Device for removing a lumen occlusion and method of manufacturing the same

Abstract

The device for removing the pipe cavity blockage includes a treatment component and a catheter, the treatment component is arranged at one end of the catheter in a telescopic mode, and the treatment component includes a push-pull component, a movable component, a guide wire, an expansion and contraction unit and a fixing component; the proximal end of the push-pull component is connected with the catheter in a telescopic mode, the distal end is provided with the movable component, the movable component is connected with the fixing component in an axial movable mode through the guide wire, the guide wire is provided with the expansion and contraction unit in a surrounding mode, and the two ends of the expansion and contraction unit are connected with the movable component and the fixing component respectively. The device can guarantee the blood flow in the pipe cavity during the operation, the expansion and contraction unit is formed into various shapes, can correspond to various pipe cavity blockage conditions, is beneficial to the implementation of the operation, and according to the characteristics of various shapes, can enhance the combination of the pipe cavity blockage and the expansion and contraction unit, facilitate the axial accumulation of the expansion and contraction unit, and can prevent the pipe cavity blockage from falling off without exerting excessive pressure on the pipe cavity, so that the secondary embolism is avoided.

Description

TECHNICAL FIELD

[0001] The present application relates to an interventional medical device, in particular to a device for removing a lumen blockage and a manufacturing method thereof. BACKGROUND

[0002] When a cerebral artery is blocked by a clot, thrombus or other material in the blood vessel, it causes the blood vessel to narrow, leading to tissue hypoxia, which can eventually lead to stroke. In treatment, the blockage in the blood vessel should be disposed of and removed as soon as possible before tissue hypoxia leads to cell death, so as to save the brain tissue. In addition to thrombolytic drugs, there is also a way to use an interventional medical device to remove the blood vessel blockage.

[0003] A device for removing a blood vessel blockage by using a balloon to close the blood vessel and then sucking the blood vessel blockage is disclosed in Chinese utility model patent CN 211357000 U. However, this will inevitably block the blood flow in the blood vessel during the operation. During the operation, it will cause further development of tissue hypoxia, which is not conducive to the recovery of the patient. SUMMARY

[0004] In view of the above problems, the purpose of the present application is to provide a device for removing a lumen blockage and a manufacturing method thereof, and the technical scheme is as follows:

[0005] The device for removing a lumen blockage comprises a treatment component and a catheter, the treatment component being telescopically arranged at one end of the catheter, the treatment component comprising a push-pull component, a movable component, a guide wire, an expansion and contraction unit and a fixed component, the proximal end of the push-pull component being telescopically connected with the catheter, the distal end being provided with the movable component, the movable component being axially movably connected with the fixed component through the guide wire, the guide wire being peripherally provided with the expansion and contraction unit, and the expansion and contraction unit being connected with the movable component and the fixed component at both ends.

[0006] The expansion and contraction unit is composed of elastic wires, and has a mesh structure in an expanded state and a tubular structure in a contracted state.

[0007] After the expansion and contraction unit is expanded to a constant size, the movable component is caused to approach the fixed component, the radial size of the expansion and contraction unit remains unchanged, the elastic wires are stacked in the axial direction, the mesh is reduced, and the lumen blockage is prevented from being separated from the treatment component.

[0008] The expansion and contraction unit is composed of an even number of elastic wires, which are spirally woven around the guide wire in opposite directions.

[0009] The expansion and contraction unit is composed of elastic wires, which are spirally woven around the guide wire in the same direction.

[0010] The expansion and contraction unit is formed by the elastic wires being wound around each other and spirally woven in opposite directions after crossing with the adjacent elastic wires.

[0011] The elastic wires of the expansion and contraction unit are branched into two elastic wires at a position close to the fixed member and the movable member, spirally woven around the guide wire, and the adjacent elastic wires are spirally woven in opposite directions after branching.

[0012] Preferably, the expansion and contraction unit is configured such that the mesh size gradually decreases from the fixed member to the movable member.

[0013] Preferably, the expansion and contraction unit is configured such that the mesh size gradually decreases from the movable member to the fixed member.

[0014] Preferably, the expansion and contraction unit is configured such that the mesh size gradually decreases from the middle position to the fixed member and the movable member.

