Interventional medical device

Abstract

The interventional medical device comprises a handle shell, a catheter assembly and an adjusting assembly, the catheter assembly comprises a catheter and a catheter connecting piece, the near end of the catheter is connected into the handle shell through the catheter connecting piece, and the far end of the catheter extends out of the handle shell; the catheter sequentially comprises a reducing section, a spring winding section and a weaving section in the axial direction, the reducing section is connected to the far end of the spring winding section, the weaving section is connected to the near end of the spring winding section, and the adjusting assembly comprises an adjusting key, a first adjusting wire and a second adjusting wire; the first adjusting wire and the second adjusting wire are fixedly connected to the adjusting key and used for applying pulling force to the variable-diameter section towards the near end under driving of the adjusting key so as to extrude the variable-diameter section. According to the interventional medical device, the retrograde guide wire can smoothly enter the catheter in clinical operation, so that the ray exposure time of an operator and a patient is shortened, the success rate and efficiency of the operation are improved, the operative complications of the patient are reduced, and the postoperative recovery time is shortened.

Description

Technical Field

[0001] The present application relates to the technical field of medical devices, and in particular to an interventional medical device. Background Art

[0002] For lower extremity arterial occlusive lesions, the usual approach is to open the contralateral common femoral artery and then traverse the artery to the affected side for target vessel treatment. This approach is suitable for the vast majority of femoropopliteal artery lesions, is easy to master, and has a low complication rate. In certain special cases, lesions in both iliac arteries can be treated simultaneously. Clinically, it is difficult to establish an antegrade approach for long-segment femoropopliteal artery occlusive lesions in some cases. Therefore, it is necessary to combine ipsilateral retrograde puncture and opening to complete the guidewire approach and subsequent treatment. However, in actual clinical practice, the retrograde guidewire (0.035 inch) often cannot smoothly enter the antegrade 6F catheter, making it impossible to advance the catheter to the healthy vessel at the distal end of the vessel in a short period of time. This causes the retrograde puncture point to remain open for a long time, resulting in complications such as hematoma and pseudoaneurysm at the retrograde puncture point.

[0003] Furthermore, with the advancement of interventional surgery, more and more complex lesions are being encountered, and many of these cases cannot or are not suitable for surgical resection. Examples include cases following EVAR (Endovascular Aneurysm Repair), stent anastomosis, aortobifemoral bypass surgery, and contralateral iliac artery occlusion. Summary of the Invention

[0004] Based on this, the present application provides an interventional medical device to solve the problem of how to improve surgical efficiency while reducing complications.

[0005] The present application provides an interventional medical device, comprising:

[0006] handle housing;

[0007] A catheter assembly comprising a catheter and a tube connector, wherein the proximal end of the catheter is connected to the handle housing via the tube connector, and the distal end of the catheter extends outside the handle housing; the catheter axially comprises a reducing section, a spring section, and a braided section, wherein the reducing section is connected to the distal end of the spring section, and the braided section is connected to the proximal end of the spring section;

[0008] An adjustment component includes an adjustment key, a first adjustment wire and a second adjustment wire; the first adjustment wire and the second adjustment wire are both fixedly connected to the adjustment key, and are used to apply a pulling force toward the proximal end of the variable diameter section under the drive of the adjustment key to squeeze the variable diameter section.

[0009] In one embodiment, the catheter assembly further includes a reinforcement tube, which is disposed in the handle housing and sleeved outside the catheter.

[0010] In one embodiment, the adjustment key is sleeved on the reinforcement tube, and the adjustment key can slide along the axial direction of the reinforcement tube.

[0011] In one embodiment, the adjustment assembly further includes an elastic member, which is sleeved on the reinforcing tube, the distal end of the elastic member abuts against the proximal end of the adjustment key, and the proximal end of the elastic member is confined within the handle housing.

[0012] In one embodiment, a limit buckle is provided on the peripheral side of the adjustment key, and a snap-in slot is provided in the handle shell. When the adjustment key moves toward the proximal end so that the limit buckle corresponds to the position of the snap-in slot, the hook of the limit buckle cooperates with the snap-in slot to limit the adjustment key from moving toward the distal end.

[0013] In one embodiment, the adjustment key is provided with two limit buckles, corresponding to the two clamping grooves provided in the handle housing, and the two limit buckles are symmetrically arranged about the axis of the adjustment key.

[0014] In one embodiment, the interventional medical device further includes a reset assembly, which includes a reset button and a reset spring. The reset button is connected to the handle housing and can be pressed radially relative to the handle housing. A supporting slope is provided on the side of the reset button close to the limit buckle. When the hook of the limit buckle is engaged with the snap-fitting groove, pressing the reset button can cause the supporting slope to squeeze the hook, so that the hook is released from the snap-fitting groove.

[0015] In one embodiment, the interventional medical device also includes a bending adjustment assembly, which includes a first bending adjustment key, a first resetting member, a first bending adjustment wire, a second bending key, a second resetting member and a second bending wire, the proximal end of the first bending adjustment wire and the proximal end of the second bending adjustment wire are respectively connected to the first bending adjustment key and the second bending key, the distal end of the first bending adjustment wire and the distal end of the second bending adjustment wire are both connected to the distal end of the spring segment, the first bending key and the second bending key are both capable of independently moving axially within the handle housing, one end of the first resetting member is against the first bending key, and the other end is limited to the handle housing, the first resetting member is used to drive the first bending key to reset toward the distal end, one end of the second resetting member is against the second bending key, and the other end is limited to the handle housing, and the second resetting member is used to drive the second bending key to reset toward the distal end.

