse not only affects the delivery of instruments or medications within the sheath but also reduces the accuracy of blood pressure measurements, impacting the effectiveness of interventional treatments or examinations. Utility Model Content

[0004] To address at least one of the aforementioned technical problems, embodiments of this application provide a delivery system for an interventional sheath and a catheter pump.

[0005] To achieve the above objectives, the embodiments of this application provide the following technical solutions: A first aspect of this utility model provides an interventional sheath, the interventional sheath comprising a sheath tube, the sheath tube comprising an outer tube and an inner tube; The inner surface of the inner tube has a lubricating layer and defines a hollow lumen that extends through both ends of the sheath, the hollow lumen being used to deliver the conduit device. A reinforcing structure is embedded between the outer surface of the outer tube and the inner surface of the inner tube. The reinforcing structure is used to maintain the gap between the catheter of the catheter pump and the inner tube, and the gap is used to measure blood pressure.

[0006] Optionally, the outer surface of the outer tube has an anticoagulant layer.

[0007] Optionally, the inner surface of the inner tube has a recess that is recessed toward the outer tube, and the lubricating layer includes a first portion for filling the recess.

[0008] Optionally, the first portion fills the pit; the lubricating layer further includes a second portion located on the side of the first portion near the hollow cavity to define the hollow cavity as a generally flat surface.

[0009] Optionally, the first portion includes an anti-condensation coating, and the second portion includes a hydrophilic coating.

[0010] Optionally, the reinforcing structure has multiple support units, with gaps between the multiple support units, and the inner tube wall is recessed towards the gap side to form the pit.

[0011] Optionally, the reinforcing structure includes a braided layer, and the support unit includes braided filaments, with multiple braided filaments cross-connected to form the gaps.

[0012] Optionally, the braided yarn is a flat yarn.

[0013] Optionally, the braided layer includes a metal braided layer.

[0014] Optionally, the reinforcing structure includes multiple metal joint rings, with adjacent metal joint rings rotatably connected.

[0015] Optionally, the reinforcing structure is embedded within the wall of the outer tube.

[0016] Optionally, the lubricating layer includes at least one of a hydrophilic coating, an anticoating coating, and a hybrid coating, wherein the hybrid coating includes a coating that is a mixture of anticoating and hydrophilic materials.

[0017] Optionally, the elastic modulus of the outer tube is greater than that of the inner tube.

[0018] Optionally, the friction coefficient of the inner tube is less than that of the outer tube.

[0019] Optionally, the interventional sheath further includes a sheath seat connected to the sheath tube, the proximal end of the sheath tube being connected to the sheath seat, the sheath seat having a blood pressure detection interface, and the blood pressure detection interface being in fluid communication with the hollow lumen.

[0020] A second aspect of this utility model provides a delivery system for a conduit pump, the conduit pump having a conduit and a pump head assembly, the pump head assembly being disposed at the distal end of the conduit; The delivery system includes an interventional sheath as described in the first aspect embodiment, the interventional sheath being used to deliver the catheter pump; The hollow tube is used for radial compression and delivery of the pump head assembly, and the conduit passes through the hollow tube.

[0021] Effects of the utility model Based on the external-to-internal channel established by the sheath, catheters and other instruments can be inserted into the sheath and extended to the desired location in the body for interventional treatment or examination. Because the reinforced structure enhances the radial strength of the sheath and improves its resistance to axial pressure and torsional forces, even if the sheath bends or collapses due to external forces—for example, when the sheath is partially inside and partially outside the body, and the junction between the two parts is prone to bending or collapse—the reinforced structure maintains the hollow lumen of the sheath, ensuring fluid communication between the two parts and preventing the collapse of the hollow lumen, which could lead to inaccurate blood pressure readings. Attached Figure Description

[0022] To more clearly illustrate the technical solutions in the embodiments of this application 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 some embodiments of this application. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0023] Figure 1 This application provides schematic diagrams of the structure of a conveying system according to some embodiments; Figure 2 The following are schematic diagrams of the expander structure in some embodiments of this application; Figure 3 This is a partial structural diagram of the expander in some embodiments of this application; Figure 4 Cross-sectional views of the expander provided for some embodiments of this application; Figure 5 This is a partial cross-sectional view of the expander in some embodiments of this application; Figure 6 This is an exploded view of one type of expander in cross-sectional view in some embodiments of this application; Figure 7 This is an exploded view of another expander in cross-sectional view in some embodiments of this application; Figure 8 This is an exploded view of another expander in cross-sectional view in some embodiments of this application; Figure 9 The following are schematic diagrams of the sheath structure in some embodiments of this application; Figure 10 This is a partial cross-sectional schematic diagram of the cavity wall of the hollow lumen of the sheath in some embodiments of this application; Figure 11 The following are schematic diagrams of the reinforcing structure in some embodiments of this application. Figure 12This is a partial structural diagram of the conveying system in some embodiments of this application; Figure 13 This is a partial cross-sectional view of the conveying system in some embodiments of this application; Figure 14 This is a schematic diagram of a blood pressure measurement structure in a delivery system provided in some embodiments of this application.

[0024] Explanation of reference numerals in the attached figures: 1. Dilator; 101. Groove; 102. Protrusion; 1021. Distal sidewall of the protrusion; 1022. Proximal sidewall of the protrusion; 11. Handle; 111. Space; 112. Connecting structure; 12. Tube body; 121. Distal end; 122. Middle part; 123. Proximal end; 124. Hollow inner cavity; 13. Radial bearing structure; 131. Bearing component; 2. Intervention sheath; 20. Lubricating layer; 201. First part; 202. Second part; 21. Sheath seat; 211. Seat body ; 212, Hemostatic valve; 213, Locking buckle; 214, Blood pressure monitoring interface; 22, Sheath; 221, Inner tube; 2211, Recess; 222-a / 222-b, Reinforcing structure; 2221, Support unit; 2222, Gap; 2223, Braided wire; 2224, Metal joint ring; 223, Outer tube; 224, Anticoagulant layer; 3, Catheter; 41, Operating part; 411, Chamber; 42, Tubing assembly; 421, Reservoir bag; 422, Pressurization device; 43, Pressure sensor. Detailed Implementation

[0025] To make the technical solution and beneficial effects of this utility model more apparent and understandable, a detailed description is provided below by listing specific embodiments. The accompanying drawings are not necessarily drawn to scale, and local features may be enlarged or reduced to more clearly show the details of the local features; unless otherwise defined, the technical and scientific terms used herein have the same meanings as those in the technical field to which this application pertains.

[0026] In the description of this utility model, the terms "length", "width", "thickness", "upper", "lower", "inner", "outer", etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the drawings. They are only for the purpose of simplifying the description of this utility model and do not indicate that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. That is, they should not be construed as limitations on this utility model.