[0015] The manufacturing method of the device for removing the lumen blockage is for manufacturing the device for removing the lumen blockage described above, and the radial size of the expansion and contraction unit is limited to a constant diameter by heating and processing the expansion and contraction unit while keeping the expansion and contraction unit expanded to a constant diameter.

[0016] By heating and processing the maximum diameter of the expanded expansion and contraction unit to a constant diameter, even if the movable member is continuously moved closer to the fixed member after the radial size of the expansion and contraction unit reaches a constant diameter, the radial size of the expansion and contraction unit does not change, and the elastic wires are stacked in the axial direction.

[0017] Preferably, when heating and processing is performed, the temperature is 350°C to 550°C, which can better fix the expansion and contraction unit to a constant diameter.

[0018] Compared with the prior art, the advantages and effects of the present application are that the blood flow in the lumen can be ensured during surgery, the expansion and contraction unit can be configured in various shapes, and various blockage conditions formed due to the large diameter variation of the human body lumen, the multiple branching conditions, and the complex shape can be corresponded to, which is beneficial to the implementation of the surgery, and according to the characteristics of various shapes, the combination of the lumen blockage and the expansion and contraction unit can be enhanced, the expansion and contraction unit can be stacked in the axial direction, and the lumen blockage can be prevented from falling off without applying excessive pressure to the lumen, thereby avoiding the formation of secondary embolism. BRIEF DESCRIPTION OF DRAWINGS

[0019] Figure 1 is a diagram of the overall structure of the device for removing the lumen blockage of Example 1;

[0020] Figure 2 is a diagram of the weaving structure of the expansion and contraction unit of Example 2;

[0021] Figure 3 is a diagram of a braid structure of the expansion and contraction unit of Example 3;

[0022] Figure 4 is a diagram of a braid structure of the expansion and contraction unit of Example 4;

[0023] Figure 5 is a diagram of a braid structure of the expansion and contraction unit of Example 5;

[0024] Figure 6 is a diagram of a change in mesh of the expansion and contraction unit of Example 6;

[0025] Figure 7 is a diagram of a change in mesh of the expansion and contraction unit of Example 7;

[0026] Figure 8 is a diagram of a change in mesh of the expansion and contraction unit of Example 8;

[0027] Figure 9 is a diagram of a case where the treatment member of Example 9 is extended from the catheter;

[0028] Figure 10 is a diagram of a case where the expansion and contraction unit of Example 9 is expanded in the radial direction;

[0029] Figure 11 is a diagram of a case where the expansion and contraction unit of Example 9 is stacked in the axial direction;

[0030] Figure 12 is a diagram of a case where the expansion and contraction unit of Example 9 is contracted in the radial direction;

[0031] In the figure: 1, device for removing a luminal occlusion, 9, thrombus, 10, treatment member, 20, catheter, 101, guide wire, 102, fixed member, 103, movable member, 104, expansion and contraction unit, 105, push-pull member, 1041, 1041A, 1041B, 1041C, 1041D, 1041E, 1041F, 1041G, 1041H, 1041I, elastic thread. DETAILED DESCRIPTION

[0032] Embodiments for carrying out the present application are explained in detail with reference to the accompanying drawings. The present application is not limited to the content described in the following embodiments. Also, the structural elements described below include substantially equivalent elements that can be easily derived by those skilled in the art. Furthermore, the structures described below can be appropriately combined. Also, various omissions, substitutions, or changes of the structures can be made within a range not departing from the gist of the present application.

[0033] Furthermore, the dimensions of the structural components in the accompanying drawings do not strictly represent the actual dimensions of the structural components or the proportions of each structural component; they are merely used to schematically illustrate the principles and ideas of the present invention.

[0034] The apparatus for removing blockages in a lumen according to the present invention will be described with reference to the accompanying drawings.

[0035] Example 1

[0036] like Figure 1 As shown, the device 1 for removing blockages in a lumen includes a treatment component 10 and a catheter 20. The treatment component 10 is telescopically movable relative to the catheter 20. The treatment component 10 can extend out of the catheter 20 and retract back into the catheter 20 and be housed by the catheter 20.

[0037] The treatment component 10 includes a guide wire 101, a fixing component 102, a movable component 103, an expansion / contraction unit 104, and a push-pull component 105. The guide wire 101 preferably has a certain axial strength and a small diameter, allowing it to move relative to the conduit 20. The fixing component 102 is fixed relative to the guide wire 101, and the fixing method can be any method such as bonding, welding, or chiseling. The movable component 103 is connected to the push-pull component 105 and can move axially relative to the guide wire 101.

