Leading-in assembly and medical device

By incorporating the inlet sheath and push rod design within the inlet component, and using an anchoring device to fix the urethral stent in a preset position, the problem of urethral stent displacement during the push process is solved, thereby improving the success rate of the surgery and the quality of patient recovery.

CN223682677UActive Publication Date: 2025-12-19COPPER MEDICAL TECH CO LTD
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Patent Information

Application Number
CN202422956913.2
Authority / Receiving Office
CN · China
Patent Type
Utility models(China)
Current Assignee / Owner
Filing Date
2024-12-02
Publication Date
2025-12-19
Estimated Expiration
2034-12-02

AI Technical Summary

Technical Problem

In existing technologies, urethral stents are prone to positional deviation during the delivery process, which can prevent the urethral stent from accurately reaching the preset position, affecting the treatment effect and the quality of patient recovery.

Method used

An induction component was designed, including an induction sheath, a push rod, and a bracket. The bracket body and anchoring device are installed in the induction channel. The bracket is fixed in a preset position by the anchoring device. Combined with the induction sheath, it provides a stable pushing path to ensure the accuracy and stability of the bracket.

Benefits of technology

This effectively solves the problem of urethral stent displacement during the delivery process, improves the success rate and efficiency of the surgery, reduces the risk of complications, ensures the stable fixation of the stent in the ureter, and guarantees the continuity and reliability of the treatment effect.

✦ Generated by Eureka AI based on patent content.

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Abstract

The utility model relates to the technical field of medical instruments, in particular to a leading-in assembly and a medical device. The leading-in assembly comprises a leading-in sheath tube, a pushing rod and a support, a leading-in channel is formed in the leading-in sheath tube, and the leading-in channel penetrates through the leading-in sheath tube in the first direction; the support comprises a support body and an anchoring device which are connected. The pushing rod, the anchoring device and the support body are all installed in the guide-in channel, at least one of the support body and the anchoring device is connected to the pushing rod, the pushing rod can push the anchoring device and the support body to a preset position in the first direction, and the anchoring device can fix the support body to the preset position. According to the utility model, the bracket can be prevented from easily deviating in the pushing process, and meanwhile, the bracket can be kept stable in the ureter.
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Description

TECHNICAL FIELD

[0001] The utility model belongs to the technical field of medical apparatus and instruments, especially relates to a lead-in assembly and medical device. BACKGROUND

[0002] Prostatic hyperplasia is high in middle-aged and old men, is easy to lead to ureteral stricture and urinary retention, seriously affects the life quality of patient. At present, urethral stent implantation is the main means for treating the disease, and its core lies in expanding ureter through urethral stent and restoring urine drainage.

[0003] In prior art, the urethral stent is pushed to the narrow part of ureter by the way of guide wire pushing. However, the urethral guide wire is relatively thin, and its direct control ability on the urethral stent is weak, so the urethral stent is prone to position deviation in the process of pushing. UTILITY MODEL CONTENT

[0004] The utility model solves the technical problem that the urethral stent is prone to position deviation in the process of pushing in prior art, and provides a lead-in assembly and medical device.

[0005] To solve the above technical problem, on the one hand, the utility model embodiment provides a lead-in assembly which comprises a lead-in sheath pipe, a pushing rod and a stent, the inside of the lead-in sheath pipe is provided with a lead-in channel, the lead-in channel penetrates the lead-in sheath pipe along a first direction;

[0006] The stent comprises a stent main body and an anchoring device which are connected;

[0007] The pushing rod, the anchoring device and the stent main body are all installed in the lead-in channel, at least one of the stent main body and the anchoring device is connected to the pushing rod, the pushing rod can push the anchoring device and the stent main body to a preset position along the first direction, and the anchoring device can fix the stent main body at the preset position.

[0008] Optionally, the anchoring device is detachably connected to the pushing rod, and the anchoring device has switchable constraint state and release state; when the anchoring device is in the constraint state, the anchoring device is connected to the pushing rod;

[0009] When the anchoring device is switched to the release state, the anchoring device and the pushing rod are in a separated state.

