Interventional sheath and dilator

Abstract

The utility model relates to the technical field of medical instruments, and particularly discloses an intervention sheath and a dilator. According to the intervention sheath, the guide piece is arranged in the lock catch, the guide hole in the guide piece and the opening of the hemostasis valve are coaxially arranged, and the guide hole is used for guiding the insertion piece to penetrate through the hemostasis valve, so that the hemostasis valve is prevented from being poked and damaged due to the fact that the insertion piece cannot be aligned with the opening of the hemostasis valve when penetrating through the hemostasis valve; when the lock catch and the sheath tube seat are locked, the lock catch acts on the hemostasis valve to enable the far end of the hemostasis valve to abut against the near end of the sheath tube seat, pressing force directly acts on the hemostasis valve, the lock catch acts on the guide piece to enable the far end of the guide piece to abut against the near end of the hemostasis valve, and the guide piece also exerts force on the hemostasis valve to enable the hemostasis valve to abut against the near end of the sheath tube seat. The sealing performance of the hemostasis valve is improved, and meanwhile positioning installation of the hemostasis valve and the guiding piece is achieved.

Description

Technical Field

[0001] The utility model relates to the technical field of medical devices, in particular to an interventional sheath and a dilator. Background Art

[0002] At present, in the field of cardiovascular disease treatment, interventional therapy is widely used due to its advantages of less bleeding, less trauma, fewer complications, safety and reliability, and fast postoperative recovery. Interventional sheath is an auxiliary medical device that plays an important role in interventional therapy. It is required in almost all vascular interventional surgeries. Through the interventional sheath, a connection channel can be established between the human blood vessels and the outside world to assist the delivery system in delivering diagnostic and / or therapeutic devices (collectively referred to as interventional devices) to the target lesion location.

[0003] The interventional sheath provides a channel for interventional instruments to enter the human body, and also creates an outlet for blood or other body fluids to flow out. In order to prevent blood loss, it is usually necessary to set a hemostatic valve in the catheter sheath. Based on the structure of the interventional sheath in the prior art, when the insert is inserted into the interventional sheath and passes through the hemostatic valve, it is easy to damage the hemostatic valve due to the inability to align with the opening of the hemostatic valve. In order to solve the above technical problems, a technical solution is proposed to add a guide member to the proximal end of the hemostatic valve. The guide member is clamped between the lock buckle and the hemostatic valve. The hemostatic valve requires a larger tightening force to ensure that it does not leak blood due to poor sealing. However, in the prior art, the tightening force applied to the hemostatic valve by the lock buckle needs to be transmitted through the guide member, which will reduce the locking force of the lock buckle, resulting in poor sealing of the hemostatic valve during use. Utility Model Content

[0004] The utility model aims to provide an interventional sheath and a dilator, which solves the problem that the fastening force applied by the lock buckle to the hemostatic valve needs to be transmitted through a guide member, thereby reducing the locking force of the lock buckle and causing poor sealing of the hemostatic valve.

[0005] To achieve this purpose, the utility model adopts the following technical solutions:

[0006] In one aspect, an interventional sheath is provided, comprising:

[0007] Sheath seat;

[0008] A lock buckle, wherein the lock buckle has an inner cavity, and the proximal end of the sheath tube seat is inserted into the distal end of the inner cavity;

[0009] A guide member, disposed in the inner cavity, wherein the guide member has a guide hole;

[0010] A hemostatic valve is arranged between the distal end of the guide member and the proximal end of the sheath seat, the locking buckle is locked with the sheath seat, the locking buckle directly acts on the guide member to press the distal end of the guide member against the proximal end of the hemostatic valve, and the locking buckle directly acts on the hemostatic valve to press the distal end of the hemostatic valve against the proximal end of the sheath seat, and the guide hole is coaxially arranged with the opening of the hemostatic valve.

[0011] As an optional technical solution for the above-mentioned interventional sheath, the wall of the inner cavity is provided with a proximal limiting portion and a distal limiting portion, the distal limiting portion is in contact with the hemostatic valve and makes the distal end of the hemostatic valve press against the proximal end of the sheath tube seat, and the proximal limiting portion is in contact with the guide member and makes the distal end of the guide member press against the proximal end of the hemostatic valve.

[0012] As an optional technical solution of the above-mentioned interventional sheath, the proximal limiting portion includes a proximal step surface, the distal end of the guide member is provided with a boss along the circumference of the outer side wall, the proximal step surface is pressed against the proximal surface of the boss, and the outer diameter of the boss is smaller than the outer diameter of the hemostatic valve;

[0013] The distal limiting portion includes a distal step surface connected to the proximal step surface, and the distal step surface is pressed against the proximal surface of the hemostatic valve.

[0014] As an optional technical solution for the above-mentioned interventional sheath, a sheath seat hole is provided on the sheath seat, and the sheath seat hole is coaxially arranged with the opening of the hemostatic valve. The width of the proximal end face of the sheath seat is t1, and the width of the distal step surface in contact with the hemostatic valve is t2, 0.5≤t2 / t1≤0.75.