[0038] The push-pull component 105 controls the movement of the movable component 103 relative to the guide wire 101. The surgeon can manipulate the push-pull component 105 externally via the guide wire (not shown). Alternatively, the push-pull component 105 can be coupled to an actuator, and the surgeon can manipulate the push-pull component 105 by operating the actuator.

[0039] The expansion and contraction unit 104 is woven by a plurality of elastic wires 1041. The elastic wires 1041 have elasticity and can be made of metal such as platinum, titanium, etc., stainless steel, alloy such as nickel-titanium alloy, platinum-iridium alloy, etc. As long as a material which is not toxic to the human body is used. Platinum wire is easily seen under fluoroscopy, so that the surgeon can confirm the state of the blood vessel and the expansion and contraction unit 104. If other materials are used, a coating which enhances visibility under fluoroscopy can be applied to the elastic wires 1041. The cross section of the elastic wires 1041 can be circular, or rectangular or triangular or other shapes. The expansion and contraction unit 104 is connected to the fixed member 102 and the movable member 103 at both ends. The connection can be by adhesion, welding, caulking, knotting, etc. The relative movement of the fixed member 102 and the movable member 103 causes the expansion and contraction unit 104 to expand or contract in the radial direction. When the fixed member 102 and the movable member 103 are close to each other, the plurality of elastic wires 1041 are arched and form a mesh, so that the expansion and contraction unit 104 expands in the radial direction. When the fixed member 102 and the movable member 103 are apart from each other, the elastic wires 1041 are pulled to both ends, so that the expansion and contraction unit 104 contracts in the radial direction. Also, the mesh structure formed by the plurality of elastic wires becomes smaller as the expansion and contraction unit 104 contracts.

[0040] In manufacturing the expansion and contraction unit 104, a pipe having a constant inner diameter is fitted to the expanded processed expansion and contraction unit 104, so that the diameter of the expanded expansion and contraction unit 104 is defined as the inner diameter of the pipe. At this time, the expansion and contraction unit 104 is subjected to heat processing, so that the alloy material of the elastic wires 1041 of the expansion and contraction unit 104 undergoes phase transition. Thus, the radial dimension of the expansion and contraction unit 104 is defined as the above diameter. At this time, even if the movable member 103 is further brought close to the fixed member 102, the radial dimension of the expansion and contraction unit 104 does not change, and the elastic wires 1041 are stacked in the axial direction.

[0041] Alternatively, in manufacturing the expansion and contraction unit 104, the expanded processed expansion and contraction unit 104 is tightly fitted to a shaft having a constant outer diameter, so that the diameter of the expanded expansion and contraction unit 104 is defined as the outer diameter of the shaft. At this time, the expansion and contraction unit 104 is subjected to heat processing, so that the alloy material of the elastic wires 1041 of the expansion and contraction unit 104 undergoes phase transition. Thus, the radial dimension of the expansion and contraction unit 104 is defined as the above diameter. Thereafter, even if the movable member 103 is further brought close to the fixed member 102, the radial dimension of the expansion and contraction unit 104 does not change, and the elastic wires 1041 are stacked in the axial direction.

[0042] The temperature of the heat treatment varies depending on the material of the elastic wire 1041. In the case where the material of the elastic wire 1041 is a nickel-titanium alloy, the temperature of the heat treatment varies depending on the ratio of nickel to titanium. The temperature of the heat treatment is preferably 350°C to 550°C. More preferably, the temperature of the heat treatment is 350°C and 550°C. When the temperature of the heat treatment is 550°C, the elastic wire 1041 is easily subjected to a metal phase change, and is easily shaped. When the temperature of the heat treatment is 350°C, the elastic wire 1041 is safely prevented from being broken, the yield is improved, and the cost is reduced.