[0010] Optionally, the inside of the pushing rod is provided with a liquid infusion channel, and the liquid infusion channel penetrates the pushing rod along the first direction;

[0011] In a direction perpendicular to the first direction, the anchor device has opposite first and second sides, the stent body has opposite third and fourth sides, and the distance between the first and second sides of the anchor device when the anchor device is in the constrained state is less than the distance between the first and second sides of the anchor device when the anchor device is switched to the released state.

[0012] When the anchor device is switched to the released state, the first side of the anchor device is beyond the third side of the stent body, and the second side of the anchor device is beyond the fourth side of the stent body.

[0013] Optionally, the lead-in channel is cylindrical, and the diameter of the cross-sectional circle of the lead-in channel is greater than the distance between the first and second sides of the anchor device when the anchor device is switched to the released state.

[0014] Optionally, an outer periphery of the end of the push rod close to the stent is provided with external threads, the anchor device is helical, and when the anchor device is in the constrained state, a screw connection is formed between the anchor device and the external threads.

[0015] Optionally, an outer periphery of the end of the push rod close to the stent is provided with external threads, the stent body is helical, and a screw connection is formed between the stent body and the external threads.

[0016] Optionally, the number of anchor devices is two, and the stent body has opposite first and second ends in the first direction, one of the anchor devices is connected to the first end of the stent body, and the other of the anchor devices is connected to the second end of the stent body.

[0017] Optionally, the lead-in assembly further comprises a corrosion-resistant coating, and the coating is coated on the outer periphery of the stent.

[0018] Optionally, the end of the lead-in sheath for extending into the ureter is provided with a circular truncated cone-shaped guide structure, and in a direction perpendicular to the first direction, the cross-sectional area of the end of the guide structure close to the push rod is greater than the cross-sectional area of the other end of the guide structure.

[0019] According to the embodiment of the utility model, in working, first bracket main part, anchoring device and push rod are installed in the introduction channel of introduction sheath in proper order. After preparation, push the push rod along the first direction, and the push rod will drive the anchoring device and the bracket main part connected with it to move synchronously in the introduction channel, and push them to the preset position in the ureter gradually. When reaching the preset position, the anchoring device plays a role, and the bracket main part is fixed firmly in the ureter, and then the push rod can be withdrawn from the introduction channel, and the introduction sheath can be reserved or withdrawn according to the need. In the process of pushing, because the bracket main part and the anchoring device are installed in the introduction channel of the introduction sheath, the introduction sheath provides a stable pushing path for them, and the shaking range of the bracket in pushing is limited, and the risk of position deviation caused by external interference (such as the bending of urethra, muscle contraction, etc.) is greatly reduced. Moreover, the relative position between the push rod, the anchoring device and the bracket main part is relatively fixed, and the accuracy and stability of pushing are further guaranteed when pushing, so that the bracket can accurately reach the preset position and be reliably fixed by the anchoring device, thereby effectively solving the problem that the bracket is prone to position deviation in the process of pushing. Meanwhile, the combined design of the introduction sheath, the push rod and the bracket makes the whole operation process clear and orderly. The cooperation between the components is close and reasonable, and the doctor can operate more conveniently, reduces the possible errors caused by complex operation, and improves the success rate and efficiency of the operation. The anchoring device is specially used for fixing the bracket main part in the ureter, compared with the traditional bracket without anchoring structure, it can better adapt to the physiological environment of the ureter, resist the influence of factors such as urine flow impact and body movement, make the bracket stable in the ureter, be conducive to long-term indwelling, and guarantee the continuity and reliability of the treatment effect.

