Special-shaped miniature guide wire for biliary calculus removal

Abstract

The invention discloses a special-shaped miniature guide wire for biliary tract calculus removal, and relates to the technical field of medical instruments, the special-shaped miniature guide wire comprises a catheter and a guide wire collecting tube, the special-shaped miniature guide wire is arranged in the guide wire collecting tube, a deformation part is arranged on the special-shaped miniature guide wire, the special-shaped miniature guide wire is made of nickel-titanium alloy, and the special-shaped miniature guide wire is made of nickel-titanium alloy. The catheter is fixedly connected with the guide wire collecting tube, and one end, far away from the catheter, of the special-shaped micro guide wire is fixedly connected with a push rod. The surgical operation and the endoscope technology are innovatively combined, and the problem that the time for taking out gallbladder and common bile duct calculi is long is solved.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a special-shaped micro guide wire for bile duct lithotripsy. Background Art

[0002] Common duct stones occur in 11% to 21% of patients with common duct stones. In modern laparoscopic cholecystectomy, controversy has arisen regarding the management of common duct stones prior to cholecystectomy. The approach to common duct stones depends on the timing of diagnosis and whether the patient has an in situ gallbladder. If a gallbladder is absent, the consensus is to perform endoscopic retrograde cholangiography (ERCP) with sphincterotomy and common duct stone removal. If a gallbladder is present, the course of treatment will depend on the timing of diagnosis. When cholelithiasis is confirmed prior to laparoscopic cholecystectomy, ERCP is performed first, followed by surgical treatment of the cholelithiasis 1 to 2 days later. As long as there are no post-ERCP complications, the incidence is 5% to 16%. The most common complications are acute pancreatitis, bleeding, bile duct infection (cholangitis or cholecystitis), and sometimes intestinal perforation. The present invention provides a special-shaped micro guidewire system for biliary lithotripsy, which mainly solves the problem of being unable to detect whether there are stones in the common bile duct during cholecystolithotomy surgery. At the same time, this system can be used for endoscopic biliary lithotripsy. When using this system for biliary lithotripsy, the stone removal time can be shortened and the incidence of postoperative complications can be reduced.

[0003] To address common bile duct stones in the shortest possible time with minimal complications, hospitalization time, and expense, the present invention proposes a shaped micro-guidewire system for biliary stone removal. This technology involves the simultaneous collaboration of surgeons and endoscopists during the same anesthesia procedure to address the pathological issues of gallbladder and common bile duct stones. The present invention involves placing a shaped micro-guidewire within a catheter, which is then passed through a small incision in the cystic duct into the common bile duct and then through the ampulla into the duodenum. The shaped micro-guidewire is directly visible under the endoscope, and other endoscopic instruments are then passed through the shaped micro-guidewire into the sphincter section, selectively entering the common bile duct through the sphincter. This procedure shortens the operation time and reduces the potential complications associated with intubation. Summary of the Invention

[0004] Purpose of the invention: The technical problem to be solved by the present invention is to provide a special-shaped micro guide wire for bile duct lithotripsy, which solves the problems of long operation time and excessive complications in existing gallbladder lithotripsy.

[0005] Technical Solution

[0006] In order to solve the above problems, the technical solution provided by the present invention is:

[0007] A special-shaped micro guidewire for bile duct stone removal includes a catheter and a guidewire collection tube. The guidewire collection tube is provided with a special-shaped micro guidewire, which is provided with a deformation portion. The special-shaped micro guidewire is made of nickel-titanium alloy. The catheter is fixedly connected to the guidewire collection tube. The end of the special-shaped micro guidewire away from the catheter is abutted against a push rod. The guidewire collection tube straightens the deformed portion of the special-shaped micro guidewire.

[0008] Furthermore, the nickel-titanium alloy is TiNi-01 with a transformation temperature of 20°C-40°C.

[0009] Furthermore, a developing ring is fixedly provided at one end of the catheter away from the guidewire collecting tube, and the developing ring is arranged close to the catheter port.

[0010] Furthermore, the special-shaped micro guide wire is wrapped with a heat shrink tube.

[0011] Furthermore, the heat shrink tube leaves a margin on the deformed portion of the special-shaped micro guidewire.

[0012] Furthermore, a fixing sleeve is fixedly wrapped at the connection position between the guidewire collecting tube and the catheter.

[0013] Furthermore, an adjustment sleeve is fixedly provided on a side of the guidewire collecting tube away from the fixed sleeve, the inner diameter of the adjustment sleeve is slightly larger than the outer diameter of the push rod, and the push rod is partially inserted into the guidewire collecting tube.