[0015] As an optional technical solution for the above-mentioned interventional sheath, a sheath seat hole is provided on the sheath seat, and the sheath seat hole is coaxially arranged with the opening of the hemostatic valve. The width of the proximal end face of the sheath seat is t1, the width of the distal step surface in contact with the hemostatic valve is t2, and the width of the distal end face of the guide member is t3, 1.4≤(t2+t3) / t1≤1.55.

[0016] As an optional technical solution for the above-mentioned interventional sheath, a clearance hole is provided at the distal end of the guide hole, the clearance hole is coaxially arranged with the guide hole, the aperture of the clearance hole is larger than the aperture of the guide hole, and the axial length of the clearance hole is smaller than the axial length of the boss.

[0017] As an optional technical solution for the above-mentioned interventional sheath, the guide hole includes a tapered hole and a straight hole, the inner diameter of the proximal end of the tapered hole is larger than the inner diameter of the distal end, the proximal end of the straight hole is connected to the distal end of the tapered hole, the axial length of the straight hole is smaller than the axial length of the tapered hole, and the inner diameter of the straight hole matches the outer diameter of the insert.

[0018] As an optional technical solution of the above-mentioned interventional sheath, the hole wall at the proximal end of the tapered hole is provided with a transition surface along the circumferential direction, the transition surface extends to the proximal end surface of the tapered hole, and the transition surface is bent toward the inside of the tapered hole.

[0019] As an optional technical solution of the above-mentioned interventional sheath, the interventional sheath further comprises a locking nut and a sheath tube, the proximal end of the locking nut is connected to the distal end of the sheath tube seat, and a suture buckle is sleeved on the outer side of the locking nut;

[0020] The sheath tube comprises a tapered section at the distal end, a sheath tube body in the middle, and a trumpet-shaped section at the proximal end. The distal end of the sheath tube body is connected to the tapered section, the proximal end of the sheath tube body is connected to the trumpet-shaped section, the locking nut is passed through the proximal end of the sheath tube, and the trumpet-shaped section is clamped between the sheath tube seat and the locking nut.

[0021] As an optional technical solution for the above-mentioned interventional sheath, the sheath tube body is a three-layer structure and is provided with an inner layer, a reinforcement layer and an outer layer in sequence from the inside to the outside, the distal end of the inner layer and the distal end of the outer layer extend to form the tapered section, and the outer diameter of the outer layer gradually decreases, the proximal end of the outer layer extends to form a trumpet-shaped section, a sheath layer is provided on the outside of the trumpet-shaped section, and the distal end of the sheath layer extends beyond the distal end of the suture buckle.

[0022] As an optional technical solution for the above-mentioned interventional sheath, the distal end of the reinforcement layer does not extend into the conical section, and the proximal end of the reinforcement layer does not extend into the bell-mouth section; the proximal end of the inner layer does not extend into the bell-mouth section; the inner layer is a PTFE layer, the reinforcement layer is a spring layer, the outer layer is a pebax layer, and the sheath layer is a pebax layer.

[0023] As an optional technical solution of the above-mentioned interventional sheath, the proximal end of the reinforcement layer is arranged adjacent to the distal end of the bell-mouth-shaped section; the proximal end of the inner layer is arranged adjacent to the distal end of the bell-mouth-shaped section.

[0024] As an optional technical solution of the above-mentioned interventional sheath, the outer wall of the sheath tube is provided with a hydrophilic coating.

[0025] On the other hand, a dilator is provided, which is used in conjunction with any one of the above-mentioned interventional sheaths.

[0026] As an optional technical solution of the above-mentioned expander, the expander includes an expander seat and a expander tube, the proximal end of the expander tube is connected to the distal end of the expander seat, and the distal end of the expander seat is clamped with the proximal end of the lock buckle.

[0027] As an optional technical solution for the above-mentioned expander, the distal outer wall of the expander seat is provided with a protrusion along the circumferential direction, the inner cavity of the lock buckle passes through the proximal end surface of the lock buckle, and a snap-in hole is provided at the proximal end of the inner cavity. The aperture of the snap-in hole is smaller than the outer diameter of the protrusion, and the protrusion can pass through the snap-in hole and be confined in the inner cavity.

[0028] As an optional technical solution of the above-mentioned expander, the distal outer wall of the expander seat is provided with a groove along the circumferential direction, and the groove is arranged on the proximal side of the protrusion, the hole wall of the snap-in hole is placed in the groove, and the axial width of the groove is 0.03mm-0.10mm larger than the axial length of the snap-in hole.