[0020] On the other hand, the utility model embodiment provides a kind of medical device, including mould, nickel-titanium alloy wire and above-mentioned introduction assembly, the nickel-titanium alloy wire can be wound on the outer surface of the mould and form the bracket. BRIEF DESCRIPTION OF DRAWINGS

[0021] Figure 1 It is the schematic diagram of the introduction assembly provided by the utility model embodiment;

[0022] Figure 2 It is the schematic diagram of the bracket of the introduction assembly provided by the utility model embodiment, and the schematic diagram of the anchoring device when in the release state;

[0023] Figure 3 It is the schematic diagram of the bracket of the introduction assembly provided by the utility model embodiment, and the schematic diagram of the anchoring device when in the release state;

[0024] Figure 4 It is the schematic diagram of the bracket of the introduction assembly provided by the utility model another embodiment, and the schematic diagram of the anchoring device when in the release state.

[0025] Figure 5 is the schematic view of the support of the introduction assembly and the anchor device in the released state, provided by another embodiment of the utility model;

[0026] Figure 6 is the structural schematic view of the support of the introduction assembly and the softened anchor device, provided by an embodiment of the utility model;

[0027] Figure 7 is the schematic view of the nickel-titanium alloy wire of the medical device, provided by an embodiment of the utility model;

[0028] Figure 8 is the structural schematic view of the medical device and the nickel-titanium alloy wire wound on the mold to form the support, provided by an embodiment of the utility model.

[0029] The reference signs in the specification are as follows:

[0030] 1, introduction sheath tube; 2, push rod; 3, support; 4, mold; 5, nickel-titanium alloy wire; 11, introduction channel; 12, guide structure; 21, infusion channel; 31, support body; 32, anchor device. DETAILED DESCRIPTION

[0031] In order to make the technical problems, technical schemes and beneficial effects solved by the utility model more clearly understood, the utility model is further described in detail below in combination with the drawings and embodiments. It should be understood that the specific embodiments described herein are only used to explain the utility model, and are not used to limit the utility model.

[0032] As shown in Figures 1 to 6 an embodiment of the utility model provides a kind of introduction assembly, including introduction sheath tube 1, push rod 2 and support 3, the inside of introduction sheath tube 1 is equipped with introduction channel 11, introduction channel 11 is along first direction and passes through introduction sheath tube 1;

[0033] Support 3 includes the support body 31 and anchor device 32 connected;

[0034] The push rod 2, the anchoring device 32 and the stent body 31 are all installed on the introduction channel 11, at least one of the stent body 31 and the anchoring device 32 is connected to the push rod 2, the push rod 2 can push the anchoring device 32 and the stent body 31 to a preset position in a first direction, and the anchoring device 32 can fix the stent body 31 at the preset position. In this embodiment, the introduction sheath 1 is a cylindrical pipe, the first direction coincides with the axis of the introduction sheath 1, and by accurately controlling the position of the stent 3, the complications such as urinary tract irritation and infection caused by displacement or improper placement of the stent 3 are reduced, thereby improving the postoperative recovery quality and life quality of the patient. The anchoring device 32 can ensure the stable fixation of the stent body 31 in the ureter, and reduce or avoid the risk of complications and reoperation caused by displacement. The preset position can be at a narrow position of the ureter.

[0035] In an embodiment, the anchoring device 32 is detachably connected to the push rod 2, and the anchoring device 32 has a switchable constrained state and a released state. When the anchoring device 32 is in the constrained state, the anchoring device 32 is connected to the push rod 2.