[0027] In this invention, the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating the relative importance of the indicated features or the number of indicated technical features. Therefore, a feature specified as "first" or "second" can explicitly include at least one of those features. In the description of this invention, "a plurality of" means at least two, such as two, three, etc.

[0028] In this utility model, unless otherwise explicitly defined, the terms "installation," "connection," "linking," "fixing," and "setting," etc., should be interpreted broadly. For example, "connection" can be a fixed connection, a detachable connection, or an integral part; it can be a mechanical connection or an electrical connection; it can be a direct connection or an indirect connection through an intermediate medium; it can also refer to the internal communication of two components or the interaction between two components. Those skilled in the art can understand the specific meaning of the above terms in this utility model according to the specific circumstances.

[0029] In this invention, "proximal end" refers to the end of the instrument that is closer to the operator (such as a doctor), and "distal end" refers to the end of the instrument that is farther away from the operator and penetrates into the patient's body. "Proximal end" and "distal end" are relative to the operator.

[0030] See Figure 1 and Figure 2 This embodiment provides a delivery system, which includes an interventional sheath 2 and a dilator 1. The dilator 1 includes a handle 11 and a tube 12, and the handle 11 is detachably connected to the interventional sheath 2.

[0031] The delivery system is used to dilate intravascular coagulation and provide a pathway for drugs or devices to enter the intravascular coagulation. Generally, dilator 1 is first inserted into interventional sheath 2, and dilator 1 and interventional sheath 2 are inserted percutaneously into the body to dilate the intravascular coagulation and establish a pathway from outside the body to inside. After interventional sheath 2 is advanced to the desired position in the body, dilator 1 is withdrawn separately, and interventional sheath 2 remains in the body temporarily as a pathway for drugs or devices to enter the intravascular coagulation for subsequent interventional examinations or interventional treatments.

[0032] See Figure 12The interventional sheath 2 includes a sheath tube 22. After the dilator 1 is withdrawn from the body, a catheter can be inserted through the sheath tube 22 to deliver drugs or instruments into the blood vessel and guide them to the desired location within the body, based on the percutaneous access route established by the sheath tube 22. Depending on the purpose of the interventional examination or treatment, the catheter has different functions. For example, in interventional examinations, contrast agents can be delivered to specific locations within the body via the catheter for angiographic imaging diagnosis, or local lesions can be punctured via the catheter to extract tissue for pathological diagnosis. As another example, in interventional treatments, catheters can be used to place devices such as catheter pumps and stents at designated locations within the body.

[0033] In some embodiments, the delivery system of this embodiment includes a delivery system using a conduit pump, wherein, see... Figure 14 The catheter pump has a catheter 3 and a pump head assembly 52, the pump head assembly 52 being disposed at the distal end of the catheter 3; the delivery system includes an interventional sheath 2 as described in any of the preceding embodiments, the interventional sheath 2 being used to deliver the catheter pump; the interventional sheath 2 includes a sheath tube 22 having a hollow lumen extending through both ends of the sheath tube 22. The hollow lumen is used for radial compression and delivery of the pump head assembly 52, and the catheter 3 is inserted within the hollow lumen.

[0034] The pump head assembly 52 includes a foldable pump head assembly, which has a radially expanding configuration and a radially compressing configuration. When the duct pump delivers within the sheath 22, the foldable pump head assembly is in a radially compressed configuration under the compression of the sheath 22, and the membrane of the pump head assembly rubs against the inner wall of the sheath 22 during delivery. When the duct pump is operating, the foldable pump head assembly extends outside the sheath 22 and expands radially, opening the membrane to form a radially expanding configuration. The conduit 3 of the duct pump passes through the hollow tube cavity, and a gap is formed between the conduit 3 and the inner wall of the inner tube 221. See also... Figure 14 The catheter 3 has a drive shaft 302 inside, preferably a flexible drive shaft, which can bend with the catheter 3 within the human vascular system to reach the desired location within the body. A pump housing 521 is connected to the distal end of the catheter 3. An impeller 522 is located inside the pump housing 521, and both the pump housing 521 and the impeller 522 are foldable. When the pump housing 521 reaches the desired location within the body, such as the left ventricle, the impeller 522 is driven by the rotational power provided by the drive shaft 302, drawing blood from the inlet of the pump housing 521 located in the left ventricle and expelling it from the outlet of the pump housing 521 located in the aorta, thereby assisting in the heart's pumping function.

[0035] Internal lumens refer to lumens that exist naturally within the human body or form pathologically. Common internal lumens include blood vessels. For ease of description, unless otherwise specified, blood vessels will be used as examples of internal lumens in this embodiment.

[0036] Before percutaneous insertion into the blood vessel, the dilator 1 and the interventional sheath 2 are connected by the handle 11 to form a combined unit, facilitating their integrated placement and synergistic dilation of the blood vessel. Although the tube 12 is located inside the interventional sheath 2 and enters the blood vessel as a combined unit, the distal end of the dilator 1 extends outside the interventional sheath 2. During dilation of the blood vessel by operating the handle 11 or during withdrawal of the dilator 1 from the blood vessel, the rotational action applied to the handle 11 is highly likely to be applied to the inner wall of the blood vessel through the distal end of the dilator 1, potentially damaging the blood vessel and leading to vascular complications. Therefore, it is important to ensure that the tube is in a non-rotating state when rotational action occurs.

[0037] like Figures 2 to 5 As shown, the dilator 1 includes a handle 11 and a tube 12, which are rotatably connected to the handle 11. The tube 12 includes a distal end 121, a middle portion 122, and a proximal end 123; the distal end 121 is located distal to the middle portion 122 and can be operably inserted percutaneously into the body lumen; the proximal end 123 is located proximal to the middle portion 122 and is located inside the handle 11. A radial bearing structure 13 is provided between the proximal end 123 and the handle 11 to allow the handle 11 to rotate relative to the tube 12.

[0038] During interventional treatment or examination, the operator can perform at least the following operations on the dilator 1 using the handle 11: connect the dilator 1 to the interventional sheath 2 to form a combination, insert the combination percutaneously into the body to dilate the pathway, and after the interventional sheath 2 has reached the desired position in the body, disassemble the dilator 1 separately and withdraw the dilator 1 from the body. During the connection of the dilator 1 and the interventional sheath 2, or during the delivery of the dilator 1 and the interventional sheath 2 in the body while connected, or during the disassembly of the dilator 1 and the interventional sheath 2, if the operator's operation of the handle 11 involves rotation, the radial bearing structure 13 allows the handle 11 to rotate relative to the tube body 12. This reduces or even eliminates the transmission of torque to the tube body 12, allowing the tube body 12 to remain as non-rotating as possible relative to the lumen wall, thus reducing the risk of damage to the lumen wall of the body due to rotation of the distal end 121 of the tube body 12.