[0016] In one embodiment, the catheter assembly includes a reinforcing tube, the first bending key and the second bending key are snapped onto the reinforcing tube, and part of the structure is exposed from the handle shell, and by pushing the parts of the first bending key and the second bending key exposed from the handle shell, the first bending key and the second bending key can slide along the axial direction of the reinforcing tube.

[0017] In one embodiment, the variable diameter section includes an intermediate layer and an outer layer, wherein the intermediate layer of the variable diameter section is woven from nickel-titanium alloy round wire, the braiding angle of the intermediate layer of the variable diameter section is 30°-45°, and the outer layer of the variable diameter section is made of elastic material.

[0018] In one embodiment, the catheter assembly includes a reinforcing tube, which is provided with an axial groove along the axial direction. The catheter is provided with at least two wire-passing cavities, and at least two of the wire-passing cavities are used to set the first adjustment wire and the second adjustment wire. The wire outlet of the wire-passing cavity corresponds to the position of the axial groove, so that the wire outlet of the wire-passing cavity is connected to the axial groove.

[0019] In the above-mentioned interventional medical device, the catheter includes a reducing section, a spring section and a braided section in sequence along the axial direction. The reducing section is connected to the distal end of the spring section, and the braided section is connected to the proximal end of the spring section. The adjustment assembly includes an adjustment key, a first adjustment wire and a second adjustment wire; the first adjustment wire and the second adjustment wire are both fixedly connected to the adjustment key, and are used to apply tension to the reducing section toward the proximal end under the drive of the adjustment key to squeeze the reducing section, thereby increasing the diameter of the distal end of the catheter, facilitating the smooth entry of the retrograde guidewire into the catheter during clinical operation, thereby reducing the radiation exposure time of the operator and the patient, thereby improving the success rate and efficiency of the operation, reducing the patient's surgical complications, and shortening the postoperative recovery time. BRIEF DESCRIPTION OF THE DRAWINGS

[0020] Figure 1 This is a schematic structural diagram of an interventional medical device according to one embodiment.

[0021] Figure 2 This is a schematic structural diagram of an interventional medical device from another perspective according to one embodiment.

[0022] Figure 3 Schematic diagram of the structure of a catheter assembly in an interventional medical device according to one embodiment.

[0023] Figure 4 for Figure 3 A schematic bottom view of a catheter assembly in an interventional medical device is shown.

[0024] Figure 5 This is a schematic cross-sectional structure diagram of a catheter in a catheter assembly of an interventional medical device according to one embodiment.

[0025] Figure 6 This is a schematic structural diagram of a catheter assembly of an interventional medical device according to one embodiment, when the diameter of a reducing section of the catheter increases.

[0026] Figure 7 This is a structural schematic diagram of an interventional medical device according to one embodiment when the second cover is removed.

[0027] Figure 8 for Figure 7 Enlarged view of the local structure in the middle circle.

[0028] Figure 9 This is a schematic diagram of the local structure of the corresponding adjustment component in an interventional medical device according to one embodiment.

[0029] Figure 10 for Figure 9 A schematic diagram of the partial structure of the corresponding adjustment component of an interventional medical device when the adjustment key is removed is shown in one embodiment.

[0030] Figure 11 1 is a schematic diagram of a local structure corresponding to a resetting component in an interventional medical device according to one embodiment.

[0031] Figure 12 1 is a schematic diagram of the local structure of the interventional medical device corresponding to the positions of the adjustment component and the reset component in one embodiment.

[0032] Figure 13 for Figure 12 A schematic diagram of the local structure of the corresponding adjustment component of an interventional medical device when the reset button is removed is shown.

[0033] Figure 14 This is a partial structural diagram of an interventional medical device with the first cover and the second cover removed according to one embodiment.

[0034] Figure 15 for Figure 14 A bottom view schematically shows a partial structure of an interventional medical device.

[0035] Figure 16 FIG1 is a schematic diagram of the arrangement structure of the first bending adjustment wire and the second bending adjustment wire in a catheter in an interventional medical device according to one embodiment.

[0036] Figure 17 This is a schematic axial cross-sectional view of a catheter of a catheter assembly in an interventional medical device according to one embodiment.

[0037] Figure 18 This is a schematic structural diagram of an interventional medical device during bending adjustment according to one embodiment.

[0038] Figure 19An interventional medical device according to an embodiment of the present invention corresponds to Figure 18 Schematic diagram of catheter bending in the bending adjustment state.

[0039] Reference numerals:

[0040] 10. Handle housing; 101. Snap-fit groove; 102. First guide groove; 103. Second guide groove; 11. First cover; 12. Second cover; 13. First end cap; 14. Second end cap; 20. Catheter assembly; 21. Catheter; 211. Variable diameter section; 212. Spring section; 213. Braiding section; 21a. Central lumen; 21b. Wire lumen; 22. Reinforcement tube; 221. First axial groove; 222. Second axial groove; 23. Tube connector ;30. Adjustment assembly;31. Adjustment key;311. Limit buckle;3111. Hook;32. Elastic member;33. First adjustment wire;34. Second adjustment wire;40. Bending adjustment assembly;41. First bending adjustment key;42. First reset member;43. First bending adjustment wire;44. Second bending adjustment key;45. Second reset member;46. Second bending adjustment wire;47. Mounting seat;50. Reset assembly;51. Reset key;511. Supporting inclined surface;52. Reset spring. DETAILED DESCRIPTION

[0041] To make the above-mentioned objects, features, and advantages of the present application more clearly understood, the specific embodiments of the present application are described in detail below with reference to the accompanying drawings. The following description sets forth many specific details to facilitate a full understanding of the present application. However, the present application can be implemented in many other ways than those described herein, and those skilled in the art can make similar improvements without violating the scope of the present application. Therefore, the present application is not limited to the specific embodiments disclosed below.