[0036] When the anchoring device 32 is switched to the released state, the anchoring device 32 is in a separated state from the push rod 2. In this embodiment, the anchoring device 32 is made of nickel-titanium alloy. The nickel-titanium alloy has a body-centered cubic structure at high temperature, which is called austenite phase. When it is cooled, the structure will spontaneously change to a monoclinic structure with a large number of twin crystals, which is called martensite phase, when the temperature is lower than the temperature required for martensite transformation. This cooling process does not significantly change the shape of the material. Then, stress is applied to change its shape; this macro-scale deformation is achieved by moving the twin boundaries within the material at the micro-scale. Next, the deformed nickel-titanium is heated, and when the temperature is higher than the austenite transformation temperature, the crystal structure of the nickel-titanium will change back to the original body-centered cubic structure, so the material also returns to its original shape. That is, the anchoring device 32 can form a structure in the released state through some process, such as a two-dimensional or three-dimensional structure formed by heat treatment at a temperature of 500-540°C for 15-30 minutes. Then, by press-fitting, the anchoring device 32 is switched to the constrained state. At the same time, the anchoring device 32 in the constrained state can be switched to the released state by the action of 45-55°C hot water, so that the anchoring device 32 is separated from the push rod 2. In addition, the anchoring device 32 can be softened into a filamentous structure by the action of 0-10°C cold water, facilitating the removal of the stent 3. Since the anchoring device 32 can be accurately controlled, the possibility of displacement of the stent 3 is reduced, thereby possibly reducing the discomfort and complications of the patient and improving the postoperative experience of the patient. By safely pushing the stent 3 to the preset position in the constrained state and then separating the anchoring device 32 from the push rod 2 in the released state, this design reduces the risk of displacement or accidental release of the stent 3 during the operation.

[0037] In an embodiment, the inner part of the pushing rod 2 is provided with a liquid delivery channel 21, which penetrates the pushing rod 2 in the first direction;

[0038] In a direction perpendicular to the first direction, the anchoring device 32 has opposite first and second sides, and the bracket body 31 has opposite third and fourth sides, the distance between the first and second sides of the anchoring device 32 in the constrained state is less than the distance between the first and second sides when the anchoring device 32 is switched to the released state;

[0039] When the anchoring device 32 is switched to the released state, the first side of the anchoring device 32 exceeds the third side of the bracket body 31, and the second side exceeds the fourth side of the bracket body 31. In this embodiment, the anchoring device 32 in the released state can be a circular truncated cone structure, or other shapes, such as an anchoring device 32 composed of three three-dimensional structures of triangular shape and mutually offset angle of 120°. The provision of the liquid delivery channel 21 facilitates the injection of the required liquid, simplifies the surgical operation process, reduces the complexity and difficulty of the surgical operation, reduces the surgical time and the work intensity of the doctor, and also reduces the risk of surgical errors caused by instrument conversion or complicated operation steps. For example, when the anchoring device 32 is pushed to the preset position and needs to be switched to the released state, hot water at 45-55°C is delivered to the position of the anchoring device 32 through the liquid delivery channel 21, so that the anchoring device 32 is unwound and switched to the released state.

[0040] In an embodiment, the guide channel 11 is in the shape of a cylinder, and the diameter of the cross-sectional circle of the guide channel 11 is greater than the distance between the first and second sides of the anchoring device 32 when it is switched to the released state. In this embodiment, the guide channel 11 provides a release space for the anchoring device 32, facilitating the release of the anchoring device 32. At the same time, the cylindrical guide channel 11 provides a smooth and continuous path, so that the anchoring device 32 can pass through smoothly in the constrained state without worrying about jamming or obstruction, which helps to ensure the smoothness of the operation.

[0041] In an embodiment, the outer periphery of the end of the pushing rod 2 close to the bracket 3 is provided with external threads, and the anchoring device 32 is in the shape of a spiral, and the anchoring device 32 and the external threads form a screw connection when the anchoring device 32 is in the constrained state. In this embodiment, the anchoring device 32 is connected to the pushing rod 2, and the bracket body 31 is not connected to the pushing rod 2. The screw connection between the external threads and the spiral anchoring device 32 can enhance the stability of the connection between the pushing rod 2 and the anchoring device 32, and ensure that the anchoring device 32 does not accidentally come off during the pushing process, so that the bracket 3 can be accurately placed at the predetermined position.