[0039] In an exemplary implementation, see Figure 5The tube body 12 is hollow, and the hollow inner cavity 124 extends axially through the tube body 12. A space 111 communicating with the hollow inner cavity 124 can also be provided inside the handle 11. This space 111 extends through the handle 11, and the space 111 and the hollow inner cavity 124 of the tube body 12 are approximately coaxially aligned, forming a channel for the entry and exit of drugs or devices. For example, during percutaneous establishment of an intra- and extra-human channel, a guidewire passes through the channel between the hollow inner cavity 124 and the handle 11, allowing the dilator 1 to be inserted into the intra-human lumen along the guidewire. This ensures that the dilator 1 can advance precisely along a predetermined and safe path within the body, minimizing the risk of the dilator 1 accidentally entering a branch or puncturing a blood vessel wall.

[0040] It is understandable that the tube 12 does not have to be hollow; a solid tube 12 can also help to construct a pathway.

[0041] The distal end 121 of the tube body 12 is a tapered section that extends beyond the distal end of the sheath 22. The tapered section can gradually widen the small incision caused by the puncture needle, reducing trauma. The middle part 122 and the proximal end 123 of the tube body 12 can both be approximately cylindrical sections.

[0042] The diameter of the handle 11 is larger than the diameter of the tube body 12, which makes it easier to operate.

[0043] Optionally, the handle 11 and the tube body 12 are coaxially arranged.

[0044] In some embodiments, the proximal end 123 is fixedly connected to the handle 11 axially. This ensures that during intraoperative delivery of the tube 12 and handle 11, the handle 11 will hardly slide relative to the tube 12 axially, allowing the handle 11 to synchronously deliver the tube 12. For example, during the percutaneous insertion of the distal end 121 of the tube 12 into the intraoperative lumen, pushing the handle 11 axially can advance the tube 12 into the intraoperative lumen. When it is necessary to withdraw the dilator 1, pulling the handle 11 axially will withdraw the handle 11 along with the tube 12 from the body.

[0045] The axial connection between the proximal end 123 and the handle 11 includes, but is not limited to, bonding and locking connections.

[0046] See Figure 6 In some embodiments, the radial bearing structure 13 includes a bearing element 131.

[0047] Optionally, bearing 131 includes an inner circumference, an outer circumference, and rolling elements (such as balls or rollers) located between the inner and outer circumferences. The inner circumference of bearing 131 is connected to the proximal end 123, and the outer circumference of bearing 131 is connected to the handle 11. When the handle 11 is subjected to torque, the handle 11 drives the outer circumference of the connected bearing 131 and the rolling elements to rotate. Compared to sliding, the rolling friction of the rolling elements is smaller. Bearing 131 makes the relative rotation between the handle 11 and the tube 12 smoother and more fluid.

[0048] Bearing component 131 is a relatively mature mechanical component that is easier to obtain, which helps to reduce the design, development and production costs of expander 1.

[0049] In some embodiments, the bearing member 131 is sleeved on the outer periphery of the proximal end 123, the inner periphery of the bearing member 131 is fixedly connected to the proximal end 123, and the outer periphery of the bearing member 131 is fixedly connected to the handle 11.

[0050] For example, see Figure 6 The outer periphery of the proximal end 123 is a generally smooth surface, and even the outer periphery of the entire tube 12 is a generally smooth surface.

[0051] The inner circumference of the bearing component 131 and the proximal end 123 are fixedly connected by methods including but not limited to bonding, threaded connection, and interference fit. Taking bonding as an example: the material of the tube body 12 includes a high-molecular elastic material. The proximal end 123 can be molten by heat fusion, and the molten proximal end 123 is combined with the bearing component 131 and cured to form an adhesive structure, without the need for additional connection structures.

[0052] To illustrate further, let's take an interference fit as an example: the inner diameter of the bearing component 131 can be less than or equal to the outer diameter of the near end 123.

[0053] Optionally, the inner circumferential diameter of the bearing component 131 is slightly smaller than the outer circumferential diameter of the proximal end 123. This allows the inner circumference of the bearing component 131 to be interference-fitted with the proximal end 123, thus achieving the connection between the bearing component 131 and the proximal end 123 and restricting the axial movement of the handle 11 relative to the tube body 12. It also utilizes the rotational characteristics of the bearing component 131 itself to allow the handle 11 to rotate circumferentially relative to the tube body 12.

[0054] In some embodiments, the handle 11 is an injection-molded part formed outside the proximal end 123 and the bearing member 131.

[0055] After the proximal end 123 and the bearing component 131 are connected as a whole (for example, the inner circumference of the bearing component 131 is fitted onto the outer circumference of the proximal end 123), the whole is used as an insert, and the handle 11 is formed on the insert by injection molding. This method can achieve the fixed connection between the handle 11 and the bearing component 131 while making the handle 11.

[0056] See Figure 7 and Figure 8 In some embodiments, one of the proximal end 123 and the handle 11 is provided with a protrusion 102 and the other is provided with a groove 101. The protrusion 102 is embedded in the groove 101, and the protrusion 102 and the groove 101 cooperate to form a radial bearing structure 13.

[0057] In one implementation, the protrusion 102 is slidable within the recess 101. By setting the shape or size of the recess 101, the protrusion 102 can slide circumferentially within the recess 101, or slide axially within the recess 101 with a restriction, or slide both circumferentially and axially within the recess 101 with a restriction. For example, the recess 101 is a generally annular groove provided circumferentially along the proximal end 123 or the handle 11, the annular groove being generally coaxial with the tube body 12. The protrusion 102 is embedded in the recess 101, and the protrusion 102 can slide circumferentially within the recess 101, thereby enabling the handle 11 to rotate circumferentially relative to the proximal end 123. In other implementations, the protrusion 102 is fixedly connected to the inner circumference of the recess 101. At this time, the relative rotation between different components of the protrusion 102 also allows the handle 11 to rotate relative to the proximal end 123. For example, the protrusion 102 is located at the proximal end 123, and the groove 101 is located at the handle 11. The protrusion 102 includes a relatively rotatable inner circumferential portion and an outer circumferential portion, both of which are approximately coaxial with the tube section of the proximal end 123. The inner circumferential portion of the protrusion 102 is fitted onto the tube section of the proximal end 123 and is fixedly connected to it. The outer circumferential portion of the protrusion 102 is fixedly connected to the inner circumferential portion of the groove 101. By utilizing the relative rotation of the inner circumferential portion of the protrusion 102 relative to its outer circumferential portion, the handle 11 can rotate relative to the proximal end 123.