[0014] Furthermore, the push rod is made of PTFE material.

[0015] Furthermore, the deformation portion is any one of spiral, triangle or wave shape.

[0016] Furthermore, the spiral shape is any one of a single spiral, a double spiral, or a multi-helix.

[0017] Compared with the prior art, the technical solution provided by the present invention has the following beneficial effects:

[0018] The innovative combination of surgical procedures and endoscopic technology solves the problem of long gallbladder and common bile duct stone removal time. The special-shaped micro guidewire is made of nickel-titanium alloy, which is a shape memory alloy. Shape memory alloy is a special alloy that can automatically restore its own plastic deformation to its original shape at a certain temperature and has good plasticity. Taking advantage of this characteristic of nickel-titanium alloy, it is made into special-shaped micro guidewires of different shapes, which will deform when affected by temperature and return to their original shape when not affected by temperature. Special-shaped micro guidewires of different shapes can be used to meet the stone removal needs in different situations. Nickel-titanium alloy deforms when subjected to external force in the guidewire collection tube and can return to its original shape under the action of temperature when not subjected to external force. BRIEF DESCRIPTION OF THE DRAWINGS

[0019] Figure 1 This is a schematic structural diagram of Example 1 of the present invention;

[0020] Figure 2 This is an axonometric view of Example 1 of the present invention;

[0021] Figure 3 This is an enlarged view of the guidewire collection tube of Example 1 of the present invention;

[0022] Figure 4 1 is a comparison diagram of deformation parts of different shapes on the special-shaped micro guidewire of Example 1 of the present invention;

[0023] Figure 5 This is a schematic exploded view of the zigzag deformation portion of Example 1 of the present invention;

[0024] Figure 6 This is a schematic exploded view of the single rotation deformation portion of Example 1 of the present invention;

[0025] Figure 7 This is a schematic exploded view of the double helix deformation portion of Example 1 of the present invention;

[0026] Figure 8 This is a schematic exploded view of the multi-helical deformation portion of Example 1 of the present invention;

[0027] Figure 9 This is a schematic diagram of the use of Example 1 of the present invention.

[0028] 1. Catheter; 2. Special-shaped micro guidewire; 3. Guidewire collection tube; 4. Push rod; 11. Development ring;

[0029] 5. Fixed sleeve; 6. Adjustment sleeve; DETAILED DESCRIPTION

[0030] In order to make the technical solution of the present invention clearer, the present invention is further described in detail below with reference to the accompanying drawings and specific embodiments.

[0031] Example 1

[0032] Combined with attachment Figure 1-9 A special-shaped micro-guidewire for bile duct stone removal includes a catheter 1, a special-shaped micro-guidewire 2, a guidewire collection tube 3, a push rod 4, and a developing ring 11. The catheter 1 and the guidewire collection tube 3 are both hollow tubes. The catheter 1 is fixed at the end of the guidewire collection tube 3. The special-shaped micro-guidewire 2 is placed in the guidewire collection tube 3 when not in use. The special-shaped micro-guidewire 2 can move smoothly within the guidewire collection tube 3 and the catheter 1. The special-shaped micro-guidewire 2 moves from the inside of the guidewire collection tube 3 to the inside of the catheter 1 and can eventually partially extend out of the catheter 1.

[0033] A developing ring 11 is provided at the end of the catheter 1 away from the guidewire collection tube 3. The developing ring 11 is set close to the port of the catheter 1. The developing ring 11 is used to display the position of the catheter 1 away from the end of the catheter collection tube 3. The developing ring 11 is visible under X-rays, so that medical staff can judge the position of the end of the catheter 1 inserted into the patient's body through X-rays, and thus judge the position reached by the catheter 1 when it is inserted into the patient's body. The closer the developing ring 11 is to the port of the catheter 1, the more accurately the position of the catheter 1 indicated by the developing ring 11. Medical staff can observe the position of the developing ring 11 to form feedback adjustment of the catheter 1, and adjust the next insertion or extension of the catheter 1 and the angle of the catheter 1 according to the position of the developing ring 11 relative to the patient.

[0034] A push rod 4 is provided at the end of the special-shaped micro guidewire 2, which is used to drive the special-shaped micro guidewire 2 to move in the guidewire collection tube 3 and the catheter 1. The diameter of the push rod 4 is smaller than the inner diameter of the guidewire collection tube 3 and the catheter 1, so that the push rod 4 can enter the guidewire collection tube 3 and the catheter 1. The length of the push rod 4 can push the special-shaped micro guidewire 2 to move to the port position at one end of the catheter 1 where the developing ring 11 is provided and partially extend out of the catheter 1.