[0042] In an embodiment, the outer circumferential surface of the end of the push rod 2 close to the support 3 is provided with external threads, and the support body 31 is helical, and a screw connection is formed between the external threads and the helical support body 31. In this embodiment, the screw connection between the external threads and the helical support body 31 can enhance the stability of the connection between the push rod 2 and the support body 31, ensuring that the support body 31 will not accidentally come off during the pushing process, thereby improving the safety and reliability of the operation, so that the support 3 can be accurately placed at the predetermined position. For example, when pushing the support 3, after the support 3 is pushed to the predetermined position, the introducer sheath 1 is first withdrawn, so that part of the structure of the support body 31 is exposed from the introducer sheath 1 and is clamped in the ureter, and then the push rod 2 is detached from the support body 31 by screwing, completing the separation of the push rod 2 and the support body 31.

[0043] In an embodiment, the number of anchoring devices 32 is two, and the support body 31 has a first end and a second end opposite to the first end in the first direction, one of the anchoring devices 32 is connected to the first end of the support body 31, and the other anchoring device 32 is connected to the second end of the support body 31. In this embodiment, the anchoring devices 32 at both ends can provide a more stable fixing effect, especially in the dynamic environment of the ureter, the anchoring at both ends can better resist the displacement of the support 3, thereby improving the stability of the support 3.

[0044] In an embodiment, the introducer assembly further comprises a corrosion-resistant coating applied to the outer circumferential surface of the support 3. In this embodiment, the coating is made of diamond material and is applied to the outer circumferential surface of the support 3 by chemical vapor deposition technology, which can improve the corrosion resistance of the support 3 and prolong its service life.

[0045] In an embodiment, the end of the introducer sheath 1 for extending into the ureter is provided with a circular truncated cone-shaped guide structure 12, and in a direction perpendicular to the first direction, the cross-sectional area of the end of the guide structure 12 close to the push rod 2 is greater than that of the other end. In this embodiment, the circular truncated cone-shaped guide structure 12 is designed so that the cross-sectional area of the end of the introducer sheath 1 gradually increases, and such a gradual design helps to reduce the resistance when inserting into the ureter, making it easier for the sheath to pass through the tortuous part of the urethra and ureter, improving the passability of the operation.

[0046] According to the embodiment of the utility model, in working, first bracket main body 31, anchoring device 32 and push rod 2 are installed in the introduction channel 11 of introduction sheath tube 1 in turn, after preparation, push push rod 2 along the first direction, and push rod 2 will drive the anchoring device 32 and bracket main body 31 connected with it synchronous movement in introduction channel 11, gradually push them to the preset position in ureter, when reaching the preset position, anchoring device 32 plays a role, and bracket main body 31 is firmly fixed in ureter, then push rod 2 can be withdrawn from introduction channel 11, and introduction sheath tube 1 can also be reserved or withdrawn according to the need, in the push process, because bracket main body 31 and anchoring device 32 are installed in the introduction channel 11 of introduction sheath tube 1, introduction sheath tube 1 provides stable push path for them, and the shaking range of bracket 3 is limited when pushing, and the risk of position deviation caused by external interference (such as the bending of urethra, muscle contraction etc.) is greatly reduced, and the relative position between push rod 2, anchoring device 32 and bracket main body 31 is relatively fixed, and the accuracy and stability of pushing are further guaranteed when pushing, ensure that bracket 3 can accurately reach the preset position and be reliably fixed by anchoring device 32, thereby effectively solve the problem that urethral bracket 3 is prone to position deviation in the push process, meanwhile, the combined design of introduction sheath tube 1, push rod 2 and bracket 3 makes the whole operation process clear and orderly, the cooperation between parts is close and reasonable, and doctors can operate more conveniently, reduce the possible errors caused by complex operation, improve the success rate and efficiency of operation, anchoring device 32 is specially used for fixing bracket main body 31 in ureter, compared with the bracket 3 of traditional anchoring structure, it can better adapt to the physiological environment of ureter, resist the influence of factors such as urine flow impact and body movement, make bracket 3 keep stable in ureter, be conducive to long-term indwelling, and guarantee the continuity and reliability of treatment effect.