[0058] In some embodiments, the sidewalls of the protrusion 102 and the sidewalls of the recess 101 at least partially abut against each other to limit the relative sliding or sliding distance of the handle 11 with respect to the tube body 12 in the axial direction.

[0059] As shown in the figure Figure 5 When the distal sidewall 1021 of the protrusion 102 abuts against the distal sidewall of the groove 101, the handle 11 cannot slide proximally relative to the tube body 12. When the proximal sidewall 1022 of the protrusion 102 abuts against the proximal sidewall of the groove 101, the handle 11 cannot slide distally relative to the tube body 12.

[0060] The sidewalls of the protrusion 102 and the groove 101 at least partially abut against each other, limiting the relative sliding of the handle 11 relative to the tube body 12, so that the handle 11 and the tube body 12 form a whole. They can rotate relative to each other, but are not easily disassembled. During the withdrawal of the dilator 1 from the internal lumen, when the handle 11 separates from the interventional sheath 2, the tube body 12 is also pulled out of the sheath 2 by the handle 11. When the handle 11 is connected and fixed to the interventional sheath 22, the tube body 12 can be stably inserted into the interventional sheath 2. That is, the connection or disconnection of the dilator 1 and the interventional sheath 2 is achieved in one step, reducing the number of steps in the surgical procedure. Moreover, the limitation of the axial sliding of the handle 11 relative to the tube body 12 also facilitates the synchronous delivery of the tube body 12 by the handle 11 within the body.

[0061] If the length of the groove 101 along the axial direction is approximately equal to the length of the protrusion 102 along the axial direction, the distal sidewall 1021 of the protrusion 102 abuts against the distal sidewall of the groove 101, and the proximal sidewall 1022 of the protrusion 102 abuts against the proximal sidewall of the groove 101, then the handle 11 has almost no relative sliding with respect to the tube body 12 along the axial direction.

[0062] If the axial length of the recessed portion 101 is greater than the axial length of the protrusion 102, then the opposite sidewalls of the protrusion 102 along the axial direction cannot simultaneously abut against the corresponding sidewalls of the recessed portion 101. Taking the protrusion 102 located at the proximal end 123 and the recessed portion 101 located at the handle 11, with the protrusion 102 embedded in the recessed portion 101 as an example: one possibility is that the proximal sidewall 1022 of the protrusion 102 abuts against the proximal sidewall of the recessed portion 101, preventing the handle 11 from sliding distally relative to the tube body 12. However, due to the gap between the distal sidewall 1021 of the protrusion 102 and the distal sidewall of the recessed portion 101, the sliding of the handle 11 towards the proximal end relative to the tube body 12 is limited only when the distal sidewall 1021 of the protrusion 102 abuts against the distal sidewall of the recessed portion 101. Another possibility is that the distal sidewall 1021 of the protrusion 102 abuts against the distal sidewall of the groove 101, preventing the handle 11 from sliding proximally relative to the tube 12. However, there is a gap between the proximally adjacent sidewall 1022 of the protrusion 102 and the proximally adjacent sidewall of the groove 101. The sliding of the handle 11 towards the distal end relative to the tube 12 is limited only when the proximally adjacent sidewall 1022 of the protrusion 102 abuts against the proximally adjacent sidewall of the groove 101.

[0063] See Figure 7 In some embodiments, the proximal end 123 is provided with a protrusion 102, the diameter of the protrusion 102 is larger than the diameter of the middle part 122, and the handle 11 is provided with a groove 101.

[0064] Compared to the tube body 12, the handle 11 has a larger diameter, making it easier to set a groove in the handle 11 and having less impact on the strength of the handle 11.

[0065] The protrusion 102 may be part of the proximal end 123. For example, the tube 12 with the protrusion 102 on the proximal end 123 may be formed by machining or injection molding. Alternatively, the protrusion 102 and the proximal end 123 may be separate structures, with the protrusion 102 fixedly connected to the tube segment of the proximal end 123.

[0066] The aforementioned protrusion 102 may not be part of the proximal end portion 123, for example, see [link to example]. Figure 5 The protrusion 102 includes a bearing member 131, which is sleeved on at least a portion of the tube section of the proximal end 123. The inner circumference of the bearing member 131 is fixedly connected to the proximal end 123, and the outer circumference of the bearing member 131 is fixedly connected to the inner circumference of the groove 101.

[0067] The outer periphery of the bearing component 131 is fixedly connected to the inner periphery of the groove portion, and the inner periphery of the bearing component 131 is fixedly connected to the outer periphery of the tube section near the end portion 123. Both of these fixed connections can be made using methods including, but not limited to, bonding, interference fit, and threaded connection. For example, the tube section near the end portion 123 can be bonded to the inner periphery of the bearing component 131 via heat fusion curing, and the inner periphery of the groove portion 101 of the handle 11 can be bonded to the outer periphery of the bearing component 131 via heat fusion curing.

[0068] See Figure 8 In some embodiments, the proximal end 123 is provided with a groove 101, the diameter of which is smaller than the diameter of the middle part 122, and the handle 11 is provided with a protrusion 102.

[0069] When the protrusion 102 is provided on the handle 11, the protrusion 102 may also include a bearing member 131. The outer periphery of the bearing member 131 is fixedly connected to the inner wall of the handle 11, and at least the inner periphery of the bearing member 131 is embedded in the groove 101. The positional relationship and structure between the bearing member 131 and the groove 101 can be referred to the foregoing embodiments, and will not be described again here.

[0070] In some embodiments, the expander 1 can be operatively connected to the target component; see also Figure 3 and Figure 5 The handle 11 is provided with a connection structure 112 at its proximal end so that the handle 11 can be rotatably connected to the target component; the radial bearing structure 13 is used to keep the tube body 12 in a substantially non-rotating state relative to the internal lumen during the rotation of the handle 11.

[0071] In related technologies, the handle 11 is connected to the target component via a plug-in method. For example, the handle 11 and the target component are connected by a stepped interlocking contact. Both the handle 11 and the target component are typically molded parts with small dimensions (e.g., diameter). Compared to larger instruments, the smaller handle 11 and target component are more susceptible to tolerance variations. Errors in different batches of the same product can cause variations in the plugging force. Tensile strength and connection feel are almost contradictory aspects for this interlocking contact method, and the plugging and unplugging action relies on instantaneous material deformation, making it difficult for the operator to control a precise plugging force range. In this embodiment, the handle 11 is rotatably connected to the target component using a connecting structure 112. The rotation stroke is variable, which can better compensate for tolerance effects. Furthermore, the rotation operation provides a continuous force feedback process. Therefore, the connection force of the rotational connection method in this embodiment is more controllable, and it is easier to coordinate the connection feel and tensile strength.