[0043] Example 2

[0044] According to Figure 2 An expansion and contraction unit 104 of one embodiment will be described. The expansion and contraction unit 104 is formed in such a manner that an even number of elastic wires 1041 are spirally woven around the guide wire 101, and the spiral directions of each pair of adjacent elastic wires 1041 are opposite to each other. For example, the elastic wire 1041A and the elastic wire 1041B are adjacent to each other, the elastic wire 1041A is spirally wound clockwise around the guide wire 101, and the elastic wire 1041B is spirally wound counterclockwise around the guide wire 101. They cross at point B. The weaving is continued in this manner, so that the expansion and contraction unit 104 is formed in a mesh shape.

[0045] Example 3

[0046] According to Figure 3 An expansion and contraction unit 104 of another embodiment will be described. The expansion and contraction unit 104 is formed in such a manner that a plurality of elastic wires 1041 are spirally woven around the guide wire 101 in the same direction. The elastic wires 1041 can be spirally woven clockwise or counterclockwise.

[0047] Example 4

[0048] According to Figure 4 An expansion and contraction unit 104 of another embodiment will be described. The expansion and contraction unit 104 is formed in such a manner that an even number of elastic wires 1041 are spirally woven around the guide wire 101, and the spiral directions of each pair of adjacent elastic wires 1041 are opposite to each other. For example, the elastic wire 1041C and the elastic wire 1041D are adjacent to each other, the elastic wire 1041C is spirally wound clockwise around the guide wire 101, and the elastic wire 1041D is spirally wound counterclockwise around the guide wire 101. When they cross at point B, the elastic wire 1041C and the elastic wire 1041D are entangled with each other. Then, the elastic wire 1041C is spirally wound counterclockwise around the guide wire 101, and the elastic wire 1041D is spirally wound clockwise around the guide wire 101. The weaving is continued in this manner, so that the expansion and contraction unit 104 is formed in a mesh shape.

[0049] Example 5

[0050] According to Figure 5 , another embodiment of the expansion and contraction unit 104 is described. The expansion and contraction unit 104 is configured such that a plurality of elastic wires 1041 are spirally woven in the same direction around the guide wire 101, each of the elastic wires 1041 branches into two elastic wires 1041 at a position close to the fixed member 102 and the movable member 103, and continues to be spirally woven around the guide wire 101, the spiral directions of each of the two adjacent elastic wires 1041 after branching are opposite. For example, the elastic wire 1041E is spirally woven around the guide wire 101, branches into the elastic wire 1041F and the elastic wire 1041G at a position close to the point E of the fixed member 102. The elastic wire 1041F and the elastic wire 1041G continue to be spirally woven in the manner of Figure 2 . The elastic wire 1041E branches into the elastic wire 1041H and the elastic wire 1041I at a position close to the point F of the movable member 103. The elastic wire 1041H and the elastic wire 1041I continue to be spirally woven in the manner of Figure 2 .

[0051] Example 6

[0052] As shown in Figure 6 , one embodiment of the expansion and contraction unit 104 is configured such that the mesh gradually becomes smaller from the fixed member 102 to the movable member 103.

[0053] Example 7

[0054] As shown in Figure 7 , another embodiment of the expansion and contraction unit 104 is configured such that the mesh gradually becomes smaller from the movable member 103 to the fixed member 102.

[0055] Example 8

[0056] As shown in Figure 8 , another embodiment of the expansion and contraction unit 104 is configured such that the mesh gradually becomes smaller from the middle position to the fixed member 102 and the movable member 103.

[0057] Example 9

[0058] Referring to Figures 9 to 12 , the steps of removing the occlusion in the blood vessel using the device for removing the luminal occlusion according to one embodiment of the present application are described in detail. The luminal occlusion is a thrombus, and the blood vessel is a cerebral artery. The surgeon removes the luminal occlusion by interventional surgery using the device for removing the luminal occlusion according to one embodiment of the present application.

[0059] First, in the state that the catheter 20 receives the treatment member 10, the catheter 20 is made to approach the occlusion position where the thrombus 9 is located along the blood vessel, thereby reaching the proximal position which is closer to the proximal end than the thrombus 9 of the occlusion position.