[0029] Beneficial effects of the utility model:

[0030] The interventional sheath provided by the utility model has a guide piece arranged in the locking buckle, and the guide hole on the guide piece is arranged coaxially with the opening of the hemostatic valve, and the guide hole is used to guide the insert piece to penetrate the hemostatic valve, so as to avoid the hemostatic valve being damaged due to the inability to align with the opening of the hemostatic valve when the insert piece penetrates the hemostatic valve; when the locking buckle and the sheath tube seat are locked, the locking buckle acts on the hemostatic valve to press the distal end of the hemostatic valve against the proximal end of the sheath tube seat, and the pressing force directly acts on the hemostatic valve, and the locking buckle acts on the guide piece to press the distal end of the guide piece against the proximal end of the hemostatic valve, and the guide piece also applies force on the hemostatic valve to press the hemostatic valve against the proximal end of the sheath tube seat, thereby improving the sealing performance of the hemostatic valve and realizing the positioning and installation of the hemostatic valve and the guide piece at the same time. BRIEF DESCRIPTION OF THE DRAWINGS

[0031] Figure 1 It is a schematic diagram of the structure of the interventional sheath provided by an embodiment of the utility model;

[0032] Figure 2 is a cross-sectional view of an interventional sheath provided by an embodiment of the utility model;

[0033] Figure 3 yes Figure 2 A local enlarged structural schematic diagram;

[0034] Figure 4 It is a schematic diagram of the positional relationship structure of the sheath tube seat, the lock buckle and the guide member provided in the embodiment of the utility model;

[0035] Figure 5 It is a schematic diagram of the structure of the sheath tube provided in an embodiment of the utility model;

[0036] Figure 6 It is a structural schematic diagram of the expander provided by an embodiment of the utility model;

[0037] Figure 7 yes Figure 5 Schematic diagram of the local enlarged structure at B.

[0038] In the figure:

[0039] 1. Sheath seat; 2. Lock buckle; 3. Guide piece; 4. Hemostatic valve; 5. Lock nut; 6. Sheath; 7. Suture buckle;

[0040] 11. Sheath seat hole;

[0041] 21. Proximal limit portion; 22. Distal limit portion; 23. Snap-fit ​​hole;

[0042] 31. Guide hole; 311. Tapered hole; 312. Straight hole; 32. Boss; 33. Clearance hole;

[0043] 61, sheath body; 611, inner layer; 612, reinforcement layer; 613, outer layer; 62, tapered section; 63, flared section; 64, sheath layer;

[0044] 101, dilator seat; 1011, protrusion; 1012, groove; 102, dilator tube. DETAILED DESCRIPTION

[0045] In order to make the technical problems solved by the present invention, the technical solutions adopted and the technical effects achieved clearer, the technical solutions of the embodiments of the present invention will be further described in detail below in conjunction with the accompanying drawings. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of them. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative work are within the scope of protection of the present invention.

[0046] In the description of the present invention, unless otherwise clearly specified and limited, the terms "connected", "connected", and "fixed" should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; 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 be the internal connection of two elements or the interaction relationship between two elements. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0047] In the present utility model, unless otherwise clearly specified and limited, a first feature being "above" or "below" a second feature may include that the first and second features are in direct contact, or may include that the first and second features are not in direct contact but are in contact through another feature between them. Moreover, a first feature being "above", "above" and "above" a second feature includes that the first feature is directly above and obliquely above the second feature, or simply indicates that the first feature is higher in level than the second feature. A first feature being "below", "below" and "below" a second feature includes that the first feature is directly below and obliquely below the second feature, or simply indicates that the first feature is lower in level than the second feature.

[0048] In the field of medical devices, "proximal" refers to the end of the medical device close to the operator (such as a doctor), and "distal" refers to the end of the medical device away from the operator. "Proximal" and "distal" are relative positions with respect to the operator.

[0049] like Figures 1 to 4 As shown, the interventional sheath includes a sheath seat 1, a locking buckle 2, a sheath 6, a locking nut 5 and a suture buckle 7. The distal end of the locking buckle 2 is connected to the proximal end of the sheath seat 1, the distal end of the sheath seat 1 is connected to the proximal end of the locking nut 5, and the suture buckle 7 is sleeved on the outside of the locking nut 5. The sheath 6 is sandwiched between the sheath seat 1 and the locking nut 5.

[0050] Specifically, in this embodiment, the interventional sheath further includes a guide member 3 and a hemostatic valve 4. The lock buckle 2 has an inner cavity, the proximal end of the sheath seat 1 is inserted into the distal end of the inner cavity, the guide member 3 is arranged in the inner cavity, and the guide member 3 has a guide hole 31. The hemostatic valve 4 is arranged between the distal end of the guide member 3 and the proximal end of the sheath seat 1, the lock buckle 2 is locked with the sheath seat 1, the lock buckle 2 directly acts on the guide member 3 so that the distal end of the guide member 3 is pressed against the proximal end of the hemostatic valve 4, and the lock buckle 2 directly acts on the hemostatic valve 4 so that the distal end of the hemostatic valve 4 is pressed against the proximal end of the sheath seat 1, and the guide hole 31 is coaxially arranged with the opening of the hemostatic valve 4.