[0072] While the detachable, rotatable connection between the handle 11 and the target component improves the connection feel, without the aforementioned radial bearing structure 13, the handle 11 could cause the tube body 12 to rotate, potentially damaging the blood vessel. Taking the interventional sheath 2 as an example: after the dilator 1 inserts the interventional sheath 2 into the intended location in the blood vessel, the interventional sheath 2 needs to remain in the body while the dilator 1 is withdrawn separately. During the withdrawal of the dilator 1, the handle 11 is rotated relative to the interventional sheath 2 to separate it. Without the aforementioned radial bearing structure 13, the tube body 12 would rotate with the handle 11. The distal end 121 of the tube body 12 is a free end, and its rotation could potentially damage the blood vessel and cause complications. With the aforementioned radial bearing structure 13, the tube body 12 and the handle 11 can rotate relative to each other. When the handle 11 rotates, the tube body 12 can almost remain in a non-rotating state relative to the blood vessel, which helps reduce or even avoid vascular damage and related vascular complications. The target component includes instruments that need to cooperate with the dilator 1 in interventional procedures, such as the interventional sheath 2 and catheters, but is not limited to these.

[0073] To distinguish it from the connection structure located on the sheath seat 21 mentioned below, the connection structure located at the distal end of the handle 11 is referred to as the first connection structure, and the connection structure located on the sheath seat 21 is referred to as the second connection structure.

[0074] Taking the interventional sheath 2 as an example, the handle 11 is connected to the interventional sheath 2 by rotation, making the dilator 1 and the interventional sheath 2 a single unit, facilitating synchronous delivery of both within the body lumen. When the dilator 1 needs to be withdrawn from the body lumen separately, the handle 11 is rotated, separating it from the interventional sheath 2. Based on the foregoing description, the handle 11 and the tube body 12 are fixedly connected axially. After the handle 11 and the interventional sheath 2 are separated, pulling the handle 11 can synchronously withdraw the tube body 12 from the body. The connection or separation of the tube body 12 and the handle 11 with the target component can be achieved in a single operation, eliminating the need for two separate steps.

[0075] like Figure 3 As shown, in some embodiments, the connection structure 112 on the handle 11 includes a threaded structure. The threaded structure may be an external thread, with an internal thread provided near the proximal end of the target component, and the handle 11 and the target component are threadedly connected.

[0076] Of course, the threaded structure can also be an internal thread located on the near-end outer periphery of the handle 11.

[0077] In some implementations, the first connection structure includes a protruding structure. A circumferentially extending limiting groove, such as a spirally extending limiting groove, is provided near the proximal end of the target component. The protruding structure is embedded within the limiting groove, the end of which has a limiting section with a reduced inner diameter. The protruding structure rotates from the starting section of the limiting groove towards the end until it reaches the limiting section, where it is press-fitted with the limiting section to connect the handle 11 and the target component. Conversely, to remove the handle 11 from the target component, it can be done by rotating the handle 11 in the opposite direction to the aforementioned locking. The above description of the first connection structure is merely illustrative and is not intended to limit this embodiment.

[0078] See Figures 9 to 11 This embodiment also provides an interventional sheath 2, which includes a sheath tube 22, comprising an outer tube 223 and an inner tube 221. The inner surface of the inner tube 221 has a lubrication layer 20 and defines a hollow lumen extending through both ends of the sheath tube 22. The hollow lumen is used at least for delivering the catheter device. A reinforcing structure 222-a / 222-b is embedded between the outer surface of the outer tube 223 and the inner surface of the inner tube 221. The reinforcing structure 222-a / 222-b is used to maintain the gap between the catheter of the catheter device and the inner tube 221, and the gap is used for measuring blood pressure. Optionally, the above-mentioned catheter device includes a catheter pump.

[0079] In one possible implementation, such as Figure 9As shown, the reinforcing structures 222-a / 222-b are located between the outer tube 223 and the inner tube 221. In another possible configuration, the reinforcing structures 222-a / 222-b are embedded within the wall of the inner tube 221, forming a four-layer structure: outer tube - inner tube material - reinforcing structure - inner tube material. This results in a stronger bond between the reinforcing structures 222-a / 222-b and the wall of the inner tube 221, increasing the rigidity of the sheath and reducing the difficulty of instrument delivery.

[0080] Instruments such as catheter pumps, catheters, and dilators 1 enter and exit the body through a hollow lumen. The lubrication layer 20 reduces the friction between these instruments and the inner surface of the inner tube 221 during transport, improving the ease of instrument delivery. Some catheter pumps have a foldable pump head assembly. When the foldable pump head assembly is transported within the hollow lumen in a radial compression configuration, it exerts significant pressure on the lumen wall. The lubrication layer 20 reduces the friction on the lumen wall, facilitating the transport of the foldable pump head assembly.

[0081] The reinforcing structures 222-a / 222-b enhance the radial strength of the sheath 22, improve its resistance to axial pressure and torsional forces, and reduce changes in the inner diameter of the sheath 22 caused by bending, folding, and compression. This ensures that even if the sheath 22 bends after intervention, it will hardly cause inner wall collapse, thus improving the overall stability of the inner diameter of the sheath 22. For example, after the intervention sheath is inserted into the human body, part of it is inside the body and part is outside the body. At the junction of the two parts, the intervention sheath is prone to bending or bending due to external forces. The aforementioned reinforcing structures 222-a / 222-b help maintain the shape of the hollow lumen, keeping the two parts of the lumen in a state of fluid communication and preventing the collapse of the hollow lumen from causing inaccurate blood pressure readings.

[0082] After the dilator 1 assists the interventional sheath 2 in expanding the puncture site within the blood vessel, the dilator 1 is withdrawn, leaving the interventional sheath 2 inside the vessel. Based on the percutaneous access pathway for endovascular instruments established using the sheath 22, the catheter is inserted through the interventional sheath and into the blood vessel for subsequent interventional treatments or examinations. Blood pressure, a measure of blood pressure, characterizes the functioning of the circulatory system and is data that physicians wish to monitor in real time during interventional examinations or treatments. The principle of blood pressure measurement includes: in a closed tubing system, the pressure is equal at all interconnected points. Since there is often a gap between the catheter and the interventional sheath 2, and because the distal ends of the interventional sheath 2 and the catheter extend into the circulatory system, the gap between the interventional sheath 2 and the catheter allows for fluid communication with the vascular system. The gap between the catheter and the inner tube 221, along with the circulatory system within the body, together constitute a closed tubing system that is interconnected. See [link to relevant documentation]. Figure 14Blood pressure data can be obtained by detecting the liquid pressure in the pipe that is in fluid communication with the gap using pressure sensor 43.