[0035] The push rod 4 pushes the shaped micro-guidewire 2 partially out of the end of the catheter 1. The length of the catheter 1 is set according to the desired insertion depth. The developing ring 11 is visible under X-ray during movement, helping medical personnel determine the real-time position of the end of the catheter 1 and, further, the position of the shaped micro-guidewire 2 based on the length of the push rod 4 entering the guidewire collection tube 3.

[0036] A fixing sleeve 5 and an adjustment sleeve 6 are provided at both ends of the guidewire collection tube 3. The fixing sleeve 5 is arranged at the connection position between the catheter 1 and the guidewire collection tube 3. The fixing sleeve 5 can not only strengthen the connection strength between the catheter 1 and the guidewire collection tube 3, but also play the role of indicating the remaining length of the catheter 1. When the catheter 1 is inserted into the patient's body, the medical staff can judge the remaining length of the catheter 1 that can be inserted into the patient's body according to the position of the fixing sleeve 5. When in use, the fixing sleeve 5 and the guidewire collection tube 3 cannot be extended into the patient's body.

[0037] The end of the push rod 4 abuts against the end of the special-shaped micro guidewire 2 away from the catheter 1, and the end of the push rod 4 toward the special-shaped micro guidewire 2 extends into the guidewire collecting tube 3. The end extending into the guidewire collecting tube 3 abuts against the push rod 4. When the push rod 4 moves into the guidewire collecting tube 3, the push rod 4 can push the special-shaped micro guidewire 2 to move. The push rod 4 can push the special-shaped micro guidewire 2 into the catheter 1. The push rod 4 can also enter the guidewire collecting tube 3, so that the special-shaped micro guidewire 2 can be extended out of the catheter 1 by continuously pushing the push rod 4.

[0038] After the special-shaped micro guidewire 2 is completely extended out of the catheter 1 , the special-shaped micro guidewire 2 is separated from the push rod 4 , and the special-shaped micro guidewire 2 can now be operated alone.

[0039] Adjustment sleeve 6 is located at the end of guidewire collection tube 3 not connected to catheter 1. The inner diameter of adjustment sleeve 6 is slightly larger than the outer diameter of push rod 4. When push rod 4 bends or deflects, a local protrusion appears at the location of the bend or deflection. When the protrusion moves to adjustment sleeve 6, adjustment sleeve 6 squeezes push rod 4, restoring push rod 4 to its original smooth structure. Adjustment sleeve 63 makes push rod 4 smoother. When push rod 4 overlaps or rotates, causing it to be significantly bent, adjustment sleeve 63 can restore the push rod to a smooth state, preventing push rod 4 from bending when pushing special-shaped micro guidewire 2. This could cause special-shaped micro guidewire 2 to move out of position, or cause special-shaped micro guidewire 2 to deflect at an angle and fail to accurately reach the stone location.

[0040] The push rod 4 is preferably made of PTFE material, which can be deformed by external forces while retaining a certain hardness, making it convenient for medical staff to store it.

[0041] The main body of the special-shaped micro-guidewire 2 is made of nickel-titanium wire. The nickel-titanium alloy used to make the special-shaped micro-guidewire 2 is a shape-memory alloy. Shape-memory alloys are metals that can deform under external stimuli. When the external environment reaches its phase transition temperature, the nickel-titanium alloy itself will deform, resulting in excellent plasticity. Utilizing this characteristic of nickel-titanium alloy, special-shaped micro-guidewires that can deform into different shapes are made from nickel-titanium alloy. They deform when affected by temperature and return to their original shape when no force is applied.

[0042] The special-shaped micro-guidewire 2 is an elongated structure with a deformable portion located in the middle section. This deformable portion grips the stone and carries it along the special-shaped micro-guidewire 2. Under the influence of the phase transition temperature, the deformable portion can be deformed into various shapes, such as spiral, triangle, and wave. The various shapes of the special-shaped micro-guidewire can be used to meet different stone removal requirements.

[0043] The deformable shape of the deformable portion of the anisotropic micro guidewire 2 is a spiral shape, and the deformable portion can be deformed into a zigzag shape, a single spiral, a double spiral, a multi-helix structure, etc. When the deformable portion is a spiral shape, it is suitable for granular or irregularly shaped stones. The spiral guidewire is used to capture small and irregular stones, the triangular guidewire is used to capture long stones, the wavy guidewire is used to capture long and protruding stones, and the zigzag shape is used to capture U-shaped stones.