[0042] It should be noted that when an element is referred to as being "fixed to" or "disposed on" another element, it may be directly on the other element or there may be an intermediate element. When an element is considered to be "connected to" another element, it may be directly connected to the other element or there may be an intermediate element.

[0043] It should be noted that the terms "distal" and "proximal" are commonly used in the field of interventional medical devices. "Distal" refers to the end away from the operator (e.g., physician) during surgery, while "proximal" refers to the end closer to the operator. Axial refers to the direction along which the central axis of the medical device extends, while radial refers to the direction perpendicular to the axial direction.

[0044] Combine Figure 1 and Figure 2 As shown, an embodiment of the present application provides an interventional medical device, which includes a handle housing 10 , a catheter assembly 20 , an adjustment assembly 30 and a bending adjustment assembly 40 .

[0045] The handle housing 10 includes a first cover 11 and a second cover 12. The first cover 11 and the second cover 12 are connected to form a space for mounting other components, such as the adjustment assembly 30 and the bending adjustment assembly 40. The connection between the first cover 11 and the second cover 12 includes, but is not limited to, a snap-fit connection, glue, or screws.

[0046] The handle housing 10 also includes two end caps, namely a first end cap 13 and a second end cap 1414. The first end cap 13 is connected to the distal end of the first cover 11 and the distal end of the second cover 12, thereby reducing the risk of cracking at the corresponding distal ends of the first cover 11 and the second end cap 14. The second end cap 14 is connected to the proximal end of the first cover 11 and the proximal end of the second cover 12, thereby reducing the risk of cracking at the corresponding proximal ends of the first cover 11 and the second end cap 14.

[0047] In some embodiments, the first cover body 11 and the second cover body 12 are snap-fitted together, the first end cover 13 is embedded in the distal ends of the first cover body 11 and the second cover body 12, and the second end cover 1414 is embedded in the proximal ends of the first cover body 11 and the second cover body 12, so that the first cover body 11 and the second cover body 12 limit the axial movement of the first end cover 13 and the second end cover 1414.

[0048] The first end cap 13 and the second end cap 14 each have two radial protrusions in the circumferential direction, and radial grooves are provided at corresponding positions on the first cover body 11 and the second cover body 12. The radial protrusions cooperate with the radial grooves to restrict the circumferential movement of the first end cap 13 and the second end cap 14, thereby fixing the first end cap 13 and the second end cap 14. It should be noted that the number of radial protrusions is not limited to two. For example, the number of radial protrusions can be three or more. The number of radial protrusions and the number of radial grooves cooperating therewith are not limited herein.

[0049] It should be noted here that the arrangement of the first end cover 13 and the second end cover 14 can provide a basis for the installation of other structural members to stably support other structural members. This part will be introduced in an appropriate position later and is not limited here.

[0050] Combine Figure 3 and Figure 4 As shown, the catheter assembly 20 includes a catheter 21, a reinforcement tube 22 and a tube connector 23. The proximal end of the catheter 21 is connected to the handle housing 10 through the tube connector 23, and the distal end of the catheter 21 extends out of the handle housing 10.

[0051] The proximal end of the catheter 21 is connected to the distal end of the tube connector 23 , and the two can be fixedly connected by, but not limited to, injection molding or glue.

[0052] Combine Figure 5and Figure 6 As shown, in some embodiments, the catheter 21 includes a diameter-reducing section 211 , a spring section 212 , and a braided section 213 in sequence along the axial direction.

[0053] The diameter-reducing section 211 is connected to the distal end of the spring section 212, and the braided section 213 is connected to the proximal end of the spring section 212. When the diameter-reducing section 211 is subjected to axial extrusion force, its diameter increases, and when the axial extrusion force decreases, its diameter decreases, thereby changing the diameter of the distal end of the catheter 21. When the spring section 212 is subjected to axial tension, it generates directional bending, thereby achieving the purpose of directional bending adjustment. In this way, the distal end of the catheter 21 can not only adjust the angle, but also adjust the diameter of the catheter 21 according to actual clinical needs, thereby facilitating the smooth entry of the retrograde guidewire into the catheter 21 during clinical operations, thereby reducing the radiation exposure time of the surgeon and the patient, thereby improving the success rate and efficiency of the operation, reducing the patient's surgical complications, and shortening the postoperative recovery time.

[0054] Combine Figure 7 As shown, the reinforcing tube 22 is provided in the handle housing 10 , and the reinforcing tube 22 is sleeved outside the conduit 21 , thereby reinforcing the conduit 21 and preventing the portion of the conduit 21 located in the handle housing 10 from bending.

[0055] The proximal end of the reinforcing tube 22 is sleeved on the distal end of the tube connector 23. The reinforcing tube 22 and the tube connector 23 can be fixedly connected by, but not limited to, glue or a heat shrink tube.

[0056] The distal end of the reinforcement tube 22 is connected to the first end cover 13 , so that the first end cover 13 limits the axial movement and circumferential rotation of the reinforcement tube 22 .

[0057] The distal end of the reinforcing tube 22 is plugged into and matched with the first end cover 13. For example, the proximal end of the first end cover 13 is provided with an insertion hole, and the distal end of the reinforcing tube 22 is inserted into the insertion hole.