[0083] In one possible implementation, see Figure 12 and Figure 13 The interventional sheath 2 also includes a sheath seat 21 connected to the sheath tube 22. The proximal end of the sheath tube 22 is connected to the sheath seat 21, and the sheath seat 21 has a blood pressure detection interface 214 (see...). Figure 14 The blood pressure detection interface 214 is in fluid communication with the hollow lumen.

[0084] During the delivery of the catheter of the catheter pump within the sheath 22, the blood pressure monitoring interface 214 is in fluid communication with the gap between the catheter and the inner tube 221.

[0085] Based on the foregoing description of the expander 1, the distal end of the handle 11 is detachably connected to the proximal end of the sheath seat 21 via a first connecting structure. The sheath seat 21 is connected to the proximal end of the sheath 22.

[0086] See Figure 14 The proximal end of catheter 3 is provided with an operating part 41, located outside the subject's body, and contains a chamber 411. Chamber 411 is in fluid communication with the gap between the interventional sheath 2 and catheter 3 via a blood pressure monitoring interface 214. Chamber 411 is also in fluid communication with a reservoir bag 421 via a tubing assembly 42, which stores flushing fluid. Tubing assembly 42 includes a control valve 423 and a pressurizing device 422. The control valve 423 controls the flow of flushing fluid to chamber 411 in real time and can also adjust the flow rate of flushing fluid from reservoir bag 421 to chamber 411. The pressurizing device 422 acts on reservoir bag 421 to pressurize the flushing fluid to a set pressure value to meet the pressure requirements of the human circulatory system and the gap between interventional sheath 2 and catheter 3. The flushing fluid enters chamber 411 through tubing assembly 42 to flush the gap between catheter 3 and interventional sheath 2, effectively preventing thrombus formation. In summary, the gap between the catheter 3 and the intervention sheath 2, together with the blood circulation system in the body, constitute a closed tubing system that is interconnected. Based on this, a pressure sensor 43 is installed in the operation unit 41. The pressure sensor 43 is used to sense the liquid pressure in the chamber 411, thereby calculating the blood pressure data in the human body based on the pressure of the flushing fluid in the chamber 411.

[0087] The improved inner diameter stability of the sheath 22 and the reduced friction on the inner surface of the inner tube 221 can reduce the obstruction of blood pressure transmission and improve the accuracy of blood pressure testing.

[0088] Generally, the lubricating layer 20 can also reduce blood adhesion on the inner surface of the inner tube 221, which is beneficial to reducing the formation of thrombi.

[0089] The lubricating layer 20 can be applied to the inner surface of the inner tube 221 in the form of a coating or film.

[0090] The inner tube 221 can be made of a material with a low coefficient of friction and that is human-friendly. For example, a polymeric fluorine material.

[0091] For example, the inner tube 221 may be made of polytetrafluoroethylene (PTFE) or polyurethane (thermoplastic urethane).

[0092] The outer tube 223 can be made of high-strength polymer materials, such as TPU (Thermoplastic Polyurethane), Pebax (Polyether Block Amide), nylon and other high-strength elastomers.

[0093] In some embodiments, the elastic modulus of the outer tube 223 is greater than that of the inner tube 221.

[0094] Compared to the inner tube 221, the outer tube 223, with its higher elastic modulus, has better mechanical strength and is less prone to bending. The inner tube 221, on the other hand, has better flexibility. This combination of "strong" on the outside and "soft" on the inside ensures that the sheath 22 has a more stable diameter, reducing the problem of hollow lumen collapse, and also allows it to adapt to the natural curvature of the blood vessel, reducing the rigid stimulation of the sheath 22 on the inner wall of the blood vessel.

[0095] For example, the elastic modulus of the outer tube 223 reaches 50 MPa or higher at room temperature (approximately between 0-35℃). The elastic modulus of the inner tube 221 at room temperature can be less than 50 MPa.

[0096] In some embodiments, the friction coefficient of the inner tube 221 is less than that of the outer tube 223.

[0097] Catheters and other instruments primarily move within the hollow lumen of the inner tube 221. The inner tube 221 has a lower coefficient of friction, meaning that these instruments experience less resistance when moving within it, which also helps reduce wear on the lubricating layer on the inner surface of the inner tube 221. The outer tube 223 provides anchoring and support. Its external friction helps the operator better feel the contact between the instrument and the vessel wall during delivery, resulting in better tactile feedback and allowing for more precise instrument manipulation.

[0098] The outer tube 223 and the inner tube 221 are arranged approximately coaxially. The reinforcing structure 222-a / 222-b can also be arranged in a tubular shape. In this case, the reinforcing structure 222-a / 222-b, the outer tube 223, and the inner tube 221 are all arranged approximately coaxially.

[0099] See Figure 9 In some embodiments, the outer surface of the outer tube 223 has an anticoagulant layer 224. While the sheath 22 is within the body lumen, the outer surface of the outer tube 223 also comes into contact with blood; the anticoagulant layer 224 can reduce blood clotting and decrease organ damage caused by vascular obstruction.

[0100] The anticoagulant layer 224 can be applied to the outer surface of the outer tube 223 in the form of a coating or film.

[0101] See Figure 10 In some embodiments, the inner surface of the inner tube 221 has a recess 2211 that is recessed toward the outer tube 223, and the lubrication layer 20 includes a first portion 201 for filling the recess 2211.

[0102] The recess 2211 can store more lubricating material, which can lubricate more effectively and for longer, reducing the problem of reduced lubrication effect due to wear of instruments or corrosion of drugs inside the hollow tube, and extending the service life of the lubricating layer 20. Moreover, using the recess 2211 to fill the lubricating layer 20 is also beneficial to maintaining the small size characteristics of the sheath 22, such as thinner wall thickness and smaller diameter.

[0103] The number of pits 2211 is not a limitation of this application. The pits 2211 can be distributed substantially evenly at various locations on the inner surface of the inner tube 221. The dimensions (e.g., diameter, depth) of multiple pits 2211 can be the same or different.

[0104] In some embodiments, the first portion 201 fills the pit 2211; the lubricating layer 20 further includes a second portion 202 located on the side of the first portion 201 near the hollow cavity to define the hollow cavity as a generally flat surface.

[0105] The second part 202 may cover the first part 201 and the connection between two adjacent recesses 2211. Alternatively, the second part may cover the first part, or even not cover the first part, and the second part may be located at the connection between two adjacent recesses 2211.