[0051] A guide member 3 is arranged in the lock buckle 2, and a guide hole 31 on the guide member 3 is arranged coaxially with the opening of the hemostatic valve 4. The guide hole 31 is used to guide the insert to penetrate the hemostatic valve 4, so as to prevent the insert from piercing the hemostatic valve 4 and damaging the hemostatic valve 4 due to failure to align with the opening of the hemostatic valve 4 when penetrating the hemostatic valve 4; when the lock buckle 2 and the sheath seat 1 are locked, the lock buckle 2 acts on the hemostatic valve 4 to press the distal end of the hemostatic valve 4 against the proximal end of the sheath seat 1, and the clamping force acts directly on the hemostatic valve 4, and the lock buckle 2 acts on the guide member 3 to press the distal end of the guide member 3 against the proximal end of the hemostatic valve 4, and the guide member 3 also applies force on the hemostatic valve 4 to press the hemostatic valve 4 against the proximal end of the sheath seat 1, thereby improving the sealing performance of the hemostatic valve 4 and realizing the positioning and installation of the hemostatic valve 4 and the guide member 3 at the same time.

[0052] The guide member 3 is clamped between the hemostatic valve 4 and the lock buckle 2, and the lock buckle 2 presses the hemostatic valve 4 onto the sheath seat 1. The hardness of the guide member 3 is greater than the hardness of the hemostatic valve 4, and the hardness of the guide member 3 is less than or equal to the hardness of the lock buckle 2.

[0053] The sheath tube seat 1, locking buckle 2, sheath tube 6, locking nut 5, suture buckle 7, guide member 3 and hemostatic valve 4 are all coaxially arranged.

[0054] In some embodiments, the inner cavity wall is provided with a proximal limiter 21 and a distal limiter 22, the distal limiter 22 contacts the hemostatic valve 4 and causes the distal end of the hemostatic valve 4 to press against the proximal end of the sheath seat 1, and the proximal limiter 21 contacts the guide member 3 and causes the distal end of the guide member 3 to press against the proximal end of the hemostatic valve 4. The sheath seat 1 cooperates with the distal limiter 22 to clamp the hemostatic valve 4, and the proximal limiter 21 applies pressure to the guide member 3, so that the guide member 3 and the sheath seat 1 cooperate to clamp the hemostatic valve 4, thereby increasing the pressing force on the hemostatic valve 4 and thereby improving the sealing performance of the hemostatic valve 4.

[0055] Optionally, the proximal limiting portion 21 includes a proximal step surface, and the distal end of the guide member 3 is provided with a boss 32 along the circumferential direction of the outer wall, and the proximal step surface is pressed against the proximal surface of the boss 32, and the outer diameter of the boss 32 is smaller than the outer diameter of the hemostatic valve 4. The proximal step surface presses the boss 32 against the proximal surface of the hemostatic valve 4, which improves the sealing performance of the hemostatic valve 4 and ensures the positioning and installation of the guide member 3, preventing the guide member 3 from rotating during the insertion of the insert.

[0056] The distal limiting portion 22 includes a distal step surface connected to the proximal step surface, and the distal step surface presses against the proximal surface of the hemostatic valve 4, so that the clamping force of the lock buckle 2 directly acts on the hemostatic valve 4, ensuring the sealing of the hemostatic valve 4, and also plays a role in fixing the hemostatic valve 4.

[0057] The proximal step surface and the distal step surface are both arranged along the circumference of the inner cavity. In the actual processing process, the inner cavity is in a stepped shape, and is sequentially set as the first cavity, the second cavity, and the third cavity from the proximal end to the distal end of the lock buckle 2, and the inner diameters of the first cavity, the second cavity, and the third cavity gradually increase. The bottom of the second cavity is the proximal step surface, and the bottom of the third cavity is the distal step surface. The distal step surface acts on the circumferential edge of the proximal surface of the hemostatic valve 4, and the proximal step surface acts on the middle of the proximal surface of the hemostatic valve 4. The surface and circumferential surface of the hemostatic valve 4 are both subjected to pressure, which improves the sealing performance of the hemostatic valve 4 and reduces the probability of blood leakage.

[0058] In order to facilitate the installation of the guide member 3 into the inner cavity of the lock 2, the outer diameter of the guide member 3 is slightly smaller than the inner diameter of the inner cavity, that is, the guide member 3 and the lock 2 are clearance-matched. The boss 32 needs to have sufficient structural strength to prevent the guide member 3 from being displaced along its axial direction.