[0058] The tube connector 23 can be snap-fitted to the first cover 11 and the second cover 12. For example, the tube connector 23 includes at least two latching protrusions, and the first cover 11 and the second cover 12 are provided with latching grooves corresponding to the latching protrusions. The latching protrusions cooperate with the corresponding latching grooves to secure the tube connector 23 using the first cover 11 and the second cover 12. In this way, the proximal end of the entire catheter assembly 20 is fixed relative to the handle housing 10.

[0059] Combine Figures 5 to 8 As shown, the adjustment assembly 30 includes an adjustment key 31 , an elastic member 32 , a first adjustment wire 33 and a second adjustment wire 34 .

[0060] The first adjustment wire 33 and the second adjustment wire 34 are both fixedly connected to the adjustment key 31, and are used to apply tension to the variable diameter section 211 toward the proximal end under the drive of the adjustment key 31 to squeeze the variable diameter section 211, thereby shortening the variable diameter section 211 and increasing its diameter, that is, the diameter of the distal end of the catheter 21 increases, thereby facilitating the smooth entry of the retrograde guide wire into the catheter 21 during clinical operation, so as to reduce the radiation exposure time of the surgeon and the patient, thereby improving the success rate and efficiency of the operation, reducing the patient's surgical complications, and shortening the postoperative recovery time.

[0061] In some embodiments, the adjustment key 31 is sleeved on the reinforcing tube 22, and the adjustment key 31 can slide along the axial direction of the reinforcing tube 22. The adjustment key 31 is provided with a limiting protrusion, and the limiting protrusion corresponds to the limiting groove on the first cover body 11 and the second cover body 12 to further limit the rotation of the adjustment key 31. It should be noted that the adjustment key 31 can slide along the limiting groove when moving axially. The number of limiting protrusions can be 1, or 2 or more, and the number of limiting grooves is the same as the number of limiting protrusions to facilitate one-to-one matching. There is no limitation on the number of limiting protrusions and limiting grooves. For example, in some embodiments, the adjustment key 31 is provided with 4 limiting protrusions, and the 4 limiting protrusions are evenly distributed along the circumference of the adjustment key 31 to improve the movement stability of the adjustment key 31.

[0062] The first cover body 11 and the second cover body 12 are provided with mounting grooves, and the adjustment key 31 is mounted in the mounting grooves. The mounting grooves guide the adjustment key 31 to slide axially, so that the adjustment key 31 slides within a limited stroke.

[0063] Combine Figure 7 and Figure 8 As shown, the elastic member 32 is sleeved on the reinforcing tube 22, and the distal end of the elastic member 32 abuts against the proximal end of the adjustment key 31, and the proximal end of the elastic member 32 is limited within the handle housing 10. For example, the proximal end of the elastic member 32 abuts against the limiting plates on the inner walls of the first cover 11 and the second cover 12.

[0064] It should be noted that when the adjustment key 31 moves axially toward the proximal end, the first adjustment wire 33 and the second adjustment wire 34 exert a pulling force on the diameter-changing section 211, thereby increasing the diameter of the diameter-changing section 211. Since the two ends of the elastic member 32 respectively abut against the adjustment key 31 and the limit plate, when the pushing force on the adjustment key 31 is released, the adjustment key 31 moves axially toward the distal end under the elastic force of the elastic member 32. In this way, the first adjustment wire 33 and the second adjustment wire 34 gradually release the pulling force on the diameter-changing section 211, and then the pulling force on the diameter-changing section 211 is reduced, thereby reducing the axial extrusion force, and the diameter-changing section 211 is stretched and the diameter is reduced.

[0065] In this embodiment, the elastic member 32 includes but is not limited to a spring.

[0066] Combine Figure 9 and Figure 10 As shown, a limit buckle 311 is provided around the adjustment key 31, and a snap-fit groove 101 is provided in the handle housing 10. It should be noted that the snap-fit groove 101 can be formed on the inner walls of the first cover 11 and the second cover 12, or can be formed by a rib connected to the inner wall of the handle housing 10. The structural form of the snap-fit groove 101 is not limited here.

[0067] In some embodiments, the adjustment key 31 is provided with two limit buckles 311, corresponding to the two engaging grooves 101 provided in the handle housing 10. The two limit buckles 311 can be axially symmetrically arranged about the adjustment key 31, thereby facilitating the stability of the adjustment key 31 when it is locked in position.

[0068] In the above embodiment, the adjustment key 31 can be positioned on the handle housing 10 by disposing the limiting buckle 311 and the engaging groove 101 , thereby maintaining the adjusted diameter of the catheter 21 . For example, during the process of the adjustment key 31 moving toward the proximal end, the adjustment key 31 squeezes the elastic member 32 and applies tension to the variable diameter section 211 through the first adjustment wire 33 and the second adjustment wire 34, so that the diameter of the variable diameter section 211 increases. As the adjustment key 31 continues to move toward the proximal end, the adjustment key 31 moves to make the limit buckle 311 correspond to the position of the snap-in groove 101, the hook 3111 of the limit buckle 311 cooperates with the snap-in groove 101 to limit the adjustment key 31 from moving toward the distal end. At this time, even if the thrust acting on the adjustment key 31 is released, the elastic member 32 cannot drive the adjustment key 31 to reset toward the distal end, and then the first adjustment wire 33 and the second adjustment wire 34 continue to apply tension to the variable diameter section 211 to keep the diameter of the adjusted variable diameter section 211 unchanged, which is conducive to the subsequent insertion of the retrograde guide wire from the variable diameter section 211 into the catheter 21. Due to this structural setting, the operator does not need to continuously apply proximal thrust to the adjustment key 31 to maintain the adjusted diameter of the variable diameter section 211, which makes the operation flexible and avoids improper release of the adjustment key 31, which may cause the retrograde guide wire to be unable to smoothly penetrate the catheter 21, thereby improving the safety of the operation.