[0106] The second part 202 can fill the unevenness of the inner surface of the inner tube 221 with the first part 201, increase the flatness of the inner wall of the hollow tube cavity, and ensure the low coefficient of friction of the inner wall of the hollow tube cavity.

[0107] In some embodiments, the first part 201 includes an anti-condensation coating, and the second part 202 includes a hydrophilic coating.

[0108] The anticoagulant contained in the anticoagulant coating can be released into the hollow lumen through the hydrophilic coating. Because of the hydrophilic coating, the anticoagulant can also be released slowly, supporting long-term continuous anticoagulation. The hydrophilic coating can reduce the friction between the catheter device and the inner surface of the inner tube 221 during delivery. In addition, the hydrophilic coating lubricates the wall of the hollow lumen and can also effectively prevent coagulation problems. The lubrication layer 20 has the dual function of anticoagulation and reducing the friction of the inner wall of the hollow lumen.

[0109] In some embodiments, see Figure 10 The reinforced structure 222-a / 222-b has multiple support units 2221, and there are gaps 2222 between the multiple support units 2221. The wall of the inner tube 221 is recessed towards the gap 2222 to form a pit 2211.

[0110] Optionally, the support unit 2221 includes braided filaments 2223 ( Figure 9 The reinforcing structure 222-a / 222-b can be formed by braiding filaments 2223 or by winding a spring. The reinforcing structure 222-a / 222-b obtains higher strength through the support unit 2221, thereby improving the wall strength of the inner tube 221.

[0111] The support unit 2221 enhances the mechanical strength of the sheath 22 and provides clearance for the formation of the recess 2211, reducing the wall thickness of the sheath 22. For example, the inner tube 221 deforms towards the gap 2222 to form the recess 2211. Based on this, the support unit 2221 and the inner tube 221 cooperate to increase the thickness of the lubrication layer 20 and strengthen the bonding force between the inner tube 221 and the reinforcing structures 222-a / 222-b, reducing the difficulty of transporting the instrument within the hollow lumen.

[0112] The shape of the pit 2211 can be roughly the same as the shape of the gap 2222, but it is not necessary.

[0113] Exemplarily, the process of connecting the inner tube 221 to the reinforcing structure 222-a / 222-b includes: fitting the hollow cavity of the inner tube 221 onto the outer periphery of an inflatable rubber tube, and fitting a heating sleeve onto the outer periphery of the outer tube 223. Inflation is applied to the rubber tube, and the reinforcing structure 222-a / 222-b is heated through the outer tube 223, causing the rubber tube to laminate the inner tube 221 onto the reinforcing structure 222-a / 222-b. Furthermore, during the compression of the inner tube 221 by the rubber tube, the gas pressure "squeezes" the inner tube 221 into the gap 2222, thereby forming a recess 2211. After lamination is complete and the heating sleeve cools down, the rubber tube is deflated, and the sheath 22 is removed. This is merely an example, and the formation of the recess 2211 is not intended to limit this embodiment.

[0114] The shape of the gap 2222 can be circular, rhomboid, square, or any other shape. The shape of the gap 2222 is not intended to limit this embodiment.

[0115] The wall of the inner tube 221 can be recessed towards the gap 2222 until it contacts the inner surface of the outer tube 223, and such a recess 2211 is deeper. Or, as Figure 10 As shown, the inner tube 221 is recessed towards the gap 2222 to a certain distance from the inner surface of the outer tube 223, and the depth of such a pit 2211 is smaller.

[0116] The inner tube 221 has a flexible wall to maintain the shape of the pit 2211 as much as possible. Alternatively, the outer surface of the inner tube 221 is fixedly connected (e.g., by bonding or fusion bonding) to the reinforcing structure 222-a / 222-b or the outer tube 223, which also maintains the shape of the pit 2211 as much as possible.

[0117] See Figure 9 In some embodiments, the reinforcing structure 222-a includes a braided layer, and the support unit 2221 includes braided filaments 2223, with multiple braided filaments 2223 intersecting to form gaps 2222. The wall of the inner tube 221 is recessed towards the gaps 2222 to form pits 2211.

[0118] Optionally, the woven layer is a mesh, with the mesh openings being voids.

[0119] The braided filament 2223 can be braided in multiple strands (e.g., double strands) with a PPI (picks per inch) of 30-150, which balances the strength and maneuverability of the catheter. Examples of PPIs are 50-100, 30-80, 40-120, or 60-150.

[0120] In some embodiments, the braided filament 2223 is a flat filament. Compared to cylindrical braided filaments, flat filaments can maintain the mechanical strength of the sheath 22 and also help to reduce the wall thickness of the sheath 22.

[0121] In some embodiments, the braided layer includes a metal braided layer.

[0122] Metal braided wires can be made of materials such as titanium alloy and stainless steel.

[0123] See Figure 11 In some embodiments, the reinforcing structure 222-b includes a plurality of metal articulated rings 2224, with adjacent metal articulated rings 2224 being rotatably connected.

[0124] The metal joint ring 2224 can be a hollow short cylindrical metal joint unit. Two adjacent metal joint rings 2224 are connected in series through a pivot structure (such as a ball socket or pin) on the end face, similar to the structure of a snake bone tube.

[0125] In some embodiments, the reinforcing structure 222-a / 222-b is embedded in the wall of the outer tube 223, forming a four-layer structure of outer tube material - reinforcing structure - outer tube material - inner tube. This makes the reinforcing structure 222-a / 222-b and the wall of the outer tube 223 more firmly bonded, improves the rigidity of the sheath, and reduces the difficulty of instrument delivery.

[0126] In some embodiments, the lubricating layer 20 includes at least one of a hydrophilic coating, an anticoating coating, and a hybrid coating, wherein the hybrid coating includes a coating that is a mixture of an anticoating material and a hydrophilic material.

[0127] The anticoagulant coating includes an anticoagulant material, providing anticoagulant functionality to the inner tube 221. The hydrophilic coating includes a hydrophilic material, providing lubrication functionality to the inner tube 221 to reduce the coefficient of friction. The hybrid coating has both anticoagulant and lubricating functions.

[0128] For example, anticoagulant materials include polymers containing polyethylene glycol (PEG). Another example: anticoagulant materials include heparin, polyethylene glycol, and one or more compositions containing sulfates or sulfonates.

[0129] For example, the hydrophilic material includes one or more combinations of polyvinyl pyrrolidone (PVP), acrylic resin (PAA), and oxidized polyethylene (PEO).

[0130] See Figures 11 to 12This embodiment also provides a delivery system including an interventional sheath 2 and an expander 1 as described in any of the preceding embodiments, with a handle 11 detachably connected to the interventional sheath 2; a radial bearing structure 13 is used to keep the tube body 12 in a substantially non-rotating state relative to the intra-body lumen during the period when the handle 11 is operably detached or connected.