[0044] The single-helix deformation site is suitable for larger stones, the double-helix deformation structure is suitable for medium-sized stones, and the multi-helix deformation structure is suitable for granular stones or smaller stones.

[0045] The nickel-titanium alloy of the special-shaped micro guide wire 2 is preferably TiNi-01, which has a phase change temperature of 20° C.-40° C., which matches the body temperature of the human body, enabling the special-shaped micro guide wire 2 to deform after entering the human body.

[0046] When the special-shaped micro guide wire 2 is manufactured, the special-shaped micro guide wire 2 is processed at a phase-changing temperature. A deformation part is set on the special-shaped micro guide wire 2, and the deformation part can be processed into a spiral shape, a triangle shape, a wave shape, etc., so that the special-shaped micro guide wire 2 can be deformed at the phase-changing temperature and return to the shape of the special-shaped micro guide wire 2 after being processed.

[0047] A layer of heat shrink tubing is wrapped around the special-shaped micro guide wire 2, and the heat shrink tubing wraps the special-shaped micro guide wire 2 as much as possible. The heat shrink tubing plays a lubricating role on the special-shaped micro guide wire 2. Since the special-shaped micro guide wire 2 will rub against the human tissue wall after entering the human body, the heat shrink tubing can greatly reduce the friction, thereby reducing the patient's discomfort and making it easier for the special-shaped micro guide wire 2 to reach the stone location. At the same time, the lubricating effect of the heat shrink tubing on the special-shaped micro guide wire 2 can move the stone relatively to the deformed part of the special-shaped micro guide wire 2. After the deformed part of the special-shaped micro guide wire 2 is gradually deformed due to the human body temperature, the deformed part of the special-shaped micro guide wire 2 can wrap, entangle or cover the stone, so that the special-shaped micro guide wire 2 can carry the stone to move. Therefore, the medical staff pulls back the push rod 4 to make the special-shaped micro guide wire 2 carry the stone out of the patient's body, and the special-shaped micro guide wire 2 brings the stone into the catheter collection tube 3.

[0048] The heat shrink tube leaves a margin on the deformation portion of the special-shaped micro guide wire 2 , thereby facilitating the deformation of the special-shaped micro guide wire 2 .

[0049] When the special-shaped micro guide wire 2 is in use, the special-shaped micro guide wire 2 with different shapes is placed in the guide wire collection tube 3. The guide wire collection tube 3 will press or straighten the deformed part of the special-shaped micro guide wire 2 from a triangle or other deformed shape as much as possible, so that it has the ability to deform again at the phase change temperature.

[0050] When inserting the special-shaped microguidewire 2 into the guidewire collection tube 3, the special-shaped microguidewire 2 needs to be gradually pressed into the guidewire collection tube 3, so that the deformed portion of the special-shaped microguidewire 2 is straightened to a state similar to the rest of the special-shaped microguidewire 2. After being straightened, the special-shaped microguidewire 2 does not directly return to its deformed shape when not under force. Instead, the special-shaped microguidewire 2 is placed in an environment with a temperature change, and slowly returns to its deformed shape. Based on this principle, after being straightened by the guidewire collection tube 1, the special-shaped microguidewire 2 enters the catheter 1. Since the catheter is inside the human body and reaches the temperature change of the special-shaped microguidewire 2, the special-shaped microguidewire 2 slowly deforms. The time required for the special-shaped microguidewire 2 to move to the deformed portion, extend out of the catheter 1, and pass through the stone. When the deformed portion reaches the stone location, the deformed portion of the special-shaped microguidewire 2 slowly returns to a deformed shape such as a triangle or spiral, thereby clamping the stone and causing the stone and the special-shaped microguidewire 2 to move synchronously.

[0051] The special-shaped micro guidewire 2 is placed in the guidewire collection tube 3, and the special-shaped micro guidewire 2 is straightened in the guidewire collection tube 3. The push rod 4 is inserted into the guidewire collection tube 3, and the push rod 4 is pushed to allow the special-shaped micro guidewire 2 to enter the catheter 1. The special-shaped micro guidewire 2 entering the catheter 1 is in an environment of phase-changing temperature because the catheter 1 is inserted into the patient's body during use, so that the special-shaped micro guidewire 2 entering the catheter 1 is in an environment of phase-changing temperature, thereby starting to change.