[0059] The proximal end of the sheath seat 1 is inserted into the distal end of the inner cavity of the lock buckle 2. The sheath seat 1 is provided with a sheath seat hole 11, and the sheath seat hole 11 is coaxially arranged with the guide hole 31 and the opening of the hemostatic valve 4. In some embodiments, the width of the proximal end face of the sheath seat 1 is t1, and the width of the distal step surface in contact with the hemostatic valve 4 is t2, and 0.5≤t2 / t1≤0.75. The hemostatic valve 4 is soft in texture, and the width of the distal step surface cannot be much smaller than the width of the proximal end face of the sheath seat 1, otherwise the pressure of the distal step surface will cause the proximal surface of the hemostatic valve 4 to be unevenly stressed and deformed, affecting the sealing of the hemostatic valve 4, so t2 / t1≥0.5. Since the guide member 3 is clamped between the hemostatic valve 4 and the proximal step surface, the proximal end face of the sheath tube 6 in contact with the distal end of the hemostatic valve 4 provides support for the distal end of the guide member 3. Therefore, the axial projections of the distal end face of the guide member 3 and the proximal end face of the sheath tube seat 1 should overlap, and the overlap amount is t1-t2. Therefore, the value of t2 should not be too large, and t2 / t1 is limited to 0.75, thereby ensuring that the proximal and distal ends of the guide member 3 can be subjected to sufficient extrusion pressure and be stably fixed.

[0060] In some embodiments, a sheath seat hole 11 is provided on the sheath seat 1, and the sheath seat hole 11 is coaxially arranged with the guide hole 31 and the opening of the hemostatic valve 4. The width of the proximal end surface of the sheath seat 1 is t1, the width of the distal step surface contacting the hemostatic valve 4 is t2, and the width of the distal end surface of the guide member 3 is t3, 1.4≤(t2+t3) / t1≤1.55. The large width t3 of the distal end face of the guide member 3 can ensure that the distal end of the guide member 3 is in stable contact with the hemostatic valve 4, thereby improving the sealing performance of the hemostatic valve 4. However, the larger t3 is, the better. As the size of t3 increases, the distal end face of the guide member 3 will be close to the opening of the hemostatic valve 4, and the clamping force of the guide member 3 on the hemostatic valve 4 near the opening will be relatively large. Since the hemostatic valve 4 is soft in texture, the opening of the hemostatic valve 4 will be opened, thereby affecting the sealing performance of the hemostatic valve 4. The setting of the size of t1 needs to take into account the impact on the distal surface of the hemostatic valve 4, and minimize the deformation of the hemostatic valve 4 near the opening.

[0061] The guide member 3 is provided with a guide hole 31, which is used to guide the insert to penetrate the opening of the hemostatic valve 4. In some embodiments, a clearance hole 33 is provided at the distal end of the guide hole 31, and the clearance hole 33 is coaxially arranged with the guide hole 31, and the aperture of the clearance hole 33 is larger than the aperture of the guide hole 31, and the length of the clearance hole 33 along the axial direction is smaller than the length of the boss 32 along the axial direction, so as to improve the structural strength of the guide member 3.

[0062] The guide hole 31 includes a tapered hole 311 and a straight hole 312, which are arranged in sequence from the proximal end to the distal end of the guide member 3. The inner diameter of the proximal end of the tapered hole 311 is larger than the inner diameter of the distal end, the proximal end of the straight hole 312 is connected to the distal end of the tapered hole 311, the length of the straight hole 312 is smaller than the length of the tapered hole 311, and the inner diameter of the straight hole 312 matches the outer diameter of the insert. The tapered hole 311 guides the insertion of the insert. When the insert extends from the tapered hole 311 into the straight hole 312, the insert and the straight hole 312 are matched in a surface-to-surface manner, and the insert will not shake along the radial direction of the guide hole 31, so that the insert can be accurately and stably guided to the center of the hemostatic valve 4. If the straight hole 312 is not set, the circumferential side wall of the insert and the distal end of the tapered hole 311 are matched in a line-surface manner, and it cannot be guaranteed that the insert will not shake when penetrating the opening of the hemostatic valve 4. At the same time, in order to reduce the insertion resistance of the insert, the axial length of the straight hole 312 is smaller than the axial length of the tapered hole 311. Optionally, the axial length of the tapered hole 311 is 10 to 15 times the axial length of the straight hole 312. When the axial length of the guide hole 31 remains unchanged, the axial length of the tapered hole 311 is greater than the axial length of the straight hole 312, so that the insert can be smoothly moved to the position of the hemostatic valve 4. In addition, the taper of the tapered hole 311 should not be too large to ensure that the insert smoothly transitions from the tapered hole 311 to the straight hole 312.

[0063] The hole wall at the proximal end of the tapered hole 311 is provided with a transition surface along the circumferential direction, the transition surface extends to the proximal end surface of the tapered hole 311, and the transition surface is bent toward the inside of the tapered hole 311. The transition surface makes a smooth transition between the tapered hole 311 and the cavity wall of the inner cavity of the lock buckle 2, and when the insert is inserted into the proximal end of the tapered hole 311 at any angle, it can smoothly enter the tapered hole 311 during the process of being pushed forward.

[0064] Continue to refer to Figure 3 As shown, the interventional sheath comprises a locking nut 5 and a sheath tube 6, the proximal end of the locking nut 5 is connected to the distal end of the sheath tube seat 1, and a suture buckle 7 is sleeved on the outer side of the locking nut 5. The sheath tube 6 is clamped between the sheath tube seat 1 and the locking nut 5.