[0060] As shown in FIG. 10, the treatment member 10 is made to protrude from the catheter 20, at this time, the treatment member 10 is in the state that the expansion and contraction unit 104 is radially minimum. Until the treatment member 10 reaches the occlusion position in the axial direction. Preferably, the treatment member 10 completely passes through the thrombus 9. It can pass from one side of the thrombus 9 or eccentrically, or it can pass from the middle of the thrombus 9. Figure 9

[0061] Then, as shown in FIG. 11, the push and pull member 105 is operated to make the movable member 103 approach the fixed member 102, thereby making the expansion and contraction unit 104 radially expand. The expansion and contraction unit 104 forms a mesh shape, so that the thrombus 9 enters the inside of the expanded expansion and contraction unit 104 via at least a part of the mesh. The more the thrombus 9 enters the expanded expansion and contraction unit 104 via the mesh, the more the thrombus 9 is combined with the expansion and contraction unit 104. At this time, the treatment member 10 is fixed with the thrombus 9. Figure 10 Preferably, as shown in FIG. 12, after the expansion and contraction unit 104 is expanded to a certain size, even if the movable member 103 is made to approach the fixed member 102, the size of the expansion and contraction unit 104 in the radial direction does not change, the elastic wire 1041 is stacked in the axial direction, the mesh is reduced, and the thrombus 9 is prevented from being separated from the treatment member 10.

[0062] Figure 11 Pulling back the treatment member 10, the treatment member 10 moves from the above-mentioned occlusion position to the above-mentioned proximal position, so that the thrombus 9 is separated from the lumen. At this time, as shown in FIG. 13, the push and pull member is operated to make the movable member 103 away from the fixed member 102, thereby reducing the mesh of the expansion and contraction unit 104, and preventing the thrombus 9 from being separated from the treatment member 10.

[0063] Finally, the treatment member 10 is made to enter the catheter 20 in combination with the thrombus 9, thereby recovering the thrombus 9, thereby completing the surgery. Figure 12 Example 10

[0064] The manufacturing method of the lumen occlusion removing device is to heat process the expansion and contraction unit at 350°C while keeping the expansion and contraction unit expanded to a constant diameter.

[0065] Example 11

[0066]

[0067]

[0068] ​​​​The manufacturing method of the device for removing the lumen blockage is to heat the expansion and contraction unit at a temperature of 450°C while keeping the expansion and contraction unit expanded to a constant diameter.

[0069] Example 12

[0070] The manufacturing method of the device for removing the lumen blockage is to heat the expansion and contraction unit at a temperature of 550°C while keeping the expansion and contraction unit expanded to a constant diameter.

[0071] Example 13

[0072] The operation steps of the device for removing the lumen blockage are as follows:

[0073] The approaching step is to make the catheter approach the proximal end position in the lumen, and the approaching step is to make the catheter approach the proximal end position in the lumen, which is closer to the proximal end of the blocked lumen than the position of the blockage, that is, it is easier to remove the blockage.

[0074] The extending step is to make the treatment part extend from the catheter with the expansion and contraction unit in the smallest radial state until the treatment part reaches the blockage position in the axial direction.

[0075] The expansion step is to operate the push-pull part to make the movable part approach the fixed part, so that the expansion and contraction unit expands in the radial direction to form a mesh, and at least part of the lumen blockage enters the interior of the expanded expansion and contraction unit through the mesh, so that the treatment part is fixed with the lumen blockage.

[0076] The pulling back step is to pull back the treatment part to make the lumen blockage separate from the lumen and move from the blockage position to the proximal end position.

[0077] The contraction step is to operate the push-pull part to make the movable part away from the fixed part, so as to reduce the mesh of the expansion and contraction unit and avoid the lumen blockage from the treatment part.

[0078] The recovery step is to make the treatment part and the lumen blockage enter the catheter, so as to recover the lumen blockage. After the expansion and contraction unit is expanded to a constant size, the movable part approaches the fixed part, the size of the radial direction of the expansion and contraction unit does not change, the elastic line is stacked in the axial direction, the mesh is reduced, and the lumen blockage is prevented from separating from the treatment part.

[0079] In the expansion step, the expanded expansion and contraction unit forms a mesh and does not close the lumen, so that the treatment of the lumen blockage does not affect the flow of substances.

[0080] In the expansion step, the lumen blockage enters the interior of the expanded expansion and contraction unit through the mesh by being squeezed in the radial direction, so that the treatment part is fixed with the blockage, and the lumen blockage is prevented from falling off from the expansion and contraction unit after separating from the lumen to form a distal secondary embolism.