[0052] The special-shaped micro-guidewire 2 is used in conjunction with an endoscope. After the special-shaped micro-guidewire 2 carries the stone, the push rod 4 cooperates with the catheter 1 to deliver the special-shaped micro-guidewire 2 carrying the stone to the location of the duodenal papilla. The endoscope can then reach the location of the duodenal papilla and remove the special-shaped micro-guidewire 2, thus completing the stone removal. The use of the endoscope and the special-shaped micro-guidewire 2 in conjunction can greatly improve the efficiency of stone removal.

[0053] During use, an incision is made in the cystic duct in advance, and the catheter 1 enters the common bile duct through the small incision of the cystic duct. Then the endoscope enters the duodenum through the ampulla. The position of the catheter 1 can be directly confirmed by the developing ring 11 until the catheter 1 reaches the stone position. At this time, the push rod 4 is pushed to extend the special-shaped micro guide wire 2 from the catheter 1. The special-shaped micro guide wire 2 passes through the stone in the common bile duct from the side of the stone. The special-shaped micro guide wire 2 is deformed by the body temperature of the human body, and the special-shaped micro guide wire 2 is inserted into the common bile duct through the spiral structure of the deformed part. The stone in the tube is clamped and carried, causing the stone and the special-shaped micro guidewire 2 to move synchronously. At this time, the catheter 1 and the special-shaped micro guidewire 2 are moved to the position of the duodenal papilla, and the synchronous push rod 4 pushes the special-shaped micro guidewire 2 to the duodenal papilla, while the endoscope and the stone removal instrument carried by the endoscope are moved to the position of the duodenal papilla in advance. When the special-shaped micro guidewire 2 carrying the stone arrives, the endoscope is used to remove the special-shaped micro guidewire 2 and the stone in the duodenum, thereby realizing the stone removal operation. This operation time is shorter and reduces the complications that may be caused by intubation.

[0054] The above-described embodiments merely illustrate several implementations of the present invention, 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 numerous variations and improvements without departing from the spirit of the present invention, all of which fall within the scope of protection of the present invention. Therefore, the scope of protection of the present invention shall be determined by the appended claims.

Claims

1. A special-shaped micro guide wire for bile duct stone removal, characterized in that: The invention comprises a catheter and a guidewire collection tube, wherein a special-shaped micro guidewire is arranged in the guidewire collection tube, and a deformation part is arranged on the special-shaped micro guidewire. The special-shaped micro guidewire is made of nickel-titanium alloy. The catheter is fixedly connected to the guidewire collection tube, and one end of the special-shaped micro guidewire away from the catheter is abutted against a push rod. The guidewire collection tube straightens the deformation part of the special-shaped micro guidewire.

2. The special-shaped micro guidewire for bile duct stone removal according to claim 1, characterized in that: The nickel-titanium alloy is TiNi-01 with a phase transformation temperature of 20°C-40°C.

3. The special-shaped micro guidewire for bile duct stone removal according to claim 1, characterized in that: A developing ring is fixedly provided on one end of the catheter away from the guidewire collecting tube, and the developing ring is arranged close to the catheter port.

4. The special-shaped micro guidewire for bile duct stone removal according to claim 1, characterized in that: The special-shaped micro guide wire is wrapped with a heat shrink tube.

5. The special-shaped micro guide wire for bile duct stone removal according to claim 4, characterized in that: The heat shrink tube leaves a margin on the deformed portion of the special-shaped micro guide wire.

6. The special-shaped micro guidewire for bile duct stone removal according to claim 1, characterized in that: The connection position between the guidewire collecting tube and the catheter is fixedly wrapped with a fixing sleeve.

7. The special-shaped micro guidewire for bile duct stone removal according to claim 6, characterized in that: An adjustment sleeve is fixedly provided on one side of the guidewire collecting tube away from the fixed sleeve. The inner diameter of the adjustment sleeve is slightly larger than the outer diameter of the push rod. The push rod is partially inserted into the guidewire collecting tube.

8. The special-shaped micro guidewire for bile duct stone removal according to claim 1, characterized in that: The push rod is made of PTFE material.

9. The special-shaped micro guidewire for bile duct stone removal according to claim 1, characterized in that: The deformation portion is any one of a spiral shape, a triangle shape or a wave shape.

10. The special-shaped micro guidewire for bile duct stone removal according to claim 9, characterized in that: The helical shape is any one of a single helix, a double helix, or a multi-helix.

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