[0065] In some embodiments, in combination Figure 3 and Figure 5 As shown, the sheath tube 6 includes a tapered section 62 at the distal end, a sheath tube body 61 in the middle, and a flared section 63 at the proximal end. The distal end of the sheath tube body 61 is connected to the tapered section 62, and the proximal end of the sheath tube body 61 is connected to the flared section 63. The proximal end of the sheath tube 6 is penetrated by a locking nut 5, and the flared section 63 is clamped between the sheath tube seat 1 and the locking nut 5. The flared section 63 is clamped between the sheath tube seat 1 and the locking nut 5 to ensure that the sheath tube 6 will not fall off. The distal end of the sheath tube 6 is the tapered section 62, which is convenient for insertion into the wound.

[0066] Optionally, the sheath body 61 is a three-layer structure and is provided with an inner layer 611, a reinforcement layer 612 and an outer layer 613 in sequence from the inside to the outside. The distal end of the inner layer 611 and the distal end of the outer layer 613 extend to form a tapered section 62, and the outer diameter of the outer layer 613 gradually decreases. The proximal end of the outer layer 613 extends to form a bell-shaped section 63, and a sheath layer 64 is provided on the outside of the bell-shaped section 63. The distal end of the sheath layer 64 extends to the outer surface of the sheath body 61 and extends beyond the distal end of the suture buckle 7. The reinforcement layer 612 is provided to improve the structural strength of the sheath body 61, so that the sheath 6 is not easily damaged, and the radial size of the sheath body 61 is stable and not easily expanded by an expandable interventional device. The distal end of the inner layer 611 and the distal end of the outer layer 613 extend to the same position. The sheath layer 64 is arranged on the outside of the bell-shaped section 63, which improves the structural strength of the proximal end of the sheath tube 6, so that the bell-shaped section 63 has sufficient strength, and will not produce large distortion and deformation as the locking nut 5 is locked, thereby causing the problem of reduced connection strength between the sheath tube 6 and the sheath tube seat 1. Moreover, the bell-shaped section 63 has only two layers of structure, the outer layer 613 and the sheath layer 64. When the bell-shaped section 63 is squeezed and fixed by the locking nut 5 and the sheath tube seat 1, the bell-shaped section 63 can produce a small deformation to improve the clamping effect of clamping the bell-shaped section 63. At the same time, the distal end of the sheath layer 64 extends beyond the distal end of the suture buckle 7, and the sheath tube 6 will not bend at a large angle at the position close to the suture buckle 7 to cause damage to the sheath tube 6, and the overall flexibility of the sheath tube 6 will not be affected, ensuring that the sheath tube body 61 has the performance of adaptive bending, so that the sheath tube body 61 can be inserted into the human body.

[0067] Optionally, the inner layer 611 is a PTFE layer, the reinforcing layer 612 is a spring layer, the outer layer 613 is a pebax layer, and the sheath layer 64 is a pebax layer. The inner layer 611 is a PTFE layer, and the outer layer 613 is a pebax layer, which can reduce the friction between the inner and outer side walls of the sheath tube 6, facilitate intervention in the human body and insertion of the insert into the sheath tube 6. The sheath layer 64 is a pebax layer, which improves the structural strength of the bell-shaped section 63.

[0068] The distal end of the reinforcing layer 612 does not extend into the conical section 62, so that the structural strength of the conical section 62 is not too large, so that it is easy to insert into the human body. The proximal end of the reinforcing layer 612 does not extend into the bell-shaped section 63, and the proximal end of the inner layer 611 does not extend into the bell-shaped section 63, so that the bell-shaped section 63 has a certain flexibility. When the locking nut 5 is tightened, the bell-shaped section 63 can produce a certain deformation to increase the clamping force on the bell-shaped section 63.

[0069] Optionally, the proximal end of the reinforcing layer 612 is disposed adjacent to the distal end of the bell-shaped section 63, and the proximal end of the inner layer 611 is disposed adjacent to the distal end of the bell-shaped section 63, so as to ensure that the inner diameter and shape of the sheath body 61 adjacent to the bell-shaped section 63 remain unchanged. Otherwise, because the reinforcing layer 612 and the inner layer 611 are not disposed at the distal end of the bell-shaped section 63, the connection between the sheath body 61 and the bell-shaped section 63 will be too soft, and the tightening force of the locking nut 5 will be stretched, causing the sheath body 61 to be deformed and the insert to be difficult to pass through, and the proximal cavity wall of the sheath body 61 will be thinned, and the sheath 6 will be easy to fall off.

[0070] The sheath tube 6 mentioned above has no direct connection with the suture buckle 7 and the locking nut 5, but is connected to the sheath tube seat 1 by being confined in the locking nut 5 by the trumpet-shaped section 63 to ensure that the sheath tube 6 will not undergo significant deformation and ensure that the insert can pass through the sheath tube 6 smoothly.

[0071] In some embodiments, the outer wall of the sheath tube 6 is provided with a hydrophilic coating, which has a lubricating effect, ensuring that the sheath tube 6 can be smoothly inserted into the human body and reducing friction.