[0069] It should be noted here that there can be one snap-in groove 101, and the setting position of the snap-in groove 101 can correspond to the movement of the adjustment key 31 toward the proximal end to the extreme position. In other words, when the adjustment key 31 moves toward the proximal end to the extreme position, the hook 3111 of the limit buckle 311 cooperates with the snap-in groove 101. It can be understood that since the adjustment key 31 is in the proximal extreme position, the diameter-reducing section 211 is adjusted to the maximum diameter at this time. Therefore, under this structural setting, the cooperation between the limit buckle 311 and the snap-in groove 101 can lock the diameter-reducing section 211 at the maximum diameter, thereby facilitating the retrograde guidewire from being able to smoothly penetrate the catheter 21.

[0070] In some embodiments, the snap-fitting slot 101 may be located at other positions to lock the reducing section 211 at different diameters to accommodate surgical needs. Alternatively, the handle housing 10 may include snap-fitting slots 101 at correspondingly different axial positions. When the stop buckle 311 engages with the snap-fitting slots 101 at different axial positions, the reducing section 211 may be locked at different diameters, thereby accommodating the insertion of retrograde guidewires of varying sizes.

[0071] Further, combined with Figure 11 As shown, in an embodiment in which a limit buckle 311 is provided on the circumferential side of the adjustment key 31 and a snap-in groove 101 is provided in the handle housing 10. The interventional medical device further comprises a reset assembly 50, which comprises a reset key 51 and a reset spring 52. The reset key 51 is connected to the handle housing 10 and can be pressed and moved radially relative to the handle housing 10. In some embodiments, the first cover 11 and the second cover 12 are slotted at the position corresponding to the reset key 51 to limit the movement of the reset key 51 in directions other than the radial direction, that is, the reset key 51 can only move radially at the position corresponding to the slot.

[0072] Combine Figure 11 and Figure 12 As shown, a supporting inclined surface 511 is provided on one side of the reset button 51 near the limit buckle 311. In this embodiment, when the hook 3111 of the limit buckle 311 engages with the engaging groove 101, pressing the reset button 51 causes the supporting inclined surface 511 on the reset button 51 to squeeze the hook 3111. This releases the hook 3111 from the engaging groove 101, thereby allowing the adjustment key 31 to regain axial freedom of movement, allowing it to move toward the distal end under the drive of the elastic member 32. This allows the diameter-reducing section 211 to recover its deformation and reduce its diameter.

[0073] After the reset button 51 is pressed and released, the reset button 51 can rebound and reset under the action of the reset spring 52.

[0074] Combine Figures 13 to 16 As shown, the bending adjustment assembly 40 includes a first bending adjustment key 41 , a first resetting member 42 , a first bending adjustment wire 43 , a second bending adjustment key 44 , a second resetting member 45 , a second bending adjustment wire 46 and a mounting seat 47 .

[0075] The proximal ends of the first bending wire 43 and the proximal ends of the second bending wire 46 are connected to the first bending key 41 and the second bending key 44, respectively. The distal ends of the first bending wire 43 and the distal ends of the second bending wire 46 are both connected to the distal end of the spring segment 212. Connection methods between the various structural components include, but are not limited to, welding, clamping, or gluing.

[0076] The first bending key 41 and the second bending key 44 can both independently move axially within the handle housing 10 .

[0077] The first and second bending keys 41, 44 are fastened to the reinforcement tube 22, and portions of the structures are exposed from the handle housing 10. By pushing the portions of the first and second bending keys 41, 44 exposed from the handle housing 10, the first and second bending keys 41, 44 can slide axially along the reinforcement tube 22. Thus, when the first bending key 41 moves axially toward the proximal end, it pulls the catheter 21 via the first bending wire 43, causing the catheter 21 to bend toward the side where the first bending wire 43 is located. Correspondingly, when the second bending key 44 moves axially toward the proximal end, it pulls the catheter 21 via the second bending wire 46, causing the catheter 21 to bend toward the side where the second bending wire 46 is located.

[0078] See again Figure 1 and Figure 2 As shown, the handle housing 10 is provided with a first guide groove 102 and a second guide groove 103. In an embodiment where the handle housing 10 includes a first cover 11 and a second cover 12, the first guide groove 102 and the second guide groove 103 are formed in the first cover 11 and the second cover 12 at positions corresponding to the first bending key 41 and the second bending key 44. Part of the structure of the first bending key 41 extends from the first guide groove 102, and part of the structure of the second bending key 44 extends from the second guide groove 103.

[0079] When the first bending key 41 moves axially, the structure of the first bending key 41 located within the first guide slot 102 slides along the first guide slot 102. The first guide slot 102 is used to limit axial rotation of the first bending key 41, thereby improving the movement stability of the first bending key 41. Furthermore, since the first bending key 41 slides along the first guide slot 102, the extension length of the first guide slot 102 along the handle housing 10 corresponds to the travel of the first bending key 41, thereby fixing the travel of the first bending key 41.