[0131] As mentioned above, since the radial bearing structure 13 enables the handle 11 to rotate relative to the tube body 12, the torque acting on the handle 11 during rotation can be transmitted to the tube body 12 as little as possible. The tube body 12 can remain in a non-rotating state relative to the wall of the internal lumen, so the tube body 12 will hardly damage the wall of the internal lumen due to rotation.

[0132] In some embodiments, the interventional sheath 2 includes a sheath tube 22 and a sheath seat 21 disposed at the proximal end of the sheath tube 22. The tube body 12 is operably inserted into the sheath tube 22 through the sheath seat 21, and the distal end 121 extends out from the distal opening of the sheath tube 22. A rotatable connection structure is provided between the handle 11 and the sheath seat 21 so that the handle 11 can be rotatably connected to the sheath seat 21. Specifically, the radial bearing structure 13 is used to keep the tube body 12 in a substantially non-rotating state relative to the lumen inside the body during the rotation of the handle 11.

[0133] The rotary connection structure includes a first connection structure disposed on the handle 11 and a second connection structure disposed on the sheath seat 21. As mentioned above, one of the first connection structure and the second connection structure can be an internal thread, and the other can be an external thread. Alternatively, the first connection structure includes a protrusion structure, and the second connection structure includes a limiting groove.

[0134] During the insertion of the tube body 12 into the sheath 22 via the sheath seat 21, the handle 11 gradually approaches the sheath seat 21. When the first connecting structure at the distal end of the handle 11 contacts the second connecting structure at the proximal end of the sheath seat 21, the tube body 12 can be further inserted into the sheath 22 while rotating the handle 11. When the handle 11 and the sheath seat 21 are rotated into place, the distal end of the tube body 12 also protrudes from the distal opening of the sheath 22, meaning that the handle 11 and the tube body 12 are respectively installed with the interventional sheath 2. To remove the dilator 1, simply reverse the rotation. This one-step operation allows for convenient and complete connection or disassembly of the dilator 1 and the interventional sheath 2, making it simple, convenient, and reliable.

[0135] The sheath seat 21 can be a single component.

[0136] Alternatively, the sheath seat 21 may comprise a combination of multiple components. For example: see [link to documentation]. Figure 13In some embodiments, the sheath seat 21 includes a seat body 211, a locking buckle 213, and a hemostatic valve 212. The distal end of the seat body 211 is connected to the sheath 22. The hemostatic valve 212 is directly or indirectly disposed at the proximal end of the seat body 211. The distal end of the locking buckle 213 is sleeved on the proximal end of the seat body 211 and abuts against the hemostatic valve 212. When the locking buckle 213 is locked to the seat body 211, the locking buckle 213 is tightly against the hemostatic valve 212, thereby positioning the hemostatic valve 212 between the locking buckle 213 and the proximal end of the seat body 211. The locking buckle 213 has a hollow structure, and the tube body 12 passes through the proximal opening of the locking buckle 213, the hemostatic valve 212, and the seat body 211 in sequence. The aforementioned radial bearing structure 13 may be located between the locking buckle 213 and the handle 11.

[0137] The various embodiments or implementation methods described in this specification are presented in a progressive manner. Each embodiment focuses on the differences from other embodiments, and the same or similar parts between the embodiments can be referred to each other.

[0138] In the description of this specification, references to "one embodiment," "some embodiments," "illustrative embodiment," "example," "specific example," or "some examples," etc., indicate that a specific feature, structure, material, or characteristic described in connection with an embodiment or example is included in at least one embodiment or example of this application. In this specification, the illustrative expressions of the above terms do not necessarily refer to the same embodiment or example. Furthermore, the specific features, structures, materials, or characteristics described may be combined in any suitable manner in one or more embodiments or examples.

[0139] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of this application, and are not intended to limit them. Although this application has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some or all of the technical features therein. Such modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the scope of the technical solutions of the embodiments of this application.

Claims

1. An intervention sheath, characterized in that, The interventional sheath includes a sheath tube, which includes an outer tube and an inner tube; The inner surface of the inner tube has a lubricating layer and defines a hollow lumen that extends through both ends of the sheath, the hollow lumen being used to deliver the conduit device. A reinforcing structure is embedded between the outer surface of the outer tube and the inner surface of the inner tube. The reinforcing structure is used to maintain the gap between the catheter of the catheter pump and the inner tube, and the gap is used to measure blood pressure.

2. The access sheath of claim 1, wherein, The outer surface of the outer tube has an anticoagulant layer; and / or, the lubricating layer includes at least one of a hydrophilic coating, an anticoagulant coating, and a mixed coating, wherein the mixed coating includes a coating that combines an anticoagulant material and a hydrophilic material.

3. The access sheath of claim 1, wherein, The inner surface of the inner tube has a recess that is recessed toward the outer tube, and the lubricating layer includes a first portion for filling the recess.

4. The access sheath of claim 3, wherein, The first portion fills the pit; the lubricating layer also includes a second portion located on the side of the first portion near the hollow cavity to define the hollow cavity as a generally flat surface.

5. The access sheath of claim 4, wherein, The first part includes an anti-condensation coating, and the second part includes a hydrophilic coating.

6. The access sheath of claim 3, wherein, The reinforcing structure has multiple support units, and there are gaps between the multiple support units. The inner tube wall is recessed towards the gap side to form the pit. The reinforcing structure includes a braided layer, the support unit includes braided wires, multiple braided wires are cross-connected to form the gap, the braided wires are flat wires, and / or the braided layer includes a metal braided layer; Alternatively, the reinforcing structure may include multiple metal joint rings, with adjacent metal joint rings rotatably connected.

7. The access sheath of any one of claims 1 to 6, wherein, The reinforcing structure is embedded within the wall of the outer tube.

8. The access sheath of any one of claims 1 to 6, wherein, The elastic modulus of the outer tube is greater than that of the inner tube; and / or, the coefficient of friction of the inner tube is less than that of the outer tube.

9. The access sheath of claim 1, wherein, The interventional sheath also includes a sheath seat connected to the sheath tube, the proximal end of the sheath tube being connected to the sheath seat, the sheath seat having a blood pressure detection interface, and the blood pressure detection interface being in fluid communication with the hollow lumen.

10. A delivery system for a catheter pump, characterized by The duct pump has a duct and a pump head assembly, the pump head assembly being disposed at the distal end of the duct; The delivery system includes an interventional sheath as described in any one of claims 1 to 9, the interventional sheath being used to deliver the catheter pump; The hollow tube is used for radial compression and delivery of the pump head assembly, and the conduit passes through the hollow tube.

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