[0072] like Figure 3 , Figure 6 and Figure 7 As shown, this embodiment also provides a dilator, which is used in conjunction with the above-mentioned interventional sheath.

[0073] The dilator includes a dilator seat 101 and a dilator tube 102. The proximal end of the dilator tube 102 is connected to the distal end of the dilator seat 101, and the distal end of the dilator seat 101 is snap-fitted with the proximal end of the lock buckle 2. The dilator is used to facilitate the intervention of the intervention sheath into the wound of the human body. The distal end of the dilator seat 101 is snap-fitted with the proximal end of the lock buckle 2. The dilator needs to be removed from the intervention sheath after the intervention sheath completes the intervention. The dilator seat 101 is snap-fitted with the lock buckle 2, which is convenient for connecting or separating the dilator seat 101 and the lock buckle 2.

[0074] Optionally, the distal outer wall of the expander seat 101 is provided with a protrusion 1011 along the circumferential direction, the inner cavity of the lock buckle 2 passes through the proximal end surface of the lock buckle 2, and the proximal end of the inner cavity is provided with a snap-on hole 23, the inner diameter of the snap-on hole 23 is smaller than the outer diameter of the protrusion 1011, and the protrusion 1011 can pass through the snap-on hole 23 and be confined in the inner cavity. The setting of this structure can ensure that after the expander seat 101 is connected to the lock buckle 2, the expander is not easy to fall off, and when the expander needs to be removed, applying a certain pulling force to the expander seat 101 can easily overcome the force of the protrusion 101 being stopped. In addition, the snap-on structure is simple and convenient for doctors to operate.

[0075] The outer wall of the distal end of the expander seat 101 is provided with a groove 1012 along the circumferential direction, and the groove 1012 is arranged on one side of the proximal end of the protrusion 1011, the hole wall of the clamping hole 23 is placed in the groove 1012, and the protrusion 1011 is limited in the inner cavity by the hole wall of the clamping hole 23. The width of the groove 1012 along the axial direction is 0.03mm-0.10mm larger than the length of the clamping hole 23 along the axial direction. After the expander seat 101 is engaged with the lock buckle 2, the expander seat 101 will not shake along the axial direction, and there is still enough space to accommodate the hole wall of the clamping hole 23.

[0076] Obviously, the above embodiments of the present invention are merely examples for clearly illustrating the present invention, and are not intended to limit the implementation methods of the present invention. For those skilled in the art, other different forms of changes or modifications can be made based on the above description. It is not necessary and impossible to list all implementation methods here. Any modifications, equivalent substitutions, and improvements made within the spirit and principles of the present invention shall be included in the protection scope of the claims of the present invention.

Claims

1. An interventional sheath, characterized in that include: Sheath seat (1); A lock buckle (2), wherein the lock buckle (2) has an inner cavity, and the proximal end of the sheath tube seat (1) is inserted into the distal end of the inner cavity; A guide member (3) is arranged in the inner cavity, and the guide member (3) has a guide hole (31); The hemostatic valve (4) is arranged between the distal end of the guide member (3) and the proximal end of the sheath seat (1), the locking buckle (2) is locked with the sheath seat (1), the locking buckle (2) directly acts on the guide member (3) so that the distal end of the guide member (3) is pressed against the proximal end of the hemostatic valve (4), and the locking buckle (2) directly acts on the hemostatic valve (4) so ​​that the distal end of the hemostatic valve (4) is pressed against the proximal end of the sheath seat (1), and the guide hole (31) is coaxially arranged with the opening of the hemostatic valve (4).

2. The interventional sheath according to claim 1, characterized in that: The wall of the inner cavity is provided with a proximal limiting portion (21) and a distal limiting portion (22), wherein the distal limiting portion (22) contacts the hemostatic valve (4) and causes the distal end of the hemostatic valve (4) to press against the proximal end of the sheath seat (1), and the proximal limiting portion (21) contacts the guide member (3) and causes the distal end of the guide member (3) to press against the proximal end of the hemostatic valve (4).

3. The interventional sheath according to claim 2, characterized in that: The proximal limiting portion (21) comprises a proximal step surface, the distal end of the guide member (3) is provided with a boss (32) along the circumference of the outer wall, the proximal step surface is pressed against the proximal surface of the boss (32), and the outer diameter of the boss (32) is smaller than the outer diameter of the hemostatic valve (4); The distal limiting portion (22) comprises a distal step surface connected to the proximal step surface, and the distal step surface is pressed against the proximal surface of the hemostatic valve (4).

4. The interventional sheath according to claim 3, characterized in that: The sheath seat (1) is provided with a sheath seat hole (11), and the sheath seat hole (11) is coaxially arranged with the opening of the hemostatic valve (4). The width of the proximal end face of the sheath seat (1) is t1, and the width of the contact between the distal step surface and the hemostatic valve (4) is t2, and 0.5≤t2 / t1≤0.

75.