[0080] Accordingly, when the second bending key 44 moves axially, the structure of the second bending key 44 located within the second guide slot 103 will slide along the second guide slot 103. The second guide slot 103 is used to limit the axial rotation of the second bending key 44, thereby improving the movement stability of the second bending key 44. Furthermore, because the second bending key 44 slides along the second guide slot 103, the extension length of the second guide slot 103 along the handle housing 10 corresponds to the movement stroke of the second bending key 44, thereby fixing the movement stroke of the second bending key 44.

[0081] In some embodiments, the first and second covers 11 and 12 are provided with a plurality of scale lines at positions corresponding to the first and second guide slots 102 and 103. As the first and second bending keys 41 and 44 move within the corresponding first and second guide slots 102 and 103, they correspond to scale lines at different positions, thereby conveniently displaying the deflection angle of the distal end of the catheter 21 at that time. This arrangement allows the operator to conveniently observe the adjusted angle of the catheter 21 outside the body without fluoroscopy, thereby improving operational flexibility.

[0082] It should be noted that the scale lines represent various scale values between 0° and 180° as needed. For example, assuming the distal end of the catheter 21 is not pulled and remains straight, which is the initial state, the deflection angle in the initial state is zero. From 0° to 180°, corresponding scale values are marked every 10°. That is, the marked scale values are 0°, 10°, 20°, 30°, 40°, 50°, 60°, 70°, 80°, 90°, 100°, 110°, 120°, 130°, 140°, 150°, 160°, 170°, and 180°. In other embodiments, corresponding scale values may be marked every 5°. The scale value marking method is not limited herein, as long as the corresponding scale lines can intuitively display the deflection angle of the distal end of the catheter 21 at that time.

[0083] Combine Figure 14 and Figure 15 As shown, one end of the first return member 42 abuts against the first bending adjustment key 41, while the other end is confined within the handle housing 10. The first return member 42 is used to drive the first bending adjustment key 41 toward its distal return movement. One end of the second return member 45 abuts against the second bending adjustment key 44, while the other end is confined within the handle housing 10. The second return member 45 is used to drive the second bending adjustment key 44 toward its distal return movement.

[0084] In some embodiments, the mounting seat 47 is provided with two columns, the first bending key 41 and the second bending key 44 are both provided with columns, and the columns on the first bending key 41 and the second bending key 44 correspond axially to the two columns on the mounting seat 47 respectively.

[0085] The proximal ends of the first and second return members 42 and 45 respectively mate with the two columns on the mounting base 47. The distal end of the first return member 42 mates with the column on the first bending key 41. The distal end of the second return member 45 mates with the column on the second bending key 44. In this way, the columns at both ends of the first return member 42 are used to position the first return member 42, improving the installation stability of the first return member 42. Correspondingly, the columns at both ends of the second return member 45 are used to position the second return member 45, improving the installation stability of the second return member 45.

[0086] The mounting base 47 is fixed in position within the inner cavity enclosed by the first and second covers 11, 12. That is, the mounting base 47 does not move after being installed in the handle housing 10. For example, in some embodiments, the mounting base 47 is snap-fitted to the first and second covers 11, 12. Proximal protrusions are provided on the inner walls of the first and second covers 11, 12 at locations corresponding to the mounting base 47. When the first and second covers 11, 12 are mated, their respective proximal protrusions snap onto the mounting base 47, securing the mounting base 47.

[0087] It should be noted that the mounting base 47 can also be connected to the first cover 11 and the second cover 12 by glue or screws. There is no limitation on the mounting method of the mounting base 47. As long as the mounting base 47 can be stably mounted on the first cover 11 and the second cover 12 to provide support for the first reset member 42 and the second reset member 45, it can improve the installation stability of the first reset member 42 and the second reset member 45.

[0088] The first reset member 42 and the second reset member 45 can be, but are not limited to, springs or elastic rods, as long as the first reset member 42 can drive the first bending key 41 to reset toward the distal end, and the second reset member 45 can drive the second bending key 44 to reset toward the distal end.

[0089] In some embodiments, the distal end of the first bending key 41 is provided with a first fixing slot, and the proximal end of the first bending wire 43 can be fixed to the first fixing slot. Fixing methods include, but are not limited to, welding and clamping. For example, the proximal end of the first bending wire 43 is snapped into the first fixing slot and secured with glue or a jackscrew.

[0090] Correspondingly, the distal end of the second bending key 44 is provided with a second fixing slot for fixing the second bending wire 46. The fixing method of the second bending wire 46 can refer to the fixing method of the first bending wire 43, and will not be described in detail here.

[0091] Combine Figure 17 As shown, the catheter 21 is a multi-lumen tube. For example, the catheter 21 includes a central lumen 21a and four over-the-wire lumens 21b located around the central lumen 21a.

[0092] The distal ends of the first adjustment wire 33, the second adjustment wire 34, the first bending adjustment wire 43, and the second bending adjustment wire 46 respectively pass through the four thread-passing lumens 21b, and their proximal ends exit through the thread outlets of each thread-passing lumens 21b to connect to corresponding control keys. Specifically, the proximal ends of the first adjustment wire 33 and the proximal ends of the second adjustment wire 34 pass through the corresponding thread outlets to connect to the adjustment key 31; the proximal ends of the first bending adjustment wire 43 and the proximal ends of the second bending adjustment wire 46 respectively pass through the corresponding thread outlets to connect to the first bending adjustment key 41 and the second bending adjustment key 44.

[0093] The conduit 21 may be a multi-layer composite pipe. In some embodiments, at least a portion of the conduit 21 comprises two layers, or at least a portion of the conduit 21 comprises three layers. The number of layers of each conduit 21 segment is not limited herein.