[0081] Embodiment 14

[0082] In the interventional surgery for removing the lumen blockage of the cerebral blood vessel, the cerebral blood vessel is curved and has a large diameter variation. By operating the push-pull member, the relative distance between the movable member and the fixed member is adjusted, so that the radial size of the expansion and contraction unit can be accurately adjusted to adapt to the shape and diameter of the blood vessel.

[0083] Embodiment 15

[0084] In the interventional surgery for removing the lumen blockage of the cerebral blood vessel, if the expansion and contraction unit is expanded too much in the radial direction, the excessive radial pressure is transmitted to the blood vessel wall through the lumen blockage, which may damage the blood vessel and cause cerebral hemorrhage. In the contraction step, the mesh of the expansion and contraction unit is reduced, so that the combination between the lumen blockage and the expansion and contraction unit is more closely, and the blockage is prevented from falling off from the expansion and contraction unit to form secondary embolism, without increasing the pressure on the blood vessel.

[0085] Embodiment 16

[0086] In the interventional surgery for removing the lumen blockage of the cerebral blood vessel, if the expansion and contraction unit is expanded too much in the radial direction, the excessive radial pressure is transmitted to the blood vessel wall through the lumen blockage, which may damage the blood vessel and cause cerebral hemorrhage. By keeping the radial size of the expansion and contraction unit unchanged, and accumulating the elastic wires in the axial direction to reduce the mesh, the combination between the expansion and contraction unit and the lumen blockage is enhanced, without increasing the pressure on the blood vessel.

[0087] The above describes the embodiments of the present application in detail. The above description is only as an embodiment, and the scope of the present application is not limited to this embodiment, and should be widely interpreted as the scope that can be mastered by those skilled in the art according to the same technical idea.

[0088] In the above embodiment, the movable member is located at the proximal end and the fixed member is located at the distal end. However, it is not limited to this, and the fixed member can be located at the proximal end and the movable member can be located at the distal end.

[0089] In the above embodiment, the application of the present application in the surgery for removing the cerebral thrombus is described. However, it is not limited to this, and the present application can also be applied to other lumen blockages. The lumen blockage is not only the thrombus, but also other objects such as impurities, foreign matters, etc.

Claims

1. A device for removing a luminal occlusion, comprising a treatment member and a catheter, characterized in that, The treatment component (10) is arranged at one end of the catheter (20) in an extendable and retractable manner, and the treatment component (10) comprises a push-pull component (105), a movable component (103), a guide wire (101), an expansion and contraction unit (104) and a fixed component (102). The proximal end of the push-pull component (105) is connected to the catheter (20) in an extendable and retractable manner, and the distal end is provided with the movable component (103). The movable component (103) is connected to the fixed component (102) in an axially movable manner through the guide wire (101). The guide wire (101) is provided with the expansion and contraction unit (104) around the periphery. The expansion and contraction unit (104) is connected to the movable component (103) and the fixed component (102) at both ends. The expansion and contraction unit (104) is composed of elastic threads. When the expansion and contraction unit (104) expands to a constant size, the movable component (103) is close to the fixed component (102). The radial size of the expansion and contraction unit (104) does not change. The elastic threads are stacked in the axial direction, the mesh is reduced, and the pipe lumen blockage is avoided from being separated from the treatment component (10). By heating the expansion and contraction unit (104) while keeping the expansion and contraction unit (104) expanded to a constant diameter, the radial size of the expansion and contraction unit is limited to the constant diameter. When the heating is performed, the temperature is 350-550 DEG C.

2. The device for removing a lumen blockage according to claim 1, wherein, The expansion and contraction unit (104) is in a mesh structure in the expanded state and is in a tubular structure in the contracted state.

3. The device for removing a lumen blockage of claim 2, wherein, The expansion and contraction unit (104) is composed of an even number of elastic threads, which are spirally woven around the guide wire (101) in opposite directions.

4. The device of claim 2, wherein, The expansion and contraction unit (104) is composed of elastic threads, which are spirally woven around the guide wire (101) in the same direction.

5. The device of claim 3, wherein, The expansion and contraction unit (104) is composed of elastic threads, which are spirally woven in opposite directions after being crossed with adjacent elastic threads.

6. The device of claim 4, wherein, The expansion and contraction unit (104) is composed of elastic threads, which are spirally woven around the guide wire (101) in opposite directions after being crossed with adjacent elastic threads.

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