5. The interventional sheath according to claim 3, characterized in that: The sheath seat (1) is provided with a sheath seat hole (11), and the sheath seat hole (11) is coaxially arranged with the opening of the hemostatic valve (4). The width of the proximal end face of the sheath seat (1) is t1, the width of the contact between the distal step surface and the hemostatic valve (4) is t2, and the width of the distal end face of the guide member (3) is t3, and 1.4≤(t2+t3) / t1≤1.

55.

6. The interventional sheath according to claim 3, characterized in that: A clearance hole (33) is provided at the far end of the guide hole (31). The clearance hole (33) is coaxially arranged with the guide hole (31). The aperture of the clearance hole (33) is larger than the aperture of the guide hole (31). The axial length of the clearance hole (33) is smaller than the axial length of the boss (32).

7. The interventional sheath according to any one of claims 1 to 6, characterized in that: The guide hole (31) comprises a tapered hole (311) and a straight hole (312); the inner diameter of the proximal end of the tapered hole (311) is larger than the inner diameter of the distal end; the proximal end of the straight hole (312) is connected to the distal end of the tapered hole (311); the axial length of the straight hole (312) is smaller than the axial length of the tapered hole (311); and the inner diameter of the straight hole (312) matches the outer diameter of the insert.

8. The interventional sheath according to claim 7, characterized in that: A transition surface is provided on the hole wall at the proximal end of the tapered hole (311) along the circumferential direction. The transition surface extends to the proximal end surface of the tapered hole (311), and the transition surface is bent toward the inside of the tapered hole (311).

9. The interventional sheath according to any one of claims 1 to 6, characterized in that: The interventional sheath further comprises a locking nut (5) and a sheath tube (6), the proximal end of the locking nut (5) being connected to the distal end of the sheath tube seat (1), and a suture buckle (7) being sleeved on the outer side of the locking nut (5); The sheath tube (6) comprises a conical section (62) at the distal end, a sheath tube body (61) in the middle, and a trumpet-shaped section (63) at the proximal end. The distal end of the sheath tube body (61) is connected to the conical section (62), and the proximal end of the sheath tube body (61) is connected to the trumpet-shaped section (63). The locking nut (5) is passed through the proximal end of the sheath tube (6), and the trumpet-shaped section (63) is clamped between the sheath tube seat (1) and the locking nut (5).

10. The interventional sheath according to claim 9, characterized in that: The sheath tube body (61) is a three-layer structure and is provided with an inner layer (611), a reinforcement layer (612) and an outer layer (613) in sequence from the inside to the outside. The distal ends of the inner layer (611) and the outer layer (613) extend to form the tapered section (62), and the outer diameter of the outer layer (613) gradually decreases. The proximal end of the outer layer (613) extends to form a bell-shaped section (63). A sheath layer (64) is provided on the outside of the bell-shaped section (63), and the distal end of the sheath layer (64) extends beyond the distal end of the suture buckle (7).

11. The interventional sheath according to claim 10, characterized in that: The distal end of the reinforcing layer (612) does not extend into the conical section (62), and the proximal end of the reinforcing layer (612) does not extend into the bell-shaped section (63); the proximal end of the inner layer (611) does not extend into the bell-shaped section (63); the inner layer (611) is a PTFE layer, the reinforcing layer (612) is a spring layer, the outer layer (613) is a pebax layer, and the sheath layer (64) is a pebax layer.

12. The interventional sheath according to claim 10, characterized in that: The proximal end of the reinforcing layer (612) is disposed adjacent to the distal end of the bell-mouth-shaped section (63); and the proximal end of the inner layer (611) is disposed adjacent to the distal end of the bell-mouth-shaped section (63).

13. The interventional sheath according to claim 9, characterized in that: The outer wall of the sheath tube (6) is provided with a hydrophilic coating.

14. A dilator, characterized in that The dilator is used in conjunction with the interventional sheath described in any one of claims 1-13.

15. The dilator according to claim 14, characterized in that The dilator comprises a dilator seat (101) and a dilator tube (102), the proximal end of the dilator tube (102) is connected to the distal end of the dilator seat (101), and the distal end of the dilator seat (101) is clamped with the proximal end of the lock buckle (2).

16. The dilator according to claim 15, characterized in that The distal outer wall of the expander seat (101) is provided with a protrusion (1011) along the circumferential direction, the inner cavity of the lock buckle (2) passes through the proximal end surface of the lock buckle (2), and the proximal end of the inner cavity is provided with a snap-fit ​​hole (23), the aperture of the snap-fit ​​hole (23) is smaller than the outer diameter of the protrusion (1011), and the protrusion (1011) can pass through the snap-fit ​​hole (23) and be confined in the inner cavity.

17. The dilator according to claim 16, characterized in that The distal outer wall of the expander seat (101) is provided with a groove (1012) along the circumferential direction, and the groove (1012) is arranged on the proximal side of the protrusion (1011), the hole wall of the clamping hole (23) is placed in the groove (1012), and the axial width of the groove (1012) is 0.03mm-0.10mm larger than the axial length of the clamping hole (23).

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