[0094] For ease of description, the three-layer structure of the catheter 21 is described as an inner layer, a middle layer, and an outer layer. The inner layer is made of a polymer material, such as PTFE.

[0095] In the embodiment where the catheter 21 includes a central lumen 21a and four wire-passing lumens 21b located on the periphery of the central lumen 21a, the central lumen 21a and the four wire-passing lumens 21b located on the periphery of the central lumen 21a are both provided in the inner layer. The middle layer may be a stainless steel flat wire braided layer, and the outer layer may be a single-layer extruded tube.

[0096] In some embodiments, the diameter-reducing section 211 includes an intermediate layer and an outer layer. The intermediate layer of the diameter-reducing section 211 may be woven from nickel-titanium alloy round wires, and the wire diameter may be 0.15 mm to 0.2 mm, for example, 0.15 mm, 0.17 mm, or 0.2 mm.

[0097] Because the diameter of the reducing section 211 increases after being compressed by axial extrusion, the intermediate layer of the reducing section 211 is braided at different angles, and the diameter change of the intermediate layer during compression also varies. For example, in some embodiments, the braiding angle of the intermediate layer in the distal reducing section 211 is 30°-45°, corresponding to a diameter change of 2-3 times. The braiding angle of the intermediate layer can be 30°, 32°, 35°, 40°, or 45°, without limitation.

[0098] It should be noted that the outer layer may be made of an elastic material with good elasticity, such as polyurethane, so as to be easily stretched or compressed along with the middle layer.

[0099] In some embodiments, the length of the catheter 21 is 75 cm to 125 cm, for example, 75 cm, 80 cm, 85 cm, 95 cm, 100 cm, 115 cm, or 125 cm.

[0100] There are many possible implementations for the structures of the spring section 212 and the braided section 213. The structures of the spring section 212 and the braided section 213 are described below by way of example only and are not intended to be limiting.

[0101] For example, in some embodiments, the inner layer of the coiled spring section 212 can be a five-lumen PTFE tube (i.e., a central lumen 21a and four peripheral filament lumens 21b). The middle layer of the coiled spring section 212 can be a spring structure. The outer layer of the coiled spring section 212 can be made of a material such as nylon or Pebax.

[0102] In some embodiments, the inner layer of the braided segment 213 may be a 5-lumen PTFE tube, the middle layer of the braided segment 213 may be a stainless steel flat wire braided structure, and the outer layer of the braided segment 213 may be made of nylon or Pebax.

[0103] In some embodiments, the reinforcement tube 22 is provided with two pairs of axial grooves along the axial direction, and the positions of the two axial grooves are the same and are symmetrical along the axial direction.

[0104] At the proximal end of the corresponding catheter 21, the wire outlets of the four wire-passing cavities 21b correspond to the positions of the four axial grooves of the reinforcing tube 22. In this way, the wire outlets of the wire-passing cavities 21b are connected to the axial grooves of the reinforcing tube 22, thereby facilitating the guidance of the adjusting wires (i.e., the first adjusting wire 33 and the second adjusting wire 34) and the bending adjusting wires (i.e., the first bending adjusting wire 43 and the second bending adjusting wire 46) out of the catheter 21.

[0105] Combine Figure 3 and Figure 4 As shown, for ease of understanding, the two pairs of axial grooves in the reinforcement tube 22 are referred to as "first axial grooves 221" and "second axial grooves 222," that is, there are two first axial grooves 221 arranged in a pair. Correspondingly, there are two second axial grooves 222 arranged in a pair.

[0106] In some embodiments, the proximal ends of the first adjustment wire 33 and the second adjustment wire 34 respectively pass through the two first axial slots 221 and are connected to the adjustment key 31. The proximal end of the first bending adjustment wire 43 passes through one of the second axial slots 222 and is connected to the first bending adjustment key 41, and the proximal end of the second bending adjustment wire 46 passes through the other second axial slot 222 and is connected to the second bending adjustment key 44.

[0107] For ease of understanding, the following describes the operating principle of an interventional medical device in conjunction with an embodiment, but this does not mean that the operating process of the interventional medical device of the present application is limited thereto.

[0108] Combine Figure 18 and Figure 19 As shown, when bending the catheter 21, for example, toward the side where the second bending wire 46 is located, the second bending key 44 is pushed proximally relative to the handle housing 10. This causes the second bending key 44 to squeeze the second return member 45, causing it to be compressed. Simultaneously, the proximal movement of the second bending key 44 bends the distal end of the catheter 21 via the second bending wire 46. If the finger is released at this point, the right return button 51 returns to its original position due to the elastic force of the second return member 45. Adjusting the catheter 21 to the left requires the same operation as for the right side.

[0109] In some embodiments, when the diameter of the catheter 21 needs to be adjusted, the adjustment key 31 is moved proximally. This compresses the return spring 52, pulling the first and second adjustment wires 33, 34 toward the proximal end of the handle. This compresses the reducing section 211 of the distal catheter 21, increasing its diameter. When the adjustment key 31 is fully pulled to its proximal limit, until the stop buckle 311 on the adjustment key 31 engages the engaging groove 101 within the handle housing 10, the distal end of the catheter 21 reaches its maximum diameter, forming a bell-shaped opening. This allows for real-time adjustment of the opening diameter based on the patient's blood vessel diameter during surgery.

[0110] To reset the diameter, press the reset button 51, causing the inclined surface 511 to enter the engaging slot 101 and squeeze the stopper 311 of the adjustment button 31, thereby deforming the stopper 311. Once the hook 3111 of the stopper 311 is completely squeezed out of the engaging slot 101, the elastic force of the elastic member 32 forces the adjustment button 31 back to its initial position, releasing the tension at the distal end of the catheter 21 and restoring the diameter. When the pressure on the reset button 51 is released, the reset spring 52 returns the reset button 51 to its initial position.