[0047] In addition, as shown in Figure 7 and Figure 8 , the utility model discloses an embodiment provides a kind of medical device, including mould 4, nickel-titanium alloy wire 5 and the introduction assembly of above-mentioned embodiment, nickel-titanium alloy wire 5 can be wound on the outer circumferential surface of mould 4 and form bracket 3.In this embodiment, the diameter of nickel-titanium alloy wire 5 is 0.4mm-0.6mm, the diameter of bracket main body 31 formed after winding is 7mm-8mm, and the maximum diameter of anchoring device 32 is 13mm-14mm.Nickel-titanium alloy has unique super-elasticity and thermal shape memory, and bracket 3 can be molded into the required shape at a certain temperature and can restore its original shape at body temperature, facilitating the deployment and positioning of bracket 3.

[0048] The above merely describes preferred embodiments of the present application and is not intended to limit the present application, and any modification, equivalent replacement, and improvement within the spirit and principle of the present application shall be included in the protection scope of the present application.

Claims

1. An introduction assembly, characterized by The introducing assembly comprises an introducing sheath, a push rod and a stent, the introducing sheath is internally provided with an introducing channel, the introducing channel penetrates the introducing sheath along a first direction; The stent comprises a stent body and an anchoring device; The push rod, the anchoring device and the stent body are all installed in the introducing channel, at least one of the anchoring device and the stent body is connected to the push rod, the push rod can push the anchoring device and the stent body to a preset position along the first direction, and the anchoring device can fix the stent body at the preset position.

2. The lead-in assembly of claim 1, wherein The anchoring device is detachably connected to the push rod, the anchoring device has switchable constraint state and release state, when the anchoring device is in the constraint state, the anchoring device is connected to the push rod; When the anchoring device switches to the release state, the anchoring device is in a separated state from the push rod.

3. The lead-in assembly of claim 2, wherein, The push rod is internally provided with an infusion channel, the infusion channel penetrates the push rod along the first direction; In a direction perpendicular to the first direction, the anchoring device has opposite first side and second side, the stent body has opposite third side and fourth side, the distance between the first side and the second side of the anchoring device when the anchoring device is in the constraint state is smaller than the distance between the first side and the second side of the anchoring device when the anchoring device switches to the release state; When the anchoring device switches to the release state, the first side of the anchoring device exceeds the third side of the stent body, and the second side exceeds the fourth side of the stent body.

4. The lead-in assembly of claim 3, wherein The introducing channel is in a cylindrical shape, the diameter of the cross section circle of the introducing channel is greater than the distance between the first side and the second side of the anchoring device when the anchoring device switches to the release state.

5. The lead-in assembly of claim 2, wherein The outer periphery surface of one end of the push rod close to the stent is provided with external threads, the anchoring device is in a spiral shape, and the anchoring device and the external threads form a screw connection when the anchoring device is in the constraint state.

6. The lead-in assembly of claim 1, wherein The outer periphery surface of one end of the push rod close to the stent is provided with external threads, the anchoring device is in a spiral shape, and the anchoring device and the external threads form a screw connection when the anchoring device is in the constraint state.

7. The lead-in assembly of claim 1, wherein The number of the anchoring devices is two, the stent body has opposite first end and second end along the first direction, one of the anchoring devices is connected to the first end of the stent body, and the other anchoring device is connected to the second end of the stent body.

8. The lead-in assembly of claim 1, wherein The introducing assembly is further provided with a corrosion-resistant coating, and the coating is coated on the outer periphery surface of the stent.

9. The lead-in assembly of claim 1, wherein, One end of the introducing sheath for extending into the ureter is provided with a circular truncated cone-shaped guide structure, in a direction perpendicular to the first direction, the cross-sectional area of one end of the guide structure close to the push rod is greater than that of the other end of the guide structure.

10. A medical device, characterized by The introducing assembly comprises a mold, a nickel-titanium alloy wire and the introducing assembly according to any one of claims 1-9, and the nickel-titanium alloy wire can be wound on the outer periphery surface of the mold and form the stent.