[0111] In some embodiments, the distal diameter reduction of the catheter 21 is mainly used to deal with complex long-segment CTO occlusive lesions, which are difficult to open in the forward direction. When a reverse guidewire is required, the reverse guidewire can be quickly pushed into the lumen of the catheter 21. A 6F catheter 21 with an inner diameter of about 1.8 mm is used in lower limb surgery. It is difficult for a normal reverse guidewire to be pushed into the lumen of the catheter 21. At this time, the diameter reduction function can be used to expand the diameter of the catheter 21 to 2 to 3 times the original catheter 21 to facilitate rapid docking.

[0112] The technical features of the above embodiments can be combined arbitrarily. To make the description concise, not all possible combinations of the technical features in the above embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0113] The above embodiments merely illustrate several implementation methods of the present application, and while their descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the present invention. It should be noted that a person skilled in the art would be able to make various modifications and improvements without departing from the inventive concept of the present application, all of which fall within the scope of protection of the present application. Therefore, the scope of protection of the present invention shall be determined by the appended claims.

Claims

1. An interventional medical device, characterized in that: include: handle housing; A catheter assembly comprising a catheter and a tube connector, wherein the proximal end of the catheter is connected to the handle housing via the tube connector, and the distal end of the catheter extends outside the handle housing; the catheter axially comprises a reducing section, a spring section, and a braided section, wherein the reducing section is connected to the distal end of the spring section, and the braided section is connected to the proximal end of the spring section; An adjustment component includes an adjustment key, a first adjustment wire and a second adjustment wire; the first adjustment wire and the second adjustment wire are both fixedly connected to the adjustment key, and are used to apply a pulling force toward the proximal end of the variable diameter section under the drive of the adjustment key to squeeze the variable diameter section.

2. The interventional medical device according to claim 1, characterized in that: The catheter assembly further includes a reinforcement tube, which is arranged in the handle housing and sleeved outside the catheter.

3. The interventional medical device according to claim 2, characterized in that: The adjusting key is sleeved on the reinforcing tube, and the adjusting key can slide along the axial direction of the reinforcing tube.

4. The interventional medical device according to claim 2 or 3, characterized in that: The adjustment component further includes an elastic member, which is sleeved on the reinforcement tube. The distal end of the elastic member abuts against the proximal end of the adjustment key, and the proximal end of the elastic member is confined within the handle housing.

5. The interventional medical device according to claim 4, characterized in that: A limit buckle is provided on the peripheral side of the adjustment key, and a snap-in slot is provided in the handle shell. When the adjustment key moves toward the proximal end so that the limit buckle corresponds to the position of the snap-in slot, the hook of the limit buckle cooperates with the snap-in slot to limit the adjustment key from moving toward the distal end.

6. The interventional medical device according to claim 5, characterized in that: The adjustment key is provided with two limit buckles, and two corresponding clamping grooves are provided in the handle housing. The two limit buckles are symmetrically arranged about the axis of the adjustment key.

7. The interventional medical device according to claim 5, characterized in that: The interventional medical device also includes a reset component, which includes a reset button and a reset spring. The reset button is connected to the handle housing and can be pressed and moved radially relative to the handle housing. A supporting slope is provided on the side of the reset button close to the limit buckle. When the hook of the limit buckle is matched with the snap-fitting groove, pressing the reset button can cause the supporting slope to squeeze the hook, so that the hook is released from the snap-fitting groove.

8. The interventional medical device according to claim 1, characterized in that: The interventional medical device also includes a bending adjustment assembly, which includes a first bending adjustment key, a first resetting member, a first bending wire, a second bending key, a second resetting member and a second bending wire, the proximal end of the first bending wire and the proximal end of the second bending wire are respectively connected to the first bending key and the second bending key, the distal end of the first bending wire and the distal end of the second bending wire are both connected to the distal end of the spring segment, the first bending key and the second bending key are both capable of independently moving axially within the handle housing, one end of the first resetting member is against the first bending key, and the other end is limited to be located within the handle housing, the first resetting member is used to drive the first bending key to reset toward the distal end, one end of the second resetting member is against the second bending key, and the other end is limited to be located within the handle housing, and the second resetting member is used to drive the second bending key to reset toward the distal end.

9. The interventional medical device according to claim 8, characterized in that: The catheter assembly includes a reinforcing tube, the first bending key and the second bending key are buckled on the reinforcing tube, and part of the structure is exposed from the handle shell. By pushing the parts of the first bending key and the second bending key exposed from the handle shell, the first bending key and the second bending key can slide along the axial direction of the reinforcing tube.

10. The interventional medical device according to claim 1, characterized in that: The variable diameter section includes a middle layer and an outer layer, wherein the middle layer of the variable diameter section is woven from nickel-titanium alloy round wires, the braiding angle of the middle layer of the variable diameter section is 30°-45°, and the outer layer of the variable diameter section is made of elastic material.

11. The interventional medical device according to claim 1, characterized in that: The catheter assembly includes a reinforcing tube, which is provided with an axial groove along the axial direction. The catheter is provided with at least two wire-passing cavities, and at least two of the wire-passing cavities are used to set the first adjusting wire and the second adjusting wire. The wire outlet of the wire-passing cavity corresponds to the position of the axial groove, so that the wire outlet of the wire-passing cavity is correspondingly connected to the axial groove.

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